Assessing the risk of Babesia to the United States blood supply using a risk‐based decision‐making approach: Report of AABB's Ad Hoc Babesia Policy Working Group (original report)

Abstract

Recognizing the increasing threat of transfusion-transmitted babesiosis to the US blood supply, the AABB Board of Directors tasked an Ad Hoc Babesia Policy Working Group (the Working Group) to use the Alliance of Blood Operators' risk-based decision-making (RBDM) framework to assess the risks and benefits of introducing Babesia donation testing in the United States. The regional nature of the Babesia microti risk added complexity to the RBDM assessment because of the unique operational and financial considerations for operators and hospitals located in endemic states. Therefore, the assessment considered safety, product availability, sector sustainability, and technology availability. After assessing safety risk, economic and operational impact, reimbursement equity, ethical considerations, and stakeholder feedback from two consultations, the Working Group concluded that a regional approach to donor screening in endemic states was appropriate because it applied the intervention where the risk was highest and appropriately allocated cost to the risk. Nucleic acid testing using a ribosomal RNA template was the recommended intervention because it was the most cost-effective, resulted in no wasted units, and captured similar numbers of infections as antibody plus DNA-based polymerase chain reaction. The current model for blood reimbursement was maintained but AABB was encouraged to facilitate collection of data to identify threats to sector sustainability in endemic states. Babesia expansion was acknowledged with a mechanism to regularly reevaluate what are "endemic states." Finally, given that public awareness of the Babesia threat is the first line of defense, AABB should work with appropriate agencies for general education about the health risk from B. microti.

Risk‐based decision making: a good start to aiding US blood policy decisions?

“…Despite AABB's significant effort in applying the RBDM framework to the risk of Babesia , the resulting report highlights several challenges that AABB should address as it refines the use of this important tool, including: 1) appropriate communication and timeliness for releasing recommendations, 2) the need for a formal mechanism to update reports and recommendations as new technologies and information become available, and 3) the use of the RBDM framework to inform decision makers with variable risk tolerance in a competitive market. Importantly, AABB seeks feedback from its membership and other stakeholders on the RBDM process and the recommendations of the Babesia Report …”

“…Cases of transfusion‐transmitted B. duncani have been reported in the United States in nonendemic states such as Washington and California, and possible B. divergens ‐like/MO‐1 has been reported in Arkansas . The Babesia Report recommends NAT‐only testing, while the recently released FDA draft guidance recommends NAT and antibody screening . As more data become available and additional assays are FDA approved, the recommended testing algorithms will change.…”

“…The Babesia Report, taken in conjunction with the FDA Draft Guidance, highlights the lack of consensus around which states should be treated as Babesia ‐endemic or as Babesia ‐risk states . The known map of B. microti incidence is expanding .…”

“…AABB is to be commended for engaging in its first exercise utilizing the risk‐based decision‐making (RBDM) framework. In 2016, AABB's Board of Directors tasked the Ad Hoc Babesia Policy Working Group to use the Alliance of Blood Operators (ABO) RBDM framework in assessing the risks and benefits of Babesia microti blood donation screening of the US blood supply . Through this exercise, AABB and the broader blood community can work together to identify the strengths, weaknesses, and potential modifications to the RBDM framework to improve its utility for AABB and its membership.…”

“…Through this exercise, AABB and the broader blood community can work together to identify the strengths, weaknesses, and potential modifications to the RBDM framework to improve its utility for AABB and its membership. In this issue of TRANSFUSION , Ward and colleagues present the recommendations of the Working Group (the “ Babesia Report”) based on the RBDM framework. The group's primary conclusion is that a regional approach—screening donors for Babesia in endemic states only—is appropriate as it targets the intervention to where the risk is highest and makes the best use of limited resources.…”