BILL ANALYSIS Ó
SENATE JUDICIARY COMMITTEE
Senator Noreen Evans, Chair
2013-2014 Regular Session
AB 446 (Mitchell)
As Amended June 17, 2013
Hearing Date: July 2, 2013
Fiscal: Yes
Urgency: No
NR
SUBJECT
HIV testing
DESCRIPTION
This bill would revise the informed consent requirements when a
person is tested for HIV. Specifically, this bill would:
expand the existing provision that persons who independently
request an HIV test from a medical care provider in a clinical
setting are exempt from the informed consent requirements, to
tests requested in non-clinical settings by an HIV counselor;
require a person's independent request for an HIV test to be
documented by the person administering the test;
allow informed consent to be given orally or in writing;
require the person who administers a test to ensure the
patient receives timely information and counseling, as
appropriate, to explain the results and implications for the
patient's health;
would require, when a patient tests positive for HIV, the
person who administers the test to inform the patient that
there are numerous treatment options available, and identify
follow up testing and care that may be recommended, including
contact information for medical and psychological services;
require patients between 12 and 65 years of age who have blood
drawn at a primary care clinic, to be offered an HIV test, as
specified;
require a primary care clinic to attempt to provide test
results to a patient before he or she leaves the facility, but
would authorize the facility to inform a patient who tests
negative for HIV by telephone or letter, and require a
facility to inform a patient who tests positive for HIV in a
manner consistent with existing law; and
(more)
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authorize, under specified circumstances, the result of an HIV
test to be posted on a secure website which can only be viewed
with the use of a secure code that can access a single set of
test results, and that is provided to the patient at the time
of testing, as specified.
BACKGROUND
According to the Centers for Disease Control and Prevention
(CDC), in 2010, more than 1.1 million persons 13 years of age
and older were living with an HIV infection in the United
States, including 207,600 who were unaware of their infection.
Over the past decade, the number of people living with HIV has
increased while the annual number of new HIV infections has
remained relatively stable, indicating that HIV testing,
prevention, and treatment programs are reducing the rate of
transmission. However, the pace of new infections continues at
about 50,000 infections per year. (DHAP Annual Report, Division
of HIV/AIDS Prevention: Maximizing Impact,
[as of June 28, 2013].)
In 2007, AB 682 (Berg, Ch. 550, Stats. 2008) was introduced to
facilitate routine screening for HIV in all health care
settings, as recommended by the CDC. It sought to give
incentives to providers to comply with CDC guidelines, and make
HIV screening a routine part of health care delivery. The final
AB 682 language, which is now law, authorized HIV testing
without written, informed consent in clinical settings, but did
not remove the written consent requirement in non-clinical
settings. To address the need for more accessible testing for
high risk individuals, this bill would revise the existing
informed consent requirements, and expand the exemption from
written informed consent to non-clinical settings as well.
This bill unanimously passed out of the Senate Health Committee
on June 26, 2013.
CHANGES TO EXISTING LAW
Existing law 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, 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
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test. Existing law further provides that if a patient declines
the test, the medical care provider shall note that fact in the
patient's medical file. (Health & Saf. Code Sec. 120990(a).)
Existing law 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. (Health & Saf. Code Sec. 120990(c).)
Existing law provides that the above requirements do not apply
when a person independently requests an HIV test from the
provider. (Health & Saf. Code Sec. 120990(b).)
Existing law defines an HIV counselor as a person trained by the
Department of Public Health Office of AIDS 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. Additionally, existing law allows HIV counselors to
order and report HIV and other test results to patients without
authorization from a licensed health care professional. (Health
& Saf. Code Sec. 120917(a).)
Existing law requires that the patient be informed that the
preliminary result of the HIV test is indicative of the
likelihood of infection, but 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. (Health & Saf. Code
Sec. 120917(a).)
Existing law provides that, unless the patient requests the
disclosure or 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. (Health & Saf. Code
Sec. 123148(f).)
