Existing law requires the State Department of Public Health to license, inspect, and regulate clinical laboratories and specified clinical laboratory personnel. Existing law requires a clinical laboratory, as defined, performing clinical laboratory tests or examinations classified as of moderate or of high complexity under the federal Clinical Laboratory Improvement Amendments (CLIA) to obtain a clinical laboratory license, as specified. Existing law requires a separate license or registration to be obtained for each laboratory location, except for, among other things, laboratories that are not at a fixed location, as specified.

This bill would authorize, upon determination by the department that the authorization conforms to federal law, practice by a pathologist who is performing pathology services at a primary laboratory site licensed by the state to review digital materials, as defined, at a remote location under a primary sites CLIA certificate. The bill would require the department, on or before June 30, 2025, to consult with the federal Centers for Medicare and Medicaid Services and would require the department to make a determination on or before January 1, 2026, for those purposes. This bill would require the department, if it determines that the authorization conforms to federal law, to communicate its determination to the Legislature and the Legislative Counsel Bureau. The bill would classify a location where digital materials are accessed by pathologists through virtual private networks, or other secure method, to be an extension of a primary sites CLIA certificate and would prohibit that remote location from requiring a separate license or registration, consistent with the interpretation of CLIA regulations by the federal Centers for Medicare and Medicaid Services guidelines, as specified.

Existing law requires the State Department of Public Health to license, inspect, and regulate clinical laboratories and specified clinical laboratory personnel. Existing law requires a clinical laboratory, as defined, performing clinical laboratory tests or examinations classified as of moderate or of high complexity under the federal Clinical Laboratory Improvement Amendments (CLIA) to obtain a clinical laboratory license, as specified. Existing law requires a separate license or registration to be obtained for each laboratory location, except for, among other things, laboratories that are not at a fixed location, as specified.

This bill would authorize, upon determination by the department that the authorization conforms to federal law, practice by a pathologist who is performing pathology services at a primary laboratory site licensed by the state to review digital materials, as defined, at a remote location under a primary sites CLIA certificate. The bill would require the department, on or before June 30, 2025, to consult with the federal Centers for Medicare and Medicaid Services and would require the department to make a determination on or before January 1, 2026, for those purposes. This bill would require the department, if it determines that the authorization conforms to federal law, to communicate its determination to the Legislature and the Legislative Counsel Bureau. The bill would classify a location where digital materials are accessed by pathologists through virtual private networks, or other secure method, to be an extension of a primary sites CLIA certificate and would prohibit that remote location from requiring a separate license or registration, consistent with the interpretation of CLIA regulations by the federal Centers for Medicare and Medicaid Services guidelines, as specified.

Existing law requires the State Department of Public Health to license, inspect, and regulate clinical laboratories and specified clinical laboratory personnel. Existing law requires a clinical laboratory, as defined, performing clinical laboratory tests or examinations classified as of moderate or of high complexity under the federal Clinical Laboratory Improvement Amendments (CLIA) to obtain a clinical laboratory license, as specified. Existing law requires a separate license or registration to be obtained for each laboratory location, except for, among other things, laboratories that are not at a fixed location, as specified.

This bill would authorize practice, authorize, upon determination by the department that the authorization conforms to federal law, practice by a pathologist who is performing pathology services at a primary laboratory site licensed by the state to review digital materials, as defined, at a remote location under a primary sites CLIA certificate. The bill would require the department, on or before June 30, 2025, to consult with the federal Centers for Medicare and Medicaid Services and would require the department to make a determination on or before January 1, 2026, for those purposes. This bill would require the department, if it determines that the authorization conforms to federal law, to communicate its determination to the Legislature and the Legislative Counsel Bureau. The bill would classify a location where digital materials are accessed by pathologists through virtual private networks, or other secure method, to be an extension of a primary sites CLIA certificate and would prohibit that remote location from requiring a separate license or registration, consistent with the interpretation of CLIA regulations by the federal Centers for Medicare and Medicaid Services guidelines, as specified.

Existing law requires the State Department of Public Health to license, inspect, and regulate clinical laboratories and specified clinical laboratory personnel. Existing law requires a clinical laboratory, as defined, performing clinical laboratory tests or examinations classified as of moderate or of high complexity under the federal Clinical Laboratory Improvement Amendments (CLIA) to obtain a clinical laboratory license, as specified. Existing law requires a separate license or registration to be obtained for each laboratory location, except for, among other things, laboratories that are not at a fixed location, as specified.

This bill would authorize pathologists acting within their scope of practice practice, a pathologist who is performing pathology services at a primary laboratory site licensed by the state to review digital materials, as defined, at a remote location under a primary sites CLIA certificate. The bill would require classify a location where digital materials are accessed by pathologists through virtual private networks, or other secure method, to be an extension of a primary sites CLIA certificate and would prohibit that remote location from requiring a separate license or registration, consistent with the interpretation of CLIA regulations by the federal Centers for Medicare and Medicaid Services guidelines, as specified.

Existing law requires the State Department of Public Health to license, inspect, and regulate clinical laboratories and specified clinical laboratory personnel. Existing law requires a clinical laboratory, as defined, performing clinical laboratory tests or examinations classified as of moderate or of high complexity under the federal Clinical Laboratory Improvement Amendments (CLIA) to obtain a clinical laboratory license, as specified. Existing law requires a separate license or registration to be obtained for each laboratory location, except for, among other things, laboratories that are not at a fixed location, as specified.

This bill would authorize pathologists and licensed laboratory personnel acting within their scope of practice to review digital materials, as defined, at a remote location under a primary sites CLIA certificate if CLIA requirements are met. The bill would authorize a clinical laboratory to utilize a temporary or intermittent site for remote review and for reporting of digital materials if the designated primary site or home base is certified under CLIA and the work being performed in the temporary or intermittent site falls within the parameters of the primary sites CLIA certificate. The bill would authorize pathologists and licensed laboratory personnel to remotely review digital materials if the digital materials are related to their ordinary course of onsite work. certificate. The bill would require a location where digital materials are accessed by pathologists through virtual private networks, or other secure method, to be an extension of a primary sites CLIA certificate and prohibit that remote location from requiring a separate license or registration, consistent with the interpretation of CLIA regulations by the federal Centers for Medicare and Medicaid Services guidelines, as specified.

Existing law requires the State Department of Public Health to license, inspect, and regulate clinical laboratories and specified clinical laboratory personnel. Existing law requires a clinical laboratory, as defined, performing clinical laboratory tests or examinations classified as of moderate or of high complexity under the federal Clinical Laboratory Improvement Amendments (CLIA) to obtain a clinical laboratory license license, as specified. Existing law requires a separate license or registration to be obtained for each laboratory location, except for, among other things, laboratories that are not at a fixed location location, as specified.

This bill would authorize pathologists and licensed laboratory personnel acting within their scope of practice to review digital clinical laboratory data, digital results, and digital images materials, as defined, at a remote location under a primary sites CLIA certificate if CLIA requirements are met. The bill would authorize a clinical laboratory to utilize a temporary or intermittent site for remote review and for reporting of digital clinical laboratory data, digital results, and digital images materials if the designated primary site or home base is certified under CLIA and the work being performed in the temporary or intermittent site falls within the parameters of the primary sites CLIA certificate. The bill would authorize pathologists and licensed laboratory personnel to remotely review digital materials if the digital materials are related to their ordinary course of onsite work.

Existing law requires the State Department of Public Health to license, inspect, and regulate clinical laboratories and specified clinical laboratory personnel. Existing law requires a clinical laboratory, as defined, performing clinical laboratory tests or examinations classified as of moderate or of high complexity under the federal Clinical Laboratory Improvement Amendments (CLIA) to obtain a clinical laboratory license as specified. Existing law requires a separate license or registration to be obtained for each laboratory location, except for, among other things, laboratories that are not at a fixed location as specified.

This bill would authorize pathologists and laboratory personnel acting within their scope of practice to review digital clinical laboratory data, digital results, and digital images at a remote location under a primary sites CLIA certificate if CLIA requirements are met. The bill would authorize a clinical laboratory to utilize a temporary site for remote review and for reporting of digital slides clinical laboratory data, digital results, and digital images if the designated primary site or home base is certified under CLIA and the work being performed in the temporary site falls within the parameters of the primary sites CLIA certificate.

Existing law requires the State Department of Public Health to license, inspect, and regulate clinical laboratories and specified clinical laboratory personnel. Existing law requires a clinical laboratory, as defined, performing clinical laboratory tests or examinations classified as of moderate or of high complexity under the federal Clinical Laboratory Improvement Amendments (CLIA) to obtain a clinical laboratory license as specified. Existing law requires a separate license or registration to be obtained for each laboratory location, except for, among other things, laboratories that are not at a fixed location as specified.

This bill would authorize pathologists and laboratory personnel to review digital clinical laboratory data, digital results, and digital images at a remote location under a primary sites CLIA certificate if CLIA requirements are met. The bill would authorize a clinical laboratory to utilize a temporary site for remote review and for reporting of digital slides if the designated primary site or home base is certified under CLIA and the work being performed in the temporary site falls within the parameters of the primary sites CLIA certificate.

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 2107

Author:(Chen)

As Amended Ver:August 20, 2024

Majority vote

SUMMARY

Authorizes pathologists who review and report digital materials to do so from a remote location.

Senate Amendments

Make the authority contingent upon a determination by the Department of Public Health that the provisions of this bill comply with federal law.

COMMENTS

Background. 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 the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA). While CLIA establishes the minimum standards under federal law, it allows states to establish more stringent requirements. The purpose of CLIA and the state requirements is to minimize the risk of incorrect or unreliable results, patient harm during testing, and improper diagnoses, among other things. Laboratories are licensed and regulated by the California Department of Public Health.

Both CLIA and state law require ordinarily require the performance of laboratory tests, which includes the review and reporting of the test results, to be done in a licensed clinical laboratory. The purpose of the requirement is to ensure that the proper equipment and protocols needed to ensure accuracy and quality are in place.

This bill would authorize California laboratories to allow remote reviewing and reporting of digital materials if federal CLIA requirements are met. CLIA, pursuant to Centers for Medicare and Medicaid Services (CMS) guidance, allows remote reviewing and reporting by pathologists and other laboratory personnel of digital materials, defined as digital laboratory data, digital results, and digital images.

