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suitability for blood donation is to guide and support countries in establishing effective national systems for blood donor selection, including policies, guidelines and criteria in order to ensure the safety of the recipients of blood and blood products and protect donor health and safety. Objectives These guidelines are intended for use in countries which have not yet established national systems for blood donor selection or which are in the process of developing or revising donor selection guidelines and criteria. The specific objectives are to: 1 Provide guidance on the measures needed to develop and implement effective systems for assessing the suitability of individuals to donate blood. 2 Review the available evidence base and provide recommendations on criteria for blood donor selection. The donor selection criteria recommended in these guidelines apply to donors of whole blood, red cells, platelets, plasma and other blood components, donated as whole blood or through apheresis, including plasma for fractionation. These include a) criteria that have worldwide applicability and should be applied uniformly, and b) criteria that require local adaptation in the light of epidemiological data, demography, the health of the population, the screening and confirmatory tests performed and the available technology. Whilst these guidelines are designed to promote best practice in blood transfusion services to ensure the collection of donations from the lowest risk donors possible, consideration should always be given to the issue of sufficiency, balancing any risk of infection against the risk of blood shortages resulting from the development of too stringent national guidelines. Infectious risks are not the same in all countries, or even within individual countries, and it is crucial that selection guidelines are developed according to the circumstances and needs of each country. 18 1.3 TARGET AUDIENCE The target audience includes personnel and representatives from the following institutions and organizations: n National blood programmes in ministries of health n National advisory bodies responsible for policy making on blood safety, such as national blood commissions or councils n Blood transfusion services, including directors, medical officers, blood donor managers, quality managers, donor care staff responsible for blood donor selection, laboratory managers and other staff n Public health institutions n Reference laboratories n Regulatory agencies n Blood donor organizations and other nongovernmental organizations and institutions involved in blood donor education and recruitment n Professional societies and patient associations. These guidelines may also be useful for other relevant stakeholders such as education and training institutions, transplantation services, plasma collection and fractionation facilities and disease prevention programmes focusing on infections such as HIV, hepatitis, malaria and Chagas disease. 1.4 METHODOLOGY In 2009, the WHO Blood Transfusion Safety programme scoped the guidelines to define the content and assess the topics on which recommendations on blood donor selection were required. It identified three key questions to be addressed: 1 What are the components of an effective national system for assessing the suitability of prospective donors to donate blood? 2 What are the criteria for the acceptance or deferral of prospective blood donors to avoid blood donation by unsuitable individuals in order to protect the health and safety of recipients of transfusion and ensure patient safety? 3 What are the criteria for the acceptance or deferral of prospective blood donors to protect donor health and safety while avoiding the unnecessary deferral of suitable donors? WHO/BTS convened a guideline development group (GDG) whose members were selected on the basis of their specialist expertise in haematology, transfusion medicine and blood donor management (refer to Acknowledgements) (16). The role of the GDG, in conjunction with WHO/BTS, included identification of priority questions and outcomes; retrieval of the evidence; assessment and synthesis of the evidence; identification of issues that are controversial or where change of practice is recommended; review of internationally-recognized guidelines and current practices worldwide; formulation of recommendations; preparation of the text; and planning for the dissemination, implementation, impact evaluation and updating of the guidelines. WHO/BTS also established an external review group (ERG) comprising members of the WHO Expert Advisory Panel on Blood Transfusion Medicine and experts from WHO Collaborating Centres in Transfusion Medicine as well as directors of national blood

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