BILL ANALYSIS Ó
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: AB 2179 Hearing Date: June 20,
2016
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|Author: |Gipson |
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|Version: |April 14, 2016 |
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|Urgency: |No |Fiscal: |Yes |
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|Consultant|Sarah Huchel |
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Subject: Hepatitis C testing
SUMMARY: Authorizes a hepatitis C counselor to perform any hepatitis C
virus (HCV) test that is classified as waived under the federal
Clinical Laboratory Improvement Act (CLIA), as specified.
Existing state law:
1)Provides for the licensure, registration, and regulation of
clinical laboratories and various clinical laboratory
personnel, including cytotechnologists, by the California
Department of Public Health (DPH). (Business and Professions
Code (BPC) §§ 1200-1327)
1)Defines a "clinical laboratory test or examination" as the
detection, identification, measurement, evaluation,
correlation, monitoring, and reporting of any particular
analyte, entity, or substance within a biological specimen for
the purpose of obtaining scientific data which may be used as
an aid to ascertain the presence, progress, and source of a
disease or physiological condition in a human being, or used
as an aid in the prevention, prognosis, monitoring, or
treatment of a physiological or pathological condition in a
human being, or for the performance of nondiagnostic tests for
assessing the health of an individual. (BPC § 1206)
2)Requires an individual who draws blood to be certified by the
DPH as a certified phlebotomy technician. (BPC § 1246)
AB 2179 (Gipson) Page 2
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3)Allows any person to request, and any licensed clinical
laboratory or public health laboratory to perform, the
following laboratory tests if the test is waived under CLIA
and the laboratory has registered with the DPH: pregnancy,
glucose level, cholesterol, occult blood, and any other test
for which there is a test for a particular analyte approved by
the federal Food and Drug Administration (FDA) for sale to the
public without a prescription in the form of an
over-the-counter test kit. A test approved only as an
over-the-counter collection device may not be conducted
pursuant to this section. (BPC § 1246.5)
4)Authorizes an HIV counselor who meets specified requirements to
perform any HIV, HCV, or combination HIV/HCV test that is
classified as waived under CLIA as specified, and is
authorized to perform skin punctures for the purpose of
withdrawing blood for a test without being certified as a
phlebotomy technician or a limited phlebotomy technician.
(Health & Safety Code § 120917)
5)Defines a "local health jurisdiction" (LHJ) as a county health
department or combined health department in the case of
counties acting jointly or city health department, as
specified. (HSC § 124030)
Existing federal law:
1)Establishes conditions that laboratories must meet for
certification to perform testing on human specimens under
CLIA. (Title 42, Code of Federal Regulations (CFR) § 493.1)
2)Classifies laboratory tests using three categories: "waived,"
"moderate complexity," or "high complexity." (42 CFR § 493.5)
3)Requires tests for certificate of waiver to be simple
laboratory examinations and procedures which:
a) Are cleared by FDA for home use;
b) Employ methodologies that are so simple and accurate as
to render the likelihood of erroneous results negligible;
AB 2179 (Gipson) Page 3
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or
c) Pose no reasonable risk of harm to the patient if the
test is performed incorrectly. (42 CFR § 493.15)
This bill:
1)Authorizes a hepatitis C counselor to perform a HCV test under
the overall operation and administration of a laboratory
director, as specified.
2)Requires a hepatitis C 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 DPH through a
LHJ, or its agents.
b) Is working in an HIV counseling and testing site that
meets both of the following criteria:
i) Utilizes HIV counseling staff who are trained by the
Office of AIDS or its agents to provide both HIV
counseling and testing and hepatitis C counseling and
testing.
ii) Has and retains 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 DPH.
c) 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, and retained by
the site, or approved by the DPH, 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.
AB 2179 (Gipson) Page 4
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3)Authorizes a hepatitis C counselor to do all of the following:
a) Perform any HCV test that is classified as waived under
CLIA if all of the following conditions exist:
i) The performance of the HCV test meets the
requirements of state and federal law regarding clinical
labs.
ii) Perform skin punctures for the purpose of
withdrawing blood for waived HCV testing without a
certificate as a certified phlebotomy technician, 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.
(2) He or she has been trained in rapid test
proficiency for skin puncture blood 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).
iii) The person performing the HCV test meets the
requirements for the performance of waived laboratory
testing, as specified.
iv) The patient is informed that the preliminary
result of the HCV 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
federal CDC for that purpose, a second, different rapid
HCV test. This does not allow a hepatitis C counselor to
perform any HCV test that is not classified as waived
under CLIA.
b) Order and report HCV test results to patients without
authorization from a licensed health care practitioner or
his or her authorized representative. A patient who has an
indeterminate or positive test result shall be referred to
AB 2179 (Gipson) Page 5
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a licensed health care practitioner whose scope of practice
includes the authority to refer a patient for laboratory
testing for further evaluation.
4)Prohibits a hepatitis C counselor who meets the requirements of
this section from performing any other test unless that person
meets the statutory and regulatory requirements for performing
that other test.
5)States that compliance with bill does not fulfill any
requirements for certification as a phlebotomy technician or a
limited phlebotomy technician, unless the hepatitis C
counselor has otherwise satisfied the certification
requirements.
