BILL ANALYSIS
SJR 15
Page 1
Date of Hearing: June 15, 2010
ASSEMBLY COMMITTEE ON HEALTH
Bill Monning, Chair
SJR 15 (Alquist) - As Amended: August 17, 2009
SENATE VOTE : 40-0
SUBJECT : Public health laboratories.
SUMMARY : Encourages federal officials to amend regulations and
enact legislation to allow nondoctoral, nonboard certified
persons to serve as directors of local public health
laboratories (PHLs) if they are qualified under applicable state
laws. Specifically, this resolution :
1)Encourages the federal Centers for Medicare and Medicaid
Services (CMS) to amend the Clinical Laboratory Improvement
Amendments of 1988 (CLIA) regulations, and the United States
(U.S.) Congress and President to enact legislation, to allow
nondoctoral, nonboard certified persons to serve as local PHL
directors if they are qualified under the law of the state in
which the PHL is located, with the goal of ensuring adequate
PHL support for response to communicable disease events,
adequate supply of PHL directors, and protection for the
nation by increasing national security through adequate
disease identification.
2)Makes legislative findings and declarations concerning CLIA
regulations and the closure of needed PHLs in California,
California's exemplary and internationally recognized PHL
system, the loss of PHLs as a national security concern, and
Congresswoman Matsui's legislation to provide states with
authority to permit PHLs to operate with changes in CLIA
requirements for laboratory director qualifications.
EXISTING FEDERAL LAW , through CLIA, regulates all laboratory
testing (except research) performed on humans in the U.S. to
ensure quality laboratory testing. CLIA includes standards for
proficiency testing, facility administration, quality control,
and personnel qualifications. CLIA requires laboratory
directors to be licensed as a laboratory director in the state
where the laboratory is located, if the state requires such
licensing. CLIA regulations also require laboratory directors
to meet the following requirements:
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1) Be a licensed doctor of medicine, osteopathy, or podiatry
in the state where the laboratory is located, be certified in
anatomic or clinical pathology, and have laboratory training
or experience supervising high complexity testing, as
specified;
2) Hold a doctoral degree in a chemical, physical,
biological, or clinical laboratory science and be certified by
a board approved by the U.S. Department of Health and Human
Services (DHHS); or,
3) Be serving as, or be qualified under state law to serve
as a laboratory director on or before February 28, 1992, as
specified.
EXISTING STATE LAW :
1) Defines a clinical laboratory as any establishment or
institution operated for the performance of clinical
laboratory tests or examinations, or the practical application
of clinical laboratory sciences, and a PHL as a laboratory
that is operated by a city or county.
2) Requires a clinical laboratory that performs tests of
moderate or high complexity to be licensed by the Department
of Public Health.
3) Requires a director of a clinical laboratory, except an
acute care hospital laboratory, to be licensed as a physician
in California, or a master's or doctoral scientist or
bioanalyst.
4) Requires a PHL director to be a certified public health
microbiologist and have four years of experience in a public
health laboratory, including two years as a supervisor. A
certified public health microbiologist must have a bachelor's
or doctoral degree and a specified level of training in a
public health laboratory, pass a specified exam, and meet CLIA
requirements for a laboratory director.
FISCAL EFFECT : None
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COMMENTS :
1)PURPOSE OF THIS RESOLUTION . According to the author, many
local PHLs are at risk of closing due to the CLIA requirement
that a laboratory director hold a doctoral degree or be
board-certified. Data from the California Association of
Public Health Laboratory Directors (CAPHLD) indicate that
within five years, half of current PHL directors in California
will likely retire. The author states that closure of PHLs
will make Californians more vulnerable to disasters, both
naturally occurring and man-made. The author contends this
resolution is needed to communicate to federal elected
representatives and officials the burden that California
struggles under due to CLIA regulations, which is coupled with
a national shortage of doctoral directors for PHLs, and how
this has weakened California's local public health
infrastructure.