Specifically, CMS allows laboratories to allow staff to remotely review digital materials if the following criteria are met:

1. The primary, home site, laboratory has a current, unrevoked or unsuspended certificate of waiver, registration certificate, certificate of compliance, certificate for provider-performed microscopy procedures, or certificate of accreditation issued by the federal Department Health and Human Services applicable to the category of examinations or procedures performed by the laboratory.
2. The primary laboratory complies with other applicable federal laws, including the Health Insurance Portability and accountability Act (HIPPA).
3. The laboratory director of the primary site CLIA number is responsible for all testing performed under its CLIA certificate, including testing and reporting performed remotely.
4. Survey findings are cited under the primary laboratory's CLIA certificate and enforcement actions, if taken, will affect the primary laboratory's CLIA certificate.
5. The primary laboratory's test reports indicate the remote site location where the testing is performed.
6. The primary laboratory is certified in the specialties or subspecialties of the work performed at the remote site.
7. The primary laboratory provides CMS a list of all staff working remotely, upon request.
8. The primary location is responsible for retaining all documentation, including testing performed by staff working remotely.
9. The individual performing remote review must be on the primary laboratory's Form CMS-209, Laboratory Personnel Report under CLIA.

According to the Author

"Unfortunately, California law does not allow remote review of digital slides or data despite [authorization from the Centers for Medicare & Medicaid Services (CMS)]. [This bill] will bring California into conformity with federal law, and 49 other states, by allowing Pathologists and licensed lab personnel, to review digital clinical laboratory data, digital results and digital images at a remote location under a primary location's Clinical Laboratory Improvement Amendments (CLIA) certificate as long as CLIA requirements under the Code of Federal Regulations are met."

Arguments in Support

The California Society of Pathologists (sponsor) writes in support:

Without [the authorization under this bill], pathologists and other laboratory personnel will be limited to viewing digital data, results, and images inside a licensed laboratory, even though no actual laboratory equipment is utilized or needed. For example, a pathologist can walk into their laboratory, open their laptop, and review any digital image on their computer. However, if that same pathologist went home with that same laptop and wanted to review those same images, current law does not allow it. Such limitations impede timely access to health care, most notably test results and diagnosis.

By allowing remote digital data review and interpretation, [this bill] will benefit a wide range of health care practices and services, including anatomic pathology (digital slides), hematology (digital slides, urinalysis, HPLC), immunology (SPEP/UPEP, flow cytometry), microbiology (NGS, PCR, LC-MS), blood bank (immunotyping), histocompatibility, molecular analysis, cytogenetic analysis (karyotype and FISH), etc. As an example, much of the COVID PCR results early in the pandemic required pathologist interpretation; this interpretation could have occurred remotely.

[This bill] can expedite diagnosis of critical conditions. For example, diagnosing a specific subtype of acute leukemia in order to emergently initiate therapy must be done within hours, lest the patient have a 20% mortality risk; this can only reliably be done during non-business hours for all patients, regardless of hospital location, using digital image review. The same applies to the use of remote interpretation of flow cytometry data in the diagnosis of acute leukemia which also requires same day diagnosis in order to initiate critically important chemotherapy.

Additionally, allowing digital data review/interpretation will also address workforce shortages. For example, licensed cytogenetics are in extremely short supply at present and most jobs across the country offer 100% remote work options. Without being able to offer a similar option, California labs will not be competitive in hiring/retaining necessary clinical staff.

In medically underserved rural and urban areas, a lack of primary care practitioners, specialty providers, clinical laboratory personnel and other medical professionals continues to pose significant barriers to access to health care services. Digital pathology and remote review by pathologists will become increasingly vital for the efficient delivery of health care in these and other communities.

Arguments in Opposition

No opposition on file.

FISCAL COMMENTS

According to the Senate Appropriations Committee, the California Department of Public Health reports limited term costs of approximately $91,000 annually over a three-year period beginning in Fiscal Year 2024-25 (Clinical Laboratory Improvement Fund).

VOTES:

ASM BUSINESS AND PROFESSIONS: 16-0-2

YES: Berman, Flora, Alanis, Bains, Juan Carrillo, Chen, Dixon, Grayson, Irwin, Low, Lowenthal, McKinnor, Stephanie Nguyen, Pellerin, Sanchez, Soria

ABS, ABST OR NV: Jackson, Zbur

ASM APPROPRIATIONS: 14-0-1

YES: Wicks, Sanchez, Arambula, Bryan, Calderon, Wendy Carrillo, Dixon, Mike Fong, Grayson, Haney, Hart, Jim Patterson, Pellerin, Ta

ABS, ABST OR NV: Villapudua

ASSEMBLY FLOOR: 69-0-11

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

ABS, ABST OR NV: Bennett, Cervantes, Megan Dahle, Essayli, Holden, Mathis, McKinnor, Luz Rivas, Blanca Rubio, Wicks, Zbur

UPDATED

VERSION: August 20, 2024

CONSULTANT: Vincent Chee / B. & P. / (916) 319-3301 FN: 0002838

 THIRD READING  

Bill No: AB 2107

Author: Chen (R)

Amended: 8/20/24 in Senate

Vote: 21

SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 12-0, 6/24/24

AYES: Ashby, Nguyen, Alvarado-Gil, Archuleta, Becker, Dodd, Eggman, Glazer, Menjivar, Niello, Smallwood-Cuevas, Wilk

NO VOTE RECORDED: Roth

SENATE APPROPRIATIONS COMMITTEE: 7-0, 8/5/24

AYES: Caballero, Jones, Ashby, Becker, Bradford, Seyarto, Wahab

ASSEMBLY FLOOR: 69-0, 5/23/24 - See last page for vote

SUBJECT: Clinical laboratory technology: remote review

SOURCE: California Society of Pathologists

DIGEST:

This bill authorizes pathologists who primarily perform pathology services at a licensed laboratory, are acting within their scope of practice, and review digital data, results, and images, to do so from a temporary remote site with access to a private network or other secured method so long as no laboratory equipment is needed.

Senate Floor Amendments of 8/20/24 make conforming changes to provide the California Department of Public Health (CDPH) approval authority for the remote pathologist service upon the finding that there is no conflict with CLIA.

ANALYSIS:

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 CDPH. (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))

This bill:

1. Authorizes pathologists who primarily perform pathology services at a licensed laboratory and who are acting within their scope of practice to review digital clinical laboratory data, digital results, and digital images at a remote location under a primary site’s CLIA certificate if CLIA requirements are met.
2. Defines “digital materials” as digital laboratory data, digital results, and digital images that do not require a microscope or other equipment essential to a separate laboratory
3. Requires remote review of digital materials to be conducted on virtual private networks or other secure method
4. Limits remote review to digital materials for which no other laboratory equipment is required.

Background

During the COVID-19 public health emergency, the federal Department of Health & Human Services, Centers for Medicare & Medicaid Services (CMS) announced a policy authorizing pathologists to review pathology slides and digital data, results, and images remotely. Upon conclusion of the public health emergency, CMS removed authorization for the remote review of physical slides, but continued to permit remote review of digital data, results, and images, including that of slides.

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. The purpose of CLIA and the state requirements is to minimize the risk of incorrect or unreliable results, patient harm during testing, and improper diagnoses, among other things. Laboratories are licensed and regulated by the California Department of Public Health.

Requiring laboratory tests reviews that do not need specialized laboratory equipment and only encompass digital review, which would be conducted on a computer inside a lab requires personnel to be available at all hours or to delay making diagnoses. By allowing remote review of digital results, this bill would reduce the time needed for diagnoses and allow pathologists to make determinations after hours or on weekends in emergency cases or provide diagnosis services to patients from remote locations where access to care is limited. The author states this bill “can expedite diagnosis of critical conditions. For example, diagnosing a specific subtype of acute leukemia in order to emergently initiate therapy must be done within hours, lest the patient have a 20% mortality risk; this can only reliably be done during non-business hours for all patients, regardless of hospital location, using digital image review. The same applies to the use of remote interpretation of flow cytometry data in the diagnosis of acute leukemia which also requires same day diagnosis in order to initiate critically important chemotherapy.”

Both CLIA and state law require the performance of laboratory tests, which includes the review and reporting of the test results, to be done in a licensed clinical laboratory. The purpose of the requirement is to ensure that the proper equipment and protocols needed to ensure accuracy and quality are in place.

This bill authorizes California pathologists to allow remote reviewing and reporting of digital materials if federal CLIA requirements are met. CLIA, pursuant to Centers for Medicare and Medicaid Services (CMS) guidance, allows remote reviewing and reporting by pathologists and other laboratory personnel of digital materials, defined as digital laboratory data, digital results, and digital images.

Specifically, CMS allows laboratories to allow staff to remotely review digital materials if specified criteria are met.

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

According to the Senate Appropriations Committee the CDPH reports limited term costs of approximately $91,000 annually over a three-year period beginning in Fiscal Year 2024-25.

SUPPORT: (Verified 8/20/24)

California Society of Pathologists (source)

California Life Sciences

Kaiser Permanente

University of California

OPPOSITION: (Verified 8/20/24)

None received

ARGUMENTS IN SUPPORT: California Life Sciences writes in support, “The federal Center for Medicare and Medicaid Services (CMMS) has recently taken steps to allow for remote review of pathology slides in order to respond to recent public health emergencies. However, existing state law prevents California’s clinical laboratories from taking advantage of these updated federal guidelines – which compromises our clinical labs’ ability to respond to threats from a growing number of respiratory illness and other pathogens. In order to increase capacity and decrease response time, our clinical lab pathologists and technicians must be allowed to follow CMMS guidance and remotely review certain digital laboratory data.”

The California Society of Pathologists writes, “In medically underserved rural and urban areas, a lack of primary care practitioners, specialty providers, and other medical professionals continues to pose significant barriers to access to health care services. Digital pathology and remote review by pathologists will become increasingly vital for the efficient delivery of health care in these and other Communities.”

Kaiser Permanente supports this bill and notes, “Clinical laboratory services continue to be in high demand in California and patients may experience delays or have difficulty accessing services. AB 2107 will help address a multitude of challenges, such as workforce shortages in medically underserved rural and urban areas while improving access to timely and potentially expedited clinical lab results that can help improve patient care.”