FISCAL
EFFECT: This bill is keyed "fiscal" by the Legislative Counsel.
According to the Assembly Committee on Appropriations analysis
dated April 27, 2016, this bill has uncertain, potential cost
pressures to the DPH. The analysis notes that this bill does
not place direct requirements on the department, but is intended
to allow LHJs flexibility to approve and implemented their own
training programs. According to the analysis, DPH 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:
1. Purpose. This bill is sponsored by Project Inform .
According to the Author's office,
"AB 2179 would allow LHJs as well as DPH, to certify training
standards for hepatitis C test counselors to administer
low-risk, easy-to-use, finger-stick rapid tests that meet the
standards for "waiver" under the CLIA. The bill would remove
the prerequisite that personnel be trained to administer an
HIV rapid test before be trained to administer the hepatitis
C rapid test. Only persons working in sites authorized by
LHJs to offer HCV rapid testing would be allowed to
administer CLIA-compliant tests.
AB 2179 (Gipson) Page 6
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"The California Hepatitis Alliance did a series of interviews
with community based programs in California in 2015 and 2016
and identified significant barriers to screening at-risk
population, even when local resources existed to provide the
tests. Even if tests were available and staff was available -
either the training was not available or was too distant or
too expensive for small community-based programs to access.
"Current state statute mandates that a person must complete
an HIV rapid test counseling training as a prerequisite, even
if the local conditions call for deployment of HCV screening.
"The State Office of AIDS currently pays contractors to
provide HIV and HCV rapid test training, but only offers it
to persons from 18 local health jurisdictions that have been
prioritized due to high rates of HIV. The prioritization is
based on HIV rates, not HCV rates, which is very high in many
rural counties. 40 other counties (total of 60 LHJs) may ask
for a seat in the trainings, but are wait-listed to see if
there will be any availability.
"The trainings generally take place in San Francisco and Los
Angeles, far from programs. A small community based program,
with very tight budgets, assumes the high cost of travel,
accommodations, and the loss of staff for 4 days to complete
a training that, if the law were changed, could be provided
locally in half the time.
"AB 2179 will trust local health officers and local health
departments to certify a training for a test has been judged
by the federal government to be easy-to-use, and very
low-risk."
2. CLIA waived tests. Federal law, CLIA, establishes conditions
that laboratories must meet for certification to perform
testing on human specimens. This law classifies laboratory
tests and establishes corresponding regulatory parameters
using three categories: "waived," "moderate complexity," and
"high complexity." "Waived" tests constitute the lowest
category, and may be granted for those exams and procedures
which are cleared by the FDA for home use; employ
methodologies that are so simple and accurate as to render
the likelihood of erroneous results negligible; or pose no
AB 2179 (Gipson) Page 7
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reasonable risk of harm to the patient if the test is
performed incorrectly.
This bill establishes criteria under which a hepatitis
counselor may perform a waived HCV test after training, using
a curriculum approved by the local health department, or the
DPH, 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.
3. Hepatitis C. Hepatitis C is a contagious liver disease that
ranges in severity from a mild illness lasting a few weeks to
a serious, lifelong illness that attacks the liver. It
results from infection with HCV, which is spread primarily
through contact with the blood of an infected person. While
infection rates are high among baby boomers who were exposed
to the virus prior to effective blood screenings, most
individuals become infected currently by sharing injection
equipment.
Hepatitis C's effects can be mitigated through early
detection and treatment, which can also reduce new
infections. This is especially important in California, as
the CDC reports that between 2009 and 2013, reported rates of
acute hepatitis C increased by 100 percent in this state.
4. HIV Counselors. Existing law allows HIV counselors to
perform HIV, HCV, and combination HIV/HCV tests that are
classified, as waived under CLIA, if the facility or clinic
has obtained a certificate of waiver from Center for Medicaid
Services and DPH approval, and the HIV counselor has attended
trainings specific to each type of test. Currently, the
Office of AIDS (OA) establishes or approves a LHJ's HIV
Counseling and Testing training programs, which are conducted
by community-based, non-profit HIV organizations for HIV
testing. However, not all LHJs are able to access the
trainings.
According to the Office of AIDS Integrated HIV Surveillance,
Prevention, and Care Plan (Integrated Plan), budget cuts
during fiscal year 2009-10 reduced the OA's funding for many
AB 2179 (Gipson) Page 8
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of its AIDS programs. Since 2012, the majority of the OA's
HIV prevention activities have been funded solely through a
five-year funding opportunity from the CDC. The program
established three funding areas in California: the Los
Angeles and San Francisco Metropolitan Statistical Areas
(which receive funds directly from the CDC), and the
California Project Area (CPA). The CPA includes a limited
number of LHJs that have demonstrated a high incidence of
HIV. LHJs within the CPA receive the Counseling and Testing
training as a part of the CDC's program, but the remaining
LHJs must pay for the Counseling and Testing training out of
their own funds, and spaces within the C&T trainings are
limited.
