Test Method Validation and Verification

Test Method Validation and Verification All Checklists are 2017. College of American Pathologists. All rights reserved. Page 1 of 9 Excerpts from CAP All Common Checklist, August 21, 2017 release Inspector Instructions: Policies and procedures for the introduction of new tests , methods , or instruments Sampling of assay Validation and Verification studies with emphasis on tests introduced in the past two years, especially high volume tests and tests with the highest risk to patients Sampling of patient reports for laboratory-developed assays Which laboratory tests or instruments have been implemented in the past two years, particularly those that are not FDA-cleared/approved? Do you follow the manufacturer's instructions exactly for all FDA-cleared/approved diagnostic kits or devices?

The laboratory director's signature on the written test procedure may be used to show approval of the test for use in patient testing. Evidence of Compliance: Records of test approval **REVISED** 08/21/2017 COM.40000 Method Validation and Verification Approval - Nonwaived Tests Phase II

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  Tests, Verification, Methods, Validation, Procedures, Method validation and verification, Test method validation and verification

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