BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 2179
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|AUTHOR: |Gipson |
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|VERSION: |June 22, 2016 |
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|HEARING DATE: | June 29, 2016 | | |
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|CONSULTANT: |Melanie Moreno |
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SUBJECT : Hepatitis C testing
SUMMARY : Authorizes a hepatitis C counselor who meets specific
requirements to perform any hepatitis C virus (HCV) test that is
classified as waived under the federal Clinical Laboratory
Improvement Act.
Existing federal law:
1)Defines "laboratory" or "clinical laboratory" (lab or clinical
lab) as a facility for the biological, microbiological,
serological, chemical, immuno-hematological, hematological,
biophysical, cytological, pathological, or other examination
of materials derived from the human body for the purpose of
providing information for the diagnosis, prevention, or
treatment of disease or impairment or health assessment of
human beings.
2)Requires labs to obtain a certificate, meet quality standards,
and undergo inspections, among other things, before accepting
materials derived from the human body. Exempts laboratories
with a certificate of waiver from the Clinical Laboratory
Improvement Amendments (CLIA), provided that the laboratory
follows the manufacturer's instructions.
3)Provides that a lab is eligible for a certificate of waiver if
it only performs "waived tests," which are simple examinations
and procedures that:
a) Have been approved by the Food and Drug
Administration (FDA) for home use;
b) The FDA has determined are so simple and
accurate that there is a negligible chance of
erroneous results; or,
AB 2179 (Gipson) Page 2 of ?
c) Pose no unreasonable risk of harm to the
patient if performed incorrectly.
4)Authorizes a state to enact and enforce laws relating to CLIA
to the extent that the state laws are not inconsistent with
the CLIA laws and regulations.
Existing state law:
1)Provides for the licensure, registration, and regulation of
clinical labs and various clinical lab personnel by the
Department of Public Health (DPH).
2)Prohibits a person from performing a clinical lab test or
examination classified as waived under CLIA unless the
clinical lab test or examination is performed under the
overall operation and administration of the lab director, as
specified, and the test is performed by one the following
persons if within the person's scope of practice:
a) A licensed physician and surgeon holding a
M.D. or D.O. degree;
b) A licensed podiatrist, a licensed dentist, or
a licensed naturopathic doctor;
c) A person licensed in California to engage in
clinical laboratory practice or to direct a clinical
laboratory;
d) A person authorized by a local health
laboratory to perform tests pursuant to a certificate
issued by the DPH;
e) A licensed physician assistant;
f) A licensed nurse;
g) A licensed vocational nurse;
h) A certified perfusionist (a specialized
healthcare professional who uses the heart-lung
machine during cardiac surgery and other surgeries
that require cardiopulmonary bypass to manage the
patient's physiological status);
i) A licensed respiratory care practitioner;
j) A medical assistant;
aa) A pharmacist;
bb) A naturopathic assistant;
cc) A licensed optometrist;
dd) Other health care personnel providing direct
patient care; or,
ee) Any other person performing non-diagnostic
AB 2179 (Gipson) Page 3 of ?
testing.
3)Establishes the Office of AIDS (OA) within DPH as the lead
agency within the state, responsible for coordinating state
programs, services, and activities relating to HIV/AIDS, and
AIDS-related conditions (ARC).
4)Requires DPH to authorize the establishment of training
programs throughout the state for counselors for publicly
funded HIV testing programs.
5)Permits a HIV counselor to perform a HIV, HCV, or combination
HIV/HCV test that is classified as waived under CLIA if the
following conditions exist:
a) The performance of the HIV, HCV, or
combination HIV/HCV test meets the requirements of
CLIA and the California clinical lab requirements.
b) The HIV counselor meets one of the following
criteria:
i. Is trained by the OA and working in a HIV
counseling and testing site funded by the DPH
through a local health jurisdiction, or its agents;
ii. Is working in a HIV counseling and testing
site that utilizes HIV counseling staff who are
trained by the OA or its agents; or, 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 DPH.
c) The HIV, HCV, or combination HIV/HCV test is
performed under the overall operation and
administration of a lab director;
d) The patient is informed that the preliminary
result of the test is indicative of the likelihood of
HIV infection or HCV exposure 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 (CDC) for that purpose, a second
different rapid HIV, HCV, or combination HIV/HCV test;
and,
e) If performing skin punctures for the purpose
AB 2179 (Gipson) Page 4 of ?
of withdrawing blood for HIV, HCV, or combination
HIV/HCV testing, the counselor must:
i. Work under the direction of a
licensed physician and surgeon;
ii. Have specific authorization from a
licensed physician and surgeon; and,
iii. Be trained in both rapid HIV, HCV,
or combination HIV/HCV test proficiency for skin
puncture blood tests and oral swab tests and 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.
6) Permits a HIV counselor to order and report the results
from the HIV, HCV, or combination HIV/HCV test to a patient
without authorization from a licensed health care
professional or the patient's authorized representative.
7) Requires patients with indeterminate or positive results
from the HIV, HCV, or combination HIV/HCV test be referred
to a licensed health care provider whose scope of practice
includes the authority to refer patients for laboratory
testing for further evaluation.
