BILL ANALYSIS Ó
AB 2179
Page 1
ASSEMBLY THIRD READING
AB
2179 (Gipson)
As Amended April 14, 2016
Majority vote
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|Committee |Votes|Ayes |Noes |
| | | | |
| | | | |
| | | | |
|----------------+-----+----------------------+--------------------|
|Business & |16-0 |Salas, Brough, Baker, | |
|Professions | |Bloom, Campos, | |
| | |Chávez, Dahle, Dodd, | |
| | |Burke, Gatto, Gomez, | |
| | |Holden, Jones, | |
| | |Mullin, Ting, Wood | |
| | | | |
|----------------+-----+----------------------+--------------------|
|Health |19-0 |Wood, Maienschein, | |
| | |Bonilla, Burke, | |
| | |Campos, Chiu, | |
| | |Dababneh, Gomez, | |
| | | | |
| | | | |
| | |Roger Hernández, | |
| | |Lackey, Nazarian, | |
| | |Olsen, Patterson, | |
| | |Ridley-Thomas, | |
| | |Rodriguez, Santiago, | |
| | |Steinorth, Thurmond, | |
AB 2179
Page 2
| | |Waldron | |
| | | | |
|----------------+-----+----------------------+--------------------|
|Appropriations |20-0 |Gonzalez, Bigelow, | |
| | |Bloom, Bonilla, | |
| | |Bonta, Calderon, | |
| | |Chang, Daly, Eggman, | |
| | |Gallagher, Eduardo | |
| | |Garcia, Roger | |
| | |Hernández, Holden, | |
| | |Jones, Obernolte, | |
| | |Quirk, Santiago, | |
| | |Wagner, Weber, Wood | |
| | | | |
| | | | |
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SUMMARY: Authorizes a hepatitis C counselor, who meets
specified training requirements and works in specified testing
sites, to perform hepatitis C virus (HCV) tests classified as
waived under the federal Clinical Laboratory Improvement
Amendments of 1988 (CLIA). Specifically, this bill:
1)Authorizes a hepatitis C counselor to perform a HCV test that
is classified as waived under CLIA if the following conditions
exist:
a) The performance of the HCV test meets the requirements
of CLIA and California's clinical laboratory requirements;
b) The counselor meets one of the following training and
workplace requirements:
i) Is trained by the California Department of Public
Health's (CDPH's) Office of Aids (OA) and is working in a
HIV counseling and testing site funded by the CDPH
through a local health jurisdiction (LHJ), or its agents;
or,
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ii)Is working in a HIV counseling and testing site that
meets both of the following criteria:
(1)Utilizes HIV counseling staff trained by the OA or
its agents to provide both HIV counseling and testing
and hepatitis C counseling and testing; and,
(2)Has a quality assurance plan approved by the local
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 by the CDPH; or,
iii)Is working at a site approved by the local health
department to provide hepatitis C rapid testing and
counseling, and has been trained using a curriculum
approved by the local health department or the CDPH,
which, at a minimum, provides training in universal
precautions, safe working conditions, proper running and
reading of hepatitis C rapid test kit technology, and
providing accurate information to clients including the
importance of confirmatory tests, linkages to medical
care, and the prevention of hepatitis C transmission;
c) The HCV test is performed under the overall operation
and administration of a laboratory director. Defines, for
purposes of this requirement, an HIV counselor who meets
the specified requirements as "other health care personnel
providing direct patient care" under California's clinical
laboratory requirements;
d) The patient is informed that the preliminary result of
the test is indicative of the likelihood of HCV exposure
and that the result must be confirmed by an additional,
more specific test, or, if approved by the Center for
Disease Control and Prevention (CDC) for that purpose, a
second, different rapid HCV test; and,
e) If performing a skin punctures for the purpose of
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withdrawing blood for HCV testing, the counselor must meet
the following additional requirements:
i) Work under the direction of a licensed physician and
surgeon;
ii)Obtain specific authorization from a licensed physician
and surgeon; and,
iii)Be trained in rapid test proficiency either for skin
puncture blood tests or oral swab tests in universal
infection control precautions, consistent with best
infection control practices established by the Division
of Occupational Safety and Health (DOSH) in the
Department of Industrial Relations (DIR) and the CDC.
