Terms of Reference
OBJECTIVES
Haemovigilance is defined as ‘a set of surveillance procedures covering the whole transfusion chain from the collection of blood and its components to the follow-up of its recipients, intended to collect and assess information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products, and to prevent their occurrence and recurrence’.
The haemovigilance working party will work on the following main areas.
A. To develop the different elements to be included in haemovigilance
• Haemovigilance will cover events surrounding the whole chain from blood donation to the transfusion of donor blood components
• Aspects of all different autologous techniques, including donation, will be included
• Encouragement to report new types of adverse outcome associated with transfusion, even if they do not fall within recognised types of transfusion reactions. This is particularly critical at a time when new types of component are emerging eg pathogen inactivated components, or when procedures such as leucocyte depletion are being performed on an extremely large scale
• Encouragement of ‘no-fault’ reporting so that inherent weaknesses in the transfusion chain can be rectified without fear of disciplinary action
• Donor haemovigilance and hazardous events in donors will be included in this framework
• Recognition that epidemiology of infectious diseases in donors is an important part of haemovigilance
• Recognition that appropriate blood usage is an element contributing to overall transfusion safety
• Recognition that vigilance extends to reagents and materials used in the blood transfusion chain
• Recognition of common goals and methodology and need for close links with the vigilance of cells, tissues and organs (“biovigilance”).
B. To help standardize data elements
• Develop standard definitions of complications of blood donation and adverse transfusion events
• Create new categories of events to be reported as deemed necessary
• Develop diagnostic criteria for aspects relevant to surveillance of adverse events and reactions, along with flow charts or other tools for their assessment
• Identify denominator data to be used to calculate incidence of adverse events
• Provide framework for data reporting at an international level.
C. To be a source of information and guidance for countries setting up new haemovigilance systems, including:
• Sample documentation
• Access to expert advice
D. To collaborate with the International Haemovigilance Network
• Support and contribute to the exchange of information between countries on the operation of different types of haemovigilance systems, and on the results
• Recognition of the need for arrangements for ‘rapid alert’ networks in the case of emergence of new infectious or non-infectious transfusion complications.
E. To be a partner to other ISBT working parties involved in improving quality and safety of the blood donation process and clinical transfusion
•Shared discussion on data elements
•Expertise in surveillance.
WORKING PARTY ORGANISATION
Membership and attendance at meetings
Membership is open to individual ISBT members with an interest and practical involvement in haemovigilance as defined above. Voting is limited to members of the working party. Other people may attend the meetings as observers with the agreement of the working party committee, but may not vote.
Administrative structure
The working party has a committee with an elected chairperson and secretary. These posts are to be filled by election among the working party members after (email) announcement. The president of the International Haemovigilance Network is an ex-officio member of the committee. The chair and secretary may propose up to two further members of the committee whose chief tasks will be assist in planning the annual meeting and ensuring that the activities are as thematically and geographically representative as possible. One member of the committee shall coordinate the working party’s activities in the area of donor haemovigilance. The role of treasurer is to be fulfilled by mutual agreement within the committee. These proposals are to be made at the annual meeting; in the event of counter-nominations an election procedure will be followed as above.
Members fulfilling a post on the committee may serve for a term of up to four years after which they may stand for re-election once only.
Annual meeting
The annual meeting of the working party is held during or in the days preceding the international or Europe-Middle East regional ISBT congress. The secretary prepares an agenda and ensures that minutes are kept and circulated to all members.
During the meeting there will also be reports and discussion of ongoing working party projects and relevant projects of working party members.
During the annual meeting a financial report is presented for approval by members. The terms of reference and organisational rules should be reviewed and updated every four years, or more often if necessary. These documents are to be approved at the annual meeting.
Accountability
The working party submits the annual financial reports and any revision of the terms of reference to the ISBT Board. The (draft) minutes of the annual meeting are forwarded to the ISBT Board by way of information on activities and outputs, and an annual report will be made for inclusion in the ISBT annual report if this is requested.
