[1]钟 堃a,方 遥b,王艳惠c.临床实验室室间质量评价不同计划的结果评价探讨与研究[J].现代检验医学杂志,2022,37(02):162-166.[doi:10.3969/j.issn.1671-7414.2022.02.033]
 ZHONG Kuna,FANG Yaob,WANG Yan-huic.Discussion and Research on the Result Evaluation of External Quality Assessment Scheme for Clinical Laboratory[J].Journal of Modern Laboratory Medicine,2022,37(02):162-166.[doi:10.3969/j.issn.1671-7414.2022.02.033]
点击复制

临床实验室室间质量评价不同计划的结果评价探讨与研究()
分享到:

《现代检验医学杂志》[ISSN:/CN:]

卷:
第37卷
期数:
2022年02期
页码:
162-166
栏目:
质量控制·实验室管理
出版日期:
2022-03-15

文章信息/Info

Title:
Discussion and Research on the Result Evaluation of External Quality Assessment Scheme for Clinical Laboratory
文章编号:
1671-7414(2022)02-162-06
作者:
钟 堃a方 遥b王艳惠c
(北京医院/ 国家老年医学中心/ 中国医学科学院老年医学研究院a. 国家卫生健康委临床检验中心;b. 纪检监察室 ;c. 人事处,北京 100730)
Author(s):
ZHONG Kuna FANG Yaob WANG Yan-huic
(a. National Center for Clinical Laboratories;b. Department of Supervision; c. Department of Human Resource, Beijing Hospital/National Center of Gerontology/Institute of Geriatric Medicine, Chinese Academy of Medical Sciences,P.R. China, Beijing 100730,Ch
关键词:
室间质量评价统计分析方法结果评价与反馈
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2022.02.033
文献标志码:
A
摘要:
在室间质量评价计划(能力验证)中,对各参评实验室回报结果的处理和评价是最为重要的环节之一,直接影响到室间质量评价计划的有效性,这也是室间质量评价组织者和参评单位最常出现争议的环节。室间质量评价计划(external quality assessment,EQA) 的结果和反馈报告应及时有效,应包括(但不限于):定量、半定量和定性项目所有参评实验室结果的统计分析、总体和不同分组中离群值的判断与剔除、单样本和多样本以及单参数和多参数的结果和分布的评价、指定值的确定、标准差的确定、图形显示,以及在不同室间质量评价计划中多个样本和参数的整合信息等。室间质量评价计划结果的处理与评价方式一直在向着更加客观与合理的方向发展。
Abstract:
The work of handling data and evaluating results in external quality assessment (EQA) scheme is one of the most important parts, which will directly affect the performance of EQA scheme. The results of EQA scheme and participants’ feedback reports should be timely and effective. The contents of the results and reports should include: the performances of quantitative, semi-quantitative and qualitative analysis, the elimination of outliers, the distribution evaluations of results of one or multiple parameters and/or one or multiple samples,determining the assigned values; determining the standard deviation, graphical presentation for one or more parameters or samples,combining information from different parameters and/or samples, etc. Staff should always pursue more objective and accurate methods and procedures for handling EQA results.

参考文献/References:

