Westgard J O
Department of Pathology and Laboratory Medicine, University of Wisconsin Medical School, Madison.
Arch Pathol Lab Med. 1992 Jul;116(7):765-9.
United States governmental regulations describe quality assurance as a system in which quality control (QC) and proficiency testing are to be used to substantiate that routine tests conform to specified performance criteria. Careful planning of analytical processes is necessary to guarantee that routine tests will achieve the analytical performance defined by the Health Care Financing Administration proficiency testing criteria. These proficiency testing criteria are analytical "total error" requirements that need to be translated into operational process specifications for the allowable imprecision, allowable inaccuracy, and the QC procedure (decision rules, number of control measurements) necessary to provide a known or specified level of analytical quality assurance. The level of assurance will depend on the QC procedure's probability for detecting critical sized errors that would cause the quality requirement to be exceeded. Analytical quality can be guaranteed by applying statistical QC to verify, with a specified probability, that a desired quality requirement is actually achieved in routine laboratory testing. Analytical quality assurance, applied in this way, can be a quantitative approach for guaranteeing quality through process planning and QC.
美国政府法规将质量保证描述为一种系统，在该系统中，质量控制（QC）和能力验证用于证实常规检测符合特定的性能标准。必须对分析过程进行精心规划，以确保常规检测能够达到医疗保健财务管理局能力验证标准所定义的分析性能。这些能力验证标准是分析“总误差”要求，需要转化为操作过程规范，以规定允许的不精密度、允许的不准确度以及为提供已知或特定水平的分析质量保证所需的质量控制程序（决策规则、控制测量次数）。保证水平将取决于质量控制程序检测到会导致超出质量要求的临界大小误差的概率。通过应用统计质量控制，以特定概率验证在常规实验室检测中实际达到了所需的质量要求，从而保证分析质量。以这种方式应用的分析质量保证可以是一种通过过程规划和质量控制来保证质量的定量方法。
