Implementation of the quality control system of blood components at the Blood Bank - Western processing hub (Liguria Region - National Health System): analysis of the data of the activity carried out in 2024.

Blood and its components represent an important factor of life for many patients; blood donations in Italy in fact save about 630,000 lives every year. Components are those therapeutic constituents of blood that can be prepared by centrifugation, separation, filtration and freezing. Blood components are: whole blood, leukodepleted red blood cell concentrate, platelet concentrates from buffy coat pools, platelet concentrates from apheresis, fresh frozen plasma from fractionation, plasma from apheresis and factor VIII. Each of them has their own quality standards. The number of quality controls performed corresponds to approximately 1% of total production as required by the ministerial decree of 2/11/2015, except for platelet units that they were evaluated on all units produced. The samples intended for quality control were collected at the Immunohematology and Transfusion Medicine Department of the San Paolo Hospital in Savona - ASL2 Savonese (Liguria Region Health System) and analyzed at the Immunohematology and Transfusion Medicine Department, Clinical Pathology Department (Analysis Laboratory) and S.C. Pathological Anatomy of the San Paolo Hospital in Savona - ASL2 Savonese (Liguria Region Health System) during the year 2024. The data presented suggest a compliant and controlled production process. A maintenance of quality levels is identified in comparison to previous years. A reduction in the presence of residual leukocytes in plasma units is highlighted compared to the year 2023. All units found not to comply with quality controls were discarded except for plasma units which were sent to the plasma derivation industry. Considering the very small number of non-conformities for whole blood and blood components for the year 2024 and the data recorded in previous years, we propose to reduce the quality control sampling from 1% of production to 0.5% for the year 2025. It could be interesting to evaluate possible implementations of waste material for research purposes in the clinical field.