Comments

Sierra Donor Services | 09/19/2023

The proposal to limit transplant programs to accept one organ offer at a time is an attempt to improve efficiency of organ allocation and should be considered in the context of the larger organ donation and transplantation system. The allocation process is incredibly complex and OPOs routinely experience challenges with the acceptance of multiple organs by transplant centers, creating unnecessary inefficiencies and inconsistencies in the system. Our ability to collect and understand the data surrounding offer acceptances and declines is limited. SDS supports this proposal yet recommends the committee consider:
- Exceptions to the proposal for DCD donors (given the potential for the DCD case not to reach asystole) or for higher status patients.
- Creating a standard definition of a late decline, collecting and transparent reporting on late decline data, and accountabilities for programs. Late declines have far reaching implications: adversely impacting donor families by prolonging the donation process, impacting hospitals/care teams and extending use of their critical resources, creating additional work for OPO staff to scramble to reallocate, often forces out of sequence allocation bypassing potential candidates, leads to increased organ non-utilization, and overall creates incredible inefficiency in the donation system.
- Expanded analysis of organ acceptance and decline data

Colleen O'Donnell Flores | 09/19/2023

I think an enhancement to Data Services to report on late turndowns would be very helpful. Thank you

HonorBridge | 09/19/2023

HonorBridge is pleased the committee has advanced this proposal which is key to maximizing organ utilization and reducing non-use of organs. Late declines of previously accepted organs should not be tolerated within the OPTN. Livers are frequently declined within 2 hours of cross clamp, making the logistics of re-allocation extremely challenging for the OPO as well as the transplant centers and recipients next in line to receive these offers. The data shows that allowing two acceptances for a single patient is disadvantaging other high-status patients, these organs are going to lower status patients 80% of the time in the case of livers and 83% of the time lungs are reallocated. We support programs continuing to receive offers and support declining an offer before being able to accept a different offer.

Region 1 | 09/19/2023

Sentiment: 3 strongly support, 1 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose 

The region supported this proposal.  A member commented that while liver programs in Region 1 have been good stewards, other programs outside of the region have not,  so this change is needed, especially with teams from other regions coming into Region 1.  Attendees commended the OPO Committee on their work and expressed complete support, as this practice results in late declines. Another attendee also stated support, adding they felt the proposal should go farther by saying once you accept an organ, you will not get other organ offers.  One member said that very few of these organs were discarded, as they were considered good enough to be used by someone.  One member asked if the committee might consider focusing only on liver, since it seems to be the biggest issue. Another member suggested adding a deadline after which a program could not back out of an offer.  

Hospital of the University of Pennsylvania | 09/19/2023

This policy proposal has the potential to be abused by OPOs who have not completed a donor eval or have not uploaded adequate data or up to date data.

New England Donor Services | 09/19/2023

New England Donor Services strongly supports modifying the organ offer acceptance limit to a single acceptance for a single candidate. Current OPTN policy allows transplant centers to simultaneously accept multiple organs for a single candidate which results in concurrently accepted livers being declined 90 minutes prior to cross-clamp on average. Many of these declines occur when the donor has already been moved to the operating room, risking non-use of the organ. In these cases, out-of-sequence allocation occurs at double the national average and while this policy purportedly exists to maximize transplant opportunities for the most medically urgent patients, the data shows that 80% of livers and 83% of lungs that are concurrently accepted and then declined are ultimately reallocated to less medical urgent candidates (MELD/PELD score < 34 and LAS score of < 50 respectively).

Successful allocation of extra-renal organs after entry to the OR creates significant challenges as transplant centers lack adequate time to evaluate the donor, prepare their recipient, and mobilize the resources necessary for safe and successful transplantation. In many cases, these organs are not successfully placed at all resulting in non-use. In fact, OPTN data revealed 131 concurrently accepted livers that were ultimately not recovered for transplant between March 2021 - September 2022. The timeframes and logistical challenges created by the late decline of a concurrently accepted organ, particularly in the era of broader sharing, contributes to organ non-use and delays for all stakeholders (donor families, donor hospitals, transplant and OPO teams.) It is critical that the system be redesigned to reduce this outcome.

