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EDMUND G. BROWN JR.
Governor

State of California—Health and Human Services Agency
California Department of Public Health


August 19, 2020


TO:
Laboratory Directors and Managers

SUBJECT:
Letter to Laboratories Testing for SARS-CoV-2/COVID-19: Reporting, Testing Personnel Requirements, and Emergency Use Authorized Tests.

***Last updated: July 7, 2023***

​​​



Dear Laboratory Directors and Managers,​

The California Department of Public Health (CDPH) is providing the following information to laboratories testing for SARS-CoV-2, the virus that causes COVID-19 disease, to address laboratory concerns.​

Disease Reporting

California law regulates the reporting of test results through the state electronic reporting system (CalREDIE), by all facilities performing such testing, including schools and other facilities performing waived testing.​

On March 9, 2020, the list of reportable diseases in Title 17, California Code of Regulations (17 CCR) section 2500 was a​​mended to include COVID-19 and Novel coronavirus infections, and the list in 17 CCR section 2505 was amended to include SARS-CoV-2 and Coronavirus, novel strains, effective immediately.

On July 28, 2020, the reporting regulations at 17 CCR section 2500 and 2505 were amended to change reporting times and require additional patient information. The Department of Public Health is issuing updated reporting requirements for SARS-CoV-2, influenza, and RSV. For updated information about reporting requirements, please visit the ​​ Reportable Diseases and Conditions​​ webpage​​​​

Laboratory Personnel Requirements

On March 2, 2023, Assembly Bill (AB) 269​ was approved and signed, and became effective immediately as California law.

AB 269 incorporated and made permanent the provisions of Paragraph 9 of Executive Order (EO) N-25-20 (PDF), which expired when the Governor terminated the California State of Emergency on February 28, 2023. 

AB 269 added Section 1206.7 to the Business and Profession Code (BPC) to allow a person to perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory if the person meets the federal requirements in Section 493.1489​ of Title 42 of the Code of Federal Regulations (42 CFR) for high complexity testing.

AB 269 also added Section 101161 to the Health and Safety Code (HSC) to allow a person to perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in any city or county public health laboratory if the person meets the federal requirements in 42 CFR section 493.1489 for high complexity testing. 

AB 269 made other changes that do not affect laboratory law. These changes are not addressed in this letter.

Please note that 

  • The new law does not affect laboratory facility licensure. It applies only to lab personnel who perform testing for SARS-CoV-2. If a lab does not perform SARS-CoV-2 testing, the new law will not have any effect on that lab or its personnel.
  • The new law applies only to testing personnel. The suspension of licensure requirements does not change the qualifications for laboratory directors, clinical consultants, technical consultants, technical supervisors, or general supervisors. Those personnel still need to hold a valid California license to direct testing or serve as a consultant or supervisor for testing, including SARS-CoV-2 testing.
  • The lab director is responsible for ensuring documented competency assessment and supervision of all testing personnel, including personnel working under the provisions of the new law.
  • Personnel testing under the provisions of the new law may perform a multiplex respiratory panel assays that include SARS-CoV-2, for example, multiplex tests for SARS-CoV-2, Influenza A, and Influenza B, if the test detects SARS-CoV-2 and all assays are processed simultaneously on a single specimen using the same instrument.

The adoption of AB 296 means that testing personnel performing testing for SARS-CoV-2 in California clinical labs must either​

  • ​Meet the requirements of BPC section 1206.5. These requirements vary according to the complexity of testing.
    • Personnel performing waived tests must meet the requirements of 1206.5(a). Labs that perform only waived testing may not be affected by the new law if their testing personnel meet the requirements of BPC subsection 1206.5(a).
    • Personnel performing moderate complexity testing must meet the requirements of 1206.5(b). o Personnel performing high complexity testing must meet the requirements of 1206.5(c).
    • BPC section 1206.5 allows personnel in physician office labs to perform waived or non-waived testing if the test is performed under the onsite supervision of the patient’s physician and surgeon or podiatrist, who must ensure that the person is performing test methods as required for accurate and reliable tests, and have personal knowledge of the results of clinical laboratory testing or examination performed by that person before the test results are reported from the laboratory.
      OR 
  • ​Meet the requirements of 42 CFR section 493.1489.
    • ​These requirements must be met by anyone testing under this provision, regardless of whether the test is waived or non-waived (moderate or high complexity).
    • ​People testing under this provision are ONLY authorized to perform SARS-CoV-2 testing, including multiplex tests for SARS-CoV-2 and Influenza A and B, if the test detects SARS-CoV-2 and all assays are processed simultaneously on a single specimen using the same instrument.​

Personnel testing for SARS-CoV-2 in public health labs must either​

  • Meet the requirements of Title 17 of the California Code of Regulations (17 CCR) section 1079.
    OR
  • Meet the requirements of 42 CFR section 493.1489​.
    • These requirements must be met for anyone testing under this provision, regardless of whether the test is waived or non-waived (moderate or high complexity).​
    • ​People testing under this provision are ONLY authorized to perform SARS-CoV-2 testing, including multiplex tests for SARS-CoV-2 and Influenza A and B, if the test detects SARS-CoV-2 and all assays are processed simultaneously on a single specimen using the same instrument.

Emergency Use Authorization and COVID-19 Tests

  • On February 29, 2020, the Food and Drug Administration (FDA) issued an immediately in effect guidance with policy for diagnostic testing specific to the COVID-19 public health emergency, along with a template for Emergency Use Authorization (EUA) submissions, and followed it with a new guidance on March 16, 2020. The most recent edition of the guidance and template are available on the FDA website:
  • Please note: The State of California does not authorize California laboratories to develop and perform tests for COVID-19. Laboratories seeking authorization for their own tests for COVID-19 should refer to the FDA Guidance linked above and submit an EUA submission to the FDA as directed in that guidance.
  • CDPH requests that any laboratory applying for an EUA please copy Laboratory Field Services (​LFSCC@cdph.ca.gov) on the email submitting the completed EUA request to the FDA. ​

Please contact Laboratory Field Services at LFSCC​​​@cdph.ca.gov if you have questions.


Original signed by Robert J. Thomas

Robert J. Thomas

Branch Chief


     Laboratory Field Services ● 850 Marina Bay Parkway ● Richmond, CA 94804
    (510) 620-3800 ● (510) 620-3692 FAX
     LFS Website (www.cdph.ca.gov/LFS)


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