BILL NUMBER: SB 1418 AMENDED
BILL TEXT
AMENDED IN SENATE APRIL 13, 2016
AMENDED IN SENATE MARCH 28, 2016
INTRODUCED BY Senator Lara
FEBRUARY 19, 2016
An act to amend Section 1288 of, and to repeal and add
Section 1246.5 of of, 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 health
care provider's request. healing arts licensee's
order. 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, without an
order from a healing arts licensee, 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 his or her health
care provider for consultation and interpretation of the test
results. The bill would make additional conforming changes.
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
perform 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. without an order from a healing arts
licensee or his or her representative.
(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 without an order
from a healing arts licensee or his or her representative, the test
results shall be provided by the person conducting the
test to the person who was the subject of the test. The
test results report shall state in bold type that it is
the responsibility of the person who was tested to arrange with
the person's his or her 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 healing arts
licensee is not required to review or act on the
a laboratory test results of a patient
result if the health care provider
healing arts licensee or his or her representative
did not request or authorize order
the laboratory test. A health care provider
healing arts licensee 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
person if the health care provider did
not request or authorize healing arts licensee or his
or her representative did not order the laboratory test.
(d) This section does not require that a
an y laboratory test be covered by a health care
service plan contract or health insurance policy.
SEC. 3. Section 1288 of the Business
and Professions Code is amended to read:
1288. 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. 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.
SEC. 3. SEC. 4. 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.