基于ISO 15189质量体系的临床实验室风险控制系统的建立  

Establishment of clinical laboratory risk control system based on the ISO 15189 quality system

作　　者：陈平[1] 陈婷婷[1] CHEN Ping;CHEN Tingting(Zhejiang Hospital of Traditional Chinese Medicine,Hangzhou 310006,Zhejiang,China)

机构地区：[1]浙江省中医院,浙江杭州310006

出　　处：《检验医学》2021年第8期869-874,共6页Laboratory Medicine

基　　金：浙江省医药卫生科技计划项目(2019PY051)。

摘　　要：目的依据ISO 15189质量管理体系,建立完备的信息化临床实验室风险管理模型。方法基于ISO015189质量管理体系设置42个自动识别指标和147个风险点,建立从风险设定、信息采集、识别、警示、处置、定期评估和风险计划调整全过程闭环管理体系。比较运行风险控制系统前后的差异。结果运行风险控制系统后,系统共识别风险事件497次。风险事件主要分布在人员、环境、试剂、信息系统、标本、分析设备、质控、检测过程和报告以及实验室管理环节。经过5次风险评估,整体风险评估值较未使用风险控制系统前下降了27.7%。结论建立的风险管理模型可帮助临床实验室根据具体情况选择适合的风险点和风险指标进行管理、监测和定期评估,从而识别易造成患者危害的风险因素,有效减少医疗差错的发生,实现临床实验室各业务模块信息资源共享,从风险管理的角度评估和追踪临床实验室改进的效果。Objective To establish an informationization-based risk control model for clinical laboratories according to ISO 15189 quality system.Methods Based on ISO 15189 quality system,the whole process closed-loop management of risk setting,information collection,identification,warning,disposal,regular assessment and risk plan adjustment was established by means of informationization according to the 42 automatic identification indicators and 147 risk points.The difference was compared between before and after using the risk control system.Results Since the operation of the risk control system,the system had identified a total of 497 risk events.The risk events were mainly distributed in personnel,environment,reagents,information system,specimens,analytical equipment,quality control,testing process and reports and clinical laboratory management.After 5 risk assessments,the overall risk assessment value decreased by 27.7%compared with that before using the risk control management system.Conclusions The clinical laboratory can select suitable risk points and risk indicators for management,monitoring and regular assessment according to the specific situation of the clinical laboratory,so as to identify the risk factors that are easy to cause harm to patients,and effectively reduce the occurrence of medical errors.Finally,the sharing of information resources of each business module of clinical laboratory is realized,and the effect of clinical laboratory improvement is evaluated and tracked from the perspective of risk management.

关 键 词：信息系统 风险控制 质量体系 临床实验室 

分 类 号：R446.1[医药卫生—诊断学]