The agency is proposing to amend the rule on the frequency of on-site surveys of forensic toxicology laboratories that perform testing as part of the drug-free workplace program.

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 is proposing to amend the rule on the frequency of on-site surveys of forensic toxicology laboratories that perform testing as part of the drug-free workplace program.
SUMMARY: The proposed rule revisions would revise the requirement for on-site surveys and permit the acceptance of accreditation reports in lieu of some surveys.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 112.0455(13)(a) FS.
LAW IMPLEMENTED: 112.0455(12), (13) FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:
DATE AND TIME: July 27, 2009, 1:30 p.m.
PLACE: Agency for Health Care Administration, 2727 Mahan Drive, Building 3, Conference Room C, Tallahassee, FL 32308
Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 5 days before the workshop/meeting by contacting: Kaylyn Boles, Bureau of Health Facility Regulation, 2727 Mahan Drive, MS #28A, Tallahassee, FL 32308, [phone]. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Bill McCort, Bureau of Health Facility Regulation, 2727 Mahan Drive, MS #28A, Tallahassee, FL 32308, [phone]

THE FULL TEXT OF THE PROPOSED RULE IS:

59A-24.006 Drug Testing Laboratories.

(1) through (6) No change.

(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,________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Bill McCort
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Secretary Holly Benson
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 5, 2009
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: March 20, 2009