Public feedback on the protocol

All feedback, subject to the OPTN Standards for Public Comment, will be posted to this page.

OPTN Kidney Expedited Placement Workgroup | 08/02/2024

Submitted on: 05/30/2024 - The OPTN Kidney Expedited Placement Workgroup (the Workgroup) is sponsored by the OPTN Kidney Committee and consists of representation from the OPTN Kidney Transplantation, OPO, Transplant Coordinators, Ethics, and Operations and Safety Committees. The Kidney Expedited Placement Workgroup thanks the OPTN Task Force’s Rescue Allocations Pathways Workgroup for their work on this protocol and the opportunity to comment. The Workgroup expressed support for ensuring high priority candidates continue to receive offers for KDPI 75-100% organs, but noted that some categories of high priority candidates may not be interested in accepting these types of offers. In particularly, prior living donor and safety net kidney candidates may typically choose to wait for another, lower KDPI offer, based on priority on other match runs. The Workgroup remarked that it is important to appropriately balance providing opportunities for transplant for high priority candidates with efficiency and effectiveness of the expedited placement protocol. The Workgroup shared that, in looking at prior efforts to expedite organ allocation, prioritizing programs that have a demonstrated history of acceptance for those organs is more effective than opt in. One member noted that more aggressive programs should at least be stratified in data analysis to ensure effectiveness of the protocol is captured for those programs. The member added that it is important to consider cold ischemic time when considering whether a transplant program has historically used certain types of kidneys, and that most programs still have an opportunity to accept medically complex kidneys early on in allocation, at least from nearby OPOs. The Workgroup expressed support for the current size of the protocol, noting benefits to flexibility and timing. The Workgroup added that scalability could provide benefit to a greater number of OPOs working to ensure all organs are placed. The Workgroup recommended requiring participating programs to be upfront in their acceptance limitations, particularly regarding what types of post-clamp information would cause them to decline the offer. One member shared that notification of post-clamp information should be more automated to programs, and that more immediate review of that information upon availability would improve overall and expedited allocation. The Workgroup expressed support for ensuring evaluation and preparation requirements for participating programs are clearly outlined and reviewed, particularly as it relates to virtual crossmatching, contacting patients, and offer review. Members agreed that more proactive review by participating programs would support the success of this protocol. The Workgroup offered that it may be important for OPOs and CMS to understand how participating in these protocols may impact performance metrics and evaluation.

Steven R. Potter, M.D., FACS | 08/02/2024

Submitted on: 05/30/2024 - The intent of the proposal is good, but the KDPI threshold of 75% is too low. The proposal as written has the potential to substantially disadvantage waitlisted patients and undermine the fragile public trust in the organ allocation system that the OPTN and the transplant community have iteratively established over decades through a comprehensive, evidence-based, and publicly vetted process. The proposed 75% KDPI cutoff will presumably include well over 25% of the kidneys from the DSAs of the five proposed participating OPOs offered to adult kidney candidates, as many of the KDPI < 75% kidneys will be placed with pediatric recipients, to recipients receiving other lifesaving organs in addition to a kidney, and to broadly sensitized candidates. The 75% cutoff does not correspond with high-KDPI candidate consent, which occurs at an 85% cutoff, or with center practices, which typically do not view kidneys with KDPIs less than 85 as “high-KDPI” kidneys at all. The Protocol as proposed would simply serve as a bypass conduit for massive numbers and overall share of procured kidneys to be placed outside of the standard allocation framework. If the intent is, as stated in policy and the title of the proposal, to accelerate the placement of “hard-to-place” kidneys, then the KDPI threshold or cutoff utilized must be much higher than 75%. If another intent of the Protocol is indeed, as stated in policy, to gain information about best practices and outcomes for decreasing non-utilization, then any post-implementation measurements or metrics will be more valuable if the cohort studied is limited to truly high-KDPI kidneys and thus enriched with those organs that are in fact at markedly elevated risk of discard. Setting the KDPI threshold at 75% belies the stated goals of the policy as envisioned by the OPTN Expeditious Task Force, dilutes the potential value of the observations to be made from the Protocol, and maximizes the risk of inequity to the thousands of wait-listed candidates who will be deprived organ offers through reliance on an expedited pathway for kidneys that would otherwise be transplanted in-sequence through a vetted and transparent allocation process. A KDPI threshold of 90% for this Protocol would mitigate a lot of the equity concerns with the proposal while focusing it precisely on the stated goals of the OPTN Expeditious Task Force. Thank you for the opportunity to contribute

Rob Falb, AOPO | 08/02/2024

Submitted on: 05/30/2024

View attachment from Rob Falb, AOPO

Kimberly Koontz, MPH, CTBS | 08/02/2024

Submitted on: 05/30/2024 - HonorBridge supports this Expeditious task force’s proposal for accelerated placement of hard-to-place kidneys. We have seen an increase in kidney nonuse in 2024 and would appreciate the opportunity to partner in this protocol.

