BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                      



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          |SENATE RULES COMMITTEE            |                   SB 594|
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                                 THIRD READING


          Bill No:  SB 594
          Author:   Wolk (D)
          Amended:  5/11/11
          Vote:     21

           
           SENATE HEALTH COMMITTEE  :  6-3, 05/04/11
          AYES:  Hernandez, Alquist, De León, DeSaulnier, Rubio, Wolk
          NOES:  Strickland, Anderson, Blakeslee

           SENATE APPROPRIATIONS COMMITTEE  :  6-3, 05/23/11
          AYES:  Kehoe, Alquist, Lieu, Pavley, Price, Steinberg
          NOES:  Walters, Emmerson, Runner


           SUBJECT  :    Local public health laboratories

           SOURCE  :     California Association of Public Health 
          Laboratory Directors


           DIGEST  :    This bill requires the California Department of 
          Public Health (CDPH) to promulgate regulations by January 
          1, 2013, that establishes minimum requirements for 
          laboratories that train public health 
          microbiologist-trainees, approve of and monitor a program 
          of continuing education for public health microbiologists, 
          and to require continuing education for public health 
          microbiologists as a condition for renewal of a certificate 
          issued by CDPH.  The bill also requires CDPH to develop an 
          examination in consultation with California Association of 
          Public Health Laboratory Directors, make minor changes to 
          laws related to the relationship between local health 
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          departments and public health laboratories and would codify 
          various definitions existing in regulation related to 
          public health laboratory staff.

           ANALYSIS  :    Existing federal law:

          Under the Clinical Laboratory Improvement Amendments of 
          1988 (CLIA), establishes various conditions that 
          laboratories must meet in order to be certified to perform 
          testing on human specimens.  Laboratory standards 
          established under CLIA include standards for proficiency 
          testing, facility administration, personnel qualifications, 
          and quality control.

          Existing federal regulations:

          Establish qualifications for directors of labs performing 
          high complexity tests that include being licensed as a 
          laboratory director and either licensed to practice 
          medicine, hold a doctoral degree in specified fields, or be 
          serving on or before February, 1992 as a lab director and 
          meet qualifications for lab directors that existed in 1990. 


          Existing state law:

          1.Requires the local health department to have available 
            the services of a public health laboratory (PHL) to 
            examine specimens from suspected cases of infectious and 
            environmental diseases and to assist in community disease 
            surveillance. 

          2.Requires any city or county PHL and its personnel to be 
            approved by CDPH and comply with CLIA. 

          3.Defines a "clinical laboratory" as any establishment or 
            institution operated for the performance of clinical 
            laboratory tests or examinations, or the practical 
            application of clinical laboratory sciences.  Requires a 
            clinical laboratory that performs tests that are of 
            moderate or high complexity to be licensed by CDPH.  

          Existing state regulations:


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          1.Require certificates of approval received from CDPH after 
            inspection to be on display in every PHL. Prohibit a 
            laboratory from operating without a certificate from 
            CDPH.  

          2.Designate the laboratory of CDPH as the PHL for all local 
            health jurisdictions that are not covered by local PHL 
            service. 

          3.Allow written or oral, or both written and oral, 
            examinations for the certificate of PHM to be held as 
            needed and where designated by CDPH, under CDPH's 
            supervision. 

          4.Describe PHM-trainee as a person receiving professional 
            training required for certification as a PHM.  

          5.State that CDPH will establish minimum requirements for 
            laboratories that train PHM-trainees and laboratories 
            which accept personnel for training, must be specifically 
            approved to provide training by CDPH. 

          6.Allow a health officer of a municipality or county to 
            designate any laboratory as an official PHL to perform 
            any of the basic services as defined in regulation, 
            subject to the same requirements as an official public 
            lab. Basic services include those deemed necessary for 
            the various programs of the health department, and 
            consultation and reference services to further the 
            development of improved procedures and practices.  

          This bill:

          1.Requires the public health laboratory director to be 
            responsible to the appropriate local health officer;

          2.Permits a local health department, after consulting with 
            the local health officer, to contract with any official 
            city or county public health laboratory or with the 
            laboratories of CDPH to provide services;

          3.Designates the laboratories of CDPH as the public health 
            laboratory for all local health department jurisdictions 
            that do not otherwise have access to local public health 

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            laboratory service;

          4.Requires any city or county public health laboratory to 
            be certified by CDPH and to comply with specified 
            California regulations;

          5.Codifies the definitions of "public health laboratory 
            director," "public health microbiologist," and "public 
            health microbiologist-trainee";

          6.Requires the examination for public health 
            microbiologists to be developed by CDPH in consultation 
            with the California Association of Public Health 
            Laboratory Directors;

          7.Requires CDPH to adopt regulations by January 1, 2013, to 
            establish minimum requirements for laboratories that 
            train public health microbiologist-trainees, would 
            require CDPH to approve of and monitor a program of 
            continuing education for public health microbiologists, 
            and would require continuing education for public health 
            microbiologists.

