摘要
目的分析中国临床实验室标本可接受性质量指标(QI)的现状并制定初步质量规范。方法使用基于Web的室间质量评价软件,收集从2015年~2017年(截至6月15日)参加"临床检验专业医疗质量控制指标"室间质评的实验室数据,包括2015年1次,2016年2次和2017年1次的标本类型错误率、标本容器错误率、标本采集量错误率和抗凝标本凝集率。用率和西格玛两种方式度量评价。采用各指标总体分布的P25和P75制定初步的高、中等和低性能规范。结果分别有5 346,7 593,5 950和6 874家实验室回报了有效数据。生化(除标本采集量错误率外)、免疫和微生物专业4项指标的P50达到6σ水平。临检专业除标本容器错误率外,其它指标的P50为4σ~6σ水平不等。连续3年的QI数据没有明显变化。以2017年第一次结果为依据制定初步质量规范,标本类型错误率的P25为0,P75为0.084 4%;标本容器错误率的P25为0,P75为0.047 6%;标本采集量错误率的P25为0,P75为0.114 2%;抗凝标本凝集率的P25为0,P75为0.0784%。结论大部分实验室生化、免疫和微生物4项指标表现良好,临检专业有待加强。实验室应加强信息系统建设,保证采集数据真实可靠,从而长期纵向监控实现质量改进。
Objective To analyze the status of quality indicators（QI）on specimen acceptability and establish preliminary quality specification.Methods Web-based External Quality Assessment system was used to collect data of laboratories participated in＂Medical quality control indicators in clinical laboratory＂from 2015 to 2017,including once in 2015 and 2017 and twice in 2016.Rate and sigma scales were used to evaluate incorrect sample type,incorrect sample container,incorrect fill level and anticoagulant sample clotted.The 25 th percentile（P25）and 75 th percentile（P75）of the distribution of each QI were employed to establish the high,medium and low specification.Results 5 346,7 593,5 950 and 6 874 laboratories submitted the survey results respectively.The P50 of biochemistry（except incorrect fill level）,immunology and microbiology reach to 6σ.The P50 of clinical laboratory is 4 to 6σexcept for incorrect sample container.There is no significant change of the continuous survey results.Based on results in 2017 to establish the quality specification,the P25 and P75 of the four QIs is 0 and 0.084 4%,0 and 0.047 6%,0 and 0.114 2%,0 and 0.078 4%,respectively.Conclusion According to the results of the survey,most laboratories had a faire performance in biochemistry,immunology and microbiology,and clinical laboratory needs to be strengthened.Laboratories should strengthen the laboratory information system construction to ensure the actual and reliable data collection,and make a long-time monitoring to achieve a better quality.
作者
叶圆圆
王薇
赵海建
康凤凤
郦卫星
卢志明
邹伟民
金雨琦
黄文芳
许斌
陈发林
王清涛
牛华
马斌国
赵建宏
周向阳
沈佐君
祝卫平
吕岳峰
刘良军
张琳
魏力强
桂晓美
韩艳秋
许健
魏莲花
廖璞
阿祥仁
王华梁
张朝霞
吴皓瑜
符生苗
朴文花
彭林
王治国
YE Yuan-yuan;WANG Wei;ZHAO Hai-jian;KANG Feng-feng;LI Wei-xing;LU Zhi-ming;ZOU Wei-min;JIN Yu-qi;HUANG Wen-fang;XU Bin;CHEN Fa-lin;WANG Qing-tao;NIU Hua;MA Bin-guo;ZHAO Jian-hong;ZHOU Xiang-yang;SHEN Zuo-jun;ZHU Wei-ping;LU Yue-feng;LIU Liang-jun;ZHANG Lin;WEI Li-qiang;GUI Xiao-mei;HAN Yan-qiu;XU Jian;WEI Lian-hua;LIAO Pu;A Xiang-ren;WANG Hua-liang;ZHANG Zhao-xia;WU Hao-yu;FU Sheng-miao;PU Wen-hua;PENG Lin;WANG Zhi-guo(Beijing Hospital,National Center of Gerontology,National Center for Clinical Laboratorie;Graduate School of Peking Union Medical Colleg;Zhejiang Center for Clinical Laborator;Shandong Center for Clinical Laborator;Guangdong Center for Clinical Laborator;Henan Center for Clinical Laborator;Sichuan Center for Clinical Laborator;Jiangsu Center for Clinical Laborator;Fujian Center for Clinical Laborator;eijing Center for Clinical Laborator;unnan Center for Clinical Laborator;hanxi Center for Clinical Laborator;ebei Center for Clinical Laborator;uangxi Autonomous Region Center for Clinical Laborator;nhui Center for Clinical Laborator;ubei Center for Clinical Laborator;unan Center for Clinical Laborator;ilin Center for Clinical Laborator;iaoning Center for Clinical Laborator;haanxi Center for Clinical Laborator;iangxi Center for Clinical Laborator;nnr Mongolia Autonomous Region Center for Clinical Laborator;uizhou Center for Clinical Laborator;ansu Center for Clinical Laborator;hongqing Center for Clinical Laborator;inghai Center for Clinical Laborator;hanghai Center for Clinical Laborator;injiang Autonomous Region Center for Clinical Laborator;eilongjiang Center for Clinical Laborator;ainan Center for Clinical Laborator;ingxia Center for Clinical Laborator;ianjin Center for Clinical Laboratory,300074,Chin)
出处
《现代检验医学杂志》
CAS
2018年第2期134-138,142,共6页
Journal of Modern Laboratory Medicine
关键词
质量指标
标本
室间质量评价
质量规范
西格玛
quality indicator
specimen
external quality assessment
quality specification
sigma
作者简介
叶圆圆（1992），女，在读硕士研究生，研究方向：实验室质量管理，E-mail：2312123505@qq．com。;通讯作者：王治国，硕士，研究员，主要从事临床检验质量控制方法研究和室间质量评价工作，Email：zgwang@nccl．org．cn。
