What to know
Summary of Recent Changes (Updates as of May 11, 2023)
Effective May 11, 2023, HHS announced the Public Health Emergency declaration for COVID-19 has ended. In addition, HHS and CLIA regulatory requirements under the CARES Act Authority requiring reporting of laboratory test data to the federal government has also ended. State-specific reporting requirements may still apply. Laboratories and testing sites should review state-specific reporting requirements for COVID-19 testing. They may be required to continue reporting for COVID-19 testing to their State Health Departments.
Who can report
All COVID-19 testing sites must:
- have a Clinical Laboratory Improvement Amendments (CLIA) certificate,
- meet all requirements to perform testing, including only using FDA-authorized test systems according to their instructions for use, and
- follow all state specific-reporting requirements for COVID-19 test results.
COVID-19 testing sites are defined as:
- laboratories that perform clinical diagnostic or screening testing under CLIA
- non-laboratory COVID-19 diagnostic or screening testing locations
- other facilities or locations offering COVID-19 point-of-care diagnostic or screening tests, or in-home diagnostic or screening tests.
CMS-certified long-term care (LTC) facilities may submit point-of-care SARS-CoV-2 testing data to CDC's National Healthcare Safety Network (NHSN). This CDC- and CMS-preferred pathway to submit data to CDC's NHSN applies only to CMS-certified long-term care facilities. Test data submitted to NHSN will be reported to appropriate state and local health departments using standard electronic laboratory messages. Other types of LTC facilities may also report testing data in NHSN for self-tracking or to fulfill state or local reporting requirements, if any.
Testing sites that perform COVID-19 surveillance testing on de-identified samples, regardless of their CLIA status, should not report the results of their surveillance testing to state, tribal, local, and territorial public health departments. If at any time a facility intends to report a patient-specific test result, it must first obtain a CLIA certificate and meet all requirements to perform testing. For more information, see the Center for Medicare and Medicaid Service's (CMS) Research Testing and Clinical Laboratory Improvement Amendments of 1988 (CLIA) Regulations.
Note regarding self-test results: While there are no current mechanisms that require reporting of self-test results to public health authorities, CDC encourages everyone who uses a self-test to report any positive results to their healthcare provider. Healthcare providers can ensure that those who have tested positive for COVID-19 receive the most appropriate medical care, including specific treatments if necessary. COVID-19 home tests can be safely and privately reported at MakeMyTestCount.org.
How to report
Laboratory data elements may be reported in the following ways:
- Submit laboratory testing data directly to state or local public health departments according to state/or local law or policy. Data must be sent using existing reporting channels to ensure rapid initiation of case investigations, and concurrent reporting of results must be shared with the ordering provider or patient, as applicable.
- Submit laboratory testing data to state and local public health departments through a centralized platform, where the data will then be routed to the appropriate state and local authorities and may be routed to CDC after removal of personally identifiable information according to applicable rules and regulations.
- Submit laboratory testing data through a state or regional Health Information Exchange (HIE) to the appropriate state or local public health department.
- CMS-certified long-term care facilities may submit point-of-care SARS-CoV-2 testing data, including antigen testing data, to CDC's National Healthcare Safety Network (NHSN). This CDC- and CMS-preferred pathway to submit data to CDC's NHSN applies only to CMS-certified long-term care facilities. Test data submitted to NHSN will be reported to appropriate state and local health departments using standard electronic laboratory messages. Other types of LTC facilities may also report testing data in NHSN for self-tracking or to fulfill state or local reporting requirements, if any.
CSTE Tools
What to report
Laboratories should make every reasonable effort to provide the following data elements when reporting to state and jurisdictional health departments.
- Test ordered – use harmonized LOINC codes provided by CDC
- Device Identifier
- Test result–use appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC
- Test Result date (date format)
- Accession # / Specimen ID
- Patient age
- Patient race
- Patient ethnicity
- Patient sex
- Patient residence zip code
- Patient residence county
- Ordering provider name and nonpharmaceutical interventions (as applicable)
- Ordering provider zip code
- Performing facility name and CLIA number
- Performing facility zip code
- Specimen Source – use appropriate LOINC, SNOMED-CT, or SPM4 codes, or equivalently detailed alternative codes
- Date test ordered (date format)
- Date specimen collected (date format)
The following additional demographic data elements should also be collected and reported to state or local public health departments.
- Patient name (Last name, First name, Middle initial)
- Patient street address
- Patient phone number with area code
- Patient date of birth
- Ordering provider address
- Ordering provider phone number
To protect patient privacy, any data that state and jurisdictional health departments send to CDC will be deidentified and will not include some patient-level information. The deidentified data shared with CDC will contribute to understanding COVID-19's impact, case rate positivity trends, testing coverage, and will help identify supply chain issues for reagents and other materials.
How to report using standard terminology
CDC has posted a LOINC In-Vitro Diagnostic (LIVD) Test Code Mapping Guide for COVID-19 test results for tests with Emergency Use Authorization and/or granted Traditional Marketing Authorization from the U.S. Food and Drug Administration (FDA) that can be used by clinical laboratories and instrument manufacturers. This specification supports the use of standardized LOINC and SNOMED Clinical Terms (CT) codes to improve the accuracy of reporting tests for the SARS-CoV-2 virus. Using these harmonized LOINC and SNOMED-CT codes helps ensure that the same type of test is represented uniformly across the United States.
For those COVID-19 tests that have not yet received these authorizations, CDC encourages test developers and laboratories that use COVID-19 tests to work together to obtain appropriate and interoperable LOINC and SNOMED-CT codes for reporting purposes.
LOINC codes must be used to represent the "question" a test asks of a specimen (e.g., does this specimen have SARS-CoV-2 RNA?), and SNOMED-CT codes must be used to represent the diagnostic "answer" (e.g., what was detected?). More background on these terminology standards can be found here:
Whenever possible, laboratories must use standard codes that already exist. Before requesting a new code, search the list of currently available LOINC codes for COVID-19 tests. If a LOINC test code cannot be identified whose attributes appropriately match the test for which coding is needed, new terms can be submitted, and a new code can be requested through LOINC.
Technical assistance for electronic reporting
Electronic reporting options are available to reduce the burden on providers reporting test results. Laboratories that are not currently reporting electronically to their state or local health department and want assistance in establishing electronic reporting can contact EDX@cdc.gov.