BILL ANALYSIS Ó
AB 1382
Page 1
Date of Hearing: April 26, 2011
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Mary Hayashi, Chair
AB 1382 (Roger Hernandez) - As Amended: March 31, 2011
SUBJECT : HIV Counselors.
SUMMARY : Allows human immunodeficiency virus (HIV) counselors
to perform hepatitis C virus (HCV) or combined HIV/HCV rapid
tests. Specifically, this bill :
1)Allows an HIV counselor, as specified, to do all of the
following:
a) Perform any HCV or combination HIV/HCV test that is
classified as waived under the federal Clinical Laboratory
Improvement Act (CLIA) of 1988 if all of the following
conditions exist:
i) The performance of the HCV or combination HIV/HCV
test meets the requirements of CLIA and current law
governing clinical laboratory technology, as specified;
ii) An HIV counselor may perform skin punctures for the
purpose of withdrawing blood for HCV or combination
HIV/HCV testing upon specific authorization from a
licensed physician and surgeon, provided that the person
meets both of the following requirements:
(1) He or she works under the direction of a
licensed physician and surgeon; and,
(2) He or she has been trained in rapid HCV or
combination HIV/HCV test proficiency for skin puncture
blood tests and oral swab tests and in universal
infection control precautions, as specified.
iii) The person performing the HCV or combination HIV/HCV
test meets the requirements for the performance of waived
laboratory testing pursuant to current law, as specified;
and,
iv) The patient is informed that the preliminary result
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of the test is indicative of the likelihood of HIV
infection and that the result must be confirmed by an
additional more specific test, or, if approved by the
federal Centers for Disease Control and Prevention (CDCP)
for that purpose, a second different rapid HIV, HCV, or
combination HIV/HCV test. Nothing in this bill shall be
construed to allow an HIV counselor to perform any HCV or
combination HIV/HCV test that is not classified as waived
under CLIA.
b) Order and report HCV or combination HIV/HCV test results
from tests performed pursuant to the above requirements to
patients without authorization from a licensed health care
professional or his or her authorized representative.
Patients with indeterminate or positive test results shall
be referred to a licensed health care provider whose scope
of practice includes the authority to refer patients for
laboratory testing for further evaluation.
2)Specifies that HIV counselors certified before September 1,
2009, who will administer rapid HCV or combination HIV/HCV
skin puncture tests shall obtain training in rapid HCV or
combination HIV/HCV test proficiency for skin puncture blood
tests and oral swab tests and in universal infection control
precautions before September 1, 2011. The HIV counselor shall
not, unless also certified as a limited phlebotomist
technician, perform a skin puncture pursuant to this bill
until he or she has completed this training.
3)Provides that an HIV counselor who meets this bill's
requirements for performing any waived HCV or combination
HIV/HCV test may not perform any other test unless that person
meets the statutory and regulatory requirements for performing
that other test.
4)In order to perform waived HCV or combination HIV/HCV tests,
requires an HIV counselor to meet one of the following
criteria:
a) Is trained by the Office of AIDS and working in an HIV
counseling and testing site funded by the Department of
Public Health (DPH) through a local health jurisdiction, or
its agents; or,
b) Is working in an HIV counseling and testing site that
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utilizes HIV counseling staff who are trained by the Office
of AIDS (OA) or its agents, or that meets specified quality
assurance guidelines.
EXISTING LAW
1)Establishes CLIA under federal law, which regulates clinical
laboratories that perform tests on human specimens and sets
standards for facility administration, personnel
qualifications and quality control.
2)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.
3)Establishes OA within DPH to be the lead agency in the state
responsible for coordinating state programs, services and
activities related to HIV, acquired immune deficiency syndrome
(AIDS), and AIDS related conditions.
4)Allows HIV counselors to perform waived HIV tests pursuant to
the same requirements of this bill for the performance of HCV
or combination HIV/HCV tests.
