BILL ANALYSIS Ó
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 594
S
AUTHOR: Wolk
B
AMENDED: April 28, 2011
HEARING DATE: May 4, 2011
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CONSULTANT:
9
Orr
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SUBJECT
Local public health laboratories
SUMMARY
Specifies that a local health department (LHD) must use a
city or county public health laboratory (PHL). Specifies
that PHLs shall provide services to examine specimens from
suspected cases of infectious and environmental diseases.
Requires PHL directors to report to local health officers
in matters concerning the public's health. Requires the
California Department of Public Health (CDPH) to adopt
regulations to establish minimum requirements for
laboratories that train Public Health
Microbiologist-trainees (PHM-trainees). Requires continuing
education for Public Health Microbiologists (PHMs).
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.
Continued---
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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:
Requires LHDs to have available the services of a PHL to
examine specimens from suspected cases of infectious and
environmental diseases and to assist in community disease
surveillance.
Requires any city or county PHL and its personnel to be
approved by CDPH and comply with CLIA.
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
clinical laboratory that performs tests that are of
moderate or high complexity to be licensed by CDPH.
Existing state regulations:
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.
Designate the laboratory of CDPH as the PHL for all local
health jurisdictions that are not covered by local PHL
service.
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.
Describe public health microbiologist-trainee (PHM-trainee)
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as a person receiving professional training required for
certification as a PHM.
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.
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:
Specifies that the LHD must have the services of a city or
county PHL available.
Designates in statute the laboratories of CDPH as the PHL
for all local health jurisdictions that do not otherwise
have access to local PHL service.
Requires a LHD to consult with the health officer and the
PHL director prior to contracting with any official city or
county PHL or with the state laboratories for the purpose
of providing laboratory, consultation and reference
services.
Specifies that PHLs provide laboratory services necessary
for examining specimens from suspected cases of infectious
and environmental diseases to support the communicable
disease and environmental health programs of the LHD.
Specifies that PHLs may support other programs of the local
health department or other departments.
Specifies that PHL directors are responsible to local
health officers in matters concerning the public's health,
but can be administratively responsible to other LHD
personnel.
Requires, in statute, the PHL provide consultation and
reference services to further the development of improved
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laboratory procedures and practices related to the
identification, prevention, control, and surveillance of
human disease in the community.
For the purpose of PHL and personnel approval by CDPH,
defines "approved" to mean certified by CDPH to be in
compliance with state and federal statutory or regulatory
requirements pertaining to PHLs and personnel. Also for
this purpose, defines "certificate" to mean a certificate
of approval issued by CDPH to a city or county facility or
an individual after CDPH determines that the city or county
facility personnel, or training program qualifications, are
in conformity with statutory provisions.
Defines a "PHL" to mean a laboratory that is operated by a
city or county, singularly or in conjunction with other
cities or counties.
Defines a "PHL director" to mean a person meeting CLIA
requirements for laboratory directors, and who is
authorized to direct a PHL certified pursuant to statutory
provisions.
Defines "PHM" to mean a person meeting CLIA requirements
for testing personnel and who is authorized to perform
laboratory tests or analyses certified pursuant to
statutory provisions.
Defines "PHM-trainee" to mean a person meeting academic
qualifications and approved by CDPH to train in an approved
PHL, leading to examination and PHM certification pursuant
to statutory provisions.
States that CDPH must develop the written examination for
the certificate of PHM in consultation with the California
Association of Public Health Laboratory Directors (CAPHLD).
Prohibits fees from being charged to individuals taking the
examination for the PHM certificate.
In consultation with CAPHLD, requires CDPH to adopt
regulations to establish minimum requirements for training
laboratories that train PHM-trainees by January 1, 2013.
Requires training laboratories that accept these personnel
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to be approved and certified by CDPH.
Requires CDPH to initiate, administer, and monitor a
program of continuing education for PHMs. Adds specific
requirements for the quantity of continuing education hours
that must be completed for certificate renewal.
Prohibits fees from being levied upon county or municipal
PHLs or PHL personnel for approval or renewal of any
certificates or for maintaining the continuing education
program.
FISCAL IMPACT
This bill has not been analyzed by a fiscal committee.
BACKGROUND AND DISCUSSION
The author states several reasons for the provisions of
SB594, including the need to ensure quality PHL services,
to ensure a baseline of standards for local PHL practice,
and to ensure continuing education requirements for
state-certified PHMs. The author believes that PHL
directors should have easy access to local health officers
in order to collectively protect the public, and believes
that medical authority over public health decisions should
rest with the local health officer. The author also seeks
to ensure that certified PHMs are updated in current PHL
practices by mandating continuing education requirements.
The author also believes CAPHLD should be involved in the
development of examinations for PHMs because these
professionals will be ultimately responsible for the
quality of the work produced by the trainees seeking
certification.
Public health laboratories
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
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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.
