Scientific and Standardization Committee Communication: A Reference System Approach to Future Standardization of Laboratory Tests for Hemostasis

A description of the development of a strategy for improving the standardization of coagulation tests and the rationale behind the recommendations that follow are the subject of this position paper. Such an endeavor has been occasioned by the advances in the technology for the diagnosis and therapeutic treatment of hemorrhagic and thromboembolic diseases. These and anticipated further advances make it imperative that the standardization of laboratory tests used in diagnosis and in monitoring therapeutic treatments be the ‘state-of-the-art’ so that the accuracy, comparability and clinical utility is of the highest order. The complexity of the hemostatic system makes achieving accuracy and comparability among these tests a substantial challenge. Another impetus for improving the comparability of the results from different laboratories throughout the world arises as a consequence of the globalization of the pharmaceutical and medical diagnostic companies that began in the 1990’s and is continuing into this, the 21 century.