Analytical and post analytical phase of an ISO 15189:2012 Certified cytopathology laboratory-a five year institutional experience

Abstract

Objective: Analytical and post analytical phase are integral part of total quality management system and include steps from submission of slides till reports are dispatched. The present study was conducted to analyze the analytical and post analytical phase of the ISO15189:2012 certified cytopathology laboratory. It was also intended to study the various errors which were encountered and steps taken to reduce these discrepancies. Methods: The study included all documents of quality program from 1 November 2014 till 31 Oct 2019 in medical institute situated in north Himalayan region of India. All the data was recorded and analyzed for analytical and post analytical phase. Results: The number of samples received in cytopathology lab was 21,566 with total quality errors of 5.19%. Out of these pre-analytical errors were 55%, analytical 10.5% and post analytical errors constituted 34.4%. The maximum errors detected were due to typographical errors followed by delayed turnaround time. Cyto-histopathological discordance was 10.5% in non-gynecological cases and 2.2% in gynecological cases. Conclusion: Analytical and post analytical phase analysis is essential to minimize the errors and improve the quality of cytopathology lab. Cyto-histopathological correlation is valuable for continuous data tracking in the cytopathology with analytical errors analysis. Maintenance of external, internal quality program, turnaround time with documentation, continuous training and communication with clinician is fundamental for quality improvement in any cytopathology lab. Acknowledgement of nonconformance with root cause analysis and sincere efforts to minimize them is the basic key for successful quality management.

Keywords

• analytical phase
• cytopathology
• post analytical phase
• quality management