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-2.002Definitions

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 defines terms used in Florida’s HIV testing requirements.

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: 381.003(2), 381.004(9), 381.0041(10) FS

LAW IMPLEMENTED: 381.0011, 381.003, 381.004 FS

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-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 certified by the Centers for Medicare and Medicaid Services under the federal Clinical Laboratory Improvement Amendments 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,          .

 

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