Background: Comprehensive quality control (QC) procedures are necessary to ensure accurate analytic method performance. Highly automated systems typically have inherent QC programs that facilitate performance and maintenance of QC procedures; however, for bench-top analyzers that lack internal systems, independent QC programs must be used.
Objective: The goal of this study was to evaluate the adaptability of an independent QC program, EZ Runs (Westgard QC Inc, Madison, WI, USA), to the maintenance of QC procedures for a mechanical, bench-top coagulation unit and to compare the results with our current, manual, QC method in a qualitative way.
Methods: A QC application file for activated partial thromboplastin time (aPTT) performed on a STart4 (Diagnostica Stago, Parsippany, NJ) was created in EZ Runs. Results were recorded and interpreted using this software package as well as the current, manual, QC method.
Results: EZ Runs was adaptable to QC monitoring for the bench-top analyzer, and the program permitted identification of both random and systematic errors not detected by the manual QC system.
Conclusions: EZ Runs improved the performance and maintenance of QC procedures for this bench-top coagulation analyzer. The results indicated the need to improve staff training in assay performance and QC interpretation. In addition, use of the software program indicated that a multirule QC design was needed to monitor assay performance.