FISCAL EFFECT : Unknown
COMMENTS :
Purpose of this bill . According to the author's office,
"Current law allows counselors trained by the California Office
of AIDS to perform CLIA-waived rapid HIV tests. These tests
(are) simple, finger stick tests which provide results in as
little as (30 minutes). OA counselors receive training on this
testing along with Hep C testing during the courses required to
be an OA counselor. At the time this measure was signed, there
was no equivalent Hep C test approved. The FDA recently
approved a CLIA-waived Hep C rapid finger stick test. This
measure would allow OA counselors to also perform the rapid Hep
C test."
Background . The OA, within DPH, has lead responsibility for
coordinating state programs, services, and activities relating
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to HIV/AIDS.
The OA's HIV Education and Prevention Services Branch, HIV
Counseling and Testing (C&T)
Program provides HIV prevention counseling, standard and rapid
HIV testing services, HIV rapid test kits for local health
jurisdictions (LHJs), and HIV counselor training. HIV C&T
services are provided by 54 LHJs and their subcontractors at
anonymous and confidential HIV C&T sites in California at no or
low cost.
HIV and HCV carry common risk factors, and approximately 25-35%
of people infected with HIV are also infected with HCV.
According to the United States Department of Health and Human
Services (Department), "chronic HCV infection is a leading cause
of morbidity and mortality among persons with HIV. Effective
therapy is available for HCV and a cure is achievable in a
substantial proportion of patients who undergo therapy. Cure of
HCV significantly reduces the patient's risk of developing
cirrhosis, liver failure, or hepatocellular cancer. In
addition, the presence of chronic HCV infection may affect the
decision of whether to initiate antiretroviral therapy." The
Department recommends routine screening for HCV infection in all
HIV-infected patients. HCV testing became fully integrated into
California's HIV C&T Program as of January 1, 2008.
AB 221 (Portantino), Chapter 421, Statutes of 2009, authorized
HIV counselors to perform skin punctures to withdraw blood for
HIV rapid testing, and required additional curriculum elements
in HIV counselor training programs to cover test proficiency and
infection control precautions. When this measure was approved,
there was no rapid HCV test available. The FDA has since
approved a rapid HCV test, in June of 2010, the OraQuick HCV
Rapid Antibody Test.
Rapid tests yield results within 20 to 40 minutes, while
traditional tests typically take about two weeks. According to
DPH, only 35% of those currently tested for HCV return to the
testing site for their results.
Hepatitis . "Hepatitis" means inflammation of the liver and also
refers to a group of viral infections that affect the liver.
The most common types are Hepatitis A, Hepatitis B (HBV), and
HCV.
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Unlike Hepatitis A and HBV, there is no vaccine for HCV.
According to the California Research Bureau, HCV is the most
common blood-borne viral infection, and HCV-related deaths in
California more than doubled between 1995 and 2004. The death
rate from HCV is expected to triple in the next 10-20 years.
HCV, which can pass through blood or bodily fluids, can result
in mild illness lasting a few weeks to a serious, lifelong
illness. Today, most people become infected with HCV by sharing
needles during intravenous drug use. Health care workers are
also at risk for contracting HCV, and the virus can be
transmitted through sexual contact. An infected pregnant woman
can also pass the virus to her unborn baby. Before 1992, when
widespread screening of the blood supply began in the United
States, HCV was also commonly spread through blood transfusions
and organ transplants.
Hepatitis C can be either "acute" or "chronic." Acute HCV
infection is a short-term illness that occurs within the first
six months after someone is exposed to HCV. Chronic Hepatitis C
is a serious disease than can result in long-term health
problems, such as liver disease and liver cancer, or even death.
Approximately 75% to 85% of those infected develop chronic
infection, and 75% of those with chronic infection develop
chronic liver disease.
According to DPH's California Adult Viral Hepatitis Prevention
Strategic Plan, 2010-1014, "Viral hepatitis is an important
public health problem in California and nationwide. In the
United States, there are more than 5 million people living with
chronic HBV or chronic HCV. Viral hepatitis is a major cause of
liver cancer and the leading cause of liver transplants
nationwide. From 2010 to 2030, the number of liver cancer cases
in the U.S. is expected to rise 59 percent, with the highest
increases expected among Hispanics and Asian American and
Pacific Islanders.
