Notice of Development of Rulemaking

AGENCY FOR HEALTH CARE ADMINISTRATION
Health Facility and Agency Licensing
RULE NO: RULE TITLE
59A-24.006: Drug Testing Laboratories
PURPOSE AND EFFECT: The Agency proposes to revise the rule on surveying forensic toxicology laboratories.
SUBJECT AREA TO BE ADDRESSED: The proposed changes to this rule would revise the frequency of on-site surveys of forensic toxicology laboratories that perform testing as part of the drug-free workplace program and permit acceptance of accreditation reports in lieu of some surveying.
SPECIFIC AUTHORITY: 112.0455(13)(a) FS.
LAW IMPLEMENTED: 112.0455(12), (13) FS.
IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE NOTICED IN THE NEXT AVAILABLE FLORIDA ADMINISTRATIVE WEEKLY.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Bill McCort, (850)487-0641

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:

59A-24.006 Drug Testing Laboratories.

(1) through (6) are not changed.

(7) Inspections. The agency or the representatives of the federal Department of Health and Human Services Federal Workplace Drug Testing Program shall conduct announced or unannounced inspections of the laboratory at any reasonable time for the purpose of determining compliance with this rule chapter. The right of entry and inspection shall also be extended to any collection sites under contract with the laboratory. Inspections shall document the overall quality of the laboratory setting for the purpose of licensure to conduct drug free workplace testing. Inspection reports shall also contain any requirements of the laboratory to correct deficiencies noted during the inspections.

(a) Prior to laboratory licensure and at least once twice a year after licensure, an on-site inspection of the laboratory shall be conducted.

(b) In order to be considered for licensure renewal, laboratories certified by the federal Department of Health and Human Services Federal Workplace Drug Testing Programs shall submit an one inspection report of the federal Department of Health and Human Services Federal Workplace Drug Testing Programs in lieu of one of the two required bi-annual inspections. This provision does not apply to laboratories applying for initial licensure. In addition, such laboratories certified by the federal Department of Health and Human Services Federal Workplace Drug Testing Programs shall:

1. Maintain a policy to conduct the testing of all specimens authorized under Section 112.0455, F.S., in the same manner as required for those drugs included under the Mandatory Guidelines for Federal Workplace Drug Testing Programs. This policy must be in writing and contained in the laboratory’s policy and procedure manual.

2. Submit to the agency all reports of such inspections, post inspection activities and reports including any corrective action taken by the laboratory within 45 days of the receipt of the initial evaluation report in the laboratory.

3. Request in writing that the inspection report be accepted in lieu of an on-site inspection by the agency.

(c) Laboratories that are accredited by a nationally recognized accreditation organization may submit an accreditation report and proof of non-provisional accreditation or reaccreditation for the current year in lieu of the annual on-site inspection.

(8) through (15) No change.

Rulemaking Specific Authority 112.0455(12)(c), (13)(a) FS. Law Implemented 112.0455(12), (13) FS. History–New 3-15-90, Amended 6-28-91, Formerly 10E-18.006, Amended 5-1-96, 12-5-96, 3-11-98, 3-29-00, ________.