Laboratory, Radiology, and Respiratory Services  



    Health Facility and Agency Licensing


    59A-3.242Laboratory, Radiology, and Respiratory Services


    Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 45 No. 39, February 26, 2019 issue of the Florida Administrative Register.

    The following sections of the proposed rule will be changed to read:


    59A-3.242 Laboratory, Radiology, and Respiratory Services.

    (1) Clinical and Pathology Laboratory Services. Each hospital must provide on the premises, or by contract, clinical and pathology laboratory services commensurate with the hospital’s needs. The hospital laboratory, and any contracted laboratory providing services for hospital patients, must be certified by the Centers for Medicare and Medicaid Services under the federal Clinical Laboratory Improvement Amendments (CLIA) and the federal rules adopted thereunder in all specialties or subspecialties in which testing is performed. Hospitals may operate more than one CLIA certified laboratory. Each hospital laboratory shall have a qualified laboratory director. Qualifications for laboratory director, supervisor, technologist, and technician are found in Chapter 483, part II, F.S., and the rules adopted thereunder.

    (a) through (f) No change.

    (g) Alternate-site testing locations (alternate-sites) are hospital units or departments on the hospital premises that are located outside of the physical or administrative confines of the hospital’s central laboratory (hospital laboratory), but still under the administrative control of the hospital and under the supervision of the laboratory director. Each hospital laboratory may operate more than one alternate-site.

    1. No change.

    2. Testing at alternate-sites shall not exceed test categorization of moderate complexity moderately complex test procedures as described in Title 42 CFR Part 493.17 and administered by the Centers for Medicare and Medicaid Services and shall be limited to those tests:

    a. through d. No change.

    3. through 8. No change.

    (2) through (3) No change.

    Rulemaking Authority 395.0091, 395.1055, FS. Law Implemented 395.0091, 395.1055, FS. History–New 8-15-18,_Amended______, Formerly 59A-3.2085(9), 59A-3.2085(10), 59A-3.2085(11), F.A.C.

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Related Rules: (1)