BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  SB 289
                                                                  Page  1

          Date of Hearing:   July 3, 2012

              ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER 
                                     PROTECTION
                                 Mary Hayashi, Chair
                   SB 289 (Hernandez) - As Amended:  June 19, 2012

           SENATE VOTE  :   36-2
           
          SUBJECT  :   Clinical laboratory techniques: training and 
          instruction.

           SUMMARY  :   Allows the Department of Public Health (DPH) to 
          approve additional providers of clinical laboratory instruction. 
           Specifically,  this bill  :   

          1)Allows DPH to approve any of the following to provide 
            instruction in clinical laboratory technic which in DPH's 
            judgment will adequately prepare individuals to meet the 
            requirements for licensure or performance of duties under laws 
            and DPH regulations governing clinical laboratory technology:

             a)   A California licensed clinical laboratory;

             b)   An accredited United States (U.S.) college or 
               university;

             c)   A U.S. military medical laboratory specialist program of 
               at least 52 weeks in duration; or,

             d)   A laboratory owned and operated by the U.S. government.

          2)Prohibits a college or university holding valid accreditation 
            by the National Accrediting Agency for Clinical Laboratory 
            Sciences (NAACLS) that meets the requirements of 1), above, 
            from being required to obtain separate approval for a clinical 
            training site, provided that the clinical training site has 
            obtained certification under the federal Clinical Laboratory 
            Improvement Amendments of 1988 (CLIA), as specified.  

          3)Defines a clinical training site as any place, establishment, 
            or institution used by a DPH-approved program for the training 
            of clinical laboratory scientists (CLS) or limited CLS to 
            conduct training or instruction of licensed trainees or 
            phlebotomy students in clinical laboratory practice, 








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            techniques, theory or other training, as specified. 

          4)Revises and recasts existing definitions and makes other 
            technical, non-substantive and clarifying changes.

           EXISTING LAW  : 

          1)Provides for the licensure and regulation of clinical 
            laboratories and their personnel by DPH under the Laboratory 
            Field Services (LFS).

          2)Authorizes DPH to approve schools seeking to provide 
            instruction in clinical laboratory technic which in the 
            judgment of DPH will provide instruction adequate to 
            prepare individuals to meet the requirements for 
            licensure or performance of duties, as specified.  
            Requires DPH to establish by regulation the ratio of 
            licensed clinical scientists to licensed trainees on the 
            staff of the laboratory approved as a school and the 
            minimum requirements for training in any specialty or in 
            the entire field of clinical laboratory science or 
            practice.

          3)Authorizes DPH to approve schools that are accredited by 
            NAACLS.

          4)Provides that it is unlawful for any person to operate a 
            school or conduct any course for the purpose of training 
            or preparing persons to perform duties, as specified, 
            without approval by DPH.

          5)Establishes educational and examination requirements for 
            a number of clinical lab personnel, including CLS and 
            limited CLS licensees and trainees and a variety of CLS 
            sub-specialties.

          6)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.

           FISCAL EFFECT  :   Unknown









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           COMMENTS  :   

           Purpose of this bill  .  According to the author, "In order to be 
          trained as a CLS in California, the LFS has interpreted its 
          regulations for the past 40 years to mean that the 50-week CLS 
          training program be undertaken at a single site, usually a 
          hospital or a biotech lab.  A CLS training program is costly for 
          the host institution, running anywhere from $55,000 to $110,000 
          a year per student.  Thus, running a CLS training program can be 
          quite prohibitive for an institution to undertake.

          "SB 289 would broaden the definition of an approved training 
          site, and allow an institution of higher education to be an 
          approved training entity for a CLS training program.  Please 
          note that the students would not train at the institution of 
          higher education; rather, (the bill) would allow the institution 
          to act as the central administrator by coordinating the 50-week 
          program among different hospitals/labs.  

          "Schools (that) offer CLS programs include California State 
          University (CSU), San Francisco, CSU San Jose, CSU Dominguez 
          Hills, CSU, Los Angeles, University of California, Irvine, and 
          University of Southern California.  Under SB 289, the program 
          coordinators at these schools would be able to work with various 
          hospitals and labs in the region to build a consortium of sites 
          willing to train students for varying periods of time.  This 
          would allow various hospitals/labs to share in the cost of the 
          program while not compromising quality or content, resulting in 
          more entities willing to be a CLS training site."

