Objective: To evaluate the capacity of laboratories which participated in the proficiency testing for pH determination and explore the statistical methods for proficiency testing.Methods: The study was performed according to the procedure of China National Accreditation Service for Conformity Assessment(CNAS).JMP was used to evaluate the homogeneity and stability of the test samples.All results conformed to the requirements.Z-scores were calculated using the results of expert laboratories,assigned value and the standard deviation for proficiency assessment.These scores were used to evaluate results.Results: A total of 251 labs participated.The satisfaction rate of the laboratory was 86.45%,the suspicious rate was 4.78%,the rate of dissatisfaction was 8.76%.Conclusion: In the proficiency testing,we used the new statistical evaluation method and statistical tools.The new method has a significant advantage compared with common methods.
[1] ISO/IEC 17043:2010,能力验证提供者认可准则[S].2010:3.7 ISO/IEC 17043:2010 General requirements for proficiency testing[S].2010:3.7
[2] BELK WP,SUNDERMAN FW.A survey of the accuracy of chemical analyses in clinical laboratories[J].Am J Clin Pathol,1947,17(11):853
[3] SUNDERMAN FW.The history of proficiency testing/quality control[J].Clin Chem,1992,38(7):1205
[4] LAESSIG RH,EHRMEYER SS.Proficiency testing programs-promises,progress,and problems.A 40-year prospective[J].Arch Pathol Lab Med,1988,112(4):329
[5] SUNDERMAN FW.Forty-five years of proficiency testing[J].Annal Clin Lab Sci,1991,21(2):143
[6] 刘小娟,黄亨建,李萍.以CAP能力验证提高临床生化检验质量[J].检验医学,2005(5):470 LIU XJ,HUANG HJ,LI P.Improving quality of clinical laboratory through taking part in College of American Pathologists proficiency testing[J].Lab Med,2005(5):470
[7] 王厚芳,孙芾,柳杰.通过CAP能力验证提高血液寄生虫检查质量[J].实验与检验医学,2006,24(6):495. WANG HF,SUN F,LIU J.Improving quality of blood parasite check through taking part in College of American Pathologists proficiency testing[J]Exper Lab Med,2006,24(6):495
[8] 柯培峰,梁铮,黄迪,等.化学发光检测系统参加CAP校准检验活动结果的分析[J],实用医学杂志,2011,27(12):2254 HE PF,LIANG Z,HUANG D,et al.Analysis of the results of CAP calibration verification in the chemiluminescence detection system[J].J Pract Med,2011,27(12):2254
[9] CNAS-RL02:2010,能力验证规则[S].2010:5 CNAS-RL02:2010,Rules for Proficiency Testing[S].2010:5
[10] 宋桂兰.能力验证工作历史回顾[J].中国计量,2009(2):35 SONG GL.The review of ability verification work history[J].China Metrol,2009(2):35
[11] 毛歆,项新华,肖新月.2013年食品药品系统实验室能力验证结果分析[J].中国药事,2015(29):1145 MAO X,XIANG XH,XIAO XY.Proficiency testing results of food and drug laboratories in 2013[J].Chin Pharm Aff,2015(29):1145
[12] CNAS-G03:2006,能力验证样品均匀性和稳定性评价指南[S].2015:4 CNAS-G03:2006,Guidance on Evaluating the Homogeneity and Stability of Samples Used for Proficiency Testing[S].2015:4
[13] CNAS-GL02:能力验证结果的统计处理和能力评价指南[S].2015:4.4 CNAS-GL02:Guidance on Statistic Treatment of Proficiency Testing Results and Performance Evaluation[S].2015:4.4
[14] GB/T 6379.2-2004,测量方法与结果的准确度(正确度与精密度)第2部分:确定标准测量方法重复性与再现性的基本方法[S].2005:7.3 GB/T 6379.2-2004,Accuracy(trueness and precision) of measurement methods and results-Part2:Basic method for the determination of repeatability and reproducibility of a standard measurement method[S].2005:7.3
[15] ISO 13528:2015,实验室间比对能力验证用统计方法[S].2015:8.5 ISO 13528:2015,Statistical methods for use in proficiency testing by interlaboratory comparison[S].2015:8.5