摘要
目的：采用卫生部室间质评及正确度验证获得的偏倚,分别计算20项常规化学项目的西格玛（σ）值,比较其σ水平大小及分布情况.方法：收集生化室2017年参加的卫生部室间质评及正确度验证的数据,计算常规化学项目的偏倚.以实验室的室内质控累计6个月的变异系数作为不精密度的估计值.以卫生行业标准WS/T406-2012的允许总误差作为质量规范.利用公式σ=（TEa％-│Bias│％）/CV％计算出不同偏倚下的σ水平.结果：20项化学项目采用卫生部室间质评获得的偏倚计算受检项目的σ值,钾、 尿酸等10个项目达到6以上,丙氨酸氨基转移酶、 碱性磷酸酶、 乳酸脱氢酶位于5～6之间,钠、 葡萄糖、 镁位于4～5之间,总蛋白、 γ-谷氨酰氨基转移酶、 尿素位于2～3之间,钙位于2以下;用正确度验证获得的偏倚计算的σ值,钾、 尿酸等9个项目达到6以上,镁位于5～6之间,钠、 天门冬氨酸氨基转移酶、 碱性磷酸酶位于4～5之间,葡萄糖位于3～4之间,总蛋白、 尿素等5各项目位于2～3之间,钙位于2以下.个别项目如胆固醇在前者获得的σ值要明显高于后者.鉴于正确度验证更能反映实验室检测的准确性,故实验室某些在室间质评中表现良好的项目仍需改进.结论：卫生部室间质评与正确度验证联合应用于实验室检测项目的σ水平评估,能够有效促进实验室的质量管理改进,提高实验室的检测水平.
Objective： To calculate the sigma （σ） values of 20 routine chemical test items by different Biases obtained from the external quality assessment and trueness verfication scheme, and compared their σ values and distribution. Methods： The Biases were calculated by the data collected from the external quality assessment and trueness verfication scheme by biochemistry laboratory in 2017. Regarded the accumulated coefficient of variablity from the internal quality control in 6 months as the extimation value of imprecision. Using the total allowable errors in health industry standard WS/T406-2012 as a quality specification, σ values were calculated according to the formula σ= （TEa%- ｜ Bias｜%）/CV % by different Biases. Results： K, UA and other 8 items were distributed beyond 6ix, ALT, ALP, LDH were distributed between 5cr and 6σ, Na, Glu and Mg were distributed between 4σ and 5σ, TP, GGT, UN were distributed between 2σ and 3σ, Ca was distributed under 2σ by the Bias of external quality assessment. And by the Bias of trueness verification scheme, K, UA and other 7 items were distributed beyond 6σ, Mg were distributed between 5σ and 6σ, Na, AST and ALP were distributed between 4σ and 5σ, Glu was distributed between 3σ and 4σ, UN, TP, and other 3 items were distributed between 2σ and 3σ, Ca was distributed under 2σ, And the σ values in the former were significantly higher than the latter in some items, such as CHO. In view of the trueness verfication scheme can reflect the accuracy of laboratory testing better, some projects in the laboratory which have shown good performance in the external quality assessment still need to be improved. Conclusion： Apply external quality assessment and trueness verfication scheme by Ministry of health to the σ level evaluation of laboratory testing items, which can effectively improve the quality management of laboratories and improve the detection level of laboratories.
作者
程姗姗
白雪
王毅
CHENG Shan-shan;BAI Xue;WANG Yi(The clinical laboratory of Tianjin Hospital,Tianjin 300211)
出处
《医学检验与临床》
2018年第6期11-14,共4页
Medical Laboratory Science and Clinics
关键词
六西格玛
常规化学
偏倚
室间质评
正确度验证
Six sigma
Routine chemistry
Bias
External quality assessment
Trueness verfication scheme
