BILL ANALYSIS
AB 568
Page 1
Date of Hearing: April 19, 2005
ASSEMBLY COMMITTEE ON HEALTH
Wilma Chan, Chair
AB 568 (Garcia) - As Amended: April 4, 2005
SUBJECT : Rapid HIV tests.
SUMMARY : Requires a physician and surgeon or other person
performing an annual gynecological examination (annual exam), at
the time of the annual exam, to offer to test a woman for the
presence of the human immunodeficiency virus (HIV) through a
blood specimen or a rapid HIV test. Specifically, this bill :
1)Requires a physician and surgeon or other person performing an
annual exam, at the time of the annual exam, to offer to the
woman an HIV test.
2)Requires the physician and surgeon or other person performing
the annual exam to ensure that the woman is informed of the
routine nature of the blood test, the purpose of the testing,
the risks and benefits of the test, the risk of transmission
of HIV, that approved treatments are known to decrease the
risk of transmission of HIV, and that the woman has a right to
accept or refuse this testing.
3)Requires the acceptance of HIV testing to be documented in
writing on a form, as specified, and signed by the patient.
Requires a copy of this form to be maintained in the medical
record.
4)Requires the physician and surgeon or other person performing
the annual exam, if the woman chooses to be tested for HIV
through a blood test, to obtain a blood specimen from the
woman and submit it to a clinical laboratory licensed by the
Department of Health Services (DHS) or to an approved public
health laboratory, as specified.
5)Requires the results to be reported to:
a) A physician and surgeon or other person performing an
annual exam who ordered the test, and who subsequently
informs the woman tested; and,
b) The local health officer, in the case of a positive
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test, with the information required and within the
timeframes established by DHS, as specified.
6)Requires the test to be conducted only as authorized pursuant
to current statute pertaining to the Office of AIDS'
participation in a rapid HIV test research program conducted
with the Centers for Disease Control and Prevention (CDC) if
the woman chooses to be tested with a rapid HIV test.
7)Requires the physician and surgeon or other person attending
the woman at the time the results are received, to ensure that
the woman receives information and counseling, as appropriate,
to explain the results and the implications for the woman's
health, including any follow-up care that is indicated.
8)Requires a referral to a provider, provider group, or
institution specializing in care for HIV positive women if the
woman tests positive for HIV.
9)Requires the HIV information and counseling provided pursuant
to #7) above to include, but not be limited to:
a) A description of the modes of HIV transmission;
b) A discussion of risk reduction behavior modifications
including methods to reduce the risk of transmission; and,
c) If appropriate, referral information to other HIV
prevention and psychosocial services including anonymous
and confidential test sites approved by the Office of AIDS.
10) Prohibits anything in this bill to be construed to require
mandatory testing. Requires any documentation or disclosure of
HIV related information to be made in accordance with current
law regarding confidentiality and informed consent, as
specified.
EXISTING LAW :
1)Permits the DHS Office of AIDS to participate in a rapid HIV
test research program conducted with the CDC.
2)Requires that the blood of a pregnant woman that is drawn for
testing for rhesus (Rh) blood type and hepatitis B also be
tested for HIV unless the woman refuses.
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FISCAL EFFECT : Unknown.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, current law
does not require a woman to be offered a HIV test as part of
her annual gynecological exam or to be provided with
information on the subject. The CDC reported in 2003 that
heterosexual women accounted for 26% of all new HIV cases,
with African American and Hispanic women accounting for 83% of
these diagnoses. Heterosexual sex has been the primary method
of HIV exposure for women, with a growing number becoming
infected by male partners who share needles or had sex with
males. The author contends that there are many reasons why
fewer women seek care, especially in communities where social
and cultural norms may discourage them from speaking out about
their sexuality. In some cultures, the promiscuous behavior
of male partners is ignored, and in others, seeking assistance
brings fear of being stigmatized. As a result, women fail to
recognize the early symptoms of HIV/AIDS and do not raise
questions even with their doctors. According to the author,
this bill is sponsored by Working Wonders of Cathedral City.
