六西格玛质量管理方法在血细胞分析仪质量管理中的应用  

Application of 6σ quality management method in quality management of blood cell analyzer

作　　者：任鹏[1] 李金兰[2] 孔建新[1] 

机构地区：[1]中国人民解放军第一0五医院检验科,合肥230031 [2]中国人民解放军电子工程学院门诊部,合肥230031

出　　处：《检验医学与临床》2016年第10期1344-1346,共3页Laboratory Medicine and Clinic

摘　　要：目的应用六西格玛（6σ）质量管理方法分析血细胞分析仪质量控制数据,评价其分析性能,指导质量改进。方法收集2014年7月至2015年5月血细胞分析仪室内质量控制和室间质量评价数据,依据临床血液学常规项目分析质量要求（WS/T 406-2012）标准,计算白细胞计数（WBC）等项目的偏差（bias）、变异系数（CV）、西格玛（σ）值,结合标准化6σ性能决定图,评价检验项目分析性能,提出改进方法。结果 2014年7~12月希森美康XE-2100血细胞分析仪,高、中、低三水平质控品WBC、血红蛋白浓度（Hb）、红细胞计数（RBC）、血小板计数（PLT）项目σ均值分别为3.7、4.3、5.0、2.8。低值水平WBC、Hb、PLT的σ〈3,存在严重质量问题,PLT各水平均在临界值附近。采取改进措施后,2015年1~5月σ值明显提高。结论 6σ质量管理方法可以有效地应用于血细胞分析仪的质量管理,有助于提高血常规项目的质量水平。Objective To apply the 6σquality management method to analyze the quality control data of blood cell analyzer,and to evaluate its analytic performance for guiding the quality improvement.Methods The data of internal and external quality control evaluation of blood cell analyzer were collected from July 2014 to May 2015.According to the analytical quality requirements of clinical hematological routine items（WS/T 406-2012）,the items of bias,coefficient of variation（CV）and Sigma value of WBC were calculated,by combining with the standardized 6σperformance decision chart,the analytic capability of detection items was evaluated and the improvement methods were proposed.Results From July to December 2014,the detection result of Sysmex XE-2100 hematology analyzer showed that,σ-mean value in WBC count of high,medium and low level quality control was 3.7,Hb was 4.3,RBC count was 5.0,PLT was 2.8.σ-value of low level of WBC,Hb,PLT was less than 3,existing serious quality problems,each level of PLT in the vicinity of the critical value.After taking corrective measures,σ-value was increased significantly from January to May 2015.Conclusion The 6σquality management method can be effectively used in the quality management of the blood cell analyzer,help to improve the quality level of the blood routine items.

关 键 词：六西格玛 质量管理 血细胞分析仪 

分 类 号：R446.113[医药卫生—诊断学]