通过ISO 15189认可医学实验室检验前质量指标结果分析
DOI:
作者:
作者单位:

作者简介:

通讯作者:

中图分类号:

基金项目:

国家自然科学基金(81871737)


Study on pre-analytical quality indicators in clinical laboratory accredited by ISO 15189
Author:
Affiliation:

Fund Project:

  • 摘要
  • |
  • 图/表
  • |
  • 访问统计
  • |
  • 参考文献
  • |
  • 相似文献
  • |
  • 引证文献
  • |
  • 资源附件
  • |
  • 文章评论
    摘要:

    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。

    Abstract:

    Abstract:?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.

    参考文献
    相似文献
    引证文献
引用本文

杜雨轩,段敏,王薇,陈兵权,王治国.通过ISO 15189认可医学实验室检验前质量指标结果分析[J].临床检验杂志,2020,(7):548-552

复制
分享
文章指标
  • 点击次数:
  • 下载次数:
  • HTML阅读次数:
  • 引用次数:
历史
  • 收稿日期:2020-03-26
  • 最后修改日期:
  • 录用日期:
  • 在线发布日期: 2020-11-13
  • 出版日期:
您是第位访问者  苏ICP备12051282号-1
主管单位:江苏省医学会  出版单位:临床检验杂志
单位地址:江苏省南京市中央路42号  邮编:210008
电话:025-83620683 E-MAIL:lcjyzz@163.com
技术支持:北京勤云科技发展有限公司