Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health.

Existing law authorizes unlicensed laboratory personnel who have earned a high school diploma or its equivalent and who meet specified training requirements to perform specified activities in a licensed clinical laboratory under the direct and constant supervision of a physician and surgeon or licensed person, including biological specimen collection, assisting in preventive maintenance, and preparing and storing reagents and culture media. Existing law authorizes unlicensed laboratory personnel who do not meet the specified training requirements only to perform specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storing. A violation of these provisions is a crime.

This bill would revise the activities that may be performed by an unlicensed person to specify those activities that may be performed under direct and constant supervision of a physician and surgeon or licensed person, those activities that may be performed under supervision and control, as defined, and those activities that may not be performed by an unlicensed person.

Existing law prohibits unlicensed laboratory personnel from performing any test or part thereof that involves the quantitative measurement of the specimen or test reagent or any mathematical calculation relative to determining the results or validity of a test procedure, and from performing any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation.

This bill would provide an exception to these prohibitions if the unlicensed person is assisting a licensed physician and surgeon or a licensed person, other than a trainee, in a licensed clinical laboratory. The bill would also prohibit unlicensed laboratory personnel from releasing results of waived, moderate-, or high-complexity testing. The bill would make conforming changes.

By expanding the scope of an existing crime, this bill would create a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health.

Existing law authorizes unlicensed laboratory personnel who have earned a high school diploma or its equivalent and who meet specified training requirements to perform specified activities in a licensed clinical laboratory under the direct and constant supervision of a physician and surgeon or licensed person, including biological specimen collection, assisting in preventive maintenance, and preparing and storing reagents and culture media. Existing law authorizes unlicensed laboratory personnel who do not meet the specified training requirements only to perform specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storing. A violation of these provisions is a crime.

This bill would revise the activities that may be performed by an unlicensed person to specify those activities that may be performed under direct and constant supervision of a physician and surgeon or licensed person, those activities that may be performed under supervision and control, as defined, and those activities that may not be performed by an unlicensed person.

Existing law prohibits unlicensed laboratory personnel from performing any test or part thereof that involves the quantitative measurement of the specimen or test reagent or any mathematical calculation relative to determining the results or validity of a test procedure. procedure, and from performing any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation.

This bill would provide an exception to this prohibition these prohibitions if the unlicensed person is assisting a licensed physician and surgeon or a licensed person, other than a trainee, in a licensed clinical laboratory. The bill would also prohibit unlicensed laboratory personnel from releasing results of waived, moderate-, or high-complexity testing and from performing any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation, as specified. testing. The bill would make conforming changes.

By expanding the scope of an existing crime, this bill would create a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health.

Existing law authorizes unlicensed laboratory personnel who have earned a high school diploma or its equivalent and who meet specified training requirements to perform specified activities in a licensed clinical laboratory under the direct and constant supervision of a physician and surgeon or licensed person, including biological specimen collection, assisting in preventive maintenance, and preparing and storing reagents and culture media. Existing law authorizes unlicensed laboratory personnel who do not meet the specified training requirements only to perform specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storing. A violation of these provisions is a crime.

This bill would revise the activities that may be performed by an unlicensed person to specify those activities that may be performed under direct and constant supervision of a physician and surgeon or licensed person, those activities that may be performed under supervision and control, as defined, and those activities that may not be performed by an unlicensed person.

Existing law prohibits unlicensed laboratory personnel from performing any test or part thereof that involves the quantitative measurement of the specimen or test reagent or any mathematical calculation relative to determining the results or validity of a test procedure.

The bill would provide an exception to this prohibition if the unlicensed person is assisting a licensed physician and surgeon or a licensed person, other than a trainee, in a licensed clinical laboratory. The bill would also prohibit unlicensed laboratory personnel from releasing waived, moderate-, or high-complexity testing and from performing any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation, as specified. The bill would make conforming changes.

By expanding the scope of an existing crime, this bill would create a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health. Existing law requires the department to issue a clinical laboratory scientists or a limited clinical laboratory scientists license in specified areas of laboratory specialty or subspecialty. Existing law requires an applicant to meet both an educational requirement and a training or experience requirement to qualify for admission to the examination for this license.

Existing law authorizes unlicensed laboratory personnel who have earned a high school diploma or its equivalent and who meet specified training requirements to perform specified activities in a licensed clinical laboratory under the direct and constant supervision of a physician and surgeon or licensed person, including biological specimen collection, assisting in preventive maintenance, and preparing and storing reagents and culture media. Existing law authorizes unlicensed laboratory personnel who do not meet the specified training requirements only to perform specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storing. A violation of these provisions is a crime.

This bill would revise the activities that may be performed by an unlicensed person to specify those activities that may be performed under direct and constant supervision of a physician and surgeon or licensed person, those activities that may be performed under supervision and control, as defined, and those activities that may not be performed by an unlicensed person.

Existing law prohibits unlicensed laboratory personnel from performing any test or part thereof that involves the quantitative measurement of the specimen or test reagent or any mathematical calculation relative to determining the results or validity of a test procedure.

The bill would provide an exception to this prohibition if the unlicensed person is assisting a licensed physician and surgeon or a licensed person, other than a trainee, in a licensed clinical laboratory. The bill would also prohibit unlicensed laboratory personnel from releasing waived, moderate-, or high-complexity testing. testing and from performing any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation, as specified. The bill would make conforming changes.

By expanding the scope of an existing crime, this bill would create a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health. Existing law requires the department to issue a clinical laboratory scientists or a limited clinical laboratory scientists license in specified areas of laboratory specialty or subspecialty. Existing law requires an applicant to meet both an educational requirement and a training or experience requirement to qualify for admission to the examination for this license.

This bill would allow a persons experience as an unlicensed person performing specified duties in a California-licensed laboratory for at least 18 months to count toward qualification of licensure.

Existing law authorizes unlicensed laboratory personnel who have earned a high school diploma or its equivalent and who meet specified training requirements to perform specified activities in a licensed clinical laboratory under the direct and constant supervision of a physician and surgeon or licensed person, including biological specimen collection, assisting in preventive maintenance, and preparing and storing reagents and culture media. Existing law authorizes unlicensed laboratory personnel who do not meet the specified training requirements only to perform specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storing. A violation of these provisions is a crime.

This bill would revise the activities that may be performed by an unlicensed person to specify those activities that may be performed under direct and constant supervision of a physician and surgeon or licensed person, those activities that may be performed under supervision and control, as defined, and those activities that may not be performed by an unlicensed person.

Existing law prohibits unlicensed laboratory personnel from performing any test or part thereof that involves the quantitative measurement of the specimen or test reagent or any mathematical calculation relative to determining the results or validity of a test procedure.

The bill would provide an exception to this prohibition if the unlicensed person is assisting a licensed physician and surgeon or a licensed person, other than a trainee, in a licensed clinical laboratory. The bill would also prohibit unlicensed laboratory personnel from releasing waived, moderate-, or high-complexity testing.

By expanding the scope of an existing crime, this bill would create a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

GOVERNOR'S VETO

GV Bill Id:AB 1741

Author:(Waldron)

As Enrolled Ver:September 18, 2023

2/3 vote

SUMMARY

Lowers the level of supervision required for unlicensed laboratory personnel to perform specified activities and expands the scope of practice of the personnel in a licensed clinical laboratory.

Senate Amendments

Define "assistance," for purposes of assisting a physician or clinical laboratory licensee, to mean acting under the direction of a licensed physician and surgeon or personnel licensed under this chapter, other than a trainee, under direct and constant supervision, and during which time no independent decision-making or judgment is exercised.

Governor’s Veto Message

This bill would revise training requirements for unlicensed laboratory personnel, change the scope of work authorized, and clarify the level of supervision required. While I appreciate the author's intent to address the licensed workforce shortage in labs and improve testing capacity, this bill contains a provision that could enable unlicensed laboratory personnel to perform tasks that exceed their level of training, posing a danger to the health and safety of Californians. As a result, this bill could conflict with the Clinical Laboratory Improvement Act, a federal law that prohibits individuals who do not meet the specified education and training requirements from performing any aspect of the analytical phase of testing.

I encourage the author and stakeholders to work with the Department of Public Health on a solution that ensures that personnel performing specified testing have the skills necessary to reliably receive accurate results.

COMMENTS

Background. Existing law limits the use of laboratory testing because the tests are generally used in the diagnostic process. The purpose of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the California requirements is to minimize the risk of incorrect or unreliable results, patient harm during testing, and improper diagnoses, among other things. Existing law authorizes unlicensed personnel to perform laboratory activities under direct supervision, which is defined as personal observation and critical evaluation of the activity of unlicensed laboratory personnel by a physician and surgeon, or by a clinical laboratory licensee. This bill authorizes some of those tasks under supervision and control, which is defined to mean the supervisor is on site.

CLIA. At both the federal and state levels, a facility or location where people perform laboratory tests on human specimens for diagnostic or assessment purposes must be certified under CLIA. While CLIA establishes the minimum standards under federal law, it allows states to establish more stringent requirements.

In all cases, the requirements for CLIA certification vary depending on the complexity of the laboratory tests performed. Clinical laboratories or other testing sites need to know whether each test system used is waived, moderate, or high complexity. In general, the more complicated the test, the more stringent the requirements, including increased training and licensing of laboratory personnel. At a minimum, all laboratories must have a licensed clinical laboratory director.

The FDA determines the complexity of laboratory tests under CLIA. Waived tests are simple tests with a low risk of an incorrect result. They include tests listed in the CLIA regulations, tests cleared by the FDA for home use, and tests approved for a waiver by the FDA using the CLIA criteria. Tests not classified as waived are assigned a moderate or high complexity category based on seven criteria given in the CLIA regulations, including ease of use, the knowledge required, and the types of materials tested. For commercially available FDA-cleared or approved tests, the test complexity is determined by the FDA during the pre-market approval process.

Under federal and California law, anyone providing direct care may perform a waived test in a federally certified laboratory or as part of a nondiagnostic health assessment program under the overall direction of a laboratory director, unless otherwise limited. In applying for a CLIA certificate of waiver, the laboratory director must list the types of analytes to be tested, the tests performed, and the test manufacturer. Existing law requires a laboratory director of a clinical laboratory to document the adequacy of the qualifications of any personnel in the laboratory, including educational background, training, and experience, of the personnel.

According to the Author

"California clinical laboratories have a unique workforce shortage applicable to licensed personnel due to a very narrow path to licensure. [This bill] proposes to update the rules governing what unlicensed personnel can do in a lab and expands the pathway to licensure for Clinical Laboratory Scientists. This will help alleviate the licensed workforce shortage in labs, improve laboratory testing capacity, and create new jobs in the industry and increase access to care."

Arguments in Support

Quest Diagnostics (co-sponsor) writes in support, "There is an acute shortage of licensed clinical laboratory scientists in California. This workforce shortage is adversely impacting CA laboratories' abilities to meet testing demand in a timely manner. The staffing challenges have been recognized by the California Department of Public Health (CDPH) Clinical Laboratory Technology Advisory Committee (CLTAC) which in 2022 formed the Laboratory Workforce Subcommittee tasked to study the issue and develop recommendations to improve the workforce shortage. Their report makes various recommendations which include updating licensing requirements and developing accelerated pathways to licensure. [This bill] would update licensing rules by expanding the activities that unlicensed personnel that meet Federal (CLIA) standards can perform under supervision of licensed personnel/physicians in order to meet testing demands. To provide an accelerated path to licensure, the bill would allow eighteen or more months of this experience as unlicensed personnel to count toward qualification for licensure."

The California Clinical Laboratories Association (CCLA) (co-sponsor) writes in support that this bill "will address critical workforce shortages of clinical laboratory personnel. CCLA is pleased to see that this bill expands the activities the unlicensed laboratory personnel can perform within a clinical laboratory, under the supervision of licensed personnel. Importantly, the bill also allows this work experience to be counted as qualification toward clinical laboratory licensure. This will 'level the playing field' as compared to out of state personnel who are able to count these hours towards licensure.”

Arguments in Opposition

SEIU California writes, "This bill would remove training requirements and create the potential for significant patient harm. For example, making a mistake with lab reagents can lead to destroying tissue samples. With a single machine that can hold 30-40 slides, a mistake can impact 30-40 samples, which is particularly problematic in bone marrow smears which are extremely painful processes to collect on a patient… Put simply, [this bill] puts the financial bottom line above patient care by eroding lab safety standards to the detriment of the professionals we represent and the patients we serve.”

FISCAL COMMENTS

According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, no significant state costs anticipated.

