ISO 15189:2012 Technical Requirements for Cytopathology Laboratory Information Systems

Abstract

Medical laboratories are complex systems composed of specialized personnel and medical modalities. Despite complexity, they are well-organized systems with standardized workflow. Especially for cytopathology laboratories the human factor is extremely important, because examination of glass slides is the majority of the workflow from experts (cytopathologists). Recently there is an increasing need to ensure the quality of medical laboratories by applying quality standards, such as ISO 15189:2012 which is proposed by many organizations and in many countries is enforced by law. ISO15189 does not oblige the application of Laboratory Information Systems (LISs); however, nowadays, it is extremely difficult for a laboratory to routinely operate without it. In this paper we present the design and requirements of an enhanced LIS (eLIS), adapted to support not only the standard routine of a cytopathology laboratory (and other laboratory types) but to facilitate the support of technical requirements posed by ISO15189.