Here’s an additional note confirming Denise Solieau’s February 12 discussion of PT validation and analytical measurable ranges (AMRs). Page 83 of the July 31, 2012 CAP survey references the value of AMRs in coagulation testing and includes this statement, “The new checklist requirements (meaning AMR) apply to hemostasis test methods that are calibrated and directly measure the concentration or activity of an analyte by employing enzyme immunoassay (EIA) immunoturbidity, and chromogenic methods. Clot-based methods, euglobulin lysis time, qualitative clot stability, and all platelet function assays, including ristocetin cofactor activity are exempt.”
Feb 13 2013
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