§ 26.607 — Drug and alcohol testing.

§ 26.607 Drug and alcohol testing.

Licensees and other entities must perform drug and alcohol testing that complies with the following requirements—

(a) Split specimens. Split specimen collections of oral fluid or urine must be used for the test conditions described in paragraph (b) of this section. Testing of the split specimen (specimen B) requires the donor's permission unless ordered by the MRO to resolve an invalid test result obtained for specimen A.

(b) Test conditions. Individuals identified in § 26.4 must be subject to drug and alcohol testing under the following conditions:

(1) Pre-access. A pre-access test must be conducted for drugs and alcohol before performing or directing the conduct of roles and responsibilities making the individual subject to this subpart or being granted unescorted access to the protected areas of the NRC-licensed facility. A pre-access test must have been conducted no more than 14 days before the individual is granted unescorted access.

(2) Random. Random testing for drugs and alcohol must—

(i) Be administered in a manner that provides reasonable assurance that individuals are unable to predict the time periods during which specimens will be collected;

(ii) Require individuals who are selected for random testing to report to the onsite collection site as soon as reasonably practicable after notification, within the time period specified in the FFD program procedure;

(iii) Ensure that all individuals in the population that is subject to random testing on a given day have an equal probability of being selected and tested;

(iv) Ensure that an individual completing a test is immediately eligible for another random test; and

(v) Ensure that the sampling process used to select individuals for random testing provides that the number of random tests performed annually is equal to at least 50 percent of the population that is subject to the FFD program at the NRC-licensed site.

(vi) If the number of individuals subject to random testing at an NRC-licensed site is such that paragraph (b)(2)(v) of this section cannot be implemented without predictable outcomes, the licensee must use a consortium/third-party administrator to manage the random testing pool and make selections for testing throughout the year.

(3) For-cause. For-cause drug and alcohol tests must be conducted onsite in response to an individual's observed behavior or physical condition indicating possible substance abuse, as defined in § 26.5. A for-cause drug test, alcohol test, or both, must be conducted onsite after receiving credible information either that an individual is engaging in substance abuse or in response to a portal area screening test result under paragraph (j) of this section.

(4) Post-event. A post-event test for drugs and alcohol must be conducted—

(i) As soon as practical after an event involving a human error that was committed by an individual specified in § 26.4, where the human error may have caused or contributed to the event. This test must be conducted onsite unless the individual requires offsite medical care. The licensee or other entity must test the individual(s) who committed or directed the error and need not test individuals who were affected by the event and whose actions likely did not cause or contribute to the event. The licensee or other entity must describe in its procedures what constitutes a human error.

(ii) Within 4 hours of an event unless immediate medical intervention precludes the conduct of the test on the individual(s) who caused or contributed to the accident(s), if the event results in—

(A) An illness or personal injury to any individual which results in death, days away from work, restricted work, transfer to another job, medical treatment beyond first aid, loss of consciousness, or other significant illness or injury, as diagnosed by a licensee- or other entity-designated physician or other licensed health care professional, even if the illness or injury does not result in death, days away from work, restricted work or job transfer, medical treatment beyond first aid, or loss of consciousness; or

(B) Damage to any safety- or security-related structures, systems, and components; and

(5) Follow-up. An individual subject to this part who has violated the FFD policy for substance use or abuse, or the sale, use, or possession of illegal drugs must be subject to a follow-up series of tests for drugs, alcohol, or both to verify an individual's continued abstinence from substance abuse.

(c) Urine and oral fluid specimens. (1) All urine or oral fluid specimens must be tested for the substances listed in § 26.31(d)(1), except as allowed by § 26.603(e)(3). All urine specimens must be subject to validity testing as specified in either this part or the HHS Guidelines. All oral fluid specimens may be subject to validity testing, including a biological marker, as specified in either this part or the HHS Guidelines.

(2) For the use of urine as the biological specimen to be tested, the following requirements must be implemented—

(i) Section 26.115, for collecting a urine specimen under direct observation;

(ii) Section 26.119, for determining “shy” bladder; and

(iii) Section 26.163, for cutoff levels for drugs and drug metabolites.

(3) For alcohol testing onsite, the following requirements must be implemented—

(i) Section 26.91, for acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use;

(ii) Section 26.93, for preparing for alcohol testing;

(iii) Section 26.95, for conducting an initial test for alcohol using a breath specimen;

(iv) Section 26.97, for collecting oral fluid specimens for alcohol and drug testing;

(v) Section 26.99, for determining the need for a confirmatory test for alcohol;

(vi) Section 26.101, for conducting a confirmatory test for alcohol; and,

(vii) Section 26.103, for determining a confirmed positive test result for alcohol.

(4) For all test conditions in paragraph (b) of this section and for MRO-directed tests under § 26.185, drug testing must be performed at an HHS-certified laboratory for the specific biological specimen to be tested. Only HHS-certified laboratory test results from urine and oral fluid specimens may be used for the issuance of a sanction required under this part. The licensee or other entity must establish and maintain a contract with a primary and a back-up HHS-certified laboratory (with a different Certifying Scientist) for the specimen(s) to be tested. These contracts must stipulate that the laboratories are subject to inspection or audit by the licensee or other entity and that records and documents must be provided and/or able to be photocopied and removed from the premises to support the inspection or audit.

