BILL NUMBER: SB 1418	AMENDED
	BILL TEXT

	AMENDED IN SENATE  MARCH 28, 2016

INTRODUCED BY   Senator  Galgiani   Lara 

                        FEBRUARY 19, 2016

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



	LEGISLATIVE COUNSEL'S DIGEST


   SB 1418, as amended,  Galgiani   Lara  .
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,   perform specified
clinical laboratory tests, including  pregnancy, glucose level,
cholesterol,  and  occult  blood, and other
specified   blood  tests. Existing law authorizes a
registered clinical laboratory to perform these  tests, as
specified.   tests   if the test is s 
ubject to a certificate of waiver under the Clinical Laboratory
Improvement Amendments of 1988 and the laboratory has registered with
the State Department of Public Health. 
   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.   repeal those provisions and instead
allow a person to request, and a licensed clinical laboratory or
public health laboratory to perform, any laboratory test that the
laboratory offers to the public on a direct access basis without a
health care provider's request. If a laboratory test of a person is
conducted by or under the supervision of a person other than a health
care provider and not at the request or with the written
authorization of a health care provider, the bill would require any
report of the test results to be provided by the person conducting
the test to the person who was the subject of the test. The bill
would require the report to state in bold type that it is the
responsibility of the person who was tested to arrange with the
person's health care provider for consultation and interpretation of
the test results. By changing the definition of an existing crime,
this bill would impose a state-mandated local program.  
   The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.  
   This bill would provide that no reimbursement is required by this
act for a specified reason. 
   Vote: majority. Appropriation: no. Fiscal committee:  no
  yes  . State-mandated local program:  no
  yes  .


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

   SECTION 1.    Section 1246.5 of the  
Business and Professions Code   is repealed.  
   1246.5.  Notwithstanding any other provision of law, any person
may request, and any 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 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 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. 
   SEC. 2.    Section 1246.5 is added to the  
Business and Professions Code   , to read:  
   1246.5.  (a) Notwithstanding any other law, a person may request,
and a licensed clinical laboratory or public health laboratory may
perform any laboratory test that the laboratory offers to the public
on a direct access basis without a health care provider's request or
written authorization.
   (b) If a laboratory test of a person is conducted by or under the
supervision of a person other than a health care provider and not at
the request or with the written authorization of a health care
provider, any report of the test results shall be provided by the
person conducting the test to the person who was the subject of the
test. The report shall state in bold type that it is the
responsibility of the person who was tested to arrange with the
person's health care provider for consultation and interpretation of
the test results.
   (c) A health care provider's duty of care to a patient does not
include any responsibility to review or act on the laboratory test
results of a patient if the health care provider did not request or
authorize the laboratory test. A health care provider is not subject
to liability or disciplinary actions for the failure to review or act
on the results of a laboratory test of any patient if the health
care provider did not request or authorize the laboratory test.
   (d) This section does not require that a laboratory test be
covered by a health care service plan contract or health insurance
policy. 
   SEC. 3.    No reimbursement is required by this act
pursuant to Section 6 of Article XIII B of the California
Constitution because the only costs that may be incurred by a local
agency or school district will be incurred because this act creates a
new crime or infraction, eliminates a crime or infraction, or
changes the penalty for a crime or infraction, within the meaning of
Section 17556 of the Government Code, or changes the definition of a
crime within the meaning of Section 6 of Article XIII B of the
California Constitution.  
  SECTION 1.    Section 1246.5 of the Business and
Professions Code is amended to read:
   1246.5.  (a) Notwithstanding any law, a person may request, and 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
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.
   (b) (1) The tests that may be conducted pursuant to this section
are 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.