The transfusion of blood and blood products is a life-saving intervention. However, there are risks of adverse events associated with the donation of blood and its components, and with the transfusion of blood and blood products to patients. Adverse events include all reactions, incidents, near misses, errors, deviations from standard operating procedures and accidents associated with blood donation and transfusion. Learning from adverse events and identifying systems problems can drive the introduction of measures to enhance the quality, safety, efficacy, and cost-effectiveness of blood and blood products as well as the donation and transfusion processes. Haemovigilance is a set of surveillance procedures covering the entire transfusion chain, from the donation and processing of blood and its components, to their provision and transfusion to patients and their followup. Haemovigilance includes the monitoring, reporting, investigation and analysis of adverse events related to the donation, processing and transfusion of blood, as well as the development and implementation of recommendations to prevent their occurrence or recurrence. The ultimate goal of haemovigilance is continuous quality improvement of the transfusion chain through corrective and preventive actions to improve patient safety and outcomes, enhance donor safety and reduce wastage. Haemovigilance should be fully integrated into the quality systems of all institutions involved in the donation and provision of blood and blood products, including processing, inventory management, storage and distribution, and in clinical transfusion. The organization of a haemovigilance system is largely determined by the structure of the national blood system and the health system. A system of haemovigilance is dependent on the traceability of blood and blood products from donors to recipients and vice versa, and on the monitoring, reporting, investigation and analysis of adverse events. The rigorous management of information generated through this system is key to introducing amendments in blood policies and guidelines that lead to changes in processes and practices in donation and transfusion. The establishment of a haemovigilance system involves coordination and collaboration among all stakeholders, including the ministry of health, blood transfusion services, hospitals, professional bodies, public health institutions and regulatory agencies, as well as patient and donor groups.#
Haemovigilance in the donation and provision of blood and blood products

# Words of advice
 Provide effective leadership, governance and adequate resources for establishing and maintaining an effective haemovigilance system  Incorporate haemovigilance into national blood and health policies and systems  Adopt a stepwise approach in establishing a haemovigilance system  Engage all stakeholders in the blood transfusion chain  Set up efficient organizational arrangements for the haemovigilance system and ensure integration with institutional quality management systems  Develop a confidential and non-punitive system
The ministry of health (MoH) holds ultimate responsibility for its national blood system and for the quality, safety and sufficiency of the supply of blood and blood products. A haemovigilance system contributes to the safety of donation, blood products and transfusion. It improves risk management, increases trust and should be confidential and non-punitive in nature. The MoH should provide effective leadership and governance for a national haemovigilance system, including:  systematic and comprehensive surveillance of the entire transfusion chain as an element of the national blood policy and plan, and legislative and regulatory framework;  haemovigilance advisory committee(s)
with medical, scientific and quality expertise;  adequate human and financial resources for the establishment, development and sustainability of the haemovigilance system

# Key elements
 standards and definitions in line with international recommendations. The MoH should define the scope and elements of the haemovigilance system for a stepwise development of the system. This should include:  Reporting characteristics: whether it is mandatory, voluntary or mixed;  Coverage: whether it concerns donors, processes, clinical practices or patients;  Blood products: whether it covers only blood components for transfusion or also plasma-derived medicinal products;  Types of events to be reported: whether it covers all types of adverse events or selected reactions, near misses and errors;  Severity of adverse events to be reported:
fatal, serious or all levels of severity;  Imputability: the probability of attribution (definite, probable and possible, or also unlikely and excluded) in the context of blood donation, processing and clinical transfusion;  Collection and use of denominators to calculate rates of adverse events. An efficient haemovigilance system requires:  Traceability of the blood product from donor to patient, and vice versa;  Effective structure and clear channels for adverse events reporting, investigation, feedback and communication of findings, as well as monitoring and evaluation;  Methods and mechanisms for data collection, validation and analysis;  Guidelines, procedures and formats for notification and modalities of reports;  A quality system throughout the transfusion chain, and implementation of corrective or preventive actions to quickly rectify weaknesses and deficiencies.
Organization and coordination of a haemovigilance system

# Haemovigilance in the donation and provision of blood and blood products
In a national haemovigilance system, blood centres and transfusion services have the following roles and responsibilities:  Donor haemovigilance, including recognition and clinical management of adverse events associated with donation, and their monitoring, reporting, investigation and analysis;  Implementation of policies, guidelines, protocols and standard operating procedures for all processes in the donation and provision of blood and blood products;  Epidemiological surveillance of donors, post-donation information and look-back;  Identification, recording and reporting of:
-Near misses, errors and deviations associated with these processes; -Abnormalities in intermediate and finished blood products.  Traceability of each donation from the donor to blood processing, the blood product, its issue to a health-care facility and transfusion to the patient, and vice versa;  Response to notification of a patient adverse event, by retrieval of all blood components associated with the index blood component(s);  Implementation of haemovigilance as part of the quality system, and mechanisms for taking corrective and preventive actions and monitoring their outcomes;  Training and assessment of staff involved in all steps of the donation and provision of blood and blood products;  Liaison with hospitals: administration, blood banks, transfusion committees and clinical services.

# Haemovigilance in clinical transfusion