BILL ANALYSIS �
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|SENATE RULES COMMITTEE | AB 2425|
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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 Le�n, 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.
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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;
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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
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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
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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
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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
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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, Ch�vez, 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 Hern�ndez,
Holden, Jones, Jones-Sawyer, Levine, Linder, Logue, Lowenthal,
Maienschein, Medina, Melendez, Mullin, Muratsuchi, Nazarian,
Nestande, Olsen, Pan, Patterson, Perea, John A. P�rez, V.
Manuel P�rez, 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
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SUPPORT/OPPOSITION: SEE ABOVE
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