| 摘要: |
| 目的 探讨我国当前检验后阶段的质量指标及其质量规范，为临床实验室建立QI体系提供参考。 方法 采用卫生部临床检验中心和北京科临易检信息技术有限公司共同设计开发的网络平台，向参加中心2015年全国临床检验专业质量指标调查的所有实验室发放调查表按照不同专业和不同医院等级进行分组，采用Kolmogorov-Smirnov检验判断数据正态性，Kruskal-Wallis检验和Mann-Whitney检验分别进行多组和两组间的比较。结果 分别有5 229家、4 643家和4 421家实验室上报了检验报告不正确率、危急值通报率和危急值通报及时率的相关数据。各指标均有超过95%的实验室、σ水平≥3 σ和≥6 σ的实验室则分别占47.87%、91.17%、85.95%。各指标在不同专业之间存在显著差异；除危急值通报率以外，其余2项指标在不同等级医院之间也存在显著差异。结论 我国临床实验室检验后阶段3项QI的差错率相对较低，多数实验室危急值通报率和危急值通报及时率达到了100%。临床实验室应基于此调查，进一步监测3项指标，同时正确有效地识别检验后阶段的薄弱环节，建立更多合适的QI并基于当前技术水平确定相应的质量规范。 |
| 关键词: 检验后阶段 质量指标 质量规范 |
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| Quality Indicators and Quality Specifications for the Clinical Post-testing Phase |
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| Abstract: |
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Objective To discuss quality indicators (QI) and their quality specification of post-testing phase in China, and to provide a reference for the establishment of the QI system in clinical laboratories. Method Using the network platform designed and developed by National Center for Clinical Laboratories (NCCL) and the Clinet website (www.clinet.com.cn), questionnaires were distributed to all clinical laboratories participating in the Investigation of Quality Indicators for Laboratory Medicine in China in 2015. The Kolmogorov-Smirnov test was employed to determine the normality of data of every group, and the Kruskal-Wallis test and Mann-Whitney test were used to compare the difference among several groups or between two groups, respectively. Result The number of clinical laboratories submitting relevant data about incorrect laboratory reports, critical values notification rate and timely critical values notification rate were 5 229, 4 643 and 4 421, respectively. For 3 quality indicators, the percentage of laboratories with sigma level≥3 and the percentage with sigma level≥6 were all more than 95%, and were 47.87%, 91.17% and 85.95% of three groups respectively. Significant difference existed among different subjects. Except for critical values notification rate，other 2 quality indicators were also different significantly among different hospital ranks.Conclusion Currently, the error rates of 3 quality indicators in post-testing phase in Chinese clinical laboratories are relatively low. The critical values notification rate and timely critical values notification rate of a great number of laboratories has reached 100%. To improve the quality level of post-testing phase continuously, clinical laboratories should further monitor these 3 quality indicators, correctly and effectively recognize weaknesses of post-testing phase, set up more appropriate quality indicators and establish their quality specifications based on this survey. |
| Key words: post-testing phase,quality indicator,quality specification |
