Current practices in donor selection and protection across european countries and suggestions for improvement-the case of blood and plasma

Abstract

Background: TRANSPOSE-TRANSfusion and transplantation PrOtection and SElection of donors is a European consortium project, including partners from 16 countries, that reviews donor selection and protection policies for blood, plasma, tissues, assisted reproductive technology (ART) and stem cells (together SoHO). Donor selection criteria (DSC) in Europe are based on EU-directives, guidelines and countries' own additional criteria. Literature shows that particular criteria are outdated or not risk-based, often leading to unnecessary donor deferral or an underestimation of risks for donors. Aim(s): To 1) provide a comprehensive inventory of current systems for selection and protection of donors and donations, 2) critically review them and 3) recommend an over-arching Donor Health Questionnaire (DHQ) including all necessary criteria currently used by different EU-Member states (EU-MS). Method(s): In-depth semi-structured interviews with key stakeholders in blood collection were conducted to identify main topics for improvement in the current DSC. These formed the basis for a survey sent to professionals from collection institutions of all SoHO to get feedback on current systems from as many EU-MS organisations as possible. Questionnaires were sent to a total of 163 experts (40 blood; 40 plasma; 27 tissues; 47 stem cells; 9 ART) and 39 (24%) completed questionnaires were received. Where information was lacking, additional experts were asked to recommend upon DSC. Result(s): For blood and plasma donation four main areas of concern in DSC were identified: risk-based selection, adaptability, flexibility and consistency. The stakeholders agreed that DSC are often outdated and lack evidence, hence leading to unnecessary deferral of donors and underestimated risks for donors. They suggested to base DSC on group risk-assessment (risk-based selection) and on conducting more research to achieve standardized risk perceptions and evidence-based deferrals, either for safety of recipient or donors. Criteria could be made more detailed to fit specific groups to defer less donors (adaptability). Furthermore, implementing criteria was considered easy, but abolish criteria when not regarded as a risk anymore seems almost impossible (flexibility). Additionally, deferral periods are perceived too long, seen as both negative, i.e. jeopardizing donor return intention and positive, i.e. no risk for safety (consistency). Changing legislation into guidance was an often-mentioned suggestion to improve DSC. Specific feedback on plasma donations revealed that many whole blood topics are not applicable to plasma-only donors, e.g. parasite infections such as malaria (no deferral needed); travel history (no deferral needed), and recent bacterial and viral infections (deferral periods currently too long). A clear need for more research on plasma collection-related issues was identified. Summary/Conclusions: DSC are perceived redundant on a substantial number of aspects by most stakeholders. Besides achieving the goal of save and sufficient SoHO for patients, many regulations could be improved to diminish deferrals and decrease donor risks. TRANSPOSE will add to reviewing, improving and harmonising these regulations and criteria. Furthermore, TRANSPOSE will provide suggestions to improve directives and guidelines and a DHQ, focusing on both donor health protection and safety of donations, but also removing deferral criteria that are not relevant (anymore), and offer a future research agenda to make DSC more evidence-based.