摘要
目的通过分析我国获得ISO 15189认可医学实验室检验前质量指标结果,了解国内临床实验室检验前过程的质量水平。方法国家卫生健康委临床检验中心联合31个省级临床检验中心同步开展质量指标室间质量评价计划,并通过已开发的Clinet-EQA系统下发调查表,收集2016—2019年获得ISO 15189认可医学实验室的基本信息和检验前质量指标数据,并按照专业类别、信息化建设水平等进行统计分析。结果2016—2019年,除了血培养污染率和标本溶血率外,所有通过ISO 15189认可医学实验室的所有检验前质量指标都达到3σ的最低可接受标准。其标本类型错误率、标本采集量错误率、标本容器错误率、标本溶血率、抗凝标本凝集率以及血培养污染率在4σ以上水平的实验室分别为99.67%、99.51%、100%、97.11%、96.75%和38.74%,急诊标本和住院标本检验前周转时间中位数的分布分别为50 min内和10~100 min。结论我国通过ISO 15189认可实验室检验前质量表现较好,但实验室仍需关注血培养污染率、抗凝标本凝集率和标本溶血率。
Objective To study the quality level of the clinical laboratory accredited by ISO 15189 in China by analyzing the data of pre-analytical quality indicators. Methods The National Center for Clinical Laboratories organized 31 provincial centers to launch a synchronous quality indicators(QIs)-External Quality Assessment(EQA) program. The data were reported via online Clinet-EQA system. The essential information of the clinical laboratories accredited by ISO 15189 and the data of pre-analytical quality indicators during the period from 2016 to 2019 were collected. The statistical analysis was conducted according to professional categories or the levels of informatization. Results All the pre-analytical quality indicators achieved the minimum acceptable 3σ metric in the clinical laboratories accredited by ISO 15189 except for contamination rates of blood culture and hemolysis rate of specimens. The ratios of laboratories over 4σ metric were 99.67%, 99.51%, 100%, 97.11%, 96.75% and 38.74% for the rates of incorrect sample type, incorrect fill level, incorrect sample container, sample hemolysis, clotting of anticoagulant samples and blood culture contamination, respectively. The distributions of median pre-examination turnaround time of the specimens from the emergency and inpatients were 50 minutes and 10-100 minutes respectively. Conclusion The quality levels of pre-analytical quality indicators of the clinical laboratories accredited by ISO 15189 in China have presented better performance to some extent, but the contamination rate of blood culture, clotted rate of anticoagulant samples and the hemolysing rate of specimen should be paid considerable attention in the future.
作者
杜雨轩
段敏
王薇
陈兵权
王治国
DU Yuxuan;DUAN Min;WANG Wei;CHEN Bingquan;WANG Zhiguo(National Center for Clinical Laboratories/Beijing Engineering Research Center of Laboratory Medicine,Beijing Hospital,National Center of Gerontology,CAMS,Beijing 100730;Beijing Clinet Information Technology Co.,Ltd,Beijing 100020,China)
出处
《临床检验杂志》
CAS
2020年第7期548-552,共5页
Chinese Journal of Clinical Laboratory Science
基金
国家自然科学基金(81871737)。
