BILL ANALYSIS
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|SENATE RULES COMMITTEE | SJR 15|
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CONSENT
Bill No: SJR 15
Author: Alquist (D), et al
Amended: 8/17/09
Vote: 21
SENATE HEALTH COMMITTEE : 10-0, 7/15/09
AYES: Alquist, Strickland, Aanestad, Cedillo, Cox,
DeSaulnier, Leno, Negrete McLeod, Pavley, Wolk
NO VOTE RECORDED: Maldonado
SUBJECT : Public health laboratories
SOURCE : California Association of Public Health
Laboratory Directors
Health Officers Association of California
DIGEST : This resolution encourages the Centers for
Medicare and Medicaid Services to amend regulations, and
the Congress and the President to enact legislation, that
would allow qualified non-doctoral, non-board certified
persons to serve as laboratory directors of local public
health laboratories.
ANALYSIS : Under existing federal law, the Clinical
Laboratory Improvement Amendments of 1988 (CLIA),
establishes various conditions that laboratories must meet
in order to be certified to perform testing on human
specimens. Laboratory standards established under CLIA
include standards for proficiency testing, facility
administration, personnel qualifications, and quality
CONTINUED
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control.
Existing federal regulations establish qualifications for
directors of labs performing high complexity tests, which
require that the director:
1. Posses a current license as a laboratory director issued
by the state in which the laboratory is located.
2. Be one of the following:
A. A doctor of medicine or doctor of osteopathy
licensed to practice medicine or osteopathy in the
state in which the laboratory is located, and be
certified in anatomic or clinical pathology, or
both, as specified.
B. A doctor of medicine, doctor of osteopathy, or
doctor of podiatric medicine with specified levels
of lab training and experience directing or
supervising high complexity lab tests.
C. Hold a doctoral degree in chemical, physical,
biological, or clinical laboratory science, as
specified, and be certified, or have served or be
serving as the director of a lab that performs high
complexity tests and have specified levels of lab
training and of directing or supervising high
complexity testing, as specified.
D. Be serving on or before February, 1992 as a lab
director and meet qualifications for lab directors
that existed in 1990, or be qualified on or before
February 28, 1992 under state law to direct a lab.
This resolution:
1. Encourages Centers for Medicare and Medicaid Services
(CMS) to amend the CLIA regulations, and the Congress
and the President to enact legislation to allow
qualified non-doctoral, non-board certified persons to
serve as laboratory directors of local public health
laboratories, if they are qualified to direct those
laboratories under the law of the state in which the
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laboratory is located.
2. Encourages the federal Secretary of Health and Human
Services, the Department of Homeland Security, and other
relevant federal regulatory authorities to encourage CMS
to amend the CLIA regulations, and the Congress and
President to enact legislation, to accomplish these
policy goals.
3. Cites a number of issues and problems with current CLIA
regulations related to laboratory director
qualifications, and the role and importance of public
health labs in California.
4. Refers to pending legislation that would provide states
with authority to permit local public health labs to
receive flexibility with respect to CLIA laboratory
director qualifications.
Background
California clinical laboratories, including local public
health laboratories, are subject to both federal and state
oversight. Federal CLIA requirements establish standards
for laboratories to ensure the accuracy, reliability, and
timeliness of patient test results, and specify numerous
quality standards, including those for facility
administration, personnel qualifications, quality control,
and proficiency testing, a process used by laboratories to
verify the accuracy and reliability of their test results.
CLIA standards apply to laboratory testing in all settings,
including commercial, hospital, or physician office
laboratories.
CLIA standards are based on the complexity of the testing
(waived, moderate, or high complexity). To become
certified under CLIA, a clinical laboratory must pay
applicable fees, meet all applicable standards, and be
surveyed biennially. In California, the Department of
Public Health (DPH) conducts the biennial CLIA survey on
behalf of the federal government. CLIA certification fees
are based on the type of certification sought by a
laboratory, and the annual volume and types of testing
performed.
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In addition to CLIA standards, clinical laboratories in
California, including local public health laboratories,
must meet state licensure requirements in order to operate.
Similar to CLIA, state licensing law requires biennial
surveys, proficiency testing, and specified personnel
requirements.
CLIA allows CMS to deem a laboratory as having met federal
requirements through accreditation by a recognized
accrediting organization, as long as the standards of the
organization meet or exceed those in federal regulations.
California law also requires DPH to deem accredited
clinical laboratories as having met state licensure or
registration requirements, if the organization allows DPH
to inspect its accredited labs at random, and the
organization has been approved by CMS. There are currently
six accrediting organizations approved by CMS, including
the College of American Pathologists and the Joint
Commission.
FISCAL EFFECT : Fiscal Com.: No
SUPPORT : (Verified 7/22/09) (Unable to reverify at time
of writing)
California Association of Public Health Laboratory
Directors (co-source)
Health Officers Association of California (co-source)
ARGUMENTS IN SUPPORT : According to California
Association of Public Health Laboratory Directors (CAPHLD),
a co-sponsor of this resolution, current federal
requirements for lab directors is threatening the state's
capacity to respond to public health problems and threats.
CAPHLD states that the federal requirements are resulting
in the closure of many local labs, and cites the example of
Mendocino County, which in 2008 closed its public health
lab after failing to attract a federally qualified director
for over two years.
CAPHLD notes that California's public lab system has been
in operation since 1950. Since then, the state's
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population has quadrupled and public health departments and
labs are dealing with the reemergence of diseases such as
tuberculosis, rabies, syphilis, plague, and anthrax, while
also facing several new diseases, such as H1N1 influenza,
SARS, HIV, West Nile virus, E. coli, and Lyme disease.
CAPHLD argues that given these threats, it is imperative
that further closures of public health labs be averted, by
modifying current unrealistic and unnecessary federal
requirements.
CTW:do 8/19/09 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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