East Texas Medical Center Gilmer v. Birder Porter

Opinion

ACCEPTED 12-14-00220-CV TWELFTH COURT OF APPEALS TYLER, TEXAS 9/4/2015 3:01:53 PM Pam Estes CLERK

ORAL ARGUMENT REQUESTED

No. 12-14-00220-CV FILED IN 12th COURT OF APPEALS _______________________________________________ TYLER, TEXAS 9/4/2015 3:01:53 PM COURT OF APPEALS PAM ESTES Clerk for the

TWELFTH DISTRICT OF TEXAS

Tyler, Texas _______________________________________________

EAST TEXAS MEDICAL CENTER GILMER Appellant,

v.

BIRDER PORTER Appellee. _______________________________________________

Appeal from Cause No. 697-13 th 115 District Court, Upshur County, Texas Honorable Lauren Parish, Presiding Judge _______________________________________________

APPELLANT’S SUPPLEMENTAL BRIEF ON APPLICATION OF ROSS v. ST. LUKE’S EPISCOPAL HOSPITAL _______________________________________________

Russell G. Thornton THIEBAUD REMINGTON THORNTON BAILEY LLP Two Energy Square 4849 Greenville Avenue, Suite 1150 Dallas, Texas 75206 (214) 954-2200 – Telephone (214) 754-0999 – Telecopier

ATTORNEYS FOR DEFENDANT – APPELLANT EAST TEXAS MEDICAL CENTER GILMER

September 4, 2015 TABLE OF CONTENTS

INDEX OF AUTHORITIES ....................................................................................iv

SUMMARY OF ARGUMENT ................................................................................ 2

ARGUMENT ............................................................................................................6

I. Limited Scope and Application of Ross ............................................... 6 II. Appellee’s Claim Is An HCLC Under Ross ......................................... 7 III. Substantive Nexus to Health Care Exists ...........................................16

CONCLUSION .......................................................................................................21

PRAYER .................................................................................................................24

CERTIFICATE OF COMPLIANCE ......................................................................25

CERTIFICATE OF SERVICE ...............................................................................26

APPENDIX ........................................................................................... INDEX TAB

1. Ross v. St. Luke’s Episcopal Hosp., 462 S.W.3d 496 (Tex. 2015)

2. Loaisiga v. Cerda, 379 S.W.3d 248 (Tex. 2012)

3. Yamada v. Friend, 335 S.W.3d 192 (Tex. 2010)

4. 42 C.F.R., §§482.1 and 482.11

5. 42 C.F.R., §482.21

6. 42 C.F.R., §§482.41 and 482.42

7. 25 TEX. ADMIN. CODE, §133.1

8. 25 TEX. ADMIN. CODE, §133.41

9. 25 TEX. ADMIN. CODE, §133.142

i 10. TEXAS HEALTH & SAFETY CODE, Chapter 241

11. Excerpts from the CMS State Operations Manual, Appendix A, Survey Protocol, Regulations and Interpretive Guidelines for Hospitals. (This is a 510-page document, a complete copy of which is available at – https://www.cms.gov/Regulations-and- Guidance/Guidance/Manuals/downloads/som107ap_a_hospitals.pdf)

12. Centers for Medicare & Medicaid Services, Hospital Infection Control Worksheet (accessed from and available at – https://www.cms.gov/Medicare/Provider-Enrollment-and- Certification/SurveyCertificationGenInfo/Downloads/Survey-and- Cert-Letter-15-12-Attachment-1.pdf)

13. Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee, Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (2008)

14. Sehulster LM, Chinn RYW, Ardino MJ, Carpenter J, et al., Guidelines for Environmental Infection Control in Health-Care Facilities, U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (2003)

15. Occupational Safety & Health Administration, Hospital eTool (accessed from and available at – https://www.osha.gov/SLTC/etools/hospital/)

16. Occupational Safety & Health Administration, Housekeeping, Hospital eTool (accessed from and available at – https://www.osha.gov/SLTC/etools/hospital/housekeeping/housekeepi ng.html)

17. Occupational Safety & Health Administration, Healthcare Wide Hazards Slips, Trips and Falls, Hospital eTool (accessed from and available at – https://www.osha.gov/SLTC/etools/hospital/hazards/slips/slips.html)

ii 18. Joint Commission Standards, Chapter EC.01.01.01; Chapter EC.02.01.01

iii INDEX OF AUTHORITIES

TEXAS SUPREME COURT CASES

Garland Community Hosp. v. Rose, 156 S.W.3d 541 (Tex. 2004) .............................................................................19, 20

Harris Methodist Fort Worth v. Ollie, 342 S.W.3d 525 (Tex. 2011) ...................................................................................16

Loaisiga v. Cerda, 379 S.W.3d 248 (Tex. 2012) .............................................................................16, 19

Ross v. St. Luke’s Episcopal Hosp., 462 S.W.3d 496 (Tex. 2015) ...........................................................6, 7, 8, 16, 19, 22

Texas West Oaks Hospital, L.P. v. Williams, 371 S.W.3d 171 (Tex. 2012) ...................................................................................16

Yamada v. Friend, 335 S.W.3d 192 (Tex. 2010) .............................................................................17, 20

TEXAS COURTS OF APPEALS CASES

Baylor All Saints v. Martin, 340 S.W.3d 529 (Tex. App.—Fort Worth 2011, no pet.) .......................................18

Christus Health Southeast Texas v. Lanham, 2007 Tex. App. LEXIS 1103 (Tex. App.—Beaumont)(Jan. 11, 2007)(no pet.)(mem. op.) ..........................................................................................................................19

Denton Regional Medical Center v. LaCroix, 947 S.W.2d 941 (Tex. App.—Fort Worth 1997, writ dism’d by agr.) ...................18

Hightower v. Baylor University Medical Center, 348 S.W.3d 512 (Tex. App.—Dallas 2011, pet. denied) ........................................18

iv Kraus v. Alamo Nat’l Bank, 586 S.W.2d 202 (Tex. Civ. App.—Waco 1979), aff’d on o.g., 616 S.W.2d 908 (Tex. 1981) ..............................................................................................................18

Methodist Hospital of Dallas v. King, 365 S.W.3d 847 (Tex. App.—Dallas 2012, no pet.) ..............................................18

Sanchez v. Martin, 378 S.W.3d 581 (Tex. App.—Dallas 2012, no pet.) ..............................................18

FEDERAL STATUTORY PROVISIONS

42 C.F.R.., §482.1(a)(1) ............................................................................................9

42 C.F.R.., §482.11(a) ...............................................................................................9

42 C.F.R., §482.21(e)(1) ...........................................................................................9

42 C.F.R., §482.21(e)(3) ...........................................................................................9

42 C.F.R., §482.41(a) ................................................................................................9

42 C.F.R., §482.41(c)(2) ...........................................................................................9

42 C.F.R., § 482.42 .................................................................................................10

TEXAS STATUTORY PROVISIONS

25 TEX. ADMIN. CODE, §133.1(a) ...........................................................................10

25 TEX. ADMIN. CODE, §133.41(g) .........................................................................10

25 TEX. ADMIN. CODE, §133.142 ............................................................................10

TEXAS HEALTH & SAFETY CODE, §241.002 ............................................................10

TEXAS HEALTH & SAFETY CODE, §241.026(a)(3) ...................................................10

v TEXAS HEALTH & SAFETY CODE, §241.026(a)(5) ...................................................10

MISCELLANEOUS MATERIALS

CMS State Operations Manual, Appendix A, Survey Protocol, Regulations and Interpretive Guidelines for Hospitals ................................................................11, 12

Centers for Medicare & Medicaid Services, Hospital Infection Control Worksheet .................................................................................................................................11

Joint Commission Standards, Chapter EC.01.01.01 ...............................................14

Joint Commission Standards, Chapter EC.02.01.01 ...............................................15

Occupational Safety & Health Administration, Healthcare Wide Hazards Slips, Trips and Falls, Hospital eTool ........................................................................13, 14

Occupational Safety & Health Administration, Hospital eTool ............................13

Occupational Safety & Health Administration, Housekeeping, Hospital eTool 13, 14

Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee, Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (2008) .......................................................................................12, 13

Sehulster LM, Chinn RYW, Ardino MJ, Carpenter J, et al., Guidelines for Environmental Infection Control in Health-Care Facilities, U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (2003) ...........................................................................................................................12, 13

vi No. 12-14-00220-CV ___________________________________________________

COURT OF APPEALS

for the

TWELFTH DISTRICT OF TEXAS

Tyler, Texas ___________________________________________________

EAST TEXAS MEDICAL CENTER GILMER Appellant,

v.

BIRDER PORTER Appellee. ___________________________________________________

Appeal from Cause No. 697-13 th 115 Judicial District Court, Upshur County, Texas Honorable Lauren Parish, Presiding Judge ___________________________________________________

TO THE TWELFTH COURT OF APPEALS:

Appellant East Texas Medical Center Gilmer, defendant in Cause No. 697-

13 in the 115th Judicial District Court of Upshur County, Texas, Honorable

Lauren Parish presiding, pursuant to this Court’s August 4, 2015 order,

respectfully submits its Supplemental Brief on Application of Ross v. St. Luke’s

Episcopal Hospital. Appellee is Birder Porter, Plaintiff in the district court.

1 SUMMARY OF ARGUMENT

On August 6, 2015, the Twelfth Court of Appeals ordered Appellant East

Texas Medical Center Gilmer (“ETMCG”) to submit additional briefing “on

whether Birder Porter’s claim is a ‘health care liability claim’ in light of Ross v. St.

Luke’s Episcopal Hosp., No. 13-0439, 2105 WL 2009744 (Tex. May 1, 2015) and

its progeny” within 30 days (emphasis in Order). Pursuant to this order, ETMCG

submits this Supplemental Brief on Application of Ross v. St. Luke’s Episcopal

Hospital.

Based on existing pertinent Texas Supreme Court authority, including Ross

v. St. Luke’s Episcopal Hosp., 462 S.W.3d 496 (Tex. 2015), Appellee’s claim

against ETMCG is a health care liability claim (“HCLC”), as defined in Chapter 74

of the TEXAS CIVIL PRACTICE & REMEDIES CODE (“Chapter 74”).

Review of the Ross opinion shows that it is not controlling here because

there were two situations absent from Ross that are present here. The Texas

Supreme Court was forced to address and evaluate whether Ross’ claims were

health care liability claims (“HCLC”) in Ross because St. Luke’s Episcopal

Hospital did not argue that the incident at hand occurred in an area where patients

might be when receiving medical services, and because St. Luke’s did not argue

that the area where the incident occurred was subject to any particular maintenance

2 or cleanliness standards related to the provision of health care or related to patient

safety.

In contrast to Ross, Appellee admits that this incident occurred in the

ETMCG emergency room and that she was in the emergency room that day

seeking medical services. Thus, in contrast to Ross, it cannot be disputed that the

underlying incident occurred in a location patients could be when receiving

medical services. Also in contrast to Ross, is the fact that the ETMCG emergency

room is subject to a number of cleanliness and maintenance standards that are

related to the provision of health care and related to patient safety. For these

reasons, Ross really does not apply to this appeal.

Appellee’s claim is an HCLC even if this Court applies Ross and evaluates

this matter pursuant to the guidance provided in Ross. Two key points came out of

Ross in connection with evaluating whether or not a claim like this is an HCLC.

One, Ross provided seven non-exclusive factors for courts to consider in

evaluation of whether a claim is an HCLC. Five of these sevens factors are present

here when one applies the legal framework within which hospitals like ETMCG

have to operate and the facts of this case to the seven factors set forth in Ross.

More importantly, however, is the fact that in Ross the Texas Supreme Court

held that when evaluating whether a safety-based claim is an HCLC the “pivotal

issue” is whether or not the standards on which the claim are based implicates a

3 hospital’s duties as a health care provider, as well as the fact that the Texas

Supreme Court did not abrogate its prior decisions regarding the general

considerations courts must apply when evaluating whether a claim is an HCLC.

Specifically, disposition of this appeal is also controlled by the Texas Supreme

Court’s opinions, in Harris Methodist Fort Worth v. Ollie, 432 S.W.3d 525 (Tex.

2011), Texas West Oaks Hospital, L.P. v. Williams, 371 S.W.3d 171 (Tex. 2012),

Loaisiga v. Cerda, 379 S.W.3d 248 (Tex. 2012), Yamada v. Friend, 335 S.W.3d

192 (Tex. 2010), and Garland Community Hosp. v. Rose, 156 S.W.3d 541 (Tex.

2004).

Ollie establishes that a slip-and-fall can be an HCLC. Texas West Oaks

Hospital establishes that that a safety-based HCLC – like this matter – does not

have to be directly related to the provision of health care. Loaisiga and Yamada

establish that an HCLC exists if the underlying facts could support a claim that the

defendant health care provider departed from safety standards related to health

care, even if that specific allegation is not made. Rose establishes that accepted

standards of health care exist if a hospital’s conduct is governed by federal and

state law, as well as regulatory guidelines.

The CODE OF FEDERAL REGULATIONS and the TEXAS ADMINISTRATIVE CODE

place cleanliness and maintenance requirements on hospitals like ETMCG

pertinent to the claim Appellee asserts against ETMCG. In addition, federal

4 guidelines and guidelines from The Joint Commission (an entity that accredits and

certifies hospitals like ETMCG) also place cleanliness and maintenance

requirements on hospitals like ETMCG that are pertinent to Appellee’s claim.

Because these accepted standards that relate to health care could provide the basis

of a claim against ETMCG under the facts alleged, Appellee’s claim against

ETMCG is an HCLC based on existing stare decisis from the Texas Supreme

Court.

As such, even if the Court determines that Ross is controlling or applicable,

Appellee’s claim against ETMCG is an HCLC. It is for these additional reasons

that the decision of the trial court should be reversed and that Appellee’s claims

against ETMCG should be dismissed with prejudice.

5 ARGUMENT

I. LIMITED SCOPE AND APPLICATION OF ROSS:

A careful consideration and reading of Ross reveals two circumstances that

significantly distinguish it from this case and render Ross inapplicable here. In

Ross, the Texas Supreme Court stated it was required to address the question of

whether Ross’s claims against St. Luke’s were HCLCs because of two factors

absent from that matter that are present here. First, St. Luke’s did not claim “that

the area where Ross fell was a patient care area or an area where patients possibly

would be in the course of the hospital’s providing services to them.” Ross,

462 S.W.3d at 503. Second, St. Luke’s did not argue that the area of the hospital

where Ross fell “had to meet particular cleanliness or maintenance standards

related to the provision of health care or patient safety.” Id.

Because there was no claim the incident occurred in an area where patients

might be and because there was no reference to any particular maintenance

standards specifically applicable to St. Luke’s and related to patient safety, the

Texas Supreme Court in Ross was forced to address “the question of whether

Ross’s claims are nevertheless HCLCs, as the hospital would have us hold.” Id. at

503-504. (emphasis added). The situation in Ross is not the situation here.

First, Appellee not only admits that she fell in the ETMCG emergency room,

she admits that she was in the ETMCG emergency room at that time because she

6 was “seeking treatment” (CR 23). Second, as shown below, ETMCG is required

“to meet particular cleanliness or maintenance standards related to the provision of

health care or patient safety” set forth in federal law, Texas law, federal agency

regulations, and requirements of The Joint Commission, an accrediting and

certification agency. For these reasons, Appellee’s claim is an HCLC. The Tyler

Court of Appeals has no need to go further to evaluate under Ross why,

“nevertheless,” Appellee’s claim is an HCLC.

II. Appellee’s Claim Is An HCLC Under Ross:

Even if this matter is evaluated under the guidance provided in Ross, Appellee’s

claim against ETMCG is an HCLC. In Ross, the Texas Supreme Court provided

seven non-exclusive factors to be used by courts in evaluation of whether a claim

was an HCLC. Id. at 505.

In Ross, the Texas Supreme Court also reduced evaluation of whether a safety

standards-based claim is an HCLC down to whether or not there is “a substantive

nexus between the safety standards allegedly violated and the provision of health

care.” Id. at 504. The Texas Supreme Court went on to state “the pivotal issue in a

safety standards-based claim is whether the standards on which the claim is based

implicate the defendant’s duties as a health care provider, including its duties to

provide for patient safety.” Id. at 505.

7 A. Seven Non-Exclusive Factors:

Five of the seven non-exclusive considerations provided in Ross that can be

used to determine whether or not a safety standards claim is an HCLC exist here.

These five factors are whether the alleged negligence (1) occurred in connection

with tasks related to protecting patients from harm, (2) occurred in a location that

patients might be, (3) occurred in connection with seeking or receiving health care,

(4) is based on safety standards arising from professional duties owed by a health

care provider, and (5) occurred in connection with a failure “to take action

necessary to comply with safety-related requirements set for health care providers

by governmental or accrediting agencies.” Id. at 505.

Factors (2) and (3) are present here because Appellee admits her fall

occurred in the ETMCG emergency room and that she was in the emergency room

“seeking treatment” at the time (CR 23). Factors (1), (4), and (5) are present here

because – as shown below – the maintenance of ETMCG’s premises is subject to

requirements set by federal law, Texas law, federal regulations, and accrediting

agency regulations that relate to the provision of health care and patient safety.

1. Federal Law Requirements:

Under federal law, the Centers for Medicare & Medicaid Services (“CMS”)

have promulgated standards that must be met for participating hospitals. See,

8 42 C.F.R., §§482.1(a)(1), 482.11(a)(Appendix 4). Subpart C of this statute

provides specific hospital functions that are conditions for participation.

Pertinent to this case are Sections 482.21, 482.41, and 482.42 of Subpart C.

Section 482.21 requires not only that hospitals have “an ongoing program for

quality improvement and patient safety,” but also that “clear expectations for

safety are established by hospital executives.” 42 C.F.R., §482.21(e)(1), (3)

(Appendix 5, page 2).

Section 482.41 of Title 42 of the CODE OF FEDERAL REGULATIONS

establishes requirements related to the “physical environment” of a hospital. The

first sentence of this regulation requires that hospitals be “maintained to ensure the

safety of the patient…” Within this regulation, it is specifically required that “the

physical plant and overall hospital environment must be developed and maintained

in such a manner that the safety and well-being of patients are assured.” 42 C.F.R.,

§482.41(a)(Appendix 6, page 1). Hospitals must also “be maintained to ensure an

acceptable level of safety and quality.” 42 C.F.R., §482.41(c)(2)(Appendix 6, page

2).

Section 482.42 of the CODE OF FEDERAL REGULATIONS requires an infection

control program also be in place and followed. 42 C.F.R., §482.42 (Appendix 6,

page 2). One cannot dispute that a hospital’s infection control program relates to

both the provision of health care and patient safety. The significance of an

9 infection control program and its relevance to maintenance of the floors at

ETMCG will be shown below.

2. Texas Law Requirements:

Texas law imposes requirements on hospitals in order for them to be

licensed to operate. 25 TEX. ADMIN. CODE, §133.1(a) (Appendix 7); TEXAS

HEALTH & SAFETY CODE, §241.002 (Appendix 10, page 1). Under this set of

laws, Texas hospitals are required to “provide a sanitary environment to avoid

sources and transmission of infections and communicable diseases.” 25 TEX.

ADMIN. CODE, §133.41(g)(Appendix 8, page 21) See also, TEXAS HEALTH &

SAFETY CODE, §241.026(a)(3)(Appendix 10, page 9). Hospitals are also required

to appoint a safety committee and safety officer and to take steps to promote

general safety in the facility. 25 TEX. ADMIN. CODE, §133.142 (Appendix 9).

Texas law also requires that hospitals comply with “federal laws affecting

the health, safety, and rights of hospital patients.” TEXAS HEALTH & SAFETY

CODE, §241.026(a)(5)(Appendix 10, page 9). As such, Texas law requires that

hospitals like ETMCG follow the CODE OF FEDERAL REGULATION provisions

discussed above.

10 3. CMS Surveys and Applicable CDC and OSHA Regulations and Guidelines:

CMS performs unannounced surveys of participating hospitals to determine

if they are in compliance with federal law (Appendix 11, pages 3-4). 1 In

evaluation of whether a facility is properly maintained, as required under C.F.R.,

§482.41, surveyors must “verify that the condition of the hospital is maintained in

a manner to assure the safety and well being of patients (e.g., condition [of]

ceilings, walls, and floors, presence of patient hazards, etc.)” (Appendix 11,

page 7) (emphasis added).

In evaluation of the infection control program required by 42 C.F.R.,

§482.42, hospital surveyors must determine if the hospital “[m]aintains a sanitary

environment” and if the hospital has and follows an infection control program

(Appendix 11, pages 10-11, 14). Facility housekeeping and maintenance must be

included in and monitored as part of a proper infection control program (Appendix

11, page 17). CMS provides surveyors a worksheet to track a hospital’s infection

control compliance (Appendix 12). The CMS infection control worksheet requires

surveyors to specifically evaluate and assess a hospital’s housekeeping services

like cleaning floors in patient care areas (Appendix 12, page 16). Under

1 See, 2015 CMS State Operations Manual, Appendix A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals (Appendix 11)(excerpts only are provided of this 510-page document in Appendix 11)(a complete copy of this document is available at - https://www.cms.gov/Regulations-and- Guidance/Guidance/Manuals/downloads/som107ap_a_hospitals.pdf).

11 Rule 201(b)(2) of the TEXAS RULES OF EVIDENCE, ETMCG requests the Court take

judicial notice of these regulatory compliance materials.

When evaluating a facility’s infection control program, surveyors are

instructed that such a program should be conducted in accordance with nationally

recognized practices and guidelines, such as practices and guidelines promulgated

by the Centers for Disease Control and Prevention (“CDC”) and the U.S.

Occupational Health and Safety Administration (“OHSA”) (Appendix 11,

pages 13, 17). Surveyors are also informed that hospital emergency departments

provide special challenges in infection control (Appendix 11, page 18). ETMCG

requests that under Rule 201(b)(2), the Court take judicial notice of the fact that the

Centers for Disease Control and the Centers for Medicare & Medicaid Services are

agencies within the United States Department of Health & Human Services.2

ETMCG also requests that judicial notice be taken of the fact that OSHA is an

agency of the United States Department of Labor. 3

The CDC has promulgated two sets of guidelines that apply to infection

control in hospitals like ETMCG. These are (1) the Guideline for Disinfection and

Sterilization in Healthcare Facilities 2008 (Appendix 13) and (2) the Guidelines for

Environmental Infection Control in Health-Care Facilities, published in 2003

(Appendix 14).

2 See, HHS Organizational Chart (available at – http://www.hhs.gov/about/agencies/orgchart/index.html). 3 See, Department of Labor agencies (available at – http://www.dol.gov/dol/organization.htm)

12 The CDC Guidelines recognize that hospital floors are a source of

microorganism and blood-borne pathogen contamination (Appendix 13, page 23,

29). Significantly, the Guidelines also recognize that removal of these pathogens

“is a component in controlling health-care-associated infections” (Appendix 13,

page 29). Both Guidelines address cleaning hospital floors in order to prevent

them from serving as a source of health-care associated infections (Appendix 13,

pages 11, 12, 23, 30; Appendix 14, pages 74-75). The CDC also cautions that

improper mopping procedure in a hospital “actually can spread heavy microbial

contamination throughout the health-care facility” (Appendix 13, page 12).

Based on these underlying facts and concerns, the CDC Guidelines provide

floor care recommendations “to reduce rates of health-care-associated

infections…” (See, Appendix 13, page 83). These recommendations address

(1) when hospital floors should be cleaned, (2) the specific types of solutions to be

used, (3) how frequently the floor mopping solution should be changed, and (4) the

decontamination of mops (Appendix 13, pages 84-85; Appendix 14, pages 133-

135).

A summary of OSHA guidelines applicable to health care facilities like

ETMCG is available on line through its “Hospital eTool” (Appendix 15). Specific

items addressed by OSHA through its Hospital eTool include “Housekeeping”

(Appendix 16) and “Slips, Trips and Falls” (Appendix 17). Similar to the CDC

13 guidelines, the OSHA guidelines require hospitals maintain a sanitary environment

and they provide recommendations about when floors should be cleaned and how

they should be cleaned (Appendix 16, 17). Based on these materials, one cannot

dispute that floor care at a hospital like ETMCG is related to the provision of

health care and patient safety; specifically it is related to infection control.

ETMCG requests that under Rule 201(b)(2) of the TEXAS RULES OF

EVIDENCE, the Court take judicial notice of these applicable CDC and OSHA

guidelines.

4. Joint Commission Regulations and Guidelines:

The Joint Commission also places safety-based requirements on hospitals

related to health care and patient safety. ETMCG requests that under

Rule 201(b)(2) of the TEXAS RULES OF EVIDENCE, the Court take judicial notice of

the fact that The Joint Commission is a nationwide accrediting and certification

agency. 4

Under Joint Commission standards, hospitals are evaluated in regard to

management of “[t]he environmental safety of patients and everyone else who

enters the hospital’s facilities,” as well as “[t]he security of everyone who enters

the hospital’s facilities.” Joint Commission Standard, Chapter EC.01.01.01,

Elements of Performance 3 and 4)(Appendix 18, page 1). The Joint Commission

4 See, http://www.jointcommission.org/about_us/about_the_joint_commission_main.aspx.

14 also evaluates whether a hospital “identifies safety and security risks associated

with the environment of care that could affect patients, staff and other people

coming to the hospital’s facilities,” whether a hospital “takes action to minimize or

eliminate identified safety and security risks in the physical environment,” and

whether a hospital “maintains all grounds…” Joint Commission Standard,

Chapter EC.02.01.01, Elements of Performance 1, 3 and 5 (Appendix 18, page 3).

5. Conclusion:

After consideration and review of the laws, regulations, agency guidelines and

accreditation guidelines applicable to ETMCG in maintaining its facilities in

general and its floors specifically, one cannot question that ETMCG was required

to meet particular cleanliness and maintenance standards related to the provision of

health care and patient safety in its emergency room where Appellee fell. When

the existence of these applicable laws, regulations and guidelines is combined with

the fact that Appellee fell in an area where patients could be receiving treatment at

ETMCG and with the fact that Appellee was in the ETMCG emergency room that

day seeking treatment; it is clear Appellee’s claim against ETMCG is an HCLC

under the seven non-exclusive factors provided by the Texas Supreme Court in

Ross.

15 III. Substantive Nexus to Health Care Exists:

When the Texas Supreme Court in Ross cited to its earlier opinion in Harris

Methodist Fort Worth v. Ollie, 342 S.W.3d 525 (Tex. 2011) – a slip-and-fall case –

without abrogating that opinion, the Court recognized and affirmed that a slip-and-

fall at a hospital like ETMCG can still be an HCLC. Ross, 462 S.W.3d at 502. See

also, Ollie, 342 S.W.3d at 527. In Ross, the Texas Supreme Court also expressly

recognized its holding in Texas West Oaks Hospital, L.P. v. Williams, 371 S.W.3d

171 (Tex. 2012) that a safety-based HCLC did not need “to be directly related to

the provision of health care” and that this part of its holding in Texas West Oaks

Hospital is still good law “entitled to stare decisis treatment.” Ross, 462 S.W.3d

at 502. See also, Texas West Oaks Hosp., 371 S.W.3d at 186.

In Ross, the Texas Supreme Court also recognized and reiterated its holding

in Loaisiga v. Cerda, 379 S.W.3d 248 (Tex. 2012), when it stated that “if the facts

underlying a claim could support claims against a physician or health care provider

for departures from accepted standards of medical care, health care, or safety or

professional or administrative services directly related to health care, the claims are

HCLCs regardless of whether plaintiff alleged the defendants were liable for

breach of the standards.” Ross, 462 S.W.3d at 503 (emphasis in original)(citing

Loaisiga v. Cerda, 379 S.W.3d 248, 255 (Tex. 2012)).

16 Finally, in Ross the court did not abrogate or modify its earlier opinion in

Yamada v. Friend, 335 S.W.3d 192 (Tex. 2010). This is significant in the

evaluating and deciding this appeal because the Texas Supreme Court in Yamada

held that “claim-splitting” was not allowed by claimants in an effort to circumvent

application of Chapter 74 of the TEXAS CIVIL PRACTICE & REMEDIES CODE. In

particular, in Yamada the Texas Supreme Court held that in circumstances where

there is one set of operative facts, a claimant cannot elect to pursue a claim not

covered by Chapter 74 if that claim also falls within the ambit of Chapter 74.

Specifically, the Texas Supreme Court stated in Yamada:

When the underlying facts are encompassed by provisions of the TMLA [Chapter 74] in regard to a defendant, then all claims against that defendant based on those facts must be brought as health care liability claims. Application of the TMLA cannot be avoided by artfully pleading around it or splitting claims into both health care liability claims and other types of claims such as ordinary negligence claims.

Id. at 193-94.

These holdings and rulings by the Texas Supreme Court are significant in

the evaluation and resolution of this appeal because ETMCG has shown above that

federal and state law, as well as federal and Joint Commission regulations, apply to

the maintenance of its floors and that these requirements relate to the provision of

health care and patient safety because they involve infection control. As such,

based on the underlying facts of this case and these applicable laws and

regulations, Appellee could have elected to pursue an HCLC against ETMCG

17 based on its alleged failure to comply with these laws and regulations. For that

reason, based on the above Texas Supreme Court authority, Appellee’s claim

against ETMCG is an HCLC.

Support for ETMCG’s position on this point also comes from two additional

facts established by Texas case law. First, under Texas law the statutes and

regulations that apply to ETMCG in maintenance of its floors and premises

provide evidence of the standard of care applicable to ETMCG. See, Denton

Regional Medical Center v. LaCroix, 947 S.W.2d 941, 951 n.7 (Tex. App.—Fort

Worth 1997, writ dism’d by agr.)(Joint Commission guidelines can be viewed as

providing evidence of a hospital’s standard of care). See also, Kraus v. Alamo

Nat’l Bank, 586 S.W.2d 202, 208 (Tex. Civ. App.—Waco 1979), aff’d on o.g., 616

S.W.2d 908 (Tex. 1981)(similar holding regarding OSHA regulations).

Second, and even more significant, is the fact that CMS, CDC and Joint

Commission guidelines and regulations have been cited and utilized by claimants

to establish the standard of applicable to hospitals and breaches of that standard of

care in Chapter 74 expert reports. See, Sanchez v. Martin, 378 S.W.3d 581, 593

(Tex. App.—Dallas 2012, no pet.)(use of CDC guidelines); Methodist Hospital of

Dallas v. King, 365 S.W.3d 847, 851 (Tex. App.—Dallas 2012, no pet.)(use of

CMS and Joint Commission requirements); Hightower v. Baylor University

Medical Center, 348 S.W.3d 512, 517, 518 (Tex. App.—Dallas 2011, pet.

18 denied)(use of CDC guidelines); Baylor All Saints v. Martin, 340 S.W.3d 529, 533-

34 (Tex. App.—Fort Worth 2011, no pet.); Christus Health Southeast Texas v.

Lanham, 2007 Tex. App. LEXIS 1103 *4 (Tex. App.—Beaumont)(Jan. 11,

2007)(no pet.)(mem. op.)(use of Joint Commission standards).

Finally, in 2004 the Texas Supreme Court held that accepted standards of

health care exist and are at issue when a hospital’s conduct is governed by a

combination of existing federal law, state law and Joint Commission regulations.

See, Garland Community Hosp. v. Rose, 156 S.W.3d 541, 546 (Tex.

2004)(existence of applicable federal and state law, as well as Joint Commission

guidelines make a negligent credentialing claim against a hospital an HCLC

because “accepted standards of…health care” are involved). As shown above,

ETMCG’s actions at issue here are governed by applicable federal and state law

and Joint Commission guidelines. For this reason, ETMCG’s conduct here

involves accepted standards of health care.

Not only does this authority bolster ETMCG’s position that Appellee alleges

an HCLC against it under Ross, this authority establishes without question that

under the facts of this case Appellee could have asserted an HCLC against

ETMCG based on violation of these accepted standards of health care and safety

directly related to its duties as a hospital. In light of the Texas Supreme Court’s

holdings and rulings in Ross, Loaisiga, Yamada, and Rose, there can be no doubt

19 that Appellee’s claim against ETMCG is an HCLC. See, Ross, 462 S.W.3d at 502-

203; Loaisga, 379 S.W.3d at 255 (claim is an HCLC if the underlying facts could

support a claim of departure from accepted standards of safety); Yamada, 335

S.W.3d at 193 (one set of facts cannot give rise to both an HCLC and an ordinary

negligence claim); Rose, 156 S.W.3d at 546 (network of applicable federal and

state law and Joint Commission regulations create applicable existing standards of

health care). For these reasons, Appellee’s claim against ETMCG is an HCLC.

20 CONCLUSION

In its recent decision in Ross, the Texas Supreme Court provided trial courts

and courts of appeals guidance to assist in the evaluation of whether a safety-based

claim against a hospital like ETMCG is an HCLC under Chapter 74. In Ross, the

Texas Supreme Court provided seven non-exclusive factors for courts to use in

determining whether such a claim is an HCLC. Five of the Texas Supreme Court’s

seven non-exclusive factors are present here when one considers the underlying

circumstances and facts. As such, Appellee’s claim against ETMCG is an HCLC.

The fact of the matter is, however, that Ross is really not applicable to this

matter because the very reasons the Texas Supreme Court had to evaluate Ross and

come up with the above-referenced seven non-exclusive factors to determine if the

claims there were HCLCs are not present here. Specifically, in Ross there was no

claim that the incident occurred in an area where patients might be receiving

treatment and there was no claim that certain cleanliness and maintenance

standards were applicable to location of the incident that arose out of the defendant

hospital’s duties as a health care provider. That is not the situation here.

First, Appellee admits her fall occurred in the ETMCG emergency room.

One cannot question that the emergency room at ETMCG is a location where

patients might be receiving treatment at ETMCG. Second, ETMCG has shown

that there are a number of cleanliness and maintenance standards applicable to its

21 premises that relate to the provision of health care and patient safety. These

standards involve infection control and come from federal law, Texas law, federal

regulatory agency regulations and guidelines, and accrediting entity guidelines.

Finally, unlike in Ross, Appellee was in the ETMCG emergency room at the time

of this incident “seeking” medical care. She was not at the hospital as a visitor.

Most important, however, is the fact that the Texas Supreme Court in Ross

did not abrogate or modify its prior opinions in Texas West Oaks Hospital,

Loaisiga, Ollie, Yamada, and Rose. In fact, the Texas Supreme Court directly

stated that its holding in Texas West Oaks that safety-related HCLCs did not need

to be directly related to the provision health care was still good law and entitled to

stare decisis, and reiterated its holding in Loaisiga that if the facts underlying a

claim could support a claim that a physician or health care providers departed from

accepted standards of safety, the claim was an HCLC regardless of whether or not

plaintiff specifically alleged liability based on a breach of those standards. Ross,

462 S.W.3d at 502, 503-504. These actions are important not only because

Appellee’s claim can be an HCLC even though it is not directly related to the

provision of health care, but more significantly because the touchstone issue in

determining whether or not Appellee’s claim is an HCLC remains whether, based

on the underlying facts, a claim could be made that ETMCG departed from

accepted standards of safety.

22 ETMCG has established through existing case law the fact that Appellee

could have elected to proceed with an HCLC against ETMCG. Appellee could

have asserted an HCLC against ETMCG based on its failure to comply with

applicable federal and state law, as well as federal agency regulations and

guidelines and accrediting organization guidelines. Existing Texas case law shows

us that these laws, regulations and standards have previously been used to establish

the standard of care applicable to a hospital like ETMCG in similar situations and

that existence of these laws and guidelines create accepted standards of health care

applicable to hospitals like ETMCG. Since Appellee could have maintained an

HCLC against ETMCG based on this applicable federal law, state law, and

regulatory guidelines, one cannot dispute and must conclude based on existing

Texas Supreme Court authority that Appellee’s claim against ETMCG is an HCLC

under Chapter 74 of the TEXAS CIVIL PRACTICE & REMEDIES CODE.

For these reasons the trial court erred in denying ETMCG’s Chapter 74

motion to dismiss. Accordingly, the Twelfth Court of Appeals should reverse the

trial court’s denial of ETMCG’s motion to dismiss and should dismiss Appellee’s

claims against ETMCG with prejudice.

23 PRAYER

Because the trial court erred in denying Appellant East Texas Medical Center

Gilmer’s Motion to Dismiss, Appellant requests that this Twelfth District Court of

Appeals:

1. Reverse the trial court’s denial of East Texas Medical Center Gilmer’s Motion to Dismiss (CR 36, Appendix “A”);

2. Dismiss with prejudice Appellee’s claim against East Texas Medical Center Gilmer, and:

3. Remand this matter to the trial court for further proceedings consistent with the above actions.

Respectfully Submitted,

THIEBAUD REMINGTON THORNTON BAILEY, LLP

By:/s/Russell G. Thornton RUSSELL G. THORNTON State Bar Card No. 19982850 4849 Greenville Avenue Suite 1150 Dallas, Texas 75206 (214) 954-2200 (214) 754-0999 (Fax) rthornton@trtblaw.com

24 CERTIFICATE OF COMPLIANCE

Pursuant to TEXAS RULES OF APPELLATE PROCEDURE 9.4(i)(3) Appellant

certifies that its Supplemental Brief on Application of Ross v. St. Luke’s Episcopal

Hospital, filed on September 4, 2015, in the Twelfth Court of Appeals, contains

4,793 words.

/s/Russell G. Thornton RUSSELL G. THORNTON

25 CERTIFICATE OF SERVICE

The undersigned certifies that on the 4th day of September, 2015, a true and

correct copy of the foregoing document was delivered to counsel listed below:

VIA E-SERVE &/OR CMRRR: Mr. Michael Bernoudy THE BERNOUDY LAW FIRM 2400 W. Grand Avenue Marshall, Texas 75670 mlbjr@bernoudylawfirm.com

/s/Russell G. Thornton RUSSELL G. THORNTON

26 APPEND IX - ''1 '' Page 1

LexisNexis® 1 of1098 DOCUMENTS

LEZLEA ROSS, PETITIONER, v. ST. LUKE'S EPISCOPAL HOSPITAL, RE- SPONDENT

NO. 13-0439

SUPREME COURT OF TEXAS

462 S. W.3d 496; 2015 Tex. LEX1S 361; 58 Tex. Sup. J. 766; 58 Tex. Sup. J. 802

November 5, 2014, Argued May 1, 2015, Opinion Delivered

PRIOR HISTORY: [**1] ON PETITION FOR ory after she slipped and fell near the lobby exit doors. REVIEW FROM THE COURT OF APPEALS FOR The issue is whether her suit is a health care liability THE FOURTEENTH DISTRICT OF TEXAS. claim under the Texas Medical Liability Act. See TEX. Ross v. St. Luke's Episcopal Hosp., 459 S. W.3d 617, [**2] CIV. PRAC. & REM. CODE ch. 74. The trial court 2013 Tex. App. LEXIS 2796 (Tex. App. Houston 14th and court of appeals concluded that it is. We hold that it Dist., Mar. 19, 2013) is not, because the record does not demonstrate a rela- tionship between the safety standards she alleged the hospital breached--standards for maintaining the floor COUNSEL: For The Texas Trial Lawyers Association inside the lobby exit doors--and the provision of health (TTLA), Amicus Curiae: Michael G. Guajardo, Guajardo care, other than the location of the occurrence and the & Marks, LLP, Dallas TX; Peter M. Kelly, Kelly, hospital's status as a health care provider. Durham & Pittard, L.L.P., Houston TX. We reverse and remand to the trial court for further proceedings. For Ross, Lezlea, Petitioner: Harold Kenneth 'Ken' Tummel, Tummel & Casso, Edinburg TX; Sean Michael [*499] I. Background Reagan, Leyh Payne & Mallia PLLC, Houston TX. Lezlea Ross accompanied a friend who was visiting For St. Luke's Episcopal Hospital, Respondent: Charles a patient in St. Luke's Episcopal Hospital. Ross was Creighton Carr II, Manning, Gosda & Arredondo, L.L.P ., leaving the hospital through the lobby when, as she ap- Houston TX; Elizabeth Dale Burrus, Kroger I Burrus, proached the exit doors, she slipped and fell in an area Houston TX; Gregory Alan Schlak, Manning, Gosda & where the floor was being cleaned and buffed She sued Arredondo, L.L.P., Houston TX; Lauren Nelson, Kroger! St. Luke's and Aramark Management Services, a com- Burrus, Houston TX; Marsha A. Bradley, Kroger I Bur- pany that contracted with the hospital to perform rus, Houston TX. maintenance services, on a premises liability theory. Aramark is not a party to this appeal. JUDGES: JUSTICE JOHNSON delivered the opinion After Ross filed suit we decided Texas West Oaks of the Court. JUSTICE LEHRMANN filed a concurring opinion, in which JUSTICE DEVINE joined. JUSTICE Hospital, L.P. v. Williams, 371 S.W3d 171 (Tex. 2012). There we held, in part, that when a safety stand- BROWN did not participate in the decision. ards-based claim is made against a health care provider, the Texas Medical Liability Act (TMLA), TEX. CIV. OPINION BY: Phil Johnson PRAC. & REM. CODE ch. 74, does not require the safety [**3] standards to be directly related to the provision of OPINION health care in order for the claim to be a health care lia- [*498] In this case a visitor to St. Luke's Episco- bility claim (HCLC). Williams, 371 S. W3d at 186. Re- pal Hospital sued the hospital on a premises liability the- lying on Williams, the hospital asserted that Ross's claim Page 2 462 S.W.3d 496, *; 2015 Tex. LEXIS 361, **; 58 Tex. Sup. J. 766; 58 Tex. Sup. J. 802

was an HCLC and moved for dismissal of her suit be- Ross asserts that this Comt has jurisdiction because cause she failed to serve an expert report. See TEX. C!v. the court of appeals 1 opinion in this case conflicts with PRAC. &REM. CODE§ 74.351(a), (b) (requiring dismissal Good Shepherd Medical Center-Linden, Inc. v. Twilley, of an HCLC if a claimant fails to timely serve an expert 422 S.W.3d 782 (Tex. App.--Texarkana 2013, pet. de- report); Williams, 371 S. W.3d at 186. nied). In that case, Bobby Twilley, the director of plant operations for a medical center, asserted premises liabil- The trial court granted the motion to dismiss. The ity claims against his employer after he fell from a ladder court of appeals affim1ed. Ross v. St. Luke's Episcopal and also tripped over a mound of hardened cement. Id. at Hasp., 459 S.W.3d 617, 2013 Tex. App. LEXIS 2796 783. The medical center moved for dismissal under the (Tex. App.--Houston [14th Dist.] 2013). The appeals TMLA because Twilley failed to file an expert report. I d. court concluded that under Williams it is not necessary at 783-84. The trial court denied the motion and the for any connection to exist between health care and the medical center appealed, arguing that even though safety standard on which a claim is based in order for the Twilley's claims were unrelated to the provision of health claim to come within the TMLA. Id. at , 2013 Tex. care, under Williams they still fell within the ambit of the App. LEXIS 2796. TMLA. The court of appeals interpreted Williams as Ross asserts that the lower courts erred because holding that a safety standards-based claim need not be claims based on departures from "accepted standards of directly related to the provision of health care to be an safety" do not come within the provisions of the TMLA HCLC. Id. at 789. The court stated, however, that it did unless there is at least some connection between the not understand Williams to hold that a safety standards standards underlying the allegedly negligent actions and claim falls under the TMLA when the claim is com- the provision of health care, even if they are not directly pletely untethered from health care. I d. The appeals court related. She then argues that her claims are not HCLCs concluded that at least an indirect relationship between because the hospital's alleged negligence is completely the claim and health care is required and, because unrelated to the provision of health care. Twilley's [**6] claims did not have such a relationship, an expert report was not required. I d. at 785. The hospital [**4] responds with three arguments. It first urges that we lack jurisdiction. See TEX. Gov'T In this case the court of appeals held that under Wil- CODE§ 22.001(a)(2), (3), (6). It next asserts that even if liams u a connection between the act or omission and we have jurisdiction, Ross waived the issue of whether health care is urmecessary for purposes of determining her claim is an HCLC because she failed to properly whether Ross brings an HCLC." Ross, S. W.3d at brief and urge it in the court of appeals. Third, the hospi- , 2013 Tex. App. LEXIS 2796. The hospital asserts that tal addresses the merits by asserting that the court of ap- the decision of the court of appeals and Twilley do not peals correctly held that a safety standards-based claim conflict. But, for purposes of our jurisdiction, one court need not be related to health care to fall within the holds differently from another when there is incon- TMLNs provisions, but in any event Ross 1s claims are sistency in their decisions that should be clarified to re- related to accepted standards of patient safety because move unnecessary uncertainty in the law. TEX Gov'T she fell inside the hospital. CODE§ 22.001 (e). As other courts of appeals have noted, Ross and Twilley are inconsistent in their interpretations We first address our jurisdiction. See Rusk State of Williams and the TMLA, leaving uncertainty in the Hasp. v. Black, 392 S. W.3d 88, 95 (Tex. 2012) (noting law regarding whether a safety standards-based claim that if a court does not have jurisdiction, its opinion ad- must be related to health care. See, e.g., Weatheiford dressing any issues other than its jurisdiction is adviso- Tex. Hasp. Co. v. Smart, 423 S. W.3d 462, 467-68 (Tex. ry). App.--Fort Worth 2014, pet. filed); DHS Mgmt. Servs., Inc. v. Castro, 435 S.W.3d 919, 922 & n.3 (Tex. II, Jurisdiction App.--Dallas 2014, no pet). That being so, we have ju- Texas Civil Practice and Remedies Code § risdiction and move to the hospital's waiver claim, 51.014(a)(10) permits an appeal from an interlocutory order granting relief sought by a motion to dismiss an III. Waiver HCLC for failure to file an expert report. Generally, the The hospital argues that Ross waived any challenge court of appeals' judgment is final on interlocutory ap- to her claim being classified as an HCLC by failing to peals. See TEX. Gov'T CODE § 22.225(b)(3). However, argue the point or cite relevant authority in tl1e court of we have jurisdiction if the justices of the court of appeals appeals. We disagree. disagree on a question of law material to the decision, or if a court of appeals holds differently from a prior [**5] A brief in the court of appeals "must contain a clear decision [*500] of another court of appeals or this and concise argument for the contentions made, [**7] Court. 1d. § 22.225(c). with appropriate citations to authorities and to the rec- Page 3 462 S.W.3d496, *; 2015 Tex. LEXIS 361, **; 58 Tex. Sup. J. 766; 58 Tex. Sup, J, 802

ord." TEX R. APP. P. 38.1(1). Failure to provide citations the claimant's claim or cause of action or argument and analysis as to an appellate issue may sounds in tort or contract. waive it. See ERJ Consulting Eng'rs, Inc. v. Swinnea, 318 S.W.3d 867, 880 (Tex. 2010). TEX C!V. PRAC. & REM. CODE § 74.00l(a)(l3). This In her court of appeals brief, Ross discussed the Court construed 11 Safety" under the prior statute accord- purpose of the TMLA and asserted that classifying her ing to its common meaning as nthe condition of being claim as an HCLC would conflict with the Government 'untouched by danger; not exposed to danger; secure Code. See TEX Gov'TCODE § 311.021(3) (providing that [**9] from danger, harm or loss.ur Diversicare Gen. when a statute is enacted, there is a presumption that "a Partner, Inc. v. Rubio, 185 S. W.3d 842, 855 (Tex. 2005) just and reasonable result is intended"). The court of ap- (quoting BLACK'S LAW DICTIONARY 1336 (6th ed. peals implicitly determined that Ross's citations and ar- 1990)). We also recognized that the Legislature's inclu- gument were enough to avoid waiver because it ad- sion of the word "safety" in the statute expanded the dressed the issue. See Republic Undenvriters Ins. Co. v. statute's scope beyond what it would be if the statute Mex-Tex, Inc., 150 S.W.3d 423, 427 [*501] (Tex. only included the terms medical care and health care. Id. 2004) (concluding that an argument in the court of ap- The Court explained its disagreement with the position peals was not waived and noting that "we have instructed of Chief Justice Jefferson who, in a concurring opinion, the courts of appeals to construe the Rules of Appellate argued that some of the patient's claims arising from an Procedure reasonably, yet liberally, so that the right to assault by another patient were premises liability claims: appeal is not lost by imposing requirements not abso- Rubio is not complaining about an un- lutely necessary to effect the purpose of a rule" (quoting locked window that gave an intruder ac- Verburg/ v. Dorner, 959 S.W.2d 615, 616-17 (Tex. cess to the facility or a rickety staircase 1997))). We agree with the court of appeals that Ross did that gave way under her weight. All of her not waive the issue. claims arise from acts or omissions that are inseparable from the provision of IV. Health Care Liability Claims health care. We do not distinguish Rubio's The merits of the appeal require us to review the health care claims from premises liability lower courts' construction of the TMLA. Under such claims "simply because the landowner is a circumstances our review is de novo, Williams, 3 71 health care provider" but because the gra- S. W.3d at 177, and our goal [**8] is to give effect to vamen of Rubio's complaint is the alleged legislative intent. Certified EMS, Inc. v. Potts, 392 failure of Diversicare to implement ade- S. W.3d 625, 631 (Tex. 2013). In determining that intent quate policies to care for, supervise, and we look first and foremost to the language of the statute. protect its residents who require special, City of Rockwall v. Hughes, 246 S.W.3d 621, 625 (Tex. medical care. 2008). We construe a statute's words according to their plain and common meaning unless they are statutorily defined otherwise,. a different meaning is apparent from Id. at854. the context, or unless such a construction leads to absurd The Legislature added the phrase "or professional or or nonsensical results. See Tex. Lottery Comm 'n v. First administrative services directly [**10] related to health State Bank of DeQueen, 325 S. W.3d 628, 635 (Tex. care" to the definition [*502] of health care liability 2010). Determining legislative intent requires that we claim in 2003. Compare Act of May 30, 1977, 65th Leg., consider the statute as a whole, reading all its language in R.S., ch. 817, § 1.03(a)(4), 1977 Tex. Gen. Laws 2039, context, and not reading individual provisions in isola- 2041, repealed by Act of June 2, 2003, 78th Leg., ch. tion. See Union Carbide Corp. v. Synatzske, 438 S. W.3d 204, § 10.09, 2003 Tex. Gen. Laws 847, 884 (absence of 39, 51 (Tex. 2014). language), with TEX CIV. PRAC. & REM. CODE § The TMLA defines a health care liability claim as: 74.00l(a)(l3) (language added). After that statutory amendment we addressed the "safety" part of the defini- a cause of action against a health care tion in Omaha Healthcare Ctr., L.L.C. v. Johnson, 344 provider or physician for treatment, lack S. W.3d 392 (Tex. 2011), and Harris Methodist Fort of treatment, or other claimed departure Worth v. Ollie, 342 S. W.3d 525 (Tex. 2011). Although from accepted standards of medical care, the claims in both cases alleged general negligence, they or health care, or safety or professional or were HCLCs because the underlying nature of the claims administrative services directly related to involved violations of safety standards directly related to health care, which proximately results in the provision of health care, including protecting pa- injmy to or death of a claimant, whether tients. Johnson, 344 S. W.3d at 394-95 (nursing home Page 4 462 S.W.3d 496, *; 2015 Tex. LEXIS 361, **; 58 Tex. Sup. J. 766; 58 Tex. Sup. J. 802

patient's death caused by a brown recluse spider); Ollie, medical care, treatment, or confinement" TEX. C!V. PRAC. 342 S. W.3d at 527 (post-operative patient's slip and fall & REM. CODE§ 74.001 (a)(10)), and that if the facts un- on a wet bathroom floor). But given that the claims were derlying a claim could support claims against a physician based on injuries to patients and were directly related to or health care provider for departures from accepted the provision of health care, we did not address the issue standards of medical care, health care, or safety or pro- of whether safety standard-based claims must be directly fessional or administrative services directly related to related to health care in order for them to be HCLCs. health care, the claims [**13] were HCLCs regardless Johnson, 344 S. W.3d at 394 n.2; Ollie, 342 S. W.3d at of whether the plaintiff alleged the defendants were lia- 527 n.2. ble for breach of the standards. See Loaisiga, 379 S. W.3d at 255. But that being so, we further explained: The next year we considered whether a psychiatric technician's claims for injuries in an altercation with a we fail to see how the Legislature patient were HCLCs. Williams, 371 S.W.3d at 181. In could have intended the requirement of an reaching our decision [**II] we specifically and sepa- expert report to apply under circumstanc- rately analyzed both whether the claims were based on es where the conduct of which a plaintiff the health care provider's allegedly departing from complains is wholly and conclusively in- standards for health care, and whether they were also consistent with, and thus separable from, based on its allegedly departing from standards for safe- the rendition of 11 medical care, or health ty. Id. at 180-86. Regarding the safety standards issue, care, or safety or professional or adminis~ we reviewed the definition of HCLC and determined that trative services directly related to health the phrase "directly related to health care" modified the care" even though the conduct occurred in terms immediately before it--professional or administra- a health care context. See TEX. C!V. PRAC. tive services--but not the word safety. Id. at 185. We said & REM. CODE§ 74.001(a)(J3); see also that "Williams'[s] claims are indeed for departures from TEX. Gov'T CODE § 311.021 ("In enacting accepted standards of safety. We conclude that the safety a statute, it is presumed that ... a just and component of HCLCs need not be directly related to the reasonable result is intended .... "). provision of health care and that Williams'[s] claims against West Oaks implicate this prong of HCLCs." Id. at 186. Because we also concluded that Williams's Id. at 257. Our reasoning led to the conclusion that a claims were HCLCs because they were for departures patient's claim against a medical provider for assault from health care standards, our decision that his claims during a medical examination is not an HCLC if the only were HCLCs rested on alternative holdings that are both possible relationship between the alleged improper con- entitled to stare decisis treatment: the claims were for duct and the rendition of medical services or health care departures from health care standards and they were for was the setting in which the conduct took place. !d. departures from safety standards. Id.; see State Farm Mut. Auto. Ins. Co. v. Lopez, 156 S. W.3d 550, 554 (Tex. In this case, the hospital advances two positions in 2004) (distinguishing alternative holdings from dictum). support of the lower courts' rulings and its assertion that Ross's claim is (**14] an HCLC. First, it addresses slip The [**12] purpose of the TMLA's expert report and fall claims generally, and says that any slip and fall requirement is not to have claims dismissed regardless of event within a hospital is directly related to health care their merits, but rather it is to identify and deter frivolous because it necessarily is related to the safety of patients. claims while not unduly restricting a claimant's rights. Second, it focuses on Ross 1s claim specifically and ar- Scoresby v. Santillan, 346 S. W.3d 546, 554 (Tex. 2011). gues that her claim is related to health care because she And the Legislature did not intend for the expert report alleges the hospital breached standards applicable to requirement to apply to every claim for conduct that oc- maintaining a safe environment for patients. We disagree curs in a health care context. See Loaisiga v. Cerda, 3 79 with both positions. S. W.3d 248, 258 (Tex. 2012). For example, in Loaisiga patients claimed that a doctor improperly touched them As to the hospital's first contention, even though the during the course of medical exams and thereby assault- claims in Loaisiga were by a patient and the nature of the ed them. 379 S. W.Jd at 253. The trial court concluded claims differ from Ross's safety standards-based claim, that the claim was not an HCLC and the court of appeals the principle we explicated there applies here. A safety affirmed. Id. at 254. We pointed out that the statutory standards-based claim does not come within the TMLA's definition of "health care" is broad ("any act or treatment provisions· just because the underlying occurrence took· performed or furnished, or that should have been per- place in a health care facility, the claim is against a formed or furnished, by any health care provider for, to, health care provider, or both. See Loaisiga, 379 S.W.3d or on behalf of a patient [*503] during the patient's at 257. Page 5 462 S.W.3d 496, *; 2015 Tex. LEXIS 361, **; 58 Tex. Sup. J. 766; 58 Tex. Sup. J. 802

As to its second contention, Ross alleged that the CODE§ 31l.021 ("In enacting a statute, it is presumed hospital failed to exercise reasonable care in making the that ... a just and reasonable result is intended .... "); floor safe. The standards Ross says the hospital breached Synatzske, 438 S. W.3d at 54 (declining to attribute to the regarding maintenance of its floor may be the same as Legislature an intent to require a meaningless, arbitrary the hospital1s standards for maintaining a safe environ- procedural hurdle for injured persons to bring suit). ment inpatient care areas--but those may [**15] also be the same standards many businesses generally have for I Hi/co Elec. Co-op. v. Midlothian Butane Gas maintaining their floors. And the hospital does not claim, Co., Ill S. W.3d 75, 81 (Tex. 2003) ("[T]he rule nor does the record show, that the area where Ross fell of ejusdem generis ... provides that when words was a patient care area or an area where patients possibly of a general nature are used in connection with would be in the course of the hospital's providing health the designation of particular objects or classes of care services to them. Nor does the hospital reference persons or things, the meaning of the general support in the record for the position that the area had to words will be restricted to the particular designa- meet particular cleanliness or maintenance standards tion."); see also ANTONIN SCALIA & BRYAN A. related to the provision of health care or patient safety. GARNER, READING LAW: THE INTERPRETATION See Ollie, 342 S. W.3d at 527 ("[S]ervices a hospital pro- OF LEGAL TEXTS 199 (20 12) ("Where general vides its patients necessarily include those services re- words follow an enumeration of two or more quired to meet patients' fundamental needs such as clean- things, they apply only to persons or things of the liness ... and safety."). Which leads to the question of same general kind or class specifica11y men- whether [*504] Ross's claims are nevertheless tioned.11). HCLCs, as the hospital would have us hold. Thus, we conclude that for a safety standards-based The TMLA does not specifically state that a safety claim to be an HCLC there must be a substantive nexus standards-based claim fa11s within its provisions only if between the safety standards allegedly violated and the the claim has some relationship to the provision of health provision of [**18] health care. And that nexus must be care other than the location of the occurrence, the status more than a "but for" relationship. That is, the fact that of the defendant, or both. But the Legislature must have Ross, a visitor and not a patient, would not have been intended such a relationship to be necessa1y, given the injured but for her fa11ing inside the hospital is not a suf- legislative intent explicitly set out in the TMLA and the ficient relationship between the standards Ross a1leges context [** 16] in which "safety" is used in the statute. the hospital violated and the hospital's health care activi- We said as much in Loaisiga. 379 S.W.3d at 257. Even ties for the claim to be an HCLC. As we recognized in though the statute's phrase "directly related to health Loaisiga, "[i]n some instances the only possible rela- care11 does not modify its reference to safety standards, tionship between the conduct underlying a claim and the that reference occurs within a specific context, which rendition of medical services or healthcare will be the defines an HCLC to be "a cause of action against a health healthcare setting (i.e., the physical location of the con- care provider or physician for [a] treatment, [b] lack of duct in a health care facility), the defendant's status as a treatment, [c] or other claimed departure from accepted doctor or health care provider, or both." 379 S.W.3d at standards of medical care, or health care, or safety. 11 TEX. 256. But although the mere location of an injury in a C!V. PRAC. & REM. CODE§ 74.00l(a)(l3). Where the health care facility or in a health care setting [*505] more specific items, [a] and [b], are fo11owed by a does not bring a claim based on that injury within the catcha11 "other," [c], the doctrine of ejusdem generis TMLA so that it is an HCLC, the fact that the incident teaches that the latter must be limited to things like the could have occurred outside such a facility or setting former.' And here, the catcha11 "other" itself refers to does not preclude the claim from being an HCLC. The standards of 11 medical care' 1 or 11 health care 11 or "safety." pivotal issue in a safety standards-based claim is whether Considering the purpose of the statute, the context of the the standards on which the claim is based implicate the language at issue, and the rule of ejusdem generis, we defendant's duties as a health care provider, including its conclude that the safety standards refeiTed to in the defi- duties [**19] to provide for patient safety. nition are those that have a substantive relationship with As this case demonstrates, the line between a safety the providing of medical or health care. And if it were standards-based claim that is not an HCLC and one that not so, the broad meaning of "safety" would afford de- is an HCLC may not always be clear. But certain fendant health care providers a special procedural ad- non-exclusive considerations lend themselves to analyz- vantage in the guise of requiring [**17] plaintiffs to file ing whether such a claim is substantively related to the expert reports in their suits regardless of whether tl1eir defendant's providing of medical or healt11 care and is cause of action implicated the provision of medical or therefore an HCLC: health care. We do not believe the Legislature intended the statute to have such arbitrary results. See TEX. Gov'T Page 6 462 S.W.3d 496, *; 2015 Tex. LEXIS 361, **; 58 Tex. Sup. J. 766; 58 Tex. Sup. J. 802

1. Did the alleged negligence of the V. Conclusion defendant occur in the course of the de- Under this record Ross's claim is based on safety fendant's performing tasks witl1 the pur- standards that have no substantive relationship to the pose of protecting patients from harm; hospital's providing of health care, so it is not an HCLC. 2. Did the injuries occur in a place Because her claim is not an HCLC, she was not required where patients might be during the time to serve an expert report to avoid dismissal of her suit. they were receiving care, so that the obli- We reverse the judgment of the court of appeals and gation of the provider to protect persons [*506] remand the case to the trial court for further who require special, medical care was proceedings. implicated; Phil Johnson Justice 3. At the time of the injury was the OPINION DELIVERED: May 1, 2015 claimant in the process of seeking or re- ceiving health care; CONCUR BY: Debra H. Lehrmann 4. At the time of the injury was the claimant providing or assisting in provid- CONCUR ing health care; WSTICE LEHRMANN, joined by JUSTICE 5. Is the alleged negligence based on DEVINE, concurring. safety standards arising from professional I join the Court's opinion and agree that the claims duties owed by the health care provider; asserted in this case have no connection to the provision 6. If an instrumentality was involved of health care. I write separately, however, to emphasize in the defendant's alleged negligence, was my concern that a statute intended to address the insur- it a type used in providing health care; or ance crisis stemming from the volume of frivolous med- ical-malpractice lawsuits has become a nebulous barrier 7. Did the alleged negligence occur to what were once ordinary negligence suits brought by [**20] in the course of the defendant's plaintiffs alleging no breach of any professional duty of taking action or failing to take action nec- care. essary to comply with safety-related re- quirements set for health care providers In Texas West Oaks Hospital, LP v. Williams, the by governmental or accrediting agencies? Court held that a plaintiffs claim against [**22] a phy- sician or health care provider may constitute a health care liability claim subject to the Texas Medical Liability Act even where no patient--physician or pa- Measuring Ross's claim by the foregoing considera- tient--health-care-provider relationship exists between tions, it is clear that the answer to each is 11 no. 11 The rec- the parties. 371 S.W.3d 171, 177-78 (Tex. 2012). In my ord does not show that the cleaning and buffing of the dissent in that case, I disagreed with the Court's holding floor near the exit doors was for the purpose of protect- 11 that the mere peripheral involvement of a patient trans- ing patients. Nor does the record reflect that the area forms an ordinary negligence claim into a health care where Ross fell was one where patients might be during claim." !d. at 194-95 (Lehrmann, J., dissenting). I la- their treatment so that the hospital's obligation to protect mented what I viewed as the Court's departure from the patients was implicated by the condition of the floor at importance we had previously placed on the relationship that location. Ross was not seeking or receiving health between health care providers and their patients in con- care, nor was she a health care provider or assisting in cluding that a patient's claims were covered by the Act. providing health care at the time she fell. There is no Id. at 196-97 (citing Diversicare Gen. Partner, Inc. v. evidence the negligence alleged by Ross was based on Rubio, 185 S. W.3d 842 (Tex. 2005)). The consequences safety standards arising from professional duties owed by of that departure are evident in cases like this, in which the hospital as a health care provider. There is also no defendants who happen to be health care providers seek evidence that the equipment or materials used to clean the protections of the Medical Liability Act with respect and buff the floor were particularly suited to providing to claims that have nothing to do with medical liability. for the safety of patients, nor does the record demon- strate that the cleaning and buffing of the floor near The Court holds, and I agree, that a cause of action [**21] the exit doors was to comply with a safe- against a health care provider for a departure from safety ty-related requirement set for health care providers by a standards is a health care liability claim only if it has a governmental or accrediting authority. 11 substantive relationship 11 with the provision of medical or health care.' S.W.3d at . I write separately to Page 7 462 S.W.3d 496, *; 2015 Tex. LEXIS 361, **; 58 Tex. Sup. J. 766; 58 Tex. Sup. J. 802

emphasize [**23] the significance of the third and fifth constitute health care liability claims. !d. at 854. These factors, which consider whether the claimant was in the statements are consistent with our recognition that health process of seeking or receiving health care at the time of care liability claims involve a "specialized standard of the injmy and whether the alleged negligence was based care" that is established by expert testimony. Garland on safety standards arising from professional duties owed Cmty. Hasp. v. Rose, 156 S.W.3d 541, 546 (Tex. 2004); by the health care provider. see also Jackson v. Axelrad, 221 S. W.3d 650, 655 (Tex. 2007) (explaining that a physician's duty of care owed to 2 "Substantive" is defined as 11 Considerable in a patient is that of "a reasonable and prudent member of amount or numbers; substantial. 11 WEBSTER 1S the medical profession ... under the same or similar cir- THIRD NEW INT'LDICTIONARY 2280 (2002). cumstances" (quoting Hood v. Phillips, 554 S.W.2d 160, 165 (Tex. 1977))). As we recognized in Diversicare, the duty of care that health care providers owe to their patients is funda- In my view, focusing a safety-standards claim on the mentally different from the duty of care owed to, say, duty health care providers owe to their patients ensures employees or visitors. 185 S.W.3d at 850-51 ("The obli- that Diversicare's hypothetical visitor-assault and rick- gation of a health care facility to its patients is not the ety-staircase claims do not fall under the Medical Liabil- same as the general duty a premises owner owes to in~ ity Act's umbrella. It also ensures that a covered cause of vitees."). To that end, when we held in Diversicare that a action will "implicate[] the provision of medical or nursing home resident1s claim that she was sexually as- health care" in accordance with the Court's holding in saulted by another resident was a health care liability this case. S.W.3d at . With these considerations claim, we rejected the argument that the claim should be in mind, I respectfully join the Court's opinion and treated the same as that of a visitor who had been as- judgment. saulted at the facility precisely because of the distinct Debra H. Lehrmann nature of those duties. Id. We also distinguished the cir- cumstances at issue in that case from hypothetical claims Justice involving an "unlocked [**24] window that gave an OPINION DELIVERED: May I, 2015 intruder access to the facility" and a 11 rickety staircase [*507] that gave way," which we implied would not APPENDIX- ''2'' Page I

LexisNexis@ I of 6 DOCUMENTS

RAUL ERNESTO LOAISIGA, M.D., AND RAUL ERNESTO LOAISIGA, M.D., P.A., PETITIONERS, v. GUADALUPE CERDA, INDIVIDUALLY AND AS NEXT FRIEND OF MARISSA CERDA, A MINOR, AND CINDY VELEZ, RESPOND- ENTS

N0.10-0928

SUPREME COURT OF TEXAS

379 S.W.3d 248; 2012 Tex. LEXIS 736; 55 Tex. Sup. J. 1373

Febq1ary 29, 2012, Argued August 31,2012, Opinion Delivered

SUBSEQUENT HISTORY: Released for Publica- TICE HECHT filed a concurring and dissenting opinion, tion October 12, 2012. in which JUSTICE MEDINA joined. JUSTICE WIL- LETT filed a concurring and dissenting opinion. JUS- PRIOR HISTORY: [**!] TICE LEHRMANN filed a concurring and dissenting ON PETITION FOR REVIEW FROM THE COURT opinion. OF APPEALS FOR THE THIRTEENTH DISTRICT OF TEXAS. OPINION BY: Phil Johnson Loaisiga v. Cerda, 2010 Tex. App. LEXIS 6326 (Tex. App. Cmpus Christi, Aug. 5, 20/0) OPINION [*252] The Texas Medical [**2] Liability Act (TMLA) requires plaintiffs asserting health care liability COUNSEL: For Sunshine Pediatrics LLP, Other inter- claims (HCLCs) to timely serve each defendant with an ested party: Michael Raphael Cowen, The Cowen Law expert report meeting certain requirements. In this case Group, PC, Brownsville TX. we consider whether claims that a doctor assaulted pa- tients by exceeding the proper scope of physical exami- For Loaisiga, M.D., Raul Emesto and Raul Emesto nations are subject to the TMLA's expert report require- Loaisiga, M.D., P.A., Petitioners: , Escobar Law Firm, ments. PLLC, McAllen TX; Carlos EscobarGilberto Hinojosa, Gilberto Hinojosa & Associates PC, Brownsville TX. Two female patients sued a medical doctor, the pro- fessional association bearing his name, and a clinic, al- For Cerda, Guadalupe, Individually and as next friend of leging the doctor assaulted the patients by groping their Marissa Cerda, Minor, and Cindy Velez., Respondent: breasts while examining them for sinus and flu symp- Benigno (Trey) Martinez III, Martinez Barrera & Mar- toms. Although they maintained that the claims were not tinez LLP, Brownsville TX; Brendan K. McBride, The HCLCs, the patients served the doctor and professional McBride Law Firm, San Antonio TX; Stephanie Elaine association with reports from a physician who, based Burnett, The Law Office of Benigno (Trey) Martinez, only on the assumption that allegations in the plaintiffs' P.L.L.C., Brownsville, TX. pleadings were true, opined that the defendant doctor's alleged actions did not fall within any appropriate stand- JUDGES: JUSTICE JOHNSON delivered the opinion ard of care. The defendants argued that the claims were of the Court in which CHIEF JUSTICE JEFFERSON, HCLCs and moved for dismissal of the suit on the basis JUSTICE WAINWRIGHT, JUSTICE GREEN, and that the reports were deficient. The trial court denied the JUSTICE GUZMAN joined, and in Parts I through V.A. motions. The court of appeals held that the claims were and VI.A. of which JUSTICE WILLET! joined. JUS- not HCLCs, expert reports were not required, and af- Page 2 379 S.W.3d 248, *; 2012 Tex. LEXIS 736, **; 55 Tex. Sup. J. 1373

fitmed the trial court's [**3) order without considering curriculum vitae from Michael R. Kilgore, M.D., a fam- the reports' adequacy. ily practitioner. See id. § 74.351(a), (b). Dr. Kilgore stated in the report that he had reviewed the plaintiffs' We hold that the TMLA creates a rebuttable pre- petition. He recited allegations from the pet:tion .and sumption that a patient1s claims against a physician or stated that if they were true, then Dr. LoalS!ga s actwns health care provider based on facts implicating the de- were not within any appropriate standard of care, com- fendanes conduct during the patient1s care, treatment, or prised an assault, and harmed the plaintiffs. In .a .supple- confinement are HCLCs. The record before us does not mental report, Dr. Kilgore stated that the opmwns he rebut the presumption as it relates to the TMLA's expert expressed as to Dr. Loaisiga also applied to the P.A. report requirements, nor are the expert reports served by the plaintiffs adequate under the TMLA. We reverse the Dr. Loaisiga and the P .A. filed objections to the re- judgment of the court of appeals and remand the case to ports and motions to dismiss. They argued that the re- the trial court for further proceedings. ports were deficient because they failed to (I) implicate conduct of either Dr. Loaisiga or the P.A., (2) set out the I. Background applicable standard of care, (3) identify a breach of the standard of care, or (4) identify how the actions of Dr. Guadalupe Cerda, individually and as next friend of Loaisiga or the P.A. proximately caused the alleged IUJU- her daughter Marissa Cerda, and Cindy Velez (collec- ries. The motions also asserted that Dr. Kilgore's report tively, the plaintiffs) sued Raul Emesto Loaisiga,, M.D., was "based [**6] upon pure speculation and assump- [*253) Raul Emesto Loaisiga, M.D., P.A. (heremafter, tion11 and Dr. Kilgore, as a family practitioner, was not the P.A,), and Sunshine Pediatrics, LLP. The plaintiffs' qualified to render an expert opinion regarding Dr. claims are based on two separate incidents. Guadalupe Loaisiga's conduct as a pediatrician. The P.A. separately alleges that she took Marissa, then age seventeen, to argued that neither the original nor the supplemental re- Sunshine Pediatrics for treatment of a sinus problem, port addressed any theories of liability as to it and, in any According to the pleadings, Dr. Loaisiga examined event, the supplemental report was deficient because it Marissa and "under the guise of listening to [Marissa's) gave no explanation of why the opinions in the original heart through the stethoscope . . . cupped [Marissa's) report applied to the P.A. The plaintiffs' response to each breast with the [**4] palm of his hand." Velez, who motion maintained that Dr. Kilgore's reports were ade- was employed as a nurse at Sunshine Pediatrics, alleges quate; Dr. Loaisiga was acting both individually and as that Dr. Loaisiga offered to examine her when she ar- the P.A., so there was no difference between the actiOns rived at work with flu-like symptoms. She further alleges of the two; and Dr. Kilgore's reports were directed to that during the examination Dr. Loaisiga had her take off both. In the alternative, the plaintiffs requested thirty-day her upper garment, then "he undid her bra from the front extensions to cure any defects in the reports. See id. § , , , [and] palmed her breast with one hand during his 74.351(c) (stating that if an expert report is not timely entire examination. 11 served "because the elements of the report are [*254) The plaintiffs sued for assault, medical negligence, found deficient, the court may grant one 30-day exten- negligence, gross negligence, and intentional infliction of sion to the claimant in order to cure the deficiency"). emotional distress. They allege that Dr. Loaisiga knew or The trial court held a hearing on the motions to dis- reasonably should have believed that Marissa and Velez miss and denied them without stating why. Dr. Loaisiga would regard his touching of their breasts as offenstve or and the P.A. appealed, See id. § 51.014(a)(9) (permitting provocative and Sunshine Pediatrics breached its duty [**7) immediate appeal of a trial court order denying all and the appropriate standard of care by allowing Dr. or part of a motion to dismiss for failure to serve an ex- Loaisiga to fondle them. The plaintiffs assert that alt- pert report in an HCLC). The court of appeals affirmed. hough the case is actually for assault, in an 11 abundance S.W.3d , The court reasoned that the plaintiffs were of caution and in the alternative," they claim Dr. Loaisi- not required to file expert reports because their claims ga,s actions 11 fell below the standard of care 11 for a doctor against Dr. Loaisiga are assault claims, not HCLCs. See treating female patients. The pleadings of medical negli- id. at , It did not reach the question of whether Dr. gence specifically reference "Chapter 74 of the Kilgore's reports were deficient. The court also conclud- CPRC"--the TMLA. See TEX. C!V. PRAC. & REM. CODE ed that the TMLA does not apply to the plaintiffs' claims §§ 74.001-.507. The plaintiffs pray for judgment [**5) against the P .A, because the plaintiffs refer to the P .A. against the three defendants, but they do not specifically only in the introductory part oftheir pleadings and do not allege any type of claim, either direct or vicarious, assert liability claims against it. See id. at against the P.A. We granted the petition for review of Dr. Loaisiga Within 120 days after filing their petition, the plain- and the P.A. 55 Tex. Sup. C!. J. 145 (Dec, 16, 2011). tiffs served Dr. Loaisiga and the P .A. with a report and Before turning to the parties' arguments on the merits, we Page 3 379 S.W.3d 248, *; 2012 Tex. LEXIS 736, **; 55 Tex. Sup. J. 1373

address our jurisdiction to consider this interlocutory The TMLA defines an HCLC as: appeal. a cause of action against a health care II. Jurisdiction provider or physician for treatment, lack of treatment, or other claimed departure Texas appellate courts generally have jurisdiction from accepted standards of medical care, only over final judgments. Baily Total Fitness Corp. v. or health care, or safety or professional or Jackson, 53 S. W.3d 352, 355 (Tex. 2001). But an excep- administrative services directly related to tion exists for certain interlocutory orders. See TEX Civ. health care, which proximately results in PRAC. &REM. CODE§ 51.014(a); Jackson, 53 S.W.3d at injury to or death of a claimant, whether 355. Section 51.014(a) [**8] provides in relevant part: the claimant's claim or cause of action sounds in tort or contract. A person may appeal from an interloc- utory order of a district court, county court at law, or county court that: TEX CIV. PRAC. &REM. CODE§ 74.001(a)(13). Accord- ing to its definition, an HCLC has three elements: (I) the (9) denies all or part of the relief defendant is a health care provider or physician; [**10] sought by a motion under Section (2) the claimant's cause of action is for treatment, lack of 74.351(b), except that an appeal may not treatment, or other claimed departure from accepted be taken from an order granting an exten- standards of medical care, health care, or safety or pro- sion under Section 74.351. fessional or administrative services directly related to health care; and (3) the defendant's alleged departure from accepted standards proximately caused the claim- TEX CIV. PRAC. &REM. CODE§ 51.014(a)(9). ant's injury or death. Marks v. St. Luke's Episcopal A court of appeals' judgment ordinarily is conclusive Hasp., 319 S.W.3d 658, 662 (Tex. 2010) (plurality opin- when an interlocutory appeal is taken pursuant to section ion). 51.014(a)(9). See TEX GOV'T CODE § 22.225(b)(3). This case focuses on the second element which con- However, we may consider an interlocutory appeal when cerns the nature of a claimant's "cause of action" and the the court of appeals 1 decision creates an inconsistency in definitions of medical care, health care, safety and pro- the law that should be clarified to remove unnecessary fessional or administrative services directly related to uncertainty and unfairness to litigants. Id. §§ health care. See TEX CIV. PRAC. & REM. CODE § 22.001(a)(2), (e); 22.225(c), (e). This case involves an 74.001 (a)(J3). The TMLA does not define the term issue on which the courts of appeals have issued incon- "cause of action," but the generally accepted meaning of sistent decisions. Compare S.W.3d at (holding that phrase refers to the "'fact or facts entitling one to that a doctor's alleged fondling of the plaintiffs' breasts institute and maintain an action, which must be alleged during medical examinations could not feasibly be ex- and proved in order to obtain relief."' In re Jorden, 249 plained as a necessary part of medical treatment and S.W.3d 416, 421 (Tex. 2008) (quotingA.H. Bela Cmp. v. therefore does not give rise to an HCLC), with Blanton, 133 Tex. 391, 129 S.W.2d 619, 621 (1939)). Vanderwerff v. Beathard, 239 S. W.3d 406, 409 (Tex. "Health care" is broadly defined as "any act ... per- App.--Da//as 2007, no pet.) (concluding [**9] that a formed ... by any health care provider for [or] to ... a chiropractor's alleged rubbing of a plaintiffs genitals [**II] patient during the patient's medical care, treat- during a chiropractic examination gave rise to an HCLC 1 ment, or confinement." TEX. CIV. PRAC. & REM. CODE§ because whether the chiropractor s actions were within 74.001(a)(10). And "medical care" is defined as "any act the scope of a chiropractic examination could not be defined as practicing medicine under Section 151.002, answered without reference to the standard of care re- Occupations Code, performed or furnished, or which quired of a chiropractic provider). We have jurisdiction should have been performed, by one hcensed to practiCe to resolve this issue. TEX. GOV'TCODE § 22.001(a)(2). medicine in this state for, to, or on behalf of a patient during the patient's care, treatment, or confinement." !d. III. Health Care Liability Claims § 74.001(a)(19). The Occupations Code, in turn, defines "practicing medicine" as "the diagnosis, treatment, or A. General offer to treat a mental or physical disease or disorder or a Determining whether claims are HCLCs requires physical deforn1ity or injury by any system or method, or courts to constme the TMLA. We review issues of statu- the attempt to effect cures of those conditions by a per- tory interpretation [*255] de novo. Mo/inet v. Kim- son who ... publicly professes to be a physician." TEX brell, 356 S.W.3d 407, 411 (Tex. 2011). Occ. CODE§ 151.002(a)(13). Page 4 379 S.W.3d 248, *; 2012 Tex. LEXIS 736, **; 55 Tex. Sup. J. 1373

Analysis of the second element--the cause of ac- (3) intentionally or knowingly causes tion--focuses on the facts underlying the claim, not the physical contact with another when the form of, or artfully-phrased language in, the plaintiffs person knows or should reasonably be- pleadings describing the facts or legal theories asserted. lieve that the other will regard the contact See, e.g., Yamada v. Friend, 335 S.W.3d 192, 196-97 as offensive or provocative. (Tex. 2010); Diversicare Gen. Partner, Inc. v. Rubio, 185 S. W.Jd 842, 847, 854 (Tex. 2005). We have previously determined that [**12] a claim based on one set of facts TEX PENAL CODE§ 22.01(a). [**14] As relevant to the cannot be spliced or divided into both an HCLC and an- case before us, an assault occurs if a person 11 intentional- other type of claim. See Yamada, 335 S. W.3d at 197; ly or knowingly causes physical contact with another Diversicare, 185 S.W.3d at 854. It follows that claims when the person knows or should reasonably believe that premised on facts that could support claims against a the other will regard the contact as offensive or provoca- physician or health care provider for departures from tive." !d.§ 22.01(a)(3). accepted standards of medical care, health care, or safety Distinguishing between claims to which the TMLA or professional or administrative services directly related applies and those to which it does not apply can be diffi- to health care are HCLCs, regardless of whether the cult when the plaintiff alleges an assault took place dur- plaintiff alleges the defendant is liable for breach of any ing a physical examination to which the patient consent- of those standards. See TEX CIV. PRAC. & REM. CODE § ed. The scope of medical examinations generally are 74.001(a)(13). infmmed, and largely guided, by a combination of the [*256] The broad language of the TMLA evi- patient's complaints and the examiner's training and pro- dences legislative intent for the statute to have expansive fessional judgment. During an examination for the pur- application. See, e.g., TEX CJV. PRAC. & REM. CODE § pose of diagnosing or treating a patient's condition, a 74.001(a)(JO) (defining "health care" to include "any act medical or health care provider almost always will touch ... by any health care provider for, to, or on behalf of a the patient intentionally. Frequently, examinations in- patient during the patient1s medical care, treatment, or volve examiners touching the patient's body in places confinement." (emphasis added)); see also Moline/, 356 and in ways that would be assaults were it not for the S. W.3d at 411 (noting that when interpreting statutes we actual or implied consent of the patient in the context of strive to ascertain and give effect to the Legislature1S the medical or health care relationship. And the examiner intent). The breadth of the statute's text essentially cre- may need to examine parts of the patient's body that ates a presumption that a claim is an HCLC if it [**13] might not be anticipated by a person without medical or is against a physician or health care provider and is based [* * 15] health care training. Such a situation is demon- on facts implicating the defendant's conduct during the strated by Vanderwe1:f{, a case in which no expert report course of a patient1s ·care, treatment, or confinement. See was filed. There, Kristina Beathard sought treatment Marks, 319 S. W.Jd at 662. But the presumption is nec- from Eric Vanderwerff, a chiropractor, complaining of essarily rebuttable. In some instances the only possible pain in various parts of her body. 239 S. W.3d at 407. relationship between the conduct underlying a claim and Beathard later sued Vande1werff, alleging that "during the rendition of medical services or healthcare will be the the course of a routine examination of her knee" he healthcare setting (i.e., the physical location of the con- rubbed her genitals. Id. at 409. The trial court denied duct in a health care facility), the defendant's status as a Vanderwerffs motion to dismiss for Beathard's failure to doctor or health care provider, or both. serve an expert report, but the court of appeals reversed. !d. In doing so, it noted that Beathard had marked an B. Assaults and the TMLA anatomical drawing to show her areas of pain, and those markings indicated she was having pain not only in her The elements of a civil assault mirror those of a neck, wrists, ankle, and left knee, but also running from criminal assault. See Wajj/e House, Inc. v. Williams, 313 her knee to her upper thigh. [*257] Id. The court of S. W.3d 796, 801 n.4 (Tex. 2010). Under the Penal Code, appeals set out the issue and its conclusion as follows: an assault occurs if a person: The threshold questions raised by (I) intentionally, knowingly, or reck- Beathard's pleadings are whether she lessly causes bodily injmy to another, in- consented to treatment and whether cluding the person's spouse; Vanderwerffs examination was within the (2) intentionally or knowingly threat- scope of a chiropractic examination. Was ens another with imminent bodily injury, the examination a "routine" examination including the person's spouse; or as Beathard contends? These questions cannot be answered without reference to Page 5 379 S.W.3d 248, *; 2012 Tex. LEXIS 736, **; 55 Tex. Sup. J. 1373

the standard of care required [**16] of a of a metal weight in the patient's hand during a neuro- chiropractic provider. logical examination).

IV. Expert Reports Id. In essence, the court of appeals recognized that an The TMLA's expert report requirements do not re- expert report was necessary because Vanderwerffs con- quire a trial court to make a merits determination re- duct in the overall context of the chiropractic examina- garding whether the claim is an HCLC. See Murphy, 167 tion could have been part of the care he was rendering S.W.3d at 838 (explaining that the [*258] requirement pursuant to Beathard's consent to be examined and treat- is a threshold over which a plaintiff must proceed); Am. ed for pain which, in part, she reported extended from Transitional Care Ctrs. of Tex., Inc. v. Palacios, 46 her knee to the upper thigh. S. W.3d 873, 878 (Tex. 2001) ("[T]he expert report must In balancing the respective rights of and burdens on represent only a good-faith effort to provide a fair sum- claimants and medical and healthcare defendants, the mary of the expert's opinions. A report need not marshal Legislature has determined that requiring claimants to all the plaintiffs proof, but it must include the expert's bear the expense of obtaining and serving expert reports opinion on each of the elements identified in the stat- early in HCLCs is preferable to having parties incur sub- ute."). Nor does a determination that the TMLA's expert stantial expense and devote considerable time to devel- report requirements apply to a claim affect other matters oping claims through discovery and trial preparation such as whether a physician or health care provider may before a trial court determines which ones are meritless. be subject to professional sanctions or criminal prosecu- See Scoresby, 346 S. W.3d at 552, 556; Palacios, 46 tion for the conduct [**19] on which a plaintiff bases a S. W.3d at 877. However, we fail to see how the Legisla- claim. See Vanderweif.t: 239 S. W.3d at 407 n.1 (noting ture could have intended the requirement of an expert that in addition to a civil case alleging sexual assault report to apply under circumstances where the conduct of against a chiropractor for rubbing the patient's genitals which a plaintiff complains is wholly and conclusively during an examination, a criminal complaint was filed inconsistent with, and thus separable from, the rendition against the defendant). The requirements are meant to of 11 medical care, or health care, or safety or professional identify frivolous claims and reduce the expense and [** 17] or administrative services directly related to time to dispose of any that are filed. See Scoresby v. San- health care" even though the conduct occurred in a health tillan, 346 S. W.3d 546, 554 (Tex. 2011) ("The purpose of care context. See TEX C!V. PRAC. & REM. CODE § the expert report requirement is to deter frivolous claims, 74.001(a)(I3); see also TEX GOV'TCODE § 311.021 ("In not to dispose of claims regardless of their merits." (cita- enacting a statute, it is presumed that ... a just and rea- tion omitted)); see a/so TEX C!V. PRAC. & REM. CODE§ sonable result is intended .... "). 74.351(k), (t) (providing that an expert report is not ad- missible in and shall not be used during depositions, trial, We conclude that a claim against a medical or health or other proceedings, nor shall it be referred to for any care provider for assault is not an HCLC if the record purpose absent the plaintiffs using it in a way other than conclusively shows that (I) there is no complaint about serving it pursuant to the 120-day service requirement of any act of the provider related to medical or health care section 74.351(a)); id. § 74.351(s) (limiting discovery services other than the alleged offensive contact, (2) the until the expert report and curriculum vitae of the expert alleged offensive contact was not pursuant to actual or have been served). implied consent by the plaintiff, and (3) the only possible relationship between the alleged offensive contact and In Palacios we held that the TMLA's language re- the rendition of medical services or healthcare was the quires a trial court to determine a report's adequacy from setting in which the act took place. See Mwphy v. Rus- its four comers. 46 S. W.3d at 878. [**20] The statute sell, 167 S. W.3d 835, 838 (Tex. 2005) (per curiam) does not similarly limit what a trial court may consider (holding that a plaintiffs battery claim was an HCLC when the question is whether a claim is subject to the because "[t]here may [have] be[en] reasons for providing TMLA's expert report requirements. Thus, when making treatment without specific consent that do not breach any that determination courts should consider the entire court applicable standard of care[, and] [t]he existence or non- record, including the pleadings, motions and responses, existence of such reasons is necessarily the subject of and relevant evidence properly admitted. This could in- [**18] expert testimony"); Buck v. Blum, 130 S.W.3d clude, but is not limited to, reports such as those the 285, 289-90 (Tex. App.--Houston [14th Dist.] 2004, no plaintiffs served here, medical records regarding exami- pet.) (concluding that a neurologist's conduct was not in nation or treatment of the plaintiff, if any, and the de- the course and scope of his employment when a patient fendant's pleadings and explanation for how the contact complained that the neurologist placed his penis instead at issue was part of medical care, or health care, or safety Page 6 379 S.W.3d 248, *; 2012 Tex. LEXIS 736, **; 55 Tex. Sup. J. 1373

or professional or administrative services directly related to listen to the heartbeat of the patient. to health care. However, in all applicable medical stand- ards of care, it is unnecessary that a pa- In light of the foregoing, we tum to the parties' con- tient remove their brazier, nor is it neces- tentions. We address the defendants separately, begin- sary to cup, palm or touch the breast of a ning with Dr. Loaisiga. female patient either with the hand hold- ing the stethoscope or the other hand not V. Dr. Loaisiga holding the instrument to listen to a heart beat. A. Was an Expert Report Required Dr. Loaisiga argues that the plaintiffs were required to file an expert report because the alleged assaults oc- Another distinction is that the record in Vanderweljf curred during the course of his administering medical contained an anatomical drawing on which the plaintiff services and all his actions were inseparable from the indicated to the chiropractor that she [**23] had pain rendition of those medical services. The plaintiffs urge running from her knee to her upper thigh. Id. at 409. that, as the court of appeals held, their [**21] assault Based on that document, the court of appeals recognized claims are not subject to the TMLA's expert report re- that the chiropractor1s touching of, or near, the patienfs quirements because Dr. Loaisiga's acts do not implicate genitals could have been part of the examination. See id. medical or health care services, regardless of whether Here, the record does not contain any documents other medical treatment was occurring at the time of the as- than the plaintiffs' pleadings to shed light on the plain- saults. Rather, they say the alleged acts of assault are so tiffs' symptoms or their complaints to Dr. Loaisiga. As inconsistent with the medical services Dr. Loaisiga was discussed in more detail below, apart from allegations in rendering, that the TMLA does not apply. In analyzing the plaintiffs' pleadings, Dr. Kilgore's reports make no these arguments, we consider the entire record before the reference to the plaintiffs' medical records or the com- trial court and the overall context of the plaintiffs' suit, plaints they made to Dr. Loaisiga in the clinical setting. including the nature of the factual allegations in their pleadings, [*259] Dr. Loaisiga's contentions, and the The substance of the plaintiffs' complaint is that Dr. motions to dismiss and responses. Loaisiga1S conduct exceeded the scope of the examina- tions to which they consented, and Dr. Kilgore's report We look first to the pleadings. The plaintiffs' plead- shows that it is unnecessary for a physician to touch a ings contain allegations that except for Dr. Loaisiga's female patient1s breasts during routine examinations of touching of their breasts, the examinations were routine. the type Dr. Loaisiga was performing. But even taken The pleadings do not assert a lack of proper care by Dr. together, these aspects of the record do not conclusively Loaisiga other than his touching of their breasts. Further, rebut the presumptive application of the TMLA's expert the plaintiffs' brief on the merits posits that their plead- report requirements. The lack of information to give ings made "no factual allegations that they were injured context to Dr. Loaisiga1s actions during the examina- by any deficiencies in the medical care provided by Dr. tions--such as medical [* *24] records, if any, reference Loaisiga." to the medical records by Dr. Kilgore in his reports, or The plaintiffs' claims are qualitatively similar to the other information regarding the plaintiffs' symptoms and claims in Vanderwerff See 239 S. W.3d at 407. [**22] complaints to Dr. Loaisiga--prevents the plaintiffs from Like the plaintiff in Vanderweiff, the plaintiffs here al- showing conclusively that the only relationship between lege an examining doctor inappropriately touched parts the alleged touching of their breasts and Dr. Loaisiga's of their bodies during the course of otherwise routine rendition of medical services was the physical location of examinations. See id. But because the determination of the examinations at the offices of Sunshine Pediatrics whether the plaintiffs were required to serve an expert and his status as a doctor or health care provider. report is to be made based on the whole record, we must We conclude that the record does not contain suffi- also consider other relevant documents in the record and cient information to conclusively show that Dr. Loaisi- Dr. Loaisiga's contentions. In that regard, this case is ga's conduct [*260] could not have been part of the distinguishable from Vanderwerff examination he was perfom1ing. But because we are One distinguishing factor is that the plaintiff in clarifying the standard for whether claims are subject to Vanderweljf did not serve an expet1 repot1. Here the the TMLA's expert report requirements and the plaintiffs plaintiffs served a report that stated, in part: maintain that theirs are not, we conclude it is appropriate to remand the case to the trial court for further proceed- During a routine "sick 11 visit with a ings regarding that issue. See Low v. Henry, 221 S. W.3d physician, a stethoscope may be utilized Page 7 379 S.W.3d 248, *; 2012 Tex. LEXIS 736, **; 55 Tex. Sup. J. 1373

609, 621 (Tex. 2007) (remanding "to allow the parties to on his position that Dr. Kilgore's reports cannot be good present evidence responsive to our guidelines 11 ) . faith attempts to provide expert reports because they merely assume the truth of [**27] what is in the plain- B. Adequacy of the Reports tiffs' pleadings. Dr. Loaisiga first argues that Dr. Kil- gore's assuming the truth of the plaintiffs' pleadings re- The court of appeals did not consider whether Dr. sults in the reports being wholly speculative because the Kilgore's reports are adequate to meet the requirements pleadings are merely unverified allegations. He also as- of [**25] section 74.351 because it concluded that no serts that the reports (1) improperly require the trial court expert reports were necessary. S.W.3d at . If, on to assume facts outside their four comers and (2) do not remand, the trial court determines expert reports are nec- in good faith identity and state the breach and causation essary under the TMLA, the adequacy of Dr. Kilgore's elements required to be contained in expert reports be- reports must be determined. Dr. Loaisiga preserved the cause they are conditioned on certain facts being true. In adequacy issue in the courts below and briefed and ar- response, the plaintiffs maintain that Dr. [*261] Kil- gued it here. Therefore, without expressing any opinion gore was entitled to rely on their pleadings as true. They as to whether the TMLA's expert report requirements posit that whether their allegations are credible is a mat- will ultimately apply to this case, in the interest of judi- ter for the jury to decide, not a matter for the trial judge cial efficiency we address whether Dr. Kilgore's reports in passing on whether the reports are a good faith effort comply with the TMLA's requirements. See TEX R. APP. to comply with the TMLA requirements. To a certain P. 53.4; Reid Road Mun. Uti/. Dis!. No. 2 v. Speedy Stop extent we agree with both parties. Food Stores, Ltd., 337 S. W.3d 846, 855 (Tex. 2011). The fact that pleadings are not verified does not re- When a document purporting to be an expert report lieve attorneys and parties from their obligation to avoid is timely served in an HCLC and is properly challenged, including groundless or bad faith allegations in them. To the trial court the contrary, including such allegations in pleadings is sanctionable. See TEX R. CIV. P. 13. Thus, we do not see shall grant a motion challenging the why an expert, [**28] in formulating an opinion, adequacy of an expert report only if it ap- should be precluded from considering and assuming the pears to the court, after hearing, that the validity of matters set out in pleadings in the suit, absent report does not represent an objective a showing that the pleadings are groundless or in bad good faith effort to comply with the defi- faith or rebutted by evidence in the record. nition of an expert report in Subsection (r)(6). On the other hand, the purpose of an expert report is to give the trial court sufficient information within the four corners of the report to determine if the plaintiffs TEX C!V. PRAC. &REM. CODE§ 74.351(1). To qualify as claim has merit. Scoresby, 346 S. W.3d at 554, 556. If an an objective good faith effort the report must (1) inform expert could formulate an adequate expert report by the defendant [**26] of the specific conduct the plain- merely reviewing the plaintiffs pleadings and assuming tiff questions, and (2) provide a basis for the trial court to them to be tme, then artful pleading could neutralize the conclude that the plaintiffs claims have merit. Scoresby, Legislature's requirement that expert reports demonstrate 346 S. W.3d at 556 (citing Palacios, 46 S. W.3d at 879). A the plaintiffs claims have merit. See id. That is because report meets the minimum qualifications for an expert the facts and circumstances alleged in the plaintiffs report under the statute 11 if it contains the opinion of an pleadings might omit or misstate, inadvertently or other- individual with expertise that the claim has merit, and if wise, matters critical to a valid expert opinion. An expert the defendant's conduct is implicated." Id. at 557. If a report based only on the plaintiffs pleadings could mask report meets these qualifications but is deficient, and an the context of the medical services or health care ren- extension to cure is requested, the trial court may grant dered. Significant matters involved in the rendition of the one thirty-day extension to cure the deficiencies. See care, such as the patient's complaints or the health care TEX C!V. PRAC. &REM. CODE§ 74.351(c). But if a report provider's findings, could wan·ant investigation [**29] does not meet the standard set in Scoresby, it is not an and examination beyond that which might otherwise expert report under the statute, and the trial court must seem to have been appropriate, yet be unknown to the dismiss the plaintiffs claims if the defendant has proper- expert. If such matters were not in the plaintiffs plead- ly moved for dismissal. TEX CIV. PRAC. & REM. CODE§ ings the expert would not have considered them, the ex- 74.351(b). pert report would not reference them, and because they are outside the four comers of the report, the trial court Dr. Loaisiga advances three arguments why the case could not consider them in deciding whether the plain- should be dismissed if the TMLA's expert report re- quirements apply. The arguments all substantively rely Page 8 379 S.W.3d 248, *; 2012 Tex. LEXIS 736, **; 55 Tex. Sup. J. 1373

tiffs claims have merit, That is not what we believe the that we interpret statutory text according to its plain Legislature intended. See id. at 552-54. meaning and context unless such a construction leads to absurd or nonsensical results). The beginning of the sen- We conclude that in formulating an adequate expert tence the court of appeals quoted refers to "a health care report under section 74.351, an expert may consider and liability claim." TEX CIV. PRAC, & REM. CODE § rely on the plaintiffs pleadings, but the expert must con- 74.351(a), Reading the sentence as a whole shows that "a sider more than the pleadings. How much more will de- liability claim'' is merely an abbreviated reference to "a pend on the particular circumstances of the claim, But health care liability claim," which is elsewhere defined in we fail to see how in most instances, and particularly in the TMLA as "a cause of action." Id. § 74.001(a)(l3); claims involving the scope of an examination, an expert [**32] see also Mokkala v. Mead, 178 S.W.3d 66, 71 report could be adequate unless the expert at least con- (Tex. App.--Houston [14th Dist.] 2005, pet, denied) ("A sidered and commented on the patient's medical records 'health care liability claim' is a 'cause of action,' not a to the extent the records and their contents--or lack of lawsuit"). And as we have explained, a 11 Cause of action" appropriate contents--are relevant to the expert's opinion.' means the "fact or facts entitling one to institute and In this case Dr. Kilgore's reports and curriculum vi- maintain an action, which must be alleged and proved in tae demonstrate that he is a trained and practicing physi- order to obtain relief." In re Jorden, 249 S.W.3d at 421 cian. [**30) He has sufficient expertise in the medical (citation omitted). Therefore, the expert report require- field to be qualified to provide an adequate expert report. ments are triggered when a plaintiff names a person or See Scoresby, 346 S. W.3d at 557. The reports also entity as a defendant and seeks to obtain relief from that demonstrate that he is of the opinion the plaintiffs' claims defendant based on facts that. possibly implicate the have merit. See id. But his failure to consider any matters TMLA, other than the plaintiffs' pleadings in formulating his This construction of the statute furthers the purpose opinion make his existing reports inadequate to comply of the expert report requirements. See Scoresby, 346 with section 74.351's expert report requirements. On the S.W.3d at 554; see also Moline/, 356 S.W.3d at 4JI other hand, we disagree with Dr. Loaisiga's position that (stating that our objective in construing a statute is to the deficiencies in Dr. Kilgore's reports require dismissal ascertain and give effect to the Legislature's intent). If a of the plaintiffs' claims against him. The reports meet the plaintiff could name and seek judgment against a medi- standard set out in Scoresby, and the [*262] plaintiffs cal or health care provider based on facts that fall within requested a thirty-day extension to cure defects in them the TMLA's coverage without triggering the 120-day in the event they were deficient. Accordingly, if on re- deadline for serving an expert report, it would open the mand the trial court determines that the TMLA's expert door to artful pleading and undermine the Legislature's report requirements apply to this case, the court should goal of accelerating the disposition [**33) of consider the plaintiffs' request for an extension of time to non-meritorious HCLCs. See Scoresby, 346 S. W.3d at cure deficiencies in the reports as to Dr. Loaisiga. See id. 554; Diversicare, 185 S.W.3d at 854. VI. The P.A. In this case the plaintiffs made the P .A. a party to the case and sought judgment against it based on no facts A. Was an Expert Report Required other than those underlying their claims against Dr. Loaisiga. The P .A. is named after Dr. Loaisiga, and he The plaintiffs' petition names the P .A. as a defendant has not disputed the plaintiffs' allegation that he was and and prays for judgment against it, but the pleading does is its sole officer and director. The plaiutiffs' response to not mention the P.A. otherwise. [**31) The court of the P.A.'s motion to dismiss alleged that Dr. Loaisiga appeals concluded that the 1MLA did not apply to the acted both individually and as the P.A. when he assaulted P.A., given the lack of"allegations of medical negligence the plaintiffs and there "is no differentiation between the or otherwise" against the P.A. S.W.3d at . We two. 11 disagree with that conclusion. [*263) As we discuss above, the determiuation of The court of appeals focused on the latter part of the whether a plaintiffs expert report is adequate is not a first sentence of section 74.351(a}, emphasizing there- merits determination, but rather a preliminary determina- quirement of an expert report 11 for each physician or tion designed to expeditiously weed out claims that have health care provider against whom a liability claim is no merit. In this case the pleadings and record were suf- asserted." S.W.3d at (quoting TEX Civ. PRAC. & ficient to make the plaintiffs' claims as to the P.A. clear: REM. CoDE § 74.351(a)). However, that portion of the they claimed it was vicariously liable for Dr. Loaisiga's statute's text must be read in conjunction with the words conduct. The P.A. could have excepted to and sought that surround it. See Omaha Healthcare Ctr., LLC v. clarification of the pleadings if it desired to have them Johnson, 344 S. W.3d 392, 395 (Tex. 20JI) (explaining clarified, but it did not do so. Page 9 379 S.W.3d 248, *; 2012 Tex. LEXIS 736, **; 55 Tex. Sup. J. 1373

We conclude that if the plaintiffs' claims assert Principal among the Legislature's stated purposes in HCLCs, then [**34] the TMLA's expert report re- enacting the Medical Liability Act was decreasing the quirements apply to the claims against the P.A. just as cost of health care liability claims without unduly re- they do to the claims against Dr. Loaisiga individually. stricting a claimant's rights.' But disagreements [*264] over the Act's expert report requirement/ which is mere- B. Adequacy of the Reports ly intended to weed out frivolous claims early on,' have resulted [**36] in protracted pretrial proceedings and The court of appeals did not consider whether Dr. multiple interlocutory appeals, threatening to defeat the Kilgore's reports are adequate to meet the requirements Act's purpose by increasing costs and delay that do of section 74.351 as to the P.A. S.W.3d at . We nothing to advance claim resolution. In an effort to address the issue for the same reasons expressed above staunch this waste of time and money, we have tried to as to Dr. Loaisiga. See TEX. R. APP. P. 53.4; Reid Road minimize the grounds for such disagreements. We have Mun. Uti/. Dist. No.2, 337 S. W.3d at 855. held that the standard for adequacy of a report is lenient,' Dr. Kilgore stated in his September 3, 2009 report and that leave to cure any deficiencies in a report must be that "[a]ll opinions expressed and contained in my pre- freely given.' As a result, objections and appeals should vious report are adopted in this supplemental report and be fewer. are also applicable to [the P.A.]." His previous report demonstrated that he is a trained and practicing physician 1 Act of June 2, 2003, 78th Leg., R.S., ch. 204, who holds the opinion that Dr. Loaisiga's conduct is im- §§ 10.01, lO.ll(b) (2), (3), 2003 Tex. Gen. Laws plicated and the plaintiffs' claims against Dr. Loaisiga 847, 864, 884-885 (adopting the Medical Liabil- have merit. See supra Part V.B. But, as we explain ity Act as Chapter 74 of the Texas Civil Practice above, Dr. Kilgore's previous report is not adequate to & Remedies Code, and providing that "it is the comply with section 74.351 because he considered only purpose of [the Act] to improve and modifY the the plaintiffs' pleadings in formulating his opinions, By system by which health care liability claims are adopting the previous report, the supplemental report determined in order to ... decrease the cost of meets the minimal standard set out in Scoresby, just as those claims and . . . do so in a manner that will the [**35] original report did, but it is deficient as to not unduly restrict a claimant's rights . .. .u); see the P .A., just as the original report was deficient as to Dr. also Scoresby v. Santillan, 346 S. W.3d 546, 552 Loaisiga. So, if on remand the plaintiffs' claims are de- (Tex. 2011) ("Fundamentally, the goal of [the termined to be HCLCs subject to the TMLA's expert Act] has been to make health care in Texas more report requirements, the trial court should consider the available and less expensive by reducing the cost plaintiffs' request for an extension of time to cure the of health care liability [**37] claims."). reports as to the P.A. See TEX. C!V. PRAC. & REM. CODE§ 2 The Act requires that within 120 days of fil- 74.351(c). ing suit, a claimant must serve a defendant with an expert report setting out the applicable stand- VII. Conclusion ard of care, how the defendant breached it, and how that breach caused the claimant's damages. We reverse the judgment of the court of appeals. We TEX. C!V. PRAC. &REM. CODE§ 74.351(a), M(6). remand the case to the trial court for further proceedings 3 Scoresby, 346 S. W.3d at 552 (stating that the in accordance with this opinion. See id.; Scoresby, 346 Act seeks "to deter frivolous lawsuits by requir- S. W.3d at 557. ing a claimant early in litigation to produce the Phil Johnson opinion of a suitable expert that his claim has merit11 ). Justice 4 Id. at 549 ("[A] document qualifies as an ex- OPINION DELIVERED: August31, 2012 pert report if it contains a statement of opinion by an individual with expertise indicating that the CONCUR BY: Nathan L. Hecht (In Part); Don R. Wil- claim asserted by the plaintiff against the de- lett (In Part); Debra H. Lehrmann fendant has merit. An individual's lack of relevant qualifications and an opinion's inadequacies are DISSENT BY: Nathan L. Hecht (In Part); Don R. Wil- deficiencies the plaintiff should be given an op- lett (In Part); Debra H. Lehrmann portunity to cure if it is possible to do so. This le- nient standard avoids the expense and delay of DISSENT multiple interlocutory appeals and assures a claimant a fair opportunity to demonstrate that his JUSTICE HECHT, joined by JUSTICE MEDINA, concur- claim is not frivolous.11 ), ring in part and dissenting in part. Page 10 379 S.W.3d 248, *; 2012 Tex. LEXIS 736, **; 55 Tex. Sup. J. 1373

5 Id. ("[The Act] authorizes the trial court to the alleged touching will suffice. Thus, it is unnecessary give a plaintiff who meets the 120-day deadline for the Court to allow the claimants on remand to attempt an additional thirty days in which to cure [**38] to show, again, that an expert rep01i is not required. The a 'deficiency' in the elements of the report. The Court's suggestion that they might succeed contradicts trial court should err on the side of granting the the standard the Court announces. I would not allow fur- additional time and must grant it if the deficien- ther proceedings on the issue and risk another appeal. In cies are curable." (footnotes omitted)). all other respects, I join the Court's opinion. With the same goal in mind, the Court today tackles Nathan L. Hecht the issue of when an expert report is required. The Court Justice concludes that "[t]he breadth of the statute's text essen- tially creates a presumption that a claim is an HCLC if it Opinion delivered: August 31, 2012 is against a physician or health care provider and is based JUSTICE WILLETT, concurring in part and dissenting on facts implicating the defendant's conduct during the in part. course of a patient's care, treatment, or confinement. tt 6 I agree that the Act creates such a presumption and that it I join today's well-reasoned decision save one quib- is, as the Court says, "necessarily rebuttable 11 •7 ble: Because I find Parts V.B and Vl.B of the Court's opinion advisory--and thus inadvisable--! respectfully 6 Ante at . dissent from those sections. 7 Ante at . Today the Court clarifies the standard for defining a For the claimant who contends his claim is not an healthcare liability claim (HCLC) and remands so the HCLC, obtaining an expert report should not present a trial court can apply our new guidance. So far so good. If major obstacle, as this case illustrates. The expert report the trial court concludes these claims are not HCLCs, here says, in essence, that sexual assault is not a part of then no expert report is necessary. The Court, however, health care. One need not tum to the Mayo Clinic for proceeds to (p)review the [**41] reports' sufficiency such an opinion. An expert report, as we have interpreted just in case the trial court goes the other way. it, is a low threshold a person claiming against a health This analysis is premature. The trial court hasn't care provider must cross merely to show that his claim is even applied our new test to determine whether these are not frivolous. Occasionally [**39] there will be cases-- HCLCs in the first place. I wouldn't short-circuit its re- this may be one -- in which an expeti report is required view by pre-deciding an issue that might never need de- even though evidence later shows that the claim is not an ciding at all and that might benefit immensely from low- HCLC. While the requirement is thus not perfect, it is er-court analysis. nevertheless a reasonable effort by the Legislature to address what it found to be a crisis in HCLCs. But the As a judiciary, our constitutional role dictates that Act's limitations on damages and other restrictions are we decide concrete cases and not dispense contingent far more severe. A conclusion made early in the case that advice. "[T]he judicial power does not embrace the giv- an expert report must be produced does not preclude a ing of advisory opinions,' 11 and prudent development of later determination, after the [*265] case is more fully the law requires that courts refrain from speculating on developed, that the Act's provisions do not apply after situations that may never arise. all. I Firemen's Ins. Co. of Newark, N.J. v. Burch, The claimants in this case proceeded exactly as they 442 S.W.2d 331, 333 (Tex. 1968). should have. Insisting that their claims are not HCLCs but claims for assault, they nevertheless produced an The Coures motivation, of course, is commendable: expert report. I agree with the Court that the expert could to advance judicial efficiency and squeeze out inordinate not rely entirely on the claimants' petition. A requirement delay. But unless and until the lower courts conclude that that an expert do no more than opine that a pleaded plaintiffs' claims are indeed HCLCs, I would not suggest claim, if true, has merit would do little to forestall frivo- a premature predecision that presupposes--if not predes- lous claims. In most instances, medical records will be tines--a certain lower-court path. enough to support an expert's opinion. In this case, it seems unlikely that a chart notation, "groped patient un- Don R. Willett necessarily", will be found, and the expert may need to Justice base [**40] his opinion on an interview with the claimants. In any event, the deficiency should be simple OPINION DELIVERED: August31, 2012 to cure. The expert's review of records showing that the JUSTICE LEHRMANN, concurring and dissenting. claimants' medical or physical conditions did not warrant Page 11 379 S.W.3d 248, *; 2012 Tex. LEXIS 736, **; 55 Tex. Sup. J. 1373

Whether a claim against a health care provider In describing the expert report requirement imposed [**42] is a health care liability claim is a knotty issue by the Act's predecessor, we have noted on more than this Court has repeatedly struggled with. See, e.g., Tex. one occasion that claimants are not required to marshal W. Oaks Hosp., LP v. Williams, 371 S.W.3d 171, 2012 their proof to [**44] comply with the statute. Bowie Tex. LEXIS 561, 2012 WL 2476807 {Tex. 2012); St. Da- Mem'l Hosp. v. Wright, 79 S. W.3d 48, 52 (Tex. 2002); vid's Health care P'ship v. Esparza, 348 S. W.3d 904 {Tex. Am. Transitional Care Ctrs. of Tex., Inc. v. Palacios, 46 2011); Omaha Healthcare Ctr., LLC v. Johnson, 344 S. W.3d 873, 878 (Tex. 2001). The policy underlying the S. W.3d 392 (Tex. 2011); Diversicare Gen. Partner, Inc. expert report requirement in the current Act remains un- v. Rubio, 185 S. W.3d 842 (Tex. 2005). Claims alleging changed; not to shield health care providers from legiti- that a [*266] physician's actions in examining a pa- mate claims, but to weed out frivolous claims at an early tient amounted to an assault can be particularly con- stage, before the parties and the courts have expended founding, for the reasons the Court discusses: the physi- extensive resources. Scoresby v. Santillan, 346 S. W.3d cal examination of a patient necessarily involves touch- 546, 554 (Tex. 2011). It makes sense not to place a heavy ing, which may be uncomfortable, unexpected, and mis- burden on claimants early in the process, in part, because understood. I concur in the Court's judgment remanding the Act greatly restricts the discovery that is available this case to allow the plaintiffs an opportunity to estab- before an expert report is filed. TEX. CIV. PRAC. & REM. lish that their assault claims are not health care liability CODE§ 74.351(s). In my view, the Court's imposition of claims. I write separately, however, because I believe the a requirement that claimants conclusively establish that Court places too onerous a burden on claimants by re- their allegations do not amount to health care liability quiring them to conclusively establish that their claims claims is inconsistent with those considerations. are not health care liability claims. I would require a In light of the Act's purposes and its broad applica- claimant to satisfy a standard comparable to a "clear and tion, I agree that claimants must to do more than estab- convincing" standard of proof. Under that standard, a lish that their claims are plausibly, or even likely, not trial court should require a [**43] claimant asserting health care liability claims. But I would not go so far as claims against a health care provider arising in the con- the Court. Instead, I would hold that plaintiffs [**45] text of the delivery of medical services to file an expert whose claims arise in the medical context are not re- report unless the record justifies a finn conviction or quired to provide expert reports if the record justifies a belief that the claims presented are not health care liabil- firm belief or conviction that the claims are not health ity claims. care liability claims. This is essentially the same as the Unquestionably, the Legislature intended to alleviate burden of proof required to terminate parental rights. See what it deemed a "health care liability crisis" when it Santosky v. Kramer, 455 U.S. 745, 769, 102 S. Ct. 1388, enacted the Texas Medical Liability Act, TEX. C!V. PRAC. 71 L. Ed. 2d 599 (1982); In re G.M, 596 S.W.2d 846, & REM. CODE§§ 74.001-.507. Accordingly, I agree that 847 (Tex. 1980). Surely a burden sufficient to protect claims arising in the context of the delivery of health parents' constitutional rights in raising their children care services are presumptively health care liability should be sufficiently stringent to protect any interest claims. But, as the Court recognizes, nothing in the Act medical providers might enjoy in having a cause of ac- signals an intent to shield physicians from liability for tion alleging assault [*267] proceed as a health care sexual assaults or similar intentional misconduct. I fear liability claim. Accordingly, I respectfully concur in the that the requirement the Court imposes, that a claimant Court's judgment but disagree with the standard the conclusively establish that a claim is not a health care Court imposes. liability claim in order to rebut the Act's presumptive Debra H. Lehrmann application, may force assault victims to submit expert reports or see their cases dismissed. Justice OPINION DELIVERED: August 31,2012 APPENDIX- ''3'' Page 1

LexisNexis® 1 of 4 DOCUMENTS

ROY KENJI YAMADA, M.D., PETITIONER, v. LAURA FRIEND, INDIVIDU- ALLY AND AS PERSONAL REPRESENTATIVE OF THE ESTATE OF SARAH ELIZABETH FRIEND, DECEASED, AND LUTHER FRIEND, INDIVIDUALLY, RESPONDENTS

NO. 08-0262

SUPREME COURT OF TEXAS

335 S.W.3d 192; 2010 Tex. LEXJS 1012; 54 Tex. Sup. J. 382

March 10, 2009, Argued December 17, 2010, Opinion Delivered

SUBSEQUENT HISTORY: Released for Publica- tion January 28, 2011. OPINION [*193] In this appeal we address whether claims PRIORHISTORY: [**l] against a health care provider based on one set of under- ON PETITION FOR REVIEW FROM THE COURT lying facts can be brought as both health care liability OF APPEALS FOR THE SECOND DISTRICT OF claims subject to the Texas Medical Liability Act TEXAS. (TMLA) and ordinary negligence claims not subject to Yamada v. Friend, 335 S. W.Jd 201, 2008 Tex. App. the TMLA. We hold that they cannot. LEXIS 1680 (Tex. App. Fort Worth, Feb. 28, 2008) Sarah Friend collapsed at a water park and later died. As a result of her death her parents sued several COUNSEL: For ROY KENJI YAMADA, M.D., PETI- parties, including Roy Yamada, M.D. Sarah's parents TIONER: Mr. J. Kevin Carey, Carey Law Firm, Fort alleged that Dr. Yamada negligently advised the water Worth, TX; Ms. Bonnie Susan Bleil, Law Office of Bleil park about safety procedures and placement of defibril- & King, Fort Worth, TX. lators. They did not file an expert report as is required by the TMLA for health care liability claims. For LAURA FRIEND, RESPONDNET: Mr. Darrell L. The court of appeals held that the Friends' allega- Keith, Ms.· Cominey Shannon Keith, Ms. Arin Kay tions that Dr. Yamada's actions violated medical stand- Schall, Keith Law Firm, P.C., Fort Wmih, TX; Mr. Jef- ards of care were health care liability claims and the frey H. Kobs, Kobs, Haney & Hundley, LLP, Fort Friends were required to comply with provisions of the Worth, TX. TMLA as to those claims. The Friends do not dispute that holding. The court also held, however, that the For City of North Richland Hills, OTHER: Mr. George Friends' allegations that the same actions by Dr. Yamada A. Staples Jr., Taylor Olson Adkins Sralla & Elam, Fort violated ordinary standards [**2] of care and were not Worth, TX. subject to the TMLA. For Jeff Ellis, OTHER: Mr. Russell Ramsey, Ramsey & We hold that because all the claims against Dr. Murray, Houston, TX. Yamada were based on the same underlying facts, they must be dismissed because the Friends did not timely file JUDGES: WSTICE JOHNSON delivered the opinion an expert report. When the underlying facts are encom- of the Court. passed by provisions of [*194] the TMLA in regard to a defendant, then all claims against that defendant based OPINION BY: Phil Johnson on those facts must be brought as health care liability Page 2 335 S.W.3d 192, *; 2010 Tex. LEXIS 1012, **; 54 Tex. Sup. J. 382

claims. Application of the TMLA cannot be avoided by court denied Dr. Yamada's motion and he appealed. See artfully pleading around it or splitting claims into both id. § 51.014(a)(9) (authorizing interlocutory appeal from health care liability claims and other types of claims such an order denying a motion to dismiss for lack of an ex- as ordinary negligence claims, pert report).

I. Background B. Court of Appeals The court of appeals noted that the only alleged acts A. Trial Court or omissions on which the Friends based their claims The city of North Richland Hills owns and operates against Dr. Yamada were his failure to properly provide North Richland Hills Family Water Park. In July 2004, advice and recotmnendations to the City about its safety twelve-year-old Sarah Friend was waiting in line for one practices, including the placement and maintenance of of the water park rides when she collapsed. Personnel AEDs. S.W.3d . It determined that the from the water park and North Richland Hills Fire De- pleadings stated claims for negligence based on breach partment administered emergency aid and she was then of an emergency medicine physicians' standard of care, transported to a hospital where she died from a heart but also stated claims for ordinary negligence. Id. at condition. The appeals court reasoned that [**5] medical testimo- ny is not required to establish [*195] the proper Sarah's mother and father, Laura ' and Luther placement of AED devices, thus such claims were not Friend, sued the City and several individual defendants. health care liability claims because the alleged negli- They alleged that Sarah's death was proximately caused gence was not based on advice directly related to acts by the defendants' [**3] failure to timely and properly performed or furnished by a health care provider to Sarah evaluate and care for her after she collapsed. The during her medical care, treatment, or confinement. The Friends' allegations focused on the failure of water park court held that the trial court properly refused to dismiss personnel to use an automated external defibrillator the claims based on allegations of ordinary negligence. (AED) in attending to Sarah. Id. at . However, the court also held that the pleadings alleging Dr. Yamada gave negligent advice about where Laura sued individually and as representative to locate AEDs were health care liability claims to the of Sarah's estate. extent they alleged Dr. Yamada had a duty to act as an The Friends eventually joined Dr. Yamada as a de- emergency physician under the circumstances and he fendant. They alleged that he (1) was a licensed medical breached that duty. The court held that the Friends' fail- doctor who specialized in emergency medicine; (2) "had ure to file an expert report required dismissal of the a duty to exercise ordinary ,care and act as an emergency claims based upon allegations of breach of an emergency medicine physician of reasonable and ordinary prudence room physician's standard of care. Id. at . Thus, the under the same or similar circumstances 11 ; (3) "was re- court of appeals held that the same acts and omissions by sponsible for and provided medical consultative advice Dr. Yamada formed the basis of both health care and and recommendations to and for the various safety prac- non-health care claims based on pleadings alleging that tices and procedures 11 at the water park prior to and as of the acts and omissions breached different standards of the date Sarah collapsed; (4) "had a duty under Texas care. law to exercise ordinary care and act as an emergency medicine physician of reasonable and ordinary prudenceu C. [**6] Positions of the Parties in providing services to the water park; and (5) breached The Friends did not file a petition for review. But "that duty" by (a) failing to timely, properly, and ade- Dr. Yamada did and we granted it. 52 Tex. Sup. Ct. J. quately provide services to the water park and (b) com- 331, 333 (Feb. 13, 2009). mitting "other acts or omissions of negligence or wrongdoing." There was never a doctor-patient [**4] Dr. Yamada asserts that the court of appeals erred in relationship between Dr. Yamada and Sarah. two ways. First, he argues the court construed the defini- tion of health care liability claim based on a breach of The Friends did not file an expert report pursuant to accepted standards of safety too narrowly. Second, he Texas Civil Practice and Remedies Code section 74.351 asserts the court impermissibly allowed "claim splitting" after they sued Dr. Yamada, so he filed a motion to dis- by holding that the same underlying facts gave rise to an miss. See TEX C!V. PRAC. & REM. CODE§ 74.351 (a), (b). ordinary negligence claim, which the court held ·could The Friends' response specified that their claims were continue, and a health care liability claim, which the based on Dr. Yamada1s provision of medical consultative court dismissed. The difference between the claims, Dr. advice and recommendations in regard to various safety Yamada urges, is nothing more than artful pleading. practices and procedures at the water park. The trial Page 3 335 S.W.3d 192, *; 2010 Tex. LEXIS 1012, **; 54 Tex. Sup. J. 382

In their brief, the Friends specify that Dr. Yamada's whether the claimant's claim or cause of connection to Sarah's death was his consultative services action sounds in tort or contract. in regard to placement of life-saving devices such as the AEDs. They do not dispute the court of appeals' charac- terization of their claims as alleging only that Dr. Yama- ld. § 74.00J(a)(13). da failed to properly provide advice and recommenda- Whether a claim is a health care liability claim de- tions to the City about its safety practices. And they pends on the underlying nature of the claim being made. agree that the court of appeals "correctly ... reversed the Garland Cmty. Hosp. v. Rose, 156 S. W.3d 541, 543 (Tex. trial court's order denying Petitioner Dr. [**7] Yama- 2004) (addressing former TEX. REV. Civ. STAT. art. 45901, da's motion to dismiss [their] claims that are based on a repealed by Act of June 2, 2003, 78th [**9] Leg., ch. standard of medical care and dismissed those claims with 204, § 10.09, 2003 Tex. Gen. Laws 847, 884). Artful prejudice." However, they argue that their ordinary neg- pleading does not alter that nature. Diversicare Gen. ligence claim should not be dismissed because it is not in Partne1~ Inc. v. Rubio, 185 S. W.3d 842, 854 (Tex. 2005); essence a health care liability claim. The Friends first Garland Cmty. Hosp., 156 S. W.3d at 543. assert that their ordinary negligence claim is not for breach of standards of medical care or health care as III. Discussion those terms are defined in the TMLA. Next, they argue that to be a health care liability claim for breach of an In Diversicare, Maria Rubio was the victim of a accepted standard of safety under the TMLA, the claim sexual assault at a nursing home. 185 S.W.3d at 845. must be for an act or omission directly related to health Rubio filed suit against the nursing home based in part care, which their ordinary negligence claim is not. See on claims that the home failed to hire and train appropri- TEX. CiV. PRAC. &REM. CODE§ 74.00l(a)(l3). ate personnel to monitor Rubio, failed to provide twen- ty-four-hour nursing services from a sufficient uumber of We agree with Dr. Yamada in part. 2 The court of qualified nursing personnel to meet her nursing needs, appeals' holding that the Friends asserted health care hired incompetent staff who were unqualified to care for liability claims against Dr. Yamada is unchallenged and her, and failed to establish and implement appropriate all their claims were based on the same facts. The safety policies to protect its residents. I d. The concurring Friends' claims against [*196] Dr. Yamada cannot be and dissenting justices in Diversicare concluded that split into health care and non-health care claims by Rubio asserted a premises liability claim against the pleading that his actions violated different standards of nursing home independent of her health care liability care; all their claims must be dismissed. claim. ld. at 857-58 (Jefferson, C.J., concuning in part, and dissenting in part) (pointing to Rubio's claims that 2 Our decision makes it unnecessary to consid- the home failed to protect her by failing to implement er whether the court of appeals [**8] properly safety precautions and establish appropriate corporate construed the TMLA's language regarding safety, training, and staffing [**10] policies); id. at breaches of accepted standards of safety. It is also 861-66 (O'Neill, J., dissenting) (construing Rubio's claim unnecessary to consider the effect, if any, of the that the facility failed to use ordinary care to protect her lack of a doctor-patient relationship between Dr. from a known danger to be a premises liability claim). Yamada and Sarah. The Court rejected the view that Rubio could allege a claim for premises liability independent of her healthcare II. Claims Under the TMLA liability claim because it "would open the door to splic- The TMLA requires the trial court to dismiss a suit ing health care liability claims into a multitude of other asserting health care liability claims against a physician causes of action with standards of care, damages, and or health care provider if the plaintiff does not timely file procedures contrary to the Legislature's explicit require- an expert report as to that defendant. ld. § 74.351. The ments. It is well settled that such artful pleading and re- TMLA defines "health care liability claim" as casting of claims is not permitted." ld. at 854; see also Murphy v. Russell, 167 S. W.3d 835, 838 (Tex. 2005) [A] cause of action against a health ("[A] claimant cannot escape the Legislature's statutory care provider or physician for treatment, scheme by artful pleading."); Garland Cmty. Hosp., 156 lack of treatment, or other claimed depar- S. W.3d at 543 ("Plaintiffs cannot use artful pleadiug to ture from accepted standards of medical avoid the MUlA's requirements when the essence of the care, or health care, or safety or profes- suit is a health care liability claim."). sional or administrative services directly Because the Friends do not challenge the court of related to health care, which proximately appeals' holding that their claims against Dr. Yamada are results in injmy to or death of a claimant, in part health care liability claims and based on facts Page 4 335 S.W.3d 192, *; 2010 Tex. LEXIS 1012, **; 54 Tex. Sup. J. 382

covered by the TMLA, the question before us is whether tient tries to sit down in it. Nevertheless, the Friends note claims based on the [**11] [*197] same facts can their agreement with the court of appeals' holding that alternatively be maintained as ordinary negligence the Azua's claim, although pled as an ordinary negli- claims. We hold that they cannot. gence claim, was a health care liability claim. !d. Despite agreeing that the court of appeals correctly Clearly, particular actions or omissions underlying dismissed their health care liability claims based on the health care liability claims can be highlighted and al- acts and omissions of Dr. Yamada, the Friends allege leged to be breaches of ordinary standards of care. But if that his conduct can also be measured by ordinary stand- the same underlying facts are allowed to give rise to both ards of care as opposed to standards that require specific types of claims, then the TMLA and its procedures and expertise in health care. But it would be hard to find a limitations will effectively be negated. Plaintiffs will be health care liability claim in which some action by the able to entirely avoid application of the TMLA by care- health care provider or physician arguably would not be fully choosing the acts and omissions on which to base within the common knowledge of jurors, and thus would their claims and the language by which they assert the support a claim for ordinary negligence. This case is a claims. prime example of such a claim. The Friends assert that Our prior decisions are to the effect that if the gra- the same actions and omissions by Dr. Yamada are gov- vamen or essence of a cause of action is a health care erned by both standards requiring expert testimony to liability claim, then allowing the claim to be split or establish--one of the factors that can be considered in spliced into a multitude of other causes of action with dete1mining whether a claim is a health care liability differing standards of care, damages, and procedures claim--and standards that do not require expert testimo- would contravene the Legislature's explicit requirements. ny. Diversicare, 185 S.W.3d at 854. Those decisions dictate The Friends reference other examples in their brief. the outcome here. The Friends' allegations that Dr. In Institute for Women's Health, P.L.L.C. v. !mad, 2006 Yamada's actions breached ordinary [**14] standards Tex. App. Lexis 1182 (Tex. App.--San Antonio Feb. 15, of care did [*198] not change either the substantive 2006, no pet.), an embryologist dropped a tray of em- basis or the nature of the claims. bryos [**12] and destroyed all of them except one. The Friends note their agreement with the holding that the IV. Conclusion claims against the emb1yologist were health care liability Based on the unchallenged holding of the court of claims because the specific acts and omissions of the appeals that the Friends' claims based on Dr. Yamada's embryologist were an inseparable part of the health and actions encompassed health care liability claims, all their medical transaction. But even though the carrying of the claims should have been dismissed because they did not tray was an inseparable part of the health and medical file an expert report. We affirm the court of appeals' services, the care required in carrying a tray of embryos judgment to the extent it reversed the trial court's order without dropping it could have been asserted as ordinary and dismissed some of the Friends' claims. We reverse negligence because the care required to carry a the court of appeals' judgment to the extent it affumed tray--whether one carrying embryos or something else the trial court's order denying Dr. Yamada's motion to such as a child's lunch--is not generally outside the dismiss. Because Dr. Yamada requested his attorney's common knowledge of jurors. fees and costs iu the trial court under Texas Civil Prac- The Friends also reference Valley Baptist Medical tice and Remedies Code section 74.35l(b)(l), we remand Center v. Azua, 198 S.W.3d 810 (Tex. App.--Corpus to that court with instructions to dismiss all the Friends' Christi 2006, no pet.). There a hospital employee was claims against Dr. Yamada and consider his request for assisting a patient into a wheelchair. The employee al- attorney's fees and costs. legedly failed to block the wheels of the wheelchair and Phil Johnson the patient was injured when the wheelchair moved as the patient was attempting to sit in it. Id. at 814. It cer- Justice tainly could be argued, as Azua did, that expert testimo- OPINION DELIVERED: December 17,2010 ny is not necessary to establish the need to secure a wheelchair so it will not move when an ill [**13] pa- APPENDIX- ''4'' A\JTit£NTICA·mfl US. GOVERNMENT INFO~MATION

GPO

§482.1 42 CFR Ch. IV (1 0-1-11 Edition) AUTHORITY: Sees. 1102, 1871 and 1881 of the Medicaid must meet the requirements Social Security Act (42 U.S.O. 1302, 1395hh, for participation in Medicare (except in and l395rr), unless otherwise noted, the case of medical supervision of SouRCE:: 51 FR 22042, June 17, 1986, unless nurse-midwife services. See §§ 440.10 and otherwise noted. 440.165 of this chapter.). (b) Scope. Except as provided in sub- Subpart A-General Provisions part A of part 488 of this chapter, the § 482.1 Basis and scope. provisions of this part serve as the basis of survey activities for the pur- (a) Statutory basis. (1) Section 1861(e) pose of determining whether a hospital of the Act provides that-- qualifies for a provider agreement (i) Hospitals participating in Medi- under Medicare and Medicaid. care must meet certain specified re- quirements; and (51 FR 22042, June 17, 1986, as amended at 60 (ii) The Secretary may impose addi- FR 50442, Sept. 29, 19951 tional requirements if they are found necessary in the interest of the health § 482,2 Provision of emergency serv- and safety of the individuals who are ices by nonparticipating hospitals. furnished services in hospitals. (a) The services of an institution that (2) Section 1861(f) of the Act provides does not have an agreement to partici- that an institution participating in pate in the Medicare program may, Medicare as a psychiatric hospital nevertheless, be reimbursed under the must meet certain specified require- program if- ments imposed on hospitals under sec- (1) The services are emergency serv- tion l86l(e), must be primarily engaged ices; and in providing, by or under the super- (2) The institution meets the require- vision of a physician, psychiatric serv- ices for the diagnosis and treatment of ments of section 186l(e) (1) through (5) mentally ill persons, must maintain and (7) of the Act. Rules applicable to clinical records and other records that emergency services furnished by non- the Secretary finds necessary, and participating hospitals are set forth in must meet staffing requirements that subpart G of part 424 of this chapter. the Secretary finds necessary to carry (b) Section 440.170(e) of this chapter out an active program of treatment for defines emergency hospital services for individuals who are furnished services purposes of Medicaid reimbursement. in the hospital. A distinct part of an [51 FR 22042, June 17, 1986, as amended at 53 institution can participate as a psy- FR 6648, Mar. 2, 1986] chiatric hospital if the institution meets the specified 1861(e) require- ments and is primarily engaged in pro- Subpcirt 8-Administralion viding psychiatric services, and if the § 482.11 Condition of participation: distinct part meets the records and Compliance with Federal, State and staffing requirements that the Sec- local laws, retary finds necessary, (3) Sections 186l(k) and 1902(a)(30) of (a) The hospital must be in compli- the Act provide that hospitals partici- ance with applicable Federal laws re- pating in Medicare and Medicaid must lated to the health and safety of pa- have a utilization review plan that tients. meets specified requirements. (b) The hospital must be--- (4) Section 1883 of the Act sets forth (1) Licensed; or the requirements for hospitals that (2) Approved as meeting standards for provide long term care under an agree- licensing established by the agency of ment with the Secretary, the State or locality responsible for li- (5) Section 1905(a) of the Act provides censing hospitals. that "medical assistance" (Medicaid) payments may be applied to various (c) The hospital must assure that hospital services. Regulations inter- personnel are licensed or meet other preting those provisions specify that applicable standards that are required hospitals receiving payment under by State or local laws.

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Centers tor Medicare & Medicaid Services, HHS §482.21 his or her other rights under this sec- (b) Standard: Program data. (l) The tion. program must incorporate quality indi- (2) Inform each patient (or support cator data including patient care data, person, where appropriate) of the right, and other relevant data, for example, subject to his or her consent, to receive information submitted to, or received the visitors whom he or she designates, from, the hospital's Quality Improve- including, but not limited to, a spouse, ment Organization. a domestic partner (including a same- (2) The hospital must use the data sex domestic partner), another family collected to------ member, or a friend, and his or her (i) Monitor the effectiveness and right to withdraw or deny such consent safety of services and quality of care; at any time. and (3) Not restrict, limit, or otherwise (ii) Identify opportunities for im- deny visitation privileges on the basis provement and changes that will lead of race, color, national origin, religion, to improvement. sex, gender identity, sexual orienta- (3) The frequency and detail of data tion, or disability. collection must be specified by the hos- (4) Ensure that all visitors enjoy full pital's governing body. and equal visitation privileges con- (c) Standard: Program activities. (1) sistent with patient preferences. The hospital must set priorities for its (71 FR 71426, Dec. 8, 2006, as amended at 75 performance improvement activities FR 70844, Nov. 19, 2010] that-- (i) Focus on high-risk, hig·h-volume, Subpart c-Basic Hospital or problem-prone areas; Functions (ii) Consider the incidence, preva- lence, and severity of problems in those § 482.21 Condition of participation: areas; and Quality assessment and perform· ance improvement program. (iii) Affect health outcomes, patient safety, and quality of care, The hospital must develop, imple- (2) Performance improvement activi- ment, and maintain an effective, ongo- ties must track medical errors and ad- ing, hospital-wide, data-driven quality verse patient events, analyze their assessment and performance improve- causes, and implement preventive ac- ment program. The hospital's gov- erning body must ensure that the pro- tions and mechanisms that include feedback and learning throughout the gram reflects the complexity of the hospital's organization and services; hospital. involves all hospital departments and (3) The hospital must take actions services (including those services fur- aimed at performance improvement nished under contract or arrangement); and, after implementing those actions, and focuses on indicators related to im- the hospital must measure its success, proved health outcomes and the pre- and track performance to ensure that vention and reduction of medical er- improvements are sustained. rors. The hospital must maintain and (d) Standard: Performance improvement demonstrate evidence of its QAPI pro- projects. As part of its quality assess- gram for review by OMS. ment and performance improvement (a) Standard: Program scope. (1) The program, the hospital must conduct program must include, but not be lim- performance improvement projects. ited to, an ongoing program that shows (1) The number and scope of distinct measurable improvement in indicators improvement projects conducted annu- for which there is evidence that it will ally must be proportional to the scope improve health outcomes and identify and complexity of the hospital's serv- and reduce medical errors. ices and operations. (2) The hospital must measure, ana- (2) A hospital may, as one of its lyze, and track quality indicators, in- projects, develop and implement an in- cluding adverse patient events, and formation technology system explic- other aspects of performance that as- itly designed to improve patient safety sess processes of care, hospital service and quality of care. This project, in its and operations. initial stage of development, does not

VerDate Mar<15>2010 14:23 Jan 03, 2012 Jkt 223185 PO 00000 Frm 00023 Fmt 8010 Sfmt 8010 Q:\42\X42\COPY223185.XXX ofr150 PsN: PC150 §482.22 42 CFR Ch.IV (10-1-11 Edition) need to demonstrate measurable im- (1) The medical staff must periodi- provement in indicators related to cally conduct appraisals of its mem- health outcomes. bers. (3) The hospital must document what (2) The medical staff must examine quality improvement projects are credentials of candidates for medical being conducted, the reasons for con- staff membership and make rec- ducting these projects, and the measur- ommendations to the governing body able progress achieved on these on the appointment of the candidates. projects. (3) When telemedicine services are (4) A hospital is not required to par- furnished to the hospital's patients ticipate in a QIO cooperative project, through an agreement with a distant- but its own projects are required to be site hospital, the governing body of the of comparable effort. hospital whose patients are receiving (e) Standard: Executive responsibilities. the telemedicine services may choose, The hospital's governing body (or orga- in lieu of the requirements in para- nized group or individual who assumes g'l'aphs (a)(l) and (a)(2) of this section, full legal authority and responsibility to have its medical staff rely upon the for operations of the hospital), medical credentialing and privileging decisions staff, and administrative officials are made by the distant-site hospital when responsible and accountable for ensur- making recommendations on privi1eges ing the following: for the individual distant-site physi- (1) That an ongoing program for qual- cians and practitioners providing such ity improvement and patient safety, services, if the hospital's governing including the reduction of medical er- body ensures, through its written rors, is defined, implemented, and agreement with the distant-site hos- maintained. pital, that all of the following provi- (2) That the hospital-wide quality as- sions are met: sessment and performance improve- (i) The distant-site hospital providing ment efforts address priorities for im- the telemedicine services is a Medi- proved quality of care and patient safe- care-participating hospital. ty; and that all improvement actions (ii) The individual distant-site physi- are evaluated. cian or practitioner is privileged at the (3) That clear expectations for safety distant-site hospital providing the tale- are established. medicine services, which provides a (4) That adequate resources are allo- current list of the distant-site physi- cated for measuring, assessing, improv- cian's or practitioner's privileges at ing, and sustaining the hospital's per- the distant-site hospital. formance and reducing risk to patients. (iii) The individual distant-site phy- (5) That the determination of the sician or practitioner holds a license number of distinct improvement issued or recognized by the State in projects is conducted annually. which the hospital whose patients are receiving the telemedicine services is f6B FR 3454, Jan. 24, 2003] located. (iv) With respect to a distant-site § 482.22 Condition of participation: physician or practitioner, who holds Medical staff, current privileges at the hospital The hospital must have an organized whose patients are receiving the tele- medical staff that operates under by- medicine services, the hospital has evi- laws approved by the governing body dence of an internal review of the dis- and is responsible for the quality of tant-site physician's or practitioner's medical care provided to patients by performance of these privileges and the hospital. sends the distant-site hospital such (a) Standard: Composition of the med- performance information for use in the ical staff, The medical staff must be periodic appraisal of the distant-site composed of doctors of medicine or os- physician or practitioner. At a min- teopathy and, in accordance with State imum, this information must include law, may also be composed of other all adverse events that result from the practitioners appointed by the gov- telemedicine services provided by the erning body. distant-site physician or practitioner

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§482.41 42 CFR Ch. IV (1 0-1-11 Edition)

professional services provided, to de- (ii) Chapter 19.3.6.3.2, exception num- termine medical necessity and to pro- ber 2 of the adopted edition of the LSC mote the most efficient use of avail- does not apply to hospitals. able health facilities and services. (2) After consideration of State sur- vey agency findings, OMS may waive §482.41 Condition of participation: specific provisions of the Life Safety Physical environment, Code which, if rigidly applied, would The hospital must be constructed, ar- result in unreasonable hardship upon ranged, and maintained to ensure the the facility, but only if the waiver does safety of the patient, and to provide fa- not adversely affect the health and cilities for diagnosis and treatment and safety of the patients. for special hospital services appro- (3) The provisions of the Life Safety priate to the needs of the community. Code do not apply in a State where (a) Standard: Buildings. The condition CMS finds that a fire and safety code of the physical plant and the overall imposed by State law adequately pro- hospital environment must be devel- tects patients in hospitals. oped and maintained in such a manner (4) Beginning March 13, 2006, a hos- that the safety and well-being of pa- pital must be in compliance with Chap- tients are assured. ter 19.2.9, Emergency Lighting. (1) There must be emergency power (5) Beginninjr March 13, 2006, Chapter and lighting in at least the operating, 19.3.6.3.2, exception number 2 does not recovery, intensive care, and emer- apply to hospitals. gency rooms, and stairwells. In all (6) The hospital must have proce- other areas not serviced by the emer- dures for the proper routine storage gency supply source, battery lamps and and prompt disposal of trash. flashlights must be available. (2) There must be facilities for emer- (7) The hospital must have written gency gas and water supply. fire control plans that contain provi- sions for prompt reporting of fires; ex- (b) Standard: Life safety [rom [ire. (1) tinguishing fires; protection of pa- Except as otherwise provided in this tients, personnel and guests; evacu- section- (1) The hospital must meet the appli- ation; and cooperation with fire fight- cable provisions of the 2000 edition of ing authorities. the Life Safety Code of the National (8) The hospital must maintain writ- Fire Protection Association. The Di- ten evidence of regular inspection and rector of the Office of the Federal Reg- approval by State or local fire control ister has approved the NFPA 101 ® 2000 agencies. edition of the Life Safety Code, issued (9) Notwithstanding any provisions of January 14, 2000, for incorporation by the 2000 edition of the Life Safety Code reference in accordance with 5 U.S.C. to the contrary, a hospital may install 552(a) and 1 CFR part 51. A copy of the alcohol-based hand rub dispensers in Code is available for inspection at the 1ts facility if- OMS Information Resource Center, 7500 (i) Use of alcohol-based hand rub dis- Security Boulevard, Baltimore, MD or pensers does not conflict with any at the National Archives and Records State or local codes that prohibit or Administration (NARA). For informa- otherwise restrict the placement of al- tion on the availability of this mate- cohol-based hand rub dispensers in rial at NARA, call 202-741-6030, or go health care facilities; to: htlp:!lwww.aTchives.gov/ (ii) The dispensers are installed in a [ederal_Tegisterl manner that minimizes leaks and spills code_of__federal_regulations/ that could lead to falls; ibr_locations.html. Copies may be ob- (iii) The dispensers are installed in a tained from the National Fire Protec- manner that adequately protects tion Association, 1 Batterymarch Park, against inappropriate access; Quincy, MA 02269. If any changes in (iv) The dispensers are installed in this edition of the Code are incor- accordance with chapter 18.3.2.7 or porated by reference, CMS will publish chapter 19.3.2.7 of the 2000 edition of notice in the FEDERAL REGISTER to an- the Life Safety Code, as amended by nounce the changes. NFPA Temporary Interim Amendment

VerDa!e Mar<15>2010 14:23 Jan 03, 2012 Jkt 223185 PO 00000 Frm 00034 Fm! 8010 Sfmt 8010 Q:\42\X42\COPY223185.XXX ofr150 PsN: PC150 Centers for Medicare & Medicaid Services, HHS §482.43 00-1(101), issued by the Standards Coun- fying, reporting, investigating, and cil of the National Fire Protection As- controlling infections and commu- sociation on April 15, 2004. The Direc- nicable diseases of patients and per- tor of the Office of the Federal Register sonnel. has approved NFPA Temporary In- (2) The infection control officer or of- terim Amendment 00-1(101) for incorpo- ficers must maintain a log of incidents ration by reference in accordance with related to infections and commu- 5 U .S.C. 552(a) and 1 CFR part 51. A nicable diseases. copy of the amendment is available for (b) Standard: Responsibilities of chief inspection at the OMS Information Re- executive officer, medical staff, and dime- source Center, 7500 Security Boulevard, tor of nursing services. The chief execu- Baltimore, MD and at the Office of the tive officer, the medical staff, and the Federal Register, 800 North Capitol director of nursing services must- Street NW., Suite 700, Washington, DC. (1) Ensure that the hospital-wide Copies may be obtained from the Na- quality assurance program and train- tional Fire Protection Association, 1 ing programs address problems identi- Batterymaroh Park, Quincy, MA 02269; fied by the infection control officer or and officers; and (v) The dispensers are maintained in (2) Be responsible for the implemen- accordance with dispenser manufac- tation of successful corrective action turer guidelines. plans in affected problem areas. (c) Standard: Facilities. The hospital must maintain adequate facilities for § 482.43 Condition of participation: its services. Dischal'ge planning. (1) Diagnostic and therapeutic facili- ties must be located for the safety of The hospital must have in effect a patients. discharge planning process that applies (2) Facilities, supplies, and equip-- to all patients. The hospital's policies ment must be maintained to ensure an and procedures must be specified in acceptable level of safety and quality. writing. (3) The extent and complexity of fa- (a) Standard: Identification of patients cilities must be determined by the in need of discharge planning. The hos- services offered. pital must identify at an early stage of (4) There must be proper ventilation, hospitalization all patients who are light, and temperature controls in likely to suffer adverse health con- pharmaceutical, food preparation, and sequences upon discharge if there is no other appropriate areas. adequate discharge planning, (b) Standard: Discharge planning eval- (51 FR 22042, June 17, 1966, as amended at 53 uation. (1) The hospital must provide a FR 11509, Apr, 7, 1988; 68 FR 1386, Jan. 10, 2003; 69 FR 49267, Aug, 11, 2004; 70 FR 15238, discharge planning evaluation to the Mar. 25, 2005; 71 FR 55340, Sept, 22, 2006] patients identified in paragraph (a) of this section, and to other patients upon § 482.42 Condition of participation: In· the patient's request, the request of a fection control. person acting on the patient's behalf, The hospital must provide a sanitary or the request of the physician. environment to avoid sources and (2) A registered nurse, social worker, transmission of infections and commu- or other appropriately qualified per- nicable diseases. There must be an ac- sonnel must develop, or supervise the tive program for the prevention, con- development of, the evaluation. trol, and investigation of infections (3) The discharge planning evaluation and communicable diseases. must include an evaluation of the like- (a) Standard: Organization and poli- lihood of a patient needing post-- hos- cies. A person or persons must be des- pital services and of the availability of ignated as infection control officer or the services. officers to develop and implement poli- {4) The discharge planning evaluation cies governing control of infections and must include an evaluation of the like- communicable diseases. lihood of a patient's capacity for self- (1) The infection control officer or of- care or of the possibility of the patient ficers must develop a system for identi- being cared for in the environment

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<> Texas Administrative Code TITLE 25 HEALTH SERVICES PART I DEPARTMENT OF STATE HEALTH SERVICES CHAPTER 133 HOSPITAL LICENSING SUBCHAPTER A GENERAL PROVISIONS RULE §133.1 Purpose -----·-·------- (a) The purpose of this chapter is to implement the Health and Safety Code, Chapter 241, which requires general and special hospitals to be licensed by the Department of State Health Services.

(b) This chapter provides procedures for obtaining a hospital license; minimum standards for hospital functions and services; patient rights standards; discrimination or retaliation standards; patient transfer and other policy and protocol requirements; reporting, posting and training requirements relating to abuse and neglect; standards for voluntary agreements; waiver provisions; inspection and investigation procedures; enforcement standards; fire prevention and protection requirements; general safety standards; physical plant and construction requirements for existing and new hospitals, and mobile transportable and relocatable units; and standards for the preparation, submittal, review and approval of construction documents.

(c) Compliance with this chapter does not constitute release from the requirements of other applicable federal, state, or local laws, codes, mles, regulations and ordinances. This chapter must be followed where it exceeds other codes and ordinances.

Source Note: The provisions of this §133.1 adopted to be effective June 21,2007, 32 TexReg 3587

List of Titles -] L[___Ba_c_k_to_Li_st_ _ _j

TEXAS REGISTER TEXAS ADMINISTRATIVE CODE OPEN MEETINGS

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<> Texas Administrative Code TITLE25 HEALTH SERVICES PART I DEPARTMENT OF STATE HEALTH SERVICES CHAPTER 133 HOSPITAL LICENSING SUBCHAPTER C OPERATIONAL REQUIREMENTS RULE §133.41 Hospital Functions and Services

(a) Anesthesia services. If the hospital furnishes anesthesia services, these services shall be provided in a well-organized manner under the direction of a qualified physician in accordance with the Medical Practice Act and the Nursing Practice Act. The hospital is responsible for and shall document all anesthesia services administered in the hospital.

(1) Organization and staffing. The organization of anesthesia services shall be appropriate to the scope of the services offered. Only personnel who have been approved by the facility to provide anesthesia services shall administer anesthesia. All approvals or delegations of anesthesia services as authorized by law shall be documented and include the training, experience, and qualifications of the person who provided the service.

(2) Delivery of services. Anesthesia services shall be consistent with needs and resources. Policies on anesthesia procedure shall include the delineation of pre-anesthesia and post-anesthesia responsibilities. The policies shall ensure that the following are provided for each patient.

(A) A pre-anesthesia evaluation by an individual qualified to administer anesthesia under paragraph (1) of this subsection shall be performed within 48 hours prior to surgery.

(B) An intraoperative anesthesia record shall be provided. The record shall include any complications or problems occurring during the anesthesia including time, description of symptoms, review of affected systems, and treatments rendered. The record shall correlate with the controlled substance administration record.

(C) A post-anesthesia follow-up report shall be written by the person administering the anesthesia before transferring the patient from the post-anesthesia care unit and shall include evaluation for recovery from anesthesia, level of activity, respiration, blood pressme, level of consciousness, and patient's oxygen saturation level.

(i) With respect to inpatients, a post-anesthesia evaluation for proper anesthesia recovery shall be performed after transfer from the post-anesthesia care unit and within 48 hours after surgery by the person administering the anesthesia, registered nurse (RN), Ol' physician in accordance with policies and procedures approved by the medical staff and using criteria written in the medical staff bylaws for postoperative monitoring of anesthesia.

(ii) With respect to outpatients, immediately prior to discharge, a post-anesthesia evaluation for proper anesthesia recovery shall be performed by the person administering the anesthesia, RN, or physician in accordance with policies and procedures approved by the medical staff and using criteria written in the medical staff bylaws for postoperative monitoring of anesthesia. 1

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(b) Chemical dependency services.

(1) Chemical dependency unit. A hospital may not admit patients to a chemical dependency services unit unless the unit is approved by the Department of State Health Services (department) as meeting the requirements of§ 133.163(q) of this title (relating to Spatial Requirements for New Construction).

(2) Admission criteria. A hospital providing chemical dependency services shall have written admission criteria that are applied uniformly to all patients who are admitted to the chemical dependency unit.

(A) The hospital's admission criteria shall include procedures to prevent the admission of minors for a condition which is not generally recognized as responsive to treatment in an inpatient setting for chemical dependency services.

(i) The following conditions are not generally recognized as responsive to treatment in a treatment facility for chemical dependency unless the minor to be admitted is qualified because of other disabilities, such as:

(I) cognitive disabilities due to intellectual disability;

(II) learning disabilities; or

(III) psychiatric disorders.

(ii) A minor may be qualified for admission based on other disabilities which would be responsive to chemical dependency services.

(iii) A minor patient shall be separated from adult patients.

(B) The hospital shall have a preadmission examination procedure under which each patient's condition and medical history are reviewed by a member of the medical staff to determine whether the patient is likely to benefit significantly from an intensive inpatient program or assessment.

(C) A voluntarily admitted patient shall sign an admission consent form prior to admission to a chemical dependency unit which includes verification that the patient has been informed of the services to be provided and the estimated charges.

(3) Compliance. A hospital providing chemical dependency services in an identifiable unit within the hospital shall comply with Chapter 448, Subchapter B of this title (relating to Standard of Care Applicable to All Providers).

(c) Comprehensive medical rehabilitation services.

(I) Rehabilitation units. A hospital may not admit patients to a comprehensive medical rehabilitation services unit unless the unit is approved by the department as meeting the requirements of §133.163(z) of this title.

(2) Equipment and space. The hospital shall have the necessary equipment and sufficient space to implement the treatment plan described in paragraph (7)(C) of this subsection and allow for adequate care. Necessary equipment is all equipment necessary to comply with all parts of the written 2

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treatment plan. The equipment shall be on-site or available through an atTangement with another provider. Sufficient space is the physical area of a hospital which in the aggregate, constitutes the total amount of the space necessary to comply with the written treatment plan.

(3) Emergency requirements. Emergency personnel, equipment, supplies and medications for hospitals providing comprehensive medical rehabilitation services shall be as follows.

(A) A hospital that provides comprehensive medical rehabilitation services shall have emergency equipment, supplies, medications, and designated personnel assigned for providing emergency care to patients and visitors.

(B) The emergency equipment, supplies, and medications shall be properly maintained and immediately accessible to all areas of the hospital. The emergency equipment shall be periodically tested according to the policy adopted, implemented and enforced by the hospital.

(C) At a minimum, the emergency equipment and supplies shall include those specified in subsection (e)(4) of this section.

(D) The personnel providing emergency care in accordance with this subsection shall be staffed for 24-hour coverage and accessible to all patients receiving comprehensive medical rehabilitation services. At least one person who is qualified by training to perform advanced cardiac life support and administer emergency drugs shall be on duty each shift.

(E) All direct patient care licensed personnel shall maintain current certification in cardiopulmonary resuscitation (CPR).

(4) Medications. A rehabilitation hospital's governing body shall adopt, implement and enforce policies and procedures that require all medications to be administered by licensed nurses, physicians, or other licensed professionals authorized by law to administer medications.

(5) Organization and Staffing.

(A) A hospital providing comprehensive medical rehabilitation services shall be organized and staffed to ensure the health and safety of the patients.

(i) All provided services shall be consistent with accepted professional standards and practice.

(ii) The organization of the services shall be appropriate to the scope of the services offered.

(iii) The hospital shall adopt, implement and enforce written patient care policies that govern the services it furnishes.

(B) The provision of comprehensive medical rehabilitation services in a hospital shall be under the medical supervision of a physician who is on duty and available, or who is on-call 24 hours each day.

(C) A hospital providing comprehensive medical rehabilitation services shall have a medical director or clinical director who supervises and administers the provision of comprehensive medical rehabilitation services.

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(i) The medical director or clinical director shall be a physician who is board certified or eligible for board certification in physical medicine and rehabilitation, orthopedics, neurology, neurosurgery, internal medicine, or rheumatology as appropriate for the rehabilitation program.

(ii) The medical director or clinical director shall be qualified by training or at least two years training and experience to serve as medical director or clinical director. A person is qualified under this subsection if the person has training and experience in the treatment of rehabilitation patients in a rehabilitation setting.

(6) Admission criteria. A hospital providing comprehensive medical rehabilitation services shall have written admission criteria that are applied uniformly to all patients who are admitted to the comprehensive medical rehabilitation unit.

(A) The hospital's admission criteria shall include procedures to prevent the admission of a minor for a condition which is not generally recognized as responsive to treatment in an inpatient setting for comprehensive medical rehabilitation services.

(i) The following conditions are not generally recognized as responsive to treatment in an inpatient setting for comprehensive medical rehabilitation services unless the minor to be admitted is qualified because of other disabilities, such as:

(I) cognitive disabilities due to intellectual disability;

(II) learning disabilities; or

(III) psychiatric disorders.

(ii) A minor may be qualified for admission based on other disabilities which would be responsive to comprehensive medical rehabilitation services.

(B) The hospital shall have a preadmission examination procedure under which each patient's condition and medical history are reviewed by a member of the medical staffto determine whether the patient is likely to benefit significantly from an intensive inpatient program or assessment.

(7) Care and services.

(A) A hospital providing comprehensive medical rehabilitation services shall use a coordinated interdisciplinary team which is directed by a physician and which works in collaboration to develop and implement the patient's treatment plan.

(i) The interdisciplinary team for comprehensive medical rehabilitation services shall have available to it, at the hospital at which the services are provided or by contract, members of the following professions as necessary to meet the treatment needs of the patient:

(I) physical therapy;

(II) occupational therapy;

(III) speech-language pathology;

(IV) therapeutic recreation; 4

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(V) social services and case management;

(VI) dietetics;

(VII) psychology;

(VIII) respiratory therapy;

(IX) rehabilitative nursing;

(X) ce1iified orthotics;

(XI) certified prosthetics;

(XII) phmmaceutical care; and

(XIII) in the case of a minor patient, persons who have specialized education and training in emotional, mental health, or chemical dependency problems, as well as the treatment of minors.

(ii) The coordinated interdisciplinary temn approach used in the rehabilitation of each patient shall be documented by periodic entries made in the patient's medical record to denote:

(I) the patient's status in relationship to goal attainment; and

(II) that team conferences are held at least every two weeks to determine the appropriateness of treatment.

(B) An initial assessment and preliminary treatment plaJI shall be performed or established by the physician within 24 hours of admission.

(C) The physiciaJI in coordination with the interdisciplinary team shall establish a written treatment plan for the patient within seven working days of the date of admission.

(i) Comprehensive medical rehabilitation services shall be provided in accordaJice with the written treatment plan.

(ii) The treatment provided under the written treatment plan shall be provided by staff who are qualified to provide services under state law. The hospital shall establish written qualifications for services provided by each discipline for which there is no applicable state statute for professional licensure or certification.

(iii) Services provided under the written treatment plan shall be given in accordance with the orders of physiciaJis, dentists, podiatrists or practitioners who are authorized by the governing body, hospital administration, and medical staff to order the services, and the orders shall be incorporated in the patient's record.

(iv) The written treatment plan shall delineate anticipated goals and specifY the type, amount, frequency, and anticipated duration of service to be provided.

Cont'd ...

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List of Titles ~ [_ Back to List ·--- J TEXAS REGISTER TEXAS ADMINISTRATIVE CODE OPEN MEETINGS

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<> Texas Administrative Code TITLE 25 HEALTH SERVICES PART I DEPARTMENT OF STATE HEALTH SERVICES CHAPTER 133 HOSPITAL LICENSING SUBCHAPTER C OPERATIONAL REQUIREMENTS RULE §133.41 Hospital Functions and Services

(v) Within 10 working days after the date of admission, the written treatment plan shall be provided. It shall be in the person's primary language, if practicable. What is or would have been practicable shall be determined by the facts and circumstances of each case. The written treatment plan shall be provided to:

(I) the patient;

(II) a person designated by the patient; and

(III) upon request, a family member, guardian, or individual who has demonstrated on a routine basis responsibility and participation in the patient's care or treatment, but only with the patient's consent unless such consent is not required by law.

(vi) The written treatment plan shall be reviewed by the interdisciplinary team at least every two weeks.

(vii) The written treatment plan shall be revised by the interdisciplinary team if a comprehensive reassessment of the patient's status or the results of a patient case review conference indicates the need for revision.

(viii) The revision shall be incorporated into the patient's record within seven working days after the revision.

(ix) The revised treatment plan shall be reduced to writing in the person's primary language, if practicable, and provided to:

(I) the patient;

(II) a person designated by the patient; and

(III) upon request, a family member, guardian, or individual who has demonstrated on a routine basis responsibility and participation in the patient's care or treatment, but only with the patient's consent unless such consent is not required by law.

(8) Discharge and continuing care plan. The patient's interdisciplinary team shall prepare a written continuing care plan that addresses the patient's needs for care after discharge.

(A) The continuing care plan for the patient shall include recommendations for treatment and care and information about the availability of resources for treatment or care. 7

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(B) If the patient's interdisciplinary team deems it impracticable to provide a written continuing care plan prior to discharge, the patient's interdisciplinary team shall provide the written continuing care plan to the patient within two working days after the date of discharge.

(C) Prior to discharge or within two working days after the date of discharge, the written continuing care plan shall be provided in the person's primary language, if practicable, to:

(i) the patient;

(ii) a person designated by the patient; and

(iii) upon request, to a family member, guardian, or individual who has demonstrated on a routine basis responsibility and participation in the patient's care or treatment, but only with the patient's consent unless such consent is not required by law.

(d) Dietary services. The hospital shall have organized dietary services that are directed and staffed by adequate qualified personnel. However, a hospital that has a contract with an outside food management company or an a!1'angement with another hospital may meet this requirement if the company or other hospital has a dietitian who serves the hospital on a full-time, part-time, or consultant basis, and if the company or other hospital maintains at least the minimum requirements specified in this section, and provides for the frequent and systematic liaison with the hospital medical staff for recommendations of dietetic policies affecting patient treatment. The hospital shall ensure that there are sufficient personnel to respond to the dietary needs of the patient population being served.

(1) Organization.

(A) The hospital shall have a full-time employee who is qualified by experience or training to serve as director of the food and dietetic service, and be responsible for the daily management of the dietary services.

(B) There shall be a qualified dietitian who works full-time, part-time, or on a consultant basis. If by consultation, such services shall occur at least once per month for not less than eight hours. The dietitian shall:

(i) be currently licensed under the laws of this state to use the titles oflicensed dietitian or provisional licensed dietitian, or be a registered dietitian;

(ii) maintain standards for professional practice;

(iii) supervise the nutritional aspects of patient care;

(iv) make an assessment of the nutritional status and adequacy of nutritional regimen, as appropriate;

(v) provide diet counseling and teaching, as appropriate;

(vi) document nutritional status and pertinent information in patient medical records, as appropriate;

(vii) approve menus; and 8

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(viii) approve menu substitutions.

(C) There shall be administrative and teclmical personnel competent in their respective duties. The administrative and technical personnel shall:

(i) participate in established departmental or hospital training pertinent to assigned duties;

(ii) conform to food handling teclmiques in accordance with paragraph (2)(E)(viii) of this subsection;

(iii) adhere to clearly defined work schedules and assignment sheets; and

(iv) comply with position descriptions which are job specific.

(2) Director. The director shall:

(A) comply with a position description which is job specific;

(B) clearly delineate responsibility and authority;

(C) participate in conferences with administration and department heads;

(D) establish, implement, and enforce policies and procedures for the overall operational components of the department to include, but not be limited to:

(i) quality assessment and performance improvement program;

(ii) frequency of meals served;

(iii) nonroutine occurrences; and

(iv) identification of patient trays; and

(E) maintain authority and responsibility for the following, but not be limited to:

(i) orientation and training;

(ii) performance evaluations;

(iii) work assignments;

(iv) supervision of work and food handling techniques;

(v) procur~ment of food, paper, chemical, and other supplies, to include implementation of first- in first-out rotation system for all food items;

(vi) ensuring there is a four-day food supply on hand at all times;

(vii) menu planning; and

(viii) ensuring compliance with §§229.161 -229.171 of this title (relating to Texas Food Establishments). 9

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(3) Diets. Menus shall meet the needs of the patients.

(A) Therapeutic diets shall be prescribed by the physician(s) responsible for the care of the patients. The dietary department of the hospital shall:

(i) establish procedures for the processing of therapeutic diets to include, but not be limited to:

(I) accurate patient identification;

(II) transcription from nursing to dietary services;

(III) diet planning by a dietitian;

(IV) regular review and updating of diet when necessary; and

(V) written and verbal instruction to patient and family. It shall be in the patient's primary language, if practicable, prior to discharge. What is or would have been practicable shall be determined by the facts and circumstances of each case;

(ii) ensure that therapeutic diets are planned in writing by a qualified dietitian;

(iii) ensure that menu substitutions are approved by a qualified dietitian;

(iv) document pertinent information about the patient's response to a therapeutic diet in the medical record; and

(v) evaluate therapeutic diets for nutritional adequacy.

(B) Nutritional needs shall be met in accordance with recognized dietmy practices and in accordance with orders of the physician(s) or appropriately credentialed practitioner(s) responsible for the care of the patients. The following requirements shall be met.

(i) Menus shall provide a sufficient variety of foods served in adequate mnounts at each meal according to the guidance provided in the Recommended Dietmy Allowances (RDA), as published by the Food and Nutrition Board, Commission on Life Sciences, National Research Council, Tenth edition, 1989, which may be obtained by writing the National Academies Press, 500 Fifth Street, NW Lockbox 285, Washington, D.C. 20055, telephone (888) 624-8373.

(ii) A maximum of 15 hours shall not be exceeded between the last meal of the day (i.e. supper) and the breakfast meal, unless a substantial snack is provided. The hospital shall adopt, implement, and enforce a policy on the definition of "substantial" to meet each patient's varied nutritional needs.

(C) A current therapeutic diet manual approved by the dietitian and medical staff shall be readily available to all medical; nursing, and food service personnel. The therapeutic manual shall:

(i) be revised as needed, not to exceed 5 years;

(ii) be appropriate for the diets routinely ordered in the hospital;

(iii) have standards in compliance with the RDA;

(iv) contain specific diets which are not in compliance with RDA; and 10

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(v) be used as a guide for ordering and serving diets.

(e) Emergency services. All licensed hospital locations, including multiple-location sites, shall have an emergency suite that complies with §133.161(a)(l)(A) of this title (relating to Requirements for Buildings in Which Existing Licensed Hospitals are Located) or § 133.163(f) of this title, and the following.

(I) Organization. The organization of the emergency services shall be appropriate to the scope of the services offered.

(A) The services shall be organized under the direction of a qualified member of the medical staff who is the medical director or clinical director.

(B) The services shall be integrated with other departments of the hospital.

(C) The policies and procedures governing medical care provided in the emergency suite shall be established by and shall be a continuing responsibility of the medical staff.

(D) Medical records indicating patient identification, complaint, physician, nurse, time admitted to the emergency suite, treatment, time discharged, and disposition shall be maintained for all emergency patients.

(E) Each freestanding emergency medical care facility shall advertise as an emergency room. The facility shall display notice that it functions as an emergency room.

(i) The notice shall explain that patients who receive medical services will be billed according to comparable rates for hospital emergency room services in the same region.

(ii) The notice shall be prominently and conspicuously posted for display in a public area of the facility that is readily available to each patient, managing conservator, or guardian. The postings shall be easily readable and consumer-friendly. The notice shall be in English and in a second language appropriate to the demographic makeup of the community served.

(2) Personnel.

(A) There shall be adequate medical and nursing personnel qualified in emergency care to meet the written emergency procedures and needs anticipated by the hospital.

(B) Except for comprehensive medical rehabilitation hospitals and pediatric and adolescent hospitals that generally provide care that is not administered for or in expectation of compensation:

(i) there shall be on duty and available at all times at least one person qualified as determined by the medical staff to initiate immediate appropriate lifesaving measures; and

(ii) in general hospitals where the emergency treatment area is not contiguous with other areas of the hospital that maintain 24 hour staffing by qualified staff (including but not limited to separation by one or more floors in multiple-occupancy buildings), qualified personnel must be physically present in the emergency treatment area at all times.

(C) Except for comprehensive medical rehabilitation hospitals and pediatric and adolescent hospitals that generally provide care that is not administered for or in expectation of compensation, 11

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the hospital shall provide that one or more physicians shall be available at all times for emergencies, as follows.

(i) General hospitals, except for hospitals designated as critical access hospitals (CAHs) by the Centers for Medicare & Medicaid Services (CMS), located in counties with a population of I 00,000 or more shall have a physician qualified to provide emergency medical care on duty in the emergency treatment area at all times.

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TEXAS REGISTER TEXAS ADMINISTRATIVE CODE OPEN MEETINGS

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<> Texas Administrative Code TITLE 25 HEALTH SERVICES PARTl DEPARTMENT OF STATE HEALTH SERVICES CHAPTER 133 HOSPITAL LICENSING SUBCHAPTER C OPERATIONAL REQUIREMENTS RULE §133.41 Hospital Functions and Services

(ii) Special hospitals, hospitals designated as CAHs by the CMS, and general hospitals located in counties with a population of less than 100,000 shall have a physician on-call and able to respond in person, or by radio or telephone within 30 minutes.

(D) Schedules, names, and telephone numbers of all physicians and others on emergency call duty, including alternates, shall be maintained. Schedules shall be retained for no less than one year.

(3) Supplies and equipment. Adequate age appropriate supplies and equipment shall be available and in readiness for use. Equipment and supplies shall be available for the administration of intravenous medications as well as facilities for the control of bleeding and emergency splinting of fractures. Provision shall be made for the storage of blood and blood products as needed. The emergency equipment shall be periodically tested according to the policy adopted, implemented and enforced by the hospital.

(4) Required emergency equipment. At a minimum, the age appropriate emergency equipment and supplies shall include the following:

(A) emergency call system;

(B) oxygen;

(C) mechanical ventilatory assistance equipment, including airways, manual breathing bag, and mask;

(D) cardiac defibrillator;

(E) cardiac monitoring equipment;

(F) laryngoscopes and endotracheal tubes;

(G) suction equipment;

(H) emergency dmgs and supplies specified by the medical staff;

(I) stabilization devices for cervical injuries;

(J) blood pressure monitoring equipment; and

(K) pulse oximeter or similar medical device to measure blood oxygenation. 13

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(5) Participation in local emergency medical service (EMS) system.

(A) General hospitals shall participate in the local EMS system, based on the hospital's capabilities and capacity, and the locale's existing EMS plan and protocols.

(B) The provisions of subparagraph (A) of this paragraph do not apply to a comprehensive medical rehabilitation hospital or a pediatric and adolescent hospital that generally provides care that is not administered for or in expectation of compensation.

(6) Emergency services for survivors of sexual assault. This section does not affect the duty of a health care facility to comply with the requirements of the federal Emergency Medical Treatment and Active Labor Act of 1986 (42 U.S.C. § 1395dd) that are applicable to the facility.

(A) The hospital shall develop, implement and enforce policies and procedures to ensure that, except as otherwise provided by subparagraph (C) of this paragraph, after a sexual assault survivor presents to the hospital following a sexual assault, the hospital shall provide the care specified under subparagraph (D) of this paragraph.

(B) A facility that is not a health care facility designated in a community-wide plan as the primary health care facility in the community for treating sexual assault survivors shall inform the survivor that:

(i) the facility is not the designated facility and provide to the survivor the name and location of the designated facility; and

(ii) the survivor is entitled, at the survivor's option:

(I) to receive the care described by subparagraph (D) of this paragraph at that facility, subject to subparagraph (D)(i) of this paragraph; or

(II) to be stabilized and to be transferred to and receive the care described by subparagraph (D) of this paragraph at a health care facility designated in a community-wide plan as the primary health care facility in the community for treating sexual assault survivors.

(C) If a sexual assault survivor chooses to be transferred under subparagraph (B)(ii)(II) of this paragraph, after obtaining the survivor's written, signed consent to the transfer, the facility shall stabilize and transfer the survivor to a health care facility in the community designated in a community-wide plan as the health care facility for treating sexual assault survivors, where the survivor will receive the care specified under subparagraph (D) of this paragraph.

(D) A hospital providing care to a sexual assault survivor shall provide the survivor with the following:

(i) subject to subparagraph (G) of this paragraph, a forensic medical examination in accordance with Government Code, Chapter 420, Subchapter B, when the examination has been requested by a law enforcement agency under Code of Criminal Procedure, Article 56.06, or is conducted under Code of Criminal Procedure, Article 56.065. If a sexual assault survivor is age 18 or older and has not reported the assault to a law enforcement agency, a hospital shall provide this forensic medical examination, when the sexual assault survivor has arrived at the facility not later than 96 hours after the time the assault occurred and has consented to the examination; 14

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(ii) a private area, if available, to wait or speak with the appropriate medical, legal, or sexual assault crisis center staff or volunteer until a physician, nurse, or physician assistant is able to treat the survivor;

(iii) access to a sexual assault program advocate, if available, as provided by Code of Criminal Procedure, Article 56.045;

(iv) the infmmation form required by Health and Safety Code, §323.005;

(v) a private treatment room, if available;

(vi) if indicated by the histmy of contact, access to appropriate prophylaxis for exposure to sexually transmitted infections; and

(vii) the name and telephone number of the nearest sexual assault crisis center.

(E) The hospital must obtain documented consent before providing the forensic medical examination and treatment.

(F) Upon request, the hospital shall submit to the department its plan for the provision of service to sexual assault survivors. The plan must describe how the hospital will ensure that the services required under subparagraph (D) of this paragraph will be provided.

(i) The hospital shall submit the plan by the 60th day after the department makes the request.

(ii) The department will approve or reject the plan not later than the !20th day following the submission of the plan.

(iii) If the department is not able to approve the plan, the department will return the plan to the hospital and will identify the specific provisions of statutes or rules with which the hospital's plan failed to comply.

(iv) The hospital shall correct and resubmit the plan to the department for approval not later than the 90th day after the plan is returned to the hospital.

(G) A person may not perform a forensic examination on a sexual assault survivor unless the person has the basic training described by Health and Safety Code, §323.0045, or the equivalent education and training.

(H) Basic Sexual Assault Forensic Evidence Collection Training.

