BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  AB 1215
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          Date of Hearing:   April 16, 2013

              ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER  
                                     PROTECTION
                              Richard S. Gordon, Chair
               AB 1215 (Hagman and Holden) - As Amended:  April 9, 2013
           
          SUBJECT  :   Clinical laboratories.

           SUMMARY  :   Redefines the term "laboratory director" to allow a  
          licensed clinical laboratory scientist (CLS) to operate as the  
          director of a clinical laboratory when performing simple tests  
          exempted from the federal Clinical Laboratory Improvements  
          Amendments (CLIA) of 1988.

           EXISTING STATE LAW  : 

          1)Provides for the licensure and regulation of clinical  
            laboratories and their personnel by the California Department  
            of Public Health, and requires clinical laboratories to be  
            operated under the supervision of a laboratory director, as  
            specified. (Business and Professions Code [BPC] Section 1260  
            et seq.; California Code of Regulations, Title 17, Division 1,  
            Chapter 2) 

          2)Prohibits the performance of a clinical laboratory test or  
            examination classified as waived under the federal CLIA of  
            1988 unless the test or examination is performed under the  
            overall operation and administration of a laboratory director,  
            as defined, and is performed by specified persons, including  
            certain health care personnel.  (BPC 1209)

          3)Defines the following terms:

             a)   "Clinical laboratory scientist" shall mean any person  
               other than a licensed clinical laboratory bioanalyst or  
               trainee who is licensed to engage in clinical laboratory  
               practice under the supervision of a laboratory director.  A  
               licensed CLS may perform clinical laboratory tests or  
               examinations classified as of high complexity under CLIA  
               and the duties and responsibilities of a technical  
               consultant, clinical consultant, technical supervisor, and  
               general supervisor, as specified under CLIA, in the  
               specialties of histocompatibility, microbiology, diagnostic  
               immunology, chemistry, hematology, immunohematology,  








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               genetics, or other specialty or subspecialty specified by  
               regulation adopted by the department.  A licensed CLS may  
               perform any clinical laboratory test or examination  
               classified as waived or of moderate complexity under CLIA;  
               (BPC 1204) and, 

             b)   "Laboratory director" shall mean any person who is a  
               duly licensed physician and surgeon, or, only for purposes  
               of a clinical laboratory test or examination classified as  
               waived, is a duly licensed naturopathic doctor, or is  
               licensed to direct a clinical laboratory and who  
               substantially meets the laboratory director qualifications  
               under CLIA for the type and complexity of tests being  
               offered by the laboratory. (BPC 1209) 

          EXISTING FEDERAL LAW  : 

          1)Establishes CLIA under federal law, which regulates clinical  
            laboratories that perform tests on human specimens and sets  
            standards for facility administration, personnel  
            qualifications and quality control.  These standards apply to  
            all settings, including commercial, hospital or physician  
            office laboratories. (Title 42 of the Code of Federal  
            Regulations [CFR], Part 493)

          2)Defines CLIA waived tests as simple laboratory examinations  
            and procedures that are approved by the Food and Drug  
            Administration (FDA) for home use, employ methodologies that  
            are simple and accurate as to render the likelihood of  
            erroneous results negligible, or pose no reasonable risk of  
            harm to the patient if the test is performed incorrectly. (42  
            CFR 493)

           FISCAL EFFECT  :   None.  This bill is keyed non-fiscal by the  
          Legislative Counsel. 

           COMMENTS  :   

           1)Purpose of this bill .  This bill would allow CLSs to operate  
            as laboratory directors overseeing clinical laboratories  
            performing less complex CLIA-waived tests, thereby expanding  
            the pool of individuals qualified to fill such positions.  As  
            federal law already authorizes CLSs to become laboratory  
            directors but California does not, AB 1215 would conform state  
            law to federal law.  This bill is sponsored by the California  








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            Association of Medical Laboratory Technology and multiple  
            labor organizations. 

           2)Author's statement  .  According to the author's office,  
            "Current law prohibits the performance of a clinical  
            laboratory test or examination classified as waived by the  
            CLIA, unless the test or examination is performed under the  
            overall operation and administration of a laboratory director.  
             Securing a laboratory director in California is a complex and  
            expensive task that precludes other healthcare providers from  
            being able to provide waived testing services to their  
            patients.  In recent years, bills have passed expanding who  
            can be a laboratory director, but the most highly trained  
            people, who actually work in the laboratories, cannot."

