BILL ANALYSIS Ó
AB 446
Page 1
Date of Hearing: April 30, 2013
ASSEMBLY COMMITTEE ON JUDICIARY
Bob Wieckowski, Chair
AB 446 (Mitchell) - As Introduced: February 19, 2013
As Proposed to Be Amended
SUBJECT : HIV TESTING: INFORMATION AND CONSENT PROCEDURES
KEY ISSUE : IN ORDER TO ADDRESS REPORTED PROCEDURAL BARRIERS
THAT MAY DELAY OR DEFER HIV TESTING, SHOULD PROCEDURES FOR
GIVING PRE-TEST INFORMATION TO AND OBTAINING CONSENT FROM TEST
SUBJECTS BE STREAMLINED WITHOUT ELIMINATING INFORMED CONSENT IN
NON-CLINICAL SETTINGS?
FISCAL EFFECT : As currently in print this bill is keyed
non-fiscal.
SYNOPSIS
This bill, sponsored by the AIDS Healthcare Foundation, 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. As proposed
to be amended, this bill would no longer require an HIV
counselor working in a non-clinical setting 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 website that a test subject may
access with a unique personal identification number that
protects the confidentiality of the patient's identity. The
bill is opposed by the ACLU and numerous other AIDS-related
organizations in a joint letter on grounds that the bill, among
other things, erodes informed consent for HIV testing in both
clinical and nonclinical settings, and eliminates documented
consent for HIV testing. Although several specific concerns in
the joint letter are addressed by the author's proposed
amendments, it could not be determined at the time of this
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analysis whether the proposed author's amendments are sufficient
to cause any or all of the signatories to the joint letter to
remove their opposition to the bill. Should the bill be
approved by this Committee, it will be referred to the Assembly
Health Committee for focused analysis of issues raised by
expanding laboratory testing of blood draws that is more
appropriately analyzed under the expertise of the Health
Committee.
SUMMARY : 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. Provides instead that, in a
non-clinical setting, informed consent may be provided orally
or in writing, but the person administering the test must
maintain documentation of consent, whether obtained orally or
in writing, in the client's record.
2)Modifies the information that a medical provider is required
to give to a person about to receive a HIV test in a clinical
setting.
3)Exempts from the opt-out screening requirement any person who
independently requests an HIV test from a medical care
provider, public health clinic, laboratory, or HIV counseling
and testing site that employs a trained HIV counselor pursuant
to Section 120917.
4)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.
5)Exempts the emergency department of a general acute care
hospital from the general requirement that each draw of blood
ordered for a patient be tested for HIV, provided patient
consent has been obtained.
6)Allows, under specified circumstances, the result of an HIV
test to be posted on a secure Internet Web site viewable only
with the use of a secure personal ID number provided to the
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patient at the time of testing.
EXISTING LAW :
1)Requires a medical care provider, prior to ordering an
HIV-diagnostic test, to inform the patient that the test is
planned, provide information about the test, inform the
patient that there are numerous treatment options available
for a patient who tests positive for HIV and that a person who
tests negative for HIV should continue to be routinely tested,
and advise the patient that he or she has the right to decline
the test. Further provides that if a patient declines the
test, the medical care provider shall note that fact in the
patient's medical file. (Health and Safety Code Section
120990(a).)
2)Provides that the above requirements do not apply when a
person independently requests an HIV test from the provider.
(Section 120990(b).)
3)Except as provided (including in clinical health care
settings), prohibits a person from administering any test for
HIV infection unless the person being tested or his or her
parent, guardian, conservator, or other designee, signs a
written statement documenting the person's informed consent to
the test. (Section 120990(c.)
4)Establishes the position of HIV counselor, a person trained by
the Department of Public Health (DPH) Office of AIDS (OA) and
working in an HIV counseling and testing site funded by DPH or
that complies with a quality assurance plan approved by the
local health department. (Section 120917(a).)
5)Allows HIV counselors to order and report HIV, HCV and other
test results to patients without authorization from a licensed
health care professional. (Section 120917(a).)
