BILL ANALYSIS Ó AB 940 Page 1 CONCURRENCE IN SENATE AMENDMENTS AB 940 (Ridley-Thomas and Waldron) As Amended August 20, 2015 Majority vote -------------------------------------------------------------------- |ASSEMBLY: |79-0 |(June 1, 2015) |SENATE: |40- |(August 31, | | | | | | |2015) | | | | | | | | | | | | | | | -------------------------------------------------------------------- Original Committee Reference: B. & P. SUMMARY: Clarifies that a qualified licensed bioanalyst may act as a laboratory director, allows an applicant for a bioanalyst license to obtain four years of experience in any laboratory approved under the federal Clinical Laboratory Improvement Amendments (CLIA), and authorizes the California Department of Public Health (CDPH) to charge a renewal fee for specified licenses. Specifically, this bill: 1)Defines "CLIA laboratory director" as the person identified as the laboratory director on the CLIA certificate issued to the laboratory by the federal Centers for Medicare and Medicaid Services (CMS). 2)Clarifies that the laboratory director on the laboratory's AB 940 Page 2 CLIA certificate must meet the qualifications under CLIA for the type and complexity of tests being offered by the laboratory. 3)Clarifies that a licensed bioanalyst may, if qualified under CLIA, act as the CLIA laboratory director or co-director of a laboratory performing high complexity tests. 4)Allows a clinical laboratory scientist that is not licensed in this state, who is applying for a bioanalyst license, to obtain four years of experience in a CLIA-approved laboratory, rather than a laboratory inspected by the CDPH. 5)Authorizes the CDPH to charge a renewal fee for the existing license categories of clinical cytogeneticist and clinical molecular biologist licenses. 6)Makes other conforming changes. The Senate amendments: 1)Clarify that a licensed bioanalyst, if qualified under CLIA, may act as a CLIA laboratory director or as a co-laboratory director. 2)Delete the two new license categories of reproductive biology and biochemical genetics. 3)Rename the license for clinical molecular biologist to the license for clinical genetic molecular biologist. 4)Make conforming changes. AB 940 Page 3 FISCAL EFFECT: According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, negligible state costs. COMMENTS: Purpose. This bill is sponsored by the California Clinical Laboratory Association. According to the author, "[this bill] will reestablish a true career ladder in the California clinical laboratory field. Without this bill, the growing shortage of licensed clinical laboratory personnel in California will continue. To meet the healthcare demands of the California population, increased numbers of licensed clinical laboratory personnel are needed." Background. Under federal law, all clinical laboratories must have a laboratory director that complies with the CLIA requirements. This bill will clarify the distinction between a CLIA laboratory director and a co-laboratory director. It will also allow a licensed bioanalyst who is qualified under CLIA to serve as either the CLIA laboratory director or the co-director. Bioanalyst Experience Requirement. Under current law, bioanalysts must complete four years of training in a CDPH approved facility as a California licensed clinical laboratory scientist. When approving laboratories, CDPH performs an onsite survey and requires ownership information prior to issuing a laboratory a state license. This bill will allow an applicant for a bioanalyst license to use experience acquired in CLIA-approved laboratories in other states, without being licensed as a clinical laboratory scientist in this state. California, New York, Florida, and about 10 other states have state personnel licensing schemes that are in addition to the federal CLIA requirements. AB 940 Page 4 Workforce Shortages. At this time, it is unclear whether there is a current laboratory personnel shortage. However, California is behind the national average in clinical laboratory technologists. This bill seeks to increase employment in clinical laboratories by providing more career opportunities for personnel. Clinical Genetic Molecular Biologist Name Change. Existing CDPH regulations describe the clinical molecular biologist license as the clinical genetic molecular biologist license (California Code of Regulations, Title 17, Section 1031.3). This bill amends the statute to match the regulations. Analysis Prepared by: Vincent Chee / B. & P. / (916) 319-3301 FN: 0001552