VOTES

ASM BUSINESS AND PROFESSIONS: 13-2-3

YES: Berman, Flora, Alanis, Alvarez, Dixon, Gipson, Grayson, Irwin, Jackson, Lowenthal, Stephanie Nguyen, Joe Patterson, Ting

NO: Lee, McKinnor

ABS, ABST OR NV: Bonta, Chen, McCarty

ASM APPROPRIATIONS: 15-0-1

YES: Holden, Megan Dahle, Bryan, Calderon, Wendy Carrillo, Dixon, Mike Fong, Hart, Lowenthal, Mathis, Papan, Pellerin, Robert Rivas, Sanchez, Weber

ABS, ABST OR NV: Ortega

ASSEMBLY FLOOR: 70-0-10

YES: Addis, Alanis, Alvarez, Bains, Bauer-Kahan, Bennett, Berman, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Chen, Connolly, Megan Dahle, Davies, Dixon, Essayli, Flora, Mike Fong, Vince Fong, Friedman, Gabriel, Gallagher, Garcia, Gipson, Grayson, Haney, Hart, Holden, Hoover, Irwin, Jackson, Jones-Sawyer, Lackey, Low, Lowenthal, Maienschein, Mathis, McCarty, McKinnor, Muratsuchi, Stephanie Nguyen, Pacheco, Papan, Jim Patterson, Joe Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Luz Rivas, Rodriguez, Blanca Rubio, Sanchez, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Rendon

ABS, ABST OR NV: Aguiar-Curry, Arambula, Boerner, Kalra, Lee, Ortega, Reyes, Robert Rivas, Santiago, Schiavo

SENATE FLOOR: 36-1-3

YES: Allen, Alvarado-Gil, Archuleta, Ashby, Atkins, Becker, Blakespear, Bradford, Caballero, Cortese, Dahle, Dodd, Eggman, Glazer, Grove, Hurtado, Jones, Laird, Limón, McGuire, Menjivar, Min, Newman, Nguyen, Niello, Ochoa Bogh, Portantino, Roth, Rubio, Seyarto, Skinner, Stern, Umberg, Wahab, Wiener, Wilk

NO: Gonzalez

ABS, ABST OR NV: Durazo, Padilla, Smallwood-Cuevas

ASSEMBLY FLOOR: 74-0-6

YES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bauer-Kahan, Bennett, Berman, Boerner, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Chen, Connolly, Megan Dahle, Davies, Dixon, Essayli, Flora, Mike Fong, Vince Fong, Gabriel, Gallagher, Garcia, Gipson, Grayson, Haney, Hart, Holden, Hoover, Irwin, Jackson, Jones-Sawyer, Kalra, Lackey, Low, Lowenthal, Maienschein, Mathis, McCarty, McKinnor, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Jim Patterson, Joe Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Luz Rivas, Rodriguez, Blanca Rubio, Sanchez, Santiago, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Robert Rivas

ABS, ABST OR NV: Bonta, Friedman, Lee, Rendon, Reyes, Schiavo

UPDATED

VERSION: September 18, 2023

CONSULTANT: Vincent Chee / B. & P. / (916) 319-3301 FN: 0001003

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 1741

Author:(Waldron)

As Amended Ver:September 8, 2023

Majority vote

SUMMARY

Lowers the level of supervision required for unlicensed laboratory personnel to perform specified activities and expands the scope of practice of the personnel in a licensed clinical laboratory.

Senate Amendments

Define "assistance," for purposes of assisting a physician or clinical laboratory licensee, to mean acting under the direction of a licensed physician and surgeon or personnel licensed under this chapter, other than a trainee, under direct and constant supervision, and during which time no independent decisionmaking or judgment is exercised.

COMMENTS

Background. Existing law limits the use of laboratory testing because the tests are generally used in the diagnostic process. The purpose of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the California requirements is to minimize the risk of incorrect or unreliable results, patient harm during testing, and improper diagnoses, among other things. Existing law authorizes unlicensed personnel to perform laboratory activities under direct supervision, which is defined as personal observation and critical evaluation of the activity of unlicensed laboratory personnel by a physician and surgeon, or by a clinical laboratory licensee. This bill authorizes some of those tasks under supervision and control, which is defined to mean the supervisor is on site.

CLIA. At both the federal and state levels, a facility or location where people perform laboratory tests on human specimens for diagnostic or assessment purposes must be certified under CLIA. While CLIA establishes the minimum standards under federal law, it allows states to establish more stringent requirements.

In all cases, the requirements for CLIA certification vary depending on the complexity of the laboratory tests performed. Clinical laboratories or other testing sites need to know whether each test system used is waived, moderate, or high complexity. In general, the more complicated the test, the more stringent the requirements, including increased training and licensing of laboratory personnel. At a minimum, all laboratories must have a licensed clinical laboratory director.

The FDA determines the complexity of laboratory tests under CLIA. Waived tests are simple tests with a low risk of an incorrect result. They include tests listed in the CLIA regulations, tests cleared by the FDA for home use, and tests approved for a waiver by the FDA using the CLIA criteria. Tests not classified as waived are assigned a moderate or high complexity category based on seven criteria given in the CLIA regulations, including ease of use, the knowledge required, and the types of materials tested. For commercially available FDA-cleared or approved tests, the test complexity is determined by the FDA during the pre-market approval process.

Under federal and California law, anyone providing direct care may perform a waived test in a federally certified laboratory or as part of a nondiagnostic health assessment program under the overall direction of a laboratory director, unless otherwise limited. In applying for a CLIA certificate of waiver, the laboratory director must list the types of analytes to be tested, the tests performed, and the test manufacturer. Existing law requires a laboratory director of a clinical laboratory to document the adequacy of the qualifications of any personnel in the laboratory, including educational background, training, and experience, of the personnel.

According to the Author

"California clinical laboratories have a unique workforce shortage applicable to licensed personnel due to a very narrow path to licensure. [This bill] proposes to update the rules governing what unlicensed personnel can do in a lab and expands the pathway to licensure for Clinical Laboratory Scientists. This will help alleviate the licensed workforce shortage in labs, improve laboratory testing capacity, and create new jobs in the industry and increase access to care."

Arguments in Support

Quest Diagnostics (co-sponsor) writes in support, "There is an acute shortage of licensed clinical laboratory scientists in California. This workforce shortage is adversely impacting CA laboratories' abilities to meet testing demand in a timely manner. The staffing challenges have been recognized by the California Department of Public Health (CDPH) Clinical Laboratory Technology Advisory Committee (CLTAC) which in 2022 formed the Laboratory Workforce Subcommittee tasked to study the issue and develop recommendations to improve the workforce shortage. Their report makes various recommendations which include updating licensing requirements and developing accelerated pathways to licensure. [This bill] would update licensing rules by expanding the activities that unlicensed personnel that meet Federal (CLIA) standards can perform under supervision of licensed personnel/physicians in order to meet testing demands. To provide an accelerated path to licensure, the bill would allow eighteen or more months of this experience as unlicensed personnel to count toward qualification for licensure."

The California Clinical Laboratories Association (CCLA) (co-sponsor) writes in support that this bill "will address critical workforce shortages of clinical laboratory personnel. CCLA is pleased to see that this bill expands the activities the unlicensed laboratory personnel can perform within a clinical laboratory, under the supervision of licensed personnel. Importantly, the bill also allows this work experience to be counted as qualification toward clinical laboratory licensure. This will 'level the playing field' as compared to out of state personnel who are able to count these hours towards licensure."

Arguments in Opposition

SEIU California writes, "This bill would remove training requirements and create the potential for significant patient harm. For example, making a mistake with lab reagents can lead to destroying tissue samples. With a single machine that can hold 30-40 slides, a mistake can impact 30-40 samples, which is particularly problematic in bone marrow smears which are extremely painful processes to collect on a patient… Put simply, [this bill] puts the financial bottom line above patient care by eroding lab safety standards to the detriment of the professionals we represent and the patients we serve."

FISCAL COMMENTS

According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, no significant state costs anticipated.

VOTES:

ASM BUSINESS AND PROFESSIONS: 13-2-3

YES: Berman, Flora, Alanis, Alvarez, Dixon, Gipson, Grayson, Irwin, Jackson, Lowenthal, Stephanie Nguyen, Joe Patterson, Ting

NO: Lee, McKinnor

ABS, ABST OR NV: Bonta, Chen, McCarty

ASM APPROPRIATIONS: 15-0-1

YES: Holden, Megan Dahle, Bryan, Calderon, Wendy Carrillo, Dixon, Mike Fong, Hart, Lowenthal, Mathis, Papan, Pellerin, Robert Rivas, Sanchez, Weber

ABS, ABST OR NV: Ortega

ASSEMBLY FLOOR: 70-0-10

YES: Addis, Alanis, Alvarez, Bains, Bauer-Kahan, Bennett, Berman, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Chen, Connolly, Megan Dahle, Davies, Dixon, Essayli, Flora, Mike Fong, Vince Fong, Friedman, Gabriel, Gallagher, Garcia, Gipson, Grayson, Haney, Hart, Holden, Hoover, Irwin, Jackson, Jones-Sawyer, Lackey, Low, Lowenthal, Maienschein, Mathis, McCarty, McKinnor, Muratsuchi, Stephanie Nguyen, Pacheco, Papan, Jim Patterson, Joe Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Luz Rivas, Rodriguez, Blanca Rubio, Sanchez, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Rendon

ABS, ABST OR NV: Aguiar-Curry, Arambula, Boerner, Kalra, Lee, Ortega, Reyes, Robert Rivas, Santiago, Schiavo

UPDATED

VERSION: September 8, 2023

CONSULTANT: Vincent Chee / B. & P. / (916) 319-3301 FN: 0001003

 THIRD READING  

Bill No: AB 1741

Author: Waldron (R)

Amended: 9/8/23 in Senate

Vote: 21

SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 10-0, 6/19/23

AYES: Roth, Nguyen, Alvarado-Gil, Archuleta, Ashby, Dodd, Eggman, Glazer, Niello, Wilk

NO VOTE RECORDED: Becker, Smallwood-Cuevas, Wahab

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

ASSEMBLY FLOOR: 70-0, 5/31/23 - See last page for vote

SUBJECT: Healing arts: clinical laboratories: personnel

SOURCE: California Clinical Laboratory Association

Quest Diagnostics

DIGEST:

This bill provides that unlicensed laboratory personnel can perform certain functions under the supervision and control of a physician and surgeon, or a person licensed as specified; defines supervision and control, as specified. This bill states the laboratory director will maintain responsibility for the performance of unlicensed laboratory personnel and any delegated supervision or training of the unlicensed personnel; and prohibits actions of unlicensed personnel.

Senate Floor Amendments of 9/8/23 address implementation issues by adding a definition of “assistance” in order to clarify that personnel are acting under the direction of a licensed physician and surgeon or other appropriate licensed laboratory personnel and are not engaging in independent decision making or judgment.

ANALYSIS:

Existing law:

1. Provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the California Department of Public Health, with specified exceptions. (Business and Professions Code (BPC) § 1200-1327)
2. Defines, for purposes of state regulation of clinical laboratories, the following:
   1. “CLIA” to mean the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a; P.L. 100-578) and the regulations adopted thereunder by the federal Health Care Financing Administration and effective on January 1, 1994, or any later date, when adopted in California pursuant to subdivision (b) of Section 1208. (BPC § 1202.5(a))
   2. “Clinical laboratory” to mean any place used, or any establishment or institution organized or operated, for the performance of clinical laboratory tests or examinations or the practical application of the clinical laboratory sciences. That application may include any means that applies the clinical laboratory sciences. (BPC § 1206(a)(8))
   3. Prohibits a person from performing a clinical laboratory test or examination classified as waived under CLIA unless the clinical laboratory test or examination is performed under the overall operation and administration of the laboratory director, as described in Section 1209, including, but not limited to, documentation by the laboratory director of the adequacy of the qualifications and competency of the personnel, and the test is performed by specified personnel. (BPC § 1206.5(a))
3. States that no person shall perform clinical laboratory tests or examinations classified as of high complexity under CLIA unless the clinical laboratory test or examination is performed under the overall operation and administration of the laboratory director, where the test is performed by one of specified individuals (BPC § 1206.5(c) and Health and Safety Code (HSC) § 101150)
4. Permits, during a declared federal, state, or local emergency, the Board of Pharmacy (BOP) to waive application of any provisions of the Pharmacy Law or the regulations adopted pursuant to it if, in BOP’s opinion, the waiver will aid in the protection of public health or the provision of patient care. (BPC § 4062 (b))
5. Permits BOP to continue to waive application of any provision of the Pharmacy Law for up to 90 days following the termination of the declared emergency if, in BOP’s opinion, the continued waiver will aid in the protection of the public health or in the provision of patient care. (BPC § 4062 (d))

This bill:

