Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel, including cytotechnologists, by the State Department of Public Health, subject to certain exceptions. Under existing law, only a licensed cytotechnologist may perform examinations of cytological slides.

This bill would additionally authorize 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, subject to specified requirements.

Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel, including cytotechnologists, by the State Department of Public Health, subject to certain exceptions. Under existing law, only a licensed cytotechnologist may perform examinations of cytological slides.

This bill would additionally authorize 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, subject to specified requirements.

Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel, including cytotechnologists, by the State Department of Public Health, subject to certain exceptions. Under existing law, only a licensed cytotechnologist may perform examinations of cytological slides.

This bill would additionally authorize 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, subject to specified requirements.

Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel, including cytotechnologists, by the State Department of Public Health, subject to certain exceptions. Under existing law, only a licensed cytotechnologist may perform examinations of cytological slides.

This bill would additionally authorize 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. diagnosis, under the overall operation and administration of a laboratory director.

Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel, including cytotechnologists, by the State Department of Public Health, subject to certain exceptions. Under existing law, only a licensed cytotechnologist may perform examinations of cytological slides.

This bill would additionally authorize 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. methodologies that are performed on cytologic specimens related to infectious disease or cancer diagnosis.

Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel, including cytotechnologists, by the State Department of Public Health, subject to certain exceptions. Under existing law, only a licensed cytotechnologist may perform examinations of cytological slides.

This bill would additionally authorize 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.

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 599

Author:(Bonilla)

As Amended Ver:August 24, 2015

Majority vote

Original Committee Reference: B. & P.

SUMMARY: Authorizes a licensed cytotechnologist to perform all tests and procedures pertaining to cytology, under the overall operation and administration of a laboratory director. Specifically, this bill:

1. Defines, for purposes of this bill, a "qualified pathologist" as a physician and surgeon who is certified or eligible for certification in clinical or anatomical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology.

2. Authorizes a licensed cytotechnologist to perform all tests and procedures pertaining to cytology under the overall operation and administration of a laboratory director, who must be a qualified pathologist.

3. Provides examples of tests and procedures pertaining to cytology, including:

   1. Microscopic and nonmicroscopic methodologies; and,

   2. Tests and procedures that use molecular or genetic methodologies that are performed on cytologic specimens related to infectious disease or cancer diagnoses.

4. Provides that tests or procedures performed by a licensed cytotechnologist under this bill (Business and Professions Code Section 1270) must be performed in a licensed clinical laboratory certified in the subspecialty of diagnostic cytology.

5. Makes other technical, nonsubstantive changes.

The Senate amendments:

1. Clarify that a cytotechnologist must perform all tests under the overall operation and administration of a laboratory director.

2. Require that the laboratory director must be a qualified pathologist.

3. Define "qualified pathologist" as a physician and surgeon who is certified or eligible for certification in clinical or anatomical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology.

4. Require tests or procedures performed by a licensed cytotechnologist to be performed in a licensed clinical laboratory certified in the subspecialty of diagnostic cytology.

FISCAL EFFECT: According to the Senate Appropriations Committee, this bill will result in 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 Department of Public Health. The costs will be covered by licensing fee revenues. This bill will also result in minor ongoing costs to license cytotechnologists and enforce the revised standards by the Department of Public Health.

COMMENTS:

Purpose. This bill is co-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.

[This bill] 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."

Background. A cytotechnologist is a type of laboratory technician that performs tests specific to the field of cytology. According to 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.

Nonmicroscopic Tests. Under current state law, licensed cytotechnologists are limited to the examination of cells using a microscope. 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.

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.

Analysis Prepared by: Vincent Chee / B. & P. / (916) 319-3301 FN: 0001634

 THIRD READING  

Bill No: AB 599

Author: Bonilla (D)

Amended: 8/24/15 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 qualified laboratory director, as specified.

Senate Floor Amendments of 8/24/15 restate existing federal law regarding lab certification, and require that a cytotechnologist work under a lab director who is a physician certified or eligible for certification in clinical or anatomical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology.

ANALYSIS:

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. (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:

   1. The slide interpretation results of each gynecologic and nongynecologic cytology case he or she examined or reviewed.

   2. 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.

   3. 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. Requires that a cytotechnologist work under a lab director who is a physician and surgeon certified or eligible for certification in clinical or anatomical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology.

3. Requires that any tests or procedures performed by a licensed cytotechnologist be performed in a licensed clinical laboratory certified in the subspecialty of diagnostic cytology.

