标准化6σ方法性能决定图制作及在临床生化检验质量管理中的应用

Exploration of the performance value by using 6 sigma metric and excel software and MEDx chart in clinical chemistry

目的应用6σ管理理论和Excel软件制作标准化6σ方法性能决定图,并研究其在临床生化检验质量管理中的应用价值。方法使用Excel软件制作标准化6σ方法性能决定图。采集广州医学院第一附属医院检验科生化室12个项目2009年上半年质控数据,计算各项目的偏倚(Bias%)和批内精密度(CV%);参考美国临床实验室改进法案(CLIA′88)中相关项目的总允许误差(TEa%),计算Bias%占TEa百分数和CV%占TEa%;以前值为纵坐标,后值为横坐标绘图。并根据σ=(TEa%-Bias%)/CV%画出西格玛性能线,最后根据各项目操作点所在σ区域判断检验项目的质量水平。结果使用Excel软件制作的标准化6σ方法性能决定图能同时对12个项目的性能水平进行评价,并了解整体质量水平。结果显示,12个检验项目的质量参差不齐,血液淀粉酶、三酰甘油(TG)、丙氨酸氨基转移酶(ALT)质量达到6σ水平,天门冬氨酸氨基转移酶(AST)达5σ水平,总蛋白(TP)、高密度脂蛋白胆固醇(HDL-C)、肌酸激酶(CK)、乳酸脱氢酶(LDH)位于4σ水平,葡萄糖(Glu)、总胆固醇(TC)处于3σ水平,清蛋白(Alb)、直接胆红素(DBIL)仅达到2σ水平。结论临床生化检验各个项目的性能好坏不一,标准化6σ方法性能决定图能有效进行质量评价。

Objective To make method evaluation decision chart （MEDx Chart） by using 6 sigma metric and excel software,and study its value of performance in clinical chemistry. Methods To make standardization 6 sigma MEDx Chart by using excel software. First,collect the data from 12 clinical chemistry items made by the Clinical Laboratory of First Affiliated Hospital of Guangzhou Medical College in 2009. Then, calculate the inaccuracy （bias%） and imprecision （CV%） of each item. And the allowed total error （TEA） of the items proposed by the Clinical Laboratory Improvement is taken account and the Amendments of 1988 （CLIA ＇88） is referenced, and also the bias%/ TEa and CV%/Tea are caucolated. Fourth,make a chart which displays bias%/TEa on the y-axis and CV%/TEa on the x-axis. Fifth, draw the decision lines bias ＋ 2s, bias ＋ 3s, bias ＋ 4s, bias＋5 s, and bias ＋ 6s in accordence withσ = （TEa%-Bias % ）/CV% And finally, evaluate the performances of each item through their operate points which are located in the sigma area. Results MEDx Chart made by excel software can evaluate 12 items at the same time and show the whole performance. The MEDx Chart tells us that the performances of the 12 items are uneven,AMY,TG and ALT are 6 sigma performance, AST is 5 sigma performance, TP, HDL-C, CK and LDH are 4 sigma level, Glu and TC are 3 sigma level and Alb and DBIL are only 2 sigma level. Conclusion The performances of clinical chemistry items are different and standardization 6 sigma MEDx Chart can be used to evaluate them effectively.