Senate Bill No. 1418

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.  

begin insert (a) end insert begin insert   end insert Notwithstanding any begin delete other provision of law, any end delete
begin insert law, a end insert person may request, and begin delete any end delete begin insert a end insert 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 begin delete CLIA end delete begin insert the federal Clinical
Laboratory Improvement Amendments of 1988 (42 U.S.C. 263a)
(CLIA) end insert 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.

begin delete

The

end delete

begin insert (b) end insert begin insert   end insert begin insert (1) end insert begin insert   end insert begin insert The end insert tests that may be conducted pursuant to this section
are begin delete : 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 all of the following: end insert

begin insert

(A) Pregnancy.

end insert begin insert

(B) Glucose level.

end insert begin insert

(C) Cholesterol.

end insert begin insert

(D) Occult blood.

end insert begin insert

(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.

end insert begin insert

(2) A test approved only as an over-the-counter collection device
may not be conducted pursuant to this section.

end insert