ISO 15189:2012 Technical Requirements for Cytopathology Laboratory Information Systems

Abraham Pouliakis, Niki Margari, Aris Spathis, Christine Kottaridi, Marilena Stamouli, Antonia Mourtzikou, Stavros Archondakis (fourfouras@yahoo.com), Efrossyni Karakitsou, Elena Athanasiadi and Petros Karakitsos
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Abraham Pouliakis: Department of Cytopathology, University of Athens, “ATTIKON” University Hospital, Athens, Greece
Niki Margari: Department of Cytopathology, University of Athens, “ATTIKON” University Hospital, Athens, Greece
Aris Spathis: Department of Cytopathology, University of Athens, Faculty of Medicine, “ATTIKON” University Hospital, Athens, Greece
Christine Kottaridi: Department of Cytopathology, University of Athens, Faculty of Medicine, “ATTIKON” University Hospital, Athens, Greece
Marilena Stamouli: Department of Biochemistry, Naval and Veterans Hospital, Athens, Greece
Antonia Mourtzikou: Department of Biochemistry, “Asclepeion” Voulas Hospital, Athens, Greece & Department of Cytopathology, University of Athens, Faculty of Medicine, “ATTIKON” University Hospital, Athens, Greece
Efrossyni Karakitsou: Biomedical Engineering Laboratory, National Technical University of Athens, Athens, Greece
Elena Athanasiadi: Department of Cytopathology, University of Athens “ATTIKON” University Hospital, Athens, Greece
Petros Karakitsos: Department of Cytopathology, University of Athens, “ATTIKON” University Hospital, Athens, Greece

International Journal of Reliable and Quality E-Healthcare (IJRQEH), 2014, vol. 3, issue 3, 58-80

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.

Date: 2014
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