Modifying the organ acceptance limit as proposed does not prevent a candidate from continuing to receive offers, nor does it prevent a team from accepting an offer. It only requires that the team make a decision about which offer they are accepting for their candidate. That timely decision allows allocation to continue to the next highest priority patient on the match run, rather than delaying a decision that later results in requiring OPOs to expedite placement to a patient who may be less in need but is able to be mobilized more quickly. OPTN members put a great deal of time and effort into developing equitable and effective allocation policies. Adjusting the organ acceptance limit to a single organ for a single candidate not only should increase organ utilization, it should also allow OPOs to follow those allocation policies to the benefit of the next medically urgent candidate on the waitlist.

ARORA | 09/19/2023

ARORA supports the proposal to reduce the number of candidate acceptances from two to one. When transplant centers accept multiple organs, this creates late declines of organs. Late declines often lead to loss of opportunity for transplant of the organ. This causes complications for transplant team coordination and may lead to increased allocations out of sequence and/or organ discard. Acceptance of two organs for one recipient can also result in increased case times and an unnecessarily increased workload for the system.

Region 8 | 09/19/2023

Sentiment: 7 strongly support, 6 support, 3 neutral/abstain, 2 oppose, 1 strongly oppose

An attendee strongly supported the proposal to improve efficiency and minimize non-use. Another supported this proposal but with modification/clarification to ABO errors reporting. A member suggested that the committee look into why this is happening and that the proposal is just a shuffling of who doesn't get a transplant instead of identifying the reasons/circumstances that multiple organ offer acceptance occur. A center recommended to limit this proposal to liver transplant programs initially and the committee should consider imposing a limit related to the initial operating room time (even if the time changes later). An attendee was supportive of the concept to accept only one primary organ offer and not able to continue with two primary offers. And pointed out that late turndowns seemed to impact abdominal programs more where there might be pushback as program stay in the mix as primary for two offers at the same time and then backing out of organ at time of cross-clamp. They supported not having exclusions and applying this to all organs. A member explained that OPOs should have visibility and/or communication when the transplant center candidate has accepted two offers and prepare for a solid back-up center/candidate. They believed this proposal will not be in the best interest of the potential recipient.

Association of Organ Procurements Organizations | 09/19/2023

AOPO supports the proposal of reducing the number of candidate acceptances from two to one. Transplant center “acceptances” of multiple organs for the same candidate creates extreme systemic challenges, one of which is a late decline of the organ when the decision is made to accept one organ over the other. Late declines lead to delays for the donor whose organ was not accepted. These delays can be hours long as the donor OPO must re-allocate the organ and allow time for the new accepting team to travel to the donor OR. Such delays affect the other organ transplant teams involved, as well as the donor family, the donor hospital, and the donor OPO. In some cases, the late decline comes during the donor OR, and the donor OPO must re-allocate the organ in question, often bypassing sicker patients who could have benefited from the transplant, but who cannot now receive the organ because of the short notice and prolonged cold ischemic time. (We note that out of sequence allocation occurs at nearly double the rate in concurrently accepted organs as in baseline cases.) While AOPO understands the need for transplant centers to advocate for the best option for their patients, that advocacy should not be at the expense of so many others involved in the OPTN.

OPTN Transplant Administrators Committee | 09/19/2023

The OPTN Transplant Administrators Committee thanks the OPTN Organ Procurement Organization Committee for their dedication and work on this project. The Committee notes that there might be a greater nuance in scenarios involving pediatric patients or those with high MELD scores asks that the OPO Committee make consideration for those scenarios as they develop this policy.

Region 9 | 09/19/2023

Sentiment: 2 strongly support, 3 support, 5 neutral/abstain, 2 oppose, 1 strongly oppose

Several attendees disagreed with this proposal, saying that this potentially disadvantages patients. They do not believe this solves the problem of non-use of organs, and there needs to be a meaningful discussion between transplant programs and OPOs to ensure there are back up candidates waiting. Another attendee agreed with those points, and added that it is important for transplant centers and OPOs to communicate clearly and often. Several members agreed with the fact that communication is at the root of this issue. Several attendees stated support for an exception for high status liver candidates, high status lung candidates, and DCD donors, as this would still solve a good amount of the problem. One attendee remarked that not all back up offers and acceptances are created equal, and if there can be an agreed up and accepted process for back up offers, it will make the process smoother in the event of a late decline. A suggestion was made to provide a time limit on how long transplant centers can hold on to two offers at the same time. A member commented that all organ offers should be considered provisional and not accepted until a donor OR has been set, allowing centers to hold multiple offers for the same recipient until then. They added that it is impossible to determine the quality of a liver prior to recovery, especially for extended criteria and marginal donors, and this policy change would disadvantage patients and may limit the use of extended criteria livers. 

