California Senate Bill SB1418 Introduced / Bill

 BILL NUMBER: SB 1418INTRODUCED BILL TEXT 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.  (a)    Notwithstanding any  other provision of law, any   law, a  person may request, and  any   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  CLIA   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.  The   (b)     (1)     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.   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.