(d) Privacy and integrity. The specimen collection and drug and alcohol testing procedures of FFD programs must protect the donor's privacy and the integrity of the specimen and implement quality controls to ensure that test results are valid and attributable to the correct individual.

(e) Offsite collection facilities. At the licensee's or other entity's discretion, except for those specimens that must be collected onsite under paragraphs (b)(3) and (4) of this section, specimen collections and alcohol testing may be conducted at a local hospital or other facility licensed to conduct specimen collections and perform alcohol testing and audited by the State or a State-designated entity. The licensee or other entity must audit these facilities, if used, before their initial use and then on a biennial basis to confirm that the facility procedures are comparable to those described in subpart E of this part or the HHS Guidelines for urine and oral fluid.

(f) Initial testing. A licensee or other entity subject to this subpart performing an initial test must use an immunoassay, or an alternative technology as specified in the HHS Guidelines for the specific biological specimen that is to be tested. Specimens that yield positive, positive and dilute, adulterated, substituted, or invalid initial validity or drug test results or discrepant biological markers must be subject to confirmatory testing by an HHS-certified laboratory, certified for that biological specimen, except for invalid specimens that cannot be tested.

(g) Oral fluid testing. (1) If the licensee or other entity elects to use oral fluid for drug or alcohol testing, the collection, packaging, temporary storage, and shipment of an oral fluid specimen to an HHS-certified laboratory for drug testing, or the collection of an oral fluid specimen for alcohol testing must be performed in accordance with licensee- or other entity-established procedures based either on the requirements in this part or the procedures in HHS Guidelines identified by the licensee or other entity in § 26.606(b)(1)(iv). The oral fluid device must not expire before the date of the collection of the specimen for testing. The drugs, drug metabolites, initial and confirmatory testing cutoffs, and biological markers, if applicable, must be those established by the HHS Guidelines for oral fluid testing and the alcohol cutoffs in this part or, if not established by the HHS Guidelines or this part for the panel of drugs and drug metabolites to be tested, as determined and documented by a forensic toxicologist review conducted pursuant to § 26.31(d)(1)(i)(D).

(2) The virtual collection of oral fluid specimens for drug and alcohol testing is only permitted for sites that must use a C/TPA to implement random testing under paragraph (b)(2)(vi) of this section. For a licensee or other entity to utilize a virtual oral fluid specimen collection process, the following must apply or should be considered, as applicable:

(i) The specimen collector completing the virtual collection must meet the requirements in § 26.85.

(ii) The oral fluid specimen collection process must be completed as described under §§ 26.97 and 26.99.

(iii) An individual other than the donor (i.e., a virtual collection monitor) may be needed in the location where the specimen collection is to be performed to assist the virtual collector in completing activities, performing observations, or both.

(iv) If a virtual collection monitor is used to assist the specimen collector in completing an oral fluid specimen collection, then the virtual specimen collector must explain the collection process to the monitor and provide instruction to the monitor on required activities to be performed during the collection process. The monitor's name must be recorded on the Federal custody and control form (Federal CCF) for drug testing specimens, or an analogous document for alcohol testing.

(v) Video teleconference communication method(s) must provide sufficient visual and aural clarity to complete the process and ensure that a donor is not able to subvert the testing process.

(vi) Collection kit materials must be maintained in a secure fashion until the virtual collector initiates the virtual collection process with the donor.

(vii) The licensee or other entity's written FFD procedures must describe in detail the virtual collection process and when and how it is to be implemented.

(viii) The virtual collection procedure must address problem collections, such as the video teleconference becomes inoperable during the collection process or the donor is unable to provide an oral fluid specimen of sufficient quantity to complete the specimen collection process for drug or alcohol testing.

(ix) The virtual collection procedure must include steps to collect a breath specimen using an evidential breath testing device (EBT) if the oral fluid specimen test result under § 26.99(b) requires a confirmatory testing for alcohol under § 26.101. At a minimum, a donor with an oral fluid specimen test result requiring confirmatory testing for alcohol must be removed from duty pending additional testing.

(h) [Reserved]

(i) Hair testing. The testing of hair specimens may only be used to inform a licensee's or other entity's determination of whether the individual is trustworthy and reliable under the test condition in paragraph (b)(1) of this section to supplement the information gained from a pre-access test using oral fluid or urine as the test specimen and must be conducted at an HHS-certified laboratory certified to test hair specimens.

(1) If used, this process must be described in the licensee's or other entity's FFD policy and described in detail in its procedure. The panel of drugs and drug metabolites to be evaluated must only include those listed as Schedule I or II of section 202 of the Controlled Substances Act [21 U.S.C. 812]. The collection, packaging, and temporary storage of a hair specimen and shipment of the specimen to an HHS-certified laboratory must be conducted in accordance with the HHS Guidelines. The licensee- or other entity-designated FFD program personnel must conduct the collection, packaging, temporary storage, shipping, and custody and control of the specimen.

