BILL ANALYSIS �
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|SENATE RULES COMMITTEE | SB 594|
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THIRD READING
Bill No: SB 594
Author: Wolk (D)
Amended: 5/25/11
Vote: 21
SENATE HEALTH COMMITTEE : 6-3, 05/04/11
AYES: Hernandez, Alquist, De Le�n, DeSaulnier, Rubio, Wolk
NOES: Strickland, Anderson, Blakeslee
SENATE APPROPRIATIONS COMMITTEE : 6-3, 05/23/11
AYES: Kehoe, Alquist, Lieu, Pavley, Price, Steinberg
NOES: Walters, Emmerson, Runner
SUBJECT : Local public health laboratories
SOURCE : California Association of Public Health
Laboratory Directors
DIGEST : This bill requires the California Department of
Public Health (CDPH) to promulgate regulations by January
1, 2014, that establishes minimum requirements for
laboratories that train public health
microbiologist-trainees, approve of and monitor a program
of continuing education for public health microbiologists,
and to require continuing education for public health
microbiologists as a condition for renewal of a certificate
issued by CDPH. The bill also requires CDPH to develop an
examination in consultation with California Association of
Public Health Laboratory Directors, make minor changes to
laws related to the relationship between local health
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departments and public health laboratories and would codify
various definitions existing in regulation related to
public health laboratory staff.
Senate Floor Amendments of 5/25/11 clarify who will pay for
the continuing education and examinations required by this
bill, and spread out the cost of promulgating the
regulations required in the bill over a longer time period.
ANALYSIS : 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 that include being licensed as a
laboratory director and either licensed to practice
medicine, hold a doctoral degree in specified fields, or be
serving on or before February, 1992 as a lab director and
meet qualifications for lab directors that existed in 1990.
Existing state law:
1.Requires the local health department to have available
the services of a public health laboratory (PHL) to
examine specimens from suspected cases of infectious and
environmental diseases and to assist in community disease
surveillance.
2.Requires any city or county PHL and its personnel to be
approved by CDPH and comply with CLIA.
3.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. Requires a
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clinical laboratory that performs tests that are of
moderate or high complexity to be licensed by CDPH.
Existing state regulations:
1.Require certificates of approval received from CDPH after
inspection to be on display in every PHL. Prohibit a
laboratory from operating without a certificate from
CDPH.
2.Designate the laboratory of CDPH as the PHL for all local
health jurisdictions that are not covered by local PHL
service.
3.Allow written or oral, or both written and oral,
examinations for the certificate of PHM to be held as
needed and where designated by CDPH, under CDPH's
supervision.
4.Describe PHM-trainee as a person receiving professional
training required for certification as a PHM.
5.State that CDPH will establish minimum requirements for
laboratories that train PHM-trainees and laboratories
which accept personnel for training, must be specifically
approved to provide training by CDPH.
6.Allow a health officer of a municipality or county to
designate any laboratory as an official PHL to perform
any of the basic services as defined in regulation,
subject to the same requirements as an official public
lab. Basic services include those deemed necessary for
the various programs of the health department, and
consultation and reference services to further the
development of improved procedures and practices.
This bill:
1.Requires the public health laboratory director to be
responsible to the appropriate local health officer in
matters related to public health;
2.Permits a local health department, after consulting with
the local health officer, to contract with any official
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city or county public health laboratory or with the
laboratories of CDPH to provide services;
3.Designates the laboratories of CDPH as the public health
laboratory for all local health department jurisdictions
that do not otherwise have access to local public health
laboratory service;
4.Requires any city or county public health laboratory to
be certified by CDPH and to comply with specified
California regulations;
5.Codifies the definitions of "public health laboratory
director," "public health microbiologist," and "public
health microbiologist-trainee";
6.Requires the examination for public health
microbiologists to be developed by CDPH in consultation
with the California Association of Public Health
Laboratory Directors;
7.Requires CDPH to adopt regulations by January 1, 2014, to
establish minimum requirements for laboratories that
train public health microbiologist-trainees, would
require CDPH to approve of and monitor a program of
continuing education for public health microbiologists,
and would require continuing education for public health
microbiologists.
