BILL ANALYSIS Ó
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: AB 599 Hearing Date: June 8,
2015
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|Author: |Bonilla |
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|Version: |May 28, 2015 |
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|Urgency: |No |Fiscal: |Yes |
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|Consultant|Sarah Huchel |
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Subject: Clinical laboratories: cytotechnologists.
SUMMARY: Expands the scope of practice for a licensed cytotechnologist
by authorizing the performance of all tests and procedures
pertaining to cytology under the supervision of a laboratory
director.
Existing law:
1)Provides for the licensure, registration, and regulation of
clinical laboratories and various clinical laboratory
personnel, including cytotechnologists, by the California
Department of Public Health (DPH). (Business and Professions
Code (BPC) §§ 1200-1327)
2)Requires DPH to adopt regulations identifying the
modification, education, training, and examination necessary
whenever it determines that the specialties or subspecialties
authorized under an existing license category should be
modified. (BPC § 1208 (a))
3)Defines cytological slides as cellular materials submitted for
preliminary cytologic examination. (BPC § 1211.5)
4)Prohibits a person from performing examinations of cytological
slides unless he or she has either a cytotechnologist license
issued by the DPH or a valid physician's and surgeon's
certificate. (BPC § 1270)
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5)Establishes conditions that laboratories must meet for
certification to perform testing on human specimens under
Clinical Laboratory Improvement Amendments (CLIA). (Title 42,
Code of Federal Regulations (CFR) § 493.1)
6)Requires that all cytology slide preparations to be evaluated
on the premises of a laboratory certified to conduct testing
in the subspecialty of cytology and requires the laboratories
to establish written policies and procedures for staining,
error controls, workload limits, slide retention, automated
and semi-automated screening devices, and documentation. (42
CFR § 493.1274)
7)Requires a cytotechnologist to document:
a) The slide interpretation results of each gynecologic and
nongynecologic cytology case he or she examined or
reviewed.
b) For each 24-hour period, the total number of slides
examined or reviewed in the laboratory as well as the total
number of slides examined or reviewed in any other
laboratory or for any other employer.
c) The number of hours spent examining slides in each
24-hour period.
(42 CFR § 493.1485)
8)Requires a lab to establish and follow written policies and
procedures for a program designed to detect errors in the
performance of cytologic examinations and the reporting of
results. (42 CFR 493.1274 (c))
9)Requires a lab to establish and follow written policies and
procedures that ensure that the technical supervisor
establishes a maximum workload limit for each individual who
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performs primary screening, and reassesses each individual's
workload limit at least every six months and adjust when
necessary.
(42 CFR 493.1274 (d))
10)Requires the DPH to establish standards for the evaluation of
cytological slides and for reporting the adequacy of
cytological slides. (BPC § 1272.4)
This bill:
1) Authorizes a licensed cytotechnologist to perform all tests
and procedures pertaining to cytology, including, but not
limited to, microscopic and nonmicroscopic methodologies and
tests and procedures that utilize molecular or genetic
methodologies that are performed on cytologic specimens
related to infectious disease or cancer diagnosis, under the
overall operation and administration of a laboratory
director.
2) Makes technical and clarifying changes.
FISCAL
EFFECT: This measure is keyed "fiscal" by Legislative Counsel.
According to the Assembly Appropriations Analysis dated April
22, 2015, there are costs to promulgate regulations to the DPH
of $115,000 per year for two years (Clinical Laboratory
Improvement Fund, which is supported by license fees). Ongoing
costs are projected to be minor and absorbable.
COMMENTS:
1.Purpose. This bill is sponsored by the California Society of
Pathologists and California Association of Cytotechnologists .
According to the Author's office, this bill
"updates the scope of practice for cytotechnologists to allow
them to perform all tests and procedures pertaining to
cytology, including microscopic and nonmicroscopic. Current
statute refers to procedures performed on 'slides' which
limits the type of tests a cytotechnologist can perform. New
technological advances have resulted in non-slide based tests
and techniques. Although not slide-based, these new tests
and techniques are still cytological in purview."
2.Cytotechnology and Cytotechnologists. Cytotechnology is the
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microscopic study of cells for evidence of disease, such as
cancer. Many other conditions, including viral and bacterial
infections, also are identified using cytological techniques.
The field is perhaps best known for the Pap test, an
evaluation of cells from the uterine cervix, but
cytotechnology techniques can identify precancerous or cancer
cells in virtually any area of the body.
