失效模式与效应分析在血液制品安全管理中的应用研究

Research on Applying Healthcare Failure Mode and Effect in Management of Blood Product Safety

目的探讨医疗失效模式与效应分析(Healthcare Failure Mode and Effect Analysis,HFMEA)在血液制品安全管理中的应用效果。方法运用HFMEA评估院内血液制品的采购、验收、储存、院内流通环节中易发生失效的原因,进行风险评估、决策树分析、对策拟定、实施整改,以预防失效模式的再次发生,比较实施前后血液制品院内冷链管理的断链点、断链时长、风险优先指数(Risk Priority Number,RPN)等。结果应用HFMEA后影响血液制品安全性的断链点、断链时长、RPN值均有下降,其中断链点大幅减少,断链时长从1.5个小时降低到0,RPN值从369到45,下降88%。结论通过HFMEA的运用可以预见血液制品院内管理中的失效环节,切实改善血液制品院内冷链管理。

Objective To investigate the effects of Healthcare Failure Mode and Effect Analysis（HFMEA） in the management of blood product safety. Method HFMEA was employed to evaluate the causes of failure in the process of hospital blood products purchase, acceptance, storage and circulation within hospital. Risk assessment, decision tree analysis, measures exploration and implementation was also conducted to help prevent recurrence of failures. The chain rupture point, length of rupture, and Risk Priority Number（RPN） of the blood product cold chain of the hospital were compared before and after HFMEA was carried out. Results After applying HFMEA, chain rupture point, length of rupture, and RPN which affected safety of blood products all went down. Specifically, the number of chain rupture points decreased greatly. Length of rupture decreased to 0 from 1.5 hours. RPN value declined by 88% from 369 to 45. Conclusion The application of HFMEA can predict the failure segment in the management of hospital blood products and improve the cold-chain management of blood products, practically.