Comments

UC San Diego Health Center for Transplantation | 03/20/2024

UCSD Center for Transplantation (CASD) appreciates the effort the Ad Hoc Multi-Organ Transplantation Committee put forward in the proposal to Modify Effects of Acceptance Policy as well as the opportunity to comment. We agree that an accepted organ offer takes priority over a multi-organ offer in the event one of the required multi-organs has already been accepted by a single organ candidate. This change is essential to improving organ allocation efficiency, providing clarity on the order of allocation and improving equity in multi-organ allocation. Additionally, we would support the Committee continuing work to improve specifications in policy around order and priority of allocation.

Infinite Legacy | 03/19/2024

Infinite Legacy supports the proposal, as it would provide guidance to OPOs in managing MOT; however, we suggest the Ad Hoc Multi Organ Committee ensure that MOT and acceptance policy development are not in conflict with each other. We also recommend the Committee consider the risk of increased wait time for MOT. Standardization of MOT policy and consideration of safety net access for candidates with high pre-transplant mortality would impact this policy. Additionally, if the intent of this proposal is to ensure clarity in the order of allocation, the policy should be specific to this. Furthermore, a clear definition of “acceptance” needs to be ensured for consistency among transplant centers. Finally, there is concern over whether the proposal truly provides guidance. For instance, if the heart is placed, and then the kidneys are placed, and then there is an MOT candidate, there is no need to reallocate. The proposal, though, does not prescribe in what order to allocate, i.e., do isolated organs take priority, or is there an obligation to run thorough MOTs first?

HonorBridge | 03/19/2024

HonorBridge supports this policy. This policy will allow OPOs to move through the allocation process more efficiently. We support the suggestion that this policy take effect once the organs are accepted and an OR time is determined, as opposed to incorporating a time frame.

International Society for Heart and Lung Transplantation | 03/19/2024

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OPTN Transplant Administrators Committee | 03/19/2024

The OPTN Transplant Administrators Committee appreciates the opportunity to comment on the OPTN Multi-Organ Transplantation Committee’s policy proposal on ­Modify Effect of Acceptance Policy. The Committee is in support of the policy as proposed, and maintains that potential multi-organ transplants should not be negatively impacted by the policy language.

Region 10 | 03/19/2024

7 strongly support, 11 support, 2 neutral/abstain, 2 oppose, 0 strongly oppose

Members of the region are supportive of the proposal. Concerns were raised about the frequency of MOTs and their potential impact on patients, particularly in the pediatric population. There was a suggestion to review data from the past year to understand the prevalence of MOTs and whether there should be exceptions, such as carving out pediatric patients from these proposed changes. Another attendee acknowledged the challenges of handling MOT allocation on a case-by-case basis and emphasized the importance of time as a significant variable in allocation. There was a suggestion to define specific timeframes or match sequence number for determining allocation and holding single organs. Another attendee proposed modifications in the allocation of low Kidney Donor Profile Index (KDPI) kidneys to MOTs, with considerations for vulnerable populations like highly sensitized individuals, pediatrics, and prior living donors. Several attendees recommended protecting high CPRA patients and limiting MOT kidney placement to one MOT candidate per donor. The unequal distribution of kidneys based on KDPI categories, especially affecting vulnerable populations like pediatric patients, is a cause for concern. There's was also apprehension about the potential impact on liver/kidney or heart/kidney candidates if they are bypassed because the kidney is not available.

American Nephrology Nurses Association | 03/19/2024

ANNA supports improving organ allocation efficiency. We agree with providing clarity to decrease confusion when one organ is declined. We believe it is important to not slow the process of organ acceptance during these situations and that providing clarity is essential. We also strongly support the policy that when a single organ has been offered and accepted, this offer should stand and not be rescinded.  

•For example, a donor heart has been accepted by a heart candidate and both donor kidneys have been accepted by two kidney candidates. If the heart candidate declines the heart, and the next candidate on the heart match run needs both a heart and a kidney, the OPO offering the organs is not required to offer both organs to the heart/kidney candidate since the kidneys have already been accepted by other candidates.