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 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.: Yes Local: 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: (Verified 8/20/15)

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

OPPOSITION: (Verified 8/20/15)

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

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

8/25/15 15:25:42

**** END ****

 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:

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:

   1. The slide interpretation results of each gynecologic and nongynecologic cytology case he or she examined or reviewed.

   2. 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.

   3. 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.

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 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.: Yes Local: 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: (Verified 6/24/15)

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

OPPOSITION: (Verified 6/24/15)

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

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

**** END ****

SENATE COMMITTEE ON APPROPRIATIONS

Senator Ricardo Lara, Chair

2015 - 2016 Regular Session

AB 599 (Bonilla) - Clinical laboratories: cytotechnologists

This bill does not meet the criteria for referral to the Suspense File.

Bill Summary:

AB 599 would expand the scope of practice for cytotechnologists by allowing a licensed cytotechnologist to perform all tests and procedures pertaining to cytology, under the supervision of a laboratory director.

Fiscal Impact:

• 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 Department of Public Health (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 Department of Public Health (Clinical Laboratory Improvement Fund).

Background:

Under current law, the Department of Public Health licenses clinical laboratories and certain occupations associated with clinical laboratories, including cytotechnologists. Cytotechnologists perform processing and review of microscopic samples to determine pathology. Current law limits the scope of practice for cytotechnologists to the examination of cytological slides. Since the adoption of current statutory requirements, technology in the area of cytotechnology has evolved and there are non-slide based tests and techniques taught in cytotechnology training programs. Concerns have been raised by the author and others that current statutory limitations on the practice of cytotechnology are causing trained cytologists to leave the state to practice in other states where they can utilize all of their training.

Proposed Law:

AB 599 would expand the scope of practice for cytotechnologists by allowing a licensed cytotechnologist to perform all tests and procedures pertaining to cytology, under the supervision of a laboratory director.

-- END --

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Jerry Hill, Chair

2015 - 2016 Regular

Bill No: AB 599 Hearing Date: June 8, 2015

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:

   1. The slide interpretation results of each gynecologic and nongynecologic cytology case he or she examined or reviewed.

   2. 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.

   3. 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 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.”

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:

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

-- END --

Date of Hearing: April 22, 2015

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Jimmy Gomez, Chair

ABPCA Bill Id:AB 599

Author:(Bonilla) – As Amended Ver:April 6, 2015

Urgency: No State Mandated Local Program: No Reimbursable: No

SUMMARY:

This bill authorizes a licensed cytotechnologist to perform all tests and procedures pertaining to cytology.

FISCAL EFFECT:

Costs to promulgate regulations to the California Department of Public Health (CDPH) 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. The author indicates California's regulatory restrictions on the practice of cytology, which is the study of human cells to detect cancer or other abnormalities, are out of date with current technology. Other states allow a more expansive scope of practice that reflects current technology. According to the author, keeping scope of practice aligned with best practices in the field is critical to keeping jobs in the state and ensuring an adequate supply of cytotechnologists. The bill is co-sponsored by the California Society of Pathologists and the California Association of Cytotechnologists, and there is no opposition.

2. Background. Cytological tests are used to determine what the cells look like and whether they are abnormal. For example, a pap smear is a common cytological test. Cytologists work closely with pathologists, who usually perform confirmatory testing on specimens to identify and diagnose abnormalities. Cytotechnologists are regulated by CDPH under the Laboratory Field Services program. There are 770 active cytotechnologists in the state, and about 20 new licenses are issued per year. The costs of an initial license is $175.

The field of cytology is evolving as new tests are being developed, including molecular and genetic tests that rely on advanced tools other than microscopes and slides. Because the new techniques are not limited to microscopes or slides, cytotechnologists are not authorized in California to perform them.

3. Related Legislation. AB 940 (Ridley-Thomas), pending in the Assembly Business and Professions Committee, would create two new license categories in reproductive biology and biochemical genetics.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: April 14, 2015

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Susan Bonilla, Chair

ABPCA Bill Id:AB 599

Author:(Bonilla) – As Amended Ver: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)

   1. 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,

      1. 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.

   2. Possess a current license as a cytotechnologist issued by the state in which the laboratory is located, if such licensing is required; and,

      1. 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 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)

   1. The slide interpretation results of each gynecologic and nongynecologic cytology case he or she examined or reviewed (as specified in § 493.1274(c));

   2. 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,

   3. 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:

   1. Microscopic and nonmicroscopic methodologies; and,

   2. 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 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:

1. Papanicolaou test (Pap test) – a test for cervical cancer, where cells scraped from the opening of the cervix are examined under a microscope.

2. 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.

3. 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.

4. 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.

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 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)

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