Department of Health & Rehabilitative Services v. Tallahassee Memorial Regional Medical Center, Inc.

23 Fla. Supp. 2d 254
CourtState of Florida Division of Administrative Hearings
DecidedSeptember 17, 1986
DocketCase No. 85-3247
StatusPublished

This text of 23 Fla. Supp. 2d 254 (Department of Health & Rehabilitative Services v. Tallahassee Memorial Regional Medical Center, Inc.) is published on Counsel Stack Legal Research, covering State of Florida Division of Administrative Hearings primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Department of Health & Rehabilitative Services v. Tallahassee Memorial Regional Medical Center, Inc., 23 Fla. Supp. 2d 254 (Fla. Super. Ct. 1986).

Opinion

OPINION

DIANE A. GRUBBS, Hearing Officer.

RECOMMENDED ORDER

Pursuant to notice, a hearing was held in this cause on March 27, [255]*2551986, in Tallahassee, Florida, before Diane A. Grubbs, a hearing officer with the Division of Administrative Hearings.

ISSUES

Whether respondent was in violation of Section 43.201(6), Florida Statutes, and Rule 10D-41.33(2), Florida Administrative Code, by failing to observe certain quality control procedures and by failing to document actions taken as alleged in the Administrative Complaint.

BACKGROUND

By Administrative Complaint dated July 25, 1985, Petitioner alleged that respondent had violated Section 43.201(6), Florida Statutes and Rule 10D-41.33(2), Florida Administrative Code. The following specific violations were alleged:

(a) Respondent failed to observe quality control procedures, in that RIA background record did not contain acceptable limits.
(b) Respondent failed to provide documentation to show that the osmometer was calibrated each day of use.
(c) Respondent failed to include controls with each run of toxi lab determination.
(d) Respondent failed to observe quality control procedures, in that three levels of controls were not run on the first shift and a minimum of two (2) levels of controls were not run on each eight hour shift thereafter in the Blood Gas laboratory.
(e) Respondent failed to consistently document corrective action when control results were out of limits in the chemistry lab.
(f) Respondent failed to observe quality control procedures, in that tapes from the Quantum drift test were not retained for two (2) years.
(g) Respondent failed to observe quality control procedures in that the constant packing of the microhematocrit centrifuge, in the hematology lab, was not checked quarterly.
(h) Respondent failed to provide documentation to show that controls were included with factor assay.
(i) Respondent failed to insure that the actual results for the fibrometer timer and stopwatch were recorded.
(j) Respondent failed to insure that corrective action was consistently documented when control results were out of limits.
(k) Respondent failed to observe quality control procedures, in that [256]*256the constant packing of the microhematocrit centrifuge, [in] the family practice lab, was not checked quarterly.

On August 21, 1985, Tallahassee Memorial Regional Medical Center (TMRMC) petitioned for a formal administrative hearing alleging that the petitioner’s “own rule is vague and misleading and does not set a standard and, therefore, the [respondent] is not in violation of either the statute or the rule. ...” The Department referred the matter to the Division of Administrative Hearings for further proceedings.

At the hearing, the petitioner presented the testimony of Laura M. Phillips, a Biological Administrator with the HRS Office of Licensure and Certification; and Frances Bass, the HRS surveyor who inspected the TMRMC laboratory. The respondent presented the testimony of James Alan Parker, Laboratory Manager at TMRMC, and Dr. Benjamin M. Turner, a pathologist who is one of the medical directors for the TMRMC laboratory. Petitioner’s exhibits 1 through 10 and respondent’s exhibits number 1 were admitted into evidence.

Both parties timely filed proposed findings of fact and conclusions of law, and a ruling on each proposed finding of fact has been made in the appendix to this recommended order.

FINDINGS OF FACT

GENERAL BACKGROUND

STANDARDS APPLIED:

(1) In 1967, the Medicare program was established by the federal government. It provided for reimbursement to independent clinical laboratories for services furnished to Medicare patients. Standards for the clinical laboratories were set forth No. 5 (Code of Federal Regulations, Title 20, Chapter 3, Part 405), entitled Conditions for Coverage of Services of Independent Laboratories (henceforth Subpart M). Sub-part M was administered by the Health Care Financing Administration (HCFA). Also, in 1967, the Clinical Laboratories Improvement Act of 1967 (CLIA) was passed by the federal government which applied to laboratories engaged in interstate commerce, and a new Part 74 was added to the Public Health Services Regulations, Title 42, Code of Federal Regulations, which set forth the standards for these laboratories.

(2) In 1967, the Florida legislature completely revised the clinical laboratory law that had been in effect in Florida since 1949 by enacting the Florida Clinical Laboratory Law. Ms. Phillips testified that the purpose of the legislation was to parallel the federal requirements for clinical laboratories so that the same standards would apply to all [257]*257laboratories in Florida. Thus, Florida has applied federal standards in its state inspections since 1967.

(3) Rule 10D-41.33, Florida Administrative Code,1

contains language patterned after the language set forth in Subpart M in 1967.2

Thus, although the rule does not incorporate the federal standards by reference, HRS contends that clinical laboratories would be aware that federal standards would apply to state inspections due to the language used in the Rule.3

However, clinical laboratories in Florida were never specifically notified that federal standards would apply to state inspections and they were never sent federal regulations, standards or guidelines.

(4) TMRMC has been accredited by the Joint Commission on Accreditation of Hospitals (JCAH) since 1979. In 1978, the JCAH adopted the federal quality control standards. Therefore, JCAH accredited hospitals are not subject to federal inspection because, if they meet JCAH standards, they met federal standards. However, the JCAH inspects only once every three years.

HRS INSPECTIONS:

(5) HRS has a contract with the federal government to perform the inspections of clinical laboratories that are required under federal law. HRS also performs the inspections required by state law. HRS applies the same standards regardless of whether it is a state or federal inspection.

(6) Since 1983, state inspections of clinical laboratories have been required annually. However, due to a lack of personnel, annual inspections of every laboratory have not been possible.

When an inspection is done, the HRS surveyor has a checklist form to provide a guidelines for the inspection. The checklist form follows the requirements in the rules and policies put out by the federal government. After the inspection is concluded, the hospital is not provided with a copy of the checklist but is given a list of deficiencies [258]*258which are taken from the checklist. The inspector also informs the laboratory director of the deficiencies verbally at an exit conference.

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Related

Fla. Med. Center v. Dept. of H. & Rehab. Serv.
463 So. 2d 380 (District Court of Appeal of Florida, 1985)
Anheuser-Busch, Inc. v. Dept. of Business
393 So. 2d 1177 (District Court of Appeal of Florida, 1981)

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Bluebook (online)
23 Fla. Supp. 2d 254, Counsel Stack Legal Research, https://law.counselstack.com/opinion/department-of-health-rehabilitative-services-v-tallahassee-memorial-fladivadminhrg-1986.