质量控制工具在临床生化项目过程能力验证中的应用

目的:运用质量控制工具,验证本实验室的过程能力,设计最佳的室内质量控制规则.方法:参考美国临床实验室改进法案(CLIA’88)中的分析质量要求,作为临床允许总误差(total allowed error,TEa),结合本实验室的室内质控变异系数(CV%)作为分析方法的不精密度,生化室间质评的偏倚(Bias%)作为分析方法的不准确度,以方法决定图反映检测方法的过程稳定性,用Westgard质控选择表格确定候选方法,以功效函数图和操作过程规范图确定最佳的质控方案.结果:各项目据其分析方法性能特征选择最佳质控规则进行室内质量控制.结论:实验室运用质量控制工具,确定质控方案,查找本实验室存在问题,开展全面质量控制策略(TQC),保证临床实验室的质量要求.

The Application of Quality Control Tools for Clinical Biochemical Process Capability Verification

Using quality control tools, this article aims to verify the laboratory process capability, and design best in- ternal quality control rules. According to analysis of the quality of requirements of the United States Clinical Laboratory Improvement Act （CLIA＇88） , as the clinical total allowed error （TEa）, this paper uses the coefficients of variation of internal quality control as imprecision, EQA bias as inaccuracy; method decision chart can reflect process capability. Using Westgard QC selection grids determining a candidate method, power function graphs and OPSpecs charts can determine the optimal plan of quality control. According to the characteristics of optimal control rules which make internal quality control, we can use quality control tools the laboratory, determine the quality con- trol plan, find the problems in the laboratory, launch total quality control strategy （TQC）, and ensure the quality of clinical laboratory requirements.