The agency shall adopt rules to implement this part, which rules must include, but are not limited to, the following:
(1) LICENSING; QUALIFICATIONS.—The agency shall provide for biennial licensure of all clinical laboratories meeting the requirements of this part and shall prescribe the qualifications necessary for such licensure.
(2) STANDARDS OF PERFORMANCE IN THE EXAMINATION OF SPECIMENS.—The agency shall prescribe:
(a) Overall standards of performance that comply with the federal Clinical Laboratory Improvement Amendments of 1988, and the federal rules adopted thereunder, for a comprehensive quality assurance program. The purpose of the quality assurance program is to monitor and evaluate the ongoing and overall quality of a laboratory’s total testing process.
(b) Standards of performance in the examination of specimens for clinical laboratory proficiency testing programs using external quality control procedures. As part of a clinical laboratory proficiency testing program, clinical laboratory personnel may be required to analyze test samples and report on the results of such analyses. The agency may accept proficiency testing reports of organizations approved by the agency if the agency finds that the standards of such organizations are equal to or exceed those of the agency. The agency shall establish, by rule, criteria for satisfactory performance for a clinical laboratory that participates in an approved proficiency testing program.
(3) SHIPMENT OF SPECIMENS.—The agency may prescribe requirements for collecting, transporting, handling, and storing specimens shipped by common carrier from clinical laboratories or collection stations. Each specimen must be sent to a laboratory for analysis as rapidly as possible, but no later than 12 hours after collection unless appropriate measures are taken to preserve the specimen, except that the 12-hour requirement does not apply to blood banks or to plasmapheresis centers in shipping samples. Specimens may be sent to any out-of-state clinical laboratory for examination if the laboratory holds a current license issued by the agency. When the specimen has been referred for examination to another laboratory, the report must include a clear statement that such findings were obtained in another laboratory and must specify its name and location.
(4) CONSTRUCTION OF CLINICAL LABORATORIES.—A clinical laboratory must comply with all applicable local, county, state, and federal standards for the construction, renovation, maintenance, and repair of clinical laboratories, including standards for plumbing, heating, lighting, ventilation, electrical services, and similar conditions which standards will ensure the conduct and operation of the laboratory in a manner that will protect the public health.
(5) SAFETY AND SANITARY CONDITIONS WITHIN A CLINICAL LABORATORY AND ITS SURROUNDINGS.—The agency shall establish standards relating to safety and sanitary conditions within a clinical laboratory and its surroundings, including standards for water supply; sewage; the handling of specimens; identification, segregation, and separation of biohazardous wastes as required by s. 381.0098; storage of chemicals; workspace; firesafety; and general measures that will protect the public health. The agency shall determine compliance by a clinical laboratory with the requirements of s. 381.0098 by verifying that the laboratory has obtained all required permits.
(6) EQUIPMENT.—The agency shall establish minimum standards for clinical laboratory equipment essential to its proper operation, its calibration, and its adequacy for testing procedures.
(7) POLICY AND PROCEDURE MANUAL.—The agency shall require that each clinical laboratory adopt and maintain a written policy and procedure manual that must address, but is not limited to:
(a) The performance of all analytical methods used by the clinical laboratory, including specimen collection and preservation.
(b) Instrument calibration.
(c) Quality control systems, measures, and remedial actions.
(d) Equipment performance evaluations.
(e) Test performance.
(f) Maintenance and filing of required records and reports.
(g) Channels of communication.
(h) Space, equipment, and supply requirements.
The policy and procedure manual must be readily available to laboratory personnel and must be followed by laboratory personnel.
(8) STANDARDS FOR PATIENT TEST MANAGEMENT.—The agency shall adopt rules that prescribe standards for patient test management, including requirements for record retention and patient test reporting.
(9) ALTERNATE-SITE TESTING.—The agency, in consultation with the Board of Clinical Laboratory Personnel, shall adopt, by rule, the criteria for alternate-site testing to be performed under the supervision of a clinical laboratory director. The elements to be addressed in the rule include, but are not limited to: a hospital internal needs assessment; a protocol of implementation including tests to be performed and who will perform the tests; criteria to be used in selecting the method of testing to be used for alternate-site testing; minimum training and education requirements for those who will perform alternate-site testing, such as documented training, licensure, certification, or other medical professional background not limited to laboratory professionals; documented inservice training as well as initial and ongoing competency validation; an appropriate internal and external quality control protocol; an internal mechanism for identifying and tracking alternate-site testing by the central laboratory; and recordkeeping requirements. Alternate-site testing locations must register when the clinical laboratory applies to renew its license. For purposes of this subsection, the term “alternate-site testing” means any laboratory testing done under the administrative control of a hospital, but performed out of the physical or administrative confines of the central laboratory.