           Background  .  A CLS is an integral part of health care delivery 
          and conducts a wide range of diagnostic assessments, from blood 
          tests to genetic testing, in order to assist physicians in 
          diagnosing illness and determining treatment plans.  

          According to the author, current regulations, promulgated in the 
          1970s, require DPH-approved CLS training sites or entities to be 
          a laboratory where the clinical experience takes place.  This 
          law has been interpreted by DPH to preclude an institution of 
          higher learning from being an approved training entity.  This 
          has limited CLS training capacity in California because it 
          prevents many smaller labs and hospitals (such as rural 
          hospitals) from participating in training.  

          The California Hospital Association estimates that the lack of 








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          CLS is one of the top vacancy problems in the state for 
          non-nursing health care professions.  According to the U.S. 
          Bureau of Labor Statistics, between now and 2018, California is 
          projected to have 510 CLS openings annually due to growth and 
          job separations.  This number is particularly sobering when 
          compared to the annual number of CLS graduates in the state 
          (approximately 110 - 130).  

          California clinical laboratories are subject to both federal and 
          state oversight.  Federal oversight is stipulated in CLIA, which 
          is administered by the Centers for Medicare and Medicaid 
          Services within the U.S. Department of Health and Human 
          Services.  CLIA regulates clinical labs based on the complexity 
          of tests the lab offers.  

          "Waived" tests are approved by the Food and Drug Administration 
          (FDA) for home use, use simple and accurate methods that make 
          the possibility of error negligible, or pose no significant risk 
          of harm to the patient if incorrectly performed.  Clinical labs 
          performing only "waived" tests must register with the CLIA 
          program, pay biennial certificate fees, allow inspections, and 
          perform tests according to manufacturers' instructions.

          "Moderate" or "high" tests, which are more complex, may be 
          performed by clinical labs that pay higher fees, undergo 
          biennial inspections, and meet tougher standards for personnel, 
          supervision, quality assurance and proficiency testing.

          DPH regulates about 19,000 clinical labs and their personnel 
          statewide, monitors proficiency testing, investigates 
          complaints, and sanctions labs that violate the law or 
          regulations.  In accordance with CLIA, DPH licenses or registers 
          clinical labs according to the complexity of testing 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.

          DPH has authority to approve schools seeking to provide 
          instruction in clinical laboratory techniques to meet CLS 
          licensure requirements.  According to regulations, any person 
          operating a school or conducting any course for CLS must comply 
          with DPH's personnel, equipment, quality of instruction, and 
          scope of activities requirements.  A training school can only 








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          accept a person licensed for training in clinical laboratory 
          procedures if there are on active duty in the laboratory a 
          minimum of two full-time actively employed persons who possess 
          any of the following licenses: clinical laboratory technologist; 
          clinical laboratory bioanalyst; physician and surgeon; or, an 
          appropriate laboratory specialty.  The ratio of clinical 
          laboratory personnel to trainees is no less than 2:1.  

          Regulations also specify the minimum requirements necessary for 
          approval of a laboratory to employ clinical laboratory 
          technologist trainees, including: necessary equipment, as 
          specified; workload requirements; and, 52 weeks of practical 
          training, including biochemistry, hematology, pre-transfusion 
          procedures, urinalysis, bacteriology, serology, and 
          parasitology.  Colleges or universities accredited by the 
          Western College Association or the Northwest Association of 
          Secondary and Higher Schools or an essentially equivalent 
          accrediting agency, as determined by DPH, that conduct CLS 
          training courses must be approved by DPH.  However, when 
          training is carried out in cooperation with laboratories other 
          than those of the institution, specific approval must be 
          obtained from DPH.  Regulations also specify the timeframes for 
          DPH to approve training programs and to process applications for 
          renewals. 

          This bill specifies that a college or university accredited by 
          NAACLS for clinical laboratory sciences is not required to 
          obtain separate approval for a clinical training site, if the 
          site is certified under CLIA.  According to its Web site, NAACLS 
          accredits and approves education programs in clinical laboratory 
          sciences and related health care professions, including those 
          that offer a clinical doctorate in clinical laboratory science, 
          medical laboratory scientist, medical laboratory technician, 
          histotechnologist, histotechnician, diagnostic molecular 
          scientist, cytogenetic technologist, and pathologists' 
          assistant.  NAACLS also independently approves phlebotomist and 
          clinical assistant educational programs.  NAACLS is recognized 
          by the Council for Higher Education Accreditation.