The University of California states, “Without this authorization, pathologists will be limited to viewing digital slides, images, and clinical data inside a licensed laboratory, even though no actual laboratory equipment is utilized or needed. By allowing remote digital review, the on-call pathologist will be able to contact a UC pathologist with more specialized training and/or expertise, for a second opinion, if needed. Without remote digital data review, important test results can be delayed by several hours or to the next day when the patient presents after hours, on the weekend, or during holidays. This amount of delay can be very significant in certain clinical situations and could impede UC’s ability to provide advanced patient care in a timely manner.”

ASSEMBLY FLOOR: 69-0, 5/23/24

AYES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bauer-Kahan, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Chen, Connolly, Davies, Dixon, Flora, Mike Fong, Vince Fong, Friedman, Gabriel, Gallagher, Garcia, Gipson, Grayson, Haney, Hart, Hoover, Irwin, Jackson, Jones-Sawyer, Kalra, Lackey, Lee, Low, Lowenthal, Maienschein, McCarty, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Jim Patterson, Joe Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Rendon, Reyes, Rodriguez, Sanchez, Santiago, Schiavo, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wilson, Wood, Robert Rivas

NO VOTE RECORDED: Bennett, Cervantes, Megan Dahle, Essayli, Holden, Mathis, McKinnor, Luz Rivas, Blanca Rubio, Wicks, Zbur

Prepared by: Yeaphana La Marr / B., P. & E.D. /

8/21/24 16:12:27

**** END ****

 THIRD READING  

Bill No: AB 2107

Author: Chen (R)

Amended: 5/20/24 in Assembly

Vote: 21

SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 12-0, 6/24/24

AYES: Ashby, Nguyen, Alvarado-Gil, Archuleta, Becker, Dodd, Eggman, Glazer, Menjivar, Niello, Smallwood-Cuevas, Wilk

NO VOTE RECORDED: Roth

SENATE APPROPRIATIONS COMMITTEE: 7-0, 8/5/24

AYES: Caballero, Jones, Ashby, Becker, Bradford, Seyarto, Wahab

ASSEMBLY FLOOR: 69-0, 5/23/24 - See last page for vote

SUBJECT: Clinical laboratory technology: remote review

SOURCE: California Society of Pathologists

DIGEST:

This bill authorizes pathologists who primarily perform pathology services at a licensed laboratory, are acting within their scope of practice, and review digital data, results, and images, to do so from a temporary remote site with access to a private network or other secured method so long as no laboratory equipment is needed.

ANALYSIS:

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))

This bill authorizes pathologists who primarily perform pathology services at a licensed laboratory and who are acting within their scope of practice to review digital clinical laboratory data, digital results, and digital images at a remote location under a primary site’s CLIA certificate if CLIA requirements are met.

This bill also: (a) defines, “digital materials” as digital laboratory data, digital results, and digital images that do not require a microscope or other equipment essential to a separate laboratory; (b) requires remote review of digital materials to be conducted on virtual private networks or other secure method; and (c) limits remote review to digital materials for which no other laboratory equipment is required.

Background

During the COVID-19 public health emergency, the federal Department of Health & Human Services, Centers for Medicare & Medicaid Services (CMS) announced a policy authorizing pathologists to review pathology slides and digital data, results, and images remotely. Upon conclusion of the public health emergency, CMS removed authorization for the remote review of physical slides, but continued to permit remote review of digital data, results, and images, including that of slides.

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. The purpose of CLIA and the state requirements is to minimize the risk of incorrect or unreliable results, patient harm during testing, and improper diagnoses, among other things. Laboratories are licensed and regulated by the California Department of Public Health.

Requiring laboratory tests reviews that do not need specialized laboratory equipment and only encompass digital review, which would be conducted on a computer inside a lab requires personnel to be available at all hours or to delay making diagnoses. By allowing remote review of digital results, this bill would reduce the time needed for diagnoses and allow pathologists to make determinations after hours or on weekends in emergency cases or provide diagnosis services to patients from remote locations where access to care is limited. The author states this bill “can expedite diagnosis of critical conditions. For example, diagnosing a specific subtype of acute leukemia in order to emergently initiate therapy must be done within hours, lest the patient have a 20% mortality risk; this can only reliably be done during non-business hours for all patients, regardless of hospital location, using digital image review. The same applies to the use of remote interpretation of flow cytometry data in the diagnosis of acute leukemia which also requires same day diagnosis in order to initiate critically important chemotherapy.”

Both CLIA and state law require ordinarily require the performance of laboratory tests, which includes the review and reporting of the test results, to be done in a licensed clinical laboratory. The purpose of the requirement is to ensure that the proper equipment and protocols needed to ensure accuracy and quality are in place.

This bill authorizes California pathologists to allow remote reviewing and reporting of digital materials if federal CLIA requirements are met. CLIA, pursuant to Centers for Medicare and Medicaid Services (CMS) guidance, allows remote reviewing and reporting by pathologists and other laboratory personnel of digital materials, defined as digital laboratory data, digital results, and digital images.

Specifically, CMS allows laboratories to allow staff to remotely review digital materials if the following criteria are met:

• The primary, home site, laboratory has a current, unrevoked or unsuspended certificate of waiver, registration certificate, certificate of compliance, certificate for provider-performed microscopy procedures, or certificate of accreditation issued by the federal Department Health and Human Services applicable to the category of examinations or procedures performed by the laboratory.

• The primary laboratory complies with other applicable federal laws, including the Health Insurance Portability and accountability Act (HIPPA).

• The laboratory director of the primary site CLIA number is responsible for all testing performed under its CLIA certificate, including testing and reporting performed remotely.

• Survey findings are cited under the primary laboratory's CLIA certificate and enforcement actions, if taken, will affect the primary laboratory's CLIA certificate.

• The primary laboratory's test reports indicate the remote site location where the testing is performed.

• The primary laboratory is certified in the specialties or subspecialties of the work performed at the remote site.

• The primary laboratory provides CMS a list of all staff working remotely, upon request.

• The primary location is responsible for retaining all documentation, including testing performed by staff working remotely.

• The individual performing remote review must be on the primary laboratory's Form CMS-209, Laboratory Personnel Report under CLIA.

This bill was amended in the Assembly Committee on Business and Professions to: reduce the use of serial lists and conform the bill to CMS terminology; (1) clarify that materials needing laboratory equipment for interpretation may not be reviewed remotely; (2) further limit temporary remote sites to intermittent use; and (3) clarify that remote review and reporting may only be performed if related to onsite work. This bill was also amended to address concerns that authorizing all licensed laboratory staff to review laboratory results from a remote location could impose expectations of laboratory staff to be available at all times and remote review could lead to outsourcing. This bill limits availability of remote review to pathologists who primarily perform pathology services at a licensed laboratory and who are acting within their scope of practice.

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

The Senate Committee on Appropriations analysis provides, “The California Department of Public Health reports limited term costs of approximately $91,000 annually over a three-year period beginning in Fiscal Year 2024-25 (Clinical Laboratory Improvement Fund).”

SUPPORT: (Verified 8/6/24)

California Society of Pathologists (source)

California Life Sciences

Kaiser Permanente

University of California

OPPOSITION: (Verified 8/6/24)

None received

ARGUMENTS IN SUPPORT: California Life Sciences writes in support, “The federal Center for Medicare and Medicaid Services (CMMS) has recently taken steps to allow for remote review of pathology slides in order to respond to recent public health emergencies. However, existing state law prevents California’s clinical laboratories from taking advantage of these updated federal guidelines – which compromises our clinical labs’ ability to respond to threats from a growing number of respiratory illness and other pathogens. In order to increase capacity and decrease response time, our clinical lab pathologists and technicians must be allowed to follow CMMS guidance and remotely review certain digital laboratory data.”

The California Society of Pathologists writes, “In medically underserved rural and urban areas, a lack of primary care practitioners, specialty providers, and other medical professionals continues to pose significant barriers to access to health care services. Digital pathology and remote review by pathologists will become increasingly vital for the efficient delivery of health care in these and other Communities.”

Kaiser Permanente supports this bill and notes, “Clinical laboratory services continue to be in high demand in California and patients may experience delays or have difficulty accessing services. AB 2107 will help address a multitude of challenges, such as workforce shortages in medically underserved rural and urban areas while improving access to timely and potentially expedited clinical lab results that can help improve patient care.”

The University of California states, “Without this authorization, pathologists will be limited to viewing digital slides, images, and clinical data inside a licensed laboratory, even though no actual laboratory equipment is utilized or needed. By allowing remote digital review, the on-call pathologist will be able to contact a UC pathologist with more specialized training and/or expertise, for a second opinion, if needed. Without remote digital data review, important test results can be delayed by several hours or to the next day when the patient presents after hours, on the weekend, or during holidays. This amount of delay can be very significant in certain clinical situations and could impede UC’s ability to provide advanced patient care in a timely manner.”

ASSEMBLY FLOOR: 69-0, 5/23/24

AYES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bauer-Kahan, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Chen, Connolly, Davies, Dixon, Flora, Mike Fong, Vince Fong, Friedman, Gabriel, Gallagher, Garcia, Gipson, Grayson, Haney, Hart, Hoover, Irwin, Jackson, Jones-Sawyer, Kalra, Lackey, Lee, Low, Lowenthal, Maienschein, McCarty, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Jim Patterson, Joe Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Rendon, Reyes, Rodriguez, Sanchez, Santiago, Schiavo, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wilson, Wood, Robert Rivas

NO VOTE RECORDED: Bennett, Cervantes, Megan Dahle, Essayli, Holden, Mathis, McKinnor, Luz Rivas, Blanca Rubio, Wicks, Zbur

Prepared by: Yeaphana La Marr / B., P. & E.D. /

8/7/24 14:34:38

**** END ***

SENATE COMMITTEE ON APPROPRIATIONS

Senator Anna Caballero, Chair

2023 - 2024 Regular Session

AB 2107 (Chen) - Clinical laboratory technology: remote review

Bill Summary:

AB 2107 authorizes a pathologist to review digital material, as defined, at a remote location, as specified.

