品管圈方法在基于ISO 15189构建医学实验室质量管理体系中的应用效果

Effect of quality control circle in constructing clinical laboratory quality management system based on ISO 15189

目的评价运用课题研究型品管圈(QCC)方法基于国际标准化组织ISO 15189构建医学实验室质量管理体系的效果。方法按照QCC活动步骤,从人员、设备、设施环境、信息以及检验前、检验中、检验后程序等多个维度把握实验室现状水平,对攻坚点进行分析、挖掘和合并,整合为3大方策群组并加以实施:①构建质量管理体系文件;②加强人员培训及管理;③完善检验过程的质量管理。结果通过方策群组的实施进行效果确认,条款知晓率提高了50.2百分点,室内质控项目开展率提高了17.0百分点,室内质控达标率提高了15.0百分点,标本标签不合格率降低了6.1百分点,标本溶血率降低了1.1百分点,室间质评项目不合格率降低了4.0百分点,标本类型错误率降低了0.32百分点,标本容器错误率降低了0.33百分点,患者满意度和医护满意度均提高了15.0百分点。结论采用QCC管理方式能构建实验室质量管理体系,提高QCC成员运用QCC工具解决检验科实际问题的能力。

Objective To evaluate the effect of applying research-oriented quality control circle(QCC)for construction of clinical laboratory quality management system based on International Organization for Standardization ISO 15189.Methods According to the method of activity steps of research-oriented QCC,the status of clinical laboratory was investigated from multiple aspects of personnel,equipment,facilities and environment,information,pre-examination processes,examination,post-examination processes,etc.The key points were excavated,analyzed and merged,corresponding to three countermeasures groups,and were proposed and implemented:①construction of quality management system documents;②strengthening personnel training and management;③improving quality management of inspection process.Results The effect confirmation was carried on by the implementation of countermeasures groups.The ISO 15189 terms awareness rate increased by 50.2 percentage points,implementation rate of external quality assessment increased by 17.0 percentage points,compliance rate of internal quality increased by 15.0 percentage points,specimen label failure rate reduced by 6.1 percentage points,specimen hemolysis rate reduced by 1.1 percentage points,failure rate internal quality assessment reduced by 4.0 percentage points,specimen type error rate reduced by 0.32 percentage point,specimen container error rate reduced by 0.33 percentage point,patient satisfaction and medical staff satisfaction both increased by 15.0 percentage points,respectively.Conclusion Adopting QCC management can build the laboratory quality management system and improve the ability of circle members to use QCC tools to solve practical problems in the laboratory department.