BILL ANALYSIS �
SB 289
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Date of Hearing: July 3, 2012
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Mary Hayashi, Chair
SB 289 (Hernandez) - As Amended: June 19, 2012
SENATE VOTE : 36-2
SUBJECT : Clinical laboratory techniques: training and
instruction.
SUMMARY : Allows the Department of Public Health (DPH) to
approve additional providers of clinical laboratory instruction.
Specifically, this bill :
1)Allows DPH to approve any of the following to provide
instruction in clinical laboratory technic which in DPH's
judgment will adequately prepare individuals to meet the
requirements for licensure or performance of duties under laws
and DPH regulations governing clinical laboratory technology:
a) A California licensed clinical laboratory;
b) An accredited United States (U.S.) college or
university;
c) A U.S. military medical laboratory specialist program of
at least 52 weeks in duration; or,
d) A laboratory owned and operated by the U.S. government.
2)Prohibits a college or university holding valid accreditation
by the National Accrediting Agency for Clinical Laboratory
Sciences (NAACLS) that meets the requirements of 1), above,
from being required to obtain separate approval for a clinical
training site, provided that the clinical training site has
obtained certification under the federal Clinical Laboratory
Improvement Amendments of 1988 (CLIA), as specified.
3)Defines a clinical training site as any place, establishment,
or institution used by a DPH-approved program for the training
of clinical laboratory scientists (CLS) or limited CLS to
conduct training or instruction of licensed trainees or
phlebotomy students in clinical laboratory practice,
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techniques, theory or other training, as specified.
4)Revises and recasts existing definitions and makes other
technical, non-substantive and clarifying changes.
EXISTING LAW :
1)Provides for the licensure and regulation of clinical
laboratories and their personnel by DPH under the Laboratory
Field Services (LFS).
2)Authorizes DPH to approve schools seeking to provide
instruction in clinical laboratory technic which in the
judgment of DPH will provide instruction adequate to
prepare individuals to meet the requirements for
licensure or performance of duties, as specified.
Requires DPH to establish by regulation the ratio of
licensed clinical scientists to licensed trainees on the
staff of the laboratory approved as a school and the
minimum requirements for training in any specialty or in
the entire field of clinical laboratory science or
practice.
3)Authorizes DPH to approve schools that are accredited by
NAACLS.
4)Provides that it is unlawful for any person to operate a
school or conduct any course for the purpose of training
or preparing persons to perform duties, as specified,
without approval by DPH.
5)Establishes educational and examination requirements for
a number of clinical lab personnel, including CLS and
limited CLS licensees and trainees and a variety of CLS
sub-specialties.
6)Establishes CLIA under federal law, which regulates clinical
laboratories that perform tests on human specimens and sets
standards for facility administration, personnel
qualifications and quality control. These standards apply to
all settings, including commercial, hospital or physician
office laboratories.
FISCAL EFFECT : Unknown
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COMMENTS :
Purpose of this bill . According to the author, "In order to be
trained as a CLS in California, the LFS has interpreted its
regulations for the past 40 years to mean that the 50-week CLS
training program be undertaken at a single site, usually a
hospital or a biotech lab. A CLS training program is costly for
the host institution, running anywhere from $55,000 to $110,000
a year per student. Thus, running a CLS training program can be
quite prohibitive for an institution to undertake.
"SB 289 would broaden the definition of an approved training
site, and allow an institution of higher education to be an
approved training entity for a CLS training program. Please
note that the students would not train at the institution of
higher education; rather, (the bill) would allow the institution
to act as the central administrator by coordinating the 50-week
program among different hospitals/labs.
"Schools (that) offer CLS programs include California State
University (CSU), San Francisco, CSU San Jose, CSU Dominguez
Hills, CSU, Los Angeles, University of California, Irvine, and
University of Southern California. Under SB 289, the program
coordinators at these schools would be able to work with various
hospitals and labs in the region to build a consortium of sites
willing to train students for varying periods of time. This
would allow various hospitals/labs to share in the cost of the
program while not compromising quality or content, resulting in
more entities willing to be a CLS training site."
Background . A CLS is an integral part of health care delivery
and conducts a wide range of diagnostic assessments, from blood
tests to genetic testing, in order to assist physicians in
diagnosing illness and determining treatment plans.
