医疗集团化管理背景下临床检验分析前质量精细化管理

目的　针对检验分析前质量管理存在的问题，以ISO15189 质量管理体系为导向，通过改进管理措施，评估管理 措施对分析前质量提升的效果。方法　以郴州市第一人民医院集团四个医疗区2016 年~2018 年检验样本质量为研究对 象，依据检验样本不合格率指标的变化，评估各种持续改进措施的效果。结果　2016 年改善措施实施前，2 539 292 例 标本中有14 881 例不合格，不合格率为5.86‰。2017 年启动ISO15189 申报工作，联合多学科多部门联动改善措施实施后， 2 818 615 例标本中有5 975 例不合格，不合格率为2.12‰。2018 年再次改进后，3 072 291 例标本中有5 199 例不合格， 不合格率为1.69‰。差异均有统计学意义（P <0.05）。标本总量增长的同时，不合格标本数量呈下降趋势。结论　以 ISO15189 质量管理体系为导向，通过建立和完善分析前质量管理制度，建立多部门合作体系，对样本的采集、运送及 保存实施精细化管理，能显著提升分析前检验质量。

Refined Management of the Pre-analytical Phases of the Clinical Laboratory in Medical Group

Objective　To solve the problems of quality management before inspection and analysis, and the ISO 15189 quality management system was taken as the guide to evaluate the effect of management measures on quality improvement before analysis by improving management measures. Methods　The quality of test samples from four medical districts of the Chenzhou First People’s Hospital group from 2016 to 2018 was taken as the research object to evaluated the effectiveness of various continuous improvement measures according to the change of unqualified rate index of test sample. Results　Prior to the implementation of improvement measures in 2016，14 881 out of 2 539 292 specimens were unqualified, the unqualified rate was 5.86‰. ISO15189 declaration in 2017 was started, after implementation of joint multi-disciplinary and multi-sectoral linkage improvement measures， 5 975 out of 2 818 615 specimens were unqualified, the unqualified rate was 2.12‰. After further improvement in 2018， 5 199 out of 3 072 291 specimens were unqualified, the unqualified rate was 1.69‰（P <0.05）. While the total number of specimens increased, the number of unqualified specimens showed a downward trend. Conclusion　Guided by ISO15189 quality management system, through the establishment and improvement of pre-analysis quality management system, the establishment of a multi-department cooperation system, the implementation of fine management of sample collection, transportation and preservation, can significantly improve the quality of pre-analysis inspection.