2)BACKGROUND . According to the CDC, early in the AIDS epidemic,
HIV infection was diagnosed for relatively few women. However,
the HIV/AIDS epidemic now represents a growing and persistent
health threat to women in the United States, especially young
women and women of color. In 2001, HIV infection was the
leading cause of death for African American women aged 25-34
years and was among the four leading causes of death for
African American women aged 20-24 and 35-44 years, as well as
Latinas aged 35-44 years. Through 2003, 170,679 women were
diagnosed with AIDS, and an estimated 81,864 women with the
disease died. From 1999 through 2003, the annual number of
estimated AIDS diagnoses increased 15% among women and
increased 1% among men. According to a recent CDC study of
more than 19,500 patients in ten US cities, HIV-infected women
were 12% less likely than infected men to receive
prescriptions for the most effective treatments for HIV
infection. African American women and Latinas represented
about 25% of all US women, yet they account for 83% of AIDS
diagnoses reported in 2003.
3)RAPID HIV TESTING . A rapid HIV testing device was approved by
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the FDA in November 2002 as a Clinical Laboratory Improvement
Amendment (CLIA) for testing finger-prick blood samples for
antibodies to HIV. This test provides highly accurate results
in approximately 20 minutes. Positive tests require
confirmation by a standard laboratory-based test prior to
reporting any results. A negative test is considered
definitive and does not require follow-up testing. The test
authorized by the FDA was initially categorized as a moderate
complexity test under CLIA, the federal law regulating
clinical laboratory testing. This limited the use of the test
to laboratory facilities and personnel who meet specific
criteria, which most California publicly-funded HIV testing
clinics do not have. Because the device is relatively simple
to use, does not require laboratory equipment, and contains an
internal control mechanism, the device was "waived" under
CLIA. HIV counselors who are trained by the Office of AIDS
and working in an HIV counseling and testing site funded by
DHS through a local health jurisdiction may administer the
test, provided they meet federal and state requirements.
4)PREVIOUS LEGISLATION . AB 1676 (Dutra), Chapter 749, Statutes
of 2003, requires that the blood of a pregnant woman that is
drawn for testing for rhesus (Rh) blood type and hepatitis B
also be tested for HIV unless the woman refuses. AB 1263
(Migden), Chapter 324, Statutes of 2001, authorizes DHS to
participate in the CDC rapid HIV test research program and
provides that HIV counselors may administer the test.
5)POLICY QUESTIONS . The bill requires that the rapid HIV test
permitted under this bill only be conducted as authorized by
the statute that permits the Office of AIDS participation in
the CDC program. Is it the author's intention that women who
chose the rapid HIV test only obtain them at the Office of
AIDS-funded sites? This bill also requires the physician or
person attending the woman at the time the results are
received to ensure that the woman receives information and
counseling and specifies what that information and counseling
must include. What will the practical affect of this
requirement be? Does it mean that if the physician does not
have staff indicated for this purpose, that he or she is
ultimately responsible for providing the information and
counseling? Finally, this bill requires the physician or
other person attending the woman at the time the test is
received to provide referral information to anonymous and
confidential test sites approved by the Office of AIDS. It is
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unclear why the woman would require this referral after
already receiving a HIV test.
6)DOUBLE REFERRAL . This bill has been double-referred. Should
this bill pass out of this Committee, it will be referred to
the Assembly Committee on Judiciary.
7)OPPOSITION . The American College of Obstetricians and
Gynecologists (ACOG) writes that they hesitate to put
specifics of the practice of medicine into law except under
very limited and specific circumstances, such as making HIV
testing of pregnant and delivering women routine. ACOG
contends that this was a situation that presented a unique
circumstance where hours can make the difference in whether
HIV is transmitted from mother to infant. ACOG guidelines
recommend HIV testing for a woman who "?(is) seeking treatment
for STDs; (has a history of) drug use by injection; (has a)
history of prostitution; (has a) past or present sexual
partner who is HIV positive or bisexual or injects drugs; (has
a) long-term residence or birth in an area with high
prevalence of HIV infection; (has a) history of transfusion
from 1978 to 1985; (or, has) invasive cervical cancer."
REGISTERED SUPPORT / OPPOSITION :
Support
None on file.
Opposition
American College of Obstetricians and Gynecologists
Analysis Prepared by : Melanie Moreno / HEALTH / (916)
319-2097