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