1. Defines “assistance” as acting under the direction of a licensed physician and surgeon or appropriate and licensed laboratory personnel, other than a trainee, under direct and constant supervision, and during which time no independent decision making or judgment is exercised. Defines “supervision and control” as direction, management, and awareness of the activity of unlicensed laboratory personnel by a physician and surgeon or by a person licensed under this bill other than a trainee, who must be physically present in the laboratory and readily available for consultation during the entire time that the unlicensed laboratory personnel are engaged in the duties, as specified.
2. States the laboratory director will designate the supervisor and maintain overall responsibility for the supervision and performance of the unlicensed laboratory personnel.
3. Provides that that unlicensed laboratory personnel may perform any of the activities identified in 4) below can be done under the supervision and control of a physician and surgeon, or a person licensed in the clinical laboratory chapter of the Business and Professions Code other than a trainee, in a clinical laboratory by meeting all of the following criteria:
   1. Adds “working knowledge” to the criteria: “the skills [and working knowledge] required to perform preventative maintenance, and troubleshooting.”
   2. Adds “stability, storage, and safety requirements related to chemical, biochemical, and electrical hazards and biohazardous materials” to the following criteria: a working knowledge of reagent [stability, storage, and safety requirements related to chemical, biochemical, and electrical hazards and biohazardous materials.]”
   3. Adds “a working knowledge of the medical terminology necessary for the transcription of results” as criteria.
4. States the laboratory director will maintain responsibility for the performance of unlicensed laboratory personnel and any delegated supervision or training of the unlicensed personnel.
5. States that activities that can be performed under direct and constant supervision include, in the case of qualitative and semiquantitative “spot, tablet, or stick” tests, the personnel may add the test reagent to the specimen or vice versa, but the results must be read by a physician and surgeon or person licensed under this chapter.
6. States an unlicensed laboratory personnel under the control of a physician and surgeon or a person licensed under the clinical laboratory statute in the Business and Professions Code can do all of the following:
   1. Perform biological specimen collection, including patient preparation, specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storage of specimens if the collection activities do not require a certificate or license, as specified.
   2. Complete preparation and storage of reagents and culture media. 
   3. Transcribe results that have been previously recorded, either manually by a physician and surgeon or personnel licensed as specified, or automatically by a testing  instrument, with documented verification by the physician and surgeon or licensed personnel who reports the test. 
   4. Make primary or subsequent inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media for microbiological tests.
7. States unlicensed laboratory personnel will not do any of the following:
   1. Record test results, except as authorized as specified.
   2. Perform any test or part thereof that involves the quantitative measurement of the specimen or test reagent, or any mathematical calculation relative to determining the results or the validity of a test procedure, unless they are assisting a physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory. 
   3. Perform any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation, unless they are assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory.  
   4. Release results of waived, moderate-, or high-complexity testing. 

Background

Federal and State Regulation for Clinical Laboratory Testing. A facility that performs laboratory tests on human specimens for diagnosis or assessment must be certified under CLIA. CLIA certification requirements vary depending on the complexity of the laboratory tests performed.

Clinical laboratories or other testing sites need to know whether each test system used is waived, moderate, or high complexity. In general, the more complicated the test, the more stringent the requirements, including increased training and licensing of laboratory personnel. At a minimum, all laboratories must have a licensed clinical laboratory director. The FDA determines the complexity of CLIA laboratory tests. Waived tests are simple tests with a low risk for an incorrect result. They include tests listed in the CLIA regulations, tests cleared by the FDA for home use, and tests approved for waiver by the FDA using the CLIA criteria. Tests not classified as waived are assigned a moderate or high complexity category based on seven criteria given in the CLIA regulations, including ease of use, knowledge required, and types of materials tested. For commercially available FDA-cleared or approved tests, the test complexity is determined by the FDA during the pre-market approval process. While CLIA establishes minimum federal standards, it allows states to enact more stringent state law requirements.

Additional Authority In Response To the COVID-19 Pandemic. In the wake of the COVID-19 pandemic, federal and state governments expedited certain processes and waived certain requirements to protect the health and safety of the public. At the federal level, this meant providing emergency use authorizations for COVID-19 tests and vaccines.

In 2020, California undertook similar efforts to combat the COVID-19 pandemic. In March 2020, the Governor issued Executive Order N-25-20 (EO) to suspend statutes and regulations in support of the state’s pandemic response efforts. One part of the EO states:

The certification and licensure requirements of California Code of Regulations, Title 17, section 1079 and Business and Professions Code section 1206.5 are suspended as to all persons who meet the requirements under the Clinical Laboratory Improvement Amendments of section 353 of the Public Health Service Act for high complexity testing and who are performing analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in any certified public health laboratory or licensed clinical laboratory.

Therefore, anyone who meets the CLIA requirements for high complexity testing can perform analyses of samples to test for SARS-CoV-2, the virus that causes COVID-19, in any certified public health laboratory or licensed clinical laboratory. Professionals who are able to perform these tests due to the waiver include a physician, podiatrist, dentist, naturopathic doctor, person licensed to engage in clinical laboratory practice or to direct a clinical lab, physician assistant, perfusionist, respiratory care practitioner, medical assistant, pharmacist, naturopathic assistant, licensed optometrist, other health care personnel providing direct patient care, any other person performing non-diagnostic testing, as specified. This expansion of professionals allowed for the increased staff required to support California through the COVID-19 pandemic.

Given that this EO’s authority relies on a Governor-issued state of emergency, and given that the Governor has stated that California’s COVID-19 state of emergency will end on February 28, 2023, the EO would not have retained the force of law after this date.

ABs 269 and 1341. Earlier this year, AB 269 (Berman, Chapter 1, Statutes of 2023) authorized a person to perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory or a city, county, or city and county public health laboratory if they meet certain requirements, without a sunset date. This bill adds a January 1, 2028 sunset date for these provisions. AB 1341 (Berman, 2023), which is currently moving through the Legislature also adds a sunset date of July 1, 2028, to the current provision that a person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory if they meet the requirements under CLIA for high complexity testing, as specified. Authorizes a pharmacist to furnish COVID-19 oral therapeutics following a positive test for SARS-CoV-2, as specified, until January 1, 2025, among other things.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

SUPPORT: (Verified 9/8/23)

California Clinical Laboratory Association (co-source)

Quest Diagnostics (co-source)

California Life Sciences

OPPOSITION: (Verified 9/8/23)

SEIU California

ARGUMENTS IN SUPPORT: Supporters argue that this bill will address critical shortages in clinical laboratory personnel, which will in turn allow California laboratories to meet testing demand in a timely manner.

ARGUMENTS IN OPPOSITION: SEIU California writes, “This bill would remove training requirements and create the potential for significant patient harm. For example, making a mistake with lab reagents can lead to destroying tissue samples. With a single machine that can hold 30-40 slides, a mistake can impact 30-40 samples, which is particularly problematic in bone marrow smears which are extremely painful processes to collect on a patient… Put simply, AB 1741 puts the financial bottom line above patient care by eroding lab safety standards to the detriment of the professionals we represent and the patients we serve.”

ASSEMBLY FLOOR: 70-0, 5/31/23

AYES: Addis, Alanis, Alvarez, Bains, Bauer-Kahan, Bennett, Berman, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Chen, Connolly, Megan Dahle, Davies, Dixon, Essayli, Flora, Mike Fong, Vince Fong, Friedman, Gabriel, Gallagher, Garcia, Gipson, Grayson, Haney, Hart, Holden, Hoover, Irwin, Jackson, Jones-Sawyer, Lackey, Low, Lowenthal, Maienschein, Mathis, McCarty, McKinnor, Muratsuchi, Stephanie Nguyen, Pacheco, Papan, Jim Patterson, Joe Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Luz Rivas, Rodriguez, Blanca Rubio, Sanchez, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Rendon

NO VOTE RECORDED: Aguiar-Curry, Arambula, Boerner, Kalra, Lee, Ortega, Reyes, Robert Rivas, Santiago, Schiavo

Prepared by: Dana Shaker / B., P. & E.D. /

9/11/23 12:23:51

**** END ****

 THIRD READING  

Bill No: AB 1741

Author: Waldron (R)

Amended: 5/25/23 in Assembly

Vote: 21

SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 10-0, 6/19/23

AYES: Roth, Nguyen, Alvarado-Gil, Archuleta, Ashby, Dodd, Eggman, Glazer, Niello, Wilk

NO VOTE RECORDED: Becker, Smallwood-Cuevas, Wahab

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

ASSEMBLY FLOOR: 70-0, 5/31/23 - See last page for vote

SUBJECT: Healing arts: clinical laboratories: personnel

SOURCE: California Clinical Laboratory Association

Quest Diagnostics

DIGEST:

This bill provides that unlicensed laboratory personnel can perform certain functions under the supervision and control of a physician and surgeon, or a person licensed as specified; defines supervision and control, as specified. This bill states the laboratory director will maintain responsibility for the performance of unlicensed laboratory personnel and any delegated supervision or training of the unlicensed personnel; and prohibits actions of unlicensed personnel.

ANALYSIS:

Existing law:

1. Provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the California Department of Public Health, with specified exceptions. (Business and Professions Code (BPC) § 1200-1327)
2. Defines, for purposes of state regulation of clinical laboratories, the following:
   1. “CLIA” to mean the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a; P.L. 100-578) and the regulations adopted thereunder by the federal Health Care Financing Administration and effective on January 1, 1994, or any later date, when adopted in California pursuant to subdivision (b) of Section 1208. (BPC § 1202.5(a))
   2. “Clinical laboratory” to mean any place used, or any establishment or institution organized or operated, for the performance of clinical laboratory tests or examinations or the practical application of the clinical laboratory sciences. That application may include any means that applies the clinical laboratory sciences. (BPC § 1206(a)(8))
   3. Prohibits a person from performing a clinical laboratory test or examination classified as waived under CLIA unless the clinical laboratory test or examination is performed under the overall operation and administration of the laboratory director, as described in Section 1209, including, but not limited to, documentation by the laboratory director of the adequacy of the qualifications and competency of the personnel, and the test is performed by specified personnel. (BPC § 1206.5(a))
3. States that no person shall perform clinical laboratory tests or examinations classified as of high complexity under CLIA unless the clinical laboratory test or examination is performed under the overall operation and administration of the laboratory director, where the test is performed by one of specified individuals (BPC § 1206.5(c) and Health and Safety Code (HSC) § 101150)
4. Permits, during a declared federal, state, or local emergency, the Board of Pharmacy (BOP) to waive application of any provisions of the Pharmacy Law or the regulations adopted pursuant to it if, in BOP’s opinion, the waiver will aid in the protection of public health or the provision of patient care. (BPC § 4062 (b))
5. Permits BOP to continue to waive application of any provision of the Pharmacy Law for up to 90 days following the termination of the declared emergency if, in BOP’s opinion, the continued waiver will aid in the protection of the public health or in the provision of patient care. (BPC § 4062 (d))

This bill:

1. Defines “supervision and control” as direction, management, and awareness of the activity of unlicensed laboratory personnel by a physician and surgeon or by a person licensed under this bill other than a trainee, who must be physically present in the laboratory and readily available for consultation during the entire time that the unlicensed laboratory personnel are engaged in the duties, as specified.
2. States the laboratory director will designate the supervisor and maintain overall responsibility for the supervision and performance of the unlicensed laboratory personnel.
3. Provides that that unlicensed laboratory personnel may perform any of the activities identified in 4) below can be done under the supervision and control of a physician and surgeon, or a person licensed in the clinical laboratory chapter of the Business and Professions Code other than a trainee, in a clinical laboratory by meeting all of the following criteria:
   1. Adds “working knowledge” to the criteria: “the skills [and working knowledge] required to perform preventative maintenance, and troubleshooting.”
   2. Adds “stability, storage, and safety requirements related to chemical, biochemical, and electrical hazards and biohazardous materials” to the following criteria: a working knowledge of reagent [stability, storage, and safety requirements related to chemical, biochemical, and electrical hazards and biohazardous materials.]”
   3. Adds “a working knowledge of the medical terminology necessary for the transcription of results” as criteria.
4. States the laboratory director will maintain responsibility for the performance of unlicensed laboratory personnel and any delegated supervision or training of the unlicensed personnel.
5. States that activities that can be performed under direct and constant supervision include, in the case of qualitative and semiquantitative “spot, tablet, or stick” tests, the personnel may add the test reagent to the specimen or vice versa, but the results must be read by a physician and surgeon or person licensed under this chapter.
6. States an unlicensed laboratory personnel under the control of a physician and surgeon or a person licensed under the clinical laboratory statute in the Business and Professions Code can do all of the following:
   1. Perform biological specimen collection, including patient preparation, specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storage of specimens if the collection activities do not require a certificate or license, as specified.
   2. Complete preparation and storage of reagents and culture media. 
   3. Transcribe results that have been previously recorded, either manually by a physician and surgeon or personnel licensed as specified, or automatically by a testing  instrument, with documented verification by the physician and surgeon or licensed personnel who reports the test. 
   4. Make primary or subsequent inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media for microbiological tests.
7. States unlicensed laboratory personnel will not do any of the following:
   1. Record test results, except as authorized as specified.
   2. Perform any test or part thereof that involves the quantitative measurement of the specimen or test reagent, or any mathematical calculation relative to determining the results or the validity of a test procedure, unless they are assisting a physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory. 
   3. Perform any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation, unless they are assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory.  
   4. Release results of waived, moderate-, or high-complexity testing. 