          This bill codifies a requirement in regulation for CDPH to 
          establish minimum requirements for laboratories that train 
          public health microbiologist-trainees that has been in 
          existence since the 1970s.  It is unclear whether or not 
          CDPH has developed such minimum requirements.  The costs to 
          CDPH to promulgate regulations to set minimum requirements 
          and to approve and monitor a program of continuing 
          education would be approximately $180,000 from the Clinical 
          Laboratory Improvement Fund. 

           Background
           
          There are currently 38 PHLs in California that are 
          administered locally by city or county public health 
          departments.  Local PHLs provide services relating to the 
          examination of specimens from suspected cases of infectious 
          and environmental diseases, including specimens from 
          humans, milk, water, food, vectors, and the environment.  
          These labs also screen newborns for various genetic and 
          congenital disorders; watch for disease-producing agents in 
          food, humans, and animals; and test for new threats like 

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          West Nile virus, Severe Acute Respiratory Syndrome (SARS), 
          avian influenza, and bioterrorism.  

          While public health laboratories may conduct patient 
          diagnostic testing, they differ from clinical laboratories 
          in that the scope of their work, including their patient 
          diagnostic testing, revolves around the prevention and 
          control of communicable disease, community surveillance of 
          infectious or communicable disease, and promoting and 
          maintaining public health.  
          Local PHLs are approved by CDPH, meaning that they are 
          certified to meet state and federal law and regulations.  
          All of the laboratories meet CLIA standards for conducting 
          high-complexity lab tests.  CDPH also certifies PHMs and 
          PHL directors to ensure that they meet all educational and 
          training requirements required by state regulations. 
          Existing state regulations set forth specific requirements 
          and standards that PHLs must meet, including requirements 
          pertaining to personnel, reporting, and safety procedures 
          and precautions.  

           FISCAL EFFECT  :    Appropriation:  No   Fiscal Com.:  Yes   
          Local:  Yes

          According to the Senate Appropriations Committee:

           Major Provisions                2011-12     2012-13    
           2013-14   Fund  
          CDPH start-up costs      $15       $180      $0   Special*
            and regulations

          * Clinical Laboratory Improvement Fund

           SUPPORT :   (Verified  5/24/11)

          California Association of Public Health Laboratory 
          Directors (source) 
          Napa-Solano County Public Health Laboratory
          Mosquito and Vector Control Association of California 

           OPPOSITION  :    (Verified  5/24/11)

          California Association for Medical Laboratory Technology
          California State Association of Counties

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          City and County of San Francisco
          County Health Executives Association of California
          County of Nevada
          County of San Bernardino
          County of Santa Clara Board of Supervisors
          Los Angeles County Board of Supervisors
          Orange County Board of Supervisors
          Placer County Board of Supervisors
          Regional Council of Rural Counties
          San Joaquin County Board of Supervisors
          Urban Counties Caucus
          Ventura County Board of Supervisors

           ARGUMENTS IN SUPPORT  :    CAPHLD is sponsoring this bill to 
          ensure quality PHL services are sufficiently available 
          statewide to protect local communities from communicable 
          disease threats like H1N1, tuberculosis, HIV, SARS and 
          foodborne and waterborne outbreaks, and to respond to 
          emergencies and security threats like biological and 
          chemical terrorist attacks, like the anthrax scares 
          following the September 11 attacks.  CAPHLD mentions 
          incidences when PHL directors have had to carry out 
          medically-oriented duties that CAPHLD claims were not in 
          accord with public health, based on instructions from 
          non-medical government personnel. CAPHLD also believes that 
          due to the technical nature of a public health 
          microbiologist's duties and its importance to the 
          protection of the public, certification tests should be 
          developed with sufficient stakeholder input, which CAPHLD 
          can provide. 

           ARGUMENTS IN OPPOSITION  :    The County Health Executives 
          Association of California (CHEAC) is opposed to SB 594 
          because they believe the bill would limit county 
          flexibility in how PHL services could be provided. They are 
          particularly concerned about the provisions of the bill 
          that require a local health department's designated PHL to 
          be operated by a city or county and would dictate the types 
          of laboratory services that must be performed only by a 
          county or city's designated PHL.  CHEAC has asked for 
          specific amendments to remove several provisions of the 
          bill. 

          The California Association for Medical Laboratory 

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          Technology (CAMLT) acknowledges that areas of practice and 
          responsibility of the certified PHM may be significantly 
          different in some areas from Limited License Microbiologist 
          /Clinical Laboratory Scientist (LLM/CLS).  CAMLT says that 
          the two professions share in their analysis of human 
          specimens and that CLS/LLM must successfully complete a 
          year-long post baccalaureate program and pass a state 
          licensing exam for the exact breadth and scope of function 
          for human testing.  CAMLT claims that SB 594 allows PHMs to 
          do many of the same tasks that LLM/CLS can do, but with 
          only six months of training. This six-month program would 
          not only include human specimen testing, but also cover all 
          the other functions that the PHM is required to perform: 
          testing on milk, dairy products, air, water, sewage, 
          animals, insects and other vector sources.  CAMLT believes 
          that if PHMs are to perform the exact same function as the 
          CLS with regard to human testing, then education and 
          training should be equivalent. 
           

          CTW:nl  5/25/11   Senate Floor Analyses 

                         SUPPORT/OPPOSITION:  SEE ABOVE

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