(i) A person who performs a forensic examination on a sexual assault survivor must have at least basic forensic evidence collection training or the equivalent education.

(ii) A person who completes a continuing medical or nursing education course in forensic evidence collection that is approved or recognized by the appropriate licensing board is considered to have basic sexual assault forensic evidence training for purposes of this chapter.

(iii) Each health care facility that has an emergency depmiment and that is not a health care facility designated in a community-wide plan as the primary health care facility in the community for

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treating sexual assault survivors shall develop a plan to train personnel on sexual assault forensic evidence collection.

(I) Sexual Assault Survivors Who Are Minors. This chapter does not affect participating entities of children's advocacy centers under Family Code, Chapter 264, Subchapter E, or the working protocols set forth by their multidisciplinary teams to ensure access to specialized medical assessments for sexual assault survivors who are minors. To the extent of a conflict with Family Code, Chapter 264, Subchapter E, that subchapter controls.

(f) Governing body.

(I) Legal responsibility. There shall be a governing body responsible for the organization, management, control, and operation of the hospital, including appointment of the medical staff. For hospitals owned and operated by an individual or by partners, the individual or partners shall be considered the governing body.

(2) Organization. The governing body shall be formally organized in accordance with a written constitution and bylaws which clearly set forth the organizational structure and responsibilities.

(3) Meeting records. Records of governing body meetings shall be maintained.

(4) Responsibilities relating to the medical staff.

(A) The governing body shall ensure that the medical staff has current bylaws, rules, and regulations which are implemented and enforced.

(B) The governing body shall approve medical staff bylaws and other medical staff rules and regulations.

(C) In hospitals that provide obstetrical services, the governing body shall ensure that the hospital collaborates with physicians providing services at the hospital to develop quality initiatives, through the adoption, implementation, and enforcement of appropriate hospital policies and procedures, to reduce the number of elective or nonmedically indicated induced deliveries or cesarean sections performed at the hospital on a woman before the 39th week of gestation.

(D) In hospitals that provide obstetrical services, the governing body shall ensure that the hospital implements a newborn audiological screening program, consistent with the requirements of Health and Safety Code, Chapter 47 (Hearing Loss in Newborns), and performs, either directly or through a referral to another program, audiological screenings for the identification of hearing loss on each newborn or infant born at the facility before the newborn or infant is discharged. These audiological screenings are required to be performed on all newborns or infants before discharge from the facility unless:

(i) a parent or legal guardian of the newborn or infant declines the screening;

(ii) the newbom or infant requires emergency transfer to a tertiary care facility prior to the completion of the screening;

(iii) the screening previously has been completed; or

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(iv) the newborn was discharged from the facility not more than I 0 hours after birth and a referral for the newborn was made to another program.·

(E) In hospitals that provide obstetrical services, the governing body shall adopt, implement, and enforce policies and procedures related to the testing of any newborn for critical congenital heart disease (CCHD) that may present themselves at birth. The facility shall implement testing programs for all infants born at the facility for CCHD. In the event that a newborn is presented at the emergency room following delivery at a birthing center or a home birth that may or may not have been assisted by a midwife, the facility shall ascertain if any testing for CCHD had occurred and, if not, shall provide the testing necessary to make such determination. The rules conceming the CCHD procedures and requirements are described in §§37.75- 37.79 of this title.

(F) The governing body shall determine, in accordance with state law and with the advice ofthe medical staff, which categories of practitioners are eligible candidates for appointment to the medical staff.

(i) In considering applications for medical staff membership and privileges or the renewal, modification, or revocation of medical staff membership and privileges, the governing body must ensure that each physician, podiatrist, and dentist is afforded procedural due process.

(I) If a hospital's credentials committee has failed to take action on a completed application as required by subclause (VIII) of this clause, or a physician, podiatrist, or dentist is subject to a professional review action that may adversely affect his medical staff membership or privileges, and the physician, podiatrist, or dentist believes that mediation of the dispute is desirable, the physician, podiatrist, or dentist may require the hospital to participate in mediation as provided in Civil Practice and Remedies Code (CPRC), Chapter 154. The mediation shall be conducted by a person meeting the qualifications required by CPRC §154.052 and within a reasonable period of time.

(II) Subclause (I) of this clause does not authorize a cause of action by a physician, podiatrist, or dentist against the hospital other than an action to require a hospital to pmticipate in mediation.

(III) An applicant for medical staff membership or privileges may not be denied membership or privileges on any ground that is otherwise prohibited by law.

(IV) A hospital's bylaw requirements for staff privileges may require a physician, podiatrist, or dentist to document the person's cmTent clinical competency and professional training and experience in the medical procedures for which privileges are requested.

Cont'd ...

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L_is_t_o_f_T_itl_e_s__~l L __ _ _ ~~ _____B_a_c_k_to__Li_st____~ TEXAS REGISTER TEXAS ADMINISTRATIVE CODE OPEN MEETINGS

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<> Texas Administrative Code TITLE 25 HEALTH SERVICES PART! DEPARTMENT OF STATE HEALTH SERVICES CHAPTER 133 HOSPITAL LICENSING SUBCHAPTER C OPERATIONAL REQUIREMENTS RULE §133.41 Hospital Functions and Services

(V) In granting or refusing medical staff membership or privileges, a hospital may not differentiate on the basis of the academic medical degree held by a physician.

(VI) Graduate medical education may be used as a standard or qualification for medical staff membership or privileges for a physician, provided that equal recognition is given to training programs accredited by the Accreditation Council for Graduate Medical Education and by the American Osteopathic Association.

(VII) Board certification may be used as a standard or qualification for medical staff membership or privileges for a physician, provided that equal recognition is given to certification programs approved by the American Board of Medical Specialties and the Bill'eau of Osteopathic Specialists.

(VIII) A hospital's credentials committee shall act expeditiously and without unnecessary delay when a licensed physician, podiatrist, or dentist submits a completed application for medical staff membership or privileges. The hospital's credentials committee shall take action on the completed application not later than the 90th day after the date on which the application is received. The governing body of the hospital shall take final action on the application for medical staff membership or privileges not later than the 60th day after the date on which the recommendation of the credentials committee is received. The hospital must notify the applicant in writing of the hospital's final action, including a reason for denial or restriction of privileges, not later than the 20th day after the date on which final action is taken.

(ii) The governing body is authorized to adopt, implement and enforce policies concerning the granting of clinical privileges to advanced practice nurses and physician assistants, including policies relating to the application process, reasonable qualifications for privileges, and the process for renewal, modification, or revocation of privileges.

(I) If the governing body of a hospital has adopted, implemented and enforced a policy of granting clinical privileges to advanced practice nurses or physician assistants, an individual advanced practice nurse or physician assistant who qualifies for privileges under that policy shall be entitled to certain procedural rights to provide fairness of process, as determined by the governing body of the hospital, when an application for privileges is submitted to the hospital. At a minimum, any policy adopted shall specify a reasonable period for the processing and consideration of the application and shall provide for written notification to the applicant of any final action on the application by the hospital, including any reason for denial or restriction of the privileges requested.

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(II) If an advanced practice nurse or physician assistant has been granted clinical privileges by a hospital, the hospital may not modifY or revoke those privileges without providing certain procedural rights to provide fairness of process, as determined by the governing body of the hospital, to the advanced practice nurse or physician assistant. At a minimum, the hospital shall provide the advanced practice nurse or physician assistant written reasons for the modification or revocation of privileges and a mechanism for appeal to the appropriate committee or body within the hospital, as determined by the governing body of the hospital.

(III) If a hospital extends clinical privileges to an advanced practice nurse or physician assistant conditioned on the advanced practice nurse or physician assistant having a sponsoring or collaborating relationship with a physician and that relationship ceases to exist, the advanced practice nurse or physician assistant and the physician shall provide written notification to the hospital that the relationship no longer exists. Once the hospital receives such notice from an advanced practice nurse or physician assistant and the physician, the hospital shall be deemed to have met its obligations under this section by notifYing the advanced practice nurse or physician assistant in writing that the advanced practice nurse's or physician assistant's clinical privileges no longer exist at that hospital.

(IV) Nothing in this clause shall be construed as modifYing Subtitle B, Title 3, Occupations Code, Chapter 204 or 301, or any other law relating to the scope of practice of physicians, advanced practice nurses, or physician assistants.

(V) This clause does not apply to an employer-employee relationship between an advanced practice nurse or physician assistant and a hospital.

(G) The goveming body shall ensure that the hospital complies with the requirements concerning physician communication and contracts as set out in Health and Safety Code, §241.10 15 (Physician Communication and Contracts).

(H) The governing body shall ensure the hospital complies with the requirements for reporting to the Texas Medical Board the results and circumstances of any professional review action in accordance with the Medical Practice Act, Occupations Code, §160.002 and §160.003.

(I) The governing body shall be responsible for and ensure that any policies and procedures adopted by the governing body to implement the requirements of this chapter shall be implemented and enforced.

(5) Hospital administration. The governing body shall appoint a chief executive officer or administrator who is responsible for managing the hospital.

( 6) Patient care. In accordance with hospital policy adopted, implemented and enforced, the governing body shall ensure that:

(A) every patient is under the care of:

(i) a physician. This provision is not to be construed to limit the authority of a physician to delegate tasks to other qualified health care personnel to the extent recognized under state law or the state's regulatory mechanism;

(ii) a dentist who is legally authorized to practice dentistry by the state and who is acting within the scope of his or her license; or 19

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(iii) a podiatrist, but only with respect to functions which he or she is legally authorized by the state to perform.

(B) patients are admitted to the hospital only by members of the medical staff who have been granted admitting privileges;

(C) a physician is on duty or on-call at all times;

(D) specific colored condition alert wrist bands that have been standardized for all hospitals licensed under Health and Safety Code, Chapter 241, are used as follows:

(i) red wrist bands for allergies;

(ii) yellow wrist bands for fall risks; and

(iii) purple wrist bands for do not resuscitate status;

(E) the governing body shall consider the addition of the following optional condition alert wrist bands. This consideration must be documented in the minutes of the meeting of the governing body in which the discussion was held:

(i) green wrist bands for latex allergy; and

(ii) pink wrist bands for restricted extremity; and

(F) the governing body shall adopt, implement, and enforce a policy and procedure regarding the removal of personal wrist bands and bracelets as well as a patient's right to refuse to wear condition alert wrist bands.

(7) Services. The governing body shall be responsible for all services furnished in the hospital, whether furnished directly or under contract. The governing body shall ensure that services are provided in a safe and effective manner that permits the hospital to comply with applicable rules and standards. At hospitals that have a mental health service tmit, the governing body shall adopt, implement, and enforce procedures for the completion of criminal background checks on all prospective employees that would be considered for assignment to that unit, except for persons currently licensed by this state as health professionals.

(8) Nurse Staffing. The governing body shall adopt, implement and enforce a written nurse staffing policy to ens me that an adequate number and skill mix of nurses are available to meet the level of patient care needed. The governing body policy shall require that hospital administration adopt, implement and enforce a nurse staffing plan and policies that:

(A) require significant consideration be given to the nurse staffing plan recommended by the hospital's nurse staffing committee and the committee's evaluation of any existing plan;

(B) are based on the needs of each patient care unit and shift and on evidence relating to patient care needs;

(C) ensure that all nursing assignments consider client safety, and are commensurate with the nurse's educational preparation, experience, knowledge, and physical and emotional ability;

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(D) require use of the official nurse services staffing plan as a component in setting the nurse staffing budget;

(E) encourage nurses to provide input to the nurse staffing committee relating to nurse staffing concerns;

(F) protect from retaliation nurses who provide input to the nurse staffing committee; and

(G) comply with subsection (o) of this section.

(9) Photo identification badge. The governing body shall adopt a policy requiring employees, physicians, contracted employees, and individuals in training who provide direct patient care at the hospital to wear a photo identification badge during all patient encounters, unless precluded by adopted isolation or sterilization protocols. The badge must be of sufficient size and worn in a manner to be visible and must clearly state:

(A) at minimum the individual's first or last name;

(B) the department of the hospital with which the individual is associated;

(C) the type of license held by the individual, if applicable under Title 3, Occupations Code; and

(D) the provider's status as a student, intern, trainee, or resident, if applicable.

(g) Infection control. The hospital shall provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There shall be an active program for the prevention, control, and surveillance of infections and communicable diseases.

(1) Organization and policies. A person shall be designated as infection control professional. The hospital shall ensure that policies governing prevention, control and surveillance of infections and communicable diseases are developed, implemented and enforced.

(A) There shall be a system for identifYing, reporting, investigating, and controlling health care associated infections and communicable diseases between patients and personnel.

(B) The infection control professional shall maintain a log of all reportable diseases and health care associated infections designated as epidemiologically significant according to the hospital's infection control policies.

(C) A written policy shall be adopted, implemented and enforced for reporting all reportable diseases to the local health authority and the Infectious Disease Surveillance and Epidemiology Branch, Department of State Health Services, Mail Code 2822, P.O. Box 149347, Austin, Texas 78714-9347, in accordance with Chapter 97 of this title (relating to Communicable Diseases), and Health and Safety Code, §§98.103, 98.104, and 98.1045 (relating to Reportable Infections, Alternative for Reportable Surgical Site Infections, and Reporting of Preventable Adverse Events).

(D) The infection control program shall include active participation by the pharmacist.

(2) Responsibilities ofthe chief executive officer (CEO), medical staff, and chief nursing officer (CNO). The CEO, the medical staff, and the CNO shall be responsible for the following.

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(A) The hospital-wide quality assessment and performance improvement program and training programs shall address problems identified by the infection control professional.

(B) Successful corrective action plans in affected problem areas shall be implemented.

(3) Universal precautions. The hospital shall adopt, implement, and enforce a written policy to monitor compliance of the hospital and its personnel and medical staff with universal precautions in accordance with HSC Chapter 85, Acquired Immune Deficiency Syndrome and Human Immunodeficiency Virus Infection.

(h) Laboratory services. The hospital shall maintain directly, or have available adequate laboratory services to meet the needs of its patients.

(1) Hospital laboratory services. A hospital that provides laboratory services shall comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988), in accordance with the requirements specified in 42 Code ofPederal Regulations (CPR), §§493.1 - 493.1780. CLIA 1988 applies to all hospitals with laboratories that examine human specimens for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.

(2) Contracted laboratory services. The hospital shall ensure that all laboratory services provided to its patients through a contractual agreement are performed in a facility certified in the appropriate specialties and subspecialties of service in accordance with the requirements specified in 42 CPR Part 493 to comply with CLIA 1988.

(3) Adequacy of laboratory services. The hospital shall ensure the following.

Cont'd ...

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TEXAS REGISTER TEXAS ADMINISTRATIVE CODE OPEN MEETINGS

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<> Texas Administrative Code TITLE 25 HEALTH SERVICES PART 1 DEPARTMENT OF STATE HEALTH SERVICES CHAPTER 133 HOSPITAL LICENSING SUBCHAPTER C OPERATIONAL REQUIREMENTS RULE §133.41 Hospital Functions and Services

(A) Emergency laboratory services shall be available 24 hours a day.

(B) A written description of services provided shall be available to the medical staff.

(C) The laboratory shall make provision for proper receipt and reporting of tissue specimens.

(D) The medical staff and a pathologist shall determine which tissue specimens require a macroscopic (gross) examination and which require both macroscopic and microscopic examination.

(E) When blood and blood components are stored, there shall be written procedures readily available containing directions on how to maintain them within permissible temperatures and including instructions to be followed in the event of a power failure or other disruption of refrigeration. A label or tray with the recipient's first and last names and identification number, donor unit number and interpretation of compatibility, if performed, shall be attached securely to the blood container.

(F) The hospital shall establish a mechanism for ensuring that the patient's physician or other licensed health care professional is made aware of critical value lab results, as established by the medical staff, before or after the patient is discharged.

(4) Chemical hygiene. A hospital that provides laboratory services shall adopt, implement, and enforce written policies and procedures to manage, minimize, or eliminate the risks to laboratory personnel of exposure to potentially hazardous chemicals in the laboratory which may occur during the normal course of job performance.

(i) Linen and laund1y services. The hospital shall provide sufficient clean linen to ensm-e the comfort of the patient.

(1) For purposes of this subsection, contaminated linen is linen which has been soiled with blood or other potentially infectious materials or may contain sharps. Other potentially infectious materials means:

(A) the following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardia! fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids;

(B) any unfixed tissue or organ (other than intact skin) from a human (living or dead); and

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(C) Human Immunodeficiency Virus (HIV)-containing cell or tissue cultures, organ cultures, and HIV or Hepatitis B Virus (HBV)-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV.

(2) The hospital, whether it operates its own laundry or uses commercial service, shall ensure the following.

(A) Employees of a hospital involved in transporting, processing, or otherwise handling clean or soiled linen shall be given initial and follow-up in-service training to ensure a safe product for patients and to safeguard employees in their work.

(B) Clean linen shall be handled, transported, and stored by methods that will ensure its cleanliness.

(C) All contaminated linen shall be placed and transported in bags or containers labeled or color- coded.

(D) Employees who have contact with contaminated linen shall wear gloves and other appropriate personal protective equipment.

(E) Contaminated linen shall be handled as little as possible and with a minimum of agitation. Contaminated linen shall not be sorted or rinsed in patient care areas.

(F) All contaminated linen shall be bagged or put into carts at the location where it was used.

(i) Bags containing contaminated linen shall be closed prior to transport to the laundry.

(ii) Whenever contaminated linen is wet and presents a reasonable likelihood of soalc-tlu·ough of or leakage from the bag or container, the linen shall be deposited and transported in bags that prevent leakage of fluids to the exterior.

(iii) All linen placed in chutes shall be bagged.

(iv) If chutes are not used to convey linen to a central receiving or sorting room, then adequate space shall be allocated on the various nursing units for holding the bagged contaminated linen.

(G) Linen shall be processed as follows:

(i) If hot water is used, linen shall be washed with detergent in water with a temperature of at least 71 degrees Centigrade (160 degrees Fahrenheit) for 25 minutes. Hot water requirements specified in Table 5 of §133.169(e) of this title (relating to Tables) shall be met.

(ii) If low-temperature (less than or equal to 70 degrees Centigrade) (!58 degrees Fahrenheit) laundry cycles are used, chemicals suitable for low-temperature washing at proper use concentration shall be used.

(iii) Commercial dry cleaning of fabrics soiled with blood also renders these items free of the risk of pathogen transmission.

(H) Flammable liquids shall not be used to process laundry, but may be used for equipment maintenance. 24

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G) Medical record services. The hospital shall have a medical record service that has administrative responsibility for medical records. A medical record shall be maintained for every individual who presents to the hospital for evaluation or treatment.

(I) The organization of the medical record service shall be appropriate to the scope and complexity of the services performed. The hospital shall employ or contract with adequate personnel to ensure prompt completion, filing, and retrieval of records.

(2) The hospital shall have a system of coding and indexing medical records. The system shall allow for timely retrieval by diagnosis and procedure, in order to support medical care evaluation studies.

(3) The hospital shall adopt, implement, and enforce a policy to ensure that the hospital complies with HSC, Chapter 241, Subchapter G (Disclosure of Health Care Information).

(4) The medical record shall contain information to justifY admission and continued hospitalization, support the diagnosis, reflect significant changes in the patient's condition, and describe the patient's progress and response to medications and services. Medical records shall be accurately written, promptly completed, properly filed and retained, and accessible.

(5) Medical record entries must be legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, consistent with hospital policies and procedures.

(6) All orders (except verbal orders) must be dated, timed, and authenticated the next time the prescriber or another practitioner who is responsible for the care of the patient and has been credentialed by the medical staff and granted privileges which are consistent with the written orders provides care to the patient, assesses the patient, or documents information in the patient's medical record.

(7) All verbal orders must be dated, timed, and authenticated within 96 hours by the prescriber or another practitioner who is responsible for the care of the patient and has been credentialed by the medical staff and granted privileges which are consistent with the written orders.

(A) Use of signature stamps by physicians and other licensed practitioners credentialed by the medical staff may be allowed in hospitals when the signature stamp is authorized by the individual whose signature the stamp represents. The administrative offices of the hospital shall have on file a signed statement to the effect that he or she is the only one who has the stamp and uses it. The use of a signature stamp by any other person is prohibited.

(B) A list of computer codes and written signatures shall be readily available and shall be maintained under adequate safeguards.

(C) Signatures by facsimile shall be acceptable. If received on a thermal machine, the facsimile document shall be copied onto regular paper.

(8) Medical records (reports and printouts) shall be retained by the hospital in their original or legally reproduced fmm for a period of at least ten years. A legally reproduced form is a medical record retained in hard copy, microform (microfilm or microfiche), or other electronic medium. Films, scans, and other image records shall be retained for a period of at least five years. For retention purposes, medical records that shall be preserved for ten years include: 25

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(A) identification data;

(B) the medical history of the patient;

(C) evidence of a physical examination, including a health history, performed no more than 30 days prior to admission or within 24 hours after admission. The medical histoty and physical examination shall be placed in the patient's medical record within 24 hours after admission;

(D) an updated medical record entry documenting an examination for any changes in the patient's condition when the medical history and physical examination are completed within 30 days before admission. This updated examination shall be completed and documented in the patient's medical record within 24 hours after admission;

(E) admitting diagnosis;

(F) diagnostic and therapeutic orders;

(G) properly executed informed consent forms for procedures and treatments specified by the medical staff, or by federal or state laws if applicable, to require written patient consent;

(H) clinical observations, including the results of therapy and treatment, all orders, nursing notes, medication records, vital signs, and other infmmation necessary to monitor the patient's condition;

(I) reports of procedures, tests, and their results, including laboratory, pathology, and radiology reports;

(J) results of all consultative evaluations of the patient and appropriate findings by clinical and other staff involved in the care of the patient;

(K) discharge summaty with outcome of hospitalization, disposition of care, and provisions for follow-up care; and

(L) final diagnosis with completion of medical records within 30 calendar days following discharge.

(9) If a patient was less than 18 years of age at the time he was last treated, the hospital may authorize the disposal of those medical records relating to the patient on or after the date of his 20th birthday or on or after the 1Oth anniversary of the date on which he was last treated, whichever date is later.

(1 0) The hospital shall not destroy medical records that relate to any matter that is involved in litigation if the hospital knows the litigation has not been finally resolved.

(11) The hospital shall provide written notice to a patient, or a patient's legally authorized representative, that the hospital may authorize the disposal of medical records relating to the patient on or after the periods specified in this section. The notice shall be provided to the patient or the patient's legally authorized representative not later than the date on which the patient who is or will be the subject of a medical record is treated, except in an emergency treatment situation. In an emergency treatment situation, the notice shall be provided to the patient or the patient's legally authorized representative as soon as is reasonably practicable following the emergency treatment situation. 26

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(12) If a licensed hospital should close, the hospital shall notify the department at the time of closure the disposition of the medical records, including the location of where the medical records will be stored and the identity and telephone number of the custodian of the records.

(k) Medical staff.

(I) The medical staff shall be composed of physicians and may also be composed of podiatrists, dentists and other practitioners appointed by the governing body.

(A) The medical staff shall periodically conduct appraisals of its members according to medical staff by laws.

(B) The medical staff shall examine credentials of candidates for medical staff membership and make recommendations to the governing body on the appointment of the candidate.

(2) The medical staff shall be well-organized and accountable to the governing body for the quality of the medical care provided to patients.

(A) The medical staff shall be organized in a manner approved by the governing body.

(B) If the medical staff has an executive committee, a majority of the members of the committee shall be doctors of medicine or osteopathy.

(C) Records of medical staff meetings shall be maintained.

(D) The responsibility for organization and conduct of the medical staff shall be assigned only to an individual physician.

(E) Each medical staff member shall sign a statement signifying they will abide by medical staff and hospital policies.

(3) The medical staff shall adopt, implement, and enforce bylaws, rules, and regulations to carry out its responsibilities. The bylaws shall:

(A) be approved by the governing body;

(B) include a statement of the duties and privileges of each category of medical staff (e.g., active, courtesy, consultant);

(C) describe the organization of the medical staff;

Cont'd ...

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TEXAS REGISTER TEXAS ADMINISTRATIVE CODE OPEN MEETINGS

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<> Texas Administrative Code TITLE25 HEALTH SERVICES PART I DEPARTMENT OF STATE HEALTH SERVICES CHAPTER 133 HOSPITAL LICENSING SUBCHAPTER C OPERATIONAL REQUIREMENTS RULE §133.41 Hospital Functions and Services

(D) describe the qualifications to be met by a candidate in order for the medical staff to recommend that the candidate be appointed by the governing body;

(E) include criteria for determining the privileges to be granted and a procedure for applying the criteria to individuals requesting privileges; and

(F) include a requirement that a physical examination and medical history be done no more than 30 days before or 24 hours after an admission for each patient by a physician or other qualified practitioner who has been granted these privileges by the medical staff. The medical history and physical examination shall be placed in the patient's medical record within 24 hours after admission. When the medical history and physical examination are completed within the 30 days before admission, an updated examination for any changes in the patient's condition must be completed and documented in the patient's medical record within 24 hours after admission.

(I) Mental health services.

(1) Mental health services unit. A hospital may not admit patients to a mental health services unit unless the unit is approved by the department as meeting the requirements of§ 133 .163(q) of this title.

(2) Admission criteria. A hospital providing mental health services shall have written admission criteria that are applied uniformly to all patients who are admitted to the service.

(A) The hospital's admission criteria shall include procedures to prevent the admission of minors for a condition which is not generally recognized as responsive to treatment in an inpatient setting for mental health services.

(i) The following conditions are not generally recognized as responsive to treatment in a hospital unless the minor to be admitted is qualified because of other disabilities, such as:

(I) cognitive disabilities due to intellectual disability; or

(II) learning disabilities.

(ii) A minor may be qualified for admission based on other disabilities which would be responsive to mental health services.

(B) The medical record shall contain evidence that admission consent was given by the patient, the patient's legal guardian, or the managing conservator, if applicable. 28

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(C) The hospital shall have a preadmission examination procedure under which each patient's condition and medical histmy are reviewed by a member of the medical staff to determine whether the patient is likely to benefit significantly from an intensive inpatient program or assessment.

(D) A voluntarily admitted patient shall sign an admission consent form prior to admission to a mental health unit which includes verification that the patient has been informed of the services to be provided and the estimated charges.

(3) Compliance. A hospital providing mental health services shall comply with the following rules administered by the department. The rules are:

(A) Chapter 411, Subchapter J of this title (relating to Standards of Care and Treatment in Psychiatric Hospitals);

(B) Chapter 404, Subchapter E of this title (relating to Rights of Persons Receiving Mental Health Services);

(C) Chapter 405, Subchapter E of this title (relating to Electroconvulsive Therapy (ECT));

(D) Chapter 414, Subchapter I of this title (relating to Consent to Treatment with Psychoactive Medication--Mental Health Services); and

(E) Chapter 415, Subchapter F of this title (relating to Interventions in Mental Health Programs).

(m) Mobile, transportable, and relocatable units. The hospital shall adopt, implement and enforce procedures which address the potential emergency needs for those inpatients who are taken to mobile units on the hospital's premises for diagnostic procedures or treatment.

(n) Nuclear medicine services. If the hospital provides nuclear medicine services, these services shall meet the needs of the patients in accordance with acceptable standards of practice and be licensed in accordance with §289.256 of this title (relating to Medical and Veterinary Use of Radioactive Material).

(1) Policies and procedures. Policies and procedures shall be adopted, implemented, and enforced which will describe the services nuclear medicine provides in the hospital and how employee and patient safety will be maintained.

(2) Organization and staffing. The organization of the nuclear medicine services shall be appropriate to the scope and complexity of the services offered.

(A) There shall be a medical director or clinical director who is a physician qualified in nuclear medicine.

(B) The qualifications, training, functions, and responsibilities of nuclear medicine personnel shall be specified by the medical director or clinical director and approved by the medical staff.

(3) Delivety of services. Radioactive materials shall be prepared, labeled, used, transported, stored, and disposed of in accordance with acceptable standards of practice and in accordance with §289.256 of this title.

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(A) In-house preparation ofradiopharmaceuticals shall be by, or under, the direct supervision of an appropriately trained licensed pharmacist or physician.

(B) There shall be proper storage and disposal of radioactive materials.

(C) If clinical laboratory tests are performed by the nuclear medicine services staff, the nuclear medicine staff shall comply with CLIA 1988 in accordance with the requirements specified in 42 CFR Part 493.

(D) Nuclear medicine workers shall be provided personnel monitoring dosimeters to measure their radiation exposure. Exposure repotts and documentation shall be available for review.

(4) Equipment and supplies. Equipment and supplies shall be appropriate for the types of nuclear medicine services offered and shall be maintained for safe and efficient performance. The equipment shall be inspected, tested, and calibrated at least annually by qualified personnel.

(5) Records. The hospital shall maintain signed and dated reports of nuclear medicine interpretations, consultations, and procedures.

(A) The physician approved by the medical staff to interpret diagnostic procedures shall sign and date the interpretations of these tests.

(B) The hospital shall maintain records of the receipt and disposition ofradiopharmaceuticals until disposal is authorized by the department's Radiation Safety Licensing Branch in accordance with §289.256 of this title.

(C) Nuclear medicine services shall be ordered only by an individual whose scope of state licensure and whose defined staff privileges allow such referrals.

(o) Nursing services. The hospital shall have an organized nursing service that provides 24-hour nursing services as needed.

(1) Organization. The hospital shall have a well-organized service with a plan of administrative authority and delineation of responsibilities for patient care.

(A) Nursing services shall be under the administrative authority of a chief nursing officer (CNO) who shall be an RN and comply with one of the following:

(i) possess a master's degree in nursing;

(ii) possess a master's degree in health care administration or business administration;

(iii) possess a master's degree in a health-related field obtained through a curriculum that included courses in administration and management; or

(iv) be progressing under a written plan to obtain the nursing administration qualifications associated with a master's degree in nursing. The plan shall:

(I) describe efforts to obtain the knowledge associated with graduate education and to increase administrative and management skills and experience;

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(II) include courses related to leadership, administration, management, performance improvement and theoretical approaches to delivering nursing care; and

(III) provide a time-line for accomplishing skills.

(B) The CNO in hospitals with I 00 or fewer licensed beds and located in counties with a population of less than 50,000, or in hospitals that have been certified by the Centers for Medicare and Medicaid Services as critical access hospitals in accordance with the Code of Federal Regulations, Title 42, Volume 3, Part 485, Subpa1t F, §485.606(b), shall be exempted from the requirements in subparagraph (A)(i)- (iv) of this paragraph.

(C) The CNO shall be responsible for the operation of the services, including determining the types and numbers of nursing personnel and staff necessary to provide nursing care for all areas of the hospital.

(D) The CNO shall report directly to the individual who has authority to represent the hospital and who is responsible for the operation of the hospital according to the policies and procedures ofthe hospital's governing board.

(E) The CNO shall participate with leadership from the governing body, medical staff, and clinical areas, in planning, promoting and conducting performance improvement activities.

(2) Staffing and delivery of care.

(A) The nursing services shall adopt, implement and enforce a procedure to verify that hospital nursing personnel for whom licensure is required have valid and current licensure.

(B) There shall be adequate numbers ofRNs, licensed vocational nurses (LVNs), and other personnel to provide nursing care to all patients as needed.

(C) There shall be supervisory and staff personnel for each depmtment or nursing unit to provide, when needed, the immediate availability of an RN to provide care for any patient.

(D) An RN shall be on duty in each building of a licensed hospital that contains at least one nursing unit where patients are present. The RN shall supervise and evaluate the nursing care for each patient and assign the nursing care to other nursing personnel in accordance with the patient's needs and the specialized qualifications and competence of the nursing staff available.

(E) The nursing staff shall develop and keep cmTent a nursing plan of care for each patient which addresses the patient's needs.

(F) The hospital shall establish a nurse staffing committee as a standing committee of the hospital. The committee shall be established in accordance with Health and Safety Code (HSC), §§161.031- 161.033, to be responsible for soliciting and receiving input from mu·ses on the development, ongoing monitoring, and evaluation of the staffing plan. As provided by HSC, §161.032, the hospital's records and review relating to evaluation of these outcomes and indicators are confidential and not subject to disclosure under Government Code, Chapter 552 and not subject to disclosure, discove1y, subpoena or other means of!egal compulsion for their release. As used in this subsection, "committee" or "staffing committee" means a nurse staffing committee established under this subparagraph.

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(i) The committee shall be composed of:

(I) at least 60% registered nurses who are involved in direct patient care at least 50% of their work time and selected by their peers who provide direct care during at least 50% of their work time;

(II) at least one representative from either infection control, quality assessment and performance improvement or risk management;

(III) members who are representative of the types of nursing services provided at the hospital; and

(IV) the chief nursing officer of the hospital who is a voting member.

(ii) Participation on the committee by a hospital employee as a committee member shall be part of the employee's work time and the hospital shall compensate that member for that time accordingly. The hospital shall relieve the committee member of other work duties during committee meetings.

(iii) The committee shall meet at least quarterly.

(iv) The responsibilities of the committee shall be to:

(I) develop and recommend to the hospital's governing body a nurse staffing plan that meets the requirements of subparagraph (G) of this paragraph;

(II) review, assess and respond to staffing concerns expressed to the committee;

(III) identify the nurse-sensitive outcome measures the committee will use to evaluate the effectiveness of the official nurse services staffing plan;

(IV) evaluate, at least semiannually, the effectiveness of the official nurse services staffing plan and variations between the plan and the actual staffing; and

(V) submit to the hospital's governing body, at least semiannually, a report on nurse staffing and patient care outcomes, including the committee's evaluation of the effectiveness of the official nurse services staffing plan and aggregate variations between the staffing plan and actual staffing.

(G) The hospital shall adopt, implement and enforce a written official nurse services staffing plan. As used in this subsection, "patient care unit" means a unit or area of a hospital in which registered nurses provide patient care.

(i) The official nurse services staffing plan and policies shall:

Con!' d ...

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<> Texas Administrative Code TITLE25 HEALTH SERVICES PART 1 DEPARTMENT OF STATE HEALTH SERVICES CHAPTER 133 HOSPITAL LICENSING SUBCHAPTER C OPERATIONAL REQUIREMENTS RULE §133.41 Hospital Functions and Services

(I) require significant consideration to be given to the nurse staffing plan recommended by the hospital's nurse staffing committee and the committee's evaluation of any existing plan;

(II) be based on the needs of each patient care unit and shift and on evidence relating to patient care needs;

(III) require use of the official nurse services staffing plan as a component in setting the nurse staffing budget;

(IV) encourage nurses to provide input to the nurse staffing committee relating to nurse staffing concerns;

(V) protect from retaliation nurses who provide input to the nurse staffing committee; and

(VI) comply with subsection (o) of this section.

(ii) The plan shall:

(I) set minimum staffing levels for patient care units that are:

(-a-) based on multiple nurse and patient considerations including:

(-1-) patient characteristics and number of patients for whom care is being provided, including number of admissions, discharges and transfers on a unit;

(-2-) intensity of patient care being provided and variability of patient care across a nursing unit;

(-3-) scope of services provided;

(-4-) context within which care is provided, including architecture and geography of the environment, and the availability of technology; and

(-5-) nursing staff characteristics, including staff consistency and tenure, preparation and experience, and the number and competencies of clinical and non-clinical support staffthe nurse must collaborate with or supervise.

(-b-) determined by the nursing assessment and in accordance with evidence-based safe nursing standards; and 33

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(-c-) recalculated at least annually, or as necessary;

(II) include a method for adjusting the staffing plan shift to shift for each patient care unit based on factors, such as, the intensity of patient care to provide staffing flexibility to meet patient needs;

(III) include a contingency plan when patient care needs unexpectedly exceed direct patient care staff resources;

(IV) include how on-call time will be used;

(V) reflect current standards established by private accreditation organizations, governmental entities, national nursing professional associations, and other health professional organizations and should be developed based upon a review of the codes of ethics developed by the nursing profession tlll'ough national nursing organizations;

(VI) include a mechanism for evaluating the effectiveness of the official nurse services staffing plan based on patient needs, nursing sensitive quality indicators, nurse satisfaction measures collected by the hospital and evidence based nurse staffing standards. At least one from each of the following three types of outcomes shall be coJTelated to the adequacy of staffing:

(-a-) nurse-sensitive patient outcomes selected by the nurse staffing committee, such as, patient falls, adverse drug events, injuries to patients, skin breakdown, pneumonia, infection rates, upper gastrointestinal bleeding, shock, cardiac arrest, length of stay, or patient readmissions;

(-b-) operational outcomes, such as, work-related injury or illness, vacancy and turnover rates, nursing care hours per patient day, on-call use, or overtime rates; and

(-c-) substantiated patient complaints related to staffing levels;

(VII) incorporate a process that facilitates the timely and effective identification of concerns about the adequacy of the staffing plan by the nurse staffing committee established pursuant to subparagraph (F) of this paragraph. This process shall include:

(-a-) a prohibition on retaliation for reporting concerns;

(-b-) a requirement that nurses report concerns timely through appropriate channels within the hospital;

(-c-) orientation of nurses on how to report concerns and to whom;

(-d-) encouraging nurses to provide input to the committee relating to nurse staffing concerns;

(-e-) review, assessment, and response by the committee to staffing concerns expressed to the committee;

(-f-) a process for providing feedback during the committee meeting on how concerns are addressed by the committee established under subparagraph (F) of this paragraph; and

(-g-) use of the nurse safe harbor peer review process pursuant to Occupations Code, §303.005;

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(VIII) include policies and procedures that require:

(-a-) orientation of nurses and other personnel who provide nursing care to all patient care units to which they are assigned on either a temporary or permanent basis;

(-b-) that the orientation of nurses and other personnel and the competency to perform nursing services is documented in accordance with hospital policy;

(-c-) that nursing assignments be congruent with documented competency; and

(IX) be used by the hospital as a component in setting the nurse staffing budget and guiding the hospital in assigning nurses hospital wide.

(iii) The hospital shall make readily available to nurses on each patient care unit at the beginning of each shift the official nurse services staffing plan levels and current staffing levels for that unit and that shift.

(iv) There shall be a semiannual evaluation by the staffing committee of the effectiveness ofthe official nurse services staffing plan and variations between the staffing plan and actual staffing. The evaluation shall consider the outcomes and nursing-sensitive indicators as set out in clause (ii)(VI) of this subparagraph, patient needs, nurse satisfaction measures collected by the hospital, and evidence based nurse staffing standards. This evaluation shall be documented in the minutes of the committee established under subparagraph (F) of this paragraph and presented to the hospital's governing body. Hospitals may determine whether this evaluation is done on a unit or facility level basis. To assist the committee with the semiannual evaluation, the hospital shall report to the committee the variations between the staffing plan and actual staffing. This report of variations shall be confidential and not subject to disclosure under Government Code, Chapter 552 and not subject to disclosure, discovery, subpoena or other means oflegal compulsion for their release.

(v) The staffing plan shall be retained for a period of two years.

(H) Nonemployee licensed nurses who are working in the hospital shall adhere to the policies and procedures of the hospital. The CNO shall provide for the adequate orientation, supervision, and evaluation of the clinical activities of nonemployee nursing personnel which occur within the responsibility of the nursing services.

(I) The hospital shall annually report to the department on:

(i) whether the hospital's governing body has adopted a nurse staffing policy;

(ii) whether the hospital has established a nurse staffing committee that meets the membership requirements of subparagraph (F) of this paragraph;

(iii) whether the nurse staffing committee has evaluated the hospital's official nurse services staffing plan and has reported the results of the evaluation to the hospital's goveming body; and

(iv) the nurse-sensitive outcome measures the committee adopted for use in evaluating the hospital's official nurse services staffing plan.

(3) Mandatory ove1time. The hospital shall adopt, implement and enforce policies on use of mandatory overtime. 35

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(A) As used in this subsection:

(i) "on-call time" means time spent by a nurse who is not working but who is compensated for availability; and

(ii) "mandatory overtime" means a requirement that a nurse work hours or days that are in addition to the hours or days scheduled, regardless of the length of a scheduled shift or the number of scheduled shifts each week. Mandatory overtime does not include prescheduled on-call time or time immediately before or after a scheduled shift necessary to document or communicate patient status to ensure patient safety.

(B) A hospital may not require a nurse to work mandatmy overtime, and a nurse may refuse to work mandatory overtime.

(C) This section does not prohibit a nurse from volunteering to work overtime.

(D) A hospital may not use on-call time as a substitute for mandatory overtime.

(E) The prohibitions on mandatory overtime do not apply if:

(i) a health care disaster, such as a natural or other type of disaster that increases the need for health care personnel, unexpectedly affects the county in which the nurse is employed or affects a contiguous county;

(ii) a federal, state, or county declaration of emergency is in effect in the county in which the nurse is employed or is in effect in a contiguous county;

(iii) there is an emergency or unforeseen event of a kind that:

(I) does not regularly occur;

(II) increases the need for health care personnel at the hospital to provide safe patient care; and

(III) could not prudently be anticipated by the hospital; or

(iv) the nurse is actively engaged in an ongoing medical or surgical procedure and the continued presence of the nurse through the completion of the procedure is necessary to ensure the health and safety of the patient. The nurse staffing committee shall ensure that scheduling a nurse for a procedure that could be anticipated to require the nurse to stay beyond the end of his or her scheduled shift does not constitute mandatmy overtime.

(F) If a hospital determines that an exception exists under subparagraph (E) of this paragraph, the hospital shall, to the extent possible, make and document a good faith effort to meet the staffing need through voluntary overtime, including calling per diems and agency nurses, assigning floats, or requesting an additional day of work from off-duty employees.

(G) A hospital may not suspend, terminate, or otherwise discipline or discriminate against a nurse who refuses to work mandatory overtime.

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( 4) Dmgs and biologicals. Dmgs and biologicals shall be prepared and administered in accordance with federal and state laws, the orders of the individuals granted privileges by the medical staff, and accepted standards of practice.

(A) All drugs and biologicals shall be administered by, or under supervision of, nursing or other personnel in accordance with federal and state laws and regulations, including applicable licensing mles, and in accordance with the approved medical staff policies and procedures.

(B) All orders for dmgs and biologicals shall be in writing, dated, timed, and signed by the individual responsible for the care of the patient as specified under subsection (f)(6)(A) of this section. When telephone or verbal orders must be used, they shall be:

(i) accepted only by personnel who are authorized to do so by the medical staff policies and procedures, consistent with federal and state laws;

(ii) dated, timed, and authenticated within 96 hours by the prescriber or another practitioner who is responsible for the care of the patient and has been credentialed by the medical staff and granted privileges which are consistent with the written orders; and

(iii) used infrequently.

(C) There shall be a hospital procedure for immediately reporting transfusion reactions, adverse dmg reactions, and errors in administration of drugs to the attending physician and, if appropriate, to the hospital-wide quality assessment and performance improvement program.

(5) Blood transfusions.

(A) Transfusions shall be prescribed in accordance with hospital policy and administered in accordance with a written protocol for the administration of blood and blood components and the use of infusion devices and ancillary equipment.

(B) Personnel administering blood transfusions and intravenous medications shall have special training for this duty according to written, adopted, implemented and enforced hospital policy.

(C) Blood and blood components shall be transfused through a sterile, pyrogen-free transfusion set that has a filter designed to retain particles potentially harmful to the recipient.

(D) The patient must be observed during the transfusion and for an appropriate time thereafter for suspected adverse reactions.

(E) Pretransfusion and posttransfusion vital signs shall be recorded.

(F) When warming of blood is indicated, this shall be accomplished during its passage through the transfusion set. The warming system shall be equipped with a visible thermometer and may have an audible warning system. Blood shall not be warmed above 42 degrees Celsius.

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TEXAS REGISTER TEXAS ADMINISTRATIVE CODE OPEN MEETINGS

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<> Texas Administrative Code TITLE 25 HEALTH SERVICES PART I DEPARTMENT OF STATE HEALTH SERVICES CHAPTER 133 HOSPITAL LICENSING SUBCHAPTER C OPERATIONAL REQUIREMENTS RULE §133.41 Hospital Functions and Services

(G) Drugs or medications, including those intended for intravenous use, shall not be added to blood or blood components. A 0.9% sodimn chloride injection, United States Pharmacopeia, may be added to blood or blood components. Other solutions intended for intravenous use may be used in an administration set or added to blood or blood components under either of the following conditions:

(i) they have been approved for this use by the Federal Drug Administration; or

(ii) there is documentation available to show that addition to the component involved is safe and efficacious.

(H) There shall be a system for detection, reporting and evaluation of suspected complications of transfusion. Any adverse event experienced by a patient in association with a transfusion is to be regarded as a suspected transfusion complication. In the event of a suspected transfusion complication, the personnel attending the patient shall notify immediately a responsible physician and the transfusion service and document the complication in the patient's medical record. All suspected transfusion complications shall be evaluated promptly according to an established procedure.

(I) Following the transfusion, the blood transfusion record or a copy shall be made a part of the patient's medical record.

(6) Reporting and peer review of a vocational or registered nurse. A hospital shall adopt, implement, and enforce a policy to ensure that the hospital complies with the Occupations Code §§301.401- 301.403, 301.405 and Chapter 303 (relating to Grounds for Reporting Nurse, Duty of Nurse to Report, Duty of Peer Review Committee to Report, Duty of Person Employing Nurse to Report, and Nursing Peer Review respectively), and with the rules adopted by the Board of Nurse Examiners in 22 T AC §217.16 (relating to Minor Incidents), §217.19 (relating to Incident-Based Nursing Peer Review and Whistleblower Protections), and §217.20 (relating to Safe Harbor Peer Review for Nurses and Whistleblower Protections).

(7) Policies and procedures related to workplace safety.

(A) The hospital shall adopt, implement and enforce policies and procedures related to the work environment for nurses which:

(i) improve workplace safety and reduce the risk of injury, occupational illness, and violence; and

(ii) increase the use of ergonomic principles and ergonomically designed devices to reduce injury and fatigue. 39

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(B) The policies and procednres adopted under subparagraph (A) of this paragraph, at a minimum, must include:

(i) evaluating new products and technology that incorporate ergonomic principles;

(ii) educating nurses in the application of ergonomic practices;

(iii) conducting workplace audits to identify areas of risk of injury, occupational illness, or violence and recommending ways to reduce those risks;

(iv) controlling access to those areas identified as having a high risk of violence; and

(v) promptly reporting crimes committed against nurses to appropriate law enforcement agencies.

(8) Safe patient handling and movement practices.

(A) The hospital shall adopt, implement and enforce policies and procednres to identify, assess, and develop strategies to control risk of injnry to patients and nurses associated with the lifting, transfening, repositioning, or movement of a patient.

(B) The policies and procedures shall establish a process that, at a minimum, includes the following:

(i) analysis of the risk of injury to both patients and nurses posed by the patient handling needs of the patient populations served by the hospital and the physical environment in which patient handling and movement occurs;

(ii) education of nurses in the identification, assessment, and control of risks of injnry to patients and nurses during patient handling;

(iii) evaluation of alternative ways to reduce risks associated with patient handling, including evaluation of equipment and the environment;

(iv) restriction, to the extent feasible with existing equipment and aids, of manual patient handling or movement of all or most of a patient's weight to emergency, life-threatening, or otherwise exceptional circumstances;

(v) collaboration with and annual report to the nurse staffing committee;

(vi) procedures for nurses to refuse to perform or be involved in patient handling or movement that the nnrse believes in good faith will expose a patient or a nnrse to an unacceptable risk of injnry;

(vii) submission of an annual report to the governing body on activities related to the identification, assessment, and development of strategies to control risk of injury to patients and nurses associated with the lifting, transfening, repositioning, or movement of a patient; and

(viii) development of architectural plans for constructing or remodeling a hospital or a unit of a hospital in which patient handling and movement occurs, with consideration of the feasibility of incorporating patient handling equipment or the physical space and construction design needed to incorporate that equipment at a later date.

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(p) Outpatient services. If the hospital provides outpatient services, the services shall meet the needs of the patients in accordance with acceptable standards of practice.

(1) Organization. Outpatient services shall be appropriately organized and integrated with inpatient services.

(2) Personnel.

(A) The hospital shall assign an individual to be responsible for outpatient services.

(B) The hospital shall have appropriate physicians on staff and other professional and nonprofessional personnel available.

(q) Phmmacy services. The hospital shall provide pharmaceutical services that meet the needs of the patients.

(1) Compliance. The hospital shall provide a pharmacy which is licensed, as required, by the Texas State Board of Pharmacy. Pharmacy services shall comply with all applicable statutes and rules.

(2) Organization. The hospital shall have a pharmacy directed by a licensed pharmacist.

(3) Medical staff. The medical staff shall be responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital's organized pharmaceutical services.

(4) Pharmacy management and administration. The pharmacy or drug storage area shall be administered in accordance with accepted professional principles.

(A) Standards of practice as defined by state law shall be followed regarding the provision of pharmacy services.

(B) The pharmaceutical services shall have an adequate number of personnel to ensure quality pharmaceutical services including emergency services.

(i) The staff shall be sufficient in number and training to respond to the pharmaceutical needs of the patient population being served. There shall be an arrangement for emergency services.

(ii) Employees shall provide pharmaceutical services within the scope of their license and education.

(C) Drugs and biologicals shall be properly stored to ensure ventilation, light, security, and temperature controls.

(D) Records shall have sufficient detail to follow the flow of drugs from entry through dispensation.

(E) There shall be adequate controls over all drugs and medications including the floor stock. Drug storage m·eas shall be approved by the pharmacist, and floor stock lists shall be established.

(F) Inspections of drug storage areas shall be conducted throughout the hospital under phmmacist supervision. 41

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(G) There shall be a drug recall procedure.

(H) A full-time, part-time, or consulting pharmacist shall be responsible for developing, supervising, and coordinating all the activities of the pharmacy services.

(i) Direction ofphatmaceutical services may not require on-premises supervision but may be accomplished through regularly scheduled visits in accordance with state law.

(ii) A job description or other written agreement shall clearly define the responsibilities of the pharmacist.

(I) Current and accurate records shall be kept of the receipt and disposition of all scheduled drugs.

(i) There shall be a record system in place that provides the information on controlled substances in a readily retrievable manner which is separate from the patient record.

(ii) Records shall trace the movement of scheduled drugs throughout the services, documenting utilization or wastage.

(iii) The pharmacist shall be responsible for determining that all drug records ru·e in order and that an account of all scheduled drugs is maintained and reconciled with written orders.

(5) Delivery of services. In order to provide patient safety, drugs and biologicals shall be controlled and distributed in accordance with applicable standards of practice, consistent with federal and state laws.

(A) All compounding, packaging, and dispensing of dmgs and biologicals shall be under the supervision of a pharmacist and performed consistent with federal and state laws.

(B) All drugs and biologicals shall be kept in a secure area, and locked when appropriate.

(i) A policy shall be adopted, implemented, and enforced to ensure the safeguarding, transferring, and availability of keys to the locked storage area.

(ii) Drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 shall be kept locked within a secure area.

(C) Outdated, mislabeled, or otherwise unusable drugs and biologicals shall not be available for patient use.

(D) When a pharmacist is not available, drugs and biologicals shall be removed from the pharmacy or storage area only by personnel designated in the policies of the medical staff and pharmaceutical service, in accordance with federal and state laws.

(i) There shall be a current list of individuals identified by name and qualifications who are designated to remove drugs from the pharmacy.

(ii) Only amounts sufficient for immediate therapeutic needs shall be removed.

(E) Drugs and biologicals not specifically prescribed as to time or number of doses shall automatically be stopped after a reasonable time that is predetermined by the medical staff. 42

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(i) Stop order policies and procedures shall be consistent with those of the nursing staff and the medical staff rules and regulations.

(ii) A protocol shall be established by the medical staff for the implementation of the stop order policy, in order that drugs shall be reviewed and renewed, or automatically stopped.

(iii) A system shall be in place to determine compliance with the stop order policy.

(F) Drug administration e!Tors, adverse drug reactions, and incompatibilities shall be immediately reported to the attending physician and, if appropriate, to the hospital-wide quality assessment and performance improvement program. There shall be a mechanism in place for capturing, reviewing, and tracking medication elTors and adverse drug reactions.

(G) Abuses and losses of controlled substances shall be reported, in accordance with applicable federal and state laws, to the individual responsible for the pharmaceutical services, and to the chief executive officer, as appropriate.

(H) Information relating to drug interactions and information on drug therapy, side effects, toxicology, dosage, indications for use, and routes of administration shall be immediately available to the professional staff.

(i) A pharmacist shall be readily accessible by telephone or other means to discuss chug therapy, interactions, side effects, dosage, assist in drug selection, and assist in the identification of drug induced problems.

(ii) There shall be staff development programs on drug therapy available to facility staff to cover such topics as new drugs added to the formulary, how to resolve drug therapy problems, and other general information as the need arises.

(I) A formulary system shall be established by the medical staff to ensure quality pharmaceuticals at reasonable costs.

(r) Quality assessment and performance improvement. The governing body shall ensure that there is an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program to evaluate the provision of patient care.

(1) Program scope. The hospital-wide QAPI program shall reflect the complexity of the hospital's organization and services and have a written plan of implementation. The program must include an ongoing program that shows measurable improvements in the indicators for which there is evidence that they will improve health outcomes, and identify and reduce medical errors.

(A) All hospital departments and services, including services furnished under contract or arrangement shall be evaluated.

(B) Health care associated infections shall be evaluated.

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L- - List of Titles ]I_ Back to List ==:J IIIII TEXAS REGISTER TEXAS ADMINISTRATIVE CODE OPEN MEETINGS

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<> Texas Administrative Code TITLE 25 HEALTH SERVICES PART I DEPARTMENT OF STATE HEALTH SERVICES CHAPTER 133 HOSPITAL LICENSING SUBCHAPTER C OPERATIONAL REQUIREMENTS RULE §133.41 Hospital Functions and Services

(C) Medication therapy shall be evaluated.

(D) All medical and surgical services performed in the hospital shall be evaluated as they relate to appropriateness of diagnosis and treatment

(E) The program must measure, analyze and track quality indicators, including adverse patients' events, and other aspects of performance that assess processes of care, hospital services and operations.

(F) Data collected must be used to monitor the effectiveness and safety of service and quality of care, and to identify opportunities for changes that will lead to improvement

(G) Priorities must be established for performance improvement activities that focus on high-risk, high-volume, or problem-prone areas, taking into consideration the incidence, prevalence and severity of problems in those areas, and how health outcomes and quality of care may be affected.

(H) Performance improvement activities which affect patient safety, including analysis of medical errors and adverse patient events, must be established, and preventive actions implemented.

(I) Success of actions implemented as a result of performance improvement activities must be measured, and ongoing performance must be tracked to ensure improvements are sustained.

(2) Responsibility and accountability. The hospital's governing body, medical staff and administrative staff are responsible and accountable for ensuring that:

(A) an ongoing program for quality improvement is defined, implemented and maintained, and that program requirements are met;

(B) an ongoing program for patient safety, including reduction of medical errors, is defined, implemented and maintained;

(C) the hospital-wide QAPI efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated; and

(D) adequate resources are allocated for measuring, assessing, improving and sustaining the hospital's resources, and for reducing risk to patients.

(3) Medically-related patient care services. The hospital shall have an ongoing plan, consistent with available community and hospital resources, to provide or make available social work, 45

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psychological, and educational services to meet the medically-related needs of its patients. The hospital also shall have an effective, ongoing discharge planning program that facilitates the provision of follow-up care.

(A) Discharge planning shall be completed prior to discharge.

(B) Patients, along with necessary medical information, shall be transfened or refened to appropriate facilities, agencies, or outpatient services, as needed for follow-up or ancillary care.

(C) Screening and evaluation before patient discharge from hospital. In accordance with 42 Code of Federal Regulations (CFR), Part 483, Subpart C (relating to Requirements for Long Term Care Facilities) and the rules of the Department of Aging and Disability Services (DADS) set forth in 40 T AC Chapter 17 (relating to Preadmission Screening and Resident Review (PASRR)), all patients who are being considered for discharge from the hospital to a nursing facility shall be screened, and if appropriate, evaluated, prior to discharge by the hospital and admission to the nursing facility to determine whether the patient may have a mental illness, intellectual disability or developmental disability. If the screening indicates that the patient has a mental illness, intellectual disability or developmental disability, the hospital shall contact and arrange for the local mental health authority designated pursuant to Health and Safety Code, §533.035, to conduct prior to hospital discharge an evaluation of the patient in accordance with the applicable provisions of the PASRR rules. The purpose ofPASRR is:

(i) to ensure that placement of the patient in a nursing facility is necessary;

(ii) to identifY alternate placement options when applicable; and

(iii) to identity specialized services that may benefit the person with a diagnosis of mental illness, intellectual disability, or developmental disability.

(4) Implementation. The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained.

(s) Radiology services. The hospital shall maintain, or have available, diagnostic radiologic services according to needs of the patients. All radiology equipment, including X-ray equipment, mammography equipment and laser equipment, shall be licensed and registered as required under Chapter 289 of this title (relating to Radiation Control). Iftherapeutic services are also provided, the services, as well as the diagnostic services, shall meet professionally approved standards for safety and personnel qualifications as required in §§289.227, 289.229, 289.230 and 289.231 of this title (relating to Registration Regulations). In a special hospital, portable X-ray equipment may be acceptable as a minimum requirement.

(1) Policies and procedures. Policies and procedures shall be adopted, implemented and enforced which will describe the radiology services provided in the hospital and how employee and patient safety will be maintained.

(2) Safety for patients and personnel. The radiology services, particularly ionizing radiology procedures, shall minimize hazards to patients and personnel.

(A) Proper safety precautions shall be maintained against radiation hazards. This includes adequate radiation shielding, safety procedures and equipment maintenance and testing. 46

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(B) Inspection of equipment shall be made by or under the supervision of a licensed medical physicist in accordance with §289.227(o) of this title (relating to Use of Radiation Machines in the Healing Arts). Defective equipment shall be promptly repaired or replaced.

(C) Radiation workers shall be provided personnel monitoring dosimeters to measure the amount of radiation exposure they receive. Exposure reports and documentation shall be available for review.

(D) Radiology services shall be provided only on the order of individuals granted privileges by the medical staff.

(3) Personnel.

(A) A qualified full-time, part-time, or consulting radiologist shall supervise the ionizing radiology services and shall interpret only those radiology tests that are determined by the medical staff to require a radiologist's specialized knowledge. For purposes of this section a radiologist is a physician who is qualified by education and experience in radiology in accordance with medical staff bylaws.

(B) Only personnel designated as qualified by the medical staff shall use the radiology equipment and administer procedures.

(4) Records. Records of radiology services shall be maintained. The radiologist or other individuals who have been granted privileges to perform radiology services shall sign reports of his or her interpretations.

(t) Renal dialysis services.

(1) Hospitals may provide inpatient dialysis services without an additional license under HSC Chapter 251. Hospitals providing outpatient dialysis services shall be licensed under HSC Chapter 251.

(2) Hospitals may provide outpatient dialysis services when the governor or the president of the United States declares a disaster in this state or another' state. The hospital may provide outpatient dialysis only during the term of the disaster declaration.

(3) Equipment.

(A) Maintenance and repair. All equipment used by a facility, including backup equipment, shall be operated within manufacturer's specifications, and maintained free of defects which could be a potential hazard to patients, staff, or visitors. Maintenance and repair of all equipment shall be performed by qualified staff or contract personnel.

(i) Staff shall be able to identify malfunctioning equipment and repmt such equipment to the appropriate staff for immediate repair.

(ii) Medical equipment that malfunctions must be clearly labeled and immediately removed from service until the malfunction is identified and corrected.

(iii) Written evidence of all maintenance and repairs shall be maintained.

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(iv) After repairs or alterations are made to any equipment or system, the equipment or system shall be thoroughly tested for proper operation before returning to service. This testing must be documented.

(v) A facility shall comply with the federal Food, Drug, and Cosmetic Act, 21 United States Code (USC), §360i(b ), concerning reporting when a medical device as defined in 21 USC §321 (h) has or may have caused or contributed to the injury or death of a patient of the facility.

(B) Preventive maintenance. A facility shall develop, implement and enforce a written preventive maintenance program to ensure patient care related equipment used in a facility receives electrical safety inspections, if appropriate, and maintenance at least annually or more frequently as recommended by the manufacturer. The preventive maintenance may be provided by facility staff or by contract.

(C) Backup machine. At least one complete dialysis machine shall be available on site as backup for every ten dialysis machines in use. At least one of these backup machines must be completely operational during hours of treatment. Machines not in use during a patient shift may be counted as backup except at the time of an initial or an expansion survey.

(D) Pediatric patients. If pediatric patients are treated, a facility shall use equipment and supplies, to include blood pressure cuffs, dialyzers, and blood tubing, appropriate for this special population.

(E) Emergency equipment and supplies. A facility shall have emergency equipment and supplies immediately accessible in the treatment area.

(i) At a minimum, the emergency equipment and supplies shall include the following:

(I) oxygen;

(II) mechanical ventilatory assistance equipment, to include airways, manual breathing bag, and mask;

(III) suction equipment;

(IV) supplies specified by the medical director;

(V) electrocardiograph; and

(VI) automated external defibrillator or defibrillator.

(ii) If pediatric patients are treated, the facility shall have the appropriate type and size emergency equipment and supplies listed in clause (i) of this subparagraph for this special population.

(iii) A facility shall establish, implement, and enforce a policy for the periodic testing and maintenance of the emergency equipment. Staff shall properly maintain and test the emergency equipment and supplies and document the testing and maintenance.

(F) Transducer protector. A transducer protector shall be replaced when wetted during a dialysis treatment and shall be used for one treatment only.

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(4) Water treatment and dialysate concentrates.

(A) Compliance required. A facility shall meet the requirements of this section. A facility may follow more stringent requirements than the minimum standards required by this section.

(i) The facility administrator and medical director shall each demonstrate responsibility for the water treatment and dialysate supply systems to protect hemodialysis patients from adverse effects arising from known chemical and microbial contaminates that may be found in improperly prepared dialysate, to ensure that the dialysate is conectly formulated and meets the requirements of all applicable quality standards.

(ii) The facility administrator and medical director must assure that policies and procedures related to water treatment and dialysate are understandable and accessible to the operator(s) and that the training program includes quality testing, risks and hazards of improperly prepared concentrate and bacterial issues.

(iii) The facility administrator and medical director must be inf01med prior to any alteration of, or any device being added to, the water system.

(B) Water treatment. These requirements apply to water intended for use in the delivery of hemodialysis, including the preparation of concentrates from powder at a dialysis facility and dialysate.

(i) The design for the water treatment system in a facility shall be based on considerations of the source water for the facility and designed by a water quality professional with education, training, or experience in dialysis system design.

(ii) When a public water system supply is not used by a facility, the source water shall be tested by the facility at monthly intervals in the same manner as a public water system as described in 30 TAC §290.1 04 (relating to Summary of Maximum Contaminant Levels, Maximum Residual Disinfectant Levels, Treatment Techniques, and Action Levels), and §290.109 (relating to Microbial Contaminants) as adopted by the Texas Commission on Environmental Quality (TCEQ).

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<> Texas Administrative Code TITLE25 HEALTH SERVICES PART I DEPARTMENT OF STATE HEALTH SERVICES CHAPTER 133 HOSPITAL LICENSING SUBCHAPTER C OPERATIONAL REQUIREMENTS RULE §133.41 Hospital Functions and Services

(iii) The physical space in which the water treatment system is located must be adequate to allow for maintenance, testing, and repair of equipment. If mixing of dialysate is performed in the same area, the physical space must also be adequate to house and allow for the maintenance, testing, and repair of the mixing equipment and for performing the mixing procedure.

(iv) The water treatment system components shall be aJTanged and maintained so that bacterial and chemical contaminant levels in the product water do not exceed the standm·ds for hemodialysis water quality described in §4.2.1 (concerning Water Bacteriology) and §4.2.2 (concerning Maximum Level of Chemical Contaminants) of the American National Standard, Water Treatment Equipment for Hemodialysis Applications, August 2001 Edition, published by the Association for the Advancement of Medical Instrumentation (AAMI). All documents published by the AAMI as referenced in this section may be obtained by writing the following address: 1110 North Glebe Road, Suite 220, Arlington, Virginia 22201.

(v) Written policies and procedures for the operation of the water treatment system must be developed and implemented. Parameters for the operation of each component of the water treatment system must be developed in writing and known to the operator. Each major water system component shall be labeled in a manner that identifies the device; describes its function, how performance is verified and actions to take in the event performance is not within an acceptable range.

(vi) The materials of any components of water treatment systems (including piping, storage, filters and distribution systems) that contact the purified water shall not interact chemically or physically so as to affect the purity or quality of the product water adversely. Such components shall be fabricated from unreactive materials (e. g. plastics) or appropriate stainless steel. The use of materials that are known to cause toxicity in hemodialysis, such as copper, brass, galvanized material, or aluminum, is prohibited.

(vii) Chemicals infused into the water such as iodine, acid, flocculants, and complexing agents shall be shown to be nondialyzable or shall be adequately removed from product water. Monitors or specific test procedures to verify removal of additives shall be provided and documented.

(viii) Each water treatment system shall include reverse osmosis membranes or deionization tanks and a minimum of two carbon tanks in series. If the source water is from a private supply which does not use chlorine/chloramine, the water treatment system shall include reverse osmosis membranes or deionization tanks and a minimum of one carbon tank.

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(I) Reverse osmosis membranes. Reverse osmosis membranes, if used, shall meet the standards in §4.3.7 (concerning Reverse Osmosis) of the American National Standard, Water Treatment Equipment for Hemodialysis Applications, August 200 I Edition, published by the AAMI.

(II) Deionization systems.

(-a-) Deionization systems, if used, shall be monitored continuously to produce water of one megohm-centimeter (em) or greater specific resistivity (or conductivity of one microsiemen/cm or less) at 25 degrees Celsius. An audible and visual alarm shall be activated when the product water resistivity falls below this level and the product water stream shall be prevented from reaching any point of use.

(-b-) Patients shall not be dialyzed on deionized water with a resistivity less than 1.0 megohm- em measured at the output of the deionizer.

(-c-) A minimum of two deionization (DI) tanks in series shall be used with resistivity monitors including audible and visual alarms placed pre and post the final DI tank in the system. The • alarms must be audible in the patient care area.

(-d-) Feed water for deionization systems shall be pretreated with activated carbon adsorption, or a comparable alternative, to prevent nitrosamine formation.

(-e-) If a deionization system is the last process in a water treatment system, it shall be followed by an ultrafilter or other bacteria and endotoxin reducing device.

(III) Carbon tallies.

(-a-) The carbon tanks must contain acid washed carbon, 30-mesh or smaller with a minimum iodine number of900.

(-b-) A minimum of two carbon adsorption beds shall be installed in a series configuration.

(-c-) The total empty bed contact time (EBCT) shall be at least ten minutes, with the final tank providing at least five minutes EBCT. Carbon adsorption systems used to prepare water for portable dialysis systems are exempt from the requirement for the second carbon and a ten minute EBCT if removal of chloramines to below 0.1 milligram (mg)/1 is verified before each treatment.

(-d-) A means shall be provided to sample the product water immediately prior to the final bed (s). Water from this port(s) must be tested for chlorine/chloramine levels immediately prior to each patient shift.

(-e-) All samples for chlorine/chloramine testing must be drawn when the water treatment system has been operating for at least 15 minutes.

(-f-) Tests for total chlorine, which include both free and combined forms of chlorine, may be used as a single analysis with the maximum allowable concentration of0.1 mg/liter (L). Test results of greater than 0.5 parts per million (ppm) for chlorine or 0.1 ppm for chloramine from the pmi between the initial tank(s) and final tan1c(s) shall require testing to be perfmmed at the final exit and replacement of the initial tan1c(s).

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(-g-) In a system without a holding tank, if test results at the exit of the final tank(s) are greater than the parameters for chlorine or chloramine described in this subclause, dialysis treatment shall be immediately terminated to protect patients from exposure to chlorine/chloramine and the medical director shall be notified. In systems with holding tanks, if the holding tank tests <1 mg/L for total chlorine, the reverse osmosis (RO) may be turned off and the product water in the holding tank may be used to finish treatments in process. The medical director shall be notified.

(-h-) If means other than granulated carbon are used to remove chlorine/chloramine, the facility's governing body must approve such use in writing after review of the safety of the intended method for use in hemodialysis applications. If such methods include the use of additives, there must be evidence the product water does not contain unsafe levels of these additives.

(ix) Water softeners, if used, shall be tested at the end of the treatment day to verify their capacity to treat a sufficient volume of water to supply the facility for the entire treatment day and shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration.

(x) If used, the face(s) oftimer(s) used to control any component of the water treatment or dialysate delivery system shall be visible to the operator at all times. Written evidence that timers are checked for operation and accuracy each day of operation must be maintained.

(xi) Filter housings, if used during disinfectant procedures, shall include a means to clear the lower portion of the housing of the disinfecting agents. Filter housings shall be opaque.

(xii) Ultrafilters, or other bacterial reducing filters, if used, shall be fitted with pressure gauges on the inlet and outlet water lines to monitor the pressure drop across the membrane. Ultrafilters shall be included in routine disinfection procedures.

(xiii) If used, storage tanks shall have a conical or bowl shaped base and shall drain from the lowest point of the base. Storage tanks shall have a tight-fitting lid and be vented through a hydrophobic 0.2 micron air filter. Means shall be provided to effectively disinfect any storage tank installed in a water distribution system.

(xiv) Ultraviolet (UV) lights, if used, shall be monitored at the frequency recommended by the manufacturer. A log sheet shall be used to record monitoring.

(xv) Water treatment system piping shall be labeled to indicate the contents of the pipe and direction of flow.

(xvi) The water treatment system must be continuously monitored during patient treatment and be guarded by audible and visual alarms which can be seen and heard in the dialysis treatment area should water quality drop below specific parameters. Quality monitor sensing cells shall be located as the last component of the water treatment system and at the beginning of the distribution system. No water treatment components that could affect the quality of the product water as measured by this device shall be located after the sensing cell.

(xvii) When deionization tanks do not follow a reverse osmosis system, parameters for the rejection rate of the membranes must assure that the lowest rate accepted would provide product water in compliance with §4.2.2 (concerning Maximum Level of Chemical Contan1inants) of the

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American National Standard, Water Treatment Equipment for Hemodialysis Applications, August 2001 Edition published by the AAMI.

(xviii) A facility shall maintain written logs of the operation of the water treatment system for each treatment day. The log book shall include each component's operating parameter and the action taken when a component is not within the facility's set parameters.

(xix) Microbiological testing of product water shall be conducted.

(I) Frequency. Microbiological testing shall be conducted monthly and following any repair or change to the water treatment system. For a newly installed water distribution system, or when a change has been made to an existing system, weekly testing shall be conducted for one month to verify that bacteria and endotoxin levels are consistently within the allowed limits.

(II) Sample sites. At a minimum, sample sites chosen for the testing shall include the beginning of the distribution piping, at any site of dialysate mixing, and the end of the distribution piping.

(III) Technique. Samples shall be collected immediately before sanitization/disinfection of the water treatment system and dialysis machines. Water testing results shall be routinely trended and reviewed by the medical director in order to determine if results seem questionable or if there is an opportunity for improvement. The medical director shall determine if there is a need for retesting. Repeated results of "no growth" shall be validated via an outside laboratory. A calibrated loop may not be used in microbiological testing of water samples. Colonies shall be counted using a magnifying device.

(IV) Expected results. Product water used to prepare dialysate, concentrates from powder, or to reprocess dialyzers for multiple use, shall contain a total viable microbial count less than 200 colony forming units (CFU)/millimeter (ml) and an endotoxin concentration less than 2 endotoxin units (EU)/ml. The action level for the total viable microbial count in the product water shall be 50 CFU/ml and the action level for the endotoxin concentration shall be 1 EU/ml.

(V) Required action for unacceptable results. If the action levels described at subclause (IV) of this clause are observed in the product water, corrective measures shall be taken promptly to reduce the levels into an acceptable range.

(VI) Records. All bacteria and endotoxin results shall be recorded on a log sheet in order to identify trends that may indicate the need for corrective action.

(xx) If ozone generators are used to disinfect any portion of the water or dialysate delivery system, testing based on the manufacturer's direction shall be used to measure the ozone concentration each time disinfection is performed, to include testing for safe levels of residual ozone at the end of the disinfection cycle. Testing for ozone in the ambient air shall be conducted on a periodic basis as recommended by the manufacturer. Records of all testing must be maintained in a log.

(xxi) If used, hot water disinfection systems shall be monitored for temperature and time of exposure to hot water as specified by the manufacturer. Temperature of the water shall be recorded at a point furthest from the water heater, where the lowest water temperature is likely to occur. The water temperature shall be measured each time a disinfection cycle is performed. A record that verifies successful completion of the heat disinfection shall be maintained. 53

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(xxii) After chemical disinfection, means shall be provided to restore the equipment and the system in which it is installed to a safe condition relative to residual disinfectant prior to the product water being used for dialysis applications.

(xxiii) Samples of product water must be submitted for chemical analysis every six months and must demonstrate that the quality of the product water used to prepare dialysate or concentrates from powder, meets §4.2.2 (concerning Maximum Level of Chemical Contaminants) of the American National Standard, Water Treatment Equipment for Hemodialysis Applications, August 2001 Edition, published by the AAMI.

(I) Samples for chemical analysis shall be collected at the end of the water treatment components and at the most distal point in each water distribution loop, if applicable. All other outlets from the distribution loops shall be inspected to ensure that the outlets are fabricated from compatible materials. Appropriate containers and pH adjustments shall be used to ensure accurate determinations. New facilities or facilities that add or change the Cont'd ...

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List of Titles ] ~~____B_a_c_kt_o_L_is_t__~

TEXAS REGISTER TEXAS ADMINISTRATIVE CODE OPEN MEETINGS

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<> Texas Administrative Code TITLE 25 HEALTH SERVICES PART I DEPARTMENT OF STATE HEALTH SERVICES CHAPTER 133 HOSPITAL LICENSING SUBCHAPTER C OPERATIONAL REQUIREMENTS RULE §133.41 Hospital Functions and Services

configuration ofthe water distribution system must draw samples at the most distal point for each water distribution loop, if applicable, on a one time basis.

(II) Additional chemical analysis shall be submitted if substaotial changes are made to the water treatment system or if the percent rejection of a reverse osmosis system decreased 5.0% or more from the percent rejection measured at the time the water sample for the preceding chemical analysis was taken.

(xxiv) Facility records must include all test results and evidence that the medical director has reviewed the results of the water quality testing and directed corrective action when indicated.

(xxv) Only persons qualified by the education or experience may operate, repair, or replace components of the water treatment system.

(C) Dialysate.

(i) Quality control procedures shall be established to ensure ongoing conformance to policies and procedures regarding dialysate quality.

(ii) Each facility shall set all hemodialysis machines to use only one family of concentrates. When new machines are put into service or the concentrate family or concentrate manufacturer is chaoged, samples shall be sent to a laboratory for verification.

(iii) Prior to each patient treatment, staff shall verify the dialysate conductivity aod pH of each machine with an independent device.

(iv) Bacteriological testing shall be conducted.

(I) Frequency. Responsible facility staff shall develop a schedule to ensure each hemodialysis machine is tested quarterly for bacterial growth aod the presence of endotoxins. Hemodialysis machines of home patients shall be cultured monthly until results not exceeding 200 CFU/ml are obtained for three consecutive months, then quarterly samples shall be cultured.

(II) Acceptable limits. Dialysate shall contain less than 200 CFU/ml and an endotoxin concentration ofless than 2 EU/ml. The action level for total viable microbial count shall be 50 CFU/ml and the action level for endotoxin concentration shall be 1 EU/ml.

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(III) Action to be taken. Disinfection and retesting shall be done when bacterial or endotoxin counts exceed the action levels. Additional samples shall be collected when there is a clinical indication of a pyrogenic reaction and/or septicemia.

(v) Only a licensed nurse may use an additive to increase concentrations of specific electrolytes in the acid concentrate. Mixing procedures shall be followed as specified by the additive manufacturer. When additives are prescribed for a specific patient, the container holding the prescribed acid concentrate shall be labeled with the name of the patient, the final concentration of the added electrolyte, the date the prescribed concentrate was made, and the name of the person who mixed the additive.

(vi) All components used in concentrate preparation systems (including mixing and storage tanks, pumps, valves and piping) shall be fabricated from materials (e.g., plastics or appropriate stainless steel) that do not interact chemically or physically with the concentrate so as to affect its purity, or with the germicides used to disinfect the equipment. The use of materials that are known to cause toxicity in hemodialysis such as copper, brass, galvanized material and aluminum is prohibited.

(vii) Facility policies shall address means to protect stored acid concentrates from tampering or from degeneration due to exposure to extreme heat or cold.

(viii) Procedures to control the transfer of acid concentrates from the delivety container to the storage tank and prevent the inadvertent mixing of different concentrate formulations shall be developed, implemented and enforced. The storage tanks shall be clearly labeled.

(ix) Concentrate mixing systems shall include a purified water source, a suitable drain, and a ground fault protected electrical outlet.

(I) Operators of mixing systems shall use personal protective equipment as specified by the manufacturer during all mixing processes.

(II) The manufacturer's instructions for use of a concentrate mixing system shall be followed, including instructions for mixing the powder with the correct amount of water. The number of bags or weight of powder added shall be determined and recorded.

(III) The mixing tank shall be clearly labeled to indicate the fill and final volumes required to correctly dilute the powder.

(IV) Systems for preparing either bicarbonate or acid concentrate from powder shall be monitored according to the manufacturer's instructions.

(V) Concentrates shall not be used, or transferred to holding tanks or distribution systems, until all tests are completed.

(VI) If a facility designs its own system for mixing concentrates, procedures shall be developed and validated using an independent laboratory to ensure proper mixing.

(x) Acid concentrate mixing tanks shall be designed to allow the inside of the tank to be rinsed when changing concentrate formulas.

(I) Acid mixing systems shall be designed and maintained to prevent rust and corrosion.

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(II) Acid concentrate mixing tanks shall be emptied completely and rinsed with product water before mixing another batch of concentrate to prevent cross contamination between different batches.

(III) Acid concentrate mixing equipment shall be disinfected as specified by the equipment manufacturer or in the case where no specifications are given, as defined by facility policy.

(IV) Records of disinfection and rinsing of disinfectants to safe residual levels shall be maintained.

(xi) Bicarbonate concentrate mixing tanks shall have conical or bowl shaped bottoms and shall drain from the lowest point of the base. The tank design shall allow all internal surfaces to be disinfected and rinsed.

(I) Bicarbonate concentrate mixing tanks shall not be prefilled the night before use.

(II) If disinfectant remains in the mixing tank overnight, this solution must be completely drained, the tank rinsed and tested for residual disinfectant prior to preparing the first batch of that day of bicarbonate concentrate.

(III) Unused portions of bicarbonate concentrate shall not be mixed with fresh concentrate.

(IV) At a minimum, bicarbonate distribution systems shall be disinfected weekly. More frequent disinfection shall be done if required by the manufacturer, or if dialysate culture results are above the action level.

(V) If jugs are reused to deliver bicarbonate concentrate to individual hemodialysis machines:

(-a-) jugs shall be emptied of concentrate, rinsed and inverted to drain at the end of each treatment day;

(-b-) at a minimum, jugs shall be disinfected weekly, more frequent disinfection shall be considered by the medical director if dialysate culture results are above the action level; and

(-c-) following disinfection, jugs shall be drained, rinsed free of residual disinfectant, and inverted to dry. Testing for residual disinfectant shall be done and documented.

(xii) All mixing tanks, bulk storage tanks, dispensing tanks and containers for single hemodialysis treatments shall be labeled as to the contents.

(I) Mixing tanks. Prior to batch preparation, a label shall be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling shall remain on the mixing tank until the tank has been emptied.

(II) Bulk storage/dispensing tanks. These tanks shall be permanently labeled to identifY the chemical composition or formulation of their contents.

(III) Single machine containers. At a minimum, single machine containers shall be labeled with sufficient information to differentiate the contents from other concentrate formulations used in the facility and permit positive identification by users of container contents.

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(xiii) Permanent records of batches produced shall be maintained to include the concentrate formula produced, the volume of the batch, lot number(s) of powdered concentrate packages, the manufacturer of the powdered concentrate, date and time of mixing, test results, person performing mixing, and expiration date (if applicable).

(xiv) If dialysate concentrates are prepared in the facility, the manufacturers' recommendations shall be followed regarding any preventive maintenance. Records shall be maintained indicating the date, time, person performing the procedure, and the results (if applicable).

(5) Prevention requirements concerning patients.

(A) Hepatitis B vaccination.

(i) With the advice and consent of a patient's attending nephrologist, facility staff shall make the hepatitis B vaccine available to a patient who is susceptible to hepatitis B, provided that the patient has coverage or is willing to pay for vaccination.

(ii) The facility shall make available to patients literature describing the risks and benefits of the hepatitis B vaccination.

(B) Serologic screening of patients.

(i) A patient new to dialysis shall have been screened for hepatitis B surface antigen (HBsAg) within one month before or at the time of admission to the facility or have a !mown hepatitis B surface antibody (anti-HBs) status of at least 10 milli-international units per milliliter no more than 12 months prior to admission. The facility shall document how this screening requirement is met.

(ii) Repeated serologic screening shall be based on the antigen or antibody status of the patient.

(I) Monthly screening for HBsAg is required for patients whose previous test results are negative for HBsAg.

(II) Screening ofHBsAg-positive or anti-HBs-positive patients may be performed on a less frequent basis, provided that the facility's policy on this subject remains congruent with Appendices i and ii of the National Surveillance of Dialysis Associated Disease in the United States, 2000, published by the United States Department of Health and Human Services.

(C) Isolation procedures for the HBsAg-positive patient.

(i) The facility shall treat patients positive for HBsAg in a segregated treatment area which includes a hand washing sink, a work area, patient care supplies and equipment, and sufficient space to prevent cross-contamination to other patients.

(ii) A patient who tests positive for HBsAg shall be dialyzed on equipment reserved and maintained for the HBsAg-positive patient's use only.

(iii) When a caregiver is assigned to both HBsAg-negative and HBsAg-positive patients, the HBsAg-negative patients assigned to this grouping must be Hepatitis B antibody positive. Hepatitis B antibody positive patients are to be seated at the treatment stations nearest the isolation station and be assigned to the same staff member who is caring for the HBsAg-positive patient.

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(iv) If an HBsAg-positive patient is discharged, the equipment which had been reserved for that patient shall be given intermediate level disinfection prior to use for a patient testing negative for HBsAg.

(v) In the case of patients new to dialysis, if these patients are admitted for treatment before results ofHBsAg or anti-HBs testing are known, these patients shall undergo treatment as if the HBsAg test results were potentially positive, except that they shall not be treated in the HBsAg isolation room, area, or machine.

(I) The facility shall treat potentially HBsAg-positive patients in a location in the treatment area which is outside of traffic patterns until the HBsAg test results are known.

(II) The dialysis machine used by this patient shall be given intermediate level disinfection prior to its use by another patient.

(III) The facility shall obtain HBsAg status results of the patient no later than three days from admission.

(u) Respiratory care services. The hospital shall meet the needs of the patients in accordance with acceptable standards of practice.

(1) Policies and procedures shall be adopted, implemented, and enforced which describe the provision of respiratory care services in the hospital.

(2) The organization of the respiratory care services shall be appropriate to the scope and complexity of the services offered.

(3) There shall be a medical director or clinical director of respiratmy care services who is a physician with the knowledge, experience, and capabilities to supervise and administer the services properly. The medical director or clinical director may serve on either a full-time or part-time basis.

(4) There shall be adequate numbers of respiratory therapists, respiratmy therapy technicians, and other personnel who meet the qualifications specified by the medical staff, consistent with the state law.

(5) Personnel qualified to perform specific procedures and the amount of supervision required for personnel to carry out specific procedures shall be designated in writing.

(6) If blood gases or other clinical laboratory tests are performed by the respiratory care services staff, the respiratmy care staff shall comply with CLIA 1988 in accordance with the requirements specified in 42 CPR, Part 493.

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TEXAS REGISTER TEXAS ADMINISTRATIVE CODE OPEN MEETINGS

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<> Texas Administrative Code TITLE 25 HEALTH SERVICES PART! DEPARTMENT OF STATE HEALTH SERVICES CHAPTER 133 HOSPITAL LICENSING SUBCHAPTER C OPERATIONAL REQUIREMENTS RULE §133.41 Hospital Functions and Services

(7) Services shall be provided only on, and in accordance with, the orders of a physician.

(v) Sterilization and sterile supplies.

(1) Supervision. The sterilization of all supplies and equipment shall be under the supervision of a person qualified by education, training and experience. Staff responsible for the sterilization of supplies and equipment shall participate in a documented continuing education program; new employees shall receive initial orientation and on-the-job training.

(2) Equipment and procedures.

(A) Sterilization. Every hospital shall provide equipment adequate for sterilization of supplies and equipment as needed. Equipment shall be maintained and operated to perfotm, with accuracy, the sterilization of the various materials required.

(B) Written policy. Written policies and procedures for the decontamination and sterilization activities performed shall be adopted, implemented and enforced. Policies shall include the receiving, cleaning, decontaminating, disinfecting, preparing and sterilization of reusable items, as well as those for the assembly, wrapping, storage, distribution and quality control of sterile items and equipment. These written policies shall be reviewed at least every other year and approved by the infection control practitioner or committee.

(C) Separation. Where cleaning, preparation, and sterilization functions are performed in the same room or unit, the physical facilities, equipment, and the policies and procedures for their use, shall be such as to effectively separate soiled or contaminated supplies and equipment from the clean or sterilized supplies and equipment. Hand washing facilities shall be provided and a separate sink shall be provided for safe disposal ofliquid waste.

(D) Labeling. All containers for solutions, drugs, flammable solvents, ether, alcohol, and medicated supplies shall be clearly labeled to indicate contents. Those which are sterilized by the hospital shall be labeled so as to be identifiable both before and after sterilization. Sterilized items shall have a load control identification that indicates the sterilizer used, the cycle or load number, and the date of sterilization.

(E) Preparation for sterilization.

(i) All items to be sterilized shall be prepared to reduce the bioburden. All items shall be thoroughly cleaned, decontaminated and prepared in a clean, controlled environment. 60

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(ii) All articles to be sterilized shall be arranged so all surfaces will be directly exposed to the sterilizing agent for the prescribed time and temperature.

(F) Packaging. All wrapped articles to be sterilized shall be packaged in materials recommended for the specific type of sterilizer and material to be sterilized.

(G) External chemical indicators.

(i) External chemical indicators, also known as sterilization process indicators, shall be used on each package to be sterilized, including items being flash sterilized to indicate that items have been exposed to the sterilization process.

(ii) The indicator results shall be interpreted according to manufacturer's written instructions and indicator reaction specifications.

(iii) A log shall be maintained with the load identification, indicator results, and identification of the contents of the load.

(H) Biological indicators. Biological indicators are commercially-available microorganisms (e.g., United States Food and Drug Administration (FDA) approved strips or vials of Bacillus species endospores) which can be used to verify the performance of waste treatment equipment and processes (or sterilization equipment and processes).

(i) The efficacy of the sterilizing process shall be monitored with reliable biological indicators appropriate for the type of sterilizer used.

(ii) Biological indicators shall be included in at least one run each week of use for steam sterilizers, at least one run each day of use for low-temperature hydrogen peroxide gas sterilizers, and every load for ethylene oxide (EO) sterilizers.

(iii) Biological indicators shall be included in eve1y load that contains implantable objects.

(iv) A log shall be maintained with the load identification, biological indicator results, and identification of the contents of the load.

(v) If a test is positive, the sterilizer shall immediately be talcen out of service.

(!)Implantable items shall be recalled and reprocessed if a biological indicator test (spore test) is positive.

(II) All available items shall be recalled and reprocessed if a sterilizer malfunction is found and a list of those items not retrieved in the recall shall be submitted to infection control.

(III) A malfunctioning sterilizer shall not be put back into use until it has been serviced and successfully tested according to the manufacturer's recommendations.

(!) Sterilizers.

(i) Steam sterilizers (saturated steam under pressure) shall be utilized for sterilization of heat and moisture stable items. Steam sterilizers shall be used according to manufacturer's written instructions. 61

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(ii) EO sterilizers shall be used for processing heat and moistme sensitive items. EO sterilizers and aerators shall be used and vented according to the manufacturer's written instructions.

(iii) Flash sterilizers shall be used for emergency sterilization of clean, unwrapped instruments and porous items only.

(J) Disinfection.

(i) Written policies, approved by the infection control committee, shall be adopted, implemented and enforced for the use of chemical disinfectants.

(ii) The manufacturer's written instructions for the use of disinfectants shall be followed.

(iii) An expiration date, determined according to manufacturer's written recommendations, shall be marked on the container of disinfection solution cunently in use.

(iv) Disinfectant solutions shall be kept covered and used in well-ventilated areas.

(v) Chemical germicides that are registered with the United States Environmental Protection Agency as "sterilants" may be used either for sterilization or high-level disinfection.

(vi) All staff personnel using chemical disinfectants shall have received training on their use.

(K) Performance records.

(i) Performance records for all sterilizers shall be maintained for each cycle. These records shall be retained and available for review for a minimum of five years.

(ii) Each sterilizer shall be monitored continuously during operation for pressure, temperature, and time at desired temperature and pressure. A record shall be maintained and shall include:

(I) the sterilizer identification;

(II) sterilization date;

(III) cycle number;

(IV) contents of each load;

(V) duration and temperature ofexposme phase (if not provided on sterilizer recording charts);

(VI) identification of operator(s);

(VII) results of biological tests and dates perfmmed;

(VIII) time-temperature recording charts from each sterilizer;

(IX) gas concentration and relative humidity (if applicable); and

(X) any other test results.

(L) Storage of sterilized items. 62

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(i) Sterilized items shall be transpmied so as to maintain cleanliness and sterility and to prevent physical damage.

(ii) Sterilized items shall be stored in well-ventilated, limited access areas with controlled temperature and humidity.

(iii) The hospital shall adopt, implement and enforce a policy which describes the mechanism used to determine the shelf life of sterilized packages.

(M) Preventive maintenance. Preventive maintenance of all sterilizers shall be performed according to individual adopted, implemented and enforced policy on a scheduled basis by qualified personnel, using the sterilizer manufacturer's service manual as a reference. A preventive maintenance record shall be maintained for each sterilizer. These records shall be retained at least two years and shall be available for review.

(w) Surgical services. If a hospital provides surgical services, the services shall be well-organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered, the services shall be consistent in quality with inpatient care in accordance with the complexity of services offered. A special hospital may not offer surgical services.

(1) Organization and staffing. The organization ofthe surgical services shall be appropriate for the scope of the services offered.

(A) The operating rooms shall be supervised by an experienced RN or physician.

(B) Licensed vocational nmses (LVNs) and surgical technologists (operating room technicians) may serve as scrub nmses or technologists under the supervision of an RN.

(C) Circulating duties in the operating room must be performed by qualified RNs. In accordance with approved medical staff polices and procedures, LVNs and surgical technologists may assist in circulatory duties under the direct supervision of a qualified RN circulator.

(D) Surgical privileges shall be delineated for all physicians, podiatrists, and dentists performing surgery in accordance with the competencies of each. The surgical services shall maintain a roster specifYing the surgical privileges of each.

(E) If the facility employs smgical technologists, the facility shall adopt, implement, and enforce policies and procedures to comply with Health and Safety Code, Chapter 259 (relating to Surgical Technologists at Health Care Facilities).

(2) Delivery of service. Surgical services shall be consistent with needs and resources. Written policies governing surgical care which are designed to ensure the achievement and maintenance of high standards of medical practice and patient care shall be adopted, implemented and enforced.

(A) There shall be a complete medical history and physical examination, as required under subsection (k)(3 )(F) of this section, in the medical record of every patient prior to smgery, except in emergencies. If this has been dictated, but not yet recorded in the patient's medical record, there shall be a statement to that effect and an admission note in the record by the individual who admitted the patient.

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(B) A properly executed informed consent form for the operation shall be in the patient's medical record before surgery, except in emergencies.

(C) The following equipment shall be available in the operating room suites:

(i) communication system;

(ii) cardiac monitor;

(iii) resuscitator;

(iv) defibrillator;

(v) aspirator; and

(vi) tracheotomy set.

(D) There shall be adequate provisions for immediate postoperative care.

(E) The operating room register shall be complete and up-to-date. The register shall contain, but not be limited to, the following:

(i) patient's name and hospital identification number;

(ii) date of operation;

(iii) operation performed;

(iv) operating surgeon and assistant( s);

(v) type of anesthesia used and name of person administering it;

(vi) time operation began and ended;

(vii) time anesthesia began and ended;

(viii) disposition of specimens;

(ix) names of scrub and circulating personnel;

(x) unusual occmrences; and

(xi) disposition of the patient.

(F) An operative report describing techniques, findings, and tissue removed or altered shall be written or dictated immediately following surgery and signed by the surgeon.

(x) Therapy services. If the hospital provides physical therapy, occupational therapy, audiology, or speech pathology services, the services shall be organized and staffed to ensure the health and safety of patients.

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(1) Organization and staffing. The organization of the services shall be appropriate to the scope of the services offered.

(A) The director of the services shall have the necessary knowledge, experience, and capabilities to properly supervise and administer the services.

(B) Physical therapy, occupational therapy, speech therapy, or audiology services, if provided, shall be provided by staff who meet the qualifications specified by the medical staff, consistent with state law.

(2) Delivery of services. Services shall be furnished in accordance with a written plan of treatment. Services to be provided shall be consistent with applicable state laws and regulations, and in accordance with orders of the physician, podiatrist, dentist or other licensed practitioner who is authorized by the medical staffto order the services. Therapy orders shall be incorporated in the patient's medical record.

Cont'd ...

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Iiiii TEXAS REGISTER TEXAS ADMINISTRATIVE CODE OPEN MEETINGS

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<> Texas Administrative Code TITLE 25 HEALTH SERVICES PART! DEPARTMENT OF STATE HEALTH SERVICES CHAPTER 133 HOSPITAL LICENSING SUBCl:IAPTER C OPERATIONAL REQUIREMENTS RULE §133.41 Hospital Functions and Services

(y) Waste and waste disposal.

(1) Special waste and liquid/sewage waste management.

(A) The hospital shall comply with the requirements set forth by the depmtment in §§1.131 - 1.137 of this title (relating to Definition, Treatment, and Disposition of Special Waste from Health Care- Related Facilities) and the TCEQ requirements in 30 TAC §330.1207 (relating to Generators of Medical Waste).

(B) All sewage and liquid wastes shall be disposed of in a municipal sewerage system or a septic tank system permitted by the TCEQ in accordance with 30 TAC Chapter 285 (relating to On-Site Sewage Facilities).

(2) Waste receptacles.

(A) Waste receptacles shall be conveniently available in all toilet rooms, patient areas, staff work areas, and waiting rooms. Receptacles shall be routinely emptied of their contents at a central location(s) into closed containers.

(B) Waste receptacles shall be properly cleaned with soap and hot water, followed by treatment of inside surfaces of the receptacles with a germicidal agent.

(C) All containers for other municipal solid waste shall be leak-resistant, have tight-fitting covers, and be rodent-proof.

(D) Nonreusable containers shall be of suitable strength to minimize animal scavenging or rupture during collection operations.

Source Note: The provisions of this §133.41 adopted to be effective June 21, 2007, 32 TexReg 3587; amended to be effective December 9, 2010, 35 TexReg 10716; mnended to be effective November 11, 2012, 37 TexReg 8809; amended to be effective May 24,2013,38 TexReg 3001; amended to be effective September 14,2014, 39 TexReg 7140

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IIIII TEXAS REGISTER TEXAS ADMINISTRATIVE CODE OPEN MEETINGS

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(a) Safety committee. Each hospital shall have a multidisciplinary safety committee. The hospital chief executive officer (CEO) shall appoint the chairman and members of the safety committee.

(1) Safety officer. The CEO shall appoint a safety officer who is knowledgeable in safety practices in health care facilities. The safety officer shall be a member of the safety committee, and shall carry out the functions of the safety program.

(2) Safety committee meetings. The safety committee shall meet as required by the chairman, but not less than quarterly. Written minutes of each meeting shall be retained for at least one year.

(3) Safety activities.

(A) Incident reports. The safety committee shall establish an incident reporting system which includes a mechanism to ensure that all incidents recorded in safety committee minutes are evaluated, and documentation is provided to show follow-up and corrective actions.

(B) Safety policies and procedures. Safety policies and procedures for each department or service shall be developed, implemented and enforced.

(C) Safety training and continuing education. Safety training shall be established as part of new employee orientation and in the continuing education of all employees.

(4) Written authority. The authority of the safety committee to take action when conditions exist that are a possible threat to life, health, or building damage, shall be defined in writing and approved by the governing body.

(b) Safety manual. Each department or service shall have a safety policy and procedure manual within their own area that becomes a part of the overall facility safety manual.

(c) Emergency communication system. An emergency communication system shall be provided in each facility. The system shall be self-sufficient and capable of operating without reliance on the building's service or emergency power supply. Such system shall have the capability of communicating with the available community or state emergency networks, including police and fire departments.

Source Note: The provisions of this §133.142 adopted to be effective June 21,2007,32 TexReg 3587

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I HOME TEXAS REGISTER TEXAS ADMINISTRATIVE CODE OPEN MEETINGS

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HEALTH AND SAFETY CODE

TITLE 4. HEALTH FACILITIES

SUBTITLE B. LICENSING OF HEALTH FACILITIES

CHAPTER 241. HOSPITALS

SUBCHAPTER A. GENERAL PROVISIONS

Sec. 241.001. SHORT TITLE. This chapter may be cited as the Texas Hospital Licensing Law.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 241.002. PURPOSE. The purpose of this chapter is to protect and promote the public health and welfare by providing for the development, establishment, and enforcement of certain standards in the construction, maintenance, and operation of hospitals.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. 219, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.003. DEFINITIONS. In this chapter: (1) "Advanced practice nurse" means a registered nurse recognized as an advanced practice nurse by the Texas Board of Nursing. (2) "Board" means the Texas Board of Health. (3) "Comprehensive medical rehabilitation hospital" means a general hospital that specializes in providing comprehensive medical rehabilitation services, including surgery and related ancillary services. (4) "Department" means the Texas Department of Health. (5) "General hospital" means an establishment that: (A) offers services, facilities, and beds for use for more than 24 hours for two or more unrelated individuals requiring diagnosis, treatment, or care for illness, injury, deformity, abnormality, or pregnancy; and (B) regularly maintains, at a minimum, clinical laboratory services, diagnostic X-ray services, treatment facilities including surgery or obstetrical care or both, and other definitive medical or surgical treatment of similar extent. (6) "Governmental unit" means a political subdivision of the state,

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including a hospital district, county, or municipality, and any department, division, board, or other agency of a political subdivision. (7) "Hospital'' includes a general hospital and a special hospital. (8) "Medical staff'' means a physician or group of physicians and a podiatrist or a group of podiatrists who by action of the governing body of a hospital are privileged to work in and use the facilities of a hospital for or in connection with the observation, care, diagnosis, or treatment of an individual who is, or may be, suffering from a mental or physical disease or disorder or a physical deformity or injury. (9) "Pediatric and adolescent hospital'' means a general hospital that specializes in providing services to children and adolescents, including surgery and related ancillary services. (10) "Person" means an individual, firm, partnership, corporation, association, or joint stock company, and includes a receiver, trustee, assignee, or other similar representative of those entities. (11) "Physician" means a physician licensed by the Texas State Board of Medical Examiners. (12) ''Physician assistant" means a physician assistant licensed by the Texas State Board of Physician Assistant Examiners. (13) "Podiatrist" means a podiatrist licensed by the Texas State Board of Podiatric Medical Examiners. (14) Repealed by Acts 2005, 79th Leg., Ch. 1286, Sec. 2, eff. September 1, 2005. ( 15) "Special hospital" means an establishment that: (A) offers services, facilities, and beds for use for more than 24 hours for two or more unrelated individuals who are regularly admitted, treated, and discharged and who require services more intensive than room, board, personal services, and general nursing care; (B) has clinical laboratory facilities, diagnostic X-ray facilities, treatment facilities, or other definitive medical treatment; (C) has a medical staff in regular attendance; and (D) maintains records of the clinical work performed for each patient.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1995, 74th Leg., ch. 965, Sec. 79, eff. Sept. 1, 1995; Acts 1997, 75th Leg., ch. 43, Sec. 1, eff. May 7, 1997; Acts 1997, 75th Leg., ch. 623, Sec. 2, eff. Sept. 1, 1997; Acts 1999, 76th Leg., ch. 428, Sec, 1, eff. Sept. 1, 1999. Amended by: Acts 2005, 79th Leg., Ch. 1286 (H.B. 2471), Sec. 2, eff. September 1, 2005. Acts 2007, 80th Leg., R.S., Ch. 889 (H.B. 212£), Sec. 67, eff. September 1,

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2007.

Sec. 241.004. EXEMPTIONS. This chapter does not apply to a facility: (1) licensed under Chapter 242 or 577; (2) maintained or operated by the federal government or an agency of the federal government; or (3) maintained or operated by this state or an agency of this state.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 76, Sec. 16, eff. Sept. 1, 1991.

Sec. 241.005. EMPLOYMENT OF PERSONNEL. The department may employ stenographers, inspectors, and other necessary assistants in carrying out the provisions of this chapter.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. Zl2, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.006. COORDINATION OF SIGNAGE REQUIREMENTS IMPOSED BY STATE AGENCIES. (a) The department is authorized to review current and proposed state rules issued by the department or by other state agencies that mandate that a hospital place or post a notice, poster, or sign in a conspicuous place or in an area of high public traffic, concerning the rights of patients or others or the responsibilities of the hospital, which is directed at patients, patients' families, or others. The purpose of this review shall be to coordinate the placement, format, and language contained in the required notices in order to: (1) eliminate the duplication of information; (2) reduce the potential for confusion to patients, patients' families, and others; and (3) reduce the administrative burden of compliance on hospitals. (b) Notwithstanding any other law, this section applies to all notices, posters, or signs described in Subsection (a).

Added by Acts 1995, 74th Leg., ch. 965, Sec. 3, eff. June 16, 1995.

Sec. 241.007. COMPLIANCE WITH CERTAIN REQUIREMENTS REGARDING SONOGRAM BEFORE ABORTION. A hospital shall comply with Subchapter B, Chapter 171.

Added by Acts 2011, 82nd Leg., R.S., Ch. 73 (H.B. 15), Sec. 6, eff. September 1,

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2011.

Sec. 241.008. INDUCED DELIVERIES OR CESAREAN SECTIONS BEFORE 39TH WEEK. A hospital that provides obstetrical services shall collaborate with physicians providing services at the hospital to develop quality initiatives to reduce the number of elective or nonmedically indicated induced deliveries or cesarean sections performed at the hospital on a woman before the 39th week of gestation.

Added by Acts 2011, 82nd Leg., R.S., Ch. 299 (H.B. 12B2), Sec. 2, eff. September 1, 2011. Redesignated from Health and Safety Code, Section 241.007 by Acts 2013, 83rd Leg., R.S., Ch. 161 (S.B. ~), Sec. 22.001(25), eff. September 1, 2013.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. 21.9. and S.B . .ll5..3., 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.009. PHOTO IDENTIFICATION BADGE REQUIRED. (a) In this section: (1) "Health care provider" means a person who provides health care services at a hospital as a physician, as an employee of the hospital, under a contract with the hospital, or in the course of a training or educational program at the hospital. ( 2) "Hospital" means a hospital licensed under this chapter. (b) A hospital shall adopt a policy requiring a health care provider providing direct patient care at the hospital to wear a photo identification badge during all patient encounters, unless precluded by adopted isolation or sterilization protocols. The badge must be of sufficient size and worn in a manner to be visible and must clearly state: (1) at minimum the provider's first or last name; (2) the department of the hospital with which the provider is associated; (3) the type of license held by the provider, if the provider holds a license under Title 3, Occupations Code; and (4) if applicable, the provider's status as a student, intern, trainee, or resident.

Added by Acts 2013, 83rd Leg., R.S., Ch. 108 (S.B. 212), Sec. 1, eff. January 1, 2014.

SUBCHAPTER B. HOSPITAL LICENSES

Sec. 241.021. LICENSE REQUIRED. A person or governmental unit, acting

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severally or jointly with any other person or governmental unit, may not establish, conduct, or maintain a hospital in this state without a license issued under this chapter.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. ~' 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.022. LICENSE APPLICATION. (a) An application for a license must be made to the department on a form provided by the department. (b) The application must contain: (1) the name and social security number of the sole proprietor, if the applicant is a sole proprietor; (2) the name and social security number of each general partner who is an individual, if the applicant is a partnership; (3) the name and social security number of any individual who has an ownership interest of more than 25 percent in the corporation, if the applicant is a corporationi and (4) any other information that the department may reasonably require. (c) The department shall require that each hospital show evidence that: (1) at least one physician is on the medical staff of the hospital, including evidence that the physician is currently licensed; (2) the governing body of the hospital has adopted and implemented a patient transfer policy in accordance with Section 241.027; and (3) if the governing body has chosen to implement patient transfer agreements, it has implemented the agreements in accordance with Section 241.028. (d) The application must be accompanied by: (1) a copy of the hospital's current patient transfer policy; (2) a nonrefundable license fee; (3) copies of the hospital's patient transfer agreements, unless the filing of copies has been waived by the hospital licensing director in accordance with the rules adopted under this chapter; and (4) a copy of the most recent annual fire safety inspection report from the fire marshal in whose jurisdiction the hospital is located. (e) The department may require that the application be approved by the local health authority or other local official for compliance with municipal ordinances on building construction, fire prevention, and sanitation. A hospital located outside the limits of a municipality shall comply with

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corresponding state laws. (f) The department shall post on the department's Internet website a list of all of the individuals named in applications as required by Subsections (b) (1)-(3). The department may not post on its Internet website a social security number of an individual required to be named in an application under Subsections (b) (1)- (3).

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 82, eff. Sept. 1, 1991; Acts 1993, 73rd Leg., ch. 584, Sec. 1, eff. Sept. 1, 1993. Amended by: Acts 2005, 79th Leg., Ch. 1161 (H.B. J]21), Sec. 1, eff. September 1, 2005.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. Z12, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.023. ISSUANCE OF LICENSE. (a) On receiving a license application and the license fee, the department shall issue a license if it finds that the applicant and the hospital comply with this chapter and the rules or standards adopted under this chapter. (b) A license may be renewed annually after payment of the required fee and submission of an application for license renewal that contains the information required by Section 241.022(b). (c) Except as provided by Subsection (c-1), the department may issue a license only for the premises of a hospital and person or governmental unit named in the application. (c-1) The department may issue one license for multiple hospitals if: (1) all buildings in which inpatients receive hospital services and inpatient services of each of the hospitals to be included in the license are subject to the control and direction of the same governing body; (2) all buildings in which inpatients receive hospital services are within a 30-mile radius of the main address of the applicant; (3) there is integration of the organized medical staff of each of the hospitals to be included in the license; (4) there is a single chief executive officer for all of the hospitals who reports directly to the governing body and through whom all administrative authority flows and who exercises control and surveillance over all administrative activities of the hospital; (5) there is a single chief medical officer for all of the hospitals who reports directly to the governing body and who is responsible for all

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medical staff activities of the hospital; (6) each building of a hospital to be included in the license that is geographically separate from other buildings of the same hospital contains at least one nursing unit for inpatients, unless providing only diagnostic or laboratory services, or a combination of diagnostic or laboratory services, in the building for hospital inpatients; and (7) each hospital that is to be included in the license complies with the emergency services standards: (A) for a general hospital, if the hospital provides surgery or obstetrical care or both; or (B) for a special hospital, if the hospital does not provide surgery or obstetrical care. (c-2) The hospital licensing director may recommend a waiver of the requirement of Subsection (c-1) (7) for a hospital if another hospital that is to be included in the license: (1) complies with the emergency services standards for a general hospital; and (2) is in close geographic proximity to the hospital. (c-3) The executive commissioner of the Health and Human Services Commission shall adopt rules to implement the waiver provision of Subsection (c- 2). The rules must provide for a determination by the department that the waiver will facilitate the creation or operation of the hospital seeking the waiver and that the waiver is in the best interest of the individuals served or to be served by the hospital. (d) Subject to Subsection (e), a license issued under this section for a hospital includes each outpatient facility that is not separately licensed, that is located apart from the hospital, and for which the hospital has submitted to the department: (1) a copy of a fire safety survey that is dated not earlier than one year before the submission date indicating approval by: (A) the local fire authority in whose jurisdiction the outpatient facility is located; or (B) the nearest fire authority, if the outpatient facility is located outside of the jurisdiction of a local fire authority; and (2) if the hospital is accredited by the Joint Commission on Accreditation of Healthcare Organizations or the American Osteopathic Association, a copy of documentation from the accrediting body showing that the outpatient facility is included within the hospital's accreditation. (e) Subsection (d) applies only if the federal Department of Health and Human Services, Health Care Financing Administration, or Office of Inspector

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General adopts final or interim final rules requiring state licensure of outpatient facilities as a condition of the determination of provider-based status for Medicare reimbursement purposes. (f) A license may not be transferred or assigned without the written approval of the department. (g) A license shall be posted in .a conspicuous place on the'licensed premises.

Acts 1989, 7lst Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1999, 76th Leg., ch. 1411, Sec. 2.01, eff. Sept. 1, 1999. Amended by: Acts 2005, 79th Leg., Ch. 1161 (H.B. 3357), Sec. 2, eff. September 1, 2005. Acts 2005, 79th Leg., Ch. 1286 (H.B. 2471), Sec. 1, eff. September 1, 2005.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. ~, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.024. HOSPITAL LICENSING DIRECTOR. (a) The commissioner of health shall appoint, with the advice and consent of the board, a person to serve as hospital licensing director. (b) A person appointed as the hospital licensing director must: (1) have at least five years experience or training, or both, in the field of hospital administration; (2) be of good moral character; and (3) have been a resident of this state for at least three years. (c) The hospital licensing director shall administer this chapter and is directly responsible to the department.

Acts 1989, 7lst Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. 219, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.025. LICENSE FEES. (a) The department shall charge each hospital an annual license·fee for an initial license or a license renewal. (b) The board by rule shall adopt the fees authorized by Subsection (a) according to a schedule under which the number of beds in the hospital determines the amount of the fee. The fee may not exceed $15 a bed. A minimum license fee may be established. The minimum fee may not exceed $1,000. (c) A fee adopted under this chapter must be based on the estimated cost

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to and level of effort expended by the department to conduct the activity for which the fee is imposed. (d) All license fees collected shall be deposited in the state treasury to the credit of the department to administer and enforce this chapter. These fees are hereby appropriated to the department. (e) Notwithstanding Subsection (d), to the extent that money received from the fees collected under this chapter exceeds the costs to the department to conduct the activity for which the fee is imposed, the department may use the money to administer Chapter 324 and similar laws that require the department to provide information related to hospital care to the public. The department may not consider the costs of administering Chapter 324 or similar laws in adopting a fee imposed under this section.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1993, 73rd Leg., ch. 584, Sec. 3, eff. Sept. 1, 1993; Acts 1999, 76th Leg., ch. 1411, Sec. 2.02, eff. Sept. 1, 1999. Amended by: Acts 2007, 80th Leg., R.S., Ch. 997 (S.B. 1221), Sec. 4, eff. September 1, 2007.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. 219, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.026. RULES AND MINIMUM STANDARDS. (a) The board shall adopt and enforce rules to further the purposes of this chapter. The rules at a minimum shall address: (1) minimum requirements for staffing by physicians and nurses; (2) hospital services relating to patient care; (3) fire prevention, safety, and sanitation requirements in hospitals; ( 4) patient care and a patient bill of rights; ( 5) compliance with other state and federal laws affecting the health, safety, and rights of hospital patients; and ( 6) compliance with nursing peer review under Subchapter I, Chapter 301, and Chapter 303, Occupations Code, and the rules of the Texas Board of Nursing relating to peer review. (b) In adopting rules, the board shall consider the conditions of participation for certification under Title XVIII of the Social Security Act (42 U.S.C. Section 1395 et seq.) and the standards of the Joint Commission on Accreditation of Healthcare Organizations and will attempt to achieve consistency with those conditions and standards.

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(c) Upon the recommendation of the hospital licensing director and the council, the board by order may waive or modify the requirement of a particular provision of this Act or minimum standard adopted by board rule under this section to a particular general or special hospital if the board determines that the waiver or modification will facilitate the creation or operation of the hospital and that the waiver or modification is in the best interests of the individuals served or to be served by the hospital. (d) The board shall adopt rules establishing procedures and criteria for the issuance of the waiver or modification order. The criteria must include at a minimum a statement of the appropriateness of the waiver or modification against the best interests of the individuals served by the hospital. (e) If the board orders a waiver or modification of a provision or standard, the licensing record of the hospital granted the waiver or modification shall contain documentation to support the board's action. The board's rules shall specify the type and specificity of the supporting documentation that must be included. (f) A comprehensive medical rehabilitation hospital or a pediatric and adolescent hospital shall have an emergency treatment room but is not required to have an emergency department.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 350, Sec. 1, eff. Aug. 26, 1991; Acts 1993, 73rd Leg., ch. 584, Sec. 4, eff. Sept. 1, 1993; Acts 1997, 75th Leg., ch. 43, Sec. 2, eff. May 7, 1997; Acts 1997, 75th Leg., ch. 617, Sec. 2, eff. Sept. 1, 1997; Acts 1997, 75th Leg., ch. 623, Sec. 3, eff. Sept. 1, 1997; Acts 2001, 77th Leg., ch. 1420, Sec. 14.786, eff. Sept. 1, 2001. Amended by: Acts 2007, BOth Leg., R.S., Ch. 889 (H.B. 2426), Sec. 68, eff. September 1, 2007.

Sec. 241.0262. CIRCULATING DUTIES FOR SURGICAL SERVICES. Circulating duties in the operating room must be performed by qualified registered nurses. In accordance with approved medical staff policies and procedures, licensed vocational nurses and surgical technologists may assist in circulatory duties under the direct supervision of a qualified registered nurse circulator.

Added by Acts 2005, 79th Leg., Ch. 966 (H.B . .LZJJl), Sec. 2, eff. September 1, 2005.

Sec. 241.0263. RECOMMENDATIONS RELATING TO MISSING INFANTS. (a) The department shall recommend hospital security procedures to:

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(1) reduce the likelihood of infant patient abduction; and (2) aid in the identification of missing infants. (b) In making recommendations, the department shall consider hospital size and location and the number of births at a hospital. (c) The procedures recommended by the department under Subsection (a) (1) may include: (1) controlling access to newborn nurseries; (2) expanding observation of newborn nurseries through the use of video cameras; and (3) requiring identification for hospital staff and visitors as a condition of entrance to newborn nurseries. (d) The procedures recommended by the department under Subsection (a) (2) may include: (1) footprinting, photographing, or writing descriptions of infant patients at birth; and (2) obtaining umbilical cord blood samples for infant patients born at the hospital and storing the samples for genetic testing purposes. (e) Each hospital licensed under this chapter shall consider implementing the procedures recommended under this section.

Added by Acts 1997, 75th Leg., ch. 314, Sec. 1, eff. Sept. 1, 1997.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. 2~~, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.0265. STANDARDS FOR CARE FOR MENTAL HEALTH AND CHEMICAL DEPENDENCY. (a) The care and treatment of a patient receiving mental health services in a facility licensed by the department under this chapter or Chapter 577 are governed by the standards adopted by the Texas Department of Mental Health and Mental Retardation to the same extent as if the standards adopted by that department were rules adopted by the board under this chapter or Chapter 577. (b) The care and treatment of a patient receiving chemical dependency treatment in a facility licensed by the department under this chapter are governed by the same standards that govern the care and treatment of a patient receiving treatment in a treatment facility licensed under Chapter 464 and that are adopted by the Texas Commission on Alcohol and Drug Abuse, to the same extent as if the standards adopted by the commission were rules adopted by the board under this chapter. (c) The department shall enforce the standards provided by Subsections (a)

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and (b). A violation of a standard is subject to the same consequence as a violation of a rule adopted by the board under this chapter or Chapter 577. The department is not required to enforce a standard if the enforcement violates a federal law, rule, or regulation.

Added by Acts 1993, 73rd Leg., ch. 573, Sec. 3.02, eff. Sept. 1, 1993.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. 219, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.027. PATIENT TRANSFERS. (a) The board shall adopt rules to govern the transfer of patients between hospitals that do not have a transfer agreement and governing services not included in transfer agreements. (b) The rules must provide that patient transfers between hospitals be accomplished through hospital policies that result in medically appropriate transfers from physician to physician and from hospital to hospital by providing: (1) for notification to the receiving hospital before the patient is transferred and confirmation by the receiving hospital that the patient meets the receiving hospital's admissions criteria relating to appropriate bed, physician, and other services necessary to treat the patient; (2) for the use of medically appropriate life support measures that a reasonable and prudent physician exercising ordinary care in the same or a similar locality would use to stabilize the patient before the transfer and to sustain the patient during the transfer; (3) for the provision of appropriate personnel and equipment that a reasonable and prudent physician exercising ordinary care in the same or a similar locality would use for the transfer; (4) for the transfer of all necessary records for continuing the care for the patient; and (5) that the transfer of a patient not be predicated on arbitrary, capricious, or unreasonable discrimination because of race, religion, national origin, age, sex, physical condition, or economic status. (c) The rules must require that if a patient at a hospital has an emergency medical condition which has not been stabilized, the hospital may not transfer the patient unless: (1) the patient or a legally responsible person acting on the patient's behalf, after being informed of the hospital's obligations under this section and of the risk of transfer, in writing requests transfer to another medical facility;

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(2) a licensed physician has signed a certification, which includes a summary of the risks and benefits, that, based on the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the patient and, in the case of labor, to the unborn child from effecting the transfer; or (3) if a licensed physician is not physically present in the emergency department at the time a patient is transferred, a qualified medical person has signed a certification described in Subdivision (2) after a licensed physician, in consultation with the person, has made the determination described in such clause and subsequently countersigns the certificate. (d) The rules also shall provide that a public hospital or hospital district shall accept the transfer of its eligible residents if the public hospital or hospital district has appropriate facilities, services, and staff available for providing care to the patient. (e) The rules must require that a hospital take all reasonable steps to secure the informed refusal of a patient or of a person acting on the patient's behalf to a transfer or to related examination and treatment. (f) The rules must recognize any contractual, statutory, or regulatory obligations that may exist between a patient and a designated or mandated provider as those obligations apply to the transfer of emergency or nonemergency patients.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 83, eff. Sept. 1, 1991; Acts 1993, 73rd Leg., ch. 584, Sec. 5, eff. Sept. 1, 1993.

Sec. 241.028. TRANSFER AGREEMENTS. (a) If hospitals execute a transfer agreement that is consistent with the requirements of this section, all patient transfers between the hospitals are governed by the agreement. (b) The hospitals shall submit the agreement to the department for review for compliance with the requirements of this section. The department shall complete the review of the agreement within 30 days after the date the agreement is submitted by the hospitals. (c) At a minimum, a transfer agreement must provide that: (1) transfers be accomplished in a medically appropriate manner and comply with Sections 241.027(b) (2) through (5) and Section 241.027(c); (2) the transfer or receipt of patients in need of emergency care not be based on the individual's inability to pay for the services rendered by the transferring or receiving hospital; (3) multiple transfer agreements be entered into by a hospital based

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on the type or level of medical services available at other hospitals; (4) the hospitals recognize the right of an individual to request transfer to the care of a physician and hospital of the individual's choice; (5) the hospitals recognize and comply with the requirements of Chapter 61 (Indigent Health Care and Treatment Act) relating to the transfer of patients to mandated providers; and (6) consideration be given to availability of appropriate facilities, services, and staff for providing care to the patient. (d) If a hospital transfers a patient in violation of Subsection (c) (1), (2), (4), (5), or (6), relating to required provisions for a transfer agreement, the violation is a violation of this chapter.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 84, eff. Sept. 1, 1991; Acts 1993, 73rd Leg., ch. 584, Sec. 6, eff. Sept. 1, 1993.

Sec. 241.029. POLICIES AND PROCEDURES RELATING TO WORKPLACE SAFETY. (a) The governing body of a hospital shall adopt policies and procedures related to the work environment for nurses to: (1) improve workplace safety and reduce the risk of injury, occupational illness, and violence; and (2) increase the use of ergonomic principles and ergonomically designed devices to reduce injury and fatigue. (b) The policies and procedures adopted under Subsection (a), at a minimum, must include: (1) evaluating new products and technology that incorporate ergonomic principles; (2) educating nurses in the application of ergonomic practices; (3) conducting workplace audits to identify areas of risk of injury, occupational illness, or violence and recommending ways to reduce those risks; (4) controlling access to those areas identified as having a high risk of violence; and (5) promptly reporting crimes committed against nurses to appropriate law enforcement agencies.

Added by Acts 2003, 78th Leg., ch. 876, Sec. 13, eff. June 20, 2003.

SUBCHAPTER C. ENFORCEMENT

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. 219, 84th Legislature, Regular Session, for amendments affecting this section.

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Sec. 241.051. INSPECTIONS. (a) The department may make any inspection, survey, or investigation that it considers necessary. A representative of the department may enter the premises of a hospital at any reasonable time to make an inspection, a survey, or an investigation to assure compliance with or prevent a violation of this chapter, the rules adopted under this chapter, an order or special order of the commissioner of health, a special license provision, a court order granting injunctive relief, or other enforcement procedures. The department shall maintain the confidentiality of hospital records as applicable under state or federal law. (b) The department or a representative of the department is entitled to access to all books, records, or other documents maintained by or on behalf of the hospital to the extent necessary to enforce this chapter, the rules adopted under this chapter, an order or special order of the commissioner of health, a special license provision, a court order granting injunctive relief, or other enforcement procedures. (c) By applying for or holding a hospital license, the hospital consents to entry and inspection of the hospital by the department or a representative of the department in accordance with this chapter and the rules adopted under this chapter. (d) All information and materials obtained or compiled by the department in connection with a complaint and investigation concerning a hospital are confidential and not subject to disclosure under Section 552.001 et seq., Government Code, and not subject to disclosure, discovery, subpoena, or other means of legal compulsion for their release to anyone other than the department or its employees or agents involved in the enforcement action except that this information may be disclosed to: (1) persons involved with the department in the enforcement action against the hospital; (2) the hospital that is the subject of the enforcement action, or the hospital's authorized representative; (3) appropriate state or federal agencies that are authorized to inspect, survey, or investigate hospital services; (4) law enforcement agencies; and (5) persons engaged in bona fide research, if all individual- identifying and hospital-identifying information has been deleted. (e) The following information is subject to disclosure in accordance with Section 552.001 et seq., Government Code: (1) a notice of alleged violation against the hospital, which notice shall include the provisions of law which the hospital is alleged to have violated, and a general statement of the nature of the alleged violation;

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(2) the pleadings in the administrative proceeding; and (3) a final decision or order by the department.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1993, 73rd Leg., ch. 584, Sec. 8, eff. Sept. 1, 1993; Acts 1999, 76th Leg., ch. 1444, Sec. 15, eff. Aug. 30, 1999.

Sec. 241.052. COMPLIANCE WITH RULES AND STANDARDS. (a) A hospital that is in operation when an applicable rule or minimum standard is adopted under this chapter must be given a reasonable period within which to comply with the rule or standard. (b) The period for compliance may not exceed six months, except that the department may extend the period beyond six months if the hospital sufficiently shows the department that it requires additional time to complete compliance with the rule or standard.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. 2l2, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.053. DENIAL OF APPLICATION, SUSPENSION, REVOCATION, PROBATION, OR REISSUANCE OF LICENSE. (a) The department, after providing notice and an opportunity for a hearing to the applicant or license holder, may deny, suspend, or revoke a hospital's license if the department finds that the hospital: (1) failed to comply with: (A) a provision of this chapter; (B) a rule adopted under this chapter; (C) a special license condition; (D) an order or emergency order by the commissioner of health; or (E) another enforcement procedure permitted under this chapter; (2) has a history of noncompliance with the rules adopted under this chapter relating to patient health, safety, and rights which reflects more than nominal noncompliance; or (3) has aided, abetted, or permitted the commission of an illegal act. (b) A hospital whose license is suspended or revoked may apply to the department for the reissuance of a license. The department may reissue the license if the department determines that the hospital has corrected the conditions that led to the suspension or revocation of the hospital's license, the initiation of enforcement action against the hospital, the assessment of administrative penalties, or the issuance of a court order enjoining the

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hospital from violations or assessing civil penalties against the hospital. A hospital whose license is suspended or revoked may not admit new patients until the license is reissued. (c) A hospital must apply for reissuance in the form and manner required in the rules adopted under this chapter. (d) Administrative hearings required under this section shall be conducted under the board's formal hearing rules and the contested case provisions of Chapter 2001, Government Code. (e) Judicial review of a final decision by the department is by trial de novo in the same manner as a case appealed from the justice court to the county court. The substantial evidence rule does not apply. (f) If the department finds that a hospital is in repeated noncompliance under Subsection (a) but that the noncompliance does not endanger public health and safety, the department may schedule the hospital for probation rather than suspending or revoking the hospital's license. The department shall provide notice to the hospital of the probation and of the items of noncompliance not later than the lOth day before the date the probation period begins. The department shall designate a period of not less than 30 days during which the hospital will remain under probation. During the probation period, the hospital must correct the items that were in noncompliance and report the corrections to the department for approval. (g) The department may suspend or revoke the license of a hospital that does not correct items that were in noncompliance or that does not comply with the applicable requirements within the applicable probation period.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1993, 73rd Leg., ch. 584, Sec. 9, eff. Sept. 1, 1993; Acts 1993, 73rd Leg., ch. 705, Sec. 3.01, eff. Sept. 1, 1993; Acts 1995, 74th Leg., ch. 76, Sec. 5.95(51), eff. Sept. 1, 1995; Acts 2003, 78th Leg., ch. 802, Sec. 1, 2, eff. June 20, 2003.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. 219, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 2 41. 0531. COMMISSIONER'S EMERGENCY ORDERS. (a) Following notice to the hospital and opportunity for hearing, the commissioner of health or a person designated by the commissioner may issue an emergency order, either mandatory or prohibitory in nature, in relation to the operation of a hospital licensed under this chapter if the commissioner or the commissioner's designee determines that the hospital is violating or threatening to violate this chapter, a rule

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adopted pursuant to this chapter, a special license provision, injunctive relief issued pursuant to Section 241.054,. an order of the commissioner or the commissioner's designee, or another enforcement procedure permitted under this chapter and the provision, rule, license provision, injunctive relief, order, or enforcement procedure relates to the health or safety of the hospital's patients. (b) The department shall send written notice of the hearing and shall include within the notice the time and place of the hearing. The hearing must be held within 10 days after the date of the hospital's receipt of the notice. (c) The hearing shall not be governed by the contested case provisions of Chapter 2001, Government Code but shall instead be held in accordance with the board's informal hearing rules. (d) The order shall be effective on delivery to the hospital or at a later date specified in the order.

Added by Acts 1993, 73rd Leg., ch. 584, Sec. 10, eff. Sept. 1, 1993. Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(51), eff. Sept. 1, 1995.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. 219, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 2 41. 0 54. VIOLATIONS; INJUNCTIONS. (a) The department shall: (1) notify a hospital of a finding by the department that the hospital is violating or has violated this chapter or a rule or standard adopted under this chapter; and (2) provide the hospital an opportunity to correct the violation. (b) After the notice and opportunity to comply, the commissioner of health may request the attorney general or the appropriate district or county attorney to institute and conduct a suit for a violation of this chapter or a rule adopted under this chapter. (c) The department may petition a district court for a temporary restraining order to restrain a continuing violation if the department finds that the violation creates an immediate threat to the health and safety of the patients of a hospital. (d) On his own initiative, the attorney general, a district attorney, or a county attorney may maintain an action in the name of the state for a violation of this chapter or a rule adopted under this chapter. (e) The district court shall assess the civil penalty authorized by Section 241.055, grant injunctive relief, or both, as warranted by the facts. The injunctive relief may include any prohibitory or mandatory injunction

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warranted by the facts, including a temporary restraining order, temporary injunction, or permanent injunction. (f) The department and the party bringing the suit may recover reasonable expenses incurred in obtaining injunctive relief, civil penalties, or both, including investigation costs, court costs, reasonable attorney fees, witness fees, and deposition expenses. (g) Venue may be maintained in Travis County or in the county in which the violation occurred. (h) Not later than the seventh day before the date on which the attorney general intends to bring suit on his own initiative, the attorney general shall provide to the department notice of the suit. The attorney general is not required to provide notice of a suit if the attorney general determines that waiting to bring suit until the notice is provided will create an immediate threat to the health and safety of a patient. This section does not create a requirement that the attorney general obtain the permission of a referral from the department before filing suit. (i) The injunctive relief and civil penalty authorized by this section and Section 241.055 are in addition to any other civil, administrative, or criminal penalty provided by law.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1993, 73rd Leg., ch. 705, Sec. 3.02, eff. Sept. 1, 1993.

Sec. 241.055. CIVIL PENALTY. (a) A hospital shall timely adopt, implement, and enforce a patient transfer policy in accordance with Section 241.027. A hospital may implement patient transfer agreements in accordance with Section 241.028. (b) A hospital that violates Subsection (a), another provision of this chapter, or a rule adopted or enforced under this chapter is liable for a civil penalty of not more than $1,000 for each day of violation and for each act of violation. A hospital that violates this chapter or a rule or order adopted under this chapter relating to the provision of mental health, chemical dependency, or rehabilitation services is liable for a civil penalty of not more than $25,000 for each day of violation and for each act of violation. (c) In determining the amount of the penalty, the district court shall consider: (1) the hospital's previous violations; (2) the seriousness of the violation, including the nature, circumstances, extent, and gravity of the violation; (3) whether the health and safety of the public was threatened by the violation;

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(4) the demonstrated good faith of the hospital; and (5) the amount necessary to deter future violations. (d) A penalty collected under this section by the attorney general shall be deposited to the credit of the general revenue fund. A penalty collected under this section by a district or county attorney shall be deposited to the credit of the general fund of the county in which the suit was heard.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 86, eff. Sept. 1, 1991; Acts 1993, 73rd Leg., ch. 584, Sec. 11, eff. Sept. 1, 1993; Acts 1993, 73rd Leg., ch. 705, Sec. 3.03, eff. Sept. 1, 1993.

Sec. 241.056. SUIT BY PERSON HARMED. (a) A person who is harmed by a violation under Section 241.028 or 241.055 may petition a district court for appropriate injunctive relief. (b) Venue for a suit brought under this section is in the county in which the person resides or, if the person is not a resident of this state, in Travis County. (c) The person may also pursue remedies for civil damages under common law.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 87, eff. Sept. 1, 1991; Acts 1993, 73rd Leg., ch. 584, Sec. 12, eff. Sept. 1, 1993.

Sec. 241.057. CRIMINAL PENALTY. (a) A person commits an offense if the person establishes, conducts, manages, or operates a hospital without a license. (b) An offense under this section is a misdemeanor punishable by a fine of not more than $100 for the first offense and not more than $200 for each subsequent offense. (c) Each day of a continuing violation constitutes a separate offense.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. 219, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.058. MINOR VIOLATIONS. (a) This chapter does not require the commissioner of health or a designee of the commissioner to report a minor violation for prosecution or the institution of any other enforcement proceeding authorized under this chapter, if the commissioner or a designee of the

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commissioner determines that prosecution or enforcement is not in the best interests of the persons served or to be served by the hospital. (b) For the purpose of this section, a "minor violation'' means a violation of this chapter, the rules adopted under this chapter, a special license provision, an order or emergency order issued by the commissioner of health or the commissioner's designee, or another enforcement procedure permitted under this chapter by a hospital that does not constitute a threat to the health, safety, and rights of the hospital's patients or other persons.

Added by Acts 1993, 73rd Leg., ch. 584, Sec. 13, eff. Sept. 1,1993.

Sec. 241.0585. RECOVERY OF COSTS. If the attorney general brings an action to enforce an administrative penalty assessed under Section 241.058 and the court orders the payment of the penalty, the attorney general may recover reasonable expenses incurred in the investigation, initiation, or prosecution of the enforcement suit, including investigative costs, court costs, reasonable attorney fees, witness fees, and deposition expenses.

Added by Acts 1993, 73rd Leg., ch. 705, Sec. 3.041, eff. Sept. 1, 1993.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. 219, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.059. ADMINISTRATIVE PENALTY. (a) The commissioner of health may assess an administrative penalty against a hospital that violates this chapter, a rule adopted pursuant to this chapter, a special license provision, an order or emergency order issued by the commissioner or the commissioner's designee, or another enforcement procedure permitted under this chapter. The commissioner shall assess an administrative penalty against a hospital that violates Section 166.004. (b) In determining the amount of the penalty, the commissioner of health shall consider: (1) the hospital's previous violations; (2) the seriousness of the violation; (3) any threat to the health, safety, or rights of the hospital's patients; (4) the demonstrated good faith of the hospital; and (5) such other matters as justice may require. (c) The penalty may not exceed $1,000 for each violation, except that the penalty for a violation of Section 166.004 shall be $500. Each day of a continuing violation, other than a violation of Section 166.004, may be

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considered a separate violation. (d) When it is determined that a violation has occurred the commissioner of health shall issue a report that states the facts on which the determination is based and the commissioner's recommendation on the imposition of a penalty, including a recommendation on the amount of the penalty. (e) Within 14 days after the date the report is issued, the commissioner of health shall give written notice of the report to the person, delivered by certified mail. The notice must include a brief summary of the alleged violation and a statement of the amount of the recommended penalty and must inform the person that the person has a right to a hearing on the occurrence of the violation, the amount of the penalty, or both the occurrence of the violation and the amount of the penalty. (f) Within 20 days after the date the person receives the notice, the person in writing may accept the determination and recommended penalty of the commissioner of health or may make a written request for a hearing on the occurrence of the violation, the amount of the penalty, or both the occurrence of the violation and the amount of the penalty. (g) I f the person accepts the determination and recommended penalty of the commissioner of health, the commissioner by order shall impose the recommended penalty. (h) If the person requests a hearing or fails to respond timely to the notice, the commissioner of health shall set a hearing and give notice of the hearing to the person. The hearing shall be held by the department. The person conducting the hearing shall make findings of fact and conclusions of law and promptly issue to the commissioner a proposal for a decision about the occurrence of the violation and the amount of the penalty. Based on the findings of fact, conclusions of law, and proposal for a decision, the commissioner by order may find that a violation has occurred and impose a penalty or may find that no violation occurred. (i) The notice of the commissioner of health's order given to the person under Chapter 2001, Government Code must include a statement of the right of the person to judicial review of the order. (j) Within 30 days after the date the commissioner of health's order is final as provided by Subchapter F, Chapter 2001, Government Code, the person shall: (1) pay the amount of the penalty; (2) pay the amount of the penalty and file a petition for judicial review contesting the occurrence of the violation, the amount of the penalty, or both the occurrence of the violation and the amount of the penalty; or (3) without paying the amount of the penalty, file a petition for

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judicial review contesting the occurrence of the violation, the amount of the penalty, or both the occurrence of the violation and the amount of the penalty. (k) Within the 30-day period, a person who acts under Subsection (j) (3) may: (1) stay enforcement of the penalty by: (A) paying the amount of the penalty to the court for placement in an escrow account; or (B) giving to the court a supersedeas bond that is approved by the court for the amount of the penalty and that is effective until all judicial review of the board's order is final; or (2) request the court to stay enforcement of the penalty by: (A) filing with the court a sworn affidavit of the person stating that the person is financially unable to pay the amount of the penalty and is financially unable to give the supersedeas bond; and (B) giving a copy of the affidavit to the commissioner of health by certified mail. (1) When the commissioner of health receives a copy of an affidavit under Subsection (k) (2), he may file with the court, within five days after the date the copy is received, a contest to the affidavit. The court shall hold a hearing on the facts alleged in the affidavit as soon as practicable and shall stay the enforcement of the penalty on finding that the alleged facts are true. The person who files an affidavit has the burden of proving that the person is financially unable to pay the amount of the penalty and to give a supersedeas bond. (m) If the person does not pay the amount of the penalty and the enforcement of the penalty is not stayed, the commissioner of health may refer the matter to the attorney general for collection of the amount of the penalty. (n) Judicial review of the order of the commissioner of health: (1) is instituted by filing a petition as provided by Subchapter G, Chapter 2001, Government Code; and (2) is under the substantial evidence rule. (o) If the court sustains the occurrence of the violation, the court may uphold or reduce the amount of the penalty and order the person to pay the full or reduced amount of the penalty. I f the court does not sustain the occurrence of the violation, the court shall order that no penalty is owed. (p) When the judgment of the court becomes final, the court shall proceed under this subsection. If the person paid the amount of the penalty and if that amount is reduced or is not upheld by the court, the court shall order that the appropriate amount plus accrued interest be remitted to the person within 30 days after the judgment of the court becomes final. The rate of the interest is

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the rate charged on loans to depository institutions by the New York Federal Reserve Bank, and the interest shall be paid for the period beginning on the date the penalty was paid and ending on the date the penalty is remitted. If the person gave a supersedeas bond and if the amount of the penalty is not upheld by the court, the court shall order the release of the bond. If the person gave a supersedeas bond and if the amount of the penalty is reduced, the court shall order the release of the bond after the person pays the amount. (q) A penalty collected under this section shall be remitted to the comptroller for deposit in the general revenue fund. (r) All proceedings under this section are subject to Chapter 2001, Government Code.

Added by Acts 1993, 73rd Leg., ch. 584, Sec. 14, eff. Sept. 1, 1993. Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(51), (53), (55), (60), eff. Sept. 1, 1995; Acts 1999, 76th Leg., ch. 450, Sec. 2.03, eff. Sept. 1, 1999.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. 219, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.060. ADMINISTRATIVE PENALTY FOR MENTAL HEALTH, CHEMICAL DEPENDENCY, OR REHABILITATION SERVICES. (a) The board may impose an administrative penalty against a person licensed or regulated under this chapter who violates this chapter or a rule or order adopted under this chapter relating to the provision of mental health, chemical dependency, or rehabilitation services. (b) The penalty for a violation may be in an amount not to exceed $25,000. Each day a violation continues or occurs is a separate violation for purposes of imposing a penalty. (c) The amount of the penalty shall be based on: (1) the seriousness of the violation, including the nature, circumstances, extent, and gravity of any prohibited acts, and the hazard or potential hazard created to the health, safety, or economic welfare of the public; (2) enforcement costs relating to the violation; (3) the history of previous violations; (4) the amount necessary to deter future violations; (5) efforts to correct the violation; and (6) any other matter that justice may require. (d) If the commissioner determines that a violation has occurred, the commissioner may issue to the board a report that states the facts on which the

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determination is based and the commissioner's recommendation on the imposition of a penalty, including a recommendation on the amount of the penalty. (e) Within 14 days after the date the report is issued, the commissioner shall give written notice of the report to the person. The notice may be given by certified mail. The notice must include a brief summary of the alleged violation and a statement of the amount of the recommended penalty and must inform the person that the person has a right to a hearing on the occurrence of the violation, the amount of the penalty, or both the occurrence of the violation and the amount of the penalty. (f) Within 20 days after the date the person receives the notice, the person in writing may accept the determination and recommended penalty of the commissioner or may make a written request for a hearing on the occurrence of the violation, the amount of the penalty, or both the occurrence of the violation and the amount of the penalty. (g) If the person accepts the determination and recommended penalty of the commissioner, the board by order shall approve the determination and impose the recommended penalty. (h) If the person requests a hearing or fails to respond timely to the notice, the commissioner shall set a hearing and give notice of the hearing to the person. The administrative law judge shall make findings of fact and conclusions of law and promptly issue to the board a proposal for a decision about the occurrence of the violation and the amount of a proposed penalty. Based on the findings of fact, conclusions of law, and proposal for a decision, the board by order may find that a violation has occurred and impose a penalty or may find that no violation occurred. (i) The notice of the board's order given to the person under Chapter 2001, Government Code must include a statement of the right of the person to judicial review of the order. (j) Within 30 days after the date the board's order is final as provided by Subchapter F, Chapter 2001, Government Code, the person shall: ( 1) pay the amount of the penalty; ( 2) pay the amount of the penalty and file a petition for judicial review contesting the occurrence of the violation, the amount of the penalty, or both the occurrence of the violation and the amount of the penalty; or (3) without paying the amount of the penalty, file a petition for judicial review contesting the occurrence of the violation, the amount of the penalty, or both the occurrence of the violation and the amount of the penalty. (k) Within the 30-day period, a person who acts under Subsection (j) (3) may: (1) stay enforcement of the penalty by:

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(A) paying the amount of the penalty to the court for placement in an escrow account; or (B) giving to the court a supersedeas bond that is approved by the court for the amount of the penalty and that is effective until all judicial review of the board's order is final; or (2) request the court to stay enforcement of the penalty by: (A) filing with the court a sworn affidavit of the person stating that the person is financially unable to pay the amount of the penalty and is financially unable to give the supersedeas bond; and (B) giving a copy of the affidavit to the commissioner by certified mail. (l) The commissioner on receipt of a copy of an affidavit under Subsection (k) (2) may file with the court within five days after the date the copy is received a contest to the affidavit. The court shall hold a hearing on the facts alleged in the affidavit as soon as practicable and shall stay the enforcement of the penalty on finding that the alleged facts are true. The person who files an affidavit has the burden of proving that the person is financially unable to pay the amount of the penalty and to give a supersedeas bond. (m) If the person does not pay the amount of the penalty and the enforcement of the penalty is not stayed, the commissioner may refer the matter to the attorney general for collection of the amount of the penalty. (n) Judicial review of the order of the board: (1) is instituted by filing a petition as provided by Subchapter G, Chapter 2001, Government Code; and (2) is under the substantial evidence rule. (o) If the court sustains the occurrence of the violation, the court may uphold or reduce the amount of the penalty and order the person to pay the full or reduced amount of the penalty. If the court does not sustain the occurrence of the violation, the court shall order that no penalty is owed. (p) When the judgment of the court becomes final, the court shall proceed under this subsection. If the person paid the amount of the penalty and if that amount is reduced or is not upheld by the court, the court shall order that the appropriate amount plus accrued interest be remitted to the person. The rate of the interest is the rate charged on loans to depository institutions by the New York Federal Reserve Bank, and the interest shall be paid for the period beginning on the date the penalty was paid and ending on the date the penalty is remitted. If the person gave a supersedeas bond and if the amount of the penalty is not upheld by the court, the court shall order the release of the bond. If the person gave a supersedeas bond and if the amount of the penalty is

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reduced, the court shall order the release of the bond after the person pays the amount. (q) A penalty collected under this section shall be remitted to the comptroller for deposit in the general revenue fund. (r) All proceedings under this section are subject to Chapter 2001, Government Code.

Added by Acts 1993, 73rd Leg., ch. 705, Sec. 3.04, eff. Sept. 1, 1993. Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), (53), (59), eff. Sept. 1,1995. Renumbered from Health & Safety Code Sec. 241.058 by Acts 1995, 74th Leg., ch. 76, Sec. 17.01(22), eff. Sept. 1, 1995.

SUBCHAPTER E. STAFF, RECORDS, AND PLAN REVIEWS

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. 219, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.101. HOSPITAL AUTHORITY CONCERNING MEDICAL STAFF. (a) Except as otherwise provided by this section and Section 241.102, this chapter does not change the authority of the governing body of a hospital, as it considers necessary or advisable, to: (1) make rules, standards, or qualifications for medical staff membership; or (2) grant or refuse to grant membership on the medical staff. (b) This chapter does not prevent the governing body of a hospital from adopting reasonable rules and requirements in compliance with this chapter relating to: (1) qualifications for any category of medical staff appointments; (2) termination of appointments; or (3) the delineation or curtailment of clinical privileges of those who are appointed to the medical staff. (c) The process for considering applications for medical staff membership and privileges or the renewal, modification, or revocation of medical staff membership and privileges must afford each physician, podiatrist, and dentist procedural due process that meets the requirements of 42 U.S.C. Section 11101 et seq., as amended. (d) If a hospital's credentials committee has failed to take action on a completed application as required by Subsection (k), or a physician, podiatrist, or dentist is subject to a professional review action that may adversely affect his medical staff membership or privileges, and the physician, podiatrist, or dentist believes that mediation of the dispute is desirable, the physician,

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podiatrist, or dentist may require the hospital to participate in mediation as provided in Chapter 154, Civil Practice and Remedies Code. The mediation shall be conducted by a person meeting the qualifications required by Section 154.052, Civil Practice and Remedies Code, and within a reasonable period of time. (e) Subsection (d) does not authorize a cause of action by a physician, podiatrist, or dentist against the hospital other than an action to require a hospital to participate in mediation. (f) An applicant for medical staff membership or privileges may not be denied membership or privileges on any ground that is otherwise prohibited by law. (g) A hospital's bylaw requirements for staff privileges may require a physician, podiatrist, or dentist to document the person's current clinical competency and professional training and experience in the medical procedures for which privileges are requested. (h) In granting or refusing medical staff membership or privileges, a hospital may not differentiate on the basis of the academic medical degree held by a physician. (i) Graduate medical education may be used as a standard or qualification for medical staff membership or privileges for a physician, provided that equal recognition is given to training programs accredited by the Accreditation Council on Graduate Medical Education and by the American Osteopathic Association. (j) Board certification may be used as a standard or qualification for medical staff membership or privileges for a physician, provided that equal recognition is given to certification programs approved by the American Board of Medical Specialties and the Bureau of Osteopathic Specialists. (k) A hospital's credentials committee shall act expeditiously and without unnecessary delay when a licensed physician, podiatrist, or dentist submits a completed application for medical staff membership or privileges. The hospital's credentials committee shall take action on the completed application not later than the 90th day after the date on which the application is received. The governing body of the hospital shall take final action on the application for medical staff membership or privileges not later than the 60th day after the date on which the recommendation of the credentials committee is received. The hospital must notify the applicant in writing of the hospital's final action, including a reason for denial or restriction of privileges, not later than the 20th day after the date on which final action is taken.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1995, 74th Leg., ch. 77, Sec. 1, eff. May 11, 1995; Acts 1999, 76th Leg., ch. 159, Sec. 1, eff. May 21, 1999; Acts 2001, 77th Leg., ch. 1175, Sec. 1, eff.

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June 15, 2001.

Sec. 241.1015. PHYSICIAN COMMUNICATION AND CONTRACTS. (a) A hospital, whether by contract, by granting or withholding staff privileges, or otherwise, may not restrict a physician's ability to communicate with a patient with respect to: (1) the patient's coverage under a health care plan; (2) any subject related to the medical care or health care services to be provided to the patient, including treatment options that are not provided under a health care plan; (3) the availability or desirability of a health care plan or insurance or similar coverage, other than the patient's health care plan; or (4) the fact that the physician's staff privileges or contract with a hospital or health care plan have terminated or that the physician will otherwise no longer be providing medical care or health care services at the hospital or under the health care plan. (b) A hospital, by contract or otherwise, may not refuse or fail to grant or renew staff privileges, or condition staff privileges, based in whole or in part on the fact that the physician or a partner, associate, or employee of the physician is providing medical or health care services at a different hospital or hospital system. (c) A hospital may not contract to limit a physician's participation or staff privileges or the participation or staff privileges of a partner, associate, or employee of the physician at a different hospital or hospital system. (d) This section does not prevent a hospital from entering into contracts with physicians to ensure physician availability and coverage at the hospital or to comply with regulatory requirements or quality of care standards established by the governing body of the hospital. (e) This section does not prevent the governing body of a hospital from: (1) limiting the number of physicians granted medical staff membership or privileges at the hospital based on a medical staff development plan that is unrelated to a physician's professional or business relationships or associations including those with another physician or group of physicians or to a physician or a partner, associate, or employee of a physician having medical staff membership or privileges at another hospital or hospital system; or (2) limiting the ability of hospital medical directors to contract with or hold medical staff memberships or clinical privileges at different hospitals or hospital systems provided that such limitations do not extend to the medical directors' professional or business relationships or associations

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including those with another physician, group of physicians, or other health care providers, other than hospitals or hospital systems. (f) A contract provision that violates this section is void. (g) In this section, "health care plan'' has the meaning assigned by Section 843.002, Insurance Code, and "hospital medical directors" means physicians who have been employed by or are under contract with a hospital to manage a clinical department or departments of the hospital.

Added by Acts 1997, 75th Leg., ch. 735, Sec. 2, eff. Sept. 1, 1997. Amended by Acts 2003, 78th Leg., ch. 1276, Sec. 10A.526, eff. Sept. 1, 2003.

Sec. 241.102. AUTHORIZATIONS AND RESTRICTIONS IN RELATION TO PHYSICIANS AND PODIATRISTS. (a) This chapter does not authorize a physician or podiatrist to perform medical or podiatric acts that are beyond the scope of the respective license held. (b) This chapter does not prevent the governing body of a hospital from providing that: (1) a podiatric patient be coadmitted to the hospital by a podiatrist and a physician; (2) a physician be responsible for the care of any medical problem or condition of a podiatric patient that may exist at the time of admission or that may arise during hospitalization and that is beyond the scope of the podiatrist's license; or (3) a physician determine the risk and effect of a proposed podiatric surgical procedure on the total health status of the patient. (c) An applicant for medical staff membership may not be denied membership solely on the ground that the applicant is a podiatrist rather than a physician. (d) This chapter does not automatically entitle a physician or a podiatrist to membership or privileges on a medical staff. (e) The governing body of a hospital may not require a member of the medical staff to involuntarily: (1) coadmit patients with a podiatrist; (2) be responsible for the care of any medical problem or condition of a podiatric patient; or (3) determine the risk and effect of any proposed podiatric procedure on the total health status of the patient.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 241.103. PRESERVATION OF RECORDS. (a) A hospital may authorize the

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disposal of any medical record on or after the lOth anniversary of the date on which the patient who is the subject of the record was last treated in the hospital. (b) If a patient was younger than 18 years of age when the patient was last treated, the hospital may authorize the disposal of medical records relating to the patient on or after the date of the patient's 20th birthday or on or after the lOth anniversary of the date on which the patient was last treated, whichever date is later. (c) The hospital may not destroy medical records that relate to any matter that is involved in litigation if the hospital knows the litigation has not been finally resolved. (d) A hospital shall provide written notice to a patient, or a patient's legally authorized representative as that term is defined by Section 241.151, that the hospital, unless the exception in Subsection (c) applies, may authorize the disposal of medical records relating to the patient on or after the periods specified in this section. The notice shall be provided to the patient or the patient's legally authorized representative not later than the date on which the patient who is or will be the subject of a medical record is treated, except in an emergency treatment situation. In an emergency treatment situation, the notice shall be provided to the patient or the patient's legally authorized representative as soon as is reasonably practicable following the emergency treatment situation.

Acts 1989, 7lst Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by: Acts 2011, 82nd Leg., R.S., Ch. 466 (H.B. 118), Sec. 1, eff. September 1, 2011.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. 219, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.104. HOSPITAL PLAN REVIEWS. (a) The board by rule shall adopt fees for hospital plan reviews according to a schedule based on the estimated construction costs. (b) The fee schedule may not exceed the following: Cost of Construction Fee ( 1) $ 100,000 or less $ 500 (2) $ 100,001 - $ 600,000 $1,500

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(3) $ 600,001 - $ 2,000,000 $3,000 (4) $ 2,000,001 - $ 5,000,000 $4,500 (5) $ 5,000,001 - $10,000,000 $6,000 (6) $ 10,000,001 and over $7,500 (c) The department shall charge a fee for field surveys of construction plans reviewed under this section. The board by rule shall adopt a fee schedule for the surveys that provides a minimum fee of $500 and a maximum fee of $1,000 for each survey conducted.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1993, 73rd Leg., ch. 584, Sec. 15, eff. Sept. 1, 1993; Acts 1999, 76th Leg., ch. 1411, Sec. 2.03, eff. Sept. 1,1999.

Sec. 241.105. HOSPITAL PRIVILEGES FOR ADVANCED PRACTICE NURSES AND PHYSICIAN ASSISTANTS. (a) The governing body of a hospital is authorized to establish policies concerning the granting of clinical privileges to advanced practice nurses and physician assistants, including policies relating to the application process, reasonable qualifications for privileges, and the process for renewal, modification, or revocation of privileges. (b) If the governing body of a hospital has adopted a policy of granting clinical privileges to advanced practice nurses or physician assistants, an individual advanced practice nurse or physician assistant who qualifies for privileges under that policy shall be entitled to certain procedural rights to provide fairness of process, as determined by the governing body of the hospital, when an application for privileges is submitted to the hospital. At a minimum, any policy adopted shall specify a reasonable period for the processing and consideration of the application and shall provide for written notification to the applicant of any final action on the application by the hospital, including any reason for denial or restriction of the privileges requested. (c) If an advanced practice nurse or physician assistant has been granted clinical privileges by a hospital, the hospital may not modify or revoke those privileges without providing certain procedural rights to provide fairness of process, as determined by the governing body of the hospital, to the advanced practice nurse or physician assistant. At a minimum, the hospital shall provide the advanced practice nurse or physician assistant written reasons for the modification or revocation of privileges and a mechanism for appeal to the

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appropriate committee or body within the hospital, as determined by the governing body of the hospital. (d) If a hospital extends clinical privileges to an advanced practice nurse or physician assistant conditioned on the advanced practice nurse or physician assistant having a sponsoring or collaborating relationship with a physician and that relationship ceases to exist, the advanced practice nurse or physician assistant and the physician shall provide written notification to the hospital that the relationship no longer exists. Once the hospital receives such notice from an advanced practice nurse or physician assistant and the physician, the hospital shall be deemed to have met its obligations under this section by notifying the advanced practice nurse or physician assistant in writing that the advanced practice nurse's or physician assistant's clinical privileges no longer exist at that hospital. (e) Nothing in this section shall be construed as modifying Subtitle B, Title 3, Occupations Code, Chapter 204 or 301, Occupations Code, or any other law relating to the scope of practice of physicians, advanced practice nurses, or physician assistants. (f) This section does not apply to an employer-employee relationship between an advanced practice nurse or physician assistant and a hospital.

Added by Acts 1999, 76th Leg., ch. 428, Sec. 2, eff. Sept. 1, 1999. Amended by Acts 2001, 77th Leg., ch. 1420, Sec. 14.787, eff. Sept. 1, 2001.

SUBCHAPTER F. MEDICAL REHABILITATION SERVICES

Sec. 241.121. DEFINITION. In this subchapter, "comprehensive medical rehabilitation" means the provision of rehabilitation services that are designed to improve or minimize a person's physical or cognitive disabilities, maximize a person's functional ability, or restore a person's lost functional capacity through close coordination of services, communication, interaction, and integration among several professions that share the responsibility to achieve team treatment goals for the person.

Added by Acts 1993, 73rd Leg., ch. 707, Sec. 1, eff. Sept. 1, 1993.

Sec. 241.122. LICENSE REQUIRED. Unless a person has a license issued under this chapter, a person other than an individual may not provide inpatient comprehensive medical rehabilitation to a patient who requires medical services that are provided under the supervision of a physician and that are more intensive than nursing facility care and minor treatment.

Added by Acts 1993, 73rd Leg., ch. 707, Sec. 1, eff. Sept. 1, 1993.

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This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. 219, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.123. REHABILITATION SERVICES STANDARDS. (a) The board by rule shall adopt standards for the provision of rehabilitation services by a hospital to ensure the health and safety of a patient receiving the services. (b) The standards adopted by the board at a minimum shall require a hospital that provides comprehensive medical rehabilitation: (1) to have a director of comprehensive medical rehabilitation who is: (A) a licensed physician; (B) either board certified or eligible for board certification in a medical specialty related to rehabilitation; and (C) qualified by training and experience to serve as medical director; (2) to have medical supervision by a licensed physician for 24 hours each day; and (3) to provide appropriate therapy to each patient by an interdisciplinary team consisting of licensed physicians, rehabilitation nurses, and therapists as are appropriate for the patient's needs. (c) An interdisciplinary team for comprehensive medical rehabilitation shall be directed by a licensed physician. An interdisciplinary team for comprehensive medical rehabilitation shall have available to it, at the hospital at which the services are provided or by contract, members of the following professions as necessary to meet the treatment needs of the patient: (1) physical therapy; (2) occupational therapy; (3) speech-language pathology; (4) therapeutic recreation; (5) social services and case management; (6) dietetics; (7) psychology; (8) respiratory therapy; (9) rehabilitative nursing; (10) certified orthotics; and (11) certified prosthetics. (d) A hospital shall prepare for each patient receiving inpatient rehabilitation services a written treatment plan designed for that patient's needs for treatment and care. The board by rule shall specify a time after admission of a patient for inpatient rehabilitation services by which a hospital

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must evaluate the patient for the patient's initial treatment plan and by which a hospital must provide copies of the plan after evaluation. (e) A hospital shall prepare for each patient receiving inpatient rehabilitation services a written continuing care plan that addresses the patient's needs for care after discharge, including recommendations for treatment and care and information about the availability of resources for treatment or care. The board by rule shall specify the time before discharge by which the hospital must provide a copy of the continuing care plan. The board's rules may allow a facility to provide the continuing care plan by a specified time after discharge if providing the plan before discharge is impracticable. (f) A hospital shall provide a copy of a treatment or continuing care plan prepared under this section to the following persons in the person's primary language, if practicable: ( 1) the patient; (2) a person designated by the patient; and (3) as specified by board rule, family members or other persons with responsibility for or demonstrated participation in the patient's care or treatment. (g) Rules adopted by the board under this subchapter may not conflict with a federal rule, regulation, or standard.

Added by Acts 1993, 73rd Leg., ch. 707, Sec. 1, eff. Sept. 1, 1993.

SUBCHAPTER G. DISCLOSURE OF HEALTH CARE INFORMATION

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. 219, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.151. DEFINITIONS. In this subchapter: (1) "Directory information" means information disclosing the presence of a person who is receiving inpatient, outpatient, or emergency services from a licensed hospital, the nature of the person's injury, the person's municipality of residence, sex, and age, and the general health status of the person as described in terms of 11 critical, 11 "poor," "fair," 11 good," "excellent," or similar terms. (2) "Health care information" means information, including payment information, recorded in any form or medium that identifies a patient and relates to the history, diagnosis, treatment, or prognosis of a patient. (3) "Health care provider'' means a person who is licensed, certified, or otherwise authorized by the laws of this state to provide health care in the

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ordinary course of business or practice of a profession. (4) "Institutional review board" means a board, committee, or other group formally designated by an institution or authorized under federal or state law to review or approve the initiation of or conduct periodic review of research programs to ensure the protection of the rights and welfare of human research subjects. (5) "Legally authorized representative" means: (A) a parent or legal guardian if the patient is a minor; (B) a legal guardian if the patient has been adjudicated incapacitated to manage the patient's personal affairs; (C) an agent of the patient authorized under a durable power of attorney for health care; (D) an attorney ad litem appointed for the patient; (E) a person authorized to consent to medical treatment on behalf of the patient under Chapter 313; (F) a guardian ad litem appointed for the patient; (G) a personal representative or heir of the patient, as defined by Section 3, Texas Probate Code, if the patient is deceased; (H) an attorney retained by the patient or by the patient's legally authorized representative; or (I) a person exercising a power granted to the person in the person's capacity as an attorney-in-fact or agent of the patient by a statutory durable power of attorney that is signed by the patient as principal.

Added by Acts 1995, 74th Leg., ch. 856, Sec. 1, eff. Sept. 1, 1995. Amended by Acts 1997, 75th Leg., ch. 498, Sec. 1, eff. Sept. 1, 1997. Amended by: Acts 2005, 79th Leg., Ch. 1138 (H.B. 2765), Sec. 1, eff. September 1, 2005. Acts 2009, 81st Leg., R.S., Ch. 1003 (H.B. ~~~), Sec. 1, eff. September 1, 2009.

Sec. 241.152. WRITTEN AUTHORIZATION FOR DISCLOSURE OF HEALTH CARE INFORMATION. (a) Except as authorized by Section 241.153, a hospital or an agent or employee of a hospital may not disclose health care information about a patient to any person other than the patient or the patient's legally authorized representative without the written authorization of the patient or the patient's legally authorized representative. (b) A disclosure authorization to a hospital is valid only if it: (1) is in writing; (2) is dated and signed by the patient or the patient's legally authorized representative;

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(3) identifies the information to be disclosed; (4) identifies the person or entity to whom the information is to be disclosed; and (5) is not contained in the same document that contains the consent to medical treatment obtained from the patient. (c) A disclosure authorization is valid until the 180th day after the date it is signed unless it provides otherwise or unless it is revoked. (d) Except as provided by Subsection (e), a patient or the patient's legally authorized representative may revoke a disclosure authorization to a hospital at any time. A revocation is valid only if it is in writing, dated with a date that is later than the date on the original authorization, and signed by the patient or the patient's legally authorized representative. (e) A patient or the patient's legally authorized representative may not revoke a disclosure that is required for purposes of making payment to the hospital for health care provided to the patient. (f) A patient may not maintain an action against a hospital for a disclosure made by the hospital in good-faith reliance on an authorization if the hospital's medical record department did not have notice that the authorization was revoked. (g) Repealed by Acts 1997, 75th Leg., ch. 498, Sec. 5, eff. Sept. 1,1997.

Added by Acts 1995, 74th Leg., ch. 856, Sec. 1, eff. Sept. 1, 1995. Amended by Acts 1997, 75th Leg., ch. 498, Sec. 2, 5, eff. Sept. 1, 1997; Acts 1999, 76th Leg., ch. 271, Sec. 1, eff. Sept. 1, 1999.

Sec. 241.153. DISCLOSURE WITHOUT WRITTEN AUTHORIZATION. A patient's health care information may be disclosed without the patient's authorization if the disclosure is: (1) directory information, unless the patient has instructed the hospital not to make the disclosure or the directory information is otherwise protected by state or federal law; (2) to a health care provider who is rendering health care to the patient when the request for the disclosure is made; (3) to a transporting emergency medical services provider for the purpose of: (A) treatment or payment, as those terms are defined by the regulations adopted under the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191); or (B) the following health care operations described by the regulations adopted under the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191):

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(i) quality assessment and improvement activities; (ii) specified insurance functions; (iii) conducting or arranging for medical reviews; or (iv) competency assurance activities; (4) to a member of the clergy specifically designated by the patient; (5) to a procurement organization as defined in Section 692A.002 for the purpose of making inquiries relating to donations according to the protocol referred to in Section 692A.015; (6) to a prospective health care provider for the purpose of securing the services of that health care provider as part of the patient's continuum of care, as determined by the patient's attending physician; (7) to a person authorized to consent to medical treatment under Chapter 313 or to a person in a circumstance exempted from Chapter 313 to facilitate the adequate provision of treatment; (8) to an employee or agent of the hospital who requires health care information for health care education, quality assurance, or peer review or for assisting the hospital in the delivery of health care or in complying with statutory, licensing, accreditation, or certification requirements and if the hospital takes appropriate action to ensure that the employee or agent: (A) will not use or disclose the health care information for any other purpose; and (B) will take appropriate steps to protect the health care information; (9) to a federal, state, or local government agency or authority to the extent authorized or required by law; (10) to a hospital that is the successor in interest to the hospital maintaining the health care information; (11) to the American Red Cross for the specific purpose of fulfilling the duties specified under its charter granted as an instrumentality of the United States government; (12) to a regional poison control center, as the term is used in Chapter 777, to the extent necessary to enable the center to provide information and education to health professionals involved in the management of poison and overdose victims, including information regarding appropriate therapeutic use of medications, their compatibility and stability, and adverse drug reactions and interactions; (13) to a health care utilization review agent who requires the health care information for utilization review of health care under Chapter 4201, Insurance Code; (14) for use in a research project authorized by an institutional

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review board under federal law; (15) to health care personnel of a penal or other custodial institution in which the patient is detained if the disclosure is for the sole purpose of providing health care to the patient; (16) to facilitate reimbursement to a hospital, other health care provider, or the patient for medical services or supplies; (17) to a health maintenance organization for purposes of maintaining a statistical reporting system as required by a rule adopted by a state agency or regulations adopted under the federal Health Maintenance Organization Act of 1973, as amended (42 U.S.C. Section 300e et seq.); (18) to satisfy a request for medical records of a deceased or incompetent person pursuant to Section 74.051(e), Civil Practice and Remedies Code; (19) to comply with a court order except as provided by Subdivision (20); or (20) related to a judicial proceeding in which the patient is a party and the disclosure is requested under a subpoena issued under: (A) the Texas Rules of Civil Procedure or Code of Criminal Procedure; or (B) Chapter 121, Civil Practice and Remedies Code.

Added by Acts 1995, 74th Leg., ch. 856, Sec. 1, eff. Sept. 1, 1995. Amended by Acts 1997, 75th Leg., ch. 498, Sec. 3, eff. Sept. 1, 1997; Acts 1997, 75th Leg., ch. 847, Sec. 1, eff. Sept. 1, 1997. Amended by: Acts 2005' 79th Leg., Ch. 136 (H.B. 739), Sec. 1, eff. September 1, 2005. Acts 2005, 79th Leg., Ch. 337 (S. B. 1113), Sec. 1, eff. September 1, 2005. Acts 2009' 81st Leg., R. S., Ch. 186 (H.B. 2022), Sec. 2, eff. September 1, 2009.

Sec. 241.1531. EXCHANGE OF INMATE'S HEALTH CARE INFORMATION. Notwithstanding any other law of this state, the health care information of a patient who is a defendant or inmate confined in a facility operated by or under contract with the Texas Department of Criminal Justice may be exchanged between health care personnel of the department and health care personnel of The University of Texas Medical Branch at Galveston or the Texas Tech University Health Sciences Center. The authorization of the defendant or inmate is not required for the exchange of information.

Added by Acts 2005, 79th Leg., Ch. 1270 (H.B. 2195), Sec. 1, eff. June 18, 2005.

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Sec. 241.154. REQUEST. (a) On receipt of a written authorization from a patient or legally authorized representative to examine or copy all or part of the patient's recorded health care information, except payment information, or for disclosures under Section 241.153 not requiring written authorization, a hospital or its agent, as promptly as required under the circumstances but not later than the 15th day after the date the request and payment authorized under Subsection (b) are received, shall: (1) make the information available for examination during regular business hours and provide a copy to the requestor, if requested; or (2) inform the authorized requestor if the information does not exist or cannot be found. (b) Except as provided by Subsection (d) , the hospital or its agent may charge a reasonable fee for providing the health care information except payment information and is not required to permit the examination, copying, or release of the information requested until the fee is paid unless there is a medical emergency. The fee may not exceed the sum of: (1) a basic retrieval or processing fee, which must include the fee for providing the first 10 pages of the copies and which may not exceed $30; and (A) a charge for each page of: (i) $1 for the 11th through the 60th page of the provided copies; (ii) 50 cents for the 61st through the 400th page of the provided copies; and (iii) 25 cents for any remaining pages of the provided copies; and (B) the actual cost of mailing, shipping, or otherwise delivering the provided copies; (2) if the requested records are stored on microform, a retrieval or processing fee, which must include the fee for providing the first 10 pages of the copies and which may not exceed $45; and (A) $1 per page thereafter; and (B) the actual cost of mailing, shipping, or otherwise delivering the provided copies; or (3) if the requested records are provided on a digital or other electronic medium and the requesting party requests delivery in a digital or electronic medium, including electronic mail: (A) a retrieval or processing fee, which may not exceed $75; and (B) the actual cost of mailing, shipping, or otherwise delivering the provided copies. (c) In addition, the hospital or its agent may charge a reasonable fee

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for: (1) execution of an affidavit or certification of a document, not to exceed the charge authorized by Section 22.004, Civil Practice and Remedies Code; and (2) written responses to a written set of questions, not to exceed $10 for a set. (d) A hospital may not charge a fee for: (1) providing health care information under Subsection (b) to the extent the fee is prohibited under Subchapter M, Chapter 161; (2) a patient to examine the patient's own health care information; (3) providing an itemized statement of billed services to a patient or third-party payor, except as provided under Section 311.002(f); or ' ( 4) health care information relating to treatment or hospitalization for which workers' compensation benefits are being sought, except to the extent permitted under Chapter 408, Labor Code. (e) Effective September 1, 1996, and annually thereafter, the fee for providing health care information as specified in this section shall be adjusted accordingly based on the most recent changes to the consumer price index as published by the Bureau of Labor Statistics of the United States Department of Labor that measures the average changes in prices of goods and services purchased by urban wage earners and clerical workers' families and single workers living alone. (f) A request from a patient or legally authorized representative for payment information is subject to Section 311.002.

Added by Acts 1995, 74th Leg., ch. 856, Sec. 1, eff. Sept. 1, 1995. Amended by Acts 1997, 75th Leg., ch. 498, Sec. 4, eff. Sept. 1, 1997; Acts 1999, 76th Leg., ch. 610, Sec. 1, eff. Sept. 1, 1999. Amended by: Acts 2009, 81st Leg., R.S., Ch. 1003 (H.B. 4029), Sec. 2, eff. September 1, 2009.

Sec. 241.155. SAFEGUARDS FOR SECURITY OF HEALTH CARE INFORMATION. A hospital shall adopt and implement reasonable safeguards for the security of all health care information it maintains.

Added by Acts 1995, 74th Leg., ch. 856, Sec. 1, eff. Sept. 1, 1995.

Sec. 241.156. PATIENT REMEDIES. (a) A patient aggrieved by a violation of this subchapter relating to the unauthorized release of confidential health care information may bring an action for:

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(1) appropriate injunctive relief; and (2) damages resulting from the release. (b) An action under Subsection (a) shall be brought in: (1) the district court of the county in which the patient resides or in the case of a deceased patient the district court of the county in which the patient's legally authorized representative resides; or (2) if the patient or the patient's legally authorized representative in the case of a deceased patient is not a resident of this state, the district court of Travis County. (c) A petition for injunctive relief under Subsection (a) (1) takes precedence over all civil matters on the court docket except those matters to which equal precedence on the docket is granted by law.

Added by Acts 1995, 74th Leg., ch. 856, Sec. 1, eff. Sept. 1, 1995.

Subchapter H, consisting of Sees. 241.181 to 241.187, was added by Acts 2013, 83rd Leg., R.S., Ch. 217 (H.B. 12), Sec. 1.

For another Subchapter H, consisting of Sees. 241.181 to 241.184, added by Acts 2013, 83rd Leg., R.S., Ch. 917 (H.B. Ulll), Sec. 1, see Sec. 241.181 et seq., post.

SUBCHAPTER H. HOSPITAL LEVEL OF CARE DESIGNATIONS FOR NEONATAL AND MATERNAL CARE

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. L~ and S.B. 1296, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.181. DEFINITIONS. In this subchapter: (1) "Department" means the Department of State Health Services. (2) "Executive conunissioner" means the executive conunissioner of the Health and Human Services Commission.

Added by Acts 2013, 83rd Leg., R.S., Ch. 217 (H.B. 12), Sec. 1, eff. September 1, 2013.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. 1.2.9Ji, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.182. LEVEL OF CARE DESIGNATIONS. (a) The executive commissioner, in accordance with the rules adopted under Section 241.183, shall assign level of care designations to each hospital based on the neonatal and

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maternal services provided at the hospital. (b) A hospital may receive different level designations for neonatal and maternal care, respectively.

Added by Acts 2013, 83rd Leg., R.S., Ch. 217 (H.B. 12), Sec. 1, eff. September 1, 2013.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. 219, S.B. 425 and S.B. 122Q, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.183. RULES. (a) The executive commissioner, in consultation with the department, shall adopt rules: (1) establishing the levels of care for neonatal and maternal care to be assigned to hospitals; (2) prescribing criteria for designating levels of neonatal and maternal care, respectively, including specifying the minimum requirements to qualify for each level designation; (3) establishing a process for the assignment of levels of care to a hospital for neonatal and maternal care, respectively; (4) establishing a process for amending the level of care designation requirements, including a process for assisting facilities in implementing any changes made necessary by the amendments; (5) dividing the state into neonatal and maternal care regions; (6) facilitating transfer agreements through regional coordination; (7) requiring payment, other than quality or outcome-based funding, to be based on services provided by the facility, regardless of the facility's level of care designation; and (8) prohibiting the denial of a neonatal or maternal level of care designation to a hospital that meets the minimum requirements for that level of care designation. (b) The criteria for levels one through three of neonatal and maternal care adopted under Subsection (a) (2) may not include requirements related to the number of patients treated at a hospital. (c) The Health and Human Services Commission shall study patient transfers that are not medically necessary but would be cost-effective. Based on the study under this subsection, if the executive commissioner determines that the transfers are feasible and desirable, the executive commissioner may adopt rules addressing those transfers. (d) Each level of care designation must require a hospital to regularly submit outcome and other data to the department as required or requested.

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(e) The criteria a hospital must achieve to receive each level of care designation must be posted on the department's Internet website.

Added by Acts 2013, 83rd Leg., R.S., Ch. 217 (H.B. 12), Sec. 1, eff. September 1, 2013.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. ~and S.B. 122&, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 2 41. 18 4. CONFIDENTIALITY; PRIVILEGE. (a) All information and materials submitted by a hospital to the department under Section 241.183(d) are confidential and: (1) are not subject to disclosure under Chapter 552, Government Code, or discovery, subpoena, or other means of legal compulsion for release to any person; and (2) may not be admitted as evidence or otherwise disclosed in any civil, criminal, or administrative proceeding. (b) The confidentiality protections under Subsection (a) apply without regard to whether the information or materials are submitted by a hospital or an entity that has an ownership or management interest in a hospital. (c) A state employee or officer may not be examined in a civil, criminal, or special proceeding, or any other proceeding, regarding the existence or contents of information or materials submitted to the department under Section 241.183 (d) . (d) The submission of information or materials under Section 241.183(d) is not a waiver of a privilege or protection granted under law. (e) The provisions of this section regarding the confidentiality of information or materials submitted by a hospital in compliance with Section 241.183(d) do not restrict access, to the extent authorized by law, by the patient or the patient's legally authorized representative to records of the patient's medical diagnosis or treatment or to other primary health records. (f) A department summary or disclosure, including an assignment of a level of care designation, may not contain information identifying a patient, employee, contractor, volunteer, consultant, health care practitioner, student, or trainee.