6)Requires that the patient be informed that the preliminary
result of the HIV test is indicative of the likelihood of
infection, and the results must be confirmed with additional
testing, and further requires that patients with indeterminate
or positive test results be referred to an appropriate
licensed heath care provider. (Section 120917(a).)
7)Provides that, unless the patient requests the disclosure or
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other criteria are met, an HIV antibody test and any other
related results shall not be disclosed to a patient by
Internet posting or other electronic means. (Section
123148(f).)
8)Requires every individual or group health care service plan
contract that is issued, amended, or renewed on or after
January 1, 2009, that covers hospital, medical, or surgery
expenses to provide coverage for human immunodeficiency virus
(HIV) testing, regardless of whether the testing is related to
a primary diagnosis. (Section 1367.46.)
COMMENTS : This bill, sponsored by the AIDS Healthcare
Foundation, 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. As proposed to be amended, this bill would no longer
require an HIV counselor working in a non-clinical setting 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
website that a test subject may access with a unique personal
identification number that protects the confidentiality of the
patient's identity.
This Analysis Focuses On Issues Related To Informed Consent : In
addition to the above provisions, this bill also seeks to
require that every public health clinic or urgent care center,
if it otherwise draws blood from a patient, to test that blood
for HIV with the patient's consent. As proposed to be amended,
the bill no longer applies this requirement to hospital
emergency departments. Although the author has identified an
area where it seems that additional actions could be taken to
further the goal of expanding HIV testing, the specific proposal
set forth by the author remains controversial and appears to
involve practical medical and clinical considerations that are
properly outside the expertise of this Committee. Fortunately,
the bill is scheduled to be heard by the Health Committee,
should it be approved by this Committee. For these reasons,
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this analysis will primarily focus on the informed consent
issues raised by this bill, and the issues raised by expanding
laboratory testing of blood draws and by internet disclosure of
test results will be specifically examined and analyzed by the
Health Committee.
Author's Statement: 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.
State law explicitly authorizes HIV counselors to
administer the rapid HIV test, which has swiftly
become the most common testing protocol in the field.
However, because of a shortcoming in the law, an HIV
counselor is required to get a higher level of consent
than other medical providers. Requiring HIV
Counselors to seek a more rigid form of consent
undermines their ability to provide testing services
to people who are out-of-sync with traditional health
care delivery.
Recent HIV Statistics in California: The author and sponsor
cite compelling HIV epidemiological research and figures that
highlight the continued need for greater HIV screening and
prevention efforts. In August 2012, the California Department
of Public Health published the "California HIV/AIDS
Epidemiological Profile: 2009 Update", reflecting its analysis
of 2009 data-the most recent complete year that full statewide
data are available. (See
http://www.cdph.ca.gov/programs/aids/Documents/RSEpiProfileUpdate
2009.pdf ) Among other things, DPH found:
In 2009, there were 5,380 persons newly diagnosed with
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HIV infection in California.
There are approximately 110,966 persons in California
with HIV who were presumed to be living at the end of 2009.
More than 20,000 Californians do not know they are
HIV-positive, meaning that they are not getting treatment
and may be unknowingly exposing uninfected people to HIV.
HIV infection continues to disproportionately impact
black and Latino Californians.
o Latinos constitute the largest racial/ethnic
group newly diagnosed with HIV infection in 2009
(2,050 versus 1,880 whites and 1,091 blacks). Latinos
made up 38.1 percent of all newly diagnosed HIV
infection cases in 2009.
o The rate of newly diagnosed HIV infection
cases in 2009 was about five times greater among
blacks than whites. The rate of HIV infection
diagnoses among black males was three times that of
white males, and among black females the rate was 11
times that of white females.
o While black females represented only 6 percent
of California's female population, they accounted for
more than one-third (35 percent) of new female HIV
diagnoses in 2009.
The age at new diagnoses has shifted significantly since
2000. The proportion of newly diagnosed cases in the
20-29-year-old age group has increased significantly, while
the proportion of 30-39 year olds has likewise
significantly decreased.