Fiscal Impact:

The California Department of Public Health reports limited term costs of approximately $91,000 annually over a three-year period beginning in Fiscal Year 2024-25 (Clinical Laboratory Improvement Fund).

Background:

Both the Clinical Laboratory Improvement Amendments (CLIA) and state law ordinarily require the performance of laboratory tests, which includes the review and reporting of the test results, to be done in a licensed clinical laboratory. The purpose of the requirement is to ensure that the proper equipment and protocols needed to ensure accuracy and quality are in place.

This bill would authorize California pathologists to allow remote reviewing and reporting of digital materials if federal CLIA requirements are met. CLIA, pursuant to Centers for Medicare and Medicaid Services (CMS) guidance, allows remote reviewing and reporting by pathologists and other laboratory personnel of digital materials, defined as digital laboratory data, digital results, and digital images.

Specifically, CMS allows laboratories to allow staff to remotely review digital materials if the following criteria are met:

• The primary, home site, laboratory has a current, unrevoked or unsuspended certificate of waiver, registration certificate, certificate of compliance, certificate for provider-performed microscopy procedures, or certificate of accreditation issued by the federal Department Health and Human Services applicable to the category of examinations or procedures performed by the laboratory.
• The primary laboratory complies with other applicable federal laws, including the Health Insurance Portability and accountability Act (HIPPA).
• The laboratory director of the primary site CLIA number is responsible for all testing performed under its CLIA certificate, including testing and reporting performed remotely.
• Survey findings are cited under the primary laboratory's CLIA certificate and enforcement actions, if taken, will affect the primary laboratory's CLIA certificate.
• The primary laboratory's test reports indicate the remote site location where the testing is performed.
• The primary laboratory is certified in the specialties or subspecialties of the work performed at the remote site.
• The primary laboratory provides CMS a list of all staff working remotely, upon request.
• The primary location is responsible for retaining all documentation, including testing performed by staff working remotely.
• The individual performing remote review must be on the primary laboratory's Form CMS-209, Laboratory Personnel Report under CLIA.

Proposed Law:

• Provides that a remote location where digital materials are accessed by pathologists through virtual private networks or other secure method and for which no additional lab equipment is required, shall be an extension of a primary site’s CLIA certificate and shall not require a separate CLIA license or registration.
• Authorizes a pathologist performing pathology services at a licensed primary lab site to review digital materials at a remote location under a primary site’s CLIA certificate.
• Defines “digital materials” as digital laboratory data, digital results, and digital images that do not require a microscope of other equipment essential to a separate lab.
• States legislative findings and declarations.

-- END --

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Angelique Ashby, Chair

2023 - 2024 Regular

Bill No: Hearing Date: June 24, 2024

Subject:

SUMMARY:

Authorizes pathologists who primarily perform pathology services at a licensed laboratory, are acting within their scope of practice, and review digital data, results, and images, to do so from a temporary remote site with access to a private network or other secured method so long as no laboratory equipment is needed.

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))

This bill:

1. Authorizes pathologists who primarily perform pathology services at a licensed laboratory and who are acting within their scope of practice to review digital clinical laboratory data, digital results, and digital images at a remote location under a primary site’s CLIA certificate if CLIA requirements are met.
   
2. Defines, “digital materials” as digital laboratory data, digital results, and digital images that do not require a microscope or other equipment essential to a separate laboratory.
   
3. Requires remote review of digital materials to be conducted on virtual private networks or other secure method.
   
4. Limits remote review to digital materials for which no other laboratory equipment is required.

FISCAL EFFECT:

This bill is keyed fiscal by Legislative Counsel. According to the Assembly Committee on Appropriations, the California Department of Public Health (CDPH) estimates limited-term costs of approximately $275,000 over three fiscal years, starting FY 2024-25 to cover clarifying regulations. CDPH notes the remote sites from which pathologists and licensed laboratory personnel would review digital materials are still subject to licensing requirements under federal and state statutes, and the bill introduces vague and confusing language that would require clarifying regulations.

COMMENTS:

1. Purpose. This bill is sponsored by the California Society of Pathologists. The author states, “The bill will make California consistent with federal CMS guidance by allowing pathologists to review digital materials at a remote location under a primary location’s Clinical Laboratory Improvement Amendments (CLIA) certificate if CMS guidance and CLIA requirements under the Code of Federal Regulations are met.”
2. Background. During the COVID-19 public health emergency, the federal Department of Health & Human Services, Centers for Medicare & Medicaid Services (CMS) announced a policy authorizing pathologists to review pathology slides and digital data, results, and images remotely. Upon conclusion of the public health emergency, CMS removed authorization for the remote review of physical slides, but continued to permit remote review of digital data, results, and images, including that of slides.
   
   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. The purpose of CLIA and the state requirements is to minimize the risk of incorrect or unreliable results, patient harm during testing, and improper diagnoses, among other things. Laboratories are licensed and regulated by the California Department of Public Health.
   

Requiring laboratory tests reviews that do not need specialized laboratory equipment and only encompass digital review, which would be conducted on a computer inside a lab requires personnel to be available at all hours or to delay making diagnoses. By allowing remote review of digital results, this bill would reduce the time needed for diagnoses and allow pathologists to make determinations after hours or on weekends in emergency cases or provide diagnosis services to patients from remote locations where access to care is limited. The author states this bill “can expedite diagnosis of critical conditions. For example, diagnosing a specific subtype of acute leukemia in order to emergently initiate therapy must be done within hours, lest the patient have a 20% mortality risk; this can only reliably be done during non-business hours for all patients, regardless of hospital location, using digital image review. The same applies to the use of remote interpretation of flow cytometry data in the diagnosis of acute leukemia which also requires same day diagnosis in order to initiate critically important chemotherapy.”

Both CLIA and state law require ordinarily require the performance of laboratory tests, which includes the review and reporting of the test results, to be done in a licensed clinical laboratory. The purpose of the requirement is to ensure that the proper equipment and protocols needed to ensure accuracy and quality are in place.

This bill would authorize California pathologists to allow remote reviewing and reporting of digital materials if federal CLIA requirements are met. CLIA, pursuant to Centers for Medicare and Medicaid Services (CMS) guidance, allows remote reviewing and reporting by pathologists and other laboratory personnel of digital materials, defined as digital laboratory data, digital results, and digital images.

Specifically, CMS allows laboratories to allow staff to remotely review digital materials if the following criteria are met:

• The primary, home site, laboratory has a current, unrevoked or unsuspended certificate of waiver, registration certificate, certificate of compliance, certificate for provider-performed microscopy procedures, or certificate of accreditation issued by the federal Department Health and Human Services applicable to the category of examinations or procedures performed by the laboratory.
  
• The primary laboratory complies with other applicable federal laws, including the Health Insurance Portability and accountability Act (HIPPA).
  
• The laboratory director of the primary site CLIA number is responsible for all testing performed under its CLIA certificate, including testing and reporting performed remotely.
• Survey findings are cited under the primary laboratory's CLIA certificate and enforcement actions, if taken, will affect the primary laboratory's CLIA certificate.
• The primary laboratory's test reports indicate the remote site location where the testing is performed.
• The primary laboratory is certified in the specialties or subspecialties of the work performed at the remote site.
• The primary laboratory provides CMS a list of all staff working remotely, upon request.
• The primary location is responsible for retaining all documentation, including testing performed by staff working remotely.
• The individual performing remote review must be on the primary laboratory's Form CMS-209, Laboratory Personnel Report under CLIA.
  

This bill was amended in the Assembly Committee on Business and Professions to: reduce the use of serial lists and conform the bill to CMS terminology, (2) clarify that materials needing laboratory equipment for interpretation may not be reviewed remotely, (3) further limit temporary remote sites to intermittent use, and (4) clarify that remote review and reporting may only be performed if related to onsite work. This bill was also amended to address concerns that authorizing all licensed laboratory staff to review laboratory results from a remote location could impose expectations of laboratory staff to be available at all times and remote review could lead to outsourcing. This bill limits availability of remote review to pathologists who primarily perform pathology services at a licensed laboratory and who are acting within their scope of practice.

1. Arguments in Support. California Life Sciences writes in support, “The federal Center for Medicare and Medicaid Services (CMMS) has recently taken steps to allow for remote review of pathology slides in order to respond to recent public health emergencies. However, existing state law prevents California’s clinical laboratories from taking advantage of these updated federal guidelines – which compromises our clinical labs’ ability to respond to threats from a growing number of respiratory illness and other pathogens. In order to increase capacity and decrease response time, our clinical lab pathologists and technicians must be allowed to follow CMMS guidance and remotely review certain digital laboratory data.”

The California Society of Pathologists writes, “In medically underserved rural and urban areas, a lack of primary care practitioners, specialty providers, and other medical professionals continues to pose significant barriers to access to health care services. Digital pathology and remote review by pathologists will become increasingly vital for the efficient delivery of health care in these and other

Communities.”

Kaiser Permanente supports this bill and notes, “Clinical laboratory services continue to be in high demand in California and patients may experience delays or have difficulty accessing services. AB 2107 will help address a multitude of challenges, such as workforce shortages in medically underserved rural and urban areas while improving access to timely and potentially expedited clinical lab results that can help improve patient care.”

The University of California states, “Without this authorization, pathologists will be limited to viewing digital slides, images, and clinical data inside a licensed laboratory, even though no actual laboratory equipment is utilized or needed. By allowing remote digital review, the on-call pathologist will be able to contact a UC pathologist with more specialized training and/or expertise, for a second opinion, if needed. Without remote digital data review, important test results can be delayed by several hours or to the next day when the patient presents after hours, on the weekend, or during holidays. This amount of delay can be very significant in certain clinical situations and could impede UC’s ability to provide advanced patient care in a timely manner.”

SUPPORT AND OPPOSITION:

Support:

California Life Sciences

California Society of Pathologists

Kaiser Permanente

University of California

Opposition:

None received

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AB 2107

Author:(Chen)

As Amended Ver:May 20, 2024

Majority vote

SUMMARY

Authorizes pathologists who review and report digital materials to do so from a remote location.

