Original article

Blood Transfusion - 2 2019 (March-April)

Malaria blood safety policy in five non-endemic countries: a retrospective comparison through the lens of the ABO risk-based decision-making framework

Authors

Key words: malaria, policy decisions, selective testing, deferral
Publication Date: 2019-02-06

Abstract

Background. In non-endemic countries, malaria risk is addressed by selectively testing or deferring at-risk donors. These policy decisions were made using a variety of decision-making frameworks prior to the development of the Alliance of Blood Operators Risk Based Decision-Making Framework. It is unclear whether the range of items assessed in the decision-making process would be increased if the Framework were used. We compared assessments considered in France, England and Australia for decisions to implement selective testing, plus donor selection criteria (Canada and the USA included) with those recommended by the Framework.
Materials and methods. Elements of the Framework were identified: the intervention, safety threat, availability threat, donor impact, financial implications, risk communication, stakeholder and regulatory aspects. Decisions about selective testing and donor selection criteria were analysed separately. Assessments were compared against elements of the Framework and the level of concern for considerations rated.
Results. Sufficiency of the blood supply (plus safety in France) were the drivers for selective testing; main trade-offs were high operational impact and cost. In three donor criteria examples, transfusion-transmitted malaria cases prompted the change. Social concerns were high in France and Australia, political/regulatory concerns influenced decisions in France, Australia and Canada, while sufficiency was a consideration in Canada and the USA. Decision trade-offs involved moderate operational impact.
Discussion. The assessments considered in each country were generally consistent with the assessments recommended by the Framework. When data supported quantified risk assessment, safety and operational feasibility had the greatest weight. When risk was not well defined, contextual factors such as social and political concern had greater weight

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Authors

Sheila F. O'Brien - Epidemiology and Surveillance

Sheila Ward - International Collaboration and Corporate Secretariat, Canadian Blood Services, Ottawa, Canada

Pierre Gallian - Etablissement Français du Sang Provence Alpes Côté d'Azur et Corse, Marseille France

Cécile Fabra - Etablissement Français du Sang, La Plaine Saint-Denis, France

Josiane Pillonel - Infectious Diseases Division, Santé Publique France, Saint Maurice, France

Alan D. Kitchen - National Transfusion Microbiology Reference Laboratory, NHS Blood and Transplant, London, United Kingdom

Katy Davison - Blood Safety, Hepatitis Sexually Transmitted Infections (STI) and HIV Division, National Infection Service, Public Health England, London, United Kingdom

Clive R. Seed - Donor and Product Safety Policy Unit, Australian Red Cross Blood Service, Perth, Western Australia

Gilles Delage - Medical Affairs, Microbiology Héma Québec, St Laurent Québec, Canada

Whitney R. Steele - Scientific Affairs, American Red Cross, Rockville, MD, United States of America

David A. Leiby - Division of Emerging and Transfusion Transmitted Diseases, FDA, Silver Spring, MD, United States of America

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