scope:

This guideline covers the procedures for the collection, transport, and processing of specimens for plasma-based coagulation and molecular hemostasis tests. Many variables, including anticoagulant volume and concentration, type of tube additive, duration and temperature of speciment storage, and surface of containers used for specimen collection and storage, may affect plasma-based coagulation test results. The reliability and accuracy of molecular test results also depend upon a variety of specimen collection, transport, and storage factors. The molecular testing in this document refers to DNA testing only.

The document is directed toward laboratory and/or clinical personnel responsible for obtaining and preparing patient specimens and for plasma-based coagulation and molecular hemostasis testing. It is also aimed at manufacturers of products involved in specimen collection, storage, preparation, and testing of plasma-based or molecular hemostasis assays. This document does not address whole blood clotting tests, platelet function tests, or point-of-care testing. H21-A5 does not provide general guidelines for the performance of coagulation testing. Performance guidelines for specific coagulation assays are addressed in other CLSI documents such as those for PT and APTT assays (ie, H47¹) and fibrinogen assay (ie, H30²).