BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 1382|
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THIRD READING
Bill No: AB 1382
Author: Roger Hernández (D)
Amended: 7/7/11 in Senate
Vote: 21
SENATE HEALTH COMMITTEE : 8-0, 6/29/11
AYES: Hernandez, Strickland, Alquist, Anderson, Blakeslee,
De León, DeSaulnier, Wolk
NO VOTE RECORDED: Rubio
SENATE APPROPRIATIONS COMMITTEE : 9-0, 8/25/11
AYES: Kehoe, Walters, Alquist, Emmerson, Lieu, Pavley,
Price, Runner, Steinberg
ASSEMBLY FLOOR : 78-0, 5/19/11 (Consent) - See last page
for vote
SUBJECT : HIV counselors
SOURCE : Author
DIGEST : This bill permits HIV counselors to perform skin
punctures for hepatitis C virus (HCV) tests, or combination
HIV/HCV test, under specified conditions.
ANALYSIS :
Existing federal law :
1. Establishes quality standards for all laboratory testing
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under the Clinical Laboratory Improvement Amendments
(CLIA) in 1988. Classifies tests according to their
complexity.
2. 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 :
1. Requires that HIV counselors, who provide information
and resources about HIV testing, treatment, and
counseling, either be:
A. 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.
B. 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.
2. Permits HIV counselors, meeting one of the
abovementioned criteria, to do the following:
A. 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.
B. 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.
3. Allows HIV counselors to order and report test results
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to patients without authorization from a licensed health
care professional
4. 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.
5. Requires that patients with indeterminate or positive
test results be referred to an appropriate licensed
heath care provider.
6. Requires HIV counselors to receive specified training.
Prohibits HIV counselors from performing skin punctures
until training is complete, with specified exceptions.
7. 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.
Background
HCV . HCV infection is the most common chronic blood borne
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
infected with HCV will develop chronic infections. In
California, HCV affects approximately 600,000 people, or
two percent of the state's population, according to
CDPH/OA. Chronic HCV can have a wide range of outcomes,
most significant liver failure. Symptoms associated with
HCV infection, including fatigue, abdominal bloating,
flu-like symptoms, and jaundice, are present in only 0 to
30 percent of cases; therefore, most infections go
undiagnosed until liver disease develops 20 to 30 years
later.
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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.
IDUs were more interested in their HCV status than their
HIV status.
In January 2008, CDPH/OA integrated HCV testing into its
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
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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
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.
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FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
According to the Senate Appropriations Committee:
Fiscal Impact (in thousands)
Major Provisions 2011-12 2012-13
2013-14 Fund
Increased treatment of Unknown,
potentially significant General/
Individuals with HIV Federal/
And Hepatitis C Local
SUPPORT : (Verified 8/25/11)
California Department of Public Health
California Hepatitis Alliance
Drug Policy Alliance
Harm Reduction Coalition
Los Angeles County Board of Supervisors
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 and referrals, decrease the risk of
additional infections, and allow HCV-infected clients to
access earlier care.
ASSEMBLY FLOOR :
AYES: Achadjian, Allen, Ammiano, Atkins, Beall, Bill
Berryhill, Block, Blumenfield, Bonilla, Bradford,
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Brownley, Buchanan, Butler, Charles Calderon, Campos,
Carter, Cedillo, Chesbro, Conway, Cook, Davis, Dickinson,
Donnelly, Eng, Feuer, Fletcher, Fong, Fuentes, Furutani,
Beth Gaines, Galgiani, Garrick, Gatto, Gordon, Grove,
Hagman, Halderman, Hall, Harkey, Hayashi, Roger
Hernández, Hill, Huber, Hueso, Huffman, Jeffries, Jones,
Knight, Lara, Logue, Bonnie Lowenthal, Ma, Mansoor,
Mendoza, Miller, Mitchell, Monning, Morrell, Nestande,
Nielsen, Norby, Olsen, Pan, Perea, V. Manuel Pérez,
Portantino, Silva, Skinner, Smyth, Solorio, Swanson,
Torres, Valadao, Wagner, Wieckowski, Williams, Yamada,
John A. Pérez
NO VOTE RECORDED: Alejo, Gorell
CTW:do 8/29/11 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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