Background

Federal and State Regulation for Clinical Laboratory Testing. A facility that performs laboratory tests on human specimens for diagnosis or assessment must be certified under CLIA. CLIA certification requirements vary depending on the complexity of the laboratory tests performed.

Clinical laboratories or other testing sites need to know whether each test system used is waived, moderate, or high complexity. In general, the more complicated the test, the more stringent the requirements, including increased training and licensing of laboratory personnel. At a minimum, all laboratories must have a licensed clinical laboratory director. The FDA determines the complexity of CLIA laboratory tests. Waived tests are simple tests with a low risk for an incorrect result. They include tests listed in the CLIA regulations, tests cleared by the FDA for home use, and tests approved for waiver by the FDA using the CLIA criteria. Tests not classified as waived are assigned a moderate or high complexity category based on seven criteria given in the CLIA regulations, including ease of use, knowledge required, and types of materials tested. For commercially available FDA-cleared or approved tests, the test complexity is determined by the FDA during the pre-market approval process. While CLIA establishes minimum federal standards, it allows states to enact more stringent state law requirements.

Additional Authority In Response To the COVID-19 Pandemic. In the wake of the COVID-19 pandemic, federal and state governments expedited certain processes and waived certain requirements to protect the health and safety of the public. At the federal level, this meant providing emergency use authorizations for COVID-19 tests and vaccines.

In 2020, California undertook similar efforts to combat the COVID-19 pandemic. In March 2020, the Governor issued Executive Order N-25-20 (EO) to suspend statutes and regulations in support of the state’s pandemic response efforts. One part of the EO states:

The certification and licensure requirements of California Code of Regulations, Title 17, section 1079 and Business and Professions Code section 1206.5 are suspended as to all persons who meet the requirements under the Clinical Laboratory Improvement Amendments of section 353 of the Public Health Service Act for high complexity testing and who are performing analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in any certified public health laboratory or licensed clinical laboratory.

Therefore, anyone who meets the CLIA requirements for high complexity testing can perform analyses of samples to test for SARS-CoV-2, the virus that causes COVID-19, in any certified public health laboratory or licensed clinical laboratory. Professionals who are able to perform these tests due to the waiver include a physician, podiatrist, dentist, naturopathic doctor, person licensed to engage in clinical laboratory practice or to direct a clinical lab, physician assistant, perfusionist, respiratory care practitioner, medical assistant, pharmacist, naturopathic assistant, licensed optometrist, other health care personnel providing direct patient care, any other person performing non-diagnostic testing, as specified. This expansion of professionals allowed for the increased staff required to support California through the COVID-19 pandemic.

Given that this EO’s authority relies on a Governor-issued state of emergency, and given that the Governor has stated that California’s COVID-19 state of emergency will end on February 28, 2023, the EO would not have retained the force of law after this date.

ABs 269 and 1341. Earlier this year, AB 269 (Berman, Chapter 1, Statutes of 2023) authorized a person to perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory or a city, county, or city and county public health laboratory if they meet certain requirements, without a sunset date. This bill adds a January 1, 2028 sunset date for these provisions. AB 1341 (Berman, 2023), which is currently moving through the Legislature also adds a sunset date of July 1, 2028, to the current provision that a person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory if they meet the requirements under CLIA for high complexity testing, as specified. Authorizes a pharmacist to furnish COVID-19 oral therapeutics following a positive test for SARS-CoV-2, as specified, until January 1, 2025, among other things.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

SUPPORT: (Verified 7/3/23)

California Clinical Laboratory Association (co-source)

Quest Diagnostics (co-source)

California Life Sciences

OPPOSITION: (Verified 7/3/23)

SEIU California

ARGUMENTS IN SUPPORT: Supporters argue that this bill will address critical shortages in clinical laboratory personnel, which will in turn allow California laboratories to meet testing demand in a timely manner.

ARGUMENTS IN OPPOSITION: SEIU California writes, “This bill would remove training requirements and create the potential for significant patient harm. For example, making a mistake with lab reagents can lead to destroying tissue samples. With a single machine that can hold 30-40 slides, a mistake can impact 30-40 samples, which is particularly problematic in bone marrow smears which are extremely painful processes to collect on a patient… Put simply, AB 1741 puts the financial bottom line above patient care by eroding lab safety standards to the detriment of the professionals we represent and the patients we serve.”

ASSEMBLY FLOOR: 70-0, 5/31/23

AYES: Addis, Alanis, Alvarez, Bains, Bauer-Kahan, Bennett, Berman, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Chen, Connolly, Megan Dahle, Davies, Dixon, Essayli, Flora, Mike Fong, Vince Fong, Friedman, Gabriel, Gallagher, Garcia, Gipson, Grayson, Haney, Hart, Holden, Hoover, Irwin, Jackson, Jones-Sawyer, Lackey, Low, Lowenthal, Maienschein, Mathis, McCarty, McKinnor, Muratsuchi, Stephanie Nguyen, Pacheco, Papan, Jim Patterson, Joe Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Luz Rivas, Rodriguez, Blanca Rubio, Sanchez, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Rendon

NO VOTE RECORDED: Aguiar-Curry, Arambula, Boerner, Kalra, Lee, Ortega, Reyes, Robert Rivas, Santiago, Schiavo

Prepared by: Dana Shaker / B., P. & E.D. /

7/5/23 14:50:44

**** END ****

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Richard Roth, Chair

2023 - 2024 Regular

Bill No: Hearing Date: June 19, 2023

Subject:

SUMMARY:

1. Provides that that unlicensed laboratory personnel can perform certain

functions under the supervision and control of a physician and surgeon, or a person licensed as specified. Defines supervision and control, as specified. States the laboratory director will maintain responsibility for the performance of unlicensed laboratory personnel and any delegated supervision or training of the unlicensed personnel. Prohibits actions of unlicensed personnel.

Existing law:

1. Provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by CDPH, with specified exceptions. (Business and Professions Code (BPC) § 1200-1327)
2. Defines, for purposes of state regulation of clinical laboratories, the following:
3. “CLIA” to mean the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a; P.L. 100-578) and the regulations adopted thereunder by the federal Health Care Financing Administration and effective on January 1, 1994, or any later date, when adopted in California pursuant to subdivision (b) of Section 1208. (BPC § 1202.5(a))
4. “Clinical laboratory” to mean any place used, or any establishment or institution organized or operated, for the performance of clinical laboratory tests or examinations or the practical application of the clinical laboratory sciences. That application may include any means that applies the clinical laboratory sciences. (BPC § 1206(a)(8))
5. Prohibits a person from performing a clinical laboratory test or examination classified as waived under CLIA unless the clinical laboratory test or examination is performed under the overall operation and administration of the laboratory director, as described in Section 1209, including, but not limited to, documentation by the laboratory director of the adequacy of the qualifications and competency of the personnel, and the test is performed by specified personnel. (BPC § 1206.5(a))
6. States that no person shall perform clinical laboratory tests or examinations classified as of high complexity under CLIA unless the clinical laboratory test or examination is performed under the overall operation and administration of the laboratory director, where the test is performed by one of the following:
7. a licensed physician and surgeon holding an M.D. or D.O. degree;
8. a licensed podiatrist or a licensed dentist, as specified;
9. a person licensed to engage in clinical laboratory practice or to direct a clinical laboratory, as specified;
10. a person who supports a public health laboratory in the examination of specimens from suspected cases of infections and environmental diseases, that may include milk products, waters, and the environment, as specified;
11. a licensed physician assistant, as specified;
12. a perfusionist, as specified;
13. a respiratory care practitioner, as specified;
14. a person performing nuclear medicine technology, as specified;
15. a person if performing blood gas analysis, as specified;
16. any other person within a physician office laboratory if the test is performed under the onsite supervision of the patient’s physician and surgeon or a podiatrist who will: 1) ensure that the person is performing test methods as required for accurate and reliable tests; and 2) have personal knowledge of the results of clinical laboratory testing or examination performed by that person before the test results are reported from the laboratory. (BPC § 1206.5(c) and Health and Safety Code (HSC) § 101150)
17. Permits, during a declared federal, state, or local emergency, the BOP to waive application of any provisions of the Pharmacy Law or the regulations adopted pursuant to it if, in BOP’s opinion, the waiver will aid in the protection of public health or the provision of patient care. (BPC § 4062 (b))
18. Permits BOP to continue to waive application of any provision of the Pharmacy Law for up to 90 days following the termination of the declared emergency if, in BOP’s opinion, the continued waiver will aid in the protection of the public health or in the provision of patient care. (BPC § 4062 (d))

Existing Federal Law:

1. Establishes CLIA under federal law, which regulates clinical laboratories that perform tests on human specimens and sets standards for facility administration, personnel qualifications and quality control. These standards apply to all settings, including commercial, hospital or physician office laboratories. (Code of Federal Regulations (CFR) Title 42 § 493)
2. Defines CLIA waived tests as simple laboratory examinations and procedures that are approved by the Food and Drug Administration (FDA) for home use, employ methodologies that are simple and accurate as to render the likelihood of erroneous results negligible or pose no reasonable risk of harm to the patient if the test is performed incorrectly. (CFR Title 42 § 493)

This bill:

1. Defines “supervision and control” as direction, management, and awareness of the activity of unlicensed laboratory personnel by a physician and surgeon or by a person licensed under this chapter other than a trainee, who must be physically present in the laboratory and readily available for consultation during the entire time that the unlicensed laboratory personnel are engaged in the duties, as specified.
2. States the laboratory director will designate the supervisor and maintain overall responsibility for the supervision and performance of the unlicensed laboratory personnel.
3. Provides that that unlicensed laboratory personnel may perform any of the activities identified in 4) below can be done under the supervision and control of a physician and surgeon, or a person licensed in the clinical laboratory chapter of the Business and Professions Code other than a trainee, in a clinical laboratory by meeting all of the following criteria:
4. Adds “working knowledge” to the criteria: “the skills [and working knowledge] required to perform preventative maintenance, and troubleshooting.”
5. Adds “stability, storage, and safety requirements related to chemical, biochemical, and electrical hazards and biohazardous materials” to the following criteria: a working knowledge of reagent [stability, storage, and safety requirements related to chemical, biochemical, and electrical hazards and biohazardous materials.]”
6. Adds “a working knowledge of the medical terminology necessary for the transcription of results” as criteria.
7. States the laboratory director will maintain responsibility for the performance of unlicensed laboratory personnel and any delegated supervision or training of the unlicensed personnel.
8. States that activities that can be performed under direct and constant supervision include, in the case of qualitative and semiquantitative “spot, tablet, or stick” tests, the personnel may add the test reagent to the specimen or vice versa, but the results must be read by a physician and surgeon or person licensed under this chapter.
9. States an unlicensed laboratory personnel under the control of a physician and surgeon or a person licensed under the clinical laboratory statute in the Business and Professions Code can do all of the following:
10. Perform biological specimen collection, including patient preparation, specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storage of specimens if the collection activities do not require a certificate or license, as specified.
11. Complete preparation and storage of reagents and culture media. 
12. Transcribe results that have been previously recorded, either manually by a physician and surgeon or personnel licensed as specified, or automatically by a testing  instrument, with documented verification by the physician and surgeon or licensed personnel who reports the test. 
13. Make primary or subsequent inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media for microbiological tests.
14. States unlicensed laboratory personnel will not do any of the following:
15. Record test results, except as authorized as specified.
16. Perform any test or part thereof that involves the quantitative measurement of the specimen or test reagent, or any mathematical calculation relative to determining the results or the validity of a test procedure, unless they are assisting a physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory. 
17. Perform any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation, unless they are assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory.  
18. Release results of waived, moderate-, or high-complexity testing. 

FISCAL EFFECT:

This bill is keyed fiscal by Legislative Counsel. According to the Assembly Committee on Appropriations, the costs to the California Department of Public Health (CDPH) are minor and absorbable, and there are no costs to the Medical Board of California, the Osteopathic Medical Board, or the Podiatric Medical Board of California.

COMMENTS:

1. Purpose. Quest Diagnostics and California Clinical Laboratory Association are Co-Sponsors of this bill. According to the Author, “California clinical laboratories have a unique workforce shortage applicable to licensed personnel due to a very narrow path to licensure. AB 1741 proposes to update the rules governing what unlicensed personnel can do in a lab. This will help alleviate the licensed workforce shortage in labs, improve laboratory testing capacity, create new jobs in the industry, and increase access to care.”
2. Background.

