COVID-19 - COVID-19 Test Complexity

When the FDA authorizes a test for COVID-19 under an Emergency Use Authorization (EUA), is it waived or non-waived test complexity ?

Any examples are for illustrative purposes only.

  Organizations should consult the intended use described in the Letter of Authorization for the test:
  • For tests approved for use in high- and moderate-complexity laboratories, and organizations need to follow the requirements for nonwaived testing.  
  • For tests that are intended to be used in patient care settings (including hospitals, physician offices, urgent care, outreach clinics, and temporary patient care settings), such tests can be performed in patient care settings that have a CLIA Certificate of Waiver or Certificate of Compliance.  These terms generally do not apply to home specimen collection or at home testing unless otherwise specified. 

Please note that this is very different from the FDA’s normal test approval process and is only allowed during the EUA.  Once the EUA has ended, a test must be classified by the FDA.  If a test is not classified, it would be considered a laboratory developed test (LDT) and defaults to high complexity.

Organizations that use Joint Commission accreditation for deemed status purposes should monitor the CMS website as waivers are being approved frequently and may include state-specific waivers. Click here to access the CMS website for COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers.

Additional Resources:
Coronavirus (COVID-19) Guidance and Resources
Last updated on December 08, 2020
Manual: Laboratory
Chapter: Quality System Assessment for Nonwaived Testing QSA

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