Versiti Blood Centers Indianapolis, Indiana, United States
Background/Case Studies: An FDA guidance issued in May of 2022 removed geographic deferrals for variant Creutzfeldt-Jakob disease (vCJD), allowing previously deferred donors to be eligible. The objective of this analysis was to identify how many previously indefinitely deferred donors would be eligible for reentry with the goal to notify and recruit these donors back to the donor pool.
Study
Design/Methods: A list of donors eligible for reentry was compiled using the Blood Establishment Computer Software (BECS) systems at four affiliated blood centers in the Midwest. Complications encountered in the review included differences among centers in deferral practices in respective BECS systems and question/answer algorithms in electronic health history interview systems. This was further complicated by data located in the current BECS as well as multiple legacy systems since screening began over 23 years ago. Once the deferred donor data was compiled, donors with deferrals for reasons other than vCJD were removed from the list. Then, deferrals recorded prior to the 1999 guidance, pertaining solely to classic CJD, were removed. Finally, deferral visits with the generic code of “CJD/vCJD” were further investigated, and those that were not specific to vCJD were removed. The intent was to send a targeted communication via mail to the donors previously deferred for vCJD risk. Barriers were subsequently identified which could impede the mailing communication e.g., donors may have relocated, expired etc. Accordingly, a more targeted approach was taken excluding donors over age 65 and those who last presented greater than 10 years ago to maximize efficiency and reduce mailing costs. Mailings were prioritized according to blood type: first Group O and Rh-negative donors, followed by Rh-positive, and lastly those with unknown type.
Results/Findings: Over 20,000 donors indefinitely deferred due to vCJD risk were identified as eligible for reinstatement. Notification began in February and will continue until all donors are notified. As of 4/30/2023, 4627 donor letters had been sent and 118 (2.6%) previously deferred donors presented to donate. This group included all donors of known type. The project is ongoing with notification of potentially eligible donors of unknown type expected to be completed by the end of July 2023, after which total eligible donors returning can be assessed. Conclusions: A large population of donors previously deferred per vCJD guidance and now potentially eligible was identified. Doing so enabled the recapture of donors and enlarged the eligible donor pool, further enhancing the blood supply.
Importance of research: Analyzing historical data may not be as simple as querying a static data base. It can be complex and time consuming. In today’s reality of fewer eligible donors willing to donate, changing guidance can lead to previously deferred donors being eligible. Finding these donors, who have proven their desire to help in the past, can lead to an increase in the eligible donor pool; ultimately securing more blood for patients in need.