BILL ANALYSIS Ó
AB 2179
Page 1
Date of Hearing: April 12, 2016
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
AB 2179
(Gipson) - As Amended March 30, 2016
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 (CLIA). Specifically, this bill:
1)Requires a hepatitis C counselor to meet one of the following
criteria:
a) To be trained by the Office of AIDS (OA) and working in
an human immunodeficiency virus (HIV) counseling and
testing site funded by the Department of Public Health
(DPH) through a local health jurisdiction, or its agents;
b) To be working in an HIV counseling and testing site that
meets both of the following criteria:
i) Utilizes HIV counselling staff that is trained by
the OA or its agent to provide both HIV counseling and
testing and hepatitis C counseling and testing; and,
ii) Has a quality assurance plan approved by the local
health department in the jurisdiction where the site is
AB 2179
Page 2
located and has HIV counseling and testing staff who
comply with the quality assurance requirements as
specified by DPH; or,
c) To be 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 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.
2)Authorizes a hepatitis C counselor who meets the criteria in
1) above 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 CLIA and state law.
ii) Perform skin punctures for the purpose of
withdrawing blood for HCV testing upon authorization from
a licensed physician provided that the person meets both
of the following requirements:
(1) He or she works under the direction of a
licensed physician; and,
(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
AB 2179
Page 3
Centers for Disease Control and Prevention (CDC).
iii) The person performing the HCV tests meet the
requirements for the performance of waived laboratory
testing pursuant to existing state law as described in
existing law in 2) below. For purposes of these
provisions a hepatitis C counsel is "other health care
personnel provide direct patient care," per existing law.
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 specific test, or, if approved by the
CDC, a second, different rapid HCV test.
b) Order and report HCV test results 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 revaluations.
3)Prohibits a hepatitis C counselor as defined in these
provisions from performing any other test unless they meet the
statutory and regulatory requirements for performing that
other test.
4)Specifies that compliance with these provisions does not
fulfill any requirements for certification as a phlebotomy
technician or a limited phlebotomy technician.
EXISTING FEDERAL LAW:
AB 2179
Page 4
1)Defines "laboratory" or "clinical laboratory" 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 that laboratories 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 CLIA,
provided that the laboratory follows the manufacturer's
instructions.
3)Provides that a laboratory is eligible for a certificate of
waiver if the laboratory 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,
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:
5)Provides for the licensure, registration, and regulation of
clinical laboratories and various clinical laboratory
personnel by DPH.
AB 2179
Page 5
6)Prohibits a person from performing a clinical laboratory test
or examination classified as waived under CLIA unless the
clinical laboratory test or examination is performed under the
overall operation and administration of the laboratory
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 testing.
7)Establishes the OA within DPH as the lead agency within the
state, responsible for coordinating state programs, services,
and activities relating to HIV, acquired immune deficiency
syndrome (AIDS), and AIDS related conditions (ARC).
8)Requires DPH to authorize the establishment of training
programs throughout the state for counselors for publicly
AB 2179
Page 6
funded HIV testing programs.
9)Authorizes an 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 laboratory 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
meets both of the following criteria:
(1)Utilizes HIV counseling staff who are trained by the
OA or its agents; or,
(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 DPH.
c) The HIV, HCV, or combination HIV/HCV test is performed
under the overall operation and administration of a
laboratory director. Defines, for purposes of this
requirement, a HIV counselor who meets the specified
requirements as "other health care personnel providing
direct patient care" under the California clinical
laboratory requirements.
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.
e) If performing skin punctures for the purpose of
AB 2179
Page 7
withdrawing blood for HIV, HCV, or combination HIV/HCV
testing, the counselor must meet the following additional
requirements:
i) The counselor works under the direction of a
licensed physician and surgeon.
ii)The counselor has specific authorization from a licensed
physician and surgeon.
iii)The counselor has been 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.
10)Authorizes the 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.
11)Requires that 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.
12)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.
FISCAL EFFECT: This bill has not been analyzed by a fiscal
committee.
