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After the emergency is resolved and the Emergency Use Authorizations (EUA) are rescinded, laboratories MUST return to the full frequency required for quality control by The Joint Commission standards and CLIA regulations.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After the emergency is resolved and the Emergency Use Authorizations (EUA) are rescinded, laboratories MUST return to the full frequency required for quality control by The Joint Commission standards and CLIA regulations.
Manual:
Laboratory
Chapter:
Quality System Assessment for Nonwaived Testing QSA
Last reviewed by Standards Interpretation: December 22, 2021
Represents the most recent date that the FAQ was reviewed (e.g. annual review).
First published date: April 03, 2020
This Standards FAQ was first published on this date.
This page was last updated on May 12, 2023
with update notes of: Review only, FAQ is current
Types of changes and an explanation of change type:
Editorial changes only: Format changes only. No changes to content. |
Review only, FAQ is current: Periodic review completed, no changes to content. |
Reflects new or updated requirements: Changes represent new or revised requirements.
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