In Reply Refer To: 13B
July 18, 2001
UNDER SECRETARY FOR HEALTH’S INFORMATION LETTER
GUIDELINES FOR HIV TESTING IN VA FACILITIES FOLLOWING
OCCUPATIONAL EXPOSURES
1. This information letter provides guidance concerning Human
Immunodeficiency Virus (HIV) testing in occupational exposure
situations; clarifies Department of Veterans Affairs (VA) policy
about testing for HIV, and includes a collection of consensus
recommendations of a Committee (see subpar. 2b) that included
experts in the field of HIV, Acquired Immune Deficiency Syndrome
(AIDS), and occupational safety.
2. Background
a. Considerable progress has occurred toward the development of
therapeutic agents used to treat HIV infected individuals and
significant technical advancement has been made in diagnostic
techniques to detect HIV. These recent advancements necessitated
a re-examination of VA policies and procedures as related to
testing for HIV within the context of potential occupational
exposure.
b. A committee was established to review existing VA policies on
HIV testing in situations of potential occupational exposure.
The Committee was composed of front-line HIV care providers
including infectious disease experts, infection control and
occupational health experts both from VA Central Office and the
field; VA General Counsel’s Office; the National Center for
Ethics; and a union representative.
c. The guidelines contained in this Information Letter represent
a collection of recommendations of the Committee and provide
reference to the United States (U.S.) Public Health Service
(PHS) guidelines for management of occupational exposures and
post-exposure prophylaxis to HIV.
d. The Committee addressed six specific areas. These include:
(1) VA HIV testing policy in occupational exposures in general;
(2) Situations where the source patient refuses or is incapable
of giving consent or an appropriate authorized surrogate refuses
consent;
(3) Confidentiality issues related to exposed employees’
records;
(4) Exposures during off-duty hours;
(5) Availability of state-of-the-art diagnostic technologies to
detect HIV; and
(6) Process integrity issues.
3. General Guidance for VA Facilities
a. The U.S. PHS has developed guidelines for the management of
occupational exposures to HIV and made recommendations for
post-exposure prophylaxis (see subpar. 9a). This information,
designed as general guidance, can be used by all VA health care
facilities in establishing appropriate programs for the
management of health care workers (HCWs) who have occupational
exposure to blood and other potentially infectious materials,
and for post-exposure prophylaxis. This document is accessible
on the web site: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5011a1.htm.
4. A Reminder of VA Policy on HIV Testing
a. VA policy provides that every patient has the right to
informed participation in the patient’s health care decisions
(see subpar. 9b, VHA Handbook 1104.1, and Title 38 Code of
Federal Regulations (CFR) §17.32, regarding Informed Consent).
Public Law 100-322 Section 124, as amended, specifies that
testing for HIV must be voluntary and requires specific written
consent by the patient to be tested (see subpar. 9c). The law
also provides that HIV testing be accompanied by documented pre-
and post-test counseling.
b. This Information Letter further clarifies VA policy about
testing for HIV. A common query is whether specimen left over
from other diagnostic or therapeutic tests may be tested for HIV
when the source patient cannot be located, is incapacitated, or
refuses the HIV test. Current law mandates that VA may
administer a test to a patient that would lead to the diagnosis
of HIV infection only with the prior written consent of the
patient, or of an authorized surrogate in accordance with
applicable law and regulations. This includes circumstances
where occupational exposures have occurred.
c. In situations of occupational exposures, there are instances
where testing of the source patient is difficult or impossible.
These situations include:
(1) Source patient or appropriate authorized surrogate refuses
consent for HIV test.
Recommendation: Offer exposed employee post-exposure management
and anti-retroviral prophylaxis, as warranted by PHS guidelines.
The patient, or appropriate authorized surrogate may be
re-approached by a different provider, e.g., a counselor, an
attending physician or a nurse who is not involved in or
affected by the exposure event. Careful attention needs to be
taken to ensure that coercion is neither applied nor perceived
when a person who initially declined testing is re-approached.
If the patient, or appropriate authorized surrogate, still
declines, testing may not be performed, even on available
residual specimens.
(2) Source patient left VA medical center before consent was
obtained.
Recommendation: Offer exposed employee post-exposure management
and anti-retroviral prophylaxis, as warranted according to PHS
guidelines. Follow-up with the patient to obtain consent. The
source patient’s written consent on VA Form 10-5345, Request for
and Consent to Release of Medical Records Protected by 38 U.S.C.
§ 7332, (see subpar. 9d) is also required to disclose the HIV
test results to the exposed employee. Provide assistance or
support where possible to maximize patient’s convenience in the
consenting and testing process. A specimen previously collected
for other purposes cannot be used for HIV testing without
appropriate consent.
(3) Source patient cannot be located.
Recommendation: Offer exposed employee post-exposure management
and anti-retroviral prophylaxis, as warranted according to PHS
guidelines. Specimen previously collected for other purposes
cannot be used for HIV testing without appropriate prior
consent.
(4) Source patient is incapacitated, incompetent or comatose.
