BILL ANALYSIS
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|Hearing Date:June 28, 2010 |Bill No:AB |
| |549 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Gloria Negrete McLeod, Chair
Bill No: AB 549Author:Furutani
As Amended:June 17, 2010 Fiscal: Yes
SUBJECT: Healing arts: Licensure: clinical laboratory personnel.
SUMMARY: Includes clinical biochemical geneticist in the list of
clinical laboratory personnel that are eligible for licensure by the
Department of Public Health (DPH). 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. Requires DPH to adopt emergency regulations
creating a trainee license category, as specified.
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 the Department of Public Health (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
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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 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
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and used for the purpose of licensing, registration,
certification, inspection, or other activities relating to the
regulation of clinical laboratories.
This bill:
1) Includes clinical biochemical geneticist in the list of clinical
laboratory personnel that are eligible for licensure by the DPH to
engage in, supervise others, or direct a clinical laboratory
practice, as specified.
2) Defines biochemical genetics as the techniques used to analyze
human proteins and certain metabolites from physiological samples
for the primary purpose of detecting inborn errors of metabolism,
heritable genotypes or gene products of genetic variations or
mutations for clinical purposes that include, but are not limited
to, the use of these test results to aid in the evaluation and
diagnosis of patients, predicting risk of disease, identifying
carriers, and establishing prenatal or clinical diagnoses or
prognoses in individuals, families, and populations.
3) Requires DPH, within 30 days of receiving a completed application,
to issue a temporary license to any applicant seeking licensure as
a histocompatibility laboratory director, clinical chemist,
microbiologist, toxicologist, molecular biologist, cytogeneticist,
or biochemical geneticist, provided that the applicant meets the
following requirements:
a) The applicant has at least two years of experience as a
histocompatibility laboratory director in another state or in
Canada.
b) The applicant has board certification from the American
Board of Histocompatibility and Immunogenetics.
4) States that a temporary license issued pursuant to item # 3) above,
shall remain valid until DPH completes evaluating and processing
the applicant's completed application, the applicant has passed any
required examinations, 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.
5) Requires DPH, no later than April 1, 2011, to adopt emergency
regulations creating a trainee license in the following licensed
categories: clinical chemistry, clinical microbiology, clinical
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toxicology, clinical molecular biology, clinical biochemical
genetics, and clinical cytogenetics, and as a clinical
histocompatibility and immunology laboratory director. States that
the adoption of these emergency regulations shall be considered by
the Office of Administrative Law to be necessary to avoid serious
harm to the public health, safety, or general welfare.
6) States that the trainee license for the personnel specified in item
# 5) 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 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.
7) 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.
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.
8) 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.
9) Requires DPH, within 30 calendar days 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
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been received by the department.
10)Requires DPH to process each completed application within 90
calendar days following receipt of the completed application.
11)States that an applicant for licensure in clinical laboratory
practice shall be eligible for any required examinations upon
notification by DPH that the applicant's application has been
approved. Provides that an applicant shall be eligible for the
required examinations for 180 calendar days following the date
eligibility begins. Requires that eligibility be extended for an
additional 180 calendar days if a required examination has not been
offered or scheduled by DPH within the original 180-day period.
12)Applies existing laboratory personnel application and renewal fees
($63) to biochemical geneticists.
13)Makes other technical, non-substantive changes.
FISCAL EFFECT: According to the Assembly Appropriations Committee:
1)Absorbable one-time fee-supported special fund costs to amend
current law regulations to accommodate 30 professionals statewide
who may become licensed in this highly specialized field.
2)Unknown, likely absorbable one-time fee-supported special fund costs
for DPH to establish confirmation of employment experience by
national accrediting bodies.
COMMENTS:
1. Purpose. According to the City of Hope , the Sponsor of this
measure, 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. Lastly, the City of Hope points out that
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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.
2. Background.
a) 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.
b) 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 facilities.
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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.
c) 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 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.
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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.
3. Prior Legislation. 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.
4. Arguments in Support. Cedars Sinai Health System indicates that
this legislation is designed to overcome some of the roadblocks and
oversights in existing regulation and allow many qualified
individuals to obtain appropriate clinical laboratory licenses in
California.
5. Author's Technical Amendments. The Author would like to amend this
bill, as follows: On page 12, line 8, delete "accrediting" and
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"CLIA" and insert after recognized by "the federal HHS"
(2) The applicant has board certification from an appropriate
accrediting body recognized by CLIA the federal HHS in the area of
specialty or subspecialty for which he or she is seeking licensure.
6. Policy Issue . In light of the findings and recommendations of the
BSA audit, and the recent passage of SB 744 which was aimed at
improving DPH's responsibilities regarding inspecting laboratories,
monitoring testing results, and reviewing and investigating
complaints, will creating new laboratory licensure categories and
establishing strict timelines for the processing and approval of
laboratory personnel slow down DPH's efforts to improve oversight
of clinical laboratories?
SUPPORT AND OPPOSITION:
Support:
City of Hope (sponsor)
California Healthcare Institute
Cedars Sinai Health System
Opposition:
None on file as of June 21, 2010
Consultant:Rosielyn Pulmano