Federal and State Regulation for Clinical Laboratory Testing. A facility that performs laboratory tests on human specimens for diagnosis or assessment must be certified under CLIA. CLIA certification requirements vary depending on the complexity of the laboratory tests performed.

Clinical laboratories or other testing sites need to know whether each test system used is waived, moderate, or high complexity. In general, the more complicated the test, the more stringent the requirements, including increased training and licensing of laboratory personnel. At a minimum, all laboratories must have a licensed clinical laboratory director. The FDA determines the complexity of CLIA laboratory tests. Waived tests are simple tests with a low risk for an incorrect result. They include tests listed in the CLIA regulations, tests cleared by the FDA for home use, and tests approved for waiver by the FDA using the CLIA criteria. Tests not classified as waived are assigned a moderate or high complexity category based on seven criteria given in the CLIA regulations, including ease of use, knowledge required, and types of materials tested. For commercially available FDA-cleared or approved tests, the test complexity is determined by the FDA during the pre-market approval process. While CLIA establishes minimum federal standards, it allows states to enact more stringent state law requirements.

Additional Authority In Response To the COVID-19 Pandemic. In the wake of the COVID-19 pandemic, federal and state governments expedited certain processes and waived certain requirements to protect the health and safety of the public. At the federal level, this meant providing emergency use authorizations for COVID-19 tests and vaccines.

In 2020, California undertook similar efforts to combat the COVID-19 pandemic. In March 2020, the Governor issued Executive Order N-25-20 (EO) to suspend statutes and regulations in support of the state’s pandemic response efforts. One part of the EO states:

“The certification and licensure requirements of California Code of Regulations, Title 17, section 1079 and Business and Professions Code section 1206.5 are suspended as to all persons who meet the requirements under the Clinical Laboratory Improvement Amendments of section 353 of the Public Health Service Act for high complexity testing and who are performing analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in any certified public health laboratory or licensed clinical laboratory.”

Therefore, anyone who meets the CLIA requirements for high complexity testing can perform analyses of samples to test for SARS-CoV-2, the virus that causes COVID-19, in any certified public health laboratory or licensed clinical laboratory. Professionals who are able to perform these tests due to the waiver include a physician, podiatrist, dentist, naturopathic doctor, person licensed to engage in clinical laboratory practice or to direct a clinical lab, physician assistant, perfusionist, respiratory care practitioner, medical assistant, pharmacist, naturopathic assistant, licensed optometrist, other health care personnel providing direct patient care, any other person performing non-diagnostic testing, as specified. This expansion of professionals allowed for the increased staff required to support California through the COVID-19 pandemic.

Given that this EO’s authority relies on a Governor-issued state of emergency, and given that the Governor has stated that California’s COVID-19 state of emergency will end on February 28, 2023, the EO would not have retained the force of law after this date.

ABs 269 and 1341. Earlier this year, AB 269 (Berman, Chapter 1, Statutes of 2023) authorized a person to perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory or a city, county, or city and county public health laboratory if they meet certain requirements, without a sunset date. This bill adds a January 1, 2028 sunset date for these provisions. AB 1341 (Berman, 2023), which is currently moving through the Legislature would also add a sunset date of July 1, 2028 to the current provision that a person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments (CLIA) for high complexity testing, as specified. Authorizes a pharmacist to furnish COVID-19 oral therapeutics following a positive test for SARS-CoV-2, as specified, until January 1, 2025, among other things.

1. Related Legislation.

AB 1341 (Berman, 2023), which is currently moving through the Legislature would also add a sunset date of July 1, 2028 to the current provision that a person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments (CLIA) for high complexity testing, as specified. Authorizes a pharmacist to furnish COVID-19 oral therapeutics following a positive test for SARS-CoV-2, as specified, until January 1, 2025, among other things. (Status: this bill is currently awaiting a hearing in the Senate Appropriations Committee.)

AB 269 (Berman, Chapter 1, Statutes of 2023) authorized a person to perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory or a city, county, or city and county public health laboratory if they meet certain requirements, without a sunset date. This bill adds a January 1, 2028 sunset date for these provisions.

SB 524 (Caballero, 2023) would authorize a pharmacist to furnish medications to treat various diseases and conditions based on the results of a federal Food and Drug Administration approved test the pharmacist ordered, performed, or reported. (Status: This bill was held under submission in the Senate Committee on Appropriations.)

1. Arguments in Support. California Clinical Laboratory Association writes in co-sponsorship and support: “AB 1741 will address critical workforce shortages of clinical laboratory personnel. CCLA is pleased to see that this bill expands the activities the unlicensed laboratory personnel can perform within a clinical laboratory, under the supervision of licensed personnel. Importantly, the bill also allows this work experience to be counted as qualification toward clinical laboratory licensure. This will “level the playing field” as compared to out of state personnel who are able to count these hours towards licensure.

This bill will set-up a key road to licensure for California laboratory personnel and establish important supervision standards to help meet testing demands while maintaining accurate, high-quality testing.”

Quest Diagnostics writes in co-sponsorship and support: “There is an acute shortage of licensed clinical laboratory scientists in California. This workforce shortage is adversely impacting CA laboratories' abilities to meet testing demand in a timely manner. The staffing challenges have been recognized by the California Department of Public Health (CDPH) Clinical Laboratory Technology Advisory Committee (CLTAC) which in 2022 formed the Laboratory Workforce Subcommittee tasked to study the issue and develop recommendations to improve the workforce shortage. Their report makes various recommendations which include updating licensing requirements and developing accelerated pathways to licensure. AB 1741 would update licensing rules by expanding the activities that unlicensed personnel that meet Federal (CLIA) standards can perform under supervision of licensed personnel/physicians in order to meet testing demands. To provide an accelerated path to licensure, the bill would allow eighteen or more months of this experience as unlicensed personnel to count toward qualification for licensure.

The Legislature unanimously passed, and the Governor signed, AB 269 which allows unlicensed personnel who meet the Federal standards to perform high complexity testing for COVID. AB 1741 allows unlicensed personnel to assist with similar tasks, but under the supervision of licensed personnel.

In doing so, additional personnel can be employed to assist with testing, thereby allowing for licensed testing personnel to focus on critical tasks that are in line with their area of expertise.

Expanding the scope of work that unlicensed laboratory persons can perform and allowing for this experience to count as qualification for licensure would take significant steps towards alleviating the workforce shortage, improve laboratory testing capacity, patient access to testing, and create new jobs in the industry.”

California Life Sciences writes in support: “The United States currently faces a shortage of up to 25,000 clinical laboratory scientists. While this shortage was present before COVID-19, the pandemic and subsequent “Great Resignation” have only exacerbated it and left nearly three-quarters of clinical laboratories understaffed. This is particularly concerning given the essential role that clinical laboratories play at the interface between epidemiological surveillance, public health policy responses, and industrial partnerships. While factors including mass retirements, relatively few training programs, and bureaucratic hurdles have all contributed to this shortage – the last factor is particularly fixable via immediate state policy responses.

This bill will help California staff-up its clinical laboratories by streamlining the bureaucratic hurdles to licensure.”

SUPPORT AND OPPOSITION:

Support:

California Clinical Laboratory Association (co-sponsor)

Quest Diagnostics (co-sponsor)
California Life Sciences

Opposition:

None received.

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AB 1741

Author:(Waldron)

As Amended Ver:May 25, 2023

Majority vote

SUMMARY

Lowers the level of supervision required for unlicensed laboratory personnel to perform specified activities and expands the scope of practice of the personnel in a licensed clinical laboratory.

Major Provisions

1. Defines "supervision and control" to mean direction, management, and awareness of the activity of unlicensed laboratory personnel by a physician and surgeon, or by a clinical laboratory licensee other than a trainee, who must be physically present in the laboratory and readily available for consultation during the entire time that the unlicensed laboratory personnel are engaged in laboratory duties.
2. Requires the laboratory director to designate a supervisor and to maintain overall responsibility for the supervision and performance of the unlicensed laboratory personnel.
3. Requires unlicensed personnel to additionally have documentation of the skills to perform waived testing before performing the specified activities requiring additional supervision, education, and training.
4. Lowers the supervision required for the following unlicensed activities from "direct and constant supervision" to "supervision and control":
   1. Biological specimen collection, including patient preparation, specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storage of specimens.
   2. Preparation and storage of reagents and culture media.
   3. Transcribing results that have been previously recorded either manually by a physician and surgeon or clinical laboratory licensee or automatically by a testing instrument.
5. Authorizes unlicensed personnel to make primary and subsequent inoculations of test material onto appropriate culture media under "supervision and control."
6. Modifies the prohibition against unlicensed personnel performing any part of a test that involves the quantitative measurement of the specimen or test reagent, or any mathematical calculation relative to determining the results or the validity of a test, to allow them to perform the tests if they are assisting a physician and surgeon or clinical laboratory licensee, other than trainees, in a licensed clinical laboratory.
7. Authorizes unlicensed personnel to assist a physician and surgeon or clinical laboratory licensee with the performance of moderate- or high-complexity and immunohematology testing.
8. Prohibits unlicensed personnel from releasing the results of waived, moderate, or high-complexity testing.

COMMENTS

Background. Existing law limits the use of laboratory testing because the tests are generally used in the diagnostic process. The purpose of Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the California requirements is to minimize the risk of incorrect or unreliable results, patient harm during testing, and improper diagnoses, among other things. Existing law authorizes unlicensed personnel to perform laboratory activities under direct supervision, which is defined as personal observation and critical evaluation of the activity of unlicensed laboratory personnel by a physician and surgeon, or by a clinical laboratory licensee. This bill authorizes some of those tasks under supervision and control, which is defined to mean the supervisor is on site.

CLIA. At both the federal and state level, a facility or location where people perform laboratory tests on human specimens for diagnostic or assessment purposes must be certified under CLIA. While CLIA establishes the minimum standards under federal law, it allows states to establish more stringent requirements.

In all cases, the requirements for CLIA certification vary depending on the complexity of the laboratory tests performed. Clinical laboratories or other testing sites need to know whether each test system used is waived, moderate, or high complexity. In general, the more complicated the test, the more stringent the requirements, including increased training and licensing of laboratory personnel. At a minimum, all laboratories must have a licensed clinical laboratory director.

The FDA determines the complexity of laboratory tests under CLIA. Waived tests are simple tests with a low risk for an incorrect result. They include tests listed in the CLIA regulations, tests cleared by the FDA for home use, and tests approved for a waiver by the FDA using the CLIA criteria. Tests not classified as waived are assigned a moderate or high complexity category based on seven criteria given in the CLIA regulations, including ease of use, knowledge required, and types of materials tested. For commercially available FDA-cleared or approved tests, the test complexity is determined by the FDA during the pre-market approval process.

Under federal and California law, anyone providing direct care may perform a waived test in a federally certified laboratory or as part of a nondiagnostic health assessment program under the overall direction of a laboratory director, unless otherwise limited. In applying for a CLIA certificate of waiver, the laboratory director must list the types of analytes to be tested, the tests performed, and the test manufacturer. Existing law requires a laboratory director of a clinical laboratory to document the adequacy of the qualifications of any personnel in the laboratory, including educational background, training, and experience, of the personnel.

According to the Author

"California clinical laboratories have a unique workforce shortage applicable to licensed personnel due to a very narrow path to licensure. [This bill] proposes to update the rules governing what unlicensed personnel can do in a lab and expands the pathway to licensure for Clinical Laboratory Scientists. This will help alleviate the licensed workforce shortage in labs, improve laboratory testing capacity, and create new jobs in the industry and increase access to care."

Arguments in Support

Quest Diagnostics (co-sponsor) writes in support, "There is an acute shortage of licensed clinical laboratory scientists in California. This workforce shortage is adversely impacting CA laboratories' abilities to meet testing demand in a timely manner. The staffing challenges have been recognized by the California Department of Public Health (CDPH) Clinical Laboratory Technology Advisory Committee (CLTAC) which in 2022 formed the Laboratory Workforce Subcommittee tasked to study the issue and develop recommendations to improve the workforce shortage. Their report makes various recommendations which include updating licensing requirements and developing accelerated pathways to licensure. [This bill] would update licensing rules by expanding the activities that unlicensed personnel that meet Federal (CLIA) standards can perform under supervision of licensed personnel/physicians in order to meet testing demands. To provide an accelerated path to licensure, the bill would allow eighteen or more months of this experience as unlicensed personnel to count toward qualification for licensure."

The California Clinical Laboratories Association (CCLA) (co-sponsor) writes in support that this bill "will address critical workforce shortages of clinical laboratory personnel. CCLA is pleased to see that this bill expands the activities the unlicensed laboratory personnel can perform within a clinical laboratory, under the supervision of licensed personnel. Importantly, the bill also allows this work experience to be counted as qualification toward clinical laboratory licensure. This will 'level the playing field' as compared to out of state personnel who are able to count these hours towards licensure."