Region 3 | 09/19/2023

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

During the discussion several attendees supported the proposal as long as it does not apply to status 1A liver candidates. They added that hours matter for these candidates and since often the OR time is not set when the offer is accepted, the center will accept the first organ that becomes available. They went on to comment that there needs to be active communication between OPOs and centers in situations where a center has more than one acceptance. Another attendee agreed with the exception for 1A candidates as long as there is a clearly defined cutoff for when to release organ for further allocation. One attendee commented that when livers are recovered by local teams rather than teams from the accepting center, the accepting center is more likely to have a late turndown. Another attendee commented that the current system of using "provisional yes" acceptance for organ transplant allocation is causing delays, especially during overnight hours. They added that these delays can lead to families changing their decision to proceed with organ donation. They went on to comment that although the system was designed for final decision-makers to receive organ offers, transplant centers currently don't follow this practice. Also, the involvement of third-party service providers who work with multiple centers simultaneously further exacerbates the delay in organ allocation times. Additionally, the ability of transplant centers to accept multiple organs per recipient, lack of clear communication about which organ will be accepted, and administrative challenges contribute to the problem. To address these issues, suggestions include revising acceptance criteria to accurately reflect recipient needs, discontinuing the practice of transplant centers accepting multiple donor organs, and adjusting how electronic offers interact with organ acceptance. Lastly, the Organ Procurement and Transplantation Network (OPTN) should track reasons for provisional acceptances that are later declined, based on information available during the initial review.

NATCO | 09/19/2023

NATCO appreciates the efforts of the Organ Procurement Organization Committee in preparing this proposal. Due to NATCO’s membership being a representation of both transplant centers and organ procurement organizations (OPO), we had different viewpoints and comments from our membership.
From an OPO perspective, our membership was supportive in decreasing the modified acceptance from two to one. It was proposed that this would help decrease rapid reallocations, organ discards, OR delays, deaths on the transplant list, donor family stress and the overuse/abuse of donor hospital resources. There is an opinion that limiting organ offer acceptance could cause a disservice to those higher MELD patients and pediatric patients. Our OPO membership would be open to an exception for those two patient groups if the data supported this opinion.
From a transplant perspective, our membership was indecisive about this change. While the transplant community understands the concerns about organ discards, OR delays and deaths on the transplant lists, the transplant membership inquires if additional investigations into late declines have been made. For example, has late declines been only from specific, smaller centers vs. larger, more aggressive centers or have late declines been a cause of OPO’s delayed delivery of necessary data to determine organ acceptance? In addition, our transplant membership feels that exceptions should be made for status 1 or 2 patients as they often have a very short opportunity for transplantation due to the severity of their illness and DCD offers as they may not progress.
Ultimately, the NATCO BODs suggest quality and process improvements (QAPI) between OPO’s and transplant centers that may allow for better communication, timely data reports and a decrease in organs discards, ultimately meeting the goals of both groups: organ allocation and transplantation.

Region 10 | 09/19/2023

Sentiment: 5 strongly support, 5 support, 3 neutral/abstain, 3 oppose, 0 strongly oppose

Overall, the region is supportive of the proposal, but several attendees offered suggestions for instances when two acceptances are still appropriate. An attendee expressed support for the proposal's spirit but highlighted a concern that organ acceptance might not always align with quality due to logistical factors. They suggested exceptions for Status 1 liver candidates. Additionally, significance of timing in DCD cases was emphasized, with a second acceptance option seen as crucial for recipient assurance. Another attendee noted that managing multiple acceptances is challenging from an allocation standpoint, and the proposed policy is anticipated to reduce last-minute turndowns and organ non-utilization. Others suggested considerations for high MELD patients in addition to DCD donors. Another attendee suggested adding exceptions for Status 1 Liver or hepatic artery MELD 40 exception candidates who require the first available offer due to critical conditions. Acknowledgment was given to the necessity of exceptions for more seriously ill patients. Despite statistics indicating minimal concurrent DCD liver acceptances, there was a suggestion to allow for two liver acceptances when one is for a DCD offer. This could result in a rise in DCD liver acceptance rates. Another attendee noted that more data on DCD offer acceptances is needed. Lastly, an attendee suggested introducing a time limit for accepting subsequent organs for the same patient. 

