California Senate Bill SB1418 Amended / Bill

 BILL NUMBER: SB 1418AMENDED BILL TEXT AMENDED IN SENATE MARCH 28, 2016 INTRODUCED BY Senator  Galgiani   Lara  FEBRUARY 19, 2016 An act to  amend   repeal and add  Section 1246.5 of the Business and Professions Code, relating to clinical laboratories. LEGISLATIVE COUNSEL'S DIGEST SB 1418, as amended,  Galgiani   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,   perform specified clinical laboratory tests, including  pregnancy, glucose level, cholesterol,  and  occult  blood, and other specified   blood  tests. Existing law authorizes a registered clinical laboratory to perform these  tests, as specified.   tests   if the test is s  ubject 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  make technical, nonsubstantive changes to these provisions.   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.   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:  no   yes  . State-mandated local program:  no   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.   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.   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 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.   SEC. 3.   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.   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.