Haemovigilance

The WHO draft guidelines on adverse event reporting and learning systems: from information to action emphasize the fundamental role of reporting systems in enhancing patient safety by learning from failures of health care systems. Effectiveness of such systems should be measured not only by data reporting and analysis but by the use of such systems to improve patient safety.

• WHO draft guidelines for adverse event reporting and learning systems: from information to action

A haemovigilance system is an integral part of quality management in a blood system, developed for continual improvement of quality and safety of the transfusion process. It should cover processes throughout the entire transfusion chain, from blood donation, processing and transfusion to patients for the monitoring, reporting and investigation of adverse events and reactions and near misses related to blood transfusion. Clear definitions of adverse events, near-misses and reactions need to be established.

A system of haemovigilance is dependent on the traceability of blood and blood products from donors to recipients, spontaneous reports of transfusion adverse events/reactions and rigorous management of information related to the transfusion process. Information generated through this system is a key to introduce required changes in the transfusion policies, improve transfusion standards, assist in the formulation of transfusion guidelines and to increase the safety and quality of the entire transfusion process

The haemovigilance system should involve all relevant stakeholders, and should be coordinated between the blood transfusion service, hospital clinical staff and transfusion laboratories, hospital transfusion committees, regulatory agency and national health authorities. It should include identification, reporting, investigation and analysis of adverse events near-misses and reactions related to transfusion and manufacturing.

There should be traceability (document trail) from the blood donor and blood unit to the recipient of the transfused blood or blood product, and vice versa, to enable adverse events and reactions to be investigated and corrective action taken to minimize the potential risks associated with safety and quality in blood processing and transfusion. It should be voluntary and non-punitive. Staff and organizations should be encouraged to report adverse events and near misses that may affect blood product quality and safety and other safety concerns related to blood transfusion.

WHO response

WHO Blood Transfusion Safety (WHO/BTS) programme organized a Global consultation on universal access to safe blood transfusion, to coincide with the global launch of World Blood Donor Day in June 2007 in Ottawa, working in collaboration with the Public Health Agency of Canada, Health Canada, Canadian Blood Services and Héma-Québec.

• Global consultation on universal access to safe blood transfusion

Following this consultation, WHO/BTS has been working with key programmes in the Public Health Agency of Canada and Health Canada to collaborate on concepts and approaches for the development of such a network.

At the 8^th Global Collaboration for Blood Safety (GCBS) meeting in December 2007 in Geneva, the recommendation was discussed with key international organizations concerned with global blood safety. The GCBS participants agreed on the importance of haemovigilance as a key element in the management of blood safety globally and on the need to establish a global haemovigilance, surveillance and alert network. The GCBS then tasked interested participants and members to convene and participate in a meeting to:

• Identify existing gaps, explore opportunities for collaboration and avoid potential duplication of initiatives for a global haemovigilance network.
• Consider strategies for:
• Local monitoring of complications of donations and transfusions
• International benchmarking of rates of donation and transfusion incidents
• Rapid alert systems.

Collaborative arrangements were discussed with the International Society of Blood Transfusion and the European (now International) Haemovigilance Network to establish an informal collaborative mechanism, as a global committee in the area of haemovigilance. It was agreed that WHO Blood Transfusion Safety programme, Public Health Agency of Canada and Health Canada (Federal Government of Canada), and International Society of Blood Transfusion and the Haemovigilance Network would participate as core agencies of this committee. The goals of this collaborative initiative are:

• To provide an ongoing, international forum to develop and promote global haemovigilance.
• To share information respecting haemovigilance data.
• To function as a forum for dialogue, advice and information gathering.
• To develop and promote standardized global haemovigilance reporting tools.

The main objectives are:

• To work toward improving international and national systems for the identification and assessment of adverse events, risk of infections transmission, existing and emerging threats to blood safety.
• To work toward improving global collection, analysis and sharing of blood surveillance data/information, drawing on data/information from individual nations and organizations in a bottom-up approach.
• To assist blood safety authorities internationally and within nations to deal with the alert/response function for threats to blood safety.
• To identify, assess and share information on best practices in the field of haemovigilance.
• To promote new science, research and knowledge generation in key areas of haemovigilance.
• To work to encourage knowledge transfer respecting haemovigilance to developing countries.
• To assist in the provision of technical assistance concerning haemovigilance to developing countries.
• To explore development and distribution of related communication and educational materials.