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.
When the U.S. Food and Drug Administration (FDA) authorizes a test for COVID-19 under an Emergency Use Authorization (EUA), is it waived or non-waived test complexity?
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, organizations need to follow the requirements for nonwaived testing.
- For tests intended for use in patient care settings (including hospitals, physician offices, urgent care, outreach clinics and temporary patient care settings), such tests can be performed in these settings that have a Clinical Laboratory Improvement Amendments (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 Centers for Medicare and Medicaid Services (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.
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 and medical staff services, as well as inpatient and outpatient pharmacy services.