BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K. Alquist, Chair
BILL NO: SJR 15
S
AUTHOR: Alquist
J
AMENDED: As introduced
R
HEARING DATE: July 15, 2009
CONSULTANT:
1
Hansel/sh
5
SUBJECT
Public health laboratories
SUMMARY
Encourages the Centers for Medicare and Medicaid Services
(CMS) 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.
CHANGES TO EXISTING LAW
Existing federal law:
Under 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 control.
Existing federal regulations:
Establish qualifications for directors of labs performing
high complexity tests, which require that the director:
Continued---
STAFF ANALYSIS OF SENATE BILL SJR 15 (Alquist)Page 2
Posses a current license as a laboratory director issued
by the state in which the laboratory is located; and,
Be one of the following:
--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;
--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;
--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; or,
--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.
Existing state law and regulations
Define 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.
Require a clinical laboratory that performs tests that are
of moderate or high complexity to be licensed by DPH.
Require a public health laboratory director to be a
certified Public Health Microbiologist and have four years
of experience in a public health laboratory. A certified
Public Health Microbiologist must have a bachelor's or a
doctoral degree and a specified level of training in a
public health laboratory, and pass an exam, as specified.
STAFF ANALYSIS OF SENATE BILL SJR 15 (Alquist)Page 3
This resolution:
Encourages 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.
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.
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.
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.
FISCAL IMPACT
This resolution is keyed nonfiscal.
BACKGROUND AND DISCUSSION
According to the California Association of Public Health
Laboratory Directors (CAPHLD), a co-sponsor of SJR 15,
public health labs throughout the country are facing
onerous federal regulations requiring labs that conduct
high complexity tests to have board certified,
doctoral-level directors. These regulations ignore the
robust system of lab directorship qualifications that
exists in California that has protected Californians for
nearly sixty years.
According to CAPHLD, unrealistic federal standards have
artificially created a shortage of qualified local public
health lab directors. A recent survey of the 38 local
public health labs suggests that there are many mid-career
professionals who are experienced and qualified to be lab
STAFF ANALYSIS OF SENATE BILL SJR 15 (Alquist)Page 4
directors, although they don't possess doctoral degrees.
CAPHLD states that California has a strong system of
bachelor degreed, locally trained, and state certified
Public Health Microbiologists who can take over as lab
directors, if the CLIA regulations are modified.
.
Clinical laboratory oversight
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, 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.
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
STAFF ANALYSIS OF SENATE BILL SJR 15 (Alquist)Page 5
six accrediting organizations approved by CMS, including
the College of American Pathologists and the Joint
Commission.
Public health laboratories
There are currently 38 public health laboratories located
in California that are administered locally by city or
county public health departments. Local public health
laboratories provide services relating to the examination
of specimens from suspected cases of infectious and
environmental diseases, including specimens from humans,
milk, water, food, vectors, and the environment. While
public health laboratories may conduct patient diagnostic
testing, they differ from clinical laboratories in that the
scope of their work, including their patient diagnostic
testing, revolves around the prevention and control of
communicable disease, community surveillance of infectious
or communicable disease, and promoting and maintaining
public health. All of the laboratories meet CLIA standards
for conducting high complexity lab tests.
Local public health laboratories are approved by DPH,
meaning that they are certified to meet state and federal
law and regulations. DPH also certifies public health
microbiologists and public health laboratory directors to
ensure that they meet all educational and training
requirements required by state regulations. Existing state
regulations set forth specific requirements and standards
that public health laboratories must meet, including
requirements pertaining to personnel, reporting, and safety
procedures and precautions. Existing regulations require a
public health laboratory microbiologist, and a public
health laboratory director to meet specified education and
training requirements, and to be certified by DPH.
Federal regulations pertaining to lab directors
In response to concerns about the quality of lab testing
related to cytology laboratories (those which examine
tissue samples), federal regulations were adopted in 1992
that increased requirements for qualifications of lab
directors, including a requirement that lab directors have
doctoral degrees. The rules included a grandfather
provision allowing individuals previously qualified by
state statute as of 1992 to continue to be able to direct
STAFF ANALYSIS OF SENATE BILL SJR 15 (Alquist)Page 6
labs, including public health labs. At the time these
rules were adopted, it was thought that the grandfathering
provision would allow labs to continue until more doctoral
level directors could be trained and placed.
In practice, a significant shortage of doctoral level lab
directors has developed. The current pool of grandfathered
directors is aging, with many now retired or near
retirement. Since the adoption of these rules, CMS has
recently added board certification, in addition to the
doctoral requirement, which has further exacerbated the
shortage of qualified directors.
In 2005, an appeal from Richard Jackson, MD, MPH, the
state's public health officer, to HHS Secretary Leavitt to
allow individuals who are qualified under state law to be
deemed to be qualified under the federal regulations, was
rejected. In response, Congresswoman Doris Matsui has
drafted federal legislation to prohibit the Secretary of
Health and Human Services from requiring local public
health laboratory directors to posses a doctoral degree in
addition to meeting the applicable qualifications under
state law.
Related bills
SB 744 (Strickland) revises licensing and certification
requirements for clinical laboratories by recognizing
accreditation of clinical laboratories by private,
nonprofit organizations as specified. Revises license fees
according to the number of tests
performed, and makes other administrative changes.
Currently in the Assembly Health Committee.
Prior legislation
SB 113 (Maddy), Chapter 510, Statutes of 1995, conformed
state laboratory licensing law to federal CLIA law as a
precursor for the state to seek CLIA exemption.
Arguments in support
According to CAPHLD, a co-sponsor of SJR 15, 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
STAFF ANALYSIS OF SENATE BILL SJR 15 (Alquist)Page 7
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
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.
COMMENTS
1. Suggested technical amendmenst:
a. On page 1, lines 1 - 6, amend as follows:
WHEREAS, The federal Center Centers for Medicare and
Medicaid
Services (CMS) has adopted the Clinical Laboratory
Improvement
Amendment Amendments (CLIA) regulations related to
laboratory director
qualifications that are unreasonable for the
California local public health
laboratory system and have led to the closure of
needed local public health
laboratories in California; and
b. On page 2, lines 29 - 40, amend as follows:
Resolved by the Senate and the Assembly of the State of
California,
jointly, That the Legislature of the State of California
encourages
CMS to amend the CLIA regulations, and the Congress and
the President of the United States to enact legislation
that would,
allow qualified nondoctoral, nonboard certified persons
to serve as
laboratory directors of local public health laboratories,
STAFF ANALYSIS OF SENATE BILL SJR 15 (Alquist)Page 8
if they are
qualified to direct such laboratories under the law of
the state
in which the laboratory is located, with the express
goals of ensuring
adequate local public health laboratory support for
response to communicable
disease events, ensuring an adequate supply of local
public health
laboratory directors, and ensuring protection for the
balance of the nation
by increasing national security through adequate disease
identification;
and be it further
POSITIONS
Support: California Association of Public Health
Laboratory Directors (co-sponsor)
Health Officers Association of California
(HOAC) (co-sponsor)
Oppose: None received
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