BILL ANALYSIS Ó
AB 446
Page 1
Date of Hearing: May 7, 2013
ASSEMBLY COMMITTEE ON HEALTH
Richard Pan, Chair
AB 446 (Mitchell) - As Amended: April 30, 2013
SUBJECT : HIV testing.
SUMMARY : Requires each draw of blood ordered for a patient in a
public health clinic or an urgent care center to be tested for
HIV, provided that the patient has consented to the HIV test, as
specified. Deletes the requirement that a written statement be
obtained from anyone who is administered a test for HIV
infection and replaces this with informed consent which may be
provided orally or in writing. Authorizes the release of the
result of an HIV antibody test on an Internet Website, under
certain conditions. Specifically, this bill :
1)Requires each draw of blood ordered for a patient in a public
health clinic or an urgent care center to be tested for HIV,
provided that the patient has consented to the HIV test, as
specified. Requires the public health clinic or urgent care
center to provide the test results to the patient before he or
she leaves the facility, unless the patient leaves the
facility prior to being released.
2)Deletes a requirement, for persons other than a medical
provider, that prohibits a person from administering a test
for HIV infection unless the person being tested or his or her
parent, guardian, conservator, or other person, as specified,
signs a written statement documenting the person's informed
consent to the test.
3)Requires, before a person other than a medical provider can
administer a test for HIV infection, the person being tested,
his or her parent, guardian, conservator, or other person as
specified, to provide informed consent for the performance of
the test. Allows informed consent to be provided orally or in
writing, and requires the person administering the test to
maintain documentation of consent, whether obtained orally or
in writing, in the client's medical record. Exempts from
these requirements a test performed at an alternative testing
site, as specified. Provides that these provisions do not
authorize a person to administer a test for HIV unless that
person is otherwise lawfully permitted to administer an HIV
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test.
4)Requires the medical provider, after the results of an HIV
test have been received, to ensure that the patient receives
timely information and counseling, as appropriate, to explain
the results and the implications for the patient's health.
Requires, if the patient tests positive for HIV infection, the
provider to inform the patient that there are numerous
treatment options available and identify followup testing and
care that may be recommended. Provides that if the patient
tests negative for HIV infection and is known to be at high
risk for HIV infection, requires the provider to advise the
patient of the need for periodic retesting and may offer
prevention counseling or a referral to prevention counseling.
5)Provides if a person independently requests an HIV test,
existing requirements, such as informing a patient about
treatment options and risk reduction strategies that apply to
medical providers who order HIV tests, do not apply to a
public health clinic, laboratory, or HIV counseling and
testing site that employs a trained HIV counselor, as
specified.
6)Deletes the requirement of a medical provider who orders an
HIV test to inform a patient who tests negative for HIV to
continue to be routinely tested.
7)Deletes existing provisions that exempt blood tested for HIV
infection from the requirement that a written statement be
obtained from anyone who is administered a test for HIV
infection when that blood is tested as part of a scientific
investigation conducted either by a medical researcher
operating under the approval of an institutional review board
or by the Department of Public Health (DPH), in accordance
with a protocol for unlinked testing. Deletes the definition
of unlinked testing.
8)Authorizes the disclosure to a patient, by Internet posting or
other electronic means, of an HIV antibody test result when it
is posted on a secure Internet Website and can only be viewed
with the use of a secure personal identification number (PIN)
provided to the patient at the time of testing.
EXISTING LAW :
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1)Establishes the Office of AIDS within DPH, to coordinate state
programs, services, and activities related to HIV/AIDS.
2)Requires a medical provider, prior to ordering a test that
identifies infection with HIV, 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. Requires a medical provider,
if a patient declines the test for HIV, to note that fact in
the patient's medical file. Exempts from these provisions a
person who independently requests an HIV test from the
provider.
3)Prohibits a person other than a medical provider from
administering a test for HIV infection unless the person being
tested or his or her parent, guardian, conservator, or other
person as specified, signs a written statement documenting the
person's informed consent to the test. Exempts from these
provisions blood tested for HIV infection as part of a
scientific investigation conducted either by a medical
researcher operating under the approval of an institutional
review board or by DPH, in accordance with a protocol for
unlinked testing, as defined. Defines unlinked testing as
blood samples that are obtained anonymously, or that have the
name or identifying information of the individual who provided
the sample removed in a manner that prevents the test results
from ever being linked to a particular individual who
participated in the research or study.
