BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                            



           ----------------------------------------------------------------- 
          |SENATE RULES COMMITTEE            |                       AB 2425|
          |Office of Senate Floor Analyses   |                              |
          |1020 N Street, Suite 524          |                              |
          |(916) 651-1520         Fax: (916) |                              |
          |327-4478                          |                              |
           ----------------------------------------------------------------- 
           
                                           
                                    THIRD READING


          Bill No:  AB 2425
          Author:   Quirk (D)
          Amended:  8/5/14 in Senate
          Vote:     21


           SENATE HEALTH COMMITTEE  :  8-0, 6/25/14
          AYES:  Hernandez, Morrell, Beall, De León, DeSaulnier, Evans,  
            Monning, Nielsen
          NO VOTE RECORDED:  Wolk

           SENATE APPROPRIATIONS COMMITTEE  :  Senate Rule 28.8

           ASSEMBLY FLOOR  :  78-0, 5/15/14 (Consent) - See last page for  
            vote


           SUBJECT  :    Laboratories:  review committee

           SOURCE  :     Santa Clara District Attorney


           DIGEST  :    This bill exempts laboratories that are accredited in  
          forensic alcohol analysis by the American Society of Crime  
          Laboratory Directors/Laboratory Accreditation Board (ASCLD/LAB)  
          from existing Department of Public Health (DPH) regulations that  
          conflict with more stringent specified requirements established  
          by the accrediting agency, until the date when DPH adopts  
          regulations that incorporate the Forensic Alcohol Review  
          Committee's (FARC's) revisions.  This bill changes the  
          requirement that the FARC meet at least once in each five-year  
          period and instead requires the FARC to meet at least once in  
          each three-year period, as specified.
                                                                CONTINUED





                                                                    AB 2425
                                                                     Page  
          2


           ANALYSIS  :    

          Existing state statute:

          1.Requires labs engaged in the performance of forensic alcohol  
            analysis tests by or for law enforcement agencies on blood,  
            urine, tissue, or breath for the purposes of determining the  
            concentration of ethyl alcohol in persons involved in traffic  
            accidents or in traffic violations to comply with specified  
            regulations related to forensic alcohol labs as they exist on  
            December 31, 2004, until the time when those regulations are  
            revised pursuant to #3 below.

          2.Requires DPH to establish a review committee, the FARC, with  
            specified membership, and requires the FARC to meet at least  
            once in each five-year period after its initial meeting, or  
            within 60 days of receipt of a request by DPH or a member of  
            the FARC.

          3.Requires the FARC to evaluate the regulations in #1 above and  
            determine revisions that will limit those regulations to those  
            that the FARC determines are reasonably necessary to ensure  
            the competence of the labs and employees to prepare, analyze,  
            and report the results of the tests and comply with applicable  
            laws.  Requires the FARC to submit a summary of revisions to  
            the California Health and Human Services Agency (CHHSA).   
            Permits CHHSA, within 90 days of receiving the revisions, to  
            disapprove of one or more of the revisions.

          4.Requires DPH to adopt regulations that incorporate the FARC's  
            revisions, except those disapproved by CHHSA.

          Existing state regulations:

          1.Establish qualifications for forensic alcohol supervisors,  
            forensic alcohol analysts, or forensic alcohol analyst  
            trainees.  Require forensic laboratories to, among other  
            things:

             A.   Meet established laboratory performance and procedure  
               standards;

             B.   Employ at least one forensic alcohol supervisor;

                                                                CONTINUED





                                                                    AB 2425
                                                                     Page  
          3


             C.   Maintain a quality control program in forensic alcohol  
               analysis procedures;

             D.   Demonstrate satisfactory performance in a proficiency  
               testing program conducted, or approved, by DPH to evaluate  
               the accuracy of the forensic alcohol analyses performed by  
               the laboratory; 

             E.   Maintain records pertaining to personnel, analysis  
               results, equipment, proficiency testing; and

             F.   Pass on-site inspections by DPH.

          This bill:

          1.Exempts laboratories that are accredited in forensic alcohol  
            analysis by ASCLD/LAB from the requirements in regulations  
            related to Forensic Alcohol Analysis and Breath Alcohol  
            Analysis (Group 8 regulations), as they exist on January 1,  
            2015, that conflict with requirements established by the  
            accrediting agency, as determined by the FARC, when the  
            accrediting agency requirements are:

             A.   More stringent record keeping requirements.
             B.   Higher proficiency testing standards.
             C.   Higher number of site visits and onsite inspections.
             D.   More comprehensive training programs.
             E.   More current coursework.

          1.Requires the exemption to remain in effect until the date when  
            DPH adopts regulations that incorporate the FARC's revisions,  
            as specified.

          2.Requires the FARC meet at least once in each three-year period  
            after its initial meeting instead of once in each five-year  
            period.

