BILL NUMBER: AB 221	INTRODUCED
	BILL TEXT


INTRODUCED BY   Assembly Member Portantino

                        FEBRUARY 4, 2009

   An act to amend Section 120917 of the Health and Safety Code,
relating to public health.


	LEGISLATIVE COUNSEL'S DIGEST


   AB 221, as introduced, Portantino. HIV testing: skin punctures.
   Existing law permits the Office of AIDS in the State Department of
Public Health to participate in a rapid HIV test research program
conducted with the federal Centers for Disease Control and
Prevention. Under this program, HIV counselors trained by the Office
of AIDS in the State Department of Public Health may perform skin
punctures for purposes of withdrawing blood for 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.
   This bill would exempt an HIV counselor who is trained by
prescribed personnel and in accordance with training requirements
established by the department, and who works under a licensed
physician and surgeon, from the requirement that he or she hold a
valid certification as a phlebotomist technician.
   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.  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 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) 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.  
   (B) 
    (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. 
   (C) 
    (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 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) 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) 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.