This bill would require a medical care provider inform patients
about HIV risk reduction strategies when obtaining informed
consent.
This bill would extend a provision in existing law exempting
clinical settings from the informed consent requirements to a
requested test at an HIV counseling and testing site, as
specified. This bill would also require a person's independent
request to be documented by the person administering the test.
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This bill would delete the requirement that a written statement
documenting informed consent for an HIV test be signed, and
instead require the informed consent to be provided orally or in
writing, as specified.
This bill would require, after the results of a test have been
received, the person who administers the test to ensure that the
patient receives timely information and counseling, as
appropriate, to explain the results and implications for the
patient's health.
This bill would require, if the patient tests positive for HIV
infection, the medical provider or the person who administers
the test to inform the patient that there are numerous treatment
options available, and identify follow up testing and care that
may be recommended, including contact information for medical
and psychological services.
This bill would require the person who administers the HIV test,
if a patient tests negative for HIV infection and is known to be
at high risk, to advise the patient of the need for periodic
retesting, explain the limitations of current testing technology
and the current window period for verification of results. The
person may also offer prevention counseling or a referral to
prevention counseling.
This bill would require a patient between 12 and 65 years of age
who has blood drawn at a primary care clinic, who has consented
to the HIV test, to be offered an HIV test. This bill would
also deem the primary care clinic to be in compliance with this
bill if it chooses to test the patient using a rapid HIV test.
This bill would require a primary care clinic to attempt to
provide test results to a patient before he or she leaves the
facility. If that is not possible, this bill would authorize the
facility to inform a patient who tests negative for HIV by
letter or telephone, and would require the clinic to inform a
patient with a positive test result in a manner consistent with
existing law.
This bill would authorize, under specified circumstances, the
result of an HIV test to be posted on a secure website which can
only be viewed with the use of a secure code that can access
only a single set of test results and is provided to the patient
at the time of testing. This bill would further require the
test result to be posted only if there is no link to any
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information that identifies or refers to the subject of the
test.
COMMENT
1.Stated need for the bill
According to the author:
In terms of arresting the continued spread of the HIV/AIDS
epidemic, absolutely nothing is more important than making
sure all persons with HIV know their status, receive immediate
treatment, and practice risk reduction techniques. The
provisions of AB 446 are very substantial, practical steps
toward furthering that objective.
2.Removing barriers to HIV testing
This bill seeks to remove barriers to HIV testing in clinical
and non-clinical settings. In large part, this is accomplished
through de-exceptionalzing HIV testing, so that is as similar as
possible to, and can be combined with, other routine medical
testing. This bill would make consent and pre-test information
easier to deliver, as recommended by the CDC, and move some of
the information that is required to be given to the patient from
pre-test to post-test. This bill would also encourage rapid
testing, and give the persons who administer an HIV test the
ability to post results on the Internet in a protected,
non-identifying form.
Under existing law, individuals who request an HIV test from a
health care provider, or "self-selecting" individuals, in a
clinical setting are not required to give informed consent to
the test. Thus, the medical care provider is not required 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, 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. The absence of the informed
consent requirement in this particular situation is justified
because the patient specifically asked to be tested for HIV,
which indicates that he or she has knowledge of the disease, and
the patient also has an ongoing relationship with the healthcare
provider who is able to follow up with the patient.
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The author notes that more and more testing is being
administered by HIV counselors, a profession created by statute
where counselors are trained and certified by the state. These
counselors, however, give tests in non-clinical settings, and
are therefore subject to different informed consent standards.
The sponsor argues that "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. The potential test subjects who visit
these 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."
Accordingly, this bill would make consent requirements for
self-selecting patients similar whether in a clinical or
non-clinical setting, and would allow informed consent for
non-self-selecting patients, to be given orally or in writing.
This bill would also encourage more routine testing of patients
by requiring that medical care providers offer an HIV test to
any patient, between the age of 12 and 65, who has blood drawn
at a primary care clinic. Additionally, this bill would
explicitly authorize the clinic to use the rapid HIV test.
