BILL ANALYSIS �
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 2425
AUTHOR: Quirk
AMENDED: April 8, 2014
HEARING DATE: June 25, 2014
CONSULTANT: Moreno
SUBJECT : Laboratories: review committee.
SUMMARY : Exempts labs that are accredited in forensic alcohol
analysis by the American Society of Crime Laboratory
Directors/Laboratory Accreditation Board or another accrediting
agency, as specified, from the requirements in all existing
regulations related to Forensic Alcohol Analysis and Breath
Alcohol Analysis as they exist on January 1, 2015, until the
time when the Department of Public Health adopts regulations
that incorporate the Forensic Alcohol Review Committee's
revisions developed pursuant to existing law.
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 the Department of Public Health (DPH) to establish a
review committee (known as the Forensic Alcohol Review
Committee [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 committee.
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
Continued---
AB 2425 | Page 2
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;
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 the department.
This bill:
1.Exempts labs that are accredited in forensic alcohol analysis
by the American Society of Crime Laboratory
Directors/Laboratory Accreditation Board (ASCLD/LAB) or
another accrediting agency approved by the FARC from the
requirements in all existing regulations related to Forensic
Alcohol Analysis and Breath Alcohol Analysis (Group 8
regulations) as they exist on January 1, 2015, until the time
when DPH adopts regulations that incorporate the FARC's
revisions developed pursuant to existing law.
2.Requires the FARC to meet at least once every three years,
rather than once every five years.
3.Requires the FARC, in determining revisions to forensic
alcohol lab regulations, to take into consideration the
advancement and development of scientific processes, including
the reporting of results with an estimated uncertainty
measurement.
4.Permits CHHSA to disapprove of one or more of the revisions
within 30 days of receiving the revisions, rather than within
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90 days.
FISCAL EFFECT : According to the Assembly Appropriations
Committee analysis, negligible state fiscal effect.
PRIOR VOTES :
Assembly Health: 19- 0
Assembly Appropriations: 17- 0
Assembly Floor: 78- 0
COMMENTS :
1.Author's statement. 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 Health and
Human Services Agency (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.
2.Forensic alcohol labs in California. According to DPH, 39
forensic alcohol laboratories in California conduct alcohol
analysis of samples of blood, breath, urine, or tissue of
persons involved in traffic accidents or traffic violations.
City, county, and state governmental law enforcement agencies
operate 29 of these forensic alcohol laboratories, and 10 are
private laboratories. Some of these private laboratories
provide testing services for law enforcement through
contractual arrangements with cities and counties. Twenty-six
of the forensic alcohol laboratories (all governmental) are
accredited by the ASCLD/LAB. The 39 forensic alcohol
laboratories conduct or support the chemical testing
associated with the approximately 200,000 drunken driving
arrests each year.
According to DPH, as defined in the regulations, the only
activity of a "forensic alcohol laboratory" is the measurement
AB 2425 | Page 4
of the concentration of alcohol in samples of blood, breath,
urine, or tissue of persons involved in traffic accidents or
in traffic violations; so by definition, a "forensic alcohol
lab" only performs forensic alcohol analysis. However, the
regulations also note that forensic alcohol analysis "may be
an activity of a laboratory engaged in activities other than
alcohol analysis." Forensic alcohol analysis is often
performed by governmental crime laboratories. These
laboratories perform a wide variety of forensic tests covering
a number of separate disciplines (toxicology, controlled
substances, DNA analysis, latent fingerprints,
firearms/toolmarks, tire tracks and footwear impressions,
trace evidence, questioned documents). Of all these crime lab
tests, only alcohol analysis (a toxicology sub-discipline) is
currently subject to any regulation.
3.Group 8 regs. 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. Current statute
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
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5
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 (see discussion in 6) below).
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.
4.Regulation versus accreditation. According to DPH, ASCLD/LAB
accredits laboratories in nine disciplines (not forensic
alcohol analysis) and the requirements are very general. The
ASCLD/LAB requirements are mostly related to the management of
the laboratory, and they are not the equivalent of laboratory
regulations. ASCLD/LAB accreditation requirements do not
provide any specific laboratory performance or procedure
standards for blood or breath alcohol analysis. DPH's
regulations include specific requirements to calibrate testing
methods with specified standards and provide analysis of
quality control samples. There are also standards of procedure
covering sample collection and retention.
5.ASCLD/LAB. According to the ASCLD, it is a volunteer
not-for-profit organization, and all of its board of
directors, officers, committee members, and representatives
are volunteers who likely have a full-time management position
in a crime laboratory. The ASCLD/LAB is a body affiliated with
the ASCLD that accredits crime laboratories. To be
accredited, a lab must submit an application and supporting
documents and pass an on-site inspection. Accreditation is
good for five years. ASCLD/LAB conducts a proficiency testing
program to assist labs in identifying areas where more
training or more stringent quality controls are necessary, and
in demonstrating their competency.
6.FARC and DPH communications. In April 2010, the FARC
submitted proposed changes to the Group 8 regulations pursuant
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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 minor technical changes to
some of the supporting documentation. Once that is completed,
the regulations will start the official APA process.
7.Prior legislation. AB 599 (Hall), of 2009, would have
required FARC to submit to
CHHSA revisions to forensic alcohol laboratory regulations,
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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), of 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. 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.
8.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.
9.Policy comment. The author states that this bill is necessary
because DPH has not updated Group 8 regulations that govern
forensic alcohol labs in 30 years. This is not the only case
of outdated regulations not being addressed by DPH. There are
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numerous instances in which a regulated entity cannot operate
effectively because factors in today's world conflict with
regulations that have not been updated in 20 to 30 years. This
problem has affected health care facilities, labs, pharmacies,
and narcotic treatment facilities, among others. There have
been a number of bills that have come through this Committee
to work around outdated regulations, without leaving
facilities unregulated entirely. Those bills have been drafted
to address specific instances in which an outdated regulation
was limiting the ability of providers to practice in the most
effective manner. For example, federal regulations were
amended in 2001 to allow for Sunday or holiday closure of
methadone clinics in certain cases while state regulations
have not been updated for over 20 years and require methadone
clinics to be open seven days a week. There are take-home
doses of methadone available that are safe to use, ensuring
that patients do not have a break in treatment if a facility
were closed one day a week. Another bill heard by this
Committee permits pharmacy technicians, rather than
pharmacists, to check expiration dates on the labels of drugs
in a hospital pharmacy - something currently prohibited by a
regulation not updated since its promulgation in 1986. In
this instance, the frustration of DPH not updating regulations
resulted in the passage of SB 1923 in 2003, which took away
DPH's responsibility for updating the Group 8 regulations and
gave it to the FARC. While it has taken a long time, new
regulations are moving forward. It is unclear whether it is
good policy to permit forensic alcohol labs to go unregulated
due to frustration with a process that the Legislature itself
mandated, especially when it appears that the process is
advancing.
SUPPORT AND OPPOSITION :
Support: Santa Clara District Attorney (sponsor)
California District Attorneys Association
Oppose: None received.
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