Westgard J O
Department of Pathology and Laboratory Medicine, University of Wisconsin, Madison 53792, USA.
Scand J Clin Lab Invest. 1999 Nov;59(7):483-6. doi: 10.1080/00365519950185201.
The management of analytical quality depends on the careful evaluation of the imprecision (uncertainty) and inaccuracy (trueness) of laboratory methods and the application of statistical quality control procedures to detect medically important analytical errors that may occur during routine analysis. A system of quality standards is recommended to incorporate different types of requirements, such as clinical outcome criteria, analytical outcome criteria, and analytical performance criteria. For practical applications, all need to be translated into operating specifications for the imprecision, inaccuracy, control rules, and number of control measurements that are necessary to assure analytical quality during routine production of test results.
分析质量的管理取决于对实验室方法的不精密度（不确定度）和不准确度（真实性）进行仔细评估，以及应用统计质量控制程序来检测常规分析过程中可能出现的具有医学重要性的分析误差。建议采用一套质量标准体系，纳入不同类型的要求，如临床结果标准、分析结果标准和分析性能标准。在实际应用中，所有这些都需要转化为关于不精密度、不准确度、控制规则以及在常规检测结果生成过程中确保分析质量所需的控制测量次数的操作规范。
