On Infection Prevention & Control

Experiences, case studies and news about infection prevention and control.

Validation of COVID-19 Tests

04/22/2020

Robert Campbell, PharmD, director, Clinical Standards Interpretation for Hospital/Ambulatory Programs

Editor’s Note: This blog post is part of The Joint Commission’s daily communication on issues relevant to organizations managing the COVID-19 pandemic. The full list of FAQs is available here.

My laboratory wants to begin testing for COVID-19, what is required for validation of this test?

Laboratories that elect to conduct COVID-19 testing must follow the guidance released by the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and Clinical Laboratory Improvement Amendments (CLIA), a partnership of the Centers for Medicare and Medicaid Services (CMS).  Since this is an emergent and changing situation, it’s best to review their websites often. The FDA is allowing for an abbreviated validation process, but laboratories must follow FDA guidelines. The manufacturer should also be able provide additional information.

The Joint Commission is following the guidance from the FDA, CDC and CLIA as follows:
1. If the laboratory is using a CDC-developed Emergency Use Authorization (EUA) assay, the instructions provided with the procedure must be followed.  

2. If the laboratory is using a EUA assay not developed by the CDC but approved by the FDA, the laboratory director must determine the number of positive and negative specimens needed to verify performance and must follow manufacturer instructions.

After the emergency is resolved and the EUA’s are rescinded, laboratories must validate methods as required for the complexity of testing (Joint Commission Quality System Assessment for Nonwaived Testing [QSA] standard QSA.02.01.01 at element of performance [EP] 1 for moderate complexity and EP 2 for high complexity.) If the EUA’s are rescinded and the FDA has not assigned a complexity to the method, laboratories must validate the method as a high complexity laboratory developed test (Joint Commission standard QSA.02.01.01 at EP 2.)  

Additional Resources

CDC: 2019 Novel Coronavirus Laboratory Biosafety
CDC: Information for Laboratories: 2019-nCoV
CDC: 2019 Novel Coronavirus
FDA:  Emergency Use Authorizations
CDC:  Clinical Laboratory Improvement Amendments

Robert Campbell, PharmD, is director, clinical standards interpretation hospital/ambulatory Programs and director, medication management. Prior to these roles, he served as the pharmacist for Clinical Standards Interpretation in the Division of Healthcare Improvement at The Joint Commission. Campbell also surveys as a field representative for The Joint Commission in the Hospital Accreditation and Critical Access Hospital Accreditation Programs and is a reviewer in the Medication Compounding Certification Program. Prior to joining The Joint Commission, Campbell worked in health care organizations and held leadership positions with oversight responsibilities for performance improvement, accreditation readiness, risk management, infection control, medical staff services, as well as inpatient and outpatient pharmacy services.