"Over the next twenty years, annual medical costs for people
with HCV nationwide are expected to increase more than 2.5
times, from $30 billion to more than $85 billion. While it is
unknown exactly how many people in California are living with
viral hepatitis, in 2007 alone, HBV- and HCV-related
hospitalization costs in California totaled $2 billion."
African Americans account for 22% of HCV cases, and
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approximately 17,000 people are newly infected with the virus
every year.
In a September 2010 issue brief, "HBV & HCV: America's Hidden
Epidemics," the Trust for America's Health and the American
Association for the Study of Liver Diseases notes that 2.7
million to 3.9 million Americans live with chronic HCV, but
approximately 75% of people with the HCV virus are unaware that
they are infected. "These individuals miss out on treatments
that could spare them from serious liver diseases in the future
while they also inadvertently may be spreading it to others.
Two-thirds of the people with HCV are Baby Boomers who may have
been infected decades ago but do not know they have it.
"In the next decade, the Institute of Medicine (IOM) estimates
that 150,000 Americans could die from liver cancer or end-stage
liver disease associated with HBV or HCV, and an independent
analysis found total medical costs for HCV patients could more
than double over the next 20 years...However, we would reduce
the number of deaths and lower costs if we act now to screen
at-risk individuals so they can receive treatment earlier and
work to prevent new cases of HBV and HCV." The report
recommends several policy directions, including "build(ing) on
existing, more robust HIV and other infectious disease systems
to leverage resources and create an integrated approach," which
would aid in developing a better understanding of the diseases,
identifying those who carry the viruses, and preventing new
infections.
Support . DPH, sponsor of this bill, writes, "Allowing HIV
counselors to administer a rapid, oral HCV test would help
overcome key challenges faced by providing clients with same-day
results. It would also 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 earlier care."
Related legislation .
SCR 36 (Blakeslee) declares May 19, 2011, to be Viral Hepatitis
Awareness Day in California. This bill is pending in Senate
Rules Committee.
Previous legislation .
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ACR 141 (Blakeslee), Resolution Chapter 20, Statutes of 2010,
declares May 19, 2010, to be Viral Hepatitis Awareness Day in
California.
ACR 35 (Blakeslee), Resolution Chapter 19, Statutes of 2009,
declares May 19, 2009, to be Viral Hepatitis Awareness Day in
California.
AB 221 (Portantino), Chapter 421, Statutes of 2009, allows HIV
counselors to perform skin punctures to withdraw blood for HIV
rapid testing, and requires additional curriculum elements in
HIV counselor training programs.
AB 1858 (Blumenfield) of 2009, allows DPH to authorize certain
entities to provide hypodermic needle and syringe exchange
services consistent with state and federal standards in any
location where DPH determines that the conditions exist for the
rapid spread of HIV, viral hepatitis, or any other potentially
deadly or disabling infections that are spread through the
sharing of used hypodermic needles and syringes. This bill was
vetoed.
AB 1442 (Feuer) of 2007, requires clinical laboratories that
perform HIV tests waived under CLIA to enroll in a proficiency
testing program and to obtain the appropriate license or
registration from DPH, as specified. Held on Assembly Floor
pending concurrence.
AB 184 (Dymally) of 2007, requires DPH to implement a program,
on or before January 1, 2009, for the prevention and control of
viral hepatitis among adults. This bill was held in Senate
Appropriations.
AB 685 (Leno) Chapter 2, Statutes of 2004, exempts HIV
counselors from State Department of Health Services (DHS)
regulations that require training and certification for
phlebotomy (the practice of drawing blood) technicians.
AB 2064 (Cedillo) Chapter 273, Statutes of 2002, requires DHS to
authorize the establishment of training programs for counselors
for publicly funded HIV testing programs by specified
community-based, nonprofit organizations.
AB 1263 (Migden) Chapter 324, Statutes of 2001, authorizes DHS
to participate in a rapid HIV test research program conducted
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with the CDCP.
REGISTERED SUPPORT / OPPOSITION :
Support
California Department of Public Health (sponsor)
California Hepatitis Alliance
Opposition
None on file.
Analysis Prepared by : Angela Mapp / B.,P. & C.P. / (916)
319-3301