Transcription of Test Method Validation and Verification
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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?
method performance specifications have been separately verified for each test and instrument or device. The evaluation and data must clearly support the decision to approve the test for clinical use. The evaluation must include: 1) a written assessment of each component of the validation or
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