Arguments in Opposition

The California Association for Medical Laboratory Technology, California Labor Federation, California Nurses Association, California State Council of Service Employees International Union (SEIU California), International Federation of Professional and Technical Employees, Local 20, United Food and Commercial Workers Western States Council, and United Nurses Associations of California/Union of Health Care Professionals all write in opposition to the introduced version of this bill:

We have a number of concerns about the new personnel regime laid out in [this bill]. For example, one of the many concerning provisions of [this bill] would allow unlicensed staff to perform a range of tasks that may affect patient results, including instrument preventive maintenance, specimen collection and labeling, transcribing results, and performing waived testing. Under [this bill], these activities could all be done without the supervision from a trained clinical lab scientist, despite the licensure implications falling on the supervising professional. This is extremely concerning as transcription errors have the potential to cause significant patient harm.

Likewise, another provision of [this bill] would allow unlicensed staff to physically add test reactants to a specimen. We would argue that this provision allows for unlicensed personnel to perform analytical activity in contravention of licensure requirements under federal CLIA regulations. All the while, adding reactants to specimens is where sample mix-up errors are most common, particularly when personnel are working with more than one sample at a time.

The California Teamsters Public Affairs Council and Engineers and Scientists of California Local 20, IFPTE AFL-CIO & CLC write in opposition to the previous version of this bill:

The authors and sponsor Quest Diagnostics have claimed that this scope change is necessary given the shortage of qualified lab personnel across the State. We fundamentally disagree that diluting scope requirements does anything other than increase patient safety risks. Preventative maintenance often involves relying on analytical skills CLS' learn during their intensive education programs. Right now, Preventive maintenance requires more than "working knowledge"—the language used in [this bill] Preventive maintenance is a critical procedure that can affect accurate and reliable test results and requires a thorough understanding not only of the actual performance of the task, but also the reasons for performing in the designated manner as well as the potential repercussions of errors that could be made. This requires significant training, and therefore "working knowledge" remains insufficient for this task to be performed without direct supervision.

We offered the author and sponsor an amendment that would allow unlicensed personnel to wipe down analyzers and load them with reagents. Under current law, unlicensed personnel can already assist in preventative maintenance. We believe this expands and clarifies opportunities in labs for unlicensed workers without creating patient safety risks. It appears that the sponsor does not intend to take these amendments, and still would like unlicensed personnel to perform preventative maintenance of "ancillary laboratory equipment." For these reasons, we are still opposed to [this bill]

FISCAL COMMENTS

According to the Assembly Appropriations Committee:

Costs to the California Department of Public Health (CDPH) are minor and absorbable.

No costs to the Medical Board of California, the Osteopathic Medical Board, or the Podiatric Medical Board of California.

VOTES

ASM BUSINESS AND PROFESSIONS: 13-2-3

YES: Berman, Flora, Alanis, Alvarez, Dixon, Gipson, Grayson, Irwin, Jackson, Lowenthal, Stephanie Nguyen, Joe Patterson, Ting

NO: Lee, McKinnor

ABS, ABST OR NV: Bonta, Chen, McCarty

ASM APPROPRIATIONS: 15-0-1

YES: Holden, Megan Dahle, Bryan, Calderon, Wendy Carrillo, Dixon, Mike Fong, Hart, Lowenthal, Mathis, Papan, Pellerin, Robert Rivas, Sanchez, Weber

ABS, ABST OR NV: Ortega

UPDATED

VERSION: May 25, 2023

CONSULTANT: Vincent Chee / B. & P. / (916) 319-3301 FN: 0001003

ASSEMBLY THIRD READING

ATR Bill Id:AB 1741

Author:(Waldron)

As Amended Ver:April 27, 2023

Majority vote

SUMMARY

Lowers the level of supervision required for unlicensed laboratory personnel to perform specified activities and expands the scope of practice of the personnel in a licensed clinical laboratory.

Major Provisions

1. Defines "supervision and control" to mean direction, management, and awareness of the activity of unlicensed laboratory personnel by a physician and surgeon, or by a clinical laboratory licensee other than a trainee, who must be physically present in the laboratory and readily available for consultation during the entire time that the unlicensed laboratory personnel are engaged in laboratory duties.
2. Requires the laboratory director to designate a supervisor and to maintain overall responsibility for the supervision and performance of the unlicensed laboratory personnel.
3. Requires unlicensed personnel to additionally have documentation of the skills to perform waived testing before performing the specified activities requiring additional supervision, education, and training.
4. Lowers the supervision required for the following unlicensed activities from "direct and constant supervision" to "supervision and control":
   1. Biological specimen collection, including patient preparation, specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storage of specimens.
   2. Preventive maintenance.
   3. Preparation and storage of reagents and culture media.
   4. Transcribing results that have been previously recorded either manually by a physician and surgeon or clinical laboratory licensee or automatically by a testing instrument.
5. Authorizes unlicensed personnel to make primary and subsequent inoculations of test material onto appropriate culture media under "supervision and control."
6. Modifies the prohibition against unlicensed personnel performing any part of a test that involves the quantitative measurement of the specimen or test reagent, or any mathematical calculation relative to determining the results or the validity of a test, to allow them to perform the tests if they are assisting a physician and surgeon or clinical laboratory licensee, other than trainees, in a licensed clinical laboratory.
7. Authorizes unlicensed personnel to assist a physician and surgeon or clinical laboratory licensee with the performance of moderate- or high-complexity and immunohematology testing.
8. Prohibits unlicensed personnel from releasing the results of waived, moderate, or high-complexity testing.

COMMENTS

Background. Existing law limits the use of laboratory testing because the tests are generally used in the diagnostic process. The purpose of Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the California requirements is to minimize the risk of incorrect or unreliable results, patient harm during testing, and improper diagnoses, among other things. Existing law authorizes unlicensed personnel to perform laboratory activities under direct supervision, which is defined as personal observation and critical evaluation of the activity of unlicensed laboratory personnel by a physician and surgeon, or by a clinical laboratory licensee. This bill authorizes some of those tasks under supervision and control, which is defined to mean the supervisor is on site.

CLIA. At both the federal and state level, a facility or location where people perform laboratory tests on human specimens for diagnostic or assessment purposes must be certified under CLIA. While CLIA establishes the minimum standards under federal law, it allows states to establish more stringent requirements.

In all cases, the requirements for CLIA certification vary depending on the complexity of the laboratory tests performed. Clinical laboratories or other testing sites need to know whether each test system used is waived, moderate, or high complexity. In general, the more complicated the test, the more stringent the requirements, including increased training and licensing of laboratory personnel. At a minimum, all laboratories must have a licensed clinical laboratory director.

The FDA determines the complexity of laboratory tests under CLIA. Waived tests are simple tests with a low risk for an incorrect result. They include tests listed in the CLIA regulations, tests cleared by the FDA for home use, and tests approved for a waiver by the FDA using the CLIA criteria. Tests not classified as waived are assigned a moderate or high complexity category based on seven criteria given in the CLIA regulations, including ease of use, knowledge required, and types of materials tested. For commercially available FDA-cleared or approved tests, the test complexity is determined by the FDA during the pre-market approval process.

Under federal and California law, anyone providing direct care may perform a waived test in a federally certified laboratory or as part of a nondiagnostic health assessment program under the overall direction of a laboratory director, unless otherwise limited. In applying for a CLIA certificate of waiver, the laboratory director must list the types of analytes to be tested, the tests performed, and the test manufacturer. Existing law requires a laboratory director of a clinical laboratory to document the adequacy of the qualifications of any personnel in the laboratory, including educational background, training, and experience, of the personnel.

According to the Author

"California clinical laboratories have a unique workforce shortage applicable to licensed personnel due to a very narrow path to licensure. [This bill] proposes to update the rules governing what unlicensed personnel can do in a lab and expands the pathway to licensure for Clinical Laboratory Scientists. This will help alleviate the licensed workforce shortage in labs, improve laboratory testing capacity, and create new jobs in the industry and increase access to care."

Arguments in Support

Quest Diagnostics (co-sponsor) writes in support, "There is an acute shortage of licensed clinical laboratory scientists in California. This workforce shortage is adversely impacting CA laboratories' abilities to meet testing demand in a timely manner. The staffing challenges have been recognized by the California Department of Public Health (CDPH) Clinical Laboratory Technology Advisory Committee (CLTAC) which in 2022 formed the Laboratory Workforce Subcommittee tasked to study the issue and develop recommendations to improve the workforce shortage. Their report makes various recommendations which include updating licensing requirements and developing accelerated pathways to licensure. [This bill] would update licensing rules by expanding the activities that unlicensed personnel that meet Federal (CLIA) standards can perform under supervision of licensed personnel/physicians in order to meet testing demands. To provide an accelerated path to licensure, the bill would allow eighteen or more months of this experience as unlicensed personnel to count toward qualification for licensure."

The California Clinical Laboratories Association (CCLA) (co-sponsor) writes in support that this bill "will address critical workforce shortages of clinical laboratory personnel. CCLA is pleased to see that this bill expands the activities the unlicensed laboratory personnel can perform within a clinical laboratory, under the supervision of licensed personnel. Importantly, the bill also allows this work experience to be counted as qualification toward clinical laboratory licensure. This will 'level the playing field' as compared to out of state personnel who are able to count these hours towards licensure."

Arguments in Opposition

The California Association for Medical Laboratory Technology, California Labor Federation, California Nurses Association, California State Council of Service Employees International Union (SEIU California), International Federation of Professional and Technical Employees, Local 20, United Food and Commercial Workers Western States Council, and United Nurses Associations of California/Union of Health Care Professionals all write in opposition to the prior version of this bill:

We have a number of concerns about the new personnel regime laid out in [this bill]. For example, one of the many concerning provisions of [this bill] would allow unlicensed staff to perform a range of tasks that may affect patient results, including instrument preventive maintenance, specimen collection and labeling, transcribing results, and performing waived testing. Under [this bill], these activities could all be done without the supervision from a trained clinical lab scientist, despite the licensure implications falling on the supervising professional. This is extremely concerning as transcription errors have the potential to cause significant patient harm.

Likewise, another provision of [this bill] would allow unlicensed staff to physically add test reactants to a specimen. We would argue that this provision allows for unlicensed personnel to perform analytical activity in contravention of licensure requirements under federal CLIA regulations. All the while, adding reactants to specimens is where sample mix-up errors are most common, particularly when personnel are working with more than one sample at a time.

The California Teamsters Public Affairs Council and Engineers and Scientists of California Local 20, IFPTE AFL-CIO & CLC write in opposition:

The authors and sponsor Quest Diagnostics have claimed that this scope change is necessary given the shortage of qualified lab personnel across the State. We fundamentally disagree that diluting scope requirements does anything other than increase patient safety risks. Preventative maintenance often involves relying on analytical skills CLS' learn during their intensive education programs. Right now, Preventive maintenance requires more than "working knowledge"—the language used in [this bill] Preventive maintenance is a critical procedure that can affect accurate and reliable test results and requires a thorough understanding not only of the actual performance of the task, but also the reasons for performing in the designated manner as well as the potential repercussions of errors that could be made. This requires significant training, and therefore "working knowledge" remains insufficient for this task to be performed without direct supervision.

We offered the author and sponsor an amendment that would allow unlicensed personnel to wipe down analyzers and load them with reagents. Under current law, unlicensed personnel can already assist in preventative maintenance. We believe this expands and clarifies opportunities in labs for unlicensed workers without creating patient safety risks. It appears that the sponsor does not intend to take these amendments, and still would like unlicensed personnel to perform preventative maintenance of "ancillary laboratory equipment." For these reasons, we are still opposed to [this bill].

FISCAL COMMENTS

According to the Assembly Appropriations Committee:

Costs to the California Department of Public Health (CDPH) are minor and absorbable.

No costs to the Medical Board of California, the Osteopathic Medical Board, or the Podiatric Medical Board of California.

VOTES

ASM BUSINESS AND PROFESSIONS: 13-2-3

YES: Berman, Flora, Alanis, Alvarez, Dixon, Gipson, Grayson, Irwin, Jackson, Lowenthal, Stephanie Nguyen, Joe Patterson, Ting

NO: Lee, McKinnor

ABS, ABST OR NV: Bonta, Chen, McCarty

ASM APPROPRIATIONS: 15-0-1

YES: Holden, Megan Dahle, Bryan, Calderon, Wendy Carrillo, Dixon, Mike Fong, Hart, Lowenthal, Mathis, Papan, Pellerin, Robert Rivas, Sanchez, Weber

ABS, ABST OR NV: Ortega

UPDATED

VERSION: April 27, 2023

CONSULTANT: Vincent Chee / B. & P. / (916) 319-3301 FN: 0000413

Date of Hearing: May 17, 2023

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Chris Holden, Chair

ABPCA Bill Id:AB 1741

Author:(Waldron) – As Amended Ver:April 27, 2023

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

SUMMARY:

This bill allows unlicensed personnel in a clinical laboratory, under the direct and constant supervision of a physician or licensed person, to perform specified tasks.