[1] MILLER W G, JONES G R, HOROWITZ G L, et al. Proficiency testing/external quality assessment:current challenges and future directions[J]. Clinical Chemistry, 2011, 57(12): 1670-1680.
[2] STAVELIN A, ALBE X, MEIJER P, et al. An overview of the European Organization for External Quality Assurance Providers in Laboratory Medicine (EQALM) [J]. Biochemia Medica, 2017, 27(1): 30-36.
[3] COUCKE W, SOUMALI M R. Demystifying EQA statistics and reports[J].Biochemia Medica, 2017, 27(1): 37-48.
[4] WANG Lunan, PAN Yang, ZHANG Kuo, et al. A 10- year human hepatitis B virus nucleic test external quality assessment in China: Continual improvement[J]. Clinica Chimica Acta, 2013, 425: 139-147.
[5] ZHONG Kun, WEI Wang, HE Falin, et al. Neonatal screening external quality assessment in China, 2014[J]. Journal of Medical Screening, 2015, 22(4): 175-181.
[6] ZHONG Kun, ZHAO Yan, XIAO Yalin, et al. 8-year review of laboratory performance on blood lead level external quality assessment surveys 2006~2013 in China: continual improvement[J]. Accreditation and Quality Assurance, 2015, 20(1): 25-28.
[7] SARMANHO G F, BORGES P P, FRAGA I C, et al. Treatment of bimodality in proficiency test of pH in bioethanol matrix[J]. Accreditation and Quality Assurance, 2015, 20(3): 179-187.
[8] MANCIN M, TOSON M, GRIMALDI M, et al. Application of bootstrap method to evaluate bimodal data: an example of food microbiology proficiency test for sulfite-reducing anaerobes[J]. Accreditation and Quality Assurance, 2015, 20(4): 255-266.
[9] BARNETT V, LEWIS T. Outliers in statistical data[M]. 3rd ed. New York:Chichester, John Wiley & Sons, 1994.
[10] DAVIES P L. Statistical evaluation of inter-laboratory tests[J]. Fresenius’ Zeitschrift für analytische Chemie , 1988, 331: 513-519.
[11] COUCKE W, CHINA B, DELATTRE I, et al. Comparison of different approaches to evaluate External Quality Assessment Data[J]. Clinica Chimica Acta, 2012, 413(5-6): 582-586.
[12] International Organization for Standardization. ISO 13528:Statistical methods for use in proficiency testing by inter-laboratory comparisons [S]. Geneva:Switzerland ,ISO 13528, 2006.
[13] 中国合格评定国家认可委员会. 能力验证结果的统 计处理和能力评价指南文件 [S]. 北京:中国合格评 定国家认可委员会GL02, 2014. China National Accreditation Service for Conformity Assessment. Guidance on Statistic Treatment of Proficiency Testing Results and Performance Evaluation [S]. Beijing:CNAS GL02, 2014.
[14] 钟堃, 王薇, 李少男, 等. 稳健统计在全国临床化学 检验室间质量评价的应用[J].中国计量, 2010, 15 (9): 46-48. ZHONG Kun, WANG Wei, Li Shaonan, et al. The application of robust statistics for National External Quality Assessment in clinical chemistry [J]. China Metrology, 2010, 15 (9): 46-48.
[15] ZHONG Kun, WANG Wei, ZHANG Chuanbao, et al.The study of statistical methods for evaluating the comparability of routine chemistry analytes among 3 routine laboratory measurement systems in China[J]. Springer Plus, 2016, 5(1): 1724.
[16] WONG S K. Evaluation of the use of consensus values in proficiency testing programmes[J]. Accreditation and Quality Assurance, 2005, 10(8): 409-414.
[17] DUEWER D L. A comparison of location estimators for interlaboratory data contaminated with value and uncertainty outliers[J]. Accreditation and Quality Assurance, 2008, 13(4): 193-216.
[18] THOLEN D W. Statistical treatment of proficiency testing data[J]. Accreditation and Quality Assurance, 1998, 3(9): 362-366.
[19] COUCKE W, CHARLIER C, LAMBERT W, et al. Application of the characteristic function to evaluate and compare analytical variability in an external quality assessment scheme for serum ethanol[J]. Clinical Chemistry, 2015, 61(7): 948-954.
[20] ROSARIO P, MART?NEZ J L, SILV?N J M. Comparison of different statistical methods for evaluation of proficiency test data[J]. Accreditation and Quality Assurance, 2008, 13(9): 493-499.
[21] DE BI?VRE P. Fitness for purpose is different from a performance specification[J]. Accreditation and Quality Assurance, 2007, 12(10): 501.
[22] SANDBERG S, FRASER C G, HORVATH A R, et al. Defining analytical performance specifications: Consensus Statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine[J]. Clinical Chemistry and Laboratory Medicine, 2015, 53(6): 833-835.