           3)Clinical laboratory oversight .   California clinical  
            laboratories are subject to both federal and state oversight.   
            The federal CLIA regulates clinical labs based on the  
            complexity (low, moderate or high) of the tests offered.   
            Congress passed CLIA in 1988, which established quality  
            standards for all laboratory testing to ensure the accuracy,  
            reliability and timeliness of patient test results regardless  
            of where the test was performed. 

            State oversight of clinical labs is administered by the  
            California Department of Public Health's (DPH's) Laboratory  
            Field Services (LFS), which regulates about 19,000 clinical  
            labs and their personnel statewide, monitors proficiency  
            testing, investigates complaints, and sanctions labs that  
            violate the law or regulations.  LFS provides licensing,  
            registration, and certification services for clinical  
            laboratory facilities, blood banks, tissue banks and the  
            testing personnel who perform professional pre-analytical,  
            analytical, and post analytical testing services for these  
            facilities. 

            In conformity with CLIA, DPH licenses or registers clinical  
            labs according to the complexity of the tests they perform.   
            Labs must be licensed for moderately or highly complex  
            procedures, and registered for low complexity.  About 3,000  
            clinical labs are licensed for moderate and/or high complexity  
            testing.  The remaining are registered labs performing waived  
            tests and/or provider-performed microscopy.  

            This bill deals specifically with tests that are 'waived', or  








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            exempt from regulatory oversight, because they are approved by  
            the FDA for home use, utilize simple and accurate methods that  
            make the possibility of error negligible, or pose no  
            significant risk of harm to the patient if incorrectly  
            performed.  Any person can purchase these tests from  
            pharmacies, drugstores, supermarkets, or retail stores and  
            conveniently perform the test at home.  Examples of these  
            tests include: dipstick or tablet reagent urinalysis, stool  
            sampling, ovulation tests, urine pregnancy tests, and certain  
            tests of a small amount of blood obtained by skin prick or  
            blood draw. 

           4)Clinical laboratory director requirements and duties  .  A  
            laboratory director must be a licensed physician and surgeon  
            or meet other licensure requirements, and is responsible for  
            overseeing the overall operation and administration of the  
            laboratory.  Under federal CLIA, CLSs can be waived laboratory  
            directors.  Under state law, for the purposes of waived tests,  
            a laboratory director can also include a licensed naturopathic  
            doctor, an optometrist or a person licensed to direct a  
            clinical laboratory and who substantially meets the laboratory  
            director qualifications under CLIA for the type and complexity  
            of tests being offered by the laboratory.  In recent years,  
            state legislation has expanded the definition of who can  
            become a lab director for waived labs (naturopaths,  
            optometrists, and pharmacists), and this bill would add a CLS  
            to that list. 

            A laboratory director of a clinical laboratory performing  
            waived tests is responsible for the overall operation and  
            administration of the waived laboratory, including: ensuring  
            that testing personnel are competent to perform test  
            procedures; recording and reporting test results promptly,  
            accurately, and proficiently; and assuring compliance with the  
            applicable regulations relating to the state laboratory law  
            and the federal CLIA.  While the laboratory director may  
            delegate such duties to persons who meet appropriate  
            qualifications, the laboratory director is responsible for  
            ensuring that all assigned duties and testing are properly  
            performed.  The lab director would also be accessible to the  
            laboratory to provide onsite, telephone, or electronic  
            consultation as needed.

           5)Clinical Laboratory Scientist  .  A CLS holds, at the minimum, a  
            bachelors of science degree with specific coursework in  








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            laboratory disciplines such as hematology, medical  
            microbiology, clinical chemistry, immunology,  
            immunohematology, statistics, mathematics, quality assurance,  
            instrumentation, and/or laboratory administration.  In  
            addition, CLSs must complete 52 weeks of clinical laboratory  
            training in a DPH-approved laboratory and pass an approved  
            licensure examination.  A CLS may perform all three levels of  
            CLIA tests - waived, moderate, and high complexity testing,  
            including analyzing body fluids, cells, and tissue samples.   
            Some of a CLS's duties include supervising unlicensed staff,  
            phlebotomists, and medical laboratory technicians, managing  
            daily activities and directing quality assurance, finances,  
            and technological improvements in the laboratory.  

           6)Effects of this bill  .  By including CLSs in the definition of  
            a "laboratory director," this bill would effectively allow  
            CLSs to independently perform waived tests without supervision  
            by another lab director.  This would also allow a CLS who  
            wishes to work part-time to operate a clinical laboratory  
            performing CLIA-waived tests. 
               
