BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 289
AUTHOR: Hernandez
AMENDED: August 23, 2012
HEARING DATE: August 29, 2012
CONSULTANT: Rubin
PURSUANT TO SENATE RULE 29.10
SUBJECT : Clinical laboratory techniques: training and
instruction.
SUMMARY : Specifies the type of organization that may be
approved by the Department of Public Health (DPH) to provide
clinical laboratory scientist (CLS) programs, and permits
DPH-approved CLS programs to use multiple clinical laboratories
to provide training, as specified.
Existing law:
1.Establishes Laboratory Field Services within DPH to provide
for licensing and registration services for clinical
laboratories and clinical laboratory licensees, as specified.
2.Authorizes DPH to approve schools seeking to provide
instruction in clinical laboratory technique, 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. Requires that applications for approval
be made on forms provided by DPH.
3.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
first having secured the approval of the DPH.
4.Establishes in federal law, the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), to regulate
laboratories that perform testing on human specimens,
including the provision of laboratory standards for
Continued---
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proficiency testing, facility administration, personnel
qualifications, and quality control. Applies standards to all
settings, including commercial, hospital, or physician office
laboratories.
This bill:
1.Permits DPH to approve the following entities to provide
instruction in clinical laboratory technique, as specified:
a. A California licensed clinical laboratory;
b. An accredited college or university in the United States
(U.S.);
c. A U.S. military medical laboratory specialist program of
at least 52 weeks duration; and,
d. A laboratory owned and operated by the U.S. government.
2.Permits CLS programs, upon approval by DPH, to use multiple
clinical laboratories to provide training in clinical
laboratory technique, provided:
a. The program is permitted to apportion the clinical
training among multiple clinical laboratories in any
percentage as long as the total training meets the
requirements established by DPH.
b. Each clinical laboratory has been approved by DPH as
part of the program in accordance with regulations. The
program notifies DPH in writing within 30 days of a change
in clinical laboratories used by the program to provide
training.
c. The director of the approved program is responsible for
notifying DPH in advance of the start and end date of
training for each trainee. The program coordinates with DPH
in meeting established requirements.
d. The director of the approved program ensures that all of
DPH's requirements for training and affiliation are met.
e. The program has submitted an application on forms
provided by DPH for approval.
1.Revises and reorganizes existing definitions and makes other
technical, non-substantive, and conforming changes.
FISCAL EFFECT : According to the Assembly Appropriations
Committee analysis, negligible state fiscal effect.
PRIOR ACTIONS :
Assembly Business, Professions and Consumer Protection:8-0
Assembly Health: 16-0
Assembly Appropriations: 17-0
SB 289 | Page
3
Assembly Floor: 80-0
COMMENTS :
1.Author's statement. SB 289 would clarify that an institution
can coordinate the 50-week CLS training period among different
clinical sites. Historically, the 50-week course has been
completed at one site, and regulations governing this area are
frustratingly vague. This bill allows flexibility among
participating laboratories, and a more equitable sharing of
costs associated with the CLS training program, resulting in
more CLSs in the workplace.
2.The CLS profession. According to an April 2007 report by the
Health Workforce Tracking Collaborative, clinical laboratory
science refers to a range of complex laboratory tests and
procedures that involve knowledge of chemistry, biology,
microbiology, molecular biology, hematology, immunology,
toxicology, histology, and cytogenetics. The CLS is a
generalist, qualified to conduct necessary tests and
procedures across this entire range of specialized areas. A
February 2011 report by the California Hospital Association,
(CHA) titled Critical Roles: California's Allied Health
Workforce (CHA Report), describes CLSs as an integral part of
the health care team whose diagnostic assessments help
physicians determine treatment plans.
3.CLS training program approval. DPH has the authority to
approve schools seeking to provide instruction in clinical
laboratory technique, and has issued regulations specifying
criteria that schools must meet to gain approval. The
regulations specify that a training school must have a minimum
of two full-time actively employed persons licensed as a CLT,
clinical laboratory bioanalyst, physician and surgeon, or
appropriate laboratory specialty; and a ratio of clinical
laboratory personnel to trainees of 2-to-1 or greater.