[23] LANGTO N S D , C H E V E N N E M E N T R , NAGELKERKE N, et al. Analysing collaborative trials for qualitative microbiological methods: accordance and concordance[J]. International Journal of Food Microbiology, 2002, 79(3): 175-181.
[24] DEOM A, EL AOUAD R, HEUCK C C, et al. Requirements and guidance for external quality assessment schemes for health laboratories[S]. World Health Organization, 1999.
[25] SCOTT D W. On optimal and data-based histograms[J]. Biometrika, 1979, 66(3):605-610.
[26] COUCKE W , BLERK M V , LIBEER J C, et al. A new statistical method for evaluating long-term analytical performance of laboratories applied to an external quality assessment scheme for flow cytometry. [J]. Clinical Chemistry & Laboratory Medicine, 2010, 48(5):645-650.
[27] YOUDEN W J . Graphical diagnosis of inter-laboratory test results[J]. Journal of Quality Technology, 1959, 15(11):24-28.
[28] SHIRONO K, IWASE K, OKAZAKI H, et al. A study on the utilization of the Youden plot to evaluate proficiency test results[J]. Accreditation & Quality Assurance, 2013, 18(3):161-174.
[29] EHRMEYER S S, LAESSIG R H. Alternative statistical approach to evaluating interlaboratory performance[J]. Clinical Chemistry, 1985, 31(1): 106-108.
[30] MEIJER P, DE MAAT M P, KLUFT C, et al. Long-term analytical performance of hemostasis field methods as assessed by evaluation of the results of an external quality assessment program for antithrombin[J]. Clinical Chemistry, 2002, 48(7): 1011-1015.
[31] MATAR G, POGGI B, MELEY R, et al. Uncertainty in measurement for 43 biochemistry, immunoassay, and hemostasis routine analytes evaluated by a method using only external quality assessment data[J]. Clinical Chemistry and Laboratory Medicine, 2015, 53(11): 1725-1736.
[32] MILLER W G. Specimen materials, target values and commutability for external quality assessment (proficiency testing) schemes[J]. Clinica Chimica Acta, 2003, 327(1/2): 25-37.
[33] International Standardization Organization. ISO 15189:2012-Medical laboratories-Requirements for quality and competence[S].Geneva:Switzerland, ISO15189, 2012.
[34] STAVELIN A, RIKSHEIM B O, CHRISTENSEN N G, et al. The importance of reagent lot registration in external quality assurance/proficiency testing schemes[J]. Clinical Chemistry, 2016, 62(5): 708-715.
[35] BEZZEGH A, TAK?CS I, AJZNER ?. Toward harmonization of interpretive commenting of common laboratory tests[J]. Clinical Biochemistry, 2017, 50(10/11): 612-616.
[36] BAINBRIDGE J, ROUNTREE W, LOUZAO R, et al. Laboratory accuracy improvement in the UK NEQAS leucocyte immunophenotyping immune monitoring program: an Eleven-Year review via longitudinal mixed effects modeling[J]. Cytometry Part B-Clinical Cytometry, 2018, 94(2): 250-256.
[37] CHARREL R, M?GLING R, PAS S, et al. Variable sensitivity in molecular detection of Zika virus in European expert laboratories: external quality assessment, November 2016[J]. Journal of Clinical Microbiology, 2017, 55(11): 3219-3226.
[38] 钟堃, 王薇, 何法霖, 等.2014 年全国452 家实验室 全血铜、锌、钙、镁、铁检验项目实验室内不精密 度分析[J]. 现代检验医学杂志, 2015, 30(6):149-153. ZHONG Kun, WANG Wei, HE Falin, et al. Analysis of the imprecision of internal quality control of 452 laboratories testing Copper, Zinc, Calcium, Magnesium and Iron in whole blood of children in China[J]. Journal of Modern Laboratory Medicine, 2015, 30(6): 149-153.
[39] 钟堃, 王薇, 何法霖, 等. 半胱氨酸蛋白酶抑制剂 C 和β2 微球蛋白参考区间的调查与分析[J]. 现代检 验医学杂志, 2015, 30(4):32-34, 38. ZHONG Kun, WANG Wei, HE Falin, et al. Investigation and analysis of reference intervals of cystatin C and β2-microglobulin [J]. Journal of Modern Laboratory Medicine, 2015, 30(4): 32-34, 38.
[40] 钟堃, 王薇, 何法霖, 等. 国内临床化学9 项常规项 目参考区间与即将发布的卫生行业标准的比较和分 析[J]. 现代检验医学杂志, 2015, 30(3):38-42. ZHONG Kun, WANG Wei, HE Falin, et al. Comparison and analysis of the reference intervals of 9 serum routine chemical analytes between the current application of clinical laboratories and the latest health industrial standards draft for approval[J]. Journal of Modern Laboratory Medicine, 2015, 30(3): 38-42.

