RISK-BASED QUALITY CONTROL IN THE SURGICAL PATHOLOGY LABORATORY; BRIEF REVIEW AND DEVELOPMENT OF AN INDIVIDUALIZED QUALITY CONTROL PLAN

Abstract

One of the most important tools for reducing or preventing diagnostic errors in the surgical pathology laboratory is the establishment of a quality management system. Risk analysis and quality assurance are important components to ensure the sustainability of the quality management system. Quality assurance ensures the integrity of program design and includes interrelated activities quality control and quality monitoring-evaluation programs. Risk-based thinking is expressed as the planning of risks and how they should be managed by determining the possible dangers and risks in achieving the determined goals and objectives, using the available information systematically. Laboratories must identify and carry out a large number of interrelated activities to maintain their functions effectively. To achieve its goals, it must demonstrate the ability to measure and evaluate process performance, as well as to demonstrate the effectiveness of past decisions, along with improving operational effectiveness and efficiency. With a successful quality management process, the reliability of laboratory results can be increased. In this study, our objective was to develop a roadmap for the detection, monitoring and minimization of diagnostic errors in the surgical pathology laboratory, in line with the views of international regulatory organizations, to develop a quality plan based on risk management that covers the entire analytical cycle. It is not possible to discuss the quality control of laboratories without accepting the possibility of error in surgical pathology. Investing in continuing medical education and patient safety, as well as the training of new pathologists with a critical view to reducing errors is an imperative way to improve the practice of pathology.