医疗失效模式与效应分析在药物基因实验质量管理的应用与实践

Application and Practice of Healthfailure Mode and Effect Analysis in Quality Management of Drug Gene Experiment

关键词:  医疗失效模式与效应分析  药物基因实验  个体化用药

Key words:  healthfailure mode and effect analysis  drug gene experiment  individualized medication

摘要:

目的 通过应用医疗失效模式与效应分析(healthfailure mode and effect analysis，HFMEA)，预防药物基因实验的风险事件，提高药物基因实验的操作质量。方法 药学实验室成立失效模式与影响分析(failure mode and effect analysis，FMEA)活动小组，采用头脑风暴法，借助HFMEA模式，识别及分析药物基因实验过程前、中、后可能存在的操作、仪器及环境对药物基因实验质控造成的风险事件，同时制定相对应的解决方案。结果 开展HFMEA活动后，预防与补救了药物基因实验前、中、后的风险事件产生，风险系数值由总分值1 375分降至62.36分，降幅为95.47%(P<0.01)；活动小组成员在品管手法、解决问题能力、沟通配合、积极性等方面得到了显著提高。结论 HFMEA活动有助于降低药物基因实验产生风险事件的频次，有效提升实验室的质量管理。

Abstract:

OBJECTIVE To prevent the risk events of drug gene experiment and to improve the operation quality of drug gene experiment by applying healthfailure mode and effect analysis(HFMEA) model. METHODS Failure mode and effect analysis(FMEA) activity group was established in the pharmaceutical laboratory. The brainstorming method and HFMEA model were used to identify and analyze the possible risk events caused by operation, instrument and environment on the quality control of drug gene experiment before, during and after the process of drug gene experiment, and formulate corresponding solutions accordingly. RESULTS After HFMEA, the risk events before, during and after drug gene experiment were prevented and remedied. The risk priority number value of risk coefficient decreased from 1 375 points to 62.36 points, with a decrease of 95.47%(P<0.01). The activity team members had significantly improved their quality control methods, problem-solving skills, communication and cooperation, enthusiasm and so on. CONCLUSION HFMEA activity helps to reduce the frequency of risk events in drug gene experiment, so as to save laboratory materials and reduce time cost.