What Is Informed Consent? First used in Salgo v. Leland
Stanford Jr. University Board of Trustees (1957) 154 Cal.App.2d
560 and followed by Cobbs v. Grant (1972) 8 Cal.3d 229, the
principle of "informed consent" has been fine-tuned, but not
significantly varied, by more recent cases. The American
Medical Association writes that informed consent is "more than
simply getting a patient to sign a written consent form. It is
a process of communication between a patient and physician that
results in the patient's authorization or agreement to undergo a
specific medical intervention. In the communications process ?
the patient should have an opportunity to ask questions to
elicit a better understanding of the treatment or procedure, so
that he or she can make an informed decision to proceed or to
refuse a particular course of medical intervention." (American
Medical Association, AB 446
Page 7
ip-topics/informed-consent.page> [as of June 29, 2012].)
CDC defines informed consent for HIV testing as "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." MMWR (2006),
55(RR14), p.1-17. Available at:
http://www.cdc.gov/mmWr/preview/mmwrhtml/rr5514a1.htm .)
A requirement for written consent, on the other hand, 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 standard, such as simple consent.
Previous Legislation Changing Consent In Clinical Settings :
Existing California law requires a medical care provider, prior
to ordering an HIV-diagnostic test, to inform the patient that
the test is planned, and to advise the patient that he or she
has the right to decline the test. This standard, known as
"opt-out screening," was enacted in 2007 by AB 682 (Berg), Ch.
550, Stats. 2007, and replaced the standard of written, informed
consent that applied to HIV testing in clinical settings prior
to that. The legislative history of AB 682 indicates that the
Legislature approved opt-out screening in lieu of informed
consent based, in part, on the CDC's 2006 recommendations to
allow opt-out screening in health-care settings. The CDC report
explains why, in the clinical setting, the patient's general
consent for medical care is an important factor that justifies
relaxing specific informed consent, stating:
Patients or persons responsible for the patient's care
should be notified orally that testing is planned,
advised of the indication for testing and the
implications of positive and negative test results, and
offered an opportunity to ask questions and to decline
testing. With such notification, the patient's general
consent for medical care is considered sufficient for
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diagnostic HIV testing.
The Committee is unaware of any subsequent CDC set of
recommendations that recommend the use of opt-out screening
instead of informed consent in non-clinical settings. A 2013
CDC-issued implementation guide specifically for operators of
non-clinical settings, without making any direct
recommendations, continues to provide guidance consistent with
informed consent practices. (CDC, Planning and Implementing HIV
Testing and Linkage Programs in Non-Clinical Settings (2013),
Chap. 6.)
Changes Under This Bill to Information And Consent Procedures in
Non-Clinical Settings : According to the sponsor, AHF, "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. (See:
http://www.nccc.ucsf.edu/consultation_library/state_hiv_testing_l
aws .)
Existing law requires both written consent and informed consent
for HIV testing in non-clinical settings. As proposed to be
amended, this bill would no longer require a person working in a
non-clinical setting 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. The author's proposed amendment would presumably help
increase HIV testing by eliminating one of the major obstacles
to testing, as reported by AHF, but at the same time preserves
the important purposes that informed consent serves by ensuring
exchange of information and an opportunity for dialogue.
Modest Changes to Information Procedures Prior to HIV Testing in
the Clinical Setting : Existing California law requires a
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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.
As proposed to be amended, this bill makes a few modest changes
to these informational requirements. First, a provider must
inform the patient of risk reduction strategies before the test
is given, but need not inform the patient that a person who
tests negative for HIV should continue to be routinely tested.
Second, the bill requires the provider, after the results of the
tests have been received, to give the patient information to
explain the results and implications for the patient's health.
In addition, the provider shall deliver additional specified
information to the patient depending on the outcome of the
test-information about treatment options and follow-up care for
someone who has tested positive for HIV, different information
about the need for periodic retesting for someone who has tested
negative and is known to be at high risk. The information
specified under the author's amendments is either information
already required to be given before the test under existing law,
or else closely reflects the CDC 2006 recommendations for
post-test disclosure of information. 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.
