我国86家检测机构2020—2021年毒性病理诊断实验室间比对分析  

Analysis of external quality assessment for laboratories of toxicological pathology diagnosis in 86 organizations in China from 2020 to 2021

作　　者：宋向荣[1] 蔡婷峰[1] 黄曼琪 马超亚[1] 陈丹苹 梁旻玮 刘敏 徐颖愉 赵志强 SONG Xiangrong;CAI Tingfeng;HUANG Manqi;MA Chaoya;CHEN Danping;LIANG Minwei;LIU Min;XU Yingyu;ZHAO Zhiqiang(Guangdong Province Hospital for Occupational Disease Prevention and Treatment,Guangzhou,Guangdong 510300,China)

机构地区：[1]广东省职业病防治院,广东广州510300

出　　处：《中国职业医学》2023年第4期455-460,共6页China Occupational Medicine

基　　金：广东省医学科研基金(C2022033)。

摘　　要：目的分析我国检测机构毒性病理室间比对结果。方法采用方便抽样方法,选择参加2020—2021年毒性病理诊断室间比对的86家检测机构(以下简称“参比单位”)为研究对象,对其结果进行分析。结果86家参比单位比对总得分中位数和第0~100百分位数为92(64~100)分,76家参比单位比对结果为“优秀”,10家参比单位比对结果为“合格”,优秀率和合格率分别为88.4%和11.6%,无“不合格”机构。参比单位中公共卫生机构、医药研究机构、药物安全评价中心和检测公司优秀率分别为95.7%、84.2%、85.7%和86.7%,合格率分别为4.3%、15.8%、14.3%和13.3%,4类机构优秀和合格分布情况比较,差异无统计学意义(P>0.05)。单个样品得分为“差”“良好”“优”3个等级在公共卫生机构分别为4.9%、20.7%和74.5%,在医药研究类别机构分别为8.6%、23.7%和67.8%,在药物安全评价中心分别为12.5%、25.0%和62.5%,在检测公司分别为5.4%、17.5%和77.1%。其中,公共卫生机构“优”等级占比高于医药类研究机构(P<0.05)。结论我国毒性病理诊断能力普遍较好,各类机构技术能力相当,诊断术语仍有待规范。Objective To analyze result of the external quality assessment for laboratories of toxicological pathology diagnosis in organizations in China.Methods A total of 86 organizations that participated in the 2020-2021 external quality assessment in laboratory of toxicological pathology diagnosis(hereinafter referred to as"reference units")were selected as research subjects using convenient sampling method,and the assessment results were analyzed.Results The median of total score was 92,and the 0-100 percentiles were 64-100 in these 86 reference units.Among these reference units,76 were rated as excellent,10 as qualified,with the excellent and the qualified rate of 88.4%and 11.6%,respectively.No reference unit was rated as unqualified.The rates of excellence of the reference units in public health institutions,pharmaceutical research institutions,drug safety evaluation centers and testing companies were 95.7%,84.2%,85.7%and 86.7%,and the qualified rates were 4.3%,15.8%,14.3%and 13.3%,respectively.The distribution of excellence and qualification among the four types of reference units showed no statistical difference(P>0.05).The distribution of sample scores according to the three grades of poor,good,and excellent were 4.9%,20.7%,and 74.5%in public health institutions,8.6%,23.7%,and 67.8%in pharmaceutical research institutions,12.5%,25.0%,and 62.5%in drug safety evaluation centers,and 5.4%,17.5%,and 77.1%in testing companies.The proportion of excellence unit in public health institutions was higher than that in pharmaceutical research institutions(P<0.05).Conclusion The overall toxicological pathology diagnostic capabilities in China are good,and various types of reference units demonstrate comparable technical capabilities.However,there is a need for standardization of diagnostic terminology.

关 键 词：病理诊断 室间比对 检测能力 质量控制 

分 类 号：R13[医药卫生—劳动卫生]