8.States that CDPH may charge public health microbiologists
a fee, not exceeding the reasonable amount necessary to
cover the costs of providing, approving, and monitoring
the continuing education program, as applicable, and that
no fee shall be imposed on a public health laboratory, or
county or city health department, for approving or
renewing any certificate or maintaining the continuing
education program.
This bill codifies a requirement in regulation for CDPH to
establish minimum requirements for laboratories that train
public health microbiologist-trainees that has been in
existence since the 1970s. It is unclear whether or not
CDPH has developed such minimum requirements. The costs to
CDPH to promulgate regulations to set minimum requirements
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and to approve and monitor a program of continuing
education would be approximately $180,000 from the Clinical
Laboratory Improvement Fund.
Background
There are currently 38 PHLs in California that are
administered locally by city or county public health
departments. Local PHLs 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.
These labs also screen newborns for various genetic and
congenital disorders; watch for disease-producing agents in
food, humans, and animals; and test for new threats like
West Nile virus, Severe Acute Respiratory Syndrome (SARS),
avian influenza, and bioterrorism.
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.
Local PHLs are approved by CDPH, meaning that they are
certified to meet state and federal law and regulations.
All of the laboratories meet CLIA standards for conducting
high-complexity lab tests. CDPH also certifies PHMs and
PHL 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 PHLs must meet, including requirements
pertaining to personnel, reporting, and safety procedures
and precautions.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
According to the Senate Appropriations Committee:
Fiscal Impact (in thousands)
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Major Provisions 2011-12 2012-13
2013-14 Fund
CDPH start-up costs $15 $90 $90 Special*
and regulations
* Clinical Laboratory Improvement Fund
SUPPORT : (Verified 5/25/11)
California Association of Public Health Laboratory
Directors (source)
Napa-Solano County Public Health Laboratory
Mosquito and Vector Control Association of California
OPPOSITION : (Verified 5/25/11)
California Association for Medical Laboratory Technology
California State Association of Counties
City and County of San Francisco
County Health Executives Association of California
County of Nevada
County of San Bernardino
County of Santa Clara Board of Supervisors
Los Angeles County Board of Supervisors
Orange County Board of Supervisors
Placer County Board of Supervisors
Regional Council of Rural Counties
San Joaquin County Board of Supervisors
Urban Counties Caucus
Ventura County Board of Supervisors
ARGUMENTS IN SUPPORT : CAPHLD is sponsoring this bill to
ensure quality PHL services are sufficiently available
statewide to protect local communities from communicable
disease threats like H1N1, tuberculosis, HIV, SARS and
foodborne and waterborne outbreaks, and to respond to
emergencies and security threats like biological and
chemical terrorist attacks, like the anthrax scares
following the September 11 attacks. CAPHLD mentions
incidences when PHL directors have had to carry out
medically-oriented duties that CAPHLD claims were not in
accord with public health, based on instructions from
non-medical government personnel. CAPHLD also believes that
due to the technical nature of a public health
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microbiologist's duties and its importance to the
protection of the public, certification tests should be
developed with sufficient stakeholder input, which CAPHLD
can provide.
ARGUMENTS IN OPPOSITION : The California Association for
Medical Laboratory Technology (CAMLT) acknowledges that
areas of practice and responsibility of the certified PHM
may be significantly different in some areas from Limited
License Microbiologist /Clinical Laboratory Scientist
(LLM/CLS). CAMLT says that the two professions share in
their analysis of human specimens and that CLS/LLM must
successfully complete a year-long post baccalaureate
program and pass a state licensing exam for the exact
breadth and scope of function for human testing. CAMLT
claims that SB 594 allows PHMs to do many of the same tasks
that LLM/CLS can do, but with only six months of training.
This six-month program would not only include human
specimen testing, but also cover all the other functions
that the PHM is required to perform: testing on milk, dairy
products, air, water, sewage, animals, insects and other
vector sources. CAMLT believes that if PHMs are to perform
the exact same function as the CLS with regard to human
testing, then education and training should be equivalent.
CTW:nl 5/26/11 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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