Infinite Legacy | 09/19/2023

Infinite Legacy supports this policy as it will add efficiency to the organ placement process, specifically for lung and liver, by reducing the re-allocation and bypassing of organs required when there is a late turndown. There are concerns for offers regarding sicker patients; the proposed policy does not prevent a provisional yes from being entered for offers that transplant centers are considering. The data that the committee presented showed that 80% of livers turned down as part of concurrent acceptances are allocated to a recipient with a MELD score less than 34, and 83% of lungs turned down as part of concurrent acceptances are allocated to recipients with a LAS of less than 50. Candidates with medical urgency are being bypassed and disadvantaged due to late declines from concurrent offer acceptance due to the urgency of placing an organ with back up candidates or candidates who are readily available. By accepting an organ with the intent to transplant, the concurrent organ is released to be allocated by the match run.

UC San Diego Health | 09/19/2023

While the UCSD Health Center for Transplantation appreciates the OPO Committee’s efforts to increase efficiency in the allocation process, we do not support the proposal to limit primary organ offer acceptances to one (organ per type) per candidate. We are very concerned about the unintended consequences, particularly access transplant in a timely and efficient manner for critically ill or hard to match candidates nationally.

While operationally the arguments in support of this proposal seem reasonable, the reasons for these late declines are quite likely clinically relevant and justifiable (for example, programs that may accept for a candidate based on virtual crossmatch but later must decline due to a positive prospective). Rather than limiting the autonomy and informed decision making of transplant programs, tools to improve communication between OPOs and transplant programs should be explored. We agree with the proposal put forth by Region 6 to enhance DonorNet to allow centers and OPOs to see on the match if a candidate has simultaneous acceptances for more than one organ as this would allow OPOs and transplant centers to prepare backup candidates.

Transplant Families | 09/18/2023

Transplant Families shares the OPTN Pediatric Transplantation Committee's reservations and apprehensions regarding out-of-sequence allocation and its association with concurrent acceptances, particularly in the context of liver transplants, we find it challenging to fully endorse this proposal without further substantiating data. We also recommend a thorough examination of instances involving multiple acceptance events for pediatric candidates and pediatric donors. This analysis is crucial because diminishing the offer acceptance threshold may potentially hinder the access of critically ill pediatric patients and those with complex matching requirements.

Anonymous | 09/18/2023

Transplantation Committee's reservations and apprehensions regarding out-of-sequence allocation and its association with concurrent acceptances, particularly in the context of liver transplants, I find it challenging to fully endorse this proposal without further substantiating data. I also recommend a thorough examination of instances involving multiple acceptance events for pediatric candidates and pediatric donors. This analysis is crucial because diminishing the offer acceptance threshold may potentially hinder the access of critically ill pediatric patients and those with complex matching requirements.

OPTN Kidney Transplantation Committee | 09/18/2023

The OPTN Kidney Committee thanks the OPTN OPO Committee for the opportunity to provide a public comment on the proposal. Committee members commented the increased workload on OPOs and delays that have been caused by allowing acceptance of two organs for one candidate has caused increased strain on the overall system, lengthened case times, and stretched resources. Committee members were overall supportive of the proposal. Members were split on whether exceptions should be made for higher status candidates or candidates who have accepted DCD offers. One member noted that these exceptions would prevent sufficient resolution of current issues with late declines. Other members who perform kidney and liver transplant supported such exceptions, noting particularly the increased use of liver perfusion devices and increased liver recoveries from DCD donors. One member noted that highly medically urgent candidates who are considering DCD offers should particularly be considered for an exception to a one-acceptance rule.

