BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                     AB 940


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          CONCURRENCE IN SENATE AMENDMENTS


          AB  
          940 (Ridley-Thomas and Waldron)


          As Amended  August 20, 2015


          Majority vote


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          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  








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            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


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          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.  









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          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