[1]刘连义,史光华,崔 雯,等.生物学变异确定的要求在全血细胞分析仪质量管理中的应用[J].现代检验医学杂志,2017,32(04):152-156.[doi:10.3969/j.issn.1671-7414.2017.04.044]
　LIU Lian-yi,SHI Guang-hua,CUI Wen,et al.Application of the Requirement of Biological Variation Determination in the Quality Management of Blood Cell Analyzer[J].Journal of Modern Laboratory Medicine,2017,32(04):152-156.[doi:10.3969/j.issn.1671-7414.2017.04.044]
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生物学变异确定的要求在全血细胞分析仪质量管理中的应用()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第32卷
期数:
2017年04期
页码:
152-156
栏目:
质量控制·实验室管理
出版日期:
2017-07-25

文章信息/Info

Title:
Application of the Requirement of Biological Variation Determination in the Quality Management of Blood Cell Analyzer
文章编号:
1671-7414(2017)04-152-05
作者:
刘连义; 史光华; 崔 雯; 姜慧英
北京京煤集团总医院检验科,北京 102300
Author(s):
LIU Lian-yi; SHI Guang-hua; CUI Wen; JIANG Hui-ying
Department of Clinical Laboratory, the General Hospital of Beijing Jingmei Group,Beijing 102300,China
关键词:
生物学变异;  6σ值;  血细胞分析仪;  质量管理
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2017.04.044
文献标志码:
A
摘要:
目的 根据生物学变异确定的要求探讨其在全血细胞分析仪质量管理中的应用。方法 收集2016年4～11月份每个月全血细胞分析仪检测的8个项目的室内质控不精密度(CV%)和2016年两次卫生部室间质评回报的8个项目的偏倚(Bias%),然后按照生物学变异推导出的质量规范的最低、适当和最佳的3个层次计算出不精密度和偏倚的合格率,并利用平均偏倚和平均不精密度及生物学变异确定的3个层次的总误差(TEa)标准,算出相应的σ值和QGI值,从而综合评估全血细胞分析仪的检测性能,进而进行质量改进。结果 8个检测项目的不精密度除了MCHC的中值外,其他检测项目的不精密度均100%符合适当层次的质量规范要求。偏倚除了MCH外,其他项目的偏倚80%以上均符合适当层次的质量规范要求。而计算出的σ值,按照最佳层次的质量规范要求,除了WBC的σ值为4.6外,其他项目σ值均<3,按照适当层次的质量规范要求,除了MCHC的σ值为1.9外,其他项目σ值均>3,按照最低层次的质量规范要求,8个项目的σ值均>3。经过分析,该全血细胞分析仪除了MCHC需要按照最低层次的质量规范要求外,其他检测项目均可以按照适当层次的质量规范要求,而所计算的QGI值均<0.8。结论 根据生物学变异确定的要求及计算σ值和QGI值的方法能对全血细胞分析仪进行更精准的质量评价,是更高层次的质量管理,将更有利于质量改进和更好地服务于临床。
Abstract:
Objective To study application of the quality management of Blood Cell Analyzer according to the requirement of biological variation determination.Methods Collected the indoor imprecision value(CV%)from 8 items detected by blood cell analyzer during from April to Nov.of 2016,and the bias(Bias%)of 8 items of two EQA(external quality assessment)from the ministry of health in 2016.Then according to the 3 levels of the minium,appropriate and optimal quality specifications derived from thebiological variability the rates of imprecision and bias were culculated.The pass rate of the imprecision and bias was calculated.By using mean bias and meanimprecision and biological variation 3 levels of total error(TEa)criterion,and to calculate the corresponding σ and QGI value,so as to evaluate the performance of whole blood cell analyzer.Then improved the quality.Results For the imprecision value of 8 items,except the MCHC average value,all others were all 100% meeting the appropriate level of quality requirements.For the bias value(Bias%)from 8 items,except MCH,all others were over 80%meeting the appropriate level of quality requirements.While for the calculatedσ value,based on the best level of quality requirements,except the σ valueof WBC was 4.6,the σ value of all other items were all<3.Based on the appropriate level of quality requirements,except the σvalue of MCHC was 1.9,the value of σ of all other items were all>3,and based on the minimal requirements,the σ value of all 8 items were all >3.After analysis,this blood cell analyzer,except that MCHC should use the minimal quality standard requirements,all other examination items could used the proper quality standard requirements,and the calculated QGI were all <0.8.Conclusion Based on thebiological variation determination requirement and calculated σ and QGI value,this method could be used to more accurate quality evaluation of blood cell analyzer.Which is a higher level of quality management,will be more conducive toquality improvement and better serve the clinical.

