Quality management or the need for a quality culture in transfusion medicine

Abstract

With the development of safe blood supply and transfusion comes the introduction of managing quality as a culture. This is implemented through the introduction of a quality system (QS) and a related quality management system (QMS). In many situations in the world the idea is that when instructions are written (SOPs) a QS is in place; one just has to follow the instructions and “that is it, we're done”! However, quality does only partly depend on following instructions at the operational level. What is generally not understood is the importance of designing and implementing QS management as an institutional culture, based on the five key elements (1) organization and (infra) structure; (2) standards (technical and quality); (3) documentation to allow traceability and evidence; (4) education through continued teaching and training; (5) assessment through continued monitoring and evaluation. There are a number of QMSs available which can be applied to procurement and clinical use of blood. Some are “process”- and “operations-oriented” while others deal more with the management aspects, securing a quality environment and culture, necessary for consistency and reliability of the operational processes. The EU European Foundation for Quality Management and Canadian ISQua system are based on fundamental concepts of excellence. To achieve an optimal understanding of the values of quality in transfusion medicine, vein-to-vein, a culture has to be created through ownership development, and commitment to and implementation of the principles of fitness for purpose, the supplier-producer-customer continuum, and customer-orientation and satisfaction.