BILL ANALYSIS
AB 549
Page 1
Date of Hearing: April 28, 2009
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Mary Hayashi, Chair
AB 549 (Furutani) - As Amended: April 21, 2009
SUBJECT : Licensure: clinical laboratory personnel.
SUMMARY : Creates an interim clinical director license for Ph.D
graduates. Specifically, this bill :
1)Includes "clinical biochemical geneticist" and "clinical
cytogeneticist," to the list of individuals licensed by the
State Department of Health Services (department) who engage
in, or supervise others engaged in, clinical laboratory
practice limited to his or her area of specialization or to
direct a clinical laboratory, or portion thereof, limited to
his or her area of specialization.
2)Permits a person licensed as a "clinical biochemical
geneticist" or "clinical cytogeneticist," to perform any
clinical laboratory test or examination classified as waived
or of moderate complexity under Clinical Laboratory
Improvement Amendments of 1988 (CLIA).
3)Directs the department to adopt regulations specifying the
subspecialty of genetics or other specialty or subspecialty
and clinical laboratories that a clinical biochemical
geneticist may direct.
4)Permits the department to issue limited clinical laboratory
scientists' licenses in biochemical genetics.
5)States that to qualify for admission to the examination for a
special clinical laboratory scientist's license, an individual
must meet the following requirements:
a) Have graduated from a college or university maintaining
standards equivalent, as determined by the department, to
those institutions accredited by the Western Association of
Schools and Colleges or an essentially equivalent
accrediting agency with a baccalaureate or higher degree
with a major appropriate to the field for which a license
is being sought; and,
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b) Have one year of full-time postgraduate training or
experience in the various areas of analysis in the field
for which a license is being sought in a laboratory that
has a license issued under this chapter or which the
department determines is equivalent thereto; or,
c) Have a doctoral degree from an accredited institution
and provide evidence of completion of two years of
postdoctoral training in a training program accredited by
an approved accrediting body for the specialty, as
specified, and provide evidence of satisfactory performance
on a written examination approved by the department
relevant to each limited clinical laboratory scientist's
license.
6)Requires the department to issue, by January 1, 2010, limited
clinical laboratory scientists' licenses in:
a) Cytogenetics;
b) Genetic molecular biology;
c) Biochemical genetics; and,
To any person possessing a doctoral degree from an accredited
institution who provides evidence of completing two years of
postdoctoral training in their respective field in a training
program accredited by a relevant accrediting body for the
specialty. These applicants must also provide evidence of
satisfactory performance on a written examination administered
by the National Credentialing Agency for Laboratory Personnel
in their respective specialty.
7)Requires the department to issue, by January 1, 2010, a
limited clinical chemist scientist license to any person
possessing a doctoral degree from an accredited institution
who provides evidence of completing two years of postdoctoral
training in their respective field in a training program
accredited by a relevant accrediting body for the specialty,
and who provides evidence of satisfactory performance on a
written examination administered by the American Society for
Clinical Pathology, the National Registry in Certified
Chemistry, the American Board of Clinical Chemistry, or other
certification agency approved by the department.
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8)Requires the department to issue a clinical biochemical
geneticist license to each person who:
a) Has applied for the license on forms provided by the
department;
b) Who is a lawful holder of a master of science or
doctoral degree in the specialty for which the applicant is
seeking a license; and,
c) Who has met such additional reasonable qualifications of
training, education, and experience as the department may
establish by regulations.
9)Requires applicants for a clinical biochemical geneticist
license possessing a doctoral degree from an accredited
institution to have the equivalent of two years of
postdoctoral training in a training program accredited by a
relevant accrediting body for the specialty and requires each
applicant to provide evidence of satisfactory performance on a
written examination in the applicant's specialty administered
by an appropriate accrediting body, as specified.
10)Requires the department to issue, by January 1, 2010, a
provisional license as a:
a) clinical cytogeneticist;
b) clinical genetic molecular biologist;
c) clinical biochemical geneticist;
d) histocompatibility laboratory director;
to any person possessing a doctoral degree from an accredited
institution who also provides evidence of completing two years
of postdoctoral training in that specialty in a training
program accredited by a relevant accrediting body for that
specialty.