Specifically, this bill allows unlicensed personnel to do the following, among other things:

1. In the case of qualitative and semiquantitative “spot, tablet, or stick” tests, add the test reagent to the specimen (results must be read by a physician or licensed person).
2. Perform biological specimen collection, including patient preparation, specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storage of specimens, unless the collection activities require a certificate or license.
3. Perform preventive maintenance. 
4. Prepare and store reagents and culture media.
5. Transcribe results that have been previously recorded, either manually by a physician or licensed personnel, or automatically by a testing instrument, with verification by the physician or licensed personnel who reported the test. 
6. Make inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media for microbiological tests.

FISCAL EFFECT:

Costs to the California Department of Public Health (CDPH) are minor and absorbable.

No costs to the Medical Board of California, the Osteopathic Medical Board, or the Podiatric Medical Board of California.

COMMENTS:

1. Purpose. This bill is sponsored by Quest Diagnostics Incorporated and the California Clinical Laboratories Association. According to the author:

California clinical laboratories have a unique workforce shortage applicable to licensed personnel due to a very narrow path to licensure. AB 1741 proposes to update the rules governing what unlicensed personnel can do in a lab and expands the pathway to licensure for Clinical Laboratory Scientists. This will help alleviate the licensed workforce shortage in labs, improve laboratory testing capacity, and create new jobs in the industry and increase access to care.

1. Background. Existing law limits the use of laboratory testing by unlicensed personnel because the tests are generally used in the diagnostic process and requirements are intended to minimize the risk of incorrect or unreliable results, patient harm during testing, and improper diagnoses, among other things. Existing law authorizes unlicensed personnel to perform laboratory activities under direct supervision, which is defined as personal observation and critical evaluation of the activity of unlicensed laboratory personnel by a physician, or by a clinical laboratory licensee. This bill authorizes some of those tasks under supervision and control, which is defined to mean the supervisor is on site.

The author states CDPH’s Clinical Laboratory Technology Advisory Committee (CLTAC) created a California Laboratory Workforce Subcommittee to study the staffing challenges to the laboratory industry. In December 2022, the Workforce Subcommittee issued a preliminary white paper, which included recommendations that CDPH update regulations pertaining to training programs, trainee-licensee ratios, and licensing requirements; and develop accelerated pathways to Clinical Laboratory Scientist (CLS) licensure. The author notes CLTAC did not adopt the white paper at CLTAC’s March 2023 meeting.

1. Prior Related Legislation. SB 334 (Pan), Chapter 144, Statutes of 2019, required CDPH to develop a medical laboratory technician to clinical laboratory scientist pathway to allow work experience in a lab to count towards licensure as a clinical laboratory scientist (CLS) by January 1, 2022.

Analysis Prepared by: Allegra Kim / APPR. / (916) 319-2081

Date of Hearing:

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Marc Berman, Chair

ABPCA Bill Id:AB 1741

Author:(Waldron) – As Introduced Ver:February 17, 2023

SUBJECT: Healing arts: clinical laboratories: personnel.

SUMMARY: Lowers the level of supervision required for unlicensed laboratory personnel to perform specified activities, and expands the scope of practice of the personnel in a licensed clinical laboratory, and allows 18 months of those activities to qualify for licensure as a clinical laboratory scientist.

EXISTING LAW:

1. Defines “CLIA” as the federal Clinical Laboratory Improvement Amendments of 1988 and the relevant regulations adopted by the federal Health Care Financing Administration that are also adopted by the California Department of Public Health (CDPH). (BPC Business and Professions Code (BPC) § 1202.5(a))
2. Regulates clinical laboratories and the performance of clinical laboratory tests through the licensing of clinical laboratories and laboratory directors, scientists, and other laboratory personnel under the CDPH and CLIA. (BPC §§ 1200-1327)
3. Defines “clinical laboratory test or examination” means the detection, identification, measurement, evaluation, correlation, monitoring, and reporting of any particular analyte, entity, or substance within a biological specimen for the purpose of obtaining scientific data that may be used as an aid to ascertain the presence, progress, and source of a disease or physiological condition in a human being, or used as an aid in the prevention, prognosis, monitoring, or treatment of a physiological or pathological condition in a human being, or for the performance of nondiagnostic tests for assessing the health of an individual. (BPC § 1206(a)(5))
4. Defines “clinical laboratory” as a place or organization used for the performance of clinical laboratory tests or examinations or the practical application of the clinical laboratory sciences. (BPC § 1206(a)(8))
5. Requires every clinical laboratory to have a laboratory director who is responsible for the overall operation and administration of the clinical laboratory, including (1) administering the technical and scientific operation of a clinical laboratory, the selection and supervision of procedures, the reporting of results, and active participation in its operations to the extent necessary to ensure compliance with state clinical laboratory laws and CLIA, (2) the proper performance of all laboratory work of all subordinates, and (3) employing a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests, and report test results in accordance with the personnel qualifications, duties, and responsibilities described in CLIA and state clinical laboratory laws. (BPC § 1209(d)(1))
6. Defines “direct and constant supervision” as personal observation and critical evaluation of the activity of unlicensed laboratory personnel by a physician and surgeon, or by a clinical laboratory licensee other than a trainee, during the entire time that unlicensed laboratory personnel are engaged in specified laboratory activities that require additional supervision, education, and training. (BPC §§ 1206(a)(9), 1269)
7. Defines “unlicensed laboratory personnel” as a laboratory aide, histocompatibility technician, cardiopulmonary technician, or other person performing authorized unlicensed activities. (BPC § 1212)
8. Authorizes unlicensed laboratory personnel to perform additional activities in a licensed clinical laboratory under the direct and constant supervision of a physician and surgeon or a clinical laboratory licensee other than a trainee if they meet all of the following criteria:
   1. Have earned a high school diploma, or its equivalent. (BPC § 1269(a)(1))
   2. Have documentation of training appropriate to ensure that the individual has all of the following skills and abilities:
      1. The skills required for proper specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens. (BPC § 1269(a)(2)(A))
      2. The skills required for assisting a physician and surgeon or a clinical laboratory licensee, other than a trainee, in a licensed clinical laboratory. (BPC § 1269(a)(2)(B))
      3. The skills required for performing preventive maintenance and troubleshooting. (BPC § 1269(a)(2)(C))
      4. A working knowledge of reagent stability and storage. (BPC § 1269(a)(2)(D))
      5. The skills required for assisting in the performance of quality control procedures and an understanding of the quality control policies of the laboratory. (BPC § 1269(a)(2)(E))
      6. An awareness of the factors that influence test results. (BPC § 1269(a)(2)(F))
9. Authorizes unlicensed personnel who meet the specified education and training criteria to perform the following activities under direct and constant supervision:
   1. Biological specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens. (BPC § 1269(b)(1))
   2. Assisting a physician and surgeon or a clinical laboratory licensee, other than a trainee, in a licensed clinical laboratory. (BPC § 1269(b)(2))
   3. Assisting in preventive maintenance, and troubleshooting. (BPC § 1269(b)(3))
   4. Preparation and storage of reagents and culture media. (BPC § 1269(b)(4))
   5. Assisting in the performance of quality control procedures. (BPC § 1269(b)(5))
10. Authorizes unlicensed personnel to, under the supervision and control of a physician and surgeon or clinical laboratory licensee, perform specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storing if they have a high school diploma or its equivalent and documentation of the skills necessary to perform those activities, and. (BPC § 1269(c))
11. Prohibits unlicensed laboratory personnel from doing any of the following:
    1. Recording test results, except they may transcribe results that have been previously recorded either manually by a physician and surgeon or licensed laboratory personnel or automatically by a testing instrument. (BPC § 1269(d)(1))
    2. Performing any part of a test that involves the quantitative measurement of the specimen or test reagent, or any mathematical calculation relative to determining the results or the validity of a test procedure. (BPC § 1269(d)(2))
    3. Performing any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation. (BPC § 1269(d)(3))
12. Limits the activities unlicensed laboratory personnel may perform when using the following manual methods:
    1. In the case of qualitative and semi-quantitative “spot, tablet, or stick” tests, the personnel may add the test reagent to the specimen or vice versa, but the results must be read by a physician and surgeon or clinical laboratory licensee. (BPC § 1269(e)(1))
    2. In the case of microbiological tests, the unlicensed laboratory personnel may make primary inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media. (BPC § 1269(e)(2))
13. Prohibits unlicensed laboratory personnel from performing the following activities when using any of the following mechanical or electronic instruments:
    1. Standardizing or calibrating the instrument or assessing its performance by monitoring results of appropriate standards and control. (BPC § 1269(f)(1))
    2. Reading or recording test results, except that the personnel may transcribe results that have been previously recorded automatically by a testing instrument. (BPC § 1269(f)(2))
    3. Quantitatively measuring any sample or reagents unless done automatically by the instrument in the course of its normal operation or by the use of previously calibrated and approved automatic syringes or other dispensers. (BPC § 1269(f)(3))

THIS BILL:

1. Defines “supervision and control” to mean there is a qualified supervisor who:
   1. Is a physician and surgeon or clinical laboratory licensee other than a certified phlebotomy technician or licensed trainee.
   2. Is designated by the laboratory director to provide supervision.
   3. Is physically present onsite at the location where the unlicensed person is working.
   4. Is available for consultation as needed.
2. Counts experience as an unlicensed person performing the specified activities requiring additional supervision, education, and training in a licensed laboratory for at least 18 months towards licensure as a clinical laboratory scientist or a limited clinical laboratory scientist.
3. Authorizes an applicant for a specialty limited clinical scientist license to use eighteen months of full-time training or experience as an unlicensed person performing the specified activities requiring additional supervision, education, and training in a licensed laboratory appropriate to the field for which the license is being sought.
4. Requires unlicensed personnel to additionally have documentation of the skills to perform waived testing before performing the specified activities requiring additional supervision, education, and training.
5. Lowers the supervision required for the following unlicensed activities from “direct and constant supervision” to “supervision and control”:
   1. Biological specimen collection, including patient preparation, specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storage of specimens.
   2. Preventive maintenance.
   3. Preparation and storage of reagents and culture media.
   4. Transcribing results that have been previously recorded either manually by a physician and surgeon or clinical laboratory licensee or automatically by a testing instrument.
6. Authorizes unlicensed laboratory personnel to, under “supervision and control,” but not under “direct and constant supervision,” make subsequent inoculations of test material, rather than just primary inoculations.
7. Removes the limitations related to specified manual methods for activities performed under “direct and constant supervision,” applies them to the activities performed under “supervision and control,” and loosens the limitations to allow unlicensed laboratory personnel to make subsequent inoculations of test material onto appropriate culture media, rather than just primary inoculations.
8. Modifies the prohibition against unlicensed personnel performing any part of a test that involves the quantitative measurement of the specimen or test reagent, or any mathematical calculation relative to determining the results or the validity of a test, to allow them to perform the tests if they are assisting a physician and surgeon or clinical laboratory licensee, other than trainees, in a licensed clinical laboratory.
9. Deletes the prohibition against unlicensed personnel performing any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation.
10. Authorizes unlicensed personnel to perform any waived testing under supervision and control, but requires the results to be read by a physician and surgeon or clinical laboratory licensee.
11. Authorizes unlicensed personnel to assist a physician and surgeon or clinical laboratory licensee with the performance of moderate- or high-complexity testing.
12. Prohibits unlicensed personnel from releasing the results of waived, moderate, or high-complexity testing.

FISCAL EFFECT: Unknown. This bill is keyed fiscal by the Legislative Counsel.

COMMENTS:

Purpose. This bill is co-sponsored by Quest Diagnostics Incorporated and the California Clinical Laboratories Association. According to the author, “California clinical laboratories have a unique workforce shortage applicable to licensed personnel due to a very narrow path to licensure. [This bill] proposes to update the rules governing what unlicensed personnel can do in a lab and expands the pathway to licensure for Clinical Laboratory Scientists. This will help alleviate the licensed workforce shortage in labs, improve laboratory testing capacity, and create new jobs in the industry and increase access to care.”

Background. Existing law limits the use of laboratory testing because the tests are generally used in the diagnostic process. The purpose of CLIA and the California requirements is to minimize the risk of incorrect or unreliable results, patient harm during testing, and improper diagnoses, among other things. Existing law authorizes unlicensed personnel to perform laboratory activities under direct supervision, which is defined as personal observation and critical evaluation of the activity of unlicensed laboratory personnel by a physician and surgeon, or by a clinical laboratory licensee. This bill authorizes some of those tasks under supervision and control, which is defined to mean the supervisor is on site.

