BILL ANALYSIS Ó AB 940 Page 1 ASSEMBLY THIRD READING AB 940 (Ridley-Thomas and Waldron) As Amended April 23, 2015 Majority vote ------------------------------------------------------------------- |Committee |Votes |Ayes |Noes | | | | | | | | | | | |----------------+------+---------------------+---------------------| |Business & |14-0 |Bonilla, Jones, | | |Professions | |Baker, Bloom, | | | | |Campos, Chang, Dodd, | | | | |Eggman, Gatto, | | | | |Holden, Mullin, | | | | |Ting, Wilk, Wood | | | | | | | |----------------+------+---------------------+---------------------| |Appropriations |17-0 |Gomez, Bigelow, | | | | |Bonta, Calderon, | | | | |Chang, Daly, Eggman, | | | | |Gallagher, | | | | | | | | | | | | | | |Eduardo Garcia, | | | | |Gordon, Holden, | | | | |Jones, Quirk, | | | | |Rendon, Wagner, | | | | |Weber, Wood | | | | | | | | | | | | AB 940 Page 2 ------------------------------------------------------------------- SUMMARY: Adds the specialty of reproductive biology and the subspecialty of biochemical genetics and makes conforming changes, removes the requirement that clinical laboratory co-directors substantially comply with federal Clinical Laboratory Improvement Amendments (CLIA) requirements, and makes other technical and conforming changes. Specifically, this bill: 1)Amends the definition of laboratory director to clarify that the laboratory director on the laboratory's CLIA certificate meets the qualifications under CLIA for the type and complexity of tests being offered by the laboratory. 2)Amends the definition of laboratory director to allow a scientist, licensed under state law to direct a laboratory performing high complexity tests, such as a bioanalyst, to become a co-director of a laboratory performing high complexity tests without having to meet the CLIA requirements. 3)Amends the requirement for a bioanalyst license to allow an applicant to obtain four years of experience as any kind of CLS in any CLIA-approved laboratory instead of four years of experience as a California-licensed CLS in laboratory approved by the California Department of Public Health (CDPH). 4)Adds two new license categories: a) the specialty of reproductive biology and b) the subspecialty of biochemical genetics and makes conforming changes. 5)Authorizes CDPH to charge a renewal fee for the existing license categories of clinical cytogeneticist and clinical molecular biologist licenses. AB 940 Page 3 6)Makes conforming changes. FISCAL EFFECT: According to the Assembly Appropriations Committee, this bill would result in the following costs and revenues to the Clinical Laboratory Improvement Fund: 1)One-time costs of in the range of $400,000 over two years. This includes modifying regulations, program development, creating forms and related implementation activities. 2)Ongoing costs of under $100,000 to oversee additional licenses. 3)Projected ongoing fee revenue of approximately $90,000 associated with new licensure categories 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. This bill will allow a Bioanalyst with a Master's Degree to serve as an additional laboratory director in a laboratory performing high complexity testing and will allow an applicant for a bioanalyst license to obtain the required four years of experience in an out of state CLIA-approved laboratory. 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." AB 940 Page 4 Background. This bill seeks to address clinical laboratory workforce issues with two changes: 1) allowing qualified licensees without doctorate or medical degrees, such as a bioanalyst, to serve as laboratory co-directors and 2) providing more career opportunities within the clinical laboratory field. Clinical Lab Directors. Under federal law, all clinical laboratories must have a laboratory director that complies with the CLIA requirements. Among other things, CLIA requires that laboratory directors for laboratories performing high complexity tests must have, among other things, a medical or doctorate degree. For medium complexity tests, the minimum requirement is a bachelor's degree and a specific level of training. This bill will allow a licensee without a medical or doctorate degree, who can already perform high complexity tests, to serve as the director of a clinical laboratory performing high complexity tests. Clinical Laboratory Bioanalyst Requirements. Under current law, bioanalysts must complete four years of training in a CDPH approved facility. 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 states other states. New York, Florida, California, and about 10 other states and United States territories have personnel licensing schemes that laboratories must meet. 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. AB 940 Page 5 This bill seeks to increase employment in clinical laboratories by providing more career opportunities for personnel. Analysis Prepared by: Vincent Chee / B. & P. / (916) 319-3301 FN: 0000683