临床实验室按照 FM EA 模式构建凝血功能检测项目的风险管理程序

摘要

使用FMEA模型确定检验医学中心风险管理工作流程和关键环节。根据IS015189认可准则、CAP实验室认可检查条款等的相关标准，识别出实验室凝血功能检测工作流程中关键环节的风险。针对凝血功能检测的评价活动，采取积极的纠正措施，通过监测系统周期性地审核性能数据，可以对凝血功能检测的质量持续改进。（中华检验医学杂志，2016，39：13-17）%Definiting the workflow and key link of the risk management in medical laboratory by FMEA.Identifying risk factors of the workflow and key link of blood coagulation test by the criteria for laboratory accreditation , such as ISO15189 recognition criteria and CAP laboratory accreditation inspection . Through the evaluation of the blood coagulation test , effective corrective actions and examining performance data periodically , the quality of the blood coagulation test can be improved continuously.