BILL NUMBER: AB 221 AMENDED
BILL TEXT
AMENDED IN SENATE JUNE 11, 2009
INTRODUCED BY Assembly Member Portantino
( Coauthors: Assembly Members
Fuentes and Jeffries )
FEBRUARY 4, 2009
An act to amend Section Sections 120871
and 120917 of the Health and Safety Code, relating to public
health , and declaring the urgency thereof, to take effect
immediately .
LEGISLATIVE COUNSEL'S DIGEST
AB 221, as amended, Portantino. HIV testing: skin punctures.
Existing law provides for various programs relating to treatment
of persons with the human immunodeficiency virus (HIV) and the
acquired immunodeficiency syndrome (AIDS).
Existing law requires the State Department of Public Health to
authorize the establishment of training programs for counselors for
publicly funded HIV testing programs, by community-based, nonprofit
organizations meeting prescribed requirements. Existing law requires
the participating community-based organizations to follow curriculum
content and design for these training programs that is approved by
the department.
This bill would require the curriculum content to include training
in universal infection control precautions and rapid HIV test
proficiency, as specified.
Existing law permits the Office of AIDS in the State
Department of Public Health department to
participate in a rapid HIV test research program conducted with the
federal Centers for Disease Control and Prevention. Under
this program,
This bill would repeal the authorization for the Office of AIDS to
participate in a rapid HIV test research program conducted with the
federal Centers for Disease Control and Prevention.
Existing law also authorizes HIV counselors trained by
the Office of AIDS in the State Department of Public Health
may office to perform skin punctures for purposes of
withdrawing blood for HIV test purposes, if the HIV counselor meets
prescribed requirements. One of these requirements is that the HIV
counselor must hold a valid certification as a phlebotomist
technician by the State Department of Public Health
department .
This bill would exempt an HIV counselor who is trained by
prescribed personnel and in accordance with training
requirements established by the department pursuant to the
above-mentioned training program curriculum requirements , and
who works under a licensed physician and surgeon, from the
requirement that he or she hold a valid certification as a
phlebotomist technician.
This bill would declare that it is to take effect immediately as
an urgency statute.
Vote: majority 2/3 . Appropriation:
no. Fiscal committee: yes. State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. The Legislature finds and declares all of the
following:
(a) The United States Centers for Disease Control and Prevention
estimates that HIV incidence is 40 percent higher than previously
thought.
(b) The Office of AIDS in the State Department of Public Health
estimates that between 30,000 and 40,000 Californians are unaware
that they are HIV-positive and, therefore, are not receiving
appropriate HIV treatment and are possibly jeopardizing their own
health, and that of their sex partners and intravenous drug-using
partners.
(c) It is therefore in the interest of the people of the State of
California to take steps to ensure that people have greater access to
HIV testing.
SEC. 2. Section 120871 of the Health
and Safety Code is amended to read:
120871. (a) The department shall authorize the establishment of
training programs throughout the state for counselors for publicly
funded HIV testing programs. These training programs shall be
conducted by community-based, nonprofit organizations with
demonstrated expertise in providing free, anonymous, or confidential
HIV testing services. The programs may be offered at flexible times,
so as to facilitate the training of volunteer and part-time
counselors.
(b) All participating community-based organizations shall follow
curriculum content and design approved by the department for training
programs administered pursuant to this section. The curriculum
content shall include training in both of the following:
(1) 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.
(2) Rapid HIV test proficiency for skin puncture blood tests and
oral swab tests.
(c) All counselors trained in programs authorized by this section
shall be subject to existing state and local testing and successful
completion of training.
(d) All costs associated with training programs administered
pursuant to this section shall be absorbed by participating
community-based organizations. This section shall not be construed to
require or prohibit the funding of any training program administered
pursuant to this section by the department, or by any local
government administering a training program for HIV counselors.
(e) This section shall not be construed to prohibit or otherwise
restrict community-based organizations from participating in existing
local training programs.
(f) This section shall not be construed to certify an HIV
counselor as a phlebotomy technician or a limited phlebotomy
technician, or to fulfill any requirements for certification as a
phlebotomy technician or a limited phlebotomy technician, unless the
HIV counselor has otherwise satisfied the certification requirements
imposed pursuant to Section 1246 of the Business and Professions
Code.
