失效模式和效应分析在PIVAS全肠外营养液调配全流程风险管理的应用

Application of failure mode and effect analysis in risk management of PIVAS parenteral nutrition solution

目的:提高静脉用药调配中心肠外营养调配质量。方法:对静脉用药调配中心肠外营养液调配全流程中各个环节进行失效模式与效应分析(FMEA)。选出高风险等级的失效模式和中等风险等级中S≥4的失效模式,整理分析其失效原因,提出并实施改进措施。整改措施实施5个月后,统计失效模式错误率,分析改进效果。结果:在PIVAS肠外营养液调配全流程中,共找出19个高等和中等风险等级的失效模式,并从培训、流程、医院信息系统和质控管理等几个主要方面进行整改。经过5个月干预后,19项失效模式合计RPN值由806降至308,降幅61.8%。其中非蛋白热量不适宜、热氮比不适宜和糖脂比不适宜等9项失效模式经改进后错误率明显降低,且存在统计学差异(P<0.05)。结论:将失效模式与效应分析(FMEA)应用于PIVAS肠外营养调配全流程风险管理,能够有效提高其肠外营养液调配质量,降低差错率。

OBJECTIVE To improve the quality of parenteral nutrition deployment in PIVAS.METHODS Failure mode and effect analysis(FMEA)was carried out on each link in the whole process of parenteral nutrition solution preparation during intravenous drug preparation.Select the failure mode with high risk level and the failure mode with S≥4 in medium risk level,sort out and analyze the failure causes,and propose and implement improvement measures.Five months after the implementation of rectification measures,the failure mode error rate was counted and the improvement effect was analyzed.RESULTS A total of 19 failure modes with high and medium risk levels were found in the whole process of PIVAS parenteral nutrition solution preparation,and rectification was made from several main aspects such as training,process,HIS system and quality control management.After 5 months of intervention,the total RPN value for the 19 failure modes decreased by 61.8%from 806 to 308.Among them,the error rates of nine failure modes such as inappropriate non-protein calories,inappropriate heat to nitrogen ratio and inappropriate glycolipid ratio were significantly lower after improvement,and there were statistically significant differences(P<0.05).CONCLUSION Applying failure mode and effects analysis(FMEA)to the risk management of PIVAS parenteral nutrition deployment can effectively improve the quality of parenteral nutrition solution deployment and reduce the error rate.