应用失效模式与影响分析方法降低PIVAS危害药品调配中的职业暴露风险

Reduction the Risk of Occupational Exposure in Hazardous Drug Deployment in PIVAS by Using FMEA

目的:降低静脉用药调配中心(PIVAS)危害药品调配中的职业暴露风险。方法:应用失效模式与影响分析(FMEA)方法对我院PIVAS危害药品调配流程中可能产生职业暴露风险的失效模式(FM)进行分析,对FM的严重度、发生率和可侦测度进行评分,并计算其风险优先值(RPN),以量化并确定应优先改善的FM,制定改进措施并实施。干预3个月后再次评估,比较干预前后的RPN值。结果:在我院PIVAS危害药品调配流程中共找出药品管理不到位(RPN值为24)、调配前准备不充分(RPN值为24)、混合调配方法不正确(RPN值为45)、废弃物处置不当(RPN值为36)、药品交接不规范(RPN值为32)等9项FM,制定并实施了完善相关制度、加强操作培训、规范操作流程、加强监督检查、提高防护意识等措施。经过3个月的干预,上述5项FM的RPN值分别降为8、8、10、8、8,均处于相对低风险区域中;合计RPN值由215降低为54,差异有统计学意义(P<0.05)。结论:我院PIVAS应用FMEA方法,有效降低了危害药品调配中的职业暴露风险。

OBJECTIVE:To reduce the risk of occupational exposure during hazardous drugs deployment in pharmacy intravenous admixture service(PIVAS).METHODS:Failure mode and effect analysis(FMEA)was used to analyze the failure mode(FM)of occupational exposure during hazardous drugs deployment in PIVAS.The severity,possibility and detectability degree of the FM were scored,and the risk priority number(RPN);FM that should be given priority improvement were quantified and determined;improvement measures were developed and conducted.After 3 months of improvement management,the risk of occupational exposure was evaluated again,and then RPN was compared before and after improvement.RESULTS:In hazardous drugs deployment links of PIVAS,9 high-risk FM had been found in total,such as poor drug administration(RPN was 24),inadequate preparation before deployment(RPN was 24),incorrect method of deployment(RPN was 45),improper disposal of waste(RPN was 36),non-standard handover of hazardous drugs(RPN was 32),etc.Thus risks control measures had been formulated,including formulating and implementing related system,enhancing operational training,standardizing operating procedure,enhancing supervision and inspection,raising awareness of protection and so on.After 3 months of intervention,RPN of the above 5 FM were reduced to 8,8,10,8,8,respectively,which were all in a relatively low risk area.Accumulated RPN was reduced from 215 to 54,with statistical significance(P<0.05).CONCLUSIONS:The application of FMEA management method in PIVAS of our hospital has reduced the risks of occupational exposure in hazardous drugs deployment.