CLIA. At both the federal and state level, a facility or location where people perform laboratory tests on human specimens for diagnostic or assessment purposes must be certified under CLIA. While CLIA establishes the minimum standards under federal law, it allows states to establish more stringent requirements.

In all cases, the requirements for CLIA certification vary depending on the complexity of the laboratory tests performed. Clinical laboratories or other testing sites need to know whether each test system used is waived, moderate, or high complexity. In general, the more complicated the test, the more stringent the requirements, including increased training and licensing of laboratory personnel. At a minimum, all laboratories must have a licensed clinical laboratory director.

The FDA determines the complexity of laboratory tests under CLIA. Waived tests are simple tests with a low risk for an incorrect result. They include tests listed in the CLIA regulations, tests cleared by the FDA for home use, and tests approved for a waiver by the FDA using the CLIA criteria. Tests not classified as waived are assigned a moderate or high complexity category based on seven criteria given in the CLIA regulations, including ease of use, knowledge required, and types of materials tested. For commercially available FDA-cleared or approved tests, the test complexity is determined by the FDA during the pre-market approval process.

Under federal and California law, anyone providing direct care may perform a waived test in a federally certified laboratory or as part of a nondiagnostic health assessment program under the overall direction of a laboratory director, unless otherwise limited. In applying for a CLIA certificate of waiver, the laboratory director must list the types of analytes to be tested, the tests performed, and the test manufacturer. Existing law requires a laboratory director of a clinical laboratory to document the adequacy of the qualifications of any personnel in the laboratory, including educational background, training, and experience, of the personnel.

Prior Related Legislation. SB 334 (Pan), Chapter 144, Statutes of 2019, required CDPH to develop a medical laboratory technician to clinical laboratory scientist pathway to allow work experience in a lab to count towards licensure as a clinical laboratory scientist by January 1, 2022.

ARGUMENTS IN SUPPORT:

Quest Diagnostics (co-sponsor) writes in support, “There is an acute shortage of licensed clinical laboratory scientists in California. This workforce shortage is adversely impacting CA laboratories' abilities to meet testing demand in a timely manner. The staffing challenges have been recognized by the California Department of Public Health (CDPH) Clinical Laboratory Technology Advisory Committee (CLTAC) which in 2022 formed the Laboratory Workforce Subcommittee tasked to study the issue and develop recommendations to improve the workforce shortage. Their report makes various recommendations which include updating licensing requirements and developing accelerated pathways to licensure. [This bill] would update licensing rules by expanding the activities that unlicensed personnel that meet Federal (CLIA) standards can perform under supervision of licensed personnel/physicians in order to meet testing demands. To provide an accelerated path to licensure, the bill would allow eighteen or more months of this experience as unlicensed personnel to count toward qualification for licensure.”

The California Clinical Laboratories Association (CCLA) (co-sponsor) writes in support that this bill “will address critical workforce shortages of clinical laboratory personnel. CCLA is pleased to see that this bill expands the activities the unlicensed laboratory personnel can perform within a clinical laboratory, under the supervision of licensed personnel. Importantly, the bill also allows this work experience to be counted as qualification toward clinical laboratory licensure. This will ‘level the playing field’ as compared to out of state personnel who are able to count these hours towards licensure.”

ARGUMENTS IN OPPOSITION:

The California Association for Medical Laboratory Technology, California Labor Federation, California Nurses Association, California State Council of Service Employees International Union (SEIU California), California Teamsters Public Affairs Council, Engineers and Scientists of California Local 20, IFPTE AFL-CIO & CLC, International Federation of Professional and Technical Employees, Local 20, United Food and Commercial Workers Western States Council, and United Nurses Associations of California/Union of Health Care Professionals all write in opposition:

We have a number of concerns about the new personnel regime laid out in [this bill]. For example, one of the many concerning provisions of [this bill] would allow unlicensed staff to perform a range of tasks that may affect patient results, including instrument preventive maintenance, specimen collection and labeling, transcribing results, and performing waived testing. Under [this bill], these activities could all be done without the supervision from a trained clinical lab scientist, despite the licensure implications falling on the supervising professional. This is extremely concerning as transcription errors have the potential to cause significant patient harm.

Likewise, another provision of [this bill] would allow unlicensed staff to physically add test reactants to a specimen. We would argue that this provision allows for unlicensed personnel to perform analytical activity in contravention of licensure requirements under federal CLIA regulations. All the while, adding reactants to specimens is where sample mix-up errors are most common, particularly when personnel are working with more than one sample at a time.

POLICY ISSUES FOR CONSIDERATION:

1. Influence of Employer. Under CLIA, the laboratory director is responsible for the overall direction of a laboratory. However, the opposition raises concerns about an employer's influence over a supervisor tasked with supervising an unlicensed person.
2. Preventive Maintenance. This bill would allow unlicensed personnel to perform preventive maintenance of instruments and equipment under indirect supervision, meaning a supervisor is not directly supervising them at the time the maintenance is performed. The opposition notes that there are some preventive maintenance functions that an unlicensed could never perform.
3. Reagent Safety. This bill would allow unlicensed personnel to prepare reagents under indirect supervision. The opposition notes that there are dangerous combinations of chemicals or other hazards.
4. Transcription. This bill would allow unlicensed personnel to transcribe results under indirect supervision. The opposition notes that there could be transcription errors.
5. Spot, tablet, or stick tests. This bill would allow unlicensed personnel to add reagents to qualitative and semiquantitative “spot, tablet, or stick” tests under indirect supervision so long as a physician or licensee reads the results. The opposition notes that there are tests that are time sensitive and would not make sense for the unlicensed person to perform the test and have the physician or licensee to rush and read the result.

IMPLEMENTATION ISSUES:

18-Month Experience Qualification. According to CDPH staff, this bill “would require CDPH to accept experience obtained as unlicensed laboratory personnel toward clinical laboratory scientist and limited clinical laboratory scientist licensure. It would be difficult for CDPH to implement this because the duties authorized for unlicensed personnel do not meet the requirements for experience and training acceptable for CLS licensure in other state statutes.”

AMENDMENTS:

To address the above concerns:

Clarify that the laboratory director is ultimately responsible for the supervision, training, and performance of the unlicensed person.

Delete section 2 of the bill regarding the 18 month license requirement.

Clarify that unlicensed personnel must have documented training to ensure that they have:

The skills and working knowledge for performing preventive maintenance

A working knowledge of reagent safety requirements related to chemical, biochemical, and electrical hazards and biohazardous materials.

A working knowledge of the medical terminology necessary for the transcription of results.

Put spot, tablet, or stick tests back under direct supervision.

Clarify that specimen collection and related duties do not include activities that require a license or certificate.

Require transcribed results to be verified by the licensee reporting the results (existing law allows unlicensed personnel to do it without any verification).

Delete waived testing.

Prohibit immunohematology except when assisting a licensee under direct supervision.

Make technical and conforming changes.

On page 6, after line 15:

(19) (A) “Supervision and control” means direction, management, and awareness of the activity of unlicensed laboratory personnel by a physician and surgeon, or by a person licensed under this chapter other than a trainee, who must be physically present in the laboratory and readily available for consultation during the entire time that the unlicensed laboratory personnel are engaged in the duties specified in Section 1269.

(B) The laboratory director shall designate the supervisor and shall maintain overall responsibility for the supervision and performance of the unlicensed laboratory personnel.

a qualified supervisor who is a physician and surgeon licensed under Chapter 5 (commencing with Section 2000) or a person licensed under Chapter 3 (commencing with Section 1200), other than a certified phlebotomy technician or a licensed trainee, is designated by the laboratory director to provide supervision, and is physically present onsite at the location where the unlicensed person is working. The supervisor shall be available for consultation as needed.

On page 6, after line 38:

Strike section 2 of the bill.

On page 10, after line 6:

1269. (a) (1) Unlicensed laboratory personnel may perform any of the activities identified in subdivision (b) under the direct and constant supervision of, or any of the activities identified in subdivision (c) under the supervision and control of, a physician and surgeon, or a person licensed under this chapter other than a trainee, in a clinical laboratory upon meeting all of the following criteria:

(1) (A) Have earned a high school diploma, or its equivalent, as determined by HCFA under CLIA.

(2) (B) Have documentation of training appropriate to ensure that the individual has all of the following skills and abilities:

(A) (i) The skills required for proper specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens.

(B) (ii) The skills required for assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory.

(C) (iii) The skills and working knowledge required for performing preventive maintenance, maintenance and troubleshooting.

(D) (iv) A working knowledge of reagent stability and storage. stability, storage, and safety requirements related to chemical, biochemical, and electrical hazards and biohazardous materials.

(E) (v) The skills required for assisting in the performance of quality control procedures, and an understanding of the quality control policies of the laboratory.

(F) (vi) An awareness of the factors that influence test results.

(vii) A working knowledge of the medical terminology necessary for the transcription of results.

(G) The skills to perform waived testing.

(2) The laboratory director shall maintain responsibility for the performance of unlicensed laboratory personnel and any delegated supervision or training of the unlicensed personnel.

(b) (1) The activities that may be performed under direct and constant supervision are:

(1) (A) (i) Assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory. laboratory with the performance of moderate- or high-complexity testing.

(ii) In the case of qualitative and semiquantitative “spot, tablet, or stick” tests, the personnel may add the test reagent to the specimen or vice versa, but the results must be read by a physician and surgeon or person licensed under this chapter.

(2) (B) Assisting in troubleshooting.

(3) (C) Assisting in the performance of quality control procedures.

(c) An unlicensed Unlicensed laboratory personnel personnel, other than a trainee, may, under the supervision and control of a physician and surgeon or person licensed under this chapter, do all of the following activities:

(1) Perform biological specimen collection, including patient preparation, specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storage of

specimens. specimens if the collection activities do not require a certificate or license under this division.

(2) Perform preventive maintenance.

(3) Preparation and storage of reagents and culture media.

(4) Transcribe results that have been previously recorded, either manually by a physician and surgeon or personnel licensed under this chapter, or automatically by a testing instrument. instrument, with documented verification by the physician and surgeon or licensed personnel who reports the test.

(5) Perform waived testing, but the results shall be read by a physician and surgeon or person licensed under this chapter.

(6) When any of the following manual methods are employed, the activities shall be limited as follows:

(A) In the case of qualitative and semiquantitative “spot, tablet, or stick” tests, the personnel may add the test reagent to the specimen or vice versa, but the results must be read by a physician and surgeon or person licensed under this chapter.

(B) In the case of microbiological tests, the unlicensed laboratory personnel may make (5) Make primary or subsequent inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media. media for microbiological tests.

(d) Unlicensed laboratory personnel shall not do any of the following:

(1) Record test results, but they may transcribe results that have been previously recorded, either manually by a physician and surgeon or personnel licensed under this chapter, or automatically by a testing instrument. except as authorized under paragraph (4) of subdivisioin (c).

(2) Perform any test or part thereof that involves the quantitative measurement of the specimen or test reagent, or any mathematical calculation relative to determining the results or the validity of a test procedure, unless they are assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory.

(3) Perform any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation, unless they are assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory.

(3) Release results of waived, moderate, or high-complexity testing.

(e) When any of the following manual methods are employed, the activities of unlicensed laboratory personnel shall be limited as follows:

(1) In the case of qualitative and semi-quantitative “spot, tablet, or stick” tests, the personnel may add the test reagent to the specimen or vice versa, but the results must be read by a physician and surgeon or person licensed under this chapter.

(2) In the case of microbiological tests the unlicensed laboratory personnel may make primary inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media.

(f) When any of the following mechanical or electronic instruments are employed, unlicensed laboratory personnel shall not perform any of the following activities:

(1) Standardizing or calibrating the instrument or assessing its performance by monitoring results of appropriate standards and control.

(2) Reading or recording test results, except that the personnel may transcribe results that have been previously recorded automatically by a testing instrument. as authorized under paragraph (4) of subdivisioin (c).

REGISTERED SUPPORT:

Quest Diagnostics Incorporated (co-sponsor)

California Clinical Laboratory Association (co-sponsor)

California Life Sciences

REGISTERED OPPOSITION:

California Association for Medical Laboratory Technology

California Labor Federation

California Nurses Association

California State Council of Service Employees International Union (seiu California)

California Teamsters Public Affairs Council

Democratic Club of Claremont

Engineers and Scientists of California Local 20, Ifpte Afl-cio & Clc

International Federation of Professional and Technical Employees, Local 20

The United Food and Commercial Workers Western States Council

United Nurses Associations of California/Union of Health Care Professionals

One Individual CLS

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