BILL ANALYSIS Ó
AB 446
Page 1
ASSEMBLY THIRD READING
AB 446 (Mitchell)
As Amended May 24, 2013
Majority vote
JUDICIARY 10-0 HEALTH 18-0
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|Ayes:|Wieckowski, Wagner, |Ayes:|Pan, Ammiano, Atkins, |
| |Alejo, Chau, Dickinson, | |Bonilla, Bonta, Chesbro, |
| |Garcia, Gorell, | |Gomez, |
| |Maienschein, Muratsuchi, | |Roger Hernández, |
| |Stone | |Lowenthal, Maienschein, |
| | | |Mansoor, Mitchell, |
| | | |Nazarian, Nestande, V. |
| | | |Manuel Pérez, Wagner, |
| | | |Wieckowski, Wilk |
|-----+--------------------------+-----+--------------------------|
| | | | |
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APPROPRIATIONS 16-1
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|Ayes:|Gatto, Harkey, Bigelow, | | |
| |Bocanegra, Bradford, Ian | | |
| |Calderon, Campos, Eggman, | | |
| |Gomez, Hall, Ammiano, | | |
| |Linder, Pan, Quirk, | | |
| |Wagner, Weber | | |
| | | | |
|-----+--------------------------+-----+--------------------------|
|Nays:|Donnelly | | |
| | | | |
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SUMMARY : Expands voluntary human immunodeficiency virus (HIV)
testing outreach to certain patients at primary care clinics,
and revises requirements for obtaining consent from, and
providing information to, persons being tested for HIV
infection. Specifically, this bill :
1)Removes the requirement to obtain a signed written statement
of informed consent before administering an HIV test in a
non-clinical setting, and instead provides that informed
consent may be provided orally or in writing, but the person
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administering the test must maintain documentation of consent,
whether obtained orally or in writing, in the client's record.
2)Restores an exemption under existing law that exempts from the
above provision any blood tested as part of a scientific
investigation conducted by state health officials or medical
researchers, as specified.
3)Modifies the information that a medical provider is required
to give to a person about to receive an HIV test in a clinical
setting.
4)Exempts from the opt-out screening requirement any person who
independently requests an HIV test from a medical care
provider, laboratory, HIV counseling and testing site, or
primary care clinic, as defined, that employs a trained HIV
counselor pursuant to the Health and Safety Code Section
120917.
5)Specifies information that a medical care provider must give
to a patient after the results of the patient's HIV test have
been received, including information specific to a positive
test result and different information in the case of a
negative test.
6)Requires each patient between the ages of 18 and 65 who has
blood drawn at a primary care clinic, as defined, to be
offered an HIV test, unless within the previous year the
primary care clinic has tested the patient for HIV or offered
an HIV test that the patient declined. Further provides that
any subsequent testing of a patient by the primary care clinic
shall be consistent with the most recent guidelines issued by
the Centers for Disease Control (CDC) and United States (U.S.)
Preventive Services Task Force (USPSTF).
7)Requires the primary care clinic to attempt to provide the
test results to the patient before he or she leaves the
facility if possible; otherwise the facility must inform a
patient of a positive HIV test result consistent with existing
law, and may inform the patient of a negative HIV test result
by letter or telephone, as provided.
8)Allows, under specified circumstances, the result of an HIV
test to be posted on a secure Internet Web site viewable only
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with the use of a secure personal identification number
provided to the patient at the time of testing and only if
there is no link to any information that identifies the
subject of the test.
FISCAL EFFECT : According to the Assembly Appropriations
Committee:
1)The Office of AIDS in the Department of Public Health will
incur minor absorbable costs to provide technical assistance
and guidance regarding the new requirements and procedures to
local health departments and HIV counselors.
2)Any additional costs for student health centers at the
University of California, the California State University, and
the California Community Colleges should be absorbable and
would be partially offset by HIV testing fees.
COMMENTS : This bill, sponsored by the AIDS Healthcare
Foundation (AHF), seeks to make a number of changes to state HIV
testing law that the author believes will help facilitate
greater HIV screening of people who are hard to reach within
traditional clinical settings and using traditional testing
protocols. Under this bill, an HIV counselor working in a
non-clinical setting would no longer be required to obtain a
separate, signed written statement of informed consent from the
patient before administering the HIV test. This bill would
still require informed consent in the non-clinical setting, but
would allow it to be provided orally or in writing, as long as
the person administering the test maintains documentation of the
consent, whether obtained orally or in writing, in the patient's
record. This bill would also authorize the tester to disclose
an HIV test result on a secure Web site that a test subject may
access with a unique personal identification number intended to
protect the confidentiality of the patient's identity.
This bill also requires each patient between the ages of 18 and
65 who has blood drawn at a primary care clinic to be offered an
HIV test, unless within the previous year the primary care
clinic has tested the patient for HIV or offered an HIV test
that the patient declined. The bill also provides that any
subsequent testing of a patient by the primary care clinic shall
be consistent with the most recent guidelines issued by the CDC
and USPSTF. Additionally, the bill requires the primary care
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clinic to attempt to provide the test results to the patient
before he or she leaves the facility if possible; otherwise the
facility must inform a patient of a positive HIV test result
consistent with existing law, and may inform the patient of a
negative HIV test result by letter or telephone, as provided.