Region 9 | 03/19/2024

1 strongly support, 7 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose

Overall, the region supports this proposal. An attendee requested a closer look at instances where one candidate has had multiple acceptances with late declines, which can impact non-utilization rates due to difficult travel logistics and cause hardship for the donor family with the changing operating room time. 

OPTN Transplant Coordinators Committee | 03/19/2024

The Transplant Coordinators Committee appreciates the opportunity to provide input on the OPTN Ad Hoc Multi-Organ Transplantation Committee public comment proposal and provides the following comments for consideration:

The Committee advises against including fixed time limits in the policy language, as this could prove administratively burdensome due to the variability of workups and potential unknowns. While recognizing the need for better prioritization of MOT candidates given logistical challenges, overly complicated or prescriptive requirements should be avoided.

The Committee recommends further discussion to ensure that any adopted changes aimed at improving MOT recipient allocation adequately serve the needs of pediatric candidates. It was noted that the potential impact of repeated false starts for pediatric candidates awaiting MOT slots can cause undue distress to families.

Region 6 | 03/19/2024

1 strongly support, 8 support, 3 neutral/abstain, 1 oppose, 0 strongly oppose

Overall, attendees were supportive of the proposal, but with some opposition. Many attendees commented that there needs to be a time frame to guide allocation of multi-organ and single organ earlier in the process. They went on to comment that adding more structure to multi-organ allocation will improve efficiency of placement, allow transplant centers to better prepare their patients, and decrease risk for non-utilization of donor kidneys due to late allocation. One attendee commented that this change will particularly benefit kidney alone candidates in remote geographic areas, allowing them more opportunities to receive kidneys with shorter cold ischemic time. 

UW Health Organ and Tissue Donation | 03/18/2024

From an OPO perspective, this makes sense and facilitates organ placement. In the current system, kidney placement is not solidified until all other organs are placed definitively. This can happen even after cross-clamp. With this proposal, once an organ is accepted, the OPO would be able to offer kidneys to the kidney waitlist or other patients, and if the original organ is later declined (liver is accepted solitary, then declined) the OPO would not have to offer a kidney to the next patient who is listed for SLK. We could tell the SLK there is no kidney available as it was placed with a solitary kidney recipient. We note that many centers are hesitant to do a cross-match until they are “primary” for an organ and this would also facilitate earlier cross-matching, ultimately improving placement of kidneys.

NATCO | 03/18/2024

NATCO generally supports the “Modify Effect of Acceptance Policy” proposal and appreciates the opportunity to provide feedback. We value all efforts to clarify allocation policies and increase efficiency. We look forward to the continued work of the OPTN Ad Hoc Multi-Organ Transplantation Committee as it relates to building equity in access to transplant for kidney-alone candidates. This proposal is a good first step in that direction. We do not believe any specific time frame should be included in the policy, nor do we believe this policy should apply only after all organs are allocated and accepted, as long as other defined multi-organ policies were followed during the initial allocation and acceptance of the extra-renal organ(s). However, this policy should define what indicates pre-recovery acceptance of an organ. This must be more than a provisional yes and should detail the requirements to demonstrate full commitment to utilization with acceptable recovery information, including full clinical review with final decision maker (surgeon/nephrologist), candidate confirmed available and medically prepared for transplant, and final crossmatch (virtual and/or serological) initiated. These required action steps and responsibilities of the transplant center should be further defined in all allocation policies to improve overall consistency and efficiency.

OPTN Kidney Transplantation Committee | 03/18/2024

The Kidney Committee (the Committee) thanks the OPTN Multi-Organ Transplantation Committee for their efforts on the Modify Effect of Acceptance proposal. The Committee supports the concept of this proposal, particularly in ensuring that primary kidney offers are not withdrawn from kidney-alone candidates in order to allocate extra-renal multi-organ combinations. The Committee provides the following feedback for consideration of operationalization of this proposal.  