Furthermore, the minimum requirements for approval of
laboratories to employ CLS trainees include: adequate space
and necessary equipment; workload requirements; and 52 weeks
of training apportioned among biochemistry, hematology,
pretransfusion procedures, urinalysis, bacteriology, serology,
parasitology, miscellaneous topics, and review. Colleges or
universities accredited by the Western College Association or
the Northwest Association of Secondary and Higher Schools or
an essentially equivalent accrediting agency conducting CLS
training courses are considered approved by DPH, although
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specific approval is required when training is carried out in
cooperation with laboratories that do not meet these
accrediting criteria.
4.CLS shortage and impact. According to the CHA Report, a
survey of CHA-member hospitals conducted in 2010 revealed that
the top long-term concern of respondents was the aging
workforce. Of the 14 occupations included in the survey, CLS
had the highest average employee age and the greatest number
of employees eligible for retirement. According to the CHA
Report, 844 CLSs were projected to be eligible for retirement
between 2010 and 2015, representing nearly one-third of the
number of CLS full-time equivalents reported by respondents.
In comparison, California currently only graduates
approximately 125 CLSs annually.
The Health Workforce Development Council (HWDC), a
Sub-Committee of the California Workforce Investment Board,
assessed the future need for CLAs and the impact of CLA
shortages in its September 2011 Final Report (HWDC Report).
According to the report, the current and projected future
shortage of CLSs has wide-ranging impacts on the delivery of
primary care. In particular, the shortage results in decreased
in-house capacity which leads to increased costs for
hospitals. These higher costs manifest in many ways,
including: increased costs for recruitment of new CLSs; the
costs of sending tests to external laboratories when demand
exceeds in-house processing capacity; testing delays;
increased errors such as mislabeling of specimens and
conducting incorrect tests; and, increased cost for California
as lab work is sent to out-of-state processing centers.
5.Education and training capacity for CLSs. The HWDC Report
assessed the educational capacity for CLSs in California to be
of significant concern. The HWDC Report identified 13 programs
operating in California: four based in academic institutions
and nine in hospitals. In comparison, Texas has a population
that is two-thirds the size of California's, but has twice as
many training programs that produce five times as many
graduates; Michigan has half the population of California but
has 12 training programs that produce three times as many
graduates. The HWDC Report cites as reasons for the paucity of
training sites: long approval time from the state; program
requirements that are so prescriptive that the application is
a deterrent for sites to consider offering spaces to students;
staffs stretched thin even when training is just for the
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clinical portion; substantial cost to the organization to
train CLSs; and the inability of many smaller labs to offer
training programs because they offer a limited scope of
services, thus rendering them unqualified to offer training
slots even for those services they do provide. According to
the author, each CLS trainee costs between $55,000 and
$110,000 a year.
6.Related legislation. AB 2214 (Monning), among other
provisions, would have required clinical laboratory licensees,
as specified, to report practice status to DPH upon issuance
and renewal of license. AB 2214 was held on suspense in the
Senate Appropriations Committee.
7.Support. CHA states that the shortage of CLSs is one of the
most pressing workforce issues currently facing hospitals and
other certified clinical laboratories, and that the number of
CLSs pending retirement in California indicates and immediate
risk in the next three years. According to CHA, smaller labs,
especially in rural areas, may be inclined to train CLS
students, but do not have the resources to take on obligations
of being an approved "training entity" under current law.
Giving DPH the authority to approve CLS training programs that
use a consortium model, but do not require one site to take on
the majority of the training, will allow multiple hospitals to
work together to provide portions of clinical experience,
thereby sharing the responsibility and significant costs of
training. The Blood Centers of California (BCC) indicates that
it has been affected by the shortage of various licensed
health care providers in California, but particularly hard hit
by the shortage of CLSs over the last five or more years. BCC
adds that CLSs hired by blood centers have to meet a high
standard because of the high complexity and sophisticated
testing required to assure the safety of the blood supply.
8.Support if amended. The California Clinical Laboratory
Association (CCLA) proposes an amendment that, if taken and in
the event that California is granted exemption from CLIA,
would allow qualified non-doctoral persons to serve as
directors of clinical and public health laboratories
performing high complexity testing, as categorized under CLIA,
if they are licensed to direct those laboratories under
California law. CCLA states that this amendment would, among
other effects, help to decrease health care spending, ensure
adequate local public health laboratory support for response
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to communicable disease events, and ensure an adequate supply
of local public health laboratory directors.
SUPPORT AND OPPOSITION :
Support: Blood Centers of California
California Hospital Association
Oppose: None received.
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