CLSI H54-A (R2018)

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Procedures for Validation of INR and Local Calibration of PT/INR Systems; Approved Guideline, H54-A

Clinical and Laboratory Standards Institute , 08/19/2005

Category:
Guaranteed Safe Checkout

This document is no longer being reviewed through the Consensus Document Development Process

This document describes the use of certified plasmas to enhance performance of the prothrombin time (PT)/International Normalized Ratio (INR) system test; reviews limitations of the INR system that may occur when a manufacturer-determined ISI is used without local verification or calibration; and provides a rationale for performing local ISI verification with recommendations as to when PT calibration may be indicated. Part I is a detailed, expanded account for manufacturers and Part II is an abbreviated version useful for the clinical laboratory.