According to the author, current regulations, promulgated in the
1970s, require DPH-approved CLS training sites or entities to be
a laboratory where the clinical experience takes place. This
law has been interpreted by DPH to preclude an institution of
higher learning from being an approved training entity. This
has limited CLS training capacity in California because it
prevents many smaller labs and hospitals (such as rural
hospitals) from participating in training.
The California Hospital Association estimates that the lack of
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CLS is one of the top vacancy problems in the state for
non-nursing health care professions. According to the U.S.
Bureau of Labor Statistics, between now and 2018, California is
projected to have 510 CLS openings annually due to growth and
job separations. This number is particularly sobering when
compared to the annual number of CLS graduates in the state
(approximately 110 - 130).
California clinical laboratories are subject to both federal and
state oversight. Federal oversight is stipulated in CLIA, which
is administered by the Centers for Medicare and Medicaid
Services within the U.S. Department of Health and Human
Services. CLIA regulates clinical labs based on the complexity
of tests the lab offers.
"Waived" tests are approved by the Food and Drug Administration
(FDA) for home use, use simple and accurate methods that make
the possibility of error negligible, or pose no significant risk
of harm to the patient if incorrectly performed. Clinical labs
performing only "waived" tests must register with the CLIA
program, pay biennial certificate fees, allow inspections, and
perform tests according to manufacturers' instructions.
"Moderate" or "high" tests, which are more complex, may be
performed by clinical labs that pay higher fees, undergo
biennial inspections, and meet tougher standards for personnel,
supervision, quality assurance and proficiency testing.
DPH regulates about 19,000 clinical labs and their personnel
statewide, monitors proficiency testing, investigates
complaints, and sanctions labs that violate the law or
regulations. In accordance with CLIA, DPH licenses or registers
clinical labs according to the complexity of testing they
perform. Labs must be licensed for moderately or highly complex
procedures, and registered for low complexity. About 3,000
clinical labs are licensed for moderate and/or high complexity
testing. The remaining are registered labs performing waived
tests and/or provider-performed microscopy.
DPH has authority to approve schools seeking to provide
instruction in clinical laboratory techniques to meet CLS
licensure requirements. According to regulations, any person
operating a school or conducting any course for CLS must comply
with DPH's personnel, equipment, quality of instruction, and
scope of activities requirements. A training school can only
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accept a person licensed for training in clinical laboratory
procedures if there are on active duty in the laboratory a
minimum of two full-time actively employed persons who possess
any of the following licenses: clinical laboratory technologist;
clinical laboratory bioanalyst; physician and surgeon; or, an
appropriate laboratory specialty. The ratio of clinical
laboratory personnel to trainees is no less than 2:1.
Regulations also specify the minimum requirements necessary for
approval of a laboratory to employ clinical laboratory
technologist trainees, including: necessary equipment, as
specified; workload requirements; and, 52 weeks of practical
training, including biochemistry, hematology, pre-transfusion
procedures, urinalysis, bacteriology, serology, and
parasitology. Colleges or universities accredited by the
Western College Association or the Northwest Association of
Secondary and Higher Schools or an essentially equivalent
accrediting agency, as determined by DPH, that conduct CLS
training courses must be approved by DPH. However, when
training is carried out in cooperation with laboratories other
than those of the institution, specific approval must be
obtained from DPH. Regulations also specify the timeframes for
DPH to approve training programs and to process applications for
renewals.
This bill specifies that a college or university accredited by
NAACLS for clinical laboratory sciences is not required to
obtain separate approval for a clinical training site, if the
site is certified under CLIA. According to its Web site, NAACLS
accredits and approves education programs in clinical laboratory
sciences and related health care professions, including those
that offer a clinical doctorate in clinical laboratory science,
medical laboratory scientist, medical laboratory technician,
histotechnologist, histotechnician, diagnostic molecular
scientist, cytogenetic technologist, and pathologists'
assistant. NAACLS also independently approves phlebotomist and
clinical assistant educational programs. NAACLS is recognized
by the Council for Higher Education Accreditation.
Support . The Blood Centers of California writes, "As health
care providers, we have been affected by the shortage of various
licensed health care providers in California. We have
particularly been hard hit by the shortage of CLS over the last
five or more years. CLS hired by blood centers have to meet a
higher standard because of the high complexity and sophisticated
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testing required to assure the safety of the blood supply. We
can only employ the generalist CLS with additional blood banking
training and/or the CLS with a specialty (limited) license in
immunohematology and hematology. It also should be noted (that)
blood centers cannot employ a CLS trainee; all potential CLS
blood laboratory candidates must have a current CLS license in
good standing.
