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of evidence-based medicine (EBM) to transfusion medicine (10,11,18,19), the randomized controlled trial, the major tool of EBM, cannot apply to donor selection, and there are few directly relevant published clinical, epidemiological and observational studies, systematic reviews and audits on criteria for blood donor selection. Many long-established donor selection criteria are based on medical knowledge of the disease process and human physiology, the haemodynamic effect of blood donation and the potential for harm to either the donor or the recipient. In general, acceptance criteria specify conditions in which there is no or minimal risk to donor or recipient, based either on published evidence of safety from observational studies or on general medical principles. Deferral criteria are based almost entirely on general principles aimed at minimizing any risk to the donor or recipient. Evidence is rarely available because observational studies of blood donation in many such conditions would be unethical. Given the paucity of the evidence on donor selection criteria, formal assessment of the quality of evidence to support the recommendations was undertaken only for three topics, because of their controversial nature, discrepancies between international guidelines or the potential impact of a change of practice on the blood donor base, i.e. individuals with a history of epileptic seizures; men who have sex with men (MSM); and injecting drug users. Key citations that had important and relevant information on these topics were analysed for the quality of evidence, using the GRADE system (http://www. gradeworkinggroup.org) that considers factors such as study design, quality, consistency, directness and precision to assess the quality of the collected evidence. Summaries of evidence tables were made to assist in the development of recommendations on these topics. Where published evidence is lacking, recommendations on donor selection criteria are based on international best practice and the medical knowledge and expertise of members of the guideline development group and external review group. In conditions where emerging evidence suggests that deferral criteria may be relaxed, a precautionary approach is recommended until good evidence of safety becomes available. 21 Recommendations The document is presented in two parts. Part 1 (Sections 2 and 3) addresses the requirements for an effective national system for blood donor selection; policy recommendations are provided on pp. 12. Part 2 provides guidance on specific criteria for blood donor selection in relation to general donor assessment, donor medical history and TTI risk assessment; technical recommendations on donor selection criteria are summarized on pp. 13–22 and elaborated in Sections 4 to 7. Review and updating of the guidelines It is anticipated that the guidelines will remain valid until 2017. The WHO Blood Transfusion Safety Team will be responsible for initiating a review of the document at that time. Part 1 National system for blood donor selection 23 2 Establishing a national system for blood donor selection The selection and management of blood donors is an essential part of the blood donation process. National health authorities and blood transfusion services are responsible for ensuring that a national system is in place for the selection of all blood donors through an assessment of their suitability to donate blood. The national system for blood donor selection should include: n National policy and legislative framework n National guidelines and criteria on blood donor selection n Public information and donor education n Suitable infrastructure and facilities n Adequate financial and human resources n Quality system, including standard operating procedures, documentation and records n Donor haemovigilance n Monitoring and evaluation. 2.1 NATIONAL POLICY AND LEGISLATIVE FRAMEWORK Every country should have a national blood policy that defines the strategies for blood donor recruitment, selection, deferral, blood screening for TTI, confirmatory testing, donor notification, counselling and referral. The national blood policy should be supported and enforced by a legislative and regulatory framework and implemented through national guidelines. The legislative framework should define the fundamental principles and ethics of blood donation and donor selection. It should address the responsibilities of the BTS in: n Protecting the health and safety of blood donors and ensuring confidentiality, privacy, self-determination and non-discrimination n Protecting the health of recipients of blood and blood products and ensuring the safety, quality and availability of blood and blood

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