Development and Application of Computerized Risk Registry and Management Tool Based on FMEA and FRACAS for Total Testing Process.

摘要: Background and Objectives: Risk management is considered an integral part of laboratory medicine to assure quality patient safety. However, the concept risk philosophical, so actually performing in a clinical can be challenging. Therefore, we would like develop sustainable, practical system for continuous total management. Materials Methods: This study was composed two phases: development phase 2019 application 2020. A flow diagram computerized registry tool (RRMT) designed using failure mode effects analysis (FMEA) reporting, analysis, corrective action (FRACAS) methods. The stage divided into six according testing sequence. We applied errors this over one year priority number (RPN) score calculated by multiplying severity mode, frequency (or probability) occurrence, detection difficulty. Results: 103 cases were reported RRMT during year. Among them, 32 (31.1%) summarized FMEA method, remaining 71 (68.9%) evaluated FRACAS method. There no registration phase. Chemistry units accounted highest proportion with 18 (17.5%), while urine test lowest portion (1.9%). Conclusion: developed risk-management based on methods entire process. useful detect, evaluate, report failures. might great example optimized laboratories.