64D-2.004 Testing Requirements.
(1)
Pursuant to Section 381.004(2)(a), F.S., informed consent shall be obtained
prior to testing for HIV except in the limited situations outlined in Section
381.004(2)(h), F.S. Informed consent shall include an explanation that the
information identifying the test subject and the results of the test are
confidential and protected against further disclosure to the extent provided by
law. Information shall also be included on the fact that persons who test
positive will be reported to the local county health department, that anonymous
testing is available and the locations of anonymous testing sites.
(2) Informed consent to perform a test for
HIV need not be in writing, except in the situations listed below in subsection
64D-2.004(3), F.A.C., if there is documentation in the medical record that the
test has been explained and consent has been obtained.
(3) Informed consent to perform a test for
HIV shall be in writing for the following:
(a) From the potential donor or from the donorÕs
legal representative prior to the first donation of blood, blood components,
organs, skin, semen, or other human tissue or body part. The consent form must
specify that the donor is consenting to repeated HIV testing of each of his
donations 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 provided the minor gives informed 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., and who demonstrates
sufficient knowledge and maturity to make an informed judgment.
(b) Any minor who has reached the age of
17 years who gave consent to the donation of his or her blood, in compliance
with Section 743.06, F.S.
(c) Any married minor or unwed pregnant
minor, in accordance with Section 743.065, F.S.
(5) Any health care provider attending a
pregnant woman for conditions related to her pregnancy shall cause the woman to
be tested for HIV in accordance with Section 384.31, F.S., and Rule 64D-3.042,
F.A.C.
(6) 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 July 20, 2012, and the Model Protocol
for HIV Counseling and Testing In Non-Health Care Settings, dated July 20,
2012, consistent with the provisions of this section and incorporates these
documents by reference in this rule. The model protocols can be obtained from
the Department of Health, HIV/AIDS and Hepatitis Program, 4052 Bald Cypress
Way, Bin A09, Tallahassee, Florida 32399-1715, or online at the programÕs
website at: http://www.doh.state.fl.us/disease_ctrl/aids/legal/ctfornonchd.htm
and http://www.doh.state.fl.us/disease_ctrl/aids/legal/ctforchd.htm, or at https://www.flrules.org/Gateway/reference.asp?No=Ref-02052
and https://www.flrules.org/Gateway/reference.asp?No=Ref-02053.
(7) 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 64D-2.004(6), F.A.C. If the test
subject was tested in a facility, such as a jail or hospital emergency department,
and was released before being notified of a positive HIV test result, the
facility may inform the county health department to notify the test subject.
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), (6), F.S.
Rulemaking
Authority 381.004(9), 381.0041, 384.33 FS. Law Implemented 381.0011,
381.0031(4), 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.