CLSI QMS03-A3:2009

Clinical and Laboratory Standards Institute document GP21-A3--Training and Competence Assessment; Approved Guideline-- Third Edition provides the necessary background information and processes to permit clinical services to develop training and competence assessment programs that will meet specific quality and regulatory objectives. To be effective, training must be built on a solid foundation of documented operations processes and procedures with accompanying training documents. The competence of staff to perform their respective assigned tasks needs to be assessed initially after training and periodically thereafter. This guideline provides a structured approach for using documented work processes, related procedures, training guides, and assessment tools for the development of training and competence assessment programs.