This rule is being amended to conform to legislative changes to section 381.004, Florida Statutes, related to licensing requirements for clinical laboratories. Clinical laboratories in Florida will be federally certified under the Clinical ...

 

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, related to licensing requirements for clinical laboratories. Clinical laboratories in Florida will be federally certified under the Clinical Laboratory Improvement Amendments instead of licensed by the Agency for Health Care Administration.

SUMMARY: This rule lays out the requirements for testing pregnant persons for chlamydia, gonorrhea, hepatitis B, HIV, and syphilis during prenatal care.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: Based on the SERC checklist, this rulemaking will not have an adverse impact on regulatory costs in excess of $1 million within five years as established in s.120.541(2)(a), F.S.

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.

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

LAW IMPLEMENTED: 381.0011, 381.003(1)(c), 381.004(3), 382.008(6), 382.013(5), 384.26, 384.31 F.S.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Amber Pepe at [e-mail] or [phone].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64D-3.042 STD Testing Related to Pregnancy.

(1) through (6) No change.

(7)(a) Specimens shall be submitted to a laboratory certified by the Centers for Medicare and Medicaid Services under the federal Clinical Laboratory Improvement Amendments 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 certified 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             .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Mara Michniewicz

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Scott A. Rivkees, MD, Surgeon General and Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: November 20, 2019

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: December 13, 2018