"To that end, three of our hospital blood centers have
established clinical training programs to 'grow our own' by
collaborating with university programs and local government
programs. We are gradually increasing the numbers of candidates
that meet the strong state and national requirements for blood
banking. We believe an expansion of the facilities approved as
clinical training sites is critical."
Opposition . The California Association for Medical Laboratory
Technology states, "This bill fails to recognize the strength of
the state certifying programs, and that all the CLS training
programs in California accredited by LFS should benefit from the
proposed streamlining.
"LFS has rigorous standards that meet or exceed the NAACLS. LFS
state approved programs should not be discriminated against if
they are not NAACLS approved. Therefore, we believe the bill
should be amended to state that all state approved programs
should be free to determine their CLS training sites without the
duplicate paperwork that is currently required. We agree that
steps should be taken to address the clinical laboratory
shortage and also concur that the current system for clinical
laboratory training is too cumbersome and would benefit from
streamlining, but in a manner that is equally fair to both
NAACLS approved and non-approved colleges and universities.
Further, clinical laboratory training must be in LFS approved
California licensed labs, whether NAACLS approved or not. The
choice of the clinical training site should be up to the state
approved program."
Related legislation . AB 2214 (Monning) of 2012 requires, among
other provisions, the California Workforce Investment Board,
until January 1, 2019, to establish a special committee known as
the Health Workforce Development Council to help expand the
state's health workforce in order to provide access to quality
health care for all Californians. This bill is pending in
Senate Health Committee.
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SB 1481 (Negrete McLeod) of 2012 exempts community pharmacies
performing only specified waived tests from state law governing
the licensure and regulation of clinical laboratories. This
bill is pending in Assembly Health Committee.
Previous legislation . AB 761 (Roger Hern�ndez) of 2011 allows
optometrists to independently perform waived clinical laboratory
tests if the results can be used within the optometrist's scope
of practice, as specified. This bill was held in Assembly
Business, Professions and Consumer Protection Committee.
AB 1328 (Pan) of 2011 allows DPH to issue a CLS license to an
applicant who completes at least two years of full-time
employment as a CLS at a CLIA certified laboratory, who
possesses a baccalaureate or an equivalent or higher degree from
an accredited institution, and who passes a national examination
approved by DPH, subject to the payment of a licensing fee.
This bill was held in Assembly Business, Professions and
Consumer Protection Committee.
SB 1246 (Negrete McLeod), Chapter 523, Statutes of 2010,
includes naturopathic doctors in the list of health care
practitioners who can perform a clinical laboratory test or
examination classified as waived under CLIA, and designates
naturopathic doctors as clinical laboratory directors for CLIA
waived tests only.
AB 1442 (Feuer) of 2007 requires clinical laboratories that
perform tests for human immunodeficiency virus that are
classified as waived under CLIA to enroll in a proficiency
testing program and to obtain the appropriate license or
registration from DPH, as specified. This bill was held on the
Assembly Floor.
AB 185 (Dymally) of 2007 expands the duties that unlicensed
personnel are authorized to perform in a clinical laboratory and
revises the levels of supervision required when unlicensed
personnel perform them. This bill was held in Assembly Business
and Professions Committee.
AB 1370 (Matthews) of 2005 includes a pharmacist within the
definition of laboratory director if the clinical laboratory
test or examination is a routine patient assessment procedure,
as defined. This bill was held in Assembly Business and
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Professions Committee.
AB 433 (Nava) of 2005 exempts physician office laboratories from
licensure and regulatory requirements governing clinical
laboratories and their personnel by DPH. This bill was held in
Assembly Health Committee.
SB 1174 (Polanco), Chapter 640, Statutes of 2001, exempts
certified emergency medical technicians and licensed paramedics
providing life support who perform only CLIA-waived blood
glucose tests from state law governing the licensure and
regulation of clinical laboratories, as specified.
Double referred . This bill is double-referred to Assembly
Health Committee.
REGISTERED SUPPORT / OPPOSITION :
Support
Blood Centers of California
Opposition
California Association for Medical Laboratory Technology
Analysis Prepared by : Angela Mapp / B.,P. & C.P. / (916)
319-3301