BILL ANALYSIS Ó
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 1382
A
AUTHOR: Hernández
B
AMENDED: March 31, 2011
HEARING DATE: June 29, 2011
1
CONSULTANT:
3
Orr
8
2
SUBJECT
HIV counselors
SUMMARY
Permits HIV counselors to perform skin punctures for
hepatitis C virus (HCV) tests, or combination HIV/HCV
tests, under specified conditions.
CHANGES TO EXISTING LAW
Existing federal law:
Establishes quality standards for all laboratory testing
under the Clinical Laboratory Improvement Amendments (CLIA)
in 1988. Classifies tests according to their complexity.
Waives certain tests from CLIA requirements when those
tests use direct, unprocessed specimens (such as whole
blood or oral fluid), can be easily performed with a
negligible chance of error, and can be performed by persons
without formal laboratory training outside of traditional
laboratories.
Existing state law:
Requires that HIV counselors, who provide information and
Continued---
STAFF ANALYSIS OF ASSEMBLY BILL 1382 (Hernández) Page
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resources about HIV testing, treatment, and counseling,
either be:
Trained by the California Department of Public
Health (CDPH) Office of AIDS (OA) and working in an
HIV counseling and testing (C&T) site funded by CDPH,
or
Working in an HIV C&T site that uses HIV counselors
who are trained by CDPH/OA or its agents and that
complies with a quality assurance plan approved by the
local health department.
Permits HIV counselors, meeting one of the abovementioned
criteria, to do the following:
Perform any CLIA-waived HIV test, provided the test
meets CLIA requirements and provided the person meets
the requirements for the performance of waived
laboratory testing.
Perform skin punctures to withdraw blood for an HIV
test, provided the counselor is authorized and working
under the direction of a licensed physician and
surgeon, and provided the counselor has been trained
in oral swab tests, skin puncture tests, and universal
infection control precautions.
Allows HIV counselors to order and report test results to
patients without authorization from a licensed health care
professional. 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. Requires that patients with
indeterminate or positive test results be referred to an
appropriate licensed heath care provider.
Requires HIV counselors to receive specified training.
Prohibits HIV counselors from performing skin punctures
until training is complete, with specified exceptions.
Clarifies that these provisions do not authorize HIV
counselors to act as phlebotomy technicians.
This bill:
Permits HIV counselors who are authorized under existing
law to perform skin punctures to administer an HIV test, to
also perform skin punctures for HCV tests or combination
HIV/HCV tests.
STAFF ANALYSIS OF ASSEMBLY BILL 1382 (Hernández) Page
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FISCAL IMPACT
The Assembly Appropriations Committee analysis estimates a
negligible direct state fiscal impact, and an unknown
indirect state fiscal impact on state health programs, to
the extent that added flexibility in administration of
these tests encourages more testing, diagnosis, and
treatment of HCV and HIV.
BACKGROUND AND DISCUSSION
The author has introduced AB 1382 to allow HIV counselors
who are authorized to perform HIV tests waived under CLIA,
to also perform any HCV test that is also waived under
CLIA. The author claims that currently, HIV counselors who
are trained by CDPH/OA are currently allowed to perform an
oral swab for the rapid oral HIV test. Until recently,
there was no FDA-approved rapid HCV test available, which
meant that the counselors' clients wishing to be tested for
HCV had to use self-administered HCV antibody fingerstick
tests. These tests require that a client return after two
weeks to receive his or her test results, which the author
asserts results in a substantial proportion of clients not
receiving necessary referrals for follow-up testing and
support services, and potentially puts others at risk for
infection. The author claims that the FDA recently
approved a rapid HCV test, which works similarly to the
rapid HIV test by providing immediate results. Allowing HIV
counselors to administer a rapid HCV test would help
address the problem of clients failing to return for test
results, increase the number of persons with HCV who
receive counseling and referrals, and decrease the risk of
further transmission stemming from undiagnosed infections.
HCV
HCV infection is the most common chronic bloodborne
infection in the United States. Approximately 3.2 million
persons are chronically infected nationwide, and about
17,000 people are newly infected each year, according to
the Centers for Disease Control and Prevention (CDC). HCV
is associated with an estimated 12,000 deaths annually.
Approximately 75 to 85 percent of people who become
STAFF ANALYSIS OF ASSEMBLY BILL 1382 (Hernández) Page
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infected with HCV will develop chronic infections. In
California, HCV affects approximately 600,000 people, or 2
percent of the state's population, according to CDPH/OA.
Chronic HCV can have a wide range of outcomes, most
significantly liver failure. Symptoms associated with HCV
infection, including fatigue, abdominal bloating, flu-like
symptoms, and jaundice, are present in only 20 to 30
percent of cases; therefore, most infections go undiagnosed
until liver disease develops 20 to 30 years later.
HCV and HIV
CDPH/OA estimates that 50 to 80 percent of injection drug
users (IDUs) who are HIV-
positive are also infected with HCV. Both HIV and HCV are
transmitted by exposure to infected blood, and both can be
prevented by decreasing exposure to infected blood, for
example by using new sterile syringes and not sharing
injection equipment. Although HCV is not efficiently
transmitted sexually, persons at risk for infection through
injection drug use might seek care in facilities that treat
sexually transmitted diseases (STDs), HIV C&T facilities,
correctional facilities, drug treatment facilities, and
other public health settings where STD and HIV prevention
and control services are available. Unlike HIV, HCV can
potentially be cured by an infected individual's own immune
system or by medical treatment. HCV progresses more quickly
in people who are co-infected with HIV, and HCV treatment
is less successful in HIV-positive people than in
HIV-negative people.
