Amended in Senate March 28, 2016

Senate Bill No. 1418

Introduced by Senator begin delete Galgiani end delete begin insert Lara end insert

February 19, 2016

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

LEGISLATIVE COUNSEL’S DIGEST

SB 1418, as amended, begin delete Galgiani end delete   begin insert Lara end insert . 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 begin delete perform, end delete begin insert perform specified clinical laboratory tests, including end insert pregnancy, glucose level, cholesterol, begin insert and end insert occult begin delete blood, and other specified end delete begin insert blood end insert tests. Existing law authorizes a registered clinical laboratory to perform these begin delete tests, as specified. end delete begin insert tests end insert begin insert if the test is subject 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. end insert

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 begin delete make technical, nonsubstantive changes to these provisions. end delete begin insert 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. end insert

begin insert

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.

end insert begin insert

This bill would provide that no reimbursement is required by this act for a specified reason.

end insert

Vote: majority. Appropriation: no. Fiscal committee:  begin delete no end delete begin insert yes end insert . State-mandated local program:  begin delete no end delete begin insert yes end insert .

The people of the State of California do enact as follows:

begin insert

begin insert SECTION 1. end insert   

end insert

begin insert Section 1246.5 of the end insert begin insert Business and Professions
Code end insert begin insert is repealed. end insert

begin delete

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.

end delete

begin insert

begin insert SEC. 2. end insert   

end insert

begin insert Section 1246.5 is added to the end insert begin insert Business and Professions
Code end insert begin insert , to read: end insert

begin insert

begin insert 1246.5. end insert   

(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.

end insert

begin insert

begin insert SEC. 3. end insert   

end insert begin insert

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.

end insert

begin delete

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.

end delete