OPTN Kidney Transplantation Committee | 08/02/2024

Submitted on: 05/30/2024 - The OPTN Kidney Transplantation Committee thanks the Expeditious Task Force and Rescue Allocations Pathway Workgroup for their work and the opportunity to comment. The Committee expressed overall support for this initial proposed protocol. The Committee discussed mandatory use of perfusion pumps, and expressed interest in determining whether variation in use of pumps yields critical information about how pump use may impact likelihood of transplant. The Committee also noted support for a model of transplant program selection that is both transparent and accounts for shifting program practices, allowing programs to participate as they become more aggressive. The Committee asked for clarification as to which KDPI would be used to determine the threshold (match KDPI, KDPI at recovery), and noted that it may make the most sense to use match KDPI based on the protocol’s logistics, although KDPI at recovery may be most accurate. Finally, the Committee remarked that it will be important for the Rescue Allocation Pathway Workgroup and Task Force to ensure negative impact to pediatric candidates is avoided or minimized.

Emily Besser, MA, CAE | 08/02/2024

Submitted on: 05/29/2024

View attachment from Emily Besser, MA, CAE

Ieesha Johnson, AMAT, President | 08/02/2024

Submitted on: 05/29/2024 - The Association for Multicultural Affairs in Transplantation (AMAT) broadly supports the OPTN’s initiative to accelerate the placement of hard-to-place kidneys. The proposed protocol for the accelerated placement of kidneys with a Kidney Donor Profile Index (KDPI) of 75 percent or higher is one step in this broader initiative and aligns with AMAT’s goals of ensuring that multicultural communities receive equitable and effective care and outcomes in the transplant system. Multicultural communities are crucial to America’s transplant system, both as donors and recipients, and often face unique challenges. According to recent data from UNOS, approximately 60% of individuals on the national waiting list for kidney transplants—or roughly 54,000 individuals—are from multicultural backgrounds, including African Americans, Hispanics, Asians, Pacific Islanders, and Native Americans. If successful, the proposed protocol will increase kidney placements, thus helping to address the urgent transplant need within these and other multicultural communities who are disproportionately affected by kidney disease. In addition to the proposed evaluation metric of number and rate of hard-to-place kidneys, a meaningful evaluation of outcomes would ensure that quality and not just quantity is considered in measuring the protocol’s effectiveness. Additionally, the protocol could provide some guidance on how participating transplant centers identify those willing to accept high KDPI kidneys to ensure equitable access and meaningful consent. Finally, consideration should be given to permitting all transplant programs to apply for the protocol, not just those with a demonstrated history of accepting and using hard-to-place kidneys. This initiative is an important step in reducing the disparity in transplant opportunities for multicultural patients and aligns with AMAT’s goals of promoting health equity and improving transplant outcomes in underserved communities.

Jon Miller | 08/02/2024

Submitted on: 05/29/2024 - I am concerned about the evaluation design of this protocol. My understanding is that it will be a pre-post design for aggregate metrics at 5 OPOs. This type of design has a high risk for confounding. A recent example – Liver Acuity Circles went into effect at the same time as the COVID pandemic started – making it impossible to disentangle any policy effects from the effects of the pandemic. A better design for evaluation would be to randomize donors within the 5 OPOS to the new protocol or to standard practice. I recognize though that this design could present barriers to a timely implementation. A compromise could be to identify 5 ‘matched’ OPOs that don’t implement the protocol and used them for a control group for a difference in difference analysis. I understand the need for timeliness in these experiments, but the evaluation design as stated seems to have a high risk for not being able to determine that the new protocol caused a change in donation metrics.