2)BACKGROUND . According to the California Conference of Local
Health Officers, the mission of local health departments and
PHLs is to protect the public against communicable diseases
and outbreaks, assure the safety of food and water, respond to
bioterrorism and chemical threats, and address other public
health needs of our communities. A report by CAPHLD indicates
that in 2001, California had 39 local PHLs, all of which were
designated as high complexity labs and had full-time
directors. In addition, many of these PHLs were designated as
reference labs, meaning that they have national security
responsibilities to protect the nation during national
emergencies, such as a bioterrorist attack or an influenza
pandemic.
3)THE PHL DIRECTOR SHORTAGE . CLIA included a grandfather
provision to allow laboratories to continue with non-doctoral
trained directors until more doctoral level directors could be
trained. CMS has since added a requirement for board
certification. As grandfathered directors have been retiring,
a shortage of qualified, doctoral level lab directors has
developed. The CAPHLD report states that by 2009, 22 of the
PHL directors had retired, and only nine of the directorships
were filled on a full-time basis, all by directors who are
eligible only under the CLIA grandfather clause, that is, they
served as directors or were eligible in 1992. Currently, over
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one-third of PHL directors serve only on a part-time basis.
In 2008, the Mendocino PHL closed due to inability to hire a
director. The CAPHLD report also notes that in the past 60
years, only five California PHLs have been directed by
board-certified doctoral directors. Further, the report
states a survey conducted three years ago indicated that most
PHLs have staff who would make excellent full-time directors
if not for the doctoral degree and board certification
requirement.
In 2005, the State Public Health Officer, Dr. Richard Jackson,
wrote to urge the U.S. Secretary of DHHS to consider revising
CLIA to allow local PHLs to be directed by individuals who are
qualified under state law. Dr. Jackson's appeal noted that
California's requirements for PHL directors had served
California well for over 50 years, without requiring a
doctoral degree, and that since 1992, only one new director
with a doctoral degree had entered California's PHL system.
The appeal also noted that 80% of local PHLs in California had
[grandfathered] directors who did not possess a doctoral
degree but met CLIA performance standards, that PHLs in small
and rural counties would have greater difficulty recruiting
directors with doctoral degrees and board certification, and
closure of these labs would impair critical national
infrastructure for bioterrorism preparedness. The letter
cited research indicating that a doctorate does not assure
laboratory quality, but standards for laboratory bench
professionals are correlated with laboratory quality. Dr.
Jackson further argued that California's standard for
laboratory bench professionals exceeds CLIA.
4)SUPPORT . CAPHLD, a co-sponsor of this resolution, writes in
support of this resolution that PHLs are the local government
science centers that provide necessary laboratory support to
local public health department programs, including
communicable disease control; bioterrorism preparedness;
disaster response; and, environmental health programs, such as
food, dairy, and water safety, and vector control. CAPHLD
writes that CLIA and related regulations were promulgated in
response to problems with cervical cancer cytology smears in
clinical laboratories, without regard to state laws. As a
result, PHLs throughout the nation are facing a shortage of
qualified PHL directors. CAPHLD argues the federal
regulations are not realistic given the number of individuals
who are available to meet the need. CAPHLD contends that many
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California PHLs are on the brink of closure solely due to the
federal regulations requiring board-certified, doctoral level
directors. CAPHLD contends the quality of California PHLs is
noted nationally and is beyond reproach, and that many
experienced, qualified, mid-career professionals could serve
as PHL directors if given the chance through modified CLIA
regulations.
5)PREVIOUS LEGISLATION . SB 744 (Strickland), Chapter 201,
Statutes of 2009, revises licensing and certification
requirements for clinical laboratories to recognize
accreditation of clinical laboratories by approved, private,
nonprofit organizations, revises license fees on clinical
laboratories according to the number of tests performed,
increases licensing fees on laboratory personnel, and makes
other administrative changes.
REGISTERED SUPPORT / OPPOSITION :
Support
California Association of Public Health Laboratory Directors
(co-sponsor)
Health Officers Association of California (co-sponsor)
Opposition
None on file.
Analysis Prepared by : Martin Radosevich / HEALTH / (916)
319-2097