Multiple Committee members shared experiences where their program had a patient checked in and prepared for transplant surgery when a primary kidney offer was withdrawn in order to allocate the kidney with a multi-organ. The Committee members acknowledged the need to reduce OPO variation in withdrawing single-organ offers to make multi-organ offers, and to ensure OPOs can continue allocation as efficiently and rapidly as possible in the case of late declines. The Committee expressed support that kidney-alone offers should not be withdrawn from kidney candidates in order to allocate multi-organ combinations. One member remarked that it would be particularly concerning for patient access for a primary single kidney offer to a highly sensitized candidate to be withdrawn in order to offer the kidney as part of a multi-organ combination. 

The Committee expressed concern that policy language may not provide adequate clarity to allow OPOs to maintain primary offers to single organ candidates. The Committee noted that typically, kidney allocation is not finalized until after recovery of the organ, particularly as it can be difficult to know which kidney a program is being offered (i.e. left or right kidney), and if a program has choice, which kidney would be accepted prior to cross clamp. Members agreed that, though kidneys may not be fully accepted until after recovery, it would not be appropriate to withdraw a primary offer from a kidney-alone candidate. The Committee also pointed out that currently, the OPTN Donor Data and Matching System is not established to account for formal kidney acceptance ahead of laterality determinations, as OPOs are required to enter laterality into the system when entering in acceptances. Members agreed that ideally, there is some mechanism available in the OPTN Donor Data and Matching System for kidney transplant programs to indicate intent to accept the offer without having to indicate laterality prior to recovery. Some members remarked that system programming changes may be necessary to ensure it is clear that a kidney is already allocated, particularly in order to reduce confusion and save time for OPOs working with multi-organ programs. 

A few members noted that a mechanism for kidney programs to indicate intent to accept a kidney offer could help an OPO determine if the program is serious about the offer, or would be willing to decline the offer in order to allow the OPO to allocate the kidney as part of a multi-organ combination. One member offered that potentially, the policy could outline a threshold of kidney patients from whom the primary kidney offer would not be pulled, noting that this could provide clarity. These members noted that, outside of a way for programs to indicate acceptance or intent to accept in the system, only the OPO and the accepting center would be aware of the program’s intent to accept the offer.  

The Committee acknowledged that while most multi-organ donors are low KDPI, healthy donors, the policy should still account the many cases where post-recovery information, including anatomy and biopsy results, are relevant to final kidney offer acceptance.  

OPTN Lung Transplantation Committee | 03/18/2024

The Lung Transplantation Committee appreciates the opportunity to comment on the OPTN Ad Hoc Multi-Organ Transplantation Committee’s proposal. The Committee supports the proposed changes to clarify OPTN policy and recommends that organ offer acceptance be finalized as soon as a transplant program commits to donor recovery. A member commented that arrangements for donor recovery may take an additional 5-6 hours after offer acceptance. During this time, the potential recipient is notified, and members felt strongly that candidates should not be vulnerable to having an offer retracted to fulfill multi-organ shares.

Region 7 | 03/18/2024

4 strongly support, 9 support, 2 neutral/abstain, 1 oppose, 0 strongly oppose 

Overall, members of the region are supportive of the proposal. The discussion centered on the challenges of kidney acceptance and allocation, particularly regarding the emotional impact on patients and the logistical complexities faced by organ procurement organizations (OPOs). Participants expressed concerns about retracting kidney offers and suggested a potential solution, such as involving the Membership and Professional Standards Committee (MPSC) to review such cases. There was a debate about when kidneys should be considered accepted, with questions raised about the timing in relation to the donor recovery. Suggestions were made to establish clearer guidelines and timeframes for kidney acceptance, with considerations for provisional acceptance and the implications for multi-organ transplant recipients. Attendees emphasized the need for clarity on what constitutes acceptance and advocated for policies that prioritize accepted kidneys over multi-organ shares. They highlighted the importance of providing OPOs with appropriate guidance to streamline the allocation process while ensuring equitable access to organs for all patients.