SEC. 2. SEC. 3. Section 120917 of
the Health and Safety Code is amended to read:
120917. (a) The department, through its Office of AIDS and the
authorized agents of the office, may participate in a rapid human
immunodeficiency virus test research program conducted with the
federal Centers for Disease Control and Prevention, involving
innovative HIV testing and counseling programs. Under the rapid HIV
test research program, as authorized by this section, the department
may do the following:
(1) Perform and report clinical test results using a rapid HIV
test for diagnosis, prior to test approval by the federal Food and
Drug Administration (FDA). However, test performance and reporting
shall only be done to the extent allowed under that device's
investigational approval by the FDA and pursuant to a California
Health and Human Services Agency Institutional Review Board-approved
research protocol.
(2) Use a second independent HIV test to confirm initially
reactive test results to the extent allowed under the investigational
approval by the FDA. All rapid tests shall be confirmed using
technology approved by the federal Food and Drug Administration. If
the results from this confirmatory testing differ from the results of
the rapid test, the subject shall be notified. No subject shall
participate in the research protocol who does not provide appropriate
contact information.
(b)
120917. (a) An HIV counselor who 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, may do all of the following:
(1) Perform any HIV test that is classified as waived under the
federal Clinical Laboratory Improvement Act (CLIA) (42 U.S.C. Sec.
263a and following) if all of the following conditions exist:
(A) The performance of the HIV test meets the requirements of CLIA
and, subject to subparagraph (B), 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, an HIV counselor may perform skin punctures for the purpose of
withdrawing blood for HIV 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 accordance with training
requirements established by the department , by a licensed
physician and surgeon, or by a licensed clinical laboratory scientist
or bioanalyst in the proper procedures to be employed when
conducting the skin puncture, and has a statement signed by the
instructing physician and surgeon, scientist, or bioanalyst that the
training has been successfully completed. pursuant to
subdivision (b) of Section 120871. An HIV counselor who has been
certified using a curriculum pursuant to subdivision (b) of Section
120871 prior to the inclusion of the curriculum content required in
paragraphs (1) and (2) of that subdivision and who will administer
rapid HIV skin puncture tests shall obtain training in the curriculum
content required by those paragraphs within two years of the date
that the department approves a curriculum that meets the requirements
of those paragraphs. The HIV counselor shall not, unless also
certified as a limited phlebotomist technician, perform a skin
puncture pursuant to this section until he or she has completed the
training for the new curriculum content.
(C) The person performing the HIV 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, an HIV counselor trained by the
Office of AIDS shall be "other health care personnel providing direct
patient care" as referred to in paragraph (12) 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 HIV infection and that the
result must be confirmed by an additional more specific test, or, if
approved by the federal Food and Drug Administration
FDA for that purpose, a second different rapid
HIV test. Nothing in this subdivision shall be construed to allow an
HIV counselor trained by the Office of AIDS to perform any HIV test
that is not classified as waived under the CLIA.
(2) Notwithstanding Sections 1246.5 and 2053 of the Business and
Professions Code, order and report HIV test results from tests
performed pursuant to paragraph (1) to patients without authorization
from a licensed health care professional or his or her authorized
representative. Patients with indeterminate or positive test results
from tests performed pursuant to paragraph (1) shall be referred to a
licensed health care provider whose scope of practice includes the
authority to refer patients for laboratory testing for further
evaluation.
(c)
(b) Notwithstanding any other provision of law, an HIV
counselor acting in accordance with this section who successfully
completes the HIV counselor training shall be deemed to have
demonstrated sufficient literacy and comprehension to advance to the
limited phlebotomy technician training and may substitute successful
completion of the HIV counselor curriculum for the requirement for a
high school diploma or General Education Development (GED) equivalent
for a limited phlebotomy technician, as defined in Section 1029.116
of Title 17 of the California Code of Regulations pursuant to Section
1246 of the Business and Professions Code.
(d)
(c) An HIV counselor who meets the requirements of this
section with respect to performing any HIV test that is classified
as waived under the CLIA may not perform any other test unless that
person meets the statutory and regulatory requirements for performing
that other test.
SEC. 4. This act is an urgency statute necessary
for the immediate preservation of the public peace, health, or safety
within the meaning of Article IV of the Constitution and shall go
into immediate effect. The facts constituting the necessity are:
Because HIV screening is so critical to containing the AIDS
epidemic, and therefore, persons who can administer rapid HIV testing
must be employed as soon as possible, it is necessary that this act
go into immediate effect.