Continued harmonization of the international normalized ratio across a large laboratory network: Evidence of sustained low interlaboratory variation and bias after a change in instrumentation

Abstract

Objectives Our objective was to maintain low interlaboratory variation and bias in international normalized ratio (INR) results following a network change in instrumentation and reagents, using a process of ongoing standardization and harmonization. Methods Network-wide standardization to new common instrument and reagent platforms followed by network-wide application of a simple novel process of verification of international sensitive index and mean normal prothrombin time values for each new lot of prothrombin time (PT) reagent that does not require use of World Health Organization reference thromboplastin or INR calibration/certified plasma. Results The network transitioned from mechanical hemostasis detection instruments with associated PT reagent (Diagnostica Stago; NeoPTimal) to optical detection (ACL TOPs) with associated PT reagent (Werfen; RecombiPlasTin 2G). Comparing 3 years of data for each situation, the network (n = 27 laboratories) maintained low INR variability and bias relative to general mechanical and optical groups and other laboratories. Conclusions Harmonized support for patient management of vitamin K antagonists such as warfarin was continuously maintained in our geography, with potentially positive implications for other coagulation laboratories and geographies. For the United States in particular, paucity of US Food and Drug Administration–cleared INR certified plasmas potentially compromises INR test accuracy; our novel approach may provide workable alternatives for other laboratories/networks.