BILL NUMBER: AB 2179 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY APRIL 14, 2016
AMENDED IN ASSEMBLY MARCH 30, 2016
AMENDED IN ASSEMBLY MARCH 28, 2016
INTRODUCED BY Assembly Member Gipson
FEBRUARY 18, 2016
An act to amend Section 1206.5 of the Business and
Professions Code, and to add Section 122440 to the Health and
Safety Code, relating to public health.
LEGISLATIVE COUNSEL'S DIGEST
AB 2179, as amended, Gipson. Hepatitis C testing.
Existing
Under existing law, the State Department of Public Health
licenses, registers, and regulates clinical laboratories and various
clinical laboratory personnel. Existing law prohibits a person from
performing a clinical laboratory test or examination classified as
waived under the federal Clinical Laboratory Improvement Amendments
of 1988 unless the test or examination is performed under the overall
operation and administration of a laboratory director and the test
or examination is performed by any one of specified professionals and
others, including a licensed physician and surgeon or
pharmacist. Existing law establishes the Office of AIDS in the
State Department of Public Health department
and defines human immunodeficiency virus (HIV) as the etiologic
agent of acquired immunodeficiency syndrome (AIDS). Existing law
authorizes an HIV counselor who receives specified training and works
in specified counseling and testing sites to perform HIV, hepatitis
C virus (HCV), or combined HIV/HCV tests, including performing skin
punctures for purposes of withdrawing blood for purposes of these
tests, as specified.
This bill would authorize a hepatitis C counselor who receives
specified training and works in described counseling and testing
sites to perform HCV tests. tests, and add
hepatitis C counselors performing those tests to the specified
professionals and others referred to above.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 1206.5 of the
Business and Professions Code is amended to read:
1206.5. (a) Notwithstanding subdivision (b) of Section 1206 and
except as otherwise provided in Sections 1206.6 and 1241, no person
shall perform 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 described in Section 1209, including, but not
limited to, documentation by the laboratory director of the adequacy
of the qualifications and competency of the personnel, and the test
is performed by any of the following persons:
(1) A licensed physician and surgeon holding a M.D. or D.O.
degree.
(2) A licensed podiatrist, a licensed dentist, or a licensed
naturopathic doctor, if the results of the tests can be lawfully
utilized within his or her practice.
(3) A person licensed under this chapter to engage in clinical
laboratory practice or to direct a clinical laboratory.
(4) A person authorized to perform tests pursuant to a certificate
issued under Article 5 (commencing with Section 101150) of Chapter 2
of Part 3 of Division 101 of the Health and Safety Code.
(5) A licensed physician assistant if authorized by a supervising
physician and surgeon in accordance with Section 3502 or 3535.
(6) A person licensed under Chapter 6 (commencing with Section
2700).
(7) A person licensed under Chapter 6.5 (commencing with Section
2840).
(8) A perfusionist if authorized by and performed in compliance
with Section 2590.
(9) A respiratory care practitioner if authorized by and performed
in compliance with Chapter 8.3 (commencing with Section 3700).
(10) A medical assistant, as defined in Section 2069, if the
waived test is performed pursuant to a specific authorization meeting
the requirements of Section 2069.
(11) A pharmacist, as defined in Section 4036, if ordering drug
therapy-related laboratory tests in compliance with paragraph (2) of
subdivision (a) of Section 4052.1 or paragraph (2) of subdivision (a)
of Section 4052.2, or if performing skin puncture in the course of
performing routine patient assessment procedures in compliance with
Section 4052.1.
(12) A naturopathic assistant, as defined in Sections 3613 and
3640.2, if the waived test is performed pursuant to a specific
authorization meeting the requirements of Sections 3613 and 3640.2.
(13) A licensed optometrist as authorized under Chapter 7
(commencing with Section 3000).
(14) Other health care personnel providing direct patient care.
(15) Any other person performing nondiagnostic testing pursuant to
Section 1244.
(16) A hepatitis C counselor performing a hepatitis C virus (HCV)
test pursuant to Section 122440 of the Health and Safety Code.
(b) Notwithstanding subdivision (b) of Section 1206, no person
shall perform clinical laboratory tests or examinations classified as
of moderate complexity under CLIA unless the clinical laboratory
test or examination is performed under the overall operation and
administration of the laboratory director, as described in Section
1209, including, but not limited to, documentation by the laboratory
director of the adequacy of the qualifications and competency of the
personnel, and the test is performed by any of the following persons:
(1) A licensed physician and surgeon holding a M.D. or D.O.
degree.