Major Provisions

1. Defines "digital materials" as digital laboratory data, digital results, and digital images that do not require a microscope or other equipment essential to a separate laboratory.
2. Authorizes pathologists to review digital materials at a remote location under a primary site's federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) certificate.
3. Specifies that a location where digital materials are accessed by pathologists is an extension of a primary site's CLIA certificate and does not require a separate license or registration, except as specified in the federal Centers for Medicare and Medicaid Services CLIA guidelines.

COMMENTS

Background. 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. The purpose of CLIA and the state requirements is to minimize the risk of incorrect or unreliable results, patient harm during testing, and improper diagnoses, among other things. Laboratories are licensed and regulated by the California Department of Public Health.

Both CLIA and state law require ordinarily require the performance of laboratory tests, which includes the review and reporting of the test results, to be done in a licensed clinical laboratory. The purpose of the requirement is to ensure that the proper equipment and protocols needed to ensure accuracy and quality are in place.

This bill would authorize California laboratories to allow remote reviewing and reporting of digital materials if federal CLIA requirements are met. CLIA, pursuant to Centers for Medicare and Medicaid Services (CMS) guidance, allows remote reviewing and reporting by pathologists and other laboratory personnel of digital materials, defined as digital laboratory data, digital results, and digital images.

Specifically, CMS allows laboratories to allow staff to remotely review digital materials if the following criteria are met:

1. The primary, home site, laboratory has a current, unrevoked or unsuspended certificate of waiver, registration certificate, certificate of compliance, certificate for provider-performed microscopy procedures, or certificate of accreditation issued by the federal Department Health and Human Services applicable to the category of examinations or procedures performed by the laboratory.
2. The primary laboratory complies with other applicable federal laws, including the Health Insurance Portability and accountability Act (HIPPA).
3. The laboratory director of the primary site CLIA number is responsible for all testing performed under its CLIA certificate, including testing and reporting performed remotely.
4. Survey findings are cited under the primary laboratory's CLIA certificate and enforcement actions, if taken, will affect the primary laboratory's CLIA certificate.
5. The primary laboratory's test reports indicate the remote site location where the testing is performed.
6. The primary laboratory is certified in the specialties or subspecialties of the work performed at the remote site.
7. The primary laboratory provides CMS a list of all staff working remotely, upon request.
8. The primary location is responsible for retaining all documentation, including testing performed by staff working remotely.
9. The individual performing remote review must be on the primary laboratory's Form CMS-209, Laboratory Personnel Report under CLIA.

According to the Author

"Unfortunately, California law does not allow remote review of digital slides or data despite [authorization from the Centers for Medicare & Medicaid Services (CMS)]. [This bill] will bring California into conformity with federal law, and 49 other states, by allowing Pathologists and licensed lab personnel, to review digital clinical laboratory data, digital results and digital images at a remote location under a primary location's Clinical Laboratory Improvement Amendments (CLIA) certificate as long as CLIA requirements under the Code of Federal Regulations are met."

Arguments in Support

The California Society of Pathologists (sponsor) writes in support:

Without [the authorization under this bill], pathologists and other laboratory personnel will be limited to viewing digital data, results, and images inside a licensed laboratory, even though no actual laboratory equipment is utilized or needed. For example, a pathologist can walk into their laboratory, open their laptop, and review any digital image on their computer. However, if that same pathologist went home with that same laptop and wanted to review those same images, current law does not allow it. Such limitations impede timely access to health care, most notably test results and diagnosis.

By allowing remote digital data review and interpretation, [this bill] will benefit a wide range of health care practices and services, including anatomic pathology (digital slides), hematology (digital slides, urinalysis, HPLC), immunology (SPEP/UPEP, flow cytometry), microbiology (NGS, PCR, LC-MS), blood bank (immunotyping), histocompatibility, molecular analysis, cytogenetic analysis (karyotype and FISH), etc. As an example, much of the COVID PCR results early in the pandemic required pathologist interpretation; this interpretation could have occurred remotely.

[This bill] can expedite diagnosis of critical conditions. For example, diagnosing a specific subtype of acute leukemia in order to emergently initiate therapy must be done within hours, lest the patient have a 20% mortality risk; this can only reliably be done during non-business hours for all patients, regardless of hospital location, using digital image review. The same applies to the use of remote interpretation of flow cytometry data in the diagnosis of acute leukemia which also requires same day diagnosis in order to initiate critically important chemotherapy.

Additionally, allowing digital data review/interpretation will also address workforce shortages. For example, licensed cytogenetics are in extremely short supply at present and most jobs across the country offer 100% remote work options. Without being able to offer a similar option, California labs will not be competitive in hiring/retaining necessary clinical staff.

In medically underserved rural and urban areas, a lack of primary care practitioners, specialty providers, clinical laboratory personnel and other medical professionals continues to pose significant barriers to access to health care services. Digital pathology and remote review by pathologists will become increasingly vital for the efficient delivery of health care in these and other communities.

Arguments in Opposition

The California Labor Federation, Service Employees International Union, California State Council, and United Food and Commercial Workers, Western States Council, write in opposition to the March 21, 2024, version of this bill:

During the COVID-19 Public Health Emergency, the US Department of Health and Human Services temporarily allowed for pathologists to review slides and laboratory data from a remote location to reduce the exposure and transmission of COVID-19 within our labs and allowed for off-site review of slides for speciality practices, like gastrointestinal and dermatology practices, without violating the Stark Law on-site requirements. Since the ending of the public health emergency, off-site pathology interpretations expired but the Centers for Medicare and Medicaid services temporarily extended the Clinical Laboratory Improvements Amendments (CLIA) certificate flexibilities to allow for remote review of digital data. The same risks that clinical laboratory workers faced at the height of the pandemic are not present today, prompting the question why remote review of digital laboratory data is still needed?

The waivers issued through the pandemic applied in scope to pathologists, but [this bill] seeks to make these waivers permanent and significantly expand the laboratory personnel that would be able to conduct remote review, including unlicensed personnel. Additionally, [this bill] lacks safeguards to protect and secure sensitive patient information from being accessed in an individual's home, requirements on the workspace where digital laboratory tests will be analyzed, recordkeeping, and lacks enforcement mechanisms to promote compliance with CLIA and other requirements set forth by the primary site before tests can be remotely analyzed. Sensitive patient data could fall into the hands of bad actors, significantly compromising the privacy of patients and the integrity of our health care system. Lastly, if there are challenges with interpreting or reading digital laboratory data, there are no other laboratory personnel in the individual's home to assist with the interpretation or the ability for that laboratory personnel to rerun a test for a patient, potentially leading to delayed results or inaccurate test results.

Furthermore, the push to a fully remote at-home model will impact employment of clinical laboratory workers. There are no protections in the bill that prevent outsourcing of jobs in California out of state or out of country. We are deeply concerned with the potential job loss that could occur within our clinical laboratories if this bill is passed. Furthermore, there are no protections in this proposal to ensure that already overworked laboratory personnel are not expected to continue to work after they have left the primary job site, which could impact the analysis of digital tests.

We understand that clinical laboratories in California can experience surges or waves of tests that need to be analyzed in an urgent and timely manner, which is why we understand the need for transfer of tests between licensed facilities to assist with these workload challenges. Licensed facilities offer additional security and safety of patient information, allow access to other personnel and equipment needed to analyze clinical tests, and give peace of mind to the laboratory personnel performing work that their license isn't in jeopardy if something goes wrong at home.

While we agree that timely access to lab results are vital, we must oppose the bill in its current form. This bill would put patients' lives at risk with insufficient guardrails for patient safety, includes no protocols for reviewing sensitive information at home, and lacks protections from outsourcing jobs.

FISCAL COMMENTS

According to the Assembly Appropriations Committee analysis of the April 3, 2024, version of this bill, the "California Department of Public Health (CDPH) estimates limited-term costs of approximately $275,000 over three fiscal years, starting FY 2024-25 to cover clarifying regulations (Clinical Laboratory Improvement Fund). CDPH notes the remote sites from which pathologists and licensed laboratory personnel would review digital materials are still subject to licensing requirements under federal and state statutes, and the bill introduces vague and confusing language that would require clarifying regulations."

VOTES

ASM BUSINESS AND PROFESSIONS: 16-0-2

YES: Berman, Flora, Alanis, Bains, Juan Carrillo, Chen, Dixon, Grayson, Irwin, Low, Lowenthal, McKinnor, Stephanie Nguyen, Pellerin, Sanchez, Soria

ABS, ABST OR NV: Jackson, Zbur

ASM APPROPRIATIONS: 14-0-1

YES: Wicks, Sanchez, Arambula, Bryan, Calderon, Wendy Carrillo, Dixon, Mike Fong, Grayson, Haney, Hart, Jim Patterson, Pellerin, Ta

ABS, ABST OR NV: Villapudua

UPDATED

VERSION: May 20, 2024

CONSULTANT: Vincent Chee / B. & P. / (916) 319-3301 FN: 0002838

ASSEMBLY THIRD READING

ATR Bill Id:AB 2107

Author:(Chen)

As Amended Ver:April 3, 2024

Majority vote

SUMMARY

Authorizes pathologists who review and report digital materials to do so from a remote location.

Major Provisions

1. Defines "digital materials" as digital laboratory data, digital results, and digital images that do not require a microscope or other equipment essential to a separate laboratory.
2. Authorizes pathologists to review digital materials at a remote location under a primary site's federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) certificate.
3. Specifies that a location where digital materials are accessed by pathologists is an extension of a primary site's CLIA certificate and does not require a separate license or registration, except as specified in the federal Centers for Medicare and Medicaid Services CLIA guidelines.

COMMENTS

Background. 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. The purpose of CLIA and the state requirements is to minimize the risk of incorrect or unreliable results, patient harm during testing, and improper diagnoses, among other things. Laboratories are licensed and regulated by the California Department of Public Health.

Both CLIA and state law require ordinarily require the performance of laboratory tests, which includes the review and reporting of the test results, to be done in a licensed clinical laboratory. The purpose of the requirement is to ensure that the proper equipment and protocols needed to ensure accuracy and quality are in place.

This bill would authorize California laboratories to allow remote reviewing and reporting of digital materials if federal CLIA requirements are met. CLIA, pursuant to Centers for Medicare and Medicaid Services (CMS) guidance, allows remote reviewing and reporting by pathologists and other laboratory personnel of digital materials, defined as digital laboratory data, digital results, and digital images.

