Haemovigilance is a continuous process of data collection and analysis of transfusion-related adverse events and reactions in order to investigate their causes and outcomes, and prevent their occurrence or recurrence. It covers all activities of the blood chain, vein-to-vein, from donor to recipient to identify and prevent adverse reactions and unwanted events, and to increase the safety, efficacy and efficiency of blood transfusion. It should include the identification, reporting, investigation and analysis of adverse reactions and events in recipients and blood donors as well as incidents in manufacturing processes and, eventually errors and “near-misses”. A haemovigilance system is also an integral part of quality management in a blood system, triggering corrective and preventive actions, and for the continual improvement of the quality and safety of blood products and the transfusion process.
A system of haemovigilance is dependent on the traceability of blood and blood products from donors to recipients and vice versa (bi-directional tracking), the monitoring, investigation and reporting of transfusion related adverse reactions and events and the rigorous management of information related to the transfusion process. Information generated through this system is key to introduce required amendments in transfusion policies, to improve transfusion standards, to assist in the formulation of transfusion guidelines, to change processes in blood services and transfusion practices in hospitals, and to increase the safety and quality of the entire transfusion process.
The establishment of a haemovigilance system involves all relevant stakeholders and should be coordinated between the national blood programme under the ministry of health, blood services, hospital clinical units and transfusion laboratories, hospital transfusion committees, professional bodies, public health institutions, regulatory agencies and other stakeholders.