BILL ANALYSIS �
SB 289
Page 1
Date of Hearing: July 3, 2012
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
SB 289 (Ed Hernandez) - As Amended: June 19, 2012
SENATE VOTE : Not relevant.
SUBJECT : Clinical laboratory techniques: training and
instruction.
SUMMARY : Authorizes the Department of Public Health (DPH) to
approve a clinical training site seeking to provide instruction
in clinical laboratory techniques which in the judgment of DPH
will provide adequate instruction to prepare individuals to meet
the requirements for licensure or performance of duties, as
specified. Specifically, this bill :
1)Revises which clinical training sites DPH is authorized to
approve to provide instruction in clinical laboratory
techniques 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, to include any of the following:
a) A California licensed clinical laboratory;
b) An accredited college or university in the United States
of America (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)Exempts 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,
techniques, theory, or other training, as specified.
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4)Revises and recasts existing definitions and makes other
technical, non-substantive and clarifying changes.
EXISTING LAW :
1)Establishes within DPH the Laboratory Field Services
which provides 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
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, 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.
FISCAL EFFECT : This bill, as currently amended, has not been
analyzed by a fiscal committee.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, the California
Hospital Association estimates that the lack of clinical
laboratory scientists is one of the top vacancy problems in
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the State for non-nursing health care professions. A CLS is
an integral part of health care delivery, conducting 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 U.S. Bureau
of Labor and Statistics, between now and 2018 California is
projected to have 510 CLS openings annually due to growth and
job separations. Stakeholders argue that a key obstacle to
increasing the supply of CLS in the State is the insufficient
number and maldistribution of approved clinical training
sites.
2)BACKGROUND .
a) Approval of Clinical Laboratory Training Programs . DPH
is granted the authority to approve schools seeking to
provide instruction in clinical laboratory technique to
meet 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 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
licensees: clinical laboratory technologist; clinical
laboratory bioanalyst; physician and surgeon; or,
appropriate laboratory specialty. The ratio of clinical
laboratory personnel to trainees is no less than 2:1.
Regulations also specify minimum requirements for approval
of a laboratory to employ clinical laboratory technologist
trainees, including: necessary equipment; workload
requirements; and, 52 weeks of practical training in the
areas of biochemistry, hematology, pretransfusion
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, conducting
courses for the training of CLS also required to be
approved by DPH. According to DPH, it has approved 92 CLS
programs in California, over 100 phlebotomy training
programs, and 10 medical laboratory technician programs.
b) Shortage of CLS . According to the Center for the Health
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Professions report entitled "California's Health Care
Workforce: Readiness for the ACA Era," California's
employment of CLS has been stagnant since 2001, while
national CLS employment has grown 15%. California's per
capita supply of CLS is much lower than the nation's; 35
CLS per 100,000 population in California compared to 54.4
per 100,000 in the US overall. From 1980 to 2005, the
number of CLS licensure candidates dropped from 2,515 to
724. The report also states that California's hospitals
are concerned about the supply of clinical lab
professionals, as vacancies in these areas have a
significant impact on care delivery and hospital
efficiency.
According to a California Hospital Association (CHA) policy
paper, current law that was adopted in the 1970s requires
hospital laboratories to be individually approved by DPH to
train CLS students for licensure. This approval is in
addition to required federal certification under CLIA that
ensures the accuracy and reliability of all laboratory
testing. This state approval requirement, the paper points
out prevents educational programs from using a training
consortium that allows federally certified laboratories to
come together to provide a portion of the required clinical
training to students. This has limited CLS training
program capacity because it prevents many smaller
laboratories from participating in training. Smaller labs,
especially in rural areas, may be inclined to train CLS
students, but do not have the resources to take on the
obligations of being an approved training entity.
c) National Accrediting Agency for Clinical Laboratory
Sciences . This bill specifies that a college or university
that holds valid accreditation by NAACLS for clinical
laboratory sciences will not be required to obtain separate
approval for a clinical training site provided that the
site has a certification under CLIA. According to its
website, NAACLS accredits and approves education programs
in clinical laboratory sciences and related health care
professions.
According to DPH, NAACLS standards are less rigorous than
training required under existing regulations, including:
i) CLS programs approved in California require one year
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of practical training. NAACLS does not specify the
length of the program and currently some NAACLS CLS
training programs are as short as 16 weeks;
ii) CLS programs approved in California require a
specified number of weeks in each major area of the
clinical laboratory. NAACLS programs for CLS do not
specify the period of time spent in each area of the
clinical laboratory;
iii) Current regulations specify a ratio of licensed
personnel to trainee of 2:1. NAACLS does not have a
specified ratio;
iv) Existing regulations specify a minimum number of
California licensed persons on duty in the laboratory.
NAACLS does not specify that California licensed persons
must be on duty in the laboratory;
v) California regulations specify that the teaching
staff must have qualifications considered equivalent to
minimum for California licensure. NAACLS specifies that
they possess nationally recognized certification.
vi) NAACLS does not specify that the program director
must be licensed in California by DPH, only that he or
she possess a specific degree and hold nationally
recognized certification (not defined) as a medical
laboratory scientist/medical technologist.
vii) Existing regulations specify that DPH approves the
clinical training conducted in conjunction with a college
program. This bill allows NAACLS to approve the clinical
program.
3)SUPPORT . The California Hospital Association states that
giving DPH the authority to approve CLS training programs that
use the consortium model 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 believes that an expansion of
the facilities approved as clinical training sites is
critical.
4)OPPOSE UNLESS AMENDED . The California Association for Medical
Laboratory Technology (NAML) states that DPH has rigorous
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standards that meet or exceed NAACLS and state approved
programs should not be discriminated against if they are not
NAACLS approved. NAML states that this bill should be amended
to indicate that all state approved programs should be free to
determine their CLS training sites.
5)RELATED LEGISLATION . AB 2214 (Monning), among other
provisions, requires clinical laboratory licensees, as
specified, to report practice status to DPH upon issuance and
renewal of license. AB 2214 is pending in the Senate
Appropriations Committee.
6)DOUBLE REFERRAL . This bill is double referred and is
scheduled to be heard in the Assembly Business, Professions &
Consumer Protection Committee on July 3, 2012.
7)AUTHOR'S AMENDMENTS . In an effort to address concerns raised
by Committee staff and the opposition, the author has agreed
to amend this bill to delete the provisions relating to NAACLS
accreditation on page 8, lines 11 - 17.
REGISTERED SUPPORT / OPPOSITION :
Support
Blood Centers of California
California Hospital Association
California Society of Pathologists
Sharp HealthCare
Oppose Unless Amended
California Association for Medical Laboratory Technology
Analysis Prepared by : Rosielyn Pulmano / HEALTH / (916)
319-2097