The purpose is to amend the rule to incorporate updated Model Protocols for HIV Counseling and Testing in both health care and non-health care settings, to clarify and conform to new statutory language.

 

DEPARTMENT OF HEALTH

Division of Disease Control

RULE NO.:RULE TITLE:

64D-2.004Testing Requirements

PURPOSE AND EFFECT: The purpose is to amend the rule to incorporate updated Model Protocols for HIV Counseling and Testing in both health care and non-health care settings, to clarify and conform to new statutory language.

SUMMARY: The rule describes activities regarding the requirements for persons conducting HIV testing in any setting and the receiving of informed and/or written consent from the person being tested.

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.

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: 381.004(9), 381.0041(10), 384.33 FS

LAW IMPLEMENTED: 381.0011, 381.004, 381.0041, 384.31 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: Derrick Traylor at [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64D-2.004 Testing Requirements.

(1) No change.

(2) Informed consent to perform a test for HIV in a non-health care setting need not be in writing, except in the situations listed below in subsection (3), if there is documentation in the medical record that the test has been explained and consent has been obtained.

(3) In health care and non-health care settings, iInformed consent to perform a test for HIV shall be in writing for the following:

(a) Prior to the first donation of blood, blood components, organs, skin, semen, or other human tissue or body part in accordance with Section 381.0041, F.S. The consent form must specify that the donor is consenting to repeated HIV testing of each donation for the subsequent year. The consent form must be signed annually prior to transfusion or other use;

(b) Prior to testing for HIV for insurance purposes, in accordance with Section 627.429, F.S.; or

(c) Prior to testing for HIV for contract purposes in a health maintenance organization, in accordance with Section 641.3007, F.S.

(4) No change.

(5) Pursuant to Section 381.004(7), F.S., the Department of Health developed the Model Protocol for HIV Counseling and Testing In Health Care Settings, dated June 30, 2017August 1, 2016, , and the Model Protocol for HIV Counseling and Testing In Non-Health Care Settings, dated June 30, 2017, August 1, 2015, consistent with the provisions of this section and incorporates these documents by reference in this rule. The model protocols can be obtained at https://www.flrules.org/Gateway/reference.asp?No=Ref-xxxx  and https://www.flrules.org/Gateway/reference.asp?No=Ref-xxxx.

(6) No change.

Rulemaking Authority 381.004(9), 381.0041(10), 384.33 FS. Law Implemented 381.0011, 381.004, 381.0041, 384.31 FS. History–New 11-6-85, Formerly 10D-93.67, Amended 7-12-89, 1-20-92, 5-1-96, Formerly 10D-93.067, Amended 8-24-99, 1-3-13, 9-5-16,__________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Derrick Traylor

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Celeste Philip, MD, MPH, State Surgeon General

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: February 7, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: August 17, 2017