Specifically, CMS allows laboratories to allow staff to remotely review digital materials if the following criteria are met:

1. The primary, home site, laboratory has a current, unrevoked or unsuspended certificate of waiver, registration certificate, certificate of compliance, certificate for provider-performed microscopy procedures, or certificate of accreditation issued by the federal Department Health and Human Services applicable to the category of examinations or procedures performed by the laboratory.
2. The primary laboratory complies with other applicable federal laws, including the Health Insurance Portability and Accountability Act (HIPPA).
3. The laboratory director of the primary site CLIA number is responsible for all testing performed under its CLIA certificate, including testing and reporting performed remotely.
4. Survey findings are cited under the primary laboratory's CLIA certificate and enforcement actions, if taken, will affect the primary laboratory's CLIA certificate.
5. The primary laboratory's test reports indicate the remote site location where the testing is performed.
6. The primary laboratory is certified in the specialties or subspecialties of the work performed at the remote site.
7. The primary laboratory provides CMS a list of all staff working remotely, upon request.
8. The primary location is responsible for retaining all documentation, including testing performed by staff working remotely.
9. The individual performing remote review must be on the primary laboratory's Form CMS-209, Laboratory Personnel Report under CLIA.

According to the Author

"Unfortunately, California law does not allow remote review of digital slides or data despite [authorization from the Centers for Medicare & Medicaid Services (CMS)]. [This bill] will bring California into conformity with federal law, and 49 other states, by allowing Pathologists and licensed lab personnel, to review digital clinical laboratory data, digital results and digital images at a remote location under a primary location's Clinical Laboratory Improvement Amendments (CLIA) certificate as long as CLIA requirements under the Code of Federal Regulations are met."

Arguments in Support

The California Society of Pathologists (sponsor) writes in support:

Without [the authorization under this bill], pathologists and other laboratory personnel will be limited to viewing digital data, results, and images inside a licensed laboratory, even though no actual laboratory equipment is utilized or needed. For example, a pathologist can walk into their laboratory, open their laptop, and review any digital image on their computer. However, if that same pathologist went home with that same laptop and wanted to review those same images, current law does not allow it. Such limitations impede timely access to health care, most notably test results and diagnosis.

By allowing remote digital data review and interpretation, [this bill] will benefit a wide range of health care practices and services, including anatomic pathology (digital slides), hematology (digital slides, urinalysis, HPLC), immunology (SPEP/UPEP, flow cytometry), microbiology (NGS, PCR, LC-MS), blood bank (immunotyping), histocompatibility, molecular analysis, cytogenetic analysis (karyotype and FISH), etc. As an example, much of the COVID PCR results early in the pandemic required pathologist interpretation; this interpretation could have occurred remotely.

[This bill] can expedite diagnosis of critical conditions. For example, diagnosing a specific subtype of acute leukemia in order to emergently initiate therapy must be done within hours, lest the patient have a 20% mortality risk; this can only reliably be done during non-business hours for all patients, regardless of hospital location, using digital image review. The same applies to the use of remote interpretation of flow cytometry data in the diagnosis of acute leukemia which also requires same day diagnosis in order to initiate critically important chemotherapy.

Additionally, allowing digital data review/interpretation will also address workforce shortages. For example, licensed cytogenetics are in extremely short supply at present and most jobs across the country offer 100% remote work options. Without being able to offer a similar option, California labs will not be competitive in hiring/retaining necessary clinical staff.

In medically underserved rural and urban areas, a lack of primary care practitioners, specialty providers, clinical laboratory personnel and other medical professionals continues to pose significant barriers to access to health care services. Digital pathology and remote review by pathologists will become increasingly vital for the efficient delivery of health care in these and other communities.

Arguments in Opposition

The California Labor Federation, Service Employees International Union, California State Council, and United Food and Commercial Workers, Western States Council, write in opposition to the March 21, 2024, version of this bill:

During the COVID-19 Public Health Emergency, the US Department of Health and Human Services temporarily allowed for pathologists to review slides and laboratory data from a remote location to reduce the exposure and transmission of COVID-19 within our labs and allowed for off-site review of slides for [specialty] practices, like gastrointestinal and dermatology practices, without violating the Stark Law on-site requirements. Since the ending of the public health emergency, off-site pathology interpretations expired but the Centers for Medicare and Medicaid services temporarily extended the Clinical Laboratory Improvements Amendments (CLIA) certificate flexibilities to allow for remote review of digital data. The same risks that clinical laboratory workers faced at the height of the pandemic are not present today, prompting the question why remote review of digital laboratory data is still needed?

The waivers issued through the pandemic applied in scope to pathologists, but [this bill] seeks to make these waivers permanent and significantly expand the laboratory personnel that would be able to conduct remote review, including unlicensed personnel. Additionally, [this bill] lacks safeguards to protect and secure sensitive patient information from being accessed in an individual's home, requirements on the workspace where digital laboratory tests will be analyzed, recordkeeping, and lacks enforcement mechanisms to promote compliance with CLIA and other requirements set forth by the primary site before tests can be remotely analyzed. Sensitive patient data could fall into the hands of bad actors, significantly compromising the privacy of patients and the integrity of our health care system. Lastly, if there are challenges with interpreting or reading digital laboratory data, there are no other laboratory personnel in the individual's home to assist with the interpretation or the ability for that laboratory personnel to rerun a test for a patient, potentially leading to delayed results or inaccurate test results.

Furthermore, the push to a fully remote at-home model will impact employment of clinical laboratory workers. There are no protections in the bill that prevent outsourcing of jobs in California out of state or out of country. We are deeply concerned with the potential job loss that could occur within our clinical laboratories if this bill is passed. Furthermore, there are no protections in this proposal to ensure that already overworked laboratory personnel are not expected to continue to work after they have left the primary job site, which could impact the analysis of digital tests.

We understand that clinical laboratories in California can experience surges or waves of tests that need to be analyzed in an urgent and timely manner, which is why we understand the need for transfer of tests between licensed facilities to assist with these workload challenges. Licensed facilities offer additional security and safety of patient information, allow access to other personnel and equipment needed to analyze clinical tests, and give peace of mind to the laboratory personnel performing work that their license isn't in jeopardy if something goes wrong at home.

While we agree that timely access to lab results are vital, we must oppose the bill in its current form. This bill would put patients' lives at risk with insufficient guardrails for patient safety, includes no protocols for reviewing sensitive information at home, and lacks protections from outsourcing jobs.

FISCAL COMMENTS

According to the Assembly Appropriations Committee analysis of the April 3, 2024, version of this bill, the "California Department of Public Health (CDPH) estimates limited-term costs of approximately $275,000 over three fiscal years, starting FY 2024-25 to cover clarifying regulations (Clinical Laboratory Improvement Fund). CDPH notes the remote sites from which pathologists and licensed laboratory personnel would review digital materials are still subject to licensing requirements under federal and state statutes, and the bill introduces vague and confusing language that would require clarifying regulations."

VOTES

ASM BUSINESS AND PROFESSIONS: 16-0-2

YES: Berman, Flora, Alanis, Bains, Juan Carrillo, Chen, Dixon, Grayson, Irwin, Low, Lowenthal, McKinnor, Stephanie Nguyen, Pellerin, Sanchez, Soria

ABS, ABST OR NV: Jackson, Zbur

ASM APPROPRIATIONS: 14-0-1

YES: Wicks, Sanchez, Arambula, Bryan, Calderon, Wendy Carrillo, Dixon, Mike Fong, Grayson, Haney, Hart, Jim Patterson, Pellerin, Ta

ABS, ABST OR NV: Villapudua

UPDATED

VERSION: April 3, 2024

CONSULTANT: Vincent Chee / B. & P. / (916) 319-3301 FN: 0002838

ASSEMBLY THIRD READING

ATR Bill Id:AB 2107

Author:(Chen)

As Amended Ver:April 3, 2024

Majority vote

SUMMARY

Authorizes pathologists and laboratory personnel who review digital data, results, and images to do so from a temporary remote site.

Major Provisions

1. Defines "digital materials" as digital laboratory data, digital results, and digital images that do not require a microscope or other equipment essential to a separate laboratory.
2. Authorizes pathologists and laboratory personnel acting within their scope of practice to review digital materials at a remote location on a temporary or intermittent basis under a primary site's federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) certificate if CLIA requirements are met.
3. Authorizes a clinical laboratory to utilize a temporary site or intermittent for remote review and reporting of digital materials if the designated primary site or home base is certified under CLIA and the work being performed in the temporary or intermittent site falls within the parameters of the primary site's CLIA certificate.
4. Specifies that pathologists and licensed laboratory personnel may only remotely review digital materials if the digital materials are related to their ordinary course of onsite work.

COMMENTS

Background. 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. The purpose of CLIA and the state requirements is to minimize the risk of incorrect or unreliable results, patient harm during testing, and improper diagnoses, among other things. Laboratories are licensed and regulated by the California Department of Public Health.

Both CLIA and state law require ordinarily require the performance of laboratory tests, which includes the review and reporting of the test results, to be done in a licensed clinical laboratory. The purpose of the requirement is to ensure that the proper equipment and protocols needed to ensure accuracy and quality are in place.

This bill would authorize California laboratories to allow remote reviewing and reporting of digital materials if federal CLIA requirements are met. CLIA, pursuant to Centers for Medicare and Medicaid Services (CMS) guidance, allows remote reviewing and reporting by pathologists and other laboratory personnel of digital materials, defined as digital laboratory data, digital results, and digital images.

Specifically, CMS allows laboratories to allow staff to remotely review digital materials if the following criteria are met:

1. The primary, home site, laboratory has a current, unrevoked or unsuspended certificate of waiver, registration certificate, certificate of compliance, certificate for provider-performed microscopy procedures, or certificate of accreditation issued by the federal Department Health and Human Services applicable to the category of examinations or procedures performed by the laboratory.
2. The primary laboratory complies with other applicable federal laws, including the Health Insurance Portability and accountability Act (HIPPA).
3. The laboratory director of the primary site CLIA number is responsible for all testing performed under its CLIA certificate, including testing and reporting performed remotely.
4. Survey findings are cited under the primary laboratory's CLIA certificate and enforcement actions, if taken, will affect the primary laboratory's CLIA certificate.
5. The primary laboratory's test reports indicate the remote site location where the testing is performed.
6. The primary laboratory is certified in the specialties or subspecialties of the work performed at the remote site.
7. The primary laboratory provides CMS a list of all staff working remotely, upon request.
8. The primary location is responsible for retaining all documentation, including testing performed by staff working remotely.
9. The individual performing remote review must be on the primary laboratory's Form CMS-209, Laboratory Personnel Report under CLIA.