OPTN Pancreas Transplantation Committee | 03/18/2024

The Pancreas Transplantation Committee thanks the OPTN Ad Hoc Multi-Organ Transplantation Committee for their efforts on the Modify Effect of Acceptance Policy proposal.

The Committee is in support of this proposal and provided some feedback for consideration:

• The Committee asked clarifying questions on the impact of a transplant hospital’s acceptance rate if there were a need to reallocate an organ. It was suggested that programs not be penalized in their acceptance rate since the reasoning why the organ was not accepted would be documented. There was agreement that education to clarify this further would be beneficial to have a better understanding.
• There was concern raised that there could be issues present for pancreas, such as cold ischemic time (CIT) for pancreas; there should be some idea about what an acceptable CIT for pancreas is; if there is a liver-kidney and/or some thoracic-kidney offer, the kidney-pancreas (KP) list can be tied up. It was discussed that for scenarios where there is a liver-kidney and/or heart-kidney offers, and the next patient on each list needs a kidney, OPOs tend to hold those kidneys, which disadvantages the pancreas.
• There is some bidirectionality when it pertains to KP; the pancreas is not the lifesaving organ. In contrast to the other examples provided (liver-kidney and heart-kidney), the program would not move forward with the pancreas alone. The offer may move forward with a kidney alone; however, it may not be the best thing for the patient based on what is already known about outcomes for deceased donor kidneys and pancreas after kidney. It was suggested that this be looked at as something that is unique to KP and consideration on what would be an exclusion for this.

The Committee was in overall agreement that this proposal is a good move forward to address efficiency. 

Region 1 | 03/18/2024

3 strongly support, 9 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose 

A member suggested clarifying that transplant centers are putting in a provisional yes, not an acceptance. An attendee stated that heart-lung transplants are challenging under current policy because the heart is driving the match, and if there is enough time, the OPO should finish going through the match run. The attendee also recommended setting a cutoff time or a trigger, such as cross clamp, but that otherwise the process should be to continue to go down the match. A member proposed that since policy uses nautical miles, perhaps that could be used to build in travel time. An attendee asked that the community not spend a lot of time on policies that impact so few cases. A member commented that multi-organ delays allocation.

OPTN Liver & Intestinal Organ Transplantation Committee | 03/18/2024

The OPTN Liver & Intestinal Organ Transplantation Committee thanks the OPTN Ad Hoc Multi Organ Transplantation Committee for their efforts on the Modify Effect of Acceptance Policy proposal.

The Committee supports the proposed policy as it is a reasonable and appropriate policy solution. The Committee emphasizes the importance of not changing allocation once organs have been placed.

Region 5 | 03/15/2024

10 strongly support, 19 support, 4 neutral/abstain, 1 oppose, 0 strongly oppose 

Region 5 supported this proposal and offered the following feedback. They requested clarification on what constitutes a MOT candidate and more information on a back-up scenario and a definition for a back-up offer. There was support for the concept of addressing back-ups and suggested a MELD threshold for these situations. Another member suggested addressing the back-ups in Policy and require OPOs to honor the back-up. An attendee commented that although this may be challenging, back up offers for simultaneous liver-kidney waitlisted candidates should be considered since their mortality is high. A member commented that an OPO should never take back an organ that has been allocated. Another suggested the committee include a provision to not disadvantage backup MOT candidates. If there is an immediate backup MOT candidate, that candidate should be offered the organs prior to offering the kidney to the kidney alone candidates. In support of this proposal, a member commented that this proposal will improve allocation efficiency by allowing OPOs to offer kidneys without fear of having to revoke an offer due to a late allocation of an extra-renal organ. An attendee explained that it is important to not "take away" a kidney from patients who had been allocated off the normal match run especially for pediatrics or for the highly sensitized. They believe that there is the potential that as currently written, the OPO can still "make up" their own rules. And part of the challenge is weighing mortality at the top of the list versus the isolated kidney need.  

