Development and implementation of an expert rule set for automated reflex testing and validation of routine coagulation tests in a large pathology network.

Abstract

Haemostasis laboratories play a critical role in diagnosis and treatment of individuals with bleeding or thrombotic disorders. Routine coagulation assays such as prothrombin time (PT)/ international normalized ratio (INR), and activated partial thromboplastin time (APTT), are used in monitoring of anticoagulant therapy, as provided for treatment/prevention of thromboembolic disease, and also inform on potential haemostasis dysfunction. Increasing pressure is applied on clinical laboratories to improve response (test turnaround) times, reduce error rates and standardize policies. To this end, we describe our experience with the development and implementation of an automated process for reflex testing and validation of routine coagulation test results in a large pathology network compromising 27 laboratories. Custom-built expert rules were created to perform reflex testing and fully automate routine test validation. These rules were developed/implemented over a 15-month period, including 6months for development/ testing and 9months for training/implementation of >100 personnel at 27 sites. These rules have enabled adherence of standardized pre-analytical (sample integrity) checks, automated reflex decisions, automated verification and overall alignment of network practices. In addition, clinically significant results are immediately referred to haematologists. We report an improvement in test turnaround times, also reflecting savings in operator time. The process was generally well received and generally beneficial to most laboratories in the network.