4)Establishes the AIDS Drug Assistance Program (ADAP) within DPH
to subsidize the cost of AIDS drugs for persons who do not
have private health coverage, are not eligible for Medi-Cal,
or cannot afford to purchase the drug privately. Indicates
that the subsidy program is to be funded though state and
federal sources.
5)Establishes the federal Ryan White HIV/AIDS Treatment
Extension Act (Ryan White Act) to provide grants to states and
territories to improve the quality, availability, and
organization of HIV/AIDS healthcare and support services.
6)Establishes the Low Income Health Program within the
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Department of Health Care Services as an optional
Medi-Cal-like program that expands primary medical coverage to
certain uninsured, low-income adults, including some
HIV-positive individuals who receive Ryan White Act and or
ADAP services.
7)Provides that a minor may consent to medical care or dental
care if all of the following conditions are satisfied:
a) The minor is 15 years of age or older;
b) The minor is living separate and apart from his/her
parents or guardians, whether with or without the consent
of a parent or guardian and regardless of the duration of
the separate residence;
c) The minor is managing his/her own financial affairs,
regardless of the source of the minor's income; and,
d) The parents or guardians are not liable for medical care
or dental care provided, as specified.
FISCAL EFFECT : None
COMMENTS :
1)PURPOSE OF THIS BILL . The AIDS Healthcare Foundation is the
sponsor of this bill. According to the author, the control of
AIDS in our time is possible with the tools at our disposal
today. The key is finding those persons living with HIV who
do not know they are infected and linking them into care and
suppressing the presence of HIV through adherence to
anti-retroviral treatment. California, as one of the most
profoundly affected states, has led the way. Over the past
decade, California has devoted funding, modified testing
protocols, and focused on the need to test as the first line
of offense in efforts to reduce HIV infection rates and move
more people with HIV into treatment as early as possible.
These efforts have reduced the percentage of late testers
(those who are diagnosed with AIDS less than one year after
testing) from 50% to 35%. Additionally, the author states
that the federal Centers for Disease Control and Prevention
(CDC) has long recommended that routine HIV testing occur in
all health care settings. It is a substantial drag on
achieving the goal of real routine testing when we leave it to
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the patient to execute the state's public health policy on HIV
testing.
2)BACKGROUND .
a) HIV . According to the CDC, HIV or human
immunodeficiency virus, is a virus that can lead to
acquired immunodeficiency syndrome, or AIDS. Unlike some
other viruses, the human body cannot get rid of HIV. That
means that once you have HIV, you have it for life. No
safe and effective cure currently exists, but with proper
medical care, HIV can be controlled. Treatment for HIV is
often called antiretroviral therapy or ART which can
dramatically prolong the lives of many people infected with
HIV and lower their chance of infecting others. HIV
affects specific cells of the immune system, called CD4
cells, or T cells. Over time, HIV can destroy so many of
these cells that the body can't fight off infections and
disease. When this happens, HIV infection leads to AIDS.
According to DPH, as of December 31, 2012, there were a
total of 212,442 reported HIV/AIDS cases in California.
The conventional serum test for diagnosing HIV infection is
repeated reactive immunoassay, followed by confirmatory
Western blot or immunofluorescent assay. Conventional HIV
test results are available within one to two days from most
commercial laboratories. Rapid HIV testing may use either
blood or oral fluid specimens and can provide results in
five to 40 minutes, however, initial positive results
require confirmation with conventional methods.
According to a March 2013 HIV/AIDS Policy Fact Sheet from the
Kaiser Family Foundation, the first cases of what would
later become known as AIDS were reported in the U.S. in
June of 1981. Since then, more than 1.9 million people in
the U.S. are estimated to have been infected with HIV,
including over 650,000 who have already died. Today more
than 1.1 million people are living with HIV. The following
challenges remain: while the number of new HIV infections
(incidence) is down from its peak in the 1980s, new
infections have remained at about 50,000 per year for more
than a decade; HIV testing is important for both prevention
and treatment efforts and rapid testing is now much more
widely available. Routine HIV testing is now recommended
for all people ages 13-64, yet 18% of those infected with
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HIV do not know they are infected, and many people with HIV
(32%) are diagnosed late in their illness; treatment
advances have substantially reduced AIDS-related morbidity
and mortality and extended the lives of many. Current U.S.