OPTN Membership & Professional Standards Committee | 09/18/2023

The Membership and Professional Standards Committee (MPSC) thanks the Organ Procurement Organization (OPO) Committee for their time and effort in developing and presenting this proposal. The MPSC expressed support for this proposal, but some members provided some alternative feedback. A member recommended a requirement for setting an operating room (OR) time prior to placing offers. If a procurement time were scheduled, transplant hospitals would be better prepared to only accept one organ and ensure their patient receives the transplant they need. Another member suggested considering ways to improve communication by possibly allowing other transplant hospitals to see when another transplant hospital has two acceptances. While OPOs can see this on the OPTN Computer System, other transplant hospitals are not prepared for late turndowns and are unable to properly prepare a patient for transplant. The member noted that if they were aware their patient was secondary to a patient that held two acceptances then their behavior would change. Overall, members agreed with the need to reduce late turndowns and agreed that they negatively impacted the next sickest patient on the list. The MPSC supports this proposal as it stands, overall.

Region 7 | 09/18/2023

Sentiment:  5 strongly support, 6 support, 2 neutral/abstain, 1 oppose, 2 strongly oppose

Overall, the need to improve efficiency and reduce the non-use of organs was emphasized, and several attendees strongly supported the proposal to limit accepted offers from two to one. However, it was noted that this change might not necessarily decrease the number of late turndowns, and there should be an exception for Status 1A liver candidates. One attendee noted that there is delicate balance between organ non-use, allocation out of sequence, and the potential impact on waitlist mortality. The committee needs to determine the threshold for how many out-of-sequence allocations could be deemed equivalent to waitlist mortality. Another attendee suggested that this change might align with Continuous Distribution (CD) and could be incorporated into future allocation models. Concerns were voiced about potential unintended behaviors that might arise if the change is implemented and how transplant centers might adapt to it. Another attendee added that the reasons behind liver declines and the specific codes used to indicate these reasons are important data to consider before making any changes. It was noted that having the ability to maintain a provisional yes could be valuable. In support of the proposal, an attendee emphasized the importance of timeliness in organ acceptance decisions, particularly leading up to the operating room (OR) time. Another attendee noted that programs may need to hold onto more than one organ offer if they are waiting on cross match results. They also suggested establishing timelines from organ offers to OR times to encourage communication between OPOs and transplant programs. Lastly, from a patient's perspective, the desire to have the flexibility to choose between organs in real-time was acknowledged. However, there was a consensus that this desire should not hinder the chances of someone else receiving a life-saving organ.

Mid-America Transplant | 09/18/2023

Mid-America Transplant (MT) appreciates the opportunity to provide feedback to HRSA on OPTN’s existing policy regarding organ offer acceptance limits. As a consistently high-performing organ procurement organization (OPO) with over 40 years of experience, MT is committed to saving lives through organ and tissue donation excellence.

MT recommends that transplant centers be limited to accepting one offer at a time. The current OPTN policy enables transplant centers to accept more than one offer simultaneously, leading to the decline of at least one of the organs. OPTN data shows this decline often occurs late in the allocation timeline, often during procurement in the operating room or post-procurement. This results in OPOs having to reallocate organs at the last minute or ensures non-use of the organ and fewer lives saved. Additionally, this late declination information is not transparent or included in OPTN data, inhibiting the ability of OPOs to better understand non-use rates and trends. If such data were more transparent and available, OPOs could adjust their practices to effectively mitigate these issues, allocate more organs, and save more lives.

Mid-America Transplant thanks HRSA for its efforts to improve the organ donation and transplantation system and is grateful for the chance to provide its comments.

Sincerely,

Kevin Lee, President & CEO

American Society of Transplant Surgeons | 09/18/2023

See attachment.

