Amended
IN
Senate
April 26, 2016 |
Amended
IN
Senate
April 13, 2016 |
Amended
IN
Senate
March 28, 2016 |
Introduced by Senator Lara |
February 19, 2016 |
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 healing arts licensee’s order. If a laboratory test is conducted
without an order from a healing arts licensee, the bill would require any report of the test results to be provided 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 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.
(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 without an order from a healing arts licensee or his or her representative.
(b)If a laboratory test of a person is conducted without an order from a healing arts licensee or his or her representative, the test results shall be provided 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 his or her health care provider for consultation and interpretation of the test results.
(c)A healing arts licensee is not required to review or act on a laboratory test
result if the healing arts licensee or his or her representative did not order the laboratory test. A healing arts licensee is not subject to liability or disciplinary actions for failure to review or act on the results of
a laboratory test of any person if the healing arts licensee or his or her representative did not order the laboratory test.
(d)This section does not require that any laboratory test be covered by a health care service plan contract or health insurance policy.
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.
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.