HIV treatment guidelines recommend initiating ART as soon
as one is diagnosed with HIV. Still many people with HIV
are not in care, on treatment, or virally suppressed (the
point under which the virus is under control, helps a
person remain healthy, and reduces the risk of
transmission).
b) Recommendations by the U.S. Preventive Services Task
Force (PSTF) . The PSTF is an independent panel of
non-Federal experts in prevention and evidence-based
medicine and is composed of primary care providers (such as
internists, pediatricians, family physicians,
gynecologists/obstetricians, nurses, and health behavior
specialists). It conducts scientific evidence reviews of a
broad range of clinical preventive health care services
(such as screening, counseling, and preventive medications)
and develops recommendations for primary care clinicians
and health systems. These recommendations are published in
the form of "Recommendation Statements."
In April 2013, the PSTF updated its recommendations on HIV
Screening. It recommends that clinicians screen for HIV
infection in adolescents and adults aged 15 to 65 years .
Younger adolescents and older adults who are at increased
risk should also be screened. Additionally, clinicians are
recommended to screen all pregnant women for HIV, including
those who present in labor who are untested or whose HIV
status is unknown. The PSTF also found convincing evidence
that conventional and rapid HIV antibody tests are highly
accurate in diagnosing HIV infection. It found convincing
evidence that identification and treatment of HIV infection
is associated with a markedly reduced risk of progressions
to AIDS, AIDS related events, and death in individuals with
immunologic advance disease.
On screening intervals , the PSTF indicated there is
insufficient evidence to determine optimum time intervals
for HIV screening. One reasonable approach would be
one-time screening of adolescent and adult patients to
identify persons who are already HIV-positive, with
repeated screening of those known to be at risk for HIV
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infection, those who are actively engaged in risky
behaviors, and those who live or receive medical care in a
high-prevalence setting. A reasonable approach may be to
rescreen groups at very high risk for new HIV infection at
least annually and individuals at increased risk at
somewhat longer intervals (for example, three to five
years). Routine screening may not be necessary for
individuals who have not been at increased risk since they
were found to be HIV-negative. Women screened during a
previous pregnancy should be rescreened in subsequent
pregnancies.
c) CDC HIV Testing Recommendations . In 2006, the CDC
published its Revised Recommendations for HIV Testing of
Adults, Adolescents, and Pregnant Women in Health Care
Settings (CDC Recommendations). The CDC Recommendations
address HIV testing and are intended for all health care
providers in the public and private sectors, including
those working in hospital emergency departments (EDs),
urgent care clinics, inpatient services, substance abuse
treatment clinics, public health clinics, community
clinics, correctional healthcare facilities, and primary
care settings. Specifically, the CDC Recommendations
indicated the following:
i) Adults and Adolescents . In all healthcare settings,
screening for HIV infection should be performed routinely
for all patients aged 13-64 years old . All patients
seeking treatment for STDs, including all patients
attending STD clinics, should be screened routinely for
HIV during each visit for a new complaint, regardless of
whether the patient is known or suspected to have
specific behavior risks for HIV infection. Health care
providers should subsequently test all persons likely to
be at high risk for HIV at least annually. Persons
likely to be at high risk include injection-drug users
and their sex partners, persons who exchange sex for
money or drugs, sex partners of HIV-infected persons, and
men having sex with men or heterosexual persons who
themselves, or whose sex partners, have had more than one
sex partner since their most recent HIV test. Repeat
screenings of persons not likely to be at high risk for
HIV should be performed on the basis of clinical
judgment.