Added by Acts 2013, 83rd Leg., R.S., Ch. 217 (H.B. 12), Sec. 1, eff. September 1, 2013.

Sec. 241.185. ASSIGNMENT OF LEVEL OF CARE DESIGNATION. (a) The executive commissioner, in consultation with the department, shall assign the appropriate

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level of care designation to each hospital that meets the minimum standards for that level of care. The executive commissioner shall evaluate separately the neonatal and maternal services provided at the hospital and assign the respective level of care designations accordingly. (b) Every three years, the executive commissioner and the department shall review the level of care designations assigned to each hospital and, as necessary, assign a hospital a different level of care designation or remove the hospital's level of care designation. (c) A hospital may request a change of designation at any time. On request under this subsection, the executive commissioner and the department shall review the hospital's request and, as necessary, change the hospital's level of care designation.

Added by Acts 2013, 83rd Leg., R.S., Ch. 217 (H.B. 12), Sec. 1, eff. September 1, 2013.

Sec. 241.186. HOSPITAL NOT DESIGNATED. A hospital that does not meet the minimum requirements for any level of care designation for neonatal or maternal services: (1) may not receive a level of care designation for those services; and (2) is not eligible to receive reimbursement through the Medicaid program for neonatal or maternal services, as applicable, except emergency services required to be provided or reimbursed under state or federal law.

Added by Acts 2013, 83rd Leg., R.S., Ch. 217 (H.B. 15), Sec. 1, eff. September 1, 2013.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see H.B. 3433, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.187. PERINATAL ADVISORY COUNCIL. (a) In this section, "advisory council" means the Perinatal Advisory Council established under this section. (b) The advisory council consists of 17 members appointed by the executive commissioner as follows: (1) four physicians licensed to practice medicine under Subtitle B, Title 3, Occupations Code, specializing in neonatology: (A) at least two of whom practice in a Level III or IV neonatal intensive care unit; and (B) at least one of whom practices in a neonatal intensive care unit of a hospital located in a rural area;

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(2) one physician licensed to practice medicine under Subtitle B, Title 3, Occupations Code, specializing in general pediatrics; (3) two physicians licensed to practice medicine under Subtitle B, Title 3, Occupations Code, specializing in obstetrics-gynecology; (4) two physicians licensed to practice medicine under Subtitle B, Title 3, Occupations Code, specializing in maternal fetal medicine; (5) one physician licensed to practice medicine under Subtitle B, Title 3, Occupations Code, specializing in family practice who provides obstetrical care in a rural community; (6) one registered nurse licensed under Subtitle E, Title 3, Occupations Code, with expertise in maternal health care delivery; (7) one registered nurse licensed under Subtitle E, Title 3, Occupations Code, with expertise in perinatal health·care delivery; (8) one representative from a children's hospital; (9) one representative from a hospital with a Level II neonatal intensive care unit; (10) one representative from a rural hospital; (11) one representative from a general hospital; and (12) one ex officio representative from the office of the medical director of the Health and Human Services Commission. (c) To the extent possible, the executive commissioner shall appoint members to the advisory council who previously served on the Neonatal Intensive Care Unit Council established under Chapter 818 (H. B. 2636), Acts of the 82nd Legislature, Regular Session, 2011. (d) Members of the advisory council described by Subsections (b) (1)-(11) serve staggered three-year terms, with the terms of five or six of those members expiring September 1 of each year. A member may be reappointed to the advisory council. (e) A member of the advisory council serves without compensation but is entitled to reimbursement for actual and necessary travel expenses related to the performance of advisory council duties. (f) The department, with recommendations from the advisory council, shall develop a process for the designation and updates of levels of neonatal and maternal care at hospitals in accordance with this subchapter. (g) The advisory council shall: (1) develop and recommend criteria for designating levels of neonatal and maternal care, respectively, including specifying the minimum requirements to qualify for each level designation; (2) develop and recommend a process for the assignment of levels of care to a hospital for neonatal and maternal care, respectively;

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(3) make recommendations for the division of the state into neonatal and maternal care regions; (4) examine utilization trends relating to neonatal and maternal care; and (5) make recommendations related to improving neonatal and maternal outcomes. (h) In developing the criteria for the levels of neonatal and maternal care, the advisory council shall consider: (1) any recommendations or publications of the American Academy of Pediatrics and the American Congress of Obstetricians and Gynecologists, including ''Guidelines for Perinatal Care''; (2) any guidelines developed by the Society of Maternal-Fetal Medicine; and (3) the geographic and varied needs of citizens of this state. (i) In developing the criteria for designating levels one through three of neonatal and maternal care, the advisory council may not consider the number of patients treated at a hospital. (j) The advisory council shall submit a report detailing the advisory council's determinations and recommendations to the department and the executive commissioner not later than September 1, 2015. (k) The advisory council shall continue to update its recommendations based on any relevant scientific or medical developments. (l) The advisory council is subject to Chapter 325, Government Code (Texas Sunset Act). Unless continued in existence as provided by that chapter, the advisory council is abolished and this section expires September 1, 2025.

Added by Acts 2013, 83rd Leg., R.S., Ch. 217 (H.B. 12), Sec. 1, eff. September 1, 2013.

Subchapter H, consisting of Sees. 241.181 to 241.184, was added by Acts 2013, 83rd Leg., R.S., Ch. 917 (H.B. 1J2U), Sec. 1.

For another Subchapter H, consisting of Sees. 241.181 to 241.187, added by Acts 2013, 83rd Leg., R.S., Ch. 217 (H.B. 12), Sec. 1, see Sec. 241.181 et seq., post.

SUBCHAPTER H. FREESTANDING EMERGENCY MEDICAL CARE FACILITIES ASSOCIATED WITH LICENSED HOSPITALS

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. 21~ and S.B. 122ll, 84th Legislature, Regular Session, for amendments affecting this section.

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Sec. 241.181. APPLICABILITY. This subchapter applies only to a freestanding emergency medical care facility, as that term is defined by Section 254.001, that is exempt from the licensing requirements of Chapter 254 under Section 254.052(7) or (8).

Added by Acts 2013, 83rd Leg., R.S., Ch. 917 (H.B. ~), Sec. 1, eff. September 1, 2013.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. ~' 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.182. ADVERTISING. A facility described by Section 241.181 may not advertise or hold itself out as a medical office, facility, or provider other than an emergency room if the facility charges for its services the usual and customary rate charged for the same service by a hospital emergency room in the same region of the state or located in a region of the state with comparable rates for emergency health care services.

Added by Acts 2013, 83rd Leg., R.S., Ch. 917 (H.B. lllQ), Sec. 1, eff. September 1, 2013.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. ~' S.B. 122 and S.B. 1296, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.183. POSTED NOTICE. Subject to Section 241.006, the department shall adopt rules for a notice to be posted in a conspicuous place in the facility described by Section 241.181 that notifies prospective patients that the facility is an emergency room and charges rates comparable to a hospital emergency room.

Added by Acts 2013, 83rd Leg., R.S., Ch. 917 (H.B. ~), Sec. 1, eff. September 1, 2013.

This section was amended by the 84th Legislature. Pending publication of the current statutes, see S.B. ~and S.B. -1296, 84th Legislature, Regular Session, for amendments affecting this section.

Sec. 241.184. ADMINISTRATIVE PENALTY. The commissioner of health may assess an administrative penalty under Section 241.059 against a hospital that violates this subchapter.

Added by Acts 2013, 83rd Leg., R.S., Ch. 917 (H.B. 1376), Sec. 1, eff. September

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1, 2013.

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Transmittals for Appendix A

Survey Protocol Introduction Task 1 - Off-Site Survey Preparation Task 2- Entrance Activities Task 3 - Information Gathering/Investigation Task 4- Preliminary Decision Making and Analysis of Findings Task 5 - Exit Conference Task 6 - Post-Survey Activities Psychiatric Hospital Survey Module Psychiatric Unit Survey Module Rehabilitation Hospital Survey Module Inpatient Rehabilitation Unit Survey Module Hospital Swing-Bed Survey Module Regulations and Interpretive Guidelines §482.2 Provision of Emergency Services by Nonparticipating Hospitals §482.11 Condition of Participation: Compliance with Federal, State and Local Laws §482.12 Condition of Participation: Governing Body §482.13 Condition of Participation: Patient's Rights §482.21 Condition of Participation: Quality Assessment and Performance Improvement Program §482.22 Condition of Participation: Medical staff §482.23 Condition of Participation: Nursing Services §482.24 Condition of Participation: Medical Record Services §482.25 Condition of Participation: Pharmaceutical Services §482.26 Condition of Participation: Radiologic Services §482.27 Condition of Participation: Laboratory Services §482.28 Condition of Participation: Food and Dietetic Services §482.30 Condition of Participation: Utilization Review §482.41 Condition of Participation: Physical Environment §482.42 Condition orParticipation: Infection Control §482.43 Condition orParticipation: Discharge Planning §482.45 Condition of Participation: Organ, Tissue and Eye Procurement §482.51 Condition of Participation: Surgical Services §482.52 Condition orParticipation: Anesthesia Services §482.53 Condition of Participation: Nuclear Medicine Services §482.54 Condition of Participation: Outpatient Services §482.55 Condition of Participation: Emergency Services §482.56 Condition of Participation: Rehabilitation Services §482.57 Condition of Participation: Respiratory Services Survey Protocol Introduction (Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

Hospitals are required to be in compliance with the Federal requirements set forth in the Medicare Conditions of Participation (CoP) in order to receive Medicare/Medicaid payment. The goal of a hospital survey is to determine if the hospital is in compliance with the CoP set forth at 42 CFR Part 482. Also, where appropriate, the hospital must be in compliance with the PPS exclusionmy criteria at 42 CFR 412.20 Subpart Band the swing-bed requirements at 42 CFR 482.66

Certification of hospital compliance with the CoP is accomplished through observations, interviews, and document/record reviews. The survey process focuses on a hospital's performance of patient-focused and organizational functions and processes. The hospital survey is the means used to assess compliance with Federal health, safety, and quality standards that will assure that the beneficiary receives safe, quality care and services.

Regulatory and Policy Reference

• The Medicare Conditions of Participation for hospitals are found at 42CFR Part 482.

• Survey authority and compliance regulations can be found at 42 CFR Part 488 Subpart A.

• Should an individual or entity (hospital) refuse to allow immediate access upon reasonable request to either a State Agency or CMS surveyor, the Office of the Inspector General (OIG) may exclude the hospital from participation in all Federal healthcare programs in accordance with 42 CFR 1001.1301.

• The regulatory authority for the photocopying of records and information during the survey is found at 42 CFR 489.53(a)(13).

• The CMS State Operations Manual (SOM) provides CMS policy regarding survey and certification activities.

Surveyors assess the hospital's compliance with the CoP for all services, areas and locations in which the provider receives reimbursement for patient care services billed under its provider number.

Although the survey generally occurs during daytime working hours (Monday tlu·ough Friday), surveyors may conduct the survey at other times. This may include weekends and times outside of normal daytime (Monday through Friday) working hours. When the survey begins at times outside of normal work times, the survey temn modifies the survey, if needed, in recognition of patients' activities and the staff available. All hospital surveys are unannounced. Do not provide hospitals with advance notice of the survey.

Tasks in the Survey Protocol

Listed below, and discussed in this document, are the tasks that comprise the survey protocol for hospital. §482.41 Condition of Participation: Physical Environment

The hospital must be constructed, arranged, and maintained to ensure the safety of the patient, and to provide facilities for diagnosis and treatment and for special hospital services appropriate to the needs of the community.

Interpretive Guidelines §482.41

This CoP applies to all locations of the hospital, all campuses, all satellites, all provider- based activities, and all inpatient and outpatient locations.

The hospital's Facility Maintenance and hospital departments or services responsible for the hospital's buildings and equipment (both facility equipment and patient care equipment) must be incorporated into the hospital's QAPI program and be in compliance with the QAPI requirements.

Survey Procedures §482.41

Survey of the Physical Environment CoP should be conducted by one surveyor. However, each surveyor as he/she conducts his/ber survey assignments should assess the hospital's compliance with the Physical Environment CoP. The Life Safety Code survey may be conducted separately by a specialty surveyor.

A-0701

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08) §482.41(a) Standard: Buildings

The condition of the physical plant and the overall hospital environment mnst be developed and maintained in such a manner that the safety and well-being of patients are assured.

Interpretive Guidelines §482.41(a)

The hospital must ensure that the condition of the physical plant and overall hospital environment is developed and maintained in a manner to ensure the safety and well being of patients. This includes ensuring that routine and preventive maintenance and testing activities are performed as necessary, in accordance with Federal and State laws, regulations, and guidelines and manufacturer's recommendations, by establishing maintenance schedules and conducting ongoing maintenance inspections to identify areas or equipment in need of repair. The routine and preventive maintenance and testing activities should be incorporated into the hospital's QAPI plan.

Assuring the safety and well being of patients would include developing and implementing appropriate emergency preparedness plans and capabilities. The hospital must develop and implement a comprehensive plan to ensure that the safety and well being of patients are assured during emergency situations. The hospital must coordinate with Federal, State, and local emergency preparedness and health authorities to identify likely risks for their area (e.g., natural disasters, bioterrorism threats, disruption of utilities such as water, sewer, electrical communications, fuel; nuclear accidents, industrial accidents, and other likely mass casualties, etc.) and to develop appropriate responses that will assure the safety and well being of patients. The following issues should be considered when developing the comprehensive emergency plans(s):

• The differing needs of each location where the certified hospital operates;

• The special needs of patient populations treated at the hospital (e.g., patients with psychiatric diagnosis, patients on special diets, newborns, etc.);

• Security of patients and walk-in patients;

• Security of supplies from misappropriation;

• Pharmaceuticals, food, other supplies and equipment that may be needed during emergency/disaster situations;

• Communication to external entities if telephones and computers are not operating or become overloaded (e.g., ham radio operators, community officials, other healthcare facilities if transfer of patients is necessary, etc.);

• Communication among staff within the hospital itself;

• Qualifications and training needed by personnel, including healthcare staff, security staff, and maintenance staff, to implement and carry out emergency procedures;

• Identification, availability and notification of personnel that are needed to implement and carry out the hospital's emergency plans;

• Identification of community resources, including lines of communication and names and contact information for community emergency preparedness coordinators and responders;

• Provisions if gas, water, electricity supply is shut off to the community;

• Transfer or discharge of patients to home, other healthcare settings, or other hospitals;

• Transfer of patients with hospital equipment to another hospital or healthcare setting; and • Methods to evaluate repairs needed and to secure various likely materials and supplies to effectuate repairs.

Survey Procedures §482.41(a)

• Verify that the condition of the hospital is maintained in a manner to assure the safety and well being of patients (e.g., condition or ceilings, walls, and floors, presence of patient hazards, etc.).

• Review the hospital's routine and preventive maintenance schedules to determine that ongoing maintenance inspections are perfmmed and that necessary repairs are completed.

• Verify that the hospital has developed and implemented a comprehensive plan to ensure that the safety and well being of patients are assured during emergency situations.

A-0702

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.41(a)(l)- There must be emergency power and lighting in at least the operating, recovery, intensive care, and emergency rooms, and stairwells. In all other areas not serviced by the emergency supply source, battery lamps and flashlights must be available.

Interpretive Guidelines §482.41(a)(l)

The hospital must comply with the applicable provisions of the Life Safety Code, National Fire Protection Amendments (NFPA) 101,2000 Edition and applicable references, such as, NFPA-99: Health Care Facilities, for emergency lighting and emergency power.

Survey Procedures §482.41(a)(l)

Use the Life Safety Code Survey Report Form (CMS-2786) to evaluate compliance with this item.

A-0703

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.41(a)(2)- There must be facilities for emergency gas and water supply. encouraged to work with their State and local emergency response agencies to develop their plans.

The hospital must be in compliance with the Occupational Health and Safety Administration's Bloodborne Pathogens regulation at 29 CFR 1910.1030.

Survey Procedures §482.42

• Survey of the Infection Control Condition of Participation (CoP) should be coordinated by one surveyor. However, each surveyor should assess the hospital's compliance with the Infection Control CoP as he/she conducts his/her survey assignments.

• Determine whether there are hospital-wide policies and procedures for preventing, identifYing, reporting, investigating, and controlling infections and communicable diseases of patients and hospital personnel, including contract workers and volunteers. Determine whether the infection control program can identity all hospital locations and that the policies and procedures take the various hospital locations into account.

• Determine whether the policies and procedures are implemented correctly in an active infection control program. • Determine whether the program is hospital-wide and program specific in gathering and assessing infection and communicable disease data. Review the parameters of the active surveillance program to determine whether it is consistent with infection control standards of practice and suitable to the scope and complexity of the hospital's services.

• Throughout the hospital, observe the sanitary condition of the environment of care, noting the cleanliness of patient rooms, floors, horizontal surfaces, patient equipment, air inlets, mechanical rooms, food service activities, treatment and procedure areas, surgical areas, central supply, storage areas, etc.

• Determine whether the hospital's infection prevention and control program is integrated into its hospital-wide QAPI program.

A-0748 (Rev. 95, Issued: 12-12-13, Effective: 06-07-13, Implementation: 06-07-13)

§482.42(a) Standard: Organization and Policies

A person or persons must be designated as infection control officer or officers to develop and implement policies governing control of infections and communicable diseases .... Interpretive Guidelines §482.42(a)

Hospital infection control officers are often referred to as "hospital epidemiologists (HEs)," "infection control professionals (!CPs)" or "infection preventionists." CDC has defined "infection control professional" as "a person whose primary training is in either nursing, medical technology, microbiology, or epidemiology and who has acquired specialized training in infection control."

The hospital must designate in writing an individual or group of individuals as its infection control officer or officers. In designating infection control officers, hospitals should assure that the individuals so designated are qualified through education, training, experience, or certification (such as that offered by the Certification Board of Infection Control and Epidemiology Inc. (CBIC), or by the specialty boards in adult or pediatric infectious diseases offered for physicians by the American Board of Internal Medicine (for internists) and the American Board of Pediatrics (for pediatricians)). Infection control officers should maintain their qualifications through ongoing education and training, which can be demonstrated by participation in infection control courses, or in local and national meetings organized by recognized professional societies, such as APIC and SHEA.

CMS does not specify either the number of infection control officers to be designated or the number of infection control officer hours that must be devoted to the infection prevention and control programs. However, resources must be adequate to accomplish the tasks required for the infection control program. A prudent hospital would consider patient census, characteristics of the patient population, and complexity of the healthcare services it offers in determining the size and scope of the resources it commits to infection control. The CDC's HICPAC as well as professional infection control organizations such as the APIC and the SHEA publish studies and recommendations on resource allocation that hospitals may find useful.

The infection control officer(s) must develop and implement policies governing the control of infections and communicable diseases. Infection control policies should address the roles and responsibilities for infection control within the hospital; how the various hospital committees and departments interface with the infection control program; and how to prevent infectious/communicable diseases; and how to report infectious/communicable diseases to the infection control program.

Survey Procedures §482.42(a)

• Determine whether an infection control officer(s) is designated and has the responsibility for the infection prevention and control program.

• Review the personnel file of the infection control officer(s) to determine whether he/she is qualified through ongoing education, training, experience, or certification to oversee the infection control program. • Determine whether the infection control officer(s) have developed and implemented hospital infection control policies.

A-0749 (Rev. 95, Issued: 12-12-13, Effective: 06-07-13, Implementation: 06-07-13)

§482.42(a)-.... The infection control officer or officers must develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel.

Interpretive Guidelines §482.42(a)

The infection control officer or officers must develop, implement and evaluate measures governing the identification, investigation, reporting, prevention and control of infections and communicable diseases within the hospital, including both healthcare--associated infections and community-acquired infections. Infection control policies should be specific to each department, service, and location, including off-site locations, and be evaluated and revised when indicated. The successful development, implementation and evaluation of a hospital-wide infection prevention and control program requires frequent collaboration with persons administratively and clinically responsible for inpatient and outpatient departments and services, as well as, non-patient-care support staff, such as maintenance and housekeeping staff.

Implicit in the infection control officer(s)' responsibility for measures to identifY, investigate, report, prevent and control infections and communicable diseases are the following activities:

• Maintenance of a sanitary hospital environment;

• Development and implementation of infection control measures related to hospital personnel; hospital staff, for infection control purposes, includes all hospital staff, contract workers (e.g., agency nurses, housekeeping staff, etc), and volunteers;

• Mitigation of risks associated with patient infections present upon admission:

• Mitigation of risks contributing to healthcare-associated infections:

• Active surveillance;

• Monitoring compliance with all policies, procedures, protocols and other infection conh·ol program requirements;

• Program evaluation and revision of the program, when indicated; o Coordination as required by law with federal, state, and local emergency preparedness and health authorities to address communicable disease threats, bioterrorism, and outbreaks;

o Complying with the reportable disease requirements of the local health authority; For example, a hospital with a comprehensive hospital-wide infection control program should have and implement policies and procedures, based as much as possible on national guidelines that address the following:

o Maintenance of a sanitary physical environment:

0 Ventilation and water quality control issues, including measures taken to maintain a safe environment during internal or external constmction!renovation;

0 Maintaining safe air handling systems in areas of special ventilation, such as operating rooms, intensive care units, and airborne infection isolation rooms;

0 Techniques for food sanitation;

0 Techniques for cleaning and disinfecting environmental surfaces, carpeting and furniture;

0 Techniques for textiles reprocessing, storage and distribution;

0 Techniques for disposal of regulated and non-regulated waste; and

0 Techniques for pest control.

• Hospital staff-related measures:

0 Measures - and authority - for evaluating hospital staff immunization status for designated infectious diseases, as reconnnended by the CDC and its Advisory Committee on Immunization Practices (ACIP);

0 Policies articulating the authority and circumstances under which the hospital screens hospital staff for infections likely to cause significant infectious disease or other risk to the exposed individual, and for reportable diseases, as required under local, state, or federal public health authority;

0 Policies mticulating when infected hospital staff are restricted from providing direct patient care and/or are required to remain away from the healthcare facility entirely; 0 New employee and regular update training in preventing and controlling healthcani-associated infections and methods to prevent exposure to and transmission of infections and communicable diseases;

0 Measures to evaluate staff and volunteers exposed to patients with infections and communicable disease;

• Mitigation of risks associated with patient infections present upon admission:

0 Measures for the early identification of patients who require isolation in accordance with CDC guidelines;

0 Appropriate use of personal protective equipment including gowns, gloves, masks and eye protection devices;

0 Use and techniques for "isolation" precautions as recommended by the CDC.

• Mitigation of risks contributing to healthcare-associated infections:

0 Surgery-related infection risk mitigation measures:

• Implementing appropriate prophylaxis to prevent surgical site infection (SSI), such as a protocol to assure that antibiotic prophylaxis to prevent surgical site infection for appropriate procedures is administered at the appropriate time, done with an appropriate antibiotic, and discontinued appropriately after surgery;

• Addressing aseptic technique practices used in surgery and invasive procedures performed outside the operating room, including sterilization of instruments;

0 Other hospital healthcare-associated infection risk mitigation measures:

• Promotion of hand washing hygiene among staff and employees, including utilization of alcohol-based hand sanitizers;

• Measures specific to prevention of infections caused by organisms that are antibiotic-resistant;

• Measures specific to prevention of device-associated bloodstream infection (BSI), such as a protocol for reducing infections of central venous catheters specifying aseptic precautions for line insertions, care of inserted lines, and prompt removal when a line is no longer needed; • Measures specific to prevention of other device-associated infections, e.g., those associated with ventilators, tube feeding, indwelling urinary catheters, etc.;

• Isolation procedures and requirements for highly immuno-suppressed patients who require a protective environment.

• Care techniques for tracheostomy care, respiratory therapy, burns and other situations that reduce a patient's resistance to infection; • Requiring disinfectants, antiseptics, and germicides to be used in accordance with the manufacturers' instructions;

• Appropriate use of facility and medical equipment, including negative and positive pressure isolation room equipment, portable air filtration equipment, treatment booths and enclosed beds, UV lights, and other equipment used to control the spread of infectious agents;

• Adherence to nationally recognized infection prevention and control precautions, such as current CDC guidelines and recommendations, for infections/communicable diseases identified as present in the hospital; and

• Educating patients, visitors, caregivers, and staff, as appropriate, about infections and communicable diseases and methods to reduce transmission in the hospital and in the community;

• Active surveillance:

0 The hospital is expected to identify and track infections and communicable diseases in any of the following categories occurring throughout the hospital, whether in patients or staff (patient care staff and non-patient care staff, including employees, contract staff and volunteers). Hospitals are not required to organize their surveillance according to these categories. The categories are:

• Healthcare-associated infections selected by the hospital's Infection Prevention and Control Program as part of a targeted surveillance strategy based on nationally recognized guidelines and periodic risk assessment;

• Patients or staff with identified communicable diseases that local, State, or Federal health agencies require be reported;

• Patients identified by laboratory culture as colonized or infected with multi-drug-resistant organisms (MDROs), as defined by the hospital's Infection Prevention and Control Program; • Patients who meet CDC criteria for requiring isolation precautions (other than "Standard Precautions" or a protective enviromnent) during their hospitalization;

• Patients or staff with signs and symptoms that have been requested be reported or recorded by local, State, or Federal health agencies; and

• Staff or patients who are known or suspected to be infected with epidemiologically-significant pathogens that are identified by the hospital or local, State, or Federal health agencies.

FoJ< Information- Not )lequired/Notto be Cited

Many hospitals are using automated surveillance technology (AST) or "data mining" for identification and control ofhospital-acquired infections (HAl) . and implementation o[evidence-based infection control practices. Use of ASTor similar technology is encouraged in hospititls,.but is not required.

• Provisions to monitor compliance with all policies, procedures, protocols and other infection control program requirements;

• Provision for program evaluation and revision of the program, when indicated;

• Policies and procedures developed in coordination with federal, state, and local emergency preparedness and health authorities to address communicable disease threats, bioterrorism, and outbreaks; and

• Procedures for meeting the reporting requirements of the local health authority.

Survey Procedures §482.42(a)

• Determine whether the hospital has an active, hospital-wide infection control program reflecting the infection control officer responsibilities specified in the interPretive guidelines. Specifically, surveyors should determine whether the hospital:

• Maintains a sanitary enviromnent;

• Develops and implements infection control measures related to hospital personnel;

• Mitigates risks associated with patient infections present upon admission; • Mitigates risks contributing to healthcare-associated infections (for example, observe whether staff exhibit good hand washing hygiene);

• Conducts active surveillance;

• Monitors compliance with all infection control program requirements;

• Evaluates the infection control program regularly and revises it, when indicated;

• Coordinates as required by law with federal, state, and local emergency preparedness and health authorities to address communicable disease threats, bioterrorism, and outbreaks; and

• Complies with the reportable disease requirements of the local health authority.

A-0756 (Rev. 95, Issued: 12-12-13, Effective: 06-07-13, Implementation: 06-07-13)

§482.42(b) Standard: Responsibilities of Chief Executive Officer, Medical Staff, and Director of Nursing Services

The chief executive officer, the medical staff, and the director of nursing must--

(1) Ensure that the hospital-wide quality assessment and performance improvement (QAPI) program and training programs address problems identified by the infection control officer or officers; and

(2) Be responsible for the implementation of successful corrective action plans in affected problem areas.

Interpretive Guidelines §482.42(b)

The chief executive officer (CEO), the medical staff and the director of nursing (DON) must ensure that the hospital-wide Quality Assessment and Performance Improvement (QAPI) program and staff in-service training programs address problems identified through the infection prevention and control program.

To reflect the importance of infection control the regulations specifically require that the hospital's QAPI and training programs must be involved in addressing problems identified by the infection control program, and hold the CEO, medical staff and DON jointly responsible for linking the infection control program with the QAPI and training programs. Requirements for the hospital's QAPI program are found at 42 CFR 482.21. • Verity that the hospital is in compliance with ventilation requirements for patients with contagious airborne diseases, such as tuberculosis, patients receiving treatments with hazardous chemical, surgical areas, and other areas where hazardous materials are stored.

• Verity that food products are stored under appropriate conditions (e.g., time, temperature, packaging, location) based on a nationally-accepted source such as the United States Department of Agriculture, the Food and Drug Administration, or other nationally-recognized standard.

• Verity that pharmaceuticals are stored at temperatures recommended by the product manufacturer.

• Review monitoring records for temperature to ensure that appropriate levels are maintained.

• Review humidity maintenance records for anesthetizing locations to ensure, if monitoring determined humidity levels were not within acceptable parameters, that corrective actions were perfmmed in a timely manner to achieve acceptable levels.

A-0747 (Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.42 Condition of Participation: Infection Control

The hospital must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There must be an active program for the prevention, control, and investigation of infections and communicable diseases.

Interpretive Guidelines §482.42

This regulation requires the hospital to develop, implement, and maintain an active, hospital-wide program for the prevention, control, and investigation of infections and communicable diseases. The National Institute of Allergy and Infectious Diseases defines an infectious disease as a change from a state of health to a state in which part or all of a host's body cannot function normally because of the presence of an infectious agent or its product. An infectious agent is defined by the NIAID as a living or quasi- living organism or particle that causes an infectious disease, and includes bacteria, vimses, fungi, protozoa, hehninthes, and prions. NIAID defines a communicable disease as a disease associated with an agent that can be transmitted from one host to another. (NIAID website glossary) According to the Centers for Disease Control and Prevention (CDC), healthcare- associated infections, i.e., infections that patients acquire during the course of receiving treatment for other conditions within a healthcare setting, are one of the top ten leading causes of death in the United States. The CDC estimates that there are I. 7 million healthcare-associated infections in American hospitals each year, with 99,000 associated deaths. (CDC website, Estimates ofHealthcare-Associated Infections, date last modified May 30, 2007)

The hospital must provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases. All areas of the hospital must be clean and sanitary. This includes all hospital units, campuses and off-site locations. The infection prevention and control program must include appropriate monitoring of housekeeping, maintenance (including repair, renovation and construction activities), and other activities to ensure that the hospital maintains a sanitary environment. Examples of areas to monitor would include: food storage, preparation, serving and dish rooms, refrigerators, ice machines, air handlers, autoclave rooms, venting systems, inpatient rooms, treatment areas, labs, waste handling, surgical areas, supply storage, equipment cleaning, etc.

The hospital's program for prevention, control and investigation of infections and communicable diseases should be conducted in accordance with nationally recognized infection control practices or guidelines, as well as applicable regulations of other federal or state agencies. Examples of organizations that promulgate nationally recognized infection and communicable disease control guidelines, and/or recommendations include: the Centers for Disease Control and Prevention (CDC), the Association for Professionals in Infection Control and Epidemiology (APIC), the Society for Healthcare Epidemiology of America (SHEA), and the Association of peri Operative Registered Nurses (AORN). The U.S. Occupational Health and Safety Administration (OSHA) also issues federal regulations applicable to infection control practices.

In order to prevent, control and investigate infections and communicable diseases, the hospital's program must include an active surveillance component that covers both hospital patients and personnel working in the hospital. Surveillance includes infection detection, data collection and analysis, monitoring, and evaluation of preventive interventions.

The hospital must conduct surveillance on a hospital-wide basis in order to identify infectious risks or communicable disease problems at any particular location. This does not imply "total hospital surveillance," but it does mean that hospitals must have reliable sampling or other mechanisms in place to permit identifying and monitoring infections and communicable diseases occurring throughout the hospital's various locations or departments. The hospital must document its surveillance activities, including the measures selected for monitoring, and collection and analysis methods. Surveillance activities should be conducted in accordance with recognized infection control surveillance practices, such as, for example, those utilized by the CDC's National Healthcare Safety Net (NHSN).

The hospital must develop and implement appropriate infection control interventions to address issues identified through its detection activities, and then monitor the effectiveness of interventions through further data collection and analysis.

The hospital's infection prevention and control program must be integrated into its hospital-wide Quality Assurance and Performance Improvement (QAPI) program. (See 42 CFR 482.42(b)(l).)

SPECIAL CHALLENGES IN INFECTION CONTROL

MULTI-DRUG RESISTANT ORGANISMS (MDROs)

According to the Centers for Disease Control's (CDC) publication, Management of Multi-drug Resistant Organisms in Healthcare Settings 2006, http://www.cdc.gov/ncidod/dhqp/pdf/ar/mrdoGuideline2006.pdf, MDROs are microorganisms that are resistant to one or more antimicrobial agents. Options for treating patients with MDRO infections are very limited, resulting in increased mortality, as well as increased hospital length of stay and costs. During the last several decades the prevalence of MDROs in hospitals has increased steadily. Hospitals are encouraged to have mechanisms in place for the early identification of patients with targeted MDROs prevalent in their hospital and community, and for the prevention of transmission of such MDROs. When ongoing transmission of targeted MDROs in the hospital is identified, the infection prevention and control program should use this event to identity potential breaches in infection control practice.

AMBULATORY CARE

The ambulatory care setting, including emergency departments, presents unique challenges for infection control, because: patients remain in common areas, often for prolonged periods of time, until they can be seen by a healthcare practitioner; examination or treatment rooms are turned around quickly with minimal cleaning; and infectious patients may not be recognized immediately. Furthermore, immuno- compromised patients may receive treatments in rooms among other patients who pose risks of infection.

The hospital's infection prevention and control program should be designed with these ambulatory care setting challenges in mind. After assessing the likely level of risk in its various ambulatory care settings, including off-site settings, a hospital might identity particular settings, such as the emergency department, where it would be appropriate to employ measures for screening individuals with potentially contagious diseases during their initial patient encounter, and taking appropriate control measures for those individuals who may present risk for the transmission of infectious agents by the airborne or droplet route. Guidelines promulgated by the CDC's Healthcare Infection Control Practices Advisory Committee (HICPAC) are a resource for hospitals in developing their infection control program for ambulatory care. For example, when potentially infectious individuals are identified, prevention measures should include prompt physical separation wherever possible, implementation of respiratory hygiene/cough etiquette protocols, and/or appropriate isolation precautions based on the routes of transmission of the suspected infection.

COMMUNICABLE DISEASE OUTBREAKS

Community-wide outbreaks of communicable diseases (such as measles, SARS, or influenza) present many of the same issues and require many of the same considerations and strategies as other hospital infectious disease threats. If a communicable disease outbreak occurs, an understanding of the epidemiology, likely modes of transmission, and clinical course of the disease is essential for responding to and managing the event. Among the infection control issues that may need to be addressed are:

• Preventing transmission among patients, healthcare personnel, and visitors;

• Identifying persons who may be infected and exposed;

• Providing treatment or prophylaxis to large numbers of people; and

• Logistics issues (staff, medical supplies, resupply, continued operations, and capacity).

Pandemics, or very widespread and clinically serious outbreaks of an infection, present additional challenges due to the widespread effect on the availability of back-up resources that would typically be available to address an outbreak confined to a smaller geographic area. Additionally, the duration of a pandemic may present special challenges for staffing, supplies, resupply, etc. Hospitals should work with local, State, and Federal public health agencies to identify likely communicable disease threats and develop appropriate preparedness and response strategies.

BIOTERRORISM

Healthcare facilities would confront a set of issues similar to naturally occurring communicable disease threats when dealing with a suspected bioterrorism event. The required response is likely to differ based on whether exposure is a result of a biological release or person-to-person transmission. A variety of sources offer guidance for the management of persons exposed to likely agents ofbioterrorism, including Federal agency websites (e.g., http://www.ahrg.gov/prep; http://www.usamrid.army.mil/publications/index.htrnl; http://www.bt.cdc.gov) Because of the many similarities between man-made and naturally occurring threats, an all-hazards approach to developing emergency response plans is preferred, and hospitals are APPENDIX- ''12'' ------~----~-----

Centers for Medicare & Medicaid Services

Hospital Infection Control Worksheet

Name of State Agency:

Instructions: The following is a list of items that must be assessed during the on-site survey, in order to determine compliance with the Infection Control Condition of Participation, Items are to be assessed by a combination of observation, interviews with hospital staff, patients and their family/support persons, review of medical records, and a review of any necessary infection control program documentation. During the survey, observations or concerns may prompt the surveyor to request and review specific hospital policies and procedures. Surveyors are expected to use their judgment and review only those documents necessary to investigate their concern(s) or to validate their observations.

The interviews should be performed with the most appropriate staff person(s) for the items of interest, as well as with patients, family members, and support persons_

Hospital Characteristics

1. Hospital name: J ~~--~~~~~~~~~~~~~~~~~~~~~~~~~-=~~-==-

2. CMS Certification Number (CCN): I I I cr-J I 3. Date of site visit:

III~C-r-1~[] Il-l to I I I~ITJ~I I I I I ·~~~----------------------------------------·-·---~~---------------------·

Module 1: Infection Prevention Program

hospital has developed general infection control policies and procedures that are based on nationally recognized guidelines (' No and applicable state and federal law.

If no to any of l.A.l through l.A.3, cite at 42 CFR 482.42(a) (Tag A-748)

relevant to construction, renovation, maintenance, demolition, and repair, including the requirement for an infection control C No risk assessment (ICRA) to define the scope of the project and need for barrier measures before a project gets underway.

If no to l.A.6, cite at 42 CFR 482.42(a) (Tag A-748)

2 can. problems identified in the infection control program are addressed in the hospital QAPI program (i.e., development and ('No implementation of corrective interventions, and ongoing evaluation of interventions implemented for both success and sustainability).

If no to 1.8.1, cite at 42 CFR 482.21(e)(3) (Tag A-0286)

Director of Nursing services ensures the hospital implements successful corrective action plans in affected problem area(s}. (' No

If no to 1.8.2, cite at 42 CFR 482.42(b)(2) (Tag A-0756)

selection of quality indicators for infection prevention and control. (' No

If no to 1.8.3, cite at 42 CFR 482.21(a)(2) (Tag A-Q267)

3 are or infected with a targeted MDRO and to notify receiving healthcare facilities and personnel prior to transfer of such patient I (' No between facilities.

If no to any part of l.C.l through l.C.3, cite at 42 CFR 482.42(a) (Tag A-0749)

Note: Hospitals should provide a list of MOROs that are targeted for (' No infection control because they are epidemiologically important (e.g., MRSA, VRE). Please refer to CDC's Guideline for Isolation Precautions for criteria that may be used to define epidemiology important organisms: http://www.cdc.gov/hicpac/pdf/isolation/lsolation2007.pdf

('No

(' N/A

4 ,_ -~·'" - "~~" .~ ~~-

l.C.7 The hospital has an established systemts) to ensure prompt (' Yes !

notification to the Infection Control Officer when a novel resistance pattern based on microbiology results is detected. (' No

If no to l.C.7, cite at 42 CFR 482.42(a) (Tag A-0749)

l.C.8 Patients identified as colonized or infected with target MOROs (' Yes are placed on Contact Precautions. (' No Note: This does not imply that hospitals are required to perform active surveillance testing to detect MDRO colonization among a specific subset or all patients.

If no to l.C.S, cite at 42 CFR 482.42(a) (Tag A-0749) l.C.9 The hospital has written policies and procedures whose purpose ('Yes is to improve antibiotic use (antibiotic stewardship). (' No

l.C.lO The hospital has designated a leader (e.g., physician, ('Yes pharmacist, etc.) responsible for program outcomes of antibiotic stewardship activities at the hospital. (' No

l.C.ll The hospital's antibiotic stewardship po icy and procedures (' Yes requires practitioners to document in the medical record or during order entry an indication for all antibiotics, in addition to other C No required elements such as does and duration.

l.C.12 The hospital has a formal procedure tor all practitioners to (' Yes review the appropriateness of any antibiotics prescribed after 48 hours from the initial orders (e.g., antibiotic time out). C No

l.C.13 The hospital monitors antibiotic use {consumption) at the unit It Yes and/or hospital level. (' No

No citation risk for l.C.9 through 1.C.13; for information only.

5 ---------- -·-·--· -· ---·- ----- --

an exposure follow-up including prophylaxis as appropriate, is available to the individual and performed by or under the supervision of a (' No practitioner.

Note: An exposure incident refers to a specific eye, mouth, other mucous membrane, non-intact skin, or parenteral contact with blood or other potentially infectious materials that result from the performance of an individual's duties.

ensures screenedfor tuberculosis {TB) upon hire and, for those with negative results, determine ongoing TB screening criteria based ('No upon facility/unit risk classification.

Note: Risk classification based on aggregated rates of TB test conversions are periodically reviewed by the Infection Control Officer to determine the need for modification to the screening and TB control measures due to increases or decreases in transmission.

6 1.0.7 The hospital infection control system ensures personnel with ('Yes TB test conversions are provided with appropriate follow-up (e.g. evaluation and treatment, as needed). ('No

l.D.8 The hospital infection control system ensures the hospital has ('Yes a respiratory protection program that details required worksite- specific procedures and elements for required respirator use. (' No

1.0.9 The hospital infection control system ensures that respiratory ('Yes fit testing is provided at regular intervals to personnel at risk. (' No

1.0.10 Hospital has well-defined policies concerning contact of ('Yes personnel with patients when personnel have potentially transmissible conditions. ('No

• The hospital provides education to personnel on need for prompt reporting of illness to supervisor and/or occupational health.

If no to any of 1.0.1 through 1.0.10, cite at 42 CFR 482.42(a) (Tag A-0749) 1.0.11 Personnel competency and compliance with job-specific ( Yes infection prevention policies and procedures are ensured through routine training and when the Infection Control Officer (' No has identified problems requiring additional training.

If no to 1.0.11, cite at 42 CFR 482.42(b) (Tag A-0756)

7 . - 1.0.12 The hospital intection control system provides Hepatitis B (' Yes ' vaccination series to all employees who have potential occupational exposure and offers post-vaccination testing for (' No immunity after the third vaccine dose is administered.

1.0.13 The hospital infection control system ensures and documents ( Yes that all personnel have presumptive evidence of immunity to measles, mumps, and rubella. (' No

1.0.14 The hospital infection control system provides Tdap (tetanus ( Yes toxoid, reduced diphtheria toxoid, and acellular pertussis) vaccination for all personnel who have not previously received ('No Tdap.

Note: Tdap is not licensed for multiple administrations; therefore, after receipt ofTdap, HCP should receive Td (Tetanus diphtheria) for future booster vaccination against tetanus and diphtheria.

1.0.15 The hospital infection control system ensures and documents (' Yes that all personnel have evidence of immunity to varicella. ('No

·- 1.0.16 The hospital infection control system ensures that a11 ('Yes personnel are offered annual influenza vaccination. (' No

No citation risk for 1.0.12 through 1.0.16, for information only.

8 Module 2: General Infection Prevention Elements -to be applied to all locations providing patient care

locations including, but not limited to, patient care areas and food and medication preparation areas. ( No

Note: Medications should not be prepared near areas of splashing water (e.g. within 3 feet of a sink). Alternately when space is limited, a splash guard can be mounted beside the sink.

appropriate locations. The locations may include: (No • Entrances to patient rooms, • At the bedside, • In individual pocket-sized containers carried by healthcare personnel, • Staff workstations, and/or • Other convenient locations.

• Before contact with the patient (' No • Before performing an aseptic task (e.g., insertion of IV or urinary catheter}

9 -~~----~·~-~~~~·-~-----~~-~ <--"-~"- ·~·-·~--~-~·~------

2.A.4 Personnel perform hand hygiene: ('Yes

• After contact with the patient (' No

• After contact with blood, body fluids, or visibly contaminated surfaces • After removing gloves

2.A.S Personnel perform hand hygiene using soap and water when ('Yes hands are visibly soiled (e.g., blood, body fluids) or after caring for a patient with known or suspected C. difficile or norovirus \ No during an outbreak.

Note: In all other situations, alcohol-based hand rub is preferred.

- 2.A.6 Personnel do not wear artificial fingernails and/or extenders ('Yes when having direct contact with patients at high risk of infection (e.g., those in intensive care units or ORs) per hospital (' No

policy.

If no to any of 2.A.l through 2.A.6, cite at 42 CFR 482.42(a) (Tag A-0749)

10 questions 2.8.1- 2.8.15 RIGHT column will be blocked) are prepared usmg asept1c technique m an area that has been cleaned and is free of contamination (e.g., visible blood, or body fiuids). I (' No ('No

('Unable to C Unable to observe

(' No C No

('Unable to Cunableto observe observe one manufactured prefilled syringes). ('No C No

Cunableto ('Unable to observe

C No (' No

Cunableto Cunableto observe observe

unopened or previously accessed, is disinfected with alcohol prior to piercing. CNo ('No

C Unable to ('Unable to observe observe

11 -- 2.B.6 Medication viats are entered with a new needle. ('Yes ( . Yes

Note: Reuse of syringes and/or needles to enter a medication vial ( No (No contaminates the contents of the vial, making the vial unsafe for use on additional patients. If a surveyor sees needles or (Unable to (Unable to syringes being reused to enter a vial to obtain additional observe observe medication for the same patient, no citation should be made if the vial is discarded immediately.

2.B.7 Medication vials are entered with a new syringe. ('Yes (. Yes

Note: Reuse of syringes and/or needles to enter a medication vial ( No ( No contaminates the contents of the vial making the vial unsafe for use on additional patients. If a surveyor sees needles or (Unable to (Unable to syringes being reused to enter a vial to obtain additional observe observe medication for the same patient, no citation should be made if the vial is discarded immediately. I 2.8.8 Medication vials labeled for single dose single use are only ('Yes ('Yes used for one patient. (No ( No

('Unable to (Unable to observe observe

2.8.9 Bags of IV solution are used for only one patient (and not as a ('Yes ('Yes source of flush solution for multiple patients). ( No C No

('Unable to ('Unable to observe observe

2.8.10 Medication administration tubing and connectors are used ('Yes ('Yes for onlY one patient. (No C No

(Unable to C' Unable to observe observe

12 ----~~------ --------~~,, - ·- ---- - -·-

2.8.11 Multi-dose vials are dated when they are first opened and (Yes (Yes discarded within 28 days unless the manufacturer specifies a different (shorter or longer) beyond-use date for that opened ( No (No viaL (Unable to Cunableto Note: The beyond-use date is different from the expiration date observe observe printed on the vial by the manufacturer. The beyond-use date should never exceed the expiration date. The multi-dose vial can be dated by the hospital with either the date opened or the discard date as per hospital policy, as long as it is clear what the date represents and the same policy is used consistently throughout the hospitaL

2.8.12 Multi-dose medication vials used for more than one patient (Yes ( Yes are storedappropriatelyand do not enterthe immediate patient treatment area( e.g., operating room, patient room, anesthesia (No C No carts). (Unable to (Unable to Note: If multi-dose vials enter the immediate patient treatment observe observe area, they must be dedicated for single patient use and discarded immediately after use.

2.8.13 All sharps are disposed of in puncture-resistant sharps (Yes ( Yes containers. (No C No

2.8.14 Sharps containers are replaced when the fill ine is reached. (Yes C Yes

( No C No

2.8.15 Sharps containers are disposed of appropriately as medical (Yes (Yes waste. ( No (No

If no to any of 2.B.l through 2.B.15, cite at 42 CFR 482.42(a) (Tag A-0749) *See notes on 2.8.6, 2.8.7, and 2.8.11 if ''no'' is checked. I

13 personal protective equipment (e.g., gloves, gowns, mouth, eye, nose, and face protection) are available and located near point of (' No ('No use.

2.C.2 Personnel wear gloves for procedures/activities where (' Yes (j Yes contact with blood and/or other potentially infectious materials, mucous membranes, non-intact skin or potentially 6 No 0 No contaminated intact skin could occur.

hygiene before moving from a contaminated body site to a clean body site. C No ('No

\Unable to ('Unable to observe observe

are worn clothing during procedures/activities where contact with blood, body fluids, secretions, or excretions could occur. ('No \No

('Unable to ('Unable to observe observe

14 ~o~·~·~~~o-----~

2.C.5 Gowns and gloves are removed and hand hygiene is (' Yes ( Yes performed: • Before leaving the patient's environment (e.g. including moving ('No ('No to another patient).

2.C.6 Appropriate moutn, nose and eye protect1on is worn tor ( Yes ( Yes aerosol-generating procedures and/or procedures/activities that are likely to generate splashes or sprays of blood, body (' No ('No fluids, secretions or excretions. ('Unable to tUnable to observe observe

----· 2.C.7 Facemasks (procedure or surgical) are worn by healthcare ('Yes 1 C Yes ! personnel who are placing a catheter or injecting materials into the epidural or subdural space. (' No C No

('Unable to Cunableto observe observe

I !

If no to any of 2.C.l through 2.C.7, cite at 42 CFR 482.42(a) (Tag A-0749) I

15 res~ personnel wear

appropriate PPE to prevent exposure to infectious agents or chemicals (PPE can include gloves, gowns, masks, and eye (No protection). (Unable to observe are disinfected, using an EPA-registered disinfectant on a regular basis (e.g., daily), when spills occur and when surfaces are ( No visibly contaminated. (Unable to Note: High-touch surfaces (e.g., bed rails, over-bed table, bedside observe commode, lavatory surfaces in patient bathrooms) are cleaned and disinfected more frequently than minimal-touch surfaces.

contaminated surfaces are thoroughly cleaned and disinfected and towels and bed linens are replaced with clean towels and (No bed linens. (Unable to observe

are used in accordance with manufacturer's instructions (e.g., dilution, storage, shelf-life, contact time). (No

(Unable to observe

to clean each room and corridor. ( No

(Unable to observe

16 - ~ -~~ -~-'

2.0.6 Mop heads and cleaning cloths are laundered at least daily ('Yes using appropriate laundry techniques (e.g., following manufacturer instructions when laundering microfiber items}. (' No

('Unable to observe

2.0.7 The hospital decontaminates spills of blood or other body ('Yes fluids according to its policies and procedures, using appropriate EPA-registered hospital disinfectants. t No

tUnable to observe 2.0.8 The hospital has established and follows a schedule for C Yes areas/equipment to be cleaned/serviced regularly (e.g., HVAC equipment, refrigerators, ice machines, eye wash stations, (' No scrub sinks).

Laundry is processed in a manner consistent with hospital infection control policies and procedures to maximize the pre~ention of infection and communicable disease including the following:

2.0.9 Personnel handle soiled textiles/linens with minimum ('Yes agitation to avoid contamination of air, surfaces, and persons. ('No

2.0.10 Soiled textilesjlinens are bagged or otherwise contained at ('Yes the point of collection in leak-proof containers or bags and are not sorted or rinsed in the location of use. t No

Note: Covers are not needed on contaminated textile hampers in patient care areas.

2.0.11 The receiving area for contaminated textiles is clearly ('Yes separated from clean laundry areas and is maintained at negative pressure compared with the clean areas ofthe ('No laundry in accordance with FGI (formerly AlA) construction standards in effect during the time of facility construction.

2.0.12 If hospital laundry services are contracted out and ('Yes performed offsite, the contract must show evidence that the contractor's laundry service meets these design standards. (' No

C N/A

17 2.0.13 Clean texti es are packaged, transported, and stored in a ('Yes manner that ensures cleanliness and protection from dust and soil. (' No

Reprocessing of non-critical items is accomplished in a manner consistent with hospita infection control policies and procedures to maximize the prevention of infection and communicable disease including the following:

2.0.14 Reusable noncritical patient-care devices (e.g., blood ( Yes pressure cuffs, oximeter probes) are disinfected on a regular basis (e.g., after use on each patient, once daily, or once ('No weekly) and when visibly soiled.

2.0.15 For patients on Contact Precautions, if dedicated, ( Yes disposable devices are not available, noncritical patient-care devices are disinfected after use on each patient. (' No

2.0.16 There is clear designation of responsibility for disinfection of ( · Yes reusable noncritical patient-care devices. ('No

2.0.17 Manufacturers' instructions for cleaning noncritical medical ('Yes equipment are followed. (' No

2.0.18 Hydrotherapy equipment (e.g., Hubbard tanks, tubs, ( Yes whirlpools, spas, birthing tanks) are drained, cleaned, and disinfected using an EPA-registered disinfectant according to (' No manufacturer's instructions after each patient use. (' N/A

If no to any of 2.0.1 through 2.0.18, cite at 42 CFR 482.42(a) (Tag A-0749) - ----- - - - - - - - ----

18 ··--·--'-~'~" ,.~- ..,. ~~--------~----------------------------~

INSTRUCTIONS: • Use the items in Section 3.C. "Single-Use Devices" to assess the reprocessing of any item(s) of semi-critical equipment that is (are) labeled as a single use device. Any item(s} of semi-critical equipment that is (are} labeled as a single use device must be reprocessed by a reprocessorthat is registered with the FDA as a third-party reprocessor and cleared by the FDA to reprocess the specific device in question.

• For all items labeled reusable, use section 3A.

discrepancies between a device manufacturer's instructions and automated high-level disinfection equipment manufacturer's (' No instruction for completing high-level disinfection. (Unable to observe

hospital onsite or offsite via a reprocessing vendor. ('No

(Unable to observe

disinfection prior to reuse. (' No

(Unable to observe

19 "~----------·~~~~--~----~----~

3.A.4 If any high-level disinfection is performed off-site, tne item(s) are (' Yes I

decontaminated prior to off-site transport. ('No

tUnable to observe

If no to any of 3.A.l through 3.A.4, cite at 42 CFR 482.42(a) (Tag A-0749) 3.A.S Is ALL high-level disinfection done Off-site? (' Yes: STOP here and SKIP to Section 3.8.

\ No: Answer all questions in this Section.

NOTE: If any high-level disinfection is done onsite, complete questions 3.A.6 through 3.A.18.

No citation risk for 3.A.5, for information only.

If possible, obtain two sets of observations for the items in this section. Central Reprocessing Other Reprocessing Area Observe the main area for central sterilization/reprocessing services and if possible, also assess reprocessing in another area. C Unable to observe elements in central (": Unable to observe elements in non-central reprocessing area. (If selected, questions reprocessing setting. {If selected, questions 3.A.6- 3.A.18 LEFT column will be blocked) 3.A.6- 3.A.18 RIGHT column will be blocked) 3.A.6 Flexible endoscopes are inspected for damage and leak tested as ( Yes C Yes part of each reprocessing cycle. (' No ('No (An endoscope is an instrument designed to visually examine the interior of a bodily canal or hollow organ such as the colon. ('Unable to ('Unable to bladder, or stomach) observe observe

3.A.7 Items are thoroughly pre-cleaned according to manufacturer ('Yes ( Yes •

instructions and visually inspected for residual soil prior to high- level disinfection. C No C No

Note: For instruments with lumens (e.g., endoscopes), pre-cleaning of tUnable to ('Unable to devices must include all channels using cleaning brushes of observe observe

appropriate size.

--·· . - ' --···· ------- -

20 3.A.8 Enzymatic cleaner or detergent is used and discarded according C Yes (' Yes to manufacturer's instructions (typically after each use). (' No ('No

('Unable to ('Unable to observe observe

3.A.9 Cleaning brushes are singte-use, disposable items or, if reusable, ('Yes (' Yes cleaned and either high-level disinfected or sterilized (per manufacturer's instructions} at least daily. (' No ('No

Cunableto ('Unable to observe ' observe i '' 3.A.10 For chemicals used in high-level disinfection, manufacturer's I( Yes I r Yes instructions are followed for: ('No (' No • Preparation, • Testing for appropriate concentration, and ('Unable to C Unable to observe observe • Replacement (e.g., prior to expiration or loss of efficacy) .

3.A.11 If automated reprocessing equipment is used, the (' Yes ( Yes manufacturer's recommended connectors are used to assure that all endoscope channels are appropriately disinfected. (' No (' No

('Unable to ('Unable to observe observe

3.A.12 Devices undergo disinfect-ion for the appropriate length of time ('Yes (' Yes as specified by manufacturer's instructions. ('No ('No

('Unable to tUnable to observe observe

3.A.13 Devices undergo disinfection at the appropriate temperature as ('Yes C Yes specified by manufacturer's instructions. (' No (' No

('Unable to Cunableto observe observe

----- -

21 ~--

- . --·· - 3.A.14 After high-1eve1 disinrection, devices are rinsed with sterile ('Yes ('Yes water, filtered water, or tap water followed by a rinse with 70%- 90% ethyl or isopropyl alcohol. ('No (' No

Note: There is no recommendation to use sterile or filtered water ('Unable to ('Unable to rather than tap water for rinsing semi-critical equipment that contact observe observe the mucous membranes ofthe rectum or vagina.

3.A.15 Devices are dried thoroughly prior to reuse. ( Yes ('Yes

Note: For instruments with lumens (e.g., endoscopes), this includes (' No (' No flushing all channels with alcohol and forcing air through the channels. tUnable to tUnable to observe observe

3.A.16 Routine maintenance procedures for high-level disinfection ( Yes C Yes equipment are performed regularly. (Confirm maintenance records are available.) ('No t No

tUnable to Cunableto observe observe

3.A.17 Alter high-level disintection, devices are stored in a manner to ( Yes ('Yes protect from damage or contamination - ('No C No Note: Endoscopes must be hung in a vertical position. ! tUnable to tUnable to ! i observe observe

3.A.18 The hospital has a system in place to identify which endoscope ('Yes ('Yes was used on a patient for each procedure. (' No ('No

('Unable to tUnable to observe observe

If no to any of 3.A.6 through 3.A.18, cite at 42 CFR 482.4Z(a) (Tag A-0749)

22 INSTRUCTIONS: • Use the items in Section 3.C. "Single-Use Devices" to assess the reprocessing of any item(s} of critical equipment that is (are) labeled as a single use device. Any item(s) of critical equipment that is (are} labeled as a single use device must be reprocessed by a reprocessorthat is registered with the FDA as a third-party reprocessor and cleared by the FDA to reprocess the specific device in question.

• Add reference to single use

• If possible, obtain two sets of observations for the items in this Section: one in Central Sterile Services (CSS) and another in in a non-CSS area (e.g. Gl suites, Radiology, Outpatient clinics, OS suites).

Sterilization of reusable equipment, instruments and devices is accomplished in a manner consistent with hospital infection control policies and procedures to maximize the prevention of infection and communicable diseases including the following:

any decontaminated prior to off-site transport. (' No

(' N/A

If no to any of 3.B.l through 3.B.3, cite at 42 CFR 482.42(a) (Tag A·0749)

23 3.8.4 Is All sterilization done off-site? (' Yes: STOP here and SKIP to Section 3.C I

("' No: Answer all questions in this section

Note: If any sterilization is done onsite, complete questions 3.8.5 through 3.8.19

If possible., obtain two sets of observations tor the items in this Central Steri ization Area Other non-Central Sterilization Area section. Observe the main area for central sterilization services and if possible, also assess sterilization in another area. (' Unable to observe elements in central (" Unable to observe elements in non-central sterilization area. (If selected, question 3.8.5 sterilization setting. (If selected, question 3.8.5 -3.8.19 LEFT column will be blocked) -3.8.19 RIGHT column will be blocked) 3.8.5 Items are thoroughly pre-cleaned according to (' Yes [ Yes manufacturers' instructions and visually inspected for residual soil prior to sterilization. (' No \ No

Note: For instruments with lumens, pre-cleaning of devices must include all channels using cleaning brushes of appropriate size. 3.8.6 Enzymatic cleaner or detergent is used and discarded ('Yes ( Yes according to manufacturer's instructions (typically after each use). (' No C No

3.8.7 Cleaning brushes are single-use, disposable items or, if (' Yes I[ Yes reusable, cleaned and either high-level disinfected or sterilized (per manufacturer's instructions) at least daily. (' No C No

3.8.8 After pre-cleaning, items are appropriately wrapped- ('Yes i( Yes packaged for sterilization (e.g., package system selected is compatible with the sterilization process being performed, (' No C No hinged instruments are open, and instruments are disassembled if indicated by the manufacturer).

3.8.9 A chemical indicator (process indicator) is placed correctly in (' Yes [ Yes the instrument packs in every load. C No \ No

3.8.10 A biological indicator is used at least weekly tor each IC Yes ( Yes sterilizer and with every load containing implantable items. ('No C No

3.8.11 For dynamic air removal-type sterilizers (e.g., prevacuum ( Yes . ( Yes steam sterilizer). an air removal test (Bowie-Dick test) is performed each day the sterilizer is used to verify efficacy of air \ No (' No removal. \ N/A (' N/A 24 ·----~-~-~-·--·-·--

3.B.l2 Sterile pacKS are 1aoe1ea with the sterilizer used, the cycle or IC Yes i( Yes load number, and the date of sterilization, and, if applicable, the expiration date. (' No (' No

3.8.13 logs for each steri izer cycle are current and include results (' Yes ( Yes from each load. (' No (' No

3.8.14 Routine maintenance for sterilization equipment is If Yes C Yes performed regularly (confirm maintenance records are available). C No (' No

3.B.15 After sterilization, medical devices and instruments are (' Yes ( Yes stored so that sterility is not compromised. (' No (' No

3.8.16 Steri e packages are inspected for integrity and IC Yes IC Yes compromised packages are repackaged and reprocessed prior to use. (' No ('No

3.8.17 If immediate-use steam steri ization is performed, all of the (' Yes lr Yes following criteria are met: ('No C No • Work practices ensure proper cleaning and decontamination, inspection, and arrangement of the instruments into the ('Unable to CUnableto recommended sterilizing trays or other containment devices observe observe before sterilization. I I

• Once dean, the item is placed within a container intended for immediate use.

The sterilizer cycle and parameters used are selected according to I the manufacturers' instructions for use for the device, container, and sterilizer.

The sterilizerfunction is monitored with monitors (e.g., mechanical, chemical and biologic) that are approved for the cycle being used.

• The processed item must be transferred immediately*, using aseptic technique, from the sterilizer to the actual point of use, the sterile field in an ongoing surgical procedure.

*"Immediate use" is defined as the shortest possible time between a sterilized item's removal from the sterilizer and its aseptic transfer to the sterile field. A sterilized item intended for immediate use is not stored for future use, nor held from one case to another.

25 ·--~~~~---------~~------·-------------===-··=··" ~--------------------------------------"~---------

3.8.18 Immediate-use steri ization is NOT performed on the ('Yes ( Yes following devices: ('No \ No • Implants {except in documented emergency situations when no other option is available).

• Post-procedure decontamination of instruments used on patients who may have Creutzfeldt-Jakob disease or similar disorders.

• Devices that have not been validated with the specific cycle employed.

• Single-use devices that are sold sterile .

3.8.19 In the event of a reprocessing error/failure that could result ('Yes ('Yes in the transmission of infectious disease, personnel respond (i.e., recall{ removal) of device and risk assessment) according \No \ No to hospital policies and procedures.

If no to any of 3.B.S through 3.B.19, cite at 42 CFR 482.42(a) {Tag A-0749) - .

I

26 use by the manufacturer, these devices are reprocessed by an entity or a third party reprocessor that is registered with the (' No (' No FDA as a third-party reprocessor and cleared by the FDA to reprocess the specific device in question. The hospital has (' N/A (' N/A documentation from the third party reprocessor confirming this is the case.

discarded after use and not used for more than one patient if they have not been reprocessed by an approved third-party (' No ('No reprocessor.

If no to 3.C.l or 3.C.2, cite at 42 CFR 482.42{a) (Tag A-ll749)

27 o•~• •··~-~---~----·•••••0••• ••o-••••••••••o • •p ·----~-~-~-~~~-~---------------------------

Module 4: Patient Tracers

urinary catheters. (' No

If no to 4.A.l cite at 42 CFR 482.24(c)(2)(vi) {Tag A-0467)

personnel are given the responsibility of inserting and maintaining ('No urinary catheters.

If no to 4.A.2 cite at 42 CFR 482.23(b)(S) (Tag A-0397)

questions 4A3- 4A6 RIGHT column will be blocked)

urinary catheter. C No C No

("Unable to ('Unable to observe observe

equipment. C No (' No

(' Unable to C Unable to observe observe

28 ·~~~~~~~~~~~~-~~~~~~~~·~~~ . ~ .... ·····~~ ·~~- ··-~~·-~·---~~~·~~~.~~~~~~-

4.A.5 catheter is secured properly after insertion. (' Yes ( Yes

Note: This may not apply to catheters placed in the OR if the (' No (' No catheter is removed in the OR immediately after the procedure. (' N/A (' N/A

If no to any of 4.A.3 through 4.A.S, cite at 42 CFR 482.42(a) (Tag A-0749)

4A.6 Catheter insertion and indication are documented. (' Yes ('Yes

('No C No

If no to 4.A.6 cite at to 42 CFR 482.24(c)(2)(vi) (Tag A-0467)

..... · .· •• ·. . .) . ·.·. i .•. < \ ····-.· . ·..·•.. . .•. I Urinary catheter • .•...•.. •..·. . > • ·.·.·.·.·.. . · .· ..•.·..•••... ·· •·••••··••·••••·• access. and "1aintenanc,e: > .··,· ·.•..•.·.·· ·.. .. . .·. • < • ·. •. ••• • . . .• •. ' •.-.. ' > ..·.•·.·•· >, ' ..•..••.·. 4.A.7 Hand hygiene is performed before and after manipulating (' Yes (' Yes catheter. (' No (' No

(' Unable to ('Unable to observe observe

4.A.8 Urine bag is kept below 1eve1 of bladder at au times. (' Yes (' Yes

(' No (' No

4.A.9 Catheter tubing is unobstructed and free of kinking. (' Yes C Yes

(' No • ('No '

4.A.10 Urine bag is emptied using aseptic technique, using a (' Yes ! (: Yes separate, clean collection container for each patient; drainage I spigot does not touch collecting container. (' No CNo

(' Unable to Cunableto observe observe

29 4.A.11 Urine samples are obtained aseptically (via needleless port ( Yes ('Yes for small volume). '

(' No (' No

\Unable to \Unable to observe observe

•

If no to any of 4.A.7 through 4.A.ll, cite at to 42 CFR 482.42(a) (Tag A-0749)

4.A.12 Need for urinary catheters is reviewed and documented ('Yes ('Yes daily with prompt removal of urinary catheters no longer needed. \No ('No

No citation risk 4.A.12; for information only.

30 ----------· -·--- ~~~··-~~~~~~~~~~~~-

questions 4.8.2- 4.8.7 RIGHT column will be blocked)

(' No \ No

\Unable to \Unable to observe observe

to insertion (If contraindicated [e.g., neonatal populationL tincture of iodine, an iodophor, or 70% alcohol can be used as alternatives). I ("· No \ No

C Unable to ('Unable to observe observe

gauze used to cover catheter site (may not apply for well-healed tunneled catheters). ('.No (' No

31 -~ ~" __,__ ~ -'- -~~'

4.B.61fthe femoral site is used for central venous catheter insertion for (' Yes ('Yes adults, justification for this site is in the medical record. (' No (' No

('Unable to (Unable to observe observe

If no to any of4.6.2 to 4.6.6, cite at 42 CFR 482.42(a) (Tag A-0749) 4.8.7 Central venous line insertion and indication are documented. (' Yes C Yes

C No C No

''

If no to 4.6.7, cite at to 42 CFR 482.24(c)(2)(vi) (Tag A-0467) Accessing/Maintenance .·· .· ' ·. ··.·· '

• .. •• ·.· . ·. ·· ... .· . • • ·..

4.8.8 The hospital can provide evidence that only properly trained ( Yes personnel who demonstrate competence for access and maintenance of central intravascular catheters are given this (' No responsibility.

If unable to observe the access or maintenance of any central venous ( No observations available (If selected, ALL ('Second observation not available (If selected, catheters, skip 4.8.9 through 4.8.13. questions from 4.8.9 -4.8.13 will be questions 4.8.9- 4.8.13 RIGHT column will be blocked) blocked) 4.8.9 Hand hygiene is performed before and after manipulating 1( · Yes .C Yes catheter. (' No (No

('Unable to C Unable to observe observe j 4.8.10 Dressings that are wet, soiled, or dislodged are changed (' Yes ('Yes promptly. ('No ('No

(' Unable to ('Unable to observe observe

32 ·~·--~~"'~-""" '"'." "~ "'"'"""'""~-.--·~~~~~~~~~~~~~~~~~~~~~~~~~~-~

4.8.11 Dressing is changed with aseptic technique using clean or sterile \ Yes \Yes gloves. \ No \No

\Unable to \Unable to observe observe

4.8.12 Access port is scrubbed with an appropriate antiseptic ( Yes ('Yes (chlorhexidine, povidone iodine, an iodophor, or 70% alcohol) prior to accessing. \ No \ No !

\Unable to \Unable to observe observe

4.8.13 Catheter is accessed only with sterile devices. \Yes ('Yes

\No \No

\Unable to \unable to observe - observe

If no to any of 4.8.8 to 4.8.13, cite at 42 CFR 482.42(a) (Tag A-0749} 4.8.14 Need for central venous catheters is reviewed .daily and \Yes documented with prompt removal of lines when no longer needed. \ No

No citation risk; for information only.

33 ·-·~~~,,~~~~~"

If no observations available, skip questions 4.C.1 through 4.C.8. ("', No observations available (If selected, ALL t Second observation not available (If selected, questions from 4,C.l- 4.C.8 will be blocked) questions 4.C.l- 4.C.8 RIGHT column will be blocked)

patient or any respiratory equipment used on patient. ( No ( No

(Unable to (Unable to observe observe

are worn when 1n contact With respiratory secretions and changed before contact with another patient, object, or environmental surface. ( No (No

(Unable to C Unable to observe observe

nebulization. C No (No

(Unable to (Unable to observe observe

for more than one patient. (No ( No

(Unable to (Unable to observe observe

34 4.C.5 If mutti-dose vials for aerosolized medications are used, ('Yes 1 ('Yes manufacturers' instructions for handling, storing, and dispensing the medications are followed. ('No \ No

\ N/A tN/A

C Unable to C Unable to observe observe

4.C.6 If mUlti-dose vials for aerosolized medications are used for C Yes c Yes more than one patient, they are stored appropriately and do not enter the immediate patient treatment area. C No C No

tN/A tN/A

i If no to anyof4.C.l to 4.C.6, cite at to 42 CFR 482.42(a) (Tag A-0749) 4.C.7 Jet nebulizers are for single patient use and are cleaned as Yes Yes per hospital policy, rinsed with sterile water, and air-dried ( Ic between treatments on the same patient. C No C No

Note: Mesh nebulizers, which remain in the ventilator circuit and are not cleaned or disinfected, are changed at an interval recommended by manufacturer's instructions. Nebulizer/drug combination systems are cleaned and disinfected according to manufacturer's instructions.

No citation risk; for information only.

4.C.8 Head of bed is elevated at an angle of 30--45 degrees, in the C Yes c Yes absence of medical contraindication(s), for patients at high risk for aspiration (e.g., a person receiving mechanically \No (' No assisted ventilaf1on and/or who has an enteral tube in place). i

If no to 4.C.8, cite at 42 CFR 482.42(a) (Tag A-0749)

35 ,~~~~~~~~~~~~~~~~----~~~~~~~~~~~~~~~~~--~~~~~--~~~--~~~~~

Ventilators: · ...·. ,· .. ..•.... ,.·.·.·..···· ...... ' . .. ·. . ' ' .,.. '. ·., . ' cc:·, .. · '

,. ·.·. · .. ·.. ··'· ,.,·, .. . ' ·.·... ..·,,' ' .· .··.. · · ......' ..... ·,. ' . ...,... ' .· . ·.·.··, ' '.·· ....... . '·•·.·, .... ·,•. Ventilators are used in a manner consistent with hospital infection control policies and procedures to maximize the prevention of infection and communicable disease including the following: If no observations available, skip questions 4.C.9 through 4.C.13. (' No observations available (If selected, ALL 0 Second observation not available (If selected, questions from 4.C.9 -4.C.15 will be blocked) questions 4.C.9- 4.C.15 RIGHT column will be blocked) 4.C.9 Ventilator circuit (i.e., ventilator tubing and exhalation valve (' Yes (' Yes and the attached humidifier) is changed if visibly soiled or mechanically malfunctioning. \No ('No

l Unable to ('Unable to observe observe

4.C.10 Steri e water is used to fill humidifiers. c Yes ( Yes

(' No ('No

4.C.11 Condensate that collects in the tubing of a mechanical (' Yes . ( Yes ventilator is periodically drained and discarded, taking precautions not to allow condensate to drain toward the patient. (' No ('No

(' Unable to ('Unable to observe observe

4.C.12 If single-use open-system suction catheter is employed, a ( Yes ('Yes sterile, single-use catheter is used. (' No C No

(' N/A CN/A

4.C.13 Only sterile fluid is used to remove secretions from the (' Yes r Yes suction catheter if the catheter is used for re-entry into the I I patient's lower respiratory tract. (' No ('No

('Unable to tUnable to observe observe

If no to any of 4.C.9 to 4.C.13, cite at 42 CFR 482.42(a) (Tag A-0749) ----

36 ----~-~~~~

4.C.14 Hospital has a program for sedation to be lightened daily in ('Yes ('Yes I eligible patients. \No ('No

4.C.15 Assessment of readiness to wean (e.g., spontaneous ('Yes ('Yes I breathing trials) are performed daily in eligible patients. ('No ('No I I

i

No citation risk for 4.C.14 and 4.C.15; for information only. -----------------

37 ··----·--.. ----· =="" ""'""""

(' No

a catheter or injecting materials into the epidural or subdural space. (' No

If no to any of4.0.1 to 4.0.3, cite at 42 CFR 482.42(a) (Tag A-0749)

38 """""""--··~···~-~-~---~

Note: This includes both the lancet and the lancet holding device. ('No (No

(Unable to (Unable to observe observe

device (e.g., blood glucose meter, INR monitor) is cleaned and disinfected after every use according to manufacturer's (' No (' No instructions. tN/A (' N/A Note: if manufacturer does not provide instructions for cleaning and disinfection, then the device should not be used for >1 patient. If no to any of 4.E.l to 4.E.4, cite at 42 CFR 482.42(a) (Tag A-0749)

39 ·.~~-= -~ _, .. ~

elements in multiple patient care areas in the hospital. questions from 4.F.l- 4.F.12 will be blocked) questions 4.F.l- 4.F.12 RIGHT column will be blocked) If unable to observe a patient on Contact Precautions skip elements 4.F.l to 4.F.12.

('No

('No

(' No

C No

environment. (' No C No Note: Soap and water must be used when bare hands are visibly soiled (e.g., blood, body fluids) or after caring for a patient with known or suspected C. difficife or norovirus during an outbreak. In all other situations, alcohol-based hand rub is preferred.

40 4.F.6 Gloves and gowns are donned upon entry into the room or (' Yes (' Yes cubicle. ' C No (' No

4.F.7 Gloves and gowns are removed and discarded, and hand ( Yes (' Yes hygiene is performed before leaving the patient care environment. C No ('No

4.F.8 Dedicated or disposable noncritical patient-care equipment (' Yes ( Yes (e.g., blood pressure cuffs) is used, or if not available, then equipment is cleaned and disinfected prior to use on another C No ('No

patient according to manufacturers' instructions.

4.F.9 The hospital limits the movement of patients on Contact ( Yes { Yes Precautions outside of their room to medically necessary purposes only. (' No C No

C Unable to ('Unable to observe observe

4.F.10 If a patient on Contact Precautions must leave their room for { Yes (' Yes medically necessary purposes, there are methods followed to communicate that patient's status and to prevent transmission C No (' No of infectious disease. C Unable to C Unable to observe observe

4.F.11 Objects and environmental surtaces in patient care areas that (' Yes { Yes are touched frequently (e.g., bed rails, overbed table, bedside commode, lavatory surfaces in patient bathrooms) are cleaned C No (' No

and disinfected with an EPA-registered disinfectant frequently C Unable to Cunableto (at least daily) and when visibly soiled. observe observe

4.F.l2 After patient discharge, all visibly or potentially contaminated (' Yes ( Yes surfaces are thoroughly cleaned and disinfected and all textiles (e.g. linens and towels) are replaced with clean textiles. C No C No

('Unable to ('Unable to observe observe

If no to any of 4.F.l to 4.F.12, cite at 42 CFR 482.42(a) (Tag A-0749) -------------------

41 questions from 4.G.2- 4.G.9 will be blocked) questions 4.G.2- 4.G.9 RIGHT column will be blocked) If unable to observe a patient on Droplet Precautions, skip elements 4.G.2 to 4.G.9. use.

environment or private room. (' No C No

42 ----------~---~"~--~~·-· -·~---~--·--·-~-----~-~-~--·--~---------------""C"-------------------------------

4.G.7 Facemask is removed and discarded and hand hygiene is ( Yes (' Yes performed upon leaving the patient care environment. ('No (' No

4.G.8 The hospital limits movement of patients on Droplet ( Yes ('Yes Precautions outside of their rooms to medically necessary purposes only. (' No (' No

Cunableto ('Unable to observe observe

4.G.9 If a patient on Droplet Precautions must leave their room for ( Yes ( Yes medically necessary purposes, there are methods followed to communicate that patient's status and to prevent transmission (' No (' No of infectious disease, including the use of a facemask by the patient if possible. ('Unable to ('Unable to observe observe Note: The hospital may have specific policies regarding the use of PPE for pediatric patients.

If no to any of 4.G.l to 4.G.9, cite at 42 CFR 482.42(a) [rag A·0749)

43 ----

transmitted person-to-person by the airborne route (e.g.J TB, measles, chickenpox, disseminated herpes zoster) are placed on C No Airborne Isolation Precautions.

Precautions elements in multiple patient care areas in the hospital.

If unable to observe a patient on Airborne Isolation Precautions, skip elements 4.H.2 to 4.H.8.

available and located near point of use. C No ('No

are dear and visible. (No C No

wear a or higher) when entering the airborne infection isolation room (AIIR) for patients with confirmed or suspected TB. Hospital ('No ('No policies are followed for other pathogens requiring AIIR.

44 ·--------------~·~ --~-~·-·----~-~·---- --------

4.H.S Hand hygiene is performed before contact with the patient. ( Yes ( Yes

(' No (' No

4.H.6 Patients on Airborne Precautions are housed in AIIR that meet J Yes (.Yes all of the following specifications: . At least 6 (existing facility) or 12 (new construction/renovation) (' No (' No air changes per hour or per state licensure rules; . Direct exhaust of air to outside. If not possible, all air returned to air handling system or adjacent spaces is directed through HEPA filters; . When AIIR is in use for a patient on Airborne Precautions, air pressure is monitored daily with visual indicators (e.g., smoke tubes.. flutter strips), regardless of the presence of differential pressure sensing devices (e.g., manometers); . AIIR door kept dosed when not required for entry and exit

Note: If AIIR is not available, hospital policy should address patient transfer to a hospital that has an available AIIR.

4.H.7 The hospital limits movement of patients on Airborne c· Yes I c Yes I •

Precautions outside of their room to medically-necessary i purposes. ('No (' No I i (' Unable to C Unable to i ! observe observe

4.H.8 If a patient on Airborne Precautions must leave their room for ( Yes (' Yes medically necessary purposes, there are methods followed to communicate that patient's status and to prevent transmission C No (' No of infectious disease, including the use of a facemask by the patient if possible. (' Unable to Cunableto observe observe Note: The hospital may have specific policies regarding the use of PPE for pediatric patients.

If no to any of 4.H.l to 4.H.8, cite at 42 CFR 482.42(a) (Tag A-0749)

45 -- -- --·-~ ---·-~---- --- - -

sterile gloves for surgical procedures {in OR) using either an antimicrobial surgical scrub agent or an FDA-approved alcohol- C No (' No based antiseptic surgical hand rub. C Unable to Cunableto Note: If visibly soiled, hands and forearms should be prewashed with observe observe soap and water before using an alcohol-based antiseptic surgical hand rub. arms are towel (if applicable), and sterile surgical gown and gloves are donned in the OR. C No C No

C Unable to C Unable to observe observe

head and facial hair are worn by all personnel and visitors in semi restricted and restricted areas. C No C No Note: Restricted area includes DRs, procedure rooms, and the clean core (sterile supply) area. The semi restricted area includes the peripheral support areas of the surgical suite.

personnel in restricted areas where open sterile supplies or scrubbed personnel are located. C No C No

46 -- - - -------

4.1.5 A rresn, clean surgical masK is worn ror every proceoure. ( Yes (' Yes

(' No (' No

('Unable to ('Unable to observe observe

4.1.6 Sterile drapes are used to establish sterile field. ('Yes ( Yes

(' No (' No

('Unable to (Unable to observe observe

4.1.7 Sterile field is maintained and monitored constantly. Ensure (' Yes 1 ( Yes that: • Items used within sterile field are sterile . (No (' No

• Items introduced into sterile field are opened, dispensed, and (' Unable to ('Unable to transferred in a manner to maintain sterility. observe observe • Sterile field is prepared in the location where it will be used and as close as possible to time of use. • Movement in or around sterile field is done in a manner to maintain sterility.

4.1.8 Traffic in and out of OR is kept to minimum and limited to ( Yes (' Yes essential personnel. . C No C No

•

If no to any of 4.1.1 to 4.1.8, cite at 42 CFR 482.42(a) (Tag A-0749)

47 Processes ensuring infection control in the OR are accomplished in a manner consistent with hospital infection control policies and procedures to maximize the prevention of infection and communicable disease including the following:

If the hospital does not provide any surgical services, skip 4.1.9 ( No surgical services (If selectedJ questions 4.1.9 4.1.17 will be blocked) through 4.1.17. 4.1.9 Cleaners and EPA-registered hospital disinfectants are used and ('Yes dated in accordance with hospital policies and procedures and manufacturer's instructions (e.g., dilution, storage, shelf-life, (' No contact time). ('Unable to Note: The cleaners and disinfectants can be dated by the hospital observe with either the date opened or the discard date as per hospital policy, as long as it is clear what the date represents and the same policy is used consistently throughout the hospital.

4.1.10 All horizontal surfaces (e.g., furniture, surgical lights, booms, ('Yes equipment) are damp dusted before the first procedure of the day using a dean, lint-free cloth and EPA-registered hospital l No detergent/disinfectant. l Unable to observe

4.1.11 High touch environmental surfaces are Cleaned and ( Yes disinfected between patients. (' No

('Unable to observe

4.1.12 ORs are terminally cteaned alter last proceoure or tne oay ('Yes {including weekends) and each 24-hour period during regular work week. Terminal cleaning includes wet-vacuuming or (' No mopping floor with an EPA-registered disinfectant. tUnable to observe

48 ---------------------------------------------------------

4.1.13 Anesthesia equipment surfaces that are touched by personnel ('Yes while providing patient care or while handling contaminated items are cleaned and low-level disinfected between use on (' No patients, according to manufacturers' instructions. ('Unable to observe

4.1.14 Exterior surfaces of anesthesia equipment that are not l: Yes knowingly contaminated during patient care are terminally low- level disinfected at the end of the day, according to (' No manufacturers' instructions. ('Unable to observe

4.1.15 Internal components of the anesthesia machine breathing ( Yes circuit are cleaned per hospital policy or manufacturer's instructions. ('No

[Unable to observe

4.1.16 Reusable noncritical items (e.g., blood pressure cuffs, ECG (' Yes leads, tourniquets, oximeter probes) are cleaned and disinfected between patients. C No

('Unable to observe

4.1.17 Ventilation requirements meet the tollowmg: ('Yes • Positive pressure, ~15 air exchanges per hour (at least 3 of which are fresh air) (' No

• 90% filtration (HEPA is optional), air filters checked regularly and replaced according to hospital policies and procedures • Temperature and relative humidity levels are maintained at required levels • Doors are self-closing

• Air vents and grill work are clean and dry .

If no to any of 4.1.9 to 4.1.17, cite at 42 CFR 482.42(a) (Tag A-0749)

49 APPENDIX- ''13'' Guideline lor Disinfection and StmiliznHon in Healtrtcaro Facilities, 2008

Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

William A Rutala, Ph.D., M.P.HY, David J. Weber, M.D., M.P.H. 1 •2, and the Healthcare

Infection Control Practices Advisory Committee (HICPAC) 3

1 Hospital Epidemiology University of North Carolina Health Care System Chapel Hill, NC 27514 2 Division of Infectious Diseases University of North Carolina School of Medicine Chapel Hill, NC 27599-7030 C?uidelinc for Dtsintection and Sterilization in Hoolthcnro Faci!\ties, 2008

3HICPAC Members

Robert A Weinstein, MD (Chair) Cook County Hospital Chicago, JL

Jane D. Siegel, MD (Co-Chair) University ofTexas Southwestern Medical Center Dallas, TX

Michele L. Pearson, MD (Executive Secretary) Centers for Disease Control and Prevention Atlanta, GA

Raymond Y.W. Chinn, MD Sharp Memorial Hospital San Diego, CA

Alfred DeMaria, Jr, MD Massachusetts Department of Public Health Jamaica Plain, MA

James T. Lee, MD, PhD University of Minnesota Minneapolis, MN

William A Rutala, PhD, MPH University of North Carolina Health Care System Chapel Hill, NC

William E. Scheckler, MD University of Wisconsin Madison, WI

Beth H. Stover, RN Kosair Children's Hospital Louisville, KY

Marjorie A Underwood, RN, BSN CIC Mt. Diablo Medical Center Concord, CA

This guideline discusses use of products by healthcare personnel in healthcare settings such as hospitals, ambulatory care and home care; the recommendations are not intended for consumer use of the products discussed.

2 Guideline ·for Dis!nfc~ction and Stori!izstion in He8!thcnce Ft;\d!:ties, 2008

Disinfection and Sterilization in Healthcare Facilities

Executive Summary Introduction Methods Definition ofTerms Approach to Disinfection and Sterllization Critical Items Semi critical Items Noncritical Items Changes in Disinfection and Sterilization Since 1981 Disinfection of Healthcare Equipment Concerns with Implementing the Spaulding Scheme Reprocessing of Endoscopes Laparoscopes and Arthroscopes Tonometers, Cervical Diaphragm Fitting Rings, Cryosurgical Instruments, Endocavitary Probes Dental Instruments Disinfection of HBV, HCV, HIV or Tuberculosis-Contaminated Devices Disinfection in the Hemodialysis Unit Inactivation of Clostridium difficile OSHA Bloodborne Pathogen Standard Emerging Pathogens (Cryptosporidium, Helicobacter pylori, E. coli 0157:H7, Rotavirus, Human Papilloma Virus, Norovirus, Severe Acute Respiratory Syndrome Coronavirus) Inactivation of Bioterrorist Agents Toxicological, Environmental, and Occupational Concerns Disinfection in Ambulatory Care, Home Care, and the Home Susceptibility of Antibiotic-Resistant Bacteria to Disinfectants Surface Disinfection: Should We Do It? Contact Time for Surface Disinfectants Air Disinfection Microbial Contamination of Disinfectants Factors Affecting the Efficacy of Disinfection and Sterilization Number and Location of Microorganisms Innate Resistance of Microorganisms Concentration and Potency of Disinfectants Physical and Chemical Factors Organic and Inorganic Matter Duration of Exposure Biofilms Cleaning Disinfection Chemical Disinfectants Alcohol Overview Mode of Action Microbicidal Activity Uses Chlorine and Chlorine Compounds Overview Mode of Action Microbicidal Activity

3 Guido!ine for Disinfection and S!nH!ization in Hea!th~are rm~i!itios, 2008

Uses Formaldehyde Overview Mode of Action Microbicidal Activity Uses Glutaraldehyde Overview Mode of Action Microbicidal Activity Uses Hydrogen Peroxide Overview Mode of Action Microbicidal Activity Uses lodophors Overview Mode of Action Microbicidal Activity Uses Ortho-phthalaldehyde Overview Mode of Action Microbicidal Activity Uses Peracetic Acid Overview Mode of Action Microbicidal Activity Uses Peracetic Acid and Hydrogen Peroxide Overview Mode of Action Microbicidal Activity Uses Phenolics Overview Mode of Action Microbicidal Activity Uses Quaternary Ammonium Compounds Overview Mode of Action Microbicidal Activity Uses Miscellaneous Inactivating Agents Other Germicides Ultraviolet Radiation Pasteurization Flushing- and Washer-Disinfectors Regulatory Framework for Disinfectants and Sterilants Neutralization of Germicides

4 CJuidc:!ine for Disinfection and SteHiizahon ln Hocllthccwe F acilitios, 2008

Sterilization Steam Sterilization Overview Mode of Action Microbicidal Activity Uses Flash Sterilization Overview Uses Low-Temperature Sterilization Technologies Ethylene Oxide "Gas" Sterilization Overview Mode of Action Microbicidal Activity Uses Hydrogen Peroxide Gas Plasma Overview Mode of Action Microbicidal Activity Uses Peracetic Acid Sterilization Overview Mode of Action Microbicidal Activity Uses Microbicidal Activity of Low-Temperature Sterilization Technology Bioburden of Surgical Devices Effect of Cleaning on Sterilization Efficacy other Sterilization Methods Ionizing Radiation Dry-Heat Sterilizers Liquid Chemicals Performic Acid Filtration Microwave Glass Bead "Sterilizer" Vaporized Hydrogen Peroxide Ozone Formaldehyde Steam Gaseous Chlorine Dioxide Vaporized Peracetic Acid Infrared radiation Sterilizing Practices Overview Sterilization Cycle Validation Physical Facilities Cleaning Packaging Loading Storage Monitoring (Mechanical, Chemical, Biological Indicators) Reuse of Single-Use Medical Devices Conclusion

5 Cuidclino for Disinfrc1Ction cnd Sterilization in Hc

Web-Based Disinfection and Sterilization Resources Recommendations (Category lA, IB, IC, II) Performance Indicators Acknowledgements Glossary Tables and Figure References

6 Guideline lor Disinleelion mKJ Ste1ilization in Henlt11cmn Facilities, ?008

EXECUTIVE SUMMARY

The Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, presents evidence- based recommendations on the preferred methods for cleaning, disinfection and sterilization of patient- care medical devices and for cleaning and disinfecting the healthcare environment. This document supercedes the relevant sections contained in the 1985 Centers for Disease Control (CDC) Guideline for Handwashing and Environmental Control. 1 Because maximum effectiveness from disinfection and sterilization results from first cleaning and removing organic and inorganic materials, this document also reviews cleaning methods. The chemical disinfectants discussed for patient-care equipment include alcohols, glutaraldehyde, formaldehyde, hydrogen peroxide, iodophors, ortho-phthalaldehyde, peracetic acid, phenolics, quaternary ammonium compounds, and chlorine. The choice of disinfectant, concentration, and exposure time is based on the risk for infection associated with use of the equipment and other factors discussed in this guideline. The sterilization methods discussed include steam sterilization, ethylene oxide (ETO), hydrogen peroxide gas plasma, and liquid peracetic acid. When properly used, these cleaning, disinfection, and sterilization processes can reduce the risk for infection associated with use of invasive and noninvasive medical and surgical devices. However, for these processes to be effective, health-care workers should adhere strictly to the cleaning, disinfection, and sterilization recommendations in this document and to instructions on product labels. In addition to updated recommendations, new topics addressed in this guideline include 1) inactivation of antibiotic-resistant bacteria, bioterrorist agents, emerging pathogens, and bloodborne pathogens; 2) toxicologic, environmental, and occupational concerns associated with disinfection and sterilization practices; 3) disinfection of patient-care equipment used in ambulatory settings and home care; 4) new sterilization processes, such as hydrogen peroxide gas plasma and liquid peracetic acid; and 5) disinfection of complex medical instruments (e.g., endoscopes).

7 Guideline for Dis!nfect.ion and E'lteri!i:z.ntinn ln !1ealthG1H.J F:<~cilitics, 2008

INTRODUCTION

In the United States, approximately 46.5 million surgical procedures and even more invasive medical procedures-including approximately 5 million gastrointestinal endoscopies-are performed each year. 2 Each procedure involves contact by a medical device or surgical instrument with a patient's sterile tissue or mucous membranes. A major risk of all such procedures is the introduction of pathogens that can lead to infection. Failure to properly disinfect or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person transmission (e.g., hepatitis B virus) and transmission of environmental pathogens (e.g., Pseudomonas aeruginosa).

Disinfection and sterilization are essential for ensuring that medical and surgical instruments do not transmit infectious pathogens to patients. Because sterilization of all patient-care items is not necessary, health-care policies must identify, primarily on the basis of the items' intended use, whether cleaning, disinfection, or sterilization is indicated.

Multiple studies in many countries have documented lack of compliance with established 36 guidelines for disinfection and sterilization. ' Failure to comply with scientifically-based guidelines has 6 12 led to numerous outbreaks. ' This guideline presents a pragmatic approach to the judicious selection and proper use of disinfection and sterilization processes; the approach is based on well-designed studies assessing the efficacy (through laboratory investigations) and effectiveness (through clinical studies) of disinfection and sterilization procedures.

METHODS

This guideline resulted from a review of all MEDLINE articles in English listed under the MeSH headings of disinfection or sterilization (focusing on health-care equipment and supplies) from January 1980 through August 2006. References listed in these articles also were reviewed. Selected articles published before 1980 were reviewed and, if still relevant, included in the guideline. The three major peer- reviewed journals in infection control-American Journal of Infection Control, Infection Control and Hospital Epidemiology, and Journal of Hospital Infection-were searched for relevant articles published from January 1990 through August 2006. Abstracts presented at the annual meetings of the Society for Healthcare Epidemiology of America and Association for professionals in Infection Control and Epidemiology, Inc. during 1997-2006 also were reviewed; however, abstracts were not used to support the recommendations.

DEFINITION OF TERMS

Sterilization describes a process that destroys or eliminates all forms of microbial life and is carried out in health-care facilities by physical or chemical methods. Steam under pressure, dry heat, EtO gas, hydrogen peroxide gas plasma, and liquid chemicals are the principal sterilizing agents used in health-care facilities. Sterilization is intended to convey an absolute meaning; unfortunately, however, some health professionals and the technical and commercial literature refer to "disinfection" as "sterilization" and items as "partially sterile." When chemicals are used to destroy all forms of microbiologic life, they can be called chemical sterilants. These same germicides used for shorter exposure periods also can be part of the disinfection process (i.e., high-level disinfection).

Disinfection describes a process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects (Tables 1 and 2). In health-care settings, objects usually are disinfected by liquid chemicals or wet pasteurization. Each of the various factors that affect the efficacy of

8 GuideHne tor Dlsinfection and Steri!izaHon in HealthcBrn Fnci!ities, 2008

disinfection can nullify or limit the efficacy of the process. Factors that affect the efficacy of both disinfection and sterilization include prior cleaning of the object; organic and inorganic load present; type and level of microbial contamination; concentration of and exposure time to the germicide; physical nature of the object (e.g., crevices, hinges, and lumens); presence of biofilms; temperature and pH of the disinfection process; and in some cases, relative humidity of the sterilization process (e.g., ethylene oxide).

Unlike sterilization, disinfection is not sporicidal. A few disinfectants will kill spores with prolonged exposure times (3-12 hours); these are called chemical sterilants. At similar concentrations but with shorter exposure periods (e.g., 20 minutes for 2% glutaraldehyde), these same disinfectants will kill all microorganisms except large numbers of bacterial spores; they are called high-level disinfectants. Low- level disinfectants can kill most vegetative bacteria, some fungi, and some viruses in a practical period of time ~1 0 minutes). Intermediate-level disinfectants might be cidal for mycobacteria, vegetative bacteria, most viruses, and most fungi but do not necessarily kill bacterial spores. Germicides differ markedly, primarily in their antimicrobial spectrum and rapidity of action.

Cleaning is the removal of visible soil (e.g., organic and inorganic material) from objects and surfaces and normally is accomplished manually or mechanically using water with detergents or enzymatic products. Thorough cleaning is essential before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes. Decontamination removes pathogenic microorganisms from objects so they are safe to handle, use, or discard.

Terms with the suffix cide or cidal for killing action also are commonly used. For example, a germicide is an agent that can kill microorganisms, particularly pathogenic organisms ("germs"). The term germicide includes both antiseptics and disinfectants. Antiseptics are germicides applied to living tissue and skin; disinfectants are antimicrobials applied only to inanimate objects. In general, antiseptics are used only on the skin and not for surface disinfection, and disinfectants are not used for skin antisepsis because they can injure skin and other tissues. Virucide, fungicide, bactericide, sporicide, and tuberculocide can kill the type of microorganism identified by the prefix. For example, a bactericide is an agent that kills bacteria. 13' 18

9 Guicteline lor Disinfection nnd Stmilizatlon in Hconlt.~cam Fncil!tlos, 2008

A RATIONAL APPROACH TO DISINFECTION AND STERILIZATION

More than 30 years ago, Earle H. Spaulding devised a rational approach to disinfection and sterilization of patient-care items and equipment. 14 This classification scheme is so clear and logical that it has been retained, refined, and successfully used b~ infection control professionals and others when 13 20 planning methods for disinfection or sterilization. 1• • 5 ' 17 ' 19• Spaulding believed the nature of disinfection could be understood readily if instruments and items for patient care were categorized as critical, semi critical, and noncritical according to the degree of risk for infection involved in use of the 21 items. The CDC Guideline for Handwashing and Hospital Environmental Control , Guidelines for the Prevention of Transmission of Human Immunodeficiency Virus (HIV) and Hepatitis 8 Virus (HBV) to Health-Care and Public-Safety Workers", and Guideline for Environmental infection Control in Health- Care Facilities" employ this terminology.

Critical Items Critical items confer a high risk for infection if they are contaminated with any microorganism. Thus, objects that enter sterile tissue or the vascular system must be sterile because any microbial contamination could transmit disease. This category includes surgical instruments, cardiac and urinary catheters, implants, and ultrasound probes used in sterile body cavities. Most of the items in this category should be purchased as sterile or be sterilized with steam if possible. Heat-sensitive objects can be treated with EtO, hydrogen peroxide gas plasma; or if other methods are unsuitable, by liquid chemical sterilants. Germicides categorized as chemical sterilants include :':2.4% glutaraldehyde-based formulations, 0.95% glutaraldehyde with 1.64% phenol/phenate, 7.5% stabilized hydrogen peroxide, 7.35% hydrogen peroxide with 0.23% peracetic acid, 0.2% peracetic acid, and 0.08% peracetic acid with 1.0% hydrogen peroxide. Liquid chemical sterilants reliably produce sterility only if cleaning precedes treatment and if proper guidelines are followed regarding concentration, contact time, temperature, and pH.

Semlcrlticalltems Semicritical items contact mucous membranes or nonintact skin. This category includes 24 respiratory therapy and anesthesia equipment, some endoscopes, laryngoscope blades , esophageal 25 manometry probes, cystoscopes , anorectal manometry catheters, and diaphragm fitting rings. These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible. Intact mucous membranes, such as those of the lungs and the gastrointestinal tract, generally are resistant to infection by common bacterial spores but susceptible to other organisms, such as bacteria, mycobacteria, and viruses. Semicritical items minimally require high-level disinfection using chemical disinfectants. Glutaraldehyde, hydrogen peroxide, oliho-phthalaldehyde, and peracetic acid with hydrogen peroxide are cleared by the Food and Drug Administration (FDA) and are dependable high- level disinfectants provided the factors influencing germicidal procedures are met (Table 1). When a disinfectant is selected for use with certain patient-care items, the chemical compatibility after extended use with the items to be disinfected also must be considered.

High-level disinfection traditionally is defined as complete elimination of all microorganisms in or on an instrument, except for small numbers of bacterial spores. The FDA definitron of high-level disinfection is a sterilant used for a shorter contact time to achieve a 6-log 1o kill of an appropriate Mycobacterium species. Cleaning followed by high-level disinfection should eliminate enough pathogens 26 27 to prevent transmission of infection. •

Laparoscopes and arthroscopes entering sterile tissue ideally should be sterilized between patients. However, in the United States, this equipment sometimes undergoes only high-level disinfection 30 between patients. 28' As with flexible endoscopes, these devices can be difficult to clean and high-level disinfect or sterilize because of intricate device design (e.g., long narrow lumens, hinges). Meticulous

10 Guideline for Disinfection and Sterilization in HcnltrJC:IIe Facilttles, 2008

cleaning must precede any high-level disinfection or sterilization process. Although sterilization is preferred, no reports have been published of outbreaks resulting from high-level disinfection of these scopes when they are properly cleaned and high-level disinfected. Newer models of these instruments can withstand steam sterilization that for critical items would be preferable to high-level disinfection.

Rinsing endoscopes and flushing channels with sterile water, filtered water, or tap water will prevent adverse effects associated with disinfectant retained in the endoscope (e.g., disinfectant-induced colitis). Items can be rinsed and flushed using sterile water after high-level disinfection to prevent contamination with organisms in tap water, such as nontuberculous mycobacteria, 10 • 31 · 32 Legionel/a, ,,. 35 1 17 3 38 or gram-negative bacilli such as Pseudomonas. ' • "" Alternatively, a taf.water or filtered water (0.2!1 ° 4 filter) rinse should be followed by an alcohol rinse and forced air drying. 28 ' "' Forced-air drying markedly reduces bacterial contamination of stored endoscopes, most likely by removing the wet 39 environment favorable for bacterial growth. After rinsing, items should be dried and stored (e.g., packaged) in a manner that protects them from recontamination.

Some items that may come in contact with nonintact skin for a brief period of time (i.e., hydrotherapy tanks, bed side rails) are usually considered noncritical surfaces and are disinfected with 23 intermediate-level disinfectants (i.e., phenolic, iodophor, alcohol, chlorine) • Since hydrotherapy tanks have been associated with spread of infection, some facilities have chosen to disinfect them with 23 41 recommended levels of chlorine ' •

In the past, high-level disinfection was recommended for mouthpieces and spirometry tubing ie.g., glutaraldehyde) but cleaning the interior surfaces of the spirometers was considered unnecessary. 2 This was based on a study that showed that mouthpieces and spirometry tubing become contaminated with microorganisms but there was no bacterial contamination of the surfaces inside the spirometers. Filters have been used to prevent contamination of this equipment distal to the filter; such filters and the proximal mouthpiece are changed between patients.

Noncritical Items Noncritical items are those that come in contact with intact skin but not mucous membranes. Intact skin acts as an effective barrier to most microorganisms; therefore, the sterility of items coming in contact with intact skin is "not critical." In this guideline, noncritical items are divided into noncritical 43 44 patient care items and noncritical environmental surfaces ' • Examples of noncritical patient-care items 45 are bedpans, blood pressure cuffs, crutches and computers . In contrast to critical and some semicritical items, most noncritical reusable items may be decontaminated where they are used and do not need to be transported to a central processing area. Virtually no risk has been documented for 37 transmission of infectious agents to patients through noncritical items when they are used as noncritical items and do not contact non-intact skin and/or mucous membranes. Table 1 lists several low-level disinfectants that may be used for noncritical items. Most Environmental Protection Agency (EPA)- registered disinfectants have a 10-minute label claim. However, multiple investigators have demonstrated the effectiveness of these disinfectants against vegetative bacteria (e.g., Listeria, Escherichia coli, Salmonella, vancomycin-resistant Enterococci, methicillin-resistant Staphylococcus aureus), yeasts (e.g., Candida), mycobacteria ~e.p .• Mycobacterium tuberculosis), and viruses (e.g. poliovirus) at exposure times of 30-60 seconds4 _, Federal law requires all applicable label instructions on EPA-registered products to be followed (e.g., use-dilution, shelf life, storage, material compatibility, safe use, and disposal). If the user selects exposure conditions (e.g., exposure time) that differ from those on the EPA- registered products label, the user assumes liability for any injuries resulting from off-label use and is potential~ subject to enforcement action under Federal Insecticide, Fungicide, and Rodenticide Act 5 (FIFRA) .

Noncritcal environmental surfaces include bed rails, some food utensils, bedside tables, patient furniture and floors. Noncritical environmental surfaces frequently touched by hand (e.g., bedside tables,

11 Guideline lor Disinfection ;.md Stedlization in Heolthcnre FacilitiOS, 2008

bed rails) potentially could contribute to secondary transmission by contaminating hands of health-care workers or by contacting medical equipment that subsequently contacts patients 13 • , ..... 51 ' 66 ' 67 • Mops and reusable cleaning cloths are regularly used to achieve low-level disinfection on environmental surfaces. However, they often are not adequately cleaned and disinfected, and if the water-disinfectant mixture is not changed regularly (e.g., after every three to four rooms, at no longer than 50-minute intervals), the mopping procedure actually can spread heavy microbial contamination throughout the 66 health-care facility • In one study, standard laundering provided acceptable decontamination of heavily 68 contaminated mopheads but chemical disinfection with a phenolic was less effective. Frequent laundering of mops (e.g., daily), therefore, is recommended. Single-use disposable towels impregnated with a disinfectant also can be used for low-level disinfection when spot-cleaning of noncritical surfaces is 45 needed •

Changes in Disinfection and Sterilization Since 1981 The Table in the CDC Guideline for Environmental Control prepared in 1981 as a guide to the appropriate selection and use of disinfectants has undergone several important changes (Table 1). 15 First, formaldehyde-alcohol has been deleted as a recommended chemical sterilant or high-level disinfectant because it is irritating and toxic and not commonly used. Second, several new chemical 58 69 70 sterilants have been added, including hydrogen peroxide, peracetic acid ' " , and peracetic acid and hydrogen peroxide in combination. Third, 3% phenolics and iodophors have been deleted as high-level disinfectants because of their unproven efficacy against bacterial spores, M. tuberculosis, and/or some 55 fungi. ' 71 Fourth, isopropyl alcohol and ethyl alcohol have been excluded as high-level disinfectants 15 because of their inability to inactivate bacterial spores and because of the inability of isopropyl alcohol to inactivate hydrophilic viruses (i.e., poliovirus, coxsackie virus). 72 Fifth, a 1:16 dilution of 2.0% glutaraldehyde-7.05% phenol-1.20% sodium phenate (which contained 0.125% glutaraldehyde, 0.440% phenol, and 0.075% sodium phenate when diluted) has been deleted as a high-level disinfectant because this product was removed from the marketplace in December 1991 because of a lack of bactericidal activity in the presence of or~anic matter; a lack of fungicidal, tuberculocidal and sporicidal activity; and reduced virucidal activity. 49 ' 5 ' 56' 71 ' 73.79 Sixth, the exposure time required to achieve high-level disinfection has been changed from 10-30 minutes to 12 minutes or more depending on the FDA-cleared 60 84 label claim and the scientific literature. 27 • 55 • 69• 76• " A glutaraldehyde and an ortho-phthalaldehyde have an FDA-cleared label claim of 5 minutes when used at 35'C and 25'C, respectively, in an automated endoscope reRrocessor with FDA-cleared capability to maintain the solution at the appropriate 5 temperature.

In addition, many new subjects have been added to the guideline. These include inactivation of emerging pathogens, bioterrorist agents, and bloodborne pathogens; toxicologic, environmental, and occupational concerns associated with disinfection and sterilization practices; disinfection of patient-care equipment used in ambulatory and home care; inactivation of antibiotic-resistant bacteria; new sterilization processes, such as hydrogen peroxide gas plasma and liquid peracetic acid; and disinfection of complex medical instruments (e.g., endoscopes).

12 Guideline for Disinft',clion and Sto!'ilizatlon in HOilltllcme Facilities, 2008

DISINFECTION OF HEALTHCARE EQUIPMENT

Concerns about Implementing the Spaulding Scheme One problem with implementing the aforementioned scheme is oversimplification. For example, the scheme does not consider problems with reprocessing of complicated medical equipment that often is heat-sensitive or problems of inactivating certain types of infectious agents (e.g., prions, such as Creutzfeldt-Jakob disease [CJD] agent). Thus, in some situations, choosing a method of disinfection remains difficult, even after consideration of the categories of risk to patients. This is true particularly for a few medical devices (e.g., arthroscopes, laparoscopes) in the critical category because of controversy about whether they should be sterilized or high-level disinfected."· 86 Heat-stable scopes (e.g., many rigid scopes) should be steam sterilized. Some of these items cannot be steam sterilized because they are heat-sensitive; additionally, sterilization using ethylene oxide (EtO) can be too time-consuming for routine use between patients (new technologies, such as hydrogen peroxide gas plasma and peracetic acid reprocessor, provide faster cycle times). However, evidence that sterilization of these items improves patient care by reducing the infection risk is lacking"· 87' 91 • Many newer models of these instruments can withstand steam sterilization, which for critical items is the preferred method.

Another problem with implementing the Spaulding scheme is processing of an instrument in the semicritical category (e.g., endoscope) that would be used in conjunction with a critical instrument that contacts sterile body tissues. For example, is an endoscope used for upper gastrointestinal tract investigation still a semicritical item when used with sterile biopsy forceps or in a patient who is bleeding heavily from esophageal varices? Provided that high-level disinfection is achieved, and all microorganisms except bacterial spores have been removed from the endoscope, the device should not 92 94 represent an infection risk and should remain in the semicritical category ' • Infection with spore- forming bacteria has not been reported from appropriately high-level disinfected endoscopes.

An additional problem with implementation of the Spaulding system is that the optimal contact time for high-level disinfection has not been defined or varies among professional organizations, resulting in different strategies for disinfecting different types of semicritical items (e.g., endoscopes, applanation tonometers, endocavitary transducers, cryosurgical instruments, and diaphragm fitting rings). Until simpler and effective alternatives are identified for device disinfection in clinical settings, following this 1 95 96 guideline, other CDC guidelines ' "· • and FDA-cleared instructions for the liquid chemical sterilantslhigh-level disinfectants would be prudent.

Reprocessing of Endoscopes Physicians use endoscopes to diagnose and treat numerous medical disorders. Even though endoscopes represent a valuable diagnostic and therapeutic tool in modern medicine and the incidence 97 of infection associated with their use reportedly is very low (about 1 in 1.8 million procedures) , more healthcare-associated outbreaks have been linked to contaminated endoscopes than to any other medical device 6' 8 • 12 ' 98 • To prevent the spread of health-care-associated infections, all heat-sensitive endoscopes (e.g., gastrointestinal endoscopes, bronchoscopes, nasopharygoscopes) must be properly cleaned and, at a minimum, subjected to high-level disinfection after each use. High-level disinfection can be expected to destroy all microorganisms, although when high numbers of bacterial spores are present, a few spores might survive.

Because of the types of body cavities they enter, ftexible endoscopes acquire high levels of microbial contamination (bioburden) during each use 99• For example, the bioburden found on ftexible 5 10 gastrointestinal endoscopes after use has ranged from 1 0 colonr, forming units (CFU)Iml to 10 02 CFU/ml, with the highest levels found in the suction channels,_ • The average load on bronchoscopes 4 before cleaning was 6.4x1 0 CFU/ml. Cleaning reduces the level of microbial contamination by 4-6 log 1o 83 103 ' • Using human immunovirus (HIV)-contaminated endoscopes, several investigators have shown that 104 10 cleaning completely eliminates the microbial contamination on the scopes ' '- Similarly, other investigators found that EtO sterilization or so akin~ in 2% glutaraldehyde for 20 minutes was effective 10 only when the device first was properly cleaned •

13 Ciuiddinc for Disinfection and StGiiliJ.ation in llnelthcme h:tcilittcs, 2008

FDA maintains a list of cleared liquid chemical sterilants and high-level disinfectants that can be used to reprocess heat-sensitive medical devices, such as flexible endoscopes (http://www. fda.govlcdrh/ode/germlab.html). At this time, the FDA-cleared and marketed formulations include: ;::2.4% glutaraldehyde, 0.55% ortho-phthalaldehyde (OPA), 0.95% glutaraldehyde with 1.64% phenol/phenate, 7.35% hydrogen peroxide with 0.23% peracetic acid, 1.0% hydrogen peroxide with 85 0.08% peracetic acid, and 7.5% hydrogen peroxide • These products have excellent antimicrobial activity; however, some oxidizing chemicals (e.g., 7.5% hydrogen peroxide, and 1.0% hydrogen peroxide with 0.08% peracetic acid [latter product is no longer marketed]) reportedly have caused cosmetic and functional damage to endoscopes 69• Users should check with device manufacturers for information about germicide compatibility with their device. If the germicide is FDA-cleared, then it is safe when used according to label directions; however, professionals should review the scientific literature for newly available data regarding human safety or materials compatibility. Eto sterilization of flexible endoscopes is infrequent because it requires a lengthy processing and aeration time (e.g., 12 hours) and is a potential hazard to staff and patients. The two products most commonly used for reprocessing endoscopes In the United States are glutaraldehyde and an automated, liquid chemical sterilization process that uses 107 peracetic acid • The American Society for Gastrointestinal Endoscopy (ASGE) recommends glutaraldehyde solutions that do not contain surfactants because the soapy residues of surfactants are 108 difficult to remove during rinsing • orlho-phthalaldehyde has begun to replace glutaraldehyde in many health-care facilities because it has several potential advantages over glutaraldehyde: is not known to irritate the eyes and nasal passages, does not require activation or exposure monitoring, and has a 12- minute high-level disinfection claim in the United States 69 • Disinfectants that are not FDA-cleared and should not be used for reprocessing endoscopes include iodophors, chlorine solutions, alcohols, quaternary ammonium compounds, and phenolics. These solutions might still be in use outside the United States, but their use should be strongly discouraged because of lack of proven efficacy against all microorganisms or materials incompatibility.

FDA clearance of the contact conditions listed on germicide labeling is based on the manufacturer's test results (http://www.fda.gov/cdrhlode/germlab.html). Manufacturers test the product under worst-case conditions for germicide formulation (i.e., minimum recommended concentration of the active ingredient), and include organic soil. Typically manufacturers use 5% serum as the organic soil and hard water as examples of organic and inorganic challenges. The soil represents the organic loading to which the device is exposed during actual use and that would remain on the device in the absence of cleaning. This method ensures that the contact conditions completely eliminate the test mycobacteria 5 6 (e.g., 10 to 10 Mycobacteria tuberculosis in organic soil and dried on a scope) if inoculated in the most difficult areas for the disinfectant to penetrate and contact in the absence of cleaning and thus provides a 109 margin of safety • For 2.4% glutaraldehyde that requires a 45-minute immersion at 25'c to achieve high-level disinfection (i.e., 100% kill of M. tuberculosis). FDA itself does not conduct testing but relies solely on the disinfectant manufacturer's data. Data suggest that M. tuberculosis levels can be reduced 83 101 102 110 by at least 8 log 10 with cleaning (4 log 10) • • • , followed by chemical disinfection for 20 minutes at 83 93 111 112 113 20'C (4 to 6 log 10) ' • ' • On the basis of these data, APIC , the Society of Gastroenterology 38 114 115 106 12 Nurses and Associates (SGNA) ' • , the ASGE , American College of Chest Physicians , and a 116 multi-society guideline recommend alternative contact conditions with 2% glutaraldehyde to achieve high-level disinfection (e.g., that equipment be immersed in 2% glutaraldehyde at 20'C for at least 20 minutes for high-level disinfection). Federal regulations are to follow the FDA-cleared label claim for high- level disinfectants. The FDA-cleared labels for high-level disinfection with >2% glutaraldehyde at 25'C range from 20-90 minutes, depending upon the product based on three tier testing which includes AOAC sporicidal tests, simulated use testing with mycobacterial and in-use testing. The studies supporting the efficacy of >2% glutaraldehyde for 20 minutes at 20'C assume adequate cleaning prior to disinfection, whereas the FDA-cleared label claim incorporates an added margin of safety to accommodate possible lapses in cleaning practices. Facilities that have chosen to apply the 20 minute duration at 20'C have done so based on the lA recommendation in the July 2003 SHEA position paper, "Multi-society Guideline 57 83 94 106 111 116 121 for Reprocessing Flexible Gastrointestinal Endoscopes" 19 • • • • • • ' •

14 Guideline for Di~;infcct.ion and SterHi.%ntion in Heu!tltcarn r·nd!ititSs, 2008

122 Flexible endoscopes are particularly difficult to disinfect and easy to damage because of their 123 intricate design and delicate materials. Meticulous cleaning must precede any sterilization or high- level disinfection of these instruments. Failure to perform good cleaning can result in sterilization or disinfection failure, and outbreaks of infection can occur. Several studies have demonstrated the 106 124 125 importance of cleaning in experimental studies with the duck hepatitis B virus (HBV) · , HIV and 126 He/icobacter pylori.

An examination of health-care-associated infections related only to endoscopes through July 1992 found 281 infections transmitted by gastrointestinal endoscopy and 96 transmitted by bronchoscopy. The clinical spectrum ranged from asymptomatic colonization to death. Salmonella species and Pseudomonas aeruginosa repeatedly were identified as causative agents of infections transmitted by gastrointestinal endoscopy, and M. tuberculosis, atypical mycobacteria, and P. aeruginosa 12 were the most common causes of infections transmitted by bronchoscopy • Major reasons for transmission were inadequate cleaning, improper selection of a disinfecting agent, and failure to follow 8 recommended cleaning and disinfection procedures'· ' 37 • 98 , and flaws in endoscope design 127 • 128 or 7 98 automated endoscope reprocessors. ' Failure to follow established guidelines has continued to result in infections associated with gastrointestinal endoscopes 8 and bronchoscopes 7• 12 • Potential device- associated problems should be reported to the FDA Center for Devices and Radiologic Health. One multi state investigation found that 23.9% of the bacterial cultures from the internal channels of 71 gastrointestinal endoscopes grew <:1 00,000 colonies of bacteria after completion of all disinfection and sterilization procedures (nine of 25 facilities were using a product that has been removed from the marketplace [six facilities using 1:16 glutaraldehyde phenate], is not FDA-cleared as a high-level disinfectant [an iodophor] or no disinfecting agent) and before use on the next patient"'. The incidence of postendoscopic procedure infections from an improperly processed endoscope has not been rigorously assessed.

Automated endoscope reprocessors (AER) offer several advanta~es over manual reprocessing: they automate and standardize several important reprocessing steps 130' 13 , reduce the likelihood that an essential reprocessing step will be skipped, and reduce personnel exposure to hi~h-level disinfectants or 134 chemical sterilants. Failure of AERs has been linked to outbreaks of infections 13 or colonization 7• , and the AER water filtration system might not be able to reliably provide "sterile" or bacteria-free rinse 135 136 water ' • Establishment of correct connectors between the AER and the device is critical to ensure 137 complete flow of disinfectants and rinse water 7• • In addition, some endoscopes such as the duodenoscopes (e.g., endoscopic retrograde cholangiopancreatography [ERCP]) contain features (e.g., elevator-wire channel) that require a flushing pressure that is not achieved by most AERs and must be reprocessed manually using a 2- to 5-ml syringe, until new duodenoscopes equipped with a wider elevator-channel that AERs can reliably reprocess become available 132 . Outbreaks involving removable 139 endoscope parts 138 • such as suction valves and endoscopic accessories designed to be inserted through flexible endoscopes such as biopsy forceps emphasize the importance of cleaning to remove all 140 foreign matter before high-level disinfection or sterilization. Some types of valves are now available as single-use, disposable products (e.g., bronchoscope valves) or steam sterilizable products (e.g., gastrointestinal endoscope valves). 7 123 142 AERs need further development and redesign • 141 , as do endoscopes ' , so that they do not represent a potential source of infectious agents. Endoscopes employing disposable components (e.g., protective barrier devices or sheaths) might provide an alternative to conventional liquid chemical high- 143 144 level disinfection/sterilization ' . Another new technology is a swallowable camera-in-a-capsule that travels through the digestive tract and transmits color pictures of the small intestine to a receiver worn outside the body. This capsule currently does not replace colonoscopies.

Published recommendations for cleaning and disinfecting endoscopic equipment should be 38 108 113 14 148 strictly followed 12 • • • ' 116• '- • Unfortunately, audits have shown that personnel do not consistently 149 151 152 adhere to guidelines on reprocessing ' and outbreaks of infection continue to occur. ' 154 To ensure

15 Guideline for D:sinfection and Sturilization in Hon!thcme Facilit:os, 2008

reprocessing personnel are properly trained, each person who reprocesses endoscopic instruments should receive initial and annual competency testing 38 • 155 •

In general, endoscope disinfection or sterilization with a liquid chemical sterilant involves five steps after leak testing:

1. Clean: mechanically clean internal and external surfaces, including brushing internal channels and flushing each internal channel with water and a detergent or enzymatic cleaners (leak testing is recommended for endoscopes before immersion). 2. Disinfect: immerse endoscope in high-level disinfectant (or chemical sterilant) and perfuse (eliminates air pockets and ensures contact of the germicide with the internal channels) disinfectant into all accessible channels, such as the suction/biopsy channel and air/water channel and expose for a time recommended for specific products. 3. Rinse: rinse the endoscope and all channels with sterile water, filtered water (commonly used with AERs) or tap water (i.e., high-quality potable water that meets federal clean water standards at the point of use). 4. Dry: rinse the insertion tube and inner channels with alcohol, and dry with forced air after disinfection and before storage.

Store: store the endoscope in a way that prevents recontamination and promotes drying (e.g., hung vertically). Drying the endoscope (steps 3 and 4) is essential to greatly reduce the chance of 116 156 recontamination of the endoscope by microorganisms that can be present in the rinse water " • One study demonstrated that reprocessed endoscopes (i.e., air/water channel, suction/biopsy channel) generally were negative (100% after 24 hours; 90% after 7 days [1 CFU of coagulase-negative Staphylococcus in one channel]) for bacterial growth when stored by hanging vertically in a ventilated 157 cabinet . Other investigators found all endoscopes were bacteria-free immediately after high-level disinfection, and only four of 135 scopes were positive during the subsequent 5-day assessment (skin bacteria cultured from endoscope surfaces). All ftush-through samples remained sterile 158 • Because 159 tapwater can contain low levels of microorganisms , some researchers have suggested that only sterile 160 water (which can be prohibitively expensive) or AER filtered water be used. The suggestion to use only sterile water or filtered water is not consistent with published guidelines that allow tapwater with an 38 108 113 93 alcohol rinse and forced air-drying " • or the scientific literature. 39• In addition, no evidence of disease transmission has been found when a tap water rinse is followed by an alcohol rinse and forced- air drying. AERs produce filtered water by passage through a bacterial filter (e.g., 0.2 f.l). Filtered rinse water was identified as a source of bacterial contamination in a study that cultured the accessory and suction channels of endoscopes and the internal chambers of AERs during 1996-2001 and reported 8.7% of samples collected during 1996-1998 had bacterial growth, with 54% being Pseudomonas species. After a system of hot water flushing of the piping (6o'c for 60 minutes daily) was introduced, the 161 frequency of positive cultures fell to approximately 2% with only rare isolation of >1 0 CFU/ml • In addition to the endoscope reprocessing steps, a protocol should be developed that ensures the user knows whether an endoscope has been appropriately cleaned and disinfected (e.g., using a room or cabinet for processed endoscopes only) or has not been reprocessed. When users leave endoscopes on movable carts, confusion can result about whether the endoscope has been processed. Although one guideline recommended endoscopes (e.g., duodenoscopes) be reprocessed immediately before use 147 , other guidelines do not require this activity 38 " 108 • 115 and except for the Association of periOperative Registered Nurses (AORN), professional organizations do not recommended that reprocessing be repeated as long as the original processing is done correctly. As part of a quality assurance program, healthcare facility personnel can consider random bacterial surveillance cultures of processed endoscopes to ensure high-level disinfection or sterilization'·"'-"' . Reprocessed endoscopes should be free of microbial pathogens except for small numbers of relatively avirulent microbes that represent exogenous environmental contamination (e.g., coagulase-negative Staphylococcus, Bacillus species, diphtheroids). Although recommendations exist for the final rinse water used during endoscope 165 reprocessing to be microbiologically cultured at least monthly , a microbiologic standard has not been

16 Guid01ina for Disinfection Qnti Stedltzation in Healfhcmnlacil;ties, 200/l

166 set, and the value of routine endoscope cultures has not been shown . In addition, neither the routine culture of reprocessed endoscopes nor the final rinse water has been validated by correlating viable counts on an endoscope to infection after an endoscopic procedure. If reprocessed endoscopes were cultured, sampling the endoscope would assess water quality and other important steps (e.g., disinfectant effectiveness, exposure time, cleaning) in the rep,rocessin~ procedure. A number of methods for sampling 23 57 161 7 168 endoscopes and water have been described ' ' • 16'· 1 ' • Novel approaches \e.g., detection of 170 adenosine triphosphate [ATP]) to evaluate the effectiveness of endoscope cleaning "· or endoscope 171 reprocessing also have been evaluated, but no method has been established as a standard for assessing the outcome of endoscope reprocessing.

The carrying case used to transport clean and reprocessed endoscopes outside the health-care environment should not be used to store an endoscope or to transport the instrument within the health- care facility. A contaminated endoscope should never be placed in the carrying case because the case can also become contaminated. When the endoscope is removed from the case, properly reprocessed, and put back in the case, the case could recontaminate the endoscope. A contaminated carrying case should be discarded (Olympus America, June 2002, written communication).

Infection-control professionals should ensure that institutional policies are consistent with national guidelines and conduct infection-control rounds periodically (e.g., at least annually) in areas where endoscopes are reprocessed to ensure policy compliance. Breaches in policy should be documented and corrective action instituted. In incidents in which endoscopes were not exposed to a high-level disinfection process, patients exposed to potentially contaminated endoscopes have been assessed for possible acquisition of HIV, HBV, and hepatitis C virus (HCV). A 14-step method for managing a failure incident associated with high-level disinfection or sterilization has been described [Rutala WA, 2006 #12512]. The possible transmission of bloodborne and other infectious agents highlights the importance of rigorous 172 173 infection control ' .

Laparoscopes and Arthroscopes Although high-level disinfection appears to be the minimum standard for processing 28 89 90 laparoscopes and arthroscopes between patients ' "· 174 • 175 , this practice continues to be debated ' ' 17 • However, neither side in the high-level disinfection versus sterilization debate has sufficient data on 29 which to base its conclusions. Proponents of high-level disinfection refer to membership surveys or 87 institutional experiences involving more than 117,000 and 10,000 laparoscopic procedures, respectively, that cite a low risk for infection (<0.3%) when high-level disinfection is used for gynecologic laparoscopic equipment. Only one infection in the membership survey was linked to spores. In addition, growth of common skin microorganisms (e.g., Staphylococcus epiderm/dis, diphtheroids) has been documented from the umbilical area even after skin preparation with povidone-iodine and ethyl alcohol. Similar organisms were recovered in some instances from the pelvic serosal surfaces or from the laparoscopic telescop,es, suggesting that the microorganisms probably were carried from the skin into the 78 peritoneal cavity 177 • • Proponents of sterilization focus on the possibility of transmitting infection by spore-forming organisms. Researchers have proposed several reasons why sterility was not necessary for alllaparoscopic equipment: only a limited number of organisms (usually _::10) are introduced into the peritoneal cavity during laparoscopy; minimal damage is done to inner abdominal structures with little devitalized tissue; the peritoneal cavity tolerates small numbers of spore-forming bacteria; equipment is simple to clean and disinfect; surgical sterility is relative; the natural bioburden on rigid lumened devices 179 is low ; and no evidence exists that high-level disinfection instead of sterilization increases the risk for infection 87 • "· 90 . With the advent of laparoscopic cholecystectomy, concern about high-level disinfection is justifiable because the degree of tissue damage and bacterial contamination is greater than with laparoscopic procedures in gynecology. Failure to completely dissemble, clean, and high-level disinfect 180 laparoscope parts has led to infections in patients • Data from one study suggested that disassembly, cleaning, and proper reassembly of laparoscopic equipment used in gynecologic procedures before 181 steam sterilization presents no risk for infection .

17 Guideline for Disinfection nml c)terilization in Henlthcnre I"

As with laparoscopes and other equipment that enter sterile body sites, arthroscopes ideally should be sterilized before used. Older studies demonstrated that these instruments were commonly 28 (57%) only high-level disinfected in the United States ' 86• A later survey (with a response rate of only 5%) reported that high-level disinfection was used by 31% and a sterilization process in the remainder of the health-care facilities" High-level disinfection rather than sterilization presumably has been used because the incidence of infection is low and the few infections identified probably are unrelated to the use of high-level disinfection rather than sterilization. A retrospective study of 12,505 arthroscopic procedures found an infection rate of 0.04% (five infections) when arthroscopes were soaked in 2% glutaraldehyde for 15-20 minutes. Four infections were caused by S. aureus; the fifth was an anaerobic 86 streptococcal infection • Because these organisms are very susceptible to high-level disinfectants, such as 2% glutaraldehyde, the infections most likely originated from the patient's skin. Two cases of Clostridium perfringens arthritis have been reported when the arthroscope was disinfected with 182 183 glutaraldehyde for an exposure time that is not effective against spores • ,

Although only limited data are available, the evidence does not demonstrate that high-level disinfection of arthroscopes and laparoscopes poses an infection risk to the patient. For example, a prospective study that compared the reprocessing of arthroscopes and laparoscopes (per 1,000 procedures) with EtO sterilization to high-level disinfection with glutaraldehyde found no statistically significant difference in infection risk between the two methods (i.e., EtO, 7.5/1,000 procedures; 89 glutaraldehyde, 2.5/1,000 procedures) • Although the debate for high-level disinfection versus sterilization of laparoscopes and arthroscopes will go unsettled until well-designed, randomized clinical 1 trials are published, this guideline should be followed • 17 . That is, laparoscopes, arthroscopes, and other scopes that enter normally sterile tissue should be sterilized before each use; if this is not feasible, they should receive at least high-level disinfection.

Tonometers, Cervical Diaphragm Fitting Rings, Cryosurgical instruments, and Endocavitary Probes Disinfection strategies vary widely for other semicritical items (e.g., applanation tonometers, rectal/vaginal probes, cryosurgical instruments, and diaphragm fitting rings). FDA requests that device manufacturers include at least one validated cleaning and disinfection/sterilization protocol in the labeling for their devices. As with all medications and devices, users should be familiar with the label instructions. One study revealed that no uniform technique was in use for disinfection of applanation tonometers, with 28 disinfectant contact times varying from <15 sec to 20 minutes • In view of the potential for transmission 184 of viruses (e.g., herpes simplex virus [HSV], adenovirus 8, or HIV) by tonometer tips, CDC recommended that the tonometer tips be wiped clean and disinfected for 5-10 minutes with either 3% 95 hydrogen peroxide, 5000 ppm chlorine, 70% ethyl alcohol, or 70% isopropyl alcohol • However, more recent data suggest that 3% hydrogen peroxide and 70% isopropyl alcohol are not effective against adenovirus capable of causing epidemic keratoconjunctivitis and similar viruses and should not be used 49 185 for disinfecting applanation tonometers ' ' 186 . Structural damage to Schiotz tonometers has been 197 observed with a 1:10 sodium hypochlorite (5,000 ppm chlorine) and 3% hydrogen peroxide • After disinfection, the tonometer should be thoroughly rinsed in tapwater and air dried before use. Although these disinfectants and exposure times should kill pathogens that can infect the eyes, no studies directly 189 support this 188 ' . The guidelines of the American Academy of Ophthalmology for preventing infections 190 in ophthalmology focus on only one potential pathogen: HIV. Because a short and simple decontamination procedure is desirable in the clinical setting, swabbing the tonometer tip with a 70% 199 isopropyl alcohol wipe sometimes is practiced. Preliminary reports suggest that wiping the tonometer tip with an alcohol swab and then allowing the alcohol to evaporate might be effective in eliminating HSV, 199 191 192 HIV, and adenovirus • • • However, because these studies involved only a few replicates and were conducted in a controlled laboratory setting, further studies are needed before this technique can be recommended. In addition, two reports have found that disinfection of pneumotonometer tips between uses with a 70% isopropyl alcohol wipe contributed to outbreaks of epidemic keratoconjunctivitis caused

18 Guiddinc tor Disinfection ;;;nd SteH!izat1on !n !. !enfthcare r:-·acihtics, 2008

by adenovirus type 8193 ' 194 ,

Limited studies have evaluated disinfection techniques for other items that contact mucous membranes, such as diaphragm fitting rings, cryosurgical probes, transesophageal echocardiography 195 196 probes , flexible cystoscopes or vaginal/rectal probes used in sonographic scanning. Lettau, Bond, and McDougal of CDC supported the recommendation of a diaphragm fitting ring manufacturer that involved using a soap-and-water wash followed by a 15-minute immersion in 70% alcohol 96• This disinfection method should be adequate to inactivate HIV, HBV, and HSV even though alcohols are not classified as high-level disinfectants because their activity against picornaviruses is somewhat limited". No data are available regarding inactivation of human papillomavirus (HPV) by alcohol or other disinfectants because in vitro replication of complete virions has not been achieved. Thus, even though alcohol for 15 minutes should kill pathogens of relevance in gynecology, no clinical studies directly support this practice.

Vaginal probes are used in sonographic scanning. A vaginal probe and all endocavitary probes without a probe cover are semi critical devices because they have direct contact with mucous membranes (e.g., vagina, rectum, pharynx). While use of the probe cover could be considered as changing the category, this guideline proposes use of a new condom/probe cover for the probe for each patient, and because condoms/probe covers can fail 195 ' 197"199 , the probe also should be high-level disinfected. The relevance of this recommendation is reinforced with the findings that sterile transvaginal ultrasound probe covers have a very high rate of perforations even before use (0%, 25%, and 65% perforations from three suppliers). 199 One study found, after oocyte retrieval use, a ver,r high rate of perforations in used endovaginal probe covers from two suppliers (75% and 81%) 19 , other studies demonstrated a lower rate of perforations after use of condoms (2.0% and 0.9%) 197 200 • Condoms have been found superior to commercially available probe covers for covering the ultrasound probe (1.7% for condoms versus 8.3% leakage for probe covers) 201 . These studies underscore the need for routine probe disinfection between examinations. Although most ultrasound manufacturers recommend use of 2% glutaraldehyde for high- level disinfection of contaminated transvaginal transducers, the this agent has been questioned 202 because it might shorten the life of the transducer and might have toxic effects on the gametes and 203 embryos • An alternative procedure for disinfecting the vaginal transducer involves the mechanical removal of the gel from the transducer, cleaning the transducer in soap and water, wiping the transducer with 70% alcohol or soaking it for 2 minutes in 500 ppm chlorine, and rinsing with tap water and air drying 204 • The effectiveness of this and other methods 200 has not been validated in either rigorous laboratory experiments or in clinical use. High-level disinfection with a product (e.g., hydrogen peroxide) that is not toxic to staff, patients, probes, and retrieved cells should be used until the effectiveness of alternative procedures against microbes of importance at the cavitary site is demonstrated by well- designed experimental scientific studies. Other probes such as rectal, cryosurgical, and transesophageal probes or devices also should be high-level disinfected between patients.

Ultrasound probes used during surgical procedures also can contact sterile body sites. These probes can be covered with a sterile sheath to reduce the level of contamination on the probe and reduce the risk for infection. However, because the sheath does not completely protect the probe, the probes should be sterilized between each patient use as with other critical items. If this is not possible, at a minimum the probe should be high-level disinfected and covered with a sterile probe cover.

Some cryosurgical probes are not fully immersible. During reprocessing, the tip of the probe should be immersed in a high-level disinfectant for the appropriate time; any other portion of the probe that could have mucous membrane contact can be disinfected by immersion or by wrapping with a cloth soaked in a high-level disinfectant to allow the recommended contact time. After disinfection, the probe should be rinsed with tap water and dried before use. Health-care facilities that use nonimmersible probes should replace them as soon as possible with fully immersible probes.

As with other high-level disinfection grocedures, proper cleaning of probes is necessary to ensure the success of the subsequent disinfection 2 • One study demonstrated that vegetative bacteria

19 Cluirldtne for Disinfection and ,Stet·f!iz.AUon In Healtilcare Facilities, 2008

inoculated on vaginal ultrasound probes decreased when the probes were cleaned with a towel 206• No information is available about either the level of contamination of such probes by potential viral pathogens such as HBV and HPV or their removal by cleaning (such as with a towel). Because these pathogens might be present in vaginal and rectal secretions and contaminate probes during use, high-level disinfection of the probes after such use is recommended.

Dental Instruments Scientific articles and increased publicity about the potential for transmitting infectious agents in 207 dentistry have focused attention on dental instruments as possible agents for pathogen transmission • 208 • The American Dental Association recommends that surgical and other instruments that normally

penetrate soft tissue or bone (e.g., extraction forceps, scalpel blades, bone chisels, periodontal scalers, and surgical burs) be classified as critical devices that should be sterilized after each use or discarded. Instruments not intended to penetrate oral soft tissues or bone (e.g., amalgam condensers, and air/water syringes) but that could contact oral tissues are classified as semi critical, but sterilization after each use is 43 209 recommended if the instruments are heat-tolerant • • If a semicrltical item is heat-sensitive, it should, 43 210 at a minimum, be processed with high-level disinfection • • Hand pieces can be contaminated internally with patient material and should be heat sterilized after each patient. Handpieces that cannot be heat sterilized should not be used. 211 Methods of sterilization that can be used for critical or semicritical dental instruments and materials that are heat-stable include steam under pressure (autoclave), chemical (formaldehyde) vapor, and dry heat (e.g., 320"F for 2 hours). Dental professionals most commonly use the steam sterilizer 212 . All three sterilization procedures can damage some dental 213 instruments, including steam-sterilized hand p,ieces • Heat-tolerant alternatives are available for most 3 clinical dental applications and are preferred •

CDC has divided noncritical surfaces in dental offices into clinical contact and housekeeping surfaces43 • Clinical contact surfaces are surfaces that might be touched frequently with gloved hands during patient care or that might become contaminated with blood or other potentially infectious material and subsequently contact instruments, hands, gloves, or devices (e.g., light handles, switches, dental X· ray equipment, chair-side computers). Barrier protective coverings (e.g., clear plastic wraps) can be used for these surfaces, particularly those that are difficult to clean (e.g., light handles, chair switches). The coverings should be changed when visibly soiled or damaged and routinely (e.g., between patients). Protected surfaces should be disinfected at the end of each day or if contamination is evident. If not barrier-protected, these surfaces should be disinfected between patients with an intermediate-disinfectant (i.e., EPA-registered hospital disinfectant with tuberculocidal claim) or low-level disinfectant (i.e., EPA· 43 214 215 registered hospital disinfectant with an HBV and HIV label claim) ' • •

Most housekeeping surfaces need to be cleaned only with a detergent and water or an EPA· registered hospital disinfectant, depending of the nature of the surface and the type and degree of contamination. When housekeeping surfaces are visibly contaminated by blood or body substances, however, prompt removal and surface disinfection is a sound infection control practice and required by 43 214 the Occupational Safety and Health Administration (OSHA) • •

Several studies have demonstrated variability among dental practices while trying to meet these 217 recommendations'"· . For example, 68% of respondents believed they were sterilizing their instruments but did not use appropriate chemical sterilants or exposure times and 49% of respondents 216 did not challenge autoclaves with biological indicators • Other investigators using biologic indicators have found a high proportion (15%-65%) of positive spore tests after assessing the efficacy of sterilizers used in dental offices. In one study of Minnesota dental offices, operator error, rather than mechanical malfunction'", caused 87% of sterilization failures. Common factors in the improper use of sterilizers include chamber overload, low temperature setting, inadequate exposure time, failure to preheat the sterilizer, and interruption of the cycle.

Mail-return sterilization monitoring services use spore strips to test sterilizers in dental clinics, but

20 Guideline for IJisinieclion and Stodliza\ion in H0ill\hcaro hKili\ies, 2008

delay caused by mailing to the test laboratory could potentially cause false-negatives results. Studies revealed, however, that the post-sterilization time and temperature after a 7-day delay had no influence 219 on the test results • Delays (7 d"ts at 27'C and 37'C, 3-day mail delay) did not cause any predictable pattern of inaccurate spore tests 22 •

Disinfection of HBV-, HCV-, HIV- orTB-Contaminated Devices The CDC recommendation for high-level disinfection of HBV-, HCV-, HIV- orTB-contaminated devices is appropriate because experiments have demonstrated the effectiveness of high-level disinfectants to inactivate these and other pathogens that might contaminate semicritical devices 61 ' 62 • 73 • 81 105 121 125 221 238 • • • • " • Nonetheless, some healthcare facilities have modified their disinfection procedures when endoscopes are used with a patient known or suspected to be infected with HBV, HIV, or M. tuberculosis"· 239• This is inconsistent with the concept of Standard Precautions that presumes all patients are potentially infected with bloodborne pathogens 228• Several studies have highlighted the 24 242 inability to distinguish HBV- or HIV-infected patients from noninfected patients on clinical grounds o. • In addition, mycobacterial infection is unlikely to be clinically apparent in many patients. In most instances, hospitals that altered their disinfection procedure used EtO sterilization on the endoscopic 239 instruments because they believed this practice reduced the risk for infection "· • EtO is not routinely used for endoscope sterilization because of the lengthy processing time. Endoscopes and other semicritical devices should be managed the same way regardless of whether the patient is known to be infected with HBV, HCV, HIV or M. tuberculosis.

An evaluation of a rnanual disinfection procedure to eliminate HCV from experimentally contaminated endoscopes provided some evidence that cleaning and 2% glutaraldehyde for 20 minutes 236 should prevent transmission • A study that used experimentally contaminated hysteroscopes detected HCV by polymerase chain reaction (PCR) in one (3%) of 34 samples after cleaning with a detergent, but 120 no samples were positive after treatment with a 2% glutaraldehyde solution for 20 minutes • Another study demonstrated complete elimination of HCV (as detected by PCR) from endoscopes used on chronically infected patients after cleaning and disinfection for 3-5 minutes in glutaraldehyde 118 . Similarly, PCR was used to demonstrate complete elimination of HCV after standard disinfection of and endosco~es used on HCV-antibody-positive patients 236 experimentally contaminated endoscopes 24 had no detectable HCV RNA after high-level disinfection • The inhibitory activity of a phenolic and a chlorine compound on HCV showed that the phenolic inhibited the binding and replication of HCV, but the chlorine was ineffective, probably because of its low concentration and its neutralization in the presence of organic matter 244 •

Disinfection in the Hemodialysis Unit Hemodialysis systems include hemodialysis machines, water supply, water-treatment systems, and distribution systems. During hemodialysis, patients have acquired bloodborne viruses and 245 pathogenic bacteria "247 • Cleaning and disinfection are important components of infection control in a hemodialysis center. EPA and FDA regulate disinfectants used to reprocess hemodialyzers, hemodialysis machines, and water-treatment systems.

Noncritical surfaces (e.g., dialysis bed or chair, countertops, external surfaces of dialysis machines, and equipment [scissors, hemostats, clamps, blood pressure cuffs, stethoscopes]) should be disinfected with an EPA-registered disinfectant unless the item is visibly contaminated with blood; in that case a tuberculocidal agent (or a disinfectant with specific label claims for HBVand HIV) or a 1:100 248 dilution of a hypochlorite solution (500-600 ppm free chlorine) should be used 246 · • This procedure accomplishes two goals: it removes soil on a regular basis and maintains an environment that is consistent with good patient care. Hemodialyzers are disinfected with peracetic acid, formaldehyde, 249 glutaraldehyde, heat pasteurization with citric acid, and chlorine-containing compounds • Hemodialysis systems usually are disinfected by chlorine-based disinfectants (e.g., sodium hypochlorite), aqueous

21 Ouideline for Disinfection and Sterilization in llealthcnm Facilities, 2008

250 251 formaldehyde, heat pasteurization, ozone, or peracetic acid ' , All products must be used according to the manufacturers' recommendations. Some dialysis systems use hot-water disinfection to control microbial contamination.

At its high point, 82% of U.S. chronic hemodialysis centers were reprocessing (i.e., reusing) 249 dialyzers for the same patient using high-level disinfection • However, one of the large dialysis organizations has decided to phase out reuse and, b~ 2002 the percentage of dialysis facilities 52 reprocessing hemodialyzers had decreased to 63% . The two commonly used disinfectants to reprocess dialyzers were peracetic acid and formaldehyde; 72% used peracetic acid and 20% used formaldehyde to disinfect hemodialyzers. Another 4% of the facilities used either glutaraldehyde or heat pasteurization in combination with citric acid 252 • Infection-control recommendations, including disinfection and sterilization and the use of dedicated machines for hepatitis B surface antigen (HBsAg)- positive patients, in the hemodialysis setting were detailed in two reviews 245' 246, The Association for the Advancement of Medicallnstrumentation(AAMI) has published recommendations for the reuse of hemodialyzers253•

Inactivation of Clostridium difficile The source of health-care-associated acquisition of Clostridium difficile in nonepidemic settings has not been determined. The environment and carriage on the hands of health-care personnel have been considered possible sources of infection 66 ' 254• Carpeted rooms occupied by a patient with C. 255 difficile were more heavily contaminated with C. difficile than were noncarpeted rooms • Because C. difficile spore-production can Increase when exposed to nonchlorine-based cleaning agents and the spores are more resistant than vegetative cells to commonly used surface disinfectants'", some investigators have recommended use of dilute solutions of hypochlorite (1 ,600 ppm available chlorine) for routine environmental disinfection of rooms of patients with C. difficile-associated diarrhea or colitis 25 , to 258 259 reduce the incidence of C. difficile diarrhea , or in units with high C. diffici/e rates. Stool samples of patients with symptomatic C. diffici/e colitis contain spores of the organism, as demonstrated by ethanol treatment of the stool to reduce the overgrowth of fecal flora when isolating C. diffici/e in the laboratory'"· 261 • C. diffici/e-associated diarrhea rates were shown to have decreased markedly in a bone-marrow transplant unit (from 8.6 to 3.3 cases per 1,000 patient-days) during a period of bleach disinfection (1 :10 dilution) of environmental surfaces compared with cleaning with a quaternary ammonium compound. Because no EPA-registered products exist that are specific for inactivating C. diffici/e spores, use of diluted hypochlorite should be considered in units with high C. diffici/e rates. Acidified bleach and regular 6 262 bleach (5000 ppm chlorine) can inactivate 10 C. difficile spores in _::1 0 minutes • However, studies have shown that asymptomatic patients constitute an important reservoir within the health-care facility and that person-to-person transmission is the principal means of transmission between patients. Thus, combined use of hand washing, barrier precautions, and meticulous environmental cleaning with an EPA- registered disinfectant (e.g., germicidal detergent) should effectively prevent spread of the organism 263 .

Contaminated medical devices, such as colonoscopes and thermometers,can be vehicles for transmission of C. diffici/e spores 264 • For this reason, investigators have studied commonly used disinfectants and exposure times to assess whether current practices can place patients at risk. Data 267 267 268 demonstrate that 2% glutaraldehyde 79 • 26,_ and peracetic acid ' reliably kill C. diffici/e spores using exposure times of 5-20 minutes. oliho-Phthalaldeh¥de and ;':0.2% peracetic acid (WA Rutala, personal 268 communication, April2006) also can inactivate .":10 C. difficile spores in 10-12 minutes at 2o"c • Sodium dichloroisocyanurate at a concentration of 1000 ppm available chlorine achieved lower log 10 reduction factors against C. difficile spores at 10 min, ranging from 0.7 to 1.5, than 0.26% peracetic acid 268 with log 10 reduction factors ranging from 2.7 to 6.0 .

OSHA Bloodborne Pathogen Standard In December 1991, OSHA promulgated a standard entitled "Occupational Exposure to

22 GtJidefinn ·for Dlsinfectlon and Str~H!izaHon ln Hoa!t!1C(Jre Facilities, 2008

214 Bloodborne Pathogens" to eliminate or minimize occupational exposure to bloodborne pathogens . One component of this requirement is that all equipment and environmental and working surfaces be cleaned and decontaminated with an appropriate disinfectant after contact with blood or other potentially infectious materials. Even though the OSHA standard does not specify the type of disinfectant or 269 procedure, the OSHA original compliance document suggested that a germicide must be tuberculocidal to kill the HBV. To follow the OSHA compliance document a tuberculocidal disinfectant (e.g., phenolic, and chlorine) would be needed to clean a blood spill. However, in February 1997, OSHA amended its policy and stated that EPA-registered disinfectants labeled as effective against HIV and HBV would be considered as appropriate disinfectants "... provided such surfaces have not become contaminated with agent(s) or volumes of or concentrations of agent(s) for which higher level disinfection is recommended." When bloodborne pathogens other than HBV or HIV are of concern, OSHA continues to require use of EPA-registered tuberculocidal disinfectants or hypochlorite solution (diluted 1:10 or 228 1:100 with water) 215 • • Studies demonstrate that, in the presence of large blood spills, a 1:10 final dilution of EPA-registered hypochlorite solution initially should be used to inactivate bloodborne viruses"· 235 to minimize risk for infection to health-care personnel from percutaneous injury during cleanup.

Emerging Pathogens (Cryptosporidium, He/icobacter pylori, Escherichia coli 0157:H7, Rotavirus, Human Papilloma Virus, Norovirus, Severe Acute Respiratory Syndrome [SARS] Coronavirus) Emerging pathogens are of growing concern to the general public and infection-control professionals. Relevant pathogens include Cryptosporidium patvum, Helicobacter pylori, E. coli 0157:H7, HIV, HCV, rotavirus, norovirus, severe acute respiratory syndrome (SARS) coronavirus, multidrug- resistant M. tuberculosis, and nontuberculous mycobacteria (e.g., M. chelonae). The susceptibility of each of these pathogens to chemical disinfectants and sterilants has been studied. With the exceptions discussed below, all of these emerging pathogens are susceptible to currently available chemical 270 disinfectants and sterilants .

Cryptosporidium is resistant to chlorine at concentrations used in potable water. C. patvum is not 271 completely inactivated by most disinfectants used in healthcare includin~ ethyl alcohol , glutaraldehyde 271 1 271 271 2 1 271 272 • ' ', 5.25% hypochlorite , peracetic acid , ortho-phthalaldehyde , phenol ' , povidone-iodine 271 · 272 , and quaternary ammonium compounds 271 • The only chemical disinfectants and sterilants able to 271 inactivate greater than 3 log 10 of C. patvum were 6% and 7.5% hy,dro~en peroxide . Sterilization methods will fully inactivate C. parvum, including steam 271 , EtO 71 27 ' , and hydrogen peroxide gas plasma 271 • Although most disinfectants are ineffective against C. patvum, current cleaning and disinfection practices appear satisfactory to prevent healthcare-associated transmission. For example, endoscopes are unlikely to be an important vehicle for transmitting C. patvum because the results of 4 bacterial studies Indicate mechanical cleaning will remove approximately 1 0 organisms, and drying results in rapid loss of C. patvum viability (e.g., 30 minutes, 2.9 log1 0 decrease; and 60 minutes, 3.8 log1o 271 decrease) .

Chlorine at -1 ppm has been found capable of eliminating approximately 4 log 10 of E. coli 0157:H7 within 1 minute in a suspension test• . Electrolyzed oxidizing water at 23'C was effective in 10 274 minutes in producing a 5-log 10 decrease in E. coli 0157:H7 inoculated onto kitchen cutting boards • The following disinfectants eliminated >5 log 10 of E. coli 0157:H7 within 30 seconds: a quaternary ammonium compound, a phenolic, a hypochlorite (1 :10 dilution of 5.25% bleach), and ethanol 53. Disinfectants including chlorine compounds can reduce E. coli 0157:H7 experimentally inoculated onto alfalfa seeds or sprouts 275· 276 or beef carcass surfaces • 277

Data are limited on the susceptibility of H. pylori to disinfectants. Using a suspension test, one 60 study assessed the effectiveness of a variety of disinfectants against nine strains of H. pylori . Ethanol (80%) and glutaraldehyde (0.5%) killed all strains within 15 seconds; chlorhexidine gluconate (0.05%, 1.0%), benzalkonium chloride (0.025%, 0.1 %), alkyldiaminoethylglycine hydrochloride (0.1 %), povidone- iodine (0.1 %), and sodium hypochlorite (150 ppm) killed all strains within 30 seconds. Both ethanol

23 Guideline for Dimnloction and Stct·ifiza\ion in HeaKixoaro Faciltt!es, 2008

(80%) and glutaraldehyde (0.5%) retained similar bactericidal activity in the presence of organic matter; the other disinfectants showed reduced bactericidal activity. In particular, the bactericidal activity of povidone-iodine (0.1%) and sodium hypochlorite (150 ppm) markedly decreased in the presence of dried yeast solution with killing times increased to 5- 10 minutes and 5-30 minutes, respectively.

Immersing biopsy forceps in formalin before obtaining a specimen does not affect the ability to culture H. pylori from the biopsy specimen 278 • The followin~ methods are ineffective for eliminating H. pylori from endoscopes: cleaning with soap and water 119 • 27 , immersion in 70% ethanol for 3 minutes280 , instillation of 70% ethanol 126 , instillation of 30 ml of 83% methanol 279 , and instillation of 0.2% Hyamine solution 281 • The differing results with regard to the efficacy of ethyl alcohol against Helicobacterare unexplained. Cleaning followed by use of 2% alkaline glutaraldehyde (or automated peracetic acid) has 119 279 282 been demonstrated by culture to be effective in eliminating H. pylori • ' • Epidemiologic investigations of patients who had undergone endoscopy with endoscopes mechanically washed and disinfected with 2. 0%-2.3% glutaraldehyde have revealed no evidence of person-to-person transmission 126 283 of H. pylori ' • Disinfection of experimentally contaminated endoscopes using 2% glutaraldehyde (1 0- minute, 20-minute, 45-minute exposure times) or the peracetic acid system (with and without active 119 peracetic acid) has been demonstrated to be effective in eliminating H. pylori • H. pylori DNA has been detected by PCR in fiuid fiushed from endoscope channels after cleaning and disinfection with 2% 284 glutaraldehyde • The clinical significance of this finding is unclear. In vitro experiments have demonstrated a >3.5-log 10 reduction in H. pylori after exposure to 0.5 mgiL of free chlorine for 80 seconds 285 .

An outbreak of healthcare-associated rotavirus gastroenteritis on a pediatric unit has been 286 reported • Person to person through the hands of health-care workers was proposed as the mechanism of transmission. Prolonged survival of rotavirus on environmental surfaces (90 minutes to >1 0 days at room temperature) and hands (>4 hours) has been demonstrated. Rotavirus suspended in 288 289 feces can survive longer 287 ' 288 . Vectors have included hands, fomites, air, water, and food ' • Products with demonstrated efficacy (>3 log 10 reduction in virus) against rotavirus within 1 minute include: 95% ethanol, 70% isopropanol, some ~henolics, 2% glutaraldehyde, 0.35% peracetic acid, and some 293 quaternary ammonium compounds"· ",. • In a human challenge study, a disinfectant spray (0.1% ortho-phenylphenol and 79% ethanol), sodium hypochlorite (800 ppm free chlorine), and a phenol-based product (14.7% phenol diluted 1:256 in tapwater) when sprayed onto contaminated stainless steel disks, were effective in interrupting transfer of a human rota virus from stainless steel disk to fingerpads of volunteers after an exposure time of 3- 10 minutes. A quaternary ammonium product (7.05% quaternary 52 ar+!monium compound diluted 1:128 in tapwater) and tapwater allowed transfer of virus •

No data exist on the inactivation of HPV by alcohol or other disinfectants because in vitro replication of complete virions has not been achieved. Similarly, little is known about inactivation of noroviruses (members of the family Ca/iciviridae and important causes of gastroenteritis in humans) because they cannot be grown in tissue culture. Improper disinfection of environmental surfaces contaminated by feces or vomitus of infected patients is believed to play a role in the spread of 294 296 noroviruses in some settings - • Prolonged survival of a norovirus surrogate (i.e., feline calicivirus virus [FCV], a closely related cultivable virus) has been demonstrated (e.g., at room temperature, FCV in a dried state survived for 21-18 days) 297 • Inactivation studies with FCV have shown the effectiveness of chlorine, glutaraldehyde, and iodine-based products whereas the quaternary ammonium compound, 297 detergent, and ethanol failed to inactivate the virus completely. An evaluation of the effectiveness of several disinfectants against the feline calicivirus found that bleach diluted to 1000 ppm of available chlorine reduced infectivity of FCV by 4.5 logs in 1 minute. Other effective (log 10 reduction factor of >4 in virus) disinfectants included accelerated hydrogen peroxide, 5,000 ppm (3 min); chlorine dioxide, 1,000 ppm chlorine (1 min); a mixture of four quaternary ammonium compounds, 2,470 ppm (1 0 min); 79% 298 ethanol with 0.1% quaternary ammonium compound (3 min); and 75% ethanol (1 0 min) . A quaternary ammonium compound exhibited activity against feline calicivirus supensions dried on hard surface carriers in 1 0 minutes 299 • Seventy percent ethanol and 70% 1-propanol reduced FCV by a 3-4-log 10

24 Gu1del1110 for Disinfection and !3terililation in 1-ieal\!'lcarn Facilities, 2008

300 reduction in 30 seconds •

CDC announced that a previously unrecognized human virus from the coronavirus family is the 301 leading hypothesis for the cause of a described syndrome of SARS • Two coronaviruses that are known to infect humans cause one third of common colds and can cause gastroenteritis. The virucidal efficacy of chemical germicides against coronavirus has been investigated. A study of disinfectants against coronavirus 229E found several that were effective after a 1-minute contact time; these included sodium hypochlorite (at a free chlorine concentration of 1,000 ppm and 5,000 ppm), 70% ethyl alcohol, 186 and povidone-iodine (1% iodine) • In another study, 70% ethanol, 50% isopropanol, 0.05% benzalkonium chloride, 50 ppm iodine in iodophor, 0.23% sodium chlorite, 1% cresol soap and 0.7% formaldehyde inactivated >3 logs of two animal coronaviruses (mouse hepatitis virus, canine coronavirus) 302 after a 10-minute exposure time • The activity of povidone-iodine has been demonstrated against 303 human coronaviruses 229E and OC43 • A study also showed complete inactivation of the SARS coronavirus by 70% ethanol and povidone-iodine with an exposure times of 1 minute and 2.5% 304 glutaraldehyde with an exposure time of 5 minute • Because the SARS coronavirus is stable in feces and urine at room temperature for at least 1-2 days (WHO, 2003; http://www.who.int/csr/sars/survival_2003_05_04/en/index.html), surfaces might be a possible source of contamination and lead to infection with the SARS coronavirus and should be disinfected. Until more precise information is available, environments in which SARS patients are housed should be considered heavily contaminated, and rooms and equipment should be thoroughly disinfected daily and after the patient is discharged. EPA-registered disinfectants or 1:100 dilution of household bleach and water should be used for surface disinfection and disinfection on noncritical patient-care equipment. High-level disinfection and sterilization of semicritical and critical medical devices, respectively, does not need to be altered for patients with known or suspected SARS.

Free-living amoeba can be pathogenic and can harbor agents of pneumonia such as Legionella pneumophila. Limited studies have shown that 2% glutaraldehyde and peracetic acid do not completely inactivate Acanthamoeba polyphaga in a 20-minute exposure time for high-level disinfection. If amoeba are found to contaminate instruments and facilitate infection, longer immersion times or other 305 disinfectants may need to be considered •

Inactivation of Bloterrorist Agents 306 307 Publications have highlighted concerns about the potential for biological terrorism • • CDC has categorized several agents as "high priority" because they can be easily disseminated or transmitted 308 from person to person, cause high mortality, and are likely to cause public panic and social disruption • These agents include Bacillus anthracis (the cause of anthrax), Yersinia pestis (plague), variola major (smallpox), Clostridium botulinum toxin (botulism), Franc/sella tularensis (tularemia), filoviruses (Ebola hemorrhagic fever, Marburg hemorrhagic fever); and arenaviruses (Lassa [Lassa fever], Junin [Argentine· hemorrhagic fever]), and related viruses".,

A few comments can be made regarding the role of sterilization and disinfection of potential agents of bioterrorism • First, the susceptibility of these agents to ~ermicides in vitro is similar to that of 309

other related pathogens. For exam~le, variola is similar to vaccinia '· • 311 and B. anthracis is similar to 310 12 313 B. atrophaeus (formerly B. subtilis) • • B. subtilis spores, for instance, proved as resistant as, if not more resistant than, B. anthracis spores (>6 log 10 reduction of B. anthracis spores in 5 minutes with 313 acidified bleach [5,250 ppm chlorine]) • Thus, one can extrapolate from the larger database available on 314 the susceptibility of genetically similar organisms • Second, many of the potential bioterrorist agents are stable enough in the environment that contaminated environmental surfaces or fomites could lead to transmission of agents such as B. anthracis, F. tularensis, variola major, C. botulinum toxin, and C. burnett/ 315 • Third, data suggest that current disinfection and sterilization practices are appropriate for managing patient-care equipment and environmental surfaces when potentially contaminated patients are evaluated and/or admitted in a health-care facility after exposure to a bioterrorist agent. For example,

25 Gutdeline fm Disinfeclion and Sterilization in lloslt!x;ane F8ciltties, 2008

sodium hypochlorite can be used for surface disinfection (see http://www.epa.gov/pesticides/factsheets/chemicals/bleachfactsheet.htm). In instances where the health- care facility is the site of a bioterrorist attack, environmental decontamination might require special decontamination procedures (e.g., chlorine dioxide gas for 8. anthracis spores). Because no antimicrobial products are registered for decontamination of biologic agents after a bioterrorist attack, EPA has granted a crises exemption for each product (see http://www. epa. gov/pesticides/factsheets/chemicals/bleachfactsheet. htm). Of only theoretical concern is the possibility that a bioterrorist agent could be engineered to be less susceptible to disinfection and sterilization processes 309.

Toxicological, Environmental and Occupational Concerns Health hazards associated with the use of germicides in healthcare vary from mucous membrane irritation to death, with the latter involving accidental injection by mentally disturbed patients316 • Althou~h 317 320 their degrees of toxicity vary - , all disinfectants should be used with the proper safety precautions 21 and only for the intended purpose.

Key factors associated with assessing the health risk of a chemical exposure include the duration, intensity (i.e., how much chemical is involved), and route (e.g., skin, mucous membranes, and inhalation) of exposure. Toxicity can be acute or chronic. Acute toxicity usually results from an accidental spill of a chemical substance. Exposure is sudden and often produces an emergency situation. Chronic toxicity results from repeated exposure to low levels of the chemical over a prolonged period. Employers are responsible for informing workers about the chemical hazards in the workplace and implementing control measures. The OSHA Hazard Communication Standard (29 CFR 1910.1200, 1915.99, 1917.28, 1918.90, 1926.59, and 1928.21) requires manufacturers and importers of hazardous chemicals to develop Material Safety Data Sheets (MSDS) for each chemical or mixture of chemicals. Employers must have these data sheets readily available to employees who work with the products to which they could be exposed.

Exposure limits have been published for many chemicals used in health care to help provide a safe environment and, as relevant, are discussed in each section of this guideline. Only the exposure limits published by OSHA carry the legal force of regulations. OSHA publishes a limit as a time-weighted average (TWA), that is, the average concentration for a normal 8-hour work day and a 40-hour work week to which nearly all workers can be repeatedly exposed to a chemical without adverse health effects. For example, the permissible exposure limit (PEL) for EtO is 1.0 ppm, 8 hour TWA. The CDC National Institute for Occupational Safety and Health (NIOSH) develops recommended exposure limits (RELs). RELs are occupational exposure limits recommended by NIOSH as being protective of worker health and safety over a working lifetime. This limit is frequently expressed as a 40-hour TWA exposure for up to 10 hours per day during a 40-hour work week. These exposure limits are designed for inhalation exposures. Irritant and allergic effects can occur below the exposure limits, and skin contact can result in dermal effects or systemic absorption without inhalation. The American Conference on Governmental Industrial 322 Hygienists (ACGIN) also provides guidelines on exposure limits • Information about workplace exposures and methods to reduce them (e.g., work practices, engineering controls, PPE) is available on the OSHA (http://www.osha.gov) and NIOSH (http://www.cdc.gov/niosh) websites.

Some states have excluded or limited concentrations of certain chemical germicides (e.g., glutaraldehyde, formaldehyde, and some phenols) from disposal through the sewer system. These rules are intended to minimize environmental harm. If health-care facilities exceed the maximum allowable concentration of a chemical (e.g., ;:_5.0 mg/L), they have three options. First, they can switch to alternative products; for example, they can change from glutaraldehyde to another disinfectant for high-level disinfection or from phenolics to quaternary ammonium compounds for low-level disinfection. Second, the health-care facility can collect the disinfectant and dispose of it as a hazardous chemical. Third, the

26 Guideline tor Dlslnfectlon and Sterilization In !·!calthcaro Facilities, 2008

facility can use a commercially available small-scale treatment method (e.g., neutralize glutaraldehyde with glycine).

Safe disposal of regulated chemicals is important throughout the medical community. For disposal of large volumes of spent solutions, users might decide to neutralize the microbicidal activity before disposal ~e.g., glutaraldehyde). Solutions can be neutralized by reaction with chemicals such as 324 325 sodium bisulfite "· or glycine •

European authors have suggested that instruments and ventilation therapy equipment should be disinfected by heat rather than by chemicals. The concerns for chemical disinfection include toxic side effects for the patient caused by chemical residues on the instrument or object, occupational exposure to toxic chemicals, and recontamination by rinsing the disinfectant with microbially contaminated tap water 326

Disinfection in Ambulatory Care, Home Care, and the Home IJIJlth the advent of managed healthcare, increasing numbers of patients are now being cared for in ambulatory-care and home settings. Many patients in these settings might have communicable diseases, immunocompromising conditions, or invasive devices. Therefore, adequate disinfection in these settings is necessary to provide a safe patient environment. Because the ambulatory-care setting (i.e., outpatient facility) provides the same risk for infection as the hospital, the Spaulding classification scheme described in this guideline should be followed (Table 1) "-

The home environment should be much safer than hospitals or ambulatory care. Epidemics should not be a problem, and cross-infection should be rare. The healthcare provider is responsible for providing the responsible family member information about infection-control procedures to follow in the home, including hand hygiene, proper cleaning and disinfection of equipment, and safe storage of cleaned and disinfected devices. Among the products recommended for home disinfection of reusable objects are bleach, alcohol, and hydrogen peroxide. APIC recommends that reusable objects (e.g., tracheostomy tubes) that touch mucous membranes be disinfected by immersion in 70% isopropyl alcohol for 5 minutes or in 3% hydrogen peroxide for 30 minutes. Additionally, a 1:50 dilution of 5.25%- 6.15% sodium hypochlorite (household bleach) for 5 minutes should be effective 327-329 • Noncritical items (e.g., blood pressure cuffs, crutches) can be cleaned with a detergent. Blood spills should be handled according to OSHA regulations as previously described (see section on OSHA Bloodborne Pathogen Standard). In general, sterilization of critical items is not practical in homes but theoretically could be accomplished by chemical sterilants or boiling. Single-use disposable items can be used or reusable 330 331 items sterilized in a hospital • •

Some environmental groups advocate "environmentally safe" products as alternatives to commercial germicides in the home-care setting. These alternatives (e.g., ammonia, baking soda, vinegar, Borax, liquid detergent) are not registered with EPA and should not be used for disinfecting because they are ineffective against S. aureus. Borax, baking soda, and detergents also are ineffective against Salmonella Typhi and E. coli; however, undiluted vinegar and ammonia are effective against S. 332 Typhi and E. coli 53• · 333 • Common commercial disinfectants designed for home use also are effective against selected antibiotic-resistant bacteria 53 .

Public concerns have been raised that the use of antimicrobials in the home can promote development of antibiotic-resistant bacteria 334• 335 • This issue is unresolved and needs to be considered further through scientific and clinical investigations. The public health benefits of using disinfectants in the home are unknown. However, some facts are known: many sites in the home kitchen and bathroom are 337 microbially contaminated 336 , use of hypochlorites markedly reduces bacteria , and good standards of 338 339 hygiene (e.g., food hygiene, hand hygiene) can help reduce infections in the home " • In addition, laboratory studies indicate that many commercially prepared household disinfectants are effective against 53 48 common pathogens and can interrupt surface-to-human transmission of pathogens • The "targeted

27 Guideline tor D!sinfocf!on and SteHiizntion In Healti'JG

hygiene concept"-which means identifying situations and areas (e.g., food-preparation surfaces and bathroom) where risk exists for transmission of pathogens-may be a reasonable way to identify when disinfection might be appropriate 340 •

Susceptibility of Antibiotic-Resistant Bacteria to Disinfectants As with antibiotics, reduced susceptibility (or acquired "resistance") of bacteria to disinfectants can arise by either chromosomal ~ene mutation or acquisition of genetic material in the form of p\asmids 338 341 343 344 345 34 or transposons • ' ' • • • When changes occur in bacterial susceptibility that renders an antibiotic ineffective against an infection previously treatable by that antibiotic, the bacteria are referred to as "resistant." In contrast, reduced susceptibility to disinfectants does not correlate with failure of the disinfectant because concentrations used in disinfection still greatly exceed the cidal\evel. Thus, the word "resistance" when applied to these changes is incorrect, and the preferred term is "reduced susceptibility" 44 347 or "increased tolerance"' • • No data are available that show that antibiotic-resistant bacteria are less sensitive to the liquid chemical germicides than antibiotic-sensitive bacteria at currently used germicide contact conditions and concentrations.

MRSA and vancomycin-resistant Enterococcus (VRE) are important health-care-associated agents. Some antiseptics and disinfectants have been known for years to be, because of M\Cs, somewhat less inhibitory to S. aureus strains that contain a plasmid-carrying gene encoding resistance to 344 the antibiotic gentamicin • For example, gentamicin resistance has been shown to also encode 348 reduced susceptibility to propamidine, quaternary ammonium compounds, and ethidium bromide , and MRSA strains have been found to be less susceptible than methicillin-sensitive S. aureus (MSSA) strains 349 to ch\orhexidine, propamidine, and the quaternary ammonium compound cetrimide • In other studies, MRSA and MSSA strains have been equally sensitive to phenols and chlorhexidine, but MRSA strains 350 were slightly more tolerant to quaternary ammonium compounds . Two gene families (qacCD [now referred to as smr] and qacAB) are involved in providing protection against agents that are components of disinfectant formulations such as quaternary ammonium compounds. Staphylococci have been proposed to evade destruction because the protein specified by the qacA determinant is a cytoplasmic-membrane- associated protein involved in an efflux system that actively reduces intracellular accumulation of toxicants, such as quaternary ammonium compounds, to intracellular targets 351 •

Other studies demonstrated that plasmid-mediated formaldehyde tolerance is transferable from 352 Serratia marcescens to E. coli and plasmid-mediated quaternary ammonium tolerance is transferable 53 343 from S. aureus to E. coli.' • Tolerance to mercury and silver also is plasmid borne 341 • ' 34 '.

Because the concentrations of disinfectants used in practice are much higher than the MICs observed, even for the more tolerant strains, the clinical relevance of these observations is questionable. Several studies have found antibiotic-resistant hospital strains of common hea\thcare-associated pathogens (i.e., Enterococcus, P. aeruginosa, Klebsiella pneumoniae, E. coli, S. aureus, and S. epidermidis) to be equally susceptible to disinfectants as antibiotic-sensitive strains 53' 35 "'356 . The susceptibility of glycopeptide-intermediate S. aureus was similar to vancomycin-susceptible, MRSA 357 • On the basis of these data, routine disinfection and housekeeping protocols do not need to be altered because of antibiotic resistance provided the disinfection method is effective 358• 359 • A study that evaluated the efficacy of selected cleaning methods (e.g., QUAT-sprayed cloth, and QUAT-immersed cloth) for eliminating VRE found that currently used disinfection processes most likely are highly effective 358 in eliminating VRE. However, surface disinfection must involve contact with all contaminated surfaces • A new method using an invisible fiurorescent marker to objectively evaluate the thoroughness of cleaning activities in patient rooms might lead to improvement in cleaning of all objects and surfaces but needs 360 further evaluation •

Lastly, does the use of antiseptics or disinfectants facilitate the development of disinfectant- tolerant organisms? Evidence and reviews indicate enhanced tolerance to disinfectants can be

28 Guideline for DislnfBction and Steri!L:atlon in HealHJCG\rn Fad!ities, 2008

334 335 346 347 361 developed in response to disinfectant exposure ' ' • • • However, the level of tolerance is not important in clinical terms because it is low and unlikely to compromise the effectiveness of disinfectants of which much higher concentrauons are used 347 • 362 •

The issue of whether low-level tolerance to germicides selects for antibiotic-resistant strains is unsettled but might depend on the mechanism by which tolerance is attained. For example, changes in the permeability barrier or efflux mechanisms might affect susceptibility to both antibiotics and germicides, but specific changes to a target site might not. Some researchers have suggested that use of disinfectants or antiseptics (e.g., triclosan) could facilitate development of antibiotic-resistant 334 33 363 microorganisms ' • • Although evidence in laboratory studies indicates low-level resistance to triclosan, the concentrations of triclosan in these studies were low (generally <1 ~glmL) and dissimilar from the higher levels used in antimicrobial products (2,000-20,000 ~glmL) 364 3 5 • . Thus, researchers can create laboratory-derived mutants that demonstrate reduced susceptibility to antiseptics or disinfectants. In some experiments, such bacteria have demonstrated reduced susceptibility to certain antibiotics 335 • There is no evidence that using antiseptics or disinfectants selects for antibiotic-resistant organisms in nature or that such mutants survive in nature 366 • ). In addition, the action of antibiotics and the action of disinfectants differ fundamentally. Antibiotics are selectively toxic and generally have a single target site in bacteria, thereby inhibiting a specific biosynthetic process. Germicides generally are considered nonspecific antimicrobials because of a multiplicity of toxic-effect mechanisms or tar2et sites and are broader spectrum in the types of microorganisms against which they are effective 34 • 347 •

The rotational use of disinfectants in some environments (e.g., pharmacy production units~ has 68 been recommended and practiced in an attempt to prevent development of resistant microbes 367 ' • There have been only rare case reports that appropriately used disinfectants have resulted in a clinical problem arising from the selection or development of nonsusceptible microorganisms 369 •

Surface Disinfection Is Surface Disinfection Necessary? The effective use of disinfectants is part of a multibarrier strategy to prevent health-care- associated infections. Surfaces are considered noncritical items because they contact intact skin. Use of noncritical items or contact with noncritical surfaces carries little risk of causing an infection in patients or staff. Thus, the routine use of germicidal chemicals to disinfect hospital floors and other noncritical items 37 375 is controversial 1)- • A 1991 study expanded the Spaulding scheme by dividing the noncritical 376 environmental surfaces into housekeeping surfaces and medical equipment surfaces • The classes of disinfectants used on housekeeping and medical equipment surfaces can be similar. However, the frequency of decontaminating can vary (see Recommendations). Medical equipment surfaces (e.g., blood pressure cuffs, stethoscopes, hemodialysis machines, and X-ray machines) can become contaminated with infectious agents and contribute to the spread of health-care-associated infections ' 48 • 375 • For this reason, noncritical medical equipment surfaces should be disinfected with an EPA-registered low- or intermediate-level disinfectant. Use of a disinfectant will provide antimicrobial activity that is likely to be achieved with minimal additional cost or work.