          3.Requires the FARC in determining revisions, to also take into  
            consideration the advancement and development of scientific  
            processes, including the reporting of results with an  
            estimated uncertainty measurement.

           Background

                                                                CONTINUED





                                                                   AB 2425
                                                                     Page  
          4

          
           Group 8 regulations  .  According to DPH, the Group 8 regulations  
          establish the basic standards of performance and procedure for  
          forensic alcohol analysis.  They are designed to ensure the  
          competency of the forensic alcohol laboratories, the  
          qualifications of the employees of the laboratories, and the  
          accuracy of breath alcohol testing procedures used by law  
          enforcement agencies, which in turn ensures the admissibility of  
          tests into evidence in drunk-driving cases.  The performance  
          standards set the requirements for method accuracy and  
          precision, non-interference from anticoagulants and  
          preservatives added to the sample, and results obtained when  
          subjects free of alcohol are tested.  The procedure standards  
          include the requirements to calibrate a method with standards,  
          inclusion of blanks, analysis of quality control samples,  
          traceability to known primary standards, and duplicate analyses  
          of unknowns.  There are personnel qualifications requirements.   
          There are also standards of procedure covering sample collection  
          and retention.  There are similar requirements covering breath  
          alcohol analysis performed by law enforcement personnel.  These  
          procedural requirements ensure that the chemical testing in  
          drunk-driving cases is performed consistently and competently  
          throughout the state.

          SB 1623 (Johnson, Chapter 337, Statutes of 2004) removed DPH's  
          authority to license these labs.  Prior to this, DPH operated a  
          forensic alcohol laboratory licensing and regulatory program for  
          more than 30 years.  Existing law still requires forensic  
          alcohol labs to comply with Group 8 regulations, and requires  
          DPH to enforce the regulations.  SB 1623 also established the  
          FARC to evaluate the Group 8 regulations in order to determine  
          revisions that it determines are reasonably necessary.  CHHSA  
          can disapprove regulations proposed by the FARC, but neither it  
          nor DPH can promulgate regulations on its own.  FARC was formed  
          in 2005 and began its meetings that year.  It conducted 23  
          meetings of the full committee and proposed revisions to Group 8  
          regulations in 2010 and 2013.

          DPH also states that, with the passage of SB 1623, it has ceased  
          routine onsite inspections of forensic alcohol labs, but  
          continues to conduct inspections for cause, and is still  
          required to regulate the forensic alcohol laboratories.  DPH  
          annually requires two proficiency tests of each forensic alcohol  
          laboratory, but this includes one test from an  

                                                                CONTINUED





                                                                    AB 2425
                                                                     Page  
          5

          ASCLD/LAB-approved commercial provider, with the results then  
          submitted to DPH.

           FARC and DPH communications  .  In April 2010, the FARC submitted  
          proposed changes to the Group 8 regulations pursuant to SB 1623.  
           In a December 15, 2010 letter responding to the proposed  
          changes, DPH wrote: "While we agree that voluntary accreditation  
          programs are important, ASCLD/LAB guidelines do not establish  
          specific laboratory performance or procedure standards for blood  
          alcohol analysis, nor mention breath alcohol analysis.  The  
          substitution of the ASCLD/LAB requirements for the current  
          program would not achieve the statutory mandate of ensuring the  
          competence of the laboratories and their employees performing  
          chemical testing in support of California's drinking-and-driving  
          laws.  We recognize and applaud the work of the committee and  
          encourage the committee to continue to work with DPH on a  
          solution that does not diminish public health and safety by  
          ensuring independent State oversight of forensic alcohol  
          analysis."

          In March 2013, the FARC wrote a response to DPH's feedback on  
          their recommended revisions to the Group 8 regulations.  In  
          part, the letter states that the FARC did not agree that  
          replacing DPH oversight with self-oversight would diminish  
          public safety, but "?in an effort to reach compromise and to  
          move this regulation package forward after years of effort, we  
          propose?changes to the work product."  The letter went on to  
          outline four proposed changes to the proposed regulations  
          related to DPH evaluation of a lab's performance on proficiency  
          tests, DPH authority to review, approve, and test the  
          qualifications of employees, DPH authority to review and approve  
          training programs of employees, and requiring labs to provide  
          DPH with records of its activities.

          DPH's Chief Deputy Director of Policy and Programs responded in  
          February 2014, stating "?After the FARC proposed revisions were  
          incorporated, the revised regulations were submitted to CHHSA.   
          The California Department of Public Health will be adopting  
          regulations that incorporate FARC's revisions, per Health and  
          Safety Code 100702(f).  As such, I have directed the CDPH Office  
          of Regulations to proceed with the rulemaking process to adopt  
          regulations incorporating all the revisions proposed by the  
          FARC."  According to DPH, the proposed revised regulations are  
          currently with the Office of Regulations where they are making  

                                                                CONTINUED





                                                                    AB 2425
                                                                     Page  
          6

          minor technical changes to some of the supporting documentation.

