Westgard J O
Department of Pathology and Laboratory Medicine, Medical School, University of Wisconsin, Madison 53792.
Clin Chem. 1992 Jul;38(7):1226-33; discussion 1245-50.
"Operational process specifications" have been derived from an analytical quality-planning model to assess the precision, accuracy, and quality control (QC) needed to satisfy Proficiency Testing (PT) criteria. These routine operating specifications are presented in the form of an "OPSpecs chart," which describes the operational limits for imprecision and inaccuracy when a desired level of quality assurance is provided by a specific QC procedure. OPSpecs charts can be used to compare the operational limits for different QC procedures and to select a QC procedure that is appropriate for the precision and accuracy of a specific measurement procedure. To select a QC procedure, one plots the inaccuracy and imprecision observed for a measurement procedure on the OPSpecs chart to define the current operating point, which is then compared with the operational limits of candidate QC procedures. Any QC procedure whose operational limits are greater than the measurement procedure's operating point will provide a known assurance, with the percent chance specified by the OPSpecs chart, that critical analytical errors will be detected. OPSpecs charts for a 10% PT criterion are presented to illustrate the selection of QC procedures for measurement procedures with different amounts of imprecision and inaccuracy. Normalized OPSpecs charts are presented to permit a more general assessment of the analytical performance required with commonly used QC procedures.
“操作过程规范”源自一种分析质量规划模型，用于评估满足能力验证（PT）标准所需的精密度、准确度和质量控制（QC）。这些常规操作规范以“操作规范图”的形式呈现，该图描述了在特定QC程序提供所需质量保证水平时，不精密度和不准确度的操作限值。操作规范图可用于比较不同QC程序的操作限值，并选择适合特定测量程序精密度和准确度的QC程序。为选择QC程序，需将测量程序观察到的不准确度和不精密度绘制在操作规范图上，以确定当前操作点，然后将其与候选QC程序的操作限值进行比较。任何操作限值大于测量程序操作点的QC程序都将提供已知的保证，即按操作规范图规定的百分比概率检测到关键分析误差。给出了10%PT标准的操作规范图，以说明针对具有不同不精密度和不准确度的测量程序选择QC程序的过程。还给出了标准化操作规范图，以便更全面地评估常用QC程序所需的分析性能。
