ISO 15189:2012 Management Requirements for Cytopathology Laboratory Information Systems

Abstract

During the last decade, there is an increasing need for quality improvement of medical laboratories via the use of quality related standards. Recently regulatory bodies suggest and sometimes enforce the application of ISO 15189, which is designed especially for medical laboratories. Despite the standard does oblige the application of Laboratory Information Systems (LISs), it is evident that without a LIS it is difficult for laboratories to operate efficiently. Modern cytopathology laboratories form complex systems composed of a multidisciplinary human team coupled with medical modalities and capabilities. Hopefully, such laboratories have well standardized and defined workflow. The adoption of the standard, creates numerous management requirements, introduces new functions and associated overhead. In this paper, we present design and implementation issues of an enhanced LIS to support ISO 15189 in a cytopathology laboratory. The LIS designed around ISO 15189 management requirements can improve, enhance and facilitate the standard application and adoption.