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ii) Pregnant Women . All pregnant women should be
screened for HIV infection. Screening should occur after
a woman is notified that HIV screening is recommended for
all pregnant patients and that she will receive an HIV
test as part of the routine panel of prenatal tests,
unless she declines. HIV testing must be voluntary and
free from coercion, and no woman should be tested without
her knowledge. Pregnant women should receive oral or
written information that includes an explanation of HIV
infection, a description of interventions that can reduce
HIV transmission from mother to infant, and the meaning
of positive and negative test results, and should be
offered an opportunity to ask questions and to decline
testing. Providers should discuss and address the
reasons for declining the HIV test. To promote informed
and timely therapeutic decision, health care providers
should test women for HIV as early as possible during
pregnancy. A second HIV test during the third trimester,
preferably greater than 36 weeks of gestation, is
cost-effective even in areas of low HIV prevalence and
may be considered for all pregnant women. A second HIV
test during the third trimester is recommended for women
who meet specified criteria. There are also
recommendations for rapid testing during labor,
postpartum/newborn testing, and confirmatory testing.
iii) Consent and Pretest Information . Screening should
be voluntary and undertaken only with the patient's
knowledge and understanding that HIV testing is planned.
Patients should be informed orally or in writing that HIV
testing will be performed unless they decline (opt-out
screening). Oral or written information should include
an explanation of HIV infection and the meanings of
positive and negative test results, and the patient
should be offered an opportunity to ask questions and to
decline testing. With such notification, consent for HIV
screening should be incorporated into the patient's
general informed consent for medical care on the same
basis as other screening or diagnostic tests; a separate
consent form for HIV testing is not recommended. General
informed consent for medical care should be considered
sufficient to encompass informed consent for HIV testing.
Additionally, easily understood informational materials
should be made available in the languages of the commonly
encountered populations within the service area. The
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competence of interpreters and bilingual staff to provide
language assistance to patients with Limited English
Proficiency (LEP) must be ensured. If a patient declines
an HIV test, this decision should be documented in their
medical record. The CDC Recommendations define informed
consent 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.
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.
iv) Communicating Test Results . Definitive mechanisms
should be established to inform patients of their test
results. HIV-negative test results may be conveyed
without direct personal contact between the patient and
the health-care provider. Persons known to be at high
risk for HIV infection also should be advised of the need
for periodic retesting and should be offered prevention
counseling or referred for prevention counseling.
HIV-positive test results should be communicated
confidentially through personal contact by a clinician,
nurse, mid-level practitioner, counselor, or other
skilled staff. Because of the risk of stigma and
discrimination, family or friends should not be used as
interpreters to disclose HIV-positive test results to LEP
patients. Active efforts are essential to ensure that
HIV-infected patients receive their positive test results
and linkage to clinical care, counseling, support, and
prevention services. If the necessary expertise is not
available in the healthcare venue in which screening is
performed, arrangements should be made to obtain
necessary services from another clinical provider, local
health department, or community-based organization.
v) Rapid HIV Tests . Because of the time that elapses
before results of conventional HIV tests are available,
providing patients with their test results can be
resource intensive and challenging for screening
programs, especially in episodic care settings (e.g.,
EDs, urgent-care clinics, and STD clinics) in which
continuing relationships with patients typically do not
exist. The use of rapid HIV tests can substantially
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decrease the number of persons who fail to learn their
test results and reduce the resources expended to locate
persons identified as HIV infected. Positive rapid HIV
test results are preliminary and must be confirmed before
the diagnosis of HIV infection is established.
vi) Documenting HIV Test Results . Positive or negative
HIV test results should be documented in the patient's
confidential medical record and should be readily
available to all healthcare providers involved in the
patient's clinical management.
d) HIV Testing in Nonclinical Settings . According to the
CDC's "Planning and Implementing HIV Testing and Linkage
Programs in Non-Clinical Settings: A Guide for Program
Managers (Guidelines)," about 70% of sexually transmitted
cases of HIV are attributed to persons who are unaware of
their HIV-positive status, and nearly 50% of people who
test positive for HIV are diagnosed with AIDS within three
years. As such, persons most at risk for contracting HIV
or who may present with early infections are not being
reached by the clinical and non-clinical HIV testing
approaches used to date. Non-clinical settings are
settings in which medical, diagnostic, and/or treatment
services are not routinely provided. However, non-clinical
HIV testing programs provide selected diagnostic services
(HIV testing) and selected prevention services, and can
facilitate access to other medical and social services for
clients with positive or negative test results. Examples
of non-clinical settings include mobile testing units,
churches, parks, shelters, syringe services programs, and
other social service organizations. These Guidelines
indicate that there are various approaches to integrating
informed consent:
i) Provide clients with written information and consent
forms at intake. Clients can review information prior to
being engaged by testing staff. This may help prepare
them to ask questions about the test. Clients can sign
the consent form at the time of intake or after they have
had the opportunity to ask questions about HIV testing.
