应用σ度量评价河北省26家结果互认实验室常规生化项目的检测性能

Evaluation of analytical performance routine chemistry projects in 26 result mutual recognition laboratories in Hebei province by σ metric method

目的应用西格玛Sigma(σ)度量分析河北省26家互认实验室临床生化项目的检测性能,了解其质量水平,提出改进方案。方法收集河北省26家结果互认实验室室内质控(internal quality control,IQC)室间比对数据,包括丙氨酸转氨酶(alanine aminotransferase,ALT)、天冬氨酸转氨酶(aspartate aminotransferase,AST)、钠离子(Na^+)、钾离子(K^+)、总胆固醇(total cholesterol,TC)和三酰甘油(triglyceride,TG),以临床生化检验常规项目分析质量指标WS/T 403-2012作为总误差(total error allowance,TEa),统计各实验室分布情况,评价质量现状。结果26家实验室质控L1项目性能≥6σ的实验室ALT 3.85%、AST 3.85%、Na^+3.85%、K^+23.08%、TC 19.23%、TG 19.23%,质控L2项目性能≥6σ的实验室ALT 46.15%、AST 50.00%、Na^+3.85%、K^+26.92%、TC 3.85%、TG 7.69%;26家实验室质控L1项目性能3≤σ<6的实验室ALT 73.08%、AST 76.92%、Na^+96.55%、K^+77.05%、TC 73.08%、TG 77.05%,质控L2项目性能3≤σ<6的实验室ALT 53.85%、AST 50.00%、Na^+92.31%、K^+73.08%、TC 69.23%、TG 77.05%。结论河北省26家实验室质量水平检验性能优良。6σ提供统一而简单的评价标准,用于IQC室间比对更加简便直观。

Objective To measure and analyze the detection performance of clinical biochemical items in 26 mutual recognition laboratories in Hebei province by using the Sigma value(σ),to understand their quality level,and to propose improvement plans.Methods Inter-room comparison data of internal quality control(IQC)were collected from 26 laboratories in Hebei province,including alanine aminotransferase(ALT),aspartate aminotransferase(AST),Na^+,K^+,total cholesterol(TC)and triglyceride(TG)were used as total error allowance(TEa)to evaluate the quality status of clinical biochemical routine items.Results Twenty-six laboratories with quality control L1 item performance(≥6σ)accounted for ALT 3.85%,AST 3.85%,Na^+3.85%,K^+23.08%,TC 19.23%and TG 19.23%,and laboratories with quality control L2 item performance(≥6σ)accounted for ALT 46.15%,AST 50.00%,Na^+3.85%,K^+26.92%,TC 3.85%and TG 7.69%.Laboratories with performance 3≤σ<6 at L1 of quality control accounted for ALT 73.08%,AST 76.92%,Na^+96.55%,K^+77.05%,TC 73.08%and TG 77.05%.Labs with performance 3≤σ<6 at L2 of quality control accounted for ALT 53.85%,AST 50.00%,Na^+92.31%,K^+73.08%,TC 69.23%and TG 77.05%.Conclusion The quality level of 26 laboratories in Hebei province has excellent performance.6σprovides a unified and simple evaluation criterion,which is more convenient and intuitive for IQC comparisons.