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