Minimum requirements for a PHL
Existing regulations specify the minimum requirements a PHL
must meet in order to receive a certificate of approval
from CDPH:
Maintain adequate equipment and facilities and
sufficient personnel to carry on dependable PHL work;
Employ procedures, technics, and reporting
practices approved by CDPH;
Establish and maintain for a minimum of two years
adequate record systems and files of laboratory work
done;
Conduct, maintain, and operate programs, acceptable
to CDPH, for controlling the quality of test
performance;
Demonstrate satisfactory performance in a
proficiency testing program approved by CDPH;
Maintain and conduct the laboratory in a manner
approved by CDPH;
Employ personnel as provided in regulations;
Accept specimens for examination as an aid to
patient management only from, and issue reports only
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to, persons licensed under the provisions of the law
relating to the healing arts or their representatives;
and
Employ procedures and precautions to provide for
the safety and health protection of all persons in the
laboratory.
PHL disease testing
Under regulation, labs are required to report test results
on certain diseases considered to be of "public health
importance." Health care providers who know of a case or
suspected case of any disease or condition on the CDPH
reportable disease list are required to report to the local
health officer of the jurisdiction where the patient
resides and are required to send specimens to a laboratory.
Clinical laboratories are also required by regulation to
report positive specimens to the local public health
department. Several diseases require, upon discovery by a
clinical laboratory, diagnosis by a physician or direction
of the local public health officer, that samples be sent to
local PHLs for further testing. These diseases include:
amebiasis, salmonella infections, shigella infections (i.e.
dysentery), typhoid fever, tuberculosis, malaria, and
rabies.
PHMs
PHMs perform microbiological and chemical examinations for
the detection, identification and control of microbial
disease agents and other impurities, including
bacteriological, chemical, serological, parasitological,
mycological, and viral tests, using a variety of laboratory
equipment. They are expected to keep accurate records and
prepare reports of examinations; prepare or supervise
preparation of stains, media and reagents; advise health
personnel and public regarding proper methods of specimen
collection and transport; and assist in training laboratory
personnel, among other duties. Most PHMs are employed in a
county or state PHL where they perform the complex
analytical microbiological procedures.
Existing regulations establish minimum requirements for
admission to the examination for a PHM certificate, which
include: (1) holding a doctoral degree with a chemical,
physical, or biological science as a major and at least one
year of post-doctoral laboratory training in medical and
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public health microbiology approved by CDPH, (2) a
baccalaureate or higher degree with a major in medical or
public health microbiology or an equivalent major as
determined by CDPH and at least six months experience as a
PHM-trainee in a PHL approved by CDPH, or equivalent
experience as determined by CDPH.
Clinical laboratories
According to CDPH, there are approximately 19,000 clinical
laboratories in California, 3,000 of which are licensed
labs performing moderate and/or high complexity testing.
Clinical laboratories include all hospital laboratories and
community laboratories that receive tests from health care
providers for analysis.
Clinical laboratories and local PHLs 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.
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.
Related bills
AB 969 (Atkins) would prohibit discounts or donations of
laboratory services provided to Federally Qualified Health
Centers by commercial clinical laboratories from being
included in the calculation of the usual and customary
charges for purposes of determining the Medi-Cal
reimbursement rate. Pending hearing in Assembly
Appropriations.
Prior legislation
SJR 15 (Alquist), Chapter 46, Statutes of 2010, encourages
the Centers for Medicare and Medicaid Services to amend
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regulations, and Congress and the President to enact
legislation, that would allow qualified non-doctoral,
non-board certified persons to serve as laboratory
directors of local PHLs.
AB 2786 (Committee on Health) of 2010 would have required
CDPH to establish a list
of communicable diseases and conditions for which clinical
laboratories are required to submit a culture or specimen
to local and state public health laboratories, as
specified.
Would have allowed CDPH to modify the list of communicable
diseases and conditions for which clinical labs must submit
specimens to the local public health laboratory to undergo
further testing. Would have allowed CDPH to modify the
list at any time, in consultation with the California
Conference of Local Health Officers and CAPHLD. This bill
was vetoed by the governor.
SB 744 (Strickland), Chapter 201, Statutes of 2009, 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.
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
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
microbiologist's duties and its importance to the
protection of the public, certification tests should be
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developed with sufficient stakeholder input, which CAPHLD
can provide.
Arguments in opposition
The County Health Executives Association of California
(CHEAC) is opposed to SB 594 because they believe the bill
would limit county flexibility in how PHL services could be
provided. They are particularly concerned about the
provisions of the bill that require a local health
department's designated PHL to be operated by a city or
county and would dictate the types of laboratory services
that must be performed only by a county or city's
designated PHL. CHEAC has asked for specific amendments to
remove several provisions of the bill.
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.
COMMENTS
1. Designation of a PHL. Existing regulations 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 PHL. This bill limits a health
officer's flexibility by describing public health labs as
only those labs of a city or county.