           Support  .  The Blood Centers of California writes, "As health 
          care providers, we have been affected by the shortage of various 
          licensed health care providers in California.  We have 
          particularly been hard hit by the shortage of CLS over the last 
          five or more years.  CLS hired by blood centers have to meet a 
          higher standard because of the high complexity and sophisticated 








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          testing required to assure the safety of the blood supply.  We 
          can only employ the generalist CLS with additional blood banking 
          training and/or the CLS with a specialty (limited) license in 
          immunohematology and hematology.  It also should be noted (that) 
          blood centers cannot employ a CLS trainee; all potential CLS 
          blood laboratory candidates must have a current CLS license in 
          good standing.

          "To that end, three of our hospital blood centers have 
          established clinical training programs to 'grow our own' by 
          collaborating with university programs and local government 
          programs.  We are gradually increasing the numbers of candidates 
          that meet the strong state and national requirements for blood 
          banking.  We believe an expansion of the facilities approved as 
          clinical training sites is critical."

           Opposition  .  The California Association for Medical Laboratory 
          Technology states, "This bill fails to recognize the strength of 
          the state certifying programs, and that all the CLS training 
          programs in California accredited by LFS should benefit from the 
          proposed streamlining.   
           
          "LFS has rigorous standards that meet or exceed the NAACLS.  LFS 
          state approved programs should not be discriminated against if 
          they are not NAACLS approved.  Therefore, we believe the bill 
          should be amended to state that all state approved programs 
          should be free to determine their CLS training sites without the 
          duplicate paperwork that is currently required.  We agree that 
          steps should be taken to address the clinical laboratory 
          shortage and also concur that the current system for clinical 
          laboratory training is too cumbersome and would benefit from 
          streamlining, but in a manner that is equally fair to both 
          NAACLS approved and non-approved colleges and universities.  
          Further, clinical laboratory training must be in LFS approved 
          California licensed labs, whether NAACLS approved or not.  The 
          choice of the clinical training site should be up to the state 
          approved program."

           Related legislation  .  AB 2214 (Monning) of 2012 requires, among 
          other provisions, the California Workforce Investment Board, 
          until January 1, 2019, to establish a special committee known as 
          the Health Workforce Development Council to help expand the 
          state's health workforce in order to provide access to quality 
          health care for all Californians.  This bill is pending in 
          Senate Health Committee.








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          SB 1481 (Negrete McLeod) of 2012 exempts community pharmacies 
          performing only specified waived tests from state law governing 
          the licensure and regulation of clinical laboratories.  This 
          bill is pending in Assembly Health Committee.

           Previous legislation  .  AB 761 (Roger Hernández) of 2011 allows 
          optometrists to independently perform waived clinical laboratory 
          tests if the results can be used within the optometrist's scope 
          of practice, as specified.  This bill was held in Assembly 
          Business, Professions and Consumer Protection Committee.

          AB 1328 (Pan) of 2011 allows DPH to issue a CLS license to an 
          applicant who completes at least two years of full-time 
          employment as a CLS at a CLIA certified laboratory, who 
          possesses a baccalaureate or an equivalent or higher degree from 
          an accredited institution, and who passes a national examination 
          approved by DPH, subject to the payment of a licensing fee.  
          This bill was held in Assembly Business, Professions and 
          Consumer Protection Committee.

          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 requires clinical laboratories that 
          perform tests 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 expands the duties that unlicensed 
          personnel are authorized to perform in a clinical laboratory and 
          revises the levels of supervision required when unlicensed 
          personnel perform them.  This bill was held in Assembly Business 
          and Professions Committee.

          AB 1370 (Matthews) of 2005 includes a pharmacist within the 
          definition of laboratory director if the clinical laboratory 
          test or examination is a routine patient assessment procedure, 
          as defined.  This bill was held in Assembly Business and 








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          Professions Committee.

          AB 433 (Nava) of 2005 exempts physician office laboratories from 
          licensure and regulatory requirements governing clinical 
          laboratories and their personnel by DPH.  This bill was held in 
          Assembly Health Committee.

          SB 1174 (Polanco), Chapter 640, Statutes of 2001, exempts 
          certified emergency medical technicians and licensed paramedics 
          providing life support who perform only CLIA-waived blood 
          glucose tests from state law governing the licensure and 
          regulation of clinical laboratories, as specified.

           Double referred  .  This bill is double-referred to Assembly 
          Health Committee.

           REGISTERED SUPPORT / OPPOSITION  :

           Support 
           
          Blood Centers of California
           
            Opposition 
           
          California Association for Medical Laboratory Technology


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