3.Initial concerns have been addressed by prior amendments
As introduced, this bill had a lengthy list of opposition from
various groups. The author has worked diligently with
stakeholders to remove that opposition. Specifically, prior
versions of this bill would have required all emergency rooms
and urgent care clinics to offer an HIV test whenever a patient
had blood drawn.
This requirement was met with strong opposition from hospitals,
physicians, and other groups. In opposition, the California
Occupational Medicine Physicians wrote "many of our occupational
clinics not only treat injured workers but also offer urgent
care services for non-occupational conditions. We have concerns
?that these requirements would require an occupational physician
after the results of the test come back, regardless of the
result, to give the patient timely information and counseling."
Echoing this concern that emergency clinics are not well suited
for the sort of counseling required by HIV testing, the
California Society of Pathologists "while we share your concerns
with improved detection and treatment for HIV, the practical
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issues ? are substantial and we must therefore oppose those
provisions." The bill was subsequently amended to remove the
requirement that HIV tests be offered and given in emergency
rooms and urgent care clinics.
In addition, the American Civil Liberties Union led a coalition
of stakeholders who opposed prior versions of this bill. They
argued that it eroded informed consent in both the clinical and
non-clinical setting, eliminated documented consent for HIV
testing, and failed to provide linkages to care for those who
test HIV-positive. Working closely with these stakeholders, the
author has taken amendments to remove their concerns including:
(1) requiring documentation of a person's consent to HIV
testing; (2) requiring the person who administers the test to
ensure the patient receives timely information and counseling to
explain the results and implications of the test; and (3)
ensuring that a patient who tests positive for HIV is given
information about treatment options and the contact information
for medical and psychological services.
The author agreed to three additional amendments in the Senate
Health Committee which removed all remaining opposition. Those
amendments: (1) removed the requirement that prior to testing,
a medical care provider discuss risk reduction strategies; (2)
added the requirement that a medical care provider inform a
person who tests negative for HIV that he or she should continue
to be tested; and (3) corrected a technical error.
Author's amendments:
1. On page 2, lines 6 and 7, delete "and risk reduction
strategies"
2. On page 2, line 8, after "HIV" insert "and that a person
who tests negative for HIV should continue to be routinely
tested"
3. On page 4, line 7, delete "adminsters" and insert
"administers"
Support : Beyond AIDS; Black AIDS Institute; Black Women for
Wellness California Communities United Institute
Opposition : None Known
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HISTORY
Source : AIDS Healthcare Foundation
Related Pending Legislation : AB 506 (Mitchell) would authorize
social workers to consent to HIV testing for infants in
temporary custody, or who are adjudicated dependents, when such
testing is determined to be medically necessary and the parent
or guardian cannot be reached. This bill is currently on the
Senate Floor.
Prior Legislation :
AB 491 (Portantino, 2011) would have allocated state and federal
funds to test persons for HIV, would have specified that an HIV
counselor is a medical care provider, and would have authorized
a clinical laboratory test result of a negative HIV antibody
test to be posted on a secure website if specified conditions
were met. AB 491 was amended to deal with a different subject
matter.
AB 1894 (Krekorian, Chapter 631, Statutes of 2008) required
health care service plans and disability insurers selling health
insurance to offer testing for HIV and AIDS, regardless of
whether the testing is related to a primary diagnosis.
AB 682 (Berg, Chapter 550, Statutes of 2007) revised the written
and informed consent standards associated with testing blood for
HIV, including prenatal HIV testing.
Prior Vote :
Senate Health Committee (Ayes 9, Noes 0)
Assembly Floor (Ayes 72, Noes 1)
Assembly Appropriations Committee (Ayes 16, Noes 1)
Assembly Health Committee (Ayes 18, Noes 0)
Assembly Judiciary Committee (Ayes 10, Noes 0)
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