8) Provides that a HIV counselor is not authorized to
perform any other test unless that person meets the
statutory and regulatory requirements for performing the
other test.
This bill:
1)Requires HCV counselors to meet one of the following criteria:
a) Be trained by the OA and work in a HIV
counseling and testing site funded by DPH through a
LHJ, or its agents.
b) Work in a HIV counseling and testing site
that:
c) Utilize HIV counseling staff who are trained
by OA or its agents to provide both HIV counseling and
testing and hepatitis C counseling and testing;
d) Have and retain a quality assurance plan
approved by the local health department (LHD) in the
jurisdiction where the site is located and have HIV
AB 2179 (Gipson) Page 5 of ?
counseling and testing staff who comply with the
quality assurance requirements as specified by DPH;
and,
e) Work at a site approved by the LHD to provide
HCV rapid testing and counseling, and has been trained
using a curriculum approved by the LHD, and retained
by the site, or approved by DPH, which, at a minimum,
provides training in universal precautions, safe
working conditions, proper running and reading of HCV
rapid test kit technology, and providing accurate
information to clients including the importance of
confirmatory tests, linkages to medical care, and the
prevention of HCV transmission.
2)Permits HCV counselors who meet these requirements to:
a) Perform any HCV test that is classified as
waived under CLIA if:
i. The performance of the HCV test
meets the requirements of CLIA and state law.
ii. In the case of performing skin
punctures for the purpose of withdrawing blood
for waived HCV testing, specific authorization
from a licensed physician is obtained and the
person:
1) Works under the direction
of a licensed physician and surgeon.
2) 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 CDC.
iii. The person performing the HCV test
meets the requirements for the performance of
waived laboratory testing pursuant to existing
state law 2) above.
iv. 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
AB 2179 (Gipson) Page 6 of ?
specific test, or, if approved by the CDC for
that purpose, a second, different rapid HCV test.
b) Order and report HCV test results from tests
to patients without authorization from a licensed
health care practitioner or his or her authorized
representative. Requires a patient who has an
indeterminate or positive test result to be referred
to a licensed health care practitioner whose scope of
practice includes the authority to refer a patient for
laboratory testing for further evaluation.
3)Prohibits a HIV counselor who meets the requirements of this
bill with respect to performing any CLIA-waived HCV from
performing any other test unless that person meets the
statutory and regulatory requirements for performing that
other test.
4)Specifies that compliance with this bill does not fulfill any
requirements for certification as a phlebotomy technician or a
limited phlebotomy technician, unless the HCV counselor has
otherwise satisfied the certification requirements imposed
pursuant to existing state law.
FISCAL
EFFECT : According to the Assembly Appropriations Committee,
uncertain, potential cost pressure to the DPH. This bill does
not place direct requirements on the department, but is intended
to allow local health jurisdictions (LHJs) flexibility to
approve and implemented their own training programs. However,
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.
PRIOR
VOTES :
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|Assembly Floor: |80 - 0 |
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|Assembly Appropriations Committee: |20 - 0 |
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|Assembly Business and Professions |16 - 0 |
|Committee: | |
AB 2179 (Gipson) Page 7 of ?
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COMMENTS :
1)Author's statement. According to the author, the hepatitis C
virus (HCV) is a communicable disease that is spread by
blood-to-blood contact. If untreated, HCV can lead to liver
cancer, liver disease, cirrhosis, and death. Early detection
reduces the likelihood of disease progression, reduces costs
of treatment, and prevents new infections in the community. 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. AB 2179 would allow local health jurisdictions
(LHJs) as well as CDPH, 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 federal Clinical Laboratory Improvement
Amendments of 1988 (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.
Background. According to DPH, hepatitis C is a liver disease
caused by HCV and usually spread through blood. People can
become infected through sharing needles, needle-stick injuries
in health care settings, or being born to a mother who has
hepatitis C. Less commonly, a person can also get HCV
infection through sharing personal care items that may have
come in contact with another person's blood (like razors or
toothbrushes), or having sexual contact with a person infected
with the virus. Hepatitis C can be either "acute" or
"chronic," and can range in severity from a mild illness
lasting a few weeks to a lifelong illness. According to the
CDC, millions of Americans have hepatitis C, but most don't
know it, because people often have no symptoms and can live
with an infection for decades without SB 1303 | Page 3 feeling
sick. About 80 percent who have HCV infection develop a
chronic, or lifelong, infection. Hepatitis C is a leading
cause of liver cancer and the leading cause of liver
transplants. According to data from 1999 to 2008, about
three-fourths of U.S. patients with HCV infection were born
between 1945 and 1965. The most important risk factor for HCV
AB 2179 (Gipson) Page 8 of ?
infection is past or current IDU, with most studies reporting
a prevalence of 50 percent or more. The incidence of HCV
infection was more than 200,000 cases per year in the 1980s
but decreased to 25,000 cases per year by 2001. According to
the CDC, there were an estimated 16,000 new cases of HCV
infection in 2009 and an estimated 15,000 deaths in 2007.
