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

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.

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