Objective Decisions: Verify and Validate Laboratory Testing (PS04)
18 June 2009 1:00–2:00 PM Eastern (US) Time
Recent CLSI guidelines describe laboratory experiments that users can perform over a few days’ time to verify and validate manufacturer’s performance claims. These guidelines, when paired with CLSI guidelines for manufacturers, provide a resource for making objective decisions about whether the performance a user observes is consistent with the claimed performance. This session describes CLSI method evaluation guidelines designed for user verifications of performance.
Speaker:
R. Neill Carey, PhD, FACB
Clinical Chemist, Peninsula Regional Medical Center
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Related CLSI
Documents:
EP15-A2–User Verification of Performance for Precision
and Trueness
EP06-A–Evaluation of the Linearity of Quantitative
Measurement Procedures: A Statistical Approach
C28-A3–Defining, Establishing, and Verifying Reference
Intervals in the Clinical Laboratory
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