64D-2.004. Testing Requirements

(1) Prior to testing for HIV, the notification and consent requirements of sections 381.004(2)(a) and (b), F.S., must be met.

(2) Informed consent to perform a test for HIV in a non-health care setting need not be in writing 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, informed 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) The following minors can be tested for HIV without parental consent:

(a) Any minor who requests examination, testing, consultation or treatment for a sexually transmissible disease, including HIV, in accordance with section 384.30, F.S.

(b) Any minor who has reached the age of 17 years, in compliance with section 743.06, F.S.

(c) Any married minor or unwed pregnant minor, in accordance with sections 743.01 and 743.065, F.S.

(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, 2017, and the Model Protocol for HIV Counseling and Testing In Non-Health Care Settings, dated June 30, 2017, 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-09328, and https://www.flrules.org/Gateway/reference.asp?No=Ref-09329.

(6) Persons ordering an HIV test must ensure that all reasonable efforts are made to notify the test subject of the test result and relate certain information to the test subject in accordance with section 381.004(2)(c), F.S., and the applicable Model Protocol for HIV Counseling and Testing specified in subsection (5), above. Blood establishments and persons who collect blood, organs, skin, semen, or other human tissue or body parts shall comply with Rule 64D-2.005, F.A.C., and sections 381.0041(5), and (6), F.S.

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, 5-6-18.