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03/10/2022: Lab Advisory: HHS Updates COVID-19 Laboratory Reporting Guidance
Audience: Facilities Performing COVID-19 Testing
Level: Laboratory Advisory
On March 8, 2022, the U.S. Department of Health and Human Services (HHS) updated its Laboratory Data Reporting Guidance.
Beginning April 4, 2022, COVID-19 testing facilities are no longer required to report NEGATIVE results for tests authorized for use under a CLIA certificate of waiver. This includes rapid and antigen testing performed for screening testing at schools, correctional facilities, employee testing programs, long-term care facilities, and rapid testing performed in pharmacies, medical provider offices, and drive-through and pop-up testing sites. In addition, testing facilities are no longer required to report POSITIVE or NEGATIVE antibody test results.
The updated guidance still requires laboratories to report both POSITIVE AND NEGATIVE results for laboratory-based nucleic acid amplification tests (NAATs) that are performed in a facility that is certified under CLIA to perform moderate- or high-complexity tests.
The updated guidance replaces a blanket requirement to report all SARS-CoV-2 test results and reflects more tailored reporting requirements that are specific to entity and test type.
We encourage you to review the updated guidance in detail and share this information widely with your colleagues. Testing facilities should check state, local, tribal, and territorial health departments for additional reporting requirements beyond what is required in the HHS guidance.
Opt in to receive updates from the CDC Laboratory Outreach Communication System (LOCS).
Online resources:
- How to Report COVID-19 Laboratory Data
- Testing
- Guidance for SARS-CoV-2 Rapid Testing Performed in Point-of-Care Settings
- Using Antibody Tests for COVID-19
- Nucleic Acid Amplification Tests (NAATs)
- Self-Testing at Home or Anywhere
- Information for Laboratories about Coronavirus (COVID-19)
- Frequently Asked Questions about Coronavirus (COVID-19) for Laboratories
- CDC Coronavirus (COVID-19) Website
- CDC Laboratory Outreach Communication System (LOCS)
- Clinical Laboratory COVID-19 Response Calls
Questions?
- If you are a clinical or public health laboratory professional, contact LOCS.
- For media inquiries, contact the CDC Newsroom.
- For all other questions, contact CDC-INFO.
Thank you,
The Laboratory Outreach Communication System
Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)
Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)
Centers for Disease Control and Prevention (CDC)