11)Requires these provisional licensees to work under the
supervision of a laboratory director. If the licensee is
qualified under CLIA, he or she may perform clinical
laboratory tests or examinations classified as of high
complexity under CLIA, and shall have the duties and
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responsibilities of a technical supervisor and general
supervisor, as specified under CLIA, limited to that
specialty.
12)Requires each applicant for a provisional license as a
clinical cytogeneticist to provide evidence of satisfactory
performance on a written examination administered by the
American Board of Medical Genetics or the Canadian Council of
Medical Genetics in the specialty of cytogenetics.
13)Requires that any person with a provisional license as a
clinical cytogeneticist be eligible for licensure as a
laboratory director upon the completion of two years of
experience supervising or performing clinical laboratory tests
or examinations in clinical cytogenetics in a clinical
laboratory that possesses a certificate issued under CLIA for
performing high-complexity testing, provided his or her
license is not then suspended or revoked.
14)Requires each applicant for a provisional license as a
clinical genetic molecular biologist to provide evidence of
satisfactory performance on a written examination administered
by the American Board of Medical Genetics or the Canadian
Council of Medical Genetics in the specialty of molecular
biology.
15)Requires that any person with a provisional license as a
clinical genetic molecular biologist be eligible for licensure
as a laboratory director upon the completion of two years of
experience supervising or performing clinical laboratory tests
or examinations in genetic molecular biology in a clinical
laboratory that possesses a certificate under CLIA for
performing high-complexity testing, provided his or her
license is not then suspended or revoked.
16)Requires each applicant for a provisional license as a
clinical biochemical geneticist to provide evidence of
satisfactory performance on a written examination administered
by the American Board of Medical Genetics or the Canadian
Council of Medical Genetics in the specialty of biochemical
genetics.
17)States that any a licensed clinical biochemical geneticist
shall be eligible for licensure as a laboratory director upon
the completion of two years of experience supervising or
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performing clinical laboratory tests or examinations in
clinical biochemical genetics in a clinical laboratory that
possesses a certificate issued under CLIA for performing
high-complexity testing, provided his or her license is not
then suspended or revoked.
18)Requires each applicant for a provisional license as a
histocompatibility laboratory director to provide evidence of
satisfactory performance on a written examination administered
by the American Board of Histocompatibility and Immunogenetics
in the specialty of histocompatibility.
19)States that any person licensed pursuant to this section
shall be eligible for licensure as a histocompatibility
laboratory director upon the completion of two years of
experience supervising or performing clinical laboratory tests
or examinations in histocompatibility and immunology in a
clinical laboratory that possesses a certificate issued under
CLIA for performing high-complexity testing, provided his or
her license is not then suspended or revoked.
20)Permits the department to adopt emergency regulations in
accordance with the Administrative Procedure Act to implement
this bill.
EXISTING LAW :
1)Provides for the regulation and licensure of clinical
laboratories and clinical laboratory personnel by the State
Department of Public Health.
2)Authorizes the department to issue limited clinical laboratory
scientist's licenses in chemistry, microbiology, toxicology,
histocompatibility, immunohematology, genetic molecular
biology, cytogenetics, or other areas of laboratory specialty
or subspecialty when determined necessary by the department,
as specified.
3)Requires an applicant to meet various requirements in order to
qualify for admission to the examination for a special
clinical laboratory scientist's license.
4)Requires the department to issue a clinical chemist, clinical
microbiologist, clinical toxicologist, clinical molecular
biologist, clinical biochemical geneticist, or clinical
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cytogeneticist license to each person who has applied for the
license on a specified form who is also the holder of a master
of science or doctoral degree in the specialty for which the
applicant is seeking a license and who has met other
requirements.
5)Requires the graduate education to have included 30 semester
hours of coursework in the applicant's specialty.
