六西格玛度量在改进肿瘤标志物检测质量上的临床应用  

The Use of 6-sigma Measurement for Improvement of Tumor Markers Detection

作　　者：孙永梅[1] 邓芳[1] 张扬 李明[1] 陈少华[1] 方欢[1] 魏敏[1] 

机构地区：[1]安徽省肿瘤医院,安徽省立医院西区检验科,合肥230031

出　　处：《临床输血与检验》2016年第3期280-285,共6页Journal of Clinical Transfusion and Laboratory Medicine

摘　　要：目的探讨应用六西格玛（6O）度量工具在评价临床实验室9个肿瘤标志物（tumormarker，TM）检验质量水平及其在促进持续改进TM检验质量中的作用。方法收集2014-2015年度临床实验室β-HCG、CEA、CA125、CA153、CA199、AFP、t-PSA、f-PSA和FERR9项TM高、低2个水平的室内质量控制及室间质量评价数据，按照卫生部临检中心TM室间质评允许总误差（TEa）为标准，计算各TM的。值和质量目标指数（QualityGoalIndex，QGI），以6σ为最佳评价分析性能，对于未达到世界级的TM根据QGI设计最佳质量改进方案并实施改进措施，比较整改前后TM值水平，评价质量改进情况。结果2015年相比2014年9项TM18个质量水平σ值平均值由4．93上升为6．34，其中世界级项目由2个（11．1％）上升为8个（44．4％）、优秀级项目均为6个（33．3％）、良好级由4个（22．2％）上升为7个（38．9％），临界项目由2个（22．2％）和不可接受项目1个（5．6％）到均消失。结论6σ度量可以精准评价TM的临床检测水平，并能指出质量缺陷，为质量改进提供明确方向，有效提高TM检验水平，是一项有效的实验室质量管理工具。Objective To study the application of six-sigma （6-sigma） measurement tool in the evaluation of the quality level to promote detections of 9 clinical laboratory tumor markers （TMs）. Methods The data from internal quality control and external quality assessment in clinical laboratory were collected for the 9 TMs （β-HCG, CEA, beta CA125, CA153, CA199, AFP, t-PSA, f-PSA and FERR） in 2014 and 2015. Using the total allowable error （TEa） as the standard by Ministry of Health Examination Center TMs EQA, the 6- σ value and quality target index （Quality Goal, Index, QGI） of each item were calculated according to the formula （TEa = Bias / CV%）. The Sigma value is divided into world class （σ〉6）, excellent （5≤ σ 〈6）, good 4≤ σ〈5） critical （3≤σ 〈4）, bad （2≤ σ 〈3） and unacceptable （ σ 〈2） . The quality improvement plan was designed according to QGI and improvement measures were implemented of TM whose odid not reach the world-class. The rectification of TMs levels improvement of quality evaluation was compared. Result The sigma average quality level increased from 4.93（2014） to 6.34（2015）, the world class item consists of 2 （11.1%） to 8 （44.4%）, excellent level item was 6 （33.3%）, good grade increased from 4 （22.2%） to 7 （38.9%）, bu the critical item and non acceptance item decreased from 2 （22.2%） and and 1 （5.6%） to zero, respectively. Conclusion The 6- σsigma can evaluate the level of clinical of TMs quality detection precision, show the defects, provide clear direction for quality improvement, and improve the quality level of TMs test. It is an effective laboratory quality management tool.

关 键 词：肿瘤标志物 西格玛 分析质量 

分 类 号：R730.43[医药卫生—肿瘤]