COMMENTS:
AB 2179
Page 8
1)PURPOSE OF THIS BILL. According to the author, the unchecked
spread of HCV threatens the public health and economic welfare
of California. The author states that there are an estimated
750,000 Californians living with HCV, and most do not know it,
and between 2002 and 2011 there were over 400,000 hepatitis B
and HCV-related hospitalizations in California, costing $26
billion. The author contends that the burden of HCV is
expected to grow, and early detection reduces the likelihood
of disease progression, reduces treatment costs, and prevents
new infections. The author also states that community-based
programs are best positioned to serve low-income communities,
including the homeless, reaching those who are currently not
enrolled in Medi-Cal or other health insurance, or who are
disconnected from primary care services. The author asserts
that it is necessary for 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. The author states that 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. The author concludes that the current statutory
requirement that a person must complete training in HIV test
counseling before receiving HCV test counseling, and that the
training must be approved by a state health official rather
than a county health official is outdated and a barrier to
cost-effective disease control and prevention.
2)BACKGROUND.
a) HCV. 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 the HCV, which is spread
primarily through contact with the blood of an infected
AB 2179
Page 9
person. 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 the
HCV. For most people, acute infection leads to chronic
infection. Chronic Hepatitis C virus infection is a
long-term illness that occurs when HCV remains in a
person's body. HCV infection can last a lifetime and lead
to serious liver problems, including cirrhosis (scarring of
the liver) or liver cancer. According to the CDC, most
people become infected with HCV by sharing needles or other
equipment to inject drugs.
The CDC estimates that there are 3.5 million people in the
U.S. who have chronic HCV infection. Between 1994 and 2011,
DPH had received 501,664 newly reported chronic HCV cases
in California. As a result, the World Health Organization,
the CDC, and DPH 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 promote prevention by providing
screening and education services at a community level.
b) 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.
As defined by CLIA, waived tests are simple tests with a
AB 2179
Page 10
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.
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.
AB 2179
Page 11
c) 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
AB 2179
Page 12
incidence of HCV. Currently, the counselors working in
LHJs outside of the CPA 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.
3)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
AB 2179
Page 13
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.
4)PREVIOUS LEGISLATION.
a) 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.
b) SB 1481(Negrete McLeod) Chapter 874, Statutes of 2012
allows pharmacists to perform specific CLIA waived tests
without the supervision of a laboratory director.
c) 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.
d) 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 2179
Page 14
e) 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.
f) AB 1263 (Migden), Chapter 324, Statutes of 2001, among
other things, authorized HIV counselors to perform HIV
tests classified as waived under CLIA.
5)DOUBLE REFERRAL. This bill has been double referred. It
passed the Assembly Committee on Business and Professions with
a vote of 16-0 on March 29, 2016.
6)TECHNICAL AMENDMENTS. This bill is attempting to improve
access to training for persons who are providing HCV screening
by creating HCV tester training programs at the local level,
similar to the HIV training program provided at the state
level. In order to more closely align the training and
supervision requirements for persons performing HPV tests with
those for persons performing HIV tests, the bill should be
amended as follows:
a) Clarify that skin punctures are only allowed to be
performed for waived tests;
b) Require local testing sites to maintain copies of LHJ
approved training documents; and,
c) Add language to the Business & Professions code to
AB 2179
Page 15
clarify that waived HCV tests do not have to be performed
in a clinical laboratory.
7)POLICY COMMENT. Given that DPH has extensive experience in
providing and approving training programs, as this bill moves
forward, the author should consider adding in language that
would require DPH and LHJs to consult on developing the HCV
training programs.
REGISTERED SUPPORT / OPPOSITION:
Support
Project Inform (sponsor)
C.O.R.E. Medical Clinic, Inc.
Desert AIDS Project
Harm Reduction Coalition
Mendocino County AIDs/Viral Hepatitis Network
San Francisco Hepatitis C Task Force
STOP Hepatitis Task-Force
The Wall Las Memorias Project
One individual
Opposition
None on file.
Analysis Prepared by:Lara Flynn / HEALTH / (916) 319-2097
AB 2179
Page 16