The wait list for deceased donor kidneys is tightly regulated and controlled, but recent years have seen a rise in so-called “out-of-sequence” allocation — kidneys given to candidates outside of the wait-list system, ostensibly to expedite the placement of organs at risk of non-use.
But does allocating organs out of sequence affect the equity inherent in the wait-list system? And more importantly, will the perception that some recipients are able to bypass the wait-list system due to their social or insurance status erode trust, resulting in fewer people signing up to be organ donors?
Tracking the data
It’s a hot topic in the world of transplant surgery, and it’s one that Jesse Schold, PhD, professor of transplant surgery in the University of Colorado Department of Surgery, addresses as a co-author of a recent research letter published in the journal JAMA Internal Medicine.
“The concern is that, while everyone is trying to help patients get transplanted, these out-of-sequence allocations leave open the possibility that we can transplant patients who we think are best, but it’s not governed by any sort of transparent policy, and therein lies a possibility for biases that could be variable between different transplant centers or different caregivers,” Schold says. “What we found in the research paper was that there were systematic differences in the candidate characteristics who received these organs. Whether or not that is clinically appropriate is debatable.”
In the letter, Schold and his fellow researchers find that the number out-of-sequence transplants increased from 2.2% of all deceased donor kidney transplants in 2020 to 15.7% of all such transplants in 2023. Recipients tended to be older, be male, be a race other than white, have private insurance, and have received no pretransplant dialysis. The out-of-sequence kidneys also tend to be of lesser quality.
“There may be underlying characteristics as to why those patients received those organs at that particular time, but it's something that we have to recognize is a potential problem, and it's also something that government regulators have taken a lot of interest in in the past year or so,” Schold says. “It's something that is being critiqued right now in our system.”
Increased pressure on OPOs
The increase in out-of-sequence transplants, Schold says, is associated with new federal scrutiny on organ procurement organizations (OPOs) — the entities responsible for organ procurement. Allocation of deceased donor organs then uses an algorithm-derived wait list that takes into account factors such as age, geographic proximity to a transplant site, and severity of disease.
“OPOs were recently issued a new regulation by the Centers for Medicare & Medicaid Services that evaluates them using certain metrics, specifically their donation rate and their transplant rate, meaning that OPOs are being evaluated by how likely they are to procure organs and have them placed for transplant,” Schold says. “If they don't meet these metrics at a sufficient level relative to peer organizations, based on the policy, they can be shut down.”
That pressure, combined with improved methods for using high-risk organs and a new distribution system that puts less emphasis on a recipient’s proximity to a specific transplant center, has resulted in an increase in the number of deceased-donor kidneys procured and distributed across the country, Schold says.
“While these are laudable goals, it has also led to some inefficiencies, meaning there are a lot of organs being shipped all over the country,” he says. “One of the unintended consequences of that has been that more organs have gone unused, despite the fact that they were procured for the purpose of transplant. That is obviously problematic when we're talking about a potentially life-saving organ.”
Hence the rise in out-of-sequence allocations, which often arise when a kidney would otherwise go unused.
“They're just trying to find a home for it, even if it obviates the policies that we've established,” Schold says. “They essentially skipped the allocation policy because they were concerned that the organ wasn't going to get placed, and it wasn't going to provide a benefit to anybody.”
Addressing the issue
The concern about out-of-sequence kidney allocations is that because OPOs are not using a codified process, the way in which organs are being distributed is not being governed by an agreed-upon policy, Schold says, “and it is potentially susceptible to individual biases or the vagaries of individual relationships.
“If nothing else, it's evidence that we need to examine our processes more systematically,” he says. “What we really need is a more codified, transparent way of facilitating these expedited placements. Because the allocation system is complicated and probably in some ways inefficient, we need to have some pathway which everyone agrees upon for these higher-risk organs to be placed, such that we're not losing the potential benefit of the organs and we're respecting the organ donor family’s wishes, but at the same time, we're doing it in a way that everyone is playing by the same rules.”
Multiple government organizations are looking into the issue, including the Health Resources and Services Administration, which has appointed Schold to a task force looking to better understand the drivers of the practice and discussing potential remedies.
“We want to get it right,” he says. “We don't want the whole system to be considered unfair when, at the end of the day, everyone's trying to save people's lives. It's tricky to figure out how to remedy it in a way that is both fair and also benefits the most patients.”
Making it extra-tricky, he says, is addressing the issue in a way that doesn’t raise public concern about the fairness of the organ allocation system.
“All these people's lives would not be saved were it not for the generous gift of all of our donors, so having trust in our system is very, very important,” he says. “Even if there are a few anecdotes that are concerning, if it affects the public’s trust in the system, it can affect people's willingness to consent to being organ donors, which can hurt a large number of patients with end-stage organ disease.”
