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-3.042STD Testing Related to Pregnancy

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: Laboratory requirements for STD testing related to pregnancy.

RULEMAKING AUTHORITY: 381.0011, 381.003(2), 382.003(7), 384.25, 384.33 FS.

LAW IMPLEMENTED: 381.0011, 381.003(1)(c), 381.004(3), 382.008(6), 382.013(5), 384.26, 384.31 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-3.042 STD Testing Related to Pregnancy.

(1) through (6) No change.

(7)(a) Specimens shall be submitted to a laboratory 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 Part I, Chapter 483, F.S., to perform tests for chlamydia, gonorrhea, hepatitis B surface antigen (HBsAg), HIV and syphilis.

(b) The practitioner submitting the specimens for testing to a licensed laboratory shall state that these specimens are from a pregnant or postpartum woman.

(8) through (9) No change.

Rulemaking Authority 381.0011, 381.003(2), 382.003(7), 384.25, 384.33 FS. Law Implemented 381.0011, 381.003(1)(c), 381.004(3), 382.008(6), 382.013(5), 384.26, 384.31 FS. History–New 11-20-06, Amended            .