According to the author and sponsor, state laws specifying
pre-test information and consent procedures need to be revised
in order to facilitate greater HIV testing. The sponsor states,
"The key is finding those persons living with HIV who do not
know they are infected, linking them into care and suppressing
the presence of HIV through adherence to medications. . . More
and more testing is being administered by HIV Counselors, a
profession created by statute and trained and certified by the
state. As the largest private HIV testing entity in California,
AHF places its testing professionals in the community where they
can reach out to people who might otherwise never go to a
physician or clinic for an HIV test." The proponents point to
compelling HIV epidemiological research published in 2012 by the
California Department of Public Health that shows that: 1) In
2009, there were 5,380 persons newly diagnosed with HIV
infection in California; 2) There are approximately 110,966
persons living with HIV in California; and 3) More than 20,000
of them do not know they are HIV-positive, meaning that they are
not getting treatment and may be unknowingly exposing uninfected
people to HIV.
Informed consent for HIV testing, as defined by CDC, is "a
process of communication between patient and provider through
which an informed patient can choose whether to undergo HIV
testing or decline to do so." CDC also states "Elements of
informed consent typically include providing oral or written
information regarding HIV, the risks and benefits of testing,
the implications of HIV test results, how test results will be
communicated, and the opportunity to ask questions." (CDC,
"Revised Recommendations for HIV Testing of Adults, Adolescents,
and Pregnant Women in Health-Care Settings." Morbidity and
Mortality Weekly Report (2006), 55(RR14), page 1-17.)
By contrast, a requirement for written consent simply refers to
the need to obtain a signed paper documenting that the person
has given his or her consent to have the test done. Written
consent may be independently required (or not required) where
the legal standard is informed consent, or some alternative
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standard, such as simple consent. According to the sponsor,
"the potential test subjects who visit community non-clinical
settings often have to be convinced to have the test in the
first place and are more likely to skip the test altogether the
longer they are required to remain with the HIV Counselor,
especially if they have to sign a consent form." Proponents
also correctly note that CDC's 2006 recommendations for health
care settings specifically state that separate written consent
for HIV testing should not be required, and many states
currently do not require separate written consent for HIV
testing.
Existing law requires both written consent and informed consent
for HIV testing in non-clinical settings. Under this bill, a
person working in a non-clinical setting would no longer need to
obtain a separate, signed written statement of informed consent
from the patient before administering the HIV test. This bill
would still require informed consent in the non-clinical
setting, but would allow informed consent to be provided orally
or in writing, as long as the person administering the test
maintains documentation of the consent, whether obtained orally
or in writing, in the patient's record. This bill would
presumably help increase HIV testing by eliminating one of the
major obstacles to testing, as reported by AHF, but at the same
time preserve the important purposes that informed consent
serves by ensuring exchange of information and an opportunity
for dialogue.
Existing California law requires a medical care provider, prior
to ordering an HIV test to: 1) inform the patient that the test
is planned; 2) provide information about the test; 3) inform the
patient that there are numerous treatment options available for
a patient who tests positive for HIV; and 4) inform the patient
that a person who tests negative for HIV should continue to be
routinely tested.
This bill revises these informational requirements. First, a
provider or the person administering the test must ensure the
patient receives timely information and counseling, as
appropriate, to explain the results and implications for the
patient's health. If the patient tests positive for HIV
infection, the bill requires the provider or the person
administering the test to inform the patient that there are
numerous treatment options available and identify follow-up
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testing and care that may be recommended, including contact
information for medical and psychological services. If the
patient tests negative for HIV infection and is known to be at
high risk for HIV infection, the bill requires the provider or
the person administering the test to advise the patient of: 1)
the need for periodic retesting; 2) explain the limitations of
current testing technology and the current window period for
verification of results; and 3) may offer prevention counseling
or a referral to prevention counseling. It is the author's
intent that appropriately timed post-test delivery of
information will not only streamline the pre-test informational
procedure that may delay or defer the test, but will also lead
to better linkages to care for those who test positive.
Lastly, existing law provides that opt-out screening
requirements do not apply when a person independently requests
an HIV test from a medical care provider. This makes sense
because a person who independently requests an HIV test from a
provider need not be told the test is planned and advised that
he or she has the right to decline the test. This bill would
expand that principle to situations where the person requests an
HIV test not just from a medical provider, but from a
laboratory, counseling and testing site that employs a trained
HIV counselor, or a primary care clinic or other clinic, as
specified. In cases where an independent request for testing
has been made, simple consent by the requesting person should be
sufficient to authorize the HIV test in a variety of settings.
Analysis Prepared by : Anthony Lew / JUD. / (916) 319-2334
FN: 0000746 0000569