基于LSS管理法的临床分子诊断设备管理策略研究  

Analysis and research on management strategy of clinically molecular diagnostic equipment on the basis of LSS method

作　　者：费敏[1] 顾燕芳[2] 陈瑛 杨岚[4] FEI Min;GU Yan-fang;CHEN Ying(Department of Equipment,Wuxi Maternal and Child Health Care Hospital,Wuxi 214001,China)

机构地区：[1]无锡市妇幼保健院设备科,江苏无锡214001 [2]无锡市妇幼保健院,江苏无锡214001 [3]无锡市妇幼保健院中心实验室,江苏无锡214001 [4]无锡市妇幼保健院产前诊断实验室,江苏无锡214001

出　　处：《中国医学装备》2020年第3期131-135,共5页China Medical Equipment

摘　　要：目的:基于精益六西格玛(LSS)管理方法制定分子诊断类设备管理策略,降低分子诊断类设备非常规错误事件的发生率。方法:运用组织系统模型(SIPOC)流程分析,绘制分子诊断类设备非常规错误发生率影响因素鱼骨图,完成LSS管理法的定义、测量、分析、改进与控制,分析影响分子诊断类设备非常规错误事件的重要环节,寻找并优化分子诊断设备的管理策略。选取染色体微阵列基因芯片系统等分子诊断类设备,将LSS管理法执行前的分子诊断类设备非常规错误事件纳入对照组,LSS管理法执行后非常规错误事件纳入实验组,对比分析两组分子诊断类设备非常规错误事件发生率。结果:实验组的分子诊断类设备假阳性率、样本错误率和设备故障发生率明显优于对照组,两组对比差异有统计学意义(χ^2=4.25,χ^2=11.88,χ^2=8.40;P<0.05);两组样本漏检率和复检率对比差异均无统计学意义。结论:基于LSS管理方法的管理手段,通过进行根因分析,可从多方面改进分子诊断类设备质量控制工作,优化分子诊断类设备管理策略,以保证分子诊断类设备稳步运行。Objective:To formulate a management strategy of molecularly diagnostic equipment on the basis of lean six sigma(LSS)management method so as to reduce the incidence of unconventional error events of molecularly diagnostic equipment.Methods:The process analysis of supplier input process output customer(SIPOC)was applied to draw fishbone diagram of influence factors of incidence of unconventional error of molecularly diagnostic equipment,and complete the definition,measure,analysis,improvement and control of LSS management method,and analyze the important links that affect the unconventional error events of molecularly diagnostic equipment,and find and optimize the management strategy of molecularly diagnostic equipment.Molecularly diagnostic equipment such as chromosome microarray gene chip system and so on was selected as the research objects.Unconventional error events of molecularly diagnostic equipment before LSS management method was implemented were included in control group,and those after LSS management method was implemented were included in experimental group.The incidences of unconventional error events of molecularly diagnostic equipment of two groups were compared and analyzed.Results:The false positive rate,sample error rate and equipment failure rate of molecularly diagnostic equipment of experimental group were significantly better than those of control group(χ^2=4.25,χ^2=11.88,χ^2=8.40,P<0.05),respectively.And there were no significant differences in the rate of sample omission and the rate of reexamination between the two groups.Conclusion:The management means based on LSS management method can improve the quality control of molecularly diagnostic equipment in many aspects,and optimize the management strategy of that,and ensure the stable operation of that through root cause analysis.

关 键 词：精益六西格玛(LSS) 分子诊断设备 SIPOC流程 鱼骨图 假阳性率 设备故障率 

分 类 号：R197.39[医药卫生—卫生事业管理]