Westgard J O, Stein B, Westgard S A, Kennedy R
Department of Pathology and Laboratory Medicine, University of Wisconsin Medical School, Madison 53792, USA.
Comput Methods Programs Biomed. 1997 Jul;53(3):175-86. doi: 10.1016/s0169-2607(97)00017-5.
A computer program has been developed to help healthcare laboratories select statistical control rules and numbers of control measurements that will assure the quality required by clinical decision interval criteria or analytical total error criteria. The program (QC Validator 2.0 (QC Validator and OPSpecs are registered trademarks of Westgard Quality Corporation, which has applied for a patent for this automatic QC selection process. Windows is a registered trademark of Microsoft Corporation)) runs on IBM compatible personal computers operating under Windows. The user enters information about the method imprecision, inaccuracy, and expected frequency of errors, defines the quality required in terms of a medically important change (clinical decision interval) or an analytical allowable total error, then initiates automatic selection by indicating the number of control materials that are to be analyzed (1, 2, or 3). The program returns with a chart of operating specifications (OPSpecs chart) that displays the selected control rules and numbers of control measurements. The automatic QC selection process is based on user editable criteria for the types of control rules that can be implemented by the laboratory, total numbers of control measurements that are practical, maximum levels of false rejections that can be tolerated and minimum levels of error detection that are acceptable for detection of medically important systematic or random errors.
已开发出一种计算机程序，以帮助医疗保健实验室选择统计控制规则和控制测量次数，从而确保符合临床决策区间标准或分析总误差标准所要求的质量。该程序（QC Validator 2.0（QC Validator和OPSpecs是Westgard Quality Corporation的注册商标，该公司已为这种自动质量控制选择过程申请了专利。Windows是Microsoft Corporation的注册商标））在运行于Windows操作系统的IBM兼容个人计算机上运行。用户输入有关方法不精密度、不准确度和预期误差频率的信息，根据医学上重要的变化（临床决策区间）或分析允许总误差定义所需质量，然后通过指明要分析的控制材料数量（1、2或3）启动自动选择。程序返回一个操作规范图（OPSpecs图），显示所选的控制规则和控制测量次数。自动质量控制选择过程基于用户可编辑的标准，这些标准涉及实验室可实施的控制规则类型、实际可行的控制测量总数、可容忍的最大假拒收水平以及检测医学上重要的系统误差或随机误差时可接受的最小误差检测水平。
