Verification of Microbiology Tests - SWACM

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Definitions* • “Verification is the one-time process performed to determine or to confirm a test’s expected performance prior to implementation in the clinical laboratory; simply put “Does the test work”” • “Validation is an ongoing process of monitoring a test…to ensure that it continuously performs as expected; simply put “Does the test still work”... validation may include personnel competency assessment, quality control,…proficiency testing….an integral part of the laboratory’s quality assurance program.”” * Definitions used by CLIA, CLSI Source: Cumitech 31A. 2009. ASM Press 2
Definitions • Modified test: FDA-cleared or approved test performed outside of package insert instructions • Laboratory-developed test: procedures developed in-house that have not been cleared by FDA. May incorporate commercial reagents not cleared by the FDA for in vitro diagnostic use (e.g., RUO or ASRs) or reagents produced in-house 3
Page 1: Verification of Microbiology Tests
Page 5 and 6: Verification Components • Accurac
Page 7: Verification of Unmodified FDA- Cle
Page 11 and 12: Verification of Unmodified FDA- Cle
Page 13 and 14: Verification of AST • At least 30
Page 15 and 16: Modified Tests and Laboratory- Deve
Page 17 and 18: Modification Examples • Change in
Page 19 and 20: Verification vs. Establishment of
Page 21 and 22: Verification Report • Summarize p
Page 23: Acknowledgments • Cumitech 31A co

Verification of Microbiology Tests - SWACM

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