BILL ANALYSIS
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|SENATE RULES COMMITTEE | AB 549|
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THIRD READING
Bill No: AB 549
Author: Furutani (D)
Amended: 8/20/10 in Senate
Vote: 21
SENATE BUSINESS, PROF & ECON DEVELOP COMM : 5-2, 6/28/10
AYES: Negrete McLeod, Calderon, Corbett, Florez, Yee
NOES: Aanestad, Correa
NO VOTE RECORDED: Wyland, Walters
SENATE APPROPRIATIONS COMMITTEE : 7-4, 8/12/10
AYES: Kehoe, Alquist, Corbett, Leno, Price, Wolk, Yee
NOES: Ashburn, Emmerson, Walters, Wyland
ASSEMBLY FLOOR : 68-4, 1/27/10 - See last page for vote
SUBJECT : Licensure: clinical laboratory personnel
SOURCE : City of Hope
DIGEST : This bill includes clinical biochemical
geneticist in the list of clinical laboratory personnel
that are eligible for licensure by the Department of Public
Health (DPH). This bill requires DPH to issue a temporary
license to a histocompatibility laboratory director, and
other specified clinical laboratory personnel within 30
days of receiving a completed application. This bill also
requires DPH to adopt emergency regulations creating a
trainee license category, as specified.
CONTINUED
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Senate Floor Amendments of 8/20/10 delete certain
requirements for the Department of Public Health in issuing
licenses for specified clinical laboratory personnel, and
make technical, and other clarifying changes.
ANALYSIS : Existing law:
1. Establishes in federal law, the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), which regulates
laboratories when performing testing on human specimens
and includes laboratory standards for proficiency
testing, facility administration, personnel
qualifications, and quality control. Applies standards
to all settings, including commercial, hospital, or
physician office laboratories.
2. Establishes within DPH the Laboratory Field Services
(LFS) which provides for licensing and registration
services for clinical laboratories, and laboratory
personnel, as specified.
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.
4. Defines a clinical laboratory test or examination as the
detection, identification, measurement, evaluation,
correlation, monitoring, and reporting of any particular
analyte, entity, or substance within a biological
specimen for the purpose of obtaining scientific data
which may be used as an aid to ascertain the presence,
progress, and source of a disease or physiological
condition in a human being, or used as an aid in the
prevention, prognosis, monitoring, or treatment of a
physiological or pathological condition in a human
being, or for the performance of nondiagnostic tests for
assessing the health of an individual.
5. Provides that a clinical chemist, microbiologist,
toxicologist, genetic molecular biologist,
cytogeneticist or oral and maxillofacial pathologist is
any person licensed by DPH to engage in, or supervise
others engaged in, clinical laboratory practice limited
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to his or her area of specialization or to direct a
clinical laboratory, or portion thereof, limited to his
or her area of specialization. Specifies requirements
for licensure of these clinical laboratory personnel,
including requirements in training, education and
experience. States that the application and renewal
fees for these laboratory personnel are $63 commencing
on July 1, 1983.
6. States that a histocompatibility laboratory director
means a physician and surgeon licensed to practice
medicine or a licensed bioanalyst, and qualified to
serve as a laboratory director, as specified; or a
person who has earned a doctoral degree in a biological
science, who has completed, subsequent to graduation,
four years of experience in immunology, two of which
have been in histocompatibility testing.
7. States that on and after January 1, 2007, to be eligible
for licensure as a histocompatibility laboratory
director, an applicant who is not a licensed physician
and surgeon or bioanalyst must provide evidence of
satisfactory performance on a written examination in
histocompatibility, as specified.
8. States that a person who is licensed as a
histocompatibility laboratory director and qualified
under CLIA may perform clinical laboratory tests or
examinations classified as of high complexity under
CLIA, and any clinical laboratory test or examination
classified as waived or of moderate complexity under
CLIA.
9. Establishes the Clinical Laboratory Improvement Fund
into which fees collected by DPH from clinical
laboratories are deposited and used for the purpose of
licensing, registration, certification, inspection, or
other activities relating to the regulation of clinical
laboratories.
This bill:
1. Requires DPH, within 30 days of determining that an
application is complete, to issue a temporary license to
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any applicant seeking licensure as a histocompatibility
laboratory director, clinical chemist, microbiologist,
toxicologist, molecular biologist, cytogeneticist, or
biochemical geneticist, when the applicant meets the
following requirements:
A. The applicant has earned a doctoral degree in a
biological science and has completed, subsequent to
graduation, four years of training and experience in
immunology, of which two years shall have been in
histocompatibility testing in a laboratory in any
state of the United States or in Canada.
B. Provides evidence of satisfactory performance on a
written examination in histocompatibility administered
by the American Board of Histocompatibility and
Immunogenetics.
