[1]肖亚玲,王 薇,赵海建,等.西格玛性能验证图在常规化学检测项目性能评价中的应用[J].现代检验医学杂志,2016,31(04):159-161.[doi:10.3969/j.issn.1671-7414.2016.04.047]
　XIAO Ya-ling,WANG Wei,ZHAO Hai-jian,et al.Application of Sigma Verification of Performance to Evaluate the Performance of Routine Chemistry in One Laboratory[J].Journal of Modern Laboratory Medicine,2016,31(04):159-161.[doi:10.3969/j.issn.1671-7414.2016.04.047]
点击复制

西格玛性能验证图在常规化学检测项目性能评价中的应用()
分享到：

《现代检验医学杂志》[ISSN:/CN:]

卷:
第31卷
期数:
2016年04期
页码:
159-161
栏目:
质量控制·实验室管理
出版日期:
2016-08-10

文章信息/Info

Title:
Application of Sigma Verification of Performance to Evaluate the Performance of Routine Chemistry in One Laboratory
文章编号:
1671-7414(2016)04-159-04
作者:
肖亚玲; 王 薇; 赵海建; 张传宝; 何法霖; 钟 堃; 王治国
北京医院 卫生部临床检验中心,北京 100730
Author(s):
XIAO Ya-ling; WANG Wei; ZHAO Hai-jian; ZHANG Chuan-bao;  HE Fa-lin; ZHONG Kun; WANG Zhi-guo
National Center for Clinical Laboratories,Beijing Hospital,Beijing 100730,China
关键词:
西格玛性能验证图;  常规化学;  变异系数;  偏倚
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2016.04.047
文献标志码:
A
摘要:
目的 用西格玛性能验证图评价某实验室常规化学检测项目的性能。方法 选择某一家既参加了全国常规生化室间质量评价计划又上报了常规生化室内质量控制数据的实验室,将实验室的常规化学检测项目的室内质控累积变异系数作为不精密度的估计值,将该实验室在室间质评计划中的百分差值作为该实验室的偏倚估计,采用国家标准GB/T 20470-2006和卫生行业标准WS/T 403-2012的允许总误差作为质量规范,用专业软件绘制该实验室常规化学所有项目的西格玛性能验证图。结果 当使用国家标准时,只有钾、钠、血糖、尿素和三酰甘油5个项目σ<3,钙、磷、清蛋白、总蛋白、丙氨酸氨基转移酶和铁6个项目3≤σ<4,氯和肌酐4≤σ<5,总胆固醇、天门冬氨酸氨基转移酶、肌酸激酶和镁5≤σ<6,σ≥6的项目有尿酸、总胆红素、碱性磷酸酶、淀粉酶、乳酸脱氢酶和γ-谷氨酰基转移酶6项; 当使用卫生行业标准时,有钾、钠、钙、磷、血糖、尿素、总蛋白、清蛋白、三酰甘油、丙氨酸氨基转移酶、肌酸激酶、乳酸脱氢酶和铁13项的σ<3,σ≥6的项目仅有淀粉酶。该实验室常规化学项目的检测性能有待提高。结论 西格玛性能验证图可以直观地展示允许总误差不相同的多个不同检测项目的检测性能水平。
Abstract:
Objective Using sigma verification of performance to evaluate the performance of routine chemistry in one laboratory.Methods A laboratory which participanted both routine chemistry external quality assessment nationwide and internal quality control data reportingwas chosen in this research.Regarded the accumulated coefficient of variability as the estimation value of imprecision.Used the percentage difference in externalquality assessment scheme as the estimation value of bias.The total allowableerrors in national standard GB/T 20470-2006 and in health industry standard WS/T 403-2012 were adopted as the quality specification.Sigma verification of performance were drawn using a professional software.Results When using the total allowable error in national standard,there were K,Na,Glu,Urea and TG 5 analytes with σ<3; Ca,P,ALB,TP,ALT and Fe were with 3≤σ<4.Cl and Crea were with 4≤σ<5.TC,AST,CK and Mg were with 5≤σ<6; and the analytes with σ≥6 were UA,TBIL,ALP,AMY,LDH and γ-GT.When using the total allowable error in health industry standard,there were 13 analytes withσ<3,they were K,Na,Ca,P,Glu,Urea,TP,ALB,TG,ALT,CK,LDH and Fe.Andonly AMY had σ≥6.The testing performance of routine chemistry in this laboratory was needed to be improved.Conclusion Sigma verification of performance can demonstrate the testing performance of several analyteswith different total allowable errors visually.

