COVID-19 - Quality Control Testing for COVID-19 Tests

What are the quality control requirements I must follow for COVID-19 tests ?

Any examples are for illustrative purposes only. 

During the COVID-19 emergency, external quality control for COVID-19 tests may be performed less frequently than The Joint Commission and CLIA normally require.  Quality control for COVID-19 testing must be performed at least as frequently as stated in the manufacturer’s package insert, and an individual quality control plan (IQCP) is not required at this time.

After the emergency is resolved and the Emergency Use Authorizations (EUA) are rescinded, laboratories MUST return to the full frequency required for quality control by The Joint Commission standards and CLIA regulations.

Additional Resources:
Coronavirus (COVID-19) Guidance and Resources
Last updated on March 16, 2021
Manual: Laboratory
Chapter: Quality System Assessment for Nonwaived Testing QSA

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