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: 8/18/14 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 prohibits laboratories that are accredited
in forensic alcohol analysis by the American Society of Crime
Laboratory Directors/Laboratory Accreditation Board (ASCLD/LAB)
from being required to establish the concentration of each lot
of secondary alcohol standards it uses, whether prepared or
acquired, by an oxidimetric method that employs a primary
standard, and specifies that those laboratories are not limited
to reporting analytical results to the second decimal place.
This bill also changes the requirement that the Forensic Alcohol
Review Committee (FARC) meet at least once in each five-year
period and instead requires the FARC to meet at least once in
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each three-year period, as specified.
Senate Floor Amendments of 8/18/14 narrow the bill to only
exempt forensic alcohol labs from two outdated provisions of
current regulations.
ANALYSIS :
Existing law:
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 the Department of Public Health (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:
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A. Meet established laboratory performance and procedure
standards;
B. Employ at least one forensic alcohol supervisor;
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.
1.Require each forensic alcohol laboratory to establish the
concentration of each lot of secondary alcohol standards it
uses, whether prepared or acquired, by an oxidimetric method
that employs a primary standard, and require analytical
results to be reported to the second decimal place.
This bill:
1.Exempts laboratories that are accredited in forensic alcohol
analysis by the 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.
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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.
4.Prohibits laboratories that are accredited in forensic alcohol
analysis by the ASCLD/LAB from being required to establish the
concentration of each lot of secondary alcohol standards it
uses, whether prepared or acquired, by an oxidimetric method
that employs a primary standard, and specifies that those
laboratories are not limited to reporting analytical results
to the second decimal place.
Background
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
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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
ASCLD/LAB-approved commercial provider, with the results then
submitted to DPH.
Comments
According to the author's office, FARC was created in 2004, in
part, due to a 1999 audit. FARC 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 FARC has met regularly over the last 10 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
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forensic alcohol laboratory that is accredited by ASCLD/LAB in
forensic alcohol analysis satisfies requirements for external
proficiency testing. The bill 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 (DHS, now DPH) over forensic alcohol
laboratories and created 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
standards to be licensed if DHS determines that the standards
meet or exceed those in regulations. The bill 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) (Unable to reverify at time of
writing)
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
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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 FARC 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/AL:ek 8/19/14 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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