BILL ANALYSIS Ó
AB 2179
Page 1
Date of Hearing: March 29, 2016
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Rudy Salas, Chair
AB 2179
(Gipson) - As Amended March 28, 2016
NOTE: This bill is double-referred, if passed by this Committee
it will be referred to the Assembly Committee on Health.
SUBJECT: Hepatitis C testing.
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).
EXISTING FEDERAL LAW:
1)Requires that laboratories obtain a certificate, meet quality
standards, and undergo inspections, among other things, before
accepting materials derived from the human body. (CLIA, 42
USC §§ 263a - 263a-7)
2)Defines "laboratory" or "clinical laboratory" as a facility
for the biological, microbiological, serological, chemical,
immuno-hematological, hematological, biophysical, cytological,
AB 2179
Page 2
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. (Title 42
United States Code (USC) § 263a(a))
3)Exempts laboratories with a certificate of waiver from the
CLIA, provided that the laboratory follows the manufacturer's
instructions. (42 USC § 263a(d)(2)(C); Title 42 Code of
Federal Regulations (CFR) § 493.15)
4)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. (42 USC § 263a(d)(3); 42 CFR §
493.15; 69 Federal Register (FR) 22849)
5)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. (45 USC § 263a(p))
EXISTING STATE LAW:
6)Provides for the licensure, registration, and regulation of
clinical laboratories and various clinical laboratory
personnel by the California Department of Public Health
(CDPH). (Business and Professions Code (BPC) §§ 1200-1327)
AB 2179
Page 3
7)Defines "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(a)(5))
8)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:
(BPC § 1206.5)
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 CDPH.
e) A licensed physician assistant.
AB 2179
Page 4
f) A licensed nurse.
g) A licensed vocational nurse.
h) A certified perfusionist.
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.
ee)Any other person performing nondiagnostic testing, as
specified.
9)Establishes the Office of AIDS (OA) within the CDPH as the
lead agency within the state, responsible for coordinating
state programs, services, and activities relating to the human
immunodeficiency virus (HIV), acquired immune deficiency
syndrome (AIDS), and AIDS related conditions (ARC). (Health
and Safety Code (HSC) § 131019)
AB 2179
Page 5
10)Defines "human immunodeficiency virus" or "HIV" as the
etiologic virus of AIDS. (HSC § 120775(b))
11)Defines "HIV test" as any clinical test, laboratory or
otherwise, used to identify HIV, a component of HIV, or
antibodies or antigens to HIV. (HSC § 120775(c))
12)Requires the CDPH to authorize the establishment of training
programs throughout the state for counselors for publicly
funded HIV testing programs. (HSC § 120871)
13)Authorizes 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: (HSC § 120917)
a) The performance of the HIV, HCV, or combination HIV/HCV
test meets the requirements of CLIA and the California
clinical laboratory requirements (BPC §§ 1200 - 1327).
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 CDPH 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.
(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 (Title 17 California Code of
AB 2179
Page 6
Regulations (CCR) §1230).
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 (BPC § 1206.5).
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
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.
AB 2179
Page 7
14)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. (HSC §
120917(a)(2))
15)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. (HSC § 120917(a)(2))
16)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:
17)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 the California clinical laboratory requirements
(BPC § 1200 - 1327).
b) The counselor meets one of the following training and
workplace requirements:
i) Is trained by the OA and is working in a HIV
counseling and testing site funded by the CDPH 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:
AB 2179
Page 8
(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.
(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 (17 CCR §1230).
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, a HIV counselor who meets the
specified requirements as "other health care personnel
providing direct patient care" under the California
clinical laboratory requirements (BPC § 1206.5).
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 CDC for that
purpose, a second, different rapid HCV test.
e) If performing a skin punctures for the purpose of
withdrawing blood for HCV testing, the counselor must meet
the following additional requirements:
AB 2179
Page 9
i) Work under the direction of a licensed physician and
surgeon.
ii)Obtain specific authorization from a licensed physician
and surgeon.
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 DOSH in
the DIR and the CDC.
18)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.
19)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.
20)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.
FISCAL EFFECT: Unknown. This bill is keyed fiscal by the
Legislative Counsel.
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
AB 2179
Page 10
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 is a condition characterized by
inflammation of the liver (CDC Hepatitis C Fact Sheet, 2015).
Hepatitis C is an infection of the liver caused by HCV, one of
several 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.
Acute infections (short-term) are treatable with antiviral
medications. However, the World Health Organization (WHO) notes
that early detection can be difficult, medications can be
costly, and there is currently no vaccine (WHO Hepatitis C Fact
Sheet, 2015). Acute infections left untreated become chronic,
and can result in liver disease, liver failure, and liver
cancer.
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
(CDPH Chronic Hepatitis B and Hepatitis C Infections in
California: Cases Newly Reported through 2011, November 2013).
As a result, the WHO, 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
AB 2179
Page 11
increase access to HCV counselors, who will 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.
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.
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
AB 2179
Page 12
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 CDPH approval, and
the HIV counselor has attended trainings specific to each type
of test. Currently, the OA establishes or approves a 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 local health jurisdictions (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 (CDC PS12-1201 Comprehensive HIV Prevention
Programs for Health Departments). 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.
AB 2179
Page 13
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.
Existing HCV Counselor Training Programs. Because counselors
(and others) are prohibited from performing a HCV test
classified as waived under CLIA, there is no existing standalone
training program or provider. However, there is currently only
one CLIA-waived HCV test, the OraQuick HCV Rapid Antibody Test.
The OraQuick HCV Rapid test is manufactured by OraSure
Technologies Inc. and is a qualitative immunoassay to detect
antibodies to HCV in fingerstick whole blood and venipuncture
whole blood specimens (see CLIA Currently Waived Analytes
database under Hepatitis C, FDA premarket approval number (PMA)
P080027). OraSure has stated that it is able to provide
technical training and assistance in the use of its products,
which include:
1)Dedicated account managers responsible for the Public Health
and Hospital markets in California.
2)Live and webinar product training.
3)Quality Assurance Program development/support.
4)Technical assistance with test implementation.
AB 2179
Page 14
5)Troubleshooting on product complaints in the field.
6)Marketing and PR support for special event days.
7)Free promotional support for organizations in the form of
"palm cards."
In addition to the technical device and fingerstick and
venipuncture procedural trainings, non-CPA LHJs will also need
to develop the public health and community health modules that
are specific to HCV. The sponsor has stated that the process
would be the same as when the HCV-specific module was developed
for the OA's HIV training.
Prior Related Legislation. 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, as
specified, 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 2179
Page 15
AB 1263 (Migden), Chapter 324, Statutes of 2001, among other
things, authorized HIV counselors to perform HIV tests
classified as waived under CLIA , as specified.
AMENDMENT(S):
The author should make the following technical amendments:
1)Page 2, line 2, strike " A " and after "(a)" insert:
Notwithstanding any other law, a
2)Page 2, line 8, strike " and, subject to subparagraph (B), " and
insert:
and
3)Page 2, line 17, strike:
both
4)Page 2, line 18, strike:
and oral swab tests
5)Page 3, lines 18-19, strike:
This section does not certify a hepatitis C counselor as a
phlebotomy technician or a limited phlebotomy technician.
REGISTERED SUPPORT:
Project Inform (sponsor)
AB 2179
Page 16
Aids Community Research Consortium
Asian Pacific Health Foundation
California Hepatitis Alliance
HIV Education and Prevention Project of Alameda
REGISTERED OPPOSITION:
None on file.
Analysis Prepared by:Vincent Chee / B. & P. / (916) 319-3301