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 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,
(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
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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 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,
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.
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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 highpaying 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 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, 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.
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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.
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 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
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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 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
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)
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American Society for Clinical Pathology
American Society of Cytopathology
California Clinical Laboratory Association
California Hospital Association
2 physicians
1 cytotechnologist
Opposition
None on File.
Analysis Prepared by: Vincent Chee / B. & P. / (916) 319-3301