BILL ANALYSIS Ó
AB 599
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Date of Hearing: April 14, 2015
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Susan Bonilla, Chair
AB 599
(Bonilla) - As Amended April 6, 2015
SUBJECT: Clinical laboratories: cytotechnologists.
SUMMARY: Authorizes a licensed cytotechnologist to perform all
tests and procedures pertaining to cytology.
EXISTING LAW
Federal Clinical Laboratory Improvement Amendments of 1988
(CLIA)
1)Establishes the federal program for certification and
oversight of clinical laboratories under the Centers for
Medicaid and Medicare Services (CMS). (United States Code,
Title 42, § 263a)
2)Establishes the conditions that laboratories must meet for
certification to perform testing on human specimens under
CLIA. (Code of Federal Regulations (CFR), Title 42, § 493.1)
3)Requires that laboratories certify that each person examining
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cytology slide preparations meet either of the following
requirements: (42 CFR § 493.1483)
a) Be a doctor of medicine or a doctor of osteopathy
licensed to practice medicine or osteopathy in the state in
which the laboratory is located; and,
i) Meet one of the following requirements:
(1) Be certified in anatomic pathology by the
American Board of Pathology or the American
Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required
for such certification; or,
(2) Be certified by the American Society of
Cytology to practice cytopathology or possess
qualifications that are equivalent to those required
for such certification.
b) Possess a current license as a cytotechnologist issued
by the state in which the laboratory is located, if such
licensing is required; and,
i) Meet one of the following requirements:
(1) Have graduated from a school of cytotechnology
accredited by the Committee on Allied Health Education
and Accreditation or other organization approved by
the U.S. Department of Health and Human Services
(HHS); or,
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(2) Be certified in cytotechnology by a certifying
agency approved by HHS.
4)Requires that all cytology slide preparations 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)
5)Requires the laboratory to require a cytotechnologist to
document: (42 CFR § 493.1485)
a) The slide interpretation results of each gynecologic and
nongynecologic cytology case he or she examined or reviewed
(as specified in § 493.1274(c));
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; and,
c) The number of hours spent examining slides in each
24-hour period.
California Business and Professions Code (BPC)
1)Provides for the licensure, registration, and regulation of
clinical laboratories and various clinical laboratory
personnel, including cytotechnologists, by the California
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Department of Public Health (CDPH). (BPC § 1200-1327)
2)Defines "diagnostic cytology" as a subspecialty under the
specialty of pathology. (BPC § 1206(a)(18)
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 they have either a cytotechnologist license
issued by the CDPH or a valid physician's and surgeon's
certificate. (BPC § 1270)
5)Establishes a workload limit on the number of gynecological
slides a cytotechnologist can examine in a specific period of
time. (BPC § 1271)
6)Requires the CDPH 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.
2)Provides examples of tests and procedures pertaining to
cytology, including:
a) Microscopic and nonmicroscopic methodologies; and,
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b) Tests and procedures that use molecular or genetic
methodologies that are performed on cytologic specimens
related to infectious disease or cancer diagnoses.
3)Makes other technical, nonsubstantive changes.
FISCAL EFFECT: Unknown. This bill is keyed fiscal by the
Legislative Counsel.
COMMENTS
1)Purpose. This bill is sponsored by the California Society of
Pathologists and the California Association of
Cytotechnologists. According to the author, this bill,
"ensures that California law is updated as technology
advances. More importantly, it ensures that we keep
high-paying jobs here, in California. We train
cytotechnologists but cannot keep them in the state because of
our restricted statutory structure. In addition, labs send
samples out of state to be analyzed because they cannot find
enough cytotechnologists."
"AB 599 ameliorates this situation and keeps jobs in
California, removes an incentive to send tissue samples out of
state, and ensures that we have the workforce needed to fill
laboratory need in California."
2)Background. A cytotechnologist is a type of laboratory
technician that performs tests specific to the field of
cytology. According the National Institutes of Health (NIH),
cytology is the analysis of cells collected from a part of the
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body under a microscope.
Cytological tests are used to determine what the cells look
like and whether they are abnormal. Abnormal cells are
indicators of cancer and precancerous changes. The tests may
also be used to look for viral infections in cells. A
cytological test differs from a biopsy in that only cells are
examined, not pieces of tissue.
Common cytological tests are performed using cells shed from
the lining of an organ into a cavity where they can be removed
by noninvasive means (exfoliative and aspirative cytology),
such as:
a) Papanicolaou test (Pap test) - a test for cervical
cancer, where cells scraped from the opening of the cervix
are examined under a microscope.
b) Cytology exam of pleural fluid - a test to detect cancer
cells and certain other cells in the pleural space, the
area that surrounds the lungs. A fluid sample is collected
from the pleural space and is examined under a microscope.
c) Cytology exam of urine - a test used to detect cancer
and other diseases of the urinary tract. A urine sample is
collected examined under a microscope.
d) Cytology exam of sputum - a test used to detect
respiratory diseases, including cancer. A sputum sample
(mucus) is collected and examined under a microscope.
For those tests, the examining physician, physician assistant,
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or nurse practitioner will collect the sample. Usually, the
sample will then be sent to a laboratory where a
cytotechnologist will perform a preliminary examination of the
sample. If the cytotechnologist finds an abnormality, a
pathologist will perform a final review. The pathologist
reports the final diagnosis back to the examining physician.