According to the Author

"Unfortunately, California law does not allow remote review of digital slides or data despite [authorization from the Centers for Medicare & Medicaid Services (CMS)]. [This bill] will bring California into conformity with federal law, and 49 other states, by allowing Pathologists and licensed lab personnel, to review digital clinical laboratory data, digital results and digital images at a remote location under a primary location's Clinical Laboratory Improvement Amendments (CLIA) certificate as long as CLIA requirements under the Code of Federal Regulations are met."

Arguments in Support

The California Society of Pathologists (sponsor) writes in support:

Without [the authorization under this bill], pathologists and other laboratory personnel will be limited to viewing digital data, results, and images inside a licensed laboratory, even though no actual laboratory equipment is utilized or needed. For example, a pathologist can walk into their laboratory, open their laptop, and review any digital image on their computer. However, if that same pathologist went home with that same laptop and wanted to review those same images, current law does not allow it. Such limitations impede timely access to health care, most notably test results and diagnosis.

By allowing remote digital data review and interpretation, [this bill] will benefit a wide range of health care practices and services, including anatomic pathology (digital slides), hematology (digital slides, urinalysis, HPLC), immunology (SPEP/UPEP, flow cytometry), microbiology (NGS, PCR, LC-MS), blood bank (immunotyping), histocompatibility, molecular analysis, cytogenetic analysis (karyotype and FISH), etc. As an example, much of the COVID PCR results early in the pandemic required pathologist interpretation; this interpretation could have occurred remotely.

[This bill] can expedite diagnosis of critical conditions. For example, diagnosing a specific subtype of acute leukemia in order to emergently initiate therapy must be done within hours, lest the patient have a 20% mortality risk; this can only reliably be done during non-business hours for all patients, regardless of hospital location, using digital image review. The same applies to the use of remote interpretation of flow cytometry data in the diagnosis of acute leukemia which also requires same day diagnosis in order to initiate critically important chemotherapy.

Additionally, allowing digital data review/interpretation will also address workforce shortages. For example, licensed cytogenetics are in extremely short supply at present and most jobs across the country offer 100% remote work options. Without being able to offer a similar option, California labs will not be competitive in hiring/retaining necessary clinical staff.

In medically underserved rural and urban areas, a lack of primary care practitioners, specialty providers, clinical laboratory personnel and other medical professionals continues to pose significant barriers to access to health care services. Digital pathology and remote review by pathologists will become increasingly vital for the efficient delivery of health care in these and other communities.

Arguments in Opposition

The California Labor Federation, Service Employees International Union, California State Council, and United Food and Commercial Workers, Western States Council, write in opposition to the March 21, 2024, version of this bill:

During the COVID-19 Public Health Emergency, the US Department of Health and Human Services temporarily allowed for pathologists to review slides and laboratory data from a remote location to reduce the exposure and transmission of COVID-19 within our labs and allowed for off-site review of slides for speciality practices, like gastrointestinal and dermatology practices, without violating the Stark Law on-site requirements. Since the ending of the public health emergency, off-site pathology interpretations expired but the Centers for Medicare and Medicaid services temporarily extended the Clinical Laboratory Improvements Amendments (CLIA) certificate flexibilities to allow for remote review of digital data. The same risks that clinical laboratory workers faced at the height of the pandemic are not present today, prompting the question why remote review of digital laboratory data is still needed?

The waivers issued through the pandemic applied in scope to pathologists, but [this bill] seeks to make these waivers permanent and significantly expand the laboratory personnel that would be able to conduct remote review, including unlicensed personnel. Additionally, [this bill] lacks safeguards to protect and secure sensitive patient information from being accessed in an individual's home, requirements on the workspace where digital laboratory tests will be analyzed, recordkeeping, and lacks enforcement mechanisms to promote compliance with CLIA and other requirements set forth by the primary site before tests can be remotely analyzed. Sensitive patient data could fall into the hands of bad actors, significantly compromising the privacy of patients and the integrity of our health care system. Lastly, if there are challenges with interpreting or reading digital laboratory data, there are no other laboratory personnel in the individual's home to assist with the interpretation or the ability for that laboratory personnel to rerun a test for a patient, potentially leading to delayed results or inaccurate test results.

Furthermore, the push to a fully remote at-home model will impact employment of clinical laboratory workers. There are no protections in the bill that prevent outsourcing of jobs in California out of state or out of country. We are deeply concerned with the potential job loss that could occur within our clinical laboratories if this bill is passed. Furthermore, there are no protections in this proposal to ensure that already overworked laboratory personnel are not expected to continue to work after they have left the primary job site, which could impact the analysis of digital tests.

We understand that clinical laboratories in California can experience surges or waves of tests that need to be analyzed in an urgent and timely manner, which is why we understand the need for transfer of tests between licensed facilities to assist with these workload challenges. Licensed facilities offer additional security and safety of patient information, allow access to other personnel and equipment needed to analyze clinical tests, and give peace of mind to the laboratory personnel performing work that their license isn’t in jeopardy if something goes wrong at home.

While we agree that timely access to lab results are vital, we must oppose the bill in its current form. This bill would put patients' lives at risk with insufficient guardrails for patient safety, includes no protocols for reviewing sensitive information at home, and lacks protections from outsourcing jobs.

FISCAL COMMENTS

According to the Assembly Appropriations Committee, the California Department of Public Health (CDPH) estimates limited-term costs of approximately $275,000 over three fiscal years, starting FY 2024-25 to cover clarifying regulations (Clinical Laboratory Improvement Fund). CDPH notes the remote sites from which pathologists and licensed laboratory personnel would review digital materials are still subject to licensing requirements under federal and state statutes, and the bill introduces vague and confusing language that would require clarifying regulations.

VOTES

ASM BUSINESS AND PROFESSIONS: 16-0-2

YES: Berman, Flora, Alanis, Bains, Juan Carrillo, Chen, Dixon, Grayson, Irwin, Low, Lowenthal, McKinnor, Stephanie Nguyen, Pellerin, Sanchez, Soria

ABS, ABST OR NV: Jackson, Zbur

ASM APPROPRIATIONS: 14-0-1

YES: Wicks, Sanchez, Arambula, Bryan, Calderon, Wendy Carrillo, Dixon, Mike Fong, Grayson, Haney, Hart, Jim Patterson, Pellerin, Ta

ABS, ABST OR NV: Villapudua

UPDATED

VERSION: April 3, 2024

CONSULTANT: Vincent Chee / B. & P. / (916) 319-3301 FN: 0002780

Date of Hearing: April 24, 2024

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Buffy Wicks, Chair

ABPCA Bill Id:AB 2107

Author:(Chen) – As Amended Ver:April 3, 2024

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

SUMMARY:

This bill authorizes pathologists and licensed laboratory personnel to review digital materials at a remote location on a temporary or intermittent basis under a primary site’s Clinical Laboratory Improvement Amendments (CLIA) certificate.

FISCAL EFFECT:

The California Department of Public Health (CDPH) estimates limited-term costs of approximately $275,000 over three fiscal years, starting FY 2024-25 to cover clarifying regulations (Clinical Laboratory Improvement Fund). CDPH notes the remote sites from which pathologists and licensed laboratory personnel would review digital materials are still subject to licensing requirements under federal and state statutes, and the bill introduces vague and confusing language that would require clarifying regulations.

COMMENTS:

1. Purpose. This bill is sponsored by the California Society of Pathologists. According to the author:

Unfortunately, California law does not allow remote review of digital slides or data despite [authorization from the federal Centers for Medicare & Medicaid Services (CMS)]. [This bill] will bring California into conformity with federal law, and 49 other states, by allowing Pathologists and licensed lab personnel, to review digital clinical laboratory data, digital results and digital images at a remote location under a primary location’s [CLIA] certificate as long as CLIA requirements under the Code of Federal Regulations are met.

1. Background. A facility or location where laboratory tests on human specimens for diagnostic or assessment purposes are performed must be certified under CLIA. The purpose of CLIA is to minimize the risk of incorrect or unreliable results, patient harm during testing, and improper diagnoses, among other things. While CLIA establishes the minimum standards under federal law, it allows states to establish more stringent requirements.

Both CLIA and state laws ordinarily require the performance of laboratory tests, including the review and reporting of the test results, to be done in a licensed clinical laboratory to ensure the use of proper equipment and protocols needed to ensure accuracy and quality.

CLIA allows remote reviewing and reporting by pathologists and other laboratory personnel of digital materials, defined as digital laboratory data, digital results, and digital images.
CMS allows laboratories to allow staff to remotely review digital materials under certain conditions, which include, among others:

1. The primary site laboratory has a current, unrevoked or unsuspended certificate of waiver, registration certificate, certificate of compliance, certificate for provider-performed microscopy procedures, or certificate of accreditation applicable to the category of examinations or procedures performed by the laboratory.
   
2. The laboratory director of the primary site is responsible for all testing performed under its CLIA certificate, including testing and reporting performed remotely.
3. The primary laboratory’s test reports indicate the remote site location where the testing is performed.
4. The primary laboratory provides CMS a list of all staff working remotely, upon request.
5. Opposition. The California Labor Federation, Service Employees International Union, California State Council, and United Food and Commercial Workers, Western States Council, oppose this bill, citing the following concerns:
   
   1. Since the ending of the COVID-19 public health emergency, the risks that clinical laboratory workers faced at the height of the pandemic are not present today, prompting the question of why remote review of digital laboratory data is still needed.
      
   2. This bill lacks safeguards to protect and secure sensitive patient information from being accessed in an individual's home, requirements on the workspace where digital laboratory tests will be analyzed, and recordkeeping.
      
   3. This bill lacks enforcement mechanisms to promote compliance with CLIA and other requirements set forth by the primary site before tests can be remotely analyzed.
      