(2) A licensed podiatrist or a licensed dentist if the results of
the tests can be lawfully utilized within his or her practice.
(3) A person licensed under this chapter to engage in clinical
laboratory practice or to direct a clinical laboratory.
(4) A person authorized to perform tests pursuant to a certificate
issued under Article 5 (commencing with Section 101150) of Chapter 2
of Part 3 of Division 101 of the Health and Safety Code.
(5) A licensed physician assistant if authorized by a supervising
physician and surgeon in accordance with Section 3502 or 3535.
(6) A person licensed under Chapter 6 (commencing with Section
2700).
(7) A perfusionist if authorized by and performed in compliance
with Section 2590.
(8) A respiratory care practitioner if authorized by and performed
in compliance with Chapter 8.3 (commencing with Section 3700).
(9) A person performing nuclear medicine technology if authorized
by and performed in compliance with Article 6 (commencing with
Section 107150) of Chapter 4 of Part 1 of Division 104 of the Health
and Safety Code.
(10) Any person if performing blood gas analysis in compliance
with Section 1245.
(11) (A) A person certified or licensed as an "Emergency Medical
Technician II" or paramedic pursuant to Division 2.5 (commencing with
Section 1797) of the Health and Safety Code while providing
prehospital medical care, a person licensed as a psychiatric
technician under Chapter 10 (commencing with Section 4500) of
Division 2, as a vocational nurse pursuant to Chapter 6.5 (commencing
with Section 2840), or as a midwife licensed pursuant to Article 24
(commencing with Section 2505) of Chapter 5, or certified by the
department pursuant to Division 5 (commencing with Section 70001) of
Title 22 of the California Code of Regulations as a nurse assistant
or a home health aide, who provides direct patient care, if the
person is performing the test as an adjunct to the provision of
direct patient care by the person, is utilizing a point-of-care
laboratory testing device at a site for which a laboratory license or
registration has been issued, meets the minimum clinical laboratory
education, training, and experience requirements set forth in
regulations adopted by the department, and has demonstrated to the
satisfaction of the laboratory director that he or she is competent
in the operation of the point-of-care laboratory testing device for
each analyte to be reported.
(B) Prior to being authorized by the laboratory director to
perform laboratory tests or examinations, testing personnel
identified in subparagraph (A) shall participate in a preceptor
program until they are able to perform the clinical laboratory tests
or examinations authorized in this section with results that are
deemed accurate and skills that are deemed competent by the
preceptor. For the purposes of this section, a "preceptor program"
means an organized system that meets regulatory requirements in which
a preceptor provides and documents personal observation and critical
evaluation, including review of accuracy, reliability, and validity,
of laboratory testing performed.
(12) Any other person within a physician office laboratory if the
test is performed under the supervision of the patient's physician
and surgeon or podiatrist who shall be accessible to the laboratory
to provide onsite, telephone, or electronic consultation as needed,
and shall: (A) ensure that the person is performing test methods as
required for accurate and reliable tests; and (B) have personal
knowledge of the results of the clinical laboratory testing or
examination performed by that person before the test results are
reported from the laboratory.
(13) A pharmacist, if ordering drug therapy-related laboratory
tests in compliance with paragraph (2) of subdivision (a) of Section
4052.1 or paragraph (2) of subdivision (a) of Section 4052.2.
(c) Notwithstanding subdivision (b) of Section 1206, no person
shall perform clinical laboratory tests or examinations classified as
of high complexity under CLIA unless the clinical laboratory test or
examination is performed under the overall operation and
administration of the laboratory director, as described in Section
1209, including, but not limited to, documentation by the laboratory
director of the adequacy of the qualifications and competency of the
personnel, and the test is performed by any of the following persons:
(1) A licensed physician and surgeon holding a M.D. or D.O.
degree.
(2) A licensed podiatrist or a licensed dentist if the results of
the tests can be lawfully utilized within his or her practice.
(3) A person licensed under this chapter to engage in clinical
laboratory practice or to direct a clinical laboratory if the test or
examination is within a specialty or subspecialty authorized by the
person's licensure.
(4) A person authorized to perform tests pursuant to a certificate
issued under Article 5 (commencing with Section 101150) of Chapter 2
of Part 3 of Division 101 of the Health and Safety Code if the test
or examination is within a specialty or subspecialty authorized by
the person's certification.
