The CLSI has published the 'Development and Use of Quality Indicators for Process Improvement and Monitoring of Laboratory Quality: Approved Guideline' (GP35-A).
This provides guidance on the 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 organisations 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.
The goal of this document is to highlight an effective approach to selection, development, interpretation, and application of information derived from well-designed quality indicators for use by laboratory directors, managers, supervisors, and the quality manager.
This guidance can assist organisations to improve their quality management systems in order to reduce medical errors.