Paul Morrissey | 08/02/2024

Submitted on: 05/29/2024 - Early in the concept of expedited placement (EP) UNOS posed two questions: (1) Should an allocation system include an expedited placement trigger based on defined donor characteristics that would allow an OPO to expedite the placement of an organ? (2) Should the allocation system allow an OPO to move to an expedited list after a well-defined point in the allocation process? I say (1) no and (2) yes. As this experiment launches across 5 OPOs, it is crucial to have truly “hard-to-place” organs in the expedited pool. Otherwise non-participating centers will miss organs they would normally accept, and participating centers will have a “boost” in transplants that initially suggests EP is working but is augmented using the 40-50% of KPDI > 85 kidneys that ALREADY ARE being transplanted. I just calculated the KDPI of someone who looks like me: 62 y.o., healthy, on one medication - a diuretic for mild HTN and creatinine 0.8 mg/dL. As a DBD, the KDPI is 80%. These are not the kidneys that belong in your study. Our OPO (UNOS Region 1) runs a monthly “discard conference” where we review all recovered and not transplanted kidneys. Most often there is unanimity that an organ was “not transplantable.” Sometimes one or more centers, in retrospect, reconsider an obviously marginal kidney for the “right candidate” and show some interest in the organ. (These ARE the kidneys that belong in your study along with all the kidneys presently discarded.) However, that decision cannot bypass straight-forward transplantable kidneys that most centers would use. Further transplant centers cannot accept a kidney with certainty for any candidate until the anatomy and biopsy are available. Final point: for the highest KDPI kidneys that do get transplanted, longer cold ischemic times (CIT) do not seem to effect outcomes (AJT 24(2024), 781.)

Chad Waller | 08/02/2024

Submitted on: 05/29/2024

View attachment from Chad Waller

Sami Alasfar, MD MPH FASN | 08/01/2024

Submitted on 05/26/2024 - Overall, it is a great proposal and I am supportive of it. I have concerns regarding the selection criteria for patients who are considered for KDPI 75% and above offers. Most centers have criteria for KDPI 85% and higher and patients are required to sign consent for these kidneys. While the protocol aims to utilize kidneys that might otherwise go unused, it is important that the criteria for patients’ inclusion are transparent, evidence-based, and uniformly applied across all participating programs. Key considerations should include: Clinical Criteria: Clear clinical guidelines need to be established to determine which patients are most suitable for kidneys with KDPI 75% and higher. This includes considering the patient's overall health, urgency of need, and potential benefit from receiving a kidney with a higher KDPI. Equity and transparency: The process for selecting patients must be equitable, avoiding any biases based on demographics or socioeconomic status. Transparency in the selection process will help build trust among patients and ensure fair access. Cutoff Consideration: Why not use a cutoff of 85%? Are there substantial numbers of kidneys with KDPI 75%-84% that are being discarded? How many additional kidneys do we expect to utilize if we include the 75%-84% range along with the 85% and higher range?

Clark Kensinger | 08/01/2024

Submitted on 05/24/2024 - Congratulations on an excellent proposal. Sending pre-procurement offers for patients that individual transplant centers feel would gain the most benefit from a KDPI>75% is a crucial step to minimize cold ischemia time to efficiently get “hard to place” kidneys to the “right” patient quickly. Prioritizing local transplant centers within the DSA of the OPO for these pre-procurement offers will provide further help to reduce non-utilization.

Jeffrey Orlowski | 08/01/2024

Submitted on: 05/23/2024 - LifeShare of Oklahoma supports this protocol for allocating high-KDPI deceased donor kidneys and applauds efforts to both enhance equity in transplant and identify opportunities to improve the utilization of medically complex deceased donor kidneys. Recognizing the significant potential of this protocol to address both non-utilization of kidneys and disparities in transplant access, we commend the focus on organs often not utilized despite their viability. Continuous monitoring and refining of acceptance practices will be crucial for driving improvements in this area. LifeShare is committed to closely collaborating with all stakeholders to streamline processes, reduce delays in transplantation, and provide feedback for ongoing protocol enhancements. Our collective efforts are aimed at increasing utilization of available organs, increasing access to transplantable kidneys for those who are waiting, improving graft survival rates, and making a meaningful impact on the lives of those on the national waitlist, particularly those who could benefit from high-KDPI organs that all too often go unused.

Abraham Zawodni | 08/01/2024

Submitted on: 05/23/2024 - Greetings and congratulations on the launch of this exciting PDSA. The protocol is precisely what the industry needs to attempt, it is truly thinking outside of the box (or pump?). Kudos on the intent to start small and this first cycle makes perfect sense. I will add that in the future, another tweak to consider is introducing a bit more competition to the accelerated placement target list. If competition is meant to drive improvement in the OPOs, then it should also have a place in allocation. Could there be a component tested in the future where there is an element of "first come, first serve" or the first transplant center to say "yes, send the kidney"? Any small nudge like this to the decision makers in acceptance can have significant impact. A low, mandatory response time of 30-minutes is good, but it's not significantly different from the conundrum we OPOs find ourselves in with the traditional Provisional Yes vs. Acceptance evaluation timeline for centers. In the end, careful alignment of incentives will be critical to minimizing CIT as much as possible. After all, with the kidney discard rate, truly CIT is the Enemy.