View attachment from American Society of Transplant Surgeons

Versiti Wisconsin | 09/18/2023

Versiti Wisconsin strongly supports the proposal of reducing the number of candidate acceptances from two to one. Transplant center “acceptances” of multiple organs for the same candidate creates extreme systemic challenges, one of which is a late decline of the organ when the decision is made to accept one organ over the other. Late declines create significant downstream challenges that jeopardize the entire donation process. Late declines result in OPOs pausing the donation case to re-allocate the organ which can result in other transplant teams canceling flights and then scrambling for transportation options later. Late declines create undue stress on the donor family and strain ICU hospital resources to maintain the donor until the organ is placed and all accepting centers and the OPO can align on another recovery time. In some cases, the late decline comes during the donor OR, and the donor OPO must re-allocate the organ in question, often bypassing sicker patients who could have benefited from the transplant, but who cannot now receive the organ because of the short notice and prolonged cold ischemic time. Late declines create a significant risk of organ non-use. We note that out of sequence allocation occurs at nearly double the rate in concurrently accepted organs as in baseline cases. While Versiti understands the need for transplant centers to advocate for the best option for their patients, that advocacy should not be at the expense of so many others involved in the OPTN.

Society for Pediatric Liver Transplantation | 09/18/2023

The Society for Pediatric Liver Transplant opposes the current proposal to limit concurrent organ acceptance to 1 instead of 2 organ offers – unfortunately there is not enough data provided to assess the potential impact of this policy change on pediatric liver transplant candidates. We encourage the Committee to present additional data on potential impact of this change for community consideration:
1. There is no doubt that late declines are a problem for OPO’s, but the reasons for all late declines have not been clearly presented in the proposal data. The impact of this policy change on late declines thus remains unclear.
2. There is no data presented on current utilization of this practice in pediatric candidates; we thus cannot assess how changing this policy would impact pediatric candidates. It would be critical to include potential impact on the sickest children (Status 1A, 1B) and the smallest children (less than 2-3 years of age), as these are high-risk pediatric liver candidates.
3. The decision to accept a less than ideal organ because one doesn’t know when the next offer will be forthcoming should not preclude accepting a better offer depending on the candidate’s acute needs, but having to turn down the first offer to accept the second may jeopardize the candidate. Again, additional data on whether and when this practice is utilized currently for the sickest children would be helpful to our community.
4. It is somewhat reassuring that the large majority of declined livers in these scenarios are placed according to sequence (84%), although we agree that out-of-sequence placements are a potential problem in this scenario. Encouraging identification of backup offers is important when concurrent acceptance does happen.

Gift of Life Michigan | 09/15/2023

We appreciate the work of the OPTN Organ Procurement Organization (OPO) Committee on this important topic. We appreciate that any system in which donated organs fall short of helping every patient on the waitlist, measures will be taken to attempt to be fair and equitable. We do not believe the ability to accept two organs simultaneously has provided any relief; rather, it has unnecessarily complicated an already complex process to allocate organs.

We fully appreciate that some patients appearing on the match-run for donated organs are seriously ill. We also do not believe this modification limits a center’s ability to still be able to accept a subsequent offer should one become available.
When a center accepts two organs for the same patient the OPO is left essentially in limbo. No other center will act upon an offer while someone else is primary, and scrambling to place an organ turned down late in the process is at very real risk of non-use, an unacceptable consequence. To prevent organ loss, OPOs have had to devise parallel processes to try to secure a true back-up for an organ that is turned down late (after having been accepted). A process that requires veering from the match-run to prevent the loss of a viable organ is a symptom of an inadequate process.

Coordinating organ recovery often poses serious logistical challenges, especially when multiple organs and teams are involved. There are often strict limits from families who restrict the amount of time an OPO is allowed to facilitate donation. Furthermore, hospitals (and OPOs) continue to face staffing challenges in the endemic phase of the COVID-19 pandemic, often severely limiting operating room and staff availability.

Transplant surgeons and physicians decide the given suitability of a donated organ for each of their patients offered those organs. It is unclear to us how an accepted organ becomes unacceptable, assuming there have been no changes in the status of the donor or organ. As stated in the Committee’s presentation, simultaneous acceptance of two organs also seems to put other candidates at risk of losing out on a viable offer.

We would like to see acceptance of organs predicated on the studied conclusion that the organ offered and accepted is suitable for the waiting recipient, and that acceptance of two organs simultaneously instills a false sense of security that ultimately benefits no one.

Our OPO has experienced ten late declines on allocated livers through mid-August 2023 that we thought we had placed. All of these were for patients whose centers simultaneously accepted two livers.