AB 2179's sponsor and supporters note that having to pay out
of pocket for the Counseling and Testing training burdens the
LHJs that have not met the HIV-incidence thresholds but may
still have a high incidence of HCV. Currently, the
counselors working in LHJs outside of the CPA cannot attend
the HCV Counseling and Testing training without attending the
HIV Counseling and Testing training. If the LHJ does not
have the funds or the offered training is full, the counselor
will be unable to provide HCV testing and screening at the
testing site. This bill seeks to remedy by authorizing a LHJ
to approve an independent HCV Counseling and Testing training
program and authorizing a hepatitis C counselor who works at
a testing site approved by the LHJ to perform a CLIA-waived
HCV test after attending the training program.
5. Prior Related Legislation. AB 1382 (R. Hernandez, Chapter
643, Statutes of 2011) authorized HCV training for HIV test
counselors.
AB 221 (Portantino, Chapter 421, Statutes of 2009) among
other things, removed the HIV counselor training equivalency
credit towards a limited phlebotomy technician certification
and instead exempted an HIV counselor who works under a
licensed physician and surgeon, and who is trained in rapid
HIV test proficiency and universal infection control
precautions, from the requirement that he or she hold a valid
certification as a phlebotomist technician.
AB 685 (Leno, Chapter 2, Statutes of 2004) provided that HIV
counselors that completed HIV counselor training were deemed
AB 2179 (Gipson) Page 9
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to have met the requirements for certification as a limited
phlebotomy technician.
AB 1263 (Migden, Chapter 324, Statutes of 2001) among other
things, authorized HIV counselors to perform HIV tests
classified as waived under CLIA.
6. Arguments in Support. Project Inform writes, "California
must 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.
Current state law allows non-medical personnel to administer
HCV rapid tests in compliance with federal standards under
CLIA, but only if personnel are working at a DPH Office of
AIDS (OA)-funded site, or authorized by a local health
jurisdiction (LHJ); have been trained in HIV testing and
counseling using a DPH-OA approved curriculum; and have
completed an additional HCV test counseling and testing
module approved by DPH-OA.
"AB 2179 would allow LHJs, as well as DPH, to certify
training standards for HCV rapid test counselors, and remove
the prerequisite that personnel be trained to administer an
HIV rapid test before learning to administer the HCV rapid
test. Further, only those persons working in sites authorized
by LHJs to offer HCV rapid testing would be allowed to
administer CLIA-compliant tests."
Access Support Network writes that they were recently able to
train 16 local individuals to become HIV/HCV Test Counselors.
"The training was a four day training that came at a cost of
nearly $40,000 to our agency. We were fortunate to have one
time funding to facilitate this training, but, not normally
being funded by the State Office of AIDS HIV testing, this
training will not be available again for our agency. A more
simplified training for HCV test counselors is greatly
needed."
Mendocino County AIDS/Viral Hepatitis Network (MCAVHN) writes
that they are the "only HIV/AIDS/HCV service-oriented,
community based harm reduction organization in all of
Mendocino County?. MCAVHN began outreach efforts in the
mid-nineties, notably building bridges within the
AB 2179 (Gipson) Page 10
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Native-American communities who were significantly
under-represented. Our services have adapted to assist those
with multiple co-morbid conditions, and within Mendocino
County our persons who inject drugs have a projected HCV+
rate of 85%. We are the only community-based organization
delivering HCV testing to persons within our syringe exchange
services delivery, both in-house and in the field, and have
just been informed that we can no longer provide this service
due to the conditions of the SAPTBG funding stream, which for
the past two years has been our only source of funding for
this testing....
"AB 2179 would allow LHJs to certify training standards for
HCV rapid test counselors and remove the prerequisite that
personnel be trained to administer an HIV rapid test before
learning to administer the HCV rapid test. Further, only
those persons working in sites authorized by LHJs to offer
HCV rapid testing would be allowed to administer
CLIA-compliant tests. These trainings need to be available
and low-cost so that communities can deliver these services
even in resource-poor, rural areas."
7. Technical Amendment. The following are suggested technical
amendments to strike code that was amended by the inclusion
of text explicitly authorizing a hepatitis C counselor to
perform a HCV test under the overall operation and
administration of a laboratory director, as specified.
On page 7, line 36, delete everything after "Code."
On page 7, delete lines 37-39.
On page 8, delete lines 1-2
NOTE : Double-referral to Senate Committee on Health , second.
SUPPORT AND OPPOSITION:
Support:
Project Inform (Sponsor)
Access Support Network
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AIDS Community Research Consortium
Asian Pacific Health Foundation
Bay Area Black Nurses Association
California Black Health Network
California Chronic Care Coalition
California Hepatitis Alliance
California Life Sciences Association
Comprehensive Opiate Recovery Experience Medical Clinic, Inc.
Desert AIDS Project
Drug Policy Alliance
Harm Reduction Coalition
Health Officers Association of California
HIV Education and Prevention Project of Alameda County
Mendocino County AIDs/Viral Hepatitis Network
Sacramento Area Task Force for the Outreach and Prevention of
Hepatitis
San Francisco Hepatitis C Task Force
The Wall Las Memorias Project
One individual
Opposition:
None on file as of June 14, 2016.
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