Westgard James O
University of Wisconsin Medical School, 1300 University Avenue, Madison, WI 53706, USA.
Ann Clin Biochem. 2003 Nov;40(Pt 6):593-611. doi: 10.1258/000456303770367199.
The first essential in setting up internal quality control (IQC) of a test procedure in the clinical laboratory is to select the proper IQC procedure to implement, i.e. choosing the statistical criteria or control rules, and the number of control measurements, according to the quality required for the test and the observed performance of the method. Then the right IQC procedure must be properly implemented. This review focuses on strategies for planning and implementing IQC procedures in order to improve the quality of the IQC. A quantitative planning process is described that can be implemented with graphical tools such as power function or critical-error graphs and charts of operating specifications. Finally, a total QC strategy is formulated to minimize cost and maximize quality. A general strategy for IQC implementation is recommended that employs a three-stage design in which the first stage provides high error detection, the second stage low false rejection and the third stage prescribes the length of the analytical run, making use of an algorithm involving the average of normal patients' data.
在临床实验室建立检测程序的内部质量控制（IQC）时，首要任务是选择合适的IQC程序来实施，即根据检测所需的质量和方法的观察性能，选择统计标准或控制规则以及控制测量的次数。然后，必须正确实施正确的IQC程序。本综述重点关注规划和实施IQC程序的策略，以提高IQC的质量。文中描述了一种定量规划过程，该过程可通过诸如功效函数或临界误差图以及操作规范图等图形工具来实施。最后，制定了全面质量控制策略，以最小化成本并最大化质量。建议采用一种IQC实施的通用策略，该策略采用三阶段设计，其中第一阶段提供高误差检测，第二阶段提供低误拒收率，第三阶段规定分析运行的时长，并利用一种涉及正常患者数据平均值的算法。