Because of a robust and vigilant internal back-up allocation protocol we have in place, we were able to successfully reallocate six of the declined livers with local patients. This protocol unfortunately gives “evidence” to those who say that “liver transplants have increased”; however, it is a workaround that circumvents OPTN policies. We are forced to develop these workarounds, and to expend the increased time, energy, and resources to literally duplicate allocation efforts in order to try to save a viable organ.

In three other cases the late-declined livers went to research facilities because a suitable candidate was not identified in time. There is no reason to believe these organs were unsuitable for transplantation, but the late turn-down severely limited our ability to place them.

Finally, one liver was discarded because we could find neither a recipient nor a researcher in time.

Region 6 | 09/15/2023

Sentiment: 3 strongly support, 2 support, 3 neutral/abstain, 3 oppose, 1 strongly oppose 

Several attendees did not support this proposal and were concerned about limiting acceptance for liver candidates, particularly those who are medically urgent. They went on to recommend improving communication between OPOs and Transplant Centers as a solution rather than limiting the number of acceptances. Another recommendation was to enhance DonorNet to allow centers and OPOs to see on the match if a candidate has simultaneous acceptances for more than one organ.  This would allow OPOs and transplant centers to prepare with backup candidates. Another attendee recommended allowing two acceptances for DCD organs in the event of non-arrest. One attendee commented that due to the region being geographically isolated, they don't always have access to frequent liver offers for their high MELD candidates. Limiting the acceptances to one will be detrimental to these candidates who may not receive another offer in time. Another attendee commented that there are many things that contribute to holding two offers for a candidate that are not considered in the proposal. Often surgeons don’t know until they are in the operating room if the liver will be right for their patient. One attendee was concerned that limiting the acceptances could place pressure on smaller volume programs to accept higher risk organs and could worsen outcomes. They added that the reasons for late declines should be explored in more detail. One attendee commented that late declines are very challenging for OPOs and often result in non-use of the organ.

OPTN Lung Transplantation Committee | 09/15/2023

The OPTN Lung Transplantation Committee thanks the OPTN Organ Procurement Organization (OPO) Committee for this proposal. The Committee emphasized concurrent acceptance is not common in lung transplantation and it is important to retain this option for the rare circumstances in which it is needed. Members urge the OPTN OPO Committee to make an exception for donation after circulatory death (DCD) donors as they become more utilized. A member noted this concurrent acceptance practice is only a problem in liver transplantation and concurrent acceptance is used in lung transplantation when it is essential for more aggressive transplant program practices.

OPTN Liver & Intestinal Organ Transplantation Committee | 09/15/2023

The Liver and Intestinal Organ Transplantation Committee is concerned with the unintended consequences that may be affiliated with this proposal, specifically for pediatric candidates, small statured candidates, candidates with high Model for End Stage Liver Disease (MELD) or Pediatric End-Stage Liver Disease (PELD) scores, and candidates who are Status 1. The Committee is concerned that limiting the number of organ offer acceptances for these candidates could impact their ability to access transplant in a timely and efficient manner. It is important to note that the dynamics of a liver offer are different than other organs and most of the information needed to make an acceptance/decline decision is not available until the procurement team is in the operating room (OR). This proposal would limit the ability of liver transplant programs to make informed decisions in the best interest of their highly medically urgent candidates. Furthermore, OR times are typically dictated by the thoracic organs and can be days from the time the liver is accepted for a candidate. Because liver transplant programs are not able to control the OR time, they often get other offers between the time the original offer is accepted and the OR time for the original offer. In order to act in the best interest of their patients, it is imperative that liver transplant programs retain the ability to accept multiple offers for highly medically urgent candidates, small statured candidates, and pediatric candidates, who already have limited access to transplant. 

The Committee is also concerned that this proposal lacks supporting data for pediatric candidates and region-specific data. The Committee questions the lack of data about the quality of donor grafts that could be impacted by this proposal. Further, the Committee noted that this proposal could disincentivize transplant programs from accepting marginal grafts.