Recommendation: Offer exposed employee post-exposure management
and anti-retroviral prophylaxis, as warranted according to PHS
guidelines. VA regulations limit diagnostic testing of HIV and
the disclosure of information related to HIV infection, when the
patient lacks the decision-making capacity (incapacitated,
incompetent, or comatose). Testing for HIV, like any other
diagnostic or therapeutic procedure, typically requires the
patient’s (or appropriate authorized surrogate’s) informed
consent. When the purpose of the test is to confirm the
patient’s HIV status following an occupational exposure, a
written consent allowing the test for HIV is required.
Furthermore, disclosure of the test results to the exposed
employee also requires written consent from the patient, or from
the patient’s legal guardian in instances where the patient
lacks the decision-making capacity. Such disclosures require the
specific written consent of the patient’s court appointed legal
guardian on VA Form 10-5345. If the patient is incompetent and
there is no consenting court appointed legal guardian, HIV
testing and disclosure of the HIV test results are not
permitted.
(5) Source patient is deceased.
Recommendation: Offer exposed employee post-exposure management
and anti-retroviral prophylaxis, as warranted according to PHS
guidelines. If the purpose of testing at autopsy is to establish
the diagnosis of HIV, then specific consent of the deceased’s
next-of-kin, or appropriate authorized surrogate, would be
required (see subpar. 9e).
5. Employee Confidentiality and Record Keeping
a. Confidentiality of medical information pertaining to both
HCWs and patients is essential. Employee health records should
not be accessed by anyone other than Employee Health staff and
others who are involved in providing health care to the exposed
HCW without the prior written consent of the worker or as
otherwise authorized by law. Appropriate security measures and
sanctions must be in place to assure the confidentiality of all
employees’ health records.
b. Medical records and HIV test results of patients who are
identified as the potential source of exposure of blood and/or
body fluids are subject to confidentiality protections imposed
by law (see subpar. 9f). Test results or other information
concerning a patient’s HIV status may not be disclosed, in most
instances, without the patient’s specific prior written consent.
The source patient’s identity and HIV status must not be
recorded or reported in HCW’s records unless appropriate written
permission is obtained.
6. Exposure Management During Non-administrative Work Hours
a. A person can be designated within the facility to deal with
issues on occupational exposure to blood and body fluids with
coverage provided for off-duty hours.
b. A number of the exposures to blood and body fluids occur
off-shifts and during non-administrative hours. The written
policies and procedures on the management of the HCW exposed
during off-shift and non-administrative duty hours should be
uniformly in accordance with the Exposure Control Program of the
Occupational Safety and Health Administration (OSHA) (see subpar.
9g).
7. Availability of Most Advanced HIV Testing Technologies
a. The PHS guidelines on evaluation and testing of exposure
source should be followed when evaluating for possible HIV
infection (see subpar. 9a).
b. The most advanced and rapid HIV detection technologies should
be made available (see subpar. 9h). Consideration should be
given to using rapid HIV detection tests so that source
patients’ HIV status can be determined as quickly as possible.
c. In addition to the HIV antibody blood test, the direct HIV
detection test, as well as the rapid tests such as urine
antibody and oral tests that have the highest degree of
sensitivity and specificity, should be made available in
appropriate situations along with appropriately trained
technicians to perform the test(s).
8. Process Integrity Issues
a. The exposed HCW should never be the one to approach or
counsel the source patient about HIV testing.
b. An appropriately trained person should obtain the consent for
HIV testing of the source patient, or the HCW, and conduct the
counseling and post-exposure management of the exposed HCW. The
post-exposure prophylaxis, management and treatment of the
exposed HCW, may best be directed by a multidisciplinary team of
VA providers who are trained in issues dealing with occupational
exposures.
c. A facility multidisciplinary team should be available for
consultation during the off-shifts and non-administrative hours.
9. References
a. Updated U.S. Public Health Service Guidelines for the
Management of Occupational Exposures to Hepatitis B Virus (HBV),
Hepatitis C Virus (HCV), and HIV and Recommendations for
Post-exposure Prophylaxis. Morbity and Mortality Weekly Report (MMWR)
2001;50 (No. RR-11):1-43. (Web address: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5011a1.htm)
b. VHA Handbook 1004.1.
c. Title 38 CFR Section 17.32
d. Veterans’ Benefits and Services Act of 1988, Public Law No.
100-322, Section 124, 102 Stat. 487 (1988) (38 U.S.C. Section
7333).
e. Title 38 CFR Section 1.460-1.496.
f. Title 38 U.S.C. Section 7332.
g. Office of General Counsel Advisory Opinion VADIGOP 6-8-88.
Informed Consent for Testing and Autopsies for AIDS. June 8,
1988.
h. VHA Manual M-1, Part 1, Chapter 9, Release of Medical
Information.
g. Occupational Safety and Health Administration’s Regulation on
Bloodborne Pathogens. (29 CFR Section 1910.1030, Bloodborne
pathogens).
h. Holodniy M. “Establishing the Diagnosis of HIV Infection”
AIDS Therapy. Dolin, Masur & Saag Eds. Churchill Livingstone
Publisher, 1999.
i. Questions may be referred to Abid Rahman, Director,
Government Liaison, with the Public Health Strategic Health Care
Group (132/13B), at 202-273-8468 or e-mail to:
abid.rahman@mail.va.gov.
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