Impact of the April 2020 FDA blood donor eligibility changes on a hospital-based donor center

Background/Case Studies: The COVID-19 pandemic remains a threat to the blood supply due to decreased collections because of lockdowns and physical distancing practices. In April 2020, the U.S. Food and Drug Administration (FDA) changed blood donation eligibility with respect to risks related to blood borne diseases, variant Creutzfeldt-Jakob disease (vCJD) and travel exposures. We examined the impact of these changes on donations at our hospital-based blood center. Study Design/Methods: From implementation of the FDA changes on June 25, 2020 through March 2021, donors were given a voluntary survey to determine whether their eligibility was affected. Specifically, we assessed how many donors would have been previously deferred, but could now donate. Donors could identify which change allowed them to donate: blood borne infection risk, vCJD risk, and/or travel/malaria risk. Donors could also decline to elaborate. The survey was implemented as a quality improvement initiative. We counted how many blood products were collected from these donors and compared deferral rates between July 2019-June 2020 and July 2020-March 2021 by Poisson test (R 4.0.5). Results/Findings: The eligibility changes positively impacted donor acceptance. Overall deferral rate decreased from 293.2 to 224.6 per 1,000 donors between the time periods (see Table). During the survey period, 2569 donors were evaluated;1577 whole blood and 560 platelets were donated. Sixty-nine responses from 55 donors indicated that they became eligible under the new criteria: blood borne infection risk (n=11), vCJD risk (n=26), travel/malaria risk (n=30) and no answer (n = 2). Only one of these donors had a positive infectious disease test (anti-HBc). These donors provided 44 red blood cell units, 40 plasma units and 31 apheresis platelet units. Deferral rates also declined for screening criteria that had not been updated by the FDA. Conclusions: Since June 25, 2020, deferral rates at our blood center have decreased. The FDA eligibility changes had an impact. In total, 55 donors (41 first-time) reported being eligible with the new rules. Their donations helped support our patients during the pandemic. The lower deferral rate overall suggests behavior changes related to the COVID-19 pandemic (lockdowns, business restrictions, and border closures). This may have decreased the number of first-time donors especially, leaving proportionally more returning donors. (Table Presented).