Error budgets for quality management--practical tools for planning and assuring the analytical quality of laboratory testing processes.

Abstract

Analytical quality is often assumed, rather than being assured or guaranteed. Given that it is still essential that laboratories produce reliable test results, managers must continue to improve their skills in analytical quality management. This paper shows managers how to use error budgets and charts of operating specifications (¿OPSpecs¿ charts) to select appropriate control rules and numbers of control measurements, taking into account the analytical or clinical quality required for a test and the imprecision and inaccuracy observed for a method. With currently available tools and a little practice, quality control (QC) procedures can be selected quickly and easily, in just 1 minute or less. Future technology is expected to automate the QC selection process and provide dynamic quality control.