1. Provides that applicant issued a temporary license shall
work only under the supervision of a licensed laboratory
director.
2. States that a temporary license issued pursuant to item
# 3) above, shall remain valid until the applicant has
taken the oral examination offered by DPH, the applicant
has taken the oral examination offered by DPH, DPH
completes evaluating and processing of the applicant's
results and licensure, and DPH has issued a permanent
license. Provides that if the applicant fails to pass
the required examinations, DPH may revoke the temporary
license upon notice to the applicant sent by first-class
mail. Allows DPH to set and charge an application and
renewal fee sufficient to recover the costs of issuing
the temporary license.
3. States that the trainee license for the personnel
specified in item # 3) above, applies to:
A. Applicants holding an earned doctoral degree in a
biological science or field related to genetics from
an accredited university; and,
B. Who provide evidence of satisfactory performance on
a written examination in the area of specialty that is
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administered by the American Board of Medical
Genetics, the Canadian Council of Medical Genetics, or
the appropriate accrediting body for the area of
specialty for which the applicant is seeking
licensure.
1. Provides that a formal letter, or other written
documentation issued by an accredited training program
indicating that the applicant has completed the program,
and from a clinical laboratory confirming the
applicant's employment experience, shall constitute
sufficient evidence for the following licensed
categories: clinical chemistry, clinical microbiology,
clinical toxicology, clinical molecular biology,
clinical biochemical genetics, and clinical
cytogenetics.
2. Requires these applicants to provide evidence of
satisfactory performance on a written examination in the
applicant's specialty or subspecialty administered by an
appropriate accrediting body recognized by DPH. States
that to constitute sufficient evidence, formal letters
or other documentation must be provided directly by the
examining agency or appropriate accrediting body to DPH.
3. Requires DPH to maintain an expeditious process for
licensing applicants for licensure in clinical
laboratory practice. States that application forms and
instructions for each category of licensure shall be
posted on DPH's Internet Website.
4. Requires DPH, after receiving an application for
licensure in clinical laboratory practice, including a
resubmission of an application, to notify the applicant
in writing, or by electronic mail that the application
is complete and shall be processed by DPH or that the
application is incomplete. States that if the
application is incomplete, DPH shall specify in the
notification the transcripts, board certification,
verification of training, or other documents required to
complete the application for licensure that have not
been received by the department.
5. Makes other technical, non-substantive changes.
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Background
Biochemical Genetics . According to the American Board of
Medical Genetics (ABMG), an organization that certifies
individuals and accredits training programs in the field of
human genetics, a clinical biochemical geneticist is an
individual with a U.S. or Canadian earned, or the
equivalent of an earned doctoral degree (M.D., D.O., Ph.D.)
who can correctly perform and interpret biochemical
analyses relevant to the diagnosis and management of human
genetic diseases, and who acts as a consultant regarding
laboratory diagnosis of a broad range of biochemical
genetic disorders. ABMG points out that these requirements
imply that the individual possesses the following: the
ability to supervise and direct the operations of a
clinical biochemical genetics diagnostic laboratory,
including technical expertise and knowledge in quality
control and quality assessment procedures; broad knowledge
of (1) basic biochemistry and genetics, (2) the application
of biochemical techniques to the diagnosis and management
of genetic diseases, and (3) the etiology, pathogenesis,
clinical manifestations, and management of human inherited
biochemical disorders; an understanding of the
heterogeneity, variability, and natural history of
biochemical genetic disorders; diagnostic and interpretive
skills in a wide range of biochemical genetic problems; and
the ability to communicate biochemical laboratory results
in the capacity of consultant to medical genetics
professionals and other clinicians, and directly to
patients in concert with other professional staff.
Clinical Laboratories . According to DPH, there are
approximately 19,000 clinical laboratories in California,
3,000 of which are licensed laboratories performing
moderate and/or high complexity testing. The remaining
12,000 are registered labs performing waived tests and/or
provider-performed microscopy. California's clinical
laboratories are subject to both federal and state
oversight. LFS within DPH provides licensing,
registration, and certification services to various
facilities including clinical laboratories, and the
personnel who perform professional pre-analytical,
analytical, and post-analytical testing services for these
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facilities. Additionally, there are certain requirements,
including education, training and examination for specified
clinical laboratory personnel, including a clinical
laboratory scientist, clinical histocompatibility scientist
or clinical laboratory directors.
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 states,
and 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
is contracted by CMS to conduct the biennial CLIA survey on
behalf of the federal government. CLIA fees are based on
the type of certification sought by a laboratory, and the
annual volume and types of testing performed.