(5) A licensed physician assistant if authorized by a supervising
physician and surgeon in accordance with Section 3502 or 3535.
(6) A perfusionist if authorized by and performed in compliance
with Section 2590.
(7) A respiratory care practitioner if authorized by and performed
in compliance with Chapter 8.3 (commencing with Section 3700).
(8) A person performing nuclear medicine technology if authorized
by and performed in compliance with Article 6 (commencing with
Section 107150) of Chapter 4 of Part 1 of Division 104 of the Health
and Safety Code.
(9) Any person if performing blood gas analysis in compliance with
Section 1245.
(10) Any other person within a physician office laboratory if the
test is performed under the onsite supervision of the patient's
physician and surgeon or podiatrist who shall: (A) ensure that the
person is performing test methods as required for accurate and
reliable tests; and (B) have personal knowledge of the results of
clinical laboratory testing or examination performed by that person
before the test results are reported from the laboratory.
(d) Clinical laboratory examinations classified as
provider-performed microscopy under CLIA may be personally performed
using a brightfield or phase/contrast microscope by one of the
following practitioners:
(1) A licensed physician and surgeon using the microscope during
the patient's visit on a specimen obtained from his or her own
patient or from a patient of a group medical practice of which the
physician is a member or employee.
(2) A nurse midwife holding a certificate as specified by Section
2746.5, a licensed nurse practitioner as specified in Section 2835.5,
or a licensed physician assistant acting under the supervision of a
physician pursuant to Section 3502 using the microscope during the
patient's visit on a specimen obtained from his or her own patient or
from the patient of a clinic, group medical practice, or other
health care provider of which the certified nurse midwife, licensed
nurse practitioner, or licensed physician assistant is an employee.
(3) A licensed dentist using the microscope during the patient's
visit on a specimen obtained from his or her own patient or from a
patient of a group dental practice of which the dentist is a member
or an employee.
SECTION 1. SEC. 2. Section 122440 is
added to the Health and Safety Code, to read:
122440. (a) A hepatitis C counselor who meets the requirements of
subdivision (d) may do all of the following:
(1) Perform any hepatitis C virus (HCV) test that is classified as
waived under the federal Clinical Laboratory Improvement Act (CLIA)
(42 U.S.C. Sec. 263a et seq.) if all of the following conditions
exist:
(A) The performance of the HCV test meets the requirements of CLIA
and Chapter 3 (commencing with Section 1200) of Division 2 of the
Business and Professions Code.
(B) Notwithstanding Section 1246 of the Business and Professions
Code, a hepatitis C counselor may perform skin punctures for the
purpose of withdrawing blood for waived HCV testing, upon
specific authorization from a licensed physician and surgeon,
provided that the person meets both of the following requirements:
(i) He or she works under the direction of a licensed physician
and surgeon.
(ii) 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.
(C) The person performing the HCV test meets the requirements for
the performance of waived laboratory testing pursuant to subdivision
(a) of Section 1206.5 of the Business and Professions Code. For
purposes of this subdivision and subdivision (a) of Section 1206.5 of
the Business and Professions Code, a hepatitis C counselor who meets
the requirements of subdivision (d) shall be "other health care
personnel providing direct patient care" as referred to in paragraph
(13) of subdivision (a) of Section 1206.5 of the Business and
Professions Code.
(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 federal Centers for Disease Control and Prevention
for that purpose, a second, different rapid HCV test. This
subdivision does not allow a hepatitis C counselor to perform any HCV
test that is not classified as waived under CLIA.
(2) Notwithstanding Section 1246.5 of the Business and Professions
Code, order and report HCV test results from tests performed
pursuant to paragraph (1) 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 from tests performed pursuant to paragraph (1) shall 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.
(b) A hepatitis C counselor who meets the requirements of this
section with respect to performing any HCV test that is classified as
waived under CLIA may not perform any other test unless that person
meets the statutory and regulatory requirements for performing that
other test.
(c) Compliance with this section 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 imposed pursuant to Section 1246 of
the Business and Professions Code.
(d) A hepatitis C counselor shall meet one of the following
criteria:
(1) Is trained by the Office of AIDS and working in an HIV
counseling and testing site funded by the department through a local
health jurisdiction, or its agents.
(2) Is working in an HIV counseling and testing site that meets
both of the following criteria:
(A) 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.
(B) 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 State Department
of Public Health.
(3) 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 department, and retained by the site,
or approved by the State Department of Public Health,
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.