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Waived Testing: Modified or non-FDA Approved Methods

Our vendor has notified us that their reagents/cartridges/instruments/kits are not FDA approved for waived testing. If we continue using the reagents/cartridges/instruments/kits, are we out of compliance with the waived testing standards?

Any examples are for illustrative purposes only.

Yes – organizations performing waived tests with any reagents/cartridges/instruments/kits that are not FDA approved for waived testing would be out of compliance with The Joint Commission requirement to follow the manufacturer’s instructions for use.

If an organization chooses to use reagents/cartridges/instruments/kits that are not FDA approved for waived testing, the following are required:
• Obtain a CLIA certificate for high complexity testing.
Performing a waived test with any modifications other than those approved by the FDA (e.g., any changes in specimen type, reagents, instrument, procedural steps, or other components) elevates the test complexity from waived to high complexity.

• Apply for accreditation in the laboratory program.
The Joint Commission standards addressing high complexity testing are only evaluated by the laboratory accreditation program.

• Comply with the standards for laboratory developed tests outlined in the laboratory accreditation program manual.
Appendix B of the Laboratory Accreditation Manual includes the standards that apply to laboratory developed tests.
Last updated on March 17, 2021
Manual: Critical Access Hospital
Chapter: Waived Testing WT

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