ii) Some agencies use computers to gather information
from clients at intake. This is referred to as
computer-assisted self-interviewing (CASI). Information
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about HIV testing and information relevant to consent to
test can be included in the CASI programming. It may be
possible to include consent as part of the CASI
programming.
iii) Provide clients with information about HIV and HIV
testing in a waiting room (or area designated as a
waiting area in cases of outreach testing). Information
can be provided to clients in written (e.g., a pamphlet),
video, or even audio formats. Information can be
presented verbally (or verbally in combination with
videos or written material) by, for example, a health
educator. Information can be provided to a group or to
one client at a time. Some agencies find it most
efficient to conduct group education sessions when there
is a high volume of clients, such as at a large community
event. In this scenario, individuals have the
opportunity to ask questions of the health educator, as
well as, the person performing the test.
iv) Provide information and obtain consent from clients,
one client at a time. In this scenario, one person on
staff is designated-it may or may not be the same
individual performing the test-to present information to
clients, allowing them to ask questions, and obtain
consent for HIV testing.
e) Disclosure of HIV Test Results . State and federal laws
govern the release of patient medical information,
including those of lab test results. California entitles
patients to the right to inspect and copy their patient
records upon written request and payment of reasonable
costs incurred in locating and making the records
available. Patients are also authorized to obtain the
results of lab test performed at the request of a health
care professional. These lab test results may also be
conveyed in electronic form if requested by the patient and
deemed appropriate by the health care professional who
requested the test.
AB 2253 (Pan), Chapter 698, Statutes of 2012, was enacted and
authorizes the conveyance of clinical laboratory test
results relating to HIV antibody test, presence of antigens
indicating a hepatitis infection, abuse of the use of
drugs, or test results related to routinely processed
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tissues that reveal malignancy, as specified, by Internet
posting or other electronic means to a patient where: i)
the patient requests a conveyance; ii) the health care
professional deems the conveyance as the most appropriate
means; and, iii) a health care professional has first
discussed the results with the patient. This bill provides
an exemption for an HIV antibody test results posted on a
secure Internet Website and can only be viewed with the use
of a secure personal identification number provided to the
patient at the time of testing.
3)SUPPORT . AIDS Healthcare Foundation states that this bill
addresses three testing reforms. First, it clarifies that HIV
testing can be provided with informed consent in a
non-clinical setting by any person statutorily authorized to
administer an HIV test. More and more testing is being
administered by HIV Counselors who are authorized to
administer the rapid HIV test. 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.
Second, this bill authorizes the tester to disclose an HIV
test result on a secure Website, for a test subject to access
with a unique code, in order to increase the number of test
subjects who actually learn of their test results. Finally,
this bill requires every public clinic and urgent care center,
if it otherwise draws blood from a patient, to test that blood
for HIV with the patient's consent. Since the CDC has long
recommended routine HIV testing occur in all health care
settings, it is a substantial drag on achieving the goal of
real routine testing when we leave it to the patient to
execute the state's public health policy on HIV testing.
4)OPPOSITION . The California Occupational Medicine Physicians
(COMP), whose occupational clinics treat not only injured
workers but also offer urgent care services for
non-occupational conditions, states that they understand the
desire to test for HIV to allow individuals to know if they
are HIV positive, but do not believe urgent care clinics or
occupational clinics are the appropriate setting for these
test and the subsequent counseling required under this bill.
COMP states that its physicians are not trained nor qualified
to "counsel" a patient if the results come back positive.
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Additionally, this bill does not give any parameters on what
is meant by "timely information and counseling."
