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Transition to ISO 15189: 2012 for Cytopathology Laboratories Part 3: Risk Analysis and Management

Eleftherios Vavoulidis, Stavros Archondakis (), Maria Nasioutziki, Ourania Oustambasidou, Angelos Daniilidis, Konstantinos Dinas and Aristotelis Loufopoulos
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Eleftherios Vavoulidis: Medical School, Aristotle University of Thessaloniki and Hippokration General Hospital of Thessaloniki, Thessaloniki, Greece
Maria Nasioutziki: Medical School, Aristotle University of Thessaloniki and Hippokration General Hospital of Thessaloniki, Thessaloniki, Greece
Ourania Oustambasidou: 401 General Military Hospital of Athens, Athens, Greece
Angelos Daniilidis: Medical School, Aristotle University of Thessaloniki and Hippokration General Hospital of Thessaloniki, Thessaloniki, Greece
Konstantinos Dinas: Medical School, Aristotle University of Thessaloniki and Hippokration General Hospital of Thessaloniki, Thessaloniki, Greece
Aristotelis Loufopoulos: Medical School, Aristotle University of Thessaloniki and Hippokration General Hospital of Thessaloniki, Thessaloniki, Greece

International Journal of Reliable and Quality E-Healthcare (IJRQEH), 2016, vol. 5, issue 3, 42-61

Abstract: Modern cytopathology has advanced from the point when conventional Pap testing was adequate enough for medical diagnosis thanks to the implementation of the latest Laboratory Diagnostics. No matter how well-structured a cytopathology laboratory may be, it is still subjected to potential risks that could dramatically affect its services. Risk identification, evaluation and management via a Quality Control Plan can become a powerful tool for cytopathology laboratories wishing to maintain or/and enhance the quality of their diagnostic services. The authors present their experience on the implementation of such a risk analysis and control system covering all the necessary parameters and issues that should be addressed. Also, a hypothetical structure for a risk analysis is presented with useful guidance associated with cytological laboratories conducting morphological and molecular examinations. Finally, a mobile health solution is proposed that, if designed properly, could further optimize and harmonize risk management strategies globally.

Date: 2016
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