USPSTF recommendations. Released in June 2013, the USPSTF
recommendations for HCV infection screening apply to all
asymptomatic adults without known liver disease or functional
abnormalities. Persons born between 1945 and 1965 are more
likely to be diagnosed with HCV infection, possibly because
they received blood transfusions before the introduction of
screening in 1992 or have a history of other risk factors for
exposure decades earlier. The recommendations state that a
risk-based approach may miss detection of a substantial
proportion of HCV-infected persons in the birth cohort because
of a lack of patient disclosure or knowledge about prior risk
status. As a result, one-time screening for HCV infection in
the birth cohort may identify infected patients at earlier
stages of disease who could benefit from treatment before
developing complications from liver damage.
Federal and state lab requirements. Under the federal CLIA
law, labs 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.
As defined by CLIA, waived tests are simple tests with a low
risk for an incorrect result. Waived tests include tests
listed in the CLIA regulations, tests cleared by the FDA for
home use, and tests approved for waiver by the FDA using the
CLIA criteria. In order for the FDA to approve a test device
as waived, the manufacturer must show that the test is
accurate and consistent when performed by untrained
individuals. This includes performing studies conducted using
participants without laboratory training, no prior experience
of the test, and no verbal instruction. The study
participants must be able to generate accurate results using
only the product label and included instructions.
AB 2179 (Gipson) Page 9 of ?
Because waived tests are essentially consumer-level products,
facilities that use only waived tests are eligible for a
certificate of waiver. Those with a certificate of waiver are
not subject to the CLIA requirements as long as the tests are
performed according to the manufacturer's instructions.
However, CLIA still requires that all laboratories meet
individual state personnel license requirements.
Under California law, all laboratory tests classified under
CLIA must be performed by personnel specified in statute under
the overall operation and administration of a laboratory
director, with limited exceptions. As of 2014, California is
one of 15 other states that regulate laboratories in addition
to the CLIA standards.
HIV and HCV counselors. Existing law allows HIV counselors to
perform a HIV, HCV, and combination HIV/HCV test as long as it
is classified as waived under CLIA, the facility or clinic has
obtained a certificate of waiver from CMS and DPH approval,
and the HIV counselor has attended trainings specific to each
type of test. Currently, the OA establishes or approves a
local health jurisdiction's (LHJ's) HIV Counseling and Testing
(C&T) 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 OA's Integrated HIV Surveillance, Prevention,
and Care Plan (Integrated Plan), budget cuts during fiscal
year 2009-10 reduced the OA's funding for many 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 C&T training as a part of the CDC's program, but
the remaining LHJs must pay for the C&T training out of their
own funds and spaces within the C&T trainings are limited.
The sponsor notes that having to pay out of pocket for the C&T
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
AB 2179 (Gipson) Page 10 of ?
cannot attend the HCV C&T training without attending the HIV
C&T 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 this issue in two ways: 1) authorizing a
LHJ to 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.
Double referral. This bill was heard in the Senate Business
and Professions Committee on June 21, 2016, and passed with a
9-0 vote.
Previous legislation. AB 761(Roger Hernández, Chapter 714,
Statutes of 2012), provides that a laboratory director may
include a licensed optometrist and authorizes an optometrist
to perform certain clinical laboratory tests or examinations
classified as waived under CLIA.
SB 1481(Negrete McLeod Chapter 874, Statutes of 2012), allows
pharmacists to perform specific CLIA waived tests without the
supervision of a laboratory director.
AB 1382 (Roger Hernández, Chapter 643, Statutes of 2011),
authorized HIV test counselors to perform HCV or combined
HIV/HCV tests in addition to HIV tests.
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
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.
AB 2179 (Gipson) Page 11 of ?
Support. Project Inform is the sponsor of this bill and
states current state law allows non-medical personnel to
administer HCV rapid tests in compliance with CLIA standards,
but only if personnel are working at a DPH-OA funded site, or
authorized by a LHJ; have been trained to administer an 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. The sponsor notes this bill will
give local governments greater flexibility and reduce costs
related to training non-medical personnel to administer the
rapid test to screen for HCV in community settings by allowing
LHJs as well as DPH to certify training standards for HCV
rapid test counselors.
Mendocino County AIDs/Viral Hepatitis Network (MCAVNH)
supports this bill stating that they are the only HIV/IDS/HCV
service-oriented, community based harm reduction organization
in all of Mendocino County. MCAVNH notes that they have
adapted their services to assist those with multiple co-morbid
conditions, and within Mendocino County persons who inject
drugs have a projected HCV positive rate of 85%, and that
early detection reduces the likelihood of disease progression,
reduces costs of treatment, and prevents new infections in the
community. MCAVNH concludes that 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.
SUPPORT AND OPPOSITION :
Support:Project Inform (sponsor)
Access Support Network
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
C.O.R.E. Medical Clinic, Inc.
Desert AIDS Project
Drug Policy Alliance
Harm Reduction Coalition
AB 2179 (Gipson) Page 12 of ?
Health Officers Association of California
HIV Education and Prevention Project of Alameda County
Mendocino County AIDS/Viral Hepatitis Network
San Francisco Hepatitis C Task Force
S.T.O.P. Hepatitis Task Force
Wall Las Memorias Project
Oppose: None received
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