scope:

This document provides guidance on development of quality indicators and their use in the medical laboratory. These indicators include measures developed in a single laboratory for local use and indicators developed by other organizations and national bodies. The document includes criteria for development of quantitative, ordinal, and qualitative indicators; it also includes procedures for gathering data, presenting and interpreting results, monitoring performance over time, and comparing performance with other laboratories or national norms.

This guideline is intended for use by laboratory directors, managers, supervisors, and the quality manager as a means to ensure that their laboratories implement an effective approach to selection, development, interpretation, and application of information derived from well-designed quality indicators.