BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 599|
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THIRD READING
Bill No: AB 599
Author: Bonilla (D)
Amended: 5/28/15 in Senate
Vote: 21
SENATE BUS, PROF. & ECON. DEV. COMMITTEE: 9-0, 6/8/15
AYES: Hill, Bates, Berryhill, Block, Galgiani, Hernandez,
Jackson, Mendoza, Wieckowski
SENATE APPROPRIATIONS COMMITTEE: 6-0, 6/22/15
AYES: Lara, Bates, Beall, Hill, Leyva, Mendoza
NO VOTE RECORDED: Nielsen
ASSEMBLY FLOOR: 77-0, 4/30/15 (Consent) - See last page for
vote
SUBJECT: Clinical laboratories: cytotechnologists
SOURCE: California Association of Cytotechnologists
California Society of Pathologists
DIGEST: This bill 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.
ANALYSIS:
Existing law:
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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)
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.
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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
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.
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Background
Cytotechnology and Cytotechnologists. Cytotechnology is the
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, eight
semester hours of chemistry, and three 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.
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
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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 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."
FISCAL EFFECT: Appropriation: No Fiscal
Com.:YesLocal: No
According to the Senate Appropriations Committee:
One-time costs of about $120,000 per year for two years to
develop and adopt regulations regarding training standards and
the scope of practice for cytotechnologists by the DPH
(Clinical Laboratory Improvement Fund). Those costs will be
covered by licensing fee revenues.
Minor ongoing costs to license cytotechnologists and enforce
the revised standards by the DPH (Clinical Laboratory
Improvement Fund).
SUPPORT: (Verified6/24/15)
California Association of Cytotechnologists (co-source)
California Society of Pathologists (co-source)
American Society for Clinical Pathology
American Society of Cytopathology
California Clinical Laboratory Association
California Hospital Association
Numerous individuals
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OPPOSITION: (Verified6/24/15)
Engineers and Scientists of California
ARGUMENTS IN SUPPORT: The California Association of
Cytotechnologists write, "The current regulations [governing the
practice of cytotechnologists] were adopted in 1991. Since that
time, 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."
ARGUMENTS IN OPPOSITION: The Engineers and Scientists of
California express concerns that "AB 599 may have unintended
negative patient impacts. While some recently licensed
cytotechnologists may have the requisite education to have this
expanded scope of practice, the bill does not contain any
requirements that would ensure that the proper education and
training has occurred?. At the very least, the bill should be
amended to apply to only those who meet the 2013 education
standards."
ASSEMBLY FLOOR: 77-0, 4/30/15
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AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom,
Bonilla, Bonta, Brough, Brown, Burke, Calderon, Chang, Chau,
Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd,
Eggman, Frazier, Beth Gaines, Gallagher, Cristina Garcia,
Eduardo Garcia, Gatto, Gipson, Gonzalez, Gordon, Gray, Grove,
Hadley, Harper, Roger Hernández, Holden, Irwin, Jones,
Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low,
Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin,
Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Perea,
Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas, Santiago,
Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber,
Wilk, Williams, Wood, Atkins
NO VOTE RECORDED: Campos, Chávez, Gomez
Prepared by:Sarah Huchel / B., P. & E.D. / (916) 651-4104
6/24/15 16:24:15
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