Manual:
Laboratory
Chapter:
Quality System Assessment for Nonwaived Testing QSA
Topic:
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After the emergency is resolved and the Emergency Use Authorizations (EUA) are rescinded, laboratories MUST return to the full frequency required for quality control by The Joint Commission standards and CLIA regulations.
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After the emergency is resolved and the Emergency Use Authorizations (EUA) are rescinded, laboratories MUST return to the full frequency required for quality control by The Joint Commission standards and CLIA regulations.
Last updated on May 12, 2023
with update notes of: Review only, FAQ is current
First Published Date: April 03, 2020
Last Reviewed Date: December 22, 2021