Dear Laboratory Directors and Managers,
The California Department of Public Health (CDPH) expects that many CLIA-certified laboratories qualified to perform high complexity testing are eligible to test for SARS-CoV-2, the virus that causes COVID-19, or novel coronavirus infection, and is providing the following information to address laboratory concerns.
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 guidelines and template are available on the FDA website:
- Please note: The State of California is not authorizing California laboratories to develop and perform tests for COVID-19 at this time and currently has not established a process for authorizing such tests. 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 (LFSCOVID@cdph.ca.gov) on the email submitting the completed EUA request to the FDA.
- On May 4, 2020, the FDA revised its policy on serological/antibody tests to require commercial manufacturers of serological tests to submit EUA requests, with their validation data, within 10 business days from the date they notified the FDA of their validation testing OR from the date of the revised policy, whichever is later. The FDA also provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.
Disease Reporting
- On March 9, 2020, the list of reportable diseases in
Title 17, California Code of Regulations (17 CCR) section 2500 was amended to include COVID-19 and Novel coronavirus infections, and
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.
- On February 10, 2022, the State Public Health Officer issued a
public health order to revise mandatory reporting of COVID-19 results by health care providers that temporarily modified 17 CCR section 2505(a)(3) and (e)(1) to allow laboratories to report results within 24 hours from the time the laboratory notifies the health care provider or other person authorized to receive the report.
- On April 6, 2022, the State Epidemiologist issued
revised guidance for reporting (PDF).
- The following list outlines current requirements for reporting SARS-CoV-2 related laboratory results. This document includes updated information on requirements for reporting negative results for SARS-CoV-2 antigen tests.
-
Testing Conducted in Facilities Certified Under CLIA to Perform Non-waived (Moderate- or High-Complexity) Testing
- Continue to report all laboratory-based SARS-CoV-2 Nucleic Acid Amplification Tests (NAAT) results, including positive and non-positive (negative, indeterminate, etc.).
- Examples of NAAT tests includes RT-PCR, TMA, LAMP and SDA.
- Continue to report all antibody/serology testing results, including positive and non-positive (negative, indeterminate, etc.).
- CDPH uses these data to calculate seroprevalence which has been an important pandemic trend to monitor.
- Report SARS-CoV-2 POSITIVE results of non-NAAT diagnostic testing (e.g. high throughput antigen testing).
- Laboratories must continue to follow all State and CLIA requirements for recording and maintaining all laboratory results.
-
Testing Conducted in Facilities With a CLIA Certificate of Waiver
- Report SARS-CoV-2 POSITIVE diagnostic results only.
- Reporting of non-positive results (negative, indeterminate, etc.) is no longer required.
- This includes rapid testing conducted for screening or diagnostic purposes at schools*, correctional facilities, employee testing programs, long-term care facilities, and rapid testing performed in pharmacies, medical providers offices, and drive-thru and pop-up testing sites.
- Testing facilities must continue to follow all State and CLIA requirements for recording and maintaining all laboratory results.
-
Over-the-counter (OTC) Self-tests
- Tests approved for over-the-counter (OTC) use, when performed by individuals upon their own specimens without CLIA oversight are not required to be reported to public health agencies. Individuals should report their test result according to the instructions recommended by the test. Some home tests have automatic reporting, others have the option to report results through a phone application.
- If performed in a setting regulated under CLIA, positive results from self-tests are required to be reported.
- Laboratories approved to test for SARS-CoV-2 must report results for SARS-CoV-2 through the CalREDIE Electronic Laboratory Reporting system (ELR)
within twenty four hours from the time the laboratory notifies the health care provider or other person authorized to receive the report.
- Laboratories unable to report via ELR must report using one of the methods below.
- Please note that laboratories no longer need to report SARS-CoV-2 results by telephone within one hour.
- Laboratories must report data on patientsā
race and ethnicity for all COVID-19 test results. Please revise your requisition forms to include this information, and work with the healthcare providers you serve to ensure that demographic information is collected during patient intake so that you can include it when you report results through the CalREDIE system.
- For more information about ELR, please visit the
CDPH CalREDIE ELR webpage.
- Please use the encoding guidelines for ELR messages for SARS-CoV-2. The LOINC codes are pre-release codes, developed for special use. You can find them, and check for future updates, at the
LOINC website.
- In addition, please use the following SNOMED codes:
- 260373001 Detected
- 260415000 Not detected
- 419984006 Inconclusive
- 125154007 Specimen unsatisfactory
- Per Title 17, California Code of Regulations section 2505, laboratory results for influenza and SARS-CoV-2 are required to be reported. For laboratories using SARS-CoV-2/Influenza multiplex test platforms, please see the guidance about reporting SARS-CoV-2/Influenza multiplex test results to CalREDIE (PDF). Please email CalREDIEHelp@cdph.ca.gov if you have any questions or need assistance.
Laboratory and Personnel Requirements
- Please note that any California laboratory performing testing under the provisions of the EUA must hold a valid California clinical laboratory license pursuant to
Business and Professions Code (BPC) section 1265. This requirement applies to laboratories operating in California and laboratories located outside California that test specimens originating in California.
- On March 12, 2020, Governor Newsom issued Executive Order N-25-20, which suspends the certification and licensure requirements of California Code of Regulations, Title17, section 1079 and Business and Professions Code section 1206.5 for the duration of the COVID-19 emergency. This order allows all persons who meet the requirements for personnel performing high-complexity testing specified in
Title 42, Code of Federal Regulations, Section 493.1489 to test for SARS-CoV-2, the virus that causes COVID-19, in any certified public health laboratory or licensed clinical laboratory for the duration of the emergency.
- The laboratory director is responsible for the competency assessment and documentation of all personnel testing for SARS-CoV-2.
- This order applies to high-complexity testing personnel. It does not alter the qualifications required of a laboratory director, clinical consultant, technical consultant, technical supervisor, and general supervisor or the supervision requirements in current California law.
- The laboratory director must provide the list of testing personnel along with documentation of competency upon request by LFS.
Please contact Laboratory Field Services at
LFSCOVID@cdph.ca.gov if you have questions.
Original signed by Robert J. Thomas
Robert J. Thomas
Branch Chief
Laboratory Field Services ā 850 Marina Bay Parkway ā Richmond, CA 94804
(510) 620-3800 ā (510) 620-3692 FAX
LFS Website (www.cdph.ca.gov/LFS)