Lisa Kayler | 08/01/2024

Submitted on: 05/23/2024 - Most of our candidates will accept offers from 75-85, but not above 85. How was the 75 cut-off decided? Also post-recovery findings remain important for final decision-making.

Caroline Jadlowiec, MD | 08/01/2024

Submitted on: 05/23/2024 - I support this protocol proposal for improving efficiency and transparency in allocation of hard-to-place kidneys (KDPI >75%). While the message of wanting to include transplant centers that have not demonstrated a track record in accepting hard-to-place kidneys is understandable, I do have concerns that this will decrease the efficiency in the process and potentially reduce the impact of some of the metrics being monitored, such as cold ischemia time. I would propose that there be two arms to this proposal: One that only includes transplant centers that have demonstrated a track record in accepting these organs, and a second arm that includes all transplant centers, including transplant centers that have not previously shown similar organ offer acceptance patterns. Having data showing both arms would be meaningful in further refining and developing expedited placement.

Kristi Valenti | 08/01/2024

Submitted on: 05/23/2024 - Good Morning: I am looking for clarification on the “simultaneous offers.” Does this mean simultaneous offers to multiple transplant centers? Or simultaneous offers for the same transplant center and different recipients. If simultaneous offers are sent to multiple transplant centers, I have concerns about this “first come, first serve” mentality. Being rushed to accept an organ does not allow for a thorough chart review of the donor to ensure the best possible outcome for our transplant recipient. I understand the need to find homes for these statistically difficult to place organs, but this should not come at the cost of our recipient’s safety and transplant success.

Katelyn Faust | 08/01/2024

Submitted on: 05/21/2024 - We are in support of this protocol and, as an aggressive center, frequently utilize high KDPI kidneys. We do have concern regarding the availability of biologic medications such as Belatacept to patients who accept these organs and are likely to have delayed graft function. We are also concerned that this would launch near the time when the IOTA model does, and while both drive the process around organ acceptance, they do it in a very different way. How would the OPTN keep transplant programs from becoming overwhelmed by these major changes? With the new KDPI calculation (excluding race and hepatitis C), there will presumably be fewer high KDPI kidneys. How does this fit in to this protocol? We would like to see the criteria for participation for both OPOs and transplant centers to understand how selection will occur. We look forward to hearing more about this protocol and the next steps needed to be a participating transplant center.

Emily Perito | 08/01/2024

Submitted on: 05/20/2024 - I appreciate that this protocol (1) specifically focuses on kidneys at high-risk of non-use (2) specifically preserves access for high priority candidates by explicitly stating that they will NOT be skipped in the match runs and (3) specifies that the variance will be piloted in a limited number of OPOs – with very clear guidance to transplant centers about who will be eligible to receive the expedited placement organs. By limiting a programs’ pre-identified list of patients, I also hope that this will encourage ongoing sharing between OPOs and multiple centers – as opposed to set-ups that would only allow 1 or 2 transplant centers (and their patients) to benefit from the variance. I hope that the Task Force continues to require these types of safeguards in future protocols.

Larry Suplee | 08/01/2024

Submitted on: 05/16/2024 - Good morning- I was excited to see the recent release of the first protocol for hard-to-place kidneys and look forward to the townhall on Monday. Since February, Gift of Life has been engaged in a small, pre-recovery PDSA for kidney donors with a KDPI of 75% or higher with a small number of centers who agreed to our pre-recovery expectations that include: identifying, checking, clearing patients, donor review with all decision makers and completion of a final cross match. The limiting factor thus far has been the number of centers willing to engage and fully commit to these types of kidney donors pre-recovery. With our volume and proximity to several kidney centers, we eagerly wish to participate in this protocol. I look forward to hearing more about this and the next steps needed to be a participating OPO.

Nicole Patterson | 08/01/2024

Submitted on: 05/14/2024 - I like the idea of this protocol. We utilize KPDI >85 kidneys frequently and are an aggressive center. From a transplant center perspective, these kidneys oftentimes are kidney-only donors. I would urge OPO’s to ensure flights or travel are reviewed or looked at prior to going to the OR. Often we have to decline kidneys due to cold times. We have had several offers at the 15 – 18 hour mark and we would take those without hesitation however there are no flights available for another 10-12 hours. Forcing us to turn down the kidney offer.