用室间质量评价西格玛图评价脂类项目不同检测系统的质量水平

Assessing Quality of Different Measuring Systems on the Sigma Scale from External Quality Assessment

目的探讨用室间质量评价西格玛图评价脂类正确度验证不同检测系统的质量水平。方法收集参加2014年第1次全国脂类正确度验证室问质量评价获得的数据，计算Bias％和CV％，可构建一种“室间质量评价西格玛图”，以评价不同检测系统的不精密度和偏倚，并以西格玛水平表示检测系统的质量。结果剔除异常值和小于5家实验室的检测系统数据，分别以项目要求的TEa％规范进行分析。血清总胆固醇201411和201412样品的平均偏倚分剐为2．10％和2．17％，平均CV％为3．17%和3．21％，加权西格玛分别为2．53和2．50；血清总三酰甘油201411和201412样品的加权西格玛为4．16和5．10；高密度脂蛋白胆固醇201411和201412样品的加权西格玛为4．53和4．48；低密度脂蛋白胆固醇201411和201412样品加权西格玛为4．98和2．67。从西格玛图中可直观地看到不同检测系统的西格玛水平。结论用西格玛水平评估质量可提供实现预期用途要求的分析性能证据，有助于实验室检验分析质量中的识别和优化改进。

Objective To discuss the application of Six Sigma concepts and metrics, which can provide an objective assessment of current analytical quality of different examination procedures. Methods The data were collected from laboratories partici- pated in anlipid survey in 2014. A ＂Sigma External Quality Assessment Chart＂ could be constructed for data obtained from external quality assessment surveys to evaluate the observed imprecision and bias of method subgroups and determine quality on the Sigma scale. Results Abnormal values and the system whose quantity was less than 5 were excluded. When evaluated against the NCCL requirement of an allowable total error,the weighted average were 2.53 Sigma for 201411 sample of totai cholesterol （ average bias 2.10%, CV 3.17% ） and 2.50 Sigma for 201412 （ average bias 2.17%, CV 3.210%）, respietively. The weighted average were 4.16 Sigma for 201411 sample of total glycerol （average bias 3. 98% ,CV6.38%） and 5.10 Sig ma for 201412 （average bias 3.65%, CV 4.71% ）, respictively. The weighted average were 4.53 Sigma for 201411 sample of HDL-C （average bias 2.65% ,CV 6.94%） and 4.48 Sigma for 201412（average bias 1.91% ,CV 6.74%） , respictively. The weighted average were 4.98 Sigma for 201411 sample of LDL-C （average bias 2.99%,CV 5.98%） and 2.67 Sigma for 201412（average bias 14. 57% ,CV5. 93%）,respictively. The sigma scale can be seen from the Sigma External Quality Assessment Chart. Conclusion Assessment of quality on the Sigma scale provides evidence of the analytical performance that is being achieved relative to requirement for intended use and should be useful for identifying and prioritizing improvements that are needed in the analytical quality of laboratory examinations.