H54

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 systems 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.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of September 2016. The document’s next scheduled review is generally five years after the reaffirmation date.

This document is available in electronic format only.