BILL NUMBER: SB 1418	INTRODUCED
	BILL TEXT


INTRODUCED BY   Senator Galgiani

                        FEBRUARY 19, 2016

   An act to amend Section 1246.5 of the Business and Professions
Code, relating to clinical laboratories.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 1418, as introduced, Galgiani. Clinical laboratory testing.
   Existing law provides for the regulation and licensure of clinical
laboratories and clinical laboratory personnel by the State
Department of Public Health and makes a violation of a provision
under this law a misdemeanor. Existing law authorizes a person to
request, and a licensed clinical laboratory or public health
laboratory to perform, pregnancy, glucose level, cholesterol, occult
blood, and other specified tests. Existing law authorizes a
registered clinical laboratory to perform these tests, as specified.
   Existing law authorizes the results of the test to be provided
directly to the person requesting the test if the test is on or for
his or her own body. Existing law requires that those test results be
provided in a manner that presents clear information and that
identifies results indicating the need for referral to a physician.
   This bill would make technical, nonsubstantive changes to these
provisions.
   Vote: majority. Appropriation: no. Fiscal committee: no.
State-mandated local program: no.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

  SECTION 1.  Section 1246.5 of the Business and Professions Code is
amended to read:
   1246.5.   (a)    Notwithstanding any 
other provision of law, any   law, a  person may
request, and  any   a  licensed clinical
laboratory or public health laboratory may perform, the laboratory
tests specified in this section. A registered clinical laboratory may
perform the laboratory tests specified in this section if the test
is subject to a certificate of waiver under  CLIA 
 the federal Clinical Laboratory Improvement Amendments of 1988
(42 U.S.C. 263a) (CLIA)  and the laboratory has registered with
the department under paragraph (2) of subdivision (a) of Section
1265. A program for nondiagnostic general health assessment that
includes a laboratory test specified in this section shall comply
with the provisions of Section 1244. The results from any test may be
provided directly to the person requesting the test if the test is
on or for his or her own body. These test results shall be provided
in a manner that presents clear information and that identifies
results indicating the need for referral to a physician and surgeon.

    The 
    (b)     (1)     The 
tests that may be conducted pursuant to this section are  :
pregnancy, glucose level, cholesterol, occult blood, and any other
test for which there is a test for a particular analyte approved by
the federal Food and Drug Administration for sale to the public
without a prescription in the form of an over-the-counter test kit. A
test approved only as an over-the-counter collection device may not
be conducted pursuant to this section.   all of the
following:  
   (A) Pregnancy.  
   (B) Glucose level.  
   (C) Cholesterol.  
   (D) Occult blood.  
   (E) Any other test for which there is a test for a particular
analyte approved by the federal Food and Drug Administration for sale
to the public without a prescription in the form of an
over-the-counter test kit.  
   (2) A test approved only as an over-the-counter collection device
may not be conducted pursuant to this section.