Streamlining Pre-Test Procedure When a Patient Independently
Requests an HIV Test : 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. As proposed
to be amended, this bill would expand that principle to
situations where the person requests an HIV test not just from a
provider, but from a public health care clinic, laboratory, or
counseling and testing site that employs a trained HIV
Counselor. In cases where an independent request for testing
has been made, simple consent by the requesting person would be
sufficient to authorize the HIV test.
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ARGUMENTS IN OPPOSITION : The Committee received a joint letter
signed by the ACLU, and representatives of numerous other
AIDS-related organizations. In short, these signed individuals
and organization oppose the bill on grounds that the bill: (1)
erodes informed consent for HIV testing in both clinical and
nonclinical settings; (2) eliminates documented consent for HIV
testing; (3) imposes a requirement that HIV testing be conducted
every time that blood is drawn from any patient in certain
medical settings unless the patient withholds consent; and (4)
fails to provide linkages to care for those who test
HIV-positive.
With respect to informed consent, these opponents state, among
other things:
Informed consent in testing is of particular
importance in nonclinical settings: individuals who
seek tests in nonclinical settings frequently come
from high-risk populations, and are more likely to
test positive. These individuals have a greater need
for a guarantee of information and counseling to
ensure adequate linkage to care and services.
Requiring informed consent in nonclinical settings
creates no barrier to HIV testing. HIV counselors in
nonclinical settings are trained according to
California state requirements to provide information
and counseling on HIV testing and are prepared to
provide the information that informed consent
requires.
Moreover, eroding informed consent may undermine
effective testing and treatment. HIV remains a deeply
stigmatized disease, with life-long consequences, for
which effective treatment requires significant
cooperation from the patient for a lifetime. Numerous
studies show that people living with HIV are more
likely to adhere to their treatments when there is
greater communication and trust between patient and
health care provider. Testing without informed
consent, or even patient knowledge, may undermine such
relationships, contributing to patients being
distrustful of medical providers and less likely to
seek or follow through with treatment.
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As proposed to be amended, this bill retains informed (but not
written) consent for HIV testing in non-clinical settings, and
mitigates changes to existing law specifying pre-test
information to be given before an HIV test in the clinical
setting. Several other specific concerns in the joint letter
are addressed by the author's proposed amendments. However, it
could not be determined at the time of this analysis whether the
proposed author's amendments are sufficient to cause any or all
of the signatories to the joint letter to remove their
opposition to the bill.
In addition, the Association of California Healthcare Districts
and California Hospital Association submitted letters opposing
the bill over the provisions requiring an HIV test to be
performed for each blood draw that is ordered for a patient in
the emergency department of a general acute care hospital. The
proposed amendments remove this requirement for emergency
departments, but preserve the requirement for public health
clinics and urgent care clinics. It is believed but not known
for certain that the author's amendment may be sufficient to
remove the opposition of the health care districts and hospitals
to the bill. In any case, as previously stated, the mandatory
blood-testing issues will be more closely analyzed in the Health
Committee, should the bill be approved by this Committee.
REGISTERED SUPPORT / OPPOSITION :
Support
AIDS Healthcare Foundation (AHF) (sponsor)
Beyond AIDS
Black AIDS Institute
Black Women for Wellness
California Black Women's Health Project
Opposition
Association of California Healthcare Districts
California Hospital Association
Joint letter signed by representatives from the following
organizations:
American Civil Liberties Union
Williams Institute, UCLA School of Law
Equality California
Being Alive Los Angeles
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Courage Campaign
Center for HIV Law and Policy
Los Angeles HIV Law and Policy Project
Disability Rights Legal Center
HIV Prevention Justice Alliance
Health and Human Rights Law Project, UCLA School of Law
Analysis Prepared by : Anthony Lew / JUD. / (916) 319-2334