Cytotechnologists are licensed by Laboratory Field Services, a
division of the DPH. To qualify for licensure, an applicant
must have a baccalaureate degree from an accredited college or
university, with 20 semester hours of biological science, 8
semester hours of chemistry, and 3 semester hours of math;
complete a 12 month accredited cytotechnology program; and
pass the American Society for Clinical Pathology Board of
Registry examination in cytology. There are approximately 800
licensed cytotechnologists in California.
Cytotechnologists typically work in hospital laboratories,
universities, and private laboratories and perform processing
and microscopic review of various sample types to identify
pathologic conditions, particularly cancer. The primary
cytotechnologist workload is review of cervical smears (Pap
test) to detect cervical cancer. Cytotechnologists work under
the supervision of a laboratory director.
3.Scope of Practice. Current law limits the type of tests a
cytotechnologist can perform because the underlying statute
authorizing their scope refers to "slides." New technological
advances have resulted in non-slide based tests and
techniques, which are currently prohibited. Statutes related
to the scope of practice for a cytotechnologist have not been
updated since 1991.
According to the Author, statutory limitations on practice are
causing cytotechnologists to leave the state. "California has
only two approved cytotechnology training programs, University
of California and Loma Linda University (LLU), and both of
them have pared back substantially their programs in recent
years. In fact, LLU currently has no enrolled students.
Moreover, it is our understanding that many of these program's
recent graduates are now following their colleagues in seeking
careers outside of California. This workforce pipeline
setback is compounded by a recruitment problem faced by
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California laboratories in that the flawed state law makes it
very difficult to license laboratory professionals trained in
other states."
While current law requires the DPH to adopt regulations
whenever it determines that the specialties or subspecialties
authorized under an existing license category should be
modified, the Author states that an effort to update
cytotechnologist regulations has been stalled for more than
four years. Additionally, it is unclear whether regulations
would be sufficient to change a cytotechnologist's duties
because the authorizing statute refers specifically to
"slides."
4.Previous Legislation. AB 1215 (Gomez), Chapter 199, Statutes
of 2013, expanded the definition of "laboratory director" for
purposes of a clinical laboratory test or examination
classified as waived to include a duly licensed clinical
laboratory scientist and a duly licensed limited clinical
laboratory scientist.
AB 1328 (Pan) of 2011 would have authorized the DPH to issue a
clinical laboratory scientist's license to an applicant who
completes at least 2 years of full-time employment as a
clinical laboratory scientist 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 the department, subject to
the payment of the requisite licensing fee. ( Status : This
bill failed passage in the Senate Committee on Business,
Professions and Economic Development.)
AB 1370 (Matthews) of 2005 would have included a pharmacist
within the definition of laboratory director if the clinical
laboratory test or examination is a routine patient assessment
procedure, as defined. ( Status : This bill died pursuant to
Art. IV, Sec. 10(c) of the Constitution.)
5.Arguments in Support. The California Association of
Cytotechnologists write,
"The current regulations [governing the practice of
cytotechnologists] were adopted in 1991. Since that time,
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dramatic advances in medicine and indeed cytopathology have
taken place. HPV testing, which accompanies Pap smear testing
has become the standard of care for cervical cancer
surveillance. Fluorescent in situ hybridization (FISH) and
other molecular prognostic laboratory tests are rapidly
developing. The cytotechnology programs across the country
have also changed their curriculum to teach these new
technologies. Unfortunately, these outdated regulations have
crippled the cytotechnology community in California, leading
to a loss of talented educated cytotechnologists."
The California Hospital Association writes, "[Existing law] is
exacerbating an existing laboratory personnel workforce
shortage as many cytotechnologists trained in California are
moving out of state where they can practice to the full extent
of their education and training. In addition, in order to
comply with this antiquated state statute, laboratories are
sending tissues out of state to be tested. Valuable health
care personnel and services are being driven out of
California, even though cytotechnologist's education and
training in California schools includes these testing
techniques."
6.Arguments in Opposition. A group of clinical cytogenetic
scientists and clinical genetic molecular biologist scientists
write, "The language of AB 599 is too broad. Cytology should
continue doing cytology testing needed for their assays and
using other techniques such as FISH and PCR to help them with
their assessment of those specimens. ?We are very concerned
with the broad verbiage in this bill regarding FISH and PCR
assays, given that there are designated California licensed
personnel who already are performing these technologies under
their subspecialty."
SUPPORT AND OPPOSITION:
Support:
California Association of Cytotechnologists (Sponsor)
California Society of Pathologists (Sponsor)
American Society for Clinical Pathology
American Society of Cytopathology
California Clinical Laboratory Association
California Hospital Association
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Numerous individuals
Opposition:
Engineers and Scientists of California
Numerous individuals
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