FISCAL EFFECT : Unknown
COMMENTS :
Purpose of this bill . According to the author's office,
"Currently, California's licensure requirements for individuals
with doctoral degrees and post-doctoral training are higher than
those required by other states. No one wants to lower
California's standards. But the state needs to provide a
licensing program that enables post-doctoral candidates to
obtain licensure reflecting their education and training. AB
549 attempts to provide a continuum of licensing that will allow
these individuals to work in this state while obtaining the
necessary experience to achieve the licensure level they are
ultimately seeking."
Background . California requires doctoral graduates to gain two
years of experience in qualified fellowships to be eligible as
clinical director. 48 other states do not have this
requirement, and thus the sponsors and supporters argue that
much talent is lost to other states. Currently, to work in a
clinical setting, individuals with a Ph.D must have a Clinical
Laboratory Scientist (CLS) license, which requires only a
baccalaureate degree. Opponents argue that current licensing
law protects consumers by ensuring clinical directors have the
necessary experience. However, it is argued that requiring
Ph.Ds to work under a CLS license underutilizes their education
and arrests the advancement afforded elsewhere.
This bill does not suspend the two year experience requirement,
but rather creates an interim license that allows a greater
scope of practice for Ph.Ds in the clinical setting and creates
a pathway to clinical directorship.
Arguments in support . Dr. Tim Hamill, on behalf of University
of California San Francisco Clinical Laboratories, writes, "The
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state's Laboratory Field Services issues licenses to people who
have the appropriate training, education, and experience in two
basic categories: Clinical
Laboratory Scientists (CLS) and a 'director' category that
includes cytogeneticists, genetic molecular biologists, and
individuals in histocompatibility. Unfortunately, as alluded to
above the licensing structure lacks a "bridge" between these two
levels that would allow people training for the more specialized
positions to gain necessary experience to work in the labs.
What is needed is a mid-level license that would allow a
qualified person to formulate and communicate a diagnosis to
another professional or to a patient which can currently only be
done under the current "laboratory director" designation, which
is established in federal law.
"AB 549 addresses all of these problems by allowing geneticists
and clinicians in the field of histocompatibility to gain
valuable experience in labs as limited clinical laboratory
scientists while they wait to take their national board
certification exams, which only happens once every three years.
The bill would also create a provisional license for Ph.D.-level
candidates who have their board certification and who are
qualified to formulate and communicate a clinical diagnosis, but
lack the experience required for a full license in cytogenetics,
genetic molecular biology or biochemical genetics. Finally, the
bill would provide Laboratory Field Services with the statutory
authority to create a licensing category for biochemical
geneticists. California has always been at the forefront of
genetics and histocompatibility, but our state stands to lose
bright and talented people if we do not address the deficiencies
in our current licensing process. Should AB 549 become law,
Californians will reap the benefit."
Arguments in opposition . The United Food and Commercial Workers
Union, Western States Council and the Engineers and Scientists
of California write, "This bill would undermine existing
regulations pertaining to the licensure of Clinical Laboratory
Directors (LDs) by providing that certain LDs may have a
provisional license prior to achieving existing regulatory
requirements.
"While we understand that the proponents of the measure contend
that there is a shortage of qualified LDs in California, this is
not the experience in the clinical laboratories in which we are
employed. Further, good faith efforts should be made to work
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with Laboratory Field Services in an attempt to ensure that a
sufficient number of qualified candidates are meeting existing
regulatory requirements, rather than amending existing law to
diminish the existing regulatory requirements.
"The existing regulatory scheme ensures patient safety by
guaranteeing that LDs are qualified to read, interpret and
disseminate laboratory results. Diminishing the existing
regulations will result in patient safety issues."
REGISTERED SUPPORT / OPPOSITION :
Support :
City of Hope (sponsor)
California Healthcare Institute
Cedars-Sinai Health System
Director of Clinical Services, Division of Genetics, University
of California, Los Angeles
Medical Director, Director of the Department of Pathology and
Laboratory Medicine at
Children's Hospital and Research Center
University of California San Francisco Clinical Laboratories
Opposition :
California Association of Medical Laboratory Technologists
Engineers and Scientists of California, IFPTE L.20
United Food and Commercial Workers Union, Western States Council
Analysis Prepared by : Sarah Huchel / B. & P. / (916) 319-3301