           Comments
           
          According to the author, the FARC was created in 2004, in part,  
          due to a 1999 audit.  The committee is comprised of scientific,  
          law enforcement and legal representatives and was given the  
          authority to evaluate regulations and provide revisions that  
          will ensure the competence of laboratories and employees to  
          prepare, analyze, and report the results of biological samples  
          tested for alcohol content and comply with applicable laws.   
          Although the committee has met regularly over the last ten  
          years, DPH (who as of 2007, has jurisdiction over FARC), and the  
          CHHSA have yet to approve any regulatory changes.  DPH's  
          unwillingness to approve the regulations impedes FARC from  
          completing the work they have been tasked to do.  Additionally,  
          antiquated regulations compromise our public safety and  
          prosecution of drunk drivers.

           Prior Legislation
           
          AB 599 (Hall, 2009) would have required FARC to submit to CHHSA  
          revisions to forensic alcohol laboratory regulations, and would  
          have provided that until CHHSA adopts these revisions, a  
          forensic alcohol laboratory that is accredited by ASCLD/LAB in  
          forensic alcohol analysis satisfies requirements for external  
          proficiency testing.  AB 599 was vetoed by Governor  
          Schwarzenegger stating,

               "This bill is a premature delegation of regulatory  
               oversight from a state department to a private entity.  If  
               there is a more efficient manner to provide oversight for  
               forensic alcohol laboratories, I encourage the stakeholders  
               to work with the Department of Public Health on a solution  
               that does not eliminate important state functions."

          SB 1623 eliminated the licensing authority of the Department of  
          Health Services (now DPH) over forensic alcohol laboratories and  
          created the FARC.

          SB 1849 (Johnson, 2000) would have required DHS to adopt  
          regulations governing the operation of forensic alcohol labs and  
          required DHS to convene a review committee to review the  
          regulations and would have allowed labs that meet accreditation  

                                                                CONTINUED





                                                                    AB 2425
                                                                     Page  
          7

          standards to be licensed if DHS determines that the standards  
          meet or exceed those in regulations.  SB 1849 was vetoed by  
          Governor Davis who said he was "confident DHS would make  
          progress in responding to the audit report and if it did not, he  
          would consider signing legislation in the future."

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

           SUPPORT  :   (Verified  8/6/14)

          Santa Clara District Attorney (source)
          California District Attorneys Association

           ARGUMENTS IN SUPPORT  :    According to the sponsor, the Santa  
          Clara County District Attorney's Office, the failure to update  
          the regulations has put public safety at risk.  Since the last  
          update in 1986, the sponsor explains, there have been many  
          changes in the instrumentation and technology surrounding the  
          testing of specimens, the process by which it's done, education  
          requirements for laboratory employees, and California statutes  
          concerning driving under the influence.  The sponsor argues this  
          bill recognizes how important it is for the regulations to be  
          incompliance with the law and current laboratory standards and  
          will allow the concepts developed by the review committee to be  
          adopted into regulation.

           ASSEMBLY FLOOR  :  78-0, 5/15/14
          AYES:  Achadjian, Alejo, Allen, Ammiano, Bigelow, Bloom,  
            Bocanegra, Bonilla, Bonta, Bradford, Brown, Buchanan, Ian  
            Calderon, Campos, Chau, Chávez, Chesbro, Conway, Cooley,  
            Dababneh, Dahle, Daly, Dickinson, Donnelly, Eggman, Fong, Fox,  
            Frazier, Beth Gaines, Garcia, Gatto, Gomez, Gonzalez, Gordon,  
            Gorell, Gray, Grove, Hagman, Hall, Harkey, Roger Hernández,  
            Holden, Jones, Jones-Sawyer, Levine, Linder, Logue, Lowenthal,  
            Maienschein, Medina, Melendez, Mullin, Muratsuchi, Nazarian,  
            Nestande, Olsen, Pan, Patterson, Perea, John A. Pérez, V.  
            Manuel Pérez, Quirk, Quirk-Silva, Rendon, Ridley-Thomas,  
            Rodriguez, Salas, Skinner, Stone, Ting, Wagner, Waldron,  
            Weber, Wieckowski, Wilk, Williams, Yamada, Atkins
          NO VOTE RECORDED:  Mansoor, Vacancy


          JL:e  8/6/14   Senate Floor Analyses 

                                                                CONTINUED





                                                                    AB 2425
                                                                     Page  
          8


                           SUPPORT/OPPOSITION:  SEE ABOVE

                                   ****  END  ****









































                                                                CONTINUED