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2. PHL and personnel approval by CDPH. Current state law
already requires PHLs and their personnel to be approved by
CDPH and to comply with CLIA. On page 3, line 23, SB 594
describes "approved" to mean "certified by ÝCDPH] to be in
compliance with state and federal statutory or regulatory
requirements pertaining to municipal and county public
health laboratories and public health laboratory
personnel." It is unclear if this language imposes
additional duties on CDPH by requiring the department to
verify that additional requirements have been met prior to
approval. A suggested amendment would be on page 3, line
12, to strike "approved" and insert "certified by the State
Department of Public Health to be in compliance with state
and federal statutory and regulatory requirements
pertaining to municipal and county public health
laboratories and public health laboratory personnel" and to
strike lines 23-27. An additional amendment would be to
reference specific regulations and statutes.
3. Laboratory services. Existing regulations require
laboratory services provided by an approved PHL to include
services necessary for the various programs of the health
department, as well as consultation and reference services
to further the development of improved procedures and
practices in laboratories, which is vague. The author has
attempted to be more specific in SB 594 by specifying that
the PHLs provide laboratory services necessary for
examining specimens from suspected cases of infectious and
environmental diseases to support the communicable disease
and environmental health programs of the LHD. However, this
may need to be clarified further.
4. PHM examinations. The bill prohibits charging a fee to
individuals for taking the PHM examinations. Many
professional certifications charge a fee to cover
administrative costs of developing and proctoring the exams
and processing certificates. A suggested amendment would
be on page 5, line 13, delete "there shall be no fee levied
upon individuals for the examinations."
5. Regulations for labs that train PHM-trainees. Existing
regulations already call for CDPH to establish minimum
requirements for laboratories that train PHM-trainees. The
regulation to establish these requirements has been in
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place since the 1970s. It is not clear if CDPH has begun to
develop them. CDPH estimates that the length of time it
takes to promulgate regulations is a total of 727 days or
roughly 2 years, although some regulations are estimated to
take over 3 years. SB 594 requires these regulations to be
adopted by January 1, 2013.
6. Continuing education for PHMs. SB 594 requires CDPH to
initiate, administer, and monitor a program of continuing
education for PHMs. A suggested amendment would be to
allow CDPH to defer to a recognized accreditation body to
provide the continuing education, over which CDPH would
approve and monitor.
7. Codifying regulations. Several sections of this bill
codify regulations that were first established in the
1970's. It is possible that these regulations may need to
be updated in general in order to account for new
technologies, changes in work scopes and the state's
evolving needs.
8. Technical and clarifying amendments. The author may
wish to consider the following technical and clarifying
amendments.
a. Definition of certificate. SB 594 defines
"certificate" on page 3, line 28 to mean a certificate
of approval issued by CDPH to a city or county
facility or an individual after CDPH determines that
the city or county facility personnel, or training
program qualifications, are in conformity with
statutory provisions. It is unclear if this
definition is needed.
b. PHMs and PHM-trainees. Paragraphs 6 and 7
(beginning page 4, line 3) should provide references
to applicable regulations.
c. PHM examinations. Section 3 of SB 594 (beginning on
page 5, line 5) is largely duplicative of existing
regulations. A suggested amendment would be to remove
the duplicative language and provide references to the
related regulations.
d. Regulations for labs that train PHM-trainees.
Section 4 of SB 594 (beginning on page 5, line 15)
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requires CDPH to develop minimum requirements for
laboratories that train PHM-trainees, which is in
contrast to the next provision which requires CDPH to
approve and certify training laboratories that merely
accept PHM-trainees. A suggested amendment would be
on page 5 line 22, strike "and require," and strike
lines 23-25, inclusive.
e. Consultation and reference services. It is unclear
if public health lab directors are currently
prohibited from providing such services, and therefore
it is unclear as to the need for the bill's provision
allowing PHL directors to provide these services. A
suggested amendment would be to strike lines 27-31 on
page 2.
f. Authorization to contract. The bill allows a local
health department to contract with any official city
or county PHL or with the state laboratories, upon
consultation with the health officer and the PHL
director. It is not clear why the PHL director would
need to be consulted in this manner, nor is it clear
that the local health officer wouldn't already be able
to consult with a PHL director at their discretion. A
suggested amendment would be on page 2, line 33,
strike "and the public health laboratory director."
g. PHL directors. This bill defines a PHL director to
mean a "person meeting CLIA requirements for
laboratory directors, and who is authorized to direct
a public health laboratory certified under this
article." A suggested amendment would be to specify
what entity authorizes the PHL director, and on page 4
line 1, strike "under this article" and insert
"pursuant to subdivision (a)" in order to capture both
statutory and regulatory provisions (provided that the
amendments in Comment 2 are accepted).
POSITIONS
Support: California Association of Public Health
Laboratory Directors
One individual
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Oppose: 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
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