Elements of Good Practice in Decentralized Clinical Laboratories

Abstract

The possibilities of producing decentralized clinical laboratory data ‘nearer the patient’ has augmented rapidly during the last decennium due to both simple and sophisticated equipment, often intended to be operated by nonlaboratorians. The theory and practice of quality assurance in its wider sense has not kept pace with this development. The components of Good Laboratory Practice are presented under the headings: type of laboratory work, discipline, management, personnel, premises, safety, equipment, reagents, standard operating procedures, internal quality control, external quality assessment, method, dedicated operating procedure, syllabi, and clinical relevance. The projects currently being established by different national, regional, and international bodies to formulate guidelines should be coordinated to avoid duplication and conflict.