Amended in Senate April 13, 2016

Amended in Senate March 28, 2016

Senate Bill No. 1418

Introduced by Senator Lara

February 19, 2016

An act to begin insert amend Section 1288 of, and to end insert repeal and add Section 1246.5 begin delete of end delete begin insert of, end insert the Business and Professions Code, relating to clinical laboratories.

LEGISLATIVE COUNSEL’S DIGEST

SB 1418, as amended, 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 specified clinical laboratory tests, including pregnancy, glucose level, cholesterol, and occult blood tests. Existing law authorizes a registered clinical laboratory to perform these tests 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.

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 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 begin delete health care provider’s request. end delete begin insert healing arts licensee’s order. end insert If a laboratory test begin delete of a person end delete is conducted begin delete 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, end delete begin insert without an order from a healing arts licensee, end insert the bill would require any report of the test results to be provided begin delete by the person conducting the test end delete 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 begin delete the person’s end delete begin insert his or her end insert health care provider for consultation and interpretation of the test results. begin insert The bill would make additional conforming changes. end insert 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: yes. State-mandated local program: 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.

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 begin delete perform end delete begin insert perform, end insert any laboratory test that the
laboratory offers to the public begin delete on a direct access basis without a
health care provider’s request or written authorization. end delete begin insert without an
order from a healing arts licensee or his or her representative. end insert

(b) If a laboratory test of a person is conducted begin delete 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 end delete begin insert without an order from a healing
arts licensee or his or her representative, the test end insert results shall be
provided begin delete by the person conducting the test end delete to the person who was
the subject of the test. The begin insert test results end insert report shall state in bold
type that it is the responsibility of the person who was tested to
arrange with begin delete the person’s end delete begin insert his or her end insert health care provider for
consultation and interpretation of the test results.

(c) A begin delete health care provider’s duty of care to a patient does not
include any responsibility end delete begin insert healing arts licensee is not required end insert to
review or act on begin delete the end delete begin insert a end insert laboratory test begin delete results of a patient end delete begin insert result end insert if
the begin delete health care provider end delete begin insert healing arts licensee or his or her
representative end insert did not begin delete request or authorize end delete begin insert order end insert the laboratory
test. A begin delete health care provider end delete begin insert healing arts licensee end insert is not subject to
liability or disciplinary actions for begin delete the end delete failure to review or act on
the results of a laboratory test of any begin delete patient end delete begin insert person end insert if the begin delete health
care provider did not request or authorize end delete begin insert healing arts licensee or
his or her representative did not order end insert the laboratory test.

(d) This section does not require that begin delete a end delete begin insert any end insert laboratory test be
covered by a health care service plan contract or health insurance
policy.

begin insert

begin insert SEC. 3. end insert   

end insert

begin insert Section 1288 of the end insert begin insert Business and Professions Code end insert begin insert is
amended to read: end insert

1288.  

begin delete Any person conducting or operating a clinical laboratory
may accept assignments for tests only from and make reports only
to persons licensed under the provisions of law relating to the
healing arts or their representatives. This section does not prohibit
the acceptance of evaluation specimens for proficiency testing or
referral of specimens or such assignment from one clinical
laboratory to another clinical laboratory, either licensed or exempt
under this chapter, providing the report indicates clearly the
laboratory performing the test. end delete A report of results issuing from a
clinical laboratory shall show clearly the name and address of the
laboratory and the name of the director.

begin delete SEC. 3. end delete

begin insert SEC. 4. end 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.