The American Civil Liberties Union states that this bill
conflicts with research-based public health policy, the
individual rights of patients to meaningfully participate in
their healthcare, and current CDC guidance regarding HIV
testing by: a) eroding informed consent for HIV testing in
both clinical and nonclinical settings; b) eliminating
documented written consent for HIV testing; c) imposing a
requirement that HIV testing be conducted every time blood is
drawn from any patient in certain medical settings, unless the
patient withholds the consent; and, d) failing to provide
linkages of care for those who tests HIV-positive. These
groups point out that nothing has changed about the HIV/AIDS
epidemic to warrant replacing informed consent for HIV testing
in California with what is referred to as simple consent.
They also state that requiring health care workers to test
each draw of blood is costly and burdensome on the covered
health care providers, patients, insurance companies, and the
state, and that the bulk of such testing will be unnecessary.
They state that they support offering patients HIV testing in
an environment that allows them to make a decision with
healthcare providers that will be a solid foundation for
ongoing treatment and care. Lastly, they indicate that HIV
screening without linkage confers little or no benefit to the
patient.
5)DOUBLE REFERRAL . This bill is double referred. It was heard
in the Judiciary Committee on April 30, 2013 and passed on a
10-0 vote.
6)RELATED LEGISLATION . AB 506 (Mitchell) provides social
workers with additional authority 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. AB
506 is currently pending on the Assembly Floor.
7)PREVIOUS LEGISLATION .
a) AB 491 (Portantino) of 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
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of a negative HIV antibody test to be posted on a secure
Internet Website if specified conditions were met. The
funding and disclosure provisions were eventually amended
out and the bill was eventually amended to deal with a
different subject matter.
b) AB 1894 (Krekorian), Chapter 631, Statutes of 2008,
requires health care service plans and disability insurers
selling health insurance to offer testing for HIV
antibodies and AIDS, regardless of whether the testing is
related to a primary diagnosis.
c) AB 682 (Berg), Chapter 550, Statutes of 2007, revises
the written and informed consent standards associated with
testing blood for HIV, including prenatal HIV testing, to
no longer require affirmative approval prior to
administering an HIV test. Establishes the new HIV testing
consent standard as the right to decline the test,
providing that medical care providers present specified
information to the individual about treatment options and
the individual's right to decline the test, and the medical
care provider notes in the chart when the patient declines
to be tested. Exempts HIV testing at an alternative test
site, as part of an autopsy, or when part of scientific
research from these provisions.
8)AUTHOR'S AMENDMENTS .
a) Technical amendments . The author would like to amend
this bill and maintain existing consent exemption for blood
tested as part of a scientific investigation for purposes
of unlinked testing.
b) HIV Testing for Each Draw of Blood . Revises the bill
to:
i) Require HIV testing on patients between the ages of
15 and 65;
ii) Requires the public health clinic or urgent care
center to comply with specific requirements if it chooses
to test a patient using a rapid HIV test;
iii) Requires the public health clinic or urgent care
center to attempt to provide the test results to the
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patient, and if that is not possible, the facility may
inform the patient with a positive test result in a
manner consistent with current law. However, in any
case, the public health clinic or urgent care center
shall comply with the requirements relating to
counseling;
iv) Provides that a public health clinic or urgent care
center is one that is subject to Section 1204(a) of the
Health and Safety Code, including a primary care clinic
that is directly conducted, maintained, or operated by
this state or any of its political subdivisions or
districts, or by any city, and any clinic identified in
subdivision (g (clinic operated by, or affiliated with,
any institution of learning that teaches a recognized
health art, as specified)), (h (clinic operated by a
primary care community or free clinic and that is
operated on separate premises from the licensed clinic
and is only open for limited services of no more than 20
hours a week) ) and (j (student health centers operated
by public institutions of higher education)) of Section
1206.
v) Indicates that this section does not apply if the
public health clinic or urgent care center has tested the
patient for HIV within the previous year.
c) Disclosure of HIV Tests on the Internet or Other
Electronic Means . Requires an HIV test result to be posted
only if there is no link to any information that identifies
the subject of the test.