(2) Before the licensee or other entity begins to conduct hair testing, the initial and confirmatory testing cutoffs must be the cutoffs established by the HHS Guidelines for hair testing or, if not established by the HHS Guidelines or this part, as determined by a forensic toxicologist review conducted pursuant to § 26.31(d)(1)(i)(D).

(3) Confirmed positive test results must be considered potentially disqualifying FFD information until proven otherwise by a review under § 26.613. Sanctions under this subpart must not be issued for any FFD policy violation involving a drug test using a hair specimen unless the licensee or other entity determines that the individual has attempted to subvert the testing process, as defined in § 26.5, for the hair test.

(j) Portal area screening. A non-invasive testing instrument may be used to screen individuals for drugs, drug metabolites, and alcohol before the individuals' entry into or exit from a protected or vital area.

(1) The instrument must be operated in accordance with the manufacturer's specifications. If screening detects the presence of any drug, drug metabolite, or alcohol at or above the instrument set point, the individual screened by the instrument must be subject to for-cause testing under paragraph (b)(3) of this section.

(2) Annually, the licensee or other entity must verify the accuracy of the portal area screening test for each substance with any positive results. If at least 85 percent of the positive portal area screening test results for a substance in the past 12 months do not subsequently confirm positive on for-cause testing performed under paragraph (j)(1) of this section, the licensee or other entity cannot continue to use the screening test for the particular substance until such time as corrective actions have been implemented to improve the testing accuracy.

(3) A sanction under this part may not be issued to an individual based solely on a portal area screening instrument detection that drugs or alcohol exceed the instrument's established setpoint.

(k) Blood testing. The testing of blood specimens may only be conducted under the order of the licensee- or other entity-designated MRO for a valid medical reason as confirmed by the MRO pursuant to § 26.31(d)(5). This specimen must be subject to testing by a laboratory that satisfies quality control requirements that are comparable to those required for certification by the HHS.

(l) Federal custody and control form. For the collection and packaging of urine, oral fluid, and hair specimens for drug testing, the licensee or other entity must use a Federal CCF.

(m) Medical Review Officer. Licensees or other entities must—

(1) Require their designated MRO to review positive, positive and dilute, adulterated, substituted, and invalid confirmatory drug and validity test results to determine whether the donor has violated the FFD policy. The review must be completed before reporting the results to the individual designated by the licensee or other entity to assess authorization or perform the suitability and fitness determinations required under § 26.619, or, if required, that are described in subpart H of this part.

(2) Require their MRO to satisfy the requirements in § 26.183 and, prior to conducting any activities under this part, attend and pass a medical- or clinical-based training session to improve his/her knowledge of MRO duties and responsibilities, drug and alcohol testing processes and procedures, and evaluation of drug testing results. This training session must be conducted by a nationally recognized MRO training and certification organization that has been assessed by the licensee's or other entity's FFD program personnel to include the technical elements an MRO must implement under § 26.185. An MRO who performed the duties and responsibilities in §§ 26.185 and 26.187 for at least 3 continuous years in the last 10 years prior to being hired or contracted by the licensee or other entity satisfies the requirements in this paragraph (m)(2).

(3) Require their MRO to attend a medical- or clinical-based training session at least every 5 years to improve his/her knowledge of changes in drug and alcohol testing processes and procedures and evaluation of drug testing results.

(4) Require their MRO to determine whether a biological specimen is positive, positive and dilute, adulterated, substituted, or invalid by implementing the requirements in § 26.185 or the HHS Guidelines through the licensee's or other entity's procedures.

(i) If § 26.185 or the HHS Guidelines, as used by the licensee or other entity in its procedures, are insufficient to make this determination, then guidance issued by a State agency in the State in which the NRC-licensed facility is located, Federal agencies, or nationally recognized MRO training and certification organizations may be used to inform an MRO determination.

(ii) An MRO need not review alcohol test results, including positive confirmatory alcohol test results determined by an EBT under paragraphs (c)(3)(vi) and (vii) of this section.

(5) Require their MRO to determine and approve the use of oral fluid or urine as an alternative biological specimen when the donor cannot provide a specimen for testing. This determination and the retest must be documented and completed as soon as reasonably practicable.

(6) Require the MRO to review all specimen test results associated with drug-related FFD policy violations. This review includes split specimens and all specimens taken to resolve a discrepant condition, such as a possible subversion attempt, impairment without a known cause, or a donor-requested or MRO-directed re-test. To resolve a discrepant condition, the MRO is authorized to test a specimen for a biological marker, adulterants, or additional drugs.

(n) Limitations of screening and testing. Specimens collected under NRC regulations may only be designated or approved for screening and testing as described in this part and may not be used to conduct any other analysis or test without the written permission of the donor. Analyses, screens, and tests that may not be conducted include, but are not limited to, DNA testing, serological typing, or any other medical or genetic test used for diagnostic or specimen identification purposes. No biological specimens may be passively sampled and analyzed in a manner different than described in this subpart.

(o) Specimen collectors. All onsite specimen collections, except a collection by a portal area screening instrument in paragraph (j) of this section, must be conducted by licensee- or other entity-designated and -trained personnel.