Environmental surfaces (e.g., bedside table) also could potentially contribute to cross- transmission by contamination of health-care personnel from hand contact with contaminated surfaces, 50 medical equipment, or patients ' 375 • 377 • A paper reviews the epidemiologic and microbiologic data 378 (Table 3) regarding the use of disinfectants on noncritical surfaces •

Of the seven reasons to usie a disinfectant on noncritical surfaces, five are particularly noteworthy and support the use of a germicidal detergent. First, hospital floors become contaminated with microorganisms from settling airborne bacteria: by contact with shoes, wheels, and other objects; and occasionally by spills. The removal of microbes is a component in controling health-care-associated infections. In an investigation of the cleaning of hospital floors, the use of soap and water (80% reduction) was less effective in reducing the numbers of bacteria than was a phenolic disinfectant (94 %-99.9%

29 Guideline for Disinfection amJ Sterilization in Healthcam F;Jcilities, 2008

379 reduction) • However, a few hours after floor disinfection, the bacterial count was nearly back to the pretreatment level. Second, detergents become contaminated and result in seeding the patient's environment with bacteria. Investigators have shown that mop water becomes increasingly dirty during cleaning and becomes contaminated if soap and water is used rather than a disinfectant. For example, in one study, bacterial contamination in soap and water without a disinfectant increased from 10 CFU/mL to 34,000 CFU/mL after cleaning a ward, whereas contamination in a disinfectant solution did not change 380 (20 CFU/mL) • Contamination of surfaces close to the patient that are frequently touched by the patient 381 or staff (e.g., bed rails) could result in patient exposuresO • In a study, using of detergents on floors and patient room furniture, increased bacterial contamination of the patients' environmental surfaces was 2 382 found after cleaning (average increase= 103.6 CFU/24cm ) • In addition, a P. aeruginosa outbreak was reported in a hematology-oncology unit associated with contamination of the surface cleaning equipment when nongermicidal cleaning solutions instead of disinfectants were used to decontaminate 383 the patients' environment and another study demonstrated the role of environmental cleaning in controlling an outbreak of Acinetobacter baumannii " 4 . Studies also have shown that, in situations where the cleaning procedure failed to eliminate contamination from the surface and the cloth is used to wipe another surface, the contamination is transferred to that surface and the hands of the person holding the 365 cloth"'· • Third, the CDC Isolation Guideline recommends that noncritical equipment contaminated with blood, body fluids, secretions, or excretions be cleaned and disinfected after use. The same guideline recommends that, in addition to cleaning, disinfection of the bedside equipment and environmental surfaces (e.g., bedrails, bedside tables, carts, commodes, door-knobs, and faucet handles) is indicated for certain pathogens, e.g., enterococci, which can survive in the inanimate environment for prolonged 386 periods • Fourth, OSHA requires that surfaces contaminated with blood and other potentially infectious materials (e.g., amniotic, pleural fluid) be disinfected. Fifth, using a single product throughout the facility can simplify both training and appropriate practice.

Reasons also exist for using a detergent alone on floors because noncritical surfaces contribute minimally to endemic health-care-associated infections 387 , and no differences have been found in 382 healthcare-associated infections rates when floors are cleaned with detergent rather than disinfectant ' 388 389 ' • However, these studies have been small and of short duration and suffer from low statistical power because the outcome-healthcare-associated infections-is of low frequency. The low rate of infections makes the efficacy of an intervention statistically difficult to demonstrate. Because housekeeping surfaces are associated with the lowest risk for disease transmission, some researchers 376 have suggested that either detergents or a disinfectanUdetergent could be used • No data exist that show reduced healthcare-associated infection rates with use of surface disinfection of floors, but some data demonstrate reduced microbial load associated with the use of disinfectants. Given this information; other information showing that environmental surfaces (e.g., bedside table, bed rails) close to the patient and in outpatient settin~s 390 can be contaminated with epidemiologically important microbes (such as 395 VRE and MRSA) 47 ' 390-3 4 ; and data showing these organisms survive on various hospital surfaces ' 396 ; 378 some researchers have suggested that such surfaces should be disinfected on a regular schedule Spot decontamination on fabrics that remain in hospitals or clinic rooms while patients move in and out (e.g., privacy curtains) also should be considered. One study demonstrated the effectiveness of spraying the fabric with 3% hydrogen peroxide 397 • Future studies should evaluate the level of contamination on noncritical environmental surfaces as a function of high and low hand contact and whether some surfaces (e.g., bed rails) near the patient with high contact frequencies require more frequent disinfection. Regardless of whether a detergent or disinfectant is used on surfaces in a health-care facility, surfaces should be cleaned routinely and when dirty or soiled to provide an aesthetically pleasing environment and to prevent potentially contaminated objects from serving as a source for health-care-associated infections 398 • The value of designing surfaces (e.g. hexyl-polyvinylpyridine) that kill bacteria on contact 399 400 or have sustained antimicrobial activity should be further evaluated.

Several investigators have recognized heavy microbial contamination of wet mops and cleaning 68 401 cloths and the potential for spread of such contamination ' . They have shown that wiping hard 68 402 surfaces with contaminated cloths can contaminate hands, equipment, and other surfaces ' . Data

30 Guideline for Disinfection and Sterilization in Healtilcnre Faciltties, 2008

have been published that can be used to formulate effective policies for decontamination and maintenance of reusable cleaning cloths. For example, heat was the most reliable treatment of cleaning cloths as a detergent washing followed by drying at BO'C for 2 hours produced elimination of contamination. However, the dry heating process might be a fire hazard if the mop head contains petroleum-based products or lint builds up within the equipment or vent hose (American Health Care Association, personal communication, March 2003). Alternatively, immersing the cloth in h~pochlorite 3 (4,000 ppm) for 2 minutes produced no detectable surviving organisms in 10 of 13 cloths 4 . If reusable cleaning cloths or mops are used, they should be decontaminated regularly to prevent surface contamination during cleaning with subsequent transfer of organisms from these surfaces to patients or equipment by the hands of health-care workers. Some hospitals have begun using a new mopping technique involving microfiber materials to clean ftoors. Microfibers are densely constructed, polyester and polyamide (nylon) fibers, that are approximately 1/16 the thickness of a human hair. The positively charged microftbers attract dust (which has a negative charge) and are more absorbent than a conventional, cotton-loop mop. Microfiber materials also can be wet with disinfectants, such as quaternary ammonium compounds. In one study, the microfiber system tested demonstrated superior microbial removal compared with conventional string mops when used with a detergent cleaner (94% vs 68%). The use of a disinfectant did not improve the microbial elimination demonstrated by the microfiber system (95% vs 94%). However, use of disinfectant significantly improved microbial removal when a conventional string mop was used (95% vs 68%)(WA Rutala, unpublished data, August 2006). The microfiber system also prevents the possibility of transferring microbes from room to room because a new microfiber pad is used in each room.

Contact Times for Surface Disinfectants An important issue concerning use of disinfectants for noncritical surfaces in health-care settings is that the contact time specified on the label of the product is often too long to be practically followed. The labels of most products registered by EPA for use against HBV, HIV, or M. tuberculosis specify a contact time of 10 minutes. Such a long contact time is not practical for disinfection of environmental surfaces in a health-care setting because most health-care facilities apply a disinfectant and allow it to dry (-1 minute). Multiple scientific gapers have demonstrated significant microbial reduction with contact times of 30 to 60 seconds"·"· '·"'. In addition, EPA will approve a shortened contact time for any product for which the manufacturers will submit confirmatory efficacy data.

Currently, some EPA-registered disinfectants have contact times of one to three minutes. By law, users must follow all applicable label instructions for EPA-registered products. Ideally, product users should consider and use products that have the shortened contact time. However, disinfectant manufacturers also need to obtain EPA approval for shortened contact times so these products will be used correctly and effectively in the health-care environment.

Air Disinfection Disinfectant spray-fog techniques for antimicrobial control in hospital rooms has been used. This technique of spraying of disinfectants is an unsatisfactory method of decontaminating air and surfaces 386 and is not recommended for general infection control in routine patient-care areas • Disinfectant fogging is rarely, if ever, used in U.S. healthcare facilities for air and surface disinfection in patient-care areas. Methods (e.g., filtration, ultraviolet germicidal irradiation, chlorine dioxide) to reduce air 23 contamination in the healthcare setting are discussed in another guideline •

Microbial Contamination of Disinfectants Contaminated disinfectants and antiseptics have been occasional vehicles of health-care infections and pseudoepidemics for more than 50 years. Published reports describing contaminated disinfectants and antiseptic solutions leading to health-care-associated infections have been summarized

31 C1ui

Since this summary additional reports have been published ~ • An examination of reports of 404 40 408 • disinfectants contaminated with microorganisms revealed noteworthy observations. Perhaps most importantly, high-level disinfectantsmquid chemical sterilants have not been associated with outbreaks due to intrinsic or extrinsic contamination. Members of the genus Pseudomonas (e.g., P. aeruginosa) are the most frequent isolates from contaminated disinfectants---recovered from 80% of contaminated products. Their ability to remain viable or grow in use-dilutions of disinfectants is unparalleled. This survival advantage for Pseudomonas results presumably from their nutritional versatility, their unique outer membrane that constitutes an effective barrier to the passage of germicides, and/or efflux systems 409 . Although the concentrated solutions of the disinfectants have not been demonstrated to be contaminated at the point of manufacture, an undiluted phenolic can be contaminated by a Pseudomonas 410 sp. during use • In most of the reports that describe illness associated with contaminated disinfectants, the product was used to disinfect patient-care equipment, such as cystoscopes, cardiac catheters, and thermometers. Germicides used as disinfectants that were reported to have been contaminated include chlorhexidine, quaternary ammonium compounds, phenolics, and pine oil.

The following control measures should be instituted to reduce the frequency of bacterial growth in disinfectants and the threat of serious healthcare-associated infections from the use of such 404 contaminated products • First, some disinfectants should not be diluted; those that are diluted must be prepared correctly to achieve the manufacturers' recommended use-dilution. Second, infection-control professionals must learn from the literature what inappropriate activities result in extrinsic contamination (i.e., at the point of use) of germicides and train users to prevent recurrence. Common sources of extrinsic contamination of germicides in the reviewed literature are the water to make working dilutions, contaminated containers, and general contamination of the hospital areas where the germicides are prepared and/or used. Third, stock solutions of germicides must be stored as indicated on the product label. EPA verifies manufacturers' efficacy claims against microorganisms. These measures should provide assurance that products meeting the EPA registration requirements can achieve a certain level of antimicrobial activity when used as directed.

32 Guideline tor D!slntecHon and Stcdlizatlon In Hnal\llcare r:·<:!Cilit!es, 2008

FACTORS AFFECTING THE EFFICACY OF DISINFECTION AND STERILIZATION

The activity of germicides against microorganisms depends on a number of factors, some of which are intrinsic qualities of the organism, others of which are the chemical and external physical environment. Awareness of these factors should lead to better use of disinfection and sterilization processes and will be briefty reviewed. More extensive consideration of these and other factors is available elsewhere 13 ' 14 ' 16• 411- 413 .

Number and Location of Microorganisms All other conditions remaining constant, the larger the number of microbes, the more time a germicide needs to destroy all of them. Spaulding illustrated this relation when he employed identical test conditions and demonstrated that it took 30 minutes to kill 10 B. atrophaeus (formerly Bacillus subtilis) spores but 3 hours to kill 100,000 Bacillus atrophaeus spores. This reinforces the need for scrupulous cleaning of medical instruments before disinfection and sterilization. Reducing the number of microorganisms that must be inactivated through meticulous cleaning, increases the margin of safety when the germicide is used according to the labeling and shortens the exposure time required to kill the entire microbial load. Researchers also have shown that aggregated or clumped cells are more difficult to inactivate than monodispersed cells 414 .

The location of microorganisms also must be considered when factors affecting the efficacy of germicides are assessed. Medical instruments with multiple pieces must be disassembled and equipment such as endoscopes that have crevices, joints, and channels are more difficult to disinfect than are flat- surface equipment because penetration of the disinfectant of all parts of the equipment is more difficult. Only surfaces that directly contact the germicide will be disinfected, so there must be no air pockets and the equipment must be completely immersed for the entire exposure period. Manufacturers should be encouraged to produce equipment engineered for ease of cleaning and disinfection.

innate Resistance of Microorganisms Microorganisms vary greatly in their resistance to chemical germicides and sterilization 342 processes (Figure 1) Intrinsic resistance mechanisms in microorganisms to disinfectants vary. For example, spores are resistant to disinfectants because the spore coat and cortex act as a barrier, mycobacteria have a waxy cell wall that prevents disinfectant entry, and warn-negative bacteria possess 34 343 345 an outer membrane that acts as a barrier to the uptake of disinfectants • - • Implicit in all disinfection strategies is the consideration that the most resistant microbial subpopulation controls the sterilization or disinfection time. That is, to destroy the most resistant types of microorganisms (i.e., bacterial spores), the user needs to employ exposure times and a concentration of germicide needed to achieve complete destruction. Except for prions, bacterial spores possess the highest innate resistance to chemical germicides, followed by coccidia (e.g., Cryptosporidium), mycobacteria (e.g., M. tuberculosis), nonlipid or small viruses (e.g., poliovirus, and coxsackievirus), fungi (e.g., Aspergillus, and Candida), vegetative bacteria (e.g., Staphylococcus, and Pseudomonas) and lipid or medium-size viruses (e.g., herpes, and HIV). The germicidal resistance exhibited by the gram-positive and gram-negative bacteria is similar with some exceptions (e.g., P. aeruginosa which shows greater resistance to some 369 415 416 disinfectants) • • . P. aeruginosa also is significantly more resistant to a variety of disinfectants in 415 its "naturally occurring" state than are cells subcultured on laboratory media • 417 . Rickettsiae, Chlamydiae, and mycoplasma cannot be placed in this scale of relative resistance because information 416 about the efficacy of germicides against these agents is limited . Because these microorganisms contain lipid and are similar in structure and composition to other bacteria, they can be predicted to be inactivated by the same germicides that destroy lipid viruses and vegetative bacteria. A known exception 419 to this supposition is Coxiella burnett/, which has demonstrated resistance to disinfectants .

Concentration and Potency of Disinfectants With other variables constant, and with one exception (iodophors), the more concentrated the

33 Guideline for Disinfection and StuiilizaUon in ll0altl1carc Facilities, 2008

disinfectant, the greater its efficacy and the shorter the time necessary to achieve microbial kill. Generally not recognized, however, is that all disinfectants are not similarly affected by concentration adjustments. For example, quaternary ammonium compounds and phenol have a concentration exponent of 1 and 6, respectively; thus, halving the concentration of a quaternary ammonium compound requires doubling its disinfecting time, but halvinq the concentration of a phenol solution requires a 64-fold (i.e., 2 6 ) increase in 365 its disinfecting time ' 413 · 420

Considering the length of the disinfection time, which depends on the potency of the germicide, also is important. This was illustrated by Spaulding who demonstrated using the mucin-loop test that 70% 4 isopropyl alcohol destroyed 10 M. tuberculosis in 5 minutes, whereas a simultaneous test with 3% phenolic required 2-3 hours to achieve the same level of microbial kill 14 •

Physical and Chemical Factors Several physical and chemical factors also influence disinfectant procedures: temperature, pH, relative humidity, and water hardness. For example, the activity of most disinfectants increases as the temperature increases, but some exceptions exist. Furthermore, too great an increase in temperature causes the disinfectant to degrade and weakens its germicidal activity and thus might produce a potential health hazard.

An increase in pH improves the antimicrobial activity of some disinfectants (e.g., glutaraldehyde, quaternary ammonium compounds) but decreases the antimicrobial activity of others (e.g., phenols, hypochlorites, and iodine). The pH influences the antimicrobial activity by altering the disinfectant 413 molecule or the cell surface •

Relative humidity is the single most important factor influencing the activity of gaseous disinfectantslsterilants, such as EtO, chlorine dioxide, and formaldehyde. Water hardness (i.e., high concentration of divalent cations) reduces the rate of kill of certain disinfectants because divalent cations (e.~., magnesium, calcium) in the hard water interact with the 3 disinfectant to form insoluble precipitates • 421 •

Organic and Inorganic Matter Organic matter in the form of serum, blood, pus, or fecal or lubricant material can interfere with the antimicrobial activity of disinfectants in at least two ways. Most commonly, interference occurs by a chemical reaction between the germicide and the organic matter resulting in a complex that is less germicidal or nongermicidal, leaving less of the active germicide available for attacking microorganisms. Chlorine and iodine disinfectants, in particular, are prone to such interaction. Alternatively, organic 422 423 material can protect microorganisms from attack by acting as a physical barrier •

The effects of inorganic contaminants on the sterilization process were studied during the 1950s and 1960s 424 · 425 . These and other studies show the protection by inorganic contaminants of microorganisms to all sterilization processes results from occlusion in salt crystals 426• 427 . This further emphasizes the importance of meticulous cleaning of medical devices before any sterilization or 426 disinfection procedure because both organic and inorganic soils are easily removed by washing .

Duration of Exposure Items must be exposed to the germicide for the appropriate minimum contact time. Multiple investigators have demonstrated the effectiveness of low-level disinfectants against vegetative bacteria (e.g., Listeria, E. coli, Salmonella, VRE, MRSA), yeasts (e.g., Candida), mycobacteria (e.g., M. 46 64 tuberculosis), and viruses (e.g., poliovirus) at exposure times of 30-60 seconds ' , By law, all applicable label instructions on EPA-registered products must be followed. If the user selects exposure conditions that differ from those on the EPA-registered product label, the user assumes liability for any injuries resulting from off-label use and is potentially subject to enforcement action under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

34 Guideline for Disinfection and Stmilization in i"lenltl1care F'ac1litins, 2008

All lumens and channels of endoscopic instruments must contact the disinfectant Air pockets interfere with the disinfection process, and items that float on the disinfectant will not be disinfected. The disinfectant must be introduced reliably into the internal channels of the device. The exact times for disinfecting medical items are somewhat elusive because of the effect of the aforementioned factors on disinfection efficacy. Certain contact times have proved reliable (Table 1), but, in general, longer contact times are more effective than shorter contact times.

Biofilms 428 Microorganisms may be protected from disinfectants by production of thick masses of cells 421 435 and extracellular materials, or biofilms ' • Biofilms are microbial communities that are tightly attached to surfaces and cannot be easly removed. Once these masses form, microbes within them can be resistant to disinfectants by multiple mechanisms, including physical characteristics of older biofilms, genotypic variation of the bacteria, microbial production of neutralizing enzymes, and physiologic gradients within the biofilm (e.g., pH). Bacteria within biofilms are up to 1,000 times more resistant to 436 437 antimicrobials than are the same bacteria in suspension . Although new decontamination methods are being investi~ated for removing biofilms, chlorine and monochloramines can effectively inactivate 438 biofilm bacteria 4 1 • Investigators have hypothesized that the glycocalyx-like cellular masses on the interior walls of polyvinyl chloride pipe would grotect embedded organisms from some disinfectants and 430 439 440 be a reservoir for continuous contamination 4 '· ' • Biofilms have been found in whirlpools , dental 441 unit waterlines , and numerous medical devices (e.g., contact lenses, reacemakers, hemodialysis 434 4 438 442 systems, urinary catheters, central venous catheters, endoscopes) • '· ' • Their presence can have serious implications for immunocompromised reatients and patients who have indwelling medical 436 443 444 4 6 devices. Some enzymes • • and detergents can degrade biofilms or reduce numbers of viable bacteria within a biofilm, but no products are EPA-registered or FDA-cleared for this purpose.

35 Gurdel111o for Disinlection and SterilizoUon in Healtl>com Facilrt:r1s, 2008

CLEANING

Cleaning is the removal of foreign material (e.g., soil, and organic material) from objects and is normally accomplished using water with detergents or enzymatic products. Thorough cleaning is required before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes. Also, if soiled materials dry or bake onto the instruments, the removal process becomes more difficult and the disinfection or sterilization process less effective or ineffective. Surgical instruments should be presoaked or rinsed to prevent drying of blood and to soften or remove blood from the instruments.

Cleaning is done manually in use areas without mechanical units (e.g., ultrasonic cleaners or washer-disinfectors) or for fragile or difficult-to-clean instruments. \1\ilth manual cleaning, the two essential components are friction and fluidics. Friction (e.g., rubbing/scrubbing the soiled area with a brush) is an old and dependable method. Fluidics (i.e., fluids under pressure) is used to remove soil and debris from internal channels after brushing and when the design does not allow passage of a brush through a 445 channel . \1\ilhen a washer-disinfector is used, care should be taken in loading instruments: hinged instruments should be opened fully to allow adequate contact with the detergent solution; stacking of instruments in washers should be avoided; and instruments should be disassembled as much as possible.

The most common types of mechanical or automatic cleaners are ultrasonic cleaners, washer- decontaminators, washer-disinfectors, and washer-sterilizers. Ultrasonic cleaning removes soil by cavitation and implosion in which waves of acoustic energy are propagated in aqueous solutions to disrupt the bonds that hold particulate matter to surfaces. Bacterial contamination can be present in used ultrasonic cleaning solutions (and other used detergent solutions) because these solutions generally do 446 not make antibacterial label claims . Even though ultrasound alone does not significantly inactivate 44 bacteria, sonication can act synergistically to increase the cidal efficacy of a disinfectant • Users of ultrasonic cleaners should be aware that the cleaning fluid could result in endotoxin contamination of 448 surgical instruments, which could cause severe inflammatory reactions • Washer-sterilizers are modified steam sterilizers that clean by filling the chamber with water and detergent through which steam passes to provide agitation. Instruments are subsequently rinsed and subjected to a short steam- sterilization cycle. Another washer-sterilizer employs rotating spray arms for a wash cycle followed by a steam sterilization cycle at 285'F 449• 450 . Washer-decontaminators/disinfectors act like a dishwasher that uses a combination of water circulation and detergents to remove soil. These units sometimes have a 451 cycle that subjects the instruments to a heat process (e.g., 93'C for 10 minutes) • Washer-disinfectors are generally computer-controlled units for cleaning, disinfecting, and drying solid and hollow surgical and medical equipment. In one study, cleaning (measured as 5-6 log 10 reduction) was achieved on surfaces 452 that had adequate contact with the water ftow in the machine • Detailed information about cleaning and 453 454 455 preparing supplies for terminal sterilization is provided by professional organizations • and books • Studies have shown that manual and mechanical cleaning of endoscopes achieves approximately a 4- 83 104 456 457 log10 reduction of contaminating organisms ' · • • Thus, cleaning alone effectively reduces the number of microorganisms on contaminated equipment. In a quantitative analysis of residual protein contamination of reprocessed surgical instruments, median levels of residual protein contamination per 458 instrument for five trays were 267, 260, 163, 456, and 756 ~g . In another study, the median amount of protein from reprocessed surgical instruments from different hospitals ranged from 8 ~g to 91 ~g • 459

\1\ilhen manual methods were compared with automated methods for cleaning reusable accessory devices used for minimally invasive surgical procedures, the automated method was more efficient for cleaning biopsy forceps and ported and nonported laparoscopic devices and achieved a >99% reduction in soil parameters (i.e., protein, carbohydrate, hemoglobin) in the ported and nonported laparoscopic devices 460, 461

For instrument cleaning, a neutral or near-neutral pH detergent solution commonly is used because such solutions generally provide the best material compatibility profile and good soil removal.

36 Guideline for Disinfr"ction and Sterilization in Henltl>caro Fncilitins, 2008

Enzymes, usually proteases, sometimes are added to neutral pH solutions to assist in removing organic material. Enzymes in these formulations attack proteins that make up a large portion of common soil (e.g., blood, pus). Cleaning solutions also can contain lipases (enzymes active on fats) and amylases (enzymes active on starches). Enzymatic cleaners are not disinfectants, and proteinaceous enzymes can be inactivated by germicides. As with all chemicals, enzymes must be rinsed from the equipment or adverse reactions (e.g., fever, residual amounts of high-level disinfectants, proteinaceous residue) could 462 463 result • • Enzyme solutions should be used in accordance with manufacturer's instructions, which include proper dilution of the enzymatic detergent and contact with equipment for the amount of time 463 specified on the label • Detergent enzymes can result in asthma or other allergic effects in users. Neutral pH detergent solutions that contain enzymes are compatible with metals and other materials used in medical instruments and are the best choice for cleaning delicate medical instruments, especially 457 flexible endoscopes . Alkaline-based cleaning agents are used for processing medical devices because they efficiently dissolve protein and fat residues 464 ; however, they can be corrosive 457 . Some 465 466 data demonstrate that enzymatic cleaners are more effective than neutral detergents ' in removing microorganisms from surfaces but two more recent studies found no difference in cleaning efficiency 443 464 between enzymatic and alkaline-based cleaners ' • Another study found no significant difference 467 between enzymatic and non-enzymatic cleaners in terms of microbial cleaning efficacy • A new non- enzyme, hydrogen peroxide-based formulation (not FDA-cleared) was as effective as enzymatic cleaners in removing protein, blood, carbohydrate, and endotoxin from surface test carriers'" In addition, this 468 product effected a 5-log 10 reduction in microbial loads with a 3-minute exposure at room temperature •

Although the effectiveness of high-level disinfection and sterilization mandates effective cleaning, no "real-time" tests exist that can be employed in a clinical setting to verify cleaning. If such tests were 469 commercially available they could be used to ensure an adequate level of cleaning -472 • ). The only way to ensure adequate cleaning is to conduct a reprocessing verification test (e.g., microbiologic sampling), but this is not routinely recommended 473 • Validation of the cleaning processes in a laboratory-testing program is possible by microorganism detection, chemical detection for organic contaminants, 426 471 radionuclide tagging, and chemical detection for specific ions ' • During the past few years, data have been published describing use of an artificial soil, protein, endotoxin, X-ray contrast medium, or blood to verify the manual or automated cleaning process 169 ' 452 ' 474-478 and adenosine triphosphate bioluminescence and microbiologic sampling to evaluate the effectiveness of environmental surface 479 cleaning 170 • • At a minimum, all instruments should be individually inspected and be visibly clean.

37 Guiddine for Disinfection ~mel ;.)toHiizahon ln I !enllhcaro Faci!ltie~, 2008

DISINFECTION

Many disinfectants are used alone or in combinations (e.g., hydrogen peroxide and peracetic acid) in the health-care setting. These include alcohols, chlorine and chlorine compounds, formaldehyde, glutaraldehyde, orlho-phthalaldehyde, hydrogen peroxide, iodophors, peracetic acid, phenolics, and quaternary ammonium compounds. Commercial formulations based on these chemicals are considered unique products and must be registered with EPA or cleared by FDA. In most instances, a given product is designed for a specific purpose and is to be used in a certain manner. Therefore, users should read labels carefully to ensure the correct product is selected for the intended use and applied efficiently.

Disinfectants are not interchangeable, and incorrect concentrations and inappropriate disinfectants can result in excessive costs. Because occupational diseases among cleaning personnel have been associated with use of several disinfectants (e.g., formaldehyde, glutaraldehyde, and chlorine), precautions (e.g., gloves and proper ventilation) should be used to minimize exposure 316 • 460 • 481 • Asthma and reactive airway disease can occur in sensitized persons exposed to any airborne chemical, including germicides. Clinically important asthma can occur at levels below ceiling levels regulated by OSHA or recommended by NIOSH. The preferred method of control is elimination of the chemical (through engineering controls or substitution) or relocation of the worker.

The following overview of the performance characteristics of each provides users with sufficient information to select an appropriate disinfectant for any item and use it in the most efficient way.

Chemical Disinfectants Alcohol Overview. In the healthcare setting, "alcohol" refers to two water-soluble chemical compounds- 48 ethyl alcohol and isopropyl alcohol-that have generally underrated germicidal characteristics • FDA has not cleared any liquid chemical sterilant or high-level disinfectant with alcohol as the main active ingredient. These alcohols are rapidly bactericidal rather than bacteriostatic against vegetative forms of bacteria; they also are tuberculocidal, fungicidal, and virucidal but do not destroy bacterial spores. Their cidal activity drops sharply when diluted below 50% concentration, and the optimum bactericidal 483 484 concentration is 60%-90% solutions in water (volume/volume) ' •

Mode of Action. The most feasible explanation for the antimicrobial action of alcohol is denaturation of proteins. This mechanism is supported by the observation that absolute ethyl alcohol, a dehydrating agent, is less bactericidal than mixtures of alcohol and water because proteins are denatured 484 485 more quickly in the presence of water ' • Protein denaturation also is consistent with observations 486 that alcohol destroys the dehydrogenases of Escherichia coli , and that ethyl alcohol increases the lag 487 phase of Enterobacter aerogenes and that the lag phase effect could be reversed by adding certain amino acids. The bacteriostatic action was believed caused by inhibition of the production of metabolites essential for rapid cell division.

Microbicidal Activity. Methyl alcohol (methanol) has the weakest bactericidal action of the 488 alcohols and thus seldom Is used in health care • The bactericidal activity of various concentrations of ethyl alcohol (ethanol) was examined against a variety of microorganisms in exposure periods ranging 483 from 1 0 seconds to 1 hour • Pseudomonas aeruginosa was killed in 1 0 seconds by all concentrations of ethanol from 30% to 100% (v/v), and Serratia marcescens, E, coli and Salmonella typhosa were killed in 10 seconds by all concentrations of ethanol from 40% to 100%. The gram-positive organisms Staphylococcus aureus and Streptococcus pyogenes were slightly more resistant, being killed in 10 seconds by ethyl alcohol concentrations of 60%-95%. Isopropyl alcohol (isopropanol) was slightly more 489 bactericidal than ethyl alcohol for E. coli and S. aureus •

Ethyl alcohol, at concentrations of 60%-80%, is a potent virucidal agent inactivating all of the lipophilic viruses (e.g., herpes, vaccinia, and influenza virus) and many hydrophilic viruses (e.g.,

38 Guide!lne ior Disinfoctlon and Sterilization in Hea!thcm·e r.:·acl!ities, 2008

58 49 adenovirus, enterovirus, rhinovirus, and rotaviruses but not hepatitis A virus (HAV) or poliovirus) • Isopropyl alcohol is not active against the nonlipid enteroviruses but is fully active against the lipid viruses 72 • Studies also have demonstrated the ability of ethyl and isopropyl alcohol to inactivate the hepatitis B 490 virus(HBV) 224 • 225 and the herpes virus, and ethyl alcohol to inactivate human immunodeficiency virus 227 491 (HIV) , rotavirus, echovirus, and astrovirus .

In tests of the effect of ethyl alcohol against M. tuberculosis, 95% ethanol killed the tubercle bacilli 492 in sputum or water suspension within 15 seconds . In 1964, Spaulding stated that alcohols were the germicide of choice for tuberculocidal activity, and they should be the standard by which all other tuberculocides are compared. For example, he compared the tuberculocidal activity of iodophor (450 6 ppm), a substituted phenol (3%), and isopropanol (70%/volume) using the mucin-loop test (10 M. tuberculosis per loop) and determined the contact times needed for complete destruction were 120-180 minutes, 45-60 minutes, and 5 minutes, respectively. The mucin-loop test is a severe test developed to produce long survival times. Thus, these figures should not be extrapolated to the exposure times needed when these germicides are used on medical or surgical material 402 •

Ethyl alcohol (70%) was the most effective concentration for killing the tissue phase of Cryptococcus neoformans, Blastomyces dermatitidis, Coccidioides immitis, and Histoplasma capsulatum and the culture phases of the latter three organisms aerosolized onto various surfaces. The culture phase was more resistant to the action of ethyl alcohol and required about 20 minutes to disinfect the 493 494 contaminated surface, compared with <1 minute for the tissue phase • •

Isopropyl alcohol (20%) is effective in killin~ the cysts of Acanthamoeba culbertson/ (560) as are 6 chlorhexidine, hydrogen peroxide, and thimerosal 4 .

Uses. Alcohols are not recommended for sterilizing medical and surgical materials principally because they lack sporicidal action and they cannot penetrate protein-rich materials. Fatal postoperative wound infections with Clostridium have occurred when alcohols were used to sterilize surgical 497 instruments contaminated with bacterial spores • Alcohols have been used effectively to disinfect oral 4 499 500 501 502 and rectal thermometers "· , hospital pagers , scissors , and stethoscopes • Alcohols have 503 504 been used to disinfect fiberoptic endoscopes ' but failure of this disinfectant have lead to Infection 280 505 • • Alcohol towelettes have been used for years to disinfect small surfaces such as rubber stoppers of multiple-dose medication vials or vaccine bottles. Furthermore, alcohol occasionally is used to disinfect external surfaces of equipment (e.~., stethoscopes, ventilators, manual ventilation bags) 506 , 507 5 8 CPR manikins , ultrasound instruments or medication preparation areas. Two studies demonstrated the effectiveness of 70% isopropyl alcohol to disinfect reusable transducer heads in a controlled 509 510 environment ' • In contrast, three bloodstream infection outbreaks have been described when alcohol was used to disinfect transducer heads in an intensive-care setting 511 •

The documented shortcomings of alcohols on equipment are that they damage the shellac mountings of lensed instruments, tend to swell and harden rubber and certain plastic tubing after prolonged and repeated use, bleach rubber and plastic tiles 482 and damage tonometer tips (by 512 deterioration of the glue) after the equivalent of 1 working year of routine use • Tonometer biprisms soaked in alcohol for 4 days developed rough front surfaces that potentially could cause corneal dama~e; 13 this appeared to be caused by weakening of the cementing substances used to fabricate the biprisms . Corneal opacification has been reported when tonometer tips were swabbed with alcohol immediately before measurement of intraocular pressure 514 • Alcohols are flammable and consequently must be stored in a cool, well-ventilated area. They also evaporate rapidly, making extended exposure time difficult to achieve unless the items are immersed.

Chlorine and Chlorine Compounds Overview. Hypochlorites, the most widely used of the chlorine disinfectants, are available as liquid (e.g., sodium hypochlorite) or solid (e.g., calcium hypochlorite). The most prevalent chlorine

39 products in the United States are aqueous solutions of 5.25%-6.15% sodium hypochlorite (see glossary), usually called household bleach. They have a broad spectrum of antimicrobial activity, do not leave toxic 328 residues, are unaffected by water hardness, are inexpensive and fast acting , remove dried or fixed organisms and biofilms from surfaces , and have a low incidence of serious toxicity 51 ,_ 517 • Sodium 465

hypochlorite at the concentration used in household bleach (5.25-6. 15%) can produce ocular irritation or 318 oropharyngeal, esophageal, and gastric burns • , .., _ Other disadvantages of hypochlorites include corrosiveness to metals in high concentrations (>500 ppm), inactivation by organic matter, discoloring or "bleaching" of fabrics, release of toxic chlorine gas when mixed with ammonia or acid (e.g., household 52 525 327 cleaning agents) ,_ , and relative stability • The microbicidal activity of chlorine is attributed largely to undissociated hypochlorous acid (HOCI). The dissociation of HOCI to the less microbicidal form (hypochlorite ion OCr) depends on pH. The disinfecting efficacy of chlorine decreases with an increase in 329 526 pH that parallels the conversion of undissociated HOCI to ocr ' • A potential hazard is production of 52 the carcinogen bis(chloromethyl) ether when hypochlorite solutions contact formaldehyde and the 528 production of the animal carcinogen trihalomethane when hot water is hyperchlorinated After reviewing environmental fate and ecologic data, EPA has determined the currently registered uses of 529 hypochlorites will not result in unreasonable adverse effects to the environment •

Alternative compounds that release chlorine and are used in the health-care setting include demand-release chlorine dioxide, sodium dichloroisocyanurate, and chloramine-T. The advantage of these compounds over the hypochlorites is that they retain chlorine longer and so exert a more prolonged bactericidal effect. Sodium dichloroisocyanurate tablets are stable, and for two reasons, the microbicidal activity of solutions prepared from sodium dichloroisocyanurate tablets might be greater than that of sodium hypochlorite solutions containing the same total available chlorine. First, with sodium dichloroisocyanurate, only 50% of the total available chlorine is free (HOC I and OCr), whereas the remainder is combined (monochloroisocyanurate or dichloroisocyanurate), and as free available chlorine is used up, the latter is released to restore the equilibrium. Second, solutions of sodium dichloroisocyanurate are acidic, whereas sodium hypochlorite solutions are alkaline, and the more 530 microbicidal type of chlorine (HOCI) is believed to predominate -533 . Chlorine dioxide-based disinfectants are prepared fresh as required by mixing the two components (base solution [citric acid with preservatives and corrosion inhibitors] and the activator solution (sodium chlorite]). In vitro suspension tests showed that solutions containing about 140 ppm chlorine dioxide achieved a reduction factor exceeding 10 6 of S. aureus in 1 minute and of Bacillus atrophaeus spores in 2.5 minutes in the presence of 3 g/L bovine albumin. The potential for damaging equipment requires consideration because long-term use can damage the outer plastic coat of the insertion tube 534 In another study, chlorine dioxide solutions at either 600 ppm or 30 ppm killed Mycobacterium avium-intracellufare within 60 seconds after 535 contact but contamination by organic material significantly affected the microbicidal properties .

The microbicidal activity of a new disinfectant, "superoxidized water," has been examined The concept of electrolyzing saline to create a disinfectant or antiseptics is appealing because the basic materials of saline and electricity are inexpensive and the end product (i.e., water) does not damage the environment. The main products of this water are hypochlorous acid (e.g., at a concentration of about 144 mg/L) and chlorine. As with any germicide, the antimicrobial activity of superoxidized water is strongly 536 affected by the concentration of the active ingredient (available free chlorine) • One manufacturer generates the disinfectant at the point of use by passing a saline solution over coated titanium electrodes at 9 amps. The product generated has a pH of 5.0-6.5 and an oxidation-reduction potential (redox) of >950 mV. Although superoxidized water is intended to be generated fresh at the point of use, when 537 tested under clean conditions the disinfectant was effective within 5 minutes when 48 hours old • Unfortunately, the equipment required to produce the product can be expensive because parameters such as pH, current, and redox potential must be closely monitored. The solution is nontoxic to biologic tissues. Although the United Kingdom manufacturer claims the solution is noncorrosive and nondamaging to endoscopes and processing equipment, one flexible endoscope manufacturer (Olympus Key-Med, United Kingdom) has voided the warranty on the endoscopes if superoxidized water is used to disinfect 538 them , As with any germicide formulation, the user should check with the device manufacturer for

40 Guideline for Dislnfl?;Ction and Stori!ization in Hnnltllcare Facilities, 2008

compatibility with the germicide. Additional studies are needed to determine whether this solution could be used as an alternative to other disinfectants or antiseptics for hand washing, skin antisepsis, room 400 539 540 cleaning, or equipment disinfection (e.g., endoscopes, dialyzers) • • • In October 2002, the FDA cleared superoxidized water as a high-level disinfectant (FDA, personal communication, September 18, 2002).

Mode of Action. The exact mechanism by which free chlorine destroys microorganisms has not been elucidated. Inactivation by chlorine can result from a number of factors: oxidation of sulfhydryl enzymes and amino acids; ring chlorination of amino acids; loss of intracellular contents; decreased uptake of nutrients; inhibition of protein synthesis; decreased oxygen uptake; oxidation of respiratory components; decreased adenosine triphosphate production; breaks in DNA; and depressed DNA 329 347 synthesis ' • The actual microbicidal mechanism of chlorine might involve a combination of these factors or the effect of chlorine on critical sites 347 •

Microbicidal Activity. Low concentrations of free available chlorine (e.g., HOCI, ocr, and elemental chlorine-CI,) have a biocidal effect on mrcoplasma (25 ppm) and vegetative bacteria (<5 ppm) 329 in seconds in the absence of an organic load • 41 • Higher concentrations (1 ,000 ppm) of chlorine are required to kill M. tuberculosis using the Association of Official Analytical Chemists (AOAC) tuberculocidal 73 541 542 test • A concentration of 100 ppm will kill ;':99.9% of B. atrophaeus spores within 5 minutes • and 329 destroy mycotic agents in <1 hour • Acidified bleach and regular bleach (5,000 ppm chlorine) can 6 262 inactivate 10 Clostridium difficile spores in ,::10 minutes • One study reported that 25 different viruses 72 were inactivated in 10 minutes with 200 ppm available chlorine • Several studies have demonstrated 61 the effectiveness of diluted sodium hypochlorite and other disinfectants to inactivate HIV • Chlorine 54 (500 ppm) showed inhibition of Candida after 30 seconds of exposure . In experiments using the AOAC Use-Dilution Method, 100 pp,m of free chlorine killed 106-10 7 S. aureus, Salmonella choleraesuis, and P. aeruginosa in <1 0 minutes 27 • Because household bleach contains 5.25%-6.15% sodium hypochlorite, or 52,500-61,500 ppm available chlorine, a 1:1,000 dilution provides about 53-62 ppm available chlorine, and a 1:10 dilution of household bleach provides about 5250-6150 ppm.

Data are available for chlorine dioxide that sup~ort manufacturers' bactericidal, fungicidal, 543 46 sporicidal, tuberculocidal, and virucidal label claims ' . A chlorine dioxide generator has been shown 534 effective for decontaminating flexible endoscopes but it is not currently FDA-cleared for use as a high· 85 level disinfectant • Chlorine dioxide can be produced by mixing solutions, such as a solution of chlorine 329 with a solution of sodium chlorite • In 1986, a chlorine dioxide product was voluntarily removed from the market when its use caused leakage of cellulose-based dialyzer membranes, which allowed bacteria to migrate from the dialysis fluid side of the dialyzer to the blood side 547 •

Sodium dichloroisocyanurate at 2,500 ppm available chlorine is effective against bacteria in the presence of up to 20% plasma, compared with 10% plasma for sodium hypochlorite at 2,500 ppm "'-

"Superoxidized water" has been tested against bacteria, mycobacteria, viruses, fungi, and spores 537 539 549 • • Freshly generated superoxidized water is rapidly effective (<2 minutes) in achieving a 6-log10 • reduction of pathogenic microorganisms (i.e., M. tuberculosis, M. chelonae, poliovirus, HIV, multidrug- resistant S. aureus, E. coli, Candida albicans, Enterococcus faecalis, P. aeruginosa) In the absence of organic loading. However, the biocidal activit¥ of this disinfectant decreased substantially in the presence 53 549 550 of organic material (e.g., 5% horse serum) • ' No bacteria or viruses were detected on artificially 551 contaminated endoscopes after a 5-minute exposure to superoxidized water and HBV-DNA was not detected from any endoscope experimentally contaminated with HBV-positive mixed sera after a 552 disinfectant exposure time of 7 minutes • 328 Uses. Hypochlorites are widely used in healthcare facilities in a variety of settings. Inorganic 1 chlorine solution is used for disinfecting tonometer heads " and for spot-disinfection of countertoRs and 22 228 53 554 floors. A 1:10-1:100 dilution of 5.25%-6.15% sodium hypochlorite (i.e., household bleach) • • • or

41 Guideline lor Dlslnfection and Sterilization in !--!e~:l(thcarn Fad!1tins, 2008

an EPA-registered tuberculocidal disinfectant 17has been recommended for decontaminating blood spills. For small spills of blood (i.e., drops of blood) on noncritical surfaces, the area can be disinfected with a 1:100 dilution of 5.25%-6.15% sodium hypochlorite or an EPA-registered tuberculocidal disinfectant. 63 Because hypochlorites and other germicides are substantially inactivated in the presence of blood ' 548 · 555 556 • , large spills of blood require that the surface be cleaned before an EPA-registered disinfectant or a 557 1:10 (final concentration) solution of household bleach is applied If a sharps injury is possible, the 69 318 surface initially should be decontaminated ' , then cleaned and disinfected (1:10 final concentration) 63 . Extreme care always should be taken to prevent percutaneous injury. At least 500 ppm available 558 chlorine for 10 minutes is recommended for decontaminating CPR training manikins • Full-strength bleach has been recommended for self-disinfection of needles and syringes used for illicit-drug injection when needle-exchange programs are not available. The difference in the recommended concentrations of bleach reflects the difficulty of cleaning the interior of needles and syringes and the use of needles and 559 syringes for parenteral injection • Clinicians should not alter their use of chlorine on environmental 560 561 surfaces on the basis of testing methodologies that do not simulate actual disinfection practices • . 562 Other uses in healthcare include as an irrigating agent in endodontic treatment and as a disinfectant 23 41 for manikins, laundry, dental appliances, hydrotherapy tanks ' , regulated medical waste before 328 563 disposal , and the water distribution system in hemodialysis centers and hemodialysis machines ,

Chlorine long has been used as the disinfectant in water treatment. Hyperchlorination of a Legionel/a-contaminated hospital water system 23 resulted in a dramatic decrease (from 30% to 1.5%) in the isolation of L. pneumophifa from water outlets and a cessation of healthcare-associated Legionnaires' 528 564 disease in an affected unit ' • Water disinfection with monochloramine by municipal water-treatment plants substantially reduced the risk for healthcare-associated Legionnaires disease 565 ' 566 , Chlorine 567 dioxide also has been used to control Legionefla in a hospital water supply. Chloramine T 568 and 41 hypochlorites have been used to disinfect hydrotherapy equipment.

Hypochlorite solutions in tap water at a pH >8 stored at room temperature (23'C) in closed, opaque plastic containers can lose up to 40%-50% of their free available chlorine level over 1 month. Thus, if a user wished to have a solution containing 500 ppm of available chlorine at day 30, he or she should prepare a solution containing 1,000 ppm of chlorine at time 0. Sodium hypochlorite solution does not decompose after 30 days when stored in a closed brown bottle 327 •

The use of powders, composed of a mixture of a chlorine-releasing agent with highly absorbent resin, for disinfecting spills of body fluids has been evaluated by laboratory tests and hospital ward trials. The inclusion of acrylic resin particles in formulations markedly increases the volume of fluid that can be soaked up because the resin can absorb 200-300 times its own weight of fluid, depending on the fluid consistency, When experimental formulations containing 1%, 5%, and 10% available chlorine were evaluated by a standardized surface test, those containing 10% demonstrated bactericidal activity. One Problem with chlorine-releasing granules is that they can generate chlorine fumes when applied to urine '" Formaldehyde Ovetview. Formaldehyde is used as a disinfectant and sterilant in both its liquid and gaseous states. Liquid formaldehyde will be considered briefly in this section, and the gaseous form is reviewed elsewhere 570 . Formaldehyde is sold and used principally as a water-based solution called formalin, which is 37% formaldehyde b~ weight. The aqueous solution is a bactericide, tuberculocide, fungicide, 72 82 57 virucide and sporicide ' ' ·"'. OSHA indicated that formaldehyde should be handled in the workplace as a potential carcinogen and set an employee exposure standard for formaldehyde that limits an 8-hour 574 575 time-weighted average exposure concentration of 0.75 ppm • • The standard includes a second permissible exposure limit in the form of a short-term exposure limit (STEL) of 2 ppm that is the maximum 576 exposure allowed during a 15-minute period . Ingestion of formaldehyde can be fatal, and long-term exposure to low levels in the air or on the skin can cause asthma-like respiratory problems and skin irritation, such as dermatitis and itching. For these reasons, employees should have limited direct contact

42 Gutdeline for Disinfection and Sterilization In HeEl!U!c8rn FacHities, 2008

with formaldehyde, and these considerations limit its role in sterilization and disinfection processes. Key provisions of the OSHA standard that protects workers from exposure to formaldehyde appear in Title 29 of the Code of Federal Regulations (CFR) Part 1910.1048 (and equivalent regulations in states with 577 OSHA-approved state plans) .

Mode of Action. Formaldehyde inactivates microorganisms b¥, alkylating the amino and 3 6 sulfhydral groups of proteins and ring nitrogen atoms of purine bases •

Microbicidal Activity. Varying concentrations of aqueous formaldehyde solutions destroy a wide range of microorganisms. Inactivation of poliovirus in 10 minutes required an 8% concentration of formalin, but all other viruses tested were inactivated with 2% formalin n Four percent formaldehyde is a 82 tuberculocidal agent, inactivating 104 M. tuberculosis in 2 minutes , and 2.5% formaldehyde inactivated 7 572 about 10 Salmonella Typhi in 10 minutes in the presence of organic matter • The sporicidal action of formaldehyde was slower than that of glutaraldehyde in comparative tests with 4% aqueous 82 formaldehyde and 2% glutaraldehyde against the spores of B. anthracis • The formaldehyde solution 4 required 2 hours of contact to achieve an inactivation factor of 10 , whereas glutaraldehyde required only 15 minutes.

Uses. Although formaldehyde-alcohol is a chemical sterilant and formaldehyde is a high-level disinfectant, the health-care uses of formaldehyde are limited by its irritating fumes and its pungent odor even at very low levels (<1 ppm). For these reasons and others-such as its role as a suspected human 578 carcinogen linked to nasal cancer and lung cancer , this germicide is excluded from Table 1. When it is used, , direct exposure to employees generally is limited; however, excessive exposures to 574 579 formaldehyde have been documented for employees of renal transplant units ' , and students in a 580 gross anatomy laboratory • Formaldehyde is used in the health-care setting to prepare viral vaccines (e.g., poliovirus and influenza); as an embalming agent; and to preserve anatomic specimens; and historically has been used to sterilize surgical instruments, especially when mixed with ethanol. A 1997 survey found that formaldehyde was used for reprocessing hemodialyzers by 34% of U.S. hemodialysis 249 581 centers-a 60% decrease from 1983 ' . If used at room temperature, a concentration of 4% with a minimum exposure of 24 hours is required to disinfect disposable hemodialyzers reused on the same 582 583 patient • • Aqueous formaldehyde solutions (1 %-2%) also have been used to disinfect the internal 583 fluid pathways of dialysis machines • To minimize a potential health hazard to dialysis patients, the dialysis equipment must be thoroughly rinsed and tested for residual formaldehyde before use.

Paraformaldehyde, a solid polymer of formaldehyde, can be vaporized by heat for the gaseous decontamination of laminar flow biologic safety cabinets when maintenance work or filter changes require access to the sealed portion of the cabinet.

Glutaraldehyde Overview. Glutaraldehyde is a saturated dialdehyde that has gained wide acceptance as a high- 107 level disinfectant and chemical sterilant . Aqueous solutions of glutaraldehyde are acidic and generally in this state are not sporicidal. Only when the solution is "activated" (made alkaline) by use of alkalinating agents to pH 7.5-8.5 does the solution become sporicidal. Once activated, these solutions have a shelf- life of minimally 14 days because of the polymerization of the glutaraldehyde molecules at alkaline pH levels. This polymerization blocks the active sites (aldehyde groups) of the glutaraldehyde molecules that are responsible for its biocidal activity.

Novel glutaraldehyde formulations (e.g., glutaraldehyde-phenol-sodium phenate, potentiated acid glutaraldehyde, stabilized alkaline glutaraldehyde) produced in the past 30 years have overcome the problem of rapid loss of activity (e.g., use-life 28-30 days) while generally maintaining excellent 584 588 microbicidal activity ' • However, antimicrobial activity depends not only on age but also on use conditions, such as dilution and organic stress. Manufacturers' literature for these preparations suggests the neutral or alkaline glutaraldehydes possess microbicidal and anticorrosion properties superior to

43 Guideline for Dislnf()Cfion and Ster!!1zotion in HL~B!tl1care FadlitJes, 2008

those of acid glutaraldehydes, and a few published reports substantiate these claims 542 • 569 • 590• However, two studies found no difference in the microbicidal activity of alkaline and acid glutaraldehydes 73 • 591 • The use of glutaraldehyde-based solutions in health-care facilities is widespread because of their advantages, including excellent biocidal properties; activity in the presence of organic matter (20% bovine serum); and noncorrosive action to endoscopic equipment, thermometers, rubber, or plastic equipment (Tables 4 and 5),

Mode of Action. The biocidal activity of glutaraldehyde results from its alkylation of sulfhydryl, hydroxyl, carboxyl, and amino groups of microorganisms, which alters RNA, DNA, and protein synthesis. The mechanism of action of glutaraldehydes are reviewed extensively elsewhere 592 • 593 ,

Microbicidal Activity. The in vitro inactivation of microorganisms by glutaraldehydes has been extensively investigated and reviewed 592 ' 593 • Several investigators showed that :':2% aqueous solutions of glutaraldehyde, buffered to pH 7.5-8.5 with sodium bicarbonate effectively killed vegetative bacteria in <2 minutes; M. tuberculosis, fungi, and viruses in <10 minutes; and spores of Bacillus and Clostridium species in 3 hours 542 • 592- 597• Spores of C. difficile are more rapidly killed by 2% glutaraldehyde than are spores of other species of Clostridium and Bacillus 79 • 265 ' 266 • Microorganisms with substantial resistance to glutaraldehyde have been reported, including some mycobacteria (M. chelonae, Mycobacterium 598 601 602 avium-intracellulare, M. xenop1) - , Methylobacterium mesophilicum , Trichosporon, fungal ascospores (e.g., Microascus cinereus, Cheatomium globosum), and Cryptosporidium 271 • 603 • M. 604 chelonae persisted in a 0.2% glutaraldehyde solution used to store porcine prosthetic heart valves •

Two percent alkaline glutaraldehyde solution inactivated 105 M. tuberculosis cells on the surface of penicylinders within 5 minutes at 1B'c 589 • However, subsequent studies" questioned the mycobactericidal prowess of glutaraldehydes. Two percent alkaline glutaraldehyde has slow action (20 to >30 minutes) against M. tuberculosis and compares unfavorably with alcohols, formaldehydes, iodine, and phenol 82 • Suspensions of M. avium, M. intracellulare, and M. gordonae were more resistant to inactivation by a 2% alkaline glutaraldehyde (estimated time to complete inactivation: -60 minutes) than were virulent M. tuberculosis (estimated time to complete inactivation -25 minutes) 605 • The rate of kill was directly proportional to the temperature, and a standardized suspension of M. tuberculosis could not be sterilized within 10 minutes 84 • An FDA-cleared chemical sterilant containing 2.5% glutaraldehyde uses increased temperature (35'C) to reduce the time required to achieve high-level disinfection (5 minutes) 85 • 606 , but its use is limited to automatic endoscope reprocessors equipped with a heater. In another study employing membrane filters for measurement of mycobactericidal activity of 2% alkaline glutaraldehyde, complete inactivation was achieved within 20 minutes at 2o'c when the test inoculum was 106 M. tuberculosis per membrane 81 • Several investigators 55 ' 57 • 73 • 76 • 80 ' 81 ' 84 ' 605 have demonstrated that glutaraldehyde solutions inactivate 2.4 to >5.0 log 10 of M. tuberculosis in 10 minutes (including multidrug-resistant M. tuberculosis) and 4.0-6.4 log 10 of M. tuberculosis in 20 minutes. On the basis of these data and other studies, 20 minutes at room temperature is considered the minimum exposure time 17 19 27 57 83 94 needed to reliably kill Mycobacteria and other vegetative bacteria with :':2% glutaraldehyde • • • • • • 108,111,117-121,607

Glutaraldehyde is commonly diluted during use, and studies showed a glutaraldehyde 608 concentration decline after a few days of use in an automatic endoscope washer ' 609 • The decline occurs because instruments are not thoroughly dried and water is carried in with the instrument, which increases the solution's volume and dilutes its effective concentration 610 • This emphasizes the need to ensure that semicritical equipment is disinfected with an acceptable concentration of glutaraldehyde. Data suggest that 1.0%-1.5% glutaraldehyde is the minimum effective concentration for >2% glutaraldehyde solutions when used as a high-level disinfectant 76 ' 589 ' 590 ' 609 . Chemical test strips or liquid chemical monitors 610' 611 are available for determining whether an effective concentration of glutaraldehyde is present despite repeated use and dilution. The frequency of testing should be based on how frequently the solutions are used (e.g., used daily, test daily; used weekly, test before use; used 30 times per day, test each 1Oth use), but the strips should not be used to extend the use life beyond the expiration date. Data suggest the chemicals in the test strip deteriorate with time 612 and a

44 Guideline tor Disinfection and Sterilization in HonlthG[1tB r-·aci!itins, 2008

manufacturer's expiration date should be placed on the bottles. The bottle of test strips should be dated when opened and used for the period of time indicated on the bottle (e.g., 120 days). The results of test strip monitoring should be documented. The glutaraldehyde test kits have been preliminarily evaluated 612 613 for accuracy and range but the reliability has been questioned • To ensure the presence of minimum effective concentration of the high-level disinfectant, manufacturers of some chemical test strips recommend the use of quality-control procedures to ensure the strips perform properly. If the manufacturer of the chemical test strip recommends a quality-control procedure, users should comply with the manufacturer's recommendations. The concentration should be considered unacceptable or unsafe when the test indicates a dilution below the product's minimum effective concentration (MEC) (generally to .:o1.0%-1.5% glutaraldehyde) by the indicator not changing color.

A 2.0% glutaraldehyde--7.05% phenol--1.20% sodium phenate product that contained 0.125% glutaraldehyde--0.44% phenol--0.075% sodium phenate when diluted 1:16 is not recommended as a high- level disinfectant because it lacks bactericidal activity in the ~resence of organic matter and lacks 49 5 71 614 tuberculocidal, fungicidal, virucidal, and sporicidal activity • • "· • 7 "' 79 • • In December 1991, EPA issued an order to stop the sale of all batches of this product because of efficacy data showing the product is not effective against spores and possibly other microorganisms or inanimate objects as 615 claimed on the label • FDA has cleared a glutaraldehyde-phenol/phenate concentrate as a high-level disinfectant that contains 1.12% glutaraldehyde with 1.93% phenol/phenate at its use concentration. Other FDA cleared glutaraldehyde sterilants that contain 2.4%--3.4% glutaraldehyde are used undiluted 606

Uses. Glutaraldeh¥,de is used most commonly as a high-level disinfectant for medical equipment 69 04 616 such as endoscopes ' 107 ' , spirometry tubing, dialyzers , transducers, anesthesia and respiratory 617 249 618 therapy equipment , hemodialysis proportioning and dialysate delivery systems • , and reuse of 619 laparoscopic disposable plastic trocars • Glutaraldehyde is noncorrosive to metal and does not damage lensed instruments, rubber. or plastics. Glutaraldehyde should not be used for cleaning noncritical surfaces because it is too toxic and expensive.

Colitis believed caused by glutaraldehyde exposure from residual disinfecting solution in endoscope solution channels has been reported and is preventable by careful endoscope rinsing 31 ~ . 620 630 One study found that residual glutaraldehyde levels were higher and more variable after manual 631 disinfection {<0.2 mg/L to 159.5 mg/L) than after automatic disinfection (0.2--6.3 mg/L) • Similarly, keratopathy and corneal decompensation were caused by ophthalmic instruments that were inadequately 632 633 rinsed after soaking in 2% glutaraldehyde • •

Health care personnel can be exposed to elevated levels of glutaraldehyde vapor when equipment is processed in poorly ventilated rooms, when spills occur, when glutaraldehyde solutions are 634 activated or changed, , or when open immersion baths are used. Acute or chronic exposure can result in skin irritation or dermatitis, mucous membrane irritation (eye, nose, mouth), or pulmonary symptoms 318 635 639 • ' • Epistaxis, allergic contact dermatitis, asthma, and rhinitis also have been reported in 636 64 647 health care workers exposed to glutaraldehyde • o.

Glutaraldehyde exposure should be monitored to ensure a safe work environment. Testing can be done by four techniques: a silica gel tube/gas chromatography with a fiame ionization detector, dinitrophenylhydrazine (DNPH)-impregnated filter cassette/high-performance liquid chromatography (HPLC) with an ultraviolet (UV) detector, a passive badge/HPLC, or a handheld glutaraldehyde air monitor 648 • The silica gel tube and the DNPH-impregnated cassette are suitable for monitoring the 0.05 ppm ceiling limit. The passive badge, with a 0.02 ppm limit of detection, is considered marginal at the America! Council of Governmental Industrial Hygienists (ACGIH) ceiling level. The ceiling level is considered too close to the glutaraldehyde meter's 0.03 ppm limit of detection to provide confidence in the readings 646 • ACGIH does not require a specific monitoring schedule for glutaraldehyde; however, a monitoring schedule is needed to ensure the level is less than the ceiling limit. For example, monitoring

45 Guideline for Disinlnction and Sto!'iliza\ion in Hoalthcare Facilitros, 2008

should be done initially to determine glutaraldehyde levels, after procedural or equipment changes, and in 649 response to worker complaints • In the absence of an OSHA permissible exposure limit, if the glutaraldehyde level is higher than the ACGIH ceiling limit of 0.05 ppm, corrective action and repeat 649 monitoring would be prudent •

Engineering and work-practice controls that can be used to resolve these problems include dueled exhaust hoods, air systems that provide 7-15 air exchanges per hour, ductless fume hoods with absorbents for the glutaraldehyde vapor, tight-fitting lids on immersion baths, personal protection (e.g., nitrile or butyl rubber gloves but not natural latex ~loves, goggles) to minimize skin or mucous membrane 50 contact, and automated endoscope processors'· . If engineering controls fail to maintain levels below the ceiling limit, institutions can consider the use of respirators (e.g., a half-face respirator with organic 640 vapor cartridge or a type "C" supplied air respirator with a full facepiece operated in a positive 651 pressure mode) • In general, engineering controls are preferred over work-practice and administrative controls because they do not require active participation by the health-care worker. Even thou?h enforcement of the OSHA ceiling limit was suspended in 1993 by the U.S. Court of Appeals 57 , limiting employee exposure to 0.05 ppm (according to ACGIH) is prudent because, at this level, glutaraldehyde 652 can irritate the eyes, throat, and nose 318 • 5 ' 639 ' • If glutaraldehyde disposal through the sanitary sewer system is restricted, sodium bisulfate can be used to neutralize the glutaraldehyde and make it safe for disposal.

Hydrogen Peroxide Overview. The literature contains several accounts of the properties, germicidal effectiveness, and potential uses for stabilized hydrogen peroxide in the health-care setting. Published reports ascribe good germicidal activit~ to hydrogen peroxide and attest to its bactericidal, virucidal, sporicidal, and 65 655 fungicidal properties • (Tables 4 and 5) The FDA website lists cleared liquid chemical sterilants and high-level disinfectants containing hydrogen peroxide and their cleared contact conditions.

Mode of Action. Hydrogen peroxide works by producing destructive hydroxyl free radicals that can attack membrane lipids, DNA, and other essential cell components. Catalase, produced by aerobic organisms and facultative anaerobes that possess cytochrome systems, can protect cells from metabolically produced hydrogen peroxide by degrading hydrogen peroxide to water and oxygen. This defense is overwhelmed by the concentrations used for disinfection 653 • 654 •

Microbicidal Activity. Hydrogen peroxide is active against a wide range of microorganisms, 654 including bacteria, yeasts, fungi, viruses, and spores 78 • • A 0.5% accelerated hydrogen peroxide demonstrated bactericidal and virucidal activity in 1 minute and mycobactericidal and fungicidal activity in 656 5 minutes • Bactericidal effectiveness and stability of hydrogen peroxide in urine has been demonstrated against a variety of health-care-associated pathogens; organisms with high cellular catalase activity (e.g., S. aureus,s. marcescens, and Proteus m/rabilis) required 30-60 minutes of 8 exposure to 0.6% hydrogen peroxide for a 10 reduction in cell counts, whereas organisms with lower catalase activity (e.Jl·· E. coli, Streptococcus species, and Pseudomonas species) required only 15 minutes' exposure 7 . In an investigation of 3%, 10%, and 15% hydrogen peroxide for reducing spacecraft bacterial populations, a complete kill of 106 spores (i.e., Bacillus species) occurred with a 10% 6 concentration and a 50-minute exposure time. A 3% concentration for 150 minutes killed 10 spores in six 656 3 of seven exposure trials • A 10% hydrogen peroxide solution resulted in a 10 decrease in B. 5 atrophaeus spores, and a ;:1 0 decrease when tested against 13 other pathogens in 30 minutes at 2o"c 659 660 ' • A 3.0% hydrogen peroxide solution was ineffective against VRE after 3 and 10 minutes exposure 661 times and caused only a 2-log 10 reduction in the number of Acanthamoeba cysts in approximately 2 hours."'. A 7% stabilized hydrogen peroxide proved to be sporicidal (6 hours of exposure), mycobactericidal (20 minutes), fungicidal (5 minutes) at full strength, virucidal (5 minutes) and bactericidal 655 (3 minutes) at a 1:16 dilution when a quantitative carrier test was used • The 7% solution of hydrogen peroxide, tested after 14 days of stress (in the form of germ-loaded carriers and respiratory therapy equipment), was sporicidal {> 7 log 10 reduction in 6 hours), mycobactericidal {>6.5 log 10 reduction in 25

46 Guideline for Disinfection and StNilizn\ion in l·leal\hcare r:·01cililies, 2008

minutes), fungicidal {>51og 10 reduction in 20 minutes), bactericidal {>61og 10 reduction in 5 minutes) and 663 virucidal (5 log 10 reduction in 5 minutes) • Synergistic sporicidal effects were observed when spores 664 were exposed to a combination of hydrogen peroxide (5.9%-23.6%) and peracetic acid • Other studies 665 demonstrated the antiviral activity of hydrogen peroxide against rhinovirus • The time required for inactivating three serotypes of rhinovirus using a 3% hydrogen peroxide solution was 6-8 minutes; this time increased with decreasing concentrations (18-20 minutes at 1.5%, 5Q-60 minutes at 0.75%).

Concentrations of hydrogen peroxide from 6% to 25% show promise as chemical sterilants. The product marketed as a sterilant is a premixed, ready-to-use chemical that contains 7.5% hydrogen 69 peroxide and 0.85% phosphoric acid (to maintain a low pH) • The mycobactericidal activity of 7.5% 5 hydrogen peroxide has been corroborated in a study showing the inactivation of >10 multi drug-resistant 666 M. tuberculosis after a 10-minute exposure , Thirty minutes were required for >99.9% inactivation of 667 poliovirus and HAV • Three percent and 6% hydrogen peroxide were unable to inactivate HAV in 1 58 minute in a earlier test • When the effectiveness of 7.5% hydrogen peroxide at 10 minutes was compared with 2% alkaline glutaraldehyde at 20 minutes in manual disinfection of endoscopes, no significant difference in germicidal activity was observed 668 • ). No complaints were received from the nursing or medical staff regarding odor or toxicity. In one study, 6% hydrogen peroxide (unused product was 7.5%) was more effective in the high-level disinfection of flexible endoscopes than was the 2% 456 glutaraldehyde solution • A new, rapid-acting 13.4% hydrogen peroxide formulation (that is not yet FDA-cleared) has demonstrated sporicidal, mycobactericidal, fungicidal, and virucidal efficacy. Manufacturer data demonstrate that this solution sterilizes in 30 minutes and provides high-level disinfection in 5 minutes'". This product has not been used long enough to evaluate material compatibility to endoscopes and other semicritical devices, and further assessment by instrument manufacturers is needed.

Under normal conditions, hydrogen peroxide is extremely stable when properly stored (e.g., in dark containers). The decomposition or loss of potency in small containers is less than 2% per year at 670 ambient temperatures •

Uses. Commercially available 3% hydrogen peroxide is a stable and effective disinfectant when used on inanimate surfaces. It has been used in concentrations from 3% to 6% for disinfecting soft 653 671 672 513 673 397 contact lenses (e.g., 3% for 2-3 hrs) ' • , tonometer biprisms , ventilators , fabrics , and 456 397 endoscopes • Hydrogen peroxide was effective in spot-disinfecting fabrics in patients' rooms • Corneal damage from a hydrogen peroxide-soaked tonometer tip that was not properly rinsed has been 674 reported • Hydrogen peroxide also has been instilled into urinary drainage bags in an attempt to 675 eliminate the bag as a source of bladder bacteriuria and environmental contamination • Although the instillation of hydrogen peroxide into the bag reduced microbial contamination of the bag, this procedure 675 did not reduce the incidence of catheter-associated bacteriuria •

A chemical irritation resembling pseudomembranous colitis caused by either 3% hydrogen 621 peroxide or a 2% glutaraldehyde has been reported • An epidemic of pseudomembrane-like enteritis and colitis in seven patients in a gastrointestinal endoscopy unit also has been associated with inadequate rinsing of 3% hydrogen peroxide from the endoscope 676 •

As with other chemical sterilants, dilution of the hydrogen peroxide must be monitored by regularly testing the minimum effective concentration (i.e., 7.5%-6.0%). Compatibility testing by Olympus America of the 7.5% hydrogen peroxide found both cosmetic changes (e.g., discoloration of black 69 anodized metal finishes) and functional changes with the tested endoscopes (Olympus, written communication, October 15, 1999).

lodophors Overview. Iodine solutions or tinctures long have been used by health professionals primarily as antiseptics on skin or tissue. lodophors, on the other hand, have been used both as antiseptics and

47 Guideline for IJisinfeclion rmd Sterilization in Heslti1care Facilities, 2008

disinfectants. FDA has not cleared any liquid chemical sterilant or high-level disinfectants with iodophors as the main active ingredient An iodophor is a combination of iodine and a solubilizing agent or carrier; the resulting complex provides a sustained-release reservoir of iodine and releases small amounts of free iodine in aqueous solution. The best-known and most widely used iodophor is povidone-iodine, a compound of polyvinylpyrrolidone with iodine. This product and other iodophors retain the germicidal 677 efficacy of iodine but unlike iodine generally are nonstaining and relatively free of toxicity and irritancy ' 678

Several reports that documented intrinsic microbial contamination of antiseptic formulations of 67 661 povidone-iodine and poloxamer-iodine .,. caused a reappraisal of the chemistry and use of 682 iodophors • "Free" iodine (1,) contributes to the bactericidal activity of iodophors and dilutions of iodophors demonstrate more rapid bactericidal action than does a full-strength povidone-iodine solution. The reason for the observation that dilution increases bactericidal activity is unclear, but dilution of povidone-iodine might weaken the iodine linkage to the carrier polymer with an accompanying increase of 680 free iodine in solution • Therefore, iodophors must be diluted according to the manufacturers' directions to achieve antimicrobial activity. Mode of Action. Iodine can penetrate the cell wall of microorganisms quickly, and the lethal effects are believed to result from disruption of protein and nucleic acid structure and synthesis.

Microbicidal Activity. Published reports on the in vitro antimicrobial efficacy of iodophors demonstrate that iodophors are bactericidal, mycobactericidal, and virucidal but can require prolonged 290 68 686 contact times to kill certain fungi and bacterial spores 14 ' 71 -73 ' ' ,_ • Three brands of povidone-iodine solution have demonstrated more ra~id kill (seconds to minutes) of S. aureus and M. chelonae at a 1:100 68 dilution than did the stock solution • The virucidal activity of 75-150 ppm available iodine was demonstrated against seven viruses • Other investi~ators have questioned the efficacy of iodophors 72 68 290 against poliovirus in the presence of organic matter and rotavirus SA-11 in distilled or tapwater • Manufacturers' data demonstrate that commercial iodophors are not sporicidal, but they are tuberculocidal, fungicidal, virucidal, and bactericidal at their recommended use-dilution.

Uses. Besides their use as an antiseptic, iodophors have been used for disinfecting blood culture bottles and medical equipment, such as hydrotherapy tanks, thermometers, and endoscopes. Antiseptic iodophors are not suitable for use as hard-surface disinfectants because of concentration differences. lodophors formulated as antiseptics contain less free iodine than do those formulated as 376 disinfectants • Iodine or iodine-based antiseptics should not be used on silicone catheters because 687 they can adversely affect the silicone tubing •

Ortho-phthalaldehyde (OPA) Overview. Ortho-phthalaldehyde is a high-level disinfectant that received FDA clearance in October 1999. It contains 0.55% 1,2-benzenedicarboxaldehyde (OPA). OPA solution is a clear, pale- blue liquid with a pH of 7.5. (Tables 4 and 5)

Mode of Action. Preliminary studies on the mode of action of OPA suggest that both OPA and glutaraldehyde interact with amino acids, proteins, and microorganisms. However, OPA is a less potent cross-linking agent This is compensated for by the lipophilic aromatic nature of OPA that is likely to 686 690 assist its uptake through the outer layers of mycobacteria and gram-negative bacteria - • OPA 691 appears to kill spores by blocking the spore germination process .

69 100 271 Microbicidal Activity. Studies have demonstrated excellent microbicidal activity in vitro • • • 400 692 703 • ' For example, OPA has superior mycobactericidal activity (5-log 1o reduction in 5 minutes) to , glutaraldehyde. The mean times required to produce a 6-log 10 reduction forM. bovis using 0.21% OPA 693 was 6 minutes, compared with 32 minutes using 1.5% glutaraldehyde • OPA showed good activity against the mycobacteria tested, including the glutaraldehyde-resistant strains, but 0.5% OPA was not sporicidal with 270 minutes of exposure. Increasing the pH from its unadjusted level (about 6.5) to pH 8 694 improved the sporicidal activity of OPA • The level of biocidal activity was directly related to the

48 Guideline tor Disinfccli0n and S!eriiiZfltion in Hcaltl'lcaro F'acilit!es, 2008

temperature. A greater than 5-log" reduction of B. atrophaeus spores was observed in 3 hours at 35"c, than in 24 hours at 20"c. Also, with an exposure time _:::5 minutes, biocidal activity decreased with increasin~ serum concentration. However, efficacy did not differ when the exposure time was ,::10 6 minutes 7 • In addition, OPA is effective {>5-log 10 reduction) against a wide range of microorganisms, 694 including glutaraldehyde-resistant mycobacteria and B. atrophaeus spores

The influence of laboratory adaptation of test strains, such asP. aeruginosa, to 0.55% OPA has been evaluated. Resistant and multiresistant strains increased substantially in susceptibility to OPA after laboratory adaptation ~og 10 reduction factors increased by 0.54 and 0.91 for resistant and multiresistant 7 strains, respectively) 4• Other studies have found naturally occurring cells of P. aeurginosa were more 705 resistant to a variety of disinfectants than were subcultured cells •

Uses. OPA has several potential advantages over glutaraldehyde. It has excellent stability over 706 a wide pH range (pH 3-9), is not a known irritant to the eyes and nasal passages , does not require exposure monitoring, has a barely perceptible odor, and requires no activation. OPA, like glutaraldehyde, has excellent material compatibility. A potential disadvantage of OPA is that it stains proteins gray 69 (including unprotected skin) and thus must be handled with caution • However, skin staining would indicate improper handling that requires additional training and/or personal protective equipment (e.g., gloves, eye and mouth protection, and fluid-resistant gowns). OPA residues remaining on inadequately water-rinsed transesophageal echo probes can stain the patient's mouth 707 • Meticulous cleaning, using the correct OPA exposure time (e.g., 12 minutes) and copious rinsing of the probe with water should eliminate this problem. The results of one study provided a basis for a recommendation that rinsing of instruments disinfected with OPA will require at least 250 ml of water per channel to reduce the chemical 708 residue to a level that will not compromise patient or staff safety (<1 ppm) • Personal protective 400 equipment should be worn when contaminated instruments, equipment, and chemicals are handled In addition, equipment must be thoroughly rinsed to prevent discoloration of a patient's skin or mucous membrane.

In April 2004, the manufacturer of OPA disseminated information to users about patients who reportedly experienced an anaphylaxis-like reaction after cystoscopy where the scope had been reprocessed using OPA. Of approximately 1 million urologic procedures performed using instruments reprocessed using OPA, 24 cases (17 cases in the United States, six in Japan, one in the United Kingdom) of anaphylaxis-like reactions have been reported after repeated cystoscopy (typically after four to nine treatments). Preventive measures include removal of OPA residues by thorough rinsing and not using OPA for reprocessing urologic instrumentation used to treat patients with a history of bladder cancer (Nevine Erian, personal communication, June 4, 2004; Product Notification, Advanced Sterilization Products, April 23, 2004) 709 •

A few OPA clinical studies are available. In a clinical-use study, OPA exposure of 100 endoscopes for 5 minutes resulted in a >5-log 10 reduction in bacterial load. Furthermore, OPA was 100 effective over a 14-day use cycle • Manufacturer data show that OPA will last longer in an automatic endoscope reprocessor before reaching its MEC limit (MEC after 82 cycles) than will glutaraldehyde 400 (MEC after 40 cycles) • High-pressure liquid chromatography confirmed that OPA levels are 706 710 maintained above 0.3% for at least 50 cycles ' • OPA must be disposed in accordance with local and state regulations. If OPA disposal through the sanitary sewer system is restricted, glycine (25 grams/gallon) can be used to neutralize the OPA and make it safe for disposal.

The high-level disinfectant label claims for OPA solution at zo"c vary worldwide (e.g., 5 minutes in Europe, Asia, and Latin America; 10 minutes in Canada and Australia; and 12 minutes in the United States). These label claims differ worldwide because of differences in the test methodology and requirements for licensure. In an automated endoscope reprocessor with an FDA-cleared capability to maintain solution temperatures at 2s"c, the contact time for OPA is 5 minutes.

49 Guidelrne lor Disinfeclion and Sterili:w\ion in H0aithcare l'acilitres, 200il

Peracetic Acid Overview. Peracetic, or peroxyacetic, acid is characterized by rapid action against all microorganisms. Special advantages of peracetic acid are that it lacks harmful decomposition products (i.e., acetic acid, water, oxygen, hydrogen peroxide), enhances removal of organic material 711 , and leaves no residue. It remains effective in the presence of organic matter and is sporicidal even at low temperatures (Tables 4 and 5). Peracetic acid can corrode copper, brass, bronze, plain steel, and galvanized iron but these effects can be reduced by additives and pH modifications. It is considered unstable, particularly when diluted; for example, a 1% solution loses half its strength through hydrolysis in 654 6 days, whereas 40% peracetic acid loses 1%--2% of its active ingredients per month •

Mode of Action. Little is known about the mechanism of action of peracetic acid, but it is believed to function similarly to other oxidizing agents-that is, it denatures proteins, disrupts the cell wall 654 permeability, and oxidizes sulfhydryl and sulfur bonds in proteins, enzymes, and other metabolites

Microbicidal Activity. Peracetic acid will inactivate gram-positive and gram-negative bacteria, fungi, and yeasts in .::;5 minutes at <100 ppm. In the presence of organic matter, 200--500 ppm is required. For viruses, the dosage range is wide (12--2250 ppm), with poliovirus inactivated in yeast extract in 15 minutes with 1,500--2,250 ppm. In one study, 3.5% peracetic acid was ineffective against 58 HAV after 1-minute exposure using a carrier test . Peracetic acid (0.26%) was effective (log 10 reduction factor >5) against all test strains of mycobacteria (M. tuberculosis, M. avium-intrace/lulare, M. chelonae, 712 and M. fortuitum) within 20--30 minutes in the presence or absence of an organic load 607 ' • With bacterial spores, 500--10,000 ppm (0.05%--1 %) inactivates spores in 15 seconds to 30 minutes using a spore suspension test 654 • 659 ' 711-715 •

Uses. An automated machine using peracetic acid to chemically sterilize medical (e.g., 718 endoscopes, arthroscopes), surgical, and dental instruments is used in the United States 71 ,_ • As previously noted, dental handpieces should be steam sterilized. The sterilant, 35% peracetic acid, is diluted to 0.2% with filtered water at 5o'c. Simulated-use trials have demonstrated excellent microbicidal 111 718 722 activity • - , and three clinical trials have demonstrated both excellent microbial killing and no clinical 723 724 failures leading to infection"· ' • The high efficacy of the system was demonstrated in a comparison of the efficacies of the system with that of ethylene oxide. Only the peracetic acid system completely killed 6 lo~ 10 of M. chelonae, E. faecalis, and B. atrophaeus spores with both an organic and inorganic challenge 22 • An investigation that compared the costs, performance, and maintenance of urologic endoscopic equipment processed by high-level disinfection (with glutaraldehyde) with those of the peracetic acid system reported no clinical differences between the two systems. However, the use of this system led to higher costs than the high-level disinfection, including costs for processing ($6.11 vs. $0.45 per cycle), purchasing and training ($24,845 vs. $16), installation ($5,800 vs. $0), and endoscope repairs 90 ($6,037 vs. $445) • Furthermore, three clusters of infection using the peracetic acid automated endoscope reprocessor were linked to inadequately processed bronchoscopes when inappropriate 725 channel connectors were used with the system • These clusters highlight the importance of training, proper model-specific endoscope connector systems, and quality-control procedures to ensure compliance with endoscope manufacturer recommendations and professional organization guidelines. An alternative high-level disinfectant available in the United Kingdom contains 0.35% peracetic acid. 466 Although this product is rapidly effective against a broad range of microorganisms • 7"· 727 , it tarnishes 727 the metal of endoscopes and is unstable, resulting in only a 24-hour use life •

Peracetic Acid and Hydrogen Peroxide Overview. Two chemical steri\ants are available that contain peracetic acid plus hydrogen peroxide (i.e., 0.08% peracetic acid plus 1.0% hydrogen peroxide [no longer marketed]; and 0.23% peracetic acid plus 7.35% hydrogen peroxide (Tables 4 and 5).

Microbicidal Activity. The bactericidal properties of peracetic acid and hydrogen peroxide have 728 been demonstrated . Manufacturer data demonstrated this combination of peracetic acid and

50 Guideline tor Disinfection and Sterilization in Hoalt!lcme Facilitres, 2008

hydrogen peroxide inactivated all microorganisms except bacterial spores within 20 minutes. The 0.08% peracetic acid p,lus 1.0% hydrogen peroxide product effectively inactivated glutaraldehyde-resistant 9 mycobacteria' •

Uses. The combination of peracetic acid and hydrogen peroxide has been used for disinfecting 730 hemodialyzers • The percentage of dialysis centers using a peracetic acid-hydrogen peroxide-based 249 disinfectant for reprocessing dialyzers increased from 5% in 1983 to 56% in 1997 • Olympus America does not endorse use of 0.08% peracetic acid plus 1. 0% hydrogen peroxide (Olympus America, personal communication, April 15, 1998) on any Olympus endoscope because of cosmetic and functional damage and ~II not assume liability for chemical damage resulting from use of this product. This product is not currently available. FDA has cleared a newer chemical sterilant ~th 0.23% peracetic acid and 7.35% hydrogen peroxide (Tables 4 and 5). After testing the 7.35% hydrogen peroxide and 0.23% peracetic acid product, Olympus America concluded it was not compatible ~th the company's flexible gastrointestinal endoscopes; this conclusion was based on immersion studies where the test insertion tubes had failed because of swelling and loosening of the black polymer layer of the tube (Olympus America, personal communication, September 13, 2000).

Phenolics Overview. Phenol has occupied a prominent place in the field of hospital disinfection since its initial use as a germicide by Lister in his pioneering work on antiseptic surgery. In the past 30 years, however, work has concentrated on the numerous phenol derivatives or phenolics and their antimicrobial properties. Phenol derivatives originate when a functional group (e.g., alkyl, phenyl, benzyl, halogen) replaces one of the hydrogen atoms on the aromatic ring. Two phenol derivatives commonly found as constituents of hospital disinfectants are ortho-phenylphenol and ortho-benzyl-para-chlorophenol. The antimicrobial properties of these compounds and many other phenol derivatives are much improved over those of the parent chemical. Phenolics are absorbed by porous materials, and the residual disinfectant can irritate tissue. In 1970, depigmentation of the skin was reported to be caused by phenolic germicidal 731 detergents containing para-tertiary butylphenol and para-tertiary amylphenol •

Mode of Action. In high concentrations, phenol acts as a gross protoplasmic poison, penetrating and disrupting the cell wall and precipitating the cell proteins. Low concentrations of phenol and higher molecular-weight phenol derivatives cause bacterial death by inactivation of essential enzyme 732 systems and leakage of essential metabolites from the cell wall •

Microbicidal Activity. Published reports on the antimicrobial efficacy of commonly used ~henolics showed they were bactericidal, fungicidal, virucidal, and tuberculocidal 14 61 71 73 227 416 573 732 • • • • • • • - 38. One study demonstrated little or no virucidal effect of a phenolic against coxsackie 84, echovirus 11, 736 and poliovirus 1 • Similarly, 12% ortho-phenylphenol failed to inactivate any of the three hydrophilic 72 viruses after a 10-minute exposure time, although 5% phenol was lethal for these viruses • A 0.5% dilution of a phenolic (2.8% ortho-phenylphenol and 2.7% ortho-benzyl-para-chlorophenol) inactivated HIV 227 and a 2% solution of a phenolic (15% ortho-phenylphenol and 6.3% para-tertiary-amylphenol) inactivated all but one of 11 fungi tested 71 •

Manufacturers' data using the standardized AOAC methods demonstrate that commercial phenolics are not sporicidal but are tuberculocidal, fungicidal, virucidal, and bactericidal at their recommended use-dilution. Attempts to substantiate the bactericidal label claims of phenolics using the 737 AOAC Use-Dilution Method occasionally have failed 416• • However, results from these same studies have varied dramatically among laboratories testing identical products.

Uses. Many phenolic germicides are EPA-registered as disinfectants for use on environmental surfaces (e.g., bedside tables, bedrails, and laboratory surfaces) and noncritical medical devices. Phenolics are not FDA-cleared as high-level disinfectants for use with semi critical items but could be used to preclean or decontaminate critical and semicritical devices before terminal sterilization or high-

51 Guid<~line lor IJisinfcclion and Stm-ilizntion in Hefllihr:arn Faciltttcs, 2008

level disinfection,

The use of phenolics in nurseries has been questioned because of hyperbilirubinemia in infants placed in bassinets where phenolic detergents were used 739, In addition, bilirubin levels were reported to increase in phenolic-exposed infants, compared with nonphenolio-exposed infants, when the phenolic 740 was prepared according to the manufacturers' recommended dilution , If phenolics are used to clean nursery ftoors, they must be diluted as recommended on the product label. Phenolics (and other disinfectants) should not be used to clean infant bassinets and incubators while occupied, If phenolics are used to terminally clean infant bassinets and incubators, the surfaces should be rinsed thoroughly with water and dried before reuse of infant bassinets and incubators 17 ,

Quaternary Ammonium Compounds Overview. The quaternary ammonium compounds are widely used as disinfectants, Health- care-associated infections have been reported from contaminated quaternary ammonium compounds 741 742 used to disinfect patient-care supplies or equipment, such as cystoscofes or cardiac catheters ' • 7 3 The quaternaries are good cleaning agents, but high water hardness and materials such as cotton and gauze pads can make them less microbicidal because of insoluble precipitates or cotton and gauze pads absorb the active ingredients, respectively. One study showed a significant decline (-40%-50% lower at 1 hour) in the concentration of quaternaries released when cotton rags or cellulose-based wipers were used in the open-bucket system, compared with the nonwoven spunlace wipers in the closed-bucket 744 system As with several other disinfectants (e.g., phenolics, iodophors) gram-negative bacteria can survive or grow in them 404 •

Chemically, the quaternaries are organically substituted ammonium compounds in which the nitrogen atom has a valence of 5, four of the substituent radicals (R1-R4) are alkyl or heterocyclic radicals 745 of a given size or chain length, and the fifth (X') is a halide, sulfate, or similar radical • Each compound exhibits its own antimicrobial characteristics, hence the search for one compound with outstanding antimicrobial properties. Some of the chemical names of quaternary ammonium compounds used in healthcare are alkyl dimethyl benzyl ammonium chloride, alkyl didecyl dimethyl ammonium chloride, and dialkyl dimethyl ammonium chloride. The newer quaternary ammonium compounds (i.e., fourth generation), referred to as twin-chain or dialkyl quaternaries (e.g. didecyl dimethyl ammonium bromide and dioctyl dimethJel ammonium bromide), purportedly remain active in hard water and are tolerant of 7 6 anionic residues .

A few case reports have documented occupational asthma as a result of exposure to benzalkonium chloride 747 •

Mode of Action. The bactericidal action of the quaternaries has been attributed to the inactivation of energy-producing enzymes, denaturation of essential cell proteins, and disruption of the 745 746 cell membrane"'. Evidence exists that supports these and other possibilities •

Microbicidal Activity. Results from manufacturers' data sheets and from published scientific literature indicate that the quaternaries sold as hospital disinfectants are generally fungicidal, bactericidal, and virucidal against lipophilic (enveloped) viruses; they are not sporicidal and a.enerally not 14 54 56 61 71 7 166 297 746 749 tuberculocidal or virucidal against hydrophilic (nonenveloped) viruses • ·"· • • • • • • • • • 73 The poor mycobactericidal activities of quaternary ammonium compounds have been demonstrated "· Quaternary ammonium compounds (as well as 70% isopropyl alcohol, phenolic, and a chlorine- containing wipe [80 ppm]) effectively (>95%) remove and/or inactivate contaminants (i.e., multidrug- resistant S. aureus, vancomycin-resistant Entercoccus, P. aeruginosa) from computer keyboards with a 5-second application time. No functional damage or cosmetic changes occurred to the computer 45 keyboards after 300 applications of the disinfectants .

Attempts to reproduce the manufacturers' bactericidal and tuberculocidal claims using the AOAC

52 Guideline for Disinfection anrJ Sterilization in Hcalthcam Facilities, 2008

tests with a limited number of quaternary ammonium compounds occasionally have failed 73• 416• 737 • However, test results have varied extensively among laboratories testing identical products 416• 737 •

Uses. The quaternaries commonly are used in ordinary environmental sanitation of noncritical surfaces, such as floors, furniture, and walls. EPA-registered quaternary ammonium compounds are appropriate to use for disinfecting medical equipment that contacts intact skin (e.g., blood pressure cuffs).

53 Guideline 'for Disinfection and SterHiLntlon ln HerillthC<3ro Facilities, 2008

MISCELLANEOUS INACTIVATING AGENTS

Other Germicides Several compounds have antimicrobial activity but for various reasons have not been incorporated into the armamentarium of health-care disinfectants. These include mercurials, sodium hydroxide, J3-propiolactone, chlorhexidine gluconate, cetrimide-chlorhexidine, glycols (triethylene and propylene), and the Tego disinfectants. Two authoritative references examine these agents in detai1 16 ' 412 •

A peroxygen-containing formulation had marked bactericidal action when used as a 1% weight/volume solution and virucidal activity at 3% 49 , but did not have mycobactericidal activity at concentrations of 2.3% and 4% and exf,'osure times ranging from 30 to 120 minutes 750• It also required 7 1 20 hours to kill B. atrophaeus spores . A powder-based peroxygen compound for disinfecting contaminated spill was strongly and rapidly bactericidal 752 •

In preliminary studies, nanoemulsions (composed of detergents and lipids in water) showed activity against vegetative bacteria, envelo,p,ed viruses and Candida. This product represents a potential 755 agent for use as a topical biocidal agent. 7 "" .

756 703 New disinfectants that require further evaluation include glucoprotamin , tertiary amines • and a light-activated antimicrobial coating 757 . Several other disinfection technologies might have potential 758 applications in the healthcare setting .

Metals as Microbicides 759 421 760 Comprehensive reviews of antisepsis , disinfection , and anti-infective chemotherapy 761 762 barely mention the antimicrobial activity of heavy metals • • Nevertheless, the anti-infective activity of some heavy metals has been known since antiquity. Heavy metals such as silver have been used for prophylaxis of conjunctivitis of the newborn, topical therapy for burn wounds, and bonding to indwelling 763 catheters, and the use of heavy metals as antiseptics or disinfectants is again being explored • Inactivation of bacteria on stainless steel surfaces by zeolite ceramic coatings containing silver and zinc 764 765 ions has also been demonstrated • •

Metals such as silver, iron, and copper could be used for environmental control, disinfection of 400 water, or reusable medical devices or incorporated into medical devices (e.g., intravascular catheters) ' 761 763 76 770 ' • .. . A comparative evaluation of six disinfectant formulations for residual antimicrobial activity demonstrated that only the silver disinfectant demonstrated significant residual activity against S. aureus 763 and P. aeruginosa • Preliminary data suggest metals are effective against a wide variety of microorganisms.

Clinical uses of other heavy metals include copper-8-quinolinolate as a fungicide against 771 774 Aspergillus, copper-silver ionization for Legionella disinfection - , organic mercurials as an antiseptic (e.g., mercurochrome) and preservative/disinfectant (e.g., thimerosal [currently being removed from vaccines]) in pharmaceuticals and cosmetics 762 •

Ultraviolet Radiation (UV) The wavelength of UV radiation ranges from 328 nm to 210 nm (3280 A to 2100 A). Its maximum bactericidal effect occurs at 240-280 nm. Mercury vapor lamps emit more than 90% of their radiation at 77 253.7 nm, which is near the maximum microbicidal activity . Inactivation of microorgani.sms results from destruction of nucleic acid through induction of thymine dimers. UV radiation has been employed in 776 775 777 778 the disinfection of drinking water , air , titanium implants , and contact lenses . Bacteria and 775 viruses are more easily killed by UV light than are bacterial spores • UV radiation has several potential applications, but unfortunately its germicidal effectiveness and use is influenced by organic matter; wavelength; type of suspension; temperature; type of microorganism; and UV intensity, which is affected by distance and dirty tubes779 . The application of UV radiation in the health-care environment (i.e.,

54 Guideline for Disinfection and Sterilizn\ion in Healthc;,tre Facilittes, 2008

operating rooms, isolation rooms, and biologic safety cabinets) is limited to destruction of airborne organisms or inactivation of microorganisms on surfaces. The effect of UV radiation on postoperative wound infections was investigated in a double-blind, randomized study in five university medical centers. After following 14,854 patients over a 2-year period, the investigators reported the overall wound infection rate was unaffected by UV radiation, although postoperative infection in the "refined clean" surgical procedures decreased significantly (3.8%--2.9%) 780 • No data support the use of UV lamps in isolation rooms, and this practice has caused at least one epidemic of UV-induced skin erythema and keratoconjunctivitis in hospital patients and visitors 781 .

Pasteurization Pasteurization is not a sterilization process; its purpose is to destroy all pathogenic microorganisms. However, pasteurization does not destroy bacterial spores. The time-temperature relation for hot-water pasteurization is generally -70°C (158°F) for 30 minutes. The water temperature 782 and time should be monitored as part of a ;t,uality-assurance program . Pasteurization of respiratory 783 784 78 therapy • and anesthesia equipment is a recognized alternative to chemical disinfection. The efficacy of this process has been tested using an inoculum that the authors believed might simulate 7 contamination by an infected patient. Use of a large inoculum (1 0 ) of P. aeruginosa or Acinetobacter ca/coaceticus in sets of respiratory tubing before processing demonstrated that machine-assisted chemical processing was more efficient than machine-assisted pasteurization with a disinfection failure 783 rate of 6% and 83%, respectively • Other investigators found hot water disinfection to be effective (inactivation factor >5 log 10) against multiple bacteria, including multidrug-resistant bacteria, for disinfecting reusable anesthesia or respiratory therapy equipment 784 _78.,

Flushing- and Washer-Disinfectors Flushing- and washer-disinfectors are automated and closed equipment that clean and disinfect objects from bedpans and washbowls to surgical instruments and anesthesia tubes. Items such as bedpans and urinals can be cleaned and disinfected in flushing-disinfectors. They have a short cycle of a few minutes. They clean by flushing with warm water, possibly with a detergent, and then disinfect by flushing the items with hot water or with steam. Because this machine empties, cleans, and disinfects, manual cleaning is eliminated, fewer disposable items are needed, and fewer chemical germicides are used. A microbiologic evaluation of one washer/disinfector demonstrated complete inactivation of 787 suspensions of E. faeca/is or poliovirus . Other studies have shown that strains of Enterococcus faecium can survive the British Standard for heat disinfection of bedpans (80"c for 1 minute). The significance of this finding with reference to the potential for enterococci to survive and disseminate in the 788 790 health-care environment is debatable - . These machines are available and used in many European countries.

Surgical instruments and anesthesia equipment are more difficult to clean. They are run in washer-disinfectors on a longer cycle of approximately 20--30 minutes with a detergent. These machines 791 also disinfect by hot water at approximately go"c .

55 Guideline tor Disinfection and Stetilizntion in llenlt!lcarc Facilities, 2008

THE REGULATORY FRAMEWORK FOR DISINFECTANTS AND STERILANTS

Before using the guidance provided in this document, health-care workers should be aware of the federal laws and regulations that govern the sale, distribution, and use of disinfectants and sterilants. In particular, health-care workers need to know what requirements pertain to them when they apply these products. Finally, they should understand the relative roles of EPA, FDA, and CDC so the context for the guidance provided in this document is clear.

EPA and FDA In the United States, chemical germicides formulated as sanitizers, disinfectants, or sterilants are regulated in interstate commerce by the Antimicrobials Division, Office of Pesticides Program, EPA, under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) of 1947, as 792 amended • Under FIFRA, any substance or mixture of substances intended to prevent, destroy, repel, or mitigate any pest (including microorganisms but excluding those in or on living humans or animals) must be registered before sale or distribution. To obtain a registration, a manufacturer must submit specific data about the safety and effectiveness of each product. For example, EPA requires manufacturers of sanitizers, disinfectants, or chemical sterilants to test formulations by using accepted methods for microbiocidal activity, stability, and toxicity to animals and humans. The manufacturers submit these data to EPA along with proposed labeling. If EPA concludes the product can be used without causing "unreasonable adverse effects," then the product and its labeling are registered, and the manufacturer can sell and distribute the product in the United States.

FIFRA also requires users of products to follow explicitly the labeling directions on each product. The following standard statement appears on all labels under the "Directions for Use" heading: "It is a violation of federal law to use this product in a manner inconsistent with its labeling." This statement means a health-care worker must follow the safety precautions and use directions on the labeling of each registered product. F allure to follow the specified use-dilution, contact time, method of application, or any other condition of use Is considered a misuse of the product and potentially subject to enforcement action under FIFRA.

In general, EPA regulates disinfectants and sterilants used on environmental surfaces, and not those used on critical or semicritical medical devices; the latter are regulated by FDA. In June 1993, FDA and EPA issued a "Memorandum of Understanding" that divided responsibility for review and surveillance of chemical germicides between the two agencies. Under the agreement, FDA regulates liquid chemical sterilants used on critical and semicritical devices, and EPA regulates disinfectants used on noncritical 793 surfaces and gaseous sterilants • In 1996, Congress passed the Food Quality Protection Act (FQPA). This act amended FIFRA in regard to several types of products regulated by both EPA and FDA. One provision of FQPA removed regulation of liquid chemical sterilants used on critical and semicritical 792 794 medical devices from EPA's jurisdiction, and it now rests solely with FDA ' • EPA continues to register nonmedical chemical sterilants. FDA and EPA have considered the impact of FQPA, and in January 2000, FDA published its final guidance document on product submissions and labeling. Antiseptics are considered antimicrobial drugs used on living tissue and thus are regulated by FDA under the Food, Drug and Cosmetic Act. FDA regulates liquid chemical sterilants and high-level disinfectants intended to process critical and semicritical devices. FDA has published recommendations on the types of test methods that manufacturers should submit to FDA for 51 O(k] clearance for such agents.

CDC At CDC, the mission of the Coordinating Center for Infections Diseases is to guide the public on how to prevent and respond to infectious diseases in both health-care settings and at home. With respect to disinfectants and sterilants, part of CDC's role is to inform the public (in this case healthcare personnel) of current scientific evidence pertaining to these products, to comment about their safety and efficacy, and to recommend which chemicals might be most appropriate or effective for specific microorganisms and settings.

56 Cuidoline for Disinfection and Sterilization in llnaiH>rarn Facilitios, 2008

Test Methods The methods EPA has used for registration are standardized by the AOAC International; however, a survey of scientific literature reveals a number of problems with these tests that were reported 58 76 800 during 1987-1990 ' ' 80 ' 428 • 736 • 737 • 79" that cause them to be neither accurate nor reproducible 416 • 73'- As part of their regulatory authorit~, EPA and FDA support development and validation of methods for 801 80 assessing disinfection claims " • For example, EPA has supported the work of Dr. Syed Sattar and coworkers who have developed a two-tier quantitative carrier test to assess sporicidal, mycobactericidal, 701 803 bactericidal, fungicidal, virucidal, and protozoacidal activity of chemical germicides • • EPA is accepting label claims against hepatitis B virus (HBV) using a surrogate organism, the duck HBV, to 124 80 quantify disinfectant activity • • EPA also is accepting labeling claims against hepatitis C virus using the bovine viral diarrhea virus as a surrogate.

For nearly 30 years, EPA also performed intramural preregistration and postregistration efficacy testing of some chemical disinfectants in its own laboratories. In 1982, this was stopped, reportedly for budgetary reasons. At that time, manufacturers did not need to have microbiologic activity claims verified 805 by EPA or an independent testing laboratory when registering a disinfectant or chemical sterilant • This occurred when the frequency of contaminated germicides and infections secondary to their use had 404 increased . Investigations demonstrating that interlaboratory reproducibility of test results was poor 416 737 and manufacturers' label claims were not verifiable • and symposia sponsored by the American 800 Society for Microbiology heightened awareness of these problems and reconfirmed the need to improve the AOAC methods and reinstate a microbiologic activity verification program. A General 806 Accounting Office report entitled Disinfectants: EPA Lacks Assurance They Work seemed to provide the necessary impetus for EPA to initiate corrective measures, including cooperative agreements to improve the AOAC methods and independent verification testing for all products labeled as sporicidal and disinfectants labeled as tuberculocidal. For example, of 26 sterilant products tested by EPA, 15 were canceled because of product failure. A list of products registered with EPA and labeled for use as sterilants or tuberculocides or against HIV and/or HBV is available through EPA's website at http://www.epa.gov/oppad001/chemregindex.htm. Organizations (e.g., Organization for Economic Cooperation and Development) are working to standardize requirements for germicide testing and registration.

Neutralization of Germicides One of the difficulties associated with evaluating the bactericidal activity of disinfectants is prevention of bacteriostasis from disinfectant residues carried over into the subculture media. Likewise, small amounts of disinfectants on environmental surfaces can make an accurate bacterial count difficult to get when sampling of the health-care environment as part of an epidemiologic or research investigation. One wa~ these problems may be overcome is by employing neutralizers that inactivate residual disinfectants 07"809 • Two commonly used neutralizing media for chemical disinfectants are Letheen Media and D/E Neutralizing Media. The former contains lecithin to neutralize quaternaries and polysorbate 80 (Tween 80) to neutralize phenolics, hexachlorophene, formalin, and, with lecithin, ethanol. The D/E Neutralizing media will neutralize a broad spectrum of antiseptic and disinfectant chemicals, including quaternary ammonium compounds, phenols, iodine and chlorine compounds, mercurials, 810 formaldehlade, and glutaraldehyde • A review of neutralizers used in germicide testing has been 08 published •

57 Gufdc!ino for Disinfection and Ste-rilization in !-··k:n!tllcaro Facilities, 2008

STERILIZATION

Most medical and surgical devices used in healthcare facilities are made of materials that are heat stable and therefore undergo heat, primarily steam, sterilization. However, since 1950, there has been an increase in medical devices and instruments made of materials (e.g., plastics) that require low- temperature sterilization. Ethylene oxide gas has been used since the 1950s for heat- and moisture- sensitive medical devices. Vvlthin the past 15 years, a number of new, low-temperature sterilization systems (e.g., hydrogen peroxide gas plasma, peracetic acid immersion, ozone) have been developed and are being used to sterilize medical devices. This section reviews sterilization technologies used in healthcare and makes recommendations for their optimum performance in the processing of medical devices 1, 1a,a11~a2o.

Sterilization destroys all microorganisms on the surface of an article or in a fluid to prevent disease transmission associated with the use of that item. While the use of inadequately sterilized critical items represents a high risk of transmitting pathogens, documented transmission of pathogens 821 822 associated with an inadequately sterilized critical item is exceedingly rare • • This is likely due to the wide margin of safety associated with the sterilization processes used in healthcare facilities. The concept of what constitutes "sterile" is measured as a probability of sterility for each item to be sterilized. This probability is commonly referred to as the sterility assurance level (SAL) of the product and is defined as the probability of a single viable microorganism occurring on a product after sterilization. SAL is normally expressed a 1o·". For example, if the probability of a spore surviving were one in one million, the SAL would be 1 o·' 823 824 • • In short, a SAL is an estimate of lethality of the entire sterilization process and is a conservative calculation. Dual SALs (e.g., 10' 3 SAL for blood culture tubes, drainage bags; 1 o·' SAL for scalpels, implants) have been used in the United States for many years and the choice of a 1 o·' SAL was strictly arbitrary and not associated with any adverse outcomes (e.g., patient infections) 823 .

Medical devices that have contact with sterile body tissues or fluids are considered critical items. These items should be sterile when used because any microbial contamination could result in disease transmission. Such items include surgical instruments, biopsy forceps, and implanted medical devices. If these items are heat resistant, the recommended sterilization process is steam sterilization, because it has the largest margin of safety due to its reliability, consistency, and lethality. However, reprocessing heat- and moisture-sensitive items requires use of a low-temperature sterilization technology (e.g., 825 ethylene oxide, hydrogen peroxide gas plasma, peracetic acid) • A summary of the advantages and disadvantages for commonly used sterilization technologies is presented in Table 6.

Steam Sterilization Overview. Of all the methods available for sterilization, moist heat in the form of saturated steam under pressure is the most widely used and the most dependable. Steam sterilization is nontoxic, 826 inexpensive , rapidly microbicidal, sporicidal, and rapidly heats and penetrates fabrics (Table 6) 827 • Like all sterilization processes, steam sterilization has some deleterious effects on some materials, including corrosion and combustion of lubricants associated with dental handpieces 212 ; reduction in ability 828 to transmit light associated with laryngoscopes ; and increased hardening time (5.6 fold) with plaster- cast 829.

The basic principle of steam sterilization, as accomplished in an autoclave, is to expose each item to direct steam contact at the required temperature and pressure for the specified time. Thus, there are four parameters of steam sterilization: steam, pressure, temperature, and time. The ideal steam for 813 818 sterilization is dry saturated steam and entrained water (dryness fraction ;::97%) ' • Pressure serves as a means to obtain the high temperatures necessary to quickly kill microorganisms. Specific temperatures must be obtained to ensure the microbicidal activity. The two common steam-sterilizing temperatures are 121"C (250"F) and 132"C (270"F). These temperatures (and other high temperatures) 830 must be maintained for a minimal time to kill microorganisms. Recognized minimum exposure periods for sterilization of wrapped healthcare supplies are 30 minutes at 121"C (250"F) in a gravity displacement

58 Guideline tor Disinloclion and Sterilization in Hefllt!1cme FncilrUos, 200!\

sterilizer or 4 minutes at 132'C (270'C) in a prevacuum sterilizer (Table 7). At constant temperatures, sterilization times vary depending on the type of item (e.g., metal versus rubber, plastic, items with lumens), whether the item is wrapped or unwrapped, and the sterilizer type.

The two basic types of steam sterilizers (autoclaves) are the gravity displacement autoclave and the high-speed prevacuum sterilizer. In the former, steam is admitted at the top or the sides of the sterilizing chamber and, because the steam is lighter than air, forces air out the bottom of the chamber through the drain vent. The gravity displacement autoclaves are primarily used to process laboratory media, water, pharmaceutical products, regulated medical waste, and nonporous articles whose surfaces have direct steam contact. For gravity displacement sterilizers the penetration time into porous items is prolonged because of incomplete air elimination. This point is illustrated with the decontamination of 10 lbs of microbiological waste, which requires at least 45 minutes at 121'C because the entrapped air 831 832 remaining in a load of waste greatly retards steam permeation and heating efficiency ' • The high- speed prevacuum sterilizers are similar to the gravity displacement sterilizers except they are fitted with a vacuum pump (or ejector) to ensure air removal from the sterilizing chamber and load before the steam is admitted. The advantage of using a vacuum pump is that there is nearly instantaneous steam penetration even into porous loads. The Bowie-Dick test is used to detect air leaks and inadequate air removal and consists of folded 100% cotton surgical towels that are clean and preconditioned. A commercially available Bowie-Dick-type test sheet should be placed in the center of the pack. The test pack should be placed horizontally in the front, bottom section of the sterilizer rack, near the door and 813 819 over the drain, in an otherwise empty chamber and run at 134'C for 3.5 minutes ' . The test is used each day the vacuum-type steam sterilizer is used, before the first processed load. Air that is not removed from the chamber will interfere with steam contact. Smaller disposable test packs (or process challenge devices) have been devised to replace the stack of folded surgical towels for testing the 833 efficacy of the vacuum system in a prevacuum sterilizer. These devices are "designed to simulate 819 834 product to be sterilized and to constitute a defined challenge to the sterilization process" ' • They 835 should be representative of the load and simulate the greatest challenge to the load • Sterilizer vacuum performance is acceptable if the sheet inside the test pack shows a uniform color change. Entrapped air will cause a spot to appear on the test sheet, due to the inability of the steam to reach the chemical indicator. If the sterilizer fails the Bowie-Dick test, do not use the sterilizer until it is inspected by the 813 819 836 sterilizer maintenance personnel and passes the Bowie-Dick test ' • •

Another design in steam sterilization is a steam flush-pressure pulsing process, which removes air rapidly by repeatedly alternating a steam flush and a pressure pulse above atmospheric pressure. Air is rapidly removed from the load as with the prevacuum sterilizer, but air leaks do not affect this process because the steam in the sterilizing chamber is always above atmospheric pressure. Typical sterilization temperatures and times are 132'C to 135'C with 3 to 4 minutes exposure time for porous loads and instruments827 ' 837 •

Like other sterilization systems, the steam cycle is monitored by mechanical, chemical, and biological monitors. Steam sterilizers usually are monitored using a printout (or graphically) by measuring temperature, the time at the temperature, and pressure. Typically, chemical indicators are affixed to the outside and incorporated into the pack to monitor the temperature or time and temperature. The effectiveness of steam sterilization is monitored with a biological indicator containing spores of Geobacillus stearothermophi/us (formerly Bacillus stearothermophilus). Positive spore test results are a 838 839 relatively rare event and can be attributed to operator error, inadequate steam delivery , or equipment malfunction. 840 Portable (table-top) steam sterilizers are used in outpatient, dental, and rural clinics . These sterilizers are designed for small instruments, such as hypodermic syringes and needles and dental instruments. The ability of the sterilizer to reach physical parameters necessary to achieve sterilization should be monitored by mechanical, chemical, and biological indicators.

59 Guideline tor Dlslnfectlon r.1.nd Slori!izat1on in Hoaltr1csro r:·aci!itle$, /~008

Microbicidal Activity. The oldest and most recognized agent for inactivation of microorganisms is heat. D-values (time to reduce the surviving population by 90% or 11og 10) allow a direct comparison of the heat resistance of microorganisms. Because a D-value can be determined at various temperatures, a subscript is used to designate the exposure temperature (i.e., 0 1210 ). D121 c-values for Geobacillus stearothermophilus used to monitor the steam sterilization process range from 1 to 2 minutes. Heat- resistant nonspore-formina bacteria, yeasts, and fungi have such low D121 c values that they cannot be experimentally measured' 1.

Mode of Action. Moist heat destroys microorganisms by the irreversible coagulation and denaturation of enzymes and structural proteins. In support of this fact, it has been found that the presence of moisture significantly affects the coagulation temperature of proteins and the temperature at which microorganisms are destroyed.

Uses. Steam sterilization should be used whenever possible on all critical and semi critical items that are heat and moisture resistant (e.g., steam sterilizable respiratory therapy and anesthesia equipment), even when not essential to prevent pathogen transmission. Steam sterilizers also are used 831 832 842 in healthcare facilities to decontaminate microbiological waste and sharps containers • • but additional exposure time is required in the gravity displacement sterilizer for these items.

Flash Sterilization Overview. "Flash" steam sterilization was originally defined by Underwood and Perkins as sterilization of an unwrapped object at 132'C for 3 minutes at 27-28 lbs. of pressure in a gravity displacement sterilizer'". Currently, the time required for flash sterilization depends on the type of sterilizer and the type of item (i.e., porous vs non-porous items)(see Table 8). Although the wrapped method of sterilization is preferred for the reasons listed below, correctly performed flash sterilization is 844 an effective process for the sterilization of critical medical devices ' 845 • Flash sterilization is a modification of conventional steam sterilization (either gravity, prevacuum, or steam-flush pressure-pulse) in which the flashed item Is placed in an open tray or is placed in a specially designed, covered, rigid container to allow for rapid penetration of steam. Historically, it is not recommended as a routine sterilization method because of the lack of timely biological indicators to monitor performance, absence of protective packaging following sterilization, possibility for contamination of processed items during transportation to the operating rooms, and the sterilization cycle parameters (i.e., time, temperature, pressure) are minimal. To address some of these concerns, many healthcare facilities have done the following: placed equipment for flash sterilization in close proximity to operating rooms to facilitate aseptic delivery to the point of use (usually the sterile field in an ongoing surgical procedure); extended the 846 847 exposure time to ensure lethality comparable to sterilized wrapped items (e.g., 4 minutes at 132'C) ' ; 847 used biological indicators that provide results in 1 hour for flash-sterilized items'"· ; and used protective 12 packaging that permits steam penetration' • 817"81 '·"'·'". Further, some rigid, reusable sterilization container systems have been designed and validated by the container manufacturer for use with flash cycles. When sterile items are open to air, they will eventually become contaminated. Thus, the longer a sterile item is exposed to air, the greater the number of microorganisms that will settle on it. Sterilization cycle parameters for flash sterilization are shown in Table 8.

A few adverse events have been associated with flash sterilization. When evaluating an increased incidence of neurosurgical infections, the investigators noted that surgical instruments were flash sterilized between cases and 2 of 3 craniotomy infections involved plate implants that were flash sterilized 849 . A report of two patients who received burns during surgery from instruments that had been flash sterilized reinforced the need to develop policies and educate staff to prevent the use of instruments 850 hot enough to cause clinical burns • Staff should use precautions to prevent burns with potentially hot instruments (e.g., transport tray using heat-protective gloves). Patient burns may be prevented by either air-cooling the instruments or immersion in sterile liquid (e.g., saline).

Uses. Flash sterilization is considered acceptable for processing cleaned patient-care items that

60 Guideline ·for Disinfection and SterHization in Hcalthcaro r-:"ac!!Jties, 200R

cannot be packaged, sterilized, and stored before use. It also is used when there is insufficient time to sterilize an item by the preferred package method. Flash sterilization should not be used for reasons of 817 convenience, as an alternative to purchasing additional instrument sets, or to save time • Because of the potential for serious infections, flash sterilization is not recommended for implantable devices (i.e., devices placed into a surgically or naturally formed cavity of the human body); however, flash sterilization may be unavoidable for some devices (e.g., orthopedic screw, plates). If flash sterilization of an implantable device is unavoidable, recordkeeping (i.e., load identification, patient's name/hospital identifier, and biological indicator result) is essential for epidemiological tracking (e.g., of surgical site infection, tracing results of biological indicators to patients who received the item to document sterility), and for an assessment of the reliability of the sterilization process (e.g., evaluation of biological monitoring records and sterilization maintenance records noting preventive maintenance and repairs with dates).

Low-Temperature Sterilization Technologies Ethylene oxide (ETO) has been widely used as a low-temperature sterilant since the 1950s. It has been the most commonly used process for sterilizing temperature- and moisture-sensitive medical devices and supplies in healthcare institutions in the United States. Two types of ETO sterilizers are available, mixed gas and 100% ETO. Until1995, ethylene oxide sterilizers combined ETO with a chloroflourocarbon (CFC) stabilizing agent, most commonly in a ratio of 12% ETO mixed with 88% CFC (referred to as 12/88 ETO).

For several reasons, healthcare personnel have been exploring the use of new low-temperature 851 sterilization technologies""· • First, CFCs were phased out in December 1995 under provisions of the 852 Clean Air Act • CFCs were classified as a Class I substance under the Clean Air Act because of

scientific evidence linking them to destruction of the earth's ozone layer. Second, some states (e.g., California, New York, Michigan) require the use of ETO abatement technology to reduce the amount of ETO being released into ambient air from 90 to 99.9% depending on the state. Third, OSHA regulates the acceptable vapor levels of ETO (i.e., 1 ppm averaged over 8 hours) due to concerns that ETO exposure represents an occupational hazard 318 . These constraints have led to the development of alternative technologies for low-temperature sterilization in the health care setting.

Alternative technologies to ETO with chlorofluorocarbon that are currently available and cleared by the FDA for medical equipment include 100% ETO; ETO with a different stabilizing gas, such as carbon dioxide or hydrochlorofluorocarbons (HCFC); immersion in peracetic acid; hydrogen peroxide gas plasma; and ozone. Technologies under development for use in healthcare facilities, but not cleared by the FDA, include vaporized hydro~en reroxide, vapor phase peracetic acid, gaseous chlorine dioxide, 4 75 853 ionizing radiation, or pulsed light '· • • However, there is no guarantee that these new sterilization technologies will receive FDA clearance for use in healthcare facilities.

These new technologies should be compared against the characteristics of an ideal low- 851 temperature (<60'C) sterilant (Table 9). While it is apparent that all technologies will have limitations (Table 9), understanding the limitations imposed by restrictive device designs (e.g., long, narrow lumens) 854 is critical for proper application of new sterilization technology For example, the development of increasingly small and complex endoscopes presents a difficult challenge for current sterilization processes. This occurs because microorganisms must be in direct contact with the sterilant for inactivation to occur. Several peer-reviewed scientific publications have data demonstrating concerns about the efficacy of several of the low-temperature sterilization processes (i.e., gas plasma, vaporized hydrogen peroxide, ETO, peracetic acid), particularly when the test or~anisrns are challenged in the 469 825 855 presence of serum and salt and a narrow lumen vehicle ' 721 • ' • 8 6 • Factors shown to affect the efficacy of sterilization are shown in Table 10.

Ethylene Oxide "Gas" Sterilization Overview. ETO is a colorless gas that is flammable and explosive. The four essential

61 Guicle!int:i 'for Disinfection and SteH!izat1on in Hen!thcnre F<:Kilitios) 2008

parameters (operational ranges) are: gas concentration (450 to 1200 mgn); temperature (37 to 63'C); relative humidity (40 to 80%)(water molecules carry ETO to reactive sites); and exposure ~me (1 to 6 857 hours). These influence the effectiveness of ETO sterilization 814 • • 858 • Wthin certain limitations, an increase in gas concentration and temperature may shorten the time necessary for achieving sterilization. The main disadvantages associated with ETO are the lengthy cycle time, the cost, and its potential hazards to patients and staff; the main advantage is that it can sterilize heat- or moisture- sensitive medical equipment without deleterious effects on the material used in the medical devices (Table 6). Acute exposure to ETO may result in irritation (e.g., to skin, eyes, gastrointestinal or 8 862 respiratory tracts) and central nervous system depression " ' . Chronic inhalation has been linked to the formation of cataracts, cognitive impairment, neurologic dysfunction, and disabling polyneuropathies ' ~· "' • Occupational exposure in health care facilities has been linked to 860 86 86 866 867 318 870 hematologic changes and an increased risk of spontaneous abortions and various cancers ' 86.. • 871 ETO should be considered a known human carcinogen •

The basic ETO sterilization cycle consists of five stages (i.e., preconditioning and humidification, gas introduction, exposure, evacuation, and air washes) and takes approximately 2 1/2 hrs excluding aeration time. Mechanical aeration for 8 to 12 hours at 50 to 60'C allows desorption of the toxic ETO residual contained in exposed absorbent materials. Most modern ETO sterilizers combine sterilization and aeration in the same chamber as a continuous process. These ETO models minimize potential ETO exposure during door opening and load transfer to the aerator. Ambient room aeration also will achieve desorption of the toxic ETO but requires 7 days at 20'C. There are no federal regulations for ETO sterilizer emission; however, many states have promulgated emission-control regulations 814 •

The use of ETO evolved when few alternatives existed for sterilizing heat- and moisture-sensitive medical devices; however, favorable properties (Table 6) account for its continued widespread use"'. Two ETO gas mixtures are available to replace ETO-chlorofluorocarbon (CFC) mixtures for large capacity, tank-supplied sterilizers. The ETO-carbon dioxide (C0 2) mixture consists of 8.5% ETO and 91.5% C0 2 . This mixture is less expensive than ETO-hydrochlorofluorocarbons (HCFC), but a disadvantage is the need for pressure vessels rated for steam sterilization, because higher pressures (28-psi gauge) are required. The other mixture, which is a drop-in CFC replacement, is ETO mixed with HCFC. HCFCs are approximately 50-fold less damaging to the earth's ozone layer than are CFCs. The EPA will begin regulation of HCFC in the year 2015 and will terminate production in the year 2030. Two companies provide ETO-HCFC mixtures as drop-in replacement for CFC-12; one mixture consists of 8 8.6% ETO and 91.4% HCFC, and the other mixture is composed of 10% ETO and 90% HCFC "- An alternative to the pressurized mixed gas ETO systems is 100% ETO. The 100% ETO sterilizers using unit-dose cartridges eliminate the need for external tanks.

ETO is absorbed by many materials. For this reason, following sterilization the item must undergo aeration to remove residual ETO. Guidelines have been promulgated regarding allowable ETO limits for devices that depend on how the device is used, how often, and how long in order to pose a 814 minimal risk to patients in normal product use •

ETO toxicity has been established in a variety of animals. Exposure to ETO can cause eye pain, sore throat, difficulty breathing and blurred vision. Exposure can also cause dizziness, nausea, 873 headache, convulsions, blisters and vomiting and coughing • In a variety of in vitro and animal studies, ETO has been demonstrated to be carcinogenic. ETO has been linked to spontaneous abortion, genetic 873 damage, nerve damage, peripheral paralysis, muscle weakness, and impaired thinking and memory • Occupational exposure in healthcare facilities has been linked to an increased risk of spontaneous abortions and various cancers318 • Injuries (e.g., tissue burns) to patients have been associated with ETO 874 residues in implants used in surgical procedures • Residual ETO in capillary flow dialysis membranes 875 has been shown to be neurotoxic in vitro . OSHA has established a PEL of 1 ppm airborne ETO in the workplace, expressed as a TWA for an 8-hour work shift in a 40-hour work week. The "action level" for ETO is 0.5 ppm, expressed as an 8-hour TWA, and the short-term excursion limit is 5 ppm, expressed as

62 CJuidnline "for Disinfection and Stf~rili.zation In Hoa!thcarn Facilities, 2008

814 a 15-minute TWA • For details of the requirements in OSHA's ETO standard for occupational exposures, see Title 29 of the Code of Federal Regulations (CFR) Part 1910.1047873 • Several personnel monitoring methods (e.g., charcoal tubes and passive sampling devices) are in use 814. OSHA has established a PEL of 5 ppm for ethylene chlorohydrin (a toxic by-product of ETO) in the workplace 876• Additional information regarding use of ETO in health care facilities is available from NIOSH.

Mode of Action. The microbicidal activity of ETO is considered to be the result of alkylation of protein, DNA, and RNA Alkylation, or the replacement of a hydrogen atom with an alkyl group, within cells prevents normal cellular metabolism and replication 877•

Microbicidal Activitv. The excellent microbicidal activity of ETO has been demonstrated in several studies 469 ' 721 • 722 • 856 ' ~ 78 • 879 and summarized in published reports 877 • ETO inactivates all microorganisms although bacterial spores (especially B. atrophaeus) are more resistant than other microorganisms. For this reason B. atrophaeus is the recommended biological indicator.

Like all sterilization processes, the effectiveness of ETO sterilization can be altered by lumen length, lumen diameter, inorganic salts, and organic materials469' 721 ' 722 • 855 • 856• 879 • For example, although ETO is not used commonly for reprocessing endoscopes", several studies have shown failure of ETO in 879 inactivating contaminating spores in endoscope channels 855or lumen test units 469 ' 721 • and residual 456 ETO levels averaging 66.2 ppm even after the standard degassing time • Failure of ETO also has been observed when dental handpieces were contaminated with Streptococcus mutans and exposed to ET0 880 • It is recommended that dental handpieces be steam sterilized.

Uses. ETO is used in healthcare facilities to sterilize critical items (and sometimes semicritical items) that are moisture or heat sensitive and cannot be sterilized by steam sterilization.

Hydrogen Peroxide Gas Plasma Overview. New sterilization technology based on plasma was patented in 1987 and marketed in the United States in 1993. Gas plasmas have been referred to as the fourth state of matter (i.e., liquids, solids, gases, and gas plasmas). Gas plasmas are generated in an enclosed chamber under deep vacuum using radio frequency or microwave energy to excite the gas molecules and produce charged particles, many of which are in the form of free radicals. A free radical is an atom with an unpaired electron and is a highly reactive species. The proposed mechanism of action of this device is the production of free radicals within a plasma field that are capable of interacting with essential cell components (e.g., enzymes, nucleic acids) and thereby disrupt the metabolism of microorganisms. The type of seed gas used and the depth of the vacuum are two important variables that can determine the effectiveness of this process.

In the late 1980s the first hydrogen peroxide gas plasma system for sterilization of medical and surgical devices was field-tested. According to the manufacturer, the sterilization chamber is evacuated and hydrogen peroxide solution is injected from a cassette and is vaporized in the sterilization chamber to a concentration of 6 mg/1. The hydrogen peroxide vapor diffuses through the chamber (50 minutes), exposes all surfaces of the load to the sterilant, and initiates the inactivation of microorganisms. An electrical field created by a radio frequency is applied to the chamber to create a gas plasma. Microbicidal free radicals (e.g., hydroxyl and hydroperoxyl) are generated in the plasma. The excess gas is removed and in the final stage (i.e., vent) of the process the sterilization chamber is returned to atmospheric pressure by introduction of high-efficiency filtered air. The by-products of the cycle (e.g., water vapor, oxygen) are nontoxic and eliminate the need for aeration. Thus, the sterilized materials can be handled safely, either for immediate use or storage. The process operates in the range of 37-44'C and has a cycle time of 75 minutes. If any moisture is present on the objects the vacuum will not be achieved and the cycle aborts 856• 881 ' 883 •

A newer version of the unit improves sterilizer efficacy by using two cycles with a hydrogen

63 Guideline for Disinfeclion and St<11'iliza!ion in l·lealthcare l"ncilltios, 2003

peroxide diffusion stage and a plasma stage per sterilization cycle. This revision, which is achieved by a software modification, reduces total processing time from 73 to 52 minutes. The manufacturer believes that the enhanced activity obtained with this system is due in part to the pressure changes that occur during the injection and diffusion phases of the process and to the fact that the process consists of two 856 884 885 equal and consecutive half cycles, each with a separate injection of hydrogen peroxide. • • This 400 882 system and a smaller version ' have received FDA 51 O[k] clearance with limited application for sterilization of medical devices (Table 6). The biological indicator used with this system is Bacillus atrophaeus spores851 • The newest version of the unit, which employs a new vaporization system that removes most of the water from the hydrogen peroxide, has a cycle time from 28-38 minutes (see manufacturer's literature for device dimension restrictions).

Penetration of hydrogen peroxide vapor into long or narrow lumens has been addressed outside the United States by the use of a diffusion enhancer. This is a small, breakable glass ampoule of concentrated hydrogen peroxide (50%) with an elastic connector that is inserted into the device lumen 470 885 and crushed immediately before sterilization • • The diffusion enhancer has been shown to sterilize bronchoscopes contaminated with Mycobacteria tuberculosis"'. At the present time, the diffusion enhancer is not FDA cleared.

Another gas plasma system, which differs from the above in several important ways, including the use of peracetic acid-acetic acid-hydrogen peroxide vapor, was removed from the marketplace because of reports of corneal destruction to patients when ophthalmic surgery instruments had been 888 processed in the sterilizer"'· • In this investigation, exposure of potentially wet ophthalmologic surgical instruments with small bores and brass components to the plasma gas led to degradation of the brass to 888 889 copper and zinc ' • The experimenters showed that when rabbit eyes were exposed to the rinsates of the gas plasma-sterilized instruments, corneal decompensation was documented. This toxicity is highly unlikely with the hydrogen peroxide gas plasma process since a toxic, soluble form of copper would not form (LA Feldman, written communication, April1998).

Mode of Action. This process inactivates microorganisms primarily by the combined use of hydrogen peroxide gas and the generation of free radicals (hydroxyl and hydroproxyl free radicals) during the plasma phase of the cycle.

Microbicidal Activity. This process has the ability to inactivate a broad range of microorganisms, including resistant bacterial spores. Studies have been conducted a@ainst vegetative 469 721 85 881 883 890 893 bacteria (including mycobacteria), yeasts, fungi, viruses, and bacterial spores ' ' • ' • ' • Like all sterilization processes, the effectiveness can be altered by lumen length, lumen diameter, inorganic salts, and organic materials469, 721, ass, sse, aso, sst, as3.

Uses. Materials and devices that cannot tolerate high temperatures and humidity, such as some plastics, electrical devices, and corrosion-susceptible metal alloys, can be sterilized by hydrogen peroxide gas plasma. This method has been compatible with most {>95%) medical devices and 884 894 materials tested ' ' 895 •

Peracetic Acid Sterilization Overview. Peracetic acid is a highly biocidal oxidizer that maintains its efficacy in the presence 711 of organic soil. Peracetic acid removes surface contaminants (primarily protein) on endoscopic tubing ' 717 • An automated machine using peracetic acid to sterilize medical, surgical, and dental instruments chemically (e.g., endoscopes, arthroscopes) was introduced in 1988. This microprocessor-controlled, low-temperature sterilization method is commonly used in the United States 107 . The sterilant, 35% peracetic acid, and an anticorrosive agent are supplied in a single-dose container. The container is punctured at the time of use, immediately prior to closing the lid and initiating the cycle. The concentrated peracetic acid is diluted to 0.2% with filtered water (0.2 ~m) at a temperature of approximately 50°C. The diluted peracetic acid is circulated within the chamber of the machine and

64 Guideline for Disinfection 2nd Stenlizntion in llnnltiln'uc FactltMs, 2008

pumped through the channels of the endoscope for 12 minutes, decontaminating exterior surfaces, lumens, and accessories. Interchangeable trays are available to permit the processing of up to three rigid endoscopes or one flexible endoscope. Connectors are available for most types of flexible endoscopes for the irrigation of all channels by directed flow. Rigid endoscopes are placed within a lidded container, and the sterilant fills the lumens either by immersion in the circulating sterilant or by use of channel connectors to direct flow into the lumen(s) (see below for the importance of channel connectors). The peracetic acid is discarded via the sewer and the instrument rinsed four times with filtered water. 896 Concern has been raised that filtered water may be inadequate to maintain sterility • Limited data have shown that low-level bacterial contamination may follow the use of filtered water in an AER but no data 161 has been published on AERs using the peracetic acid system . Clean filtered air is passed through the chamber of the machine and endoscope channels to remove excess water719 • As with any sterilization process, the system can only sterilize surfaces that can be contacted by the sterilant. For example, bronchoscop¥-related infections occurred when bronchoscopes were processed using the wrong 15 25 connector • • Investigation of these incidents revealed that bronchoscopes were inadequately reprocessed when inappropriate channel connectors were used and when there were inconsistencies between the reprocessing instructions provided by the manufacturer of the bronchoscope and the 155 manufacturer of the automatic endoscope reprocessor • The importance of channel connectors to 137 856 achieve sterilization was also shown for rigid lumen devices ' .

The manufacturers suggest the use of biological monitors (G. stearothermophilus spore strips) both at the time of installation and routinely to ensure effectiveness of the process. The manufacturer's clip must be used to hold the strip in the designated spot in the machine as a broader clamp will not allow 897 the sterilant to reach the spores trapped under it • One investigator reported a 3% failure rate when the appropriate clips were used to hold the spore strip within the machine718 . The use of biological monitors designed to monitor either steam sterilization or ETO for a liquid chemical sterilizer has been questioned for several reasons including spore wash-oft from the filter paper strips which may cause less valid 898 901 monitoring - • The processor is equipped with a conductivity probe that will automatically abort the cycle if the buffer system is not detected in a fresh container of the peracetic acid solution. A chemical monitoring strip that detects that the active ingredient is >1500 ppm is available for routine use as an additional process control.

Mode of Action. Only limited information is available regarding the mechanism of action of peracetic acid, but it is thought to function as other oxidizing agents, i.e., it denatures proteins, disrupts cell wall permeability, and oxidizes sulflhydral and sulfur bonds in proteins, enzymes, and other 726 metabolites'"· • Microbicidal Activity. Peracetic acid will inactivate gram-positive and gram-negative bacteria, fungi, and yeasts in <5 minutes at <100 ppm. In the presence of organic matter, 200-500 ppm is required. For viruses, the dosage range is wide (12-2250 ppm), with poliovirus inactivated in yeast extract in 15 minutes with 1500 to 2250 ppm. Bacterial spores in suspension are inactivated in 15 seconds to 30 654 minutes with 500 to 10,000 ppm (0.05 to 1%) •

Simulated-use trials have demonstrated microbicidal activity 111 ' 718-722 and three clinical trials 723 724 have demonstrated both microbial killing and no clinical failures leading to infection"· ' • Alta and co- workers, who compared the peracetic acid system with ETO, demonstrated the high efficacy of the system. Only the peracetic acid system was able to completely kill 6-log 10 of Mycobacterium chelonae, 722 Enterococcus faecalis, and B. atrophaeus spores with both an organic and inorganic challenge • Like 902 other sterilization processes, the efficacy of the process can be diminished by soil challenges and test 856 conditions •

Uses. This automated machine is used to chemically sterilize medical (e.g., Gl endoscopes) and surgical (e.g., flexible endoscopes) instruments in the United States. Lumened endoscopes must be connected to an appropriate channel connector to ensure that the sterilant has direct contact with the 856 803 contaminated lumen. 137 • • Olympus America has not listed this system as a compatible product for

65 Guideline for Disinfoclion and Sterilization in l·leflltiJCi:irC Fncil;tics, 2008

use In reprocessing Olympus bronchoscopes and gastrointestinal endoscopes (Olympus America, January 30, 2002, written communication).

Microbicidal Activity of Low-Temperature Sterilization Technologies Sterilization processes used in the United States must be cleared by FDA, and they require that 904 sterilizer microbicidal performance be tested under simulated-use conditions • FDA requires that the 6 test article be inoculated with 10 colony-forming units of the most resistant test organism and prepared with organic and inorganic test loads as would occur after actual use. FDA requires manufacturers to use organic soil (e.g., 5% fetal calf serum), dried onto the device with the inoculum, to represent soil remaining on the device following marginal cleaning. However, 5% fetal calf serum as a measure of marginal cleaning has not been validated by measurements of protein load on devices following use and the level of protein removal by various cleaning methods. The inocula must be placed in various locations of the test articles, including those least favorable to penetration and contact with the sterilant (e.g., lumens). Cleaning before sterilization is not allowed in the demonstration of sterilization efficacy"". Several studies have evaluated the relative microbicidal efficacy of these low-temperature sterilization technologies (Table 11). These studies have either tested the activity of a sterilization process a9ainst 892 905 906 sp,ecific microor~anisms ' ' , evaluated the microbicidal activity of a singular technology • • • 711 19 724 8 5 879 882 884 890 91 907 • • . • • • or evaluated the comparative effectiveness of several sterilization technologies'"· 426 469 721 722 856 908 909 • • • • • • • Several test methodologies use stainless steel or porcelain carriers that are inoculated with a test organism. Commonly used test organisms include vegetative bacteria, mycobacteria, and spores of Bacillus species. The available data demonstrate that low-temperature sterilization technologies are able to provide a 6-log 10 reduction of microbes when inoculated onto carriers in the absence of salt and serum. However, tests can be constructed such that all of the available sterilization technologies are unable to reliably achieve complete inactivation of a microbial load. 425 426 469 721 856 909 • • • • • For example, almost all of the sterilization processes will fail to reliably inactivate the microbial load in the presence of salt and serum 469 • 721 • • 909

The effect of salts and serums on the sterilization process were studied initially in the 1950s and 1960s424• 910 , These studies showed that a high concentration of crystalline-type materials and a low 426 protein content provided greater protection to spores than did serum with a high protein content . A study by Doyle and Ernst demonstrated resistance of spores by crystalline material applied not only to 425 low-temperature sterilization technology but also to steam and dry heat • These studies showed that occlusion of Bacillus atrophaeus spores in calcium carbonate crystals dramatically increased the time required for inactivation as follows: 10 seconds to 150 minutes for steam (121'C), 3.5 hours to 50 hours for dry heat (121'C), 30 seconds to >2 weeks for ETO (54'C). Investigators have corroborated and 855 908 909 extended these findings 469 ' 470' 721 • ' ' • While soils containing both organic and inorganic materials impair microbial killing, soils that contain a hi~h inor~anic salt-to-protein ratio favor crystal formation and 25 426 81 impair sterilization by occlusion of organisms • • •

Alfa and colleagues demonstrated a 6-log 10 reduction of the microbial inoculum of porcelain 469 penicylinders using a variety of vegetative and spore-forming organisms (Table 11) • However, if the bacterial inoculum was in tissue-culture medium supplemented with 10% serum, only the ETO 12/88 and ETO-HCFC sterilization mixtures could sterilize 95% to 97% of the penicylinder carriers. The plasma and 100% ETO sterilizer demonstrated significantly reduced activity (Table 11 ). For all sterilizers evaluated using penicylinder carriers (i.e., ETO 12/88, 100% ETO, hydrogen peroxide gas plasma), there was a 3- to 6-log 10 reduction of inoculated bacteria even in the presence of serum and salt. For each sterilizer evaluated, the ability to inactivate microorganisms in the presence of salt and serum was reduced even further when the inoculum was placed in a narrow-lumen test object (3 mm diameter by 125 em long). Although there was a 2- to 4-log 10 reduction in microbial kill, less than 50% of the lumen test objects were sterile when processed using any of the sterilization methods evaluated except the peracetic acid 721 immersion system (Table 11) • Complete killing (or removal) of 6-log 10 of Enterococcus faecalis, Mycobacterium chelonei, and Bacillus atrophaeus spores in the presence of salt and serum and lumen test objects was observed only for the peracetic acid immersion system.

66 GuidelinCl for IJisinfcctkm and 0tmilimtion in Healthcwe F'~lcilitics, 20013

469 V'vlth respect to the results by Alia and coworkers , Jacobs showed that the use of the tissue 426 culture media created a technique-induced sterilization failure . Jacobs et al. showed that microorganisms mixed with tissue culture media, used as a surrogate body fluid, formed physical crystals that protected the microorganisms used as a challenge. If the carriers were exposed for 60 sec to nonflowing water, the salts dissolved and the protective effect disappeared. Since any device would be exposed to water for a short period of time during the washing procedure, these protective effects would 426 have little clinical relevance •

Narrow lumens provide a challenge to some low-temperature sterilization processes. For example, Rutala and colleagues showed that, as lumen size decreased, increased failures occurred with some low-temperature sterilization technologies. However, some low-temperature processes such as ETO-HCFC and the hydrogen peroxide gas plasma process remained effective even when challenged by 856 a lumen as small as 1 mm in the absence of salt and serum •

The importance of allowing the sterilant to come into contact with the inoculated carrier is demonstrated by comparing the results of two investigators who studied the peracetic acid immersion system. Alia and coworkers demonstrated excellent activity of the peracetic acid immersion system against three test organisms using a narrow-lumen device. In these experiments, the lumen test object was connected to channel irrigators, which ensured that the sterilant had direct contact with the contaminated carriers"'. This effectiveness was achieved through a combination of organism wash-off and peracetic acid sterilant killing the test organisms"'. The data reported by Rutala et al. demonstrated failure of the peracetic acid immersion system to eliminate Geobacil/us stearothermophi/us spores from a carrier placed in a lumen test object. In these experiments, the lumen test unit was not connected to channel irrigators. The authors attributed the failure of the peracetic acid immersion system to eliminate the high levels of spores from the center of the test unit to the inability of the peracetic acid to diffuse into the center of 40-cm long, 3-mm diameter tubes. This may be caused by an air lock or air bubbles formed in the lumen, impeding the flow of the sterilant through the long and narrow lumen and limiting complete access to the Bacillus spores 137 ' 856 • Experiments using a channel connector specifically designed for 1-, 2-, and 3-mm lumen test units with the peracetic acid immersion system were completely effective in eliminating an inoculum of 108 Geobacillus stearothermophilus spores'. The restricted diffusion environment that exists in the test conditions would not exist with flexible scopes processed in the peracetic acid immersion system, because the scopes are connected to channel irrigators to ensure that the sterilant has direct contact with contaminated surfaces. Alta and associates attributed the efficacy of the peracetic acid immersion system to the ability of the liquid chemical process to dissolve salts and 722 remove protein and bacteria due to the flushing action of the fluid .

Bloburden of Surgical Devices In general, used medical devices are contaminated with a relatively low bioburden of 9 911 912 organisms " • • Nystrom evaluated medical instruments used in general surgical, gynecological, orthopedic, and ear-nose-throat operations and found that 62% of the instruments were contaminated 1 2 3 with <10 organisms after use, 82% with <10 , and 91% with <10 • After being washed in an instrument 1 2 911 washer, more than 98% of the instruments had <10 organisms, and none >10 organisms • Other 179 912 investigators have published similar findings • • For example, after a standard cleaning procedure, 1 2 2912 72% of 50 surgical instruments contained <10 organisms, 86% <10 , and only 6% had >3 X 10 • In another study of rigid-lumen medical devices, the bioburden on both the inner and outer surface of the lumen ranged from 10 1 to 104 organisms per device. After cleaning, 83% of the devices had a bioburden s10 organisms'". In all of these studies, the contaminating microflora consisted main~ of vegetative 2 179 911 12 bacteria, usually of low pathogenicity (e.g., coagulase-negative Staphylococcus) • • •

An evaluation of the microbial load on used critical medical devices such as spinal anesthesia needles and angiographic catheters and sheaths demonstrated that mesophilic microorganisms were detected at levels of 101 to 102 in only two of five needles. The bioburden on used angiographic

67 Guidel111e for Disinfection and SteriliZfltion in Hea!U1cmc Facilities, 2008

3 catheters and sheath introducers exceeded 10 CFUs on 14% (3 of21) and 21% (6 of28), 907 respectively •

Effect of Cleaning on Sterilization Efficacy The effect of salt and serum on the efficacy of low-temperature sterilization technologies has raised concern regarding the margin of safety of these technologies. Experiments have shown that salts have the greatest impact on protecting microorganisms from killing'"· 469• However, other studies have suggested that these concerns may not be clinically relevant. One study evaluated the relative rate of removal of inorganic salts, organic soil, and microorganisms from medical devices to better understand 426 the dynamics of the cleaning process • These tests were conducted by inoculating Alia soil (tissue- 469 6 culture media and 10% fetal bovine serum) containing 10 G. stearothermophilus spores onto the surface of a stainless-steel scalpel blade. After drying for 30 minutes at 35'C followed by 30 minutes at room temperature, the samples were placed in water at room temperature. The blades were removed at specified times, and the concentration of total protein and chloride ion was measured. The results showed that soaking in deionized water for 60 seconds resulted in a >95% release rate of chloride ion from NaCI solution in 20 seconds, Alia soil in 30 seconds, and fetal bovine serum in 120 seconds. Thus, contact with water for short periods, even in the presence of protein, rapidly leads to dissolution of salt crystals and complete inactivation of spores by a low-temperature sterilization process (Table 10). Based on these experimental data, cleaning procedures would eliminate the detrimental effect of high salt content on a low-temperature sterilization process. 469 These articles 426• ' 721 assessing low-temperature sterilization technology reinforce the importance of meticulous cleaning before sterilization. These data support the critical need for healthcare facilities to develop rigid protocols for cleaning contaminated objects before sterilization"'. Sterilization of instruments and medical devices is compromised if the process is not preceded by meticulous cleaning.

The cleaning of any narrow-lumen medical device used in patient care presents a major challenge to reprocessing areas. While attention has been focused on flexible endoscopes, cleaning 913 issues related to other narrow-lumen medical devices such as sphinctertomes have been investigated . This study compared manual cleaning with that of automated cleaning with a narrow-lumen cleaner and found that only retro-flushing with the narrow lumen cleaner provided adequate cleaning of the three channels. If reprocessing was delayed for more than 24 hours, retro-flush cleaning was no longer 913 effective and ETO sterilization failure was detected when devices were held for 7 days . In another study involving simulated-use cleaning of laparoscopic devices, Alia found that minimally the use of retro- 914 flushing should be used during cleaning of non-ported laparoscopic devices •

Other Sterilization Methods Ionizing Radiation. Sterilization by ionizing radiation, primarily by cobalt 60 gamma rays or electron accelerators, is a low-temperature sterilization method that has been used for a number of medical products (e.g., tissue for transplantation, pharmaceuticals, medical devices). There are no FDA- cleared ionizing radiation sterilization processes for use in healthcare facilities. Because of high sterilization costs, this method is an unfavorable alternative to ETO and plasma sterilization in healthcare facilities but is suitable for large-scale sterilization. Some deleterious effects on patient-care equipment 915 associated with gamma radiation include induced oxidation in pol¥ethylene and delamination and 916 91 91 cracking in polyethylene knee bearings . Several reviews ' dealing with the sources, effects, and application of ionizing radiation may be referred to for more detail.

Dry-Heat Sterilizers. This method should be used only for materials that might be damaged by moist heat or that are impenetrable to moist heat (e.g., powders, petroleum products, sharp instruments). The advantages for dry heat include the following: it is nontoxic and does not harm the environment; a dry heat cabinet is easy to install and has relatively low operating costs; it penetrates materials; and it is noncorrosive for metal and sharp instruments. The disadvantages for dry heat are the slow rate of heat penetration and microbial killing makes this a time-consuming method. In addition, the high temperatures

68 Guideline for D1sinloction and Stn1ilization in Hoalti1cmo Facilities, 2008

919 are not suitable for most materials • The most common time-temperature relationships for sterilization with hot air sterilizers are 170°C (340°F) for 60 minutes, 160°C (320°F) for 120 minutes, and 150°C (300°F) for 150 minutes. B. atrophaeus spores should be used to monitor the sterilization process for dry heat because they are more resistant to dry heat than are G. stearothermophi/us spores. The primary lethal process is considered to be oxidation of cell constituents.

There are two types of dry-heat sterilizers: the statio-air type and the forced-air type. The statio- air type is referred to as the oven-type sterilizer as heating coils in the bottom of the unit cause the hot air to rise inside the chamber via gravity convection. This type of dry-heat sterilizer is much slower in heating, requires longer time to reach sterilizing temperature, and is less uniform in temperature control throughout the chamber than is the forced-air type. The forced-air or mechanical convection sterilizer is equipped with a motor-driven blower that circulates heated air throughout the chamber at a high velocity, permitting a more rapid transfer of energy from the air to the instruments'". Liquid Chemicals. Several FDA-cleared liquid chemical sterilants include indications for 69 sterilization of medical devices (Tables 4 and 5) • The indicated contact times range from 3 hours to 12 hours. However, except for a few of the products, the contact time is based only on the conditions to pass the AOAC Sporicidal Test as a sterilant and not on simulated use testing with devices. These solutions are commonly used as high-level disinfectants when a shorter processing time is required. Generally, chemical liquid sterilants cannot be monitored using a biological indicator to verify sterility""· 900

The survival kinetics for thermal sterilization methods, such as steam and dry heat, have been studied and characterized extensively, whereas the kinetics for sterilization with liquid sterilants are less 921 well understood • The information that is available in the literature suggests that sterilization processes based on liquid chemical sterilants, in general, may not convey the same sterility assurance level as 823 sterilization achieved using thermal or physical methods • The data indicate that the survival curves for liquid chemical sterilants may not exhibit log-linear kinetics and the shape of the survivor curve may vary depending of the formulation, chemical nature and stability of the liquid chemical sterilant. In addition, the design of the AOAC Sporicidal Test does not provide quantification of the microbial challenge. Therefore, sterilization with a liquid chemical sterilant may not convey the same sterility assurance as other sterilization methods.

One of the differences between thermal and liquid chemical processes for sterilization of devices is the accessibility of microorganisms to the sterilant. Heat can penetrate barriers, such as biofilm, tissue, and blood, to attain organism kill, whereas liquids cannot adequately penetrate these barriers. In addition, the viscosity of some liquid chemical sterilants impedes their access to organisms in the narrow 922 lumens and mated surfaces of devices • Another limitation to sterilization of devices with liquid chemical germicides is the post-processing environment of the device. Devices cannot be wrapped or adequately contained during processing in a liquid chemical sterilant to maintain sterility following processing and during storage. Furthermore, devices may require rinsing following exposure to the liquid chemical sterilant with water that typically is not sterile. Therefore, due to the inherent limitations of using liquid chemical sterilants, their use should be restricted to reprocessing critical devices that are heat- sensitive and incompatible with other sterilization methods.

Several published studies compare the sporicidal effect of liquid chemical germicides against 659 660 715 spores of Bacillus and Clostridium"· • • ,

Performic Acid. Performic acid is a fast-acting sporicide that was incorporated into an automated endoscope reprocessing system 400 • Systems using performic acid are not currently FDA cleared.

Filtration. Although filtration is not a lethality-based process and is not an FDA-cleared sterilization method, this technology is used to remove bacteria from thermolabile pharmaceutical fluids

69 Guideline for DisinfeeHon and ,Sterl!iz8tion in Hea!trlcare FHci!itios, 2008

that cannot be purified by any other means. In order to remove bacteria, the membrane pore size (e.g., 0.22 f!m) must be smaller than the bacteria and uniform throughout"'. Some investigators have appropriately questioned whether the removal of microorganisms by filtration really is a sterilization method because of slight bacterial passage through filters, viral passage through filters, and transference 924 of the sterile filtrate into the final container under aseptic conditions entail a risk of contamination •

Microwave. Microwaves are used in medicine for disinfection of soft contact lenses, dental 921 931 instruments, dentures, milk, and urinary catheters for intermittent self-catheterization ,. • However, 931 microwaves must only be used with products that are compatible (e.g., do not melt) . Microwaves are radio-frequency waves, which are usually used at a frequency of 2450 MHz. The microwaves produce friction of water molecules in an alternating electrical field. The intermolecular friction derived from the vibrations generates heat and some authors believe that the effect of microwaves depends on the heat 932 934 produced while others postulate a nonthermallethal effect - • The initial reports showed microwaves to be an effective microbicide. The microwaves produced by a "home-type" microwave oven (2.45 GHz) completely inactivate bacterial cultures, mycobacteria, viruses, and G. stearothermophilus spores within 933 60 seconds to 5 minutes depending on the challenge organism ' ,,,.,,_ Another study confirmed these results but also found that higher power microwaves in the presence of water may be needed for sterilization'". Complete destruction of Mycobacterium bovis was obtained with 4 minutes of microwave 937 exposure (600W, 2450 MHz) . The effectiveness of microwave ovens for different sterilization and disinfection purposes should be tested and demonstrated as test conditions affect the results (e.g., presence of water, microwave power). Sterilization of metal instruments can be accomplished but requires certain precautions."'. Of concern is that home-type microwave ovens may not have even distribution of microwave energy over the entire dry device (there may be hot and cold spots on solid medical devices); hence there may be areas that are not sterilized or disinfected. The use of microwave ovens to disinfect intermittent-use catheters also has been suggested. Researchers found that test bacteria (e.g., E. coli, Klebsiella pneumoniae, Candida a/bicans) were eliminated from red rubber 931 catheters within 5 minutes • Microwaves used for sterilization of medical devices have not been FDA cleared.

Glass Bead "Sterilizer". Glass bead "sterilization" uses small glass beads (1.2-1.5 mm diameter) and high temperature (217°C -232°C) for brief exposure times (e.g., 45 seconds) to inactivate 938 940 microorganisms. These devices have been used for several years in the dental profession - • FDA believes there is a risk of infection with this device because of potential failure to sterilize dental instruments and their use should be discontinued until the device has received FDA clearance.

Vaporized Hydrogen Peroxide (VHP®). Hydrogen peroxide solutions have been used as chemical sterilants for many years. However, the VHP® was not developed for the sterilization of medical equipment until the mid-1980s. One method for delivering VHP to the reaction site uses a deep vacuum to pull liquid hydrogen peroxide (30-35% concentration) from a disposable cartridge through a heated vaporizer and then, following vaporization, into the sterilization chamber. A second approach to VHP delivery is the flow-through approach in which the VHP is carried into the sterilization chamber by a carrier gas such as air using either a slight negative pressure (vacuum) or slight positive pressure. Applications of this technology include vacuum systems for industrial sterilization of medical devices and atmospheric systems for decontaminating for large and small areas'". VHP offers several appealing features that include rapid cycle time (e.g., 30-45 minutes); low temperature; environmentally safe by- products (H 2 0, oxygen [0 2]); good material compatibility; and ease of operation, installation and monitoring. VHP has limitations including that cellulose cannot be processed; nylon becomes brittle; and VHP penetration capabilities are less than those of ETO. VHP has not been cleared by FDA for sterilization of medical devices in healthcare facilities.

The feasibility of utilizing vapor-phase hydrogen peroxide as a surface decontaminant and sterilizer was evaluated in a centrifuge decontamination application. In this study, vapor-phase hydrogen 941 peroxide was shown to possess significant sporicidal activity . In preliminary studies, hydrogen

70 Guide!;ne tor Disinfoclion and Stel'iliziltion in Hoa!ti1cme FilCIIit;es, 20013

peroxide vapor decontamination has been found to be a highly effective method of eradicating MRSA, Serratia marcescens, Clostridium botulinum spores and Clostridium diffici/e from rooms, furniture, surfaces and/or equipment; however, further investigation of this method to demonstrate both safety and effectiveness in reducing infection rates are required 942- 945•

Ozone. Ozone has been used for years as a drinking water disinfectant. Ozone is produced when o, is energized and split into two monatomic (0 1) molecules. The monatomic oxygen molecules then collide with 0 2 molecules to form ozone, which is 0 3• Thus, ozone consists of 0 2 with a loosely bonded third oxygen atom that is readily available to attach to, and oxidize, other molecules. This additional oxygen atom makes ozone a powerful oxidant that destroys microorganisms but is highly unstable (i.e., half-life of 22 minutes at room temperature).

A new sterilization process, which uses ozone as the sterilant, was cleared by FDA in August 2003 for processing reusable medical devices. The sterilizer creates its own sterilant internally from USP grade oxygen, steam-quality water and electricity; the sterilant is converted back to oxygen and water vapor at the end of the cycle by a passing through a catalyst before being exhausted into the room. The duration of the sterilization cycle is about 4 hand 15m, and it occurs at 30-35'C. Microbial efficacy has o·' been demonstrated by achieving a SAL of 1 with a variety of microorganisms to include the most resistant microorganism, Geobacillus stearothermophi/us.

The ozone process is compatible with a wide range of commonly used materials including stainless steel, titanium, anodized aluminum, ceramic, glass, silica, PVC, Teflon, silicone, polypropylene, polyethylene and acrylic. In addition, rigid lumen devices of the following diameter and length can be processed: internal diameter (ID): > 2 mm, length,;; 25 em; ID > 3 mm, length,;; 47 em; and ID > 4 mm, length ,;; 60 em.

The process should be safe for use by the operator because there is no handling of the sterilant, no toxic emissions, no residue to aerate, and low operating temperature means there is no danger of an accidental burn. The cycle is monitored using a self-contained biological indicator and a chemical indicator. The sterilization chamber is small, about 4 ft 3 (Written communication, S Dufresne, July 2004).

A gaseous ozone generator was investigated for decontamination of rooms used to house patients colonized with MRSA. The results demonstrated that the device tested would be inadequate for 946 the decontamination of a hospital room •

Formaldehyde Steam. Low-temperature steam with formaldehyde is used as a low-temperature sterilization method in many countries, particularly in Scandinavia, Germany, and the United Kingdom. The process involves the use of formalin, which is vaporized into a formaldehyde gas that is admitted into the sterilization chamber. A formaldehyde concentration of 8-16 mg/1 is generated at an operating temperature of 70-75'C. The sterilization cycle consists of a series of stages that include an initial vacuum to remove air from the chamber and load, followed by steam admission to the chamber with the vacuum pump running to purge the chamber of air and to heat the load, followed by a series of pulses of formaldehyde gas, followed by steam. Formaldehyde is removed from the sterilizer and load by repeated alternate evacuations and flushing with steam and air. This system has some advantages, e.g., the cycle time for formaldehyde gas is faster than that for ETO and the cost per cycle is relatively low. However, ETO is more penetrating and operates at lower temperatures than do steam/formaldehyde sterilizers. Low-temperature steam formaldehyde sterilization has been found effective against veaetative bacteria, 7 949 mycobacteria, B. atrophaeus and G. stearothermophi/us spores and Candida albicans' ' .

Formaldeh~de vapor cabinets also may be used in healthcare facilities to sterilize heat-sensitive 50 medical equipment • Commonly, there is no circulation of formaldehyde and no temperature and humidity controls. The release of gas from paraformaldehyde tablets (placed on the lower tray) is slow 951 and produces a low partial pressure of gas. The microbicidal quality of this procedure is unknown •

71 Guideline for Disinfeclion and ilterilization in Heillt!1care r·acilillcs, 2008

Reliable sterilization using formaldehyde is achieved when performed with a high concentration of gas, at a temperature between 60' and 80'C and with a relative humidity of 75 to 100%.

Studies indicate that formaldehyde is a mutagen and a potential human carcinogen, and OSHA regulates formaldehyde. The permissible exposure limit for formaldehyde in work areas is 0. 75 ppm measured as a 8-hourTWA. The OSHA standard includes a 2 ppm STEL (i.e., maximum exposure allowed during a 15-minute period). As with the ETO standard, the formaldehyde standard requires that the employer conduct initial monitoring to identify employees who are exposed to formaldehyde at or above the action level or STEL. If this exposure level is maintained, employers may discontinue exposure monitoring until there is a change that could affect exposure levels or an employee reports 269 formaldehyde-related signs and symptoms ' 578• The formaldehyde steam sterilization system has not been FDA cleared for use in healthcare facilities.

Gaseous chlorine dioxide. A gaseous chlorine dioxide system for sterilization of healthcare 853 953 products was developed in the late 1980s ' 952 • • Chlorine dioxide is not mutagenic or carcinogenic in humans. As the chlorine dioxide concentration increases, the time required to achieve sterilization becomes progressively shorter. For example, only 30 minutes were required at 40 mg/1 to sterilize the 6 954 10 B. atrophaeus spores at 30' to 32'C • Currently, no gaseous chlorine dioxide system is FDA cleared. Vaporized Peracetic Acid. The sporicidal activity of peracetic acid vapor at 20, 40, 60, and 80% relative humidity and 25'C was determined on Bacillus atrophaeus spores on paper and glass surfaces. Appreciable activity occurred within 10 minutes of exposure to 1 mg of peracetic acid per liter at 40% or 955 higher relative humidity • No vaporized peracetic acid system is FDA cleared.

Infrared radiation. An infrared radiation prototype sterilizer was investigated and found to destroy B. atrophaeus spores. Some of the possible advantages of infrared technology include short cycle time, low energy consumption, no cycle residuals, and no toxicologic or environmental effects. This may provide an alternative technology for sterilization of selected heat-resistant instruments but there are 956 no FDA-cleared systems for use in healthcare facilities •

The other sterilization technologies mentioned above may be used for sterilization of critical medical items if cleared by the FDA and ideally, the microbicidal effectiveness of the technology has been published in the scientific literature. The selection and use of disinfectants, chemical sterilants and sterilization processes in the healthcare field is dynamic, and products may become available that are not in existence when this guideline was written. As newer disinfectants and sterilization processes become available, persons or committees responsible for selecting disinfectants and sterilization processes should be guided by products cleared by FDA and EPA as well as information in the scientific literature.

Sterilizing Practices Ovetview. The delivery of sterile products for use in patient care depends not only on the effectiveness of the sterilization process but also on the unit design, decontamination, disassembling and packaging of the device, loading the sterilizer, monitoring, sterilant quality and quantity, and the appropriateness of the cycle for the load contents, and other aspects of device reprocessing. Healthcare personnel should perform most cleaning, disinfecting, and sterilizing of patient-care supplies in a central processing department in order to more easily control quality. The aim of central processing is the orderly processing of medical and surgical instruments to protect patients from infections while minimizing risks to staff and preserving the value of the items being reprocessed 957 • Healthcare facilities should promote the same level of efficiency and safety in the preparation of supplies in other areas (e.g., operating room, respiratory therapy) as is practiced in central processing.

Ensuring consistency of sterilization practices requires a comprehensive program that ensures operator competence and proper methods of cleaning and wrapping instruments, loading the sterilizer,

72 Guideline -for Dlslnfectkm and Stet'illzahon in HoaiU1care F·act!ities, 200B

operating the sterilizer, and monitoring of the entire process. Furthermore, care must be consistent from an infection prevention standpoint in all patient-care settings, such as hospital and outpatient facilities.

Sterilization Cycle Verification. A sterilization process should be verified before it is put into use in healthcare settings. All steam, ETO, and other low-temperature sterilizers are tested with biological and chemical indicators upon installation, when the sterilizer is relocated, redesigned, after major repair and after a sterilization failure has occurred to ensure they are functioning prior to placing them into routine use. Three consecutive empty steam cycles are run with a biological and chemical indicator in an appropriate test package or tray. Each type of steam cycle used for sterilization (e.g., vacuum-assisted, gravity) is tested separately. In a prevacuum steam sterilizer three consecutive empty cycles are also run with a Bowie-Dick test. The sterilizer is not put back into use until all biolo~ical 814 819 95 indicators are negative and chemical indicators show a correct end-point response 811 " • • •

Biological and chemical indicator testing is also done for ongoing quality assurance testing of representative samples of actual products being sterilized and product testing when major changes are made in packaging, wraps, or load configuration. Biological and chemical indicators are placed in products, which are processed in a full load. When three consecutive cycles show negative biological indicators and chemical indicators with a correct end point response, you can put the change made into 811 814 958 routine use - ' • Items processed during the three evaluation cycles should be quarantined until the test results are negative. Physical Facilities. The central processing area(s) ideally should be divided into at least three areas: decontamination, packaging, and sterilization and storage. Physical barriers should separate the decontamination area from the other sections to contain contamination on used items. In the decontamination area reusable contaminated supplies (and possibly disposable items that are reused) are received, sorted, and decontaminated. The recommended airflow pattern should contain contaminates within the decontamination area and minimize the flow of contaminates to the clean areas. The American Institute of Architects 959 recommends negative pressure and no fewer than six air exchanges per hour in the decontamination area (AAMI recommends 10 air changes per hour) and 10 air changes per hour with positive pressure in the sterilizer equipment room. The packaging area is for inspecting, assembling, and packaging clean, but not sterile, material. The sterile storage area should be a limited access area with a controlled temperature (may be as high as 75'F) and relative humidity (30· 819 60% in all works areas except sterile storage, where the relative humidity should not exceed 70%) • The floors and walls should be constructed of materials capable of withstanding chemical agents used for cleaning or disinfecting. Ceilings and wall surfaces should be constructed of non-shedding materials. 811 819 920 957 Physical arrangements of processing areas are presented schematically in four references ' • • •

Cleaning. As repeatedly mentioned, items must be cleaned using water with detergents or 465 468 enzymatic cleaners ' 466• before processing. Cleaning reduces the bioburden and removes foreign material (i.e., organic residue and inor~anic salts) that interferes with the sterilization process by acting as a barrier to the sterilization agent 179 • 42 • 457 • ' 11 • 912 • Surgical instruments are generally presoaked or prerinsed to prevent drying of blood and tissue. Precleaning in patient-care areas may be needed on items that are heavily soiled with feces, sputum, blood, or other material. Items sent to central processing without removing gross soil may be difficult to clean because of dried secretions and excretions. Cleaning and decontamination should be done as soon as possible after items have been used.

Several types of mechanical cleaning machines (e.g., utensil washer-sanitizer, ultrasonic cleaner, washer-sterilizer, dishwasher, washer-disinfector) may facilitate cleaning and decontamination of most items. This equipment often is automated and may increase productivity, improve cleaning effectiveness, and decrease worker exposure to blood and body fluids. Delicate and intricate objects and heat· or moisture-sensitive articles may require careful cleaning by hand. All used items sent to the central processing area should be considered contaminated (unless decontaminated in the area of origin), handled with gloves (forceps or tongs are sometimes needed to avoid exposure to sharps), and decontaminated by one of the aforementioned methods to render them safer to handle. Items composed

73 Guicio!ine for Dlsinfcctlon and Stc1·i!izatlon ln Hea!H1care Facl!ltiBS, 2008

of more than one removable part should be disassembled. Care should be taken to ensure that all parts are kept together, so that reassembly can be accomplished efficiently'".

Investigators have described the degree of cleanliness by visual and microscopic examination. One study found 91% of the instruments to be clean visually but, when examined microscopically, 84% of the instruments had residual debris. Sites that contained residual debris included junctions between insulating sheaths and activating mechanisms of laparoscopic instruments and articulations and grooves of forceps. More research is needed to understand the clinical significance of these findings 960 and how to ensure proper cleaning.

Personnel working in the decontamination area should wear household-cleaning-type rubber or plastic gloves when handling or cleaning contaminated instruments and devices. Face masks, eye protection such as goggles or full-length faceshields, and appropriate gowns should be worn when exposure to blood and contaminated fluids may occur (e.g., when manually cleaning contaminated 961 devices) • Contaminated instruments are a source of microorganisms that could inoculate personnel through nonintact skin on the hands or through contact with the mucous membranes of eyes, nose, or 214 813 mouth • '"· • Reusable sharps that have been in contact with blood present a special hazard. Employees must not reach with their gloved hands into trays or containers that hold these sharps to 214 retrieve them • Rather, employees should use engineering controls (e.g., forceps) to retrieve these devices.

Packaging. Once items are cleaned, dried, and inspected, those requiring sterilization must be wrapped or placed in rigid containers and should be arranged in instrument travs/baskets according to 454 811 819 836 the guidelines provided by the AAMI and other professional organizations • •814. • • 962 . These guidelines state that hinged instruments should be opened; items with removable parts should be disassembled unless the device manufacturer or researchers provide specific instructions or test data to 181 the contrary ; complex instruments should be prepared and sterilized according to device manufacturer's instructions and test data; devices with concave surfaces should be positioned to facilitate drainage of water; heavy items should be positioned not to damage delicate items; and the weight of the instrument set should be based on the design and density of the instruments and the distribution of metal 811 962 mass ' • While there is no longer a specified sterilization weight limit for surgical sets, heavy metal mass is a cause of wet packs (i.e., moisture inside the case and tray after completion of the sterilization 963 cycle\ • Other parameters that may influence drying are the density of the wraps and the design of the set964.

There are several choices in methods to maintain sterility of surgical instruments, including rigid containers, peel-open pouches (e.g., self-sealed or heat-sealed plastic and paper pouches), roll stock or reels (i.e., paper-plastic combinations of tubing designed to allow the user to cut and seal the ends to form a pouch) 454 and sterilization wraps (woven and nonwoven). Healthcare facilities may use all of these packaging options. The packaging material must allow penetration of the sterilant, provide protection against contact contamination during handling, provide an effective barrier to microbial 965 penetration, and maintain the sterility of the processed item after sterilization • An ideal sterilization wrap would successfully address barrier effectiveness, penetrability (i.e., allows sterilant to penetrate), aeration (e.g., allows ETO to dissipate), ease of use, drapeability, flexibility, puncture resistance, tear strength, toxicity, odor, waste disposal, linting, cost, and transparency"'. Unacceptable packaging for use with ETO (e.g., foil, polyvinylchloride, and polyvinylidene chlorine [kitchen-type transparent wrap]) 814 or hydrogen peroxide gas plasma (e.g., linens and paper) should not be used to wrap medical items.

In central processing, double wrapping can be done sequentially or nonsequentially (i.e., simultaneous wrapping). Wrapping should be done in such a manner to avoid tenting and gapping. The sequential wrap uses two sheets of the standard sterilization wrap, one wrapped after the other. This procedure creates a package within a package. The nonsequential process uses two sheets wrapped at the same time so that the wrapping needs to be performed only once. This latter method provides

74 Guiderino 1or DislnfecHon and SleHiizstion in Hea!thcare Fad!ities, 2008

multiple layers of protection of surgical instruments from contamination and saves time since wrapping is done only once. Multiple layers are still common practice due to the rigors of handling within the facility 966 even though the barrier efficacy of a single sheet of wrap has improved over the years • Written and illustrated procedures for preparation of items to be packaged should be readily available and used by 454 personnel when packaging procedures are performed •

Loading. All items to be sterilized should be arranged so all surfaces will be directly exposed to the sterilizing agent. Thus, loading procedures must allow for free circulation of steam (or another sterilant) around each item. Historically, it was recommended that muslin fabric packs should not exceed the maximal dimensions, weight, and density of 12 inches wide x 12 inches high x 20 inches long, 121bs, and 7.2 lbs per cubic foot, respectively. Due to the variety of textiles and metal/plastic containers on the market, the textile and metal/plastic container manufacturer and the sterilizer manufacturers should be consulted for instructions on pack preparation and density parameters'".

There are several important basic principles for loading a sterilizer: allow for proper sterilant circulation; perforated trays should be placed so the tray is parallel to the shelf; nonperforated containers should be placed on their edge (e.g., basins); small items should be loosely placed in wire baskets; and 454 811 836 peel packs should be placed on edge in perforated or mesh bottom racks or baskets ' • •

Storage. Studies in the early 1970s suggested that wrapped surgical trays remained sterile for varying periods depending on the type of material used to wrap the trays. Safe storage times for sterile packs vary with the porosity of the wrapper and storage conditions (e.g., open versus closed cabinets). Heat-sealed, plastic peel-down pouches and wrapped packs sealed in 3-mil (3/1 000 inch) polyethylene oveiWrap have been reported to be sterile for as long as 9 months after sterilization. The 3-mil polyethylene is applied after sterilization to extend the shelf life for infrequently used items967 • Supplies wrapped in double-thickness muslin comprising four layers, or equivalent, remain sterile for at least 30 days. Any item that has been sterilized should not be used after the expiration date has been exceeded or if the sterilized package is wet, torn, or punctured.

Although some hospitals continue to date every sterilized product and use the time-related shelf- life practice, many hospitals have switched to an event-related shelf-life practice. This latter practice recognizes that the product should remain sterile until some event causes the item to become contaminated (e.g., tear in packaging, packaging becomes wet, seal is broken) 968 • Event-related factors that contribute to the contamination of a product include bioburden (i.e., the amount of contamination in the environment), air movement, traffic, location, humidity, insects, vermin, ftooding, storage area space, 966 969 open/closed shelving, temperature, and the .p,roperties of the wrap material ' • There are data that 0 972 support the event-related shelf-life practice' " • One study examined the effect of time on the sterile integrity of paper envelopes, peel pouches, and nylon sleeves. The most important finding was the absence of a trend toward an increased rate of contamination over time for any pack when placed in 971 covered storage • Another evaluated the effectiveness of event-related outdating by microbiologically 972 testing sterilized items. During the 2-year study period, all of the items tested were sterile • Thus, contamination of a sterile item is event-related and the probability of contamination increases with 973 increased handling •

Following the sterilization process, medical and surgical devices must be handled using aseptic technique in order to prevent contamination. Sterile supplies should be stored far enough from the ftoor (8 to 10 inches), the ceiling (5 inches unless near a sprinkler head [18 inches from sprinkler head]), and the outside walls (2 inches) to allow for adequate air circulation, ease of cleaning, and compliance with local fire codes (e.g., supplies must be at least 18 inches from sprinkler heads). Medical and surgical supplies should not be stored under sinks or in other locations where they can become wet. Sterile items that become wet are considered contaminated because moisture brings with it microorganisms from the air and surfaces. Closed or covered cabinets are ideal but open shelving may be used for storage. Any package that has fallen or been dropped on the ftoor must be inspected for damage to the packaging and

75 Guidc:!lnc for D!sinteclion and S!eri!i;::aHon 1'n Heo!tilcare F

contents (if the items are breakable). If the package is heat-sealed in impervious plastic and the seal is still intact, the package should be considered not contaminated. If undamaged, items packaged in plastic need not be reprocessed.

Monitoring. The sterilization procedure should be monitored routinely by using a combination of mechanical, chemical, and biological indicators to evaluate the sterilizing conditions and indirectly the microbiologic status of the processed items. The mechanical monitors for steam sterilization include the daily assessment of cycle time and temperature by examining the temperature record chart (or computer printout) and an assessment of pressure via the pressure gauge. The mechanical monitors for ETO include time, temperature, and pressure recorders that provide data via computer printouts, gauges, and/or displays" . Generally, two essential elements for ETO sterilization (i.e., the gas concentration and humidity) cannot be monitored in healthcare ETO sterilizers.

Chemical indicators are convenient, are inexpensive, and indicate that the item has been exposed to the sterilization process. In one study, chemical indicators were more likely than biological 847 indicators to inaccurately indicate sterilization at marginal sterilization times (e.g., 2 minutes) • Chemical indicators should be used in conjunction with biological indicators, but based on current studies should not replace them because they indicate sterilization at marginal sterilization time and because only a biological indicator consisting of resistant spores can measure the microbial killing power of the 847 974 sterilization process. ' • Chemical indicators are affixed on the outside of each pack to show that the package has been processed through a sterilization cycle, but these indicators do not prove sterilization has been achieved. Preferably, a chemical indicator also should be placed on the inside of each pack to verify sterilant penetration. Chemical indicators usually are either heat-or chemical-sensitive inks that change color when one or more sterilization parameters (e.g., steam-time, temperature, and/or saturated steam; ETO-time, temperature, relative humidity and/or ETO concentration) are present. Chemical indicators have been grouped into five classes based on their ability to monitor one or multiple sterilization parameters"'· 819 • If the internal and/or external indicator suggests inadequate processing, 815 the item should not be used . An air-removal test (Bowie-Dick Test) must be performed daily in an empty dynamic-air-removal sterilizer (e.g., prevacuum steam sterilizer) to ensure air removal.

