October 18, 2023
With requests for directed blood donations on the rise, partially due to patients and their families objecting to receiving blood from donors vaccinated against COVID-19, how can clinicians use ethical principles to evaluate such requests and create policies accordingly?
A Monday afternoon session, “Directed Donations and COVID-19 Unvaccinated Donors: Ethical Framework and Practical Considerations,” highlighted how blood suppliers may handle these requests for directed donations and blood from COVID-19-unvaccinated donors and how these requests affect the utilization of scarce resources.
The session began with three audience participation polling questions; they gauged the attendees’ institutions’ willingness to accommodate requests for directed donations and the attendees’ ethical concerns about directed donation for non-medical reasons? Tellingly, responses to the ethical concerns question included 23 respondents saying no and 77 saying yes.
Nabiha Huq Saifee, MD, PhD, then opened with two examples of blood safety concerns driving legislation: proposed Montana House Bill 645, which recommended fines for donors and distributors for knowingly donating blood or tissue after getting an mRNA vaccine, and proposed Senate Bill 531, which would give individuals the right to have a blood transfusion from an unvaccinated blood donor when practicable. Such legislation is nothing new; the 1990 Paul Gann Blood Safety Act in California mandated that patients be informed of the risks and alternatives of blood transfusions.
From a hospital’s perspective, directed donation requests bring additional cost from the blood supplier, increased wastage/outdate of directed products, no decrease in infectious disease risk, loss of donor confidentiality if the directed donor is deferred, pressure on directed donors that may lead them to omit information on the Donor History Questionnaire, an increased risk of alloimmunization or transfusion-associated graft-versus-host disease, an increased administrative burden and an increased risk of mis-transfusion from the non-standard work. At Saifee’s hospital, the decision was made to reserve directed donations only for medical indications.
A Directed Donor Program
Emily Coberly, MD, described the American Red Cross’s (ARC) directed donor program, stating that it requires more time and resources than standard collections, but may be an important option for patients with specific transfusion needs. They noticed a quadrupled spike of directed donation requests in early 2022; based on the amount of phone calls they received during this time asking about unvaccinated blood, the spike was likely due to vaccinated blood fears. This rapid and large increase strained internal resources and delayed scheduling for all directed donors.
One of the pillars of the ARC is neutrality and impartiality, something that is difficult to maintain in an era when vaccines have become increasingly political. Coberly said that her facility wondered if they should at least prioritize orders that did have a medical need, if not fully prohibit orders when they knew the underlying motivation was a desire for unvaccinated blood. “If we make a policy about this, are we making a political statement?” she asked.
Even pre-pandemic, some directed donation orders did not have a medical basis. “Are we going to pull out only COVID-19 unvaccinated requests?” Coberly asked. “Where do you draw that line? What is the place where we can say we’re not going to accept your reason that isn’t medical, but we will accept your reason that also isn’t medical?”
The struggle was how to keep directed donation requests at a manageable level but do so in a sensitive way that is fair to everyone. The measures ARC took to reduce directed donations for unvaccinated blood centered mostly on education. Leaders from ARC wrote a script for their special collections staff to use when having conversations with patients, physicians, clinical staff and others, letting them know that it was safe to use blood from the general blood supply. They posted the “Joint Statement: Blood Community Reiterates the Safety of America’s Blood Supply for Patients” on their website and shared AABB’s “Vaccination and Blood Donation” flyer with ordering doctors. They also, where unvaccinated blood was the suspected reason for an order, had orders go through their regional medical director, who then called the ordering physician to have a conversation, doctor to doctor, to provide them with resources to educate their patient.
While the impact of these measures is unclear, because direct donation orders had already declined significantly by this point, Coberly noted that there are multiple drivers of non-medical directed donations, separate from requests for unvaccinated blood. She found that subsequent spikes in direct donations correlated with general inventory shortages; when inventory is stable, directed donation orders return to the pre-pandemic baseline.
Ethical Considerations
Mithya Lewis-Newby, MD, MPH, described ethical considerations when navigating requests for directed donations and educated the audience on how to not only apply ethical theories to the challenges posed by directed donations but also formulate an ethical recommendation for if or when these requests should be accommodated.
She noted that while avoidance of COVID-19-vaccinated blood is a big reason for directed donations, there is also a general concern for the safety of the blood supply and an interest in bypassing blood supply shortages. Unfortunately, some requests stem from wanting to avoid receiving blood from donors of particular races, sexual orientations or other characteristics.
Lewis-Newby carefully discussed the ethical considerations of benefits, costs and burdens, safety and efficacy, the reasoning behind requests, equity, impact on others, legal requirements and moral duties. Weighing all these considerations, her final ethical recommendation was that directed donation should be limited to medical necessity only and individuals at all levels of the blood supply and utilization chain remain responsible for the ethical considerations of directed donations.
Two more audience polling questions were asked: “After this session, do you have ethical concerns about directed donation for non-medical reasons?” The response was that 88 said yes and 22 said no. For the “Do you think requests for directed donation for non-medical reasons should be accommodated?” question, 14 said yes, 86 said no and 18 said that it should sometimes be accommodated.