Business, Professions and Economic Development s1

SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT Senator Jerry Hill, Chair 2015 - 2016 Regular

Bill No: AB 599 Hearing Date: June 8, 2015 Author: Bonilla Version: May 28, 2015 Urgency: No Fiscal: Yes Consultant: Sarah Huchel

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)

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: AB 599 (Bonilla) Page 2 of 5

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 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 AB 599 (Bonilla) Page 3 of 5

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 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 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.” AB 599 (Bonilla) Page 4 of 5

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, 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: AB 599 (Bonilla) Page 5 of 5

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 Numerous individuals

Opposition:

Engineers and Scientists of California Numerous individuals

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