DONOR INFECTIOUS DISEASE TESTING 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) Sheila J. Ward, 1 Susan L. Stramer, 2 and Zbigniew M. Szczepiorkowski 3 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. THE NEW DECISION-MAKING PARADIGM ENVISIONED FOR BLOOD SAFETY T he risk-based decision-making (RBDM) framework is an outcome of an international consensus conference sponsored by the Alliance of Blood Operators (ABO) 1 to address the increasingly unsustainable pursuit of “zero-risk” blood products. The con- sensus panel concluded that risk is inherent “vein to vein,” zero risk is unattainable, and the well-being of transfusion recipients must be central to blood safety decision making. 2 The RBDM framework is designed to improve decision mak- ing, facilitate proportional responses to risk, ensure that deci- sions are evidence-based, increase trust in investment decisions, and allow for redirection of resources to improve effectiveness. RBDM has been used by blood operators in many parts of the world including Australia, Canada, Ireland, the United Kingdom, and Singapore, to formulate decisions that address blood safety, donor safety, and security of supply decisions. 2 This article reviews the various stages of RBDM as applied to the issue of transfusion-transmitted babesiosis (TTB) and its interventions. As such, this is the first applica- tion of RBDM in the United States. ABBREVIATIONS: ABO = Alliance of Blood Operators; RBDM = risk-based decision-making; QALY = quality-adjusted life-year; TTB = transfusion-transmitted babesiosis; TTD = transfusion-transmitted disease From 1 Canadian Blood Services, Ottawa, Ontario, Canada; 2 Scientific Affairs, American Red Cross, Gaithersburg, Maryland; and the 3 Department of Pathology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire. Address reprint requests to: Susan L. Stramer, PhD, Scientific Affairs, American Red Cross, 9315 Gaither Road, Gaithersburg, MD 20877; e-mail: susan.stramer@redcross.org. Received for publication June 27, 2018; revision received July 20, 2018; and accepted July 29, 2018. doi:10.1111/trf.14912 © 2018 AABB TRANSFUSION 2018;58;1916–1923 1916 TRANSFUSION Volume 58, August 2018