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2016-2023年实验室间比对率质量指标室间质量评价结果分析

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目的 通过分析2016-2023年实验室间比对率质量指标室间质量评价结果,了解尚未开展室间质量评价的检验项目实验室间比对的开展情况,提供比对的建议.方法 国家卫生健康委临床检验中心联合31个省(自治区、直辖市)同步开展质量指标室间质量评价计划,通过已开发的室间质量评价系统在线填报实验室的基本信息和实验室间比对率质量指标数据.计算实验室间比对率的中位数(下四分位数,上四分位数)[M(Q1,Q3)],同时用西格玛度量评价实验室质量水平,并进行分级(三级医院和二级医院)统计,了解不同医院等级间实验室间比对率的差异.使用Mann-Whitney U检验进行2组间比较(不同年份或不同医院等级),P<0.05(α=0.05)表明差异具有统计学意义.结果 回报实验室由2016年的6 701家增加到2023年的11 579家.全国中位数结果显示,实验室间比对率逐年升高(2021年除外),从2016年的1.6%上升到2023年3.8%;分级中位数结果显示,三级医院的实验室间比对率高于二级医院,2023年实验室间比对率结果为三级医院10.3%,二级医院2.3%;所有年份的结果均低于3σ水平.2023年各地区三级医院实验室间比对率中位数显示,上海、宁夏和四川中位数较高,二级医院比对率中位数显示,上海、四川和海南中位数较高.结论 目前,实验室对未开展室间质量评价计划的检验项目执行实验室间比对率较低,实验室应加强对无室间质量评价计划检验项目的实验室间比对,验证其结果的可靠性.
Analysis of external quality assessment results for quality indicators of interlaboratory comparison rate from 2016 to 2023
Objective To understand the situation of interlaboratory comparison for without external quality assessment(EQA)test by analyzing the results of quality indicators related to interlaboratory comparison rate of EQA from 2016 to 2023,in order to provide some suggestions for comparison.Methods The National Center for Clinical Laboratories organized 31 centers of provinces(autonomous re-gions and municipalities directly)to launch a synchronous Quality Indicators(QIs)-EQA program.The data were reported via devel-oped online EQA system.The essential information of the clinical laboratories and the data of quality indicators of interlaboratory com-parison rate were collected.The median(lower quartile,upper quartile)M(Q1,Q3)of the interlaboratory comparison rate was calcu-lated,and the quality level of the laboratory was evaluated by sigma measurement,and the statistics of the classification(tertiary and secondary hospitals)were carried out to understand the differences in the interlaboratory comparison rate among different hospital grades.Mann-Whitney U test was used to compare the two groups(different years or different hospital grades),and P<0.05(α=0.05)indicated that the difference was statistically significant.Results The number of return laboratories increased from 6 701 in 2016 to 11 579 in 2023.The national median results showed that the interlaboratory comparison rate had been increasing year by year(excluding 2021),from 1.6%in 2016 to 3.8%in 2023.The median grading results showed that the interlaboratory comparison rate of tertiary hospitals was higher than that of secondary hospitals.In 2023,the interlaboratory comparison rate was 10.3%for tertiary hospi-tals and 2.3%for secondary hospitals.The results of all the years were below 3σ level.The median interlaboratory comparison rate of tertiary hospitals in various regions showed that Shanghai,Ningxia,and Sichuan exhibited higher median.The median interlaboratory comparison rate of secondary hospitals showed that Shanghai,Sichuan,and Hainan exhibited higher median.Conclusion At present period,the interlaboratory comparison rate has still been low in those laboratories without EQA tests.Therefore,the medical laborato-ries without EQA tests should strengthen interlaboratory comparisons to verify the reliability of their results.

quality indicatorinterlaboratory comparison:external quality assessment:test item

张志新、王治国、杜雨轩、刘佳丽、陈兵权、王薇

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北京医院国家老年医学中心国家卫生健康委临床检验中心/北京市临床检验工程技术研究中心,中国医学科学院老年医学研究院,北京 100730

北京科临易检信息技术有限公司,北京 100020

质量指标 实验室间比对 室间质量评价 检验项目

2024

临床检验杂志
江苏省医学会

临床检验杂志

CSTPCD
影响因子:0.746
ISSN:1001-764X
年,卷(期):2024.42(12)