scope:

The purpose of this guideline is to help medical laboratories use proficiency testing (PT) as a quality improvement tool.1-6 This guideline presents a systematic approach for designing the PT process as a component of the laboratory QMS.

QMS24 is intended for clinical laboratory managers and analysts in both the public and private sectors, and is applicable to any setting in which clinical laboratory testing is performed, from bedside testing to large multispecialty laboratories. This guideline applies to both qualitative and quantitative laboratory testing, including detection and quantification of blood and fluid measurands and blood and tissue typing. Some discussions apply only to examinations with quantitative results, whereas other discussions apply to examinations with qualitative results.

The processes described in this guideline can help laboratories design a PT process, monitor PT results, and investigate and respond to unacceptable PT results. Part of this response may include preparation of information for submission to regulatory or accreditation organizations. Laboratories are cautioned, however, that regulatory and accreditation organizations may have additional requirements not supported by the guidance in QMS24.

QMS24 also provides guidance for how to use PT as a tool to prevent problems through analysis of acceptable results, education of laboratory personnel, and monitoring of internal processes.

This guideline does not recommend specific corrective actions for specific root causes (see CLSI document QMS11⁷).