Biological indicators are recognized by most authorities as being closest to the ideal monitors of 975 the sterilization process 974 ' because they measure the sterilization process directly by using the most resistant microorganisms (i.e., Bacillus spores), and not by merely testing the physical and chemical conditions necessary for sterilization. Since the Bacillus spores used in biological indicators are more resistant and present in greater numbers than are the common microbial contaminants found on patient- care equipment, the demonstration that the biological indicator has been inactivated strongly implies that 844 other potential pathogens in the load have been killed •

An ideal biological monitor of the sterilization process should be easy to use, be inexpensive, not be subject to exogenous contamination, provide positive results as soon as possible after the cycle so that corrective action may be accomplished, and provide positive results only when the sterilization parameters (e.g., steam-time, temperature, and/or saturated steam; ETO-time, temperature, relative 84 humidity and/or ETO concentration) are inadequate to kill microbial contaminates •

Biological indicators are the only process indicators that directly monitor the lethality of a given sterilization process. Spores used to monitor a sterilization process have demonstrated resistance to the 912 sterilizing agent and are more resistant than the bioburden found on medical devices 179• 911 • • B. 6 5 atrophaeus spores (1 0 ) are used to monitor ETO and dry heat, and G. stearothermophilus spores (1 0 ) are used to monitor steam sterilization, hydrogen peroxide gas plasma, and liquid peracetic acid sterilizers. G. stearothermophi/us is incubated at 55-60'C, and B. atrophaeus is incubated at 35-37'C. Steam and low temperature sterilizers (e.g., hydrogen peroxide gas plasma, peracetic acid) should be monitored at least weekly with the appropriate commercial preparation of spores. If a sterilizer is used frequently (e.g., several loads per day), daily use of biological indicators allows earlier discovery of

76 Guiddino for Disinfection and Sterilization in Hea!thcare Facilities, 2008

equipment malfunctions or procedural errors and thus minimizes the extent of patient surveillance and 811 product recall needed in the event of a positive biological indicator • Each load should be monitored if it contains implantable objects. If feasible, implantable items should not be used until the results of spore tests are known to be negative.

Originally, spore-strip biological indicators required up to 7 days of incubation to detect viable spores from marginal cycles (i.e., when few spores remained viable). The next generation of biological indicator was self-contained in plastic vials containing a spore-coated paper strip and a growth media in a crushable glass ampoule. This indicator had a maximum incubation of 48 hours but significant failures could be detected in :>24 hours. A rapid-readout biological indicator that detects the presence of enzymes of G. stearothermophilus by reading a ftuorescent product produced by the enzymatic breakdown of a nonfluorescent substrate has been marketed for the more than 10 years. Studies demonstrate that the sensitivity of rapid-readout tests for steam sterilization (1 hour for 132°C gravity sterilizers, 3 hrs for 121°C gravity and 132•c vacuum sterilizers) parallels that of the conventional 976 977 sterilization-specific biological indicators"'· " 7 • • and the fluorescent rapid readout results reliably 978 predict 24- and 48-hour and 7-day growth The rapid-readout biological indicator is a dual indicator system as it also detects acid metabolites produced during growth of the G. stearothermophilus spores. This system is different from the indicator system consisting of an enzyme system of bacterial origin without spores. Independent comparative data using suboptimal sterilization cycles (e.g., reduced time or 979 temperature) with the enzyme-based indicator system have not been published •

A new rapid-readout ETO biological indicator has been designed for rapid and reliable monitoring of ETO sterilization processes. The indicator has been cleared by the FDA for use in the United 400 States • The rapid-readout ETO biological indicator detects the presence of B. atrophaeus by detecting a fluorescent signal indicating the activity of an enzyme present within the B. atrophaeus organism, beta- glucosidase. The fluorescence indicates the presence of an active spore-associated enzyme and a sterilization process failure. This indicator also detects acid metabolites produced during growth of the B. atrophaeus spore. Per manufacturer's data, the enzyme always was detected whenever viable spores were present. This was expected because the enzyme is relatively ETO resistant and is inactivated at a slightly longer exposure time than the spore. The rapid-readout ETO biological indicator can be used to monitor 100% ETO, and ETO-HCFC mixture sterilization cycles. It has not been tested in ETO-CO, mixture sterilization cycles.

The standard biological indicator used for monitoring full-cycle steam sterilizers does not provide reliable monitoring flash sterilizers'". Biological indicators specifically designed for monitoring flash 847 981 sterilization are now available, and studies comparing them have been published"'· ' . 982 Since sterilization failure can occur (about 1% for steam) , a procedure to follow in the event of positive spore tests with steam sterilization has been provided by CDC and the Association of peri Operative Registered Nurses (AORN). The 1981 CDC recommendation is that "objects, other than implantable objects, do not need to be recalled because of a single positive spore test unless the steam sterilizer or the sterilization procedure is defective." The rationale for this recommendation is that single positive spore tests in sterilizers occur sporadically. They may occur for reasons such as slight variation in the resistance of the spores 983 , improper use of the sterilizer, and laboratory contamination during culture (uncommon with self-contained spore tests). If the mechanical (e.g., time, temperature, pressure in the steam sterilizer) and chemical (internal and/or external) indicators suggest that the sterilizer was functioning properly, a single positive spore test probably does not indicate sterilizer malfunction but the 983 spore test should be repeated immediately • If the spore tests remain positive, use of the sterilizer 1 should be discontinued until it Is serviced . Similarly, AORN states that a single positive spore test does not necessarily indicate a sterilizer failure. If the test is positive, the sterilizer should immediately be rechallenged for proper use and function. Items, other than implantable ones, do not necessarily need to be recalled unless a sterilizer malfunction is found. If a sterilizer malfunction is discovered, the items must be considered nonsterile, and the items from the suspect load(s) should be recalled, insofar as

77 Guido!ine for Dislhfectk>n and StGHI!zation in Hen!theare Fad!itios, 2008

984 possible, and reprocessed • A suggested protocol for management of positive biological indicators is 839 813 shown in Table 12 • A more conservative approach also has been recommended in which any positive spore test is assumed to represent sterilizer malfunction and requires that all materials processed in that sterilizer, dating from the sterilization cycle having the last negative biologic indicator to the next cycle showing satisfactory biologic indicator challenge results, must be considered nonsterile and retrieved, if possible, and reprocessed. This more conservative approach should be used for sterilization methods other than steam (e.g., ETO, hydrogen peroxide gas plasma). However, no action is 98 necessary if there is strong evidence for the biological indicator being defective or the growth medium contained a Bacl7/us contaminant'" .

If patient-care items were used before retrieval, the infection control professional should assess the risk of infection in collaboration with central processing, surgical services, and risk management staff. The factors that should be considered include the chemical indicator result (e.g., nonreactive chemical indicator may indicate temperature not achieved); the results of other biological indicators that followed the positive biological indicator (e.g., positive on Tuesday, negative on Wednesday); the parameters of the sterilizer associated with the positive biological indicator (e.g., reduced time at correct temperature); the time-temperature chart (or printout); and the microbial load associated with decontaminated surgical instruments (e.g., 85% of decontaminated surgical instruments have less than 100 CFU). The margin of safety in steam sterilization is sufficiently large that there is minimal infection risk associated with items in a load that show spore growth, especially if the item was properly cleaned and the temperature was achieved (e.g., as shown by acceptable chemical indicator or temperature chart). There are no published studies that document disease transmission via a nonretrieved surgical instrument following a sterilization cycle with a positive biological indicator.

False-positive biological indicators may occur from improper testing or faulty indicators. The latter may occur from improper storage, processing, product contamination, material failure, or variation in resistance of spores. Gram stain and subculture of a positive biological indicator may determine if a 986 contaminant has created a false-positive result"'· . However, in one incident, the broth used as growth 985 medium contained a contaminant, B. coagulans, which resulted in broth turbidity at 55°C • Testing of 839 paired biological indicators from different manufacturers can assist in assessing a product defect . False-positive biological indicators due to extrinsic contamination when using self-contained biological indicators should be uncommon. A biological indicator should not be considered a false-positive indicator until a thorough analysis of the entire sterilization process shows this to be likely.

The size and composition of the biological indicator test pack should be standardized to create a significant challenge to air removal and sterilant penetration and to obtain interpretable results. There is 813 987 a standard 16-towel pack recommended by AAMI for steam sterilization • 81 '· consisting of 16 clean, preconditioned, reusable huck or absorbent surgical towels each of which is approximately 16 inches by 26 inches. Each towel is folded lengthwise into thirds and then folded widthwise in the middle. One or more biological indicators are placed between the eight and ninth towels in the approximate geometric center of the pack. When the towels are folded and placed one on top of another, to form a stack (approximately 6 inch height) it should wei~h approximately 3 pounds and should have a density of 3 approximately 11.3 pounds per cubic foot' . This test pack has not gained universal use as a standard pack that simulates the actual in-use conditions of steam sterilizers. Commercially available disposable test packs that have been shown to be equivalent to the AAMI16 towel test pack also may be used. The test pack should be placed flat in an otherwise fully loaded sterilizer chamber, in the area least favorable to sterilization (i.e., the area representing the greatest challenge to the biological indicator). This area is 813 normally in the front, bottom section of the sterilizer, near the drain' 11 • . A control biological indicator from the lot used for testing should be left unexposed to the sterilant, and then incubated to verify the presterilization viability of the test spores and proper incubation. The most conservative approach would be to use a control for each run; however, less frequent use may be adequate (e.g., weekly). There also is a routine test pack for ETO where a biological indicator is placed in a plastic syringe with plunger, then placed in the folds of a clean surgical towel, and wrapped. Alternatively, commercially available disposal

78 Guideline tor Disinlection Hnd Sterilization in Healti'iccme F acil;tlns, 2008

test packs that have been shown to be e~uivalent to the AAMI test pack may be used. The test pack is 4 placed in the center of the sterilizer load' • Sterilization records (mechanical, chemical, and biological) should be retained for a time period in compliance with standards (e.g., Joint Commission for the Accreditation of Healthcare Facilities requests 3 years) and state and federal regulations.

In Europe, biological monitors are not used routinely to monitor the sterilization process. Instead, release of sterilizer items is based on monitoring the physical conditions of the sterilization process that is termed "parametric release." Parametric release requires that there is a defined quality system in place at the facility performing the sterilization and that the sterilization process be validated for the items being sterilized. At present in Europe, parametric release is accepted for steam, dry heat, and ionizing radiation processes, as the physical conditions are understood and can be monitored directly'". For example, with steam sterilizers the load could be monitored with probes that would yield data on temperature, time, and humidity at representative locations in the chamber and compared to the specifications developed during the validation process.

Periodic infection control rounds to areas using sterilizers to standardize the sterilizer's use may identify correctable variances in operator competence; documentation of sterilization records, including chemical and biological indicator test results; sterilizer maintenance and wrapping; and load numbering of packs. These rounds also may identify improvement activities to ensure that operators are adhering to established standards'".

79 Guideline for Disinfection and SterHizatl011 in He

REUSE OF SINGLE-USE MEDICAL DEVICES

The reuse of single-use medical devices began in the late 1970s. Before this time most devices were considered reusable. Reuse of single-use devices increased as a cost-saving measure. Approximately 20 to 30% of U.S. hospitals reported that they reuse at least one type of single-use device. Reuse of single-use devices involves regulatory, ethical, medical, legal and economic issues and has been extremely controversial for more than two decades 990. The U.S. public has expressed increasing concern regarding the risk of infection and injury when reusing medical devices intended and labeled for single use. Although some investigators have demonstrated it is safe to reuse disposable medical 994 devices such as cardiac electrode catheters, 991 ' 993 additional studies are needed to define the risks and document the benefits. In August 2000, FDA released a guidance document on single-use devices reprocessed by third parties or hospitals'". In this guidance document, FDA states that hospitals or third-party reprocessors will be considered "manufacturers" and regulated in the same manner. A reused single-use device will have to comply with the same regulatory requirements of the device when it was originally manufactured. This document presents FDA's intent to enforce premarket submission requirements within 6 months (February 2001) for class Ill devices (e.g., cardiovascular intra-aortic balloon pump, transluminal coronary angioplasty catheter); 12 months (August 2001) for class II devices (e.g., blood pressure cuff, bronchoscope biopsy forceps); and 18 months (February 2002) for class I devices (e.g., disposable medical scissors, ophthalmic knife). FDA uses two types of premarket requirements for nonexempt class I and II devices, a 51 O(k) submission that may have to show that the device is as safe and effective as the same device when new, and a premarket approval application. The 51 O(k) submission must provide scientific evidence that the device is safe and effective for its intended use. FDA allowed hospitals a year to comply with the non pre market requirements (registration and listing, reporting adverse events associated with medical devices, quality system regulations, and proper labeling). The options for hospitals are to stop reprocessing single-use devices, comply with the rule, or outsource to a third-party reprocessor. FDA guidance document does not apply to permanently implantable pacemakers, hemodialyzers, opened but unused single-use devices, or healthcare settings other than acute-care hospitals. The reuse of single use medical devices continues to be an evolving area of regulations. For this reason, healthcare workers should refer to FDA for the latest guidance 996 (www.fda.gov) •

80 Guideline. for Dls!nfecHon and SteHJizAt!on ln l--·!ea!thcme Facilities, 2008

CONCLUSION

When properly used, disinfection and sterilization can ensure the safe use of invasive and non- invasive medical devices. However, current disinfection and sterilization guidelines must be strictly followed.

81 Gu:doline for Disinfection and Sterilization :n Heolthcme Focilit1es, 2008

WED-BASED DISINFECTION AND STERILIZATION RESOURCES

Additional information about disinfection and sterilization is available at the following dedicated websites: Food and Drug Administration, Rockville, Maryland http://www. fda. gov/dcrh/ode/germlab. html

Environmental Protection Agency, Washington, D.C. http://www.epa.gov/oppadOO 1/chemregi ndex. htm

Centers for Disease Control and Prevention, Atlanta, Georgia http://www. cdc. gov/ncidod/dhqp/steril e. html

University of North Carolina, Chapel Hill, North Carolina http://www. disi nfecti onandsterilization. org

82 Guideline for Disinfection and Sterilization in Hoalthcnm Fi1Cilities, 2008

RECOMMENDATIONS FOR DISINFECTION AND STERILIZATION IN HEALTHCARE FACILITIES

A. Rationale

The ultimate goal of the Recommendations for Disinfection and Sterilization in Health-Care Facilities, 2008, is to reduce rates of health-care-associated infections through appropriate use of both disinfection and sterilization. Each recommendation is categorized according to scientific evidence, theoretical rationale, applicability, and federal regulations. Examples are included in some recommendations to aid the reader; however, these examples are not intended to define the only method of implementing the recommendation. The CDC system for categorizing recommendation·s is defined in the following (Rankings) section. · B. Rankings Category /A. Strongly recommended for implementation and strongly supported by well-designed experimental, clinical, or epidemiologic studies. Category 18. Strongly recommended for implementation and supported by some experimental, clinical, or epidemiologic studies, and by a strong theoretical rationale. Category /C. Required by state or federal regulations. Because of state differences, readers should not assume that the absence of an /C recommendation implies the absence of state regulations. Category II. Suggested for implementation and supported by suggestive clinical or epidemiologic studies or by a theoretical rationale. No recommendation. Unresolved issue. These include practices for which insufficient evidence or no consensus exists regarding efficacy.

C. Recommendations 1. Occupational Health and Exposure a. Inform each worker of the possible health effects of his or her exposure to infectious agents (e.g., hepatitis B virus [HBV], hepatitis C virus, human immunodeficiency virus [HIV]), and/or chemicals (e.g., EtO, formaldehyde). The information should be consistent with Occupational Safety and Health Administration (OSHA) requirements and identify the areas and tasks in which potential 214 320 959 997 998 exists for exposure. Category II, /C • • • • b. Educate health-care workers in the selection and proper use of personal protective equipment (PPE). Category II, /C c. Ensure that workers wear appropriate PPE to preclude exposure to infectious agents or chemicals through the respiratory system, skin, or mucous membranes of the eyes, nose, or mouth. PPE can include gloves, gowns, masks, and eye protection. The exact type of PPE depends on the infectious or chemical agent and the anticipated duration of exposure. The 214 997 employer is responsible for making such equipment and training available. Category II, /C. • ' 999

d. Establish a program for monitoring occupational exposure to regulated chemicals (e.g., 997 1000 1001 formaldehyde, EtO) that adheres to state and federal regulations. Category II, /C. • • e. Exclude healthcare workers with weeping dermatitis of hands from direct contact with patient- 1002 1003 care equipment. Category 18. '

2. Cleaning of Patient-Care Devices a. In hospitals, perform most cleaning, disinfection, and sterilization of patient-care devices in a 454 836 959 central processing department in order to more easily control quality. Category 11. • • b. Meticulously clean patient-care items with water and detergent, or with water and enzymatic 6 83 101 104 106 124 cleaners before high-level disinfection or sterilization procedures. Category /8. • • • " • • 179, 424-426, 436,465, 471, 911-913, 1004

i. Remove visible organic residue (e.g., residue of blood and tissue) and inorganic salts with cleaning. Use cleaning agents that are capable of removinq visible organic and inorganic residues. Category lB. 424-426,466, 4sa, 469, 471, soa, slo

83 Guideline for Disinfection and Sted!izatlon in Hea!tltcare Facilities, 2008

il: Clean medical devices as soon as practical after use (e.g., at the point of use) because soiled materials become dried onto the instruments. Dried or baked materials on the instrument make the removal process more difficult and the 55 58 disinfection or sterilization process less effective or ineffective. Category /B. ' ' 59,291,465,1005, 1006

c. Perform either manual cleaning (i.e., using friction) or mechanical cleaning (e.g., with ultrasonic 999 cleaners, washer-disinfector, washer-sterilizers). Category /B. 426• 456 • 471 • d. If using an automatic washer/disinfector, ensure that the unit is used in accordance with the manufacturer's recommendations. Category /B. 7• 133• 155• 725 e. Ensure that the detergents or enzymatic cleaners selected are compatible with the metals and other materials used in medical instruments. Ensure that the rinse step is adequate for removing cleaning residues to levels that will not interfere with subsequent disinfection/sterilization 836 1004 processes. Category II. ' f. Inspect equipment surfaces for breaks in integrity that would impair either cleaning or disinfection/sterilization. Discard or repair equipment that no longer functions as intended or 888 cannot be properly cleaned, and disinfected or sterilized. Category II. g. 3. Indications for Sterilization, High-Level Disinfection, and Low-Level Disinfection a. Before use on each patient, sterilize critical medical and surgical devices and instruments that enter normally sterile tissue or the vascular system or through which a sterile body fluid flows 179 497 821 822 907 911 912 (e.g., blood). See recommendation 7g for exceptions. Category fA. • • • • • • b. Provide, at a minimum, high-level disinfection for semicritical patient-care equipment (e.g., gastrointestinal endoscopes, endotracheal tubes, anesthesia breathing circuits, and respiratory 6 8 17 therapy equipmentl that touches either mucous membranes or nonintact skin. Category /A. - • • 20, 99, 101,108,113-115,129,138, 139, 147,152-154,471,1007

c. Perform low-level disinfection for noncritical patient-care surfaces (e.g., bedrails, over-the-bed table) and equipment le.Q., blood pressure cuff) that touch intact skin (see Recommendation 5g). Category If. 17, 4a-4s, so-s2. a'f, sa, 372,373, 37a, 382, 4ot 4. Selection and Use of Low-Level Disinfectants for Noncritical Patient-Care Devices a. Process noncritical patient-care devices using a disinfectant and the concentration of germicide listed in Table 1. Category /B. 11,46-48,50-52,67,68,378,382,401 b. Disinfect noncritical medical devices (e.g., blood pressure cuff) with an EPA-registered hospital disinfectant using the label's safety precautions and use directions. Most EPA-registered hospital disinfectants have a label contact time of 10 minutes. However, multiple scientific studies have demonstrated the efficacy of hospital disinfectants against pathogens with a contact time of at least 1 minute. By law, all applicable label instructions on EPA-registered products must be followed. If the user selects exposure conditions that differ from those on the EPA-registered product label, the user assumes liability from any injuries resulting from off-label use and is 50 53 5 potentially subject to enforcement action under FIFRA. Category !B. 11 • 47 • 48• • 51 • -57 • 59 · 5o, 62· 64, 3 5. 378, 382

c. Ensure that, at a minimum, noncritical patient-care devices are disinfected when visibly soiled and on a reoular basis (such as after use on each patient or once daily or once weekly). Category II. 37a, 3ao, tooB d. If dedicated, disposable devices are not available, disinfect noncritical patient-care equipment after using it on a patient who is on contact precautions before using this equipment on another patient. Category lB. 47, 67,391, 1oo9 5. Cleaning and Disinfecting Environmental Surfaces in Healthcare Facilities a. Clean housekeeping surfaces (e.g., floors, tabletops) on a regular basis, when spills occur, and 23 378 380 382 1008 1010 when these surfaces are visibly soiled. Category 11. • • • • • b. Disinfect (or clean) environmental surfaces on a re~ular basis (e.g., daily, three times per week) 3 8 380 402 1008 and when surfaces are visibly soiled. Category 11. • • • c. Follow manufacturers' instructions for proper use of disinfecting (or detergent) products--- such as recommended use-dilution, material compatibility, storage, shelf-life, and safe use and

84 Cu1delino for Disinfection and Stel'ilization in Heslthcare Facilltlfos, 2008

365 disposal. Category II. 327 ' ' 404 d. Clean walls, blinds, and window curtains in patient-care areas when these surfaces are visibly 1011 contaminated or soiled. Category 11. e. Prepare disinfecting (or detergent) solutions as needed and replace these with fresh solution frequently (e.g., replace ftoor mopping solution every three patient rooms, change no less often 379 than at 60-minute intervals), according to the facility's policy. Category /B. "· f. Decontaminate mop heads and cleaning cloths regularly to prevent contamination (e.g., launder 68 403 and dry at least daily). Category 11. • 402 • g. Use a one-step process and an EPA-registered hospital disinfectant designed for housekeeping purposes in patient care areas where 1) uncertainty exists about the nature of the soil on the surfaces (e.g., blood or body ffuid contamination versus routine dust or dirt); or 2) uncertainty exists about the presence of multi drug resistant organisms on such surfaces. See 5n for recommendations reauirina cleaning and disinfecting blood-contaminated surfaces. Category II. 23,47, 48, 51,214,378,379, 38~. 416, f012

h. Detergent and water are adequate for cleaning surfaces in nonpatient-care areas (e.g., 23 administrative offices). Category II. i. Do not use high-level disinfectantsfliquid chemical sterilants for disinfection of non-critical 318 surfaces. Category lB. 23 ' 69 ' j. Wet-dust horizontal surfaces regularly (e.g., daily, three times per week) using clean cloths moistened with an EPA-registered hospital disinfectant (or detergent). Prepare the disinfectant 68 378 380 402 403 1008 (or detergent) as recommended by the manufacturer. Category 11. • • • • • k. Disinfect noncritical surfaces with an EPA-registered hospital disinfectant according to the label's safety precautions and use directions. Most EPA-registered hospital disinfectants have a label contact time of 10 minutes. However, many scientific studies have demonstrated the efficacy of hospital disinfectants against pathogens with a contact time of at least 1 minute. By law, the user must follow all applicable label instructions on EPA-registered products. If the user selects exposure conditions that differ from those on the EPA-registered product label, the user assumes liability for any injuries resulting from off-label use and is potentially subject to enforcement action under FIFRA. Category II, /C. 11, 47, 48, 5o,''· 53-57,59, 5o, 62-64,355,378,382 I. Do not use disinfectants to clean infant bassinets and incubators while these items are occupied. If disinfectants (e.g., phenolics) are used for the terminal cleaning of infant bassinets and incubators, thoroughly rinse the surfaces of these items with water and.dry them before these 17 739 740 items are reused. Category lB. • ' m. Promptly clean and decontaminate spills of blood and other potentially infectious materials. 214 Discard blood-contaminated items in compliance with federal regulations. Category /B, /C. n. For site decontamination of spills of blood or other potentially infectious materials (OPIM), implement the following procedures. Use protective gloves and other PPE (e.g., when sharps are involved use forceps to pick up sharps, and discard these items in a puncture-resistant container) appropriate for this task. Disinfect areas contaminated with blood spills using an EPA- registered tuberculocidal agent, a registered germicide on the EPA Lists D and E (i.e., products with SRecific label claims for HIV or HBV or freshly diluted hypochlorite solution. Category II, /C. 214 215 557 1013 • • • If sodium hypochlorite solutions are selected use a 1:1 00 dilution (e.g., 1:1 00 dilution of a 5.25-6.15% sodium hypochlorite provides 525-615 ppm available chlorine) to decontaminate nonporous surfaces after a small spill (e.g., <10 mL) of either blood or OPIM. If a spill involves large amounts (e.g., >1 0 mL) of blood or OPIM, or involves a culture spill in the laboratory, use a 1:1 0 dilution for the first application of hypochlorite solution before cleaning in order to reduce the risk of infection during the cleaning process in the event of a sharp injury. Follow this decontamination process with a terminal disinfection, using a 1:100 dilution of sodium 63 215 557 hypochlorite. Category /B, /C. • ' o. If the spill contains large amounts of blood or body fluids, clean the visible matter with disposable absorbent material, and discard the contaminated materials in appropriate, labeled containment. 44 214 Category II, /C. • 44 214 p. Use protective gloves and other PPE appropriate for this task. Category II, /C. •

85 Guideline for Disinfrc)Ction and Stofilization in IIDBithcme rcncilities, 2008

q. In units with high rates of endemic Clostridium difficile infection or in an outbreak setting, use dilute solutions of 5.25%-6.15% sodium hypochlorite (e.g., 1:10 dilution of household bleach) for routine environmental disinfection. Currently,. no products are EPA-registered specifically for inactivating C. difficile spores. Category 11. 57· 259 r. If chlorine solution is not prepared fresh daily, it can be stored at room temperature for up to 30 days in a capped, opaque plastic bottle with a 50% reduction in chlorine concentration after 30 days of storage (e.g., 1000 ppm chlorine [arp,roximately a 1:50 dilution] at day 0 decreases to 500 ppm chlorine by day 30). Category /B. 7• 1014 s. An EPA-registered sodium hypochlorite product is preferred, but if such products are not available, generic versions of sodium hypochlorite solutions (e.g., household chlorine bleach) can be used. Category 11. 44

6. Disinfectant Fogging 23 a. Do not perform disinfectant fogging for routine purposes in patient-care areas. Category II. • 228

7. High-Level Disinfection of Endoscopes a. To detect damaged endoscopes, test each flexible endoscope for leaks as part of each reprocessing cycie. Remove from clinical use any instrument that fails the leak test, and repair 113 115 116 this instrument. Category II. • • b. Immediately after use, meticulously clean the endoscope with an enzymatic cleaner that is compatible with the endoscope. Cleanina is necessary before both automated and manual disinfection. Category lA. a3, 1o1, 1o4-1os, 113'; 11s, 11s, 124, 12a, 4ss, 4Bs, 4ss, 471, 101s

c. Disconnect and disassemble endoscopic components (e.g., suction valves) as completely as possible and completely immerse all components in the enzymatic cleaner. Steam sterilize these 115 116 139 4 5 466 components if they are heat stable. Category /B. • • • ~ - d. Flush and brush all accessible channels to remove all organic (e.g., blood, tissue) and other residue. Clean the external surfaces and accessories of the devices by using a soft cloth or 6 108 soonae or brushes. Continue brushing until no debris appears on the brush. Category /A • 17 · ' 1{3, 111r. 116, 137' 145, 147, 725, 856, 903

e. Use cleaning brushes appropriate for the size of the endoscope channel or port (e.g., bristles should contact surfaces). Cleaning items (e.g., brushes, cloth) should be disposable or, if they are not disposable, they should be thorou~hly cleaned and either high-level disinfected or 5 sterilized after each use. Category 11. 113 • 1 • 11 6 , 1°16 f. Discard enzymatic cleaners (or detergents) after each use because they are not microbicidal and, 38 113 115 116 466 therefore, will not retard microbial growth. Category /8. • • • • g. Process endoscopes (e.g., arthroscopes, cystoscope, laparoscopes) that pass through normally sterile tissues using a sterilization procedure before each use; if this is not feasible, provide at least high-level disinfection. High-level disinfection of arthroscopes, laparoscop,es, and 1 17 31 32 5 89 90 113 554 cytoscopes should be followed by a sterile water rinse. Category /B. • • • • • • • • h. Phase out endoscopes that are critical items (e.g., arthroscopes, laparoscopes) but cannot be steam sterilized. Replace these endoscopes with steam sterilizable instruments when feasible. Category II. i. Mechanically clean reusable accessories inserted into endoscopes (e.g., biopsy forceps or other cutting instruments) that break the mucosal barrier (e.g., ultrasonically, clean biopsy forceps) and then sterilize these items between each patient. Category /A. 1• 6 • 8 • 17 • 08 • 113• 115 - 1i 6,l 38 • 145 • 147,153 • m j. Use ultrasonic cleaning of reusable endoscopic accessories to remove soil and organic material from hard-to-clean areas. Category 11. ~ • 11 145 148

k. Process endoscopes and accessories that contact mucous membranes as semicritical items, and 1 6 8 17 108 113 115 116 129 use at least hiah-level disinfection after use on each patient. Category /A. • • • • • • • • • 138, 145~148, 152-154,278

I. Use an FDA-cleared sterilant or high-level disinfectant for sterilization or high-level disinfection (Table 1). Category/A. 1,6-8,17,85,108,113,115,116,147 m. After cleaning, use formulations containing glutaraldehyde, glutaraldehyde with phenol/phenate,

86 Guideline for Disinlcor:lion and Stelilizallon in HciJit11cam F'1Cilitles, 20013

ortho-phthalaldehyde, hydrogen peroxide, and both hydrogen peroxide and peracetic acid to achieve high-level disinfection followed by rinsinq and drying (see Table 1 for recommended concentrations). Category lB. 1, o.8,17, "· "· 108,113,145-148 n. Ex1end exposure times beyond the minimum effective time for disinfecting semi critical patient- care equipment cautiously and conservatively because extended exposure to a high-level disinfectant is more likely to damage delicate and intricate instruments such as ftexible endoscopes. The exposure times vary among the Food and Drug Administration (FDA)-cleared 17 69 73 76 78 83 high-level disinfectants (Table 2). Category /B. • • • • • o. Federal regulations are to follow the FDA-cleared label claim for high-level disinfectants. The FDA-cleared labels for high-level disinfection with >2% glutaraldehyde at 25°C range from 20-90 minutes, depending upon the product based on three tier testing which includes AOAC sporicidal tests, simulated use testing with mycobacterial and in-use testing. Category /C. p. Several scientific studies and professional organizations support the efficacy of >2% glutaraldehyde for 20 minutes at 2o•c; that efficacy assumes adequate cleaning prior to disinfection, whereas the FDA-cleared label claim incorporates an added margin of safety to accommodate possible lapses in cleaning practices. Facilities that have chosen to apply the 20 minute duration at 2o•c have done so based on the lA recommendation in the July 2003 SHEA position paper, "Multi-society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes 12 ' !7, \9, 26, 27, 49, 55, 57, 58, 60, 73, 76, 79-81, 83·85, 93, 94, 104-106, 110, Ill, 115-121, 124, 125,233, 235,236,243,265, 266,609

q. When using FDA-cleared high-level disinfectants, use manufacturers' recommended exposure conditions. Certain products may require a shorter exposure time (e.g., 0.55% ortho- phthalaldehyde for 12 minutes at 20°C, 7.35% hydrogen peroxide plus 0.23% peracetic acid for 15 minutes at 20'C) than glutaraldehyde at room temperature because of their rapid inactivation of mycobacteria or reduced exposure time because of increased mycobactericidal activity at 83 100 689 693 elevated temperature (e.g., 2.5% glutaraldehyde at 5 minutes at 35°C). Category /B. • • • • 694, 700

r. Select a disinfectant or chemical sterilant that is compatible with the device that is being reprocessed. Avoid using reprocessing chemicals on an endoscope if the endoscope manufacturer warns against using these chemicals because of functional damage (with or without 69 113 116 cosmetic damage). Category /B. · • s. Completely immerse the endoscope in the high-level disinfectant, and ensure all channels are 108 11 116 perfused. As soon as is feasible, phase out nonimmersible endoscopes. Category /B. · "' ' '37, 725, 856, 882

t. After high-level disinfection, rinse endoscopes and flush channels with sterile water, filtered water, or tapwater to prevent adverse effects on patients associated with disinfectant retained in the endoscope (e.g., disinfectant induced colitis). Follow this water rinse with a rinse with 70%- 90% ethyl or isopropyl alcohol. Category /B. 11,31-35,38,39,108, 113, 115, 116, 134,145-148, 620·622, 624·63o, 1011 u. After flushing all channels with alcohol, purge the channels using forced air to reduce the likelihood of contamination of the endoscope by waterborne pathogens and to facilitate drying. Category lB. 39,113,115, 116,145, w 17 108 113 115 116 145 815 v. Hang endoscopes in a vertical position to facilitate drying. Category 11. • • • • • • w. Store endoscopes in a manner that will protect them from damage or contamination. Category II. 17, 108, 113, 115, 116, 145

x. Sterilize or high-level disinfect both the water bottle used to provide intraprocedural flush solution and its connecting tube at least once daily. After sterilizin~ or high-level disinfecting the water 10 31 35 113 116 1 17 bottle, fill it with sterile water. Category /B. • • • • • y. Maintain a log for each procedure and record the following: patient's name and medical record number (if available), procedure, date, endoscopist, system used to reprocess the endoscope (if more than one system could be used in the rewocessinp, area), and serial number or other 08 113 115 16 identifier of the endoscope used. Category 11. • • • z. Design facilities where endoscopes are used and disinfected to provide a safe environment for healthcare workers and patients. Use air-exchange equipment (e.g., the ventilation system, out- exhaust ducts) to minimize exposure of all persons to potentially toxic vapors (e.g.,

87 Guideline for Disinfoclion and Sterilization in Heolthcme Facilities, 2008

glutaraldehyde vapor). Do not exceed the allowable limits of the vapor concentration of the chemical sterilant or high-level disinfectant (e.g., those of ACGIH and OSHA). Category 18, /C. 116,145,318,322,577,652

aa. Routinely test the liquid sterilantlhigh-level disinfectant to ensure minimal effective concentration of the active ingredient. Check the solution each day of use (or more frequently) using the appropriate chemical indicator (e.g., glutaraldehyde chemical indicator to test minimal effective concentration of glutaraldehyde) and document the results of this testing. Discard the solution if the chemical indicator shows the concentration is less than the minimum effective concentration. Do not use the liquid sterilantlhigh-level disinfectant beyond the reuse-life recommended by the 76 108 11 116 608 609 manufacturer (e.g., 14 days for ortho-phthalaldehyde). Category fA. • • 113 • s, • • bb. Provide personnel assigned to reprocess endoscopes with device-specific reprocessing instructions to ensure proper cleaning and high-level disinfection or sterilization. Require competency testing on a regular basis (e.g., beginnin~ of employment, annually) of all personnel who reprocess endoscopes. Category /A. 6-8,108,113; 11 , 116, 14s, 148,1ss cc. Educate all personnel who use chemicals about the possible biologic, chemical, and 116 environmental hazards of performing procedures that require disinfectants. Category 18, /C. ' 997,998,1018,1019

dd. Make PPE(e.g., gloves, gowns, eyewear, face mask or shields, respiratory protection devices) available and use these items appropriately to protect workers from ex~osure to both chemicals and microorganisms (e.g., HBV). Category IB, /C. 11S,116, 214,961,997,998,1 20,1021 ee. If using an automated endoscope reprocessor (AER), place the endoscope in the reprocessor and attach all channel connectors according to the AER manufacturer's instructions to ensure 7 8 exposure of all internal surfaces to the high-level disinfectant/chemical sterilant. Category /B. · ' 115,116, 155,725,903

ff. If using an AER, ensure the endoscope can be effectively reprocessed in the AER. Also, ensure any required manual cleaning/disinfecting steps are performed (e.g., elevator wire channel of 7 8 11 116 1 72 duodenoscopes might not be effectively disinfected by most AERs). Category lB. • • s. • ss. s gg. Review the FDA advisories and the scientific literature for reports of deficiencies that can lead to infection because design flaws and improper operation and practices have compromised the 98 13 134 72 effectiveness of AERs. Category 11. 1· • '· • iss. s hh. Develop protocols to ensure that users can readily identify an endoscope that has been properly processed and is ready for patient use. Category II. ii. Do not use the carrying case designed to transport clean and reprocessed endoscopes outside of the healthcare environment to store an endoscope or to transport the instrument within the healthcare environment. Category II. Jj. No recommendation is made about routinely performing microbiologic testing of either 116 164 endoscopes or rinse water for quality assurance purposes. Unresolved Issue. • kk. If environmental microbiologic testing is conducted, use standard microbiologic techniques. Category II. 23, 116,1S7,161, 167 II. If a cluster of endoscopy-related infections occurs, investigate potential routes of transmission 8 1022 (e.g., person-to-person, common source) and reservoirs. Category /A. • mm. Report outbreaks of endoscope-related infections to persons responsible for institutional 113 116 1023 infection control and risk management and to FDA. Category /B.'· 7 • • ' Notify the local and the state health departments, CDC, and the manufacturer(s). Category II. nn. No recommendation is made regarding the reprocessing of an endoscope again immediately before use if that endoscope has been processed alter use according to the recommendations in 157 this guideline. Unresolved issue. oo. Compare the reprocessing instructions provided by both the endoscope's and the AER's 116 1 5 manufacturer's instructions and resolve any conflicting recommendations. Category /B. · s

8. Management of Equipment and Surfaces in Dentistry a. Dental instruments that penetrate soft tissue or bone (e.g., extraction forceps, scalpel blades, bone chisels, periodontal scalers, and surgical burs) are classified as critical and should be

88 Guideline for Disinfection and Sterilization in Healthcam rcacilittes, 2008

sterilized after each use or discarded. In addition, after each use, sterilize dental instruments that are not intended to penetrate oral soft tissue or bone (e.g., amalgam condensers, air-water syringes) but that might contact oral tissues and are heat-tolerant, although classified as semi critical. Clean and, at a minimum, high-level disinfect heat-sensitive semi critical items. Category lA. 43,209211

b. Noncritical clinical contact surfaces, such as uncovered operatory surfaces (e.g., countertops, switches, light handles), should be barrier-protected or disinfected between patients with an intermediate-disinfectant (i.e., EPA-registered hospital disinfectant with a tuberculocidal claim) or low-level disinfectant (i.e., EPA-registered hospital disinfectant with HIV and HBV claim). Category 18 _43,209211 c. Barrier protective coverings can be used for noncritical clinical contact surfaces that are touched frequently with gloved hands during the delivery of patient care, that are likely to become contaminated with blood or body substances, or that are difficult to clean. Change these coverings when they are visibly soiled, when they become damaged, and on a routine basis (e.g., between patients). Disinfect protected surfaces at the end of the day or if visibly soiled. Category II. 43, 21o 9. Processing Patient-Care Equipment Contaminated with 8/oodborne Pathogens (HBV, Hepatitis C Virus, HIV), Antibiotic-Resistant Bacteria (e.g., Vancomycin-Resistant Enterococci, Methicillin-Resistant Staphylococcus aureus, Mutt/drug Resistant Tuberculosis), or Emerging Pathogens (e.g., Cryptosporidium, Helicobacter pylori, Escherichia coli 0157:H7, Clostridium diffici/e, Mycobacterium tuberculosis, Severe Acute Respiratory Syndrome Coronavirus), or Bioterrorist Agents a. Use standard sterilization and disinfection procedures for patient-care equipment (as recommended in this guideline), because these procedures are adequate to sterilize or disinfect instruments or devices contaminated with blood or other body ftuids from persons infected with bloodborne pathogens or emerging pathogens, with the exception of prions. No changes in these procedures for cleaning, disinfecting, or sterilizing are necessarv for removing bloodborne and emeraing oathoaens other than orions. Category lA. 22, 53, so.sz, 73,79-81, 1os, 11a-121, 12s, 12s, 221,224-234, zJs, 244, 265:' 266, :!71-273, ~79, 282, 283, 354-357, 666

10. Disinfection Strategies for Other Semicritica/ Devices a. Even if probe covers have been used, clean and high-level disinfect other semi critical devices such as rectal probes, vaginal probes, and cryosurgical probes with a product that is not toxic to staff, patients, probes, and retrieved germ cells (if applicable). Use a high-level disinfectant at the 68 FDA-cleared exposure time. (See Recommendations 7o and 11e for exceptions.) Category 18. ' • 17,69

b. When probe covers are available, use a probe cover or condom to reduce the level of microbial contamination. Category If. 197-201 Do not use a lower category of disinfection or cease to follow the appropriate disinfectant recommendations when using probe covers because these sheaths 197 201 and condoms can fail. Category 18 - c. After high-level disinfection, rinse all items. Use sterile water, filtered water or tapwater followed by an alcohol rinse for semicritical equipment that will have contact with mucous membranes of 10 31 35 1017 the upper respiratory tract (e.g., nose, pharynx, esophagus). Category 11. • ' • d. There is no recommendation to use sterile or filtered water rather than tapwater for rinsing semicritical equipment that contact the mucous membranes of the rectum (e.g., rectal probes, 11 anoscope) or vagina (e.g., vaginal probes). Unresolved issue. e. Wipe clean tonometer tips and then disinfect them by immersing for 5-10 minutes in either 5000 ppm chlorine or 70% ethyl alcohol. None of these listed disinfectant products are FDA-cleared 49 95 185 188 293 high-level disinfectants. Category 11. • • • •

11. Disinfection by Healthcare Personnel in Ambulatory Care and Home Care a. Follow the same classification scheme described above (i.e., that critical devices require sterilization, semicritical devices require high-level disinfection, and noncritical equipment

89 Guidelrne for Disinfection and Sterilization in Hcaltilcare Fncilrtres, 2008

requires low-level disinfection) in the ambulatory-care (outpatient medical/surgical facilities) setting because risk for infection in this setting is similar to that in the hospital setting (see Table 1). Category /B. ~ 8 • 17 • 330 b. When performing care in the home, clean and disinfect reusable objects that touch mucous membranes (e.g., tracheostomy tubes) by immersing these objects in a 1:50 dilution of 5.25%- 6.15% sodium hypochlorite (household bleach) (3 minutes), 70% isopropyl alcohol (5 minutes), or 3% hydrogen peroxide (30 minutes) because the home environment is, in most instances, safer than either hospital or ambulatory care settings because person-to-person transmission is less likely. Category II. 327' 32 ~ 330' 331 c. Clean noncritical items that would not be shared between patients (e.g., crutches, blood pressure 53 cuffs) in the home setting with a detergent or commercial household disinfectant. Category II. ' 330

12. Microbial Contamination of Disinfectants a. Institute the following control measures to reduce the occurrence of contaminated disinfectants: 1) prepare the disinfectant correctly to achieve the manufacturer's recommended use-dilution; and 2) prevent common sources of extrinsic contamination of germicides (e.g., container contamination or surface contamination of the healthcare environment where the germicide are prepared and/or used). Category /B. 404 • 406• 1024

13. Flash Sterilization 849 a. Do not flash sterilize implanted surgical devices unless doing so is unavoidable. Category /B. ' 850

b. Do not use flash sterilization for convenience, as an alternative to purchasing additional instrument sets, or to save tirne. Category 11. 817 • 962 c. When using flash sterilization, make sure the following parameters are met: 1) clean the item before placing it in the sterilizing container (that are FDA cleared for use with flash sterilization) or tray; 2) prevent exogenous contamination of the item during transport from the sterilizer to the patient; and 3) monitor sterilizer function with mechanical, chemical, and biologic monitors. Category lB. 812, 819, 846, 847. 962

d. Do not use packaging materials and containers in flash sterilization cycles unless the sterilizer 812 819 1025 and the packaging material/container are designed for this use. Category /B. ' • e. When necessary, use flash sterilization for patient-care items that will be used immediately (e.g., 845 to reprocess an inadvertently dropped instrument). Category /B. 812 • 817 • 819 • f. When necessary, use flash sterilization for processing patient-care items that cannot be packaged, sterilized, and stored before use. Category /B. 812 • 819

14. Methods of Sterilization a. Steam is the preferred method for sterilizing critical medical and surgical instruments that are not 425 426 827 841 1027 damaged by heat, steam, pressure, or moisture. Category /A. 181 • 271 • • • • • 1026 • b. Cool steam- or heat-sterilized items before they are handled or used in the operative setting. 850 Category lB. c. Follow the sterilization times, temperatures, and other operating parameters (e.g., gas concentration, humidity) recommended by the manufacturers of the instruments, the sterilizer, and the container or wrap used, and that are consistent with guidelines published by government 1026 1028 agencies and professional organizations. Category /B. 811 . 814 • 819• 825• 827• 841 • • d. Use low-temperature sterilization technologies (e.g., EtO, hydrogen peroxide gas plasma) for reprocessing critical patient-care equipment that is heat or moisture sensitive. Category /A 469 • 721 • 82~, 856,858,878,879,881,882,890,891, 1027

e. Completely aerate surgical and medical items that have been sterilized in the EtO sterilizer (e.g., polyvinylchloride tubing requires 12 hours at 50"C, 8 hours at 60"C) before using these items in patient care. Category /B. 814 f. Sterilization using the peracetic acid immersion system can be used to sterilize heat-sensitive

90 Guideline Tor !Jisinfeclion and Stel'i!izaHon in ~··!ea!thcarc Facilities) 2008

immersible medical and surgical items. Category /8. 90• 717' 719• 721 •724 g. Critical items that have been sterilized by the peracetic acid immersion process must be used immediately (i.e., items are not complete!¥ protected from contamination, making long-term 817 82 storage unacceptable). Category II. • h. Dry-heat sterilization (e.g., 340°F for 60 minutes) can be used to sterilize items (e.g., powders, 815 827 oils) that can sustain high temperatures. Category 18. • i. Comply with the sterilizer manufacturer's instructions reqardinq the sterilizer cycle parameters (e.g., time, temperature, concentration). Category 18. 15 ,;; 725 • 81 ~ 814 · 819 j. Because narrow-lumen devices provide a challenge to all low-temperature sterilization technologies and direct contact is necessary for the sterilant to be effective, ensure that the sterilant has direct contact with contaminated surfaces (e.Q., scopes processed in peracetic acid 137 725 825 856 890 891 1029 must be connected to channel irrigators). Category 18. • · · • • •

15. Packaging a. Ensure that packaging materials are compatible with the sterilization process and have received FDA 51 O[k] clearance. Category 18. 811 · 81 4, 819 • 966 b. Ensure that packaging is sufficiently strong to resist punctures and tears to provide a barrier to 454 811 81 819 966 microorganisms and moisture. Category /8. • • '· •

16. Monitoring of Sterilizers a. Use mechanical, chemical, and bioloqic monitors to ensure the effectiveness of the sterilization process. Category lB. a11-s1s, a1s, a4a, a4f. s1s-s17 b. Monitor each load with mechanical (e.g., time, temperature, pressure) and chemical (internal and external) indicators. If the internal chemical indicator is visible, an external indicator is not needed. Category II. a11-a1s, 819, a4a, 847, 975-977, sao c. Do not use processed items if the mechanical (e.g., time, temperature, pressure) or chemical 819 (internal and/or external) indicators suggest inadequate processing. Category 18 811 ' 814 • , d. Use biologic indicators to monitor the effectiveness of sterilizers at least weekly with an FDA- cleared commercial preparation of spores (e.g., Geobacillus stearothennophi/us for steam) 813 815 intended specifically for the type and cycle parameters of the sterilizer. Category 18. 1• 811 • ' • 819,846,647,976,977

e. After a single positive biologic indicator used with a method other than steam sterilization, treat as nonsterile all items that have been processed in that sterilizer, dating from the sterilization cycle having the last negative biologic indicator to the next cycle showing satisfactory biologic indicator results, These nonsterile items should be retrieved if possible and reprocessed. Category 1/, 1 f. After a positive biologic indicator with steam sterilization, objects other than implantable objects do not need to be recalled because of a single positive spore test unless the sterilizer or the sterilization procedure is defective as determined by maintenance personnel or inappropriate cycle settings. If additional spore tests remain positive, consider the items nonsterile and recall and reprocess the items from the implicated load(s). Category 1/. 1 g. Use biologic indicators for every load containing implantable items and quarantine items, 811 814 819 whenever possible, until the biologic indicator is negative. Category 18. . •

17. Load Configuration. a. Place items correctly and loosely into the basket, shelf, or cart of the sterilizer so as not to 445 454 811 813 819 836 impede the penetration of the sterilant. Category 18. • • • • •

18. Storage of Sterile Items a. Ensure the sterile storage area is a well-ventilated area that provides protection a~ainst dust, 454 819 836 69 moisture, insects, and temperature and humidity extremes. Category 11. • • • 454 b. Store sterile items so the packaging is not compromised (e.g., punctured, bent). Category II. • 816,819,968,969,1030

91 Guideline tor Disinfection and ,(3teri!izahon ln HeniHlt;.aro Ff1Cilities) 2008

c. Label sterilized items with a load number that indicates the sterilizer used, the cycle or load 811 812 814 816 number, the date of sterilization, and, if applicable, the expiration date. Category lB. • • • • 819

d. The shelf life of a packaged sterile item depends on the quality of the wrapper, the storage conditions, the conditions during transport, the amount of handling, and other events (moisture) that compromise the integrity of the package. If event-related storage of sterile items is used, then packaged sterile items can be used indefinitely unless the packaging is compromised (see f and g below). Category /B. 816,819,836,968,973,1030, 1031 e. Evaluate packages before use for loss of integrity (e. g., torn, wet, punctured). The pack can be 968 used unless the integrity of the packaging is compromised. Category 11. 819 • f. If the integrity of the packaging is compromised (e.g., torn, wet, or punctured), repack and reprocess the pack before use. Category 11. 819 • 1032 g. If time-related storage of sterile items is used, label the pack at the time of sterilization with an 968 expiration date. Once this date expires, reprocess the pack. Category 11. 819 •

19. Quality Control a. Provide comprehensive and intensive training for all staff assigned to reprocess semi critical and critical medical/surgical instruments to ensure they understand the importance of reprocessing these instruments. To achieve and maintain competency, train each member of the staff that reprocesses semicritical and/or critical instruments as follows: 1) provide hands-on training according to the institutional policy for reprocessing critical and semi critical devices; 2) supervise all work until competency is documented for each reprocessing task; 3) conduct competency testing at beginning of employment and regularly thereafter (e.g., annually); and 4) review the written reprocessing instructions regularly to ensure ther, compl¥ with the scientific literature and the manufacturers' instructions. Category lB. 6-8 • 108 • 114 • 29 • 155 • 72 • 813 • 819 b. Compare the reprocessing instructions (e.g., for the appropriate use of endoscope connectors, the capping/noncapping of specific lumens) provided by the instrument manufacturer and the sterilizer manufacturer and resolve any confticting recommendations by communicating with both manufacturers. Category lB. 155' 725 c. Conduct infection control rounds periodically (e.g., annually) in high-risk reprocessing areas (e.g., the Gastroenterology Clinic, Central Processing); ensure reprocessing instructions are current and accurate and are correctly implemented. Document all deviations from policy. All 6 8 129 stakeholders should identify what corrective actions will be implemented. Category /B. - · d. Include the following in a quality control program for sterilized items: a sterilizer maintenance contract with records of service; a system of process monitoring; air-removal testing for prevacuum steam sterilizers; visual inspection of packaging materials; and traceability of load contents. Category II 811 ' 814 ' 819 • e. For each sterilization cycle, record the type of sterilizer and cycle used; the load identification number; the load contents; the exposure parameters (e.g., time and temperature); the operator's name or initials; and the results of mechanical, chemical, and biological monitoring. Category II 811-814, 819

f. Retain sterilization records (mechanical, chemical, and biological) for a time period that complies with standards (e.g., 3 years), statutes of limitations, and state and federal regulations. Category II, /C. 1o33 g. Prepare and package items to be sterilized so that sterility can be achieved and maintained to the point of use. Consult the Association for the Advancement of Medical Instrumentation or the manufacturers of surgical instruments, sterilizers, and container systems for guidelines for the density of wrapped packages. Category 11. 811 - 814• 819 h. Periodically review policies and procedures for sterilization. Category II. 1033 i. Perform preventive maintenance on sterilizers by qualified personnel who are guided by the manufacturer's instruction. Category 11. 811 -814 • 819

92 Guideline for Disinfection and Sterilization in Hoalti1cmc Facilttios, /.008

20. Reuse of Single-Use Medical Devices a. Adhere to the FDA enforcement document for single-use devices reprocessed by hospitals. FDA considers the hospital that reprocesses a single-use device as the manufacturer of the device and regulates the hospital using the same standards by which it regulates the original equipment 995 manufacturer. Category 1/, /C.

93 Guideline for Olslnfection and SteH!lzatlon in Hea!thcare Facilities, 2008

PERFORMANCE INDICATORS

1. Monitor adherence to high-level disinfection and/or sterilization guidelines for endoscopes on a regular basis. This monitoring should indude ensuring the proper training of persons performing reprocessing and their adherence to all endoscope reprocessing steps, as demonstrated by competency testing at commencement of employment and annually. 2. Develop a mechanism for the occupational health service to report all adverse health events potentially resulting from exposure to disinfectants and sterilants; review such exposures; and implement engineering, work practice, and PPE to prevent future exposures. 3. Monitor possible sterilization failures that resulted in instrument recall. Assess whether additional training of personnel or equipment maintenance is required.

94 Guideline for Disinfection and .Stcri!L::atlon in Ho8!thc

ACKNOWLEDGEMENTS

The authors gratefully acknowledge Eva P. Clontz, M.S., for her assistance in referencing this guideline. The Healthcare Infection Control Practices Advisory Committee thanks the following experts for reviewing a draft of this guideline: Martin S. Favero, Ph. D., Syed A. Sattar, Ph. D., A. Denver Russell, D. Sc., and Martin Exner, M.D. The opinions of the reviewers might not be reflected in all the recommendations contained in this document.

95 Guideline ior Disinfection and Sterilization in Henlti1oare Facilities, 2008

GLOSSARY

Action level: concentration of a regulated substance (e.g., ethylene oxide, formaldehyde) within the employee breathing zone, above which OSHA requirements apply.

Activation of a sterilant: process of mixing the contents of a chemical sterilant that come in two containers (small vial with the activator solution; container of the chemical) Keeping the two chemicals separate until use extends the shelf life of the chemicals.

Aeration: method by which ethylene oxide (EtO) is removed from Eta-sterilized items by warm air circulation in an enclosed cabinet specifically designed for this purpose.

Antimicrobial agent: any agent that kills or suppresses the growth of microorganisms.

Antiseptic: substance that prevents or arrests the growth or action of microorganisms by inhibiting their activity or by destroying them. The term is used especially for preparations applied topically to living tissue.

Asepsis: prevention of contact with microorganisms.

Autoclave: device that sterilizes instruments or other objects using steam under pressure. The length of time required for sterilization depends on temperature, vacuum, and pressure.

Bacterial count: method of estimating the number of bacteria per unit sample. The term also refers to the estimated number of bacteria per unit sample, usually expressed as number of colony-forming units.

Bactericide: agent that kills bacteria.

Bloburden: number and types of viable microorganisms with which an item is contaminated; also called bioload or microbia/load.

Biofilm: accumulated mass of bacteria and extracellular material that is tightly adhered to a surface and cannot be easily removed.

Biologic Indicator: device for monitoring the sterilization process. The device consists of a standardized, viable population of microorganisms (usually bacterial spores) known to be resistant to the sterilization process being monitored. Biologic indicators are intended to demonstrate whether conditions were adequate to achieve sterilization. A negative biologic indicator does not prove that all items in the load are sterile or that they were all exposed to adequate sterilization conditions.

Bleach: Household bleach (5.25% or 6.00%-6.15% sodium hypochlorite depending on manufacturer) usually diluted in water at 1:1 0 or 1:1 00. Approximate dilutions are 1.5 cups of bleach in a gallon of water for a 1:10 dilution (-6,000 ppm) and 0.25 cup of bleach in a gallon of water for a 1:100 dilution (-600 ppm). Sodium hypochlorite products that make pesticidal claims, such as sanitization or disinfection, must be registered by EPA and be labeled with an EPA Registration Number.

Bleach Solution Dilution Chlorine (ooml 5.25-6.15% None 52,500-61,500 1:10 5,250-6,150 1:100 525-615 1:1000 53-62

96 Guideline lor Disinfection and Sterilization in lleriltrrcam Faciltttns, 2008

Bowie-Dick test: diagnostic test of a sterilizer's ability to remove air from the chamber of a prevacuum steam sterilizer. The air-removal or Bowie-Dick test is not a test for sterilization.

Ceiling limit: concentration of an airborne chemical contaminant that should not be exceeded during any part of the workday. If instantaneous monitoring is not feasible, the ceiling must be assessed as a 15- minute time-weighted average exposure.

Centigrade or Celsius: a temperature scale (O'C =freezing point of water; 100'C =boiling point of water at sea level). Equivalents mentioned in the guideline are as follows: 20'C = 68'F; 25'C = 77'F; 121'C = 250'F; 132'C = 270'F; 134'C = 273'F. For other temperatures the formula is: F' = (C' x 9/5) + 32 or C' = (F' -32) X 5/9.

Central processing or Central service department: the department within a health-care facility that processes, issues, and controls professional supplies and equipment, both sterile and nonsterile, for some or all patient-care areas of the facility.

Challenge test pack: pack used in installation, qualification, and ongoing quality assurance testing of health-care facility sterilizers.

Chemical indicator: device for monitoring a sterilization process. The device is designed to respond with a characteristic chemical or physical change to one or more of the physical conditions within the sterilizing chamber. Chemical indicators are intended to detect potential sterilization failures that could result from incorrect packaging, incorrect loading of the sterilizer, or malfunctions of the sterilizer. The "pass" response of a chemical indicator does not prove the item accompanied by the indicator is necessarily sterile. The Association for the Advancement of Medical Instrumentation has defined five classes of chemical indicators: Class 1 (process indicator); Class 2 (Bowie-Dick test indicator); Class 3 (single-parameter indicator); Class 4 (multi-parameter indicator); and Class 5 (integrating indicator).

Contact time: time a disinfectant is in direct contact with the surface or item to be disinfected For surface disinfection, this period is framed by the application to the surface until complete drying has occurred.

Container system, rigid container: sterilization containment device designed to hold medical devices for sterilization, storage, transportation, and aseptic presentation of contents.

Contaminated: state of having actual or potential contact with microorganisms. As used in health care, the term generally refers to the presence of microorganisms that could produce disease or infection.

Control, positive: biologic indicator, from the same lot as a test biologic indicator, that is left unexposed to the sterilization cycle and then incubated to verify the viability of the test biologic indicator.

Cleaning: removal, usually with detergent and water or enzyme cleaner and water, of adherent visible soil, blood, protein substances, microorganisms and other debris from the surfaces, crevices, serrations, joints, and lumens of instruments, devices, and equipment by a manual or mechanical process that prepares the items for safe handling and/or further decontamination.

Culture: growth of microorganisms in or on a nutrient medium; to grow microorganisms in or on such a medium.

Culture medium: substance or preparation used to grow and cultivate microorganisms.

Cup: 8 fluid ounces.

97 Guideline lor Disinfection nnd Stmilization in Healthcme FflCilltles, 2008

Decontamination: according to OSHA, "the use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal" [29 CFR 1910.1030]. In health-care facilities, the term generally refers to all pathogenic organisms.

Decontamination area: area of a health-care facility designated for collection, retention, and cleaning of soiled and/or contaminated items.

Detergent: cleaning agent that makes no antimicrobial claims on the label. They comprise a hydrophilic component and a lipohilic component and can be divided into four types: anionic, cationic, amphoteric, and non-ionic detergents.

Disinfectant: usually a chemical agent (but sometimes a physical agent) that destroys disease-causing pathogens or other harmful microorganisms but might not kill bacterial spores. It refers to substances applied to inanimate objects. EPA groups disinfectants by product label claims of "limited," "general," or "hospital" disinfection.

Disinfection: thermal or chemical destruction of pathogenic and other types of microorganisms. Disinfection is less lethal than sterilization because it destroys most recognized pathogenic microorganisms but not necessarily all microbial forms (e.g., bacterial spores).

D value: time or radiation dose required to inactivate 90% of a population of the test microorganism under stated exposure conditions.

Endoscope: an instrument that allows examination and treatment of the interior of the body canals and hollow organs.

Enzyme cleaner: a solution used before disinfecting instruments to improve removal of organic material (e.g., proteases to assist in removing protein).

EPA Registration Number or EPA Reg. No.: a hyphenated, two- or three-part number assigned by EPA to identify each germicidal product registered within the United States. The first number is the company identification number, the second is the specific product number, and the third (when present) is the company identification number for a supplemental registrant.

Exposure time: period In a sterilization process during which items are exposed to the sterilant at the specified sterilization parameters. For example, in a steam sterilization process, exposure time is the period during which items are exposed to saturated steam at the specified temperature.

Flash sterilization: process designed for the steam sterilization of unwrapped patient-care items for immediate use (or placed in a specially designed, covered, rigid container to allow for rapid penetration of steam).

Fungicide: agent that destroys fungi (including yeasts) and/or fungal spores pathogenic to humans or other animals in the inanimate environment.

General disinfectant: EPA-registered disinfectant labeled for use against both gram-negative and gram- positive bacteria. Efficacy is demonstrated against both Salmonella choleraesuis and Staphylococcus aureus. Also called broad-spectrum disinfectant.

Germicide: agent that destroys microorganisms, especially pathogenic organisms.

98 Guideline for Disintection aud Sterilization in llealthcme F'aciltttes, 2008

Germicidal detergent: detergent that also is EPA-registered as a disinfectant.

High-level disinfectant: agent capable of killing bacterial spores when used in sufficient concentration under suitable conditions. It therefore is expected to kill all other microorganisms.

Hospital disinfectant: disinfectant registered for use in hospitals, clinics, dental offices, and any other medical-related facility. Efficacy Is demonstrated against Salmonella choleraesuis, Staphylococcus aureus, and Pseudomonas aeruginosa. EPA has registered approximately 1,200 hospital disinfectants,

Huck towel: all-cotton surgical towel with a honey-comb weave; both warp and fill yarns are tightly twisted. Huck towels can be used to prepare biologic indicator challenge test packs.

Implantable device: according to FDA, "device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more" [21 CFR 812.3(d)].

Inanimate surface: nonliving surface (e.g., floors, walls, furniture).

Incubator: apparatus for maintaining a constant and suitable temperature for the growth and cultivation of microorganisms.

Infectious microorganisms: microorganisms capable of producing disease in appropriate hosts.

Inorganic and organic load: naturally occurring or artificially placed inorganic (e.g., metal salts) or organic (e.g., proteins) contaminants on a medical device before exposure to a microbicidal process.

Intermediate-level disinfectant agent that destroys all vegetative bacteria, including tubercle bacilli, lipid and some nonlipid viruses, and fungi, but not bacterial spores.

Limited disinfectant disinfectant registered for use against a specific major group of organisms (gram- negative or gram-positive bacteria). Efficacy has been demonstrated in laboratory tests against either Salmonella choleraesuis or Staphylococcus aureus bacteria.

Lipid virus; virus surrounded by an envelope of lipoprotein in addition to the usual core of nucleic acid surrounded by a coat of protein. This type of virus (e.g., HIV) is generally easily inactivated by many types of disinfectants. Also called enveloped or lipophilic virus.

Low-level disinfectant agent that destroys all vegetative bacteria (except tubercle bacilli), lipid viruses, some nonlipid viruses, and some fungi, but not bacterial spores.

Mechanical indicator: devices that monitor the sterilization process (e.g., graphs, gauges, printouts).

Medical device: instrument, apparatus, material, or other article, whether used alone or in combination, including software necessary for its application, intended by the manufacturer to be used for human beings for • diagnosis, prevention, monitoring treatment, or alleviation of disease; • diagnosis, monitoring, treatment, or alleviation of or compensation for an injury or handicap; • investigation, replacement, or modification of the anatomy or of a physiologic process; or • control of conception and that does not achieve its primary intended action in or on the human body by pharmacologic, immunologic, or metabolic means but might be assisted in its function by such means.

Microbicide: any substance or mixture of substances that effectively kills microorganisms.

99 Guidefine for Disinfection and StGrilization in Hoa!tllcan:; Faci!!ties, 2008

Microorganisms: animals or plants of microscopic size. As used in health care, generally refers to bacteria, fungi, viruses, and bacterial spores.

Minimum effective concentration (MEC): the minimum concentration of a liquid chemical germicide needed to achieve the claimed microbicidal activity as determined by dose-response testing. Sometimes used interchangeably with minimum recommended concentration.

Muslin: loosely woven (by convention, 140 threads per square inch), 100% cotton cloth. Formerly used as a wrap for sterile packs or a surgical drape. Fabric wraps used currently consist of a cotton-polyester blend.

Mycobacteria: bacteria with a thick, waxy coat that makes them more resistant to chemical germicides than other types of vegetative bacteria.

Nonlipld viruses: generally considered more resistant to inactivation than lipid viruses. Also called nonenveloped or hydrophilic viruses.

One-step disinfection process: simultaneous cleaning and disinfection of a noncritical surface or item.

Pasteurization: process developed by Louis Pasteur of heating milk, wine, or other liquids to 65--77'C (or the equivalent) for approximately 30 minutes to kill or markedly reduce the number of pathogenic and spoilage organisms other than bacterial spores.

Parametric release: declaration that a product is sterile on the basis of physical and/or chemical process data rather than on sample testing or biologic indicator results.

Penicylinder: carriers inoculated with the test bacteria for in vitro tests of germicides. Can be constructed of stainless steel, porcelain, glass, or other materials and are approximately 8 x 10 mm in diameter.

Permissible exposure limit (PEL): time-weighted average maximum concentration of an air contaminant to which a worker can be exposed, according to OSHA standards. Usually calculated over 8 hours, with exposure considered over a 40-hour work week.

Personal protective equipment (PPE): specialized clothing or equipment worn by an employee for protection against a hazard. General work clothes (e.g., uniforms, pants, shirts) not intended to function as protection against a hazard are not considered to be PPE.

Parts per million (ppm): common measurement for concentrations by volume of trace contaminant gases in the air (or chemicals in a liquid); 1 volume of contaminated gas per 1 million volumes of contaminated air or 1¢ in $10,000 both equal1 ppm. Parts per million= ~g/mL or mg/L.

Prions: transmissible pathogenic agents that cause a variety of neurodegenerative diseases of humans and animals, including sheep and goats, bovine spongiform encephalopathy in cattle, and Creutzfeldt- Jakob disease in humans. They are unlike any other infectious pathogens because they are composed of an abnormal conformational isoform of a normal cellular protein, the prion protein (PrP). Prions are extremely resistant to inactivation by sterilization processes and disinfecting agents.

Process challenge device (PCD): item designed to simulate product to be sterilized and to constitute a defined challenge to the sterilization process and used to assess the effective performance of the process. A PCD is a challenge test pack or test tray that contains a biologic indicator, a Class 5 integrating indicator, or an enzyme-only indicator.

QUAT: abbreviation for quaternary ammonium compound, a surface-active, water-soluble disinfecting

100 Guideline lor Disinfectkll1 and SIDHiization in Healthcam Faeiltlies, 20013

substance that has four carbon atoms linked to a nitrogen atom through covalent bonds.

Recommended exposure limit (REL): occupational exposure limit recommended by NIOSH as being protective of worker health and safety over a working lifetime. Frequently expressed as a 40-hour time- weighted-average exposure for up to 10 hours per day during a 40-work week.

Reprocess: method to ensure proper disinfection or sterilization; can include: cleaning, inspection, wrapping, sterilizing, and storing.

Sanitizer: agent that reduces the number of bacterial contaminants to safe levels as judged by public health requirements. Commonly used with substances applied to inanimate objects. According to the protocol for the official sanitizer test, a sanitizer is a chemical that kills 99.999% of the specific test bacteria in 30 seconds under the conditions of the test.

Shelf life: length of time an undiluted or use dilution of a product can remain active and effective. Also refers to the length oftime a sterilized product (e.g., sterile instrument set) is expected to remain sterile.

Spaulding classification: strategy for reprocessing contaminated medical devices. The system classifies a medical device as critical, semi critical, or noncritical on the basis of risk to patient safety from contamination on a device; The system also established three levels of germicidal activity (sterilization, high-level disinfection, and low-level disinfection) for strategies with the three classes of medical devices (critical, semicritical, and noncritical).

Spore: relatively water-poor round or elliptical resting cell consisting of condensed cytoplasm and nucleus surrounded by an impervious cell wall or coat. Spores are relatively resistant to disinfectant and sterilant activity and drying conditions (specifically in the genera Bacillus and Clostridium).

Spore strip: paper strip impregnated with 'it known population of spores that meets the definition of biological indicators.

Steam quality: steam characteristic reflecting the dryness fraction (weight of dry steam in a mixture of dry saturated steam and entrained water) and the level of noncondensable gas (air or other gas that will not condense under the conditions of temperature and pressure used ,during the sterilization process). The dryness fraction (i.e., the proportion of completely dry steam in the steam being considered) should not fall below 97%.

Steam sterilization: sterilization process that uses saturated steam under pressure for a specified exposure time and at a specified temperature, as the sterilizing agent.

Steam sterilization, dynamic air removal type: one of two types of sterilization cycles in which air is removed from the chamber and the load by a series of pressure and vacuum excursions (prevacuum cycle) or by a series of steam flushes and pressure pulses above atmospheric pressure (steam-flush- pressure-pulse cycle).

Sterile or Sterility: state of being free from all living microorganisms. In practice, usually described as a probability function, e.g., as the probability of a microorganism surviving sterilization being one in one million.

Sterility assurance level (SAL): probability of a viable microorganism being present on a product unit after sterilization. Usually expressed as 10-'6; a SAL of 10·' means ,::1/1 million chance that a single viable microorganism is present on a sterilized item. A SAL of 1a·' generally is accepted as appropriate for items intended to contact compromised tissue (i.e., tissue that has lost the integrity of the natural body barriers). The sterilizer manufacturer is responsible for ensuring the sterilizer can achieve the desired SAL. The

101 Guideline lor Disinfec!ion nnd Stel"iltzal.ion in Hnalthcam Facilities, 2008

user is responsible for monitoring the performance of the sterilizer to ensure it is operating in conformance to the manufacturer's recommendations.

Sterilization: validated process used to render a product free of all forms of viable microorganisms. In a sterilization process, the presence of microorganisms on any individual item can be expressed in terms of probability. Although this probability can be reduced to a very low number, it can never be reduced to zero.

Sterilization area: area of a health-care facility designed to house sterilization equipment, such as steam ethylene oxide, hydrogen peroxide gas plasma, or ozone sterilizers.

Sterilizer: apparatus used to sterilize medical devices, equipment, or supplies by direct exposure to the sterilizing agent

Sterilizer, gravity-displacement type: type of steam sterilizer in which incoming steam displaces residual air through a port or drain in or near the bottom (usually) of the sterilizer chamber. Typical operating temperatures are 121-123"C (250-254"F) and 132-135"C (270-275"F).

Sterilizer, prevacuum type: type of steam sterilizer that depends on one or more pressure and vacuum excursions at the beginning of the cycle to remove air. This method of operation results in shorter cycle times for wrapped items because of the rapid removal of air from the chamber and the load by the vacuum system and because of the usually higher operating temperature (132-135"C [270-275"F]; 141- 144"C [285-291"F]). This type of sterilizer generally provides for shorter exposure time and accelerated drying of fabric loads by pulling a further vacuum at the end of the sterilizing cycle.

Sterilizer, steam-flush pressure-pulse type: type of sterilizer in which a repeated sequence consisting of a steam flush and a pressure pulse removes air from the sterilizing chamber and processed materials using steam at above atmospheric pressure (no vacuum is required). Like a prevacuum sterilizer, a steam-fiush pressure-pulse sterilizer rapidly removes air from the sterilizing chamber and wrapped items; however, the system is not susceptible to air leaks because air is removed with the sterilizing chamber pressure at above atmospheric pressure. Typical operating temperatures are 121-123"C (250-254"F), 132-135"C (270-275"F), and 141-144"C (285-291"F).

Surfactant: agent that reduces the surface tension of water or the tension at the interface between water and another liquid; a wetting agent found in many sterilants and disinfectants.

Tabletop steam sterilizer: a compact gravity-displacement steam sterilizer that has a chamber volume of not more than 2 cubic feet and that generates its own steam when distilled or deionized water is added.

Time-weighted average (TWA): an average of all the concentrations of a chemical to which a worker has been exposed during a specific sampling time, reported as an average over the sampling time. For example, the permissible exposure limit for ethylene oxide is 1 ppm as an 8-hour TWA. Exposures above the ppm limit are permitted if they are compensated for by equal or longer exposures below the limit during the 8-hour workday as long as they do not exceed the ceiling limit; short-term exposure limit; or, in the case of ethylene oxide, excursion limit of 5 ppm averaged over a 15-minute sampling period.

Tuberculocide: an EPA-classified hospital disinfectant that also kills Mycobacterium tuberculosis (tubercle bacilli). EPA has registered approximately 200 tuberculocides. Such agents also are called mycobactericides.

Use-life: the length of time a diluted product can remain active and effective. The stability of the chemical and the storage conditions (e.g., temperature and presence of air, light, organic matter, or metals)

102 Guideline for Disinlection and Sterilization in Hoalthcme Facilities, 2008

determine the use-life of antimicrobial products.

Vegetative bacteria: bacteria that are devoid of spores and usually can be readily inactivated by many types of germicides.

Virucide: an agent that kills viruses to make them noninfective.

Adapted from Association for the Advancement of Medical Instrumentation; 811' 814• 819 Association of 815 319 16 1034 peri Operating Registered Nurses (AORN), American Hospital Association, and Block. •

103 Guide!inelor Disinfection Htld Sterilization in 1·-·!ealtl·lo:-n"C:; F<;~cHitJes, 2008

Table 1. Methods of sterilization and disi nfectlon. Sterilization Disinfection Highwlevel (semi critical items; [except Intermediate- Low-level dental] will come level (some (noncritical In contact with semi critl cal items; will 1 Critical items (will enter tissue or mucous items and come in vascular system or blood will membrane or noncritical contact with flow through them) nonintact skin) Items) intact skin} Procedure (exposure time Procedure Procedure 12-30 min at (exposure time (exposure time Object Procedure Ex~osure time ~20oC}2,3 >1m) 9 > 1 m} 9

Smooth, hard A MR D K K 14 Surface • 8 MR E L' L c MR F M M D 10 h at20-25'C H N N F 6h I' 0 G 12 m at 50-56'C J H 3-Bh

Rubber tubing and A MR D 34 catheters • 8 MR E c MR F D 10 h at 20-25'C H F 6h I' G 12 m at 50-56'C J H 3-Bh

Polyethylene tubing A MR D and catheters3.4. 7 8 MR E c MR F D 10 h at 20-25'C H F 6h I' G 12 m at 50-56'C J H 3-Bh

4 Lensed instruments A MR D c MR F D 10 hat 20-25'C H F 6h J G 12 m at 50-56'C H 3-Bh

Thermometers (oral K' 6 and rectal) 4 Hinged instruments A MR D c MR F D 1o h at 20-25'C H F 6h I' G 12 m at 5Q-56°C J H 3-Bh

Modified from Rutala and Simmons. 15 • 17 • 18• 421 The selection and use of disinfectants in the health care field is dynamic, and products may become available that are not in existence when this guideline was written. As newer disinfectants become available, persons or committees responsible for selecting disinfectants and sterilization processes should be guided by products cleared by the FDA and the EPA as well as information in the scientific literature.

104 Guid

A, Heat sterilization, including steam or hot air (see manufacturer's recommendations, steam sterilization processing time from 3-30 minutes) B, Ethylene oxide gas (see manufacturer's recommendations, generally 1-6 hours processing time plus aeration time of 8-12 hours at 50-60'C) C, Hydrogen peroxide gas plasma (see manufacturer's recommendations for internal diameter and length restrictions, processing time between 45-72 minutes). D, Glutaraldehyde-based formulations (:::2% glutaraldehyde, caution should be exercised with all glutaraldehyde formulations when further in-use dilution is anticipated); glutaraldehyde (1.12%) and 1.93% phenol/phenate. One glutaraldehyde-based product has a high-level disinfection claim of 5 minutes at 35°C. E, Ortho-phthalaldehyde (OPA) 0. 55% F, Hydrogen peroxide 7.5% (will corrode copper, zinc, and brass) G, Peracetic acid, concentration variable but 0.2% or greater is sporicidal. Peracetic acid Immersion system operates at 5D-56°C. H, Hydrogen peroxide (7.35%) and 0.23% peracetic acid; hydrogen peroxide 1% and peracetic acid 0.08% (will corrode metal instruments) I, Wet pasteurization at 70°C for 30 minutes with detergent cleaning J, Hypochlorite, single use chlorine generated on-site by electrolyzing saline containing >650-675 active free chlorine; (will corrode metal instruments) K, Ethyl or isopropyl alcohol (70-90%) L, Sodium hypochlorite (5.25-6.15% household bleach diluted 1:500 provides >1 00 ppm available chlorine) M, Phenolic germicidal detergent solution (follow product label for use-dilution) N, Iodophor germicidal detergent solution (follow product label for use-dilution) 0, Quaternary ammonium germicidal detergent solution (follow product label for use-dilution) MR, Manufacturer's recommendations NA, Not applicable

See text for discussion of hydrotherapy. The longer the exposure to a disinfectant, the more likely it is that all microorganisms will be eliminated. Follow the FDA-cleared high-level disinfection claim. Ten-minute exposure is not adequate to disinfect many objects, especially those that are difficult to clean because they have narrow channels or other areas that can harbor organic material and bacteria. Twenty-minute exposure at 20°C is the minimum time needed to reliably kill M. tuberculosis and nontuberculous mycobacteria with a 2% glutaraldehyde. Some high-level disinfectants have a reduced exposure time (e.g., ortho-phthalaldehyde at 12 minutes at 20°C) because of their rapid activity against mycobacteria or reduced exposure time due to increased mycobactericidal activity at elevated temperature (e.g., 2.5% glutaraldehyde at 5 minutes at 35°C, 0.55% OPA at 5 min at 25°C in automated endoscope reprocessor). ' Tubing must be completely filled for highMievel disinfection and liquid chemical sterilization; care must be taken to avoid entrapment of air bubbles during immersion. Material compatibility should be investigated when appropriate. 6 A concentration of 1000 ppm available chlorine should be considered where cultures or concentrated preparations of microorganisms have spilled (5.25% to 6.15% household bleach diluted 1:50 provides > 1 000 ppm available chlorine). This solution may corrode some surfaces. 6 Pasteurization (washer-disinfector) of respiratory therapy or anesthesia equipment is a recognized alternative to high- level disinfection. Some data challenge the efficacy of some pasteurization units. Thermostability should be investigated when appropriate. Do not mix rectal and oral thermometers at any stage of handling or processing. By law, all applicable label instructions on EPA-registered products must be followed. If the user selects exposure conditions that differ from those on the EPA-registered products label, the user assumes liability from any injuries resulting from off-label use and is potentially subject to enforcement action under FIFRA.

105 Cuidef!no ·for D!s\nfect!on and Sterilization in !. ·!ea!thcarr~ Faci!lh;s, 2008

Table 2. Properties of an Ideal disinfectant

Broad spectrum: should have a wide antimicrobial spectrum Fast acting: should produce a rapid kill Not affected by environmental factors: should be active in the presence of organic matter (e.g., blood, sputum, feces) and compatible with soaps, detergents, and other chemicals encountered in use Nontoxic: should not be harmful to the user or patient Surface compatibility: should not corrode instruments and metallic surfaces and should not cause the deterioration of doth, rubber, plastics, and other materials Residual effect on treated surfaces: should leave an antimicrobial film on the treated surface Easy to use with clear label directions Odorless: should have a pleasant odor or no odor to facilitate its routine use Economical: should not be prohibitively high in cost Solubility: should be soluble in water Stability: should be stable in concentrate and use-dilution Cleaner: should have good cleaning properties Environmentally friendly: should not damage the environment on disposal Modified from Molinari

106 Guideline for Oislnlection and Sterilization In Hea!Hicare Faci!itles, 2008

Table 3. Epidemiologic evidence associated with the use of surface disinfectants or detergents on noncritical environmental surfaces. Justification for Use of Disinfectants for Noncritical Environmental Surfaces Surfaces may contribute to transmission of epidemiologically important microbes (e.g., vancomycin- resistant Enterococci, methicillin-resistantS. aureus, viruses) Disinfectants are needed for surfaces contaminated by blood and other potentially infective material Disinfectants are more effective than detergents in reducing microbial load on floors Detergents become contaminated and result in seeding the patient's environment with bacteria Disinfection of noncritical equipment and surfaces is recommended for patients on isolation precautions by the Centers for Disease Control and Prevention. Advantage of using a single product for decontamination of noncritical surfaces, both floors and equipment Some newer disinfectants have persistent antimicrobial activity Justification for Using a Detergent on Noncritical Environmental Surfaces Noncritical surfaces contribute minimally to endemic healthcare-associated infections No difference in healthcare-associated infection rates when floors are cleaned with detergent versus disinfectant No environmental impact (aquatic or terrestrial) issues with disposal No occupational health exposure issues Lower costs Use of antiseptics/disinfectants selects for antibiotic-resistant bacteria (?) More aesthetically pleasing floor Modified from Rutala .

107 Guideline for Disinfection and Stei'ilization in Healthcmo F

Figure 1. Decreasing order of resistance of microorganisms to disinfection and sterilization and the level of disinfection or sterilization.

Resistant Level

I Prions (Creutzfeldt-Jakob Disease) Prion reprocessing I I Bacterial spores (Bacillus ?trophaeus) Sterilization I I Coccidia (Cryptosporidium) I I Mycobacteria (M. tuberculosis, M. terrae) High I I Nonlipid or small viruses (polio, coxsackie) Intermediate I 1 Fungi (Aspergillus, Candida) I 1 Vegetative bacteria (S. aureus, P. aeruginosa) Low

i Lipid or medium-sized viruses {HIV, herpes, hepatitis B)

Susceptible Modified from Russell and Favero

108 Gurdeline for Disinfection and Sterilization in HoaiHJcme f'acilitros, 2008

Table 4. Comparison ofthe characteristics of selected chemicals used as high-level disinfectants or chemical sterilants.

HP (7.5%) PA (0.2%) Glut (;:2.0%) OPA (0.55%) HP/PA (7.35%/0.23% i HLD Claim 30m@ 20'C NA 2Q-90 m @ 20'- 12m@ 20'C, 15m@ 20'C 25'C 5 m@ 25'C in AER Sterilization Claim 6 h Ia) 20' 12m @ 5Q-56'C 10 h @ 20'-25'C None 3 h@ 20'C Activation No No Yes (alkaline qlut) No No Reuse Life 21d Single use 14-30 d 14d 14d Shelf Life Stability" 2y 6mo zv zv 2y 3 Disposal None None Local' Local None Restrictions Materials Good Good Excellent Excellent No data Comoatibilitv Monitor MEC Yes (6%) No Yes (1.5% or Yes (0.3% OPA) No hiqher) Safety Serious eye Serious eye and Respiralory Eye Irritant, stains Eye damage damage (safety skin damage skin glasses) (cone solnl 5 Processing Manual or Automated Manual or Manual or Manual automated automated automated Organic material Yes Yes Yes Yes Yes resistance OSHA exposure 1 ppm TWA None None None HP-1 ppm limit TWA Cost profile (per + (manual), ++ +++++ + (manual), ++ ++(manual) ++(manual) cyclei' (automated) (automated) (automatecii Modified from Rutala " . Abbreviations: HLD=high-level disinfectant; HP=hydrogen peroxide; PA=peracetic acid; glut=glutaraldehyde; PAIHP=peracetic acid and hydrogen peroxide; OPA =ortho-phthalaldehyde (FDA cleared as a high-level disinfectant, included for comparison to other chemical agents used for high-level disinfection); m=minutes; h=hours; NA=not applicable; TWA=time-weighted average for a conventional 8- hour workday. 1 number of days a product can be reused as determined by re-use protocol 2 time a product can remain in storage (unused) 'no U.S. EPA regulations but some states and local authorities have additional restrictions 4 MEC=minimum effective concentration is the lowest concentration of active ingredients at which the r,roduct is still effective Cone soln=concentrated solution 6 The ceiling limit recommended by the American Conference of Governmental Industrial Hygienists is 0.05 ppm. 7 per cycle cost profile considers cost of the processing solution (suggested list price to healthcare facilities in August 2001) and assumes maximum use life (e.g., 21 days for hydrogen peroxide, 14 days for glutaraldehyde), 5 reprocessing cycles per day, 1-gallon basin for manual processing, and 4-gallon tank for automated processing. +=least expensive; +++++ = most expensive

109 Guideline for Disinfection and Sterilization in Henlthcare FclCiliti<%, 200R

1 Table 5. Summ;1ry of advantages and disadvantages of chemical agents used as chemical sterilants or as high·level disinfectants. Sterilization Method Advantages Disadvantages Peracetic Add/Hydrogen • No activation required • Materials compatibility concerns Qead, Peroxide • Odor or irritation not significant brass, copper, zinc) both cosmetic and

. functional Umlted dlnical experience • Potential for eve and skin damage Glutaraldehyde • Numerous use studies published • Respiratory Irritation from glutaraldehyde • Relatively Inexpensive vapor • Excellent materials compatibility • Pungent and irritating odor

. • Relatively slow mycobacteriddal activity Coagulates blood and fixes tissue to surfaces • Allergic contact dermatitis • Glutaraldehyde vapor monitoring recommended Hydrogen Peroxide • No activation required • Material compatibility concerns (brass, • May enhance removal of organic matter and zinc, copper, and nickel/silver plating) both organisms cosmetic and functional

..• No disposal issues No odor or irritation issues Does not coagulate blood or fix tissues to • Serious eye damage with contact

surfaces • 1nactivates Cryptosporidium

Ortho-phthalaldehyde • • Use studies published Fast acting high-level disinfectant . Stains skin, mucous membranes, clothing, • • No activation required Odor not significant . and environmental surfaces Repeated exposure may result in • Excellent materials compatib!llty claimed hypersensitivity in some patients with • Does not coagulate blood or fix tissues to surfaces claimed .. bladder cancer More expensive than glutaraldehyde

. Eye irritation with contact Slow sporicidal activity Peracetic Acid .• Rapid sterilization cycle time (30-45 minutes) Low temperature (50-55°C) liquid immersion • .. Potential material incompatibility (e.g., aluminum anodized coaling becomes dull)

. sterilization Environmental friendly by-products (acetic acid, Oz, H20) Used for lmmers ble instruments only Biological indicator may not be suitable for routine monitoring

.• Fully automated Single-use system eliminates need for • One scope or a small number of instruments can be processed in a cycle concentration testing • More expensive (endoscope repairs, • Standardized cycle operating costs, purchase costs) than high- • May enhance removal of organic material and level disinfection endotoxin • Serious eye and skin damage • No adverse health effects to operators under normal operating conditions . (concentrated solution) with contact Point-of-use system, no sterile storage • Compatible with many materials and Instruments • Does not coagulate blood or fix tissues to surfaces • Sterilant flows through scope facilltating salt, protein, and microbe removal • Rapidly sporicidal • Provides procedure standardization (constant dilution, perfusion of channel, temperatures, exposure) '" Modified from Rutala . 1 AII products effective In presence of organic soil, relatively easy to use, and have a broad spectrum of antimicrobial activity (bacteria, fungi, viruses, bacterial spores, and mycobacteria). The above characteristics are documented in the literature; contact the manufacturer of the Instrument and sterilant for additional information. All products listed above are FDA-cleared as chemical sterilants except OPA, which is an FDA-cleared high-level disinfectant.

110 Guideline tor Dlsinfoctlon nnd SterHizaHon ln HeCJ!tllcare r::·acilities, 2008

Table 6. Summary of advantages and disadvantages of commonly used sterilization technologies.

Sterilization Method AdvantaQes Disadvantages Steam Nontoxic to patient, staff, environment Deleterious for heat-sensitive instruments Cyde easy to control and monitor Microsurgical instruments damaged by Rapidly mlcrobiddal repeated exposure Least affected by organlcAnorganic soils among May leave Instruments wet, sterilization processes listed causing them to rust Rapid cyde time • Potential for burns Penetrates medical oackina, device lumens Hydrogen Peroxide Gas Safe for the environment Cellulose (paper), linens and liquids cannot Plasma Leaves no toxic residuals be processed Cyde time Is 28-75 minutes (varies with model Sterilization chamber size from 1.8-9.4 te type) and no aeration necessary total volume (varies with model type) Used for heat- and moisture-sensitive items Some endoscopes or medical devices with since process temperature <50°C long or narrow lumens cannot be Simple to operate, Install (208 V outlet), and processed at this time in the United States monitor (see manufacturer's recommendations for Compatible with most medical devices Internal diameter and length restrictions) Only requires electrical outlet Requires synthetic packaging (polypropylene wraps, polyolefin pouches) and special container tray • Hydrogen peroxide may be toxic at levels greater than 1 ppmTWA 100% Ethylene Oxide (ETO) Penetrates packaging materials, device lumens Requires aeration time to remove ETO Single-dose cartridge and negative- pressure residue chamber minimizes the potential for gas leak Sterilization chamber size from 4.0-7.9 and ETO exposure te total volume (varies with model type) Simple to operate and monitor ETO is toxic, a carcinogen, and flammable Compatible with most medical materials ETO emission regulated by states but catalytic cell removes 99.9% of ETO and converts it to C02 and H20 ETO cartridges should be stored in flammable liquid storage cabinet Lengthy cycle/aeration time

ETO Mixtures Penetrates medical packaging and many Some states (e.g., CA, NY, Ml) require plastics ETO emission reduction of 90-99.9% 8.6% ET0/91.4% HCFC Compatible with most medical materials CFC (inert gas that eliminates explosion 10% ET0/90% HCFC Cycle easy to control and monitor hazard) banned in 1995 8.5% ET0/91.5% C02 Potential hazards to staff and patients Lengthy cycle/aeration time ETO is toxic, a carcinogen, and flammable

Peracetic Acid Rapid cycle time (30-45 minutes) Point-of~use system, no sterile storage Low temperature (50-55°C liquid Immersion Biological indicator may not be suitable for sterilization routine monitoring Environmental friendly by-products Used for Immersible instruments only Sterilant flows through endoscope which Some material incompatibility (e.g., facilitates salt, protein and microbe removal aluminum anodized coating becomes dull) One scope or a small number of Instruments processed In a cycle • Potential for serious eye and skin damage (concentrated solutlorl) with contact Modified from Rutala. '" Abbreviations: CFC=chlorofluorocarbon, HCFC=hydrochlorofluorocarbon.

Ill c;uidr:line 'for Disinfection and Stecrl!lzaHnn In Hea!t!1cars r:·acl!ities, ?008

Table 7. Minimum cycle times for steam sterilization cycles

Type of sterilizer Item Exposure time at Exposure time at Drying time 250'F (121'C) 270'F (132'C) Gravity displacement Wrapped 30 min 15 min 15-30 min instruments Textile packs 30 min 25min 15 min Wrapped 30 min 15 min 15-30 min utensils Dynamic-air-removal Wrapped 4 min 20-30 min (e.g., prevacuum) instruments Textile packs 4 min 5-20 min Wrapped 4 min 20 min utensils

813 819 Modified from Association for the Advancement of Medical Instrumentation. •

112 Guideline lor Oislnfect!on and Stcri!izahon 1n Hea!thc:

Table 8. Examples of flash steam sterilization parameters.

Type of sterilizer Load configuration Temperature Time Gravity displacement Nonporous items only (i.e., routine 132°C (270°F) 3 minutes metal instruments, no lumens) Nonporous and porous items (e.g., 132°C (270°F) 10 rubber or plastic items, items with minutes lumens) sterilized together Prevacuum Nonporous items only (i.e., routine 132°C (270°F) 3 minutes metal instruments, no lumens) Nonporous and porous items (e.g., 132°C (270°F) 4 minutes rubber or plastic items, items with lumens) sterilized together Steam-flush Nonporous or mixed 132° (270°F) 4 minutes pressure-pulse nonporous/porous items Manufacturers' instruction

819 Modified from Association for the Advancement of Medical Instrumentation. "'·

113 Guideline for Disinfection and Stcri!izalion in HeafU1can~ Faci!ilies, 2008

Table 9. Characteristics of an Ideal low-temperature sterilization process.

High efficacy: the agent should be virucidal, bactericidal, tuberculocidal, fungicidal and sporicidal Rapid activity: ability to quickly achieve sterilization Strong penetrability: ability to penetrate common medical-device packaging materials and penetrate into the interior of device lumens Material compatibility: produces only negligible changes in the appearance or the function of processed items and packaging materials even after repeated cycling Nontoxic: presents no toxic health risk to the operator or the patient and poses no hazard to the environment Organic material resistance: withstands reasonable organic material challenge without loss of efficacy Adaptability: suitable for large or small (point of use) installations Monitoring capability: monitored easily and accurately with physical, chemical, and biological process monitors Cost effectiveness: reasonable cost for installation and for routine operation

851 Modified from Schneider.

114 Guideline -for Disinfection r:md Sterilization in !· !ea!thcare F:aciliti0s, 2008

Table 10. Factors affecting the efficacy of sterilization.

Factors Effect

Cleaning' Failure to adequately clean instrument results in higher bioburden, protein load, and salt concentration. These will decrease sterilization efficacy. Bioburden 1 The natural bioburden of used surgical devices is 10° to 103 organisms (primarily vegetative bacteria), which is substantially below the 105-106 spores used with biological indicators. Pathogen type Spore-forming organisms are most resistant to sterilization and are the test organisms required for FDA clearance. However, the contaminating microflora on used surgical instruments consists mainly of vegetative bacteria. Protein 1 Residual protein decreases efficacy of sterilization. However, cleaning appears to rapidly remove protein load. Salt' Residual salt decreases efficacy of sterilization more than does protein load. However, cleaning appears to rapidly remove salt load. Biofilm accumulation 1 Biofilm accumulation reduces efficacy of sterilization by impairing exposure of the sterilant to the microbial cell. Lumen length Increasing lumen length impairs sterilant penetration. May require forced flow through lumen to achieve sterilization. Lumen diameter Decreasing lumen diameter impairs sterilant penetration. May require forced fiow through lumen to achieve sterilization. Restricted fiow Sterilant must come into contact with microorganisms. Device designs that prevent or inhibit this contact (e.g., sharp bends, blind lumens) will decrease sterilization efficacy. Device design and Materials used in construction may affect compatibility with different sterilization processes and affect sterilization efficacy. Design issues (e.g., screws, hinges) construction will also affect sterilization efficacy.

416 1 Factor only relevant for reused surgical/medical devices Modified from Alia and Rutala. · i26

115 Guideline for O!s!nfoctkm and Sterilization in Hea!thcare Faci!itle~-;, 2008

Table 11. Comparative evaluation of the microbicidal activity of low~temperature sterilization technology.

Carriers Sterilized b~ Various Low·Tem[!erature Sterilization Technologies Challenge ETO 12/88 100% ETO HCFC-ETO HPGP 1QO HPGP 100S PA Reference 1 721 No salt or serum 100% 100% 96% 100% ND ND Alfa 721 10% serum and 97% 60% 95% 37% ND ND Alfa 0.65% salf Lumen (125 em ND 96% 96% ND ND ND Alfa 721 long x 3 mm wide) without serum or sate 721 Lumen (125 em 44% 40% 49% 35% ND 100%1 Alfa long x 3 mm wide) with 10'% serum and 0.65% sale 656 Lumen (40 em long ND ND 100% 95% 100% 8% Rutala 3 x 3 mm wide) 656 Lumen (40 em long ND ND 100% 93% 100% ND Rutala 3 x 2 mm wide) 656 Lumen (40 em long ND ND 100% 26% 100% ND Ruta!a x 1 mm wide) 3 656 Lumen (40 em long ND ND 100% 100% 100% ND Rutala 4 x 3 mm wide)

825 Modified from Rutala. Abbreviations: ETO=ethylene oxide; HCFC=hydrochloroftuorocarbon; ND=no data; HPGP=hydrogen peroxide gas plasma; PA=peracetic acid.

1 Test organisms induded Enterococcus faeca/is, Mycobacterium chelonae, and Bacillus atrophaeus spores. 'Test organisms included E. faecalis, P. aeruginosa, E. coli, M. chelonae, B. atrophaeus spores, G. stearothermophilus spores, and B. circu/ans spores. 'Test organism was G. stearothermophi/us spores. The lumen test units had a removable 5 em center piece (1.2 em diameter) of stainless steel sealed to the narrower steel tubing by hard rubber septums. "Test organism was G. stearothermophilus spores. The lumen test unit was a straight stainless steel tube.

116 Table 12. Suggested protocol for management of positive biological indicator in a steam sterilizer.

1. Take the sterilizer out of service. Notify area supervisor and infection control department. 2. Objects, other than implantable objects, do not need to be recalled because of a single positive spore test unless the sterilizer or the sterilization procedure is defective. As soon as possible, repeat biological indicator test in three consecutive sterilizer cycles. If additional spore tests remain positive, the items should be considered nonsterile, and supplies processed since the last acceptable (negative) biological indicator should be recalled. The items from the suspect load(s) should be recalled and reprocessed. 3. Check to ensure the sterilizer was used correctly (e.g., verify correct time and temperature setting). If not, repeat using appropriate settings and recall and reprocess all inadequately processed items. 4. Check with hospital maintenance for irregularities (e.g., electrical) or changes in the hospital steam supply (i.e., from standard _::97% steam, <3% moisture). Any abnormalities should be reported to the person who performs sterilizer maintenance (e.g., medical engineering, sterilizer manufacturer). 5. Check to ensure the correct biological indicator was used and appropriately interpreted. If not, repeat using appropriate settings. If steps 1 through 5 resolve the problem 6. If all three repeat biological indicators from three consecutive sterilizer cycles (step 2 above) are negative, put the sterilizer back in service. If one or both biological indicators are positive, do one or more of the following until problem is resolved. 7. A. Request an inspection of the equipment by sterilizer maintenance personnel. B. Have hospital maintenance inspect the steam supply lines. C. Discuss the abnormalities with the sterilizer manufacturer. D. Repeat the biological indicator using a different manufacturer's indicator. If step 7 does not resolve the problem Close sterilizer down until the manufacturer can assure that it is operating properly. Retest at that time with biological indicators in three consecutive sterilizer cycles. Modified from Bryce.

Disclosure of Financial interests and Relationships (2000- July 2004)

William A. Rutala: Honoraria from Advanced Sterilization Products, Kimberly-Clark; consultation with Advanced Sterilization Products, Aesculap, Clorox, 3M, SC Johnson, Intelligent Biocides, Metrex; and an educational grant from Consumer Specialty Products Association, Kimberly-Clark.

David J. Weber: Honoraria from Consumer Specialty Products Association; consultation with Clorox; and educational grant from Consumer Specialty Products Association. REFERENCES

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158 APPENDIX- ''14'' The recommendations in this guideline for Ebola Virus Disease has been superseded by CDC's Infection Prevention and Control Recommendations for Hospitalized Patients with Known or Suspected Ebola Virus Disease in U.S. Hospitals and by CDC's Interim Guidance for Environmental Infection Control in Hospitals for Ebola Virus issued on August 1, 2014.

This information is on pages 12, 13, 113 and 1~4.

Click here for current information on how Ebola virus is transmitted. Guidelines for Environmental Infection Control in Health-Care Facilities

Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC)

U.S. Department of Health and Human Services Centers for Disease Control and Prevention (CDC) Atlanta, GA 30333

2003 Suggested Citations:

Available from the CDC Internet Site:

The full-text version of the guidelines appears as a web-based document at the CDC's Division ofHealthcare Quality Promotion's Internet site at: www.cdc.gov/ncidod/hip/enviro/guide.htm

The full-text version of the guidelines should be cited when reference is made primarily to material in Parts I and IV. The print version of the guidelines appears as:

Sehulster LM, Chinn RYW, Arduino MJ, Carpenter J, Donlan R, Ashford D, Besser R, Fields B, McNeil MM, Whitney C, Wong S, Juranek D, Cleveland J. Guidelines for environmental infection control in health-care facilities. Recommendations from CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC). Chicago IL; American Society for Healthcare Engineering/American Hospital Association; 2004.

Part II of these guidelines appeared in the CDC's "Morbidity and Mortality Weekly Report:"

Centers for Disease Control and Prevention. Guidelines for environmental infection control in health-care facilities: recommendations of CDC and the Health care Infection Control Practices Advisory Committee (HICPAC). MMWR 2003; 52 (No. RR-1 0): 1-48.

Updates to the Part II recommendations also appeared in the MMWR in 2003 as "Errata: Vol. 52 (No. RR-1 0)" (MMWR Vol. 52 [42]: I 025-6) on October 24, 2003 and as a "Notice to Readers" scheduled to appear in February 2004. The full-text version of these guidelines (this document) incorporates these updates. Centers for Disease Control and Prevention Healthcare Infection Control Practices Advisory Committee (HICP AC)

Guidelines for Environmental Infection Control in Health-Care Facilities

Abstract

Background: Although the environment serves as a reservoil· for a variety of microorganisms, it is rarely implicated in disease transmission except in the immunocompromised population. Inadvertent exposures to environmental oppottunistic pathogens (e.g., Aspergillus spp. and Legione/la spp.) or airborne pathogens (e.g., Mycobacterium tuberculosis and varicella-zoster vims) may result in infections with significant morbidity and/or mortality. Lack of adherence to established standards and guidance (e.g., water quality in dialysis, proper ventilation for specialized care areas such as operating rooms, and proper use of disinfectants) can result in adverse patient outcomes in health-care facilities.

Objective: The objective is to develop an environmental infection-control guideline that reviews and reaffirms strategies for the prevention of environmentally-mediated infections, particularly among health-care workers and immunocompromised patients. The recommendations are evidence-based whenever possible.

Search Strategies: The contributors to this guideline reviewed predominantly English-language mticles identified from MEDLINE literature searches, bibliographies fi·mn published articles, and infection-control textbooks.

Criteria for Selecting Citations and Studies for This Review: Articles dealing with outbreaks of infection due to environmental opportunistic microorganisms and epidemiological- or laboratoty experimental studies were reviewed. Current editions of guidelines and standards from organizations (i.e., American Institute of Architects [AlA], Association for the Advancement of Medical Instrumentation [AAMI], and American Society of Heating, Refrigeration, and Air-Conditioning Engineers [ASHRAE]) were consulted. Relevant regulations from federal agencies (i.e., U.S. Food and Drug Administration [FDA]; U.S. Department of Labor, Occupational Safety and Health Administration [OSHA]; U.S. Environmental Protection Agency [EPA]; and U.S. Department of Justice) were reviewed. Some topics did not have well-designed, prospective studies nor reports of outbreak investigations. Expert opinions and experience were consulted in these instances.

Types of Studies: Reports of outbreak investigations, epidemiological assessment of outbreak investigations with control strategies, and in vitro environmental studies were assessed. Many of the recommendations are derived ii

ft·om empiric engineering concepts and reflect industry standards. A few of the infection-control measures proposed cannot be rigorously studied for ethical or logistical reasons.

Outcome Measures: Infections caused by the microorganisms described in this guideline are rare events, and the effect of these recommendations on infection rates in a facility may not be readily measurable. Therefore, the following steps to measure performance are suggested to evaluate these recommendations:

I. Document whether infection-control personnel are actively involved in all phases of a health- care facility's demolition, construction, and renovation. Activities should include performing a risk assessment of the necessary types of construction barriers, and daily monitoring and documenting of the presence of negative airflow within the construction zone or renovation area. 2. Monitor and document daily the negative airflow in airborne infection isolation rooms (All) and positive airflow in protective environment rooms (PE), especially when patients are in these rooms. 3. Perform assays at least once a month by using standard quantitative methods for endotoxin in water used to reprocess hemodialyzers, and for heterotrophic, mesophilic bacteria in water used to prepare dialysate and for hemodialyzer reprocessing. 4. Evaluate possible environmental sources (e.g., water, laboratory solutions, or reagents) of specimen contamination when nontuberculous mycobacteria (NTM) of unlikely clinical importance are isolated from clinical cultures. If environmental contamination is found, eliminate the probable mechanisms. 5. Document policies to identify and respond to water damage. Such policies should result in either repair and drying of wet structural materials within 72 hours, or removal of the wet material if drying is unlikely within 72 hours.

Main Results: Infection-control strategies and engineering controls, when consistently implemented, are effective in preventing oppo1tunistic, environmentally-related infections in immunocompromised populations. Adherence to proper use of disinfectants, proper maintenance of medical equipment that uses water (e.g., automated endoscope reprocessors and hydrotherapy equipment), water-quality standards for hemodialysis, and proper ventilation standards for specialized care environments (i.e., airborne infection isolation [All], protective environment [PE], and operating rooms [ORs]), and prompt management of water intrusion into facility structural elements will minimize health-care--associated infection risks and reduce the frequency of pseudo-outbreaks. Routine environmental sampling is not advised except in the few situations where sampling is directed by epidemiologic principles and results can be applied directly to infection control decisions, and for water quality determinations in hemodialysis.

Reviewers' Conclusions: Continued compliance with existing environmental infection control measures will decrease the risk of health-care--associated infections among patients, especially the immunocompromised, and health-care workers. iii

Centers for Disease Control and Prevention Healthcare Infection Control Practices Advisory Committee (HICPAC)

Guidelines for Environmental Infection Control in Health-Care Facilities

Table of Contents

Executive Summary .................................................................................................................... 1 Part I. Bacl

4. Parameters of the Laundry Process .......................................................................................... 100 5. Special Laundry Situations ....................................................................................................... I 02 6. Surgical Gowns, Drapes, and Disposable Fabrics .................................................................... 103 7. Antimicrobial-Impregnated Articles and Consumer Items Bearing Antimicrobial Labeling .. 103 8. Standard Mattresses, Pillows, and Air-Fluidized Beds ............................................................ 104 H. Animals in Health-Care Facilities ............................................................................................ 105 1. General Information ................................................................................................................. 105 2. Animal-Assisted Activities, Animal-Assisted Therapy, and Resident Animals ...................... 106 3. Service Animals ....................................................................................................................... 108 4. Animals as Patients in Human Health-Care Facilities ............................................................. 110 5. Research Animals in Health-Care Facilities ............................................................................ Ill I. Regulated Medical Waste ........................................................................................................... 112 1. Epidemiology ........................................................................................................................... 112 2. Categories of Medical Waste ................................................................................................... I 12 3. Management of Regulated Medical Waste in Health-Care Facilities ...................................... 113 4. Treatment of Regulated Medical Waste ................................................................................... 113 5. Discharging Blood, Fluids to Sanitary Sewers or Septic Tanks ............................................... 116 6. Medical Waste and CJD ........................................................................................................... 116 Part II. Recommendations for Environmental Infection Control in Health-Care Facilities ................................................................................................................................................... 117 A. Rationale for Recommendations .............................................................................................. 117 B. Rating Categories ....................................................................................................................... 117 C. Recommendations-Air ............................................................................................................ 118 D. Recommendations-Water ....................................................................................................... 125 E. Recommendations-Environmental Services ......................................................................... 133 F. Recommendations-Environmental Sampling ....................................................................... 138 G. Recommendations-Laundry and Bedding ............................................................................ 138 H. Recommendations-Animals in Health-Care Facilities ......................................................... 141 I. Recommendations-Regulated Medical Waste ........................................................................ 143 Part III. References ................................................................................................................ 145 Part IV. Appendices ............................................................................................................... 201 Appendix A. Glossary of Terms .................................................................................................... 201 Appendix B. Air .............................................................................................................................. 210 I. Airbome Contaminant Removal .............................................................................................. 210 2. Air Sampling for Aerosols Containing Legionellae ................................................................. 210 3. Calculation of Air Sampling Results ........................................................................................ 211 4. Ventilation Specifications for Health-Care Facilities ............................................................... 212 Appendix C. Water ......................................................................................................................... 220 I. Biofilms .............................. ;..................................................................................................... 220 2. Water and Dialysate Sampling Strategies in Dialysis .............................................................. 222 3. Water Sampling Strategies and Culture Techniques for Detecting Legionellae ...................... 223 4. Procedure for Cleaning Cooling Towers and Related Equipment ........................................... 225 5. Maintenance Pmcedures Used to Decrease Survival and Multiplications of Legionella spp. in Potable-Water Distribution Systems ............................................................................................. 227 Appendix D. Insects and Microorganisms .................................................................................... 228 Appendix E. Information Resources ............................................................................................. 229 Appendix F. A•·eas of Future Research ........................................................................................ 230 Index-Parts I and IV ............................................................................................................ 231 v

List of Figures, Boxes, and Tables

Figures

Figure I. Diagram of a ventilation system .............................................................................................. 14 Figure 2. Example of positive-pressure room control for protection from airborne environmental microbes (PE) .................................................................................................................................. 35 Figure 3. Example of negative-pressure room control for airborne infection isolation (All) ................. 36 Figure 4. Example of airborne infection isolation (All) room with anteroom and neutral anteroom ..... 37 Figure 5. Diagram of a typical air conditioning (induced draft) cooling tower ...................................... 58 Figure 6. Dialysis water treatment system .............................................................................................. 60

Boxes

Box I. Environmental infection control: performance measures .............................................................. 2 Box 2. Eight criteria for evaluating the strength of evidence for environmental sources of infection ...... 4 Box 3. Chain of infection components ...................................................................................................... 4 Box 4. Suggested members and functions of a multi-disciplinary coordination team for construction, renovation, repair, and demolition projects ..................................................................................... 24 Box 5. Construction design and function considerations for environmental infection control ............... 25 Box 6. Unresolved issues associated with microbiologic air sampling ................................................... 28 Box 7. Construction/repair projects that require barrier structures ......................................................... 32 Box 8. Strategy for managing TB patients and preventing airbome transmission in operating rooms ... 39 Box 9. Recovery and remediation measures for water-related emergencies ........................................... 52 Box I 0. Contingency planning for flooding ............................................................................................ 53 Box II. Steps in an epidemiologic investigation for legionellosis .......................................................... 56 Box 12. General steps for cleaning and maintaining ice machines, dispensers, and storage chests ....... 66 Box 13. Preliminary concerns for conducting air sampling .................................................................... 90 Box 14. Selecting an air sampling device ............................................................................................... 93 Box 15. Undertaking environmental-surface sampling ........................................................................... 95 Box C.!. Potential sampling sites for Legionel/a spp. in health-care facilities ..................................... 224 Box C.2. Procedures for collecting and processing environmental specimens for Legionel/a spp ....... 225

Tables

Table I. Clinical and epidemiologic characteristics of aspergillosis ......................................................... 7 Table 2. Environmental fungal pathogens: entry into and contamination of the health-care facility ........ 8 Table 3. Clinical and epidemiologic characteristics of tuberculosis (TB) ............................................... 10 Table 4. Microorganisms associated with airbmne transmission ............................................................ l3 Table 5. Filtration methods ..................................................................................................................... 15 Table 6, Engineered specifications for positive- and negative pressure rooms ....................................... 19 Table 7. Ventilation hazards in health-care facilities that may be associated with increased potential of airbome disease transmission .......................................................................................................... 22 Table 8. Strategies to reduce dust and moisture intrusion during external demolition and construction 30 vi

Table 9. Infection-control measures for intemal construction and repair projects ................................. 32 Table 10. Summary of ventilation specifications in selected areas of health-care facilities ................... 39 Table II. Clinical and epidemiologic characteristics of legionellosis/Legionnaires disease .................. 41 Table 12. Pseudomonas aeruginosa infections in health-care facilities ................................................. 42 Table 13. Other gram-negative bacteria associated with water and moist environments ....................... 43 Table 14. Nontuberculous mycobacteria-environmental vehicles ....................................................... 45 Table 15. Water and point-of-use fixtures as sources and reservoirs of waterborne pathogens ............. 47 Table 16. Water demand in health-care facilities during water disruption emergencies ........................ 50 Table 17. Additional infection-control measures to prevent exposure of high-risk patients to waterborne pathogens ......................................................................................................................................... 57 Table 18. Microbiologic limits for hemodialysis fluids .......................................................................... 62 Table 19. Factors influencing microbial contamination in hemodialysis systems .................................. 63 Table 20. Microorganisms and their sources in ice and ice machines .................................................... 65 Table 21. Infections associated with use of hydrotherapy equipment .................................................... 67 Table 22. Levels of disinfection by type of microorganism ................................................................... 72 Table 23. Air sampling methods and examples of equipment ................................................................ 91 Table 24. Examples of eluents and diluents for environmental-surface sampling .................................. 96 Table 25. Methods of environmental-surface sampling .......................................................................... 97 Table 26. Examples of diseases associated with zoonotic transmission ............................................... I 05 Table 27. Microorganisms and biologicals identified as select agents ................................................. 115 Table B.l. Air changes/hour (ACH) and time required for airborne-contaminant removal efficiencies of 99% and 99.9% ............................................................................................................................. 210 Table B.2. Ventilation requirements for areas affecting patient care in hospitals and outpatient facilities ······················································································································································· 212 Table B.3. Pressure relationships and ventilation ofce1iain areas of nursing facilities ........................ 217 Table B.4. Filter efficiencies for central ventilation and air conditioning systems in general hospitals ······················································································································································· 219 Table B.S. Filter efficiencies for central ventilation and air conditioning systems in outpatient facilities ······················································································································································· 219 Table B.6. Filter efficiencies for central ventilation and air conditioning systems in nursing facilities ······················································································································································· 220 Table B.7. Filter efficiencies for central ventilation and air conditioning systems in psychiatric hospitals ....................................................................................................................................................... 220 Table D.!. Microorganisms isolated from arthropods in health-care settings ...................................... 228 vii

List of Abbreviations Used in This Publication

AAA animal-assisted activity AAMI Association for the Advancement of Medical Instrumentation AAT animal-assisted therapy ACGIH American Council of Governmental Industrial Hygienists ACH air changes per hour ADA Americans with Disabilities Act AER automated endoscope reprocessor AFB acid-fast bacilli AHA American Hospital Association AHJ authorities having jurisdiction AlA American Institute of Architects All airborne infection isolation AmB amphotericin B ANC absolute neutrophil count ANSI American National Standards Institute AORN Association of peri Operative Registered Nurses ASHE American Society for Healthcare Engineering ASHRAE American Society of Heating, Refirgeration, and Air-Conditioning Engineers BCG Bacille Calmette-Guerin BCYE buffered charcoal yeast extract medium BHI brain-heatt infusion BMBL CDC/NIH publication "Biosafety in Microbiological and Biomedical Laboratories" BOD biological oxygen demand BSE bovine spongiform encephalopathy BSL biosafety level c Centigrade CAPD continuous ambulatory peritoneal dialysis CCPD continual cycling peritoneal dialysis CMAD count median aerodynamic diameter CDC U.S. Centers for Disease Control and Prevention CFR Code of Federal Regulations CFU colony- forming unit CJD Creutzfeldt-Jakob disease em centimeter CMS U.S. Centers for Medicare and Medicaid Services CPL compliance document (OSHA) CT/EC cooling tower/evaporative condenser DFA direct fluorescence assay; direct fluorescent antibody DHHS U.S. Department of Health and Human Services DHBV duck hepatitis B virus DNA deoxyribonucleic acid DOP dioctylphthalate DOT U.S. Department ofTranspotiation EC environment of care (JCAHO) ELISA enzyme-linked immunosorbent assay EPA U.S. Environmental Protection Agency ESRD end-stage renal disease viii

EU endotoxin unit F Fahrenheit FDA U.S. Food and Drug Administration FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FRC free residual chlorine ft foot (feet) FTC U.S. Federal Trade Commission GISA glycopeptide intermediate resistant Staphylococcus aureus HBV hepatitis B virus HCV hepatitis C virus HEPA high efficiency particulate air HICPAC Healthcare Infection Control Practices Advisory Committee HIV human immunodeficiency vitus HPV human papilloma vitus HSCT hematopoietic stem cell transplant HVAC heating, ventilation, air conditioning ICRA infection control risk assessment ICU intensive care unit IDso 50% median infectious dose IPD intermittent peritoneal dialysis JCAHO Joint Commission on Accreditation ofHealthcare Organizations l

PCR polymerase chain reaction PD peritoneal dialysis PE protective environment PEL permissible exposure limit PPE personal protective equipment ppm patts per million PVC polyvinylchloride RAPD randomly amplified polymorphic DNA RODAC replicate organism direct agar contact RSV respiratory syncytial virus RO reverse osmosis SARS severe acute respiratory syndrome SARS-CoV SARS coronavirus sec second spp species SSI surgical site infection TB tuberculosis TLV®-TWA threshold limit value-time weighted average TSA tryptic soy agar TSB tryptic soy broth TSE transmissible spongifotm encephalopathy u.s. United States usc United States Code USDA U.S. Department of Agriculture USPS U.S. Postal Service uv ultraviolet UVGI ultraviolet germicidal irradiation VAV variable air ventilation vCJD variant Creutzfeldt-J akob disease VISA vancomycin intermediate resistant Staphylococcus aureus VRE vancomycinwresistant Enterococcus VRSA vancomycin-resistant Staphylococcus aureus v/v volume/volume vzv varicella-zoster virus

Note: Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services. References to non-CDC sites on the Internet are provided as a service to the reader and does not constitute or imply endorsement of these organization s or their programs by CDC or the U.S. Department of Health and Human Services. CDC is not responsible for the content of pages found at these sites. X

The following CDC staff member and HICPAC member prepared this report:

Lynne Sehulster, PhD Division ofHealthcare Quality Promotion National Center for Infectious Diseases

Raymond Y.W. Chinn, MD HICPAC Advisor Sharp Memorial Hospital San Diego, Califomia

Disclosure of Relationship: Raymond Y. W. Chinn is a private-practice physician and salaried employee of Sharp Memorial Hospital in San Diego, California. Dr. Chinn received no research funds from commercial sources either directly, or indirectly through awards made to the hospital, before or during the development of these guidelines.

Contributions were made by the following CDC staff members:

Matthew Arduino, DrPH Joe Carpenter, PE Rodney Donlan, PhD Lynne Sehulster, PhD Division of Healthcare Quality Promotion National Center for Infectious Diseases

David Ashford, DVM, Dsc, MPH Richard Besser, MD Barry Fields, PhD Michael M. McNeil, MBBS, MPH Cynthia Whitney, MD, MPH Stephanie Wong, DMV, MPH Division of Bacterial and Mycotic Diseases National Center fm· Infectious Diseases

Dennis Juranek, DVM, MSC Division of Parasitic Diseases National Center for Infectious Diseases

Jennifer Cleveland, DDS, MPH Division of Oral Health National Center for Chronic Disease Prevention and Health Promotion

In collaboration with the Healthcare Infection Control Practices Advisory Committee (HICPAC) xi

HICPAC Members, February 2002

Robert A. Weinstein, MD Jane D. Siegel, MD Chair Co-Chair Cook County Hospital University of Texas Southwestern Medical Center Chicago, IL Dallas, TX

Michele L. Pearson, MD Raymond Y.W. Chinn, MD Executive Secretary Sharp Memorial Hospital Centers for Disease Control and Prevention San Diego, CA Atlanta, GA

Alfred DeMaria, Jr., MD Elaine L. Larson, RN, PhD Massachusetts Department of Public Health Columbia University School ofNursing Jamaica Plain, MA New York, NY

James T. Lee, MD, PhD Ramon E. Moncada, MD University of Minnesota Coronado Physician's Medical Center VA Medical Center Coronado, CA St. Paul, MN

William A. Rutala, PhD, MPH, CIC William E. Scheckler, MD University of North Carolina School of University of Wisconsin Medical School Medicine Madison, WI Chapel Hill, NC

Beth H. Stover, RN, C!C Marjorie A. Underwood, RN, BSN, CIC Kosair Children's Hospital Mt. Diablo Medical Center Louisville, KY Concord, CA

Liaison Members

Loretta L. Fauerbach, MS, CIC Sandra L. Fitzler, RN Association for Professionals in Infection American Health Care Association Control and Epidemiology (APIC) Washington, DC Washington, DC

Dorothy M. Fogg, RN, BSN, MA Stephen F. Jencks, MD, MPH Association of peri Operative Registered U.S. Centers for Medicare and Medicaid Nurses (AORN) Services Denver, CO Baltimore, MD

Chiu S. Lin, PhD James P. Steinberg, MD U.S. Food and Drug Administration Society for Health care Epidemiology of America, Rockville, MD Inc. (SHEA) Atlanta, GA xii

Liaison Members (continued)

Michael L. Tapper, MD Advisory Committee for the Elimination of Tuberculosis (ACET) NewYork,NY

Expert Reviewers

Trisha Barrett, RN, MBA, CIC Judene Battley, MS, MPH, CIC Alta Bates Medical Center Epidemiology Consulting Services, Inc. Berkeley, CA Beverly Hills, Ml

Michael Berry Col. Nancy Bjerke, BSN, MA, MEd, MPH, CIC University ofN01th Carolina (USAF, Retired) Chapel Hill, NC Infection Control Associates (ICA) San Antonio, TX

Walter W. Bond, MS Cheryl Catter, RN RCSA, Inc. University oflowa Health Center Lawrenceville, GA Iowa City, lA

Douglas Erickson, FASHE MartinS. Favero, PhD American Society for Healthcare Advanced Sterilization Products, Johnson and Engineering (ASHE) Johnson Park Ridge, IL Irvine, CA

Richard Miller, MD Col. Shannon E. Mills, DDS University of Louisville School of Medicine HQ USAF I Surgeon General Detail Louisville, KY Bolin AFB, DC

Gina Pugliese, RN, MS Craig E. Rubens, MD, PhD Premier Safety Institute Children's Hospital and Medical Center Oak Brook, IL Seattle, WA

James D. Scott, PE Andrew J. Streifel, MPH, REHS Michigan Department of Consumer and University of Minnesota Industry Services Minneapolis, MN Lansing, MI

Dale Woodin American Society for Healthcare Engineering (ASHE) Chicago, IL 1

Executive Summary The Guidelines for Environmental Infection Control in Health-Care Facilities is a compilation of recommendations for the prevention and control of infectious diseases that are associated with health- care environments. This document a) revises multiple sections from previous editions of the Centers for Disease Control and Prevention [CDC] document titled Guideline for Handwashing and Hospital Environmental Control;'·' b) incorporates discussions of air and water environmental concerns from CDC's Guideline for the Prevention ofNosocomial Pneumonia;' c) consolidates relevant environmental infection-control measures from other CDC guidelines;<-' and d) includes two topics not addressed in previous CDC guidelines- infection-control concerns related to animals in health-care facilities and water quality in hemodialysis settings.

Part I of this report, Background Information: Environmental Infection Control in Health-Care Facilities, provides a comprehensive review of the scientific literature. Attention is given to engineering and infection-control concerns during construction, demolition, renovation, and repairs of health-care facilities. Use of an infection-control risk assessment is strongly supported before the start of these or any other activities expected to generate dust or water aerosols. Also reviewed in Pmt I are infection-control measures used to recover from catastrophic events (e.g., flooding, sewage spills, loss of electricity and ventilation, and disruption ofthe water supply) and the limited effects of environmental surfaces, laundry, plants, animals, medical wastes, cloth furnishings, and carpeting on disease transmission in healthcare facilities.

Part II of this guideline, Recommendations for Environmental Infection Control in Health-Care Facilities, outlines environmental infection control in health-care facilities, describing measures for preventing infections associated with air, water, and other elements of the environment. These recommendations represent the views of different divisions within CDC's National Center for Infectious Diseases (NCID) (e.g., the Division ofHealthcare Quality Promotion [DHQP] and the Division of Bacterial and Mycotic Diseases [DBMD]) and the consensus of the Healthcare Infection Control Practices Advisory Committee (HICPAC), a 12-member group that advises CDC on concerns related to the surveillance, prevention, and control of health-care--associated infections, primarily in U.S. health- care facilities." In 1999, HICPAC's infection-control focus was expanded from acute-care hospitals to all venues where health care is provided (e.g., outpatient surgical centers, urgent care centers, clinics, outpatient dialysis centers, physicians' offices, and skilled nursing facilities). The topics addressed in this guideline are applicable to the majority of health-care venues in the United States. This document is intended for use primarily by infection-control professionals (!CPs), epidemiologists, employee health and safety personnel, information system specialists, administrators, engineers, facility managers, environmental service professionals, and architects for health-care facilities.

Key recommendations include a) infection-control impact of ventilation system and water system petformance; b) establishment of a multidisciplinary team to conduct infection-control risk assessment; c) use of dust-control procedures and barriers during construction, repair, renovation, or demolition; d) environmental infection-control measures for special care areas with patients at high risk; e) use of airborne patticle sampling to monitor the effectiveness of air filtration and dust-control measures; f) procedures to prevent airborne contamination in operating rooms when infectious tuberculosis [TB] patients require surgery; g) guidance regarding appropriate indications for routine culturing of water as part of a comprehensive control program for legione!lae; h) guidance for recovering from water system disruptions, water leaks, and natural disasters [e.g., flooding]; i) infection-control concepts for equipment that uses water from main lines [e.g., water systems for hemodialysis, ice machines, hydrotherapy equipment, dental unit water lines, and automated endoscope reprocessors]); j) environmental surface cleaning and disinfection strategies with respect to antibiotic-resistant 2

microorganisms; k) infection-control procedures for health-care laundry; I) use of animals in health care for activities and therapy; m) managing the presence of service animals in health-care facilities; n) infection-control strategies for when animals receive treatment in human health-care facilities; and o) a call to reinstate the practice of inactivating amplified cultures and stocks of microorganisms on-site during medical waste treatment.

Whenever possible, the recommendations in Part II are based on data fi·om well-designed scientific studies. However, ce1tain of these studies were conducted by using narrowly defined patient populations or for specific health-care settings (e.g., hospitals versus long-term care facilities), making generalization of findings potentially problematic. Construction standards for hospitals or other health- care facilities may not apply to residential home-care units. Similarly, infection-control measures indicated for immunosuppressed patient care are usually not necessary in those facilities where such patients are not present. other recommendations were derived from knowledge gained during infectious disease investigations in health-care facilities, where successful termination of the outbreak was often the result of multiple interventions, the majority of which cannot be independently and rigorously evaluated. This is especially true for constmction situations involving air or water.

Other recommendations are derived from empiric engineering concepts and may reflect an industry standard rather than an evidence-based conclusion. Where recommendations refer to guidance from the American Institute of Architects (AlA), the statements reflect standards intended for new construction or renovation. Existing structures and engineered systems are expected to be in continued compliance with the standards in effect at the time of construction or renovation. Also, in the absence of scientific confirmation, certain infection-control recommendations that cannot be rigorously evaluated are based on a strong theoretical rationale and suggestive evidence. Finally, certain recommendations are derived ti·om existing federal regulations. The references and the appendices comprise Parts III and IV of this document, respectively.

Infections caused by the microorganisms described in these guidelines are rare events, and the effect of these recommendations on infection rates in a facility may not be readily measurable. Therefore, the following steps to measure performance are suggested to evaluate these recommendations (Box 1):

Box 1. Environmental infection control: performance measures

1. Document whether infection-control personnel are actively involved in all phases of a health-care facility's demolition, construction, and renovation, Activities should include performing a risk assessment of the necessary types of construction barriers, and daily monitoring and documenting of the presence of negative airflow within the construction zone or renovation area. 2. Monitor and document daily the negative airflow in airborne infection isolation (All) rooms and positive airflow in protective environment (PE) rooms, especially when patients are in these rooms, 3. Perform assays at least once a month by using standard quantitative methods for endotoxin in water used to reprocess hemodialyzers, and for heterotrophic and mesophilic bacteria in water used to prepare dialysate and for hemodialyzer reprocessing. 4. Evaluate possible environmental sources (e.g., water, laboratory solutions, or reagents) of specimen contamination when nontuberculous mycobacteria (NTM) of unlikely clinical importance are isolated from clinical cultures. If environmental contamination is found, eliminate the probable mechanisms. 5. Document policies to identify and respond to water damage. Such policies should result in either repair and drying of wet structural or porous materials within 72 hours; or removal of the wet material if drying is unlikely with 72 hours. 3

Topics outside the scope of this document include a) noninfectious adverse events (e.g., sick building syndrome); b) environmental concerns in the home; c) home health care; d) biotenorism; and e) health- care-associated food borne illness. This document includes only limited discussion of a) handwashing/hand hygiene; b) standard precautions; and c) infection-control measures used to prevent insttument or equipment contamination during patient care (e.g., preventing waterborne contamination of nebulizers or ventilator humidifiers). These topics are mentioned only if they are impmiant in minimizing the transfer of pathogens to and from persons or equipment and the environment. Although the document discusses principles of cleaning and disinfection as they are applied to maintenance of environmental surfaces, the full discussion of sterilization and disinfection of medical instrnments and direct patient-care devices is deferred for inclusion in the Guideline for Disinfection and Sterilization in Health-Care Facilities, a document currently under development. Similarly, the full discussion of hand hygiene is available as the Guideline for Hand Hygiene in Health-Care Settings: Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC!IDSA Hand Hygiene Task Force. Where applicable, the Guidelines for Environmental Infection Control in Health-Care Facilities are consistent in content to the drafts available as of October 2002 of both the revised Guideline for Prevention of Health-Care-Associated Pneumonia and Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Facilities.

This guideline was prepared by CDC staff members from NCID and the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) and the designated H!CPAC advisor. Contributors to this document reviewed predominantly English-language manuscripts identified fi·om reference searches using the National Library of Medicine's MEDLINE, bibliographies of published miicles, and infection-control textbooks. Working drafts of the guideline were reviewed by CDC scientists, HICPAC committee members, and experts in infection control, engineering, internal medicine, infectious diseases, epidemiology, and microbiology. All recommendations in this guideline may not reflect the opinions of all reviewers.

Part I. Background Information: Environmental Infection Control in Health-Care Facilities A. Introduction The health-care environment contains a diverse population of microorganisms, but only a few are significant pathogens for susceptible humans. Microorganisms are present in great numbers in moist, organic environments, but some also can persist under dry conditions. Although pathogenic microorganisms can be detected in air and water and on fomites, assessing their role in causing infection and disease is difficult.'' Only a few repmts clearly delineate a "cause and effect" with respect to the environment and in particular, housekeeping surfaces.

Eight criteria are used to evaluate the strength of evidence for an environmental source or means of transmission of infectious agents (Box 2).''· 12 Applying these criteria to disease investigations allows scientists to assess the contribution of the environment to disease transmission. An example of this application is the identification of a pathogen (e.g., vancomycin-resistant enterococci [VRE]) on an environmental surface during an outbreak. The presence of the pathogen does not establish its causal role; its transmission from source to host could be through indirect means (e.g., via hand transferral)." The surface, therefore, would be considered one of a number of potential reservoirs for tlae pathogen, but not the "de facto" source of exposure. An understanding of how infection occurs after exposure, 4

based on the principles of the "chain of infection," is also important in evaluating the contribution of the environment to health-care-associated disease." All of the components of the "chain" must be operational for infection to occur (Box 3).

Box 2. Eight criteria for evaluating the strength of evidence for environmental sources of infection* +

1. The organism can survive after inoculation onto the fomite. 2. The organism can be cultured from in Ruse fomites, 3. The organism can proliferate in or on the fomite. 4. Some measure of acquisition of infection cannot be explained by other recognized modes of transmission. 5. Retrospective caseRcontrol studies show an association between exposure to the fomite and infection. 6, Prospective caseRcontrol studies may be possible when more than one similar type of fomite is in use. 7. Prospective studies allocating exposure to the fomite to a subset of patients show an assication between exposure and infection. 8. Decontamin~tion of the fomite results in the elimination of infection transmission.

* These criteria are listed in order of strength of evidence. + Adapted from references 11 and 12.

Box 3. Chain of infection components*

1. Adequate number of pathogenic organisms (dose) 2. Pathogenic organisms of sufficient virulence 3. A susceptible host 4. An appropriate mode of transmission or transferal of the organism in sufficient number from source to host 5. The correct portal of entry into the host

* Adapted from reference 13-

The presence of the susceptible host is one of these components that underscores the importance of the health-care environment and opportunistic pathogens on fomites and in air and water. As a result of advances in medical technology and therapies (e.g., cytotoxic chemotherapy and transplantation medicine), more patients are becoming immunocompromised in the course of treatment and are therefore at increased risk for acquiring health-care-associated opportunistic infections. Trends in health-care delivety (e.g., early discharge of patients fi·om acute care facilities) also are changing the distribution of patient populations and increasing the number ofimmunocompromised persons in non- acute-care hospitals. According to the American Hospital Association (AHA), in 1998, the number of hospitals in the United States totaled 6,021; these hospitals had a total of I ,013,000 beds, 14 representing a 5.5% decrease in the number of acute-care facilities and a I 0.2% decrease in the number of beds over the 5-year period 1994-1998. 14 In addition, the total average daily number of patients receiving care in U.S. acute-care hospitals in 1998 was 662,000 (65.4%)- 36.5% less than the 1978 average of I ,042,000. 14 As the number of acute-care hospitals declines, the length of stay in these facilities is concurrently decreasing, particularly for immunocompetent patients. Those patients remaining in acute- care facilities are likely to be those requiring extensive medical interventions who therefore at high risk for opportunistic infection. 5

The growing population of severely immunocompromised patients is at odds with demands on the health-care industry to remain viable in the marketplace; to incorporate modern equipment, new diagnostic procedures, and new treatments; and to construct new facilities. Increasing numbers of health-care facilities are likely to be faced with construction in the near future as hospitals consolidate to reduce costs, defer care to ambulatory centers and satellite clinics, and try to create more "home-like" acute-care settings. In 1998, approximately 75% of health-care-associated construction projects focused on renovation of existing outpatient facilities or the building of such facilities; 15 the number of projects associated with outpatient health care rose by 17% from 1998 through 1999. 16 An aging population is also creating increasing demand for assisted-living facilities and skilled nursing centers. Construction of assisted-living facilities in 1998 increased 49% fi·om the previous year, with 138 projects completed at a cost of$703 million. 16 Overall, from 1998 to 1999, health-care-associated construction costs increased by 28.5%, from $11.56 billion to $14.86 billion. 16

Environmental disturbances associated with construction activities near health-care facilities pose airborne and waterbome disease threats risks for the substantial number of patients who are at risk for health-care-associated oppottunistic infections. The increasing age of hospitals and other health-care facilities is also generating ongoing need fot·repair and remediation work (e.g., installing wiring for new information systems, removing old sinks, and repairing elevator shafts) that can introduce or increase contamination of the air and water in patient-care environments. Aging equipment, deferred maintenance, and natural disasters provide additional mechanisms for the entry of environmental pathogens into high-risk patient-care areas.

Architects, engineers, construction contractors, environmental health scientists, and industrial hygienists historically have directed the design and function of hospitals' physical plants. Increasingly, however, because of the growth in the number of susceptible patients and the increase in construction projects, the involvement of hospital epidemiologists and infection-control professionals is required. These experts help make plans for building, maintaining, and renovating health-care facilities to ensure that the adverse impact of the environment on the incidence of health-care-associated infections is minimal. The following are examples of adverse outcomes that could have been prevented had such expetts been involved in the planning process: a) transmission of infections caused by Mycobacterium tuberculosis, varicella-zoster virus (VZV), and measles (i.e., rubeola) facilitated by inappropriate air-handling systems in health-care facilities;' b) disease outbreaks caused by Aspergillus spp., 17- 19 Mucoraceae," and Penicillium spp. associated with the absence of environmental controls during periods of health-care facility-associated construction;21 c) infections and/or colonizations of patients and staff with vancomycin-resistant Enterococcusfaecium [VRE] and Clostridium difficile acquired indirectly from contact with organisms present on environmental surfaces in health-care facilities; 22- 25 and d) outbreaks and pseudoepidemics oflegionellae, 26• 27 Pseudomonas aeruginosa,'s-30 and the nontuberculous mycobacteria (NTM) 31 • 32 linked to water and aqueous solutions used in health-care facilities. The purpose of this guideline is to provide useful information for both health-care professionals and engineers in efforts to provide a safe environment in which quality health care may be provided to patients. The recommendations herein provide guidance to minimize the risk for and prevent tmnsmission of pathogens in the indoor environment.

B. Key Terms Used in this Guideline Although Appendix A provides definitions for terms discussed in PattI, several terms that pertain to specific patient-care areas and patients who are at risk for health-care-associated opportunistic infections are presented here. Specific engineering parameters for these care areas are discussed more 6

fully in the text. Airborne Infection Isolation (All) refers to the isolation of patients infected with organisms spread via airborne droplet nuclei <5 ~min diameter. This isolation area receives numerous air changes per hour (ACH) (2: 12 ACH for new construction as of 200 I; 2:6 ACH for construction before 2001 ), and is under negative pressure, such that the direction of the airflow is from the outside adjacent space (e.g., corridor) into the room. The air in an All room is preferably exhausted to the outside, but may be recirculated provided that the return air is filtered through a high efficiency particulate air (HEPA) filter. The use of personal respiratory protection is also indicated for persons entering these rooms.

Protective Environment (PE) is a specialized patient-care area, usually in a hospital, with a positive airflow relative to the corridor (i.e., air flows from the room to the outside adjacent space). The combination ofHEPA filtration, high numbers of air changes per hour (2:12 ACH), and minimal leakage of air into the room creates an environment that can safely accommodate patients who have undergone allogeneic hematopoietic stem cell transplant (HSCT).

Immunocompromised patients are those patients whose immune mechanisms are deficient because of immunologic disorders (e.g., human immunodeficiency vims [HIV] infection, congenital immune deficiency syndrome, chronic diseases [such as diabetes, cancer, emphysema, and cardiac failure]) or immunosuppressive therapy (e.g., radiation, cytotoxic chemotherapy, anti-rejection medication, and steroids). Jmmunocompromised patients who are identified as high-risk patients have the greatest risk of infection caused by airborne or waterborne microorganisms. Patients in this subset include those who are severely neutropenic for prolonged periods of time (i.e., an absolute neutrophil count [ANC] of;S500 cells/mL), allogeneic HSCT patients, and those who have received intensive chemotherapy (e.g., childhood acute myelogenous leukemia patients).

C. Air 1. Modes of Transmission of Airborne Diseases

A variety of airborne infections in susceptible hosts can result from exposures to clinically significant microorganisms released into the air when environmental reservoirs (i.e., soil, water, dust, and decaying organic matter) are disturbed. Once these materials are brought indoors into a health-care facility by any of a number of vehicles (e.g., people, air currents, water, construction materials, and equipment), the attendant microorganisms can proliferate in various indoor ecological niches and, if subsequently disbursed into the air, serve as a source for airborne health-care-associated infections.

Respirat01y infections can be acquired from exposure to pathogens contained either in droplets or droplet nuclei. Exposure to microorganisms in droplets (e.g., through aerosolized oral and nasal secretions from infected patients33 ) constitutes a form of direct contact transmission. When droplets are produced during a sneeze or cough, a cloud of infectious particles >5 ~m in size is expelled, resulting in the potential exposure of susceptible persons within 3 feet of the source person.' Examples of pathogens spread in this manner are influenza virus, rhinoviruses, adenoviruses, and respiratory syncytial virus (RSV). Because these agents primarily are transmitted directly and because the droplets tend to fall out of the air quickly, measures to control air flow in a health-care facility (e.g., use of negative pressure rooms) generally are not indicated for preventing the spread of diseases caused by these agents. Strategies to control the spread of these diseases are outlined in another guideline 3

The spread of airborne infectious diseases via droplet nuclei is a form of indirect transmission. 34 Droplet nuclei are the residuals of droplets that, when suspended in air, subsequently dry and produce 7

particles ranging in size from 1-5 11m. TI1ese patticles can a) contain potentially viable microorganisms, b) be protected by a coat of (hy secretions, c) remain suspended indefinitely in air, and d) be transported over long distances. Tite microorganisms in droplet nuclei persist in favorable conditions (e.g., a dty, cool atmosphere with little or no direct exposure to sunlight or other sources of radiation). Pathogenic microorganisms that can be spread via droplet nuclei include lY~rcobacterium tuberculosis, VZV. measles vims (i.e .. mbeola), and smallpox vims (i.e., vmiola major). 6 Several environmental pathogens have life-cycle forms that are similar in size to droplet nuclei and may exhibit similar behavior in the air. The spores ot'Aspergillusjinnigatns have a diameter of2-3.5 !1111, with a settling velocity estimated at 0.03 em/second (or about !meter/hour) in still air. With this enhanced buoyancy, the spores. which resist desiccation, can remain airbome indefinitely in air cunents and travel far from their source. 35

2. Airborne Infectious Diseases in Health-Care Facilities a. Aspergillosis ami Of/1er Fungal Diseases Aspergillosis is caused by molds belonging to the genus Aspergillus. Aspergillus spp. are prototype health-care-acquired pathogens associated with dusty or moist environmental conditions. Clinical and epidemiologic aspects of aspergillosis (Table 1) are discussed extensively in another guideline!

Table 1. Clinical and epidemiologic chnracteristics of nspergillosis Refert>nres Aspergillusfumigaws (90o/c-95% ofAspergillus infections among Causative agent<; hematopoietic .stem cell tran'>plnnt (HSCT) patients; A.jlnvus, A. nigel', A. 36-43 A. nidulans te/Te11S,

l\Iode.s of transmission All·bome trnnsmis<:>lou of fu>l~~al_;fores; direct inhalntion; direct inoculation 37 from environmental s.omces rare Acti\'itle.c; nssodnted with Con<;tmction. rc:novotion. r~modeling:, repairs. building demolition; rare 44-51 infection eJlisodes associated with fomites A!'ute inWJsb•e: pnt>umonin: ulcerative tracheobronchitis; osteomyelitis: abscesses (aspergiltomas) of the lungs. brain, liver, spleen, and kidneys: tlu·ombosis of deep blood vessels: necrotizing: skin uh;:ers; et}dophthalmitis; Clinlcnl !i~·udrome_s !lnd and sinusitis 44.45,52-58 disen:Ses Chronic fm•asiw: chronic pneumot1itis H.Jpersl'JISI~I'; allergic bronchopulmonmy aspergiUosis Ct1ta11eous: · orimarV c,kin and burn-wound infections H('matopoietic stem cell tl'tmsp)ant patients (HSCT): inununocompromised patients (i.e., tho>e with tmderlying disease), pntients Patient populations at undergoing chemothet-apy, organ h'attsplnnt redpients~ pretenn neonates 1 hemodialysis patients. p11ticnts wilh identifiable immune ·system deficiencies 36, 59-78 greatest risk who receive c!lre in general inten'.>ive care units (ICUs). nnd cystic fibrosis natienis fmav be colonized occasionnllv become iufe~ted) l'aetor:s nffediug scvN·ity 111e inunune '!.tatus of the patient and the dumtion of severe neutropenia 79,80 nud outt:Otut''i Rare nnd spomdi~, but increasing as proportion of itmmmocompronllfied 0CC\ll'l'eUCt' patients increases; 5% ofHSCT patients infected, <5% of solid orgnn 36,37,81-88 trnnsolaut recioients infected Rate can be as high as 100% if severe neutropenia persists; 13%-80% Mortality rate 58, 83, 89, 90 mo11a1itv amon2leukeruia Datients

Aspergillus spp. are ubiquitous, aerobic fungi that occur in soil, water, and decaying ve§etation; the organism also survives well in air. dust. and moisture present in health-care facilities."- 3 The presence of aspergilli in the health-care facility environment is a substantial extrinsic risk factor for opportunistic invasive aspergillosis (invasive aspergillosis being the most serious tonn of the disease) 69· 9 Site renovation and constmction can disturb Awm:gil/us-contaminated dust and produce bursts of airbome 8

fungal spores. Increased levels of atmospheric dust and fungal spores have been associated with clusters of health-care-acquired infections in immunocompromised patients. 17• 20• 44• 47• 49• 50• ,,_98 Absorbent building materials (e.g., wallboard) serve as an ideal substrate for the proliferation of this organism if they become and remain wet, thereby increasing the numbers of fungal spores in the area. Patient-care items, devices, and equipment can become contaminated with Aspergillus spp. spores and serve as sources of infection if stored in such areas. 57

Most cases of aspergillosis are caused by Aspergillus fitmigatus, a thermotolerant/thermophilic fungus capable of growing over a temperature range from 53.6°F-127.4°F ( I2°C-53°C); optimal growth occurs at approximately 104°F (40°C), a temperature inhibitory to most other saprophytic fungi. 99 It can use cellulose OJ' sugars as carbon sources; because its respiratory process requires an ample supply of carbon, decomposing organic matter is an ideal substrate.

Other oppmtunistic fungi that have been occasionally linked with health-care-associated infections are members of the order Mucorales (e.g., Rhizopus spp.) and miscellaneous moniliaceous molds (e.g., Fusarium spp. and Penicillium spp.) (Table 2). Many of these fungi can proliferate in moist environments (e.g., water-damaged wood and building materials). Some fungi (e.g., Fusarium spp. and Pseudoal/escheria spp.) also can be airborne pathogens. 100 As with aspergillosis, a major risk factor for disease caused by any of these pathogens is the host's severe immunosuppression fi·mn either 101 underlying disease or immunosuppressive therapy. • 102

Table 2. Environmental fungal pathogens: entry into and contamination of the health- care facility

Implicated environmental vehicle References

Aspergillus spp. Improper!): functioning ventilation systems 20, 46, 47, 97, 98, 103, 104 Air filters ,+ 17, 18, 105-107 Air filter frames 17, 18 Window air conditioners 96 Backflow of contaminated air 107 Air exhaust contamination+ 104 False ceilings 48, 57, 97, 108 Fibrous insulation and perforated metal ceilings 66 Acoustic ceiling tiles, plasterboard 18, 109 Fireproofing material 48,49 Damp wood building materials 49 Opening doors to constmction site 110 Construction 69 Open windows 20, 108, Ill Disposal conduit door 68 Hospital vacuum cleaner 68 Elevator 112 Atmboards 57 Walls 113 Unit kitchen 114 Food 21 Ornamental plants 21 Mucorales I Rhizopus spp. Air filter 20, 115 False ceilings 97 Heliport 115 Scedospol'ium spp. Construction 116 9

(Table 2. continued)

Implicated environmental vehicles References

Penicillium spp. Rotting cabinet wood, pipe leak 21 Ventilation duct fiberglass insulation 112 Air filters 105 Topical anesthetic 117 Acremonium spp. Air filters 105 Cladosporium spp. Air filters 105 Sporothrix Constmction (pseudoepidemic) 118

*. Pigeons, their droppings and roosts are associated with spread of Aspergtllus, C/Jptococcus, and Histoplasma spp. There have been at least three outbreaks linked to contamination of the filtering systems from bird droppings 98 • 103 • 104 Pigeon mites may gain access into a health-care facility through the ventilation system. 119 +. The American Institute of Architects (AlA) standards stipulate that for new or renovated construction a) exhaust outlets are to be placed >25 feet from air intake systems, b) the bottom of outdoor air intakes for HVAC systems should be 6 feet above ground or 3 feet nbove roof level, and c) exhaust outlets from contaminated areas are situated above the roof level and arranged to minimize the recirculation of exhausted air back into the building. 120

Infections due Cryptococcus neoformans, Histoplasma capsulatum, or Coccidioides immitis can occur in health-care settings if nearby ground is disturbed and a malfunction of the facility's air-intake components allows these pathogens to enter the ventilation system. C. neoformans is a yeast usually 4- 8 flm in size. However, viable particles of <2 flm diameter (and thus pennissive to alveolar deposition) 103 have been found in soil contaminated with bird droppings, particularly from pigeons."'· • 104• 121 H capsulatum, with the infectious microconidia ranging in size ft·om 2-5 ftm, is endemic in the soil of the central river valleys of the United States. Substantial numbers of these infectious particles have been associated with chicken coops and the roosts of blackbirds."'· 103 ' 104• 122 Several outbreaks of histoplasmosis have been associated with disruption of the environment; construction activities in an endemic area may be a potential risk factor for health-care--acquired airborne infection. 123 • 124 C. immitis, with arthrospores of3-5 flm diameter, has similar potential, especially in the endemic southwestern United States and during seasons of drought followed by heavy rainfall. After the 1994 earthquake centered near Northridge, California, the incidence of coccidioidomycosis in the surrounding area exceeded the historical norm. 125

Emerging evidence suggests that Pneumocystis carinii, now classified as a fungus, may be spread via airborne, person-to-person transmission. 126 Controlled studies in animals first demonstrated thatP. carinii could be spread through the air. 127 More recent studies in health-care settings have detected nucleic acids of P. carinii in air samples from areas frequented or occupied by P. carinii-infected patients but not in control areas that are not occupied by these patients."'· 129 Clusters of cases have been identified among immunocompromised patients who had contact with a source patient and with each other. Recent studies have examined the presence of P. carinii DNA in oropharyngeal washings and the nares of infected patients, their direct contacts, and persons with no direct contact. 130 • 131 Molecular analysis of the DNA by polymerase chain reaction (PCR) provides evidence for airborne transmission of P. cm·inii from infected patients to direct contacts, but immunocompetent contacts tend to become transiently colonized rather than infected. 131 The role of colonized persons in the spread of P. carinii pneumonia (PCP) remains to be determined. At present, specific modifications to ventilation systems to control spread of PCP in a health-care facility are not indicated. Current recommendations 10

outline isolation procedures to minimize or eliminate contact of inununocompromised patients not on PCP prophylaxis with PCP-infected patients.'· m

b. Tuberculosis ami Otiler Bacterial Diseases The bacterium most commonly associated with airbome transmission is Mycobacterium tuberculosis. A comprehensive review of the microbiology and epidemioloiF of M. tuberculosis and guidelines for tuberculosis (TB) infection controllwve been published.'· 1l · 134 A Slll1llllalY of the clinical and epidemiologic information from these materials is provided in this guideline (Table 3).

Table 3. Clinical and epidemiologic characteristics oftuberculosis (TB)* Cau~atiY{' ngeuts l\(l'<'Obncterlum tubnculosis, M bovis, M afiicanlutl Mode of transmission Airborne trnnstni!>sion via droplet nuclei 1-5 ~1m in dinmeter • Disease of the hmgs, airways, or lmynx: presence of coug-h or other forceful expiratory measures PMient fnrtors nssodntt>d with • Pr~sence of "cid-fasi bnciUi (AFB) in the sputum infeftivity nud transmission • FRihu·e of the patient to cover the mouth and nose when coughing or .sneezing • Presence of cavitntion on chest radiogl'aph • Inappropriate or shortened duration of chemothempy • Exposures in rehtively small, enclosed spa~s • Inadeqtmte ventilation resulting in insufficient removal of droplet nuclei Activiti(l's nssorinte-d with • Cough~produdng procedures done in areas without proper enviromnental controls infections • Recirculation of nir containing infectious droplet JlU()lei • Fnilure to me respirat01y protection whell managing open lesions for pntients with suspected extrapulmonary TB 135 Pulmoual'y TB; extrapulmonaty TB can ail'ect any organ system or tissue; lnryngcal Clinknl syndromes and dis<>ns<' TB is highly contagious * lllUnlUlOCOlllpromised peJ:>OilS (c.g., fliV.infected persons) • Medically underset'~o'ed persons. urbnn poor. homele'>s persons, elderly persons. migrant fnrm workers. close contacls of known patients Populnfions 11t grente-st ri.sk • Substance abusers, pre'>ent and fonner prison Uuuates • Foreign~bol'll persons from areas with high prevaleu~e ofTB .. Health-care worker-S • Concentration of droplet nuclei in air, duration of exposure Factors affecting sevel'ity And • Age nt infection outcomt's • Inmmnosuppression due to therapy Ol' disease, underlying cht·onic medical conditions, histoty of malia:nnncies or lesions or the luno.s OccmTem·e Worldwide; incidence in the United States is 5.6 cases/100,000 population (200 1)'" 9 Mortality 930 denths in the United States (1999)"" - Treatment of latent infection includes isoniazid (INH) or rifampin (IUF).'' Directly obsetTed therapy (DOT) for active cases as indicated: INH, RIF, ChetuOJH'ophyhtxis I tr<'-atment pymzin~mide (PZA), ethmnbutol (EMB), streptomydn (SM.f- in various combinations detennined by prev;llent level<; of specific resistance,'1·1J'I. 13 -!3!) Consult therapy 139 I Rttidelines for specific treatment indications, • Matenal m this table 1s C

1vf.wberculosis is canied by droplet nuclei generated when persons ~rimarily adults and adolescents) who have pulmonary or laryngeal TB sneeze, cough. speak. or sing; 1 9 nonnal air currents can keep these patticles airbome for prolonged periods and spread them throughout a room or building. 142 However, transmission of TB has occurred limn mycobacteria aerosolized during provision of care (e.g .• wound/lesion care or during handling of infectious peritoneal dialysis fluid) for extrapulmonaty TB patients. !JS, 140

Gram-positive cocci (i.e .. Staphylococcus nureus. group A beta-hemolytic streptococci). also important health-care-hssociated pathogens, are resLstant to inactivation by drying and can persist in the II

environment and on environmental surfaces for extended periods. These organisms can be shed from heavily colonized persons and discharged into the air. Airborne dispersal of S. aureus is directly associated with the concentration of the bacterium in the anterior nares. 143 Approximately 10% of healthy carriers will disseminate S. aureus into the air, and some persons become more effective disseminators of S. aureus than others. 144- 148 The dispersal of S. aureus into air can be exacerbated by concurrent viral upper respiratmy infection, thereby turning a carrier into a "cloud shedder." 149 Outbreaks of surgical site infections (SSis) caused by group A beta-hemolytic streptococci have been traced to airborne transmission from colonized operating-room personnel to patients. 15 0- 153 In these situations, the strain causing the outbreak was recovered from the air in the operating room 150' 151 • 154 or on settle plates in a room in which the carrier exercised. 151 - 153 S. aureus and group A streptococci have not been linked to airborne transmission outside of operating rooms, burn units, and neonatal nurseries. 155 • 156 Transmission ofthese agents occurs primarily via contact and droplets.

Other gram-positive bacteria linked to airborne transmission include Bacillus spp. which are capable of sporulation as environmental conditions become less favorable to support their growth. Outbreaks and pseudo-outbreaks have been attributed to Bacillus cereus in maternity, pediatric, intensive care, and bronchoscopy units; many of these episodes were secondary to environmental contamination. 157- 160

Gram-negative bacteria rarely are associated with episodes of airborne transmission because they generally require moist environments for persistence and growth. The main exception is Acinetobacter spp., which can withstand the inactivating effects of d1ying. In one epidemiologic investigation of bloodstream infections among pediatric patients, identical Acinetobacter spp. were cultured from the patients, air, and room air conditioners in a nursery . 161

Aerosols generated from showers and faucets may potentially contain legionellae and other gram- negative waterborne bacteria (e.g., Pseudomonas aeruginosa). Exposure to these organisms is through direct inhalation. However, because water is the source of the organisms and exposure occurs in the vicinity ofthe aerosol, the discussion of the diseases associated with such aerosols and the prevention measures used to cmtail their spread is discussed in another section of the Guideline (see Part I: Water).

c. Airborne Viral Diseases Some human viruses are transmitted from person to person via droplet aerosols, but very few viruses are consistently airborne in transmission (i.e., are routinely suspended in an infective state in air and capable of spreading great distances), and health-care-associated outbreaks of airbome viral disease are limited to a few agents. Consequently, infection-control measures used to prevent spread of these viral diseases in health-care facilities primarily involve patient isolation, vaccination of susceptible persons, and antiviral therapy as appropriate rather than measures to control air flow or quality.' Infections caused by VZV frequently are described in health-care facilities. Health-care-associated airborne outbreaks of VZV infections from patients with primary infection and disseminated zoster have been documented; patients with localized zoster have, on rare occasions, also served as source patients for outbreaks in health-care facilities. 162- 166 VZV infection can be prevented by vaccination, although patients who develop a rash within 6 weeks of receiving varicella vaccine or who develop breakthrough varicella following exposure should be considered contagious.'"

Viruses whose major mode of transmission is via droplet contact rarely have caused clusters of infections in group settings through airborne routes. The factors facilitating airborne distribution of these viruses in an infective state are unknown, but a presumed requirement is a source patient in the early stage of infection who is shedding large numbers of viral particles into the air. Airborne transmission of measles has been documented in health-care facilities. 16 B- 171 In addition, institutional outbreaks of influenza virus infections have occurred predominantly in nursing homes, l72-l76 and less frequently in medical and neonatal intensive care units, chronic-care areas, HSCT units, and pediatric 12

177 180 wards. - Some evidence supports airborne transmission of influenza viruses by droplet nuclei, 181 · 182 and case clusters in pediatric wards suggest that droplet nuclei may play a role in transmitting certain respiratmy pathogens (e.g., adenoviruses and respiratmy syncytial virus [RSV]). 177• 183· 184 Some evidence also supports airborne transmission of enteric viruses. An outbreak of a Norwalk-like virus infection involving more than 600 staff personnel over a 3-week period was investigated in a Toronto, Ontario hospital in 1985; common sources (e.g., food and water) were ruled out during the investigation, leaving airborne spread as the most likely mode oftransmission. 185

Smallpox virus, a potential agent ofbioterrorism, is spread predominantly via direct contact with infectious droplets, but it also can be associated with airborne transmission. 186· 187 A German hospital study from 1970 documented the ability of this virus to spread over considerable distances and cause infection at low doses in a well-vaccinated population; factors potentially facilitating transmission in this situation included a patient with cough and an extensive rash, indoor air with low relative humidity, and faulty ventilation patterns resulting from hospital design (e.g., open windows). 188 Smallpox patients with extensive rash are more likely to have lesions present on mucous membranes and therefore have greate1· potential to disseminate virus into the air. 188 In addition to the smallpox transmission in Germany, two cases of!aborat01y-acquired smallpox virus infection in the United Kingdom in 1978 also were thought to be caused by airborne transmission. 189

Airborne transmission may play a role in the natural spread of hantavimses and certain hemorrhagic fever viruses (e.g., Ebo!a, Marburg, and Lassa), but evidence for airborne spread of these agents in health-care facilities is inconclusive. 190 Although hantaviruses can be transmitted when aerosolized from rodent excreta, 191 ' 192 person-to-person spread ofhantavirus infection frotn source patients has not occurred in health-care facilities. 19,_ 195 Nevertheless, health-care workers are advised to contain potentially infectious aerosols and wear National Institute of Occupational Safety and Health (NIOSH) approved respirat01y protection when working with this agent in laboratories or autopsy suites. 196 Lassa virus transmission via aerosols has been demonstrated in the laborat01y and incriminated in health-care-associated infections in Africa, 19,_ 199 but airborne spread of this agent in hospitals in developed nations likely is inefficient. 200• 201 Yellow fever is considered to be a viral hemorrhagic fever agent with high aerosol infectivity potential, but health-care-associated transmission of this virus has not been described. 202 Viral hemorrhagic fever diseases primarily occur after direct exposure to infected blood and body fluids, and the use of standard and droplet precautions prevents transmission early in the course of these illnesses. 203 • 204 However, whether these viruses can persist in droplet nuclei that might remain after droplet production from coughs or vomiting in the latter stages of illness is unknown. 205 Although the use of a negative-pressure room is not required during the early stages of illness, its use might be prudent at the time of hospitalization to avoid the need for subsequent patient transfer. Current CDC guidelines recommend negative-pressure rooms with anterooms for patients with hemorrhagic fever and use ofHEPA respirators by persons entering these rooms when the patient has prominent cough, vomiting, diarrhea, or hemorrhage.'· 203 Face shields or goggles will help to prevent mucous-membrane exposure to potentially-aerosolized infectious material in these situations. If an anteroom is not available, portable, industrial-grade high efficiency particulate air (HEPA) filter units can be used to provide the equivalent of additional air changes per hour (ACH). 13

Table 4. Microorganisms associated with airborne transmission* Fungi Bact~rin Virus~s Measle~ (rubeoJa) virus ~·IIV 10 Numet·ous reports Aspergillus spp.+ MyC'obacterium in henlth-cnrt> Mucorales (Rhizopus spp.) 91• 115 tuberculosis+ VmiceHn-zoster vims 162•166 fnclllfios Atypical, Acrem_onitml ·"f£· 1 "'"· ~v" Acinqtobacter w~- IQI Smallpox vims (variola)§ 111ll' Ill'>' ocrnstonnlreports Fusarmm "'PP· Bacillus spp.~ 1 '"07 Influenza vimses 181 • 162 Pseudoal/escheria bo}'dii100 Brucella spp.** 20S-2tt RespirfttOJy syncytinl vin1s 183 Scedosporimn spp. 116 Staphvlococcus aureus 148• 156 Adenovimses 134 Sporothrix cyanesceJJS~ 118 GrouP A Sh·eptococcus 151 Nonvalk-li.ke \'i.ttts185 Airbol'ne in nature; Coccidioides inunitisw Coxiella bumetii (Q fever) Hautavimses flirboruP OJpfococctts spp. m Lns!.a viruo; ~ 05 transmi~sion in Histoplasma capsulatum 114 Marburg virus 20 ~ lt0nlth rare st>ttings Ebola vints 205 Crimean-Congo virm.205 not desrl'ibE'd Under invE'stigatiou Pmmmocystis cminii • Tius hst excludes nucroorgamsms transmuted from aerosols dern ed front \\ater . + Refer to the text for references for these di!iesion iucre;~ses with patients who are effechve. disseruinntors present in facilitie.<> with low rel

3. Heating, Ventilation, and Air Conditioning Systems in Healtb-Cat·e Facilities a. B(lsic Components (Ill(/ Opera/ions Heating. ventilntion, and air conditioning (HVAC) systems in health-care facilities are designed to a) maintain the indoor air temperann·e and humidity at comfOJiable levels for staff. patients. and visitors: b) control odors: c) remove contaminated air: d) facilitute air-handling requirements to protect susceptible staff and patients from airbome health-care-associated pathogens; and e) minimize the risk for transmission of airborne pathogens from infected patients. 35• 120 An HVAC system includes an outside air inlet or intake: filters: humidity modification mechanisms (i.e .. humidity control in summer, humidification in winter): heating and cooling equipment; fans; ductwork: air exhaust or out-takes; and registers. diffusers. or grilles for proper distribution of the air (Figure l).m.m Decreased petfonnance of health care facility HVAC systems, filter inefficiencies, improper installation, and poor tmintenance can contribute to the spread of health-care-associated airbome infections.

The American Institute of Architects (AlA) has published guidelines for the design and constmction of new health-care facilities and for renovation of existing facilities. These AlA guidelines address indoor air-qw11ity standards (e.g., ventilation rates, temperanu-e levels, humidity levels, pressure relationships, and minimum air changes per hour [ACH]) specific to each zone or area in health-care facilities (e.g., operating rooms, laboratories, diagnostic areas, patient-care areas. and support deparimellts). 120 TI1ese guidelines represent a consensus document among authorities having jurisdiction (AHJ), govemmental regulatoty agencies (i.e., Depariment of Health and Human Services [DHHS]; Department of Labor, Occupational Safety and Health Administration [OSHA]). health-care professionals. professional organizations (e.g., American Society of Heating. Reti'igeration. and Air-Conditioning Engineers [ASHRAE]. American Society for Healthcare Engineering [ASHE]). and accrediting organizations (i.e., Joint Conunission on Accreditation ofHealthcare Organizations [JCAHO]). More than40 state agencies that license health-care facilities have either incorvorated or adopted by reference these 14

guidelines into their state standards. JCAHO, through its surveys, ensures that facilities are in compliance with the ventilation guidelines of this standard for new construction and renovation.

Figure 1. Diagram of a ventilation system* EXHAUST AIR CONDITIONING () !1-ll'R IJN!1 ,bjR CLCANCR LOCATION f'*'U OVTOOOR -j : f.JR ......_..: : (MAKEIJP AIR) -t ... ; VENTilATING ; ••! AIH AlTFRNP.Tf -~~ RFCJRCUIATFO_t:}~==~ AIR .. I OTHER AIR CLEA.•\lER I I LOC:ATIONS

!{:: :r ,..,..,..y.,.,. CX rllTRAT1 ON EXHAUST..,. GEI\lERAL 1-~~~~==~i~~==·-=-=-=-===. .~~~~- Rt: IIJRN AIR

Outdoor air and recirculated air pass through air cleaners (e.g., ·filter banks) designed to reduce the concentration of airborne contaminants. Air is conditioned tOr temperature and humidity before it enters the occupied space as supply air. Infiltration is air leakage inward through cracks and interstitial spaces of walls, floors, and ceilings. Exfiltration is air leakage outward through these same cracks and spaces. Return air is largely exhausted from the system, but a pmtion is recirculated with fresh, incoming air. * Used with permission of the publisher of reference 214 (ASHRAE) Engineering controls to contain or prevent the spread of airborne contaminants center on a) local exhaust ventilation [i.e., source control], b) general ventilation, and c) air cleaning.' General ventilation encompasses a) dilution and removal of contaminants via well-mixed air distribution of filtered air, b) directing contaminants toward exhaust registers and grilles via uniform, non-mixed airflow patterns, c) pressurization of individual spaces relative to all other spaces, and d) pressurization of buildings relative to the outdoors and other attached bui Idings.

A centralized HVAC system operates as follows. Outdoor air enters the system, where low-efficiency or "roughing" filters remove large particulate matter and many microorganisms. The air enters the distribution system for conditioning to appropriate temperature and humidity levels, passes through an additional bank of filters for further cleaning, and is delivered to each zone of the building. After the conditioned air is distributed to the designated space, it is withdrawn through a return duct system and delivered back to the HVAC unit. A portion of this "return air" is exhausted to the outside while the remainder is mixed with outdoor air for dilution and filtered for removal of contaminants."' Air from toilet rooms or other soiled areas is usually exhausted directly to the atmosphere through a separate duct exhaust system. Air from rooms housing tuberculosis patients is exhausted to the outside if possible, or passed through a HEPA filter before recirculation. Ultraviolet germicidal irradiation (UVGI) can be used as an adjunct air-cleaning measure, but it cannot replace HEPA filtration. 15

b. Filtration i. Filter Types and Methods of Filtmtion Filtration. the physical removal of particulates from air. is the first step in achieving acceptable indoor air quality. Filtration is the primmy means of cleaning the air. Five methods of filtration can be used (Table 5). During filtration, outdoor air passes through two filter beds or banks (with efficiencies of 20%-40% and,::90%. respectively) for effective removal ofpmticles 1-5 pm in diameter. 35• 120 The [ow-to-medimn efficiency filters in the first bank have low resistance to airflow. but this feature allows some small particulates to pass onto heating and air conditioning coils and into the indoor environment. 35 Incoming air is mixed with recirculated air and reconditioned for temperature and humidity before being !1ltered by the second bank of filters. The perfonnm1ce of filters with .:::;90% efficiency is measured using either the dust-spot test or the weight-anestance test. 35 •216

Tnble 5. Filtration methods* Bnsie. m~thod Principle ofperfonnnnce Filtering efficiency Pmiicles in the air are larger than the openings between the Straining Low filter fibers, resulting in gross removal of large particles. Particles collide with filter fibers and remain attached to the Impingement Low tilter. Fibers mav be coated with adhesive. Particles euler into the filter and become entrapped and Interception lvfe

Maintenance costs associated with HEPA filters are high compared with other types of filters. but use of in-line disposable prefilters can increase the life of a HEPA filter by approximately 25%. Altematively, if a disposable prefilter is followed by a filter that is 90% efficient, the life of the HEPA filter can be extended ninefold. This concept, called progressive filtration, allows HEPA filters in special care areas to be used for. 10 years. 213 Although progressive filtering will extend the mechanical ability of the HEPA filter, these filters may absorb chemicals in the environment and later desorb those chemicals, thereby necessitating a more frequent replacement program. HEPA filter efficienc¥ is monitored with the dioctylphthalate (DOP) pmticle test using particles that are 0.3 run in diameter. 18

HEPA filters are usually limned with metal. although some older versions have wood fimnes. A metal fi·ame has no advantage over a properly fitted wood frame with respect to perfonnance, but wood can compromise the air quality if it becomes and remains wet. allowing the growth offtmgi and bactelia. Hospitals are therefore advised to phase out water-dmnaged or spent wood-framed filter units and replace them with metal-framed HEPA filters. 16

HEPA filters are usually fixed into the HV AC system; however, portable, industrial grade HEPA units are available that can filter air at the rate of300-800 ft3/min. Portable HEPA filters are used to a) temporarily recirculate air in rooms with no general ventilation, b) augment systems that cannot provide adequate airflow, and c) provide increased effectiveness in airflow.' Portable HEPA units are useful engineering controls that help clean the air when the central HVAC system is undergoing repairs, 219 but these units do not satisfY fresh-air requirements. 214 The effectiveness of the portable unit for particle removal is dependent on a) the configuration of the room, b) the furniture and persons in the room, c) the placement ofthe units relative to the contents and layout of the room, and d) the location of the supply and exhaust registers ot· grilles. If portable, industrial-grade units are used, they should be capable of recirculating all or nearly all of the room air through the HEPA filter, and the unit should be 3 designed to achieve the equivalent of:::I2 ACH. 4 (An average room has approximately 1,600 ft of airspace.) The hospital engineering department should be contacted to provide ACH information in the event that a portable HEPA filter unit is necessary to augment the existing fixed HVAC system for air cleaning.

ii. Filter Maintenance Efficiency of the filtration system is dependent on the density of the filters, which can create a drop in pressure unless compensated by stronger and more efficient fans, thus maintaining air flow. For optimal performance, filters require monitoring and replacement in accordance with the manufacturer's recommendations and standard preventive maintenance practices. 220 Upon removal, spent filters can be bagged and discarded with the routine solid waste, regardless of their patient-care area location. 221 Excess accumulation of dust and particulates increases filter efficiency, requiring more pressure to push the air through. The pressure differential across filters is measured by use of manometers or other gauges. A pressure reading that exceeds specifications indicates the need to change the filter. Filters also require regular inspection for other potential causes of decreased performance. Gaps in and around filter banks and heavy soil and debris upstream of poorly maintained filters have been implicated in health-care--associated outbreaks of aspergillosis, especially when accompanied by construction activities at the facility. 17 ' 18 ' 106' 222

c. Ultraviolet Germicidal Irradiation (UVGI) As a supplemental air-cleaning measure, UVGI is effective in reducing the transmission of airborne bacterial and viral infections in hospitals, military housing, and classrooms, but it has only a minimal inactivating effect on fungal spores.",_,, UVGI is also used in air handling units to prevent or limit the growth of vegetative bacteria and fungi. Most commercially available UV lamps used for germicidal purposes are low-pressure mercury vapor lamps that emit radiant energy predominantly at a wave-length of253.7 mn. 229• 230 Two systems ofUVGI have been used in health-care settings- duct irradiation and upper-room air irradiation. In duct irradiation systems, UV lamps are placed inside ducts that remove air from rooms to disinfect the air before it is recirculated. When properly designed, installed, and maintained, high levels ofUVGI can be attained in the ducts with little or no exposure of persons in the rooms. 231 • 232 In upper-room air irradiation, UV lamps are either suspended fi·om the ceiling or mounted on the wall! Upper air UVGI units have two basic designs: a) a "pan" fixture with UVGI unshielded above the unit to direct the irradiation upward and b) a fixture with a series of parallel plates to columnize the irradiation outward while preventing the light from getting to the eyes of the room's occupants. The germicidal effect is dependent on air mixing via convection between the room's .trrad'mted upper zone an d th e Iower pat'tent -care zones. 233· 234

Bacterial inactivation studies using BCG mycobacteria and Serratia marcescens have estimated the effect ofUVGI as equivalent to 10 ACH-39 ACH."'· 236 Another study, however, suggests that UVGI may result in fewer equivalent ACH in the patient-care zone, especially if the mixing of air between zones is insufficient. 234 The use of fans or HVAC systems to generate air movement may increase the effectiveness ofUVGI if airborne microorganisms are exposed to the light energy for a sufficient length 17

233 235 237 239 . oft tme. ' ' - Th e opt'tma I re Iat'wnsI.up b et ween ventt'I atton . an d UVGI.ts not known.

