Transition to ISO 15189 : 2012 for Cytopathology Laboratories Part 4: Examination Processes and QC / QA System (QCAS)

Modern cytopathology laboratories offer an outstanding portfolio of testing services that are vital for patients. Due to their clinical importance, such laboratories have to provide results of high quality and credibility. Accreditation status and the implementation of a Quality Management System according to ISO15189 requirements are usually the most effective strategies to reach the optimum quality standards. However, laboratory quality should be constantly monitored and assessed in order to avoid potential deviations from the pre-defined values. The design of a unified system of Quality Control and Assurance procedures that will guarantee excellent performance and results is essential. The authors present their experience on the implementation of such a system and describe in detail strategies for efficient quality management. Useful recommendations for the design of such a system are provided. Finally, a mobile health application that could potentially enhance the entire quality control and assurance system is also presented.