It was commented that this will allow pediatrics and high CPRA patients to receive kidneys in a more time efficient manner and that there should be exceptions for pediatric candidates. Another attendee commented that they are very interested in allowing hard to transplant and pediatric candidates who need a kidney to not be bypassed by MOT candidates. Several members commented that hard too transplant kidney candidates should be taken into consideration when allocating kidneys to MOT candidates. A member inquired about how this proposal would affect heart-lung candidates.

American Society of Transplantation | 03/15/2024

The American Society of Transplantation (AST) generally supports the proposal, “Modify Effect of Acceptance Policy,” and offers the following comments for consideration:

•The AST recognizes that including timeframes in the proposed policy language could create unnecessary confusion and inefficiencies for both OPOs and transplant hospitals; however, are there reasonable options that would circumvent these concerns and better address the allocation questions? The AST is interested in the OPTN Ad Hoc Multi-Organ Transplantation Committee’s perspectives considering its ongoing analysis and discussions of these topics.

•The AST recommends making clearer that OPTN Policy 5.6.D (Effect of Acceptance) is referring to final organ acceptance and does not include “provisional yes.”

Association of Organ Procurement Organizations | 03/14/2024

AOPO supports the proposed policy clarification that if an organ has been accepted for a single organ candidate, that will take priority over subsequent multi-organ offers. The existing OPTN Policy 5.6.D Effect of Acceptance has created delays in allocation and confusion for OPOs.

The proposed policy will achieve efficiency in allocation, clarity for OPO staff, and, most significantly, improve equity in transplantation. We recommend that this policy language take precedence after an organ that may be impacted is accepted; however, there is no need to wait until all organs are allocated and accepted.

In response to specific questions:

Should a specific timeframe be included in the policy language?

AOPO recommends that the policy specify that once a transplant program has accepted an organ, it is no longer available for allocation. For example, if a heart is accepted for a single organ candidate, it cannot be allocated to a multi-organ candidate needing a heart-kidney transplant. The timeframe should not include the scheduling of a donor recovery.

Should this apply only after all organs are allocated and accepted?

No. This policy should not apply only after all organs are allocated and accepted. Waiting for all organs to be allocated would not meet the intended goal of the proposal to ensure acceptance of a single organ candidate takes priority over multi-organ offers. 

OPTN Heart Transplantation Committee | 03/14/2024

The OPTN Heart Transplantation Committee (Committee) thanks the Ad Hoc Multi-Organ Transplantation (MOT) Committee for presenting their public comment proposal, Modify Effect of Acceptance Policy during the Committee’s February 20, 2024 meeting. The Committee Chair stated that the proposed changes made sense. A Committee member stated that in terms of a timeframe, it appears that there should be flexibility for OPOs within such a timeframe reflecting the nuances of a given OPO geographically.

Region 3 | 03/11/2024

6 strongly support, 7 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

Region 3 supported this proposal. During the discussion, one attendee commented that no specific timeframe should be included in the policy.  

American Society for Histocompatibility and Immunogenetics (ASHI) | 03/09/2024

This proposal is not pertinent to ASHI or its members.

Region 8 | 03/05/2024

5 strongly support, 11 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose

Region 8 supported this proposal, believed the recommended priorities are reasonable, and provided the following commentary. An attendee suggested to be aware of the time factors associated with the acceptance policies. A member suggested considering allocating multi organs with single organs on the same list; which could help alleviate the issues with offering organs then retracting the offer due to multi organ offers. A member noted concern that this could create the possibility for misuse if an isolated organ is allocated outside of current policy. The member recommended modifying the policy language to explicitly constrain this to situations when the OPO has fully followed Policy 5.10 (and related organ specific policies) for prioritizing multi-organ allocation. In support of the proposal an institution explained they believe that once an organ is accepted, it's accepted and shouldn't be pulled back to fill a multi-organ transplant when another organ is turned down. They explained that waiting until the donor operating room is scheduled is too late and may lead to additional late turn downs. An attendee recommended the proposal offer an explicit definition of what "acceptance" means by clarifying provisional acceptance to placed. They explained that as they receive multiple offers from multiple OPOs, it does not seem that the words mean the same thing among different OPOs and programs. While an attendee acknowledged how difficult it is to do multi-organ allocation, and the difficulty lies in when the offers are rescinded. Another attendee explained that it is difficult to understand how acceptance is completed before procurement is finished. Lastly, a member suggested that multi-organ offers only be run through the kidney match. 