Because the clinical effectiveness ofUV systems may vary, UVGI is not recommended for air management prior to air recirculation from airborne isolation rooms. It is also not recommended as a substitute for HEPA filtration, local exhaust of air to the outside, or negative pressure.< The use ofUV lamps and HEPA filtration in a single unit offers only minimal infection-control benefits over those provided by the use of a HEPA filter alone. 240 Duct systems with UVGI are not recommended as a substitute for HEPA filters if the air from isolation rooms must be recirculated to other areas of the facility_< Regular maintenance ofUVGI systems is crucial and usually consists of keeping the bulbs free of dust and replacing old bulbs as necessary. Safety issues associated with the use ofUVGI systems are described in other guidelines.<

d. Conditioned Air in Occupied Spaces Temperature and humidity are two essential components of conditioned air. After outside air passes through a low- or medium-efficiency filter, the air undergoes conditioning for temperature and humidity contro I before it passes through high-efficiency or HEP A filtration.

i. Temperature HVAC systems in health-care facilities are often single-duct or dual-duct systems."· 241 A single-duct system distributes cooled air (55°F [12.8°C]) throughout the building and uses theJmostatically controlled reheat boxes located in the terminal ductwork to warm the air for individual or multiple rooms. The dual-duct system consists of parallel ducts, one with a cold air stream and the other with a hot air stream. A mixing box in each room or group of rooms mixes the two air streams to achieve the desired temperature. Temperature standards are given as either a single temperature or a range, depending on the specific health-care zone. Cool temperature standards (68°F-73°F [20°C-23°C]) usually are associated with operating rooms, clean workrooms, and endoscopy suites. 120 A warmer temperature (75°F [24°C]) is needed in areas requiring greater degrees of patient comfort. Most other zones use a temperature range of 70°F-75°F (21 °C-24°C). 120 Temperatures outside of these ranges may be needed occasionally in limited areas depending on individual circumstances during patient care (e.g., cooler temperatures in operating rooms during specialized operations).

ii. Humidity Four measures of humidity are used to quantifY different physical properties of the mixture of water vapor and air. The most common of these is relative humidity, which is the ratio of the amount of water vapor in the air to the amount of water vapor air can hold at that temperature. 242 The other measures of humidity are specific humidity, dew point, and vapor pressme. 242

Relative humidity measures the percentage of satmation. At I 00% relative humidity, the air is satmated. For most areas within health-care facilities, the designated comfort range is 30o/.-60% relative humidity. 120• 214 Relative humidity levels >60%, in addition to being perceived as uncomfortable, promote fungal growth. 243 Humidity levels can be manipulated by either of two mechanisms. 244 In a water-wash unit, water is sprayed and drops are taken up by the filtered air; additional heating or cooling of this air sets the humidity levels. The second mechanism is by means of water vapor created from steam and added to filtered air in humidifYing boxes. Reservoir-type humidifiers are not allowed in health-care facilities as per AlA guidelines and many state codes. 120 Cool-mist humidifiers should be avoided, because they can disseminate aerosols containing allergens and microorganisms. 245 Additionally, the small, personal-use ve1~ions of this equipment can be difficult to clean. 18

iii. Ventilation The control of air pollutants (e.g., microorganisms, dust, chemicals, and smoke) at the source is the most effective way to maintain clean air. The second most effective means of controlling indoor air pollution is through ventilation. Ventilation rates are voluntaty unless a state or local government specifies a standard in health-care licensing or health department requirements. These standards typically apply to only the design of a facility, rather than its operation. 220' 246 Health-care facilities without specific ventilation standards should follow the AlA guideline specific to the year in which the building was built or the ANSIIASHRAE Standard 62, Ventilation for Acceptable Indoor Air Quality. 120• 214· 241

Ventilation guidelines are defined in terms of air volume per minute per occupant and are based on the assumption that occupants and their activities are responsible for most of the contaminants in the conditioned space. 215 Most ventilation rates for health-care facilities are expressed as room ACH. Peak efficiency for particle removal in the air space occurs between 12 ACH-15 ACH. 35• 247 •248 Ventilation rates vaty among the different patient-care areas of a health-care facility (Appendix B). 120 120 ° Health-care facilities generally use recirculated air. 35 ' ' 241 · 249· 25 Fans create sufficient positive pressure to force air through the bt1ilding duct work and adequate negative pressure to evacuate air fi·om the conditioned space into the return duct work and/or exhaust, thereby completing the circuit in a sealed system (Figure 1). However, because gaseous contaminants tend to accumulate as the air recirculates, a percentage of the recirculated air is exhausted to the outside and replaced by fresh outdoor air. In hospitals, the delivety of filtered air to an occupied space is an engineered system design issue, the full discussion of which is beyond the scope of this document.

Hospitals with areas not served by central HVAC systems often use through-the-wall or fan coil air conditioning units as the sole source of room ventilation. AlA guidelines for newly installed systems stipulate that through-the-wall fan-coil units be equipped with permanent (i.e., cleanable) or replaceable filters with a minimum efficiency of 68% weight arrestance. 120 These units may be used only as recirculating units; all outdoor air requirements must be met by a separate central air handling system with proper filtration, with a minimum of two outside air changes in general patient rooms (D. Erickson, ASHE, 2000). 120 If a patient room is equipped with an individual through-the-wall fan coil unit, the room should not be used as either All or as PE. 120 These requirements, although directed to new HVAC installations also are appropriate for existing settings. Non-central air-handling systems are prone to problems associated with excess condensation accumulating in drip pans and improper filter maintenance; health-care facilities should clean or replace the filters in these units on a regular basis while the patient is out of the room.

Laminar airflow ventilation systems are designed to move air in a single pass, usually through a bank of HEPA filters either along a wall or in the ceiling, in a one-way direction through a clean zone with parallel streamlines. Laminar airflow can be directed vertically or horizontally; the unidirectional system optimizes airflow and minimizes air turbulence. 63 • 241 Delive1y of air at a rate ofO.S meters per second (90 ±20ft/min) helps to minimize oppmiunities for microorganism proliferation. 63 • 251 · 252 Laminar airflow systems have been used in PE to help reduce the risk for health-care--associated airborne infections (e.g., aspergillosis) in high-risk patients. 63 ' "· 253 · 254 However, data that demonstrate a survival benefit for patients in PE with laminar airflow are lacking. Given the high cost of installation and apparent lack of benefit, the value oflaminar airflow in this setting is questionable?-" Few data suppoli the use oflaminar airflow systems elsewhere in a hospital. 255

iv. Pressurization Positive and negative pressures refer to a pressure differential between two adjacent air spaces (e.g., rooms and hallways). Air flows away from areas or rooms with positive pressure (pressurized), while 19

air flows into areas with negative pressure (depressurized). Ali rooms are set at negative pressure to prevent airbome microorganisms in the room from entering hallways and corridors. PE rooms housing severely neutropenic patients are set at positive pressure to keep airbome pathogens in adjacent spaces or corridors from coming into and contaminating the airspace occupied by such high-risk patients. Self- closing doors are mandatory for both of these areas to help maintain the con·ect pressure differential 4 · 6· 120 Older health-care tacilities may have variable pressure rooms (i.e .. rooms in which the ventilation can be manually switched between positive and negative pressure). These rooms are no longer pennitted in the constmction of new facilities or in renovated areas of the tacility, 110 and their use in existing facilities has been discomaged because of difficulties in assuring the proper pressure differential, especially for the negative pressure setting, and because of the potential for enor associated with switching the pressure differentials for the room Continuecl use of existing vmiable pressure rooms depends on a partnership between engineering and infection control. Both positive- and negative-pressure rooms should be maintained according to specific engineering specifications (Table 6).

Table 6. Engineered specifications for positive- nnd negative pressure rooms* PositiV(I-}>l'f:\SSUl'(> nrens (e.g., Negative pre-sslll'(> l:ll'PilS (e.g., prot{'rti\'e NlViromnf.'nts [PE]) nirborne infe-ction isolation [All]) Pt·essm·p diffe-r(>ntinls > +2.5 Pa§ (0.01'' water gauge) > ~2.5 Pn (0.01" watt:1· 2auge) Air changes f>H hour (ACH) >12 >12 (for renovation or new comhllCtion) Supply: 99.97%@ 0.3 ~1m DO-p4J Supply: 90'V<> (dtlsf spot test) Filtration efficiency Return: none requited** Reh.m1: 99.97% tffi 0.3 ~un DOFf; t Room nil'flow dh'E'rtion Out to the n£lj11cent area In lo the room Clean-to-dil'ty airflow in Away from the patient (higlNisk patient, Towards the patient (airbome disease room immunosuppressed pntieni) patient) Ideo! pressure differential >+8 Pa > ~ 2.5 Pa * Mntenolul dus 1able WU.'> compded from references 3 5 and 120. Table l'ldapted from and used ·w1th penmssJOll of the pubhsber of reference 35 (Lippincott Williams and Wilkins)- § Pais the abbreviation for Pascal, a metric unit ofmeas:urement for pressure ba-"Sed on air velocity; 250 Pa equals 1.0 inch water- gauge. ~ DOP is the nbbtt'vintiou for dloctylphth<~lnte pnttides o£0.3 11111 diameter. ** If the patient requires both PE and Ali, ret\lm air should be HEPA-filtered or otherwise exhausted to the outside, t HEPA filtration of exhaust air from All rooms shmdd uot be required, providing that the exhaust is properly located to prevent re-entry into the building.

Health-care professionals (e.g., infection control, hospital epidemiologists) must pe1fonn a risk assessment to determine the appropriate number of Ail rooms (negative pressme) and/or PE rooms (positive pressme) to serve the patient population. The AlA guidelines require a ce11ainnumber of Ail rooms as a minimum, and it is important to refer to tile edition under which the building was built for appropriate guidance. 120

In large heallh-care facilities with central HVAC systems, sealed windows help to ensure the efficient operation of the system, especially with respect to creating and maintaining pressure differentials. Sealing the windows in PE areas helps minimize the risk of airbome contamination from the outside. One outbreak of aspergillosis among innnmtosuppressed patients in a hospital was attributed in part to an open window in the 1mit during a time when both comlmction and a fire happened nearby; sealing the window prevented further ently of ftmgal spores into the lUlit from the outside air. 111 Additionally. all emergency exits (e.g .. fire escapes and emergency doors) in PE wards should be kept closed (except during emergencies) and equipped with almms.

e. llifecllon Control Impact of HVA C S)'Siem Malnlellance a11d Repair A failure or malfunction of any component of the HVAC system may subject patients and staff to cliscomfort and exposure to airbome contaminants. Only limited infonnation is available fi·om fonual 20

studies on the infection-control implications of a complete air-handling system failure or shutdown for maintenance. Most experience has been derived from infectious disease outbreaks and adverse outcomes among high-risk patients when HVAC systems are poorly maintained. (See Table 7 for potential ventilation hazards, consequences, and correction measures.)

AlA guidelines prohibit U.S. hospitals and surgical centers from shutting down their HVAC systems for purposes other than required maintenance, filter changes, and construction.'" Airflow can be reduced; however, sufficient supply, return, and exhaust rnust be provided to maintain required pressure relationships when the space is not occupied. Maintaining these relationships can be accomplished with special drives on the air-handling units (i.e., a variable air ventilation [VAV] system).

Microorganisms proliferate in environments wherever air, dust, and water are present, and air-handling systems can be ideal environments for microbial growth." Properly engineered HVAC systems require routine maintenance and monitoring to provide acceptable indoor air quality efficiently and to minimize conditions that favor the proliferation of health-care-associated pathogens.35 • 249 Performance monitoring of the system includes determining pressure differentials across filters, regular inspection of system filters, DOP testing ofHEPA filters, testing of low- or medium efficiency filters, and manometer tests for positive- and negative-pressure areas in accordance with nationally recognized standards, guidelines, and manufacturers' recommendations. The use of hand-held, calibrated equipment that can provide a numerical reading on a daily basis is preferred for engineering purposes (A.Streifel, University of Minnesota, 2000). 256 Several methods that provide a visual, qualitative measure of pressure differentials (i.e., airflow direction) include smoke-tube tests or placing flutter strips, ping-pong balls, or tissue in the air stream.

Preventive filter and duct maintenance (e.g., cleaning ductwork vents, replacing filters as needed, and properly disposing spent filters into plastic bags immediately upon removal) is important to prevent potential exposures of patients and staff dming HVAC system shut-down. The frequency of filter inspection and the parameters of this inspection are established by each facility to meet their unique needs. Ductwork in older health-care facilities may have insulation on the interior surfaces that can trap contaminants. This insulation material tends to break down over time to be discharged from the HVAC system. Additionally, a malfunction of the air-intake system can overburden the filtering system and permit aerosolization of fungal pathogens. Keeping the intakes free from bird droppings, especially those from pigeons, helps to minimize the concentration of fungal spores entering from the outside."

Accumulation of dust and moisture within HVAC systems increases the risk for spread of health-care- associated environmental fungi and bacteria. Clusters of infections caused by Aspergillus spp., P. aeruginosa, S. aureus, and Acinetobacter spp. have been linked to poorly maintained and/or malfunctioning air conditioning systems."·"'·"'·'" Efforts to limit excess humidity and moisture in the infrastructure and on air-stream smfaces in the HVAC system can minimize the proliferation and 262 dispersion of fungal spores and waterborne bacteria throughout indoor air. 25

If moisture is present in the HVAC system, periods of stagnation should be avoided. Bursts of 206 organisms can be released upon system start-up, increasing the risk of airborne infection. Proper engineering of the HVAC system is critical to preventing dispersal of airborne organisms. In one hospital, endophthalmitis caused by Acremonium kiliense infection following cataract extraction in an ambulatory smgical center was traced to aerosols derived from the humidifier water in the ventilation system. 206 The organism proliferated because the ventilation system was turned off routinely when the 21

center was not in operation; the air was filtered before humidification, but not afterwards.

Most health-care facilities have contingency plans in case of disruption of HVAC services. These plans include back-up power generators that maintain the ventilation system in high-risk areas (e.g., operating rooms, intensive~care units, negative- and positive-pressure rooms, transplantation units, and oncology units). Alternative generators are required to engage within 10 seconds of a loss of main power. If the ventilation system is out of service, rendering indoor air stagnant, sufficient time must be allowed to clean the air and re-establish the appropriate number of ACH once the HVAC system begins to function again. Air filters may also need to be changed, because reactivation of the system can dislodge substantial amounts of dust and create a transient burst of fungal spores.

Duct cleaning in health-care facilities has benefits in terms of system performance, but its usefulness for infection control has not been conclusively detennined. Duct cleaning typically involves using specialized tools to dislodge ditt and a high-powered vacuum cleaner to clean out debris. 263 Some duct- cleaning services also apply chemical biocides or sealants to the inside surfaces of ducts to minimize fungal growth and prevent the release ofpatticulate matter. The U.S. Environmental Protection Agency (EPA), however, has concerns with the use ofsanitizers and/or disinfectants to treat the surfaces of ductwork, because the label indications for most of these products may not specifically include the use of the product in HVAC systems. 264 Further, EPA has not evaluated the potency of disinfectants in such applications, nor has the agency examined the potential attendant health and safety risks. The EPA recommends that companies use only those chemical biocides that are registered for use in HVAC systems. 264 Although infrequent cleaning of the exhaust ducts in All areas has been documented as a cause of diminishing negative pressure and a decrease in the air exchange rates,214 no data indicate that duct cleaning, beyond what is recommended for optimal performance, improves indoor air quality or reduces the risk of infection. Exhaust return systems should be cleaned as patt of routine system maintenance. Duct cleaning has not been shown to prevent any health problems, 265 and EPA studies indicate that airborne patticulate levels do not increase as a result of dirty air ducts, nor do they diminish after cleaning, presumably because much of the dirt inside air ducts adheres to duct surfaces and does not enter the conditioned space. 265 Additional research is needed to determine if air-duct contamination can significantly increase the airborne infection risk in general areas of health-care facilities.

4. Construction, Renovation, Remediation, Repair, and Demolition ·a. General Information Environmental disturbances caused by construction and/or renovation and repair activities (e.g., disruption of the above-ceiling area, running cables through the ceiling, and structural repairs) in and near health-care facilities markedly increase the airborne Aspergillus spp. spore counts in the indoor air of such facilities, thereby increasing the risk for health-care-associated aspergillosis among high-risk patients. Although one case of health-care-associated aspergillosis is often difficult to link to a specific environmental exposure, the occurrence of temporarily clustered cases increase the likelihood that an environmental source within the facility may be identified and corrected. 22

Table 7. Ventilation hazards in health-care facilities that may be associated with increased potentinl of airborne disease tmnsmission* Probl•m§ Consequenct>s Possible solutions Water-damaged building materials (18. Water leaks can soak wood, wall board, 1. Replace water-damaged materials. 266) iu!>ulation. wall coYering:s. cdling tiles, 2. IncorporAte fuugistntic compounds and carpeting, All of these materials into building materials in areas at can provide microbial habitat when wet risk for moisture probkms. This is especially tme fo1· fungi growing 3. Test for nll moisture and d1y in le'>s on gypsum board, than 72 homs, Replace if the material cannot dry within 72 hours. Filter bypns;e; (17) Rig.orou<; air filtrntion requires air flow l. Use pressm·e gauges lo ellsure that resistance. Air stream will elude filters are perfonning nt proper filtrntion if opening~ are pre~ent because statk pressure. of tilter damage or poor fit. 2. Make ease of installation and maintenance critetia fol' filter .selection. 3. Properly train maintenance persotmel in HV AC concems, 4. Design system with titters down- stream from fans. 5. Avoid water on fihers or insnlntion. Improper t~n setting (267) AU: must be delivered at design voume 1. Routindy mo11itor air flow nnd to mnintain pressure billnnces. Air flow pressure b-alances tlll'ougboul in special veut rooms reverses. ct1tical parts of HVAC system. 2. Minimize or avoid using rooms that switch between positive and nert,ative presstue. Ductwork disconnections (268) Dislodged or lenky supply duct mns can 1. Design a ductwork system thai is spill into and leaky retnms may draw easy to access, maintain, and repair. from hidden area<,. PJ·e:.surc bnlance 2. Train mainlenance per<>onnel to \Vill be interrupted, and infectiml<> regtllatly monitor air flow volumes mnterial may be disturbed and entmined and pressm·e balances throughout into hospitnl air supply. the sy!.tem. 3. Te'>t critknl areas for appropriate air flow Air flow impedance (213) Debris, '>tmctural failure, or improperly 1. Design and budget for a duct ~ystem adjusted dampers can block duct work that is ea"'y to inspect, maintain, and and prevent designed air fl.O\v, repair. 2. AleJi contmctor<> to liSe caution when working around HVAC' systems during the construction phase. 3. Regularly dean ex.hnust gt"illes. 4. Provide monitoring for special ventilation nreas. Open windows (96, 247) Open windows can alter fan-induced I. Use sealed windows. pressure balance and allow dirty~to~ 2. Design HV AC systems to deliver clean air flow. sufftcient m1tdoor dilution ventilation. 3. Eusm·e that OSHA indoor air qunlity stundnt'ds are met. Dirty window flir conditioners (96, 269) Di.ti, moisture. and bit'd droppings can I. Eliminate such devices it1 plans fo!' contaminate window air conditioners, new consimction. \vhich <:an then introduce infectious 2. Where they must be used, make sure matedal into hospital moms. that they are routinely <:leaned nnd inspected. 23

Pl'oblem§ Cou$equenc"'s Po$sible solutions Inadequate filtration (270) Infectious partides may pass through l. Specify appwprhttc filters dtuing filters into vulnernble p*'ltieut areas. new constmction design pho<>e. 2. Make S.lll't" that HVAC fans are sized t<:> overcome pressure demands of filter system. 3. Inspect :md test filters for proper installation. Mniutenflnce dismption'> (271) F,·m shut~offs 1 dislodged filter cake 1. Budget for a rigorous tnnintenance material contaminates do\nlslream air schedule when designing a fadlity. supply and drain pnns. This may 2. Design system for easy mive condensate, the final filters. tUld drip pnns with stagnant water may 2. Identify 11 means to remove w11ter result from this problem. from the system. 3. Monitor humidity; all dltct take~offs: should be dowmtream of the lnunidifiers. so thai moishll'e is ah!';orbed completely. 4. Use steam humidifiers in the HVAC system.

Duct contmnination (18, 272) Debris is released during maintenance 1. Provide point~of~use filtration in the or cleaning. critical at'eas. 2. Design nir~lmndling i:oystems with insulation of the exterior of the ducts. 3. Do not use fibrous smmd atteunators. 4. Decontaminate or encap-:.ulate contaminfliion.

• Rep-outed wnh peruuss10n of the pubhsher of reference 35 (Ltppmcott W.Utams iUld Wtlkim) . § Numbers in pMenlheses are reffieJtce citalion.o;.

Constmction, renovation. repair, and demolition activities in health-care facilities require substantial planning and coordination to minimize the risk for airbome infection both dming projects and after their completion. Several organizations and experts have endorsed a nmlti-disciplinary team approach (Box 4) to coordinate the various stages of constmction activities (e.~.. project inception, project implementation. final walk-through. and completion)l 20• 249 •250 · 73- 276 Environmental services, employee health, engineering. and infection conn·olmust be represented in constmction planning and design meetings should be convened with architects and design engineers. The number of members and disciplines represented is a function of the complexity of a project. Smaller, less complex projects and maintenance may require a minimal number of members beyond the core representation fi·om engineering, infection control, environmental services, and the directors of the specialized departments. 24

Box 4. Suggested members and functions of a multi-disciplinary coordination team for construction, renovation, repair, and demolition projects

Members

Infection-control personnel, including hospital epidemiologists Laboratory personnel Facility administrators or their designated representatives, facility managers Director of engineering Risk-management personnel Directors of specialized programs (e.g., transplantation, oncology and ICU* programs) Employee safety personnel, industrial hygienists, and regulatory affairs personnel Environmental services personnel Information systems personnel Construction administrators or their designated representatives Architects, design engineers, project managers, and contractors

Functions and responsibilities

Coordinate members' input in developing a comprehensive project management plan. Conduct a risk assessment of the project to determine potential hazards to susceptible patients. Prevent unnecessary exposures of patients, visitors, and staff to infectious agents. Oversee all infection-control aspects of construction activities. Establish site-specific infection-control protocols for specialized areas. Provide education about the infection-control impact of construction to staff and construction workers. Ensure compliance with technical standards, contract provisions, and regulations. Establish a mechanism to address and correct problems quickly. Develop contingency plans for emergency response to power failures, water supply disruptions, and fires. Provide a water-damage management plan (including drying protocols) for handling water intrusion from floods, leaks, and condensation. Develop a plan for structural maintenance.

* JCU is intensive care unit

Education of maintenance and construction workers, health-care staff caring for high-risk patients, and persons responsible for controlling indoor air quality heightens awareness that minimizing dust and moisture intrusion from construction sites into high-risk patient-care areas helps to maintain a safe environment. 120• 250• 271 • 27 >-278 Visual and printed educational materials should be provided in the language spoken by the workers. Staff and construction workers also need to be aware of the potentially catastrophic consequences of dust and moisture intrusion when an HVAC system or water system fails during construction or repair; action plans to deal quickly with these emergencies should be developed in advance and kept on file. Incorporation of specific standards into construction contracts may help to prevent depattures from recommended practices as projects progress. Establishing specific lines of communication is impo1tant to address problems (e.g., dust control, indoor air quality, noise levels, and vibrations), resolve complaints, and keep projects moving toward completion. Health-care facility staff should develop a mechanism to monitor worker adherence to infection-control guidelines on a daily basis in and around the constmction site for the duration of the project. 25

b. Preliminary Considerations The three major topics to consider before initiating any construction or repair activity are as follows: a) design and function of the new structure or area, b) assessment of environmental risks for airborne disease and opportunities for prevention, and c) measures to contain dust and moisture during construction or repairs. A checklist of design and function considerations can help to ensure that a planned structure or area can be easily serviced and maintained for environmental infection control (Box 5) . 17· 250· 273 ' 275-277 spect'fiteat'tons ~10r th e cons tructton, . renovat'ton, remo de1'mg, an d mamtenance . of health-care facilities are outlined in the AlA document, Guidelines for Design and Construction of Hospitals and Health Care Faci/ities. 120• 275

Box 5. Construction design and function considerations for environmental infection control

Location of sinks and dispensers for band washing products and hand hygiene products Types offaucets (e.g., aerated vs. non-aerated) Air~handling systems engineered for optimal performance, easy maintenance, and repair ACH and pressure differentials to accommodate special patient-care areas Location of fixed sharps containers Types of surface finishes (e.g., porous vs. non-porous) Well-caulked walls with minimal seams Location of adequate storage and supply areas Appropriate location of medicine preparations areas (e.g.,z::3 ft. from a sink) Appropriate location and type of ice machines (e.g., preferably ice dispensers rather than ice bins) Appropriate materials for sinks and wall coverings Appropriate traffic flow (e.g., no "dirty" movement through "clean" areas) Isolation rooms with anterooms as appropriate Appropriate flooring (e.g., seamless floors in dialysis units) Sensible use carpeting (e.g., avoiding use of carpeting in special care areas or areas likely to become wet)* Convenient location of soiled utility areas Properly engineered areas for linen services and solid waste management Location of main generator to minimize the risk of system failure from flooding or other emergency Installation guidelines for sheetrock

* Use of carpet cleaning methods (e,g., "bonneting") that disperse microorganisms into the air may increase the risk of airborne infection among at-risk patients, especially if they are in the vicinity of the cleaning activity. 111

Proactive strategies can help prevent environmentally mediated airborne infections in health-care facilities during demolition, construction, and renovation. The potential presence of dust and moisture and their contribution to health-care-associated infections must be critically evaluated early in the planning of any demolition, construction, renovation, and repairs. 120• 250 • 251 • 273 ' 274• 276--279 Consideration must extend beyond dust generated by majo1· projects to include dust that can become airborne if disturbed during routine maintenance and minor renovation activities (e.g., exposure of ceiling spaces for inspection; installation of conduits, cable, or sprinkler systems; rewiring; and structural repairs or replacement). 273 • 276' 277 Other projects that can compromise indoor air quality include construction and repair jobs that inadvertently allow substantial amounts of raw, unfiltered outdoor air to enter the facility (e.g., repair of elevators and elevator shafts) and activities that dampen any structure, area, or item made of porous materials or characterized by cracks and crevices (e.g., sink cabinets in need of repair, carpets, 273 ceilings, floors, walls, vinyl wall coverings, upholstery, drapes, and countertops). 18' • 277 Molds grow 21 120 250 266 270 272 280 and proliferate on these surfaces when they become and remain wet • • • • • • Scrubbable 26

materials are preferred for use in patient-care areas.

Containment measures for dust and/or moisture control are dictated by the location of the construction site. Outdoor demolition and construction require actions to keep dust and moisture out of the facility (e.g., sealing windows and vents and keeping doors closed or sealed). Containment of dust and moisture generated from construction inside a facility requires batTier structures (either pre-fabricated ot· constructed of more durable materials as needed) and engineering controls to clean the air in and around the construction or repair site.

c. Infection-Control Risk Assessment An infection-control risk assessment (ICRA) conducted before initiating repairs, demolition, construction, or renovation activities can identifY potential exposures of susceptible patients to dust and moisture and determine the need for dust and moisture containment measures. This assessment centers on the type and extent of the construction or repairs in the work area but may also need to include adjacent patient-care areas, supply storage, and areas on levels above and below the proposed project. An example of designing an !CRA as a matrix, the policy for petforming an ICRA and implementing its results, and a sample permit form that streamlines the communication process are available. 281 Knowledge of the air flow patterns and pressure differentials helps minimize or eliminate the .tnadvertent d'tsperston . ofd ust that cou ld contammate . . space, patient-care an· . .ttems, an d surtaces. ' 57 282 283 ' · A recent aspergillosis outbreak among oncology patients was attributed to depressurization of the building housing the HSCT unit while construction was underway in an adjacent building. Pressure readings in the affected building (including 12 of25 HSCT-patient rooms) ranged from 0.1 Pa-5.8 Pa. Unfiltered outdoor air flowed into the building through doors and windows, exposing patients in the HSCT unit to fungal spores. 283 During long-term projects, providing temporaty essential services (e.g., toilet facilities) and conveniences (e.g., vending machines) to construction workers within the site will help to minimize traffic in and out of the area. The type of barrier systems necessaty for the scope of the project must be defined."· 120' 250• 279' 284

Depending on the location and extent of the construction, patients may need to be relocated to other areas in the facility not affected by construction dust. 51· 285 Such relocation might be especially prudent when construction takes place within units housing immunocompromised patients (e.g., severely neutropenic patients and patients on corticosteroid therapy). Advance assessment of high-risk locations and planning for the possible transport of patients to other depattments can minimize delays and waiting time in hallways. 51 Although hospitals have provided immunocompromised patients with some fonn of respiratory protection for use outside their rooms, the issue is complex and remains unresolved until more research can be done. Previous guidance on this issue has been inconsistent.' Protective respirators (i.e., N95) were well tolerated by patients when used to prevent fmther cases of construction- related aspergillosis in a recent outbreak. 283 The routine use of the N95 respirator by patients, however, has not been evaluated for preventing exposure to fungal spores during periods of non-construction. Although health-care workers who would be using the N95 respirator for personal respiratmy protect must be fit-tested, there is no indication that either patients or visitors should undergo fit-testing. 3 20 286 Surveillance activities should augment preventive strategies during construction projects. • 4 • • 110• • 287 By determining baseline levels of health-care--acquired airborne and waterborne infections, infection- control staff can monitor changes in infection rates and patterns during and immediately after construction, renovations, or repairs. 3

d. Air Sampling Air sampling in health-care facilities may be conducted both during periods of construction and on a periodic basis to determine indoor air quality, efficacy of dust-control measures, or air-handling system performance via parametric monitoring. Parametric monitoring consists of measuring the physical 27

performance of the HVAC system in accordance with the system manufacturer's specifications. A periodic assessment of the system (e.g., air flow direction and pressure, ACH, and filter efficiency) can give assurance of proper ventilation, especiaJly for special care areas and operating rooms. 288

Air sampling is used to detect aerosols (i.e., particles or microorganisms). Particulate sampling (i.e., total numbers and size range of particulates) is a practical method for evaluating the infection-control performance of the HVAC system, with an emphasis on filter efficiency in removing respirable particles (<5 flm in diameter) or larger patticles from the air. Particle size is reported in terms of the mass median aerodynamic diameter (MMAD), whereas count median aerodynamic diameter (CMAD) is useful with respect to particle concentrations.

Patticle counts in a given air space within the health-care facility should be evaluated against counts obtained in a comparison area. Particle counts indoors are commonly compared with the particulate levels of the outdoor air. This approach determines the "rank order" air quality from "dirty" (i.e., the outdoor air) to "clean" (i.e., air filtered through high-efficiency filters [90%-95% filtration]) to "cleanest" (i.e., HEPA-filtered air). 288 Comparisons fi·om one indoor area to another may also provide useful information about the magnitude of an indoor air-quality problem. Making rank-order comparisons between clean, highly-filtered areas and dirty areas and/or outdoors is one way to interpret sampling results in the absence of air quality and action level standards."· 289

In addition to verifYing filter performance, particle counts can help determine if barriers and effotts to control dust dispersion from construction are effective. This type of monitoring is helpful when performed at various times and barrier perimeter locations during the project. Gaps or breaks in the barriers' joints or seals can then be identified and repaired. The American Conference of Governmental Industrial Hygienists (ACGJH) has set a threshold limit value-time weighted average (TLV®-TWA) of I 0 mg/m3 for nuisance dust that contains no asbestos and

Patticle counters and anemometers are used.in particulate evaluation. The anemometer measures air flow velocity, which can be used to determine sample volumes. Patticulate sampling usually does not require microbiology Jaboratoty services for the reporting of results.

Microbiologic sampling of air in health-care facilities remains controversial because of currently unresolved technical limitations and the need for substantiallaboratoty support (Box 6). Infection- control professionals, laboratorians, and engineers should determine if microbiologic and/or particle sampling is warranted and assess proposed methods for sampling. The most significant technical limitation of air sampling for airborne fungal agents is the lack of standards linking fungal spore levels with infection rates. Despite this limitation, several health-care institutions have opted to use microbiologic sampling when construction projects are anticipated and/or underway in efforts to assess the safety of the environment for immunocompromised patients."· 289 Microbiologic air sampling should be limited to assays for airborne fungi; of those, the thermotolerant fungi (i.e., those capable of growing at 95°F-98.6°F [35°C-37°C]) are of particular concem because oftheir pathogenicity in immunocompromised hosts. 35 Use of selective media (e.g., Sabouraud dextrose agar and inhibitoty mold agar) helps with the initial identification of recovered organisms.

Microbiologic sampling for fungal spores performed as patt of various airborne disease outbreak 28

investigations has also been problematic18• 4 '· 106 • 111 • 112• 289 The precise source of a fungus is often difficult to trace with certainty, and sampling conducted after exposure may neither reflect the circumstances that were linked to infection nor distinguish between health-care-acquired and community-acquired infections. Because fungal strains may fluctuate rapidly in the environment, health-care-acquired Aspergillus spp. infection cannot be confirmed or excluded if the infecting strain is not found in the health-care setting. 287 Sensitive molecular typing methods (e.g., randomly amplified polymorphic DNA (RAPD) techniques and a more recent DNA fingerprinting technique that detects restriction fragment length polymorphisms in fungal genomic DNA) to identify strain differences among Aspergillus spp., however, are becoming increasingly used in epidemiologic investigations of health-care-acquired fungal infection (A.Streifel, University of Minnesota, 2000). 68 • 110• 286• 287• 292- 296 During case cluster evaluation, microbiologic sampling may provide an isolate from the environment for molecular typing and comparison with patient isolates. Therefore, it may be prudent for the clinical laboratory to save Aspergillus spp. isolated from colonizations and invasive disease cases among patients in PE, oncology, and transplant services for these purposes.

Box 6. Unresolved issues associated with microbiologic air sampling*

Lack of standards linking fungal spore levels with infection rates (i.e., no safe level of exposure) Lacl{ of standard protocols for testing (e.g., sampling intervals, number of samples, sampling locations) Need for substantial laboratory support Culture issues (e.g., false negatives, insensitivity, lag time between sampling and recording the results) New, complex polymerase chain reaction (PCR) analytical methods Unknown incubation period for Aspergillus spp. infection Variability of sampler readings Sensitivity of the sampler used (i.e., the volumes of air sampled) Lack of details in the literature about describing sampling circumstances (e.g., unoccupied rooms vs. ongoing activities in rooms, expected fungal concentrations, and rate of outdoor air penetration) Lack of correlation between fungal species and strains from the environment and clinical specimens Confounding variables with high-risk patients (e.g., visitors and time spent outside of protective environment [PE] without respiratory protection) Need for determination of ideal temperature for incubating fungal cultures (95°F [35°C] is the most commonly used temperature)

* Material in this box is compiled from references 35, 100;222, 289, and 297.

Sedimentation methods using settle plates and volumetric sampling methods using solid impactors are commonly employed when sampling air for bacteria and fungi. Settle plates have been used by numerous investigators to detect airborne bacteria or to measure air quality during medical procedures (e.g., surgery). 17• 60• 97• 151 • 161 • 287 Settle plates, because they rely on gravity during sampling, tend to select for larger particles and lack sensitivity for respirable particles (e.g., individual fungal spores), especially in highly-filtered environments. Therefore, they are considered impractical for general use. 35• 289 29 301 • 1!- Settle plates, however, may detect fungi aerosolized during medical procedures (e.g., during wound dressing changes), as described in a recent outbreak of aspergillosis among liver transplant patients. 302

The use of slit or sieve impactor samplers capable of collecting large volumes of air in shott periods of 35 289 time are needed to detect low numbers of fungal spores in highly filtered areas. ' In some 29

outbreaks, aspergillosis cases have occurred when fungal spore concentrations in PE ambient air ranged as low as 0.9-2.2 colony-forming units per cubic meter (CFU/m3) ofair. 18 • 94 On the basis of the expected spore counts in the ambient air and the performance parameters of various types of volumetric air samplers, investigators of a recent aspergillosis outbreak have suggested that an air volume of at least I 000 L (I m3) should be considered when sampling highly filtered areas. 283 Investigators have also suggested limits of IS CFU/m 3 for gross colony counts of fungal organisms and <0.1 CFU/m3 for Aspergillusfumigatus and other potentially opportunistic fungi in heavily filtered areas (2:12 ACH and filtration of?;99.97% efficiency). 120 No correlation of these values with the incidence of health-care- associated fungal infection rates has been repotted.

Air sampling in health-care facilities, whether used to monitor air quality during construction, to verity filter efficiency, or to commission new space prior to occupancy, requires careful notation of the circumstances of sampling. Most air sampling is performed under undisturbed conditions. However, when the air is sampled during or after human activity (e.g., walking and vacuuming), a higher number of airborne microorganisms likely is detected. 297 The contribution of human activity to the significance of air sampling and its impact on health-care-associated infection rates remain to be defined. Comparing microbiologic sampling results fi·om a target area (e.g., an area of construction) to those from an unaffected location in the facility can provide information about distribution and concentration of potential airborne pathogens. A comparison of microbial species densities in outdoor air versus indoor air has been used to help pinpoint fungal spore bursts. Fungal spore densities in outdoor air are variable, although the degree of variation with the seasons appears to be more dramatic in the United States than in Europe."· 287' 303

Patticulate and microbiologic air sampling have been used when commissioning new HVAC system installations; however, such sampling is patticularly impmtant for newly constructed or renovated PE or operating rooms. Particulate sampling is used as part of a battery of tests to determine if a new HVAC 268 288 system is performing to specifications for filtration and the proper number of ACH. • • 304 Microbiologic air sampling, however, remains controversial in this application, because no standards for comparison purposes have been determined. If performed, sampling should be limited to determining the density of fungal spores per unit volume of air space. High numbers of spores may indicate contamination of air-handling system components prior to installation or a system deficiency when culture results are compared with known filter efficiencies and rates of air exchange.

e. External Demolition and Construction External demolition, planned building implosions, and ditt excavation generate considerable dust and debris that can contain airborne microorganisms. In one study, peak concentrations in outdoor air at grade level and HVAC intakes during site excavation averaged 20,000 CFU/m3 for all fungi and 500 CFU/m 3 for Aspergil/usfitmigatus, compared with 19 CFU/m3 and 4 CFU/m3 , respectively, in the absence of constmction. 280 Many health-care institutions are located in large, urban areas; building implosions are becoming a more frequent concern. Infection-control risk assessment teams, patticularly those in facilities located in urban renewal areas, would benefit by developing risk management strategies for external demolition and construction as a standing policy. In light of the events of 11 Septembet· 200 1, it may be necessary for the team to identifY those dust exclusion measures that can be implemented rapidly in response to emergency situations (Table 8). Issues to be reviewed prior to demolition include a) proximity of the air intake system to the wmk site, b) adequacy of window seals and door seals, c) proximity of areas frequented by immunocompromised patients, and d) location of the 120 250 underground utilities (D. Erickson, ASHE, 2000). • • 273 • 276• 277• 280 • 305 30

Table 8. Strategies to reduce dust and moisture intrusion during external demolition and construction

Item Recommendation

Demolition site • Shroud the site if possible to reduce environmental contamination. Dust-generating equipment • Prior to placing dust~generating equipment, evaluate the location to ensure that dust produced by the equipment will not enter the building through open doorways or windows, or through ventilation air intakes. Construction materials storage • Locate this storage away from the facility and ventilation air intakes. Adjacent air intakes • Seal off affected intakes, if possible, or move if funds permit. HVACsystem • Consult with the facility engineer about pressure differentials and air recirculation options; keep facility air pressure positive to outside air. Filters • Ensure that filters are properly installed; change roughing filters frequently to prevent dust build-up on high-efficiency filters. Windows • Seal and caull{ to prevent entry of airborne fungal spores. Doors • Keep closed as much as possible; do not prop open; seal and caulk unused doors (i.e., those that are not designated as emergency exits); use mats with tacl{y surfaces at outside entrances. Water utilities • Note location relative to construction area to prevent intrusion of dust into water systems.* Medical gas piping • Ensure that these lines/pipes are insulated during periods of vibration. Rooftops • Temporarily close off during active demolition/construction those rooftop areas that are normally open to the public (e.g., rooftop atrium). Dust generation • Provide methods (e.g., misting the area with water) to minimize dust. Immunocompromised patients • Use wal1{-ways protected from demolition/construction sites; avoid outside areas close to these sites; avoid rooftops. Pedestrian traffic • Close off entry ways as needed to minimize dust intrusion. Truck traffic • Reroute if possible, or arrange for frequent street cleaning. Education and awareness+ • Encourage reporting of hazardous or unsafe incidents associated with construction.

"' Contamination of water pipes during demolition activities has been associated with health-care-associated transmission of Legionella spp. 30s + When health-care facilities have immunosuppressed patients in their census, telephoning the city building department each month to find out if buildings are scheduled for demolition is pmdenl

Minimizing the ent1y of outside dust into the HV AC system is crucial in reducing the risk for airborne contaminants. Facility engineers should be consulted about the potential impact of shutting down the system or increasing the filtration. Selected air handlers, especially those located close to excavation sites, may have to be shut off temporarily to keep from overloading the system with dust and debris. Care is needed to avoid significant facility-wide reductions in pressure differentials that may cause the building to become negatively pressured relative to the outside. To prevent excessive particulate overload and subsequent reductions in effectiveness of intake air systems that cannot be shut off temporarily, air filters must be inspected frequently for proper installation and function. Excessive dust 31

penetration can be avoided if recirculated air is maximally utilized while outdoor air intakes are shut down. Scheduling demolition and excavation during the winter, when Aspergillus spp. spores may be present in lower numbers, can help, although seasonal variations in spore density differ around the 287 303 world."· • Dust control can be managed by misting the dirt and debris during heavy dust- generating activities. To decrease the amount of aerosols from excavation and demolition projects, nearby windows, especially in areas housing immunocompromised patients, can be sealed and window and door frames caulked or weather-stripped to prevent dust intrusion 50• 301 • 306 Monitoring for adherence to these control measures throughout demolition or excavation ' is crucial. Diverting pedestrian traffic away from the construction sites decreases the amount of dust tracked back into the health-care facility and minimizes exposure of high-risk patients to environmental pathogens. Additionally, closing entrances near construction or demolition sites might be beneficial; if this is not practical, creating an air lock (i.e., pressurizing the entry way) is another option.

f. Internal Demolition, Construction, Renovations, and Repairs The focus of a properly implemented infection-control program during interior construction and repairs is containment of dust and moisture. This objective is achieved by a) educating constroction workers about the impmiance of control measures; b) preparing the site; c) notifYing and issuing advisories for staff, patients, and visitors; d) moving staff and patients and relocating patients as needed; e) issuing standards of practice and precautions during activities and maintenance; f) monitoring for adherence to control measures during construction and providing prompt feedback about lapses in control; g) monitoring HVAC performance; h) implementing daily clean-up, terminal cleaning and removal of debris upon completion; and i) ensuring the integrity of the water system during and after construction. These activities should be coordinated with engineering staff and infection-control professionals.

Physical barriers capable of containing smoke and dust will confine dispersed fungal spores to the 308 constroction zone. 279• 284• 307 • The specific type of physical barrier required depends on the project's scope and duration and on local fire codes. Short-term projects that result in minimal dust dispersion (e.g., installation of new cables OJ' wiring above ceiling tiles) require only portable plastic enclosures with negative pressure and HEPA filtration of the exhaust air from the enclosed work area. The 3 placement of a pmiable industrial-grade HEPA filter device capable of filtration rate of300-800 ft /min. adjacent to the work area will help to remove fungal spores, but its efficacy is dependent on the supplied ACH and size of the area. If the project is extensive but short-term, dust-abatement, fire-resistant plastic curtains (e.g., Visqueen®) may be adequate. These should be completely airtight and sealed from ceiling to floor with overlapping curtains; 276 • 277 • 309 holes, tears, or other perforations should be repaired promptly with tape. A pmiable, industrial-grade HEPA filter unit on continuous operation is needed within the contained area, with the filtered air exhausted to the outside of the work zone. Patients should not remain in the room when dust-generating activities are performed. Tools to assist the decision-making process regarding selection ofbaniers based on an ICRA approach are available. 281

More elaborate barriers are indicated for long-term projects that generate moderate to large amounts of dust. These banier structures typically consist of rigid, noncombustible walls constructed from sheet rock, drywall, plywood, or plaster board and covered with sheet plastic (e.g., Visqueen®). Barrier requirements to prevent the intrusion of dust into patient-care areas include a) installing a plastic dust abatement cmiain before construction of the rigid barrier; b) sealing and taping all joint edges including the top and bottom; c) extending the barrier from floor to floor, which takes into account the space [approximately 2-8ft.] above the finished, lay-down ceiling; and d) fitting or sealing any temporary doors connecting the constroction zone to the adjacent area. (See Box 7 for a list of the various constroction and repair activities that require the use of some type of barrier.) 32

Box 7. Constructiop/repair projects that require barrier structures*

DNnolitiou of walls, wallboard, pin stet·, ceT1lmlc tiles, ceiling tiles, and ceilings Removal of floot'ing illld carpeting, window~ rmd doors, and cnsework Wo1·klug with sinlction in 11 manner thnt mn~' dislodge dust D('molition, l'E'pnir, ot· construction of E'leYntor shafts Repairing water dnmnge

• Material for thi~ box was compiled from references 120,250,273,276, and 277.

Dust and moisture abatement and control rely primarily on the impenneable bmTier containment approach; as constmction continues, numerous opportunities can lead to dispersion of dust to other areas of the health-care facility. Infection-control measures that augment the use of ban1er containment should be undertaken (Table 9).

Dust-control measures for clinical laboratories are an essential part of the infection-control strategy during hospital constmction or renovation. Use of plastic or solid barriers may be needed if the ICRA detennines that air flow from constmction areas may introduce airbome contaminants into the laboratory space. In one facility, pseudofungemia clusters attdbuted to Aspergillus spp. and Penicillium spp. were linked to improper air flow patterns and coustmction projects adjacent to the laboratmy; intmsion of dust and spores into a biological safety cabinet from constmction activity inunediately next to the cabinet resulted in a cluster of cultt1res contaminated with Aspergillus niger. 310• 311 Repottedly, no banier containment was used and the HEPA llltration system was overloaded with dust. In addition. an outbreak ofpseudobacteremia caused by Bacillus spp. occuned in another hospital during constmction above a storage area for blood culttrre bottles.'07 Airbome spread of Bacillus spp. spores resulted in contamination of the bottles' plastic lids. which were not disinfected or handled with proper aseptic technique prior to collection of blood samples.

Table 9. Infection-wntrolmeasures for internal construction and repair projects*+ Infeetiou~control measure Stous for hnul•m•ntntion Prepare for the project. l. Use n lllulti~disciplinnty team approach to incotvomte infection control into the project. 2. Conduct the risk assessment nnd a prelimi.nnry wnlkwthrough with pt'oject mruu12.crs and staff. Educate staff and construction workers. 1. Educate staff and constmction workers about the imp011ance of adheting to infection·control meas11re:. during the project. 2. Provide educational matel'ials in the language of the workers. 3. Indude hmguage in the construction contract requiring constmction workers and subcontnlctors to pmiiciT>ate in infection·control training, Issue hazard nnd wanting notices. !. Post signs to identify constmction areas and potential hazards. 2. Mark delo\Jrs reQuirintt pedestrians to inmid the work area. Relocnte high~risk pntients as ni.!edepiratory equipment (e.g.. a high· efficiencv mask) when outside their PE rooms. Establi<>h altemative traffic pnttems for 1. Determiue npproprintoe altcruate routes from the risk assessment staff. patients, visitors, !lnd cohstruction 2. Designate an~as (e.g .• hallways, elevators, and entranceslex.its) for construction~ workers. worker U'i>e, .l. Do not transport patient"> on the <;nme elevator with cono;,tntction materials and debrk 33

Infection-control measure Steps for implementation Erect appropriate barrier containment. I. Use prefabricated plastic units or plastic sheeting for shmt-tetm projects that will generate minimal dust. 2. Use durable rigid bmTiers for ongoing, Jong-tenn projects. Establish proper ventilation. I. Shut off return air vents in the construction zone, if possible, and seal around grilles. 2. Exhaust air and dust to the outside, if possible. 3. If recirculated air from the construction zone is unavoidable, use a pre--filter and a HEPA filter before the air returns to the HV AC system. 4. When vibration-related work is being done that may dislodge dust in the ventilation system or when modifications are made to ductwork serving occupied spaces, install filters on the supply air grilles temporarily. 5. Set pressure differentials so that the contained work area is under negative pressure. 6. Use air flow monitoring devices to verify the direction of the air pattern. 7. Exhaust air and dust to the outside, if possible. 8. Monitor temperature, air changes per hour (ACH), and humidity levels (humidity levels should be <65%). 9. Use pmiable, industrial grade HEPA filters in the adjacent area and/or the conshuction zone for additional ACH. 10. Keep windows closed, if possible. Control solid debris. I. When replacing filters, place the old filter in a bag prior to transport and dispose as a routine solid waste. 2. Clean the constluction zone daily or more often as needed. 3. Designate a removal route for small quantities of solid debris. 4. Mist debris and cover disposal carts before transport (i.e., leaving the constmction zone). 5. Designate an elevator for construction crew use. 6. Use window chutes and negative pressure equipment for removal oflarger pieces of debris while maintaining pressure differentials in the constmction zone. 7. Schedule debris removal to periods when patient exposures to dust is minimal. Control water damage. 1. Make provisions for dry storage of building materials. 2. Do not install wet, porous building materials (i.e., sheet rock). 3. Replace water-damaged porous building materials if they cannot be completely dried out within 72 hours.

Control dust in air and on surfaces. 1. Monitor the construction area daily for compliance with the infectionRcontrol plan. 2. Protective outer clothing for construction workers should be removed before entering clean areas. 3. Use mats with tacky surfaces within the constmction zone at the entry; cover sufficient area so that both feet make contact with the mat while walking through the entry. 4. Construct an anteroom as needed where coveralls can be donned and removed. 5. Clean the consbuction zone and all areas used by construction workers with a wet mop. 6. If the area is carpeted, vacuum daily with a HEPA-filtered-equipped vacuum. 7. Provide temporary essential services (e.g., toilets) and worker conveniences (e.g, vending machines) in the constmction zone as appropriate. 8. DampRwipe tools if removed from the construction zone or left in the area. 9. Ensure that construction barriers remain well sealed; use particle sampling as needed. 10. Ensure that the clinical laboratory is fi·ee from dust contamination. 34

water system to 2. Tem1innlly dean the constmction zone before the constmction bnniers are removed. 3. Check for visible mold and mildew and eliminat<: (i.e., decontaminate and remove), if present. 4. Verify appropriate ventilation parameters for the new area as needed. 5. Do not accept ventilation ddiciendes. e-specially in special care 1ueas. 6. Clerm or repl!lce HVAC filters ming proper dust~contaimneni procedures. 7. Remove the banlers and denn the area of any dust generated during tills work. 8. Ensun~ that the de•.dgnated air balances in the operntiug rooms (OR) nnd protective environments (PE) nre achieved bef

+ Materinl in this table- wos compiled from r~ferences 19, 51, 67, 80, 106, 120, 250,266, 273, 276-278, 280, 285, and 309, 312-315.

5. Environmental Infection-Control Measures for Special Health-Care Settings AreRs in health-care facilities that require special ventilation include a) operating rooms: b) PE rooms used by high-risk, immunocompromised patients: and c) Ail rooms for isolation of patients with airbome infectious (e.g .. those caused by lvf. tuberculosis, VZV. or measles vims). T11e !llllnber of rooms required for PE and Ail are determined by a risk assessment ofthe health-care facility. 6 Continuous, visualmouitoliug of air tlow direction is required for new or renovated pn:ssmized rooms.12o. 256

a. Protectil'e Environments (PE) Although the exact cont!gurRtion and specifications of PEs might differ among hospitals. these care areas for high-risk. immunocompromised patients are designed to minimize f\mgal spore counts in air by maintaining a) filtration of incoming air by using central or point-of-use HEPA filters; b) directed room air flow [i.e .. from supply on one side of the room, across the patient. and out through the exhaust on the opposite side of the rooni]: c) positive room air ~ressure of2.5 Pa [0.01" water gauge] relative to the cotTidor; d) well-sealed rooms; and e) :;::12 ACH. 44 • 20· 251 • 254 • 31 .._319 Air flow rates must be adjusted accordingly to ensure suflkient ACH, and these rates vmy depending on certain factors (e.g .. room air leakage area). For example, to provide 2:12 ACH in a typical patient room with 0.5 sq. ft. air leakage, the air flow rate will be minimally !25 cubic feet/min (cfin). 320 • 321 Higher air flow rates may be needed. A general ventilation diagram for a positive-pressure room is given in Figme 2. Directed room air !low in PE rooms is not laminar: parallel air streams are not generated. Studies attemf:ting to demottstmte patient benefit f\·omlaminar air !low in a PE setting are equivocal. 316• 31 '·ll 9. "· m

Air tlow direction at the entrances to these areas should be maintained and verified, prefernbly on a daily basis, using either a visual means of indication (e.g .. smoke tubes and tlutter strips) or manometers. Pennanent installation of a visual monitoring device is indicated for new PE consttuction ° and renovatiou. 12 Facility service stnJchll'es can interfae with the proper unidirectional air flow from the patients' rooms to the adjacent coniclor. In one outbreak investigation, Aspergillus spp. infections in a critical care unit may have been associated with a pneumatic specimen transport system, a textile disposal duct system. and central vacuum lines for housekeeping. all of which dismpted proper air flow ll'om the patients' rooms to the outside and allowed entty of fungal spores into the unit (M.McNeil, CDC. 2000). 35

Figure 2. Example of positive,pressure room control for protection from airborne environmental microbes (PE)* + §

Monitor

Corridor -- $ Stacked black boxes represent patient's bed. Long open box ·with cro-:;s~halch represents o;,upply air. Open boxes with c;;inglet diagonal slashes l'epresent nir exhaust t·egisters. Arl'OWS indicat..: direction$ of ait· flow. + Possible uses include imnmnocompromised patient rooms (e.g., hematopoietic stem cell transplant or solid organ trnnsplant procedure rooms) and ot1hopedic opernting rooms. § Positive~pressure room engineering featut'es include • positive press1.u·c (greater !i.Upply than exhaust ;1ir volume); • pressure differential range of 2.5-8 Pn (O.Ol-Q.03w1n. water gauge), ideal nt SPa; • air flow volume ditTerential >125-cfm supply ver<:.us exhaust: • sealed room, approximately 0.5-sq. ft. Ieokag:e: • denn to dirty air flow; • monitoring: • .2;.12 air changes per hour (ACH); and • retum air if rdiltcrcd. 1j This diagram is a generk illus.trotion of ail' tlow inn typknl ins.tallation. Altemative air tlow mTangements nl'e recognized. Adapted nud used with pennission from A Streifel and the publisher of reference 328 (Penton Media, Inc.)

The use of surface fungicide treatments is becoming more common. especially lor building materials."9 Copper-based compOlmds have demonstrated ami-fungal activity and are often applied to wood or paint. Copper-8-quinolinolate was used on enviromnental s1ufaces contaminilted with Aspergillus spp. to control one reported outbreak of aspergillosis. 310 The compound was also incorporated into the fireprootlng material of a newly constmcted hospital to help decrease the enviromuental spore burden. 316

b. Alrbome lllfectlon1so/atlon (All) Acute-care inpatient facilities need at least one room equipped to house patients with airbome infectious disease. Evety health-care facility. including ambu!Moty and long-tenn care facilities, should undettake an IC:RA to identify the need for Ail areas. Once the need is established. the appropriate ventilation equipment can be identitled. Air handling systems for this pmpose need not be restricted to central systems. Guidelines lor the prevention of health-care-acquired TB have been published in response to multiple rep01ts of health-care-associated transmission of mnlti-d111g resistant strains. 4· 330 In reports documenting health-care-acquired TB. investi~ators have noted a failure to comply fttlly with preventionmeasmes in established guidelines. 31 • 345 Titese gaps highlight the impmtance of prompt recognition of the disease. isolation of patients, proper treatment, and engineeting controls. All rooms 36

are also appropriate for the care and management of smallpox patients.• Environmental infection control with respect to smallpox is currently being revisited (see Appendix E).

Salient feah1res ofengineeting controls for Ali areas include a) use of negative pressure rooms with close monitoring of air flow direction using manometers or temporary or installed visual indicators [e.g .. smoke tubes and flutter strips] placed in the room with the door closed; b) minimum 6 ACH for existing facilities, 2:;12 ACH for areas under renovntion or for new const111ction; and c) air from negative pressure rooms and treatment rooms exhausted directly to the outside if possible.'· 110·'" As with PE, airflow rates need to be determined to ensure the proper numbers of ACH. 320• 321 AU rooms can be const111cted either with (Figure 3) or without (Figure 4) an anteroom. When the recirculation of air from All rooms is unavoidable, HEPA filters should be installed in the exhaust duct leading from the room to the general ventilation system. In addition to UVGI tixtJu·es in the room, UVGI can be e!aced in the ducts as an adjunct measure to HEPA tiltration, but it can not replace the HEPA tilter.4· A UVGI fixh1re placed in the upper room, coupled with a minimum of 6 ACH. also provides adequate air cleaning.248

Figure 3. Example of negative-pressure room control for airborne infection isolation (Ail)*+§,

Monitor

! Bathroom

[S;J ll Corridor -- *" Stacked black boxes repr?sent patient's bed. Long open box with cross.hatch represents <:.Up}Jly air. Open boxes with single, ding.ona1 slashes represent ai1· exhaust regisiers. An·ows indicate din:ction of air flow. + Posi:.ible uses include treatmeut or procedm·e rooms, bronchoscopy rooms, and autopsy. § Negative-pressllre room engineering features inclnde • negative pressure (greatet' exhaust than supply oir vohune); • pressure difthential of 2.5 Pa (0.0 l-in. water galtge); • flh· flow volume diffenmtial > 125-cfm exhau<:.t versus supply: • sealo:d room, approximately 0.5~sq, ft. leakage; • dean to dirty air flow; • monitoring; • ~12 air changes per hour (ACH) n~w or renovation, 6 ACH existing: and • ex.hnust to outside or HEPA·filtered if recil'culated. ~This diagram is a generic illustration of air flow in a typical imtallation. Altemative air flow an.·augements are recognized. Adapted and used with pennis<>ion from A. Streitd and the publisher of reference 328 (Penton Media, Inc.)

One of the components of airbome infection isolation is respiratoty protection for health-care workers and visitors when entering AII rooms.'· 6• 347 Reconunendations of the type of respiratory protection are dependent on the patient's airbome infection (indicating the need for Ali) and the risk of infection to 37

persons entering the Ali room. A more in-depth discussion of respiratOJy protection in this instance is presented in the crment isolation guideline;' a revision of tllis guideline is in development Cough- inducing procedures (e.g., endotracheal intubation and suctioning of known or suspected TB patients, diagnostic sputum induction, aerosol treatments, and bronchoscopy) require similar precautions."&-350

Additional engineering measures are necessmy for the management of patients requiring PE (i.e .. allogeneic HSCT patients) who concurrently have airbome infection. For this type of patient treatment, an anteroom (Figure 4) is required in new constmction and renovation as per AlA guidelines. 120

Figure 4. Example or airborne infection isolation (All) room with anteroom and neutral nnteroom * + § Anteroom

IS] lXI

-- Bathroom

t ~ LSJ All only tt Conidor • Neutral Anteroom . Momor I I lXI ~~ ~~ Bathroom

~ All and imm uno- com prom is ed u~ 1r Corri dor // LSJ Ill / / Anteroom "' i Monnor I ""' I lSI ~~~~~ Bathroom

t All and lmm uno~ compromls ed

·LSJ ~u 1r Com'dor

""-- / ·, / Ill / ""' "' The top diagram indicates air flow pattcm<.. when patient with only airboml! infectious disease occupies room, Middle and bottom dingrmns indic.1te recommended nit· flow pattems when room is occupied by inummocomprom.hed patient with airborne infectious diseaso;. Stacko;d black boxes represent patient beds. Long open boxes with cross-hatches reprc">-ent supply air. Open boxes with single. diagonal slashes l'l!present air exhamt registers. Arrows indicate directions of air flow. + Ali isolation room with anteroom engineering fenhll'¢'> include • pressure differential of 2.5 Pa (0.01-in. water gauge) measmed at il1e door betweetl patient room nnd anteroom~ • air flow volume differential >125-cUn. depending: on anteroom air flow direction (pressurized versus depressurized): 38

• sealed room with approximately 0.5-sq. ft. leakage; • clean to dirty air flow • monitoring; • ,:::12 air changes per hour (ACH) new or renovation, 6 ACH existing; and • anteroom air flow patterns. The small • in panels I and 2 indicate the anteroom is pressurized (supply versus exhaust), while the small • in panel 3 indicates the anteroom is depressurized (exhaust versus supply). § Used with pcnnission of A. Streifel, University of Minnesota

The pressure differential of an anteroom can be positive ot· negative relative to the patient in the room. 120 An anteroom can act as an airlock (Figure 4). Jfthe anteroom is positive relative to the air space in the patient's room, staff members do not have to mask prior to entry into the anteroom if air is directly exhausted to the outside and a minimum of I 0 ACH (Figure 4, top diagram). 120 When an anteroom is negative relative to both the AJT room and the corridor, health-care workers must mask prior to entering the anteroom (Figure 4, bottom diagram). If an ATT room with an anteroom is not available, use of a portable, industrial-grade HEPA filter unit may help to increase the number of ACHs while facilitating the removal of fungal spores; however, a fresh air source must be present to achieve the proper air exchange rate. Incoming ambient air should receive HEPA filtration.

c. Operating Rooms Operating room air may contain microorganisms, dust, aerosol, lint, skin squamous epithelial cells, and respiratory droplets. The microbial level in operating room air is directly proportional to the number of people moving in the room. 351 One study documented lower infection rates with coagulase-negative staphylococci among patients when operating room traffic during the surgical procedure was limited 352 Therefore, effotts should be made to minimize personnel traffic during operations. Outbreaks of SSJs caused by group A beta-hemolytic streptococci have been traced to airborne transmission from colonized operating-room personnel to patients. 15 o- 154 Several potential health-care-associated pathogens (e.g., Staphylococcus aureus and Staphylococcus epidermidis) and dmg-resistant organisms have also been recovered from areas adjacent to the surgical field,' 53 but the extent to which the presence of bacteria near the surgical field influences the development of postoperative SS!s is not 354 clear.

Proper ventilation, humidity (<68%), and temperature control in the operating room is important for the comfort of surgical personnel and patients, but also in preventing environmental conditions that encourage growth and transmission ofmicroorganisms. 355 Operating rooms should be maintained at positive pressure with respect to corridors and adjacent areas. 356 Operating rooms typically do not have a variable air handling system. Variable air handling systems are permitted for use in operating rooms only if they continue to provide a positive pressure with respect to the cot1'idors and adjacent areas and the proper ACHs are maintained when the room is occupied. Conventional operating-room ventilation systems produce a minimum of about 15 ACH of filtered air for thermal control, three (20%) of which must be fresh air. 120' 357' 358 Air should be introduced at the ceiling and exhausted near the floor."'· 359

Laminar airflow and UVGJ have been suggested as adjunct measures to reduce SSI risk for certain operations. Laminar airflow is designed to move particle-free air over the aseptic operating field at a uniform velocity (0.3-0.5 m/sec), sweeping away particles in its path. This air flow can be directed vettically or horizontally, and recirculated air is passed through a HEPA filter. 36o-363 Neither laminar airflow nor UV light, however, has been conclusively shown to decrease overall SSI risk. 356 • 364-370

Elective surgery on infectious TB patients should be postponed until such patients have received adequate drug therapy. The use of general anesthesia in TB patients poses infection-control challenges because intubation can induce coughing, and the anesthesia breathing circuit apparatus potentially can become contaminated. 371 Although operating room suites at 15 ACH exceed the air exchanges required 39

for TB isolation, the positive air flow relative to the corridor could result in health-care-associated transmission ofTB to operating-room personnel. If feasible, intubation and extubation of the TB surgical patient should be perfonuecl in AIL AlA currently does not recommend changing pressure from positive to negative or setting it to neutral: most facilities lack the capability to do so. 20 When emergency sm·gery is indicated for a suspecte

Box 8. Strntegy for mannging TB patients and preventing airborne transmission in operating rooms*

1. If Nne-rgeucy surg(>J'Y is indiellted for n patient with nftiVE' TB, scht>dule the TB patient a~ the last surgical cnse to provide- mnxhnum time for ndt'qnatP ACH. 2. Operating r·oom pN·souue-1 should use NIOSH-nppt·-ovf'd N95 l'('Spirnfot·s without E'Xltnlntiou vnlves.'H 7 3. K('t>p thE' OJH'rnting room door closed Rft('l' the (Hltie-nt is iutubntE'd, and nHow ndE"quntt" time for sufficient ACH to remove 99% of nit·borne particles (Appeudl< B, Tnble B.l.): n) after tbe patient h intubated aucl partkularly if intubation produces eoughing; b) U the- door to thE' opN'nfing !)Uit<" mn!!:t bE' open£>d, ruul intubation inducE's coughing in th£> pnti{'nt; ol· c) after the pntient is utubnted nnd suctioned {unlt>ss n dosed suctioniug system is JH'esPntJ. 4. Extubate tlu• pnti('nt in th<' opHating room or nllolv the patit>ut to recovN' in Ail l'ather than iu the regular opNl ncovpry fa dUties. 5. TE'tn}lOI'RlJ llS(' of n portable, industrinl grndl' HEPA filter may E':Xpedite removal of airborne contnmhmnts (fl'E'SlHtir E'Xcbnng(' requirements for pi'OPN' YE'ntilation must still bE' met).+ 6. BI'NHbing circuit filtN~ with 0.1-0.2 Jim pore siz(' can be US('d ns au :Hljunct inf(letion-control measure.373' 374

* Mutcriul in this table was compiled from refe-rMlces 4, 347, nnd 372-374. + T11e placement of portable HEPA filtrr unit<; In the opemling room musl be carefully evaluated for potential dismptions in nonmd uir flow. The porti\ble unit should be turned off while the surgical procedure is 11nderway and turned on following extubation. Portable HEPA filter units previously placed in coustruction nrNIS may be n<;ed in subsequent patient cru-e, provided that ,,u internal ,md external surfaces ru-e deaued and tl1e filttr's performance i<> verified w.ith appropriate pll!ticle testing and 1s changed, if needed.

Table 10. Summary of ventilation specifications in selected nreas ofhealtb-cnre facilities* Criticnl nu·e Isolation Opel'tlting Specifications All room+ PE l'OOIU room§ itllt(';l'OOW I'ootn Po::.ilive, neglltiyc, Po<>itive or Air prc<:>Surt:~ Negative Positive Positive o1· neutl'al ne2:ative 2:6 ACH (for existing rooms); Room air changes 2:12 ACH (for 2:12 AC'H 2:6 ACH Z;lO ACH Z;l5ACH renovation ol' new constn1ction) Senled** Yes Yes No Yes Yes 90% (dust·spot Filtration supply ASHRAE 52.1 99.97%++ 2:,90% ~90°/o 90% 1992) Recirculation No~§ Yes Yes No Yes • Matenal m tlus table J.<> comptled from references 35 and 120. + Includes bronchoscopy suite'>. § Positive pressure and HEPA filten may be preferred in some room.~ in intensive cure units (lCUs) caring for large uurubern of inmnUiocompromised palients. 'i! Clean-to-dirty: negative to an infectious patient. positive away from nn iuununocompromised p<\tient. ** Minimized infiltration for ventilation control; pertains to windows, doSt"d doors, and stll·face joints. H Fungal spore fdter at 1>oint of use (HEPA at 99.97% of0.3 ~un pa11icles). 40

§§ Recirculated air may be used if the exhaust air is first processed through a HEPA filter. 'if~ Table used with permission of the publisher of reference 35 (Lippincott Williams and Wilkins).

6. Other Aerosol Hazards in Health-Care Facilities In addition to infectious bioaerosols, several crucial non-infectious, indoor air-quality issues must be addressed byhealth-care facilities. The presence of sensitizing and allergenic agents and irritants in the workplace (e.g., ethylene oxide, glutaraldehyde, formaldehyde, hexachlorophene, and latex allergens"') is increasing. Asthma and dermatologic and systemic reactions often result with exposure to these chemicals. Anesthetic gases and aerosolized medications (e.g., ribavirin, pentamidine, and aminoglycosides) represent some of the emerging potentially hazardous exposures to health-care workers. Containment of the aerosol at the source is the first level of engineering control, but personal protective equipment (e.g., masks, respirators, and glove liners) that distances the worker from the hazard also may be needed.

Laser plumes and surgical smoke represent another potential risk for health-care workers. 37G-378 Lasers transfer electromagnetic energy into tissues, resulting in the release of a heated plume that includes patticles, gases, tissue debris, and offensive smells. One concern is that aerosolized infectious material in the laser plume might reach the nasal mucosa of surgeons and adjacent personnel. Although some viruses (i.e., varicella-zoster virus, pseudorabies virus, and herpes simplex virus) do not aerosolize efficiently ,379• 380 other viruses and bacteria (e.g., human papilloma virus [HPV], HIV, coagulase- negative Staphylococcus, Corynebacterium spp., and Neisseria spp.) have been detected in laser plumes. 381 - 387 The presence of an infectious agent in a laser plume may not, however, be sufficient to cause disease from airborne exposure, especially if the normal mode of transmission for the agent is not airborne. No evidence indicated that HIV or hepatitis B virus (HBV) has been transmitted via aerosolization and inhalation. 388

Although continuing studies are needed to fully evaluate the risk of laser plumes to surgical personnel, the prevention measures in these other guidelines should be followed: a) NIOSH recommendations,'" b) the Recommended Practices for Laser Safety in Practice Settings developed by the Association of peri Operative Registered Nurses [AORN],389 c) the assessments ofECR1, 390-392 and d) the ANSI standard. 393 These guidelines recommend the use of a) respirators (N95 or NIOO) or full face shields and masks, 260 b) central wall-suction units with in-line filters to collect particulate matter from minimal plumes, and c) dedicated mechanical smoke exhaust systems with a high-efficiency filter to remove large amounts of laser plume. Although transmission ofTB has occurred as a result of abscess management practices that lacked airborne particulate control measures and respiratoty protection, use of a smoke evacuator or needle aspirator and a high degree of clinical awareness can help protect health- care workers when excising and draining an extrapulmonaty TB abscess. 137

D. Water 1. Modes of Transmission of Waterborne Diseases Moist environments and aqueous solutions in health-care settings have the potential to serve as reservoirs for waterborne microorganisms. Under favorable environmental circumstances (e.g., warm temperature and the presence of a source of nutrition), many bacterial and some protozoal microorganisms can either proliferate in active growth or remain for long periods in highly stable, environmentally resistant (yet infectious) forms. Modes of transmission for waterborne infections 41

include a) direct contact [e.g., that required for hydrotherapy]; b) ingestion of water [e.g .. through consuming contaminated ice]; c) indirect-contact transmission [e.g .. from an improperly reprocessed medical device]; 6 d) inhalation ofaerosob dispersed from water sources;' and e) aspiration of contaminated water. The tirst three modes of transmission are conuuonly associated with infections caused by gram-negative bacteria and nonmberculous mycobacteria (NTM). Aerosols generated from water sources contaminated with Legionella spp. often se1ve as the vehicle for introducing legionellae to the respiratory tract. 394

2. Waterborne Infectious Diseases in Health-Cat·e Facilities a. Leglone/losls Legionellosis is a collective tenu describing infection produced by Legion ella spp., whereas Legionnaires disease is a multi-system illness with pneumonia. 395 The clinical and epidemiologic aspects of these diseases(Table ll) are discussed extensively in another gnideline 3 Although Legionnaires disease is a respirat01y infection, infection-control measures intended to prevent health- care-associated cases center on the quality of water-the principal resetvoir for Legione/la spp.

Table 11. Clinical and epidemiologic characteristics of legionellosis/Legionnnires disease Rt>f('l'(lll("(IS I.egionefla pneumopltila (90% of inf<:ctious); L. micdadei, L. Causative ngent bozemanii, L. dumoffii,. L longbeachii. (14 additional species 395-399 can cau!>e infection in hmnnns) Mod(' of tr~msmission Aspiration of watel'. direct inhalation or water aerosols 3,394-398,400 Ex.pos\lre to environmental sourcec,. of Legionella spp. (i.e., So nrc<' of t>xposure wnter or water aerosols) 31,33.401-414 Two distinct illnesses: a) Po11tiac fevet' [a mils]; and b) progressive pneumonia that mny be 3,397-399,415-422 dis<"nses accornprmied by cardinc. renal. and gastrointcstinnl involvemenl Inummosuppress.ed patients (e.g,. transplant patients, cancer potienls, and patients receiving cotiicosteroid thempy); Populntious Rt greatl'st 395-397, 423-433 immm1ocompromised patients (e.g., surgical patients, l'isk patients \Vith undel'lying clu·onic lung disease, and dialysis patients); elderly persons; and patients who smoke Proportion of conmmnity-ncqnired pnemnonia cm1sed by Legionella spp. nmges fi·om 1'%-5%. ; estimated annual incidence among the geneml population is 8,000--18,000 OecunenrE> 396. 397, 434-444 cases in the United States; the incidence of health-care- associated pnemnonio (0%,-14%) may be tmderestimated if appropriate laboratoty diagnostic methods are \lnavailable. 1-.·fortnlity dl;clined nuukedly during 1980 1993, from34% to 12% for nil cnse'!.: the mot1nlity rate is higher among p~:rsons with henlth~care-nssociated pneumonia compm·ed with the Mortality mt• 395-397, 445 rate among conununitywacq\lired pn~:umonia patients (14% for health-care-associated pneumonia versus: 10% for conmmuity~acquired pnetunonia f1998 dntal),

Legionel/a spp. are conm10nly found in vmious natural and man-made aquatic envirOJunents'146 ' 447 and can enter health-care facility water systems in low or undetectable munbers.448 · 449 Cooling towers. evaporative condensers, heated potable water distribution sr,stems, and locally-produced distilled water can provide environments for multiplication oflegionellae. s

colonizMion and amplification of legionellae in man-made water environments include a) temperatures of 77°F-l 07.6"F [25°C-42"C],' 51i-46

b. Other Gram-Negative Bacterla/lufections Other gram-negative bactelia present in potable water also can cause health-care-associated infections. Clinically important, opportunistic organisms in tap water include Pseudomouas aemginosa, Pseudomouas spp., Burkholderia cepacia, Ra/stonia pickettii, Steuotrophomouas maltophilia, aml Sphingomonas spp. (Tables 12 and 13). Immunocompromised patients are at greatest risk of developing infection. Mectical conditions associated with these bacterial agents range trom colonization of the respirato1y and urinaJY tracts to deep, disseminated infections that can result in pneumonia and bloodstream bacteremia. Colonization by any of these organisms often precedes the development of infection. The use of tap water in medical care (e.g., in direct patient care. as a diluent for solutions, as a water source tor medical instnnuents and equipment. and dming the final stages of instnunent disinfection) therefore presents a potential risk for exposure. Colonized patients also can serve as a source of contamination. particularly for moist environments of medical equipment (e.g .. ventilators).

In addition to Legionella spp .• Pseudomonas aemginosa and Pseudomonas spp. are among the most clinically relevant, gram-negative. health-care-associated pathogens identified ti'om water. These and other gram-negative, non-fermentative bactelia have minimal nutritional requirements (i.e .. these organisms can grow in distilled water) and can tolerate a variety of physical conditions. These attributes are critical to the success of these organisms as health-care-associated pathogens. Measmes to prevent the spread of these organisms and other waterbome, gram-negative bacteria include hand hygiene, glove use, banier precautions. and eliminating potentially contaminated enviromnental reseJVohs."'· 465

Tnble 12. Pseudomonas aerrtghwsa infections in health-care facilities Rt>ferenC('S Septicemia. pneumonin (pm1icularly ventilfltor-ns.sociated), du'Onic respiratory infections among: cystic fibrosi<; patients. Cliuklll syndromes nnd urinaty Inlet infections, skin aud soft-tissue iufectiom (e.g., thsue 466-503 diseRS<'S necrosis nud hemorrhnge), bum-wound infections, folliculitis, endocarditis, central nervous sy<,.tem infections (e.g., meningitis and abscess), eve infections. and bone and joint infet;tions Direct contact \Yith water, aerowls: aspiration of wafer· and Modes of fl•:msmission inhalation of water nerosols.; and indirect transfer from moist 28.502-506 environmental surfaces vin ha11ds ofhenhh-cnre worb~rs Potable (tap) water, distilled \Vatel', antiseptic solution'> Environmeutnl sotu'('(IS of contmninated with tap water, ~inks., hydrotherapy Jlools. 28, 29, 466. 468, pseudomounds in bt>alth- whirlpooh. and whirlpool spns, water baths, lithotripsy therapy 507-520 cnre settings tanks. dinlysh water, eyewash stations. flower vase<:>, and endoscones with residual moisn.u·e in the channels E1nironmeutal ~'out·ces of F<>mites (e.g:.. drug injection equipment stored in contnminMed pseudomounds in tlu.• wnter) 494.495 connnunity Intensive care nnit (JCU) pntien!s (including: neonatnllCU), transplant patients (organ and hetnf\topoietic stem cell), 28,466.467,472, Populations flt grent!'st risk neutropenic patients., bnrn therapy and hydrothernpy patients, 477,493,506-508. pulient<;, with malig:noncies, cy<;lic fibrosis patients, patients with 5ll, 512.521-526 undedvint< medical conditions. and dialvsiS ontients 43

Table 13. Other gram-negative bacteria associated with water and moist environments

Implicated contaminated environmental vehicle References

Burkholderia cepacia Distilled watel' 527 Contaminated solutions and disinfectants 528,529 Dialysis machines 527 Nebulizers 530-532 Water baths 533 IntrinsicallyMcontaminated mouthwash* 534 Ventilator temperature probes 535 Stenotrophomonas maltophlia, Sphingomonas spp. Distilled water 536, 537 Contaminated solutions and disinfectants 529 Dialysis machines 527 Nebulizers 530-532 Water 538 Ventilator temperature probes 539 Ralstonia pickettii Fentanyl solutions 540 Chlorhexidine 541 Distilled water 541 Contaminated respiratory therapy solution 541,542 Sen·atla marcescens Potable water 543 Contaminated antiseptics (i.e., benzalkonium chloride 544-546 and chlorhexidine) Contaminated disinfectants (i.e., quaternary ammonhun 547,548 compounds and glutaraldehyde) Acinetobacter spp. Medical equipment that collects moisture (e.g., mechanical 54'1-556 ventilators, cool mist humidifiers, vaporizers, and mist tents) Room humidifiers 553,555 Environmental surfaces 557-564 Enterobacter spp. Humidifier water 565 Intravenous fluids 566-578 Unsterilized cotton swabs 573 Venti laton> 565, 569 Rubber piping on a suctioning machine 565,569 Blood gas analyzers 570

* This report describes intrinsic contamination (i.e., occurring during manufacture) prior to use by the healtlrcare facility staff. All other entries reflect extrinsic sources of contamination.

Two additional gram-negative bacterial pathogens that can proliferate in moist environments are Acinetobacter spp. and Enterobacter spp. 571 • 572 Members of both genera are responsible for health- care-associated episodes of colonization, bloodstream infections, pneumonia, and urinary tract 566 infections among medically compromised patients, especially those in JCUs and burn therapy units. • 572 583 - Infections caused by Acinetobacter spp. represent a significant clinical problem. Average infection rates are higher from July through October compared with rates from November through June. 584 Mortality rates associated with Acinetobacter bacteremia are 17%-52%, and rates as high as 71% have been reported for pneumonia caused by infection with either Acinetobacter spp. or 44

576 Pseudomonas spp. 574- Multi-drug resistance, especially in third generation cephalosporins for Enterobacter spp., contributes to increased morbidity and mortality. 569• 572

Patients and health-care workers contribute significantly to the environmental contamination of surfaces and equipment with Acinetobacter spp. and Enterobacter spp., especially in intensive care areas, because of the nature of the medical equipment (e.g., ventilators) and the moisture associated with this . eqUipment. "'' '" ' sn' sss H an d carnage . an d h and trans1er c are common 1y assoctate . d wtt. h h eatI h-care- associated transmission of these organisms and for S. marcescens. 586 Enterobacter spp. are primarily spread in this manner among patients by the hands of health-care workers. 567' 587 Acinetobacter spp. have been isolated from the hands of 4o/.-33% of health-care workers in some studies,"'-590 and transfer of an epidemic strain of Acinetobacter from patients' skin to health-care workers' hands has been demonstrated experimentally."' Acinetobacter infections and outbreaks have also been attributed to medical equipment and materials (e.g., ventilators, cool mist humidifiers, vaporizers, and mist tents) that may have contact with water of uncertain quality (e.g., rinsing a ventilator circuit in tap water). 54"- 556 Strict adherence to hand hygiene helps prevent the spread of both Acinetobacter spp. and Enterobacter spp. 577 • 592

Acinetobacter spp. have also been detected on dry environmental surfaces (e.g., bed rails, counters, sinks, bed cupboards, bedding, floors, telephones, and medical charts) in the vicinity of colonized or infected patients; such contamination is especially problematic for surfaces that are frequently touched. 557- 564 In two studies, the survival periods of Acinetobacter baumannii and Acinetobacter 593 calcoaceticus on dry surfaces approximated that for S. aureus (e.g., 26-27 days). ' 594 Because Acinetobacter spp. may come from numerous sources at any given time, laboratory investigation of health-care--associated Acinetobacter infections should involve techniques to determine biotype, anti biotype, plasmid profile, and genomic fingerprinting (i.e., macrorestriction analysis) to accurately identify sources and modes of transmission of the organism(s). 595

c. Infections and Pseudo-Infections Due to Nontuberculous Mycobacteria NTM are acid-fast bacilli (AFB) commonly found in potable water. NTM include both saprophytic and opportunistic organisms. Many NTM are of low pathogenicity, and some measure of host impairment is necessary to enhance clinical disease.'" The four most common forms of human disease associated with NTM are a) pulmonary disease in adults; b) cervical lymph node disease in children; c) skin, soft . ttssue, . c t'IOns; an d d) d'tssemma an d bone tntec . t ed d'tsease m . tmmunocompromtse . . ts. 596· 597 . d patten Person-to-person acquisition ofNTM infection, especially among immunocompetent persons, does not appear to occur, and close contacts of patients are not readily infected, despite the high numbers of organisms harbored by such patients. 596• 59..600 NTM are spread via all modes of transmission associated with water. In addition to health-care--associated outbreaks of clinical disease, NTM can colonize patients in health-care facilities through consumption of contaminated water or ice or through inhalation of aerosols. 601 - 605 Colonization following NTM exposure, particularly of the respiratory tract, occurs when a patient's local defense mechanisms are impaired; ovett clinical disease does not develop. 606 Patients may have positive sputum cultures in the absence of clinical disease.

Using tap water during patient procedures and specimen collection and in the final steps of instrument reprocessing can result in pseudo-outbreaks ofNTM contamination 607- 609 NTM pseudo-outbreaks of Mycobacterium chelonae, M gordonae, and M xenopi have been associated with both bronchoscopy and gastrointestinal endoscopy when a) tap water is used to provide irrigation to the site or to rinse off the viewing tip in situ or b) the instmments are inappropriately reprocessed with tap water in the final steps.GI0---612 45

Table 14. Nontuberculous mycobacteria-environmental vehicles

Vehicles associated with infections or colonizations References

Mycobacterium abscessus Inadequately sterilized medical instmments 613 Mycobacterium avium complex (MAC) Potable water 614-616 Mycobacterium chelonae Dialysis, reprocessed dialyzers 31,32 Inadequately-sterilized medical instruments, jet injectors 617,618 Contaminated solutions 619, 620 Hydrotherapy tanks 621 Mycobacterium fortuitum Aerosols ti·om showers or other water sources 605, 606 lee 602 Inadequately sterilized medical instmments 603 Hydrotherapy tanks 622 Mycobactel'ium marinum Hydrotherapy tanks 623 Mycobacterium ulceJ'Uits Potable water 624

Vehicles associated with pseudo-outbreaks References

Mycobactel'ium chelonae Potable water used during bronchoscopy and instrument 610 reprocessing MycobacteJ·ium foJ·tuitum lee 607 Mycobactel'ium gordonae Deionized water 611 Ice 603 Laboratory solution (intrinsically contaminated) 625 Potable water ingestion prior to sputum specimen collection 626 Mycobacterium kansasii Potable water 627 Mycobactel'ium terrae Potable water 608 Mycobacterium xenopi Potable water 609,612,627

NTM can be isolated from both natural and man-made environments. Numerous studies have identified 615 616 624 627 various NTM in municipal water systems and in hospital water systems and storage tanks. • • • - 632 Some NTM species (e.g., Mycobacterium xenopi) can survive in water at ll3°F (45°C), and can be isolated from hot water taps, which can pose a problem for hospitals that lower the temperature of their hot water systems. 627 Other NTM (e.g., Mycobacterium kansasii, M gordonae, M fortuitum, and M chelonae) cannot tolerate high temperatures and are associated more often with cold water lines and taps.'29

NTM have a high resistance to chlorine; they can tolerate free chlorine concentrations of0.05-0.2 mg/L (0.05-0.2 ppm) found at the tap. 598• 633• 634 They are 20-100 times more resistant to chlorine compared with coliforms; slow-growing strains ofNTM (e.g., Mycobacterium avium and M kanasii) appear to be 46

more resistant to chorine inactivation compared to fast-growing NTM. 635 Slow-growing NTM species have also demonstrated some resistance to formaldehyde and glutaraldehyde, which has posed problems for reuse ofhemodialyzers. 31 The ability ofNTM to form biofilms at fluid-surface interfaces (e.g., interior surfaces of water pipes) contributes to the organisms' resistance to chemical inactivation and provides a microenvironment for growth and proliferation. 636 • 637

d. Ctyptosporidiosis Cryptosporidium parvum is a protozoan parasite that causes self-limiting gastroenteritis in normal hosts but can cause severe, life-threatening disease in immunocompromised patients. First recognized as a human pathogen in 1976, C. parvum can be present in natural and finished waters after fecal contamination from either human or animal sources. 63 B-641

The health risks associated with drinking potable water contaminated with minimal numbers of C. parvum oocysts are unknown. 642 It remains to be determined if immunosuppressed persons are more susceptible to lower doses of oocysts than are immunocompetent persons. One study demonstrated that a median 50% infectious dose (ID 50) of 132 oocysts of calf origin was sufficient to cause infection among healthy volunteers. 643 In a second study, the same researchers found that oocysts obtained from infected foals (newborn horses) were infectious for human volunteers at median ID 50 of 10 oocysts, indicating that different strains or species of Cryptosporidium may vary in their infectivity for humans_644 In a small study population of 17 healthy adults with pre-existing antibody to C. parvum, the TD 5o was determined to be I ,880 oocysts, more than 20-fold higher than in seronegative persons. 645 These data suggest that pre-existing immunity derived from previous exposures to Ctyptosporidium offers some protection from infection and illness that ordinarily would result from exposure to low numbers of oocysts. 645• 646

Oocysts, pmticularly those with thick walls, are environmentally resistant, but their survival under natural water conditions is poorly understood. Under laboratory conditions, some oocysts remain viable and infectious in cold (41 op [5°C]) for months. 641 The prevalence of Ctyptosporidium in the U.S. drinking water supply is notable. Two surveys of approximately 300 surface water supplies revealed 648 that 55'%--77% of the water samples contained Cryptosporidium oocysts.'47• Because the oocysts are highly resistant to common disinfectants (e.g., chlorine) used to treat drinking water, filtration of the water is important in reducing the risk of waterborne transmission. Coagulation-floculation and sedimentation, when used with filtration, can collectively achieve approximately a 2.5 logw reduction in the number of oocysts. 649 However, outbreaks have been associated with both filtered and unfiltered drinking water systems (e.g., the 1993 outbreak in Milwaukee, Wisconsin that affected 400,000 people). 641 • 65 0-652 The presence of oocysts in the water is not an absolute indicator that infection will occur when the water is consumed, nor does the absence of detectable oocysts guarantee that infection will not occur. Health-care-associated outbreaks of cryptosporidiosis primarily have been described among groups of elderly patients and immunocompromised persons.'"

3. Water Systems in Health-Care Facilities a. Basic Components and Point-of-Use Fixtures Treated municipal water enters a health-care facility via the water mains and is distributed throughout the building(s) by a network of pipes constructed of galvanized iron, copper, and polyvinylchloride (PVC). The pipe runs should be as short as is practical. Where recirculation is employed, the pipe runs should be insulated and long dead legs avoided in effmts to minimize the potential for water stagnation, which favors the proliferation of Legionella spp. and NTM. In high-risk applications (e.g., PE areas for severely immunosuppressed patients), insulated recirculation loops should be incorporated as a design 47

feature. Recirculation loops prevent stagnation and insulation maintains return water temperature with minimal loss.

Each water setvice main. branch main. riser, and branch (to a group of fixtures) has a valve and a means to reach the valves via an access panel. 120 Each fixture has a stop valve. Valves pennit the isolation of a portion of the water system within a facility during repairs or maintenance. Vacuum breakers and other similar devices in the lines prevent water from back-flowing into the system. All systems that supply water should be evaluated to determine risk for potential back siphonage and cross connections.

Health-care facilities generate hot water from municipal water using a boiler system. Hot water heaters and storage vessels for such systems should have a drainage facility at the lowest point, and the henting element should be located as close as possible to the bottom of the vessel to facilitate mixing and to prevent water temperat:me stratification. TI10se hot or cold water systems that incoqJOrate an elevated holding tank should be inspected and cleaned mmually. Lids should fit securely to exclude foreign materials.

The most common point-of-use fixtures for wMer in patient-care areas are sinks. faucets, aerators, showers, and toilets; eye-wash stations are found primarily in laboratories. The potential for these fixtures to setve as a resetvoir for pathogenic microorganisms has long been recognized (Table 15). 509 • 65 6 .,..'" Wet surfaces and the production of aerosols facilitate the multiplication and dispersion of microbes. The level of risk associated with aerosol production from point-of-use fixtures varies. Aerosols from shower heads and aerators have been linked to a limited number of clusters of gram- negative bactetial colonizations and infections. including Legionnaires disease, especially in areas where in11nunocompromised patients are present (e.g.. surgical ICUs, transplant units, and oncology units) 412 • 415 · 65""'59 In one report, clinical infection was not evident among immunocompetent persons (e.g.. hospital staff) who used hospital showers when Legiouel/o pneumophila was present in the water system 660 Given the infrequency of reported outbreaks associated with faucet aerators, consensus has not been reached regarding the disinfection of or removal of these devices li'otn general use. If additional clusters of infections or colonizations occm· in high-risk patient-care areas. it may be pmdent to clean and decontaminate the aerators or to remove them. 658 •6' 9 ASHRAE recmmnends cleaning and monthly disinfection of aerators in high-risk patient-care areas as pari of Legiouella controlmeasures. 661 Although aerosols are produced with toilet flnshing. 662 • 663 no epidemiologic evidence suggests that these aerosols pose a direct infection hazard.

Although not considered a standard point-of-use fixture. decorative fountains are being installed in increasing numbers in health-care facilities and other public buildings. Aerosols from a decorative fountain have been associated with transmission of Legionella p11eumophilo serogroup 1 infection to a small cluster of older adnlts 664 This hotel lobby fountain had been irregularly maintained, and water in the fountain may have been heated by submersed lighting. all of which favored the proliferation of Legionella in the system. 664 Because of the potential for generations of infectious aerosols, a pnrdent prevention measure is to avoid locating these fixtures in or near high-risk patient-care areas and to adhere to written policies for routine fountainmaintenance. 120

Tnble 15. Wnter and point-of-use fixtures ns sources and reservoirs ofwnterborne pnthogens* Assoeifttt>d Strength of PJ'(>Vt>ntion And Re-servoir Transmission Rt>ft>re-nc.es pathogens e-vidNtCt>+ control Potable water Pseudomcnas. gnnn~ Contact Moderate Follow public henlth (See Tables negative bacteria, g1.1iddines. 12-14) NTM 48

Associated Strength of Prevention and Reservoir Transmission References pathoeens evidence+ control Potable water Legionella Aerosol inhalation Moderate Provide supplemental (See Table treatment for water. 11) Holy water Gram~ negative Contact Low Avoid contact with 665 bacteria severe burn injuries. Minimize use among immunocomprornised patients. Dialysis water Gram-negative Contact Moderate Dialysate should be 2,527,666-- bacteria ~2,000 cfu/mL; water 668 should be <200 cfu/mL. Automated Gram-negative Contact Moderate Use and maintain 669--675 endoscope bacteria equipment according to rcprocessors instmctions; eliminate and rinse water residual moisture by drying the channels (e.g., through alcohol rinse and forced air drying). Water baths Pseudomonas, Contact Moderate Add germicide to the 29, 533, 676, Burklwlderia, water; wrap transfusion 677 Acinetobacter products in protective plastic wrap if using the bath to modulate the temperature of these products. Tub immersion Pseudomonas, Contact Moderate Drain and disinfect tub 67&-683 Enterobacter, after each use; consider Acinetobacter adding germicide to the water; water in large hydrotherapy pools should be properly disinfected and filtered. Ice and ice NTM, Enterobacte1~ Ingestion, contact Moderate Clean periodically; use 601,684-687 machines Pseudomonas, automatic dispenser Clyptosporidiunl (avoid open chest storage compmiments Le~ionella Low in patient areas). Faucet aerators Legionella Aerosol inhalation Moderate Clean and disinfect 415,661 monthly in high-risk patient areas; consider removing if additional infections occur. Faucet aerators Pseudomonas, Contact, droplet Low No preca11tions arc 658, 659, Acinetobacter, necessary at present in 688,689 Stenotrophomonas, immunocompetent Ch1yseobacterium patient-care areas. Sinks Pseudomonas Contact, droplet Moderate Use separate sinks for 509, 653, handwashing and 685-693 disposal of contaminated fluids. Showers Legionella Aerosol inhalation Low Provide sponge baths 656 for hematopoietic stem cell transplant patients; avoid shower use for immunocompromised patients when Legionella is detected in facility water. 49

Associated Str(>ngth of Prevention nnd RPS£'1'\'0h' Tt·nusmission Ref£>l'PUC('S pnthogens evidence+ control Dentnl unit Pseudomonas, Contact Low Clean woter $ystems 636, 694-Q96 wale!' lines Legionella, according to system Sphingomonas, manufacturer's Acinetobac/er instmctions. Ice baths for Ewiugella, Contact Low Use sterile water. 697,698 thermodilution Staphylococcus catheters Decorative Legionel/a Aerosol inhalntion l.h <>tations 518, 699, 700 stations amoebae, weekly; have sterile L(l_gionella Minimum water aYnilable for eye flushes. Toilets G-ranNlegntive - .Minimum Clean regularly; use 662 bacteria 2:ood lumd hvQ:iene. Flowers Gram-negative - t>.·finimtun Avoid use in inten~-ive 515, 701, 702 ba~;h:ria, care units and in Aspergillus immunocompmmised natk~nt-care settit12:s,

* Modified from .reference 654 filld used with pennission of the publisher (Slack, Inc.) + 1\foileJ•ate: occasional well-deSt:nbed outbreak!>. Low: f~ well-described outbreaks. Minimal: actual infections not demonstrated.

b, Water Temperature ami Pressure Hot water temperature is usually measured at the point of use or at the point at which the water line enters equipment requiring hot water for proper operation, 120 Generally, tl1e hot water temperature in hospital patient-care areas is no greater than a temperature within the range of 105°F-120°F (40.6°C- 490C), depending on the AlA guidance issued at the year in which the facility was built 110 Hot water temperature in patient-care areas of skilled nursing-care facilities is set within a slightly lower range of 95°F-ll0°F (35°C-43YC) depending on the AlA guidance at the time of facility constmctionno Jvlany states have adopted a temperature setting in these ranges into their health-care regulatious and building codes, ASHRAK however, has reconunendcd higher settings!" Steam jets or booster heaters are usually needed to meet the hot water temperature requirements in ce1tain service areas of the hospital (e,g, the kitchen [120"F (49°C)] or the launchy [160°F (7!°C)])no Additionally, water lines may need to be heated to a particular temperature specified by manufacturers of specific hospital equipment Hot-water distribution systems serving patient-care areas are generally operated under constant recirculation to provide continuous hot water at each hot-water outlet."0 !fa facilitv is or has a hemodialysis unit, then continuously circulated, cold treated water is provided to that unit 11o

To minimize the growth and ~ersistence of gram-negative \~at~rborue bacteria (e,g,, thermophilic NTM and Legionella spp,), 627' 703-70 cold water m health-care facrlltles should be stored and d1stnbutecl at temperatures below 68°F (20°C:); hot water should be stored above 140°F (60°C) and circulated with a minimum retum temperature of 124°F (51 °C), 661 or the highest temperamre specified in state regulations and building codes, If the retm11 temperature setting of l24°F (51 °C) is permitted, then installation of preset thermostatic mixing valves near the point-of-use can help to prevent scalding, Valve maintenance is especially important in preventing valve failme, which can result in scalding, New shower systems in large buildings, hospitals, and nursing homes should be designed to permit mixing of hot and cold water near the shower head, TI1e wann water section of pipe between the control valve and shower head should be selt~draining, Where buildings can not be retrofitted, other 50

approaches to minimize the growth of Legione/la spp. include a) periodically increasing the temperature to at least 150°F [66°C] at the point of use [i.e., faucets] and b) adding additional chlorine and flushing the water. 601 · 710 • 711 Systems should be inspected annually to ensure that thennost8ts are functioning properly.

Adequate water pressure ensures suftlcient water supplies for a) direct patient care; b) operation of water-cooled instnunents and equipment [e.g., lasers. computer systems, telecommunications systems. and automated endoscope reprocessors712]; c) proper ftmction of vacuum suctioning systems: d) indoor climate control; and e) fire-protection systems. Maintaining adequate pressure also helps to ensme the integrity of the piping system.

c. Infectlon-Coutrol Impact of Water System Maintenance aud Repair Conective measures for water-system failures have not been studied in well-designed experiments: these measmes are instead based on empiric engineering and infection-control principles. Health-care t1cilities can occasionally sustain both intentional cut-offs by the mtmicipal water authority to permit new constmction project tie-ins and mtintentional dismptions in service when a water main breaks as a result of aging infrastmcnu·e or a constmction accident. Vacuum breakers or other similar devices can prevent backflow of water in the facility's distribution system during water-dismption emergendes. 11 To be prepared for such an emergency, all health-care facilities need contingency plans that identify a) the total demand tor potable water. b) the quantity of replacement water [e.g., bottled water] required for a minimum of 24 homs when the water system is do'Ml. c) mechanisms for emergency water distribution, and 4) procedures for conecting drops in water pressure that affect operation of essential devices and equipment that are driven or cooled by a water system [Table 16].713

Tnble 16. Water clemnnd in health-care facilities during water disruption emergencies Potnble wntt>l' Bottl{'d, stel'ile WlltN' Drinking water Surgical scmb H;mdwa<;hing Emergency surgicnl procedurec; Cnfeteria services Phummceulical prepamlions Ice Patient-care equipment (e.g,, ventilators)§ Manual flushing of toilets Patient baths, hygiene Hemodinlysis Wllt(>l' US(> ll(>('dS Hydt'ofhempy Fire prevention (e.g., ">prit1kkr ~ystems) Surgery and critical cnre nn:ns Laborat01y services LamKby and central sterile service!>* Cooling towers+ Steam Q:euerntion • . ., sef'i!Ces from anothl>r resource, Jfposstblc (e.g., ;mothe-r heahb·carc fnctbty ot controclor) . A.naug<:: to haw a conhugency pro\'lSton of these + Some cooling tower$ may use a potable water source, but most tmit'> use non~polable water. § Thi'> item is included in the table under the assumption that electrical power is available during the water emergency.

Detailed, np-to-dnte plans for hot and cold water piping systems should be readily available tor maintenance and repair pmposes in case of system problems. Opening potable water systems for repair or constmction and subjecting systems to water-pressure changes can result in water discoloration and dramatic increases in the concentrations of Legionella spp. and other gram-negative bacteria. The maintenance of a chlorine residual at all points within the piping system also offers some protection from enny of contamination to the pipes in the event of inadvertent cross-cotmection between potable and non-potable water lines. As a minimum preventive measure, ASHRAE reconunends a thorough flushing of the system. 661 High-temperan1re flushing or hyperchlorination may also be appropriate 51

strategies to decrease potentially high concentrations of waterborne organisms. The decision to pursue either of these remediation strategies, however, should be made on a case-by-case basis. If only a pottion of the system is involved, high temperature flushing or chlorination can be used on only that pottion of the system. 661

When shock decontamination of hot water systems is necessary (e.g., after dismption caused by construction and after cmss-connections), the hot water temperature should be raised to 160°F-170°F (7 I °C-77°C) and maintained at that level while each outlet around the system is progressively flushed. A minimum flush time of 5 minutes has been recommended;' the optimal flush time is not known, however, and longer flush times may be necessary. 714 The number of outlets that can be flushed simultaneously depends on the capacity of the water heater and the flow capability of the system. Appropriate safety procedures to prevent scalding are essential. When possible, flushing should be performed when the fewest building occupants are present (e.g., during nights and weekends).

When thermal shock treatment is not possible, shock chlorination may serve as an alternative method.661 Experience with this method of decontamination is limited, however, and high levels of free chlorine can corrode metals. Chlorine should be added, preferably overnight, to achieve a free chlorine residual of at least 2 mg/L (2 ppm) throughout the system. 661 This may require chlorination of the water heater or tank to levels of2G-50 mg/L (2G-50 ppm). The pH of the water should be maintained at 7.G-8.0.661 After completion of the decontamination, recolonization of the hot water system is likely to occur unless proper temperatures are maintained or a pmcedure such as continuous supplemental chlorination is continued.

Interruptions of the water supply and sewage spills are situations that require immediate recovery and remediation measures to ensure the health and safety of patients and staff. 715 When delivery of potable water through the municipal distribution system has been dismpted, the public water supplier must issue a "boil water" advisory if microbial contamination presents an immediate public health risk to customers. The hospital engineer should oversee the restoration of the water system in the facility and clear it for use when appropriate. Hospitals must maintain a high level of surveillance for waterborne disease among patients and staff after the advisory is lifted."42

Flooding fi'om either external (e.g., from a hurricane) or internal sources (e.g., a water system break) usually results in property damage and a temporary loss of water and sanitation. 71 '" 718 JCAHO requires all hospitals to have plans that address facility response for recovery from both intemal and external disasters. 713 • 719 The plans are required to discuss a) general emergency preparedness, b) staffing, c) regional planning among area hospitals, d) emergency supply of potable water, e) infection control and medical services needs, f) climate control, and g) remediation. The basic principles of structural recovery from flooding are similar to those for recovery from sewage contamination (Box 9 and I 0). Following a major event (e.g., flooding), facilities may elect to conduct microbial sampling of water after the system is restored to verifY that water quality has been returned to safe levels (<500 CFU!mL, heterotrophic plate count). This approach may help identifY point-of-use fixtures that may harbor contamination as a result of design or engineering features. 720 Medical records should be allowed to dry and then either photocopied or placed in plastic covers before returning them to the record.

Moisture meters can be used to assess water-damaged structural materials. If porous structural materials for walls have a moisture content of>20% after 72 hours, the affected material should be removed.' 66• 278 313 • The management of water-damaged structural materials is not strictly limited to major water catastrophes (e.g., flooding and sewage intrusions); the same principles are used to evaluate the damage from leaking roofs, point-of-use fixtures, and equipment. Additional sources of moisture include condensate on walls from boilers and poorly engineered humidification in HVAC systems. 52

Box 9. Recovery and remediation measures for water-related emergencies*

Potable water disruptions

Contingency plan items Ensure access to plumbing network so that repairs can be easily made. Provide sufficient potable water, either from bottled sources or truck delivery. Post advisory notices against consuming tap water, ice, or beverages made with water. Rope off or bag drinking fountains to designate these as being "out of service" until further notice. Rinse raw foods as needed in disinfected water. Disconnect ice machines whenever possible.+ Postpone laund1y services until after the water system is restored. Water treatment Heat water to a rolling boil for .2:1 minute. Remediation of the water system after the "boil water" advisory is rescinded Flush fixtures (e.g., faucet., and drinking fountains) and equipment for several minutes and restmt. Run water softene1·s through a regeneration cycle. Drain, disinfect, and refill water storage tanks, if needed. Change pretreatment filters and disinfect the dialysis water system.

Sewage spills/malfunction

Overall strategy Move patients and clean/sterile supplies out of the area. Redirect tratlic away from the. area. Close the doors or use plastic sheeting to isolate the area prior to clean~ up. Restore sewage system function first, then the potable water system (if both are malfunctioning). Remove sewage solids, drain the area, and let dry. Remediation of the structure Hard surfaces: clean with detergent/disinfectant after the area has been drained. Carpeting, loose tiles, buckled flooring: remove and allow the support surface to dry; replace the items; wet down carpeting with a low~ level disinfectant or sanitizer prior to removal to minimize dust dispersion to the air. Wallboard and other porous structural materials: remove and replace if they cannot be cleaned and dried within 72 hours.§ Furniture Hard surface furniture (e.g., metal or plastic furniture): clean and allow to dry. Wood furniture: let dry, sand the wood surface, and reapply varnish. Cloth fumiture: replace. Electrical equipment Replace ifthe item cannot be easily dismantled, cleaned, and reassembled.

* Material in this box iscompiled from references 266, 278, 315, 713, 716-719, 721-729. + Ice machines should always be disconnected from the water source in advance of planned water disruptions. * Moisture meter readings should be <20% moisture content.

An exception to these 1·ecommendations is made for hemodialysis units where water is further treated either by portable water treatment or large-scale water treatment systems usually involving reverse osmosis (RO). In the United States, >97% of dialysis facilities use RO treatment for their water. 721 However, changing pre-treatment filters and disinfecting the system to prevent colonization of the RO membrane and microbial contamination down-stream of the pre-treatment filter are prudent measures. 53

Box 10. Contingency planning for flooding

General emergency preparedness Ensure that emergency electrical generators are not located in flood-prone areas of the facility. Develop alternative strategies for moving patients, water containers, medical records, equipment, and supplies in the event that the elevators are inoperable. Establish in advance a centralized base of operations with batteries, flashlights, and cellular phones. Ensure sufficient supplies of sandbags to place at the entrances and the area around boilers, incinerators, and generators. Establish alternative strategies for bringing core employees to the facility if high water prevents travel. Staffing Patterns Temporarily reassign licensed staff as needed to critical care areas to provide manual ventilation and to perfmm vital assessments on patients. Designate a core group of employees to remain on site to keep all services operational if the facility remains open. Train all employees in emergency preparedness procedures. Regional planning among are facilities for disaster management Incorporate community suppmt and involvement (e.g., media alerts, news, and transportation). Develop in advance strategies for transfetTing patients, as needed. Develop strategies for sharing supplies and providing essential services among participating facilities (e.g., eenlral sterile department setvices, and laundry setvices). Identify sources for emergency provisions (e.g., blood, emergency vehicles, and bottled water). Medical services and infection control Use alcohol-based hand rubs in general patient-care areas. Postpone elective surgeries until full se1vices are restored, or transfer these patients to other facilities. ConsideJ' using pmtable dialysis machines.+ Provide an adequate supply of tetanus and hepatitis A immunizations for patients and staff. Climate control Provide adequate water for cooling towers.§

* Material in this box was compiled from references 713, 716-719. + Portable dialysis machines require less water compared to the larger units situated in dialysis settings. § Water for cooling towers may need to be trucked in, especially if the tower uses a potable water source.

4. Strategies for Controlling Waterborne Microbial Contamination a. Supplemental Treatment of Water with Heat and/or Chemicals In addition to using supplemental treatment methods as remediation measures after inadvertent contamination of water systems, health-care facilities sometimes use special measures to control waterborne microorganisms on a sustained basis. This decision is most often associated with outbreaks of legionellosis and subsequent efforts to controllegionellae,722 although some facilities have tried supplemental measures to better control thermophilic NTM. 627

The primary disinfectant for both cold and hot water systems is chlorine. However, chlorine residuals are expected to be low, and possibly nonexistent, in hot water tanks because of extended retention time in the tank and elevated water temperature. Flushing, especially that which removes sludge from the bottom of the tank, probably provides the most effective treatment of water systems. Unlike the situation for disinfecting cooling towers, no equivalent recommendations have been made for potable 403 723 wate1· systems, although specific intervention strategies have been published. ' The principal approaches to disinfection of potable systems are heat flushing using temperatures 160°F-170°F (71 o_ 770C), hyperchlorination, and physical cleaning of hot-water tanks. 3 • 403' 661 Potable systems are easily recolonized and may require continuous intervention (e.g., raising of hot water temperatures or continuous chlorination).' 03 • 711 Chlorine solutions lose potency over time, thereby rendering the stocking of large quantities of chlorine impractical. 54

Some hospitals with hot water systems identified as the source of Legionel!a spp. have performed emergency decontamination of their systems by pulse (i.e., one-time) thermal disinfection/superheating or hyperchlorination. 711 • 714 • 724 • 725 After either of these procedures, hospitals either maintain their heated water with a minimum return temperature of 124 °F (51 °C) and cold water at <68°F (<20°C) or 70 chlorinate their hot water to achieve 1-2 mg/L (1-2 ppm) offi·ee residual chlorine at the tap. 26 • 437• ,_711 • 726 727 ' Additional measures (e.g., physical cleaning or replacement of hot-water storage tanks, water heaters, faucets, and shower heads) may be required to help eliminate accumulations of scale and sediment that protect organisms from the biocidal effects of heat and chlorine. 457• 711 Alternative methods for controlling and eradicating legionellae in water systems (e.g., treating water with chlorine dioxide, heavy metal ions [i.e., copper/silver ions], ozone, and UV light) have limited the growth of legionellae under laboratory and operating conditions. 72 s-742 Further studies on the long-term efficacy of these treatments are needed before these methods can be considered standard applications.

Renewed interest in the use of chloramines stems from concerns about adverse health effects associated with disinfectants and disinfection by-products. 743 Monochloramine usage minimizes the formation of disinfection by-products, including trihalomethanes and haloacetic acids. Monochloramine can also reach distal points in a water system and can penetrate into bacterial biofilms more effectively than free chlorine. 744 However, monochloramine use is limited to municipal water treatment plants and is currently not available to health-care facilities as a supplemental water-treatment approach. A recent study indicated that 90% of Legionnaires disease outbreaks associated with drinking water could have been prevented ifmonochloramine rather than fi·ee chlorine has been used for residual disinfection. 745 In a retrospective comparison of health-care--associated Legionnaires disease incidence in central Texas hospitals, the same research group documented an absence of cases in facilities located in communities with monochloramine-treated municipal water. 746 Additional data are needed regarding the effectiveness of using monochloramine before its routine use as a disinfectant in water systems can be recommended. No data have been published regarding the effectiveness ofmonochloramine installed at the level of the health-care facility.

Additional filtration of potable water systems is not routinely necessaty. Filters are used in water lines in dialysis units, however, and may be inserted into the lines for specific equipment (e.g., endoscope washers and dis infectors) for the purpose of providing bacteria-free water for instmment reprocessing. Additionally, an RO unit is usually added to the distribution system leading toPE areas.

b. Primary Prevention of Legionnaires Disease (No Cases Identified) The primary and secondmy environmental infection-control strategies described in this section on the guideline pertain to health-care facilities without transplant units. Infection-control measures specific to PE or transplant units (i.e., patient-care areas housing patients at the highest risk for morbidity and mortality from Legionella spp. infection) are described in the subsection titled Preventing Legionnaires Disease in Protective Environments.

Health-care facilities use at least two general strategies to prevent health-care--associated legionellosis when no cases or only sporadic cases have been detected. The first is an environmental surveillance approach involving periodic culturing of water samples from the hospital's potable water system to monitor for Legionella spp 747- 750 If any sample is culture-positive, diagnostic testing is recommended for all patients with health-care--associated pneumonia. 748' 749 In-house testing is recommended for facilities with transplant programs as pmt of a comprehensive treatment/management program. lf2:30% of the samples are culture-positive for Legionella spp., decontamination of the facility's potable water system is warranted. 748 The premise for this approach is that no cases of health-care--associated legionellosis can occur if Legionella spp. are not present in the potable water system, and, conversely, cases of health-care--associated legionellosis could potentially occur if Legionella spp. are cultured fi·om the water."· 751 Physicians who are informed that the hospital's potable water system is culture-positive 55

for Legionella spp. are more likely to order diagnostic tests for legionellosis.

A potential advantage of the environmental surveillance approach is that periodic culturing of water is less costly than routine laboratory diagnostic testing for all patients who have health-care-associated pneumonia. The primmy argument against this approach is that, in the absence of cases, the relationship between water-culture results and legionellosis risk remains undefined.' Legionnella spp. can be present in the water systems ofbuildings752 without being associated with known cases of disease. 437• 707• 753 In a study of 84 hospitals in Quebec, 68% of the water systems were found to be colonized with Legionella spp., and 26% were colonized at> 30% of sites sampled; cases of Legionnaires disease, however, were infrequently reported from these hospitals. 707

Other factors also argue against environmental surveillance. Interpretation of results from periodic water culturing might be confounded by differing results among the sites sampled in a single water system and by fluctuations in the concentration of Leglonella spp. at the same site. 709' 754 In addition, the risk for illness after exposure to a given source might be influenced by several factors other than the presence or concentration of organisms, including a) the degree to which contaminated water is aerosolized into respirable droplets, b) the proximity of the infectious aerosol to the potential host, c) the susceptibility of the host, and d) the vimlence properties of the contaminating strain. 75 ,_757 Thus, data are insufficient to assign a level of disease risk even on the basis of the number of colony- forming units detected in samples from areas for immunocompetent patients. Conducting environmental surveillance would obligate hospital administrators to initiate water-decontamination programs if Legionella spp. are identified. Therefore, periodic monitoring of water fi·om the hospital's potable water system and from aerosol-producing devices is not widely recommended in facilities that have not experienced cases of health-care-associated legionellosis. 661 • 758

The second strategy to prevent and control health-care-associated legionellosis is a clinical approach, in which providers maintain a high index of suspicion for legionellosis and order appropriate diagnostic tests (i.e., culture, urine antigen, and direct fluorescent antibody [DFA] serology) for patients with health-care-associated pneumonia who are at high risk for legionellosis and its complications."'· 759• 760 The testing of autopsy specimens can be included in this strategy should a death resulting from health- care-associated pneumonia occur. Identification of one case of definite or two cases of possible health- care-associated Legionnaires disease should prompt an epidemiologic investigation for a hospital source of Legionella spp., which may involve culturing the facility's water for Legionella. Routine maintenance of cooling towers, and use of sterile water for the filling and terminal rinsing of nebulization devices and ventilation equipment can help to minimize potential sources of contamination. Circulating potable water temperatures should match those outlined in the subsection titled Water Temperature and Pressure, as permitted by state code.

c. Secondary prevention of Legionnaires Disease (With Identified Cases) The indications for a full-scale environmental investigation to search for and subsequently decontaminate identified sources of Legionella spp. in health-care facilities without transplant units have not been clarified; these indications would likely differ depending on the facility. Case categories for health-care-associated Legionnaires disease in facilities without transplant units include definite cases (i.e., laboratory-confirmed cases oflegionellosis that occur in patients who have been hospitalized continuously for 2:10 days before the onset of illness) and possible cases (i.e., laboratmy-confirmed infections that occur 2-9 days after hospital admission).' In settings in which as few as one to three health-care-associated cases are recognized over several months, intensified surveillance for Legionnaires disease has frequently identified numerous additional cases. 405 • 408• 432 • 453 • 739• 759• 760 This finding suggests the need for a low threshold for initiating an investigation after laboratory confirmation of cases of health-care-associated legionellosis. When developing a strategy for responding to such a finding, however, infection-control personnel should consider the level of risk for health-care- 56

associated acquisition of, and mortality from, Legione!la spp. infection at their particular facility.

An epidemiologic investigation conducted to determine the source of Legionella spp. involves several important steps (Box II). Laboratory assessment is crucial in supporting epidemiologic evidence of a link between human illness and a specific environmental source. 761 Strain determination from subtype analysis is most frequently used in these investigations 410• 762- 764 Once the environmental source is established and confi1med with laboratory support, supplemental water treatment strategies can be initiated as appropriate.

Box 11. Steps in an epidemiologic investigation for legionellosis

Review medical and microbiologic records. Initiate active surveillance to identify all recent or ongoing cases. Develop a line listing of cases by time, place, and person. Determine the type of epidemiologic investigation needed for assessing risk factors: • Case-control study, • Cohort study. Gather and analyze epidemiologic information: • Evaluate risk factors associated with potential environmental exposures (e.g., showers, cooling towers, and respiratory-therapy equipment). Collect water samples: • Sample environmental sources implicated by epidemiologic investigation, • Sample other potential source of water aerosols. Subtype strains of Legionel/a spp. cultured from both patients and environmental sources. Review autopsy records and include autopsy specimens in diagnostic testing.

The decision to search for hospital environmental sources of Legionella spp. and the choice of procedures to eradicate such contamination are based on several considerations, as follows: a) the hospital's patient population; b) the cost of an environmental investigation and institution of control measures to eradicate Legionella spp. from the water supply;76,_768 and c) the differential risk, based on host factors, for acquiring health-care--associated legionellosis and developing severe and fatal infection.

d. Preventing Legionnaires Disease in Protective Environments This subsection outlines infection-control measures applicable to those health-care facilities providing care to severely immunocompromised patients. Indigenous microorganisms in the tap water of these facilities may pose problems for such patients. These measures are designed to prevent the generation of potentially infectious aerosols from water and the subsequent exposure ofPE patients or other immunocompromised patients (e.g., transplant patients) (Table 17). Infection-control measures that address the use of water with medical equipment (e.g., ventilators, nebulizers, and equipment humidifiers) are described in other guidelines and publications.'·"'

If one case of laboratory-confirmed, health-care--associated Legionnaires disease is identified in a patient in a solid-organ transplant program or in PE (i.e., an inpatient in PE for all or part of the 2-10 days prior to onset of illness) or if two or more laboratory-confirmed cases occur among patients who had visited an outpatient PE setting, the hospital should report the cases to the local and state health departments. The hospital should then initiate a thorough epidemiologic and environmental investigation to determine the likely environmental sources of Legionella spp.' The source of Legionella should be decontaminated or removed. Isolated cases may be difficult to investigate. Because transplant recipients are at substantially higher Jisk for disease and death from legionellosis 57

compared with other hospitalized patients, peliodic cultr1ring for Legionella spp. in water samples from the potable water in the solid-organ transplant and/or PE unit can be perfonned as part of an overall strategy to prevent Legionnaires disease in PE units. 9.431 , 710• 769 TI1e optimal methodology (Le., frequency and number of sites) for environmental surveillance cultures in PE units has not been detennined, and the cost-effectiveness of this strategy has not been evaluated. Because transplant recipients are at high lisk for Legimmaires disease and because no data are available to detennine a safe concentration of legionellae organisms in potable water. the goal of environmental surveillance for Legionella spp. should be to maintain water systems with no detectable organismsY· 431 Culhrring for legionellae may be used to assess the effectiveness of water treatment or decontamination methods, a practice that provides benefits to both patients and health-care workers. 767• no

Tnble 17. Additionnl infection-control measures to prevent exposure of high-risk patients to waterborne pathogens M('HSUJ'eS Rl"fE't'('U('.(>S • Restl'ict patients from taking !>hower.s if the water is contaminated with Legionclla • 407,412, 654, 655, 658 spp. • Use water thai is not ~;ontamin

* These mea'>ures can be comidered in settings where legionellosis cases have occurred. Titese mN\S\Ires are not generally recommended in routine patient-cnre ~etting.. + 'fi1ese items have been associated with outbreaks of PMmdommms.

Protecting patient-care devices and il1stnrments 11-om inadvertent tap water contamination during room cleaning procedures is also important in any inununocompromised patient-care area. In a recent outbreak of gram-negative bacteremias among open-heart-surgery patients, pressure-monitoring equipment that was assembled and left uncovered ovemight prior to tile next day's surgeries was inadvertently contaminated with mists and splashing water from a hose-disinfectant system used for cleaning. 771

5. Cooling Towers and Evaporative Condensers lviodem health-care facilities maintain indoor climate control during wann weather by use of cooling towers (large facilities) or evaporative condensers (smaller buildings). A cooling tower is a wet-type, evaporative heat tr-ansfer device used to discharge to the atmosphere waste heat from a building's air conditioning condensers (Figme 5). 772 • 773 Warm water from air-conditioning condensers is piped to the cooling tower where it is sprayed downward into a counter- or cross-current air flow. To accelerate heat transfer to the air, the water passes over the till, which either breaks water into droplets or causes it to spread into a thin film. m. 773 Most systems use fans to move air tln'Ough the tower, although some large industrial cooling towers rely on natural draft circulation of air. TI1e cooled water from the tower is piped back to the condenser, where it again picks up heat generated during the process of chilling the system's refrigerant. The water is cycled back to the cooling tower to be cooled. Closed-circuit cooling towers and evaporative condensers are also evaporative heat-transfer devices. llr these systems, the 58

process fluid (e.g., water, ethylene glycol/water mixture, oil, or a condensing refi'igerant) does not directly contact the cooling air, but is contained inside a coil assembly. 661

Figure 5. Diagram of a typical air conditioning (induced draft) cooling tower*

Heated Refrigerant

Chilled

Water (80''Fl

Wate1· temperatures are approximate and may differ substantially according to system use and design. Wann water fi·om the condenser (or chiller) is sprayed downward into a counter~ or cross-cuJTent air flow. Water passes over the fill (a component of the system designed to increase the surface area of the water exposed to air), and heat from the water is transferred to the air. Some of the water becomes aerosolized during this process, although the volume of aerosol discharged to the air can be reduced by the placement of a drift eliminator. Water cooled in the towe1· returns to the heat source to cool refrigerant fi·om the air conditioning unit * This figure is reprinted with permission of the publisher of reference 773 (Plenum Medical). Cooling towers and evaporative condensers incorporate inertial stripping devices caiJed drift eliminators to remove water droplets generated within the unit. Although the effectiveness of these eliminators varies substantiaiJy depending on design and condition, some water droplets in the size range of <5 ~m will likely leave the unit, and some larger droplets leaving the unit may be reduced to ,:'05 ~m by evaporation. Thus, even with proper operation, a cooling tower or evaporative condenser can generate and expel respirable water aerosols. If either the water in the unit's basin or the make-up water (added to replace water lost to evaporation) contains Legionella spp. or other waterborne microorganisms, these organisms can be aerosolized and dispersed from the unit. 774 Clusters of both Legionnaires disease and Pontiac fever have been traced to exposure to infectious water aerosols originating from cooling towers and evaporative condensers contaminated with Legionella spp. Although most of these outbreaks have been community-acquired episodes of pneumonia, 77 s-782 health-care-associated Legionnaires disease 59

has been linked to cooling tower aerosol exposure. 404 • 405 Contaminated aerosols from cooling towers on hospital premises gained entry to the buildings either through open windows or via air handling system intakes located near the tower equipment.

Cooling towers and evaporative condensers provide ideal ecological niches for Legionel/a spp. The typical temperature of the water in cooling towers ranges from 85°F-95°F (29°C-35'C), although temperatures can be above l20°F (49°C) and below 70°F (21 °C) depending on system heat load, ambient temperature, and operating strategy. 661 An Australian study of cooling towers found that legionellae colonized or multiplied in towers with basin temperatures above 60.8°F (l6°C), and multiplication became explosive at temperatures above 73.4'F (23°C). 783 Water temperature in closed- circuit cooling towers and evaporative condensers is similar to that in cooling towers. Considerable variation in the piping arrangement occurs. In addition, stagnant areas or dead legs may be difficult to clean or penetrate with biocides.

Several documents address the routine maintenance of cooling towers, evaporative condensers, and whirlpool spas. 661 • 784-787 They suggest following manufacturer's recommendations for cleaning and biocide treatment of these devices; all health-care facilities should ensure proper maintenance for their cooling towers and evaporative condensers, even in the absence of Legion ella spp (Appendix C). Because cooling towers and evaporative condensers can be shut down during periods when air conditioning is not needed, this maintenance cleaning and treatment should be performed before sta1ting up the system for the first time in the warm season. 782 Emergency decontamination protocols describing cleaning procedures and hyperchlorination for cooling towers have been developed for towers implicated in the transmission of legionellosis. 786 • 787

6, Dialysis Water Quality and Dialysate a. Rationale for Water Treatment i11 Hemodialysis Hemodialysis, hemofiltration, and hemodiafiltration require special water-treatment processes to prevent adverse patient outcomes of dialysis therapy resulting from improper formulation of dialysate with water containing high levels of ce1tain chemical or biological contaminants. The Association for the Advancement of Medical Instrumentation (AAMI) has established chemical and microbiologic standards for the water used to prepare dialysate, substitution fluid, or to reprocess hemodialyzers for renal replacementtherapy. 78... 792 The AAMT standards address: a) equipment and processes used to purify water for the preparation of concentrates and dialysate and the reprocessing of dialyzers for multiple use and b) the devices used to store and distribute this water. Future revisions to these standards may include hemofiltration and hemodiafiltration.

Water treatment systems used in hemodialysis employ several physical and/or chemical processes either singly or in combination (Figure 6). These systems may be pmtable units or large systems that feed several rooms. In the United States, >97% of maintenance hemodialysis facilities use RO alone or in combination with deionization. 793 Many acute-care facilities use portable hemodialysis machines with attached portable water treatment systems that use either deionization or RO. These machines were exempted fi·om earlier versions of AAMT recommendations, but given current knowledge about toxic exposures to and inflammatmy processes in patients new to dialysis, these machines should now come 788 into compliance with current AAMI recommendations for hemodialysis water and dialysate quality. ' 789 Previous recommendations were based on the assumption that acute-care patients did not experience the same degree of adverse effects from short-term, cumulative exposures to either chemicals or microbiologic agents present in hemodialysis fluids compared with the effects encountered by patients during chronic, maintenance dialysis. 788 • 789 Additionally, JCAHO is reviewing inpatient 60

practices and record-keeping for dialysis (acute and maintenance) for adherence to AAMI standards and reconnnended practices.

Figure 6. Dialysis water treatment system*

water

Potable water

Blending valve

Mullimedia/ Softener Carbon adsorption Particulate/ Reverse Storage tank and/or sand/depth media (2 beds in 1 pm filter osmosis optional additional filtration series) components: deionization tanks UVIamp ultrafilters

* Sec text for de<;cription of the phtcement and function of these components.

Neither the water used to prepare dialysate nor the dialysate itself needs to be sterile. but tap water can not be used without additional treatment. Infections caused by rapid-growing NTM (e.g., Mycobacterium chelouae and M. abscessus) present a potential risk: to hemodialysis patients (especially those in hemodialyzer reuse progrmns) if disinfection procedures to inactivate mycobacteria in the water (low-level disinfection) and the hemodialyzers (high-level disinfection) are inadequate. 31 · 32 •633 Other factors associated with microbial contamination in dialysis systems could involve the water treatment system, the water and dialysate distribution systems, mld the type ofhemodialyzer. 666• 667 • 794-799 Understanding the various factors and their influence on contamination levels is the key to preventing high levels of microbial contamination in dialysis therapy.

In several studies, pyrogenic reactions were demonstrated to have been caused by lipopolysaccharide or endotoxin associated with gram-negative bacteria. 794 ·'0o--803 Early studies demonstmted that parenteral exposure to endotoxin at a concentration of I nglkg body weight/hom was the tlu·eshold dose for producin,ll ~6;rogenic reactions in humans, and that the relative potencies of endotoxin differ by bacterial species.' · 5 Gram-negative water bacteria (e.g., Pseudomonas spp.) have been shown to multiply rapidly in a variety of hospital-associated fluids that can be used as supply water for hemodialysis (e.g., distilled water, deionized water, RO water, and softened water) and in dialysate (a balanced salt solution made with this water). 806 Several studies have demonstrated that the attack: rates of pyrogenic reactions are directly associated with the munber of bacteria in dialysate. 666• 667• 807 TI1ese studies provided the rationale for setting the heterotrophic bacteria standards in the first AAMI hemodialysis guideline at ::;2,000 CFU/mL in dialysate and one log lower (;::200 CFU/mL) for the water used to prepare dialysate. 668• 788 If the level of bacterial contamination exceeded 200 CFU/mL in water, this level could be amplified in the system and effectively constitute a high inoculum for dialysate at the stmt of a 61

808 dialysis treatment.'"· Pyrogenic reactions did not appear to occur when the level of contamination was below 2,000 CFU/mL in dialysate unless the source of the endotoxin was exogenous to the dialysis system (i.e., present in the community water supply). Endotoxins in a community water supply have been linked to the development of pyrogenic reactions among dialysis patients. 794

Whether endotoxin actually crosses the dialyzer membrane is controversial. Several investigators have shown that bacteria growing in dialysate-generated products that could cross the dialyzer membrane. 809' 810 Gram-negative bacteria growing in dialysate have produced endotoxins that in turn stimulated the production of anti-endotoxin antibodies in hemodialysis patients; 801 • 811 these data suggest that bacterial en do toxins, although large molecules, cross dialyzer membranes either intact or as fragments. The use of the very permeable membranes known as high-flux membranes (which allow large molecules [e.g., p2 microglobulin] to traverse the membrane) increases the potential for passage ofendotoxins into the blood path. Several studies support this contention. In one such study, an increase in plasma endotoxin concentrations during dialysis was observed when patients were dialyzed against dialysate containing I 03-1 04 CFU/mL Pseudomonas spp. 812 In vitro studies using both radio labeled lipopolysaccharide and biologic assays have demonstrated that biologically active substances derived from bacteda found in dialysate can cross a variety of dialyzer membranes.'"· 81 ,_816 Patients treated with high-flux membranes have had higher levels of anti-endotoxin antibodies than subjects or patients treated with conventional membranes. 817 Finally, since 1989, 19%--22% of dialysis centers have reported pyrogenic ' reactiOns ' h b f . . 818 819 tn t e a sence o septJCemm. '

Investigations of adverse outcomes among patients using reprocessed dialyzers have demonstrated a greater risk for developing pyrogenic reactions when the water used to reprocess these devices contained >6 ng/mL endotoxin and >I 0 4 CFU/mL bacteria. 820 In addition to the variability in endotoxin assars, host factors also are involved in determining whether a patient will mount a response to endotoxin. 80 Outbreak investigations of pyrogenic reactions and bacteremias associated with hemodialyzer reuse have demonstrated that pyrogenic reactions are prevented once the endotoxin level in the water used to reprocess the dialyzers is returned to below the AAMI standard level. 821

Reuse of dialyzers and use of bicarbonate dialysate, high-flux dialyzer membranes, or high-flux dialysis may increase the potential for pyrogenic reactions if the water in the dialysis setting does not meet standards. 796- 798 Although investigators have been unable to demonstrate endotoxin transfer across dialyzer membranes, 803 • 822• 823 the preponderance of repotts now suppotts the ability of endotoxin to transfer across at least some high-flux membranes under some operating conditions. In addition to the acute risk of pyrogenic reactions, indirect evidence in increasingly demonstrating that chronic exposure to low amounts of endotoxin may play a role in some of the long-term complications of hemodialysis therapy. Patients treated with ultrafiltered dialysate for 5-6 months have demonstrated a decrease in serum p, microglobulin concentrations and a decrease in markers of an inflammatory response. 824- 826 In studies of longer duration, use of microbiologically ultrapure dialysate has been associated with a decreased incidence of p2 microglobulin-associated amyloidosis.'"· 828

Although patient benefit likely is associated with the use of ultrapure dialysate, no consensus has been reached regarding the potential adoption of this as standard in the United States. Debate continues regarding the bacterial and endotoxin limits for dialysate. As advances in water treatment and hemodialysis processes occur, effotts are underway to move improved technology from the manufacturer out into the user community. Cost-benefit studies, however, have not been done, and substantially increased costs to implement newer water treatment modalities are anticipated.

To reconcile AAMI documents with current International Organization for Standardization (ISO) format, AAMI has determined that its hemodialysis standards will be discussed in the following four installments: RD 5 for hemodialysis equipment, RD 62 for product water quality, RD 47 for dialyzer 62

reprocessing, ~nd RD 52 for di~lys~te quality. Tire Renal Dise~ses and Dialysis Committee of Ai\.MI is expected to finalize and promulgated the dialysate standard pertinent to the user community (RD 52), adopting by reference the bacterial and endotoxin limits in product water as cnnently outlined in the AAMI standard that applies to systems manufacturers (RD 62). At present, the user conummity should continue to observe water quality and dialysate standards as outlined in MMI RD 5 (Hemodialysis Systems. 1992) and MMI RD 47 (Reuse ofHemodialyzers. 1993) 1mtil the new RD 52 standard becomes available (Table 18)n9• 791

Table 18. Microbiologic limits for hemodialysis fluids* Maximum total ht"h.•rotrophs l\tlRximum (\Udotoxin Jevtll Hemodlnlysls fluid (CFU!mL)+ (EU/mL)§ Present standard Product wntet, Used to prepare dialy.sate 200 No standntd Used to reprocess dialyurs 200 5 Dialysate 2,000 No !i.hmdard Proposed standard** Product m1ter 200 2 Dialysate 200 2

* The mi\terial in this table was compiled from refere11ces 789 and 791 (ANSIIAAMI standards RD 5.1992: and ANSIIAAMI RD 47-1993). + Colony tbnuing units per milhlih'r. § Endotoxin units per ttUIIiliter. ~ Product water presently includes water 11sed 10 prepare dial~te and water used to reproces:; dialyzers. ** Dialysate for hemodialysis, RD 52. under development, American National Standard'> Institute, Association for the Advancement of Medicallnstmmentation (AAMI).

The cunent AAMI stand~rd directed at systems manufacturers (RD 62 [Water Tre~tment Equipment for Hemodialysis Applications. 2001]) now specitles that all product water used to prepare dialysate or to reprocess dialyzers for nmltiple use should contain <2 endotoxin units per milliliter (EU/mL). 792 A level of 2 EU/mL was chosen as the upper limit for endotoxin because this level is easily achieved with contempormy water treatment systems using RO and/or ultrafiltration. CDC h~s ~dvocated monthly endotoxin testing along with microbiologic assays of water, because endotoxin activity may not conespond to the total heterotrophic plate counts. 829 Additionally, the cmTent AAl'vll st~udard RD 62 for manufacturers includes action levels for product water. Because 48 hours can elapse between the time of sampling water for microbial contamin~tion and the time when results are received, and bec~use bacterial proliferation can be rapid, action levels for microbial counts and endotoxin concentrations are reported as 50 CFU/mL and 1 EUimL, respectively, in this revision of the standard. 792 These recommendations will allow users to initiate corrective action before levels exceed the maximum levels established by the standard.

In hemodialysis, the net movement of water is from the blood to the dialys~te, although within the dialyzer, loc~l movement of water fi·om the dialysate to the blood tlu'Ough the phenomenon ofback- tlltration may occur. p~rticularly in dialyzers with highly penne~ble membranes. 830 In contrast, hemoliltration m1d hemodiallltration feature infusion of large volumes of electrolyte solution (20-70 L) into the blood. Increasingly. this electrolyte solution is being prepared on-line from water and concentrate. Because of the large volumes of t1uid infused. AAMI considered the necessity of setting more stringent requirements for w~ter to be used in this application, but this organiz~tion has not yet established these because of lack of expert consensus and insufticient experience with on-line therapies in the United States. On-line hemofiltration and hemotliafiltration systems use sequential ultrafiltration as the final step in the preparation of infusion t1uid. Several experts fi·om A.AMI concm that these 63

point-of-use ultrafiltration systems should be capable of further reducing the bacteria and endotoxin burden of solutions prepared from water meeting the requirements of the AAMI standard to a safe level for infusion.

b. Microbial Co/llrol Strategies The strategy for controlling massive accumulations of gram-negative water bacteria and NTh! in dialysis systems primarily involves preventing their growth tluough proper disinfection of water- treatment systems and hemodialysis machines. Gram-negative water bacteria, their associakd lipopolysaccharides (bacterial endotoxins). and NTlv! ultimately come fi·om the community water supply, and levels of these bacteria can be amplified depending on the water treatment sy,stem, dialysate distribution system, type of dialysis machine. and method of disinfection (Table 19). 634• 94• '" Control strategies are designed to reduce levels of microbial contamination in water and dialysis t1uid to relatively low levels but not to completely eradicate it.

Table 19. Factors influencing microbial contnmination in bemodinlysis systems Fnc:tors Commt'uts Water supplv Source of community water Gr01md water Contains endotoxin and bacteria Smface water Contnins high levels of endotoxin and bacterin Water treatment at the dialr.sif center None Not recommended Filtration Prdilter Pnrticulnte filier to protect equipment: doe<> not remove lllicrool'g.auisms Ab.solute filter (depth or membrane tiller) Removes bncteria, howevel', unles'> the filter is changed frequently or disiutCcted, bacteria will accmnulate and grow through the filter; acts a<, a '>ignificant reservoir of bacteria and endotoxin Activated carbon filiet· Removes organics and available chlorine or chJonunines; acts as a si~mificant reservoir of bacteria and endotoxin Water h·eqhllent device.s Deiouizntion!iou-cxchange softener Both ~of!encrs and deionizers are significant n!'>ervoirs of bacteria and do not remove endotoxin. Reverse osmosis (RO) Remows bacteria and endotoxin, but must be disinfected: op¢rntes at high wnter pressure Ultraviolet light Kills so!ue bacteria, but thel'e is no xesidual; ultraviolet-l'esistant bacterin cuu develop if the 1mit is not properly maintained Ultmfi1ter Removes bacteria and endotoxin: opemtes on nonnal Hue pre<>Sure; can be positioned distal to deionizer; must be disinfected Water and dialysate distribution svstem Distribution pipes Size Oversized diameter nud length decrease tluid flow aud increase bacteTinl t·eser\'oir fol' both treated water and centmlly·p1·epnred dialysate. Construction Rough joint::., dead ends, mm.sed hrnnchec;, and poJyviuyl chloride (PVC) piping: can net a;; bactl!l'ial reservoir<>. Elevation Outlet taps should be located at the highest el~vation to pJevent loss of disinfectant: keep t1 recirculation loop in the system; flush unused ports routinely. Storage t(\uks Tanks are 'mdesirable becrmse they uct as a reservoir for water bacteria; if tnnks are present, they must be routinely scntbbed and disinfected. Dialvsis machines Sing:le~pass DisinfeCtant should have contact with all pru1'> of the machine that are exposed to water or dlnlysis fluid. Recirculating: single-pass or recircnlaiing Recirculi\ling pump'> and machine design allow for massiv-e contmnination (bntch) levels if uot pmpet'ly disinfected; ovemight chemical gennicide treatment is reconunended, 64

Two components of hemodialysis water distribution systems- pipes (particularly those made of polyvinyl chloride [PVC]) and storage tanks- can serve as resel'Yoirs of microbial contamination. Hemodialysis systems frequently use pipes that are wider and longer than are needed to handle the required flow, which slows the fluid velocity and increases both the total fluid volume and the wetted surface area of the system. Gram-negative bacteria in fluids remaining in pipes overnight multiply rapidly and colonize the wet surfaces, producing bacterial populations and endotoxin quantities in proportion to the volume and surface area. Such colonization results in formation of protective biofilm that is difficult to remove and protects the bacteria from disinfection.'" Routine (i.e., monthly), low- level disinfection of the pipes can help to control bacterial contamination of the distribution system. Additional measures to protect pipes from contaminations include a) situating all outlet taps at equal elevation and at the highest point of the system so that the disinfectant cannot drain from pipes by gravity before adequate contact time has elapsed and b) eliminating rough joints, dead-end pipes, and unused branches and taps that can trap fluid and serve as reservoirs of bacteria capable of continuously inoculating the entire volume of the system. 800 Maintain a flow velocity of3-5 ft/sec.

A storage tank in the distribution system greatly increases the volume of fluid and surface area available and can serve as a niche for water bacteria. Storage tanks are therefore not recommended for use in dialysis systems unless they are frequently drained and adequately disinfected, including scrubbing the 808 sides of the tank to remove bacterial biofilm. An ultrafilter should be used distal to the storage tank. ' 833

Microbiologic sampling of dialysis fluids is recommended because gram-negative bacteria can proliferate rapidly in water and dialysate in hemodialysis systems; high levels of these organisms place 668 808 patients at risk for pyrogenic reactions or health-care--associated infection. 667• •

Health-care facilities are advised to sample dialysis fluids at least monthly using standard microbiologic assay methods for waterborne microorganisms.'"· 793 • 799• 83.,_ 836 Product water used to prepare dialysate and to reprocess hemodialyzers for reuse on the same patient should also be tested for bacterial endotoxin on a monthly basis. 792 • 829• 837 (See Appendix C for information about water sampling methods for dialysis.)

Cross-contamination of dialysis machines and inadequate disinfection measures can facilitate the spread of waterborne organisms to patients. Steps should be taken to ensure that dialysis equipment is performing correctly and that all connectors, lines, and other components are specific for the equipment, in good repair, and properly in place. A recent outbreak of gram-negative bacteremias among dialysis patients was attributed to faulty valves in a drain port of the machine that allowed backflow of saline used to flush the dialyzer before patient use. 838' 839 This backflow contaminated the drain priming connectors, which contaminated the blood lines and exposed the patients to high concentrations of gram-negative bacteria. Environmental infection control in dialysis settings also includes low-level disinfection of housekeeping surfaces and spot decontamination of spills of blood (see Environmental Services in PattI of this guideline for further information).

c. Infection-Control Issues in Peritoneal Dialysis Peritoneal dialysis (PD), most commonly administered as continuous ambulatory peritoneal dialysis (CAPD) and continual cycling peritoneal dialysis (CCPD), is the third most common treatment for end- 840 stage renal disease (ESRD) in the United States, accounting for 12% of all dialysis patients. Peritonitis is the primary complication ofCAPD, with coagulase-negative staphylococci the most clinically significant causative organisms. 841 Other organisms that have been found to produce peritonitis include Staphylococcus aureus, Mycobacteriumfortuitum, M. mucogenicum, Stenotrophomonas maltophilia, Burkholderia cepacia, Cmynebacteriumjeikeium, Candida spp., and 65

other fungi. 84 2-sso Substantial morbidity is associated with peritoneal dialysis infections. Removal of peritoneal dialysis catheters usually is required for treatment of peritonitis caused by fungi, NTM, or other bacteria that are not cleared within the first several days of effective antimicrobial treatment. Furthermore, recurrent episodes of peritonitis may lead to fibrosis and loss of the dialysis membrane.

Many reported episodes of peritonitis are associated with exit-site or tunneled catheter infections. Risk factors for the development of peritonitis in PD patients include a) under dialysis, b) immune suppression, c) prolonged antimicrobial treatment, d) patient age [more infections occur in younger patients and older hospitalized patients], e) length of hospital stay, and f) hypoalbuminemia. 844• ' 51 • 852 Concern has been raised about infection risk associated with the use of automated cyclers in both inpatient and outpatient settings; however, studies suggest that PD patients who use automated cyclers have much lower infection rates. 853 One study noted that a closed-drainage system reduced the incidence of system-related peritonitis among intermittent peritoneal dialysis (TPD) patients from 3.6 to 1.5 cases/ I 00 patient days. 854 The association of peritonitis with management of spent dialysate fluids requires additional study. Therefore, ensuring that the tip of the waste line is not submerged beneath the water level in a toilet or in a drain is ptudent.

7. Ice Machines and Ice Microorganisms may be present in ice, ice-storage chests, and ice-making machines. The two main sources of microorganisms in ice are the potable water from which it is made and a transferral of organisms from hands (Table 20). Ice from contaminated ice machines has been associated with patient colonization, blood stream infections, pulmonmy and gastrointestinal illnesses, and pseudoinfections. 602 ' 603 683 684 854 855 • • • • Microorganisms in ice can secondarily contaminate clinical specimens and medical solutions that require cold temperatures for either transport or holding. 601 • 620 An outbreak of surgical- site infections was interrupted when sterile ice was used in place of tap water ice to cool cardioplegia solutions. 601

Table 20. Microorganisms and their sources in ice and ice machines

Sources of microorganisms References

From potable water Legionelta spp. 684,685,857,858 Nontuberculous mycobacteria (NTM) 602, 603, 859 Pseudomonas aeruginosa 859 Burkholderia cepacia 859, 860 Stenotrophomonas ma!tophilia 860 Flavobacterium spp. 860 From fecally-contaminated water Nmwalk virus 861-863 Giardia Iamblia 864 Cryptosporidium parvum 685 From hand-transfer of organisms Acinetobacter spp. 859 Coagulasc~negative staphylococci 859 Salmonella enteriditis 865 Cryptosporidium parvum 685 66

In a study comparing the microbial populations of hospital ice machines with organisms recovered from ice samples gathered from the community, samples from 27 hospital ice machines yielded low numbers (<10 CFU/mL) of several potentially opportunistic microorganisms, mainly gram-negative bacilli.'" During the survey period, no health-care--associated infections were attributed to the use of ice. Ice from community sources had higher levels of microbial contamination (75o/o-95% of 194 samples had total heterotrophic plate counts <500 CFU/mL, with the proportion of positive cultures dependent on the incubation temperature) and showed evidence of fecal contamination from the source water. 859 Thus, ice machines in health-care settings are no more heavily contaminated compared with ice machines in the community. If the source water for ice in a health-care facility is not fecally contaminated, then ice from clean ice machines and chests should pose no increased hazard for immunocompetent patients. Some waterborne bacteria found in ice could potentially be a risk to immunocompromised patients if they consume ice or drink beverages with ice. For example, Burkholderia cepacia in ice could present an infection risk for cystic fibrosis patients.'"· 860 Therefore, protecting immunosuppressed and otherwise medically at-risk patients from exposure to tap water and ice potentially contaminated with opportunistic pathogens is prudent. 9

No microbiologic standards for ice, ice-making machines, or ice storage equipment have been established, although several investigators have suggested the need for such standards.'"· 866 Culturing of ice machines is not routinely recommended, but it may be useful as part of an epidemiologic investigation. 867- 869 Sampling might also help determine the best schedule for cleaning open ice-storage chests. Recommendations for a regular program of maintenance and disinfection have been published. 866-869 Health-care facilities are advised to clean ice-storage chests on a regular basis. Open ice chests may require a more frequent cleaning schedule compared with chests that have covers. Pmtable ice chests and containers require cleaning and low-level disinfection before the addition of ice intended for consumption. Ice-making machines may require less frequent cleaning, but their maintenance is important to proper performance. The manufacturer's instructions for both the proper method of cleaning and/or maintenance should be followed. These instructions may also recommend an EPA-registered disinfectant to ensure chemical potency, materials compatibility, and safety. In the event that instructions and suitable EPA-registered disinfectants are not available for this process, then a generic approach to cleaning, disinfecting, and maintaining ice machines and dispensers can be used (Box 12).

lee and ice-making machines also may be contaminated via improper storage or handling of ice by patients and/or staff. 68<- 686• 85 '-858• 870 Suggested steps to avoid this means of contamination include a) minimizing or avoiding direct hand contact with ice intended for consumption, b) using a hard-surface scoop to dispense ice, and c) installing machines that dispense ice directly into pmtable containers at the touch of a control. 687' 869

Box 12. General steps for cleaning and maintaining ice machines, dispensers, and storage chests*+

1. Disconnect unit from power supply. 2. Remove and discard ice from bin or storage chest. 3, Allow unit to warm to room temperature. 4. Disassemble removable parts of machine that make contact with water to make ice. 5. Thoroughly clean machine and parts with water and detergent. 6. Dry external surfaces of removable parts before reassembling. 7. Check for any needed repair. 8. Replace feeder lines, as appropriate (e.g., when damaged, old, or difficult to clean). 9. Ensure presence of an air space in tubing leading from water inlet into water distribution system of machine. 67

(Box 12. continued)

10. Inspeft for rodt>ut or ins<>cf iufest.ntions undt>l' th<> unit and treat, as U('edt'd~ 11. Check door gaskets (oJ>Nl comp;ufJU('Ut modt'ls) for e-vidNtre of leakage or dripping into the . storagE' dt('st. 12. Clenn the INH;tpm solution), or 4 hom~ (~0 ppm solution). 14. Drain sodium hypoellJorite solutions and flush with fr<>slt tnp wntN". 15. Allow an surfaces of \l:quipmt>nt to dr;r b('fOI'e t•etnruing to setvkE".

* Material in this box is adapted from reference 869. ·~ 11ICst." general guidelines should be used only when.• manufacturer-.recommeuded methods nnd EPA-registereddisinf~tauts are not available.

8. Hydrotherapy Tanks and Pools a. General Information Hydrotherapy equipment (e.g., pools, whirlpools. whirlpool spas, hot tubs, and physiotheraJ?t tmtks) traditionally has been used to treat patients with certain medical conditions (e.g .. bums."'· septic ulcers. lesions, amputations,m orthopedic impainnents and injuries, artlu·itis,'74 and kidney lithotripsy). 654 Wound-care medicine is increasingly moving away fi·om hydrotherapy, however, in favor of bedside pulsed-lavage therapy using sterile solutions for cleaning and irrigation. 492 •875_. 78 Several episodes of health-care-associated infections have been linked to use of hydrotherapy equipment (Table 21). Potential rontes of infection include incidental ingestion of the water, S]Jrays and aerosols, and direct contact with wounds and intact skin (folliculitis). Risk factors for infection include a) age and sex of the patient, b) underlying medic~] conditions, c) length of time spent in the hydrotherapy water, and d) pm1als of entry.819

Table 21. Infections associated with use of hydrotherapy equipment Microore:anisms i\I~dic-nl conditions R('fe-reuct.>S Acinetobacter bmmumii Sep<:.is 572 Cih·obacter {l'eundii Cellulitis 880 Enterobacter cloacae Sepsis 881 Lezionella spp. Lee:ionello~is 882 Mycobnctet1um abscessus, Mycobncterittm Skin ulcers nnd soft tissue intections 621-{;23,883 jorruitum, P,Iycoba('/erium marimtm Sepsis. soft tissue infections, follic\Jlitis, mld Pseudomonas aerugiuosa 492,493.506,679,884-888 wound infection'> Adenovi.tm, adeno-assodated vims Conjunctivitis 889

Infection control for hydrotherapy tanks, pools, or bhthing tattks presents unique challenges because indigenous microorganisms are always present in the water during treatments. In addition, some studies have found free living amoebae (i.e., Naegleria lomniensis), which m·e conunonly found in association with Naegleriafow/eri, in hospital hydrotherapy pools 890 Although hydrotherapy is at times appropliate for patients with wounds, bums. or other types of non-intact skin conditions (determined on a case-by-case basis), this equipment should not be considered "semi-critical" in accordance with the Spaulding classification. 891 Microbial data to evaluate the Jisk of infection to patients using hydrotherapy pools and birthing tanks are insufficient. Nevettheless, health-care facilities should maintain stringent cleaning and disinfection practices in accordance with the manufacturer's instmctions 68

and with relevant scientific literature until data supporting more rigorous infection-control measures become available. Factors that should be considered in therapy decisions in this situation would include a) availability of alternative aseptic techniques for wound management and b) a risk-benefit analysis of using traditional hydrotherapy.

b. Hydrotherapy Tanks Hydrotherapy tanks (e.g., whirlpools, Hubbard tanks and whirlpool bath tubs) are shallow tanks constructed of stainless steel, plexiglass, or tile. They are closed-cycle water systems with hydrojets to circulate, aerate, and agitate the water. The maximum water temperature range is 50°F-I 04 op (I 0°G- 400C). The wann water temperature, constant agitation and aeration, and design of the hydrotherapy tanks provide ideal conditions for bacterial proliferation if the equipment is not properly maintained, cleaned, and disinfected. The design of the hydrotherapy equipment should be evaluated for potential infection-control problems that can be associated with inaccessible surfaces that can be difficult to clean and/or remain wet in between uses (i.e., recessed drain plates with fixed grill plates). 887 Associated equipment (e.g., parallel bars, plinths, Hoyer lifts, and wheelchairs) can also be potential reservoirs of microorganisms, depending on the materials used in these items (i.e., porous vs. non-porous materials) and the surfaces that may become wet during use. Patients with active skin colonizations and wound infections can serve as sources of contamination for the equipment and the water. Contamination from spilled tub water can extend to drains, floors, and walls:'a- 683 Health-care-associated colonization or infection can result from exposure to endogenous sources of microorganisms (autoinoculation) or exogenous sources (via cross-contamination from other patients previously receiving treatment in the unit).

Although some facilities have used tub liners to minimize environmental contamination of the tanks, the use of a tub liner does not eliminate the need for cleaning and disinfection. Draining these small pools and tanks after each patient use, thoroughly cleaning with a detergent, and disinfecting according to manufacturers' instructions have reduced bacterial contamination levels in the water from I 04 CFU/mL to

A few reports describe the addition of antiseptic chemicals to hydrotherapy tank water, especially for burn patient therapy. 89s-s 97 One study involving a minimal number of participants demonstrated a reduction in the number of Pseudomonas spp. and other gram-negative bacteria from both patients and equipment surfaces when chloramine-T ("chlorazene") was added to the water. 898 Chloramine-T has not, however, been approved for water treatment in the United States.

c, Hydrotherapy Pools Hydrotherapy pools 1ypically serve large numbers of patients and are usually heated to 91.4°F-98.6°F (31 °C-37°C). The temperature range is more narrow (94°F-96.8°F [35"C-36"C]) for pediatric and geriatric patient use. 899 Because the size of hydrotherapy pools precludes draining after patient use, proper management is required to maintain the proper balance of water conditioning (i.e., alkalinity, hardness, and temperature) and disinfection. The most widely used chemicals for disinfection of pools 69

are chlorine and chlorine compounds- calcium hypochlorite, sodium hypochlorite, lithium hypochlorite, chloroisocyanurates, and chlorine gas. Solid and liquid formulations of chlorine chemicals are the easiest and safest to use. 900 Other halogenated compounds have also been used for pool-water disinfection, albeit on a limited scale. Bromine, which forms bactericidal bromamines in the presence of ammonia, has limited use because of its association with contact dennatitis. 901 Iodine does not bleach hair, swim suits, or cause eye irritation, but when introduced at proper concentrations, it gives water a greenish-yellowish cast.'"

In practical terms, maintenance of large hydrotherapy pools (e.g., those used for exercise) is similar to that for indoor public pools (i.e., continuous filtration, chlorine residuals no less than 0.4 ppm, and pH of7.2-7.6). 902' 903 Supply pipes and pumps also need to be maintained to eliminate the possibility of this equipment serving as a reservoir for waterborne organisms. 904 Specific standards for chlorine residual and pH of the water are addressed in local and state regulations. Patients who are fecally incontinent or who have draining wounds should refrain from using these pools until their condition improves.

d. Birthing Tanks and Other Equipment The use of birthing tanks, whirlpool spas, and whirlpools is a recent addition to obstetrical practice. 905 Few studies on the potential risks associated with these pieces of equipment have been conducted. In one study of 32 women, a newborn contracted a Pseudomonas infection after being birthed in such a 906 tank, the strain of which was identical to the organism isolated from the tank water. Another repott documented identical strains of P. aeruginosa isolates from a newbom with sepsis and on the environmental surfaces of a tub that the mother used for relaxation while inlabor. 907 Other studies have shown no significant increases in the rates of post~ immersion infections among mothers and infants. 908' 909

Because the water and the tub surfaces routinely become contaminated with the mother's skin flora and blood during labor and delivery, birthing tanks and other tub equipment must be drained after each patient use and the surfaces thoroughly cleaned and disinfected. Health-care facilities are advised to follow the manufacturer's instmctions for selection of disinfection method and chemical germicide. The range of chlorine residuals for public whirlpools and whirlpool spas is 2-5 ppm? 10 Use of an inflatable tub is an alternative solution, but this item must be cleaned and disinfected between patients if it is not considered a single-use unit.

Recreational tanks and whirlpool spas are increasingly being used as hydrotherapy equipment. Although such home equipment appears to be suitable for hydrotherapy, they are neither designed nor constructed to function in this capacity. Additionally, manufacturers generally are not obligated to provide the health-care facility with cleaning and disinfecting instructions appropriate for medical equipment use, and the U.S. Food and Drug Administration (FDA) does not evaluate recreational equipment. Health-care facilities should therefore carefully evaluate this "off-label" use of home equipment before proceeding with a purchase.

9. Miscellaneous Medical/Dental Equipment Connected to Main Water Systems a. Automated Endoscope Reprocessors The automated endoscopic reprocessor (AER) is classified by the FDA as an accessory for the flexible endoscope. 654 A properly operating AER can provide a more consistent, reliable method of decontaminating and terminal reprocessing for endoscopes between patient procedures than manual reprocessing methods alone. 911 An endoscope is generally subjected to high-level disinfection using a 70

liquid chemical sterilant or a high-level disinfectant. Because the instrument is a semi-critical device, the optimal rinse fluid for a disinfected endoscope would be sterile water.' Sterile water, however, is expensive and difficult to produce in sufficient quantities and with adequate quality assurance for instrument rinsing in an AER. 912' 913 Therefore, one option to be used for AERs is rinse water that has been passed through filters with a pore size ofO.I-0.2 J.lm to render the water "bacteria-fi·ee." These filters usually are located in the water line at or near the pmt where the mains water enters the equipment. The product water (i.e., tap water passing through these filters) in these applications is not considered equivalent in microbial quality to that for membrane-filtered water as produced by pharmaceutical firms. Membrane filtration in phmmaceutical applications is intended to ensure the microbial quality of polished product water.

Water has been linked to the contamination of flexible fiberoptic endoscopes in the following two scenarios: a) rinsing a disinfected endoscope with unfiltered tap water, followed by storage of the instrument without d1ying out the internal channels and b) contamination of AERs fi·om tap water inadvertently introduced into the equipment. In the latter instance, the machine's water reservoirs and fluid cii:cuitiy become contaminated with waterbome, heterotrophic bacteria (e.g., Pseudomonas aeruginosa and NTM), which can survive and persist in biofilms attached to these components:I4-9l? Colonization of the reservoirs and water lines of the AER becomes problematic if the required cleaning, disinfection, and maintenance are not pe1·formed on the equipment as recommended by the 917 manufacturer. 669' 916' Use of the 0.1-0.2-J.tm filter in the water line helps to keep bacterial contamination to a minimum,670• 911 · 917 but filters may fail and allow bacteria to pass through to the equipment and then to the instrument undergoing reprocessing. 67 H 74 · 913· 918 Filters also require maintenance for proper performance. 670• 911 · 912· 918· 919 Heightened awareness of the proper disinfection of the connectors that hook the instrument to the AER may help to fiuther reduce the potential for contaminating endoscopes during reprocessing:20 An emerging issue in the field of endoscopy is that of the possible role of rinse water monitoring and its potential to help reduce endoscopy/bronchoscopy- associated infections. 918

Studies have linked deficiencies in endoscope cleaning and/or disinfecting processes to the incidence of post-endoscopic adverse outcomes. 921- 924 Several clusters have been traced to AERs of older designs and these were associated with water quality.'"· 91 4-916 Regardless of whether manual or automated terminal reprocessing is used for endoscopes, the internal channels of the instrument should be dried before storage:" The presence of residual moisture in the internal channels encourages the proliferation of waterborne microorganisms, some of which may be pathogenic. One of the most frequently used methods employs 70% isopropyl alcohol to flush the internal channels, followed by forced air d1ying of these channels and hanging the endoscope vertically in a protected cabinet; this method ensures internal drying of the endoscope, lessens the potential for proliferation of waterborne microorganisms, 669· 913 • 917• 922• 926' 927 and is consistent with professional organization guidance for . 928 en doscope reprocess mg.·

An additional problem with waterborne microbial contamination of AERs centers on increased microbial resistance to alkaline glutaraldehyde, a widely used liquid chemical sterilant/high-level .. c dtsmtectant. · " 0 pportumsttc ''" . . waterborne mJCroorgantsms . . ( e.g., Myeo bacterrum . cI1e lonae, Methylobacterium spp.) have been associated with pseudo-outbreaks and colonization; infection caused by these organisms has been associated with procedures conducted in clinical settings (e.g., bronchoscopy). 669' 913 ' 92 ,_931 Increasing microbial resistance to glutaraldehyde has been attributed to improper use of the disinfectant in the equipment, allowing the dilution of glutaraldehyde to fall below the manufacturer's recommended minimal use concentration. 929 71

b. Dental Unit Water Lines Dental unit water lines (DUWLs) consist of small-bore plastic tubing that delivers water used for general, non-surgical irrigation and as a coolant to dental handpieces, sonic and ultrasonic scalers, and air-water syringes; municipal tap water is the source water for these lines. The presence ofbiofilms of waterborne bacteria and fungi (e.g., Legionella spp., Pseudomonas aeruginosa, and NTM) in DUWLs 636 has been established. • 637• 694 • 695 • 932- 934 Biofilms continually release planktonic microorganisms into the water, the titers of which can exceed lxl0 6 CFU/mL. 694 However, scientific evidence indicates that immunocompetent persons are only at minimal risk for snbstantial adverse health effects after contact with water from a dental unit. Nonetheless, exposing patients or dental personnel to water of uncertain microbiological quality is not consistent with universally accepted infection-control principles. 935

In 1993, CDC issued guidelines relative to water quality in a dental setting. These guidelines recommend that all dental instruments that use water (including high-speed handpieces) should be run to discharge water for 20-30 seconds after each patient and for several minutes before the start of each clinic day. 936 This practice can help to flush out any patient materials that many have entered the turbine, air, or waterlines. 937• 938 The 1993 guidance also indicated that waterlines be flushed at the beginning of the clinic day. Although these guidelines are designed to help reduce the number of microorganisms present in treatment water, they do not address the issue of reducing or preventing biofilm formation in the waterlines. Research published subsequent to the 1993 dental infection control guideline suggests that flushing the lines at the beginning of the day has only minimal effect on the status of the biofilm in the lines and does not reliably improve the quality of water during dental treatment. 93 ._941 Updated recommendations on infection-control practices for water line use in dentistry will be available in late 2003. 942

The numbers of microorganisms in water used as coolant or irrigant for non-surgical dental treatment should be as low as reasonably achievable and, at a minimum, should meet nationally recognized standards for safe drinking water. 935 • 943 Only minimal evidence suggests that water meeting drinking water standards poses a health hazard for immunocompetent persons. The EPA, the American Public Health Association (APHA), and the American Water Works Association (A WWA) have set a maximum limit of 500 CFU/mL for aerobic, heterotrophic, mesophilic bacteria in drinking water in municipal distribution systems. 944 • 945 This standard is achievable, given improvements in water-line technology. Dentists should consult with the manufacturer of their dental unit to determine the best . eqmpment an d meth od '10r mamtammg . . . an d mom'tonng . goo d wat er quaI't 1 y. 935 · ' 946

E. Environmental Services 1. Principles of Cleaning and Disinfecting Environmental Surfaces Although microbiologically contaminated surfaces can serve as reservoirs of potential pathogens, these surfaces generally are not directly associated with transmission of infections to either staff or patients. The transferral of microorganisms from environmental surfaces to patients is largely via hand contact with the surface. 947• 948 Although hand hygiene is impmtant to minimize the impact of this transfer, cleaning and disinfecting environmental surfaces as appropriate is fundamental in reducing their potential contribution to the incidence of healthcare-associated infections.

The principles of cleaning and disinfecting environmental surfaces take into account the intended use of the surface or item in patient care. CDC retains the Spaulding classification for medical and surgical instruments, which outlines three categories based on the potential for the instrnment to transmit infection if the instrument is microbiologically contaminated before use.' 49• 950 These categories are 72

"critical," "semictitical." and "noncritical." lnl991, CDC pro~osed an additional category designated "environmental surtaces" to Spaulding's original dassification 51 to represent smfaces that generally do not come into direct contact with patients during care. Environmental smfaces cany the least risk of disease transmission and can be safdy decoll!aminated using less rigorous methods than those used on medical instmments and devices. Environmental surfaces can be fmther divided into medical equipment surfaces (e.g .. knobs or handles on hemodialysis machines. x-ray machines. instnuuent carts, and demal units) and housekeeping surfaces (e.g .. floors. walls. and tabletops). 951

The following factors influence the choice of disinfection procedme for envirormrental surfaces: a) the nature of the item to be disinfected, b) the number of microorganisms present, c) the innate resistance of those microorganisms to the inactivating effects of the germicide. d) the ammmt of organic soil present, e) the type and concentration of germicide used, !) duration and temperature of germicide contact. and g) if using a proprietmy product, other specific indications and directions for use?'2•953

Cleaning is the necessary first step of any sterilization or disinfection process. Cleaning is a fonn of decontamination that renders the enviromnental s11rface safe to handle or use by removing orgmtic matter, salts, and visible soils, all of which interfere with microbial inactivation 95 .....,60 The physical action of scmbbing with detergents and surfactants and rinsing with water removes large numbers of microorganisms from smfaces.' 57 If the surface is not cleaned before the tenninal reprocessing procedures are started, the success of the sterilization or disinfection process is compromised.

Spaulding proposed tln·ee levels of disinfection for the treatment of devices and surtaces that do not require sterility for safe use. Tirese disinfection levels are "high-level." "intennediate-Jevel," and "low- leveL "949 • 950 The basis for these levels is that microorganisms can usually be grouped according to their iJmate resistance to a spectnnn of physical or chemical gennicidal agents (Table 22). This iJrfonnation. coupled with the iJ1stnnnent/surface classitication, determines the approptiate level of tenninal disinfection for an instnunent or surface.

Table 22. Levels of disinfection by type of mict·oorgnnism* Bneterin FUIISii+ Viruses Dl•inrectiou Tuberd~?- Lipid ond Noulipid 11nd Vegetntiv{' Spons level bacillus medium sizt> small sizt> High +§ + +~ + + + Inlennediate + + -** + + +" Low + - - + + + * Material in this table compiled front reference-'> 2 nnd 951. + 1l1is class of microorganisms includes ;H;ex.ual spores but not uecess11rily cblamydospores or sexual spores. § The "'phls" sign indica!~ that a killing effect can be expec1ed when the normal use-concenfrntioos of chemical disinfe<::tants or pasteurization are properly employed; a "negative" -~ign indicates little or no killing effect. '): Only with extended ex.posure times are high-level disinfectant d1eJnicals capable ofkilling: high numbers of bacterial spores iu laboratory 1t'sts; they are, however, capable of sporicidal activity. '** Some imermediate-level disinfectants (e.g., hypochlorites) Cl'lll exhibit some sporicidal activity; other'> (e.g., alcohols and phenolics) lmve no demoustmble sporicidal activity. ++ Some in1ennediate-level disinfectant<>, although they are tuberculocida1, may have limited virucidal acli\'ity.

The process ofhigh-level disinfection, an appropriate standard of treatment for heat-sensitive, senti- critical medical instnuuents (e.g .. flexible, fiberoptic endoscopes), inactivates all vegetative bacteria, mycobaetelia, vimses, timgi, and some bactelial spores. High-level disinfection is accomplished with powerfuL sporicidal chemicals (e.g., glutaraldehyde, peracetic acid, and hydrogen peroxide) that are not appropriate for use on housekeeping surfaces. Tirese liquid chentical sterilantslhigh-level disinfectants 73

are highly toxic. 961- 963 Use of these chemicals for applications other than those indicated in their label instructions (i.e., as immersion chemicals for treating heat-sensitive medical instruments) is not appropriate. 964 Intermediate-level disinfection does not necessarily kill bacterial spores, but it does inactivate Mycobacterium tuberculosis var. bovis, which is substantially more resistant to chemical germicides than ordinmy vegetative bacteria, fungi, and medium to small viruses (with or without lipid envelopes). Chemical germicides with sufficient potency to achieve intermediate-level disinfection include chlorine-containing compounds (e.g., sodium hypochlorite), alcohols, some phenolics, and some iodophors. Low-level disinfection inactivates vegetative bacteria, fungi, enveloped viruses (e.g., human immunodeficiency virus [HIV], and influenza viruses), and some non-enveloped viruses (e.g., adenoviruses). Low-level disinfectants include quaternary ammonium compounds, some phenolics, and some iodophors. Sanitizers are agents that reduce the numbers of bacterial contaminants to safe levels as judged by public health requirements, and are used in cleaning operations, particularly in food service and dairy applications. Germicidal chemicals that have been approved by FDA as skin antiseptics are not appropriate for use as environmental surface disinfectants."'

The selection and use of chemical germicides are largely matters of judgment, guided by product label instructions, information, and regulations. Liquid sterilant chemicals and high-level disinfectants intended for use on critical and semi-critical medical/dental devices and instruments are regulated exclusively by the FDA as a result of recent memoranda of understanding between FDA and the EPA that delineates agency authority for chemical germicide regulation."'· 966 Environmental surface germicides (i.e., primarily intermediate- and low-level disinfectants) are regulated by the EPA and labeled with EPA registration numbers. The labels and technical data or product literature of these germicides specify indications for product use and provide claims for the range of antimicrobial activity. The EPA requires certain pre-registration laboratory potency tests for these products to support product label claims. EPA verifies (through laboratoty testing) manufacturers' claims to inactivate microorganisms for selected products and organisms. Germicides labeled as "hospital disinfectant" have passed the potency tests for activity against three representative microorganisms- Pseudomonas aeruginosa, Staphylococcus aureus, and Salmonella cholerae suis. Low-level disinfectants are often labeled "hospital disinfectant" without a tuberculocidal claim, because they lack the potency to inactivate mycobacteria. Hospital disinfectants with demonstrated potency against mycobacteria (i.e., intermediate-level disinfectants) may list "tuberculocidal" on the label as well. Other claims (e.g., "fungicidal," "pseudomonicidal,'' and "virucidal") may appear on labels of environmental surface germicides, but the designations of "tuberculocidal hospital disinfectant" and "hospital disinfectant" correlate directly to Spaulding's assessment of intermediate-level disinfectants and low-level .. ~ dtStnJectan ts, respect'tve Iy. 951

A common misconception in the use of surface disinfectants in health-care settings relates to the underlying purpose for use ofproprietmy products labeled as a "tuberculocidal" germicide. Such products will not interrupt and prevent the transmission ofTB in health-care settings because TB is not acquired from environmental surfaces. The tuberculocidal claim is used as a benchmark by which to measure germicidal potency. Because mycobacteria have the highest intrinsic level of resistance among the vegetative bacteria, viruses, and fungi, any germicide with a tuberculocidal claim on the label (i.e., an intermediate-level disinfectant) is considered capable of inactivating a broad spectrum of pathogens, including much less resistant organisms such the bloodborne pathogens (e.g., hepatitis B virus [HBV], hepatitis C virus [HCV], and HIV). It is this broad spectrum capability, rather than the product's specific potency against mycobacteria, that is the basis for protocols and OSHA regulations indicating the appropriateness of using tuberculocidal chemicals for surface disinfection.'" 74

2. General Cleaning Strategies for Patient-Care Areas The number and types of microorganisms present on environmental surfaces are influenced by the following factors: a) number of people in the environment, b) amount of activity, c) amount of moisture, d) presence of material capable of suppotting microbial growth, e) rate at which organisms suspended in the air are removed, and f) type of surface and orientation [i.e., horizontal or vertica1]. 968 Strategies for cleaning and disinfecting surfaces in patient-care areas take into account a) potential for direct patient contact, b) degree and frequency of hand contact, and c) potential contamination of the surface with body substances or environmental sources of microorganisms (e.g., soil, dust, and water).

a. Cleaning of Medical Equipment Ma~ufactw·ers of medical equipment should provide care and maintenance instructions specific to their equipment. These instructions should include information about a) the equipments' compatibility with chemical germicides, b) whether the equipment is water-resistant or can be safely immersed for cleaning, and c) how the equipment should be decontaminated if servicing is required. 967 In the absence of manufacturers' instructions, non-critical medical equipment (e.g., stethoscopes, blood pressure cuffs, dialysis machines, and equipment knobs and controls) usually only require cleansing followed by low- to intermediate-level disinfection, depending on the nature and degree of contamination. Ethyl alcohol or isopropyl alcohol in concentrations of 60%-90% (v/v) is often used to disinfect small surfaces (e.g., rubber stoppers of multiple-dose medication vials, and thermometers)'"· 969 and occasionally external surfaces of equipment (e.g., stethoscopes and ventilators). However, alcohol evaporates rapidly, which makes extended contact times difficult to achieve unless items are immersed, a factor that precludes its practical use as a large-surface disinfectant. 951 Alcohol may cause discoloration, swelling, hardening, and cracking of rubber and certain plastics after prolonged and repeated use and may damage the shellac mounting of lenses in medical equipment. 970

Barrier protection of surfaces and equipment is useful, especially if these surfaces are a) touched fi·equently by gloved hands during the delivery of patient care, b) likely to become contaminated with body substances, or c) difficult to clean. Impervious-backed paper, aluminum foil, and plastic or fluid- resistant covers are suitable for use as barrier protection. An example of this approach is the use of plastic wrapping to cover the handle of the operatory light in dental-care settings. 936' 942 Coverings should be removed and discarded while the health-care worker is still gloved. 936 ' 942 The health-care worker, after ungloving and performing hand hygiene, must cover these surfaces with clean materials before the next patient encounter.

b. Cleaning Housekeeping Surfaces Housekeeping surfaces require regular cleaning and removal of soil and dust. Dry conditions favor the persistence of gram-positive cocci (e.g., coagulase-negative Staphylococcus spp.) in dust and on surfaces, whereas moist, soiled environments favor the growth and persistence of gram-negative bacilli. 948• 971 • 972 Fungi are also present on dust and proliferate in moist, fibrous material.

Most, if not all, housekeeping surfaces need to be cleaned only with soap and water or a detergent/disinfectant, depending on the nature of the surface and the type and degree of contamination. Cleaning and disinfection schedules and methods vary according to the area of the health-care facility, type of surface to be cleaned, and the amount and type of soil present. Disinfectant/detergent formulations registered by EPA are used for environmental surface cleaning, but the actual physical removal of microorganisms and soil by wiping or scrubbing is probably as important, if not more so, than any antimicrobial effect of the cleaning agent used. 973 Therefore, cost, safety, product-surface compatibility, and acceptability by housekeepers can be the main criteria for selecting a registered agent. !fusing a proprietary detergent/disinfectant, the manufacturers' instructions for appropriate use 75

of the product should be followed. 974 Consult the products' material safety data sheets (MSDS) to determine appropriate precautions to prevent hazardous conditions during product application. Personal protective equipment (PPE) used during cleaning and housekeeping procedures should be appropriate to the task.

Housekeeping surfaces can be divided into two groups- those with minimal hand-contact (e.g., floors, and ceilings) and those with frequent hand-contact ("high touch surfaces"). The methods, thoroughness, and frequency of cleaning and the products used are determined by health-care facility policy.' However, high-touch housekeeping surfaces in patient-care areas (e.g., doorknobs, bedrails, light switches, wall areas around the toilet in the patient's room, and the edges of privacy curtains) should be cleaned and/or disinfected more frequently than surfaces with minimal hand contact. Infection-control practitioners typically use a risk-assessment approach to identity high-touch surfaces and then coordinate an appropriate cleaning and disinfecting strategy and schedule with the housekeeping staff.

