ISO 15189:2012 Technical Requirements for Cytopathology Laboratory Information Systems

ISO 15189:2012 Technical Requirements for Cytopathology Laboratory Information Systems

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), Stavros Archondakis (Cytopathology Department 401 Military 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) and Petros Karakitsos (Department of Cytopathology, University of Athens, “ATTIKON” University Hospital, Athens, Greece)
Copyright: © 2014 |Pages: 23
DOI: 10.4018/ijrqeh.2014070104

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.
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Cytopathology Laboratory Workflow

A modern cytopathology laboratory, especially when there are research and training activities, nowadays is composed of many branches (Figure 1). The laboratory director performs the management and quality control, and assurance procedures; assisted by the quality manager and in several cases by an assigned technical manager. The core of the laboratory subsequently is composed of units and smaller branches, each one responsible for performing specific examinations. The number of examination types performed is in the range of a few hundred due to the addition of molecular examinations. In cytopathology laboratories, usually most of the work volume is related to test Papanicolaou, for cervical cancer screening.

Figure 1.

Structure of a modern cytopathology laboratory

The Cytopathology Laboratory Cycle And The Laboratory Information Systems

The modern cytopathology laboratory follows a typical cycle for the daily workflow (Figure 2). The physician (usually a doctor from a clinic or another person, for example, a midwife) requests specific examinations and dispatches (unless it is already dispatched) a biological sample to the laboratory. Subsequently the sample is received, checked and marked (a unique identifier is assigned) in order to be traceable during the subsequent process. The creation of a worksheet that assigns examination (and additionally pre and post examination) tasks to persons or medical analyzers follows. Usually, many samples requiring the same examination are grouped together; the examinations are handled as a batch or in parallel from cytopathologists or medical modalities (analyzers). Each analysis is checked for correctness via an appropriate quality control (QC) and verification procedure. At this stage if the QC is passed the results are released to the requester, otherwise the analysis should be repeated. In some rare cases, errors may be found after the release of results; in this case the released examination results are invalidated and the requester is informed for the adverse event.

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