            CLSs are already licensed to perform the highest category of  
            tests and are specifically trained in laboratory science and  
            can ensure that tests are being performed properly and  
            specimen procurement and handling are in accordance with  
            protocols.  Therefore, CLSs are presumably capable of  
            performing the duties of a waived laboratory director, and may  
            allow healthcare providers to hire CLSs more affordably than a  
            physician or surgeon. 
           
           7)Arguments in Support  .  According to the lead sponsor, the  
            California Association for Medical Laboratory Technology,  
            "This bill permits licensed CLSs to serve as laboratory  
            directors for waived laboratories, ensuring that the very  
            individuals educated to do so function at the level of their  
            training and license. 

            "Federal law requires a clinical laboratory test to be  
            performed under the overall supervision of a laboratory  
            director.  Federal law also allows CLSs to be directors of a  
            waived laboratory.  However, California law permits only  
            physicians, surgeons, naturopaths, and to a more limited  
            extent, optometrists and pharmacists, to be a director of a  
            waived laboratory.  It seems appropriate and in the public  
            interest [that] the very profession training in clinical  








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            laboratory science should service in this capacity [as a  
            director of a waived laboratory] in California." 

           8)Related Legislation  .  AB 399 (Fox) of 2013 would authorize the  
            DPH to establish application and license renewal fees for new  
            license categories that exceed the costs for implementation.   
            This bill is pending in the Assembly Business, Professions and  
            Consumer Protection Committee. 
             
             AB 830 (Holden) of 2013 would require DPH to promulgate  
            regulations by January 1, 2015, requiring any facility  
            operating a clinical laboratory to provide specified training  
            to CLSs, medical laboratory technicians, and any individuals  
            who are charged with direct and responsible supervision of  
            either a CLS or a medical laboratory technician   This bill is  
            pending in Assembly Business, Professions and Consumer  
            Protection Committee. 

           9)Previous Legislation  .  AB 761 (Hernández), Chapter 714,  
            Statutes of 2012, allows optometrists to independently perform  
            waived clinical laboratory tests necessary for the diagnosis  
            of conditions and diseases of the eye.
          
            SB 1246 (Negrete McLeod), Chapter 523, Statutes of 2010,  
            includes naturopathic doctors in the list of health care  
            practitioners who can perform a clinical laboratory test or  
            examination classified as waived under CLIA, and designates  
            naturopathic doctors as clinical laboratory directors for  
            CLIA-waived tests only.

            AB 1442 (Feuer) of 2007 would have required clinical  
            laboratories that perform tests to screen for human  
            immunodeficiency virus that are classified as waived under  
            CLIA to enroll in a proficiency testing program and to obtain  
            the appropriate license or registration from DPH, as  
            specified.  This bill was held on the Assembly Floor.

            AB 185 (Dymally) of 2007 would have expanded the duties that  
            unlicensed personnel are authorized to perform in a clinical  
            laboratory and would have revised the level of supervision  
            required when unlicensed personnel perform them.  AB 185 was  
            held in Assembly Business and Professions Committee.

            AB 1370 (Matthews) of 2005 would have included a pharmacist  
            within the definition of laboratory director if the clinical  








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            laboratory test or examination is a routine patient assessment  
            procedure, as defined.  AB 1370 was held in Assembly Business  
            and Professions Committee.

            AB 433 (Nava) of 2005 would have exempted physician office  
            laboratories from licensure and regulatory requirements  
            governing clinical laboratories and their personnel by the  
            Department of Health Services.  AB 433 was held in Assembly  
            Health Committee.

           10)Double-referral  .  This bill is double-referred, and if passed  
            by this committee will be referred to the Assembly Health  
            Committee. 

           REGISTERED SUPPORT / OPPOSITION  :   

           Support 
           
          California Association of Medical Laboratory Technology  
          (sponsor) 
          Engineers and Scientists of California, Local 20 of the  
            International Federation of Professional and Technical  
            Engineers (sponsor) 
          United Nurses Associations of California/Union of Health Care  
          Professionals (sponsor) 
          Western States Council of the United Food & Commercial Workers  
          (sponsor) 
          Blood Centers of California
          California Society of Pathologists

           Opposition 
           
          None on file. 
           

          Analysis Prepared by  :    Joanna Gin / B.,P. & C.P. / (916)  
          319-3301