Auto-validation of routine coagulation/hemostasis assays with reflex testing of abnormal test results

Hemostasis laboratories play a crucial role in the diagnosis and treatment of individuals with bleeding or thrombotic disorders. Routine coagulation assays, including the prothrombin time (PT)/international normalized ratio (INR), and activated partial thromboplastin time (APTT), are used for various purposes. These include as a screen of hemostasis function/dysfunction (e.g., possible factor deficiency) and for monitoring of anticoagulant therapy, such as vitamin K antagonists (PT/INR) and unfractionated heparin (APTT). Clinical laboratories are also under increasing pressure to improve services, especially response (test turnaround) times. There is also a need for laboratories to try to reduce error rates and for laboratory networks to standardize/harmonize processes and policies. Accordingly, we describe our experience with the development and implementation of automated processes for reflex testing and validation of routine coagulation test results. This has been implemented in a large pathology network compromising 27 laboratories and is under consideration for expansion to our larger network (of 60 laboratories). These rules have been custom-built within our laboratory information system (LIS), perform reflex testing of abnormal results, and fully automate the process of routine test validation for appropriate results. These rules also permit adherence to standardized pre-analytical (sample integrity) checks, automate reflex decisions, automate verification, and provide an overall alignment of network practices in a large network of 27 laboratories. In addition, the rules enable clinically significant results to be quickly referred to hematopathologists for review. We also documented an improvement in test turnaround times, with savings in operator time and thus operating costs. Finally, the process was generally well received and determined to be beneficial for most laboratories in our network, in part identified by improved test turnaround times.