Horizontal surfaces with infrequent hand contact (e.g., window sills and hard-surface flooring) in routine patient-care areas require cleaning on a regular basis, when soiling or spills occur, and when a patient is discharged from the facility.' Regular cleaning of surfaces and decontamination, as needed, is also advocated to protect potentially exposed workers. 967 Cleaning of walls, blinds, and window 973 975 curtains is recommended when they are visibly soiled?"· • Disinfectant fogging is not recommended for general infection control in routine patient-care areas.'· 976 Further, paraformaldehyde, which was once used in this application, is no longer registered by EPA for this purpose. Use of paraformaldehyde in these circumstances requires either registration or an exemption issued by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FTFRA). Infection control, industrial hygienists, and environmental services supervisors should assess the cleaning procedures, chemicals used, and the safety issues to determine if a temporary relocation of the patient is needed when cleaning in the room.

Extraordinaty cleaning and decontamination of floors in health-care settings is unwarranted. Studies have demonstrated that disinfection of floors offers no advantage over regular detergent/water cleaning · · 1 or no Impact an dh as mmtma · on the occurrence ofh ea lth-care-assocta ~ t'tons. 947948977-980 · te d'mtec · ' Additionally, newly cleaned floors become rapidly recontaminated from airborne microorganisms and those transferred from shoes, equipment wheels, and body substances?71 • 975• 981 Nevertheless, health- care institutions or contracted cleaning companies may choose to use an EPA-registered detergent/disinfectant for cleaning low-touch surfaces (e.g., floors) in patient-care areas because of the difficulty that personnel may have in determining if a spill contains blood or body fluids (requiring a detergent/disinfectant for clean-up) or when a multi-drug resistant organism is likely to be in the environment. Methods for cleaning non-porous floors include wet mopping and wet vacuuming, dry 984 dusting with electrostatic materials, and spray buffing.'"· 982- Methods that produce minimal mists 20 109 272 and aerosols or dispersion of dust in patient-care areas are prefetTed.'· • •

Patt of the cleaning strategy is to minimize contamination of cleaning solutions and cleaning tools. Bucket solutions become contaminated almost immediately during cleaning, and continued use of the 971 981 solution transfers increasing numbers of microorganisms to each subsequent surface to be cleaned. ' ' 985 Cleaning solutions should be replaced frequently. A variety of"bucket" methods have been devised to address the frequency with which cleaning solutions are replaced.'"· 987 Another source of contamination in the cleaning process is the cleaning cloth or mop head, especially ifleft soaking in dirty cleaning solutions. 971 • 98 ,_990 Laundering of cloths and mop heads after use and allowing them to dry before re-use can help to minimize the degree of contamination.'" A simplified approach to cleaning involves replacing soiled cloths and mop heads with clean items each time a bucket of detergent/disinfectant is emptied and replaced with fresh, clean solution (B. Stover, Kosair Children's Hospital, 2000). Disposable cleaning cloths and mop heads are an alternative option, if costs permit. 76

Another reservoir for microorganisms in the cleaning process may be dilute solutions of the detergents or disinfectants, especially if the working solution is prepared in a dirty container, stored for long periods of time, or prepared inconectly. 547 Gram-negative bacilli (e.g., Pseudomonas spp. and Serratia marcescens) have been detected in solutions of some disinfectants (e.g., phenolics and quaternary ammonium compounds). 547• 991 Contemporary EPA registration regulations have helped to minimize this problem by asking manufacturers to provide potency data to support label claims for detergent/disinfectant properties under real- use conditions (e.g., diluting the product with tap water instead of distilled water). Application of contaminated cleaning solutions, particularly from small- quantity aerosol spray bottles or with equipment that might generate aerosols during operation, should be avoided, especially in high-risk patient areas.'"· 993 Making sufficient fresh cleaning solution for daily cleaning, discarding any remaining solution, and drying out the container will help to minimize the degree of bacterial contamination. Containers that dispense liquid as opposed to spray-nozzle dispensers (e.g., quart-sized dishwashing liquid bottles) can be used to apply detergent/disinfectants to surfaces and then to cleaning cloths with minimal aerosol generation. A pre-mixed, "ready-to-use" detergent/disinfectant solution may be used if available.

c, Cleaning Special Care Areas Guidelines have been published regarding cleaning strategies for isolation areas and operating rooms.'· 7 The basic strategies for areas housing immunosuppressed patients include a) wet dusting horizontal surfaces daily with cleaning cloths pre-moistened with detergent or an EPA-registered hospital disinfectant or disinfectant wipes;94 • 98463 b) using care when wet dusting equipment and surfaces above the patient to avoid patient contact with the detergent/disinfectant; c) avoiding the use of cleaning equipment that produces mists or aerosols; d) equipping vacuums with HEPA filte", especially for the exhaust, when used in any patient-care area housing immunosuppressed patients;'· 94 • 986 and e) regular cleaning and maintenance of equipment to ensure efficient particle removal. When preparing the cleaning cloths for wet-dusting, freshly prepared solutions of detergents or disinfectants should be used rather than cloths that have soaked in such solutions for long periods of time. Dispersal of microorganisms in the air from dust or aerosols is more problematic in these settings than elsewhere in health-care facilities. Vacuum cleaners can serve as dust disseminators if they are not operating properly. 994 Doors to immunosuppressed patients' rooms should be closed when nearby areas are being vacuumed.' Bacterial and fungal contamination of filters in cleaning equipment is inevitable, and these filters should be cleaned regularly or replaced as per equipment manufacturer instructions.

Mats with tacky surfaces placed in operating rooms and other patient-care areas only slightly minimize the overall degree of contamination of floors and have little impact on the incidence rate of health-care- associated infection in general. 351 • 971 • 983 An exception, however, is the use of tacky mats inside the entry ways of cordoned-off construction areas inside the health-care facility; these mats help to minimize the intrusion of dust into patient-care areas.

Special precautions for cleaning incubators, mattresses, and other nursery surfaces have been recommended to address reports of hyperbilirubinemia in newborns linked to inadequately diluted solutions of phenolics and poor ventilation.'',__,, These medical conditions have not, however, been associated with the use of properly prepared solutions of phenolics. Non-porous housekeeping surfaces in neonatal units can be disinfected with properly diluted or pre-mixed phenolics, followed by rinsing with clean water. 997 However, phenolics are not recommended for cleaning infant bassinets and incubators dming the stay of the infant. Infants who remain in the nursery for an extended period should be moved periodically to freshly cleaned and disinfected bassinets and incubators.'" If phenolics are used for cleaning bassinets and incubators after they have been vacated, the surfaces should be rinsed thoroughly with water and dl'ied before either piece of equipment is reused. Cleaning 77

and disinfecting protocols should allow for the full contact time specified for the product used. Bassinet mattresses should be replaced, however, if the mattress cover surface is broken. 997

3. Cleaning Strategies for Spills of Blood and Body Substances Neither HBV, HCV, nor HIV has ever been transmitted from a housekeeping surface (i.e., floors, walls, or countertops). Nonetheless, prompt removal and surface disinfection of an area contaminated by either blood or body substances are sound infection-control practices and OSHA requirements. 967

Studies have demonstrated that HIV is inactivated rapidly after being exposed to commonly used chemical germicides at concentrations that are much lower than those used in practice. 99,_ 1003 HBV is readily inactivated with a variety of germicides, including quaternary ammonium compounds. 1004 1005 Embalming fluids (e.g., formaldehyde) are also capable of completely inactivating HIV and HBV. · 1006 OSHA has revised its regulation for disinfecting spills of blood or other potentially infectious material to include proprieta1y products whose label includes inactivation claims for HBV and HIV, provided that such surfaces have not become contaminated with agent(s) or volumes of or 1007 concentrations of agent(s) for which a higher level of disinfection is recommended. These registered products are listed in EPA's List D- Registered Antimicrobials Effective Against Hepatitis B Virus and Human HIV-1, which may include products tested against duck hepatitis B virus (DHBV) as a surrogate for HBV. 1008· 1009 Additional lists of interest include EPA's List C-Registered Antimicrobials Effective Against Human HIV-1 and EPA's List E- Registered Antimicrobials Effective Against Mycobacterium spp., Hepatitis B Virus, and Human HIV-1. 1010 Sodium hypochlorite solutions are inexpensive and effective broad-spectrum germicidal solutions. ' 1011 Generic sources of sodium hypochlorite include household chlorine bleach or reagent grade chemical. Concentrations of sodium hypochlorite solutions with a range of5,000--6,150 ppm (I :10 v/v dilution of household bleaches marketed in the United States) to 500--615 ppm (1:100 v/v dilution) fi·ee chlorine are effective depending on the amount of organic material (e.g., blood, mucus, and urine) present on the surface to be cleaned and disinfected. 1010' 1011 EPA-registered chemical germicides may be more compatible with certain materials that could be corroded by repeated exposut'e to sodium hypochlorite, especially the 1:10 dilution. Appropriate personal protective equipment (e.g., gloves and goggles) should be worn when preparing and using hypochlorite solutions or other chemical ' 'd es. 967 germtcl

Despite laboratory evidence demonstrating adequate potency against bloodborne pathogens (e.g., HIV and HBV), many chlorine bleach products available in grocery and chemical-supply stores are not registered by the EPA for use as surface disinfectants. Use of these chlorine products as surface disinfectants is considered by the EPA to be an "unregistered use." EPA encourages the use of registered products because the agency reviews them for safety and performance when the product is used according to label instructions. When unregistered products are used for surface disinfection, users do so at their own risk.

Strategies for decontaminating spills of blood and other body fluids differ based on the setting in which they occur and the volume of the spill. 1010 In patient-care areas, workers can manage small spills with cleaning and then disinfecting using an intermediate-level germicide or an EPA-registered germicide from the EPA List D or E. 967• 1007 For spills containing large amounts of blood or other body substances, workers should first remove visible organic matter with absorbent material (e.g., disposable paper towels discarded into leak-proof, properly labeled containment) and then clean and decontaminate the area. 1002· 1003· 1012 If the surface is nonporous and a generic form of a sodium hypochlorite solution is used (e.g., household bleach), a 1:100 dilution is appropriate for decontamination assuming that a) the 78

worker assigned to clean the spill is wearing gloves and other personal protective equipment appropriate to the task, b) most of the organic matter of the spill has been removed with absorbent material, and c) the surface has been cleaned to remove residual organic matter. A recent study demonstrated that even strong chlorine solutions (i.e., I: I 0 dilution of chlorine bleach) may fail to totally inactivate high titers of virus in large quantities of blood, but in the absence of blood these disinfectants can achieve complete 1011 viral inactivation. This evidence supports the need to remove most organic matter from a large spill before final disinfection of the surface. Additionally, EPA-registered proprietary disinfectant label claims are based on use on a pre-cleaned surface. 951 · 954

Managing spills of blood, body fluids, or other infectious materials in clinical, public health, and research laboratories requires more stringent measures because of a) the higher potential risk of disease transmission associated with large volumes of blood and body fluids and b) high numbers of microorganisms associated with diagnostic cultures. The use of an intermediate-level gennicide for routine decontamination in the laboratory is prudent. 954 Recommended practices for managing large spills of concentrated infectious agents in the laboratory include a) confining the contaminated area, b) flooding the area with a liquid chemical germicide before cleaning, and c) decontaminating with fresh germicidal chemical of at least inte1mediate-level disinfectant potency. 1010 A suggested technique when flooding the spill with germicide is to lay absorbent material down on the spill and apply sufficient germicide to thoroughly wet both the spill and the absorbent material. 1013 !fusing a solution of household chlorine bleach, a I: I 0 dilution is recommended for this purpose. EPA-registered germicides should be used according to the manufacturers' instmctions for use dilution and contact time. Gloves should be worn during the cleaning and decontamination procedures in both clinical and laboratory settings. PPE in such a situation may include the use of respiratory protection (e.g., an N95 respirator) if clean-up procedures are expected to generate infectious aerosols. Protocols for cleaning spills should be developed and made available on record as pmt of good laboratory practice. 1013 Workers in laboratories and in patient-care areas of the facility should receive periodic training in environmental- surface infection-control strategies and procedures as pmt of an overall infection-control and safety curriculum.

4. Carpeting and Cloth Furnishings a. Carpeting Carpeting has been used for more than 30 years in both public and patient-care areas of health-care facilities. Advantages of carpeting in patient-care areas include a) its noise-limiting characteristics; b) the "humanizing" effect on health care; and c) its contribution to reductions in falls and resultant injuries, pmticularly for the elderly. 101 4- 1016 Compared to hard-surface flooring, however, carpeting is harder to keep clean, especially after spills of blood and body substances. It is also harder to push equipment with wheels (e.g., wheelchairs, carts, and gurneys) on carpeting.

Several studies have documented the presence of diverse microbial populations, primarily bacteria and fungi, in carpeting; 111 · 1017- 1024 the variety and number of microorganisms tend to stabilize over time. 1019 New carpeting quickly becomes colonized, with bacterial growth plateauing after about 4 weeks. Vacuuming and cleaning the carpeting can temporarily reduce the numbers of bacteria, but these . popu Iattons soon re b oun d an d return to pre-cIeanmg . leve Is. 1019' 1020· 102' B actena . I contamma . t•wn t en ds to increase with higher levels ofactivity. ,_ · 101 1020 1025 Soiled carpeting that is or remains damp or wet 1026 provides an ideal setting for the proliferation and persistence of gram-negative bacteria and fungi. Carpeting that remains damp should be removed, ideally within 72 hours.

Despite the evidence of bacterial growth and persistence in carpeting, only limited epidemiologic evidence demonstrates that carpets influence health-care-associated infection rates in areas housing 79

.unmunocompeten t paten t' ts. 10'' ~ - · Jo25 · 1027 Th'ts gm'd e I'tne, th ere1ore, . Iudes no recommen dat10ns me . . agatnst the use of carpeting in these areas. Nonetheless, avoiding the use of carpeting is prudent in areas where spills are likely to occur (e.g., laboratories, areas around sinks, and janitor closets) and where patients may be at greater risk of infection from airborne environmental pathogens (e.g., HSCT units, burn units, ICUs, and 0Rs). 111 · 1028 An outbreak of aspergillosis in an HSCT unit was recently attl'ibuted to carpet contamination and a pmticular method of carpet cleaning. 111 A window in the unit had been opened repeatedly during the time of a nearby building fire, which allowed fungal spore intrusion into the unit. After the window was sealed, the carpeting was cleaned using a "bonnet buffing" machine, which dispersed Aspergillus spores into the air. 111 Wet vacuuming was instituted, replacing the dry cleaning method used previously; no additional cases of invasive aspergillosis were identified.

The care setting and the method of carpet cleaning are impmtant factors to consider when attempting to minimize or prevent production of aerosols and dispersal of carpet microorganisms into the air."· 111 Both vacuuming and shampooing or wet cleaning with equipment can disperse microorganisms to the air. 111 · 994 Vacuum cleaners should be maintained to minimize dust dispersal in general, and be 986 equipped with HEPA filters, especially for use in high-risk patient-care areas.'· 94• Some formulations of carpet-cleaning chemicals, if applied or used improperly, can be dispersed into the air as 1029 a fine dust capable of causing respiratory irritation in patients and staff. Cleaning equipment, especially those that engage in wet cleaning and extraction, can become contaminated with waterborne organisms (e.g., Pseudomonas aeruginosa) and serve as a reservoir for these organisms if this equipment is not properly maintained. Substantial numbers of bacteria can then be transferred to caJ'Peting during the cleaning process. 1030 Therefore, keeping the carpet cleaning equipment in good repair and allowing such equipment to dry between uses is prudent.

Carpet cleaning should be performed on a regular basis determined by internal policy. Although spills of blood and body substances on non-porous surfaces require prompt spot cleaning using standard cleaning procedures and application of chemical germicides(" similar decontamination approaches to 1031 blood and body substance spills on carpeting can be problematic from a regulatory perspective. Most, if not all, modern carpet brands suitable for public facilities can tolerate the activity of a variety of liquid chemical germicides. However, according to OSHA, carpeting contaminated with blood or other potentially infectious materials can not be fully decontaminated. 1032 Therefore, facilities electing to use carpeting for high-activity patient-care areas may choose carpet tiles in areas at high risk for spills.'"· 1032 In the event of contamination with blood or other body substances, carpet tiles can be removed, discarded, and replaced. OSHA also acknowledges that only minimal direct skin contact occurs with carpeting, and therefore, employers are expected to make reasonable efforts to clean and sanitize carpeting using carpet detergent/cleaner products. 1032

Over the last few years, some carpet manufacturers have treated their products with fungicidal and/or bacte1·icidal chemicals. Although these chemicals may help to reduce the overall numbers of bacteria or fungi present in carpet, their use does not preclude the routine care and maintenance of the carpeting. Limited evidence suggests that chemically treated carpet may have helped to keep health-care-- associated aspergillosis rates low in one HSCT unit, 111 but overall, treated carpeting has not been shown to prevent the incidence of health-care--associated infections in care areas for immunocompetent patients.

b. Cloth Furnishings Upholstered furniture and furnishings are becoming increasingly common in patient-care areas. These furnishings range from simple cloth chairs in patients' rooms to a complete decorating scheme that gives the interior of the facility more the look of an elegant hotel. 1033 Even though pathogenic microorganisms have been isolated from the surfaces of cloth chairs, no epidemiologic evidence suggests that general patient-care areas with cloth furniture pose increased risks of health-care-- 80

associated infection compared with areas that contain hard-surfaced furniture. 1034· 1035 Allergens (e.g., dog and cat dander) have been detected in or on cloth furniture in clinics and elsewhere in hospitals in concentrations higher than those found on bed linens. 1034· 1035 These allergens presumably are transferred from the clothing of visitors. Researchers have therefore suggested that cloth chairs should be vacuumed regularly to keep the dust and allergen levels to a minimum. This recommendation, however, has generated concerns that aerosols created from vacuuming could place immunocompromised patients or patients with preexisting lung disease (e.g., asthma) at risk for development of health-care-associated, environmental airborne disease. 9· 20• 109• 988 Recovering worn, upholstered furniture (especially the seat cushion) with covers that are easily cleaned (e.g., vinyl), or replacing the item is prndent; minimizing the use of upholstered furniture and furnishings in any patient- care areas where immunosuppressed patients are located (e.g., HSCT units) reduces the likelihood of disease. 9

5. Flowers and Plants in Patient-Care Areas Fresh flowers, dried flowers, and potted plants are common items in health-care facilities. In 1974, clinicians isolated an Erwinia sp. post mortem from a neonate diagnosed with fulminant septicemia, meningitis, and respirato1y distress syndrome. 1038 Because Erwinia spp. are plant pathogens, plants brought into the delive1y room were suspected to be the source of the bacteria, although the case report did not definitively establish a direct link. Several subsequent studies evaluated the numbers and diversity of microorganisms in the vase water of cut flowers. These studies revealed that high concentrations of bactel"ia, ranging from I 04-1 0 10 CFU/mL, were often present, especially if the water was changed infrequently. 515 • 702 · 1039 The major group of microorganisms in flower vase water was gram-negattve. b actena, . h p seud omonas aerugmosa . Wit . th e mast ~11·equentIy ISO . Iate d orgamsm. . sis ' 702 · 1039· 1040 P. aeruginosa was also the primaty organism directly isolated from cluysanthemums and other potted plants. 1041 · 1042 However, flowers in hospitals were not significantly mo1·e contaminated with bacteria compared with flowers in restaurants or in the home. 702 Additionally, no differences in the diversity and degree of antibiotic resistance of bacteria have been observed in samples isolated fi·om hospital flowers versus those obtained from flowers elsewhere. 702

Despite the diversity and large numbers of bacteria associated with flower-vase water and potted plants, minimal or no evidence indicates that the presence of plants in immunocompetent patient-care areas poses an increased risk of health-care--associated infection?' In one study involving a limited number of surgical patients, no correlation was observed between bacterial isolates from flowers in the area and the incidence and etiology of postoperative infections among the patients. 1040 Similar conclusions were reached in a study that examined the bacteria found in potted plants. 1042 Nonetheless, some precautions for general patient-care settings should be implemented, including a) limiting flower and plant care to staff with no direct patient contact, b) advising health-care staff to wear gloves when handling plants, c) washing hands after handling plants, d) changing vase water every 2 days and discharging the water into 702 a sink outside the immediate patient environment, and e) cleaning and disinfecting vases after use.

Some researchers have examined the possibility of adding a chemical germicide to vase water to control bacterial populations. Certain chemicals (e.g., hydrogen peroxide and chlorhexidine) are well tolerated by plants. 1040· 1043 · 1044 Use of these chemicals, however, was not evaluated in studies to assess impact on health-care--associated infection rates. Modem florists now have a variety of products available to add to vase water to extend the life of cut flowers and to minimize bacterial clouding of the water.

Flowers (fresh and dried) and om amen tal plants, however, may serve as a reservoir of Aspergillus spp., and dispersal of conidiospores into the air from this source can occur. 109 Health-care--associated outbreaks of invasive aspergillosis reinforce the importance of maintaining an environment as fi·ee of 81

Aspergillus spp. spores as possible for patients with severe, prolonged neutropenia. Potted plants, fresh- cut flowers, and dried flower arrangements may provide a reservoir for these fungi as well as other fungal species (e.g., Fusarium spp.). 109' 1045· 1046 Researchers in one study of bacteria and flowers suggested that flowers and vase water should be avoided in areas providing care to medically at-risk patients (e.g., oncology patients and transplant patients), although this study did not attempt to correlate the observations of bacterial populations in the vase water with the incidence of health-care--associated infections."' Another study using molecular epidemiology techniques demonstrated identical Aspergillus terreus types among environmental and clinical specimens isolated from infected patients with hematological malignancies. 1046 Therefore, attempts should be made to exclude flowers and plants from areas where immunosuppressed patients are be located (e.g., HSCT units).'· 1046

6. Pest Control Cockroaches, flies and maggots, ants, mosquitoes, spiders, mites, midges, and mice are among the typical arthropod and vertebrate pest populations found in health-care facilities. Insects can serve as agents for the mechanical transmission of microorganisms, or as active participants in the disease transmission process by serving as a vector. 1047- 1049 Arthropods recovered from health-care facilities have been shown to carry a wide variety of pathogenic microorganisms. 105<>- 1056 Studies have suggested that the diversity of microorganisms associated with insects reflects the microbial populations p1·esent in the indoor health-care environment; some pathogens encountered in insects from hospitals were either absent fi·om or present to a Jesser degree in insects trapped from residential settings. 1057- 1060 Some of the microbial populations associated with insects in hospitals have demonstrated resistance to antibiotics. 1048, 1059, to6t-Jo6J

Insect habitats are characterized by warmth, moisture, and availability of food. 1064 Insects forage in and feed on substrates, including but not limited to food scraps from kitchens/cafeteria, foods in vending machines, discharges on dressings either in use or discarded, other forms of human detritis, medical wastes, human wastes, and routine solid waste. 1057- 1061 Cockroaches, in patiicular, have been known to feed on fixed sputum smears in laboratories. 1065 ' 1066 Both cockroaches and ants are frequently found in the laundry, central sterile supply departments, and anywhere in the facility where water or moisture is present (e.g., sink traps, drains and janitor closets). Ants will often find their way into sterile packs of items as they forage in a warm, moist environment. 1057 Cockroaches and othe1· insects frequent loading docks and other areas with direct access to the outdoors.

Although insects carry a wide variety of pathogenic microorganisms on their surfaces and in their gut, the direct association of insects with disease transmission (apa1i from vector transmission) is limited, especially in health-care settings; the presence of insects in itself likely does not contribute substantially to health-care-associated disease transmission in developed countries. However, outbreaks of infection attributed to microorganisms carried by insects may occur because of infestation coupled with breaks in standard infection-control practices. 1063 Studies have been conducted to examine the role of houseflies as possible vectors for shigellosis and other forms of diarrheal disease in non-health-care settings. 1046' 1067 When control measures aimed at reducing the fly population density were implemented, a concomitant reduction in the incidence of diarrheal infections, carriage of Shigella organisms, and mortality caused by diarrhea among infants and young children was observed.

Myiasis is defined as a parasitosis in which the larvae of any of a variety of flies use living or necrotic tissue or body substances of the host as a nutritional source. 1068 Larvae from health-care--acquired myiasis have been observed in nares, wounds, eyes, ears, sinuses, and the external urogenital structures. 106 ,_ 1071 Patients with this rare condition are typically older adults with underlying medical conditions (e.g., diabetes, chronic wounds, and alcoholism) who have a decreased capacity to ward off 82

the flies. Persons with underlying conditions who live or travel to tropical regions of the world are 1070 1071 especially at risk. ' Cases occur in the summer and early fall months in temperate climates when 1071 flies are most active. An environmental assessment and review of the patient's history are necessary to verity that the source of the myiasis is health-care-acquired and to identify corrective measures. 1069· 1072 Simple prevention measures (e.g., installing screens on windows) are important in reducing the incidence ofmyiasis. 1072

From a public health and hygiene perspective, arthropod and vertebrate pests should be eradicated from all indoor environments, including health-care facilities. 1073· 1074 Modern approaches to institutional pest management usually focus on a) eliminating food sources, indoor habitats, and other conditions that attract pests; b) excluding pests from the indoor environments; and c) applying pesticides as needed. 1075 Sealing windows in modern health-care facilities helps to minimize insect intrusion. When windows need to be opened for ventilation, ensuring that screens are in good repair and closing doors to the outside can help with pest control. Insects should be kept out of all areas of the health-care facility, especially ORs and any area where immunosuppressed patients are located. A pest-control specialist with appropriate credentials can provide a regular insect-control program that is tailored to the needs of the facility and uses approved chemicals and/or physical methods. Industrial hygienists can provide infonnation on possible adverse reactions of patients and staff to pesticides and suggest alternative methods for pest control, as needed.

7. Special Pathogen Concerns a. Antibiotic-Resistant Gram-Positive Cocci Vancomycin-resistant enterococci (VRE), methicillin-resistant Staphylococcus aureus (MRSA), and S. aureus with intermediate levels of resistance to glycopeptide antibiotics (vancomycin intermediate resistantS. aureus [VISA] or glycopeptide intermediate resistantS. aureus [GISA]) represent crucial and growing concerns for infection control. Although the term GISA is technically a more accurate description of the strains isolated to date (most of which are classified as having intennediate resistance to both vancomycin and teicoplanin), the tetm "glycopeptide" may not be recognized by many clinicians. Thus, the label of VISA, which emphasizes a change in minimum inhibitmy concentration (MICs) to vancomycin, is similar to that ofVRE and is more meaningful to clinicians. 1076 According to National Nosocomial Infection Surveillance (NNIS) statistics for infections acquired among ICU patients in the United States in 1999, 52.3% of infections resulting from S. aureus were identified as MRSA infections, and 25.2% of enterococcal infections were attributed to VRE. These figures reflect a 37% and a 43% increase, respectively, since 1994-1998. 1077

People represent the primmy reservoir of S. aureus. 1078 Although S. aureus has been isolated from a variety of environmental surfaces (e.g., stethoscopes, floors, charts, furniture, dty mops, and hydrotherapy tanks), the role of environmental contamination in transmission of this organism in health care appears to be minimal. 107,._ 1082 S. aureus contamination of surfaces and tanks within bum therapy units, however, may be a major factor in the transmission of infection among burn patients. 1083

Colonized patients are the principal reservoir ofVRE, and patients who are immunosuppressed (e.g., t1·ansplant patients) or otherwise medically at-risk (e.g., ICU patients, cardio-thoracic surgical patients, patients previously hospitalized for extended periods, and those having received multi-antimicrobial or 108 vancomycin therapy) are at greatest risk for VRE colonization. 4- 1087 The mechanisms by which cross-colonization take place are not well defined, although recent studies have indicated that both MRSA and VRE may be transmitted either a) directly from patient to patient, b) indirectly by transient carriage on the hands of health-care workers, 108 8- 1091 or c) by hand transfer of these gram-positive · organtsms firom contammate · d envn·onmen · t a1sur1aces , an d patten · t-care eqmpmen · t . Jo84 · 1087· 10n-1o97 In 83

one survey, hand carriage ofVRE in workers in a long-term care facility ranged from 13o/.--41 %. 1098 Many of the environmental surfaces found to be contaminated with VRE in outbreak investigations have been those that are touched frequently by the patient or the health-care worker. 1099 Such high-touch surfaces include bedrails, doorknobs, bed linens, gowns, overbed tables, blood pressure cuffs, computer table, bedside tables, and various medical equipment. 22 • 1087· 1094 · 10"· 1100- 1102 Contamination of environmental surfaces with VRE generally occurs in clinical laboratories and areas where colonized patients are present, 1087' 1092' 1094 • 1095 ' 1103 but the potential for contamination increases when such patients 1087 have diarrhea or have multiple body-site colonization. 1104 Additional factors that can be important in the dispersion of these pathogens to environmental surfaces are misuse of glove techniques by health- care workers (especially when cleaning fecal contamination from surfaces) and patient, family, and visitor hygiene.

Interest in the impmtance of environmental reservoirs of VRE increased when laboratory studies demonstrated that enterococci can persist in a viable state on dry environmental surfaces for extended 1099 periods oftime (7 days to 4 months) ' 1105 and multiple strains can be identified during extensive periods of surveillance. 1104 VRE can be recovered from inoculated hands of health-care workers (with or without gloves) for up to 60 minutes." The presence of either MRSA, VISA, or VRE on environmental surfaces, however, does not mean that patients in the contaminated areas will become colonized. Strict adherence to hand hygiene/handwashing and the proper use of barrier precautions help to minimize the potential for spread of these pathogens. Published recommendations for preventing the spread of vancomycin resistance address isolation measures, including patient cohorting and management of patient-care items.' Direct patient-care items (e.g., blood pressure cuffs) should be disposable whenever possible when used in contact isolation settings for patients with multiply resistant 1102 microorganisms.

Careful cleaning of patient rooms and medical equipment contributes substantially to the overall control ofMRSA, VISA, or VRE transmission. The major focus of a control program for either VRE or MRSA should be the prevention of hand transfer of these organisms. Routine cleaning and disinfection of the housekeeping surfaces (e.g., floors and walls) and patient-care surfaces (e.g., bedrails) should be adequate for inactivation of these organisms. Both MRSA and VRE are susceptible to several EPA- registered low- and intermediate-level disinfectants (e.g., alcohols, sodium hypochlorite, quaternaty ammonium compounds, phenolics, and iodophors) at recommended use dilutions for environmental surface disinfection. 1103 · 110 "- 1109 Additionally, both VRE and vancomycin-sensitive enterococci are . . to macttvatton equa II y sensttJve . . . by c h em tea . I germtct . 'd es, 1106· 1107· IIo9 an d snm . 'I ar o bserva t'tons I1ave been made when comparing the germicidal resistance ofMRSA to that of either methicillin-sensitiveS. aureus (MSSA) or VISA.ll 10 The use of stronger solutions of disinfectants for inactivation of either VRE, MRSA, or VISA is not recommended based on the organisms' resistance to antibiotics. 111 0- 1112 VRE from clinical specimens have exhibited some measure of increased tolerance to heat inactivation in temperature ranges <212'F (

Two cases of wound infections associated with vancomycin-resistant Staphylococcus aureus (VRSA) determined to be resistant by NCCLS standards fat· sensitivity/resistance testing were identified in Michigan and Pennsylvania in 2002.ll 14 • IllS These represented isolated cases, and neither the family members nor the health-care providers of these case-patients had evidence of colonization or infection with VRSA. Conventional environmental infection-control measures (i.e., cleaning and then 84

disinfecting surfaces using EPA-registered disinfectants with label claims for S. aureus) were used during the environmental investigation of these two cases; 111 "- 1112 however, studies have yet to evaluate the potential intrinsic resistance of these VRSA strains to surface disinfectants.

Standard procedures during terminal cleaning and disinfection of surfaces, ifperfonned incorrectly, may be inadequate for the elimination ofVRE from patient rooms. 1113 • 111 6- 1118 Given the sensitivity ofVRE to hospital disinfectants, current disinfecting protocols should be effective if they are diligently carried· out and properly performed. Health-care facilities should be sure that housekeeping staff liSe correct procedures for cleaning and disinfecting surfaces in VRE-contaminated areas, which include using sufficient amounts of germicide at proper use dilution and allowing adequate contact time. 1118

b, Clostridium difficile Clostridium difficile is the most frequent etiologic agent for health-care-associated diarrhea. 1119• 1120 In one hospital, 30% of adults who developed health-care-associated diarrhea were positive for C. difficile. 1121 One recent study employing PCR-ribotyping techniques demonstrated that cases of C. difiiciie-acquired diarrhea occurring in the hospital included patients whose infections were attributed to endogenous C. difficile strains and patients whose illnesses were considered to be health-care- associated infections. 1122 Most patients remain asymptomatic after infection, but the organism continues to be shed in their stools. Risk factors for acquiring C. difficile-associated infection include a) exposure to antibiotic therapy, particularly with beta-lactam agents; 1123 b) gastrointestinal procedures and surgery; 1124 c) advanced age; and d) indiscdminate use of antibiotics. 112 "- 1128 Of all the measures that have been used to prevent the spread of C. difficile-associated diarrhea, the most successful has been the restriction of the use of antimicrobial agents. 1129• 1130

C. difficile is an anaerobic, gram-positive bacterium. Normally fastidious in its vegetative state, it is capable of sporulating when environmental conditions no longer support its continued growth. The capacity to form spores enables the organism to persist in the environment (e.g., in soil and on dry surfaces) for extended periods of time. Environmental contamination by this microorganism is well known, especially in places where fecal contamination may occur. 1131 The environment (especially . sur fiaces) rare Iy serves as a d'trect source o f.In ~teet'ton ~tOr patten house Iceepmg . t s. 1024 · I 132-1136 H owever, direct exposure to contaminated patient-care items (e.g., rectal thermometers) and high-touch surfaces in 1130 patients' bathrooms (e.g., light switches) have been implicated as sources ofinfection. • 1135 • 1136 • 1138

Transfer of the pathogen to the patient via the hands of health-care workers is thought to be the most 1139 likely mechanism of exposure."· 1133 • Standard isolation techniques intended to minimize enteric contamination of patients, health-care-workers' hands, patient-care items, and environmental surfaces have been published. 1140 Handwashing remains the most effective means of reducing hand contamination. Proper use of gloves is an ancillmy measure that helps to further minimize transfer of these pathogens fi'Om one surface to another.

The degree to which the environment becomes contaminated with C. difficile spores is proportional to the number of patients with C. dif]iciie-associated diarrhea,24 • 1132' 1135 although asymptomatic, colonized patients may also serve as a source of contamination. Few studies have examined the use of specific chemical germicides for the inactivation of C. difficile spores, and no well-controlled trials have been conducted to determine efficacy of surface disinfection and its impact on health-care-associated diarrhea. Some investigators have evaluated the use of chlorine-containing chemicals (e.g., 1,000 ppm hypochlorite at recommended use-dilution, 5,000 ppm sodium hypochlorite [ 1:1 0 v/v dilution], I: 100 v/v dilutions of unbuffered hypochlorite, and phosphate-buffered hypochlorite [1,600 ppm]). One of the studies demonstrated that the number of contaminated environmental sites was reduced by half, 1135 whereas another two studies demonstrated declines in health-care-associated C. difficile infections in a HSCT unit 1141 and in two geriatric medical units 1142 during a period of hypochlorite use. The presence 85

of confounding factors, however, was acknowledged in one of these studies. 1142 The recommended approach to environmental infection control with respect to C. difficile is meticulous cleaning followed by disinfection using hypochlorite-based gennicides as appropriate.'"· 1130• 1143 However, because no EPA-registered surface disinfectants with label claims for inactivation of C. diffici/e spores are available, the recommendation is based on the best available evidence from the scientific literature.

c. Respiratory and Enteric Viruses in Pediatric-Care Settings Although the viruses mentioned in this guideline are not unique to the pediatric-care setting in health- care facilities, their prevalence in these areas, especially during the winter months, is substantial. Children (particularly neonates) are more likely to develop infection and substantial clinical disease from these agents compared with adults and therefore are more likely to require supportive care during their illness.

Common respiratoty viruses in pediatric-care areas include rhinoviruses, respiratory syncytial virus (RSV), adenoviruses, influenza viruses, and parainfluenza viruses. Transmission of these vimses occurs primarily via direct contact with small-particle aerosols or via hand contamination with respiratoty secretions that are then transferred to the nose or eyes. Because transmission primarily requires close personal contact, contact precautions are appropriate to interrupt transmission.' Hand contamination can occur from direct contact with secretions or indirectly from touching high-touch environmental surfaces that have become contaminated with vims from large droplets. The indirect transfer of virus from one persian to other via hand contact with frequently-touched fomites was demonstrated in a study using a bacteriophage whose environmental stability approximated that of human viral pathogens (e.g., poliovirus and parvovirus). 1144 The impact of this mode of transmission with respect to human respiratory- and enteric viruses is dependent on the ability of these agents to survive on environmental surfaces. Infectious RSV has been recovered fi·om skin, porous surfaces, and non-porous surfaces after 30 minutes, 1 hour, and 7 hours, respectively. 1145 Parainfluenza viruses are known to persist for up to 4 hours on porous surfaces and up to l 0 hours on non~ porous surfaces. 1146 Rhinoviruses can persist on porous surfaces and non-porous surfaces for approximately I and 3 hours respectively; study participants in a controlled environment became infected with rhinoviruses after first touching a surface 1147 with dried secretions and then touching their nasal or conjunctival mucosa. Although the efficiency of direct transmission of these viruses from surfaces in uncontrolled settings remains to be defined, these data underscore the basis for maintaining regular protocols for cleaning and disinfecting of high- touch surfaces.

The clinically impmiant enteric viruses encountered in pediatric care settings include enteric adenovirus, astroviruses, caliciviruses, and rotavirus. Group A rotavirus is the most common cause of infectious dian·hea in infants and children. Transmission of this virus is primarily fecal-oral, however, the role offecally contaminated surfaces and fomites in rotavirus transmission is unclear. During one epidemiologic investigation of enteric disease among children attending day care, rotavirus ' . was detected on 19" contammatwn too f'mammate ' . t he center. 1148· 1149 Inan autb reak m ob'~ects m . a pediatric unit, secondary cases of rotavirus infection clustered in areas where children with rotaviral diarrhea were located. 1150 Astroviruses cause gastroenteritis and diarrhea in newborns and young children and can persist on fecally contaminated surfaces for several months during periods of relatively low humidity. 1151 • 1152 Outbreaks of small round-structured viruses (i.e., caliciviroses [Norwalk vitus 53 and Norwalk-like viruses]) can affect both patients and staff, with attack rates of;:S0%." Routes of . ' me personNtoNperson transmtsston . Iude "1eca INora I spread an d aeroso Is generat ed firom vom1't'mg. 115 4-" 56 Fecal contamination of surfaces in care settings can spread large amounts ofviros to the environment. Studies that have attempted to use low- and intermediate-level disinfectants to inactivate rotavirus suspended in feces have demonstrated a protective effect of high concentrations of organic matter.'"'· 1158 Intermediate-level disinfectants (e.g., alcoholic quaternmy ammonium compounds, and chlorine solutions) can be effective in inactivating enteric vimses provided that a cleaning step to remove most of 86

the organic matter precedes terminal disinfection.''" These findings underscore the need for proper cleaning and disinfecting procedures where contamination of environmental surfaces with body substances is likely. EPA-registered surface disinfectants with label claims for these viral agents should be used in these settings. Using disposable, protective barrier coverings may help to minimize the c degree of sur1ace con tammatton. ••936

d. Severe Acute Respiratory Syndrome (SARS) Virus In November 2002 an atypical pneumonia of unknown etiology emerged in Asia and subsequently developed into an international outbreak of respiratory illness among persons in 29 countries during the first six months of2003. "Severe acute respiratory syndrome" (SARS) is a viral upper respiratmy infection associated with a newly described coronavirus (SARS-associated Co-V [SARS-CoV]). SARS-CoV is an enveloped RNA virus. It is present in high titers in respiratory secretions, stool, and blood of infected persons. The modes of transmission determined from epidemiologic investigations were primarily forms of direct contact (i.e., large droplet aerosolization and person-to-person contact). Respiratory secretions were presumed to be the major source of virus in these situations; airborne transmission of virus has not been completely ruled out. Little is known about the impact of fecal-oral transmission and SARS.

The epidemiology ofSARS-CoV infection is not completely understood, and therefore recommended infection control and prevention measures to contain the spread of SARS will evolve as new information becomes available. 1159 At present there is no indication that established strategies for cleaning (i.e., to remove the majority ofbioburden) and disinfecting equipment and environmental surfaces need to be changed for the environmental infection control of SARS. In-patient rooms housing SARS patients should be cleaned and disinfected at least daily and at the time of patient transfer or discharge. More frequent cleaning and disinfection may be indicated for high-touch surfaces and following aerosol-producing procedures (e.g., intubation, bronchoscopy, and sputum production). While there are presently no disinfectant products registered by EPA specifically for inactivation of SARS-CoV, EPA-registered hospital disinfectants that are equivalent to low- and intermediate-level germicides may be used on pre-cleaned, hard, non-porous surfaces in accordance with manufacturer's instructions for environmental surface disinfection. Monitoring adherence to guidelines established for cleaning and disinfection is an important component of environmental infection control to contain the spread of SARS.

e. Creutzfe/dt-Jakob Disease (CJD) in Patient-Care Areas Creutzfeldt-Jakob disease (CJD) is a rare, invariably fatal, transmissible spongiform encephalopathy 116 1162 (TSE) that occurs worldwide with an average annual incidence of I case per million population. ll- CJD is one of several TSEs affecting humans; other diseases in this group include kuru, fatal familial insomnia, and Gerstmann-Straussler-Scheinker syndrome. A TSE that affects a younger population (compared to the age range ofCJD cases) has been described primarily in the United Kingdom since 1996. 1163 This variant form of CJD (vCJD) is clinically and neuropathologically distinguishable from classic CJD; epidemiologic and laboratoty evidence suggests a causal association for bovine spongiform encephalopathy (BSE [Mad Cow disease]) and vCJD. 116,_ 1166

The agent associated with CJD is a prion, which is an abnormal isoform of a normal protein constituent of the central nervous system. 1167- 1169 The mechanism by which the normal form of the protein is converted to the abnormal, disease-causing prion is unknown. The tertiary conformation of the abnormal prion protein appears to confer a heightened degree of resistance to conventional methods of sterilization and disinfection. 1170 • 1171

Although about 90% of CJD cases occur sporadically, a limited number of cases are the result of a direct exposure to prion-containing material (usually central nervous system tissue or pituitary 87

hormones) acquired as a result of health care (iatrogenic cases). These cases have been linked to a) pituitary hotmone therapy [from human sources as opposed to hormones prepared through the use of recombinant technology], 1170- 1174 b) transplants of either dura mater or corneas, 117 ,_. 1181 and c) neurosurgical instruments and depth electrodes. 1182- 1185 In the cases involving instruments and depth electrodes, conventional cleaning and terminal reprocessing methods ofthe day failed to fully inactivate the contaminating prions and are considered inadequate by today's standards.

Prion inactivation studies involving whole tissues and tissue homogenates have been conducted to detennine the parameters of physical and chemical methods of sterilization or disinfection necessary for complete inactivation; 1170· 118 5-- 1191 however, the application of these findings to environmental infection control in health-care settings is problematic. No studies have evaluated the effectiveness of medical instrument reprocessing in inactivating prions. Despite a consensus that abnonnal prions display some extreme measure of resistance to inactivation by either physical or chemical methods, scientists disagree about the exact conditions needed for sterilization. Inactivation studies utilizing whole tissues present extraordinary challenges to any sterilizing method. 1192 Additionally, the experimental designs of these studies preclude the evaluation of surface cleaning as a part of the total approach to pathogen inactivation. 951 • 1192

Some researchers have recommended the use of either a I :2 v/v dilution of sodium hypochorite (approximately 20,000 ppm), full-strength sodium hypochlorite (50,00(}-60,000 ppm), or 1-2 N sodium hydroxide (NaOH) for the inactivation ofprions on certain surfaces (e.g., those found in the pathology laboratory). 1170· 1188 Although these chemicals may be appropriate for the decontamination of laboratory, operating-room, or autopsy-room surfaces that come into contact with central nervous system tissue from a known or suspected patient, this approach is not indicated for routine or terminal cleaning of a room previously occupied by a CJD patient Both chemicals pose hazards for the health- care worker doing the decontamination. NaOH is caustic and should not make contact with the skin. Sodium hypochlorite solutions (i.e., chlorine bleach) can conode metals (e.g., aluminum). MSDS information should be consulted when attempting to work with concentrated solutions of either chemical. Currently, no EPA-registered products have label claims for prion inactivation; therefore, this guidance is based on the best available evidence from the scientific literature.

Environmental infection-control strategies must based on the principles of the "chain of infection," regardless of the disease of concern, 13 Although CJD is transmissible, it is not highly contagious, All iatrogenic cases of CJD have been linked to a direct exposure to prion-contaminated central nervous system tissue or pituitary hormones. The six documented iatrogenic cases associated with instruments and devices involved neurosurgical instruments and devices that introduced residual contamination directly to the recipient's brain. No evidence suggests that vCJD has been transmitted iatrogenically or that either CJD or vCJD has been transmitted from environmental surfaces (e.g., housekeeping surfaces). Therefore, routine procedures are adequate for te1minal cleaning and disinfection of a CJD patient's room. Additionally, in epidemiologic studies involving highly transfused patients, blood was not 1'd entt'fi1ed as a source 1or c . pnon · , transmtsston. 119'-1198 - R out'me proce dures c101' cont ammg, · · decontaminating, and disinfecting surfaces with blood spills should be adequate for proper infection control in these situations. 951 • 1199 1197 1199 Guidance for environmental infection control in ORs and autopsy areas has been published. ' Hospitals should develop risk-assessment procedures to identity patients with known or suspected CJD in efforts to implement prion-specific infection-control measures for the OR and for instrument reprocessing. 1200 This assessment also should be conducted for older patients undergoing non-lesionous neurosurgery when such procedures are being done for diagnosis. Disposable, impermeable coverings should be used during these autopsies and neurosurgeries to minimize surface contamination, Surfaces that have become contaminated with central nervous system tissue or cerebral spinal fluid should be 88

cleaned and decontaminated by a) removing most of the tissue or body substance with absorbent materials, b) wetting the surface with a sodium hypochlorite solution containing;:o:S,OOO ppm or a IN NaOH solution, and c) rinsing thoroughly."'· 1197- 1199· 1201 The optimum duration of contact exposure in these instances is unclear. Some researchers recommend a !-hour contact time on the basis of tissue- . t'tva t'ton stu d'tes, 1197' ""' 1201 wI1ereas otI1er reviewers mac . o f the sub'~ect draw no cone Iuswns . firom th'ts research. 1199 Factors to consider before cleaning a potentially contaminated surface are a) the degree to which gross tissue/body substance contamination can be effectively removed and b) the ease with which the surface can be cleaned.

F. Environmental Sampling This po1tion of Pmt I addresses the basic principles and methods of sampling environmental surfaces and other environmental sources for microorganisms. The applied strategies of sampling with respect to environmental infection control have been discussed in the appropriate preceding subsections.

1. General Principles: Microbiologic Sampling of the Environment Before 1970, U.S. hospitals conducted regularly scheduled culturing of the air and environmental surfaces (e.g., floors, walls, and table tops). 1202 By 1970, CDC and the American Hospital Association (AHA) were advocating the discontinuation of routine environmental culturing because rates of health- care--associated infection had not been associated with levels of general microbial contamination of air or environmental surfaces, and because meaningful standards for pe1·missible levels of microbial contamination of environmental surfaces or air did not exist. 120,_ 1205 During 1970-1975, 25% of U.S. 1206 hospitals reduced the extent of such routine environmental culturing- a trend that has continued. · 1207

Random, undirected sampling (referred to as "routine" in previous guidelines) differs from the current practice of targeted sampling for defined purposes.'· 1204 Previous recommendations against routine sampling were not intended to discourage the use of sampling in which sample collection, culture, and interpretation are conducted in accordance with defined protocols.' In this guideline, targeted microbiologic sampling connotes a monitoring process that includes a) a written, defined, multidisciplinmy protocol for sample collection and culturing; b) analysis and interpretation of results using scientifically determined or anticipatory baseline values for comparison; and c) expected actions based on the results obtained. Infection control, in conjunction with laboratorians, should assess the health-care facility's capability to conduct sampling and determine when expert consultation and/or services are needed.

Microbiologic sampling of air, water, and inanimate surfaces (i.e., environmental sampling) is an expensive and time-consuming process that is complicated by many variables in protocol, analysis, and 1208 interpretation. It is therefore indicated for only four situations. The first is to suppo1t an investigation of an outbreak of disease or infections when environmental reservoirs or fomites are . I'tcate d ept'd enuo tmp . IogJCa . II y m . . 161 · 1209· 1210 It.ts tmpor ' d'tsease transmtsston. . tanttl1at sueh cu Iturmg. be supported by epidemiologic data. Environmental sampling, as with all laborat01y testing, should not be con ducted 1'f tI1ere ts . no pIan 'tor mterpretmg . . d .11 · 1211 · 1212 L'mk'mg . an d act'mg on tl1e resu Its obtame microorganisms from environmental samples with clinical isolates by molecular epidemiology is Cl1lcial whenever it is possible to do so.

The second situation for which environmental sampling may be warranted is in research. Well-designed and controlled experimental methods and approaches can provide new information about the spread of health-care--associated diseases. 126· 129 A classic example is the study of environmental microbial 89

contamination that compared health-care-associated infection rates in an old hospital and a new facility before and sho1tly after occupancy. 947

The third indication for sampling is to monitor a potentially hazardous environmental condition, confirm the presence of a hazardous chemical or biological agent, and validate the successful abatement of the hazard. This type of sampling can be used to: a) detect bioaerosols released from the operation of health-care equipment (e.g., an ultrasonic cleaner) and determine the success of repairs in containing the hazard, 1213 b) detect the release of an agent ofbioteJTorism in an indoor environmental setting and determine its successful removal or inactivation, and c) sample for industrial hygiene or safety purposes (e.g., monitoring a "sick building").

The fourth indication is for quality assurance to evaluate the effects of a change in infection-control practice or to ensure that equipment or systems perform according to specifications and expected outcomes. Any sampling for quality-assurance purposes must follow sound sampling protocols and address confounding factors through the use of properly selected controls. Results from a single environmental sample are difficult to interpret in the absence of a fi·ame of 1·eference or perspective. Evaluations of a change in infection-control practice a1·e based on the assumption that the effect will be measured over a finite period, usually of short duration. Conducting quality-assurance sampling on an extended basis, especially in the absence of an adverse outcome, is usually unjustified. A possible exception might be the use of air sampling during major const1uction periods to qualitatively detect breaks in environmental infection-control measures. In one study, which began as patt of an investigation of an outbreak of health-care-associated aspergillosis, airborne concentrations of Aspergillus spores were measured in effmts to evaluate the effectiveness of sealing hospital doors and windows during a period of constmction of a nearby building. 50 Other examples of sampling for quality-assurance purposes may include commissioning newly constructed space in special care areas (i.e., ORs and units for immunosuppressed patients) or assessing a change in housekeeping practice. However, the only types of routine environmental microbiologic sampling recommended as part of a quality-assurance program are a) the biological monitoring of sterilization processes by using bacterial spores 1214 and b) the monthly culturing of water used in hemodialysis applications and for the final dialysate use dilution. Some expe1ts also advocate periodic environmental sampling to evaluate the microbial/particulate quality for regular maintenance of the air handling system (e.g., filters) and to verity that the components of the system meet manufacturer's specifications (A. Streifel, University of Minnesota, 2000). Certain equipment in health-care settings (e.g., biological safety cabinets) may also be monitored with air flow and patticulate sampling to determine performance or as pa1t of adherence to a certification program; results can then be compared with a predetermined standard of performance. These measurements, however, usually do not require microbiologic testing.

2. Air Sampling Biological contaminants occur in the air as aerosols and may include bacteria, fungi, vimses, and pollens. 1215· 1216 Aerosols are characterized as solid or liquid particles suspended in air. Talking for 5 minutes and coughing each can pmduce 3,000 droplet nuclei; sneezing can generate approximately 1217 40,000 droplets which then evaporate to particles in the size range of0.5-12 J.tm. 137' Patticles in a biological aerosol usually vary in size from <1 J.tm to 2:50 flm. These particles may consist of a single, unattached organism or may occur in the form of clumps composed of a number of bacteria. Clumps can also include dust and dried organic or inorganic material. Vegetative forms of bacterial cells and vimses may be present in the air in a lesser number than bacterial spores or fungal spores. Factors that determine the survival of microorganisms within a bioaerosol include a) the suspending medium, b) temperature, c) relative humidity, d) oxygen sensitivity, and e) exposure to UV or electmmagnetic radiation. 1215 Many vegetative cells will not survive for lengthy periods oftime in the air unless the 90

relative humidity and other factors are favorable for survival and the organism is enclosed within some protective cover (e.g., dried organic or inorganic matter). 1216 Pathogens that resist drying (e.g., Staphylococcus spp., Streptococcus spp., and fungal spores) can survive for long periods and can be carried considerable distances via air and still remain viable. They may also settle on surfaces and become airborne again as secondary aerosols during ceJtain activities (e.g., sweeping and bed making). 1216, 121s

Microbiologic air sampling is used as needed to determine the numbers and types of microorganisms, or pa1ticulates, in indoor air. 289 Air sampling for quality control is, however, problematic because of lack ofunifonn air-quality standards. Although airborne spores of Aspergillus spp. can pose a risk for neutropenic patients, the critical number (i.e., action level) of these spores above which outbreaks of aspergillosis would be expected to occur has not been defined. Health-care professionals considering the use of air sampling should keep in mind that the results represent indoor air quality at singular points in time, and these may be affected by a variety of factors, including a) indoor traffic, b) visitors entering the facility, c) temperature, d) time of day or year, e) relative humidity, f) relative concentration of pa1ticles or organisms, and g) the performance of the ail~ handling system components. To be meaningful, air-sampling results must be compared with those obtained from other defined areas, conditions, or time periods.

Several preliminary concerns must be addressed when designing a microbiologic air sampling strategy (Box 13). Because the amount ofpa1ticulate material and bacteria retained in the respiratory system is largely dependent on the size of the inhaled particles, pa1ticle size should be dete1mined when studying airbome microorganisms and their relation to respiratory infections. Pmticles >5 f!m are efficiently trapped in the upper respiratory tract and are removed primarily by ciliary action. 1219 Particles :'05 f!m in diameter reach the lung, but the greatest retention in the alveoli is of pmticles 1-2 f!m in diameter. 1220- 1222

Box 13. Preliminary concerns for conducting air sampling

• Consider the possible characteristics and conditions of the aerosol, including size range of particles, relative amount of inert material, concentration of microorganisms, and environmental factors. • Determine the type of sampling instruments, sampling time, and duration of the sampling program. Determine the number of samples to be taken. Ensure that adequate equipment and supplies are available. Determine the method of assay that will ensure optimal recovery of microorganisms. Select a laboratory that will provide proper microbiologic support. Ensure that samples can be refrigerated if they cannot be assayed in the laboratory promptly.

Bacteria, fungi, and particulates in air can be identified and quantified with the same methods and equipment (Table 23). The basic methods include a) impingement in liquids, b) impaction on solid surfaces, c) sedimentation, d) filtration, e) centrifugation, f) electrostatic precipitation, and g) the1mal precipitation. 1218 Of these, impingement in liquids, impaction on solid surfaces, and sedimentation (on 289 settle plates) have been used for various air-sampling purposes in health-care settings.

Several instruments are available for smnpling airborne bacteria and fungi (Box 14). Some of the samplers are self-contained units requiring only a power supply and the appropriate collecting medium, but most require additional auxiliary equipment (e.g., a vacuum pump and an airflow measuring device [i.e., a flowmeter or anemometer]). Sedimentation or depositional methods use settle plates and 91

therefore need no special instnnuents or equipment. Selection of an instnunent for air sampling requires a clear understanding ofthe type ofinfonuation desired and the particular detenuinations that must be made (Box 14). Infonnationmay be needed regarding a) one particular organism or all organisms that may be present in the air, b) the concentration of viable particles or of viable organisms, c) the change in concentration with time, and d) the size distribution of the collected panicles. Before sampling begins, decisions should be made regarding whether the results are to be qualitative or quantitative. Comparing quantities of airbome microorganisms to those of outdoor air is also standard operating procedure. Infection-control professionals, hospital epidemiologists, industrial hygienists, and laborat01y supervisors, as pmt of a multidisciplinmy temn, should discuss the potential need for microbial air sampling to detennine if the capacity and expettise to conduct such sampling exists within the facility and when it is appropriate to enlist the services of an environmental microbiologist consultant.

Tnble 23. Air snmpling methods and exnmples of equipment* Coll•quipment considN' snmplers§ SUl'fllC(' (Limtn,) ne(';ded+ Impingement in Air drawn Viabl~ Buffered 12.5 Yes Autifoaming C'bemical liquids through a organi.'>UlS, and gelatin, agent maybe Coq>s. All small jet and concentration tryptose needed Glnso; directed overtime. saline, Ambient !Ulpinger against a Example use: peptone, temperuture {AGI) bqnid surfnce snmpling water nutriem and humidity aerosols to broth will influence legionella spp. length of collection lime Impaction ou Air drawn Viable Dry S\u-f.1ce, 28 (sieve) Yes Available as Andersen Air soUd !inrfat>es into the- particles; Yiable coated 30-800 sieve Sampler sampler; organisms (on ~1.1rfaces, and nnpactors or (sieve (slit) pnrticle-'> non~nntrient agar .slit impactors. impactor); deposited on "lurfaces, Sieve TDL. a dry surface limited to impactors can Cassella :MJ(. organisms that be set up to 2 (slit resist d1yiug measure impnctoH) and spores); particle size. size Slit impactors measuremt•nt, have a rotating ond .support st.1ge conce-nlr<1tion for agar plates over tillw. to allow for- E.xample use: IUC.1Sltrement sampling air for- of Aspergillus concentration spp., fungal overtime. spores Sedimentation Partide'> and micro- Viable particles. Nutrient media - No Slmple and inexpensive; Settle plates

orgamsms Example us-es: (agors) on best !>1.li~ed for seitle onto ~runpling air for plt~tes or qualitative surfaces via bacteria in the slides sampling; gravity vlcmity of and significant during a nit-borne tnedicnl fi.mgal spores procedure; are too general buoyan1 to measurements settle ofmicrobi<~l air efficiently for quality. collection u~ing this method. 92

CollN·tion Rate of Auxllliary Suitable for Points to P1·ototype Method Principle tnE'diA 01' colledion equipm(lut measuring: tonstder snmplers§ surfnee (L/min.) lt(>(>()(>d+ Filtration Air drawn Paper, 1 50 Yes Filter must be tltrough a Viable parti.d<:ls; viable cellulose, agitated f1rst - filter unit; organisms (on gla'f~ wool, in rin.w fluid particles non-nutrient gelatin foaru. to remove and trapped; S\lrfaces, and disperse 0.2jcmpore limited to membrane trapped micro- size spores and fillers organisms; organisms that rime flnid i~; resist drying); assayed; n~ed concentmtion more for overtime. sampling dust Example use: and chemicals. air sampling for Asporgillus spp., fungal spores. and dust Centdfugntion Aerosols Viable Coated glass 40-50 Yes Calibration is BiotestRCS subjected to particles; viable or plastic difficult and is Plus centrifugal organisms (on slides, and doneon1yby force~ non-nutrient agar surfac~s the: factoty; particles surface-s, relative impacted limited to comp-arison of onto a $Olid spores and airbome surface organism'> that contamination resist drying): is its general coneentrntton use. over time.. Example- me: air ~ampllng for Aspergillus spp., and fungal ~-pores Electrostarle Airdrnwn over an Viable particles; viable Solid collecting 85 Yes High volmne sampling rat~. - predpitation electro~ organism.<; (on snrfaces but equipment stati-cally non-nutrient (glass, and is complex charged surfaces. agar) and must be surfa<:e; limited to handled particles !>pores and cttrefi!lly; not become organism<.> that practical for charged resist drying); use in health- concentration cttre settings. overtime Thermal preeipitntion Air drawn over a Size measurements Glass coverslip, 0.003-0.4 Yes Determine partide size - thennal aud electron by direct gradient; micro:o;cope observation; particles grid not frequently repelled from used because bot surf.1.ce.~. ofeomplex setlle on adjustments col de! and low snrfaces sampling rates.

* Material iu dUs t11ble -is compiled from references 289. 1218, 1223. and 1224. + Most samplers require a flow meter or anemometer and a vacuum source as auxiliary equipment. § Trade names listed are fur identification purposes only <1nd are not intended as endorsements by the U.S. Public Health Servke. 93

Box 14. Selecting an air sampling device*

The following factors must be considered when choosing an air sampling instrument:

Viability and type of the organism to be sampled Compatibility with the selected method of analysis Sensitivity of particles to sampling Assumed concentrations and particle size • Whether airborne clumps must be broken (i.e., total viable organism count vs. particle count) • Volume of air to be sampled and length of time sampler is to be continuously operated Background contamination Ambient conditions Sampler collection efficiency Effort and skill required to operate sampler Availability and cost of sampler, plus back-up samplers in case of equipment malfunction • Availability of auxiliary equipment and utilities (e.g., vacuum pumps, electricity, and water)

* Material in this box is compiled from reference 1218.

Liquid impinger and solid impactor samplers are the most practical for sampling bacteria, particles, and fungal spores, because they can sample large volumes of air in relatively short periods oftime. 289 Solid impactor units are available as either slit" or "sieve" designs. Slit impactors use a rotating disc as 11

support for the collecting surface, which allows determinations of concentration over time. Sieve impactors commonly use stages with calibrated holes of different diameters. Some impactor-type samplers use centrifugal force to impact particles onto agar surfaces. The interior of either device must be made sterile to avoid inadvertent contamination from the sampler. Results obtained from either sampling device can be expressed as organisms or pmticles per unit volume of air (CFUhn 3).

Sampling for bacteria requires special attention, because bacteria may be present as individual organisms, as clumps, or mixed with or adhering to dust o1· covered with a protective coating of dried organic or inorganic substances. Reports of bacterial concentrations determined by ail' sampling therefore must indicate whether the results represent individual organisms or particles bearing multiple cells. Certain types of samplers (e.g., liquid impingers) will completely or partially disintegrate clumps and large particles; the sampling result will therefore reflect the total number of individual organisms present in the air.

The task of sizing a bioaerosol is simplified through the use of sieves or slit impactors because these samplers will separate the particles and microorganisms into size ranges as the sample is collected. 1225 These samplers must, however, be calibrated first by sampling aerosols under similar use conditions.

The use of settle plates (i.e., the sedimentation or depositional method) is not recommended when sampling air for fungal spores, because single spores can remain suspended in air indefinitely. 289 Settle plates have been used mainly to sample for particulates and bacteria either in research studies or during epidemiologic investigations."'· 1226- 1229 Results of sedimentation sampling are typically expressed as numbers of viable particles or viable bacteria per unit area per the duration of sampling time (i.e., CFU/area/time); this method can not quantifY the volume of air sampled. Because the survival of microorganisms during air sampling is inversely propmtional to the velocity at which the air is taken into the sampler, 1215 one advantage of using a settle plate is its reliance on gravity to bring organisms and particles into contact with its surface, thus enhancing the potential for optimal survival of collected organisms. This process, however, takes several hours to complete and may be impractical for some situations. 94

Air samplers are designed to meet differing measurement requirements. Some samplers are better suited for one fonn of measurement than others. No one type of sampler and assay procedure can be used to collect and enumerate I 00% of airborne organisms. The sampler and/or sampling method chosen should, however, have an adequate sampling rate to collect a sufficient number of particles in a reasonable time period so that a representative sample of air is obtained for biological analysis. Newer analytical techniques for assaying air samples include PCR methods and enzyme-linked immunosorbent assays (ELISAs).

3. Water Sampling A detailed discussion of the principles and practices of water sampling has been published. 945 Water sampling in health-care settings is used detect waterborne pathogens of clinical significance or to determine the quality of finished water in a facility's distribution system. Routine testing of the water in a health-care facility is usually not indicated, but sampling in support of outbreak investigations can help determine appropriate infection-control measures. Water-quality assessments in dialysis settings have been discussed in this guideline (see Water, Dialysis Water Quality and Dialysate, and Appendix C). Health-care facilities that conduct water sampling should have their samples assayed in a laboratory that uses established methods arid quality-assurance protocols. Water specimens are not "static specimens" at ambient temperature; potential changes in both numbers and types of microbial populations can occur during transport. Consequently, water samples should be sent to the testing laboratory cold (i.e., at approximately 39.2'F [4'C]) and testing should be done as soon as practical after collection (preferably within 24 hours).

Because most water sampling in health-care facilities involves the testing of finished water from the facility's distribution system, a reducing agent (i.e., sodium thiosulfate [Na2 S2 0 3]) needs to be added to neutralize residual chlorine or other halogen in the collected sample. Ifthe water contains elevated levels of heavy metals, then a chelating agent should be added to the specimen. The minimum volume of water to be collected should be sufficient to complete any and all assays indicated; I00 mL is considered a suitable minimum volume. Sterile collection equipment should always be used.

Sampling from a tap requires flushing of the water line before sample collection. If the tap is a mixing faucet, attachments (e.g., screens and aerators) must be removed, and hot and then cold water must be run through the tap before collecting the sample. 945 If the cleanliness of the tap is questionable, disinfection with 500--600 ppm sodium hypochlorite (I :I 00 v/v dilution of chlorine bleach) and flushing the tap should precede sample collection.

Microorganisms in finished or treated water often are physically damaged ("stressed") to the point that growth is limited when assayed under standard conditions. Such situations lead to false-negative readings and misleading assessments of water quality. Appropriate neutralization of halogens and chelation of heavy metals are cmcial to the recovery of these organisms. The choice of recovery media and incubation conditions wiJI also affect the assay. Incubation temperatures should be closer to the ambient temperature of the water rather than at 98.6°F (37°C), and recovery media should be formulated to provide appropriate concentrations of nutrients to support organisms exhibiting less than rigorous growth. 945 High-nutrient content media (e.g., blood agar and tryptic soy agar [TSA]) may actually inhibit the growth of these damaged organisms. Reduced nutrient media (e.g., diluted peptone and R2A) are preferable for recovery of these organisms. 945 95

Use of aerobic, heterotrophic plate counts allows both a qualitative and quantitative measurement for water quality. If bacterial counts in water are expected to be high in number (e.g., during waterborne outbreak investigations), assaying small quantities using pour plates or spread plates is appropriate. 945 Membrane filtration is used when low-count specimens are expected and larger sampling volumes are required (2: I 00 mL ). The sample is filtered through the membrane, and the filter is applied directly face-up onto the surface of the agar plate and incubated.

Unlike the testing of potable water supplies for coliforms (which uses standardized test and specimen collection parameters and conditions), water sampling to support epidemiologic investigations of disease outbreaks may be subjected to modifications dictated by the circumstances present in the facility. Assay methods for waterborne pathogens may also not be standardized. Therefore, conn·ol or comparison samples should be included in the experimental design. Any departure from a standard method should be fully documented and should be considered when interpreting results and developing strategies. Assay methods specific for clinically significant waterborne pathogens (e.g., Legionella spp., Aeromonas spp, Pseudomonas spp., and Acinetobacter spp.) are more complicated and costly compared with both methods used to detect coli forms and other standard indicators of water quality.

4. Environmental Surface Sampling Routine environmental-surface sampling (e.g., surveillance cultures) in health-care settings is neither cost-effective nor warranted."'· 1225 When indicated, surface sampling should be conducted with multidisciplinaty approval in adherence to carefully considered plans of action and policy (Box 15).

Box 15. Undertaking environmental-surface sampling*

The following factors should be considered before engaging in environmental-surface sampling:

Background information from the literature and present activities (i.e., preliminary results from an epidemiologic investigation) Location of surfaces to be sampled Method of sample collection and the appropriate equipment for this tasl{ Number of replicate samples needed and which control or comparison samples are required Parameters ofthe sample assay method and whether the sampling will be qualitative, quantitative, or both • An estimate of the maximum allowable microbial numbers or types on the surface(s) sampled (refer to the Spaulding classification for devices and surfaces) • Some anticipation of a corrective action plan

* The material in this box is compiled from reference 1214.

Surface sampling is used currently for research, as part of an epidemiologic investigation, or as part of a comprehensive approach for specific quality assurance purposes. As a research tool, surface sampling . a) potentia has been use d to determme . I envtronmenta . . of patI10gens,564 ' 123 0- 1232 b) survtva 1 reserv01rs . I of 1232 1233 1023 microorganisms on surfaces, • and c) the sources of the environmental contamination. Some 1232 or all of these approaches can also be used during outbreak investigations. Discussion of surface sampling of medical devices and instruments is beyond the scope of this document and is deferred to future guidelines on sterilization and disinfection issues. 1214 Meaningful results depend on the selection of appropriate sampling and assay techniques. The media, reagents, and equipment required for surface sampling are available from any well-equipped 96

microbiology laboratory and laboratory supplier. For quantitative assessment of surface organisms, non-selective, nutrient-rich agar media and broth (e.g., TSA and brain-heart infusion broth [BHI] with or without 5% sheep or rabbit blood supplement) are used for the recove1y of aerobic bactelia. Broth media are used with membrane-filtration teclmiques. Further sample work-up may require the use of selective media for the isolation and enumeration of specific groups of microorganisms. Examples of selective media are MacConkey agar (lv1AC [selects for gram-negative bacteria]), Cetrimide agar (selects for Pseudomonas aemgiuosa), or Sabonraud dextrose- and malt extract agars and broths (select for fungi). Qualitative detenninatiom of organisms from snrtaces require only the use of selective or non-selective broth media.

Effective sampling of surfaces requires moisture. either already present on the surface to be sampled or via moistened swabs, sponges, wipes, agar snrtaces, or membrane filters. 1214• 123'- 1236 Dilution fluids and rinse fluids include various buffers or general pmpose broth media (Table 24). If disinfectant residuals are expected on smfaces being sampled, specific neutralizer chemicals should be used in both the growth media and the dilution or rinse fluids. Lists of the neutralizers, the target disinfectant active ingredients, and the use concentrations have been published. 1214• 1237 Altematively. instead of adding neutralizing chemicals to existing culture media (or if the chemical nature of the disinfectant residuals is unknown), the use of either a) commercially available media including a variety of specific and non- specific neutralizers orb) double-strength broth media will facilitate optimal recove1y of microorganisms. 111e inclusion of appropriate control specimens should be included to rule out both residual antimicrobial activity from surface disinfectants and potential toxicity caused by the presence of neutralizer chemicals canied over into the assay system. 1214

Table 24. Examples of eluents and diluents for environmental-surface sampling* + Solutions Couc~utrlltion in water Ringer %strength Peplow; water O.lo/6-LO% Buffered peptone wotei' 0.067 M phosphnte. 0,43% NaCI, 0.1% peptone Pho.sphnte-buffered snline 0.02 M pho:.phatct 0.9% NnCl Sodium chloride (NaCl) 0,25%r·-0,9% Ca lg:on Ringer§ ~-4 strength 111ioo:.ulfate Ringert:! 'A strength \Vntel' - TI)'Piic soy bro1h (TSB) -· Brnin-hentt infusion broth (BHI) supplemented with 0.5% - beef extract • Matenalm tlus tablets compiled from references 1214 and 123K + A stufnctnnt (e.g., polysorbate {i.e .. Tween® SO)) may be added to elt1ents and dilueuls. A concentwtion ranging from O.oto/o-0.1% is genffillly used, depending on the speclfic appliauion. Foruning may occ\lr dming me. § Thi'> soluliotl is used for dissolution of caldulU olginate swabs. ~ This .'>olution isu$ed for ueutrnlization of residual chlorine.

Several methods can be used for collecting enviromnental surface samples (Table 25). Specific step-by- step discussions of each of the methods have been published. 1214 • 1239 For best results, all methods should inco1porate aseptic teclmiques. sterile equipment and sterile recovery media. 97

Table 25. Methods of environmental-surface sampling . Suitable fol' .Method approptillte Assay Procf'clnl'al Points: of Available Reference~ technique notes lntel'(H'etatiou staudat'ds suJ'face{s} Snmplefrila-~e Moistened Non-absorbent Dtlutions; Assay multiple Report results per YES- food 1214, 1239- swab/rinse surfaces, comets, qualitative or measure'> ilre-as measured areas or if industry; 1242 crevice.~. devices, quantitative or devices wilb assaying an object, NO-heath and ins1nm~ents assays separate swabs per t1te entire sample me site

Moistened Large artas and Dilutions; Vigorously nth a Report results per YES- food 1214, 1239- sponge/rinse housekeeping qnttlitntive or stffile sponge uv.msured area indu.~try; 1242 smfaces (e.g.. qmmtitahve over the surface NO-J1ealth floors or walls) assny.s care

Moistened Larg{l areas nnd Dliutions; Use a steril{l Report results pe-r YES- food 1214, 1239- wipeJrinse housekeeping qualitative or wipe measured area indmhy; 1242 surfaces {e.g., quantitati•:e. NO-health cotmtertops) assays biologi<:al concentration is low Contaitnnl.'ut Interior surfaces Dilutions; Use membrane Evaluate both the \'ES ~food and 12!4 of containers, qu;llitative or filtnuion if rinse types and number!i industrial tubes, or bottles quantitative volume is l<~rge of microorgani!>m~ applications for assays containers prior :fill to RODAC" Pre~·iously Direct assny Overgrowth Provide.'> direct, NO 1214, 1237, cleaned mtd occurs ifnsed on q\lantitati\'e results; 1239.1243, snnitized flnt, heavily u<>e a minimum of 1244 non--absorbent contamitltlted 15 plates per an ~;urfaces:; not surfaces; use average hospital suitable for ne\tflaliurs -in .room irregular surfaces the agar if ,~urface disinfectant retsiduals are I present

"* RODAC stands for "replicate organism dlrect agar contact:'

Sample/rinse methods are frequently chosen because of their versatility. However, )hese samplin5 methods are the most prone to errors caused by manipulation of the swab, gauze pad, or sponge. 12 8 Additionally.no microbiocidal or microbiostatic agents should be present in any of these items when used for sampling. 1238 Each of the rinse methods requires effective elution of microorganisms from the item used to sample the surface. Thorough mixing of the rinse fluids after elution (e.g .. via manual or mechanical mixing using a vortex mixer, shaking with or without glass beads, and ultrasonic bath) will help to remove and sus~end material from the sampling device and break up clumps of organisms for a more accurate count. 123 In some instances, the item used to sample the surface (e.g., gauze pad and sponge) may be immersed in the rinse fluids in a sterile bag and subjected to stomaching. 1238 This technique, however, is suitable only for soft or absorbent items that will not puncnlfe the bag dming the elution process.

If sampling is conducted as pmt of an epidemiologic investigation of a disease outbreak, identification of isolates to species level is mandat01y, and characterization beyond the species level is prefened. 1214 \Vhen iute1preting the results of the sampling, the expected degree of microbial contamination 98

associated with the various categories of surfaces in the Spaulding classification must be considered. Environmental surfaces should be visibly clean; recognized pathogens in numbers sufficient to result in secondary transfer to other animate or inanimate surfaces should be absent fi·om the surface being 1214 sampled. Although the interpretation of a sample with positive microbial growth is self-evident, an environmental surface sample, especially that obtained from housekeeping surfaces, that shows no growth does not represent a "sterile" surface. Sensitivities of the sampling and assay methods (i.e., level of detection) must be taken into account when no-growth samples at·e encountered. Properly collected control samples will help rule out extraneous contamination of the surface sample.

G. Laundry and Bedding 1. General Information Laundry in a health-care facility may include bed sheets and blankets, towels, personal clothing, patient apparel, uniforms, scrub suits, gowns, and drapes for surgical procedures. 1245 Although contaminated textiles and fabrics in health-care facilities can be a source of substantial numbers of pathogenic microorganisms, reports of health-care-associated diseases linked to contaminated fabrics are so few in number that the overall risk of disease transmission during the laundry process likely is negligible. When the incidence of such events are evaluated in the context of the volume of items laundered in health-care settings (estimated to be 5 billion pounds annually in the United States),' 246 existing control measures (e.g., standard precautions) are effective in reducing the risk of disease transmission to patients and staff. Therefore, use of current control measures should be continued to minimize the contribution of contaminated laund1y to the incidence of health-care-associated infections. The control measures described in this section of the guideline are based on principles of hygiene, common sense, and consensus guidance; they pertain to Iaund1y services utilized by health-care facilities, either in- house or contract, rather than to laund1y done in the home.

2. Epidemiology and General Aspects of Infection Control Contaminated textiles and fabrics often contain high numbers of microorganisms from body substances, including blood, skin, stool, urine, vomitus, and other body tissues and fluids. When textiles are heavily contaminated with potentially infective body substances, they can contain bacterial loads of I 06-1 08 CFU/1 00 cm 2 of fabric. 1247 Disease transmission attributed to health-care laundry has involved contaminated fabrics that were handled inappropriately (i.e., the shaking of soiled linens). Bacteria (Salmonella spp., Bacillus cereus), viruses (hepatitis B virus [HBV]), fungi (Microsporum canis), and ectoparasites (scabies) presumably have been transmitted from contaminated textiles and fabrics to workers via a) direct contact or b) aerosols of contaminated lint generated from sorting and handling contaminated textiles. 124,._. 1252 In these events, however, investigations could not rule out the possibility that some of these reported infections were acquired from community sources. Through a combination of soil removal, pathogen removal, and pathogen inactivation, contaminated laundry can be rendered hygienically clean. Hygienically clean laundty carries negligible risk to health-care workers and patients, provided that the clean textiles, fabric, and clothing are not inadvertently contaminated before use.

OSHA defines contaminated laundty as "laundty which has been soiled with blood or other potentially infectious materials or may contain sharps. " 967 The purpose of the laundry pottion of the standard is to protect the worker from exposure to potentially infectious materials during collection, handling, and sotting of contaminated textiles through the use of personal protective equipment, proper work practices, containment, labeling, hazard communication, and ergonomics. 99

Expet1s are divided regarding the practice of transporting clothes worn at the workplace to the health- care worker's home for laundering. Although OSHA regulations prohibit home laundering of items that are considered personal protective apparel or equipment (e.g., laboratory coats), 967 experts disagree about whether this regulation extends to uniforms and scrub suits that are not contaminated with blood or other potentially infectious material. Health-care facility policies on this matter vary and may be inconsistent with recommendations of professional organizations. 1253 • 1254 Uniforms without blood or body substance contamination presumably do not differ appreciably from street clothes in the degree and microbial nature of soilage. Home laundering would be expected to remove this level of soil adequately. However, if health-care facilities require the use of uniforms, they should either make provisions to launder them or provide information to the employee regarding infection control and cleaning guidelines for the item based on the tasks being performed at the facility. Health-care facilities should address the need to provide this service and should determine the frequency for laundering these items. In a recent study examining the microbial contamination of medical students' white coats, the students perceived the coats as "clean" as long as the garments were not visibly contaminated with body substances, even after weating the coats for several weeks. 1255 The heaviest bacterial load was found on the sleeves and the pockets of these garments; the organisms most frequently isolated were Staphylococcus aureus, diphtheroids, and Acinetobacter spp. 1255 Presumably, the sleeves of the coat may make contact with a patient and potentially serve to transfer environmentally stable microorganisms among patients. In this study, however, surveillance was not conducted among patients to detect new infections or colonizations. The students did, however, report that they would likely replace their coats more frequently and regularly if clean coats were provided. 1255 Apart from this study, which documents the presence of pathogenic bacteria on health-care facility clothing, reports of infections attributed to either the contact with such apparel or with home laundering have been rare. 12s6, 12s7

Laundry services for health-care facilities are provided either in-house (i.e., on-premise laundry [OPL]), co-operatives (i.e., those entities owned and operated by a group offacilities), or by off-site commercial laundries. In the latter, the textiles may be owned by the health-care facility, in which case the processor is paid for laundering only. Alternatively, the textiles may be owned by the processor who is paid for evety piece laundered on a "rental" fee. The laundty facility in a health-care setting should be designed for efficiency in providing hygienically clean textiles, fabrics, and apparel for patients and staff. Guidelines for laundry construction and operation for health-care facilities, including nursing facilities, have been published. 120• 1258 The design and engineering standards for existing facilities are 120 those cited in the AlA edition in effect during the time of the facility's construction. A laundry facility is usually partitioned into two separate areas- a "dit1y" area for receiving and handling the soiled laundry and a "clean" area for processing the washed items. 1259 To minimize the potential for recontaminating cleaned laundty with aerosolized contaminated lint, areas receiving contaminated textiles should be at negative air pressure relative to the clean areas. 1260- 1262 Laundry areas should have handwashing facilities readily available to workers. Laundry workers should wear appropriate personal protective equipment (e.g., gloves and protective garments) while sorting soiled fabrics and textiles. 967 Laundry equipment should be used and maintained according to the manufacturer's instructions to prevent microbial contamination of the system. 1250• 1263 Damp textiles should not be left in machines overnight. 1250

3. Collecting, Transporting, and Sorting Contaminated Textiles and Fabrics The laundty process starts with the removal of used or contaminated textiles, fabrics, and/or clothing from the areas where such contamination occurred, including but not limited to patients' rooms, surgical/operating areas, and laboratories. Handling contaminated laundty with a minimum of agitation 100

can help prevent the generation of potentially contaminated lint aerosols in patient-care areas.' 67 · 1259 Sorting or rinsing contaminated laundry at the location where contamination occurred is prohibited by 967 OSHA. Contaminated textiles and fabrics are placed into bags or other appropriate containment in this location; these bags are then secmely tied or otherwise closed to prevent leakage. 967 Single bags of sufficient tensile strength are adequate for containing laund1y, but leak-resistant containment is needed if the laundry is wet and capable of soaking through a cloth bag. 1264 Bags containing contaminated laundry must be clearly identified with labels, color-coding, or other methods so that health-care workers handle these items safely, regardless of whether the laundry is transported within the facility or destined for transport to an off-site laundry service. 967

Typically, contaminated laund1y originating in isolation areas of the hospital is segregated and handled with special practices; however, few, if any, cases of health-care-associated infection have been linked 1265 to this source. Single-blinded studies have demonstrated that laund1y from isolation areas is no more heavily contaminated with microorganisms than laund1y from elsewhere in the hospital. 1266 Therefore, adherence to standard precautions when handling contaminated laundry in isolation areas and minimizing agitation of the contaminated items are considered sufficient to prevent the dispersal of potentially infectious aerosols 6

Contaminated textiles and fabrics in bags can be transpotted by ca1t or chute, 1258• 1262 Laundry chutes require proper design, maintenance, and use, because the piston-like action of a laundry bag traveling in the chute can propel airborne microbial contaminants throughout the facility. 1267- 1269 Laund1y chutes should be maintained under negative air pressure to prevent the spread of microorganisms from floor to floor. Loose, contaminated pieces of laund1y should not be tossed into chutes, and laund1y bags should be closed or otherwise secured to prevent the contents from falling out into the chute, 1270 Health-care facilities should determine the point in the laundry process at which textiles and fabrics should be sorted, Sorting after washing minimizes the exposme of laund1y workers to infective material in soiled fabrics, reduces airborne microbial contamination in the laund1y area, and helps to prevent potential percutaneous injmies to personnel. 1271 Sorting laund1y before washing protects both the machinery and fabrics fmm hard objects (e.g., needles, syringes, and patients' prope1ty) and reduces the potential for recontamination of clean textiles. 1272 Sotting laund1y before washing also allows for customization of laund1y formulas based on the mix of products in the system and types of soils encountered, Additionally, if work flow allows, increasing the amount of segregation by specific product types will usually yield the greatest amount of work efficiency during inspection, folding, and pack-making operations. 1253 Protective apparel for the workers and appropriate ventilation can minimize these exposures. 967· 125 ,. 1260 Gloves used for the task of sorting laund1y should be of sufficient thickness to minimize sharps injuries. 967 Employee safety personnel and industrial hygienists can help to determine the appropriate glove choice.

4. Parameters of the Laundry Process Fabrics, textiles, and clothing used in health-care settings are disinfected during laundering and generally rendered free of vegetative pathogens (i.e., hygienically clean), but they are not sterile. 1273 1274 Laundering cycles consist of flush, main wash, bleaching, rinsing, and soming. Cleaned wet textiles, fabrics, and clothing are then dried, pressed as needed, and prepared (e.g., folded and packaged) for distribution back to the facility. Clean linens provided by an off-site laund1y must be packaged prior to transport to prevent inadve1tent contamination fmm dust and dirt during loading, delivery, and unloading, Functional packaging of laund1y can be achieved in several ways, including a) placing clean linen in a hamper lined with a previously unused liner, which is then closed or covered; b) placing clean linen in a properly cleaned cart and covering the cmt with disposable material or a properly cleaned reusable textile material that can be seemed to the catt; and c) wrapping individual bundles of clean 101

textiles in plastic or other suitable material and sealing or taping the bundles.

The antimicrobial action of the laundering process results from a combination of mechanical, thennal, an d c h emtca ' tors. 1211 · lm· I"' D'l1 ut'ton an d agttatton . I 1ac . . m . wat er remove su bstantta . I quanttttes . . of microorganisms. Soaps and detergents function to suspend soils and also exhibit some microbiocidal prope1ties. Hot water provides an effective means of destroying microorganisms. 1277 A temperature of at least 160°F (7 I"C) for a minimum of 25 minutes is commonly recommended for hot-water washing.' Water of this temperature can be provided by steam jet or separate booster heater. 120 The use of chlorine bleach assures an extra margin of safety. 1278· 1279 A total available chlorine residual of 50-150 ppm is usually achieved during the bleach cycle. 1277 Chlorine bleach becomes activated at water temperatures of 135°F-145°F (57.2°C-62.7°C). The last of the series of rinse cycles is the addition of a mild acid (i.e., sour) to neutralize any alkalinity in the water supply, soap, or detergent. The rapid shift in pH from approximately 12 to 5 is an effective means to inactivate some microorganisms. 1247 Effective removal of residual alkali from fabrics is an impmtant measure in reducing the risk for skin reactions among patients.

Chlorine bleach is an economical, broad-spectrum chemical germicide that enhances the effectiveness of the laundering process. Chlorine bleach is not, however, an appropriate laundry additive for all fabrics. Traditionally, bleach was not recommended for laundering flame-retardant fabrics, linens, and clothing because its use diminished the flame-retardant properties of the treated fabric. 1273 However, some modern-day flame retardant fabrics can now tolerate chlorine bleach. Flame-retardant fabrics, whether topically treated or inherently flame retardant, should be thoroughly rinsed during the rinse cycles, because detergent residues are capable ofsuppmting combustion. Chlorine alternatives (e.g., activated oxygen-based laund1y detergents) provide added benefits for fabric and color safety in addition to antimicrobial activity. Studies comparing the antimicrobial potencies of chlorine bleach and oxygen-based bleach are needed. Oxygen-based bleach and detergents used in health-care settings should be registered by EPA to ensure adequate disinfection oflaundry. Health-care workers should note the cleaning instructions of textiles, fabrics, drapes, and clothing to identify special laundering requirements and appropriate hygienic cleaning options. 1278

Although hot-water washing is an effective laund1y disinfection method, the cost can be substantial. Laundries are typically the largest users of hot water in hospitals. They consume 50%-75% of the total hot water, 1280 representing an average of I Oo/o-15% of the energy used by a hospital. Several studies have demonstrated that lower water temperatures of 71 °F-77°F (22°C-25°C) can reduce microbial contamination when the cycling of the washer, the wash detergent, and the amqunt of laund1y additive are carefully monitored and controlled. 1247· 128 H 285 Low-temperature laundry cycles rely heavily on the presence of chlorine- or oxygen-activated bleach to reduce the levels of microbial contamination. The selection of hot- or cold-water laundry cycles may be dictated by state health-care facility licensing standards or by other regulation. Regardless of whether hot or cold water is used for washing, the temperatures reached in d1ying and especially during ironing provide additional significant microbiocidal action. 1247 D1yer temperatures and cycle times are dictated by the materials in the fabrics. Man-made fibers (i.e., polyester and polyester blends) require shorter times and lower temperatures.

After washing, cleaned and dried textiles, fabrics, and clothing are pressed, folded, and packaged for transport, distribution, and storage by methods that ensure their cleanliness until use.' State regulations and/or accrediting standards may dictate the procedures for this activity. Clean/sterile and contaminated textiles should be transported from the laund1y to the health-care facility in vehicles (e.g., !Iucks, vans, and carts) that allow for separation of clean/sterile and contaminated items. Clean/sterile textiles and contaminated textiles may be transpo1ted in the same vehicle, provided that the use of physical barriers and/or space separation can be verified to be effective in protecting the clean/sterile items from 102

contamination. Clean, uncovered/unwrapped textiles stored in a clean location for short periods of time (e.g., uncovered and used within a few hours) have not been demonstrated to contribute to increased levels of health-care-acquired infection. Such textiles can be stored in convenient places for use during the provision of care, provided that the textiles can be maintained dry and free from soil and body- substance contamination.

In the absence of microbiologic standards for laundered textiles, no rationale exists for routine microbiologic sampling of cleaned health-care textiles and fabrics. 1286 Sampling may be used as part of an outbreak investigation if epidemiologic evidence suggests that textiles, fabrics, or clothing are a suspected vehicle for disease transmission. Sampling techniques include aseptically macerating the fabric into pieces and adding these to broth media or using contact plates (RODAC plates) for direct 1286 surface sampling. 1271 ' When evaluating the disinfecting properties of the laundering process specifically, placing pieces of fabric between two membrane filters may help to minimize the contribution of the physical removal of microorganisms.""

Washing machines and d1yers in residential-care settings are more likely to be consumer items rather than the commercial, heavy-duty, large volume units typically found in hospitals and other institutional health-care settings. Although all washing machines and d1yers in health-care settings must be properly maintained for performance according to the manufacturer's instructions, questions have been raised about the need to disinfect washers and d1yers in residential-care settings. Disinfection of the tubs and tumblers of these machines is unnecessa1y when proper laundty procedures are followed; these procedures involve a) the physical removal of bulk solids (e.g., feces) before the wash/dty cycle and b) proper use of temperature, detergent, and laundry additives. Infection has not been linked to laundry procedures in residential-care facilities, even when consumer versions of detergents and laundty additives are used.

5. Special Laundry Situations Some textile items (e.g., surgical drapes and reusable gowns) must be sterilized before use and therefore require steam autoclaving after laundering.' Although the American Academy of Pediatrics in previous guidelines recommended autoclaving for linens in neonatal intensive care units (NICUs), studies on the microbial quality of routinely cleaned NICU linen have not identified any increased risk for infection among the neonates receiving care. 1288 Consequently, hygienically clean linens are suitable for use in this setting. 997 The use of sterile linens in burn therapy units remains unresolved.

Coated or laminated fabrics are often used in the manufacture of PPE. When these items become contaminated with blood or other body substances, the manufacturer's instructions for decontamination and cleaning take into account the compatibility of the rubber backing with the chemical germicides or detergents used in the process. The directions for decontaminating these items should be followed as indicated; the item should be discarded when the backing develops surface cracks.

Dry cleaning, a cleaning process that utilizes organic solvents (e.g., perchloroethylene) for soil removal, is an alternative means of cleaning fabrics that might be damaged in conventional laundering and detergent washing. Several studies, however, have shown that dry cleaning alone is relatively . f~1ecttve me . .m re ducmg . t he numb ers o f bactena. an d vtruses . . t e d I'mens; 1289· 1290 mtcro on cont aruma . b'Ia I populations are significantly reduced only when d1y-cleaned articles are heat pressed. Dry cleaning should therefore not be considered a routine option for health-care facility laundry and should be 1291 reserved for those circumstances in which fabrics can not be safely cleaned with water and detergent. 103

6. Surgical Gowns, Drapes, and Disposable Fabrics An issue of recent concern involves the use of disposable (i.e., single use) versus reusable (i.e., multiple use) surgical attire and fabrics in health-care settings. 1292 Regardless of the material used to manufacture gowns and drapes, these items must be resistant to liquid and microbial penetration.'·"',_ 1297 Surgical gowns and drapes must be registered with FDA to demonstrate their safety and effectiveness. Repellency and pore size of the fabric contribute to gown performance, but performance capability can be influenced by the item's design and construction. 1298• 1299 Reinforced gowns (i.e., gowns with double-layered fabric) generally are more resistant to liquid strike-through. 1300 • 1301 Reinforced gowns may, however, be less comfortable. Guidelines for selection and use of barrier materials for surgical gowns and drapes have been published. 1302 When selecting a barrier product, 967 repellency level and type ofbanier should be compatible for the exposure expected. However, data are limited regarding the association between gown or drape characteristics and risk for surgical site infections.'· 1303 Health-care facilities must ensure optimal protection of patients and health-care workers. Not all fabric items in health care lend themselves to single-use. Facilities exploring options for gowns and drapes should consider the expense of disposable items and the impact on the facility's waste-management costs once these items are discarded. Costs associated with the use of durable goods involve the fabric or textile items; staff expenses to collect, sort, clean, and package the laundry; and 1305 energy costs to operate the laundry if on-site or the costs to contract with an outside service. 1304•

7. Antimicrobial-Impregnated Articles and Consumer Items Bearing Antimicrobial Labeling Manufacturers are increasingly incorporating antibacterial or antimicrobial chemicals into consumer and health-care items. Some consumer products bearing labels that indicate treatment with antimicrobial chemicals have included pens, cutting boards, toys, household cleaners, hand lotions, cat litter, soaps, cotton swabs, toothbrushes, and cosmetics. The "antibacterial" label on household cleaning products, in particular, gives consumers the impression that the products perform "better" than comparable products without this labeling, when in fact all household cleaners have antibacterial properties.

In the health-care setting, treated items may include children's pajamas, mattresses, and bed linens with label claims of antimicrobial properties. These claims require careful evaluation to determine whether they pertain to the use of antimicrobial chemicals as preservatives for the fabric or other components or whether they imply a health claim. 1306• 1307 No evidence is available to suggest that use of these products will make consumers and patients healthier or prevent disease. No data support the use of these items as patt of a sound infection-control strategy, and therefore, the additional expense of replacing a facility's bedding and sheets with these treated products is unwarranted.

EPA has reaffirmed its position that manufacturers who make public health claims for articles containing antimicrobial chemicals must provide evidence to supp01t those claims as part of the registration process. 1308 Current EPA regulations outlined in the Treated Articles Exemption of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) require manufacturers to register both the antimicrobial chemical used in or on the product and the finished product itself if a public health claim is maintained for the item. The exemption applies to the use of antimicrobial chemicals for the purpose of preserving the integrity of the product's raw material(s). The U.S. Federal Trade Commission (FTC) 1309 is evaluating manufacturer advertising of products with antimicrobial claims. 104

8. Standard Mattresses, Pillows, and Air-Fluidized Beds Standard mattresses and pillows can become contaminated with body substances during patient care if the integrity of the covers of these items is compromised. The practice of sticking needles into the mattress should be avoided. A mattress cover is generally a fitted, protective material, the purpose of which is to prevent the mattress from becoming contaminated with body fluids and substances. A linen sheet placed on the mattress is not considered a mattress cover. Patches for tears and holes in mattress covers do not provide an impermeable surface over the mattress. Mattress covers should be replaced when torn; the mattress should be replaced if it is visibly stained. Wet mattresses, in particular, can be a substantial environmental source of microorganisms. Infections and colonizations caused by Acinetobacter spp., MRSA, and Pseudomonas aeruginosa have been described, especially among burn patients. 131 0- 1315 In these reports, the removal of wet mattresses was an effective infection-control measure. Efforts were made to ensure that pads and covers were cleaned and disinfected between patients using disinfectant products compatible with mattress-cover materials to ensure that these covers remained impermeable to fluids. 131 0- 1314 Pillows and their covers should be easily cleanable, preferably in a hot water laundty cycle. 1315 These should be laundered between patients or if contaminated with body substances.

Air-fluidized beds are used for the care of patients immobilized for extended periods of time because of therapy or injuty (e.g., pain, decubitus ulcers, and burns). 1316 These specialized beds consist of a base unit filled with microsphere beads fluidized by warm, dry air flowing upward from a diffuser located at the bottom of the unit. A porous, polyester filter sheet separates the patient from direct contact with the beads but allows body fluids to pass through to the beads. Moist beads aggregate into clumps which settle to the bottom where they are removed as part of routine bed maintenance.

Because the beads become contaminated with the patient's body substances, concerns have been raised about the potential for these beds to serve as an environmental source of pathogens. Certain pathogens (e.g., Enterococcus spp., Serratia marcescens, Staphylococcus aureus, and Streptococcusfecalis) have been recovered either from the microsphere beads or the polyester sheet after cleaning. 1317• 1318 Reports of cross-contamination of patients, however, are few. 1318 Nevertheless, routine maintenance and between-patient decontamination procedures can minimize potential risks to patients. Regular removal of bead clumps, coupled with the warm, dty air of the bed, can help to minimize bacterial growth in the unit. 131 .,_ 1321 Beads are decontaminated between patients by high heat (ll3°F-194°F [45°C-90°C], depending on the manufacturer's specifications) for at least I hour; this procedure is patticularly important for the inactivation of Enterococcus spp. which are relatively resistant to heat. 1322 • 1323 The polyester filter sheet requires regular changing and thorough cleaning and disinfection, especially between patients. 1317' 1318• 1322• 1323

Microbial contamination of the air space in the immediate vicinity of a properly maintained air-fluidized bed is similar to that found in air around conventional bedding, despite the air flow out of the base unit and around the patient. 1320• 1324 • 1325 An operational air-fluidized bed can, however, interfere with proper 1326 pressure differentials, especially in negative-pressure rooms; the effect varies with the location of the bed relative to the room's configuration and supply and exhaust vent locations. Use of an air- fluidized bed in a negative-pressure room requires consultation with a facility engineer to determine appropriate placement of the bed. 105

H. Animals in Health-Care Facilities 1. Genenll Information Animals in health-eme facilities traditionally have been limited to laboratories and research areas. However, their presence in patient-care areas is now more tl·equent, both in acute-care and long:-tenn care settings. prompting consideration for the potential transmission of zoonotic pathogens tl·om animals to humans in these settings. Although dogs and cats may be conunorily encmmtered in health-care settings. other animals (e.g .. fish, birds, non-human primates, rabbits, rodents, and reptiles) also can be present as research, resident, or service animals. These animals can serve as sources of zoonotic pathogens that could potentially infect patients and health-care workers (Table 26).u27- 1340 Animals potentially can serve as reservoirs for antibiotic-resistant microorganisms, which can be introduced to the health-care setting while the animal is present. VRE have been isolated from both fann animals and pets, 1341 aud a cat in a geriatric care center was fOlmd to be colonized with MRSA. 1342

Table 26. Examples of diseases nssociatecl witll zoonotic transmission*+ Infectious disease Cats Doos Fish Birds Rabbits Rtomiasi.<; + + + Cryptospotidiosls + Giardiasis + + + T oxocariasis + + + Toxoplasmosis + + + p.,;;;;; ·-·-..-. ·- ---· ·- f---- Blastomycosis + Dermatophytosis + + + +

* Material in this table is adapted from reference 1331 and used with penuission of the publisher (Lippi.ncott William'.i and Wilkins). +· l11is table doe-s not include veclorbome disea!<>t>S. § Reptiles include lizards, snakes, and Miles. Rodents include ham-.krs, mice, and rats. 4jf The+ symbol indicates that the pathogen ass-ociated whlt the infection has been isolated from animals and Is considered to pose potential risk to humans. 106

Zoonoses can be transmitted from animals to humans either directly or indirectly via bites, scratches, aerosols, ectoparasites, accidental ingestion, or contact with contaminated soil, food, water, or 1331 unpasteurized milk. ' 1332 • 134 .,_. 1345 Colonization and hand transferral of pathogens acquired from pets in health-care workers' homes represent potential sources and modes of transmission of zoonotic pathogens in health-care settings. An outbreak of infections caused by a yeast (Ma/assezia pachydermatis) among newborns was traced to transfer of the yeast fi·om the hands of health-care workers with pet dogs at home. 1346 In addition, an outbreak of ringworm in a NICU caused by Microsporum canis was associated with a nurse and her cat, 1347 and an outbreak of Rhodococcus (Gordona) bronchia/is sternal SS!s after coronary-artery bypass surge1y was traced to a colonized nurse whose dogs were culture-positive for the organism. 1348 In the latter outbreak, whether the dogs were the sole source of the organism and whether other environmental reservoirs contributed to the outbreak are unknown. Nonetheless, limited data indicate that outbreaks of infectious disease have occurred as a result of contact with animals in areas housing immunocompetent patients. However, the low frequency of outbreaks may result from a) the relatively limited presence of the animals in health-care facilities and b) the immunocompetency ofthe patients involved in the encounters. Formal scientific studies to evaluate potential risks of transmission of zoonoses in health-care settings outside of the laboratmy are lacking.

2. Animal-Assisted Activities, Animal-Assisted Therapy, and Resident Animals Animal-Assisted Activities (AAA) are those programs that enhance the patients' quality of life. These programs allow patients to visit animals in either a common, central location in the facility or in individual patient rooms. A group session with the animals enhances opportunities for ambulatory 1351 patients and facility residents to interact with caregivers, family members, and volunteers. 1349- Alternatively, allowing the animals access to individual rooms provides the same opportunity to non- ambulatory patients and patients for whom privacy or dignity issues are a consideration. The decision to allow this access to patients' rooms should be made on a case-by-case basis, with the consultation and consent of the attending physician and nursing staff.

Animal-Assisted Therapy (AAT) is a goal-directed intervention that incorporates an animal into the 1330 treatment process provided by a credentialed therapist. • 1331 The concept for AAT arose from the observation that some patients with pets at home recover fi·om surgical and medical procedures more rapidly than patients without pets. 1352 • 1353 Contact with animals is considered beneficial for enhancing wellness in certain patient populations (e.g., children, the elderly, and extended-care hospitalized patients). 1349• 1354-1 357 However, evidence supporting this benefit is largely derived fi·om anecdotal 1357 1359 reports an d o b servatwns · ' I amma of patient . I.mteractmns. ' - G ut'deI'mes '101' establ'ts h'mg AAT 1360 programs are available for facilities considering this option.

The incorporation of non-human primates into an AAA or AAT program is not encouraged because of 1361 concerns regarding potential disease transmission from and unpredictable behavior of these animals. ' 1362 Animals participating in either AAA or AA T sessions should be in good health and up-to-date with recommended immunizations and prophylactic medications (e.g., heartwmm prevention) as determined by a licensed veterinarian based on local needs and recommendations. Regular re-evaluation of the animal's health and behavior status is essential. 1360 Animals should be routinely screened for enteric parasites and/or have evidence of a recently completed anti helminthic regimen. 1363 They should also be ft·ee of ectoparasites (e.g., fleas and ticks) and should have no sutures, open wounds, or obvious dermatologic lesions that could be associated with bacterial, fungal, or viral infections or parasitic infestations. Incorporating young animals (i.e., those aged

the immune systems of very young puppies and kittens is not completely developed, thereby placing the health of these animals at risk. Animals should be clean and well-groomed. The visits must be supervised by persons who know the animals and their behavior. Animal handlers should be trained in these activities and receive site-specific orientation to ensure that they work efficiently with the staff in 1360 the specific health-care environment. Additionally, animal handlers should be in good health. 1360

The most important infection-control measure to prevent potential disease transmission is strict enforcement of hand-hygiene measures (e.g., using either soap and water or an alcohol-based hand mb) for all patients, staff, and residents after handling the animals. 1355 • 1364 Care should also be taken to avoid direct contact with animal urine or feces. Clean-up of these substances from environmental surfaces requires gloves and the use of leak-resistant plastic bags to discard absorbent material used in the process.'. The area must be cleaned after visits according to standard cleaning procedures.

The American Academy of Allergy, Asthma, and Immunology estimates that dog or cat allergies occur in approximately 15% of the population. 1365 Minimizing contact with animal saliva, dander, and/or urine helps to mitigate allergic responses. 136,._ 1367 Some facilities may not allow animal visitation for patients with a) underlying asthma, b) known allergies to cat or dog hair, c) respiratory allergies of unknown etiology, and d) immunosuppressive disorders. Hair shedding can be minimized by processes that remove dead hair (e.g., grooming) and that prevent the shedding of dead hair (e.g., therapy capes for dogs). Allergens can be minimized by bathing therapy animals within 24 hours of a visit. 1333 • 1368

Animal therapists and handlers must take precautions to prevent animal bites. Common pathogens associated with animal bites include Capnocytophaga canimorsus, Pasteurella spp., Staphylococcus spp., and Streptococcus spp. Selecting well-behaved and well-trained animals for these programs greatly decreases the incidence of bites. Rodents, exotic species, wild/domestic animals (i.e., wolf-dog hybrids), and wild animals whose behavior is unpredictable should be excluded from AAA or AAT programs. A well-trained animal handler should be able to recognize stress in the animal and to determine when to terminate a session to mil1imize risk. When an animal bites a person during AAA or AAT, the animal is to be permanently removed from the program. If a bite does occur, the wound must be cleansed immediately and monitored for subsequent infection. Most infections can be treated with antibiotics, and antibiotics often are prescribed prophylactically in these situations.

The health-care facility's infection-control staff should participate actively in planning for and coordinating AAA and AAT sessions. Many facilities do not offer AAA or AA T programs for severely immunocompromised patients (e.g., HSCT patients and patients on cmiicosteroid therapy). 1339 The question of whether family pets or companion animals can visit terminally-ill HSCT patients or other severely immunosuppressed patients is best handled on a case-by-case basis, although animals should not be brought into the HSCT unit or any other unit housing severely immunosuppressed patients. An in-depth discussion of this issue is presented elsewhere. 1366

Immunocompromised patients who have been discharged from a health-care facility may be at higher risk for acquiring some pet-related zoonoses. Although guidelines have been developed to minimize the risk of disease transmission to HIV-infected patients,' these recommendations may be applicable for patients with other immunosuppressive disorders. In addition to handwashing or hand hygiene, these recommendations include avoiding contact with a) animal feces and soiled litter box materials, b) animals with diarrhea, c) very young animals (i.e., dogs <6 months of age and cats

Many health-care facilities are adopting more home-like environments for residential-care or extended- stay patients in acute-care settings, and resident animals are one element of this approach. 1369 One 108

concept, the "Eden Alternative," incorporates children, plants, and animals (e.g., dogs, cats, fish, birds, rabbits, and rodents) into the daily care setting. 1370' 1371 The concept of working with resident animals has not been scientifically evaluated. Several issues beyond the benefits of therapy must be considered before embarking on such a program, including a) whether the animals will come into direct contact with patients and/or be allowed to roam freely in the facility; b) how the staff will provide care for the animals; c) the management of patients' or residents' allergies, asthma, and phobias; d) precautionary measures to prevent bites and scratches; and e) measures to properly manage the disposal of animal feces and urine, thereby preventing environmental contamination by zoonotic microorganisms (e.g., Toxoplasma spp., Toxocara spp., and Ancylostoma spp.). 1372 ' 1373 Few data document a link between health-care--acquired infection rates and frequency of cleaning fish tanks or rodent cages. Skin infections caused by Mycobacterium marinum have been described among persons who have fish aquariums at home. 1374 ' 1375 Nevertheless, immunocompromised patients should avoid direct contact with fish tanks and cages and the aerosols that these items produce. Further, fish tanks should be kept clean on a regular basis as determined by facility policy, and this task should be performed by gloved staff members who are not responsible for patient care. The use of the infection-control risk assessment can help determine whether a fish tank poses a risk for patient or resident safety and health in these situations. No evidence, however, links the incidence of health-care--acquired infections among immunocompetent patients or residents with the presence of a properly cleaned and maintained fish tank, even in dining areas. As a general preventive measure, resident animal programs are advised to restrict animals from a) food preparation kitchens, b) laundries, c) central' sterile supply and any storage areas for clean supplies, and d) medication preparation areas. Resident-animal programs in acute-care facilities should not allow the animals into the isolation areas, protective environments, ORs, or any area where immunocompromised patients are housed. Patients and staff routinely should wash their hands or use waterless, alcohol-based hand-hygiene products after contact with animals.

3. Service Animals Although this section provides an overview about service animals in health-care settings, it cannot address every situation or question that may arise (see Appendix E- Jnfonnation Resources). A service animal is any animal individually trained to do work or perform tasks for the benefit of a person with a disability. 1366' 1376 A service animal is not considered a pet but rather an animal trained to provide assistance to a person because of a disability. Title III of the "Americans with Disabilities Act" (ADA) of 1990 mandates that persons with disabilities accompanied by service animals be allowed access with their service animals into places of public accommodation, including restaurants, public transportation, schools, and health-care facilities.''"· 1376 In health-care facilities, a person with a disability requiring a service animal may be an employee, a visitor, or a patient.

An overview of the subject of service animals and their presence in health-care facilities has been published. 1366 No evidence suggests that animals pose a more significant risk oftransmitting infection than people; therefore, service animals should not be excluded from such areas, unless an individual patient's situation or a particular animal poses greater risk that cannot be mitigated through reasonable measures. If health-care personnel, visitors, and patients are permitted to enter care areas (e.g., in- patient rooms, some ICUs, and public areas) without taking additional precautions to prevent transmission of infectious agents (e.g., donning gloves, gowns, or masks), a clean, healthy, well- 1366 behaved service animal should be allowed access with its handler. Similarly, if immunocompromised patients are able to receive visitors without using protective garments or equipment, an exclusion of service animals from this area would not be justified. 1366

Because health-care facilities are covered by the ADA or the Rehabilitation Act, a person with a disability may be accompanied by a service animal within the facility unless the animal's presence or 109

behavior creates a fundamental alteration in the nature of a facility's services in a pmticular area or a direct threat to other persons in a pmticular area. 1366 A "direct threat" is defined as a significant risk to the health or safety of others that cannot be mitigated or eliminated by modifying policies, practices, or 1376 procedures. The determination that a service animal poses a direct threat in any particular health- care setting must be based on an individualized assessment of the service animal, the patient, and the health-care situation. When evaluating risk in such situations, health-care personnel should consider the nature of the risk (including duration and severity); the probability that injury will occur; and whether reasonable modifications of policies, practices, or procedures will mitigate the risk (J. Wodatch, U.S. Department of Justice, 2000). The person with a disability should contribute to the risk-assessment process as part of a pre-procedure health-care provider/patient conference.

Excluding a service animal from an OR or similar special care areas (e.g., burn units, some JCUs, PE units, and any other area containing equipment critical for life support) is appropriate if these areas are considered to have "restricted access" with regards to the general public. General infection-control measures that dictate such limited access include a) the area is required to meet environmental criteria to minimize the risk of disease transmission, b) strict attention to hand hygiene and absence of dermatologic conditions, and c) barrier protective measures [e.g., using gloves, wearing gowns and masks] are indicated for persons in the affected space. No infection-control measures regarding the use of barrier precautions could be reasonably imposed on the service animal. Excludillg a service animal that becomes threatening because of a perceived danger to its handler during treatment also is appropriate; however, exclusion of such an animal must be based on the actual behavior of the particular animal, not on speculation about how the animal might behave.

Another issue regarding service animals is whether to permit persons with disabilities to be accompanied by their service animals during all phases of their stay in the health-care facility. Health- care personnel should discuss all aspects of anticipatmy care with the patient who uses a service animal. Health-care personnel may not exclude a service animal because health-care staff may be able to perform the same services that the service animal does (e.g., retrieving dropped items and guiding an otherwise ambulatory person to the restroom). Similarly, health-care personnel can not exclude service animals because the health-care staff perceive a lack of need for the service animal during the person's stay in the health-care facility. A person with a disability is entitled to independent access (i.e., to be accompanied by a service animal unless the animal poses a direct threat or a fundamental alteration in the nature of services); "need" for the animal is not a valid factor in either analysis. For some forms of care (e.g., ambulation as physical therapy following total hip replacement or knee replacement), the service animal should not be used in place of a credentialed health-care worker who directly provides therapy. However, service animals need not be restricted fi·om being in the presence of its handler during this time; in addition, rehabilitation and discharge planning should incorporate the patient's future use of the animal. The health-care personnel and the patient with a disability should discuss both the possible need for the service animal to be separated from its handler fo1· a period of time during non- emergency care and an alternate plan of care for the service animal in the event the patient is unable or unwilling to provide that care. This plan might include family members taking the animal out of the facility several times a day for exercise and elimination, the animal staying with relatives, or boarding off-site. Care of the service animal, however, remains the obligation of the person with the disability, not the health-care staff.

Although animals potentially cany zoonotic pathogens transmissible to man, the risk is minimal with a healthy, clean, vaccinated, well-behaved, and well-trained service animal, the most common of which are dogs and cats. No reports have been published regarding infectious disease that affects humans originating in service dogs. Standard cleaning procedures are sufficient following occupation of an area by a service animal. 1366 Clean-up of spills of animal urine, feces, or other body substances can be accomplished with blood/body substance procedures outlined in the Environmental Services section of I 10

this guideline. No special bathing procedures are required prior to a service animal accompanying its handler into a health-care facility.

Providing access to exotic animals (e.g., reptiles and non- human primates) that are used as service animals is problematic. Concerns about these animals are discussed in two published reviews. 1331 • 1366 Because some of these animals exhibit high-risk behaviors that may increase the potential for zoonotic disease transmission (e.g., herpes B infection), providing health-care facility access to nonhuman primates used as service animals is discouraged, especially if these animals might come into contact with the general public. 1361 ' 1362 Health-care administrators should consult the Americans with Disabilities Act for guidance when developing policies about service animals in their facilities. 1366· 1376

Requiring documentation for access of a service animal to an area generally accessible to the public would impose a burden on a person with a disability. When health-care workers are not certain that an animal is a service animal, they may ask the person who has the animal if it is a service animal required because of a disability; however, no ce1iification or other documentation of service animal status can be required. 1377

4. Animals as Patients in Human Health-Care Facilities The potential for direct and indirect n·ansmission of zoonoses must be considered when rooms and equipment in human health-care facilities are used for the medical or surgical treatment or diagnosis of animals. 1378 Inquiries should be made to veterinaty medical professionals to determine an appropriate facility and equipment to care for an animal.

The central issue associated with providing medical o1· smgical care to animals in human health-care facilities is whether cross-contamination occurs between the animal patient and the human health-care workers and/or human patients. The fundamental principles of infection control and aseptic practice should differ only minimally, if at all, between veterinary medicine and human medicine. Health-care- associated infections can and have occurred in both patients and workers in veterinary medical facilities when lapses in infection-control procedmes are evident. 137,_ 1384 Futiher, veterinary patients can be at risk for acquiring infection from veterinary health-care workers if proper precautions are not taken. 1385

The issue of providing care to veterinary patients in human health-care facilities can be divided into the following three areas of infection-control concerns: a) whether the room/area used for animal care can be made safe for human patients, b) whether the medical/smgical instruments used on animals can be subsequently used on human patients, and c) which disinfecting or sterilizing procedures need to be done for these purposes. Studies addressing these concerns are lacking. However, with respect to disinfection or sterilization in veterina1y settings, only minimal evidence suggests that zoonotic microbial pathogens are unusually resistant to inactivation by chemical or physical agents (with the exception ofprions). Ample evidence supports the contrary observation (i.e., that pathogens from human- and animal sources are similar in their relative instrinsic resistance to inactivation). 138 6-- 1391 Further, no evidence suggests that zoonotic pathogens behave differently from human pathogens with respect to ventilation. Despite this knowledge, an aesthetic and sociologic perception that animal care must remain separate from human care persists. Health-care facilities, however, are increasingly faced with requests from the veterinaty medical community for access to human health-care facilities for reasons that are largely economical (e.g., costs of acquiring sophisticated diagnostic technology and complex medical instruments). If hospital guidelines allow treatment of animals, alternate veterinary resources (including veterina1y hospitals, clinics, and universities) should be exhausted before using human health-cat·e settings. Additionally, the hospital's public/media relations should be notified of the situation. The goal is to develop policies and procedmes to proactively and positively discuss and Ill

disclose this activity to the general public.

An infection-control risk assessment (ICRA) must be undertaken to evaluate the circumstances specific to providing care to animals in a human health-care facility. Individual hospital policies and guidelines should be reviewed before any animal treatment is considered in such facilities. Animals treated in human health-care facilities should be under the direct care and supervision of a licensed veterinarian; they also should be free of known infectious diseases, ectoparasites, and other external contaminants (e.g., soil, urine, and feces). Measures should be taken to avoid treating animals with a known or suspected zoonotic disease in a human health-care setting (e.g., lambs being treated for Q fever).

If human health-care facilities must be used for animal treatment or diagnostics, the following general infection-control actions are suggested: a) whenever possible, the use ofORs or other rooms used for invasive procedures should be avoided [e.g., cardiac catheterization labs and invasive nuclear medicine areas]; b) when all other space options are exhausted and use of the aforementioned rooms is unavoidable, the procedure should be scheduled late in the day as the last procedure for that particular area such that patients are not present in the department/unit/area; c) environmental surfaces should be thoroughly cleaned and disinfected using procedures discussed in the Environmental Services portion of this guideline after the animal is removed from the care area; d) sufficient time should be allowed for ACH to help prevent allergic reactions by human patients [Table B.!. in Appendix B]; e) only disposable equipment or equipment that can be thoroughly and easily cleaned, disinfected, or sterilized should be used; f) when medical or surgical instruments, especially those invasive instrnments that are difficult to clean [e.g., endoscopes], are used on animals, these instruments should be reserved for future use only on animals; and g) standard precautions should be followed.

5. Research Animals in Health-Care Facilities The risk of acquiring a zoonotic infection from research animals has decreased in recent years because many small laboratory animals (e.g., mice, rats, and rabbits) come from quality stock and have defined microbiologic profiles. 1392 Larger animals (e.g., nonhuman primates) are still obtained frequently from the wild and may harbor pathogens transmissible to humans. Primates, in particular, benefit fi·om vaccinations to protect their health during the research period provided the vaccination does not interfere with the study of the particular agent. Animals serving as models for human disease studies pose some risk for transmission of infection to laboratmy or health-care workers from percutaneous or mucosal exposure. Exposures can occur either through a) direct contact with an infected animal or its body substances and secretions or b) indirect contact with infectious material on equipment, instruments, surfaces, or supplies."" Uncontained aerosols generated during laboratory procedures can also transmit infection.

Infection-control measures to prevent transmission of zoonotic infections from research animals are largely derived from the following basic laboratmy safety principles: a) purchasing pathogen-free animals, b) quarantining incoming animals to detect any zoonotic pathogens, c) treating infected animals or removing them from the facility, d) vaccinating animal carriers and high-risk contacts if possible, e) using specialized containment caging or facilities, and f) using protective clothing and equipment [e.g., gloves, face shields, gowns, and masks]. 1392 An excellent resource for detailed 1013 discussion of these safety measures has been published.

The animal research unit within a health-care facility should be engineered to provide a) adequate containment of animals and pathogens; b) daily decontamination and transport of equipment and waste; c) proper ventilation and air filtration, which prevents recirculation of the air in the unit to other areas of the facility; and d) negative air pressure in the animal rooms relative to the corridors. To ensure 112

adequate security and containment, no through traffic to other areas of the health-care facility should flow through this unit; access should be restricted to animal-care staff, researchers, environmental services, maintenance, and security personnel.

Occupational health programs for animal-care staff, researchers, and maintenance staff should take into consideration the animals' natural pathogens and research pathogens. Components of such programs include a) prophylactic vaccines, b) TB skin testing when primates are used, c) baseline serums, and d) hearing and respiratory testing. Work practices, PPE, and engineering controls specific for each of the four animal biosafety levels have been published. 1013· 1393 The facility's occupational or employee health clinic should be aware ofthe appropriate post-exposure procedures involving zoonoses and have available the appropriate post-exposure biologicals and medications.

Animal-research-area staff should also develop standard operating procedures for a) daily animal husband1y [e.g., protection of the employee while facilitating animal welfare]; b) pathogen containment and decontamination; c) management, cleaning, disinfecting and/or sterilizing equipment and instruments; and d) employee training for laboratoty safety and safety procedures specific to animal research worksites. 1013 The federal Animal Welfare Act of 1966 and its amendments serve as the regulatory basis for ensuring animal welfare in research. 1394• 1395

I. Regulated Medical Waste 1. Epidemiology No epidemiologic evidence suggests that most of the solid- or liquid wastes from hospitals, other health- care facilities, or clinical/research laboratories is any more infective than residential waste. Several studies have compared the microbial load and the diversity of microorganisms in residential wastes and . I

wastes obtained from a variety of health-care settings."'"- 1402 Although hospital wastes had a greater I number of different bacterial species compared with residential waste, wastes from residences were more heavily contaminated. 1397• 1398 Moreover, no epidemiologic evidence suggests thattraditional waste-disposal practices of health-care facilities (whereby clinical and microbiological wastes were decontaminated on site before leaving the facility) have caused disease in either the health-care setting or the general community. 1400· 1401 This statement excludes, however, sharps injuries sustained during or immediately after the delivery of patient care before the sharp is "discarded." Therefore, identifYing wastes for which handling and disposal precautions are indicated is largely a matter of judgment about the relative risk of disease transmission, because no reasonable standards on which to base these determinations have been developed. Aesthetic and emotional considerations (originating during the early years of the HIV epidemic) have, however, figured into the development of treatment and disposal 1402 policies, particularly for pathology and anatomy wastes and sharps. - 1405 Public concerns have resulted in the promulgation of federal, state, and local rules and regulations regarding medical waste management and disposal. 140 &- 1414

2. Categories of Medical Waste Precisely defining medical waste on the basis of quantity and type of etiologic agents present is virtually impossible. The most practical approach to medical waste management is to identity wastes that represent a sufficient potential risk of causing infection during handling and disposal and for which some precautions likely are ptudent. 2 Health-care facility medical wastes targeted for handling and disposal precautions include microbiology laboratmy waste (e.g., microbiologic cultures and stocks of microorganisms), pathology and anatomy waste, blood specimens from clinics and laboratories, blood 113

products, and other body-fluid specimens.' Moreover, the risk of either injury or infection from certain sharp items (e.g., needles and scalpel blades) contaminated with blood also must be considered. Although any item that has had contact with blood, exudates, or secretions may be potentially infective, treating all such waste as infective is neither practical nor necessary. Federal, state, and local guidelines and regulations specifY the categories of medical waste that are subject to regulation and outline the requirements associated with treatment and disposal. The categorization of these wastes has generated the term "regulated medical waste." This term emphasizes the role of regulation in defining the actual material and as an alternative to "infectious waste," given the lack of evidence of this type of waste's infectivity. State regulations also address the degree or amount of contamination (e.g., blood-soaked gauze) that defines the discarded item as a regulated medical waste. The EPA's Manual for Infectious Waste Management identifies and categorizes other specific types of waste generated in health-care facilities with research laboratories that also require handling precautions. 1406

3. Management of Regulated Medical Waste in Health-Care Facilities Medical wastes require careful disposal and containment before collection and consolidation for treatment. OSHA has dictated initial measures for discarding regulated medical-waste items. These measures are designed to protect the workers who generate medical wastes and who manage the wastes from point of generation to disposal. 967 A single, leak-resistant biohazard bag is usually adequate for containment of regulated medical wastes, provided the bag is sturdy and the waste can be discarded without contaminating the bag's exterior. The contamination or puncturing of the bag requires placement into a second biohazard bag. All bags should be securely closed for disposal. Puncture- resistant containers located at the point of use (e.g., sharps containers) are used as containment for discarded slides or tubes with small amounts of blood, scalpel blades, needles and syringes, and unused sterile sharps. 967 To prevent needlestick injuries, needles and other contaminated sharps should not be recapped, purposefully bent, or broken by hand. CDC has published general guidelines for handling sharps.'· 1415 Health-care facilities may need additional precautions to prevent the production of aerosols during the handling of blood-contaminated items for ce1tainrare diseases or conditions (e.g., 203 Lassa fever and Ebola virus infection).

Transporting and storing regulated medical wastes within the health-care facility prior to terminal treatment is often necessary. Both federal and state regulations address the safe transport and storage of on- and off-site regulated medical wastes. 140&- 1408 Health-care facilities are instructed to dispose medical wastes regularly to avoid accumulation. Medical wastes requiring storage should be kept in labeled, leak-proof, puncture-resistant containers unde1· conditions that minimize or prevent foul odors. The storage area should be well ventilated and be inaccessible to pests. Any facility that generates regulated medical wastes should have a regulated medical waste management plan to ensure health and environmental safety as per federal, state, and local regulations.

4. Treatment of Regulated Medical Waste Regulated medical wastes are treated or decontaminated to reduce the microbial load in or on the waste and to render the by-products safe for further handling and disposal. From a microbiologic standpoint, waste need not be rendered "sterile" because the treated waste will not be deposited in a sterile site. In addition, waste need not be subjected to the same reprocessing standards as are surgical instruments. Historically, treatment methods involved steam-sterilization (i.e., autoclaving), incineration, or interment (for anatomy wastes). Alternative treatment methods developed in recent years include chemical disinfection, grinding/shredding/disinfection methods, energy-based technologies (e.g., microwave or radiowave treatments), and disinfection/encapsulation methods. 1409 State medical waste regulations specify appropriate treatment methods for each category of regulated medical waste. 114

Of all the categories comprising regulated medical waste, microbiologic wastes (e.g., untreated cultures, stocks, and amplified microbial populations) pose the greatest potential for infectious disease transmission, and sharps pose the greatest risk for injuries. Untreated stocks and cultures of microorganisms are subsets of the clinical laboratory or microbiologic waste stream. If the microorganism must be grown and amplified in culture to high concentration to permit work with the specimen, this item should be considered for on-site decontamination, preferably within the laboratory unit. Historically, this was accomplished effectively by either autoclaving (steam sterilization) or incineration. If steam sterilization in the health-care facility is used for waste treatment, exposure of the waste for up to 90 minutes at 250°F ( 121 °C) in a autoclave (depending on the size of the load and type container) may be necessary to ensure an adequate decontamination cycle. 141 "- 1418 After steam sterilization, the residue can be safely handled and discarded with all other nonhazardous solid waste in accordance with state solid-waste disposal regulations. On-site incineration is another treatment option for microbiologic, pathologic, and anatomic waste, provided the incinerator is engineered to burn these wastes completely and stay within EPA emissions standards. 1410 Improper incineration of waste with high moisture and low energy content (e.g., pathology waste) can lead to emission problems. State medical-waste regulatory programs identify acceptable methods for inactivating amplified stocks and cultures of microorganisms, some of which may employ technology rather than steam sterilization or incineration.

Concerns have been raised about the ability of modern health-care facilities to inactivate microbiologic wastes on-site, given that many of these institutions have decommissioned their laboratory autoclaves. Current laboratory guidelines for working with infectious microorganisms at biosafety level (BSL) 3 recommend that all laboratory waste be decontaminated before disposal by an approved method, preferably within the laboratory. 1013 These same guidelines recommend that all materials removed fi·om a BSL 4 laboratory (unless tbey are biological materials that are to remain viable) are to be decontaminated before they leave the laboratory. 1013 Recent federal regulations for laboratories that handle certain biological agents known as "select agents" (i.e., those that have the potential to pose a severe threat to public health and safety) require these agents (and those obtained fi·om a clinical specimen intended for diagnostic, reference, or verification purposes) to be destroyed on-site before disposal. 1412 Although recommendations for laboratory waste disposal from BSL 1 or 2 laboratories (e.g., most health-care clinical and diagnostic laboratories) allow for these materials to be decontaminated off-site before disposal, on-site decontamination by a known effective method is preferred to reduce the potential of exposure during t!1e handling of infectious material.

A recent outbreak ofTB among workers in a regional medical-waste treatment facility in the United 1420 States demonstrated the hazards associated with aerosolized microbiologic wastes. 1419• The facility received diagnostic cultures of Mycobacterium tuberculosis from several different health-care facilities befo1·e these cultures were chemically disinfected; this facility treated this waste with a grinding/shredding process that generated aerosols from the material. 1419· 1420 Several operational deficiencies facilitated the release of aerosols and exposed workers to airbome M tuberculosis. Among the suggested control measures was that health-care facilities perform on-site decontamination of laboratory waste containing live cultures of microorganisms before release of the waste to a waste management company. 1419· 1420 This measure is supported by recommendations found in the CDC/NIH guideline for laboratory workers. 1013 This outbreak demonstrates the need to avoid the use of any medical-waste treatment method or technology that can aerosolize pathogens from live cultures and stocks (especially those of airborne microorganisms) unless aerosols can be effectively contained and workers can be equipped with proper PPE. 141 ,_ 1421 Safe laboratory practices, including those addressing waste management, have been published. 1013· 1422

In an era when local, state, and federal health-care facilities and laboratories are developing bioterrorism 115

response strategies and capabilities. the need to reinstate in-laborat01y capacity to destroy cultures and stocks of microorganisms becomes a relevant issue. 1423 Recent federal regulations require health-care facility labomtories to maintain the capability of destroying discarded cultures and stocks on-site if these laboratories isolate from a clinical specimen any microorganism or toxin identified as a "select agent'' from a clinical specimen (Table 27). 1412 • 1413 As an altemative, isolated culh1res of select agents can be transfened to a facility registered to accept these agents in accordance with federal regulations. 1412 State medical waste regulations can, however, complicate or completely prevent this transfer if these cultures are determined to be medical waste. because most states regulate the inter-facility transfer of untreated medical wastes.

Tnblc 27. Microorganisms nnd biologicals identified as select ngents*+ HHS Non~overlrm select n ems and toxins (42 CFR Part 73 §73.4) Crimean~Cong:o hemon1tagic fever vims; Ebolt~ vimses; C'en:opithecine herpewims 1 (herpes B vim<>): Lassa feY~!' vims; Mnrburg vims; monkeypox virus; So"th Americnn hemorrhagic fever villiS(:S (Juuiu, Machupo, Sabia, FlexaL Ommmito); tick-bome encephalitis- complex (flavi) Virus('s vintses (Central E\tropeaa tick-bome encephalitis, Fnr Eastern tick-borne encephalitis [Russian ~>pring- and summer encephalitis, Kyasnaur Forest disease. Omsk hemonhagic fever]); variola maj01· virus (srnallpox virus): and variola minor virus (ala»trim.) Exclusions, Vaccine strain of Junin virus (Candid. #1) Bat'f('ria Rickettsia prowaze/..."ii, R. rickettsii, Yersiuia pestis Fungi Coccidioides posadasii Abrin: couo!oxins: diacetm••')'scitvenol; ricin; saxitoxin; Shiga-like ribo»ome inactivating To:dus I proteins; tetrodotoxin

The following toxin'> (in purified f(mn or iu combinntions of pme nnd impur¢ fonm) if the aggt'egate amotmt under the control of n principnl investigator does not, at any time, exceed the Exclusions~ amount specified: 100 mg of abrin; 100 mg of conotoxins; I ,000 mg of diacetoxyscilvenol; 100 mg of ricin; 100 mg of saxitoxin: 100 mg of Shiga-like ribosome inactivating proteins: or 100 mg of tetrodotoxin Select agent viral nucleic acids (synthetic or natumlly-derived, contiguous or fmgmented. in host chromosomes or iu expt'es<..ion vectors) that crm encode infectious andror replkation Genetic !~lemPufs, competent fonm of any of the select agent viruses: t'ffombinnnt nudt>k • Nuclei<; acids (s-ynthetic or tmhu-ally-derived) that encode for !he functional fonn(s) of any of ndds, aud rpcombinnnt the toxins listed in this table if the nucleic acids: a) are in a vector or host chromosome: organisms, b) can be expres'>ed in vivo or in vih·o; or c) at·e iu a vector or host dtromosomc and can be expressed iu vivo or illl'ifro; • Vitmes; bacteria, fnuoi, and toxins listed in this table that have been genetically modified. Hlglt consequence livestock pathogens and toxiuslse!ect agents (overlap agents) (42 CFR Part 7-1 §73.S mtd [!.~DA ref(ulatlou 9 CFR Par/121) Eastem equine encephalitis virus: Nipah and Hendra complex vin1ses; Rift Valley fever vims; Virttst's Venezuelan equine encephalitis virus MP·12 vuccine strain of Rif! Valley fever vims; TC·83 vaccine strain of Venezudau equine Exdusions~ encephalith virus Bacillus anthmcis; Brucella abortus, B. melitensis, B. suis; Btwkhofdm·ia mollei (fonnerly Bnrtet·in Pseudomonas 111(1/lei). B. pseudomallei (formerly P, pseudomallei); botulinum neurotoxin- . producing species of Clostridium,' Coxiella bumeh'i; Francisella tularensis FuuW Cocchlioides immitis Botulinum neurotoxins; Clostridium perfringens ~psilon toxin; Shigatoxiu; .staphylococcal Toxins enterotoxins: T~2 toxin The following toxins (in purified fonn or in combinations of pure and impw·e fonns) if the aggregate- amotult under the control of a principal investigator does not, at any time, exceed the amount specified: 0,5 mg of bohtlinnm neurotoxins; 100 mg of Clostridium peifNngeus epsilon toxin; 100 mg of Shigatoxin; 5 mg of stnphylococcal enterotoxins; or 1,000 mg ofT-2 toxin Exclusions, 116

High cousequence livestock pathogens and loxlnshe!ecl agents (ow?rlap agents) (4.2 CFR .Part 73 §73.5 and USDA reeulatlou 9 CFR Partllll (contluuedl • Select agent viral nuclei acids (:>.ynthetic or uaturally derived. contiguow; or fragmented. in host chromosomes or in expression wctors) thntC!'\11 encode infectious and/or replication Genetic elements, competent form<.. of any of the select agent vin1s¢s; l'l~combiuant uudeie • Nucleic acid'> (synthetic or naturally derived) thai encode for the fnuctionnl fonu(s) of nny of acids, and l'ecombiuant the toxins listed in this table if the nucleic acids: a) are in a vector or b"st chromosome; orgnnisms~ b) can be expressed in vivo or iu vitro; or c) are in a vector or host chromosome and can be expressed in vivo Ol' in vin·o; • Viruses, bacterin, funei, and ioxins listed in thi~ !~ble that have been g:eneticallv modified

* Material in this table iscoutpiled from references 1412. 1413, and 1424. Reference 1424 also contaitt~ lists of select agents tbal include plant pathogens and pathogeru affecting livestock + 42 CFR 73 §§73.4 and 73 . .5 do not indude any ~lee! agent or toxin tbat is in its naturally-oc":urring enviroument. provided it has not beeu intentionally introduced, cultivated, collected, or otherwise extracted from it'> nan~rnl source. 1l1ese ~ctions also do not indude non-viable select agent organism<> or nonf\mctional toxim;. This Jist of select agt'llls is current ns of3

5. Discharging Blood, Fluids to Sanihu'Y Sewers or Septic Tanks The contents of all vessels that contain more than a few milliliters of blood remaining afler Jaboratmy procedures, suction fluids, or bulk blood can either be inactivated in accordance with state-approved treatment technologies or carefully poured down a utility sink drain or toilet. 1414 State regulations may dictate the maximum volume allowable for discharge ofbloocVbody fluids to the sanitaq sewer. No evidence indicates that bloodbome diseases have been transmitted from contact with raw or treated sewage. Many bloodbome pathogens. particularly bloodbome vimses. are not stable in the environment tor long periods of time; 1425 • 1426 theretore, the discharge of small quantities of blood and other body fluids to the sanitmy sewer is considered a safe method of disposing of these waste materials. 1414 Tire following factors increase the likelil1ood that bloodborne pathogens will be inactivated in the disposal process: a) dilution of the discharged materials with water: b) inactivation of pathogens resulting fi·om exposure to cleaning chemicals, disinfectants. and other chemicals in raw sewage; and c) effectiveness of sewage treatment in inactivating any residual bloodbome pathogens that reach the treatment facility. Small amounts of blood and other body fluids should not affect the !hnctioning of a municipal sewer system. However, large quantities of these fluids, with their high protein content, might interfere with the biological oxygen demmrd (BOD) of the system. Local municipal sewage treatment restrictions may dictate that an altemative method of bulk fluid disposal be selected. State regulations may dictate what quantity constitutes a small amoum of blood or body fluids.

Although concems have been raised about the discharge of blood and other body fluids to a septic tank system, no evidence suggests that septic tatrks have transmitted bloodbome infections. A properly f\mctioning septic system is adequate for inactivating bloodborne pathogens. System manufacturers' instmctions specify what materials may be discharged to the septic tank without jeopardizing its proper operation.

6. Medical Waste and CJD Concerns also have been raised about the need tor special handling atKl treatment procedures for wastes generated during the care of patients with CJD or other transmissible spongifonn encephalopathies (TSEs). Prions, the agents that cause TSEs, have signi11cant resistance to inactivation by a variety of physical, chemical, or gaseous methods. 1417 No epidemiologic evidence, however, litrks acquisition of CJD with medical-waste disposal practices. Although handling neurologic tissue tor pathologic examination and autopsy materials with care, using banier precautions. and following specific 117

procedures for the autopsy are prudent measures, 1197 employing extraordinmy measures once the materials are discarded is unnecessary. Regulated medical wastes generated during the care of the CJD patient can be managed using the same strategies as wastes generated during the care of other patients. After decontamination, these wastes may then be disposed in a sanitary landfill or discharged to the sanita1y sewer, as appropriate.

Part II. Recommendations for Environmental Infection Control in Health-Care Facilities A. Rationale for Recommendations As in previous CDC guidelines, each recommendation is categorized on the basis of existing scientific data, theoretic rationale, applicability, and possible economic benefit. The recommendations are evidence-based wherever possible. However, ce1tain recommendations are derived from empiric infection-control or engineering principles, theoretic rationale, or fi'Om experience gained from events that cannot be readily studied (e.g., floods).

The HICPAC system for categorizing recommendations has been modified to include a category for engineering standards and actions required by state or federal regulations. Guidelines and standards published by the American Institute of Architects (ATA), American Society of Heating, Refrigeration, and Aii,Conditioning Engineers (ASHRAE), and the Association for the Advancement in Medical Instrumentation (AAMT) form the basis of celiain recommendations. These standards reflect a consensus of expeli opinions and extensive consultation with agencies of the U.S. Depmtment of Health and Human Services. Compliance with these standards is usually voluntary. However, state and federal governments often adopt these standards as regulations. For example, the standards from AlA regarding construction and design of new OJ' renovated health-care facilities, have been adopted by reference by >40 states. Ce1tain recommendations have two categmy ratings (e.g., Categories TA and TC or Categories IB and !C), indicating the recommendation is evidence-based as well as a standard or regulation.

B. Rating Categories Recommendations are rated according to the following categories:

• Category lA. Strongly recommended for implementation and strongly supported by well- designed experimental, clinical, or epidemiologic studies. • Category lB. Strongly recommended for implementation and suppoJted by ceJtain experimental, clinical, or epidemiologic studies and a strong theoretical rationale. • Category IC. Required by state or federal regulation, or representing an established association standard. (Note: Abbreviations for governing agencies and regulatmy citations are listed, where appropriate. Recommendations fi'Om regulations adopted at state levels are also noted. Recommendations from ATA guidelines cite the appropriate sections ofthe standard). • Category II. Suggested for implementation and supported by suggestive clinical or epidemiologic studies, or a theoretical rationale. • Unresolved Issue. No recommendation is offered. No consensus or insufficient evidence exists regarding efficacy. 118

C. Recommendations-Air I. Air-Handling Systems in Health-Care Facilities A. Use AlA guidelines as minimum standards where state or local regulations are not in place for design and construction of ventilation systems in new or renovated health-care facilities. Ensure that existing structures continue to meet the specifications in effect at the time of construction. 120 Category IC (AlA: l.l.A, 5.4) B. Monitor ventilation systems in accordance with engineers' and manufacturers' recommendations to ensure preventive engineering, optimal performance for removal of 18 106 particulates, and elimination of excess moisture. • 35 ' • 120• 220• 222 • 333 • 336 Category IB, IC (AIA: 7.2, 7.31.0, 8.31.0, 9.3l.D, 10.31.0, 11.31.0, EPA guidance} I. Ensure that heating, ventilation, air conditioning (HVAC) filters are properly installed and maintained to prevent air leakages and dust overloads. 17• 18 • 106• 222 Category IB 2. Monitor areas with special ventilation requirements (e.g., All or PE) for ACH, filtration, and pressure differentials.Z 1• 120 • 249• 250• 273-275 • 277 • 33 3-344 Category IB, IC (AlA: 7.2.C7, 7.2.06) a. Develop and implement a maintenance schedule for ACH, pressure differentials, and filtration efficiencies using facility-specific data as part of the multidisciplinary risk assessment. Take into account the age and reliability of the system. b. Document these parameters, especially the pressure differentials. 3. Engineer humidity controls into the HV AC system and monitor the controls to ensure proper moisture removal. 120 Category IC (AlA: 7.31.09) a. Locate duct humidifiers upstream from the final filters. b. Incorporate a water-removal mechanism into the system. c. Locate all duct takeoffs sufficiently down-stream from the humidifier so that moisture is completely absorbed. 4. IncoqJorate steam humidifiers, if possible, to reduce potential for microbial proliferation within the system, and avoid use of cool mist humidifiers. Category II 5. Ensure that air intakes and exhaust outlets are located properly in construction of new facilities and renovation of existing facilities.'· 12 ° Categmy IC (AlA: 7.31.03, 8.31.03, 9.31.03, 10.31.03, 11.31.03) a. Locate exhaust outlets >25 ft. from air-intake systems. b. Locate outdoor air intakes 2:6 ft. above ground or 2:3 ft. above roof! eve!. c. Locate exhaust outlets from contaminated areas above roof level to minimize recirculation of exhausted air. 6. Maintain air intakes and inspect filters periodically to ensure proper operation.'· 120 • 249• 250 27 275 277 ' 3- , Category IC (AlA: 7.31.08) 7. Bag dust-filled filters immediately upon removal to prevent dispersion of dust and fungal spores during transport within the facility. 106• 221 Category IB a. Seal or close the bag containing the discarded filter. b. Discard spent filters as regular solid waste, regardless of the area from which they were removed. 221 8. Remove bird roosts and nests near air intakes to prevent mites and fungal spores from entering the ventilation system.'· 98• 119 Category IB 9. Prevent dust accumulation by cleaning air-duct grilles in accordance with facility- specific procedures and schedules when rooms are not occupied by patients. 21 ,. 120' 249• 250 27 275 277 • 3- · Category IC, II (AlA: 7.31.01 0) 119

I 0. Periodically measure output to monitor system function; clean ventilation ducts as part of routine HVAC maintenance to ensure optimum performance."'· 263· 264 Category II (AlA: 7.31 DlO) C. Use portable, industrial-grade HEPA filter units capable of filtration rates in the range of 3 300--800 ft /min. to augment removal of respirable particles as needed. 219 Category II I. Select portable HEPA filters that can recirculate all or nearly all ofthe room air and provide the equivalent of?:l2 ACH.' Category II 2. Poliable HEPA filter units previously placed in construction zones can be used later in patient-care areas, provided all internal and external surfaces are cleaned, and the filter's performance verified by appropriate particle testing. Category II 3. Situate portable HEPA units with the advice of facility engineers to ensure that all room air is filtered.' Category II 4. Ensure that fresh-air requirements for the area are met. 214· 219 Category II D. Follow appropriate procedures for use of areas with through-the-wall ventilation units. 120 Category IC (AlA: 8.3\.Dl, 8.3\.DB, 9.31.D23, l0.31.Dl8, Il.3l.Dl5) I. Do not use such a1·eas as PE rooms. 12° Category IC (AlA: 7.2.D3) 2. Do not use a room with a through-the-wall ventilation unit as an All room unless it can be demonstrated that all required All engineering controls required are met. 4• 120 Category IC (AlA: 7.2.C3) E. Conduct an infection-control risk assessment (!CRA) and provide an adequate number of All and PE rooms (if required) or other areas to meet the needs of the patient population.'· 6• 9, 1s, 19, 69, 94, 120, 142,331-334, 336--JJs Categmy lA, IC (AIA: ?.z.c, 7.2. 0 ) F. When UVGI is used as a supplemental engineering control, install fixtures I) on the wall near the ceiling or suspended from the ceiling as an upper air unit; 2) in the air-return duct of an All room; or 3) in designated enclosed areas or booths for sputum induction.' Category// G. Seal windows in buildings with centralized HVAC systems and especially with PE areas."· 111 ' 12° Category IB, IC (AlA: 7.2.D3) H. Keep emergency doors and exits from PE rooms closed except dming an emergency; equip emergency doors and exits with alarms. Categmy II I. Develop a contingency plan for backup capacity in the event of a general power failure. 713 Category IC (Joint Commission on Accreditation ofHealthcare Organizations IJCAHO]: Environment of Care [ECJ 1.4) I. Emphasize restoration of proper air quality and ventilation conditions in All rooms, PE rooms, operating rooms, emergency depattments, and intensive care units. 120 • 713 Categmy IC (AlA: 1.5.AI; JCAHO: Ec 1.4) 2. Deploy infection-control procedures to protect occupants until power and systems functions are restored_6· 120· 713 Category IC (AlA: 5.1, 5.2; JCAHo: EC 1.4) J. Do not shut down HVAC systems in patient-care areas except for maintenance, repair, testing of emergency backup capacity, or new construction. 120· 206 Categmy IB, IC (AlA: 5.1, 5.2.B, C) I. Coordinate HVAC system maintenance with infection-control staffto allow for relocation ofimmunocompromised patients ifnecessary. 12 ° Category IC (AlA: 5.1, 5.2) 2. Provide backup emergency power and air-handling and pressurization systems to maintain filtration, constant ACH, and pressure differentials in PE rooms, All moms, operating rooms, and other critical-care areas!· 120· 278 Catego1y IC (AlA: 1.5, 5.1, 5.2) 3. For areas not served by installed emergency ventilation and backup systems, 11se pmiable units and monitor ventilation parameters and patients in those areas. 219 Categmy II 4. Coordinate system startups with infection-control staff to protect patients in PE rooms from bursts of fungal spores!· 35 ' 120· 278 Category IC (AlA: 5.1, 5.2) 120

5. Allow sufficient time for ACH to clean the air once the system is operational (Appendix B, Table B.! )_4· 12° Category lC (AlA: 5.1, 5.2) K. HVAC systems serving offices and administration areas may be shut down for energy conservation purposes, but the shutdown must not alter or adversely affect pressure differentials maintained in laboratories or critical-care areas with specific ventilation requirements (i.e., PE rooms, All rooms, operating rooms). Category II L. Whenever possible, avoid inactivating or shutting down the entire HVAC system at one time, especially in acute-care facilities. Category II M. Whenever feasible, design and install fixed backup ventilation systems for new or renovated constJUction for PE rooms, All rooms, operating rooms, and other critical care areas identified by ICRA. 12 ° Category IC (AlA: 1.5.A1)

II. Construction, Renovation, Remediation, Repair, and Demolition A. Establish a multidisciplinmy team that includes infection-control staff to coordinate demolition, construction, and renovation projects and consider proactive preventive measures at the inception; produce and maintain summary statements of the team's activities. I?, 19, zo, 97, 109, tzo. 249, zso, 273-277 Categmy IB, IC (AIA: 5.1) B. Educate both the construction team and the health-care staff in immunocompromised patient-care areas regarding the airborne infection risks associated with construction projects, dispersal of fungal spores during such activities, and methods to control the dissemination of fungal spores. 3 · 249' 250' 273-277· 142 &- 1432 Category IB C. Incorporate mandatory adherence agreements for infection control into constJUction contracts, with penalties for noncompliance and mechanisms to ensure timely correction of problems.'· 12 ~ 249• 27,_277 Category IC (AlA: 5.1) D. Establish and maintain surveillance for airborne environmental disease (e.g., aspergillosis) as appropriate during construction, renovation, repair, and demolition activities to ensure the health and safety of immunocompromised patients.'· 64• 65• 79 Category IB I. Using active surveillance, monitor for airborne fungal infections in immunocompromised patients.'· 9• 64 • 65 Category IB 2. Periodically review the facility's microbiologic, histopathologic, and postmortem data to identifY additional cases.'· 9• 64' 65 Category IB 3. If cases of aspergillosis or other health-care-associated airborne fungal infections occur, aggressively pursue the diagnosis with tissue biopsies and cultures as feasible.'· 64, 65, 79, 249, 273-277 Category IB E. Implement infection-control measures relevant to construction, renovation, maintenance, demolition, and repair. 96• 97 • 120• 276• 277 Category IB, IC (AlA: 5.1, 5.2) I. Before the project gets underway, perform an ICRA to define the scope of the project and the need for barrier measures. 96• 97• 120' 249' 27,_277 Category IB, IC (AlA: 5.1) a. Determine if immunocompromised patients may be at risk for exposure to 277 fungal spores from dust generated during the project. 20• 109• 27,_275 • 20 109 27 275 277 b. Develop a contingency plan to prevent such exposut·es. · • 3- · 2. Implement infection-control measures for external demolition and construction activities. 50• 249• 273--277· 283 Category IB a. Determine if the facility can operate temporarily on recirculated air; if feasible, seal off adjacent air intakes. b. If this is not possible or practical, check the low-efficiency (roughing) filter banks frequently and replace as needed to avoid buildup of pmticulates. c. Seal windows and reduce wherever possible other sources of outside air intrusion (e.g., open doors in stairwells and corridors), especially in PE areas. 3. Avoid damaging the underground water distribution system (i.e., buried pipes) to prevent soil and dust contamination of the water. 120• 305 Category IB, IC (AlA: 5.1) 121

4. Implement infectionwcontrol measures for internal consttuction activities? 0· 49· 97· 120 • 249 27 277 • ,_ Category IB, IC (AlA: 5.1, 5.2) a. Construct barriers to prevent dust from construction areas from entering patient-care areas; ensure that barriers are impermeable to fungal spores and in compliance with local fire codes. zo, 49, 97, 120, 284, 3\2,713, 1431 b. Block and seal off return air vents if rigid barriers are used for containment 120• 276, 277

c. Implement dust control measures on surfaces and by diverting pedestrian traffic away from work zones. 20' 49• 97• 120 d. Relocate patients whose rooms are adjacent to work zones, depending upon their immune status, the scope ofthe project, the potential for generation of dust or water aerosols, and the methods used to control these aerosols. 49• 120• 281 5. Perform those engineering and work-site related infection-control measures as needed for internal construction, repairs, and renovations: 20· 49• 97• 109• 120• 312 Category IB, IC (AlA: 5.1, 5.2) a. Ensure proper operation of the air-handling system in the affected area after erection of barriers and before the room or area is set to negative pressure. 49• 69• 276 278 ' Category IB b. Create and maintain negative air pressure in work zones adjacent to patient-care areas and ensure that required engineering controls are maintained?0• 49• 97• 109• 120• 312

c. Monitor negative air flow inside rigid barriers. 120' 281 d. Monitor barriers and ensure the integrity of the construction barriers; repair gaps or breaks in barrier joints. 120 • 284 • 307' 312 e. Seal windows in work zones if practical; use window chutes for disposal of large pieces of debris as needed, but ensure that the negative pressure differential for the area is maintained. 20• 120• 273 f. Direct pedestrian traffic from construction zones away from patient-care areas to minimize the dispersion of dust. 20, 49, 97, 109, Ill, 120, 273--277 g. Provide constmction crews with I) designated entrances, corridors, and elevators whenever practical; 2) essential services [e.g., toilet facilities], and convenience services [e.g., vending machines]; 3) protective clothing [e.g., coveralls, footgear, and headgear] for travel to patient-care areas; and 4) a space or anteroom for changing clothing and storing equipment. 120• 249• 27,_277 h. Clean work zones and their entrances daily by I) wet-wiping tools and tool ca1is before their removal from the work zone; 2) placing mats with tacky surfaces inside the entrance; and 3) covering debris and securing this covering before removing debris from the work zone. 120• 249• 273--277 i. In patient-care areas, for major repairs that include removal of ceiling tiles and disruption of the space above the false ceiling, use plastic sheets or prefabricated plastic units to contain dust; use a negative pressure system within this enclosure to remove dust; and either pass air through an industrial grade, pmiable HEPA filter capable of filtration rates ranging from 300-800 fe/min., or exhaust air directly to the outside. 49· 276• 277• 281 • 309 j. Upon completion of the project, clean the work zone according to facility procedures, and install barrier curtains to contain dust and debris before removal of rigid barriers. 20• 97• 120• 249• 27 3--277 k. Flush the water system to clear sediment from pipes to minimize waterborne microorganism proliferation. 120· 305 I. Restore appmpriate ACH, humidity, and pressure differential; clean or replace 106 221 air filters; dispose of spent filters."· • • 278 122

F. Use airborne-patticle sampling as a tool to evaluate barrier integrity."· 10 ° Category II G. Commission the HV AC system for newly constructed health-care facilities and renovated spaces before occupancy and use, with emphasis on ensuring proper ventilation for operating rooms, All rooms, and PE areas. 100• 120• 288• 304 Category IC (AlA: 5.1: ASHRAE: 1- 1996) H. No recommendation is offered on routine microbiologic air sampling before, during, or after construction or before or during occupancy of areas housing immunocompromised patients.I7,20,49,97, 109,272,1433 Unresolved issue T. If a case of health-care-acquired aspergillosis or other opportunistic environmental airborne fungal disease occurs during or immediately after construction, implement appropriate follow-up measures. 20• 55 • 62• 77• 94 • 95 Category IB I. Review pressure differential monitoring documentation to verifY that pressure differentials in the construction zone and in PE rooms were appropriate for their settings. 94 • 95 • 12° Category IB, IC (AlA: 5.1) 2. Implement corrective engineering measures to restore proper pressure differentials as needed. 94 • • ° 95 12 Category IB, IC (AlA: 5.1) 3. Conduct a prospective search for additional cases and intensifY retrospective epidemiologic review of the hospital's medical and laboratory records.'· 20• 62• 63• 10'1 CategoryiB 4. If there is no evidence of ongoing transmission, continue routine maintenance in the area to prevent health-care-acquired fungal disease.'· 55 Category IB J. If there is epidemiologic evidence of ongoing transmission of fungal disease, conduct an environmental assessment to determine and eliminate the source. 3• 96• 97• 109• 111 • 115 • 249 • 273---277 CategoryiB 1. Collect environmental samples fi·om potential sources of airborne fungal sp,ores, 3 18 44 8 49 97 106 preferably using a high-volume air sampler rather than settle plates. • • • • • • • 111, 112, 115, 249,254, 273-277, zn, 312 Category IB 2. If either an environmental source of airborne fungi or an engineering problem with filtration or pressure differentials is identified, promptly perform corrective measures to eliminate the sow·ce and route of entty. 96• 97 Category IB 3. Use an EPA-registered anti-fungal biocide (e.g., coppet'8-quinolinolate) for decontaminating structural materials. 50· 277• 312 • 329 Category IB 4. If an environmental source of airbome fungi is not identified, review infection control measures, including engineering controls, to identify potential areas for correction or improvement. 73 • 117 Category IB 5. If possible, perform molecular subtyping of Aspergillus spp. isolated fi·om patients and the environment to establish strain identities.'"· 29,_296 Category II K. !fair-supply systems to high-risk areas (e.g., PE rooms) are not optimal, use portable, industrial-grade HEPA filters on a temporary basis until rooms with optimal air-handling systems become available.'· 120' 27,_277 Category II

III. Infection-Control and Ventilation Requirements for PE Rooms A. Minimize exposures of severely immunocompromised patients (e.g., solid organ transplant patients or allogeneic neutt·openic patients) to activities that might cause aerosolization of fungal spores (e.g., vacuuming or disruption of ceiling tiles).'· 20• 109• 272 Category IB B. Minimize the length of time that immunocompromised patients in PE are outside their 283 rooms for diagnostic procedures and other activities.'· Category IB C. Provide respiratory protection for severely immunocompromised patients when they must leave PE for diagnostic studies and other activities; consult the most recent revision of CDC's Guidelines for Prevention of Health-Care-Associated Pneumonia for information regarding the appropriate type of respiratmy protection.'· 9 Category II 123

D. Incorporate ventilation engineering specifications and dust-controlling pmcesses into the planning and constmction of new PE units. Category IB, IC 20 9 104 I. Install central or point-of-use HEPA filters for supply (incoming) air.'· 18• · 44 • 9- • 1432 1434 120. "'· 316-318, · Category IB, IC (AlA: 5.1, 5.2, 7.2.0) 2. Ensure that moms are well sealed by 1) pmperly constmcting windows, doors, and intake and exhaust ports; 2) maintaining ceilings that are smooth and free of fissures, open joints, and crevices; 3) sealing walls above and below the ceiling, and 4) monitoring for leakage and making necessary repairs.'· 111 · 120· 317• 318 Category IB, IC (AlA: 7.2.D3) 120 3. Ventilate the mom to maintain :;:12 ACH.'· '· ' 241 · 317 • 318 Categ01y IC (AlA: 7.2.0) 4. Locate air supply and exhaust grilles so that clean, filtered air enters fi·om one side of the room, flows across the patient's bed, and exits from the opposite side of the room. 3• 120• 317 • 318 Category IC (AlA: 7.31.01) 5. Maintain positive room air pressure (?:2.5 Pa [0.01-inch water gauge]) in relation to the corridor. 3· 35 · 120 · 317· 318 Category IB, IC (AlA: Table7.2) 6. Maintain airflow patterns and monitor these on a daily basis by using petmanently installed visual means of detecting airflow in new or renovated construction, or using other visual methods (e.g., flutter strips, or smoke tubes) in existing PE units. Document the monitoring results. 120' 273 Category IC (AlA: 7.2.06) 7. Install self-closing devices on all room exit doors in protective environments. 120 Category IC (AlA: 7.2.04) E. Do not use laminar air flow systems in newly constructed PE moms. 316' 318 Category II F. Take measures to protect immunocompromised patients who would benefit fmm a PE room and who also have an airborne infectious disease (e.g., acute VZV infection or tuberculosis). 1. Ensure that the patient's room is designed to maintain positive pressure. 2. Use an anteroom to ensure appropriate air balance relationships and provide independent exhaust of contaminated air to the outside, or place a HEPA filter in the exhaust duct if the return air must be recirculated. 120· 317 Category IC (AlA: 7.2.Dl, A7.2.D) 3. !fan anteroom is not available, place the patient in All and use pmtable, industrial- grade HEPA filters to enhance filtration of spores in the room. 219 Category II G. Maintain backup ventilation equipment (e.g., portable units for fans or filters) for emergency provision of ventilation requirements for PE areas and take immediate steps to restore the fixed ventilation system function.'· 120' 278 Category IC (AlA: 5.1)

IV. Infection-Control and Ventilation Requirements for All Rooms A. Incorporate ce1tain specifications into the planning, and constmction or renovation of AII units.<· 107· 120· 317• 318 Category IB, IC I. Maintain continuous negative air pressure (2.5 Pa [0.0 l-inch water gauge]) in relation to the air pressure in the corridor; monitor air pressure periodically, preferably daily, with audible manometers or smoke tubes at the door (for existing All rooms) or with a permanently installed visual monitoring mechanism. Document the results of monitoring. 120· 317• 318 Categoty IB, IC (AlA: 7.2.C7, Table 7.2) 2. Ensure that rooms are well-sealed by properly constmcting windows, doors, and air- intake and exhaust pmts; when monitoring indicates air leakage, locate the leak and make necessary repairs."'· 317• 318 Category IB, IC (AlA: 7.2.c3) 3. Install self-closing devices on all AT! room exit doors. 120 Category IC (AlA: 7.2.C4) 4. Provide ventilation to ensure 2:12 ACH for renovated rooms and new rooms, and 2:6 ACH for existing AT! rooms. 4· 107· 12° Categmy IC (AlA: Table 7 2) 124

5. Direct exhaust air to the outside, away from air-intake and populated areas. If this is not practical, air from the room can be recirculated after passing through a HEPA ° filter.'· 12 Category IC (AlA: Table 7.2) B. Where supplemental engineering c~ntrols for air cleaning are indicated fi·om a risk assessment of the All area, install UVGI units in the exhaust air ducts of the HVAC system to supplement HEPA filtration or install UVGI fixtures on or near the ceiling to irradiate upper room air.' Category II C. Implement environmental infection-control measures for persons with known or suspected airborne infectious diseases. I. Use All rooms for patients with or suspected of having an airborne infection who also require cough-inducing procedures, or use an enclosed booth that is engineered to provide I) 2:12 ACH; 2) air supply and exhaust rate sufficient to maintain a 2.5 Pa [0.01-inch water gauge] negative pressure difference with respect to all surrounding spaces with an exhaust rate of2:50 ft3/min.; and 3) air exhausted directly outside away from air intakes and traffic or exhausted after HEPA filtration prior to recirculation.'· 120. 348-350 Category IB, IC (AlA: 7.15.E, 7.31.023, 9. 10, Table 7.2) 2. Although airborne spread of viral hemoJThagic fever (VHF) has not been documented in a health-care setting, prudence dictates placing a VHF patient in an All room, preferably with an anteroom to reduce the risk of occupational exposure to aerosolized infectious material in blood, vomitus, liquid stool, and respiratmy secretions present in large amounts during the end stage of a patient's illness?02- 204 Category II a. !fan anteroom is not available, use portable, industrial-grade HEPA filters in the patient's room to provide additional ACH equivalents for removing airborne particulates. b. Ensure that health-care workers wear face shields or goggles with appropriate respirators when entering the rooms of VHF patients with prominent cough, vomiting, diarrhea, or hemorrhage. 203 3. Place smallpox patients in negative pressure rooms at the onset of their illness, preferably using a room with an anteroom if available. 6 Category II D. No recommendation is offered regarding negative pressure or isolation rooms for patients with Pneumocystis carinii pneumonia. 126 • 131 ' 132 Unresolved issue E. Maintain back-up ventilation equipment (e.g., portable units for fans or filters) for emergency provision of ventilation requirements for All rooms and take immediate steps to restore the fixed ventilation system function.'· 120' 278 Category IC (AlA: 5.1)

V, Infection-Control and Ventilation Requirements for Operating Rooms A. Implement environmental infection-control and ventilation measures for operating rooms. 1. Maintain positive-pressure ventilation with respect to corridors and adjacent areas.'· 120 356 • Category IB, IC (AlA: Table 7.2) 358 2. Maintain 2:15 ACH, of which 2:3 ACH should be fresh air. 120· 357• Category IC (AlA: Table 7.2) 3. Filter all recirculated and fresh air through the appropriate filters, providing 90% 120 362 efficiency (dust-spot testing) at a minimum. ' Category IC (AlA: Table 7.3) 4. In rooms not engineered for horizontal laminar airflow, introduce air at the ceiling and exhaust air near the floor. 120' 357 ' 359 Categ01y IC (AlA: 7.3l.D4) 5. Do not use UV lights to prevent surgical-site infections. 356• 364-370 Category IB 6. Keep operating room doors closed except for the passage of equipment, personnel, and patients, and limit entry to essential personnel. 351 · 352 Category IB 347 B. Follow precautionary procedures for TB patients who also require emergency surgeiy.'· ' 371 Category IB, IC 125

1. Use an N95 respirator approved by the National Institute for Occupational Safety and Health (NIOSH) without exhalation valves in the operating room. 347 • 372 Category JC {Occupational Safety and Health Administration [OSHA]; 29 Code of Federal Regulations [CFR] 1910.134,139) 2. Intubate the patient in either the All room or the operating room; if intubating the patient in the operating room, do not allow the doors to open until 99% of the airborne contaminants are removed (Appendix B, Table B.l). 4 • 358 Category IB 3. When anesthetizing a patient with confirmed or suspected TB, place a bacterial filter between the anesthesia circuit and patient's airway to prevent contamination of anesthesia equipment or discharge of tubercle bacilli into the ambient air. 371 • 373 Category IE 4. Extubate and allow the patient to recover in an All room.'· 358 Category IB 5. If the patient has to be extubated in the operating room, allow adequate time for ACH to clean 99% of airborne particles from the air (Appendix B, Table B.!) because extubation is a cough-producing procedure.'· 358 Category IB C. Use portable, industrial-grade HEPA filters temporarily for supplemental air cleaning during intubation and extubation for infectious TB patients who require surgety.'· 219• 358 Category II 1. Position the units appropriately so that all room air passes through the filter; obtain engineering consultation to determine the appropriate placement of the unit.' Category II 2. Switch the portable unit off during the surgical procedure. Category II 3. Provide fi·esh air as per ventilation standards for operating rooms; portable units do not meet the requirements for the number offi-esh ACH. 120 • 215 • 219 Category II D. If possible, schedule infectious TB patients as the last surgical cases of the day to maximize the time available for removal of airborne contamination. Category II E. No t•ecommendation is offered for perfmming orthopedic implant operations in rooms supplied with laminar airflow. 362 ' 364 Unresolved issue F. Maintain backup ventilation equipment (e.g., portable units for fans or filters) for emergency provision of ventilation requirements for operating rooms, and take immediate steps to restore the fixed ventilation system function."· 120• 278•372 Category IB, IC (AlA: 5.1)

VI. Other Potential Infectious Aerosol Hazards in Health-Care Facilities A. In settings where surgical lasers are used, wear appropriate personal protective equipment, including N95 or N I 00 respirators, to minimize exposure to laser plumes. 347• 378• 389 Category JC (OSHA; 29 CFR 1910.134,139) B. Use central wall suction units with in-line filters to evacuate minimal laser plumes.'"· 382• 386• 389 Category II C. Use a mechanical smoke evacuation system with a high-efficiency filter to manage the generation of large amounts of laser plume, when ablating tissue infected with human papilloma virus (HPV) or performing procedures on a patient with extrapulmonary TB.'· 382' 38 392 '- Category II

D. Recommendations-Water I. Controlling the Spread ofWaterbome Microoganisms A. Practice hand hygiene to prevent the hand transfer of waterborne pathogens, and use barrier precautions (e.g., gloves) as defined by other guidelines. 6• 464• 577• 586• 592• 1364 Category IA 126

B. Eliminate contaminated water or fluid environmental reservoirs (e.g., in equipment or solutions) wherever possible.'64 • 465 Category IB C. Clean and disinfect sinks and wash basins on a regular basis by using an EPA-registered product as set by facility policies. Category II D. Evaluate for possible environmental sources (e.g., potable water) of specimen contamination when waterborne microorganisms (e.g., NTM) of unlikely clinical importance are isolated from clinical cultures (e.g., specimens collected aseptically from sterile sites or, if post-procedural, colonization occurs after use of tap water in patient care). 607.6 10-612 Categ01y IB E. A void placing decorative fountains and fish tanks in patient-care areas; ensure disinfection and fountain maintenance if decorative fountains are used in the public areas of the health- care facility. 664 Category IB

II. Routine Prevention of Waterbome Microbial Contamination Within the Distribution System A. Maintain hot water temperature at the return at the highest temperature allowable by state regulations or codes, preferably 2:124 °F (2:51 °C), and maintain cold water temperature at <68°F ( <20°C). 3• 661 Category IC (SJuJes; ASHRAE: 12:2000) B. If the hot water temperature can be maintained at 2:124°F (2:51 °C), explore engineering options (e.g., install preset thermostatic valves in point-of-use fixtures) to help minimize the risk of scalding. 661 Category II C. When state regulations or codes do not allow hot water temperatures above the range of 105°F-!20°F (40.6°C-49°C) for hospitals o1· 95°F-Il0°F (35°C-43.3°C) for nursing care facilities or when buildings cannot be retrofitted for thermostatic mixing valves, follow either of these alternative preventive measures to minimize the growth of Legionella spp. in water systems. Category II 1. Periodically increase the hot water temperature to 2: 150°F (2:66°C) at the point of use. 661 Category II 2. Alternatively, chlorinate the water and then flush it through the system. 661 • 710· 711 Category II D. Maintain constant recirculation in hot-wate1· distribution systems serving patient-care areas. 12° Category JC (AlA: 7.3J.E3)

III. Remediation Strategies for Distribution System Repair or Emergencies A. Whenever possible, disconnect the ice machine before planned water disruptions. Category II B. Prepare a contingency plan to estimate water demands for the entire facility in advance of significant water disruptions (i.e., those expected to result in extensive and heavy microbial 719 or chemical contamination of the potable water), sewage intrusion, or flooding. 713 • Category IC (JCAHO: EC 1.4) C. When a significant water disruption or an emergency occurs, adhere to any advisory to boil water issued by the municipal water utility. 642 Cutegory IB, IC (Municipal order) 1. Alert patients, families, staff, and visitors not to consume water from drinking fountains, ice, or drinks made from municipal tap water, while the advismy is in effect, unless the water has been disinfected (e.g., by bringing to a rolling boil for 2:1 minute). 642 Categ01y IB, IC (Municipal oo·der) 2. After the advismy is lifted, run faucets and drinking fountains at full flow for 2:5 minutes, or use high-temperature water flushing or chlorination. 642• 661 Category IC, II (Municipal order; ASHRAE 12:2000) D. Maintain a high level of surveillance for waterborne disease among patients after a boil water adviso1y is lifted. Category II 127

E. Corrective decontamination of the hot water system might be necessary after a disruption in service or a cross-connection with sewer lines has occurred. I. Decontaminate the system when the fewest occupants are present in the building (e.g., nights or weekends).'· 661 Categmy IC (ASHRAE: 12:2000) 2. !fusing high-temperature decontamination, raise the hot-water temperature to 160°F- 1700F (71 °C-77°C) and maintain that level while progressively flushing each outlet around the system for ?:5 minutes.'· 661 Category IC (ASHRAE: 12:2000) 3. !fusing chlorination, add enough chlorine, preferably overnight, to achieve a free chlorine residual of;o:2 mg!L (2:2 ppm) throughout the system. 661 Category IC (ASHRAE: 12:2000) a. Flush each outlet until chlorine odor is detected. b. Maintain the elevated chlorine concentration in the system for 2:2 hrs (but ::;24 hrs). 4. Use a very thorough flushing of the water system instead of chlorination if a highly chlorine-resistant microorganism (e.g., Cryptosporidium spp.) is suspected as the water contaminant. Category II F. Flush and restart equipment and fixtures according to manufacturers' instructions. Category II G. Change the pretreatment filter and disinfect the dialysis water system with an EPA- registered product to prevent colonization of the reverse osmosis membrane and downstream microbial contamination. 721 Category II H. Run water softeners through a regeneration cycle to restore their capacity and function. Category II I. If the facility has a watet~holding reservoir or water-storage tank, consult the fucility engineer or local health department to determine whether this equipment needs to be drained, disinfected with an EPA-registered product, and refilled. Category II J. Implement facility management procedures to manage a sewage system failure or flooding (e.g., arranging with other health-care facilities for temporary transfer of patients or provision of services), and establish communications with the local municipal water utility and the local health department to ensure that advisories are received in a timely manner upon release. 713 ' 719 Category IC (JCAHO: EC 1.4; Municipal order) K. Implement infection-control measures during sewage intrusion, flooding, or other water- related emergencies. 1. Relocate patients and clean or sterilize supplies from affected areas. Category II 2. If hands are not visibly soiled or contaminated with proteinaceous material, include an alcohol-based hand rub in the hand hygiene process I) before performing invasive procedures; 2) before and after each patient contact; and 3) whenever hand hygiene is indicated. 1364 Category II 3. If hands are visibly soiled or contaminated with proteinaceous material, use soap and bottled water for handwashing. 1364 Category II 4. If the potable water system is not affected by flooding or sewage contamination, process surgical instruments for sterilization according to standard procedures. Category II 5. Contact the manufacturer of the automated endoscope reprocessor (AER) for specific instructions on the use of this equipment during a water advisoty. Category II L. Remediate the facility after sewage intrusion, flooding, or other water-related emergencies. I. Close off affected areas during cleanup procedures. Category II 2. Ensure that the sewage system is fully functional before beginning remediation so contaminated solids and standing water can be removed. Category II 128

3. If hard-surface equipment, floors, and walls remain in good repair, ensure that these are dry within 72 hours; clean with detergent according to standard cleaning procedures. Category II 4. Clean wood furniture and materials (if stiJJ in good repair); allow them to dry thoroughly before restoring varnish or other surface coatings. Category II 5. Contain dust and debris during remediation and repair as outlined in air recommendations (Air: II G 4, 5). Category II M. Regardless of the original source of water damage (e.g., flooding versus water leaks from point-of-use fixtures or roofs), remove wet, absorbent structural items (e.g., carpeting, wallboard, and wallpaper) and cloth fumishings if they cannot be easily and thoroughly cleaned and dried within 72 hours (e.g., moisture content:S20% as determined by moisture meter readings); replace with new materials as soon as the underlying structure is declared by the facility engineer to be thoroughly dry. 18• 266 • 278 · 1026 Category IB

IV. Additional Engineering Measures as Indicated by Epidemiologic Investigation for Controlling Waterborne, Health-Care-Associated Legionnaires Disease A. When using a pulse or one-time decontamination method, superheat the water by flushing each outlet for 2:5 minutes with water at J60°F-170'F (71 °C-77'C) or hyperchlorinate the system by flushing all outlets for2:5 minutes with water containing2:2 mg/L (2:2 ppm) free residual chlmine using a chlorine-based product registered by the EPA for water treatment (e.g., sodium hypochlorite [chlorine bleach]). 661 • 711 • 714 • 724 • 764 • 766 Categoty IB (ASHRAE: 12:2000) B. After a pulse treatment, maintain both the heated water temperature at the return and the cold water temperature as per the recommendation (Water: IIA) wherever practical and permitted by state codes, or chlorinate heated water to achieve 1-2 mg/L (1-2 ppm) free residual chlorine at the tap using a chlorine-based product registered by the EPA for water 661 treatment (e.g., sodium hypochlorite [bleach]). 26 • 437• • 709• 726• 727 Category IC (Stat"; ASHRAE: 12:2000) C. Explore engineering or educational options (e.g., install preset thermostatic mixing valves in point-of-use fixtures or post warning signs at each outlet) to minimize the risk of scalding for patients, visitors, and staff. Category II D. No recommendation is offered for treating water in the facility's distribution system with chlorine dioxide, heavy-metal ions (e.g., copper or silver), monochloramine, ozone, or UV light. 72&--746 Unresolved issue

V. General Infection-Control Strategies for Preventing Legionnaires Disease A. Conduct an infection-control risk assessment of the facility to determine if patients at risk or severely immunocompromised patients are present. 3• 431 • 432 Category IB B. Implement general strategies for detecting and preventing Legionnaires disease in facilities that do not provide care for severely immunocompromised patients (i.e., facilities that do not have HSCT or solid organ transplant programs). 3• 431 • 432 Category IB 1. Establish a surveillance process to detect health-care-associated Legionnaires disease. 3• 431 • 43 ' CategoryiB 2. Inform health-care personnel (e.g., infection control, physicians, patient-care staff, and engineering) regarding the potential for Legionnaires disease to occur and measures to prevent and control health-care-associated legionellosis. 437• 759 Category IE 3. Establish mechanisms to provide clinicians with labmatory tests (e.g., culture, urine antigen, direct fluorescence assay [DFA], and serology) for the diagnosis of Legionnaires disease. 3• 431 Categoty IB 129

C. Maintain a high index of suspicion for health-care-associated Legionnaires disease, and perform laboratory diagnostic tests for legionellosis on suspected cases, especially in patients at risk who do not require a PE for care (e.g., patients receiving systemic steroids; patients aged 2:65 years; or patients with chronic underlying disease [e.g., diabetes mellitus, congestive heart failure, or chronic obstructive lung disease]). 3• 395 • 417• 423--425• 432• 435 • 437• 453 Category/A D. Periodically review the availability and clinicians' use oflaboratory diagnostic tests for Legionnaires disease in the facility; if clinicians' use of the tests on patients with diagnosed or suspected pneumonia is limited, implement measures (e.g., an educational campaign) to enhance clinicians' use of the test(s). 453 Category IB E. If one case of laboratory-confirmed, health-care-associated Legionnaires disease is identified, or if two or more cases of laboratory-suspected, health-care-associated Legionnaires disease occur during a 6-month period, certain activities should be initiated. 405 • 408,431,453,739,759 Category IB I. Report the cases to the state and local health departments where required. Category IC (States) 2. If the facility does not treat severely immunocompromised patients, conduct an epidemiologic investigation, including retrospective review of microbiologic, serologic, and postmortem data to look for previously unidentified cases of health- care-associated Legionnaires disease, and begin intensive prospective surveillance for additional cases_3·405, 408,431,453,739,759 Category IB 3. If no evidence of continued health-care-associated transmission exists, continue intensive prospective surveillance for 2:2 months after the initiation of surveillance.'· 40S,40S,43J, 4sJ. 739,759 Category IB F. If there is evidence of continued health-care-associated transmission (i.e., an outbreak), 410 455 conduct an environmental assessment to determine the source of Legionella spp. 40,_ • Category IB 1209 I. Collect water samples from potential aerosolized water sources (Appendix C). Category IB 2. Save and subtype isolates of Legionella spp. obtained from patients and the environment.40J-..4JO, 453,763,764 Category IB 3. If a source is identified, promptly institute water system decontamination measures per recommendations (see Water IV). 766' 767 Category IB 4. If Legionella spp. are detected in2:lcultures (e.g., conducted at 2-week intervals during 3 months), reassess the control measures, modify them accordingly, and repeat the decontamination procedures; consider intensive use of techniques used for initial . . decontammatton, or a com b'matt.on o f superheating . an d hyperc hi anna . t'wn. 3767768 · · CategorylB G. If an environmental source is not identified during a Legionnaires disease outbreak, continue surveillance for new cases for 2:2 months. Either defer decontamination pending identification of the source of Legionella spp., or proceed with decontamination of the hospital's water distribution system, with special attention to areas involved in the outbreak. Category II H. No recommendation is offered regarding routine culturing of water systems in health-care facilities that do not have patient-care areas (i.e., PE or transplant units) for persons at high 753 risk for Legion ella spp. infection. 26' 453 ' 707 ' 709' 714• 747• Unresolved issue I. No recommendation is offered regarding the removal of faucet aerators in areas for immunocompetent patients. Unresolved issue J. Keep adequate records of all infection-control measures and environmental test results for potable water systems. Category II 130

VI. Preventing Legionnaires Disease in Protective Environments and Transplant Units A. When implementing strategies for preventing Legionnaires disease among severely immunosuppressed patients housed in facilities with HSCT or solid-organ transplant programs, incorporate these specific surveillance and epidemiologic measures in addition to the steps previously outlined (Water: V and Appendix C). I. Maintain a high index of suspicion for legionellosis in transplant patients even when environmental surveillance cultures do not yield legionellae. 430• 431 Category IB 2. If a case occurs in a severely immunocompromised patient, or if severely immunocompromised patients are present in high-risk areas ofthe hospital (e.g., PE or transplant units) and cases are identified elsewhere in the facility, conduct a combined epidemiologic and environmental investigation to determine the source of Legionella spp. 431 • 767 Category IB B. Implement culture strategies and potable water and fixture treatment measures in addition to those previously outlined (Water: V). Category II I. Depending on state regulations on potable water temperature in public buildings, 725 hospitals housing patients at risk for health-care-associated legionellosis should either maintain heated water with a minimum return temperature of?:124°F [2:51 oq and cold water at <68°F [<20°C]), or chlorinate heated water to achieve 1-2 mg/L (1-2 ppm) of free residual chlorine at the tap."· 441 • 661 ' 70,_711 • 726 • 727 Category II 2. Periodic culturing for legionellae in potable water samples from HSCT or solid-organ transplant units can be performed as part of a comprehensive strategy to prevent Legionnaires disease in these units. 9' 431 ' 710• 769 Category II 3. No recommendation is offered regarding the optimal methodology (i.e., frequency or number of sites) for environmental surveillance cultures in HSCT or solid organ transplant units. Unresolved issue 4. In areas with patients at risk, when Legionel/a spp. are not detectable in unit water, remove, clean, and disinfect shower heads and tap aerators monthly by using a chlorine-based, EPA-registered product. !fan EPA-registered chlorine disinfectant is 745 not available, use a chlorine bleach solution (500--615 ppm [I: 100 v/v dilution]). 661 • Category!! C. If Legion ella spp. are determined to be present in the water of a transplant unit, implement ceJiain measures until Legionella spp. are no longer detected by culture. 767 I. Decontaminate the water supply as outlined previously (Water: IV) 3 • 9• 661 • 766• CategoryiB 2. Do not use water from the faucets in patient-care rooms to avoid creating infectious aerosols.'· 412 Category IB 412 3. Restrict severely immunocompromised patients from taking showers. 9' Category IB 4. Use water that is not contaminated with Legionella spp. for HSCT patients' sponge baths:·"' Category IB 5. Provide patients with sterile water for tooth brushing, drinking, and for flushing nasogastric tubing during Jegionellosis outbreaks.'· 412 Category IB D. Do not use large-volume room air humidifiers that create aerosols (e.g., by Venturi principle, ultrasound, or spinning disk) unless they are subjected to high-level disinfection and filled only with sterile water.'·'· 402' 455 Category IB

VII. Cooling Towers and Evaporative Condensers A. When planning construction of new health-care facilities, locate cooling towers so that the drift is directed away from the air-intake system, and design the towers to minimize the volume of aerosol drift. 404 · 661 • 786 Category JC (ASHRAE: 12:2ooo) 131

B. Implement infection-control procedures for operational cooling towers.' 04 · 661 • 784 Category IC (ASHRAE: 12:2000) I, Install drift eliminators.'04 ' 661 ' 784 Category IC (ASHRAE: 12:2ooo) 2. Use an effective EPA-registered biocide on a regular basis, 661 Category IC (ASHRAE: 12:2000) 3. Maintain towers according to manufacturers' recommendations, and keep detailed maintenance and infection control records, including environmental test results from legionellosis outbreak investigations. 661 Category IC (ASHRAE: 12:2ooo) C. If cooling towers or evaporative condensers are implicated in health-care-associated legionellosis, decontaminate the cooling-tower system, 404• 405 • 786· 787 Category IB

VIII. Dialysis Water Quality and Dialysate A. Adhere to current AAMI standards for quality assurance performance of devices and equipment used to treat, store, and distribute water in hemodialysis centers (both acute and maintenance [chronic) settings) and for the preparation of concentrates and dialysate. 31 ' 32 ' 666--668, 789, 791, 800, 807, 809, 1454, 1455 Category JA, /C (AAMI: ANSIIAAMI RD5: 1992, ANSIIAAMI RD 47:1993) B. No recommendation is offered regarding whether more stringent requirements for water quality should be imposed in hemofiltration and hemodiafiltration. Unresolved issue C. Conduct microbiological testing specific to water in dialysis settings.'"· 791 • 792 · 834• 835 Category IA, IC (AAMI: ANS!IAAMI RD 5: 1992, ANS1/AAM1 RD 47: 1993, ANSI/AAMI RD 62:2001) I. Perform bacteriologic assays of water and dialysis fluids at least once a month and during outbreaks using standard quantitative methods. 792· 834• 835 Category IA, IC (AAMI: ANSI/AAM1 RD 62:2001) a, Assay for heterotrophic, mesophilic bacteria (e.g., Pseudomonas spp). b. Do not use nutrient-J"ich media (e.g., blood agar or chocolate agar). 2. In conjunction with microbiological testing, perform endotoxin testing on product water used to reprocess dialyzers for multiple use. 789• 791 • 806• 811 • 816 • 829 Category IA, /C (AAM1: ANS!IAAM1 RD 5:1992, ANSI/AAMl RD 47:1993) 3. Ensure that water does not exceed the limits for microbial counts and endotoxin 789 791 80 concentrations outlined in Table 18. · · ° Category IA, IC (AAMI: ANS11AAM1 RD 5:1992, ANS1/AAM1 RD 47:1993) D. Disinfect water distribution systems in dialysis settings on a regular schedule. Monthly disinfection is recommended, 66 6-66 '· 792 · 80 ° Category IA, IC (AAM1: ANST/AAM1 RD62:2001) E. Whenever practical, design and engineer water systems in dialysis settings to avoid incorporating joints, dead-end pipes, and unused branches and taps that can harbor ° bacteria. 666-668• 792• 80 Category IA, IC (AAMI: ANS11AAM1 RD62:2001) F. When storage tanks are used in dialysis systems, they should be routinely drained, disinfected with an EPA-registered product, and fitted with an ultrafilter or pyrogenic filter (membrane filter with a pore size sufficient to remove small pmticles and molecules 2:1 kilodalton) installed in the water line distal to the storage tank. 792 Category IC (AAMI: ANSl/AAMI RD62:2001)

IX. Ice Machines and Ice A. Do not handle ice directly by hand, and wash hands before obtaining ice. Categmy II B. U se a smooth~sur1ace~ . scoop to d'1spense 1ce. tee . 680· 863 Category II I, Keep the ice scoop on a chain shmt enough the scoop cannot touch the floor, or keep the scoop on a clean, hard surface when not in use.' 80• 863 Categmy II 2. Do not store the ice scoop in the ice bin. Category II C. Do not store pharmaceuticals or medical solutions on ice intended for consumption; use sterile ice to keep medical solutions cold, or use equipment specifically manufactured for this purpose. 600• 863 Category IB 132

D. Machines that dispense ice are preferred to those that require ice to be removed from bins or chests with a scoop. 687• 869 Category II E. Limit access to ice-storage chests, and keep the container doors closed except when removing ice. 863 Category II F. Clean, disinfect, and maintain ice-storage chests on a regular basis. Category II I. Follow the manufacturer's instructions for cleaning. Category II 2. Use an EPA-registered disinfectant suitable for use on ice machines, dispensers, or storage chests in accordance with label instructions. Category II 3. If instructions and EPA-registered disinfectants suitable fot· use on ice machines are not available, use a general cleaning/disinfecting regimen as outlined in Box 12. 863 Category II 4. Flush and clean the ice machines and dispensers if they have not been disconnected before anticipated lengthy water disruptions. Category II G. Install proper air gaps where the condensate lines meet the waste lines. Category II H. Conduct microbiologic sampling of ice, ice chests, and ice-making machines and dispensers where indicated during an epidemiologic investigation. 861- 863 Category IB

X, Hydrotherapy Tanks and Pools A. Drain and clean hydrotherapy equipment (e.g., Hubbard tanks, tubs, whirlpools, whirlpool spas, or birthing tanks) after each patient's use, and disinfect equipment surfaces and components by using an EPA-registered product in accordance with the manufacturer's instructions. Category II B. In the absence of an EPA-registered product for water treatment, add sodium hypochlorite to the water: I. Maintain a 15-ppm chlorine residual in the water of small hydrotherapy tanks, Hubbard tanks, and tubs. 889 Category II 2. Maintain a 2-5 ppm chlorine residual in the water of whirlpools and whirlpool spas. 905 Category II 3. If the pH of the municipal water is in the basic range (e.g., when chloramine is used as the primary drinking water disinfectant in the community), consult the facility engineer regarding the possible need to adjust the pH ofthe water to a more acid level before disinfection, to enhance the biocidal activity of chlorine. 894 Category II C. Clean and disinfect hydrotherapy equipment after using tub liners. Category II D. Clean and disinfect inflatable tubs unless they are single-use equipment. Category II E. No recommendation is offered regarding the use of antiseptic chemicals (e.g., chloramine- T) in the water during hydrotherapy sessions. Unresolved issue F. Conduct a risk assessment of patients prior to their use of large hydrotherapy pools, defening patients with draining wounds or fecal incontinence from pool use until their condition resolves. Category II G. For large hydrotherapy pools, use pH and chlorine residual levels appropriate for an indoor pool as provided by local and state health agencies. Categ01y IC (States) H. No recommendation is offered regarding the use in health care of whirlpools or spa equipment manufactured for home or recreational use. Unresolved issue

XI. Miscellaneous Medical Equipment Connected to Water Systems A. Clean, disinfect, and maintain AER equipment according to the manufacturer's instructions and relevant scientific literature to prevent inadvettent contamination of endoscopes and bronchoscopes wtt. h wat erborne mJCroorgamsms. . . 911 - 915 Category IB l. To rinse disinfected endoscopes and bronchoscopes, use water of the highest quality practical for the system's engineering and design (e.g., sterile water or 133

bacteriologically-filtered water [water filtered through O.l-0.2-ftm filters]). 912 · 914 · 915 · 918 Category IB 2. Dry the intemal channels of the reprocessed endoscope or bronchoscope using a proven method (e.g., 70% alcohol followed by forced-air treatment) to lessen the potential for the proliferation of waterborne microorganisms and to help prevent biofilm formation. 671 · 921 · 923 • 925 · 928 Category IB B. Use water that meets nationally recognized standards set by the EPA for drinking water (<500 CFU/mL for heterotrophic plate count) for routine dental treatment output water. 935· 936 943 944 • • Category IB, IC (EPA: 40 CFR 1 Part 141, Subpart G). C. Take precautions to prevent waterborne contamination of dental unit water lines and instruments. I. A Iter each patient, discharge water and air for a minimum of 20-30 seconds from any dental device connected to the dental wate1· system that enters the patient's mouth (e.g., handpieces, ultrasonic scalers, and air/water syringe). 936' 937 Category II 2. Consult with dental water-line manufacturers to I) determine suitable methods and equipment to obtain the recommended water quality; and 2) determine appropriate methods for monitoring the water to ensure quality is maintained'"· 946 Category II 3. Consult with the dental unit manufacturer on the need for periodic maintenance of anti-retraction mechanisms. 937• 946 Category IB

E. Recommendations-Environmental Services I. Cleaning and Disinfecting Strategies for Environmental Surfaces in Patient-Care Areas A. Select EPA-registered disinfectants, if available, and use them in accordance with the manufacturer's instructions?· 974• 983 Category JB, IC (EPA: 7 United States Code[USC] § 136 et seq) B. Do not use high-level disinfectants/liquid chemical sterilants for disinfection of either noncritical instrument/devices or any environmental surfaces; such use is counter to label instructions for these toxic chemicals. 951 · 952 · 961- 964 Category IB, IC (FDA: 21 CFR &01.5, 807.87.e) C. Follow manufacturers' instructions for cleaning and maintaining noncritical medical equipment. Categ01y II D. In the absence of a manufacturer's cleaning instructions, follow certain procedures. 1. Clean noncritical medical equipment surfaces with a detergent/disinfectant. This may be followed with an application of an EPA-registered hospital disinfectant with or without a tuberculocidal claim (depending on the nature of the surface and the degree of contamination), in accordance with disinfectant label instructions.'" Category II 2. Do not use alcohol to disinfect large environmental surfaces. 951 Category II 3. Use barrier protective coverings as appropriate for noncritical equipment surfaces that are I) touched frequently with gloved hands during the delivery of patient care; 2) likely to become contaminated with blood or body substances; or 3) difficult to clean (e.g., computer keyboards). 936 Category II E. Keep housekeeping surfaces (e.g., floors, walls, and tabletops) visibly clean on a regular basis and clean up spills promptly. 954 Category II I. Use a one-step process and an EPA-registered hospital disinfectant/detergent designed for general housekeeping purposes in patient-care areas when I) uncertainty exists as to the nature of the soil on these surfaces [e.g., blood or body fluid contamination versus routine dust or dirt]; or 2) uncertainty exists regarding the 983 986 987 presence or absence of multi-drug resistant organisms on such surfaces. 952• • • Category!! 134

2. Detergent and water are adequate for cleaning surfaces in nonpatient-care areas (e.g., administrative offices). Category II 3. Clean and disinfect high-touch surfaces (e.g., doorknobs, bed rails, light switches, and surfaces in and around toilets in patients' rooms) on a more frequent schedule than minimal touch housekeeping surfaces. Category II 4. Clean walls, blinds, and window curtains in patient-care areas when they are visibly dusty or soiled. 2• 971 • 972' 982 Category II F. Do not perform disinfectant fogging in patient-care areas.'· 976 Category IB G. Avoid large-surface cleaning methods that produce mists or aemsols or disperse dust in patient~care areas. 9 · • • 20 109 272 Category IB H. Follow proper procedures for effective use of mops, cloths, and solutions. Category II I. Prepare cleaning solutions daily or as needed, and replace with fresh solution frequently according to facility policies and procedures. 986• 987 Category II 2. Change the mop head at the beginning of the day and also as required by facility policy, or after cleaning up large spi11s of blood or other body substances. Category II 3. Clean mops and cloths after use and allow to dry before reuse; or use single-use, ° disposable mop heads and cloths. 971 ' 98 ,_ 99 Category II I. After the last surgical pmcedure of the day or night, wet vacuum or mop operating room floors with a single-use mop and an EPA-registered hospital disinfectant.' Category IB J. Do not use mats with tacky surfaces at the entrance to operating rooms or infection-control suites. 7 Category IB K. Use appropriate dusting methods for patient-care areas designated for immunocompromised patients (e.g., HSCT patients): 9• 94 • 986 Category IB I. Wet-dust horizontal surfaces daily by moistening a cloth with a small amount of an 94 EPA-registered hospital detergent/disinfectant.'· • 986 Category IB 2. Avoid dusting methods that disperse dust (e.g., feather-dusting). 94 Category IB L. Keep vacuums in good repair, and equip vacuums with HEPA filters for use in areas with patients at risk.'· 94 • 986 • 994 Category IB M. Close the doors of immunocompromised patients' rooms when vacuuming, waxing, or buffing corridor floors to minimize exposure to airborne dust.'· 94 · 994 Category IB N. When performing low- or intermediate-level disinfection of environmental surfaces in nurseries and neonatal units, avoid unnecessary exposure of neonates to disinfectant residues on environmental surfaces by using EPA-registered disinfectants in accordance with manufacturers' instructions and safety advisories.'"· 99,_997 Category IB, IC (EPA: 7 USC § 136 et seq.) , 1. Do not use phenolics or any other chemical germicide to disinfect bassinets or incubators during an infant's stay.'"· 99 ,_997 Category IB 2. Rinse disinfectant-treated surfaces, especially those treated with phenolics, with water.'9,_997 Category IB 0. When using phenolic disinfectants in neonatal units, prepare solutions to correct concentrations in accordance with manufacturers' instructions, or use premixed formulations.' 74 • 99,_997 Categmy IB, IC (EPA: 7USC § 136elseq.)