9)POLICY QUESTIONS .
a) Frequency of testing . The author's amendments indicate
that testing is limited to one per year, regardless of
whether a patient is considered at a high-risk or low-risk
for HIV infection. However, as the PSTF indicates there is
insufficient evidence to determine optimum time intervals
for HIV screening. One-time screening of adolescent and
adult patients is reasonable as well as rescreening very
high risk populations at least annually. Should repeated
or routine screening for HIV be limited to those known to
be at risk for HIV infection, those who are actively
engaged in risky behaviors, and those live or receive
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medical care in a high-prevalence setting? For low risk
populations, if testing occurs once per year, there could
be unnecessary testing and documentation at increased cost
to increasingly overburdened clinics and health centers.
b) Cost Implications . What are the cost implications of
such frequent testing on health care providers, payers and
patients? Although Medi-Cal, other public programs, and
health plans and disability insurers may cover testing for
HIV/AIDS, many patients served in community clinics have no
insurance or Medi-Cal coverage. For them, who will pay for
the added expense of this testing?
c) Linkage of care . This bill only indicates that public
health clinics and urgent care centers provide the test
results to the patient before he or she leaves the
facility. The CDC Recommendations point out that HIV
screening without linkage to medical care confers little or
no benefit to the patient. The Committee may wish to amend
this bill to include provisions on linking positive test
results notification to medical treatment.
d) Informed Consent . Existing law requires for purposes of
HIV testing in non-clinical settings, a person
administering a test to first obtain a written statement
documenting the informed consent of the person to be
tested. This bill deletes this requirement and instead
requires an oral or written informed consent to be
documented in the patient's medical record.
The CDC Recommendation for purposes of healthcare settings
states that patients should be informed orally or in
writing that HIV testing will be performed unless the
patient declines. The oral or written information should
include explanation of HIV infection and the meaning of
positive or negative results and give the patient
opportunity to ask questions. The CDC points out that with
such notification, consent for HIV screening should be
incorporated into the patient's general informed consent
for medical care on the same basis as other screening or
diagnostic tests and a separate consent form for HIV
testing is not recommended. In the CDC Guidelines for
non-clinical settings specified in 2) d) above, the CDC
indicates there are various approaches to integrating
informed consent, including providing clients with written
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information and consent forms at intake; using CASI
programming; or providing clients with information about
HIV and HIV testing in a waiting room/area using video or
audio formats, pamphlets either individually or in a group
format. Concerns remain that the changes in this bill
erode the informed consent requirements, and that the
written statement requirement should be maintained for HIV
testing in non-clinical settings.
e) Consent of Minors . The Family Code authorizes a minor
to consent to medical care or dental care under certain
conditions: the minor is 15 years of age or older; the
minor is living separate and apart from his/her parents or
guardians, whether with or without the consent of a parent
or guardian and regardless of the duration of the separate
residence; the minor is managing his/her own financial
affairs, regardless of the source of the minor's income;
and, the parents or guardians are not liable for medical
care or dental care provided, as specified. To be
consistent with existing law, the consent requirements for
minors in the Family Code should be cross referenced for
purposes of HIV testing.
f) Disclosure of HIV test results through the Internet or
other electronic means . This bill allows disclosure of HIV
test results through the Internet or electronic means if
the test result is posted on a secure Internet Website and
can only be viewed with the use of a PIN. Current law
requires that prior to the disclosure of HIV (and other
sensitive test results) through such mediums, as long as
the patient requests the disclosure, the health care
professional deems the disclosure as appropriate, and the
health care professional has first discussed the
test/results with the patient. In an ideal world,
healthcare providers would always discuss test results with
their patients ahead of electronic disclosure of the
results, however there are circumstances where this
conversation may not occur in a timely manner, if at all.
This bill raises a question about whether the benefits of
immediate direct patient disclosure of test results
outweigh the benefit of the healthcare provider
communication with the patient prior to communication of
the results of the test. This bill also raises a question
about whether or not HIV test results should be
communicated differently than other sensitive test results
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such as hepatitis, abuse of drugs, and malignant tissue.
g) Legislative mandates of professional guidelines . The
objective of this bill to help inform individuals with HIV
about their status and potentially get them into treatment
is laudable. However, this bill mandates guidelines to
test for HIV regardless of the risk level of the patient.
Additionally, this bill goes beyond professional
guidelines.
REGISTERED SUPPORT / OPPOSITION :
Support
AIDS Healthcare Foundation (sponsor)
California Communities United Institute
Opposition
American Civil Liberties Union
California Occupational Medicine Physicians
Analysis Prepared by : Rosielyn Pulmano / HEALTH / (916)
319-2097