Region 2 | 02/29/2024

6 strongly support, 12 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

Overall, members of the region are supportive of the proposal. Several attendees noted experiences when they had been primary for a kidney offer only to have the kidney offer rescinded so that the kidney could be offered to a multi-organ candidate. This proposal is especially beneficial to 100% CPRA candidates, as they rarely receive kidney offers. Having a kidney offer rescinded for a 100% CPRA candidate can be a life-or-death situation. Many attendees noted that the proposal should help to improve allocation efficiency. While supportive of the proposal, the OPTN should continue to consider the risk of increased waiting time for multi-organ transplant candidates. Additionally, there is a need to assess differences in safety net access for candidates with high pre-transplant mortality.

Region 11 | 02/29/2024

4 strongly support, 13 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose 

The region supports this proposal. Several members expressed support for including specific timeframes in the policy. One member said without specific timeframes, there will be inequity and inconsistency in implementation, and that multi-organ candidates should not be disadvantaged. Another attendee suggested establishing timelines based on data that balance the need for earliest allocation as possible of single organs, while minimizing the disadvantage to multi-organ candidates who tend to have a limitations to access and make up a minority of allocations. A member recommended that kidneys be offered four hours before procurement. Another attendee supported the idea of kidney allocation being done before procurement, possibly after other organs are placed or the list is exhausted, to save unnecessary work and expense. A member commented that an easy option is for OPOs currently is to not offer the kidney as primary until after procurement and instead offer as a back up.  

OPTN Pediatric Transplantation Committee | 02/27/2024

The OPTN Pediatrics Committee supports this proposal. The Committee discussed this proposal, and the devastation families have when an organ offer is pulled, which can also be traumatizing for physicians as well. The Committee welcomes this policy change, and thanks the OPTN MOT Committee for developing this proposal.

UAMS | 02/27/2024

After reviewing OPTNS proposal to modify the acceptance policy, we believe that if a patient is a MOT candidate, they should take priority except for when there are late declines. When there are late declines of these organs, then the single organ should be prioritized for placement based on ability to transplant quickly versus trying to reallocate the organ to the first on the list for a single organ. We believe this policy change will positively impact our patient population and decrease the financial strain on our patients.

Region 4 | 02/26/2024

3 strongly support, 6 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose

The region supported this proposal. During the discussion one attendee recommended adding a timeframe for OPOs to clarify when the kidneys can be offered to the kidney alone candidates making them no longer available for allocation to a multi-organ candidate. Another attendee commented that the definition of organ acceptance needs to be clarified so that the OPO and center know when the acceptance is binding. One attendee recommended that the committee consider moving toward more transparency so that candidates understand why they are not being offered the kidney. Another attendee commented that candidates have expressed a desire to centers to know what offers have been declined for them. They added that the goal would be to refine hospital screening criteria to match patient preferences. One attendee recommended requiring all multi-organ allocations to have a back-up for the kidney in the event that the multi-organ allocation has a late decline. 

Lilli | 02/20/2024

It is my opinion that priority for an organ should go to the already accepted patient in these instances. I believe this will allow for equitable organ allocation and efficient organ placement. Waiting to verify that there is no refusal slows down the time-sensitive transplant process for those who have accepted an organ. It does not seem ethical to rescind an offer once it has been accepted.

OPTN Organ Procurement Organization Committee | 02/20/2024

The OPTN Organ Procurement Organization (OPO) Committee thanks the Multi-Organ Transplantation Committee for their work on this proposal and the opportunity to provide feedback. The Committee supports this proposal. The Committee suggested that this policy take effect once the organs are accepted and an OR time is determined, as opposed to incorporating a time frame. A member noted that including specific timeframes will reduce efficiency in allocation for all organs.

Déboralis Ramos | 01/31/2024

Strongly Support