应用失效模式与效应分析方法建立医院药房质量风险管理体系

目的降低医院药房管理和操作各工作环节的质量风险,保证患者用药安全。方法应用失效模式与效应分析方法(FMEA)对医院药房各项工作环节进行研究,通过对失效模式发生的严重性、可能性、可发现性进行评分及风险优先值(RPN)计算,量化并确定各工作环节的风险等级,针对高中风险工作环节制定管理措施和标准操作规程(SOP)。结果确定管理过程和操作过程的高风险环节21个,中风险环节11个,每个风险环节都给出相应的管理措施、SOP和培训要求,以期显著降低患者用药风险。结论基于医院药房的质量风险,运用失效模式与效应分析(FMEA)工具,对各风险环节风险优先值(RPN)量化赋值,建立了医院药房质量风险管理体系,切实保证患者用药安全。

Establishment of Quality Risk Management System in Hospital Pharmacy with Failure Mode and Effect Analysis

Objective:In order to reduce the quality risk of hospital pharmacy management and operation,and ensure the safety of drug use.Method:The failure mode and effect analysis method(FMEA)were applied to study the work links of the hospital pharmacy.The severity,possibility and discoverability of the failure mode were scored and the risk priority value(RPN)was calculated to quantify and determine the risk level of each working link,and the management measures and standard operating procedures(SOP)were formulated for the high and medium risk working link.Result:21 high-risk and 11 medium-risk links were identified in the management and operation process,and corresponding management measures,SOPs and training requirements were given for each risk link,so as to significantly reduce the risk of medication for patients.Conclusion:Based on the quality risk of hospital pharmacy,the failure mode and effect analysis(FMEA)was used to quantify and assign the risk priority value(RPN)of each risk link,and the quality risk management system of hospital pharmacy was established to ensure the safety of patients’medication.