BILL ANALYSIS Ó
AB 1382
Page 1
Date of Hearing: May 3, 2011
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
AB 1382 (Roger Hernández) - As Amended: March 31, 2011
SUBJECT : HIV counselors.
SUMMARY : Permits HIV counselors who are authorized under
existing law to perform skin punctures to administer an HIV test
to also perform skin punctures for hepatitis C virus (HCV)
tests, or combination HIV/HCV tests, under specified conditions.
EXISTING LAW :
1)Establishes the federal Clinical Laboratory Improvement Act
(CLIA), which regulates clinical laboratories that perform
tests on human specimens and sets standards for facility
administration, personnel qualifications, and quality control.
Defines CLIA-waived tests as simple laboratory examinations
and procedures that are approved by the Food and Drug
Administration (FDA) for home use, employ methodologies that
are so simple and accurate as to render the likelihood of
erroneous results negligible, or pose no reasonable risk of
harm to the patient if the test is performed incorrectly.
2)Establishes the Office of AIDS (OA) within the Department of
Public Health (DPH) to be the lead agency in the state
responsible for coordinating state programs, services, and
activities related to HIV/AIDS.
3)Permits HIV counselors that meet specified requirements to
perform skin punctures for purposes of withdrawing blood for
HIV test purposes. Requires HIV counselors who perform those
skin punctures to be:
a) Trained by OA and working in a DPH-funded HIV counseling
and testing site through a local health jurisdiction, or
its agents; or,
b) Working in an HIV counseling and testing site that:
i) Utilizes HIV counseling staff who are trained by OA
or its agents; and,
ii) Has a quality assurance plan approved by the local
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health department in the jurisdiction where the site is
located and has HIV counseling and testing staff who
comply with the quality assurance requirements, as
specified.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, current law
allows counselors trained by OA to perform CLIA-waived rapid
HIV tests. These tests are simple, finger stick tests which
provide results in as little as one half hour. HIV counselors
receive training on this testing along with HCV testing during
the courses required to be an OA counselor. However, the
author states that to test for HCV, counselors must use a
"home test" kit, which requires the patient to perform the
finger-stick on themselves, give the testing kit to the
counselor, and then make an appointment to receive test
results in two weeks. According to the author, as a result,
follow-up appointments are kept in only about 35% of the
cases, leaving many in this population uninformed of their HCV
status. The author states that at the time the original law
was passed, there was no equivalent HCV test approved, but
that the FDA recently approved a CLIA-waived HCV rapid finger
stick test. The author contends that permitting HIV
counselors to perform this test allows this population to
receive both their HIV and HCV status at the time of the
visit.
2)BACKGROUND . Hepatitis C is a liver disease caused by HCV,
which is spread by contact with the blood or body secretions
of an infected person and affects approximately 600,000 people
in California. According to DPH, Hepatitis C is serious for
some persons, but not for others. Most persons who get HCV
carry the virus for many years and have some liver damage, but
many do not feel sick. Symptoms associated with HCV infection
(fatigue, abdominal bloating, flu-like symptoms, jaundice) are
present in only 20% to 30% of cases; therefore, most
infections go undiagnosed until liver disease develops 20 to
30 years later. HCV may cause serious liver damage and is the
leading reason for liver transplants in the United States.
Complications of liver disease associated with HCV have
resulted in an estimated 8,000 to 10,000 deaths per year in
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the United States although effective treatments for HCV are
available.
3)HIV AND HCV COINFECTION . According to DPH, it is estimated
that 50% to 80% of injection drug users (IDUs) who are HIV
positive also have HCV infection. Studies have shown that
offering HCV testing in conjunction with HIV counseling and
testing (C&T) has proven to be an effective prevention
strategy for identifying infected individuals and providing
referrals for treatment. An HCV C&T demonstration project in
2003 found that 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% 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.
4)PREVIOUS LEGISLATION . AB 221 (Portantino), Chapter 421,
Statutes of 2009, permits an HIV counselor to perform rapid
HIV tests if he or she has been trained in both rapid HIV test
proficiency for skin puncture blood tests, oral swab tests,
and in universal infection control precautions, consistent
with best infection control practices established by the
Division of Occupational Safety and Health in the Department
of Industrial Relations and the federal Centers for Disease
Control and Prevention (CDC).
AB 1263 (Migden), Chapter 324, Statutes of 2001, permits DPH
to participate in a rapid HIV Test research program conducted
with the CDC.
5)DOUBLE REFERRAL . This bill was heard by the Assembly
Committee on Business Professions and Consumer Protection on
April 26, 2011 and passed by a vote of 9-0.
6)SUPPORT . DPH writes that the rapid HCV test allows for
immediate results, allowing clients to receive test results
and follow up counseling and support services at the time of
the visit, and allowing HIV counselors to administer a rapid,
oral HCV test would help overcome key challenges faced by
providing clients with same-day results. DPH further states
that this bill will increase the number of persons with HCV
antibody who receive counseling and referrals, decrease the
risk of additional infection stemming from undiagnosed
infection, and allow HCV-infected clients to access care
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earlier.
REGISTERED SUPPORT / OPPOSITION :
Support
California Department of Public Health
California Hepatitis Alliance
Opposition
None on file.
Analysis Prepared by : Melanie Moreno / HEALTH / (916)
319-2097