[1]叶圆圆,王 薇,赵海建,等.中国临床实验室标本可接受性质量指标室间质量调查研究[J].现代检验医学杂志,2018,33(02):134-138,142.[doi:10.3969/j.issn.1671-7414.2018.02.001]
　YE Yuan-yuan,WANG Wei,ZHAO Hai-jian,et al.External Quality Analysis of Quality Indicators on Specimen Acceptability[J].Journal of Modern Laboratory Medicine,2018,33(02):134-138,142.[doi:10.3969/j.issn.1671-7414.2018.02.001]
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中国临床实验室标本可接受性质量指标室间质量调查研究()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第33卷
期数:
2018年02期
页码:
134-138,142
栏目:
质量控制·实验室管理
出版日期:
2018-04-05

文章信息/Info

Title:
External Quality Analysis of Quality Indicators on Specimen Acceptability
文章编号:
1671-7414(2018)02-134-06
作者:
叶圆圆1; 2; 王 薇1; 赵海建1; 康凤凤1; 郦卫星3; 卢志明4; 邹伟民5; 金雨琦6; 黄文芳7; 许 斌8
1.北京医院 国家老年医学中心 卫生部临床检验中心,北京 100730; 2.北京协和医学院研究生院,北京 100730; 3浙江省临床检验中心,杭州 310014; 4.山东省临床检验中心,济南 250021; 5.广东省临床检验中心,广州 510120; 6.河南省卫生厅临床检验中心,郑州 450052; 7.四川省临床检验中心,成都 610072;
Author(s):
YE Yuan-yuan1; 2; WANG Wei1; ZHAO Hai-jian1; KANG Feng-feng1; LI Wei-xing3; LU Zhi-ming4
1.Beijing Hospital,National Center of Gerontology,National Center for Clinical Laboratories, Beijing 100730,China; 2.Graduate School of Peking Union Medical College,Beijing 100730,China; 3.Zhejiang Center for Clinical Laboratory,Hangzhou 310014,China; 4.Shandong Center for Clinical Laboratory,Jinan 250021,China; 5.Guangdong Center for Clinical Laboratory,Guangzhou 510120,China;
关键词:
质量指标;  标本;  室间质量评价;  质量规范;  西格玛
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2018.02.001
文献标志码:
A
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0.078 4%。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。
Abstract:
Abstract: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 25th percentile(P25)and 75th 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 6σ except for incorrect sample container.There is nosignificant 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 and0.084 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.

参考文献/References:

[1] ISO15189.Medical laboratories-requirements for qu-ality and competence[S].3 rd Ed.Geneva:International Organization for Standardization,2012.
[2] 王治国,费 阳,康凤凤,等.国家卫生计生委发布临床检验专业15项医疗质量控制指标(2015年版)内容及解读[J].中华检验医学杂志,2015,38(11):777-781. Wang ZG,Fei Y,Kang FF,et al.Interpretation of 15 quality controlindicators in clinical laboratory service(2015)published by National Health and Family Planning Commission[J].Chin J Lab Med,2015,38(11):777-781.
[3] Robertson RL.Error rates in Australian chemical pathology laboratories.[J].Med J Aust,1996,165(3):128-130.
[4] Shcolnik W.Brazilian laboratory indicators program[J].Clin Chem Lab Med, 2012,50(11):1923-1934.
[5] Barth JH.Clinical quality indicators in laboratory m-edicine[J].AnnClin Biochem,2012,49(1):9-16.
[6] Simundic AM,Topic E.Quality indicators[J].Bioch-em Med,2008,18(3):311-319.
[7] Plebani M.Errors in clinical laboratories or errors in laboratory medicine?[J].Clin Chem Lab Med,2006,44(6):750-759.
[8] Sciacovelli L,Lippi G,Sumarac Z,et al.Quality indicators in laboratory medicine:the status of the progress of IFCC working group “laboratory errorsand patient safety” project[J].Clin Chem Lab Med,2017,55(2):348-357.
[9] 王治国,费 阳,王 薇,等.理解临床检验质量指标,抓质量从实验室内部做起[J].中华检验医学杂志,2016,39(1):4-6. Wang ZG,Fei Y,Wang W,et al.Understanding quality roots in improvements with in the laboratory: grasping quality starts within laboratory[J].Chin J Lab Med,2016,39(1):4-6.

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备注/Memo

备注/Memo:
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,E-mail:zgwang@nccl.org.cn。
更新日期/Last Update: 2018-04-16