II. Cleaning Spills of Blood and Body Substances A. Promptly clean and decontaminate spills of blood or other potentially infectious materials.'"· 99,_ 1004 Categmy IB, IC (OSHA: 29 CFR 1910.1030 §d.4.ii.A) B. Follow proper procedures for site decontamination of spi11s of blood or blood-containing body fluids. 967 • 99,_ 1004 Category IC (OSHA: 29 CFR 1910.1030 § d.4.ii.A) 1. Use protective gloves and other PPE appropriate for this task.'67 Category IC (OSHA: 29 CFR 1910.1030 § d.3.i, ii) 135

2. If the spill contains large amounts of blood or body fluids, clean the visible matter with disposable absorbent material, and discard the contaminated materials in appropriate, labeled containment.'67• 1002 ' 1003 ' 1010• 1012 Category IC (OSHA: 29 CFR !910.1030 § d.4.iii.B) 3. Swab the area with a cloth or paper towels moderately wetted with disinfectant, and 1010 allow the surface to dry. 967 • Category IC (OSHA: 29 CFR 1910.1030 § d.4.ii.A) C. Use EPA-registered hospital disinfectants labeled tuberculocidal or registered germicides on the EPA Lists D and E (products with specific label claims for HIV or hepatitis B virus [HBV]) in accordance with label instmctions to decontaminate spills of blood and other body tluids. 967 • 1007 • 1010 Category /C (OSHA 29 CFR 1910.1030 § d.4.iLA memorandum 2/28/97; compliance document CPL 2·2.440 [11/99]) D. An EPA-registered sodium hypochlorite product is preferred, but if such products are not available, generic versions of sodium hypochlorite solutions (e.g., household chlorine bleach) may be used. I. Use a I: I 00 dilution (500-615 ppm available chlorine) to decontaminate nonporous surfaces after cleaning a spill of either blood or body fluids in patient-care settings. 1010' 1011 Category II 2. !fa spill involves large amounts of blood or body fluids, or if a blood or culture spill occurs in the laboratory, use a 1: I 0 dilution (5,000-6,150 ppm available chlorine) for the first application of germicide before cleaning. 954 • 1010 Category II

III. Carpeting and Cloth Fumishings A. Vacuum carpeting in public areas of health-care facilities and in general patient-care areas regularly with well-maintained equipment designed to minimize dust dispersion.'" Category II B. Periodically perform a thorough, deep cleaning of carpeting as determined by facility policy by using a method that minimizes the production of aerosols and leaves little or no residue 111 Category II C. Avoid use of carpeting in high-traffic zones in patient-care areas or where spills are likely (e.g., burn therapy units, operating rooms, laboratories, and intensive care units). 111 • 1023 • 1028 Category IB D. Follow proper procedures for managing spills on carpeting. 1011 I. Spot-clean blood or body substance spills promptly. 967• 1010• ' 1032 Category IC {OSHA: 29 CFR 1910.1030 § d.4.ii.A, interpretation) 2. If a spill occurs on carpet tiles, replace any tiles contaminated by blood and body fluids or body substances. 1032 Category IC (OSHA 29 CFR 1910.1030 § d.4.ii interpretation) E. Thoroughly dry wet carpeting to prevent the growth of fungi; replace carpeting that remains wet after 72 hours.'· 1026 Category IB F. No recommendation is offered regarding the routine use of fungicidal or bactericidal treatments for carpeting in public areas of a health-care fucility or in general patient-care areas. Unresolved issue G. Do not use carpeting in hallways and patient rooms in areas housing immunosuppressed patients (e.g., PE areas). 9· 111 CategoryiB H. Avoid the use of upholstered furniture and furnishings in high-risk patient-care areas and in areas with increased potential for body substance contamination (e.g., pediatrics units).' Category II I. No recommendation is offered regarding whether upholstered furniture and fumishings should be avoided in general patient-care areas. Unresolved issue J. Maintain upholstered furniture in good repair. Category II I. Maintain the surface integrity of the upholstery by repairing tears and holes. Category II 136

2. If upholstered furniture in a patient's room requires cleaning to remove visible soil or body substance contamination, move that item to a maintenance area where it can be adequately cleaned with a process appropriate for the type of upholstery and the nature of the soil. Category II

IV. Flowers and Plants in Patient-Care Areas A. Flowers and potted plants need not be restricted from areas for immunocompetent patients.m, 702, 1040,I042 Category II B. Designate care and maintenance of flowers and potted plants to staff not directly involved with patient care. 702 Category II C. If plant or flower care by patient-care staff is unavoidable, instmct the staff to wear gloves when handling the plants and flowers and perform hand hygiene after glove removal. 702 Category II D. Do not allow fresh or dried flowers, or potted plants in patient-care areas for immunosuppressed patients.'· 109· 515 · 1046 Category II

V. Pest Control A. Develop pest-control strategies, with emphasis on kitchens, cafeterias, laundries, central sterile supply areas, operating rooms, loading docks, construction activities, and other areas prone to infestations. 1050' 1072' 1075 Category II B. Install screens on all windows that open to the outside; keep screens in good repair. 1072 Category IB C. Contract for routine pest control service by a credentialed pest-control specialist who will tailor the application to the needs of a health-care facility. 1075 Category II D. Place laboratory specimens (e.g., fixed sputum smears) in covered containers for overnight 1065 storage. · 1066 Category II

VI. Special Pathogens A. Use appropriate hand hygiene, PPE (e.g., gloves), and isolation precautions during cleaning 1130 and disinfecting procedures. 5· 952 · · 1364 Category IB B. Use standard cleaning and disinfection protocols to control environmental contamination with antibiotic-resistant gram-positive cocci (e.g., methicillin-resistant Staphylococcus aureus, vancomycin intermediate-resistant Staphylococcus aureus, or vancomycin-resistant Enterococcus [VRE] ). 5· 111 '- 1118 Categ01y IB I. Pay close attention to cleaning and disinfection of high-touch surfaces in patient-care areas (e.g., bed rails, carts, bedside commodes, bedrails, doorknobs, or faucet handles).'· 111 '- 1118 Category IB 2. Ensure compliance by housekeeping staff with cleaning and disi11fection procedures.'· 111 '- 1118 Category IB 3. Use EPA-registered hospital disinfectants appropriate for the surface to be disinfected (e.g., either low- or intermediate-level disinfection) as specified by the manufacturers' instructions. 974 • ll06-IIIO, 1118 Category JB, IC (EPA: 7USC § J36etseq.) 4. When contact precautions are indicated for patient care, use disposable patient-care items (e.g., blood pressure cuffs) whenever possible to minimize cross-contamination with multiple-resistant microorganisms. 1102 Category IB 5. Follow these same surface cleaning and disinfecting measures for managing the environment ofVRSA patients. 11 10· 111 '- 1118 Category II C. Environmental-surface culturing can be used to verify the efficacy of hospital policies and procedures before and afte1· cleaning and disinfecting rooms that house patients with VRE.'· 1084, JOB?, toss, 1092,1096 Category II 137

I. Obtain prior approval from infection-control staff and the clinical laboratory before performing environmental surface culturing. Category II 2. Infection-control staff, with clinical laboratory consultation, must supervise all environmental culturing. Category II D. Thoroughly clean and disinfect environmental and medical equipment surfaces on a regular basis using EPA-registered disinfectants in accordance with manufacturers' instructions.'"· 974 1130 1143 • • Category IB, JC (EPA: 7 usc§ 136 etseq.) E. Advise families, visitors, and patients about the importance of hand hygiene to minimize the spread of body substance contamination (e.g., respiratmy secretions or fecal matter) to surfaces. 952 Category II F. Do not use high-level disinfectants (i.e., liquid chemical sterilants) on environmental surfaces; such use is inconsistent with label instructions and because of the toxicity of the chemicals.'· 951 • 952 · 964 Category IC (FDA: 21 CFR &01.5, &07.&7.e) G. Because no EPA-registered products are specific for inactivating Clostridium difficile spores, use hypochlorite-based products for disinfection of environmental surfaces in those patient-care areas where surveillance and epidemiology indicate ongoing transmission of C. dijficile.'"· Jt3o, 1141 Category II H. No recommendation is offered regarding the use of specific EPA-registered hospital disinfectants with respect to environmental control of C. dijficile. Unresolved issue I. Apply standard cleaning and disinfection procedures to control environmental contamination with respiratmy and enteric viruses in pediatric-care units and care areas for immunocompromised patients.'"· 1158 Categmy IC (EPA: 1 usc§ 136 el seq.) J. Clean surfaces that have been contaminated with body substances; perform low- to intermediate-level disinfection on cleaned surfaces with an EPA-registered disinfectant in accordance with the manufacturer's instructions.'"· 974 • 1158 Category JC (OSHA: 29 CFR 1910.1030 § d.4.ii.A; EPA: 7 USC § 136 et seq.) K. Use disposable barrier coverings as appropriate to minimize surface contamination. Category II L. Develop and maintain cleaning and disinfection procedures to control environmental contamination with agents ofCreutzfeldt-Jakob disease (CJD), for which no EPA-registered product exists. Categmy II 1. In the absence of contamination with central nervous system tissue, extraordinary measures (e.g., use of2N sodium hydroxide [NaOH] or applying full-strength sodium hypochlorite) are not needed for routine cleaning or terminal disinfection of a room housing a confirmed or suspected CJD patient.'"· 1199 Category II 2. After removing gross tissue from the surface, use either IN NaOH or a sodium hypochlorite solution containing approximately I 0,000-20,000 ppm available chlorine (dilutions of I :5 to I :3 v/v, respectively, of U.S. household chlorine bleach; contact the manufacturers of commercially available sodium hypochlorite products for advice) to decontaminate operating room or autopsy surfaces with central nervous system or cerebral spinal fluid contamination from a diagnosed or suspected CJD patient.9st, tt7o, I Iss, Jt9t, IJ97~1199, 1201 Category II a. The contact time for the chemical used during this process should be 30 min-I hour.l191, 1197. 1201

b. Blot up the chemical with absorbent material and rinse the treated surface thoroughly with water. c. Discard the used, absorbent material into appropriate waste containment. 3. Use disposable, impervious covers to minimize body substance contamination to autopsy tables and surfaces. 1197 ' 1201 Category IB 138

M. Use standard procedures for containment, cleaning, and decontamination of blood spills on surfaces as previously described (Environmental Services: JI). 967 Categ01y IC (OSHA: 29 CFR 191Q 1030 ~d4.ii.A) I. Wear PPE appropriate for a surface decontamination and cleaning task 967• 1199 Category IC (OSHA 29 CFR 1910.1030 §d.3.i, ii) 2. Discard used PPE by using routine disposal procedures or decontaminate reusable PPE as appropriate!"· 1199 Category IC (OSHA 29 CPR 1910.1030 §d.3.viii)

F. Recommendations-Environmental Sampling I. General Information A. Do not conduct random, undirected microbiologic sampling of air, water, and environmental surfaces in health-care facilities.'· 1214 Category IB B. When indicated, conduct microbiologic sampling as pmt of an epidemiologic investigation or during assessment of hazardous environmental conditions to detect contamination and verity abatement of a hazard.'· 1214 Category IB C. Limit microbiologic sampling for quality assurance purposes to I) biological monitoring of sterilization processes; 2) monthly cultures of water and dialysate in hemodialysis units; and 3) short-term evaluation of the impact of infection-control measures or changes in infection- control protocols.'· 1214 Category IB

II. Air, Water, and Environmental-Surface Sampling A. When conducting any form of environmental sampling, identify existing comparative 1238 standards and fully document depa1tures from standard methods. 945 • 1214 • 1223 • 1224• Category II B. Select a high-volume air sampling device if anticipated levels of microbial airborne contamination are expected to be low. 290 · 1218• 1223 • 1224 Category II C. Do not use settle plates to quantity the concentration of airborne fungal spores 290 Category II D. When sampling water, choose growth media and incubation conditions that will facilitate the recovery of waterborne organisms. 945 Category II E. When using a sample/rinse method for sampling an environmental surface, develop and document a procedure for manipulating the swab, gauze, or sponge in a reproducible manner so that results are comparable. 1238 Category II F. When environmental samples and patient specimens are available for comparison, pe1'form the laboratory analysis on the recovered microorganisms down to the species level at a minimum and beyond the species level if possible. 1214 Category II

G. Recommendations-Laundry and Bedding I. Employer Responsibilities A. Employers must launder workers' personal protective garments or uniforms that are 967 contaminated with blood or other potentially infectious materials. Category IC (OSHA: 29 CFR 1910.1030 § d.3.iv) 139

II. Laundry Facilities and Equipment A. Maintain the receiving area for contaminated textiles at negative pressure compared with the clean areas of the laund1y in accordance with AlA construction standards in effect during the time of facility construction.'"· 1261H 262 C11tegory IC (AlA: 7.23.BI,B2) B. Ensure that laundry areas have handwashing facilities and products and appropriate PPE available for workers. 120· 967 Category IC (AlA: 7.23.04; osHA: 29 CFR 1910.1030 § d.2.i;;) C. Use and maintain laundry equipment according to manufacturers' instructions. 1250• 1263 Category II D. Do not leave damp textiles or fabrics in machines overnight. 125 ° Category II E. Disinfection of washing and d1ying machines in residential care is not needed as long as gross soil is removed before washing and proper washing and drying procedures are used. Category II

III. Routine Handling of Contaminated Laundry A. Handle contaminated textiles and fabrics with minimum agitation to avoid contamination of air, surfaces, and persons. 6• 967 • 1258 · 1259 Categmy IC (OSHA: 29 CFR 1910.1030 § d.4.iv) B, Bag or otherwise contain contaminated textiles and fabrics at the point ofuse. 967 Category IC (OSHA: 29 CFR 1910.1030 § d.4.;v) l, Do not sort or prerinse contaminated textiles or fabrics in patient-care areas."67 Category IC (OSHA: 29 CFR 1910.1030 §d.4.iv) 2. Use leak-resistant containment for textiles and fabrics contaminated with blood or body substances. 967• 1258 Category IC (OSHA: 29 erR 1910.1030 § d.4jv) 3. Identity bags or containers for contaminated.textiles with labels, color coding, or other alternative means of communication as appropriate.'" Category IC (OSHA: 29 CFR 1910.1030 § d.4.;v) C. Covers are not needed on contaminated textile hampers in patient-care areas. Category II D. If laundry chutes are used, ensure that they are properly designed, maintained, and used in a manner to minimize dispersion of aerosols from contaminated laundry .1253• 1267- 1270 Category IC (AAMl: ANSI/AAMl ST65:2000) 1, Ensure that laund1y bags are closed before tossing the filled bag into the chute. Category II 2. Do not place loose items in the chute. Category II E. Establish a facility policy to determine when textiles or fabrics should be smted in the laund1y facility (i.e., before or after washing). 1271 · 1272 Category II

IV. Laundry Process A. If hot-water laund1y cycles are used, wash with detergent in water 2: 160°F (2:71 °C) for 2:25 minutes.'· 12° Category IC (AlA: 7.3l.E3) B, No recommendation is offered regarding a hot-water temperature setting and cycle duration for items laundered in residence-style health-care facilities. Unresolved issue C, Follow fabric-care instmctions and special laundering requirements for items used in the facility, 1278 Category/J D, Choose chemicals suitable for low-temperature washing at proper use concentration if low- temperature (<160°F [<71 oc]) laundry cycles are used. 1247• 1281- 1285 Category II E, Package, transport, and store clean textiles and fabrics by methods that will ensure their cleanliness and protect them fi·om dust and soil during interfacility loading, transpmt, and unloading. 2 Category II

V. Microbiologic Sampling of Textiles 1286 A. Do not conduct routine microbiological sampling of clean textiles. 2' Category IB 140

B. Use microbiological sampling during outbreak investigations if epidemiologic evidence suggests a role for health-care textiles and clothing in disease transmission."" Category IB

VI. Special Laundry Situations A. Use sterilized textiles, surgical drapes, and gowns for situations requiring sterility in patient care. 7 Category IB B. Use hygienically clean textiles (i.e., laundered, but not sterilized) in neonatal intensive care units:"· 1288 Category IB C. Follow manufacturers' recommendations for cleaning fabric products including those with coated or laminated surfaces. Category II D. Do not use dry cleaning for routine laundering in health-care facilities. 128"- 1291 Category II E. Use caution when considering the use of antimicrobial mattresses, textiles, and clothing as replacements for standard bedding and other fabric items; EPA has not approved public health claims asserting protection against human pathogens for treated articles. 1306 Category II F. No recommendation is offered regarding using disposable fabrics and textiles versus durable goods. Unresolved issue

VII. Mattresses and Pillows A. Keep mattresses dry; discard them if they become and remain wet or stained, particularly in burn units. 131 ll- 1315 Category IB B. Clean and disinfect mattress covers using EPA-registered disinfectants, if available, that are compatible with the cover materials to prevent the development of tears, cracks, or holes in the cover. 131 ll- 1315 Category IB C. Maintain the integrity of mattress and pillow covers. Category II I. Replace mattress and pillow covers if they become torn or otherwise in need of repair. Category II 2. Do not stick needles into the mattress through the cover. Category II D. Clean and disinfect moisture-resistant mattress covers between patients using an EPA- registered product, if available. 131 ll- 1315 Category IB E. !fusing a mattress cover completely made of fabric, change these covers and launder between patients. 131 1)- 1315 Category IB F. Launder pillow covers and washable pillows in the hot-water cycle between patients or when they become contaminated with body substances. 1315 Category IB

VIII. Air-Fluidized Beds A. Follow manufacturers' instructions for bed maintenance and decontamination. Category II B. Change the polyester filter sheet at least weekly or as indicated by the manufacturer. 1317• 1318• 1322 1323 • Category II C. Clean and disinfect the polyester filter sheet thoroughly, especially between patients, using an EPA-registered product, ifavailable. 1317• 1318• 1322• 1323 CategoryiB D. Consult the facility engineer to determine the proper location of air-fluidized beds in negative-pressure rooms. 1326 Category II 141

H. Recommendations-Animals in Health-Care Facilities I. General Infection-Control Measures for Animal Encounters A. Minimize contact with animal saliva, dander, urine, and feces. 136 ,_ 1367 Category II B. Practice hand hygiene after any animal contact.'· 1364 Category IB I. Wash hands with soap and water, especially if hands are visibly soiled. 1364 CategoryiB 2. Use either soap and water or alcohol-based hand mbs when hands are not visibly soiled. 1364 Category IB

II. Animal-Assisted Activities, Animal-Assisted Therapy, and Resident Animal Programs A. Avoid selection of nonhuman primates and reptiles in animal-assisted activities, animal- assisted therapy, or resident animal programs. 1360- 1362 Category IB B. Enroll animals that are fully vaccinated for zoonotic diseases and that are healthy, clean, well-groomed, and negative for enteric parasites or otherwise have completed recent ° antihelminthic treatment under the regular care of a veterinarian. 1349• 136 Category II C. Enroll animals that are trained with the assistance or under the direction of individuals who ° are experienced in this field. 136 Category II D. Ensure that animals are handled by persons trained in providing activities or therapies safely, and who know the animals' health status and behavior traits. 1349• 136 ° Category II E. Take prompt action when an incident of biting or scratching by an animal occurs during an animal-assisted activity or therapy. I. Remove the animal permanently from these programs. 136 ° Category II 2. Repott the incident promptly to appropriate authorities (e.g., infection-control staff, animal program coordinator, or local animal control). 136 ° Category II 3. Promptly clean and treat scratches, bites, or other accidental breaks in the skin. Category II F. Perform an ICRA and work actively with the animal handler prior to conducting an animal- assisted activity or therapy to determine if the session should be held in a public area of the facility or in individual patient rooms. 1349 136 • ° Category II G. Take precautions to mitigate allergic responses to animals. Category II 1360 I. Minimize shedding of animal dander by bathing animals <24 hours before a visit. Category II 2. Groom amma . Is to remove Ioose hatr . betore c . ' or usmg a vtstt, . . I cape. 1358 a th erapy amma Category!! H. Use routine cleaning protocols for housekeeping surfaces after therapy sessions. Category II I. Restrict resident animals, including fish in fish tanks, from access to or placement in patient-care areas, food preparation areas, dining areas, laundry, central sterile supply areas, sterile and clean supply storage areas, medication preparation areas, operating rooms, isolation areas, and PE areas. Category II J. Establish a facility policy for regular cleaning of fish tanks, rodent cages, bird cages, and any other animal dwellings and assign this cleaning task to a nonpatient-care staff member; avoid splashing tank water or contaminating environmental surfaces with animal bedding. Category II

III. Protective Measures for Immunocompromised Patients A. Advise patients to avoid contact with animal feces and body fluids such as saliva, urine, or solid litter box material.' Category II 142

B. Promptly clean and treat scratches, bites, or other wounds that break the skin.' Category II C. ° Advise patients to avoid direct or indirect contact with reptiles. 134 Category IB D. Conduct a case-by-case assessment to determine if animal-assisted activities or animal- assisted therapy programs are appropriate for immunocompromised patients. 1349 Category II E. No recommendation is offered regarding permitting pet visits to terminally ill immunosuppressed patients outside their PE units. Unresolved issue

IV. Service Animals A. Avoid providing access to nonhuman primates and reptiles as service animals. 1340· 1362 Category IB B. Allow service animals access to the facility in accordance with the Americans with Disabilities Act of 1990, unless the presence of the animal creates a direct threat to other persons or a fundamental alteration in the nature of services. 1366· 1376 Category IC (U.s. Department of Justice: 28 CFR § 36.302) C. When a decision must be made regarding a service animal's access to any particular area of the health-care facility, evaluate the service animal, the patient, and the health-care situation on a case-by-case basis to determine whether significant risk ofhann exists and whether reasonable modifications in policies and procedures will mitigate this 1·isk. 1376 Category IC (Justice: 28 CPR § 36.208 and App.B) D. If a patient must be separated from his or her service animal while in the health-care facility I) ascertain from the person what arrangements have been made for supervision or care of the animal during this period of separation; and 2) make appropriate arrangements to address the patient's needs in the absence of the service animal. Category II

V. Animals as Patients in Human Health-Care Facilities A. Develop health-care facility policies to address the treatment of animals in human health- care facilities. I. Use the multidisciplinary team approach to policy development, including public media relations in order to disclose and discuss these activities. Category II 2. Exhaust all veterinary facility, equipment, and instrument options before undertaking the procedure. Category II 3. Ensure that the care of the animal is supervised by a licensed veterinarian. Category II B. When animals are treated in human health-care facilities, avoid treating animals in operating rooms or other patient-care areas where invasive procedures are performed (e.g., cardiac catheterization laboratories, or invasive nuclear medicine areas). Category II C. Schedule the animal procedure for the last case of the day for the area, at a time when human patients are not scheduled to be in the vicinity. Category II D. Adhere strictly to standard precautions. Category II E. Clean and disinfect environmental surfaces thoroughly using an EPA-registered product in the room after the animal is removed. Category II F. Allow sufficient ACH to clean the air and help remove airborne dander, microorganisms, and allergens [Appendix B, Table B.!.]). Category II G. Clean and disinfect using EPA-registered products or sterilize equipment that has been in contact with animals, or use disposable equipment. Category II H. If reusable medical or surgical instruments are used in an animal procedme, restrict future use of these instruments to animals only. Category II 143

VI. Research Animals in Health-Care Facilities A. Use animals obtained fi·om quality stock, or quarantine incoming animals to detect zoonotic diseases. Category II B. Treat sick animals or remove them from the facility. Category II C. Provide prophylactic vaccinations, as available, to animal handlers and contacts at high risk. Category II D. Ensure proper ventilation through appropriate facility design and location. 1395 Category IC (U.S. Department of Agriculture [USDA]: 7 USC 2131) I. Keep animal rooms at negative pressure relative to corridors. 1395 Category IC (USDA: 7 USC 2131) 2. Prevent air in animal rooms from recirculating elsewhere in the health-care facility. 1395 CategoryiC (USDA:7USC2131) E. Keep doors to animal research rooms closed. Category II F. Restrict access to animal facilities to essential personnel. Category II G. Establish employee occupational health programs specific to the animal research facility, and coordinate management of postexposure procedures specific for zoonoses with occupational health clinics in the health-care facility. 1013 • 1378 Category IC (U.S. Dcpartmenl of Health and Human Services [DHHS}: BMBL; OSHA: 29 CFR 1910.1 030.132-139) 1013 H. Document standard operating procedures for the unit. Category IC (DliHS: BMBL) I. Conduct routine employee training on worker safety issues relevant to the animal research facility (e.g., working safely with animals and animal handling). 1013 • 1393 Category IC (DHHS: BMBL; OSHA: 29 CFR 1910.1030.132-139) J. Use precautions to prevent the development of animal-induced asthma in animal workers. 1013 Category IC (DIIHS: BMBL)

I. Recommendations-Regulated Medical Waste I. Categories of Regulated Medical Waste A. Designate the following as major categories of medical waste that require special handling and disposal precautions: I) microbiology laboratory wastes [e.g., cultures and stocks of microorganisms]; 2) bulk blood, blood products, blood, and bloody body fluid specimens; 3) pathology and anatomy waste; and 4) sharps [e.g., needles and scalpels].' Category II B. Consult federal, state, and local regulations to determine if other waste items are considered regulated medical wastes. 967· 1407' 1408 Category IC (States; Authorities having jurisdiction [AHJ]; OSHA: 29 CFR 1910.1030 §g.2.1; U.S. Department of Transportation [DOl]: 49 CFR 171-180; U.S. Postal Service: C023.8)

II. Disposal Plan for Regulated Medical Wastes A. Develop a plan for the collection, handling, predisposal treatment, and terminal disposal of regulated medical wastes. 967· 1409 Category IC (S1a1es; AHJ; OSHA: 29 CFR 19101030 §g.2.i;) B. Designate a person or persons to be responsible for establishing, monitoring, reviewing, and administering the plan. Category II

III. Handling, Transporting, and Storing Regulated Medical Wastes A. Inform personnel involved in the handling and disposal of potentially infective waste of the possible health and safety hazards; ensure that they are trained in appropriate handling and disposal methods. 967 Categmy IC (OSHA: 29 CFR 1910.1030 § g.2.i) B. Manage the handling and disposal of regulated medical wastes generated in isolation areas by using the same methods as for regulated medical wastes from other patient-care areas.' Category II C. Use proper sharps disposal strategies.'" Category IC (OSHA 29 CFR 1910.1030 § d.4.iii.A) 144

I. Use a sharps container capable of maintaining its impermeability after waste treatment to avoid subsequent physical injuries during final disposal. 967 Categmy IC (OSHA; 29 CFR 1910.1030 § d.4.iii.A) 2. Place disposable syringes with needles, including sterile sharps that are being discarded, scalpel blades, and other sharp items into puncture-resistant containers located as close as practical to the point ofuse. 967 Category IC (OSHA: 29 CFR 1910.1030 § dA.iiLA) 3. Do not bend, recap, or break used syringe needles before discarding them into a container. 6• 967· 1415 Category IC (OSHA: 29 CFR 1910 !030 § d.2.vii and§ d.2.vii.A) D. Store regulated medical wastes awaiting treatment in a properly ventilated area that is inaccessible to vertebrate pests; use waste containers that prevent the development of noxious odors. Category IC (States; AHJ) E. If treatment options are not available at the site where the medical waste is generated, transport regulated medical wastes in closed, impervious containers to the on-site treatment location or to another facility for treatment as appropriate. Category IC (States; AHJ)

IV. Treatment and Disposal of Regulated Medical Wastes A. Treat regulated medical wastes by using a method (e.g., steam sterilization, incineration, interment, or an alternative treatment technology) approved by the appropriate authority having jurisdiction (AHJ) (e.g., states, Indian Health Service [IHS], Veterans Affairs [VA]) before disposal in a sanitmy landfill. Category IC (States, AHJ) B. Follow precautions for treating microbiological wastes (e.g., amplified cultures and stocks of microorganisms). 1013 Categmy IC (DHIIS: BMBL) I. Biosafety leve14 laboratories must inactivate microbiological wastes in the laboratory by using an approved inactivation method (e.g., autoclaving) before transport to and disposal in a sanitaty landfill. 1013 Categmy IC (DHHS; BMBL) 2. Biosafety level 3 laboratories must inactivate microbiological wastes in the laboratmy by using an approved inactivation method (e.g., autoclaving) or incinerate them at the facility before transport to and disposal in a sanitary landfill. 1013 Category IC (DHHS; BMBL) C. Biosafety levels I and 2 laboratories should develop strategies to inactivate amplified microbial cultures and stocks onsite by using an approved inactivation method (e.g., autoclaving) instead of packaging and shipping untreated wastes to an offsite facility for treatment and disposal. 1013 · 14 t9- 1421 Category II D. Laboratories that isolate select agents from clinical specimens must comply with federal regulations for the receipt, transfer, management, and appropriate disposal of these agents. 1412 Category IC (DHHS: 42 CFR 73 § 73.6) E. Sanitary sewers may be used for the safe disposal of blood, suctioned fluids, ground tissues, excretions, and secretions, provided that local sewage discharge requirements are met and that the state has declared this to be an acceptable method of disposal. 1414 Category II

V. Special Precautions for Wastes Generated During Care of Patients with Rare Diseases A. When discarding items contaminated with blood and body fluids from VHF patients, contain these regulated medical wastes with minimal agitation during handling.'· 203 Category II B. Manage properly contained wastes from areas providing care to VHF patients in accordance 2 6 203 with recommendations for other isolation areas (Regulated Medical Waste: III B). ' ' Category II C. Decontaminate bulk blood and body fluids from VHF patients using approved inactivation methods (e.g., autoclaving or chemical treatment) before disposal. 6' 203 Category IC, II {States; AHJ) 145

D. When discarding regulated medical waste generated during the routine (i.e., non-surgical) care of CJD patients, contain these wastes and decontaminate them using approved inactivation methods (e.g., autoclaving or incineration), appropriate for the medical waste category (e.g., blood, sharps, pathological waste).'·'·' 8• 1199 Ctttegory IC, [[ (States; AID) E. Incinerate medical wastes (e.g., central nervous system tissues or contaminated disposable materials) from brain autopsy or biopsy procedures of diagnosed or suspected CJD 1197 1201 patients. ' Category IB

Part III. References

Note: The bold item in parentheses indicated the citation number or the location of this reference listed in the MMWR version of this guideline.

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Part IV. Appendices

Appendix A. Glossary of Terms Acceptable indoor air quality: air in which there are no known contaminants at harmful concentrations as determined by knowledgeble authorities and with which a substantial majotity (2:80%) of the people exposed do not express dissatisfaction. ACGIH: American Conference of Govemmental Industrial Hygienists. Action level: the concentration of a contaminant at which steps should be taken to interrupt the trend toward higher, unacceptable levels. Aerosol: particles of respirable size generated by both humans and environmental sources and that have the capability of remaining viable and airborne for extended periods in the indoor environment. AlA: American Institute of Architects, a professional group responsible for publishing the Guidelines for Design and Construction ofHospitals and Healthcare Facilities, a consensus document for design and consiiuction of health-care facilities endorsed by the U.S. Department of Health and Human Services, health-care professionals, and professional organizations. Air changes per hour (ACH): the ratio of the volume of air flowing through a space in a certain period of time (the airflow rate) to the volume of that space (the room volume). This ratio is expressed as the number of air changes per hour (ACH). Air mixing: the degree to which air supplied to a room mixes with the air already in the room, usually expressed as a mixing factor. This factor varies from 1 (for perfect mixing) to 10 (for poor mixing). It is used as a multiplier to determine the actual airflow required (i.e., the recommended ACH multiplied by the mixing factor equals the actual ACH required). Airborne transmission: a means of spreading infection when airborne droplet nuclei (small particle residue of evaporated droplets :'05 f!m in size containing microorganisms that remain suspended in air for long periods of time) are inhaled by the susceptible host. Air-cleaning system: a device or combination of devices applied to reduce the concentration of airbome contaminants (e.g., microorganisms, dusts, fumes, aerosols, other particulate matter, and gases). Air conditioning: the process of treating air to meet the requirements of a conditioned space by controlling its temperature, humidity, cleanliness, and distribution. Allogeneic: non-twin, non-self. The term refers to transplanted tissue from a donor closely matched to a recipient but not related to that person. Ambient air: the air surrounding an object. Anemometer: a flow meter which measures the wind force and velocity of air. An anemometer is often used as a means of determining the volume of air being drawn into an air sampler. Anteroom: a small room leading from a corridor into an isolation room. This room can act as an airlock, preventing the escape of contaminants fi·om the isolation room into the corridor. ASHE: American Society for Healthcare Engineering, an association affiliated with the American Hospital Association. ASHRAE: American Society of Heating, Refrigerating, and Air-Conditioning Engineers Inc. Autologous: self. The term refers to transplanted tissue whose source is the same as the recipient, or an identical twin. Automated cycler: a machine used during peritoneal dialysis which pumps fluid into and out of the patient while he/she sleeps. Biochemical oxygen demand (BOD): a measure of the amount of oxygen removed from aquatic environments by aerobic microorganisms for their metabolic requirements. Measurement of BOD is used to determine the level of organic pollution of a stream or lake. The greater the BOD, the greater 202

the degree of water pollution. The term is also referred to as Biological Oxygen Demand (BOD). Biological oxygen demand (BOD): an indirect measure of the co11centration of biologically degradable material present in organic wastes (pertaining to water quality). It usually reflects the amount of oxygen consumed in five days by biological processes breaking down organic waste (BODS). Biosafety level: a combination of microbiological practices, laboratory facilities, and safety equipment determined to be sufficient to reduce or prevent occupational exposures of laboratory personnel to the microbiological agents they work with. There are four biosafety levels based on the hazards associated with the vat·ious microbiological agents. BODS: the amount of dissolved oxygen consumed in five days by biological processes breaking down organic matter. Bonneting: a floor cleaning method for either carpeted or hard surface floors that uses a circular motion of a large fibrous disc to lift and remove soil and dust from the surface. Capped spur: a pipe leading from the water recirculating system to an outlet that has been closed off ("capped"). A capped spur cannot be flushed, and it might not be noticed unless the surrounding wall is removed. CFU/m 3 : colony forming units per cubic meter (of air). Chlamydospores: thick-walled, typically spherical or ovoid resting spores asexually produced by certain types of fungi fi·om cells of the somatic hyphae. Chloramines: compounds containing nitrogen, hydrogen, and chlorine. These are formed by the reaction between hypochlorous acid (HOC!) and ammonia (NH3) and/or organic amines in water. The formation of chloramines in drinking water treatment extends the disinfecting power of chlorine. The term is also referred to as Combined Available Chlorine. Cleaning: the removal of visible soil and organic contamination from a device or surface, using either the physical action of scrubbing with a surfactant or detergent and water, or an energy-based process (e.g., ultrasonic cleaners) with appropriate chemical agents. Coagulation-flocculation: coagulation is the clumping of particles that results in the settling of impurities. It may be induced by coagulants (e.g., lime, alum, and iron salts). Flocculation in water and wastewater treatment is the agglomeration or clustering of colloidal and finely-divided suspended matter after coagulation by gentle stirring by either mechanical or hydraulic means, such that they can be separated from water or sewage. Commissioning (a o·oom): testing a system or de'>:ice to ensure that it meets the pre-use specifications as indicated by the manufacturer or predetermined standard, or air sampling in a room to establish a pre- occupancy baseline standard of microbial or particulate contamination. The term is also referred to as benchmarking at 77°F (25°C). Completely packaged: functionally packaged, as for laundry. Conidia: asexual spores of fungi borne externally. Conidiophores: specialized hyphae that bear conidia in fungi. Conditioned space: that part of a building that is heated or cooled, or both, for the comfott of the occupants. Contaminant: an unwanted airborne constituent that may reduce the acceptibility of air. Convection: the transfer of heat or other atmospheric properties within the atmosphere or in the airspace of an enclosure by the circulation of cutTents from one region to another, especially by such motion directed upward. Cooling tower: a structure engineered to receive accumulated heat from ventilation systems and equipment and transfer this heat to water, which then releases the stored heat to the atmosphere through evaporative cooling. Critical item (medical instrument): a medical instrument or device that contacts notmally sterile areas of the body or enters the vascular system. There is a high risk of infection from such devices if they are microbiologically contaminated prior to use. These devices must be sterilized before use. Dead legs: areas in the water system where water stagnates. A dead leg is a pipe or spur, leading from the water recirculating system to an outlet that is used infrequently, resulting in inadequate flow of 203

water from the recirculating system to the outlet. This inadequate flow reduces the perfusion of heat or chlorine into this part of the water distribution system, thereby adversely affecting the disinfection of the water system in that area. Deionization: removal of ions from water by exchange with other ions associated with fixed charges on a resin bed. Cations are usually removed and ft ions are exchanged; Olf ions are exchanged for anions. Detritis: particulate matter produced by or remaining after the wearing away or disintegration of a substance or tissue. Dew point: the temperature at which a gas or vapor condenses to form a liquid; the point at which moisture begins to condense out of the air. At dew point, air is cooled to the point where it is at 100% relative humidity OJ' saturation. Dialysate: the aqueous electrolyte solution, usually containing dextrose, used to make a concentration gradient between the solution and blood in the hemodialyzer (dialyzer). Dialyzer: a device that consists of two compartments (blood and dialysate) separated by a semipermeable membrane. A dialyzer is usually referred to as an artificial kidney. Diffuser: the grille plate that disperses the air stream coming into the conditioned air space. Direct transmission: involves direct body surface-to-body surface contact and physical transfer of microorganisms between a susceptible host and an infected/colonized person, or exposure to cloud of infectious particles within 3 feet of the source; the aerosolized pmticles are >5 11m in size. Disability: as defined by the Americans with Disabilities Act, a disability is any physical or mental impairment that substantially limits one or more major life activities, including but not limited to walking, talking, seeing, breathing, hearing, or caring for oneself. Disinfection: a generally less lethal process of microbial inactivation (compared to sterilization) that eliminates virtually all recognized pathogenic microorganisms but not necessarily all microbial forms (e.g., bacterial spores). Drain pans: pans that collect water within the HVAC system and remove it from the system. Condensation results when air and steam come together. Drift: circulating water lost from the cooling tower in the form as liquid droplets entrained in the exhaust air stream (i.e., exhaust aerosols from a cooling tower). Drift eliminators: an assembly of baffles or labyrinth passages through which the air passes prior to its exit from the cooling tower. The purpose of a drift eliminator is to remove entrained water droplets from the exhaust air. Droplets: pmticles of moisture, such as are generated when a person coughs or sneezes, or when water is converted to a fine mist by a device such as an aerator or shower head. These particles may contain infectious microorganisms. Intermediate in size between drops and droplet nuclei, these particles tend to quickly settle out from the air so that any risk of disease transmission is generally limited to persons in close proximity to the droplet source. Droplet nuclei: sufficiently small particles (1-5 11m in diameter) that can remain airborne indefinitely and cause infection when a susceptible person is exposed at or beyond 3 feet of the source of these particles. Dual duct system: an HVAC system that consists of parallel ducts that produce a cold air stream in one and a hot air stream in the other. Dust: an air suspension of particles (aerosol) of any solid material, usually with pmticle sizes ;SI 00 11m in diameter. Dust-spot test: a procedure that uses atmospheric air or a defined dust to measure a filter's ability to remove pmticles. A photometer is used to measure air samples on either side of the filter, and the difference is expressed as a percentage of particles removed. Effective leal

bacterial components. Enveloped virus: a virus whose outer surface is derived from a membrane of the host cell (either nuclear or the cell's outer membrane) during the budding phase of the maturation process. This membrane-derived material contains lipid, a component that makes these viruses sensitive to the action of chemical germicides. Evaporative condenser: a wet-type, heat-rejection unit that produces large volumes of aemsols during the process of removing heat from conditioned space air. Exhaust air: air removed fi·om a space and not reused therein. Exposure: the condition of being subjected to something (e.g., infectious agents) that could have a harmful effect. Fastidious: having complex nutritional requirements for growth, as in microorganisms. Fill: that portion of a cooling tower which makes up its primary heat transfer surface. Fill is alternatively known as "packing." Finished water: treated, or potable water. Fixed room-air HEPA recirculation systems: nonmobile devices or systems that remove airborne contaminants by recirculating air through a HEPA filter. These may be built into the room and permanently dueled or may be mounted to the wall or ceiling within the room. In either situation, they are fixed in place and are not easily movable. Fomite: an inanimate object that may be contaminated with micmorganisms and serves in their transmission. Free and available chlorine: the term applied to the three forms of chlorine that may be found in solution (i.e., chlorine [CJ,], hypochlorite [OCr], and hypochlorous acid [HOC!]). Germicide: a chemical that destroys microorganisms. Germicides may be used to inactivate microorganisms in or on living tissue (antiseptics) or on environmental surfaces (disinfectants). Health-care-associated: an outcome, usually an infection, that occurs in any health-care facility as a result of medical care. The term "health-care-associated" replaces "nosocomial," the latter term being limited to adverse infectious outcomes occurring only in hospitals. Hemodiafiltration: a form of renal replacement therapy in which waste solutes in the patient's blood are removed by both diffusion and convection thmugh a high-flux membrane. Hemodialysis: a treatment for renal replacement therapy in which waste solutes in the patient's blood are removed by diffusion and/or convection through the semipermeable membrane of an artificial kidney or dialyzer. Hemofiltration: cleansing of waste products or other toxins from the blood by convection across a semipetmeable, high-flux membrane where fluid balance is maintained by infusion of sterile, pyrogen- free substitution fluid pre- or post-hemodialyzer. HEPA filter: High Efficiency Particulate Air filters capable of removing 99.97% of particles 0.3 f!m in diameter and may assist in controlling the transmission of airborne disease agents. These filters may be used in ventilation systems to remove particles from the air or in personal respirators to filter air before it is inhaled by the person wearing the respirator. The use ofHEPA filters in ventilation systems requires expertise in installation and maintenance. To test this type of filter, 0.3 f!m particles of dioctylphthalate (DOP) are drawn through the filter. Efficiency is calculated by comparing the downstream and upstream particle counts. The optimal HEPA filter allows only three patticles to pass through for evety 10,000 pmticles that are fed to the filter. Heterotl·ophic (heterotroph): that which requires some nutrient components fi·om exogenous sources. Heterotrophic bacteria cannot synthesize all of their metabolites and therefore require cettain nutrients from other sources. High-efficiency filter: a filter with a particle-removal efficiency of90%-95%. High flux: a type of dialyzer or hemodialysis treatment in which large molecules (>8,000 daltons [e.g., p2 microglobulin]) are removed from blood. High-level disinfection: a disinfection process that inactivates vegetative bacteria, mycobacteria, fungi, and viruses, but not necessarily high numbers of bacterial spores. 205

Housekeeping surfaces: environmental surfaces (e.g., floors, walls, ceilings, and tabletops) that are not involved in direct delivery ofpatientcare in health-care facilities. Hoyer lift: an apparatus that facilitates the repositioning of the non-ambulatory patient from bed to wheelchair or gurney and subsequently to therapy equipment (immersion tanks). Hubbard tank: a tank used in hydrotherapy that may accomodate whole-body immersion (e.g., as may be indicated for burn therapy). Use of a Hubbard tank has been replaced largely by bedside post-lavage therapy for wound care management. HVAC: Heating, Ventilation, Air Conditioning. lato·ogenic: induced in a patient by a physician's activity, manner, or therapy. The term is used especially in reference to an infectious complication or other adverse outcome of medical treatment. Impactor: an air-sampling device in which particles and microorganisms are directed onto a solid surface and retained there for assay. Impingement: an air-sampling method during which particles and microorganisms are directed into a liquid and retained there for assay. Indirect transmission: involves contact of a susceptible host with a contaminated intermediate object, usually inanimate (a fomite). Induction unit: the terminal unit of an in-room ventilation system. Induction units take centrally conditioned air and further moderate its temperature. Induction units are not appropriate for areas with high exhaust requirements (e.g., research laboratories). Intermediate-level disinfection: a disinfection process that inactivates vegetative bacteria, most fungi, mycobacteria, and most viruses (patticularly the enveloped viruses), but does not inactivate bacterial spores. Isoform: a possible configuration (tertiary structure) of a protein molecule. With respect to prion proteins, the molecules with large amounts of a-conformation are the normal isoform of that pa1ticular protein, whereas those prions with large amounts of P-sheet conformation are the proteins associated with the development ofspongiform encephalopathy (e.g., Creutzfeldt-Jakob disease [CJD]). Laminar flow: HEPA-filtered air that is blown into a room at a rate of90 ± I 0 feet/min in a unidirectional pattern with 100 ACH-400 ACH. Large enveloped virus: vimses whose particle diameter is >50 nm and whose outer surface is covered by a lipid-containing structure derived from the membranes of the host cells. Examples of large enveloped viruses include influenza viruses, herpes simplex viruses, and poxviruses. Laser plume: the transfer of electromagnetic energy into tissues which results in a release of particles, gases, and tissue debris. Lipid-containing viruses: viroses whose particle contains lipid components. The term is generally synonymous with enveloped viroses whose outer surface is derived from host cell membranes. Lipid- containing viruses are sensitive to the inactivating effects of liquid chemical germicides. Lithotriptors: instruments used for crushing caliculi (i.e., calcified stones, and sand) in the bladder or kidneys. Low efficiency filter: the prefilter with a particle-removal efficiency of approximately 30% through which incoming air first passes. See also Prefilter. Low-level disinfection: a disinfection process that will inactivate most vegetative bacteria, some fungi, and some viruses, but cannot be relied upon to inactivate resistant microorganisms (e.g., mycobacteria or bacterial spores). Mal

68°F-131 op (20°C-55°C) is favorable for their growth and proliferation. Mixing box: the site where the cold and hot air streams mix in the HVAC system, usually situated close to the air outlet for the room. Mixing faucet: a faucet that mixes hot and cold water to produce water at a desired temperature. MMAD: Mass Median Aerodynamic Diameter. This is the unit used by ACGJH to describe the size of particles when particulate air sampling is conducted. Moniliaceous: hyaline or brightly colored. This is a laboratory term for the distinctive characteristics of certain oppottunistic fungi in culture (e.g., Aspergillus spp. and Fusarium spp.). Monochloramine: the result of the reaction between chlorine and ammonia that contains only one chlorine atom. Monochloramine is used by municipal water systems as a water treatment. Natural ventilation: the movement of outdoor air into a space through intentionally provided openings (i.e., windows, doors, or nonpowered ventilators). Negative pressure: air pressure differential between two adjacent airspaces such that air flow is directed into the room relative to the corridor ventilation (i.e., room air is prevented from flowing out of the room and into adjacent areas). Neutropenia: a medical condition in which the patient's concentration ofneutrophils is substantially less than that in the normal range. Severe neutropenia occurs when the concentration is <1,000 polymorphonuclear cells/flL for 2 weeks or

Potable (drinking) water: water that is fit to drink. The microbiological quality of this water as defined by EPA microbiological standards from the Surface Water Treatment Rule: a) Giardia Iamblia: 99.9% killed/inactivated; b) viruses: 99.9% inactivated; c) Legionella spp.: no limit, but if Giardia and viruses are inactivated, Legion ella will alsb be controlled; d) heterotrophic plate count [HPC]: ~500 CFU/mL; and e) >5% of water samples total coliform-positive in a month. PPE: Personal Protective Equipment. ppm: parts per million. The term is a measure of concentration in solution. Chlorine bleaches (undiluted) that are available in the U.S. (5.25%-6.15% sodium hypochlorite) contain approximately 50,000-61,500 parts per million of free and available chlorine. Prefilter: the first filter for incoming fresh air in a HVAC system. This filter is approximately 30% efficient in removing particles from the air. See also Low-Efficiency Filter. Pl'ion: a class of agent associated with the transmission of diseases knowns as transmissible spongiform encephalopathies (TSEs). Prions are considered to consist of protein only, and the abnormal isoform of this protein is thought to be the agent that causes diseases such as Creutzfeldt-Jakob disease (CJD), kum, scrapie, bovine spongiform encephalopathy (BSE), and the human version ofBSE which is variant CJD (vCJD). Product water: water produced by a water treatment system or individual component of that system. Protective envil'onment: a special care area, usually in a hospital, designed to prevent transmission of opportunistic airborne pathogens to severely immunosuppressed patients. Pseudoepidemic (pseudo-outbreak): a cluster of positive microbiologic cultures in the absence of clinical disease. A pseudoepidemic usually results from contamination of the laboratory apparatus and process used to recover microorganisms. Pyrogenic: an endotoxin burden such that a patient would receive 2:5 endotoxin units (EU) per kilogram of body weight per hour, thereby causing a febrile response. In dialysis this usually refers to water or dialysate having endotoxin concentrations of2:5 EU/mL. Rani< order: a strategy for assessing overall indoor air quality and filter performance by comparing airborne particle counts from lowest to highest (i.e., from the best filtered air spaces to those with the least filtration). RAPD: a method of genotyping microorganisms by randomly amplified polymorphic DNA. This is one version of the polymerase chain reaction method. Recirculated air: air removed from the conditioned space and intended for reuse as supply air. Relative humidity: the ratio of the amount of water vapor in the atmosphere to the amount necessary for saturation at the same temperature. Relative humidity is expressed in terms of percent and measures the percentage of saturation. At 100% relative humidity, the air is saturated. The relative humidity decreases when the temperature is increased without changing the amount of moisture in the air. Reprocessing (of medical instruments): the procedures or steps taken to make a medical instrument safe for use on the next patient. Reprocessing encompasses both cleaning and the final or terminal step (i.e., sterilization or disinfection) which is determined by the intended use ofthe instmment according to the Spaulding classification. Residuals: the presence and concentration of a chemical in media (e.g., water) or on a surface after the chemical has been added. Reservoir: a nonclinical source of infection. Respirable particles: those particles that penetrate into and are deposited in the nonciliated portion of the lung. Particles> 10 1.11n in diameter are not respirable. Return air: air removed from a space to be then recirculated. Reverse osmosis (RO): an advanced method of water or wastewater treatment that relies on a semi- permeable membrane to separate waters from pollutants. An external force is used to reverse the normal osmotic process resulting in the solvent moving from a solution of higher concentration to one of lower concentration. Riser: water piping that connects the circulating water supply line, from the level of the base of the tower or supply header, to the tower's distribution system. 208

RODAC: Replicate Organism Direct Agar Contact. This term refers to a nutrient agar plate whose convex agar surface is directly pressed onto an environmental surface for the purpose of microbiologic sampling of(hat surface. Room-air HEPA recirculation systems and units: devices (eitheo· fixed or portable) that remove airborne contaminants by recirculating air through a HEPA filter. Routine sampling: envimnmental sampling conducted without a specific, intended purpose and with no action plan dependent on the results obtained. Sanitizer: an agent that reduces microbial contamination to safe levels as judged by public health standards or requirements. Saprophytic: a naturally-occurring microbial contaminant. Sedimentation: the act or process of depositing sediment from suspension in water. The term also refers to the process whereby solids settle out of wastewater by gravity during treatment. Semicritical devices: medical devices that come into contact with mucous membranes or non-intact skin. Seo·vice animal: any animal individually trained to do work or perform tasks for the benefit of a person with a disability. Shedding: the generation and dispersion of particles and spores by sources within the patient area, through activities such as patient movement and airflow over surfaces. Single-pass ventilation: ventilation in which 100% of the air supplied to an area is exhausted to the outside. Small, non-enveloped viruses: viruses whose paoticle diameter is <50 nm and whose outer surface is the protein of the paoticle itself and not that of host cell membrane components. Examples of small, non-enveloped viruses are polioviruses and hepatitis A virus. Spaulding Classification: the categorization of inanimate medical device surfaces in the medical environment as proposed in 1972 by Dr. Earle Spaulding. Surfaces are divided into three general categories, based on the theoretical risk of infection if the surfaces are contaminated at time of use. The categories are "critical," "semicritical," and "noncritical." Specific humidity: the mass of water vapor per unit mass of moist air. It is expressed as grains of water per pound of doy air, or pounds of water per pound of doy air. The specific humidity changes as moisture is added or removed. However, temperature changes do not change the specific humidity unless the air is cooled below the dew point. Splatter: visible drops of liquid or body fluid that are expelled forcibly into the air and settle out quickly, as distinguished from pmticles of an aerosol which remain airborne indefinitely. Steady state: the usual state of an area. Sterilization: the use of a physical or chemical procedure to destroy all microbial life, including large numbers of highly-resistant bacterial endospores. Stop valve: a valve that regulates the flow of fluid through a pipe. The term may also refer to a faucet. Substitution fluid: fluid that is used for fluid management of patients receiving hemodiafiltration. This fluid can be prepared on-line at the machine through a seoies ofultmfilters or with the use of sterile peritoneal dialysis fluid. Supply air: air that is delivered to the conditioned space and used for ventilation, heating, cooling, humidification, or dehumidification. Tensile strength: the resistance of a material to a force tending to tear it apaot, measured as the maximum tension the material can withstand without tearing. Therapy animal: an animal (usually a personal pet) that, with their owners or handlers, provide supervised, goal-directed intervention to clients in hospitals, nursing homes, special-population schools, and other treatment sites. Thermophilic: capable of growing in environments warmer than body temperature. Thermotolerant: capable of withstanding high temperature conditions. TLV®: an exposure level under which most people can work consistently for 8 hours a day, day after day, without adverse effects. The term is used by the ACGJH to designate degree of exposure to 209

contaminants. TL V® can be expressed as approximate milligrams of particulate per cubic meter of air (mg/m 3 ). TLVs® are listed as either an 8-hour TWA (time weighted average) or a 15-minute STEL (short term exposure limit). TLV-TWA: Threshold Limit Value-Time Weighted Average. The term refers to the time-weighted average concentration for a normal 8-hour workday and a 40-hour workweek to which nearly all workers may be exposed repeatedly, day after day, without adverse effects. The TLV-TWA for "particulates (insoluble) not otherwise classified" (PNOC)- (sometimes referred to as nuisance dust)- are those particulates containing no asbestos and

Wright-arrestaucr: R measure of filter efficiency. used primarily when desclibing the pe1fonnance of low- and medhuu-efficiency filters. T11e measurement ofweight-anestance is pe1fonned by feeding a standardized synthetic dust to the filter and weighing the fraction of the dust removed.

Appendix B. Air 1. Airborne Contaminant Removal

Table B.L Air changes/hour (ACH) and time required for nirborne-contmninant removnl efficiencies of99% and 99.9%* Time- (mins.) t•equired for removal: ACH+§'If 99o/o pfficiencv 99.9% efficiencv '• 138 207 4 69 - - ---·"--·"-------------· 1--- 104 6 46 69 -----· 8 -- 35 52 10 28 41 12 23 35 15 18 28 20 14 21 50 6 8

"' Thi.-. t~ble i1> revised from Table S3-l in referen~e 4 and has been adapted from the fonnuln for the rate of purging airbome contaminant~ presented in reference 1435, + Shaded entries denote frequently cited ACH for patient~are areas, § Values were derived .fi:om the fonuula:

t2 - t1 = -[In (C, I C 1) I (Q J V)] x 60. with t1 = 0 and where

t1 =initial timepoint in minutes t2 = final timepoint in minutes C 1 =initial concentration of contaminant C2 =final concentration of contaminant c, j cl = 1 - (removal efficiency /I 00) Q ~ air flow rate in cubic feet/hour V =room volume in cubic feet Q/V=ACH

-r Values apply to an empty room with no aerosol~generati.ng source. \Vith a person present rmd generating aerosol, this tHble would not apply. Other equations are (Jvnilnble that include a constant generating source. However, certain disease!> (e.g.., infectious tuberculosis) are not likely to be aerosolized at n constant rate. TI1e times given assume perfect mixing of the air within the space (i.e .. mixing factor= 1). However. perfect mixing usun11y does not occur. Remo\·al times will be longer in rooms or areas with imperfect mixing or air st

2. Air Sampling for Aerosols Containing Legionellae Air sampling is an insensitive means of detecting Legionella pneumophi/a, and is of limited practical value in environmental sampling for this pathogen. In ce1tain instances, however. it can be used to a) demonstrate the presence oflegionellae in aerosol droplets associated with suspected bacterial 211

reservoirs; b) define the role of certain devices [e.g., showers, faucets, decorative fountains, or evaporate condensers] in disease transmission; and c) quantitate and determine the size of the droplets containing legionellae. 1436 Stringent controls and calibration are necessary when sampling is used to determine patticle size and numbers of viable bacteria. 1437 Samplers should be placed in locations where human exposure to aerosols is anticipated, and investigators should wear a NIOSH-approved respirator (e.g., N95 respirator) if sampling involves exposure to potentially infectious aerosols.

Methods used to sample air for legionellae include impingement in liquid, impaction on solid medium, and sedimentation using settle plates. 1436 The Chemical Corps.-type all-glass impingers (AGI) with the stem 30 mm from the bottom of the flask have been used successfully to sample for legionellae. 1436 Because of the velocity at which air samples are collected, clumps tend to become fragmented, leading to a more accurate count of bacteria present in the air. The disadvantages of this method are a) the velocity of collection tends to destroy some vegetative cells; b) the method does not differentiate patticle sizes; and c) AGis are easily broken in the field. Yeast extract broth (0.25%) is the recommended liquid medium for AGI sampling of legionellae; 1437 standard methods for water samples can be used to culture these samples.

Andersen samplers are viable pmticle samplers in which particles pass through jet orifices of decreasing size in cascade fashion until they impact on an agar surface. 1218 The agar plates are then removed and incubated. The stage distribution of the legionellae should indicate the extent to which the bacteria would have penetrated the respiratory system. The advantages of this sampling method are a) the equipment is more durable during use; b) the sampler can cetermine the number and size of droplets containing legionellae; c) the agar plates can be placed directly in an incubator with no futther manipulations; and d) both selective and nonselective BCYE agar can be used. Tfthe samples must be shipped to a laboratory, they should be packed and shipped without refrigeration as soon as possible.

3. Calculation of Air Sampling Results Assuming that each colony on the agar plate is the growth from a single bacteria-carrying particle, the contamination of the air being sainpled is determined from the number of colonies counted. The airborne microorganisms may be repmted in tenns of the number per cubic foot of air sampled. The following fonnulas can be applied to convert colony counts to organisms per cubic foot of air sampled. 1218

For solid agar impactor samplers: C I (R x P) ~ N where N = number of organisms collected per cubic foot of air sampled C ~ total plate count R =airflow rate in cubic feet per minute P = duration of sampling period in minutes

For liquid impingers: (C x V) I (Q x P x R) ~ N where C ~ total number of colonies from all aliquots plated V = final volume in mL of collecting media Q ~total number of mL plated P, R, and N are defined as above 212

4. Ventilation Specifications for Health-Care Facilities The following tables from the AlA Guidelines for Design and Construction of Hospitals and Health-Care Facilities, 200/ are reprinted with permission of the American Institute of Architects and the publisher (The Facilities Guidelines lnstitute). 120

Table B.2. Ventilation requirements for areas affecting patient care in hospitals and outpatient facilities' Notes: This table is Table 7.2 in the AlA guidelines, 2001 edition. Superscripts used in this table refer to notes following the table.

Air movement Minimum Minimum AII air relationship air changes total air exhausted Recirculated Relative Design to adjacent of outdoor changes per directly to by means of humidity' temperature9 Area designation area2 air per hour' hour4' 5 outdoors6 room units 7 (%) (degrees F [C])

Surgeru and critica] care Operating/surgical cystoscopic rooms 10• 11 Out 3 15 - No 3o-60 68-73 (20-23) 12 Delivery room 10 Out 3 15 - No 3o-60 68-73 (20-23) Recovery room 10 2 6 - No 3o-60 70-75 (21-24) Critical and intensive care - 2 6 - No 3o-60 70-75 (21-24) Newborn intensive care - 2 6 - No 30-60 72-78 (22-26) Treatment room 13 - - 6 - - - 75 (24) Trauma room 13 Out 3 15 No 3o-60 70-75 (21-24) Anesthesia gas storage In - 8 Yes Endoscopy In 2 6 - No 3o-60 68-73 (20-23) Bronchoscopy 11 In 2 12 Yes No 3o-60 68-73 (20-23) ER waiting rooms In 2 12 Yesl4, 1s - - 70-75 (21-24) Triage 2 12 Yes 14 - 70-75 (2I-24) Radiology waiting rooms In 2 12 Yesl4, ts - - 70-75 (21-24) Procedure room - Out 3 15 - No 3o-60 70-75 (21-24)

Nursing Patient room - 2 616 - - - 70-75 (21-24) Toilet room In - 10 Yes Newborn nursery suite - 2 6 - No 3(}-60 72-78 (22-26) Protective environment room 11 • 17 Out 2 12 - No - 75 (24) Airborne infection isolation room 17• 18 2 12 Yes 15 - 75 (24) Isolation alcove or anteroom 17· 18 In/Out - 10 Yes No Labor/delivery/recovery 2 616 - - 70-75 (21-24) Labor/delivery/recovery/postpartum 2 616 - - 70-75 (21-24) Patient corridor In - - 2 No In

m'" N- ~'" 213 Air movement Minimum Minimum All air relationship air changes total air exhausted Recirculated Relative Design to adjacent , of outdoor changes per directly to by means of humidity' temperature9 Area designation area- air per hour3 hour4' 5 outdoors 6 room units 7 (%) (degrees F [C])

Ancillary Radiology" X-ray (surgical/critical care and catheterization) Out 3 15 - No 30-60 7()-75 (21-24) X-ray (diagnostic & treatment) - - 6 - - - 75 (24) Darkroom In - 10 Yes No Laboratory Genera1 19 - - 6 - - - 75 (24) Biochemistry 19 Out - 6 - No - 75 (24) Cytology In - 6 Yes No - 75 (24) Glass washing In - 10 Yes Histology In - 6 Yes No - 75 (24) Microbiology 19 In - 6 Yes No - 75 (24) Nuclear medicine In - 6 Yes No - 75 (24) Pathology In - 6 Yes No - 75 (24) Serology Out - 6 - No - 75 (24) Sterilizing In - 10 Yes 11 Autopsy room - 12 Yes No Nonrefrigerated body-holding room In - 10 Yes - - 70 (21) Pharmacy Out - 4

Diagnostic and treatment Examination room - - 6 - - - 75 (24) Medication room Out - 4 Treatment room - - 6 - - - 75 (24) Physical therapy and hydrotherapy In - 6 - - - 75 (24) Soiled workroom or soiled holding In - 10 Yes No Clean workroom or clean holding Out - 4

Sterilizing and ~lmly ETC-sterilizer room In - 10 Yes No 30-60 75 (24) Sterilizer equipment room In - 10 Yes Central medical and surgical supply Soiled or decontamination room In - 6 Yes No - 68-73 (2()-23) Clean workroom Out - 4 - No 30-60 75 (24) Sterile storage Out - 4 - - (Max.) 70 214 Air movement Minimum Minimum All air relationship air changes total air exhausted Recirculated Relative Design to adjacent , of outdoor changes per directly to by means of humidity8 ternperature9 Area designation area- air per hour' hour4• 5 outdoors 6 room units 7 (%) (degrees F [C])

Service Food preparation center0 - - 10 - No Ware washing In - 10 Yes No Dietary day storage In - 2 Laundry, general - - 10 Yes Soiled linen (sorting and storage) In - 10 Yes No Clean linen storage Out - 2 Soiled linen and trash chute room In - 10 Yes No Bedpan room In - 10 Yes Bathroom In - 10 - - - 75 (24) Janitor's closet In 10 Yes No

Notes:

1. The ventilation rates in this table cover ventilation for comfort, as well as for asepsis and odor control in areas of acute care hospitals that directly affect patient Care and are determined based on health-care facilities being predominantly "No Smoking" facilities. Where smoking may be allowed, ventilation rates will need adjustment. Areas where specific ventilation rates are not given in the table shall be ventilated in accordance with ASHRAE Standard 62, Ventilation for Acceptable Indoor Air Quality, and ASHRAE Handbook- HVAC Applications. Specialized patient care areas, including organ transplant units, bum units, specialty procedure rooms, etc., shall have additional ventilation provisions for air quality control as may be appropriate. OSHA standards and/or NIOSH criteria require special ventilation requirements for employee health and safety within health-care facilities.

2. Design of the ventilation system shall provide air movement which is generally from clean to less clean areas. If any form of variable air volume or load shedding system is used for energy conservation, it must not compromise the corridor-to-room pressure balancing relationships or the minimum air changes required by the table.

3. To satisfy exhaust needs, replacement air from the outside is necessary. Table B2 does not attempt to describe specific amounts of outside air to be supplied to individual spaces except for certain areas such as those listed. Distribution of the outside air, added to the system to balance required exhaust, shall be as required by good engineering practice. Minimum outside air quantities shall remain constant while the system is in operation.

4. Number of air changes may be reduced when the room is unoccupied if provisions are made to ensure that the number of air changes indicated is reestablished any time the space is being utilized. Adjustments shall include provisions so that the direction of air movement shall remain the same when the number of air changes is reduced. Areas not indicated as having continuous directional control may have ventilation systems shut down when space is unoccupied and ventilation is not otherwise needed, if the maximum infiltration or exfiltration permitted in Note 2 is not exceeded and if adjacent pressure balancing relationships are not compromised. Air quantity calculations must account for filter loading such that the indicated air change rates are provided up until the time of filter change-out.

5. Air change requirements indicated are minimum values. Higher values should be used when required to maintain indicated room conditions (temperature andjumidity), based on the cooling load of the space (lights, equipment, people, exterior walls and windows, etc.). 215

6. Air from areas with contamination and/or odor problems shall be exhausted to the outside and not recirculated to other areas. Note that individual circumstances may require special consideration for air exhaust to the outside, (e.g., in intensive care units in which patients with pulmonary infection are treated) and rooms for bum patients.

7. Recirculating room HVAC units refer to those local units that are used primarily for heating and cooling of air, and not disinfection of air. Because of cleaning difficulty and potential for buildup of contamination, recirculating room units shall not be used in areas marked "No." However, for airborne infection contra~ air may be recirculated within individual isolation rooms ifHEPA filters are used. Isolation and intensive care unit rooms may be ventilated by reheat induction units in which only the primary air supplied from a central system passes through the reheat unit. Gravity-type heating or cooling units such as radiators or convectors shall not be used in operating rooms and other special care areas. See this table's Appendix I for a description of recirculation units to be used in isolation rooms (A7).

8. The ranges listed are the minimum and maximum limits where control is specifically needed. The maximum and minimum limits are not intended to be independent of a space's associated temperature. The humidity is expected to be at the higher end of the range when the temperature is also at the higher end, and vice versa

9. Where temperature ranges are indicate~ the systems shall be capable of maintaining the rooms at any point within the range during normal operation. A single figure indicates a heating or cooling capacity of at least the indicated temperature. This is usually applicable when patients may be undressed and require a warmer environment. Nothing in these guidelines shall be construed as precluding the use of temperatures lower than those noted when the patients' comfort and medical conditions make lower temperatures desirable. Unoccupied areas such as storage rooms shall have temperatures appropriate for the function intended.

10. National Institute for Occupational Safety and Health (NIOSH) criteria documents regarding "Occupational Exposure to Waste Anesthetic Gases and Vapors," and "Control of Occupational Exposure to Nitrous Oxide" indicate a need for both local exhaust (scavenging) systems and general ventilation of the areas in which the respective gases are utilized.

11. Differential pressure shall be a minimum of 0.0 1" water gauge (2.5 Pa). If alarms are installed, allowances shall be made to prevent nuisance alarms of monitoring devices.

12. Some surgeons may require room temperatures which are outside of the indicated range. All operating room design conditions shall be developed in consultation with surgeons, anesthesiologists, and nursing staff.

13. The term "trauma room" as used here is the operating room space in the emergency department or other trauma reception area that is used for emergency surgery. The "first aid room" and/or "emergency room" used for initial treatment of accident victims may be ventilated as noted for the "treatment room." Treatment rooms used for bronchoscopy shall be treated as Bronchoscopy rooms. Treatment rooms used for cryosurgery procedures with nitrous oxide shall contain provisions for exhausting waste gases.

14. In a ventilation system that recirculates air, HEPA filters can be used in lieu of exhausting the air from these spaces to the outside. In this application, the return air shall be passed through the HEP A filters before it is introduced into any other spaces.

15. If it is not practical to exhaust the air from the airborne infection isolation room to the outside, the air may be returned through HEPA filters to the air-handling system exclusively serving the isolation room.

16. Total air changes per room for patient rooms, labor/delivery/recovery rooms, and labor/delivery/recovery/postpartum rooms may be reduced to 4 when supplemental heating and/or cooling systems (radiant heating and cooling, baseboard heating, etc.) are used.

17. The protective environment airflow design specifications protect the patient from common environmental airborne infectious microbes (i.e., Aspergillus spores). These special ventilation areas shall be designed to provide directed airflow from the cleanest patient care area to less clean areas. These rooms shall be protected with HEP A filters at 99.97 percent efficiency for a 0.3 J..liD sized particle in the supply airstream. These interrupting filters protect patient rooms from maintenance-derived release of environmental microbes from the ventilation system components. Recirculation HEPA filters can be used to increase the equivalent room air exchanges. Constant volume airflow is required for consistent ventilation for the protected environment. If the facility determines that airborne infection isolation is necessary for protective environment patients, an anteroom should be 216 provided. Rooms with reversible airflow provisions for the purpose of switching between protective environment and airborne infection isolation functions are not acceptable.

18. The infectious disease isolation room described in these guidelines is to be used for isolating the airborne spread of infectious diseases, such as measles, varicella, or tuberculosis. The design of airborne infection isolation (Ail) rooms should include the provision for normal patient care during periods not requiring isolation precautions. Supplemental recirculating devices may be used in the patient room to increase the equivalent room air exchanges; however, such recirculating devices do not provide the outside air requirements. Air may be recirculated within individual isolation roomS ifHEPA filters are used. Rooms with reversible airflow provisions for the purpose of switching between protective environment and Ali functions are not acceptable.

19. When required, appropriate hoods and exhaust devices for the removal of noxious gases or chemical vapors shall be provided (see Section 7.3l.D 14 and 7.3l.D 15 in the AlA guideline [reference 120] and NFPA 99).

20. Food preparation centers shall have ventilation systems whose air supply mechanisms are interfaced appropriately with exhaust hood controls or relief vents so that exfiltration or infiltration to or from exit corridors does not compromise the exit corridor restrictions ofNFPA 90A, the pressure requirements ofNFPA 96, or the maximum defined in the table. The number of air changes may be reduced or varied to any extent required for odor control when the space is not in use. See Section 7.3l.D1.p in the AlA guideline (reference 120).

Appendix 1:

A 7. Recirculating devices with HEPA filters may have potential uses in existing facilities as interim, supplemental environmental controls to meet requirements for the control of airborne infectious agents. Limitations in design must be recognized. The design of either portable or fixed systems should prevent s'tae,onation and short circuiting of airflow. The supply and exhaust locations should direct clean air to areas where health-care workers are likely to work, across the infectious source, and then to the exhaust, so that the health- care worker is not in position between the infectious source and the exhaust location. The design of such systems should also allow for easy access for scheduled preventative maintenance and cleaning. ·

A 11. The verification of airflow direction can include a simple visual method such as smoke trail, bali-in-tube, or flutterstrip. These devices will require a minimum differential air pressure to indicate airflow direction. 217

Table B.3. Pressure relationships and ventilation of certain areas of nursing facilities 1 Notes: This table is Table 8.1 in the AlA guidelines, 2001 edition. Superscripts used in this table refer to notes following the table.

Air movement Minimum Minimum All air relationship air changes total air exhausted Recirculated Relative Design to adjacent of outdoor changes per directly to by means of humidi1y7 temperature8 Area designation area2 air per hour 3 hour4 outdoors5 room units 6 (%) (degrees F [C]) 9 Resident room - 2 2 - - 7G-75 (2I-24) Resident unit corridor - - 4 Resident gathering areas - 4 4 Toilet room In - IO Yes No Dining rooms - 2 4 - - - 75 (24) Activity rooms, if provided - 4 4 Physical therapy In 2 6 - - - 75 (24) Occupational therapy In 2 6 - - -- 75.(24) Soiled workroom or soiled holding In 2 IO Yes No Clean workroom or clean holding Out 2 4 - - (Max. 70) 75 (24) Sterilizer exhaust room In - IO Yes No Linen and trash chute room, if provided In - IO Yes No Laundry, general, if provided - 2 IO Yes No Soiled linen sorting and storage In - IO Yes No Clean linen storage Out - 2 Yes No Food preparation fucilities 10 - 2 10 Yes No Dietary warewashing In - 10 Yes No Dietary storage areas - - 2 Yes No Housekeeping rooms In - IO Yes No Bathing rooms In - IO Yes No - 75 (24)

Notes:

L The ventilation rates in this table cover ventilation for comfort, as well as for asepsis and odor control in areas of nursing facilities that directly affect resident care and are determined based on nursing facilities being predominantly "No Smoking'' facilities. Where smoking may be allowed, ventilation rates will need adjustment. Areas where specific ventilation rates are not given in the table shall be ventilated in accordaoce with ASHRAE Standard 62, Ventilation for Acceptable Indoor Air Quality. aod ASHRAE Handbook- HVAC Applications. OSHA standards and/or NIOSH criteria require special ventilation requirements for employee health and safety within nursing facilities.

2. Design of the ventilation system shall, insofar as possible, provide that air movement is from clean to less clean areas. However, continuous compliance may be impractical with full utilization of some forms of variable air volume and load shedding systems that may be used for energy conservation. Areas that do require positive and continuous control are noted with "Out" or "In" to indicate the required direction of air movement in relation to the space named. Rate of air movement may, of course, be varied as needed 218

within the limits required for positive control. Where indication of air movement direction is enclosed in parentheses, continuous directional control is required only when the specialized equipment or device is in use or where room use may otherwise compromise the intent of movement from clean to less clean. Air movement for rooms with dashes and nonpatient areas may vary as necessary to satisfY the requirements of those spaces. Additional adjustments may be needed when space is unused or unoccupied and air systems are deenergized or reduced.

3. To satisfy exhaust needs, replacement air from outside is necessary. Table B.3 does not attempt to describe specific amounts of outside air to be supplied to individual spaces except for certain areas such as those listed. Distribution of the outside air, added to the system to balance required exhaust, shall be as required by good engineering practice.

4. Number of air changes may be reduced when the room is unoccupied if provisions are made to ensure that the number of air changes indicated is reestablished any time the space is being utilized. Adjustments shall include provisions so that the direction of air movement shall remain the same when the number of air changes is reduced. Areas not indicated as having continuous directional control may have ventilation systems shut down when space is unoccupied and ventilation is not otherwise needed.

5. Air from areas with contamination and/or odor problems shall be exhausted to the outside and not recirculated to other areas. Note that individual circumstances may require special consideration for air exhaust to outside.

6. Because of cleaning difficulty and potential for buildup of contamination, recirculating room units shall not be used in areas marked "'No." Isolation rooms may be ventilated by reheat induction units in which only the primary air supplied from a central system passes through the reheat unit. Gravity-type heating or cooling units such as radiators or convectors shall not be used in special care areas.

7. The ranges listed are the minimum and maximum limits where control is specifically needed. See A8.3l.D in the AIA guideline (reference 120) for additional information.

8. Where temperature ranges are indicated, the systems shall be capable of maintaining the rooms at any point within the range. A single figure indicates a heating or cooling capacity of at least the indicated temperature. This is usually applicable where residents may be undressed and require a warmer environment. Nothing in these guidelines shall be construed as precluding the use of temperatures lower than those noted when the residents' comfort and medical conditions make lower temperatures desirable. Unoccupied areas such as storage rooms shall have temperatures appropriate for the function intended.

9. See A8.3l.Dl in the AlA guideline (reference 120).

10. Food preparation facilities shall have ventilation systems whose air supply mechanisms are interfaced appropriately with exhaust hood controls or relief vents so that exfiltration or infiltration to or from exit corridors does not compromise the exit corridor restrictions ofNFPA 90A, the pressure requirements ofNFPA 96, or the maximum defined in the table. The number of air changes may be reduced or varied to any extent required for odor control when the space is not in use. 219

Table B.4. Filter efficiencies for central ventilation and air conditioning systems in general hospitals* Note: This table is Table 7.3 in the AlA guidelines, 2001 edition.

Filter bed Filter bed Number of No.1 No.2 Area designation filter beds (%) (%)

All areas for inpatient care, treatment, and 2 30 90 diagnosis, and those areas providing direct se1vice or clean supplies, such as sterile and clean processing, etc.

Protective environment room 2 30 99.97

Laboratories 80

Administrative, bulk storage, soiled holding areas, 30 food preparation areas, and laundries

* Additional roughing or prefilters should be considered to reduce maintenance required for fitters with efficiency higher than 75 percent. The filtration efficiency ratings are based on average dust sopt efficiency per ASHRAE 52.1-1992.

Table B.S. Filter efficiencies for central ventilation and air conditioning systems in outpatient facilities* Note: This table is Table 9.1 in the AIA guidelines, 2001 edition.

Filter bed Filter bed Number of No.1 No.2+ Area designation filter beds (%) (%)

All areas for patient care, treatment, and/or 2 30 90 diagnosis, and those areas providing direct service or clean supplies such as sterile and clean processing, etc.

Laboratories 80

Administrative, bulk storage, soiled holding areas, 30 food preparation areas, and laundries

* Additional roughing or prefilters should be considered to reduce maintenance required for main filters. The filtration efficiency ratings are based on dust spot efficiency per ASHRAE 52.1-1992. + These requirements do not apply to small primary (e.g., neighborhood) outpatient facilities or outpatient facilities that do not perfonn invasive applications or procedures. 220

Table B.6. Filter efficiencies for central ventilation and air conditioning systems in nursing facilities · Note: This table is Table 8.2 in the AlA guidelines, 2001 edition.

Minimum Filter bed Filter bed number of No.1 No.2 Area designation filter beds (%)* (%)*

All areas for inpatient care, treatment, and/or 2 30 80 diagnosis, and those areas providing direct service or clean supplies

Administrative, bulk storage, soiled holding, 30 laundries, and food preparation areas

* The filtration efficiency ratings are based on average dust spot efficiency as per ASHRAE 52.1-1992.

Table B.7. Filter efficiencies for central ventilation and air conditioning systems in psychiatric hospitals Note: T11is table is Table 11.1 in the AIA guidelines, 200 I edition.

Minimum Filter bed Filter bed number of No.1 No.2 Area designation filter beds (%)* (%)*

All areas for inpatient care, treatment, and 2 30 90 diagnosis, and those areas providing direct services

Administrative, bulk storage, soiled holding, 30 laundries, and food preparation areas

* The filtration efficiency ratings are based on average dust spot efficiency as per ASHRAE 52.1-1992.

Appendix C. Water

1. Biofllms Microorganisms have a tendency to associate with and stick to surfaces. These adherent organisms can initiate and develop biofilms, which are comprised of cells embedded in a matrix of extracellularly produced polymers and associated abiotic particles. 1438 It is inevitable that biofilms will form in most water systems. In the health-care facility environment, biofilms may be found in the potable water supply piping, hot water tanks, air conditioning cooling towers, or in sinks, sink traps, aerators, or shower heads. Biofilms, especially in water systems, are not present as a continuous slime or film, but 221

are more often scanty and heterogeneous in nature. 1439 Biofilms may form under stagnant as well as flowing conditions, so storage tanks, in addition to water system piping, may be vulnerable to the development ofbiofilm, especially if water temperatures are low enough to allow the growth of thermophilic bacteria (e.g., Legionella spp. ). Favorable conditions for biofilm formation are present if these stmctnres and equipment are not cleaned for extended periods of time. 1440

Algae, protozoa, and fungi may be present in biofilms, but the predominant microorganisms of water system biofilms are gram-negative bacteria. Although most of these organisms will not normally pose a problem for healthy individuals, certain biofilm bacteria (e.g., Pseudomonas aeruginosa, Klebsiella spp., Pantoea agglomerans, and Enterobacter cloacae) all may be agents for oppottunistic infections for immunocompromised individuals. 1441 • 1442 These biofilm organisms may easily contaminate indwelling medical devices or intravenous (IV) fluids, and they could be transferred on the hands of health-care wor kers. 1441- 1444 B'10fil 1 ms may po ten t'ra II y provt'd e an environment . ~10r the survtva . I of path ogentc . organisms, such as Legionella pneumophila and E. coli 0157:H7. Although the association ofbiofilms and medical devices provides a plausible explanation for a variety of health-care-associated infections, it is not clear how the presence of biofilms in the water system may influence the rates of health-care- associated waterborne infection.

Organisms within biofilms behave quite differently than their planktonic (i.e., free floating) counterparts. Research has shown that biofilm-associated organisms are more resistant to antibiotics and disinfectants than are planktonic organisms, either because the cells are protected by the polymer matrix, or because they are physiologically different. 144s- 1450 Nevetiheless, municipal water utilities attempt to maintain a chlorine residual in the distribution system to discourage microbiological growth. Though chlorine in its various forms is a proven disinfectant, it has been shown to be less effective against biofilm bacteria. 1448 Higher levels of chlorine for longer contact times are necessary to eliminate biofilms.

Routine sampling of health-care facility water systems for biofilms is not warranted. If an epidemiologic investigation points to the water supply system as a possible source of infection, then water sampling for biofilm organisms should be considered so that prevention and control strategies can be developed. An established biofilm is is difficult to remove totally in existing piping. Strategies to remediate biofilms in a water system would include flushing the system piping, hot water tank, dead legs, and those areas of the facility's water system subject to low or intermittent flow. The benefits of this treatment would include a) elimination of corrosion deposits and sludge from the bottom of hot water tanks, b) removal ofbiofilms from shower heads and sink aerators, and c) circulation of fresh water containing elevated chlorine residuals into the health-care facility water system.

The general strategy for evaluating water system biofilm depends on a comparision of the bacteriological quality of the incoming municipal water and that of water sampled from within facility's distribution system. Heterotrophic plate counts and coliform counts, both of which are routinely run by the municipal wateJ' utility, will at least provide in indication of the potential for biofilm formation. Heterotrophic plate count levels in potable water should be <500 CFU/mL. These levels may increase on occasion, but counts consistently >500 CFU/mL would indicate a general decrease in water quality. 1450 A direct correlation between heterotrophic plate count and biofilm levels has been demonstrated. Therefore, an increase in heterotrophic plate count would suggest a greater rate and extent of biofilm formation in a health-care facility water system. The water supplied to the facility should also contain

Water samples can be collected from throughout the health-care facility system, including both hot and cold water sources; samples should be cultured by standard methods. 945 If heterotrophic plate counts in samples from the facility water system are higher than those from samples collected at the point of water entry to the building, it can be concluded that the facility water quality has diminished. If biofilms are detected in the facility water system and determined by an epidemiologic and environmental investigation to be a reservoir for health-care--associated pathogens, the municipal water supplier could be contacted with a request to provide higher chlorine residuals in the distribution system, or the health-care facility could consider installing a supplemental chlorination system.

Sample collection sites for biofilm in health-care facilities include a) hot water tanks; b) shower heads; and c) faucet aerators, especially in immunocompromised patient-care areas. Swabs should be placed into tubes containing phosphate buffered water, pH 7.2 or phosphate buffered saline, shipped to the laboratory under refrigeration and processed within 24 hrs. of collection. Samples m·e suspended by vmtexing with sterile glass beads and plated onto a nonselective medium (e.g., Plate Count Agar or R2A medium) and selective media (e.g., media for Legionella spp. isolation) after serial dilution. If the plate counts are elevated above levels in the water (i.e. comparing the plate count per square centimeter of swabbed surface to the plate count per milliliter of water), then biofilm formation can be suspected. In the case of an outbreak, it would be advisable to isolate organisms from these plates to determine whether the suspect organisms are~present in the biofilm or water samples and compare them to the organisms isolated from patient specimens.

2. Water and Dialysate Sampling Strategies in Dialysis In order to detect the low, total viable heterotrophic plate counts outlined by the current AAMI standards for water and dialysate in dialysis settings, it is necessary to use standard quantitative culture techniques with appropriate sensitivity levels. 792 • 832 ' 833 The membrane filter technique is particularly 834 suited for this application because it permits large volumes of water to be assayed. 792 • Since the membrane filter technique may not be readily available in clinical laboratories, the spread plate assay can be used as an altemative. 834 If the spread plate assay is used, however, the standard prohibits the use of a calibrated loop when applying sample to the plate. 792 The prohibition is based on the low sensitivity of the calibrated loop. A standard calibrated loop transfers 0.00 I mL of sample to the culture medium, so that the minimum sensitivity of the assay is 1,000 CFU/mL. This level of sensitivity is unacceptable when the maximum allowable limit for microorganisms is 200 CFU/mL. Therefore, when the spread plate method is used, a pipette must be used to place 0.1-0.5 mL of water on the culture medium.

The current AAMI standard specifically prohibits the use of nutrient-rich media (e.g., blood agar, and chocolate agar) in dialysis water and dialysate assays because these culture media are too rich for growth of the naturally occurring organisms found in water. 792 Debate continues within AAMI, however, as to the most appropriate culture medium and incubation conditions to be used. The original clinical observations on which the microbiological requirements of this standard were based used 666 Standard Methods Agar (SMA), a medium containing relatively few nutrients. The use oftiyptic soy agar (TSA), a general purpose medium for isolating and cultivating microorganisms was recommended in later versions of the standard because it was thought to be more appropriate for culturing bicarbonate- containing dialysate."'· 789• 835 Moreover, culturing systems based on TSA are readily available from commercial sources. Several studies, however, have shown that the use of nutrient-poor media, such as 1451 1452 R2A, results in an increased recovery of bacteria from water. ' The original standard also specified incubation for 48 hours at 95°F-98.6°F (35°C-37°C) before enumeration of bacterial colonies, Extending the culturing time up to 168 hours, or 7 days and using incubation temperatures of 73.4 op_ 82.4 op (23 °C-28°C) have also been shown to increase the recovery of bacteria. 1451 ' 1452 Other 223

investigators, however, have not found such clear cut differences between culturing techniques. 835 · 1453 After considerable discussion, the AAMI Committee has not reached a consensus regarding changes in the assay technique, and the use ofTSA or its equivalent for 48 hours at 95°F-98.6°F (35°C-37°C) remains the recommended method. It should be recognized, however, that these culturing conditions may underestimate the bacterial burden in the water and fail to identify the presence of some organisms. Specifically, the recommended method may not detect the presence of various NTM that have been associated with several outbreaks of infection in dialysis units. 31 •32 In these instances, however, the high numbers of mycobacteria in the water were related to the total heterotrophic plate counts, each of which was significantly greater than that allowable by the AAMI standard. Additionally, the recommended method will not detect fungi and yeast, which have been shown to contaminate water used for hemodialysis applications. 1454 Biofilm on the surface of the pipes may hide viable bacterial colonies, even though no viable colonies are detected in the water using sensitive culturing techniques. 1455 Many disinfection processes remove biofilm poorly, and a rapid increase in the level of bacteria in the water following disinfection may indicate significant biofilm formation. Therefore, although the results of microbiological surveillance obtained using the test methods outlined above may be useful in guiding disinfection schedules and in demonstrating compliance with AAMI standards, they should not be taken as an indication of the absolute microbiological purity of the water. 792

Endotoxin can be tested by one of two types of assays a) a kinetic test method [e.g., colorimetric or turbidimetric] or b) a gel-clot assay. Endotoxin units are assayed by theLirnulus Amebocyte Lysate (LAL) method. Because endotoxins differ in their activity on a mass basis, their activity is refe!1'ed to a standard Escherichia coli endotoxin. The current standard (EC-6) is prepared from E. coli 0113 :HI 0. The relationship between mass of endotoxin and its activity varies with both the lot ofLAL and the lot of control standard endotoxin used. Since standards for endotoxin were harmonized in 1983 with the introduction ofEC-5, the relationship between mass and activity of endotoxin has been approximately 5-10 EU/ng. Studies to harmonize standards have led to the measurement of endotoxin units (EU) where 5 EU is equivalent to I ng E. coli 055 :B5 endotoxin. 1456

In summary, water used to prepare dialysate and to reprocess hemodialyzers should not contain a total microbial count >200 CFU/mL as determined by assay on TSA agar for 48 hrs. at 96.8°F (36°C), and ::;2 endotoxin units (EU) per mL. The dialysate at the end of a dialysis treatment should not contain >2,000 CFU/mL.'1· ''· '"· '"· '"

3. Water Sampling Strategies and Culture Techniques for Detecting Legionellae

Legion ella spp. are ubiquitous and can be isolated from 20%-40% of freshwater environments, including man-made water systems. 1457· 1458 In health-care facilities, where legionellae in potable water rarely result in disease among immunocompromised patients, courses of remedial action are unclear.

Scheduled microbiologic monitoring for legionellae remains controversial because the presence of legionellae is not necessarily evidence of a potential for causing disease. 1459 CDC recommends aggressive disinfection measures for cleaning and maintaining devices known to transmit legionellae, but does not recommend regularly scheduled microbiologic assays for the bacteria. 396 However, scheduled monitoring of potable water within a hospital might be considered in certain settings where persons are highly susceptible to illness and mortality from Legionella infection (e.g., hematopoietic stem cell transplantation units and solid organ transplant units).' Also, after an outbreak of 224

legionellosis, health officials agree monitoring is necessary to identity the source and to evaluate the efficacy ofbiocides or other prevention measures.

Examination of water samples is the most efficient microbiologic method for identifYing sources of legionellae and is an integral part of an epidemiologic investigation into health-care-associated Legionnaires disease. Because of the diversity of plumbing and HVAC systems in health-care facilities, the number and types of sites to be tested must be determined before collection of water samples. One environmental sampling protocol that addresses sampling site selection in hospitals might serve as a prototype for sampling in other institutions. 1209 Any water source that might be aerosolized should be considered a potential source for transmission of legionellae. The bacteria are rarely found in municipal water supplies and tend to colonize plumbing systems and point-of-use devices. To colonize, legionellae usually require a temperature range of 7TF-l 08°F (25°C-42.2°C) and are most commonly located in hot water systems. 1460 Legionellae do not smvive dtying. Therefore, air-conditioning equipment condensate, which frequently evaporates, is not a likely source. 1461

Water samples and swabs from point-of-use devices or system surfaces should be collected when sampling for legionellae (Box C.1). 1437 Swabs of system surfaces allow sampling ofbiofilms, which fi·equently contain legionellae. When culturing faucet aerators and shower heads, swabs of surface areas should be collected first; water samples are collected after aerators or shower heads are removed from their pipes. Collection and culture techniques are outlined (Box C.2). Swabs can be streaked directly onto buffered charcoal yeast extract agar (BCYE) plates if the pates are available at the collection site. If the swabs and water samples must be transported back to a Iaboratoty for processing, immersing individual swabs in sample water minimizes dtying during transit. Place swabs and water samples in insulated coolers to protect specimens from temperature extremes.

Box C.l. Potential sampling sites for Legionella spp. in health-care facilities*

• Potable water systems incoming water main, water softener unit, holding tanks, cisterns, water heater tanks (at the inflows and outflows)

• Potable water outlets, especially those in or near patient rooms faucets or taps, showers

Cooling towers and evaporative condensers makeup water (e.g., added to replace water lost because of evaporation, drift, or leakage), basin (i.e., area under the tower for collection of cooled water), sump (i.e., section of basin from which cooled water returns to heat source), heat sources (e.g., chillers)

• Humidtiers (e.g., nebullizers) bubblers for oxygen, water used for respirat01y therapy equipment

Other sources decorative fountains, irrigation equipment, fire sprinkler system (if recently used), whirlpools, spas

* Material in this box is adapted from reference 1209. 225

Box C.2. Procedures for collecting and processing environmental specimens for Legionella spp. *

1. Collect water (!-liter samples, if possible) in sterile, screw-top bottles. 2. Collect culture swabs ofintemal surfaces of faucets, aerators, and shower heads in a sterile, screw-top container (e.g., 50 mL plastic centrifuge tube). Submerge each swab in 5--10 mL of sample water taken from the same device from which the sample was obtained. 3, Transport samples and process in a laboratory proficient at culturing water specimens for Legionella spp. as soon as possible after collection.+ 4, Test samples for the presence of Legionella spp. by using semiselective culture media using procedures specific to the cultivation and detection of Legionella spp.§1!

* Matel"ial in this table is compiled from references1209, 1437, 1462-1465. + Samples may be tnmspo11ed at room temperature but must be protected from temperature extremes. Samples not processed within 24 hours of collection should be refrigerated, § Detection of Legionella spp. antigen by the direct fluorescent antibody technique is not suitable for environmental samples. ~ Use of polymerase chain reaction for identification of Legionella spp. is not recommended until more data regading the sensitivity and specificity of this procedure are available.

4. Procedure for Cleaning Cooling Towers and Related Equipment

I. Perform these steps prior to chemical disinfection and mechanical cleaning. A. Provide protective equipment to workers who perform the disinfection, to prevent their exposure to chemicals used for disinfection and aerosolized water containing Legionella spp. Protective equipment may include full-length protective clothing, boots, gloves, goggles, and a full- or half-face mask that combines a HEPA filter and chemical cartridges to protect against airborne chlorine levels of up to 10 mg/L. B. Shut off cooling tower. 1. Shut off the heat source, if possible. 2. Shut off fans, if present, on the cooling tower/evaporative condenser (CTIEC). 3. Shut off the system blowdown (i.e., purge) valve. 4. Shut off the automated blowdown controller, if present, and set the system controller to manual. 5. Keep make-up water valves open. 6. Close building air-intake vents within at least 30 meters of the CT/EC until after the cleaning procedure is complete. 7. Continue operating pumps for water circulation through the CT/EC.

II. Perform these chemical disinfection procedures. A. Add fast-release, chlorine-containing disinfectant in pellet, granular, or liquid form, and follow safety instructions on the product label. Use EPA-registered products, if available. Examples of disinfectants include sodium hypochlorite (NaOCI) or calcium hypochlorite (Ca[OCI]z), calculated to achieve initial free residual chlorine (FRC) of 50 mg/L: either a) 3.0 lbs [1.4 kg] industrial grade NaOCI [12%--15% available Cl] per 1,000 gallons ofCTIEC water; b) 10.5lbs [4.8 kg] domestic grade NaOCI [3o/o--5% available Cl] per 1,000 gallons ofCT/EC water; or c) 226

0.6 lb [0.3 kg] Ca[OClh per 1,000 gallons ofCT/EC water. If significant biodeposits are present, additional chlorine may be required. If the volume of water in the CT/EC is unknown, it can be estimated (in gallons) by multiplying either the recirculation rate in gallons per minute by I 0 or the refrigeration capacity in tons by 30. Other appropriate compounds may be suggested by a water-treatment specialist. B. Record the type and quality of all chemicals used for disinfection, the exact time the chemicals were added to the system, and the time and results ofFRC and pH measurements. C. Add dispersant simultaneously with or within 15 minutes of adding disinfectant. The dispersant is best added by first dissolving it in water and adding the solution to a turbulent zone in the water system. Automatic-dishwasher compounds are examples of low- or non foaming, silicate- based dispersants. Dispersants are added at I 0--25 Jbs (4.5-11.25 kg) per I ,000 gallons of CT/EC water. D. After adding disinfectant and dispersant, continue circulating the water through the system. Monitor the FRC by using an FRC-measuring device with the DPD method (e.g., a swimming- pool test kit), and measure the pH with a pH meter every 15 minutes for 2 hours. Add chlorine as needed to maintain the FRC at_::: I 0 mg/L. Because the biocidal effect of chlorine is reduced at a higher pH, adjust the pH to 7.5-8.0. The pH may be lowered by using any acid (e.g., nuriatic acid or sulfuric acid used for maintenance of swimming pools) that is compatible with the treatment chemicals. E. Two hours after adding disinfectant and dispersant or after the FRC level is stable at_::: I 0 mg!L, monitor at 2-hour intervals and maintain the FRC at_:::IO mg!L for 24 hours. F. After the FRC level has been maintained at_::: I 0 mg!L for 24 hours, drain the system. CT/EC water may be drained safely into the sanita1y sewer. Municipal water and sewerage authorities should be contacted regarding local regulations. If a sanitary sewer is not available, consult local or state authorities (e.g., a department of natural resou1·ces or environmental protection) regarding disposal of water. If necessary, the drain-off may be dechlorinated by dissipation or chemical neutralization with sodium bisulfite. G. Refill the system with water and repeat the procedure outline in steps 2-7 in I-B above.

III. Perform mechanical cleaning. A. After water from the second chemical disinfection has been drained, shut down the CT/EC. B. Inspect all water-contact areas for sediment, sludge, and scale. Using brushes and/or a low- pressure water hose, thoroughly clean all CT/EC water-contact areas, including the basin, sump, fill, spray nozzles, and fittings. Replace components as needed. C. If possible, clean CT/EC water-contact areas within the chilJers.

IV. Perform these procedures after mechanical cleaning. A. FilJ the system with water and add chlorine to achieve an FRC level of I 0 mg!L. B. Circulate the water for I hour, then open the blowdown valve and flush the entire system until the water is free of turbidity. C. Drain the system. D. Open any air-intake vents that were closed before cleaning. E. FilJ the system with water. The CT/EC may be put back into service using an effective water- treatment program. 227

5. Maintenance Procedures Used to Decrease Survival and Multiplications of Legionella spp. in Potable-Water Distribution Systems Wherever allowable by state code, provide water at 2: I 24 op (2:5 I oq at all points in the heated water system, including the taps. This requires that water in calorifiers (e.g., water heaters) be maintained at 2:I40°F (2:60°C). In the United Kingdom, where maintenance of water temperatures at?:l22°F (2:50°C) in hospitals has been mandated, installation of blending or mixing valves at or near taps to reduce the water temperature to _:Sl 09.4°F (S63°C) has been recommended in certain settings to reduce the risk for scald injury to patients, visitors, and health care workers. 726 However, Legionella spp. can multiply even in short segments of pipe containing water at this temperature. Increasing the flow rate from the hot-water-circulation system may help lessen the likelihood of water stagnation and cooling.'"· 1465 Insulation of plumbing to ensure delive1y of cold (<68°F [<20°C]) water to water heaters (and to cold- water outlets) may diminish the opportunity for bacterial multiplication. 456 Both dead legs and capped spurs within the plumbing system provide areas of stagnation and cooling to

Continuous chlorination to maintain concentrations offi·ee residual chlorine at 1-2 mg/L (1-2 ppm) at the tap is an alternative option for treatment. This requires the placement of flow-adjusted, continuous injectors of chlorine throughout the water distribution system. Adverse effects of continuous chlorination can include accelerated corrosion of plumbing (resulting in system leaks) and production of potentially carcinogenic trihalomethanes. However, when levels offree residual chlorine are below 3 mg/L (3 ppm), trihalomethane levels are kept below the maximum safety level recommended by the EPA. n1. r46&, 1469 228

Appendix D. Insects and Microorganisms

Table D.l. Microorganisms isolated fromnrthropods in health-care settings Insect Microorganism cateO'Ol'Y ~iicl·ooreJtnisms ReferNlCPs GnmHtegntive bacteria Acinetobacter spp.; Citrobacterfi'eundil~· 1048, 1051, 1056, Entcrobocter spp., E. cloacae; Escherichia 1058. 1059. 1062 coli; Flavobacterium spp.,' Klebsiella spp.; Proteus spp.; Pseudomonas spp., P. aeruginosa, P.ftuorescens, P. pun"cla; Salmonella spp.; Serratia spp., S. marcesce11s; Shigella boydii Cockroaches Gnnn~positive bnctetia Bacillus spp.; Enterococcusfaccalis,· 1056, 1058, 1059 lvficrococcus spp.; Staphylococcus aurerw, S. epidermidis; Streptococcus spp., S. virldans Acid-fast bacteria Mycobacteriwn tuberculosis 1065 Fungi Aspergillus niger; Mucor spp.: Rhizopus 1052, 1059 >PD. Parasites: Endolimax nana; Entamoeba coli 1059 GranHleg:Mive bacteria Acinetobacter spp.; Campulobacterfetus 1047, 1048, 1050, ~ubsp. Jejuni; Chlamydia spp.; Citrobacter 1053-1055, 1060 ji-mmdii; Enterobacter spp.; Esclum'cltia coli; HehcobacUwpylOJ1; Klebsiella spp.; Proteus spp.; Pseudomonas aeruginosa,' Serratia marcescens · Shigella s1m. Houseflies Gmmvposith·e bacteria Bacillus spp.; Euterococcusfaecalis,- 1048. 1060 Micrococcus spp.; Staphylococcus spp. (congnl(lse-neg:ntive), S. am·eus; Streptococcus spp,, S. viridans Fungi I yen;ts Candida spp.; Geotriclmm spp. 1060 Parasites Endolimax naua,• Entamoeba coli 1060 Vimses Rotnviruses 1049 GranNtegatiYe bacteria Acinetobacter spp.; Esclwrichifl coli; 1057 Klebsiella spp.,· Neisseria sicca; Proteus ">pp.; Provideucia spp./ Pscudomo11as aeruginosa, P. jluorescens Ants. Grmu-positive bacteria Bacillus spp., B. cereus, B. pumilis; 1057 Clostridium cochlem1um, C welchii; Enterococcusfaecalis,· Staphylococcus spp. (coag:nlase--negntivc), S. aureus; Sn·eptococcus pyrogencs Gnun-negative bacteria Acinetobacter spp.,· Cittobacterfi'eundii; 1048 Enterobacteraerogenes; Morganella Spiders t/101'/!0tlti Gram-positive bacteria Stavh •lococcus spp. {congulase-negative) 104& Bl'am-negntive bacteria Acinetobacter spp.,- Burkholderia cepacia,· 1048 Ellterbacter agglomerans, E. aerogeues,- ~1ites, midges Ha[nia alvei,' Pseudomonas aer11mnosa Gram-positive bacteria Staphylococcus .<;.pp. (conguht'ie·ne_gntive) 1048 Gram·negative bncteria Acinetobacter calcoaceticus; Enteobacter 1048 cloacae ---·- !vlosquitoes -o;,;~;}:po<>itiw bacterin -E:nterococcu-;-s-p}}."; StCi})i~ylococcus ~ 'li!4& (coae:ulnse-negative) 229

Appendix E. Information Resonrces

The following sources of information may be helpful to the reader. Some of these are available at no charge, while others are available for purchase from the publisher.

Air andWater • Jensen PA, Schafer MP. Sampling and characterization ofbioaerosols. NIOSH Manual of Analytical Methods; revised 6/99. www.cdc.gov/niosh/nmam/pdfs/chapter-j.pdf • American Institutes of Architects. Guidelines for Design and Construction ofHospital and Health Care Facilities. Washington DC; American Institute of Architects Press; 200 I. AlA, 1735 New York Avenue, NW, Washington DC 20006. 1-800-AIA-3837 or (202) 626-7541 • ASHRAE. Standard 62, and Standard 12-2000. These documents may be purchased from: American Society of Heating, Refrigerating, and Air-Conditioning Engineers, Inc. 1791 Tullie Circle, NE, Atlanta GA 30329 1-800-527-4723 or (404) 636-8400. • University of Minnesota websites: www.dehs.umn.edu Indoor air quality site: www.dehs.umn.edu/resources.htm#indoor Water infiltration and use of the wet test (moisture) meter: www.dehs.umn.edu/remangi.html • The CDC website for bioterrorism information contains the interim intervention plan for smallpox. The plan discusses infection control issues both for home-based care and hospital- based patient management. www.bt.cdc.gov/agent/smallpox/response-plan/index.asp

Environmental Sampling • ISO. Sterilization of medical devices- microbiological methods, Part l. ISO standard 11737- 1. Paramus NJ; International Organization for Standardization; 1995.

Animals in Health-Care Facilities • Service animal information with respect to the Americans with Disabilities Act. Contact the U.S. Department ofJustice ADA Information Line at (800) 514-0301 (voice) or (800) 514-0383 (TDD), or visit the ADA website at: www.usdoj.gov/crt/ada/adahom l.htm

Regulated Medical Waste • U.S. Environmental Protection Agency. This is the Internet address on their Internet web site that will link to any state for information about medical waste rules and regulations at the state level: www.epa.gov/epaoswer/other/medical/stregs.htm

General Resources • APIC Text of!nfection Control and Epidemiology. Association for Professionals in Infection Control and Epidemiology, Inc. Washington DC; 2000. (Two binder volumes, or CD-ROM) • Abrutyn E, Goldmann DA, Scheckler WE. Saunders Infection Control Reference Service, 2"d Edition. Philadelphia PA; WB Saunders; 2000. • ECRI publications are available on a variety ofhealthcare topics. Contact ECRI at (610) 825- 6000. CRI, 5200 Butler Pike, Plymouth Meeting, PA 19462-1298. 230

Appendix F. Areas of Future Research Air Standardize the methodology and interpretation of microbiologic air sampling (e.g., determine action levels or minimum infectious dose for aspergillosis, and evaluate the significance of airborne bacteria and fungi in the surgical field and the impact on postoperative SSI). Develop new molecular typing methods to better define the epidemiology of health-care-associated outbreaks of aspergillosis and to associate isolates recovered from both clinical and environmental sources. Develop new methods for the diagnosis of aspergillosis that can lead reliably to early recognition of infection. Assess the value of laminar flow technology for surgeries other than for joint replacement surgery. Determine ifpatticulate sampling can be routinely performed in lieu of microbiologic sampling for purposes such as determining air quality of clean environments (e.g., operating rooms, HSCT units).

Water Evaluate new methods of water treatment, both in the facility and at the water utility (e.g., ozone, chlorine dioxide, copper/silver/monochloramine) and perform cost-benefit analyses of treatment in preventing health-care-associated legionellosis. Evaluate the role ofbiofilms in overall water quality and determine the impact of water treatments for the control of biofilm in distribution systems. Determine if the use of ultrapure fluids in dialysis is feasible and warranted, and determine the action level for the final bath. Develop quality assurance protocols and validated methods for sampling filtered rinse water used with AERs and determine acceptable microbiologic quality of AER rinse water.

Environmental Services Evaluate the innate resistance of microorganisms to the action of chemical germicides, and determine what, if any, linkage there may be between antibiotic resistance and resistance to disinfectants.

Laundry and Bedding Evaluate the microbial inactivation capabilities of new laundry detergents, bleach substitutes, other laund1y additives, and new laundry technologies.

Animals in Health-Care Facilities Conduct surveillance to monitor incidence of infections among patients in facilities that use animal programs, and conduct investigations to determine new infection control strategies to prevent these infections. Evaluate the epidemiologic impact of performing procedures on animals (e.g., surge1y or imaging) in human health-care facilities.

Regulated Medical Waste Determine the efficiency of current medical waste treatment technologies to inactivate emerging pathogens that may be present in medical waste (e.g., SARS-coV). Explore options to enable health-care facilities to reinstate the capacity to inactivate microbiological cultures and stocks on-site. 231

Index-Parts I and IV blood .. 12, 64, 69, 75, 77-79, 86, 87, 98, 99, 102, 113, 116 bloodborne pathogens ............................................. 73, 116 A boil water advisory ................................................... 51,52

AAMI standards ,................................. 59, 60, 62, 222, 223 Acinetobocter spp ............................ l1, 20, 43, 44. 99, 104 c aerators ................................ 47, 48, 94, 220--222,224, 225 aerosols ... l2, 27, 41, 47, 56, 59, 67, 75, 76, 78, 80, 85, 89, calibrated loop .............................................................. 222 90, 98, 106, Ill, 113, 114 carpet cleaning ................................................................ 79 AlA guidelines ............................. 17, 18, 19, 25, 37, 39, 99 carpet tiles ....................................................................... 79 All rooms ................................................................. 35--37 carpeting .................................................. 22, 25, 52, 78, 79 airchangesperhour(ACH) ....... 6, 12, 16, 18,31,111,210 cats ......................................................... l05, 106, 108, I 09 air conditioners ........................................................... 8, 22 chain of infection ........................................................ 4, 87 air conditioning systems ............................... 13, 20, 57, 59 chemical ge1micides ................................ 73, 74, 77, 80, 84 air filtration ................................................................... 111 chloramine/chloramine" T ............................................... 68 air intakes ............................................................... 31, 226 chlorine .................................... 46, 50, 53, 69, 84, 221, 226 air sampling ............................... 26, 29, 89, 90, 91, 93,210 chlorine bleach ........................................................ 78, 101 airbomc infection isolation (AU) ................................ 6, 19 chlorine residual ............................ 50, 68, 69, 94, 101,221 airbmne transmission ...................................................... 12 cleaning .. 68, 70--72, 74, 78, 80, 83, 85, 86, 107, 109, 112, air~ fluidized beds .......................................................... 104 225 alcohol" based hand rubs ................................................. 53 cleaning cloths ................................................................ 75 alkaline glutaraldehyde ................................................... 70 cleaning solutions ..................................................... 75, 76 allergens ............................................................ 17, 80, 107 Clostridium difjicile .................................................... 5, 84 American Institute of Architects (AlA) .......................... 13 cloth chairs ...................................................................... 79 Americans with Disabilities Act.. ......................... 108, 110 cockroaches .................................................................... 81 amplified stocks and cultures ................................ l 14, l 15 coliform bacteria ........................................................... 221 Animal Assisted Activities ................................... 106, l 07 colonization ...................... .42-44, 68, 70, 83, 99, 106,227 Animal Assisted Therapy ..................................... I 06, I 07 colony counts ................................................................ 211 anin1al bites ................................................................... 107 coinlnissioning .......................................................... 29, 89 anin1al handler .............................................................. 107 construction ..... 7, 13, 14, 21, 23, 26, 27, 29, 31, 37, 76,89 anilnal patient ............................................................... II 0 constmction workers ........................................... 24, 26,31 Animal Welfare Act., .................................................... 112 contact precautions ......................................................... 85 anterooms ................................................ 12, 25, 33, 3&--38 contact time ................................................ 74, 84, 88, 221 ants ................................................................................. 81 contaminants .......................................... l4, 18, 19, 59,210 ASHRAE ............................................................ 13, 47,49 contaminated fabrics ....................................... 98, 101, 102 aspergillosis ............................... ?, 8, 16, 19, 21, 35, 79,80 contingency plans ..................................................... 21, 50 Aspergillusfumigatus ............................................. 7, 8, 29 continuous chlorination ................................................ 227 Aspergillus spp .......................... 5, 7, 20, 21, 28, 32, 34,81 cooling tower .......................... .41, 53, 55, 57-59, 220, 225 auto1nated cyclers ........................................................... 65 copper/silver ions ............................................................ 54 automated endoscope reprocessor....................... 50, 69, 70 copper"8"quinolinolate .................................................... 35 autopsy suites/rooms ................................................. 12, 87 Creutzfeldt~Jakob disease ....................................... 86, 116 Cr;ptosporidium parvum ................................................ 46

B D bacterial spores ................................................... 73, 84, 89 bank offilters .................................................................. l4 dead legs ........................................................... 59, 64, 221 barrier ............................................................................. 34 decorative fountains .......................................... 47, 49, 224 barrier precautions/protection ......................... 74, 109, 116 demolition ..................................................... 23, 25, 26, 29 barriers ................................................................ 27, 31, 33 dental unit water lines ..................................................... 71 bassinets .......................................................................... 76 detergent/disinfectant.. .............................................. 74-76 biolilms .................................. 46, 54, 64, 71, 220--222, 224 dialysate .................................................................... 59-62 biosafety level ............................................................... 114 dialysis machines ............................................................ 64 bioteJTorism ............................................................ 89, 114 dialysis water ................................................................ 222 bird droppings ....................................................... 9, 20, 22 dialyzer., ......................................................................... 62 birthing tanks ............................................................ 67,69 dialyzer membranes ........................................................ 61 232

dialyzer reprocessing ...................................................... 59 floors ............................................................. 25, 75, 82, 83 dioctylphthalate (DOP) particle test.. .............................. 15 flowers ............................................................................ 80 direct contact. ....................... 6, 41, 67, 85, 86, 98, 108, 111 flush titnes ....................................................................... 51 direct threat ................................................................... 109 flutter strips ......................................................... 20, 34, 36 disinfectant fogging ........................................................ 75 fomites ................................................................ 3, 4, 7, 85 disinfectant residuals ...................................................... 96 Food and Dmg Administration (FDA) .............. 69, 73, 103 disinfectants ...................................................... 21, 76,225 free residual chlorine ................................ 51, 54, 225-227 disinfecting ........................ 71, 74, 80, 83, 85, 86, 112, 226 fungal spores ... 8, 15, 16, 19-21,26-28,31,34,38,79, 89, disinfection ................................................... 63, 64, 68, 70 93 dispersant ...................................................................... 226 fungi .................................................................................. 8 disposal (of medical waste) ........................................... ll3 furniture .............................................................. 52, 79, 82 distribution system .................................................. 94,221 dogs ...................................................... 105, 106, 108, 109 dl'ift eliminators ................... ,,,,,,,,,,,,,,,,,,,, ....................... 58 G drinking water ................................................................. 71 droplet nuclei .............................................. 6, 7, 10, 12, 89 gram-negative bacteria ... II, 41, 42, 48, 50, 60, 63, 64, 221 droplets ..................................................... 6, 55, 85, 86, 89 gram~positive bacteria ............................................... 11, 84 dry cleaning .................................................................. 102 drying .............................................................................. ll dual-duct system ............................................................. 20 duct cleaning ................................................................... 21 H ductwork ................................................................... 20, 22 dust .................................... &, 20, 24, 27, 30, 32, 74, 79, 93 hand hygiene ............................................. 25, 71, 107, 109 dust-spot test ................................................................... l5 hand transferral.. ........................ 3, 44, 65,82-84, 106,221 handwashing ......................................... 25, 80, 84, 99, 107 hantavhuses .................................................................... 12 E hematopoietic stem cell transplant .................................... 6 hemodiafiltration ............................................................. 62 hemodialysis ......................................... 59, 60, 62, 64, 223 education ........................................................................ 24 hemodialysis patients ........................................................ 7 electrical generators ........................................................ 53 hen1ofiltration ................................................................. 62 emergency ....................................................................... 53 HEPA filtration/ftlters ........ 6, 12, 14, 15, 17, 31, 32, 36,76 endotoxin .................................................... 60--62, 64, 223 hepatitis B vilus .................................................. 40, 73, 98 engineering controls ........................................................ 36 heterotrophic plate counts ............. 51, 62, 66, 95, 221-223 enteric viruses ................................................................. 85 high~ flux membranes ............................. ~ ........................ 61 environmental cultures .............................................. 83, 88 high-level disinfectants ..................................... ,............. 73 Environmental Protection Agency (EPA) .... 21,73-75,77, high-level disinfection ........................................ 60, 69, 72 103,227 high-temperature flushing ............................................... 50 environmental sampling ............................................ 88, 95 high~touch surfaces ............................................. 75,83-85 environmental surfaces ... 11, 44, 71, 72, 74, 82-86, 88, 98, holding tank .................................................................... 47 107 hospital disinfectant ........................................................ 73 environmental surveillance ....................................... 54, 55 hot water system ....................................................... 51, 54 EPA registration .................................................. 73, 76, 83 hot water tanks ................................................ 53, 220--222 EPA-registered gennicides ........................... 75, 78, 85, 86 hot \Vater temperature ..................................................... 49 evaporative condensers ....................................... 41, 57-59 housekeeping surfaces ........................ 3, 64, 72, 74-77, 83 exclusion (of a service animal) ..................................... 109 HSCT patients ............................................................. 6, 37 exotic anin1als ............................................................... 110 HSCT units ........................................... II, 26, 79, 80, 107 Hubbard tanks ................................................................. 68 human hcalth~care facilities .................................. 110, 111 F human immunodeficiency virus ...................................... 73 humidifiers .......................................................... 17, 23,41 fan-coil units .................................................................. 18 humidity ............................................ 13, 14, 17, 20, 38,90 faucets ......................................... .47, 54, 94,222,224, 225 HVAC systems ................ 13, 14, 16, 17, 19-21,27,30,51 fecal contamination ......................................................... 84 hydrotherapy equipment ........................................... 67-69 F!FRA ..................................................................... 75, 103 hydrotherapy pools ......................................................... 68 filter efficiency ......................................................... 27, 29 hydrotherapy tanks .............................................. 67, 68, 82 filtration .......................................................................... 15 hygienically-clean laundry .............................. 9&-1 00, 102 fire codes ........................................................................ 31 hyperchlorination .......................................... 50, 53, 54, 59 ftsh ........................................................................ I05, 108 fish tanks ....................................................................... l 08 flies ................................................................................. 81 flooding ........................................................................... 51 233

I,J M iatrogenic cases .............................................................. 87 manufacturer's instructions ........... 67, 69, 74, 86, 102, 116 ice machines and ice .................................... 25, 48, 65,66 material safety data sheets (MSDS) .......................... 75, 87 ice-storage chests ........................................................... 66 1nattress cover ......................................................... 77, 104 immunocompromised patients .... 6, 7, 9, 26,29-31,34,42, mattresses ........................~ ...................................... 77, 104 47, 56, 66, 80, 107, 108,223 medical equipment.. .................................................. 74, 83 impaction ................................................................ 90, 211 medical equipment surfaces ............................................ 72 ilnpactors .................................................................. 28, 93 medical gas piping .......................................................... 30 impingement ..................................................... 90, 93,211 medical records ............................. ,................................. 51 in1pingers .............. ,....................................................... 211 medicalwaste ............................................... 112, 113,117 inactivation studies ......................................................... 87 medical waste management .......................................... 112 incineration ........................................................... 113, 114 membrane filtration .................................... 70, 95, 96, 222 incubators (nursery) ........................................................ 76 methicillin-resistant Staphylococcus aureus (MRSA) ... 82, indirect trans1nission ......................................................... 6 83, 104, 105 indirect contact ............................................................... 41 microbial inactivation ..................................................... 72 indoor air ................................................. 21, 24, 26, 27,90 microbial resistance ........................................................ 70 industrial-grade HEPA filter, ........... ,,,,,,,,,,,,, 16, 31, 38,39 microbiologic air sampling ............................................. 27 infection-control risk assessment (ICRA) .... 26, 29, 31, 35, microbiologic cultures and stocks ................................. 112 108, Ill microbiologic sampling .................................................. 64 influenza viruses ............................................. 6, 12, 73, 85 microbiologic sampling of laundry ............................... l 02 innate resistance .................................................. 72, 73, 84 microbiological wastes ......................................... 112, 114 insects ....................................................................... 67,81 moisture ............... ,.......................... ,.. 20, 24, 32, 51, 70, 96 insulation material .......................................................... 20 1noisture tneters ........... ,................................................... 51 intermediate-level disinfectants ............... 73, 78, 83, 85, 86 molecular typing ............................................................. 28 intermediate-level disinfection ....................................... 72 monochloramine ............................................................. 54 isolation/isolation areas .................................... 11, 36, I 00 mop heads ....................................................................... 75 multidisciplinary team .............................................. 23, 91 JCAHO ......................................................... 13, 14, 51,59 municipal water ................................................ 47, 50, 224 municipal water systems/utilities ............................ 45, 221 Mycobacterium tuberculosis ..................... 5, 7, 10, 73, 114 L myiasis ............................................................................ 81

laboratories, 12, 13, 32, 47, 78, 79, 83, 105, Ill, 112, 114, 222 N laboratory confi1mation .................................................. 55 laminar airflow ................................................... 18, 34,38 negative airpressure ..... 6, 12, 18, 19, 21, 36, 99,100,104, laser plumes .................................................................... 40 Ill laundry ............................................................................ 49 neutralizer chemicals ...................................................... 96 laundry bags ............................................................ ,.... I 00 NIOSH ........... ,........ ,...................... ,, .......... ,, ................... 40 laundry chutes ............................................................... 100 nontuberculous mycobacteria (NTM).5, 41,44-46,60,63, laundry cycles ............................................................... 101 70, 71, 223 laundry disinfection ...................................................... 101 laundry facility ................................................................ 99 laundry packaging ................................................. 100, 10 l 0 laundry process ................................................. 98, 99, 102 laundl)' services .............................................................. 99 operating rooms ..... 13, 15, 17, 34, 38, 76, 82, 87, 109, 111 laundry transport. .................................................. 100, 101 opportunistic infections ................................................ 4, 5 Legionella pneumophi/a ....................................... 210, 221 organic matter ................................................................. 78 Legionella spp ... .41, 42, 50, 54-57, 59, 71, 222, 223, 225, OSHA ...................................... 13, 73, 77, 79, 98, 100, 113 227 outdoorair ............................................... 14, 15,18,25,91 legionellae ................................................. 41, 54, 211, 223 oxygen-based laundry detergents .................................. I 01 legionellosis ...................................................... 53-56, 224 Legionnaires disease ............................. .41, 47, 57, 58, 224 liquid chemical sterilant.. ................................................ 70 low-level disinfectants .................................. 72, 73, 83, 86 p low-level disinfection ...................... ,........................ 60, 64 pmiicle sampling ................................................. 27, 33, 89 performance measures ...................................................... 2 periodic culturing ............................................................ 57 peritoneal dialysis ..................................................... 64, 65 234

personal protective equipment ..... ??, 98, 99, 112, 114, 225 RODAC plates .............................................................. I 02 persons with disabilities ........................................ IO&, 109 rodents ............................................................................ 67 person~to~person transmission .................................. 12, 85 rooftops ........................................................................... 30 pest control ..................................................................... 82

~:~~~~~~~:::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::·i6~ s pipes .................................................. 64, 69,221,223,224 planktonic organisms .................................................... 221 Sabouraud dextrose agar ................................................. 96 plastic enclosures ............................................................ 31 sample/rinse methods .................... ,................................. 97 plastic wrapping .............................................................. 74 sanitary sewer ....................................................... 116, 117 Pneumocystis cm·inii ......................................................... 9 SARS .............................................................................. 86 pneumonia ................................................................ 42, 55 SARS-CoV ..................................................................... 86 point-of-use fixtures .......................................... 47,51 224 scalding ..................................................................... 49, 51 polyvinylchloridc (PVC) ........................................... 46, 64 screens ............................................................................ 82 pools ............................................................................... 67 scrub suits ................................................................. 98 99 positive air pressure .................................................. 18, 38 sealed windows ............................................. 19, 26, 29' 89 potable water................................................................. 220 sedimentation .................................................... 90, 93, 2tt potted plants ................................................................ 8, 80 select agents .......................................................... l 14, 115 pr~ssme differentials ............................... l8, 19, 25, 30,38 selfwclosing doors ............................................................ l9 pnmates ........................................................ 105, 106, Ill semicritical device .......................................................... 70 ~~:~~~~··~~;:t~i~~:::::::::::::::::::::::::::::::::::::::::::::::::::::::.~.~·. ~ ~~ service animal ............................................... I 05, I 08-110 settle plat~s ................................................. 28, 90, 93, 211 product Water ............................................................ 64, 70 sewage sp1lls ................................................................... 51 protective environment (PE) ............. 6, 18, 19, 34, 56, I 08 sharps containers ........................................................... 113 Pseudomonas aeruginosa .5, 11, 20, 42, 68, 70, 71, 73, 79, shock decontamination ................................................... 51 80, 96, I 04, 221 shower heads ................ 47, 49, 54, 220,221, 222, 224, 225 pseudo-~utbrea~<; ...................................................... 44, 70 pyrogenic reactions ................................................... 60,61 :~~~v;~·:i~~~ti·~~::::::::::::::::::::::::::::::::::::::::::::::::::::::::::.~.:.'. ;~ sJnallpox .......................................................................... 36

Q ::d~~~~~~~~:.:~~:·:::::::·::·:::: . : : : : : .:. : : : :.: : : ~~:·;.q~ quality assurance ................................................. 89, 94, 95 sodium hypochlorite 67, 69, 73, 77, 83, 84, 87, 88, 94, 225 solid-organ transplant program ....................................... 56 sorting (laundry) ..................................................... 98, 100 R Spaulding classification ............................................ 71, 98 spills .................................................................... 75, 77, 79 standard precautions ............................................. 100, lll R2A n1edia .................................................................... 222 standards .................................... 2, 14, 71, 88, 90,112,223 rank order ........................................................................ 27 Staphy/ococcusaureus ............... IO, 11, 38, 64, 73, 99, 104 ~:~:~~~::~:~~ ·~~~~·~·::::::::::::::: : : : : : : : : : : :::::::::::::::::.~.~. . !~ state codes/regulations .............................................. 55, 69 stemnjet ........................................................................ 101 recreational equipment .................................................... 69 steam sterilization (of medical waste) ................... 113, 114 reduced nutrient media .................................................... 94 sterile water..................................................................... 55 reducing agent. ................................................................ 94 storage tanks ............................................................. 63, 64 relative hu1nidity ............................................................. 17 streptococci ........................... ,................................... I 0, 38 reno:ation ..................................................... 13, 14, 23,37 supplemental treatment methods ............... ,..................... 53 repatrs ............................................................................. 31 surgical gowns and drapes ............................................ 103 reprocess hemodialyzers ......................................... 61, 223 surgical site infections (SSI) ............................... 11, 38, 65 research animals ............................................................ Ill surgical smoke ................................................................ 40 reservoirs ................... 3, 6, 41, 42, 71, 79, 83, 95, 105,211 surveillance ........................................... 26, 51, 57, 99,223 resident animals ............................................................ 107 swabs ............................................................................ 224 respirable particles .............................................. 27, 28, 90 respirators ................................................................. 26 40 respiratory protection ................................................ 36: 78 respiratmy syncytial virus (RSV) ......................... 6, 12, 85 T respiratory therapy equipment ...................................... 224 return air ..................... ,................................................... 14 tacky 1nats ....................................................................... 76 return temperature ........................................................... 54 tap wa~er ........................................... 42, 44, 57, 65, 66, 70 rev~r~e osmosis (RO) .............................. 52, 54, 59, 60, 63 TB patients ...................................................................... 38 l'e\VIr!Og .................................. ,............................... ,,,,,,.,, 25 temperature (air) ........................................... 13, 14, 17, 89 rinse water monitoring .................................................... 70 temperature (water) ................ 40, 45, 49, 68, 101,221,227 235

thermostatic mixing valves ................... , ......................... 49 viral hemon-hagic fever ................................................... l2 transport and storage (of medical waste) ...................... 113 viral particles .................................................................. 11 treated items/products ............................................. 79, 103 viruses ....................................................................... 11,85 tryptic soy agar ................................................. 94, 96, 222 visual rri.onitoring device ................................................. 34 tub liners ......................................................................... 68 volumetric air samplers ................................................... 29 tuberculocidal claim ....................................................... 73 volumetric sampling methods ......................................... 28 tuberculosis (TB) ............................................................ 35

w u wallboard .............................................................. 8, 22, 52 ultrapure dialysate.................................. ,,,,,,,,,,,,,,,,,,,,,,,,, 61 walls ............................................................................... 25 ultraviolet germicidal irradiation (UVGI) 14, 16, 17, 36, 38 washing machines and dryers ....................................... 102 unifonns .................................................................... 98, 99 water conditioning .......................................................... 68 water distribution systems .............................. 64, 221, 227 water droplets .................................................. ,.............. 58 v water pipes ...................................................................... 46 water pressure ................................................................. 50 water quality ............................................................. 71, 94 vacuu1n breakers ....................................................... 47,50 water sampling .......................................... 54, 94, 221, 224 vacuum cleaners ....................................................... 76, 79 water stagnation ............................................................ 227 vacuuming ...................................................................... 79 water treatn1ent system ................................................... 63 vancomycin~resistant enterococci (VRE) .. 3, 5, 82, 83, I 05 walerbome lransrnission ................................................. 46 vancomycin~ resistant Staphylococcus aureus (VRSA) ... 83 weight-arrestance test ..................................................... 15 variable air ventilation .............................................. 20, 38 wet cleaning .................................................................... 79 varicella~zostervims (VZV) ................................... 5, 7, 40 whirlpool spas ..................................................... 59, 67, 69 vase \Vater ...................................................................... 81 whirlpools ................................................................. 68, 69 vegetative bacteria .......................................................... 73 windoVl' chutes ................................................................ 33 ventilation rates .............................................................. 18 Windo\VS .................................................................... 22, 59 ventilation systems ............................................... 8, 9, 111 wood ................................................................. 8, 9, I 5, 35 viable pmticles ............................................................ 9, 91 APPENDIX- ''15'' Hospital eTool Page 1 of2

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Administration Central Supply Clinical Services i/ Dietary i) Emergency Engineering Healthcare Wideii Hazards Heliport Housel{eeping ICU laboratory laundry Pharm<1cy The OSH Act of 1970 strives to "assure safe and healthful working conditions" for today's workers, and mandates that employers provide a safe work environment for S~wgicalSuite I> employees. Hospitals and personal care facilities employ approximately 1.6 mllllon Expert Systems workers at 21,000 work sites. There are many occupational health and safety hazards throughout the hospital. This eTool* focuses on some of the hazards and controls found In the hospital setting, and describes standard requirements as well as recommended safe work practices for employee safety and health.

This eTool addresses the following areas: Administratl.Qll !CU Central Sooply laborato(Y QJ.oi.fa! S.?D!:!!:illi D!etarv Lill!lli1t:Y. Pharmacy Emergency S.i1!.9!!;';9.l.~\!!!J!. f;ngifleerlng liealthcare Wide Hazards .l::!_g!iQQJ! Other Healthcare Wtde Ha..~J.illi I:!Qlj~ekeep!D_g

How do I find out about employer responsibilities and worker rights? Workers have a right to a safe workplace. The law requires employers to provide their employees with working conditions that are free of known dangers. The OSHA law also prohibits employers from retaliating against employees for exercising their rights under the law {Including the right to raise a health and safety concern or report an Injury). For more Information see ~.wlli:=iJEJ~!.9.¥.!!~9QY or WL~eLri.Q.h.t$..

OSHA has a great deal of information to assist employers In complying with their l:f..1i.P.Qf1Jiil2l!!tiilli under the OSHA law.

OSHA can help answer questions or concerns from employers and workers. To reach your regional or area OSHA office, go to OSHA's B.e.olonal ~...1.\I~i! Offices webpage or calll-800-321-0SHA {6742),

Small business employers may contact OSHA's free and confidential g~ ~ll&!t&OMdY.i!;§. to help determine whether there are hazards at their worksltes and work with OSHA on correcting any Identified hazards, On~ s!te consultation services are separate from enforcement activities and do not result in penalties or citations. To contact OSHA's free consultation service, go to OSHA's ~.!.~Q.!l webpage or ca!ll~S00-321-0SHA (6742) and press number 4,

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Workers may file a complaint to have OSHA Inspect their workplace if they believe that their employer Is not following OSHA standards or that there are serious hazards. Employees can file a complaint with OSHA by calling 1-800-321-0SHA (6742), online via f'J'&mpliant Form or by printing the complaint form and mailing or faxing it to your local OSHA area office. Complaints that are signed by an employee are more likely to result In an Inspection.

If you think your job Is unsafe or you have questions, contact OSHA at 1-800-321-0SHA (6742). It's confidential. We can help. For other valuable worker protection Information, such as Workers' Rights, Employer Responsibll!ties, and other services OSHA offers, visit Q£:!8~~ page.

*eTools are "stand· a/one'~ interactive, Web-based training tools on occupational safety and health topics. They are highly illustrated and utilize graphical menus as well as expert system modules. These modules enable the user to answer questions, and receive reliable advice on how OSHA regulations apply to their work site. As indicated ifl the disclaimer, eToo!s do not create new OSHA requirements.

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Healthcare Wide Hazards Slips, Trips and Falls Hospital eTool Hazard

jEnlpi''Y''e exposure to wet floors or spills and clutter that to slips/trips/falls and other possible Injuries. Administration Solutions Central Supply Clinical Services\/ Keep floors clean and dry [£'i.SFR 19illJ2{a)_(2J]. In addition to being a slip hazard, continually wet surfaces Dietary ~~ promote the growth of mold, fungi, and bacteria, that can Emergency cause infections. Engineering Provide warning signs for wet floor areas [2.9JFR 1910.14S

Ensure spills are reported and cleaned up Immediately,

Use no-skid waxes and surfaces coated with grit to create non-slip surfaces In slippery areas such as toilet and shower areas.

Use waterproof footgear to decrease sUp/fall hazards.

Use only properly maintained ladders to reach items. Do not use stools, chairs, or boxes as substitutes for ladders.

Re-lay or stretch carpets that bulge or have become bunched to prevent tripping hazards.

Aisles and passageways should be sufficiently wide for easy movement and should be kept dear at aU times. Temporary electrical cords that cross aisles should be taped or anchored to the floor.

El!mlnate cluttered or obstructed work areas.

Nurses station countertops or medication carts should be free of sharp, square corners.

Use prudent housekeeping procedures such as cleaning only one side of a passageway at a time, and provide good lighting for all halls and stairwells, to help reduce accidents.

Provide adequate lfghtlng especially during night hours. You can use flashlights or low-level lighting when entering patient rooms.

Instruct workers to use the handrail on stairs, to avoid undue speed, and to maintain an unobstructed view of the stairs ahead of them even If that means requesting help to manage a bulky load.

Eliminate uneven floor surfaces.

Promote safe work In cramped working spaces, Avoid awkward positions, and """''""'m''"' I that makes lifts less awkward.

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Additional Information: Walking/Working Surfaces OSHA Safety and Health Topics Page.

2.2...C.EB.J.2J0.27_,. General Requirements (Walking/Working Surfaces). OSHA Standard. :i,mall Busln(;:~J:@.ill!D_QQf. OSHA Publication 2209-02R, (2005), Also available as a 260 KB EO£, 56 pages. Walkways Floor and Wall OnrJ.liJJ.gli Stairs and S!i>i!YI.i!}§ Elevated Surfaces

Accessibility Assistance: Contact the OSHA Directorate of Technical Support and Emergency Management at (202) 693-2300 for assistance accessing PDF me~telials.

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Administration Central SuJ,PIY Clinit:::nl services t/ Dietary l/ Emergency Engineerin9 Henlthcare Wide!~ Hazards Heliport Housekeeping ICU Common safety and health topics: Laboratory Laundry f,Qiltll.fTI.lrmt~~LWrk E.oyJm.omq_[!J;?. Shi![J'J.JijlJlQ..Qillta!Dm:~ Appropriate Disinfectants Hazardous Chemicals Pharmacy ~m!nate..r.LG!JJ.!inment ! atex Allemy Surgia~l Suite f> ~llil!!i.d.l.aundry Sl.!m>LD:in.sLFalls Expert Systems

Virtual Re!!l!.tY. Review the hazards and then tour the virtual reality room.

Contaminated Work Environments

Potential Hazard

Exposure of housekeeping staff to blood or Other Potentially Infectious Materials (OPIM) through contaminated work environments. OPIM Is defined in 29 CFR 1901.1030 (Ill.

Possible Solutions

OSHA requires:

Clean and sanitary work environments to prevent contact with blood or OPIM. Bloodborne Pathogens Standard (29 CFR 1910.1030(d)(4)fi)],

The employer must:

Determine and Implement an appropriate written schedule for cleaning and methods of decontamination.

This written schedule must be based on the:

Location within the facility,

Type of surfaces to be cleaned.

Type of soU present.

The tasks or procedures to be performed In the area. Back to Too

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Appropriate Disinfectants

The CDC states that hepatitis B virus can survive for at least one week In dried blood on environmental surfaces or contaminated needles and instruments.

Potential Hazard

Exposure of housekeeping staff to blood or OPIM by not using an appropriate or approved disinfectant.

Possible Solutions

Who determines which disinfectants are appropriate?

Appropriate or approved disinfectants are determined by the EPA (US Environmental Protection Agency), which oversees the registration of anti-microbial products. A llst maintained by the Office of Pestk!ct?. Prom~ provides the most recent Information available from the EPA on registered anti-microbials.

What disinfectants does OSHA recommend? OSHA requires that work surfaces be cleaned with an "appropriate disinfectant." Appropriate disinfectants Include a diluted bleach solution and EPA-registered antimicrobial products such as tuberculocldes (list B), ster!lants (List A), products registered against HIV/HBV (list E), and Sterila..!ltiLt~llllli'&oflli1m1..t1 for equipment sterilization.

Fresh solutions of diluted household bleach made up every 24 hours are also considered appropriate for disinfection of environmental surfaces and for decontamination of sites. Contact time for bleach Is generally considered to be the time It takes the product to air dry.

NOTE: Products registered by the EPA as HIV effective are not necessarily effective against tuberculosis (tuberculocidal) or against the hepatitis B virus (HBV). Any of the above products are considered effective when used according to the manufacturer's Instructions, provided the surfaces have not become contaminated with agents or volumes of or concentrations of agents for which higher level disinfection is recommended.

It is Important to emphasize the EPA-approved label section titled "SPECIAL INSTRUCTIONS FOR CLEANING AND DECONTAMINATION AGAINST HIV-1 AND HBV Of SURFACES\OBJECfS SOILED WITI-1 BLOOD\BODY FLUIDS." On the labels that OSHA has seen, these Instructions require: 1) personal protection devices for the worker performing the task; 2) that all the blood must be cleaned thoroughly before applying the disinfectant; 3) that the disposal of the Infectious waste Is In accordance with federal, state, or local regulations; 4) that the disposal of the Infectious waste Is in accordance with federal, state, or local regulations; and 5) that the surface is left wet with the disinfectant for 30 seconds for HIV-1 and 10 minutes for HBV. OSHA would expect all such disinfectants to be used In accordance with their EPA- approved label instructions, Q.SHA Dltectlve CPL 02·02··069. Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens,

OSHA has commented on disinfectants In the following Interpretation letters and documents:

Disinfectants claiming efficacy against the Hepatllis 8 virus. (1997, Apr!! 1).

Ou!ck Reference Guide to HH~ Bloodborne Pathoqens Standard. OSHA.

Contaminated Equipment

Potential Hazard Employee exposure to blood or OPIM through contact with contaminated:

Equipment and working surfaces

Possible Solutions

OSHA requires:

Equipment and working surfaces:

All equipment and environmental and working surfaces shall be cleaned and decontaminated after contact with blood or other potentially infectious materials [22. CFR 1910.1030(dl{4){li)J,

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Contaminated equipment, such as IV poles, require labels or tags In accordance with .l.2..Q:.B 1910 103d(Q)..(l)CUU:i). The labels must also Identify which portions of the equipment are contaminated.

Some equipment, if grossly contaminated, must be cleaned with a soap and water solution prior to decontamination, as some anti-microbial products will not work in the presence of blood, which intetferes with the sterlllzlng process. Protective coverings:

Protective coverings, such as plastic wrap or aluminum foil, shall be removed and replaced as soon as possible, when they become overtly contaminated, or at the end of a work shift if they may have become contaminated during the shift [29 .Cf.:RJ.9.lllJ.QJ_Q(d).(1}(ll).(BJJ. Reusable Containers: All bins, pails, cans, and similar receptacles intended for reuse which have a reasonable likelihood for becoming contaminated with blood or other potentially Infectious material shall be inspected and decontaminated on a regularly scheduled basis and cleaned and decontaminated immediately or as soon as feasible upon visible contamination [29 frf/3 1910.1 03Q[Ql(1l(i!lliJ].

Glassware: Broken glassware which may be contaminated, must not be picked up directly with hands; use mechanical means, such as use a brush and dustpan, tongs or forceps [29 CFR 191 Q,jj),]lli

CEi For more Information, see Healthcare Wide Hazards- N~tf;1:d!g!f.ti~kLS1li'l.rP..UJti.Yrig~. Note: Some hea!thcare facilities who rent or lease medical equipment or devices from third parties or other Institutions need to be aware that these devices may not be properly cleaned, disinfected and/or sterilized prior to delivery to the health care facility.

Potential Infection Problem With t-1edlcal Devices Rented or Leased by Health Care Facil!t!es. FDA Safety Notice, (1997, April}. Outlines FDA recommendations to prevent this hazard. fl.ack to ToQ

contaminated Laundry

Potential Hazard Employee exposure to blood and other potentially infectious agents from handling contaminated laundry during rinsing In utility rooms. Some facilities allow employees to rinse contaminated laundry (I.e., laundry contaminated with blood or Other Potentially Infectious Materials (QPJM) or that might contain sharps, In dirty utility "hopper" rooms, Instead of simply containerizing It and then transporting It to the laundry.

Possible Solutions

The Bloodborne Pathogens Standard requires:

Bagging and handling of contaminated laundry, with a minimal amount of agitation, at the location where It was used [29 CFR 191Q.JQ}J}(Q)(.1}(!y)(Lill.

Contaminated laundry shall not be sorted or rinsed In the location of use [.2~LCFR 1"9_1Q,103Q (d)(4)Civ)fA)(1)], and must be transported to the laundry for decontamination In bags or containers labeled or color-coded in accordance with 29 CFR 1910 1030(glfll(f). When universal precautions are used in the handling of all soiled laundry alternative labeling or color-coding Is sufficient If It permits all employees to recognize the containers as requiring compliance with universal precautions.

other Recommended Good Practices:

Melt away bags for the bagging process. Melt away bags can be thrown directly Into washers without having to unload or remove contaminated laundry from bags.

Rinsing soiled laundry In utility rooms is acceptable, If it Is not contaminated with blood, OPIM, or does not contain sharps.

The ergonomic stressors that can occur with Hftlng, reaching, rinsing, and transporting wet heavy laundry must also be addressed. A lift or transfer device for the lifting of these materials Is recommended. To avoid punctures from Improperly discarded syringes/sharps, do not hold contaminated laundry bags dose to the body or squeeze when transporting.

illf1] For additional Information, see Healthcare Wide Hazards- lau@a.

Sharps and Containers

Potential Hazard

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Exposure of housekeeping staff to contaminated sharps and containers from:

!J!5,;k of training fn QIQIW:I~dpJes and r)Q9.L!l!i.rNlinfLP.lill1ims of health care workers

• Sharps that are not discarded promptly/properly and are left In bedding and accidentally sent to laundry. 1..m.Q.mper handling or disposal of shams containers

• Allowing containers to overfill, or transporting Incorrectly.

Possible Solutions

Implement work practice and engineering controls to help prevent exposure to sharps,

OSHA requires:

Sharps handling:

• Sharps must be properly disposed of Immediately or as soon as feasible into the appropriate containers [29 CFR 1910.10301dll41(!il){Alfl)], Handling sharps containers:

Contaminated sharps must be properly disposed of Immediately or as soon as feasible In containers that are closable, puncture resistant, leak-proof, [Z'i'LC£l.U.9..UL1Q3Q(d)L4llii.D.{Al (1)), and labeled with the biohazard symbol or color coded In accordance with [29 CFR 1910.1030(q)(l )(!)],

• Containers must be replaced routinely and not be allowed to overfill [~'LCffi mP~1mi!Wlt11!wl0JWJ.

Disposal of Sharps Containers:

Employees should be trained In proper handling/disposal of sharps and containers, such as:

When moving containers of contaminated sharps or Q~!.!lil~s.!fl.'?, from the area of use, the containers shaH be [.?JLQ.:B.J..nO..J.!llQLdl(1){illlliili.:m:

Closed immediately prior to removal or replacement to prevent spillage or protrusion of contents during handling, storage, transport, or shipping.

Placed in a secondary container, if leakage is possible. The secondary container must meet the requirements of J2.£I.B..J.2!.QJJ)J.Q(Q)H)(~)0)@.

Disposed of in accordance with EPA, state, territorial, and local regulations [29 CFR 1910.1 030< dll 4 lfliQf C)].

Reusable sharps containers: • Shall not be opened, emptied or cleaned manually or In any other manner that would expose employees to the risk of percutaneous Injury.

im'f( For additional Information, see Healthcare Wide Hazards- N.tl~_dJ.e.s.tl(;kf_SJmn>..lt ~.

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Hazardous Chemicals

Potential Hazard Exposure to hazardous cleaning chemicals found and used in the laundry or housekeeping process.

Soaps and detergents may cause allergic reactions and dermatitis.

Broken skin from soap or detergent Irritation may provide an avenue for Infection or Injury if exposed to chemical or biological hazards.

Mixing cleaning solutions that contain ammonia and chlorine w!ll form a deadly gas.

Possible Solutions

Implement a written program which meets the requirements of the Hazard Commu.ni!;illiQ.o.....S.tiH!!.iard (HCS) to provide for worker training, warning labels, and access to Material Safety Data Sheets (MSDS).

• The Hazard Communication Standard ensures employee awareness of the hazardous chemicals they are exposed to In the workplace.

Provide appropriate PPE: (e.g., gloves, goggles, splash aprons), when handling hazardous d!shwashlng detergents and chemicals [29 CFR 1910.132]. For more Information see H.~.aJ.t.b~-~.r.§...WJd.!il..HJg~.n.t~ ..:..PJ~!;.

Medical SeiVices and First Aid: Where the eyes or body of any person may be exposed to Injurious corrosive materials, suitable facilities for quick drenching or flushing of the

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eyes and body shall be provided within the work area for Immediate emergency use {.?2 CFR 1910.15Hc)],

fE'm For additional Information, see Healthcare Wide Hazards- Hazardous Chemicals,

Latex Allergy

Potential Hazard

Exposure to latex allergy from wearing latex gloves, during housekeeping processes.

Example Controls

Employers must provide appropriate gloves when exposure to blood or other potentially Infectious materials (OPIM) exists {JllEJU.QlQ,JQ}\1 Bloodborne Pathogens Standard].

• Alternatives shall be readily accessible to those employees who are allergic to the gloves normally provided [29 CFR 1910.1030(d)(3l{lj!)], Eliminate the unnecessary use of latex gloves when no risk of exposure to Blood or Otht>r Potft.QliQ!!Y. Infectious Matc>rjals (OPIM) exists.

!Ell,~ For additional Information, see HealthCare Wide Hazards- Latex Allergy.

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Slips/Trips/Falls

Potential Hazard

Exposure to wet floors, and possible slips, trips, and falls.

Possible Solutions

Maintain floors in a clean and, so far as possible, dry condition, and mats provided where practicable. Walking/Working Surfaces Standard [29 CFR 1910.22{a}(2U.

Provide warning signs for wet floor areas [.22._£FR l91JL145fclQ)].

Other Recommended Good Practices:

Implement a program to provide safe, immediate, dean-up of floor spills.

Housekeeping procedures such as only cleaning one side of a passageway at a t!me, providing good lighting for all halls and stairwells can help reduce accidents.

Instruct workers to use the handrail on stairs, to avoid undue speed, and to maintain an unobstructed view of the stairs ahead of them·even if that means requesting help to manage a bulky load.

Eliminate uneven floor surfaces.

l[JII For additional Information, see Healthcare Wide Hazards- Sllps/Trips!Falls. Back to Top

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U.S. Department of Labor ! Occupational Safety & Health Administration ! 200 Constitution Ave., NW, Washington, DC 20210 Telephone: 800-321·0SHA (6742) I TTY www.OSHA.gov

https://www.osha.gov/SLTC/etools/hospital/housekeeping/housekeeping.html 9/2/2015 APPENDIX- ''18'' Print Standard Page 1 of2 ' i Effc~tlve D~le: July 1, 201S I I Chapter: Environment of Care EC,01,01.01: The hospital plans activities to minimize risks in the environment of care. Note: One or more per9ons c::an be assJgned to manage risks associated with the management plans described in this standard. Rationale: Risks are Inherent In the environment because of the types of care provided and the equipment and materials that are necessary to provide that care. The best way to manage these risks Is through a systematic approach that involves the proactive evaluation of the harm that could occur. By Identifying one or more IndiVIduals to coordinate and manage risk assessment and reduction activities-and to Intervene when conditions Immediately threaten life and health-organizations can be more confident that they have minimized the potential for harm.

Risks In the environment Include safety and security for people, equipment1 and other material; the handling of hazardous materials and waste; the potential for fire; the use of medical equipment; and utility systems. High-level written management plans help the hospital manage risks. These plans are not the same as operational plans, but they do provide a framework for managing the environment of care. These plans should also address the scope and objectives of risk assessment and management, describe the responsibilities of Individuals or groups, and give time frames for specific activities Identified In the plan.

Note: It is not necessary to have a separate plan for each of the areas Identified In the standard; the plans may all be contained in a single document. Introduction: Not applicable Elements of Performance

1 Leaders identify an lndlvldual(s) to manage risk, coordinate risk reduction activities in the physical environment, collect deflcien<:y [ Information, and disseminate summaries of actions and results. Note: Deficiencies Include Injuries, problems, or use errors. EP Attributes New FSA CMS MOS CR DOC sc ESP i • Diagnostic Imaging A ESP-1 I I 2 Leaders Identify an lndlvldua!(s) to Intervene whenever environmental conditions immediately threaten life or health or threaten to damage equipment or buildings. EP Attributes New FSA CMS MOS CR DOC sc ESP I - Diagnostic Imaging A ESP-1

3 The hospital has a written plan for managing the following: The environmental safety of patients and everyone else who enters the hospital's facilities. {See also EC.04.01.01, fP 15} EP Attributes New FSA CMS MOS CR DOC sc ESP - Diagnostic Imaging §482.26(b) D A ESP-1 §482.41(0)

4 The hospital has a written plan for managing the following: The security of everyone who enters the hospital's facJI!t!es. (See also EC.04.Dl.01, EP 15) E;P Attributes

New FSA CMS MOS CR DOC sc ESP §482.13(c)(2) D A ESP-1

5 The hospital has a written plan for managing the following: Hazardous materials and waste. (See also EC.04.01.01, EP 15) EP Attributes New FSA CMS MOS CR DOC sc ESP - Diagnostic Imaging §482.26(b) D A ESP-1 §482.41(0)

6 The hospital has a written plan for managing the following: Fire safety. {See also EC.04.01.01 1 EP 15) I:P Attributes New FSA CMS MOS CR DOC sc ESP §482.41(a) D A ESP-1

https://e-dition.j crinc.com/Common!PopUps/PrintableStandardEP .aspx?s= 14851 &M=7 &r... 6/18/20 15 Print Standard Page 2 of2 l ' 7 'The hospital has a written plan for managing the following: Medical equipment. (See also EC.04.01.01, EP 15) EP Attributes New FSA CMS MOS CR DOC sc ESP - Diagnostic Imaging §482.4l(a) D A ESP-! §482.4l(C)(2)

8 The hospital has a written plan for managing the following: Utility systems. {See also EC.04,01.01, EP 15) EP Attributes New FSA CMS MOS CR DOC sc ESP - Diagnostic Imaging §482.4l(a) 0 A ESP-1 §482.4l(c)(2)

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,...~teJoint Commi~lon E·dhion Effec!lve Date: July 1, 201S I Chapter: Environment of Care J:C.02.01.01: The hospital manages safety and security risks. Rationale: Safety and security risks are present In most health care environments. These risks affect all Individuals In the organizatlon~patlents, visitors, and those who work in the hospital. It Is Important to Identify these risks In advance so that the hospital can prevent or effectively respond to Incidents. In some organizations, safety and security are treated as a single function, although In others they are treated as separate functions.

Safety risks may arise from the structure of the physical environment, from the performance of everyday tasks, or from situations beyond the hospital's control, such as the weather. Safety Incidents are most often accidental. On the other hand, security Incidents are often IntentionaL Security protects Individuals and property against harm or loss. Examples of security risks Include workplace violence, theft, infant abduction, and unrestricted access to medications. Security Incidents are caused by Individuals from either outside or inside the hospitaL Introduction: Not applicable Elements of Performance

1 The hospital identifies safety and security risks associated with the environment of care that could affect patients, staff, and other people coming to the hospital's facilities. (See also EC.04.01.01, EP 14) Note: Risks are Identified from Internal sources such as ongoing monitoring of the environment, results of root cause analyses, results of proactive risk assessments of high-risk processes, and from credible external sources such as Sentinel Event Alerts. EP Attributes sc I New FSA CMS MOS CR DOC ESP §482.13(c)(2) A §482.26(b) §482.41(a)

3 The hospital takes action to minimize or eliminate identified safety and security risks In the physical environment. EP Attributes New FSA CMS MOS CR DOC sc ESP - FSA Direct Impact EPs §482.13(c)(2) M & c §482. 26(b) §482.41(a)

5 The hospital maintains all grounds and equipment. EP Attributes New FSA CMS MOS CR DOC sc ESP §4B2.41(a) M c 7 The hospital Identifies Individuals entering its facilities. Note: The hospital determines Which of those individuals require identification and how to do so. EP Attributes New FSA CMS MOS CR DOC sc ESP §482.13(c)(2) c 8 The hospital controls access to and from areas it identifies as security sensitive. EP Attributes I New FSA CMS MOS CR DOC sc ESP - FSA Direct Impact EPs §4B2.13(c)(2) A §4B2.53(b)

9 The hospital has written procedures to follow In the event of a security Incident, including an Infant or pediatric abduction. EP Attributes New FSA CMS MOS CR DOC sc ESP §482.13(c)(2) D A ESP-1

10 When a security Incident occurs, the hospital follows Its !dent! fled procedures.

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EP Attributes New FSA CMS MOS CR DOC sc ESP §482.13(c)(2) A

11 The hospital responds to product notices and recalls. (See also MM.05.01.17, EPs 1-4) EP Attributes New FSA CMS MOS CR DOC sc ESP §482.25(b) c §482.41(a)

14 The hospital manages magnetic resonance Imaging (MRI) safety risks associated with the following; ~Patients who may experience ~:laustrophobla, anxiety, or emotional distress ~ Patientswho may reqUire urgent or emergent medical care ~ Patients with medical Implants, devices, or imbedded metallic foreign obje<:ts (such as shrapnel) - Ferromagnetic objects entering the MRI environment - Acoustic noise EP Attributes New FSA CMS MOS CR DOC sc ESP New A ESP-1

16 The h'ospltal manages magnetic resonance Imaging (MRI) safety risks by doing the following: ~ Restricting access of everyone not trained In MRl safety or .screened by staff trained In MRI safety from the scanner room and the area that Immediately precedes the entrance to the MRI scanner room. ~Making sure that these restricted areas are controlled by and under the direct supervision of staff trained In MRI safety. ~ Posting slgnage at the entrance to the MRI scanner room that conveys that potentially dangerous magnetic fields are present In the room. Slgnage should also Indicate that the magnet Is always on except In cases where the MRI system, by its design, can have Its magnetic field routinely turned on and off by the operator. EP Attributes New P"SA CMS MOS CR DOC sc ESP New A ESP-1

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