2)Authorizes the counselor to order and report the results from
the HCV tests performed to a patient without authorization
from a licensed health care practitioner or the patient's
authorized representative.
3)Requires the counselor to refer a patient who has an
indeterminate or positive test result to a licensed health
care practitioner whose scope of practice includes the
authority to refer a patient for laboratory testing for
further evaluation.
4)Provides that a hepatitis C counselor is not authorized to
perform any other test unless that person meets the statutory
and regulatory requirements for performing the other test,
including those requiring certifications in phlebotomy.
FISCAL EFFECT: According to the Assembly Appropriations
Committee, uncertain, potential cost pressure to the CDPH. This
bill does not place direct requirements on the department, but
is intended to allow local health jurisdictions (LHJs)
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flexibility to approve and implemented their own training
programs. However, CDPH indicates cost pressure in the hundreds
of thousands of dollars to promulgate and implement regulations,
provide technical assistance, and review, approve, and
potentially implement Hepatitis C counselor trainings.
COMMENTS:
Purpose. This bill is sponsored by Project Inform. According
to the author, "The unchecked spread of HCV threatens the public
health and economic welfare of California. It is necessary that
California reduce the costs and procedural barriers for training
non-medical personnel to perform rapid HCV tests in order that
local health departments can respond in a manner that is safe
and appropriate to the urgency of the epidemic. [This bill]
will give local health departments greater flexibility to
respond to HCV in their communities and reduce costs related to
training non-medical personnel to administer the rapid test."
Background. Hepatitis means inflammation of the liver.
Hepatitis C is an infection of the liver caused by HCV, one of
several contagious viruses that can cause hepatitis. HCV is
spread by blood-to-blood contact and common ways people become
infected are through needle sharing, inadequate sterilization of
medical equipment, and unscreened blood transfusions.
The CDC estimates that there are 3.5 million people in the US
have chronic HCV infection. Between 1994 and 2011, the CDPH had
received 501,664 newly reported chronic HCV cases in California.
As a result, the World Health Organization, the CDC, and the
CDPH suggest policies that promote prevention and education
among high-risk populations. This bill seeks to do so by
authorizing HCV counselors to perform a HCV screening test if it
is classified as waived under CLIA. The author states that
doing so will increase access to HCV counselors, who will
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promote prevention by providing screening and education services
at a community level.
Federal and State Laboratory Requirements. Under the federal
CLIA law, laboratories that perform tests on human specimens
must be certified by the Centers for Medicare and Medicaid
Services (CMS). The requirements for CLIA certification vary
depending on the complexity of the laboratory tests performed.
The three complexities are waived, moderate, and high
complexity. In general, the more complicated the test, the more
stringent the requirements under CLIA. Waived tests are simple,
consumer-level tests with a low risk for an incorrect result.
However, California law only allows specified personnel to
perform waived tests on others.
HIV and HCV Counselors. Existing law allows HIV counselors to
perform HIV, HCV, and combination HIV/HCV tests as long as the
tests are classified as waived under CLIA, the facility or
clinic has obtained a certificate of waiver from CMS and CDPH
approval, and the HIV counselor has attended a Counseling and
Testing (C&T) training specific to each type of test.
Currently, the OA either establishes or approves
federally-funded HIV C&T training programs for a LHJ's HIV
counselors. However, not all LHJs are able to access the
trainings. Access to the trainings is determined by incidence
of HIV, but some LHJs have a high incidence of HCV but not a
high incidence of HIV. The LHJs that cannot meet the HIV
thresholds must pay for the trainings.
The sponsor notes that having to pay out of pocket for the C&T
training means that if the LHJ does not have the funds or the
offered training is full, its counselors will not be able to
provide necessary HCV testing and screenings. This bill seeks
to remedy this issue in two ways: 1) authorizing a LHJ to
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approve a HCV C&T training program and 2) authorizing a HCV
counselor who works at a testing site approved by the LHJ to
perform a CLIA-waived HCV test after attending the training
program.
Analysis Prepared by:
Vincent Chee / B. & P. / (916) 319-3301 FN:
0003188