The public health response to COVID-19 depends on comprehensive laboratory testing data. These data will contribute to understanding COVID-19’s impact and testing coverage and can contribute to the identification of supply chain issues for reagents and other materials. The information below outlines reporting requirements for laboratories.
Who must report
All COVID-19 testing sites must
- have a Clinical Laboratory Improvement Amendments (CLIA)external icon certificate,
- meet all requirements to perform testing, including only using FDA-authorized test systems according to their instructions for use, and
- report both the positive and negative results of COVID-19 diagnostic and screening tests that they perform to the appropriate state or local public health department.
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, and
- other facilities or locations offering COVID-19 point-of-care diagnostic or screening tests, or in-home diagnostic or screening tests.
Testing sites must report data for all diagnostic and screening testing completed, which includes molecular, antigen, and antibody testing for each individual tested. These data must be reported daily, within 24 hours of test completion, to the appropriate state, tribal, local, or territorial public health department based on the individual’s residence. (See considerations for reporting in the frequently asked questions below.)
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. While NHSN is the CDC- and CMS-preferred pathway, Medicare and Medicaid-certified LTC facilities may submit data through the other mechanisms described in the Current Methods of Submission section of HHS Laboratory Reporting Guidance pdf icon[PDF]external icon to meet the reporting requirements.
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) Regulationspdf iconexternal icon.