State Auditor's Report . In 2008, the Bureau of State
Audits (BSA) published a report concluding that LFS had not
provided the clinical laboratory oversight mandated by
state law and regulations. Major findings of the BSA
revealed that LFS was not inspecting laboratories every two
years, as required, inconsistently monitored laboratory
proficiency testing, closed many complaints without taking
action, sporadically imposed sanctions against laboratories
for violations, and, in three instances since fiscal year
2003-04, incorrectly adjusted licensing fees resulting in
more than $1,000,000 in lost revenue. In light of these
findings, the Auditor proposed a number of recommendations
to leverage existing resources to improve oversight of
clinical laboratories, including a recommendation for DPH
to approve accrediting organizations to conduct clinical
laboratory inspections. The Auditor stated in the report
that DPH had not approved any accreditation organizations
to perform such activities, and reported that LFS had
expressed concern over the quality of the inspections
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conducted by accrediting organizations. The Auditor
pointed out that LFS would need to approve accrediting
organizations and monitor their compliance, so LFS would
have the tools to address these concerns.
In response to the audit report, DPH generally concurred
with the Auditor's findings, and attributed much of its
inability to meet its mandated responsibilities to a lack
of staffing resources. DPH stated that LFS would take
steps to determine how to maximize the use of existing
resources, as well as assess how many additional resources
would be needed. DPH stated that licensing revenues would
likely be increased to cover costs associated with state
oversight mandates. DPH also stated that it would explore
the use of accrediting organization inspectors to conduct
inspections for compliance with state law, and that it
would work with the appropriate parties to ensure that
clinical laboratory licensing fees are properly adjusted in
accordance with the Budget Act.
To address the funding shortage, which DPH argued resulted
in its inability to conduct inspections, investigate
complaints, promptly process licensure applications, and
take enforcement action when needed, DPH sponsored SB 744
(Strickland), Chapter 201, Statutes of 2009, to among other
things, modify the clinical laboratory licensing fee
structure, and facilitate the use of private accrediting
organizations to inspect clinical laboratories. At that
time, DPH argued that by adjusting and imposing new fees
for facility and personnel licensure and certification,
charging for re-inspections of laboratories, fining for
delinquent laboratory license renewals, and charging fees
for licensure of multiple laboratory locations, would
provide additional resources for the laboratory oversight
program and address many of the problems raised by the BSA
audit.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
According to the Senate Appropriations Committee:
Fiscal Impact (in thousands)
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Major Provisions 2010-11 2011-12
2012-13 Fund
CDPH regulations $110 $220 $155 Special*
and licensing activities
* Clinical Laboratory Improvement Fund
SUPPORT : (Verified 8/17/10)
City of Hope (source)
California Healthcare Institute
Cedars Sinai Health System
ARGUMENTS IN SUPPORT : the City of Hope, states in
support that, California faces a shortage of qualified
clinical laboratory scientists that could interpret and
communicate results to other professionals or to patients
in highly complex labs in specialized fields like genetics
and histocompatibility. As a result of this shortage,
clinical labs have to outsource to laboratories in
neighboring states, which is adding additional cost and
delaying the results. This is detrimental to cancer
centers like City of Hope that deal with life threatening
diseases and require fast processing and interpretations of
laboratory results. Additionally, the City of Hope has
identified several barriers to licensing of highly
specialized clinical laboratory personnel, including
lengthy delays in the processing of applications by DPH,
and the lack of provision for the issuance of a temporary
license pending approval by DPH. The City of Hope points
out that the state currently does not have any regulations
or licensing program for biochemical geneticists, and
although this is a relatively small field, it is a highly
complex category that needs regulation.
ASSEMBLY FLOOR :
AYES: Adams, Ammiano, Arambula, Beall, Bill Berryhill, Tom
Berryhill, Blakeslee, Block, Blumenfield, Bradford,
Brownley, Buchanan, Caballero, Charles Calderon, Chesbro,
Conway, Cook, Coto, Davis, De La Torre, De Leon,
Emmerson, Eng, Evans, Feuer, Fletcher, Fong, Fuentes,
Fuller, Furutani, Galgiani, Garrick, Gilmore, Hagman,
Hayashi, Hernandez, Hill, Huber, Huffman, Jeffries,
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Jones, Knight, Lieu, Logue, Bonnie Lowenthal, Ma,
Mendoza, Monning, Nava, Nestande, Niello, Nielsen, John
A. Perez, Portantino, Ruskin, Salas, Saldana, Silva,
Skinner, Smyth, Solorio, Audra Strickland, Swanson,
Torres, Torrico, Tran, Villines, Yamada
NOES: Anderson, DeVore, Gaines, Harkey
NO VOTE RECORDED: Carter, Hall, Miller, V. Manuel Perez,
Torlakson, Bass
JA:nl 8/22/10 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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