Need for a Quality System and Quality System Management in Clinical Transfusion Medicine

A Blood System is a vein-to-vein system consisting of two major parts, the consumption (clinical) part or health care institution and the manufacturing part or blood establishment. A quality system with a quality system management has been developed for the manufacturing part. However, so far, this has not been developed for the consumption (clinical) part. As the clinical part is less regulated for quality despite the existence of manifold clinical guidelines, the question arises whether there is a need for harmonization of the clinical practices based on a quality system and its management. Over the years, awareness has grown and expressed in the design of hemovigilance and patient blood management (PBM). These systems are based on a patient-oriented approach, positioning the patient at the center of clinical practice. This chapter provides an analysis of the clinical transfusion flow and discusses the need for a structured quality system and system management in clinical transfusion medicine.