   4. If there are challenges with interpreting or reading digital laboratory data, there are no other laboratory personnel in the individual's home to assist with interpretation, nor is there the ability to rerun a test for a patient, potentially leading to delayed or inaccurate test results.
      
   5. This bill may lead to outsourcing of California jobs out of state.
      
   6. This bill lacks protections to ensure that already overworked laboratory personnel are not expected to continue to work after they have left the primary job site.

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

Date of Hearing: April 2, 2024

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Marc Berman, Chair

ABPCA Bill Id:AB 2107

Author:(Chen) – As Amended Ver:March 21, 2024

SUBJECT: Clinical laboratory technology: remote review.

SUMMARY: Authorizes pathologists and laboratory personnel who review digital data, results, and images to do so from a temporary remote site.

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))

THIS BILL:

1. Authorizes pathologists and laboratory personnel acting within their scope of practice to review digital clinical laboratory data, digital results, and digital images at a remote location under a primary site’s CLIA certificate if CLIA requirements are met.
2. Authorizes a clinical laboratory to utilize a temporary site for remote review and reporting of digital clinical laboratory data, digital results, and digital images if the designated primary site or home base is certified under CLIA and the work being performed in the temporary site falls within the parameters of the primary site’s CLIA certificate.

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

COMMENTS:

Purpose. This bill is sponsored by the California Society of Pathologists. According to the author, “Unfortunately, California law does not allow remote review of digital slides or data despite [authorization from the Centers for Medicare & Medicaid Services (CMS)]. [This bill] will bring California into conformity with federal law, and 49 other states, by allowing Pathologists and licensed lab personnel, to review digital clinical laboratory data, digital results and digital images at a remote location under a primary location’s Clinical Laboratory Improvement Amendments (CLIA) certificate as long as CLIA requirements under the Code of Federal Regulations are met.”

Background. 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. The purpose of CLIA and the state requirements is to minimize the risk of incorrect or unreliable results, patient harm during testing, and improper diagnoses, among other things. Laboratories are licensed and regulated by the California Department of Public Health.

Both CLIA and state law require ordinarily require the performance of laboratory tests, which includes the review and reporting of the test results, to be done in a licensed clinical laboratory. The purpose of the requirement is to ensure that the proper equipment and protocols needed to ensure accuracy and quality are in place.

This bill would authorize California laboratories to allow remote reviewing and reporting of digital materials if federal CLIA requirements are met. CLIA, pursuant to CMS guidance, allows remote reviewing and reporting by pathologists and other laboratory personnel of digital materials, defined as digital laboratory data, digital results, and digital images.

Specifically, CMS allows laboratories to allow staff to remotely review digital materials if the following criteria are met:

1. The primary, home site, laboratory has a current, unrevoked or unsuspended certificate of waiver, registration certificate, certificate of compliance, certificate for provider-performed microscopy procedures, or certificate of accreditation issued by the federal Department Health and Human Services applicable to the category of examinations or procedures performed by the laboratory.
2. The primary laboratory complies with other applicable federal laws, including the Health Insurance Portability and accountability Act (HIPPA).
3. The laboratory director of the primary site CLIA number is responsible for all testing performed under its CLIA certificate, including testing and reporting performed remotely.
4. Survey findings are cited under the primary laboratory’s CLIA certificate and enforcement actions, if taken, will affect the primary laboratory’s CLIA certificate.
5. The primary laboratory’s test reports indicate the remote site location where the testing is performed.
6. The primary laboratory is certified in the specialties or subspecialties of the work performed at the remote site.
7. The primary laboratory provides CMS a list of all staff working remotely, upon request.
8. The primary location is responsible for retaining all documentation, including testing performed by staff working remotely.
9. The individual performing remote review must be on the primary laboratory’s Form CMS-209, Laboratory Personnel Report (CLIA).

ARGUMENTS IN SUPPORT:

The California Society of Pathologists (sponsor) writes in support:

Without [the authorization under this bill], pathologists and other laboratory personnel will be limited to viewing digital data, results, and images inside a licensed laboratory, even though no actual laboratory equipment is utilized or needed. For example, a pathologist can walk into their laboratory, open their laptop, and review any digital image on their computer. However, if that same pathologist went home with that same laptop and wanted to review those same images, current law does not allow it. Such limitations impede timely access to health care, most notably test results and diagnosis.

By allowing remote digital data review and interpretation, [this bill] will benefit a wide range of health care practices and services, including anatomic pathology (digital slides), hematology (digital slides, urinalysis, HPLC), immunology (SPEP/UPEP, flow cytometry), microbiology (NGS, PCR, LC-MS), blood bank (immunotyping), histocompatibility, molecular analysis, cytogenetic analysis (karyotype and FISH), etc. As an example, much of the COVID PCR results early in the pandemic required pathologist interpretation; this interpretation could have occurred remotely.

[This bill] can expedite diagnosis of critical conditions. For example, diagnosing a specific subtype of acute leukemia in order to emergently initiate therapy must be done within hours, lest the patient have a 20% mortality risk; this can only reliably be done during non-business hours for all patients, regardless of hospital location, using digital image review. The same applies to the use of remote interpretation of flow cytometry data in the diagnosis of acute leukemia which also requires same day diagnosis in order to initiate critically important chemotherapy.

Additionally, allowing digital data review/interpretation will also address workforce shortages. For example, licensed cytogenetics are in extremely short supply at present and most jobs across the country offer 100% remote work options. Without being able to offer a similar option, California labs will not be competitive in hiring/retaining necessary clinical staff.

In medically underserved rural and urban areas, a lack of primary care practitioners, specialty providers, clinical laboratory personnel and other medical professionals continues to pose significant barriers to access to health care services. Digital pathology and remote review by pathologists will become increasingly vital for the efficient delivery of health care in these and other communities.

ARGUMENTS IN OPPOSITION:

The California Labor Federation, Service Employees International Union, California State Council, and United Food and Commercial Workers, Western States Council, write in opposition:

During the COVID-19 Public Health Emergency, the US Department of Health and Human Services temporarily allowed for pathologists to review slides and laboratory data from a remote location to reduce the exposure and transmission of COVID-19 within our labs and allowed for off-site review of slides for speciality practices, like gastrointestinal and dermatology practices, without violating the Stark Law on-site requirements. Since the ending of the public health emergency, off-site pathology interpretations expired but the Centers for Medicare and Medicaid services temporarily extended the Clinical Laboratory Improvements Amendments (CLIA) certificate flexibilities to allow for remote review of digital data. The same risks that clinical laboratory workers faced at the height of the pandemic are not present today, prompting the question why remote review of digital laboratory data is still needed?

The waivers issued through the pandemic applied in scope to pathologists, but [this bill] seeks to make these waivers permanent and significantly expand the laboratory personnel that would be able to conduct remote review, including unlicensed personnel. Additionally, [this bill] lacks safeguards to protect and secure sensitive patient information from being accessed in an individual's home, requirements on the workspace where digital laboratory tests will be analyzed, recordkeeping, and lacks enforcement mechanisms to promote compliance with CLIA and other requirements set forth by the primary site before tests can be remotely analyzed. Sensitive patient data could fall into the hands of bad actors, significantly compromising the privacy of patients and the integrity of our health care system. Lastly, if there are challenges with interpreting or reading digital laboratory data, there are no other laboratory personnel in the individual's home to assist with the interpretation or the ability for that laboratory personnel to rerun a test for a patient, potentially leading to delayed results or inaccurate test results.

Furthermore, the push to a fully remote at-home model will impact employment of clinical laboratory workers. There are no protections in the bill that prevent outsourcing of jobs in California out of state or out of country. We are deeply concerned with the potential job loss that could occur within our clinical laboratories if this bill is passed. Furthermore, there are no protections in this proposal to ensure that already overworked laboratory personnel are not expected to continue to work after they have left the primary job site, which could impact the analysis of digital tests.

We understand that clinical laboratories in California can experience surges or waves of tests that need to be analyzed in an urgent and timely manner, which is why we understand the need for transfer of tests between licensed facilities to assist with these workload challenges. Licensed facilities offer additional security and safety of patient information, allow access to other personnel and equipment needed to analyze clinical tests, and give peace of mind to the laboratory personnel performing work that their license isn’t in jeopardy if something goes wrong at home.

While we agree that timely access to lab results are vital, we must oppose the bill in its current form. This bill would put patients’ lives at risk with insufficient guardrails for patient safety, includes no protocols for reviewing sensitive information at home, and lacks protections from outsourcing jobs.

AMENDMENTS:

To (1) reduce the use of serial lists and conform the bill to CMS terminology, (2) clarify that materials needing laboratory equipment for interpretation may not be reviewed remotely, (3) further limit temporary remote sites to intermittent use, and (4) clarify that remote review and reporting may only be performed if related to onsite work, amend the bill as follows:

(a) For purposes of this section, “digital materials” means digital laboratory data, digital results, and digital images that do not require a microscope or other equipment essential to a separate laboratory.

(b) Pathologists and licensed laboratory personnel acting within their scope of practice may review digital clinical laboratory data, digital results, and digital images materials at a remote location on a temporary or intermittent basis under a primary site’s CLIA certificate if CLIA requirements are met.

(b) (c) A clinical laboratory may utilize a temporary or intermittent site for remote review and for reporting of digital clinical laboratory data, digital results, and digital images materials if the designated primary site or home base is certified under CLIA and the work being performed in the temporary or intermittent site falls within the parameters of the primary site’s CLIA certificate.

(d) Pathologists and licensed laboratory personnel may only remotely review digital materials under this Section if the digital materials are related to their ordinary course of onsite work.

REGISTERED SUPPORT:

California Society of Pathologists (sponsor)

Affiliated Pathologists Medical Group

American Society for Clinical Pathology

Analytic Pathology Medical Group

Association for Pathology Informatics

California Clinical Laboratory Association

California Life Sciences

College of American Pathologists

Stanford Health Care

University of California

University of California, San Francisco, Department of Laboratory Medicine

1 Individual

REGISTERED OPPOSITION:

California Labor Federation, AFL-CIO
Service Employees International Union, California State Council
United Food and Commercial Workers, Western States Council

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