Chapter 3

Waived Testing

Rebekah M. Martin PhD, D(ABMM), MLS(ASCP)CM

Rebekah M. Martin PhD, D(ABMM), MLS(ASCP)CM

Medical Affairs Manager, Molecular Solutions

BD Life Sciences - Integrated Diagnostic Solutions, Becton, Dickinson and Company

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First published: 28 February 2025

Summary

Clinical laboratories seeking to perform waived testing must obtain a Certificate of Waiver (COW). Clinical laboratories in possession of a COW may perform only waived testing. If they wish to perform nonwaived testing, they must obtain the appropriate CLIA certificate. CLIA has no qualification requirements for personnel performing waived testing. However, testing personnel must be trained on the appropriate use of the test, and they must follow all manufacturers' instructions as they are written. It is the responsibility of the laboratory where testing is taking place to ensure these criteria are met. Clinical laboratories that possess a COA and also perform waived testing should check with their accrediting agency for any additional requirements. Laboratories that perform waived testing do not need to enroll in proficiency testing for waived test systems, nor do they need to perform a verification for waived test systems.

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