Current through Register Vol. 50, No. 9, September 20, 2024
A.
Informational Provisions. Prior to the execution of informed consent, the
health care provider requesting the performance of an HIV-related test shall
provide to the subject of an HIV-related test, or, if the subject lacks
capacity to consent, to a person authorized by law to consent to health care
for the subject, an oral, videotaped, or written explanation of the nature of
AIDS and HIV-related illness, as well as oral, videotaped, or written
information about behavior known to pose risks for transmission and contraction
of HIV infection. The consent form developed by the Department of Health and
Hospitals, Office of Public Health, contains the minimal requirements for
meeting these provisions as does the informational brochure developed for this
purpose. If the information is given orally to the subject it should describe
at a minimum:
1. the voluntary nature of the
test;
2. measures for the
prevention of exposure to, and transmission of HIV, including discussion of
abstinence, monogamy, safer sex using condoms, cleaning needles, or other
prevention measures needed by the patient as well as partner
notification;
3. the accuracy and
reliability of testing for HIV;
4.
the significance of the results of such testing, including the potential for
developing the Acquired Immunodeficiency Syndrome;
5. encouraging the individual, as
appropriate, to undergo such testing;
6. the benefits of such testing, including
the medical benefits of diagnosing HIV disease in the early stages and the
medical benefits of receiving early intervention services during such
stages;
7. the possibility that the
subject may suffer discrimination if the results of the test are disclosed
inappropriately.
B.
Informed Consent
1. Except as otherwise
provided herein, no person shall order the performance of an HIV-related test
to be performed on a person at a licensed hospital without first receiving the
written informed consent of the subject of the test if the individual has
capacity to consent or, when the subject lacks capacity to consent, that of the
person authorized by law to consent to health care for such individual except
as provided herein or authorized or required by law or regulation. Louisiana
law specifically authorizes minors to consent to care for sexually transmitted
diseases without parental approval. The written form developed by the
Department of Health and Hospitals, Office of Public Health, has been developed
to fulfill the requirements of this provision. Adherence to these rules,
regulations, and forms shall constitute a legal presumption that consent for
testing was validly obtained. While other forms of written consent or verbal
consent can be obtained there shall be no legal presumption that consent
secured through such means will be deemed valid.
2. If an HIV-related test is to be performed
on a person who is an outpatient, or tested at a licensed hospital laboratory
by the delivery of blood sample for testing, the person ordering such tests
shall first obtain the consent of the patient and specifically so state on the
order or request form furnished to the hospital or hospital laboratory, and
likewise indicate the patient's choice as to the anonymity (see Subsection D
below); such statement and/or certification by the person ordering the test may
be relied upon by the hospital or hospital laboratory without the necessity for
a copy of such consent and/or election by the patient being
furnished.
3. If the HIV-related
test is to be performed on a person who is an inpatient in a licensed hospital,
a written consent form, duly completed and by the patient, must be in the
patient's chart prior to any steps in such HIV-related testing.
C. Verbal Informed Consent. If a
person is ordering an HIV-related test on a client who is in a setting other
than as an inpatient in a licensed hospital, he/she has the option of either
first receiving the written informed consent of the subject (or authorized
person as indicated above) as in Subsection A above, or receiving the verbal
informed consent of a subject contemporaneously documented in writing in the
medical record. Verbal informed consent should be immediately and
contemporaneously documented in writing in the medical record of the person
being tested. Minimal requirements of valid verbal consent include a discussion
of the topics as contained in the written consent form as summarized by the
following:
1. the voluntary nature of the
test;
2. measures for the
prevention of exposure to, and transmission of HIV, including discussions of
abstinence, monogamy, safer sex using condoms, cleaning needles, or other
prevention measures needed by the patient as well as partner
notification;
3. the accuracy and
reliability of testing for HIV;
4.
the significance of the results of such testing, including the potential for
developing the Acquired Immunodeficiency Syndrome;
5. encouraging the individual, as
appropriate, to undergo such testing;
6. the benefits of such testing, including
the medical benefits of diagnosing HIV disease in the early stages and the
medical benefits of receiving early intervention services during such
stages;
7. the possibility that the
subject may suffer discrimination if the results of the test are disclosed
inappropriately. Both the written consent form and the informational brochure
developed by the Department of Health and Hospitals, Office of Public Health,
contain (independently) the necessary written information which can be provided
to the person being tested. The informational brochure contains some additional
information which may be useful to the person being tested but is not required
to be given to the person being tested.
D. Anonymous Testing. A patient requesting
the performance of an HIV-related test shall be provided an opportunity to
remain anonymous by the use of a coded system with no correlation or
identification of the individual's identity to the specific test request or
results. A health care provided that is not able to provide this service shall
refer, at no extra charge to the individual seeking anonymity, to a site which
does provide anonymous testing. These anonymous provisions do not apply to
inpatients in hospitals. Providers can locate sites where this testing can be
done anonymously through the Louisiana AIDS Hotline at 1-800-99AIDS9 or the
local parish health unit.
E. HIV
Testing Not Requiring Informed Consent. Informed consent is not necessary as
follows:
1. by a health care
provider/facility in procuring human body parts or blood for transplantation or
transfusion;
2. for accredited
research such that the identity of the subject remains anonymous and cannot be
retrieved by the researcher;
3. on
a deceased person to determine the cause of death or for epidemiologic
purposes;
4. if, in the opinion of
the health care provider requesting the test, the request for consent would be
medically contraindicated;
5. a
child taken into custody of the Department of Social Services where department
officials have cause to believe the child is infected with HIV;
6. on a child when the child's attending
physician or health care provider reasonably believes such test to be necessary
in order to properly diagnose or treat the childs medical condition and
document such reason in the child's medical record;
7. on any person arrested, indicted, or
convicted for crimes of aggravated rape, forcible rape, simple rape, or incest
when required by a court to undergo an HIV related test;
8. for test performed pursuant to
R.S.
40:1299(D).
AUTHORITY NOTE:
Promulgated in accordance with R.S.40:38.5.