This rule is being amended to conform to legislative changes to section 381.004, Florida Statutes, eliminating licensing requirements for clinical laboratories. Clinical laboratories in Florida will be federally CLIA-certified instead of licensed by ...

 

DEPARTMENT OF HEALTH

Division of Disease Control

RULE NO.:RULE TITLE:

64D-2.002Definitions

PURPOSE AND EFFECT: This rule is being amended to conform to legislative changes to section 381.004, Florida Statutes, eliminating licensing requirements for clinical laboratories. Clinical laboratories in Florida will be federally CLIA-certified instead of licensed by the Agency for Health Care Administration.

SUBJECT AREA TO BE ADDRESSED: Definition of “laboratory” as used in regulations for HIV testing.

RULEMAKING AUTHORITY: 381.003(2), 381.004(9), 381.0041(10), FS.

LAW IMPLEMENTED: 381.0011, 381.003, 381.004, 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 REGISTER.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Mara Michniewicz at [e-mail].

 

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:

 

64D-2.002 Definitions.

Unless defined below, words and phrases used in this chapter have the same meaning as in Section 381.004(1), F.S.

(1) through (5) No change.

(6) “Laboratory” – Any facility appropriately certified by the Centers for Medicare and Medicaid Services under the federal Clinical Laboratory Improvement Amendents and the federal rules adopted thereunder, licensed under Chapter 483, F.S., where HIV tests are performed. This definition does not include blood establishments.

(7) through (9) No change.

Rulemaking Authority 381.003(2), 381.004(9), 381.0041(10) FS. Law Implemented 381.0011, 381.003, 381.004 FS. History–New 11-6-85, Formerly 10D-93.62, Amended 7-12-89, 5-30-90, 1-20-92, 5-1-96, Formerly 10D-93.062, Amended 8-24-99, 1-3-13, 9-5-16,____.