C&T for HIV and HCV
According to CDPH/OA, offering HCV testing in conjunction
with HIV C&T has proven to be an effective prevention
strategy for identifying infected individuals and providing
referrals for treatment. Results from an HCV C&T
demonstration project in 2003 included the following:
HIV testing rates among IDUs nearly doubled when
HIV C&T was offered in conjunction with HCV C&T;
HIV test disclosure return rates increased by 21
percent among IDUs when individuals were able to
receive both their HCV and HIV test results; and
IDUs were more interested in their HCV status than
their HIV status.
In January 2008, CDPH/OA integrated HCV testing into its
STAFF ANALYSIS OF ASSEMBLY BILL 1382 (Hernández) Page
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HIV C&T program as an optional service that local health
jurisdictions could provide to those at risk for HCV
infection. Currently, CDPH/OA HIV test counselors assist
the client with using a self-administered HCV antibody
fingerstick test. The current HCV testing technology
requires that the client return after two weeks to receive
his or her test results.
CDPH/OA has also developed an online HCV training program
designed to provide information regarding HCV infection,
transmission, and screening, and to provide limited
information regarding clinical management and treatment for
people with HCV infection. The primary emphasis of the
training is on counseling people who are at risk or already
infected with HCV, and providing appropriate referrals. Of
the approximately 362 CDPH/OA HIV test counselors that are
currently certified, 121 have completed this online
training.
HCV rapid test
On June 25, 2010, the U.S. Food and Drug Administration
announced approval of the first rapid blood test for HCV
antibodies for individuals age 15 and older. The HCV rapid
antibody test is used to test individuals who are at risk
for infection with HCV and people with signs or symptoms of
hepatitis, but is not approved for use in the general
population. HCV rapid test kits, also known as one-step HCV
tests, use a portable device and test strips to detect HCV
antibodies in samples from oral fluid,
fingerstick/venipuncture whole blood, or collected
serum/plasma. Results are given in about 20 to 40 minutes
as either reactive or nonreactive.
With these HCV antibody test devices, if results are shown
as reactive, this could mean the person has a short-term
infection and will get better on their own, the person has
a long-term infection and is at risk for developing
cirrhosis or liver cancer later in life, the person was
infected in the past but is no longer infected, or that the
test produced a false positive result. The only way that a
person with a positive test can know if he/she is currently
infected is to have a follow-up medical evaluation and
blood test under the administration of a physician.
Approval of this rapid test means that more patients can be
STAFF ANALYSIS OF ASSEMBLY BILL 1382 (Hernández) Page
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notified of their HCV exposure faster so that they can
consult with their physician for appropriate health
measures. Rapid tests provided at the point-of-care can
also make HCV testing accessible in locations with limited
laboratory facilities and greatly reduce the number of
persons who do not return for their test results.
Related bills
AB 491 (Portantino) would revise the requirements for the
provision of information to, and obtaining the informed
consent of, a patient in connection with HIV testing.
Pending in Senate Health Committee.
Prior legislation
AB 221 (Portantino), Chapter 421, Statutes of 2009, permits
HIV counselors to perform basic skin punctures for the
purpose of administering rapid HIV tests.
AB 682 (Berg), Chapter 550, Statutes of 2007, revised the
written and informed consent standards associated with
testing blood for the 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.
AB 685 (Leno), Chapter 2, Statutes of 2004, exempts HIV
counselors from state regulations that require training and
certification for phlebotomy (practice of drawing blood)
technicians.
AB 1263 (Migden), Chapter 324, Statutes of 2001, permits
CDPH to participate in a rapid HIV test research program
conducted with the CDC.
Arguments in support
The County of Los Angeles believes that allowing HIV
counselors to also administer HCV or HCV/HIV tests
increases the availability of HCV screenings. They believe
early detection is important to increasing the number of
individuals who enter treatment, results in better outcomes
for patients, and reduces health care costs for undetected
HCV infections. CDPH claims that allowing HIV counselors
to administer a rapid, oral HCV test would help overcome
key challenges they face by providing clients with same-day
results. CDPH also believes AB 1382 would increase the
number of persons with HCV antibody who receive counseling
STAFF ANALYSIS OF ASSEMBLY BILL 1382 (Hernández) Page
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and referrals, decrease the risk of additional infections,
and allow HCV-infected clients to access earlier care.
PRIOR ACTIONS
Assembly Business, Professions and Consumer Protection:9- 0
Assembly Health: 18- 0
Assembly Appropriations: 16- 0
Assembly Floor: 78- 0
COMMENTS
1. Clarifying amendment. Page 2, line 35, after "HIV
infection" insert "or HCV exposure."
POSITIONS
Support: California Department of Public Health
California Hepatitis Alliance
Drug Policy Alliance
Harm Reduction Coalition
Los Angeles County Board of Supervisors
Oppose:One individual
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