Non-microscopic Tests. Under current state law, licensed
cytotechnologists are limited to the examination of cells
using a microscope, such as the tests noted above. However,
the sponsors note that advances in medicine and laboratory
technology have resulted in new techniques that are not
limited to a microscope. Because the new techniques are not
limited to microscopes or slides, cytotechnologists are not
able to perform them.
For instance, historically, the standard of care for the
screening of cervical cancer has been the Pap test. However,
an emerging standard for women age 30-65 is "co-testing"-a Pap
test in conjunction with a human papillomavirus (HPV) DNA test
(Cervical Cancer: Screening Recommendations, U.S. Preventive
Services Task Services (USPSTF)). During a co-test, the Pap
test and the HPV test are performed on the same sample. The
USPSTF, along with the American Cancer Society (ACS), has
established the co-testing standard due to the high
correlation between HPV infection and cervical cancer.
In California, cytotechnologists have always been able to
examine samples for Pap tests. However, some of the techniques
used to test for HPV involve molecular and genetic tests that
are not considered examinations of cytological slides as
defined under the law. For instance, one common technique
involves the use of a polymerase chain reaction assay (PCR).
The PCR is a molecular test performed with a PCR machine, not
a microscope.
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There are also lesser used genetic tests, like the in situ
hybridization (ISH) tests. For example, the fluorescent in
situ hybridization (FISH) test is used to detect chromosomal
or DNA abnormalities using a specialized microscope. While it
does involve microscopes, they use special preparations of
cells to look at the DNA within the cells.
The law, as currently written, does not allow
cytotechnologists to perform PCR or ISH tests. If one of the
tests needs to be performed, the sample would need to be sent
to another department in the laboratory. However,
cytotechnologists are often trained in the areas of molecular
biology and cellular genetics. For instance, the CDPH
requires cytotechnologists to pass the American Society of
Clinical Pathologists (ASCP) cytotechnologist exam (or an
equivalent). The ASCP exam tests the preparation, theory, and
application of, among other things, molecular testing
(including HPV) and FISH tests.
Therefore, the author and the sponsors note that the situation
incentivizes cytotechnologists to leave the state. This bill
proposes to fix this issue by expanding the scope of practice
of a licensed cytotechnologist to include all tests and
procedures pertaining to cytology. This will allow a
cytotechnologist to perform the co-testing on a single sample,
without having to send it out.
Federal Law and Other States. Under federal law, CLIA
regulates laboratories and requires that laboratories apply
for certification with CMS. CLIA certification requires
laboratories to certify the qualifications of the personnel it
uses, including cytotechnologists. However, it does not
license the cytotechnologists individually or provide
individual standards. Therefore, it is up to the individual
states to decide the composition of the actual licensing
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schemes. In states that do not have their own regulations,
the laboratories determine the tests a cytotechnologist
performs (subject to the CLIA procedural and qualification
requirements).
California is currently the only state that limits the tests a
cytotechnologist can provide. At least five other states that
provide for the regulation of cytotechnologists appear to
permit cytotechnologists to perform the tests noted above,
including: Florida, New York, Tennessee, Louisiana, and
Nevada.
3)Current Related Legislation. AB 940 (Ridley-Thomas) of the
current legislative session, would add two new license
categories, reproductive biology and biochemical genetics,
permit clinical laboratory co-directors substantially comply
with CLIA requirements, and makes other sustentative and
nonsubstantive changes. STATUS: This bill is pending in the
Assembly Committee on Business and Professions.
AB 757 (Gomez) This bill would authorize a medical assistant,
as defined, who meets specified criteria to perform a total
protein refractometer test analysis in a licensed plasma
collection facility in this state. STATUS: This bill is
pending in the Assembly Committee on Business and Professions.
4)Previous Related 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 CDPH to issue
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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. NOTE: 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. NOTE: This bill died pursuant to Art.
IV, Sec. 10(c) of the Constitution.
ARGUMENTS IN SUPPORT
The California Association of Cytotechnologists (co-sponsor),
the California Society of Pathologists (co-sponsor), and other
supporters write in support of this bill. They all generally
agree that: 1) cytotechnologists should be able to perform
cytological tests that are not limited to a microscope; 2) the
fact that California is behind the other states on this issue
contributes to the cytotechnologist workforce shortage; and 3)
it makes sense to allow a cytotechnologist to perform both a Pap
test and HPV test on a single cytological sample.
ARGUMENTS IN OPPOSITION
None on file.
IMPLEMENTATION ISSUES
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1)BPC § 1271 places workload limits on the gynecological slides
a cytotechnologist can examine. The new techniques permitted
under this bill, unless they involve a gynecological slide,
will not be subject to this restriction.
REGISTERED SUPPORT / OPPOSITION:
Support
California Association of Cytotechnologists (co-sponsor)
California Society of Pathologists (co-sponsor)
American Society for Clinical Pathology
American Society of Cytopathology
California Clinical Laboratory Association
California Hospital Association
2 physicians
1 cytotechnologist
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Opposition
None on File.
Analysis Prepared by:Vincent Chee / B. & P. / (916) 319-3301