参考文献/References:

[1] 肖亚玲,王 薇,王治国.心肌损伤标志物四项检测性能的西格玛水平分析[J].现代检验医学杂志,2014,29(1):38-41. Xiao YL,Wang W,Wang ZG.Performance analysis of four myocardial damage marker testing with sigma level[J].J Mod Lab Med,2014,29(1):38-41.
[2] Nevalainen D,Berte L,Kraft C,et al.Evaluating laboratory performanceon quality indicators with the six sigma scale[J].Arch Pathol Lab Med,2000,124(4):516-519.
[3] 中华人民共和国国家质量监督检验检疫总局,中国国家标准化管理委员会GB/T 20470-2006.临床实验室室间质量评价要求[S].北京:标准出版社,2006. General Administration of Quality Supervision,Inspection and Quarantine,Standardization Administration of China GB/T 20470-2006.Requirements ofexternal quality assessment for clinical laboratories[S].Beijing:Standard Publishing House,2006.
[4] WS/T403-2012.临床生物化学检验常规项目分析质量指标[S].中华人民共和国国家卫生和计划生育委员会,2012. WS/T403-2012.Analytical quality specifications for routine analytes in clinical biochemistry[S].National Health and Family Planning Commissionof the People's Republic of China,2012.
[5] 王治国.临床检验质量控制技术[M].北京:人民卫生出版社,2014. Wang ZG.Technology for quality control in clinical laboratory[M].Beijing:People's Medical Publishing House,2014.
[6] 王治国.临床检验6σ质量设计与控制[M].北京:人民卫生出版社,2012. Wang ZG.6σ quality plan and control in clinical laboratory[M].Beijing:People's Medical Publishing House,2012.
[7] Kinns H,Pitkin S,Housley D,et al.Internal quality control:best practice[J].J Clin Pathol,2013,66(02):1027-1032.
[8] Schoenmakers CH,Naus AJ,Vermeer HJ,et al.Practical application of Sigma Metrics QC procedures in clinical chemistry[J].Clin Chem Lab Med,2011,49(11):1837-1843.
[9] 康凤凤,王 薇,何法霖,等.已通过ISO 15189认可的临床实验室常规生化指标的性能评价[J].临床检验杂志,2013,31(1):57-59. Kang FF,Wang W,He FL,et al.Performance evaluation of routine chemistry in clinical laboratories with ISO 15189 accreditation passed[J].Chin JClin Lab Sci,2013,31(1):57-59.
[10] 中华人民共和国国家质量监督检验检疫总局 JJF 1001-2011.通用计量术语及定义[S].北京:中国质检出版社,2012. General Administration of Quality Supervision,Inspection and Quarantine JJF 1001-2011.General Terms in Metrology and Their Definitions[S].Beijing:Chinese Quality Inspection Publishing House,2012.
[11] 王治国.临床检验方法确认与性能验证[M].北京:人民卫生出版社,2009. Wang ZG.Method validation and proficiency testing in clinical laboratories[M].Beijing:People's Medical Publishing House,2014.

相似文献/References:

[1]胡江红,袁平宗,汤雪彪,等.应用六西格玛性能验证图对18个常规化学项目的性能评价[J].现代检验医学杂志,2018,33(06):161.[doi:10.3969/j.issn.1671-7414.2018.06.042]
　HU Jiang-hong,YUAN Ping-zong,TANG Xue-biao,et al.Performance Evaluation of 18 Conventional Chemical Projects Using Six Sigma Performance Verification Diagram[J].Journal of Modern Laboratory Medicine,2018,33(04):161.[doi:10.3969/j.issn.1671-7414.2018.06.042]

备注/Memo

备注/Memo:
基金项目:北京市自然科学基金项目(7143182)。
作者简介:肖亚玲(1990-),女,硕士,研究方向:临床检验诊断学,E-mail:xiaoyaling001@sina.com。
通讯作者:王治国,Tel:010-58115054。
更新日期/Last Update: 2016-08-10