How donor selection criteria can be evaluated with limited scientific evidence: lessons learned from the TRANSPOSE project

Abstract

Background and objective Donor selection criteria (DSC) are a vital link in the chain of supply of Substances of Human Origin (SoHO) but are also subject to controversy and differences of opinion. Traditionally, DSC have been based on application of the precautionary principle. Materials and methods From 2017 to 2020, TRANSPOSE (TRANSfusion and transplantation PrOtection and SElection of donors), a European research project, aimed to identify discrepancies between current DSC by proposing a standardized risk assessment method for all SoHO (solid organs excluded) and all levels of evidence. Results The current DSC were assessed using a modified risk assessment method based on the Alliance of Blood Operators’ Risk‐based decision‐making framework for blood safety. It was found that with limited or diverging scientific evidence, it was difficult to reach consensus and an international standardized method for decision‐making was lacking. Furthermore, participants found it hard to disregard their local guidelines when providing expert opinion, which resulted in substantial influence on the consensus‐based decision‐making process. Conclusions While the field of donation‐safety research is expanding rapidly, there is an urgent need to formalize the decision‐making process regarding DSC. This includes the need for standardized methods to increase transparency in the international decision‐making process and to ensure that this is performed consistently. Our framework provides an easy‐to‐implement approach for standardizing risk assessments, especially in the context of limited scientific evidence.

How do I think about blood donor eligibility criteria for medical conditions?

“…Variability of international practice for underlying medical conditions underscores the paucity of data around risk in these conditions. 1,8,9 Product quality may be impacted by hematologic conditions in the donor, such as hereditary spherocytosis, that result in greater hemolysis of RBCs during storage. Medications such as anticoagulants and antiplatelet agents may affect the quality of plasma and platelet components, respectively.…”

“…International regulatory requirements or standards and published international studies can provide information about what is happening in other countries. 1,8,9,[15][16][17][18] Many organizations such as the Joint United Kingdom Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee (JPAC), which determines donor eligibility policies in the United Kingdom, Australian Red Cross Blood Service Lifeblood, the American Red Cross, and the New York Blood Center have detailed alphabetical lists of their criteria available online. [19][20][21][22][23] International colleagues are often very willing to share their approach and issues related to their own policies.…”

“…International studies such as the European TRANSPOSE initiative and the Biomedical Excellence for Safer Transfusion Collaborative (BEST) demonstrate the variability in international practice, suggesting that there is often more than one way to think about an eligibility issue (and unfortunately probably not much science supporting practices). 1,8,9 Epidemiologic studies on risk factors for a given condition can be helpful in determining the possible role of transfusion in disease transmission. The strongest data are provided by studies that link transfusion databases with donor and recipient illness and mortality databases.…”

Blood donor eligibility criteria for medical conditions: A BEST collaborative study

“…Some aspects of donor eligibility are based on requirements set by regulatory agencies that are variably amenable to change, depending on the jurisdiction. Although, ideally, the criteria should be evidence-based, in practice, there is often scant evidence available, and it is not obvious how to obtain such evidence in a regulated blood collection environment [1][2][3][4]. As a result, donor eligibility rules vary between blood centres, even within similar regions, depending on judgement or experience of the individual blood centre's medical leadership.…”

The new donor vigilance system in Denmark reveals regional differences in adverse reactions supposedly caused by variation in the registration

“…In recent years, there has been increasing work to align the donor vigilance systems in Europe and the rest of the world in order to improve donor safety. The International Society of Blood Transfusion's (ISBT) haemovigilance network [7–10], as well as large consortium projects [11], have worked towards proposing guidelines for a common international system aiming to improve the quality of the data collected, including within donor safety and health.…”