参考文献/References:

[1] 冯仁丰.临床实验室分析质量目标的共识(上)[J].检验医学,2016,31(1):1-8. Feng RF.Consensus on the quality goal of clinical laboratories(PartI)[J].Laboratory Medicine,2016,31(1):1-8.
[2] 王治国.临床检验质量控制技术[M].北京:人民卫生出版社,2004:42-44. Wang ZG.Clinical Laboratory Quality Control[M].Beijing:People'sMedical Publishing House,2004:42-44.
[3] 张鸿伟,段雷波.生物学变异质量规范在血细胞分析质量控制中应用的回顾分析[J].航空航天医学杂志,2013,24(2):139-142. Zhang HW,Duan LB.Application of quality specification based on biological variation in the quality control of blood cell analysis[J].Journal ofAerospace Medicine,2013,24(2):139-142.
[4] 章晓燕,王 薇,赵海建,等.生物学变异推导出的质量规范在肿瘤标志物检测指标质量评价中的应用[J].临床检验杂志,2016,34(5):388-391. Zhang XY,Wang W,Zhao HJ,et al.Application of quality specifications derived from biological variation in external quality assessment and internal quality control of tumor markers[J].Chinese Journal of Clinical LaboratorySciences,2016,34(5):388-391.
[5] 尹利民,胡大春.基于生物学变异的质量规范在临床生化质控方案设计中的应用[J].现代检验医学杂志,2012,27(1):151-153,157. Yin LM,Hu DC.Application of quality specification based on biological variation in planning quality control strategy of clinical biochemistry [J].Journal of Modern Laboratory Medicine,2012,27(1):151-153,157.
[6] 栗秀芳,钱 净,赵 莹,等.生物学变异允许总误差在血脂检测中的质量管理[J].国际检验医学杂志,2016,37(19):2708-2709,2712. Li XF,Qian J,Zhao Y,et al.Study on the quality management of biological variation allowed total error in detection of serum lipid[J].International Journal of Laboratory Medicine,2016,37(19):2708-2709,2712.
[7] 谭晓霞,兰蔚蔚,徐晓红,等.6σ理论在评价临床实验室血液分析各阶段性能及设计质控方案中的应用[J].检验医学,2012,27(1):63-66. Tan XX,Lan WW,Xu XH,et al.Application of 6 sigma theory in evaluating the performance of clinical laboratory blood analysis and the design of quality control program[J].Laboratory Medicine,2012,27(1):63-66.
[8] 杨 雪,王志国.临床检验项目的生物学变异[J].现代检验医学杂志,2012,27(2):4-6. Yang X,Wang ZG.Biological variation of analytes in laboratory medicine[J].Journal of Modern Laboratory Medicine,2012,27(2):4-6.
[9] 张秀明.分析质量指标在定量检验项目中的应用[J].中华临床实验室管理电子杂志,2016,4(1):2-7. Zhang XM.The establishment and application of qua-lity indicator in laboratory tests[J].Chinese Journal of Clinical Laboratory Management(Electronic Edition),2016,4(1):2-7.
[10] 何法霖,王治国,李少男,等.生物学变异在制定临床检验质量规范中的应用[J].国际检验医学杂志,2011,32(18):2117-2119. He FL,Wang ZG,Li SN,et al.The application of biological variation in the formulation of clinical laboratory quality standards[J].International Journal of Laboratory Medicine,2011,32(18):2117-2119.
[11] 赵 霞,汪 萍,张广慧,等.应用六西格玛理论评价和设计临床干化学检验室内质控规则[J].诊断学理论与实践,2014,13(5):495-500. Zhao X,Wang P,Zhang GH,et al.Evaluation and de-sign of quality control rules for dry chemistry in clinical laboratory by six sigma(6σ)quality management method[J].J Diagn Concepts Pract,2014,13(5):495-500.

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备注/Memo

备注/Memo:
作者简介:刘连义(1965-),男,大专,主管技师,主要从事临床检验凝血及血液形态学等方面的研究,E-mail:m18410201290@163.com。 通讯作者:姜慧英(1973-),女,研究生,副主任技师,主要从事细菌、免疫及血液形态学等方面的研究,E-mail:huiying_jiang11@sina.com。
更新日期/Last Update: 1900-01-01