相似文献/References:

[1]章晓燕,王薇,张传宝,等.用室间质量评价西格玛图评价脂类项目不同检测系统的质量水平[J].现代检验医学杂志,2015,30(06):80.[doi:10.3969/j.issn.1671-7414.2015.06.023]
 ZHANG Xiao-yan,WANG Wei,ZHANG Chuan-bao,et al.Assessing Quality of Different Measuring Systems on the Sigma Scale from External Quality Assessment[J].Journal of Modern Laboratory Medicine,2015,30(02):80.[doi:10.3969/j.issn.1671-7414.2015.06.023]
[2]何法霖,王 薇,钟 堃,等.血红蛋白A2和F的室间质量评价结果分析[J].现代检验医学杂志,2015,30(02):156.[doi:10.3969/j.issn.1671-7414.2015.02.050]
 HE Fa-lin,WANG Wei,ZHONG Kun,et al.External Quality Assessment of Hemoglobin A2(HbA2) and Hemoglobin F(HbF)Measurement[J].Journal of Modern Laboratory Medicine,2015,30(02):156.[doi:10.3969/j.issn.1671-7414.2015.02.050]
[3]李婷婷,王 薇,赵海建,等.临床实验室室间质量评价结果解释及不合格结果原因调查的建议性方法李婷婷,王 薇,赵海建,等[J].现代检验医学杂志,2017,32(05):152.[doi:10.3969/j.issn.1671-7414.2017.05.017]
 LI Ting-ting,WANG Wei,ZHAO Hai-jian,et al.Interpretation of External Quality Assessment Results in Clinical Laboratories and Suggested Approach on Investigating Unacceptable Results[J].Journal of Modern Laboratory Medicine,2017,32(02):152.[doi:10.3969/j.issn.1671-7414.2017.05.017]
[4]王 青,蒋玲丽,朱 俊,等.2019 年上海市医疗机构临床POCT 检测质量调查分析[J].现代检验医学杂志,2020,35(03):146.[doi:10.3969/j.issn.1671-7414.2020.03.039]
 WANG Qing,JIANG Ling-li,ZHU Jun,et al.Quality Analysis of POCT in Shanghai Hopitals in 2019[J].Journal of Modern Laboratory Medicine,2020,35(02):146.[doi:10.3969/j.issn.1671-7414.2020.03.039]
[5]张楠楠a,李淮淮b,王绪山a.6σ 质量管理在凝血酶原时间室间质量评价与室内质量控制分析应用[J].现代检验医学杂志,2020,35(03):149.[doi:10.3969/j.issn.1671-7414.2020.03.040]
 ZHANG Nan-nana,LI Huai-huaib,WANG Xu-shana.Application of 6 σ Theory on Prothrombin Time Quality Management Through the Data from External Quality Assessment and Internal Quality Control[J].Journal of Modern Laboratory Medicine,2020,35(02):149.[doi:10.3969/j.issn.1671-7414.2020.03.040]
[6]谢小娟,孙晶晶,樊港港,等.2020年陕西省二级公立医院临床实验室室间质量评价参加率和合格率调查分析[J].现代检验医学杂志,2021,36(04):167.[doi:10.3969/j.issn.1671-7414.2021.04.036]
 XIE Xiao-juan,SUN Jing-jing,FAN Gang-gang,et al.Investigation and Analysis of External Quality Assessment Participation andAcceptable Rates of Clinical Laboratories of Secondary Public Hospitals inShaanxi Province in 2020[J].Journal of Modern Laboratory Medicine,2021,36(02):167.[doi:10.3969/j.issn.1671-7414.2021.04.036]
[7]杨依绡,肖艳群,黄中强,等.上海市及其他地区临床实验室B 族链球菌核酸检测室间质量评价分析[J].现代检验医学杂志,2023,38(03):204.[doi:10.3969/j.issn.1671-7414.2023.03.038]
 YANG Yi-xiao,XIAO Yan-qun,HUANG Zhong-qiang,et al.Results of External Quality Assessment for Group B Streptococcus DNA Testing in Shanghai and Other Regions[J].Journal of Modern Laboratory Medicine,2023,38(02):204.[doi:10.3969/j.issn.1671-7414.2023.03.038]
[8]徐 幸,王国飞,杨依绡,等.2020~2022年度上海及其他省市临床实验室HPV6型与HPV11型核酸检测室间质量评价结果分析[J].现代检验医学杂志,2024,39(01):179.[doi:10.3969/j.issn.1671-7414.2024.01.034]
 XU Xing,WANG Guofei,YANG Yixiao,et al.Analysis of External Quality Assessment Results for HPV6 and HPV11 Nucleic Acid Testing in Clinical Laboratories of Shanghai and Other Provinces and Cities from 2020 to 2022[J].Journal of Modern Laboratory Medicine,2024,39(02):179.[doi:10.3969/j.issn.1671-7414.2024.01.034]

备注/Memo

备注/Memo:
作者简介:钟堃(1984-),男,硕士,副研究员,主要从事临床实验室质量控制和质量管理工作,E-mail:kzhong@nccl.org.cn。
更新日期/Last Update: 1900-01-01