The Committee agrees that late turndowns are a problem, but this proposal would only shift the burden of this problem from the host OPO to the transplant programs and potentially harm the potential recipient, the most important stakeholder in the process. Rather than limiting the autonomy and informed decision making of liver transplant programs, the Committee suggests the OPO Committee consider efforts to improve communication between the host OPO and transplant programs and standardize how OPOs process pre-procurement information, which would give transplant programs better information to make an informed decision about an organ offer prior to the OR. Examples include standardizing when organ placement is declared, imaging on potential donors to determine liver size, and informed collaboration about donor times when possible.

If the OPO Committee moves forward with this proposal, the Liver/Intestine Committee strongly suggests that the proposal be modified to continue to allow for multiple acceptances for candidates with a MELD/PELD score above 35 or who are Status 1, as these are the most urgent candidates. The Committee also suggests considering amending the proposal to allow for multiple acceptances outside a certain timeframe from procurement. However, as noted, OR times often change so the Committee recognizes this would be a challenge. 

The Liver/Intestine Committee appreciates the OPO Committee’s efforts to improve efficient allocation and increase utilization but believes there are more effective avenues to impact these goals besides this proposed policy.

American Society of Transplantation | 09/15/2023

The American Society of Transplantation (AST) generally supports the proposal, “Modify Organ Offer Acceptance Limit.” This proposal is an important first step towards aligning the allocation system with the goal of increased efficiency and improved organ utilization. The AST offers the following comments for consideration:

• In addition to the allocation inefficiencies outlined in the proposal that result from late declines, these inefficiencies also prompt equity concerns as deviating from the match is sometimes necessary to avoid discarding a transplantable organ.

• For additional context, consider that within Eurotransplant there is a policy that a recipient, who accepted an offer, will not receive any new offers unless the organ is turned down by the center after it was initially accepted.

• The AST suggests reconsidering the appropriateness of incorporating exceptions to this policy:
o Adding exceptions will increase the risk of non-utilization which is counter to
the goal of this proposal. If thoracic-specific and liver-specific exceptions for
DCD donors can be crafted in a way that doesn’t limit reduction of non-
utilization, then AST would support those approaches.
o The AST believes exceptions for patients of the highest medical urgency
where delay in organ acceptance may risk patient death, e.g., high priority
pediatric patients, would be reasonable. The proposed policy would be
strengthened if there was a pathway to facilitate multiple acceptances in
these scenarios to circumvent considerations about policy noncompliance.

• If feedback indicates this proposal is not supported, an alternative would be to set a time limit “prior to procurement time” (e.g., within six hours of the donor OR time) for which a program must “choose” between the two offers.

View attachment from American Society of Transplantation

Neeraj Sinha | 09/15/2023

I support the modification proposal. Even with the modification, programs will still get more offers after first acceptance, and they can turn down the already accepted one, and accept a new one.

Anonymous | 09/14/2023

I do agree wasting time is not beneficial to the patient or our community. However, I do believe OPO's getting testing done in a reasonable time period will decrease these problems since OR will be set. I also believe it should be a requirement to get LHC for anyone over 40 or with a significant smoking history, since more than often, they are asked to complete one for most centers before deciding on acceptance. I understand the hospitals completing these tests for the OPOs sometimes have difficulty facilitating testing in a timely manner, more than someone backing out at the last minute. Honestly it is whichever OPO moves faster, especially when you have a sick heart patient, and you are trying to accept the best option for your patient.

Legacy of Hope | 09/14/2023

We appreciate the opportunity to provide feedback on the proposal: Modify Organ Offer Acceptance Limit, Policy 5.6.C. In our opinion, this is an example of a well-intended policy that unfortunately has resulted in unforeseen downstream consequences. By allowing a transplant center to have two organ offer acceptances for each organ type, there has been an increase in last-minute organ declines, out-of-sequence allocation and most importantly organ discard. The best solution is to modify Policy 5.6.C to only allow one primary organ offer acceptance. For extenuating circumstances defined in other solution recommendations, we encourage transplant centers and OPOs to work collaboratively on a case-by-case basis.

American Society for Histocompatibility and Immunogenetics | 09/14/2023

This proposal is not pertinent to ASHI or its members.

View attachment from American Society for Histocompatibility and Immunogenetics

George Surratt | 09/13/2023

As a two-time transplant patient, ten years apart, I would like nothing more than for me and my medical team to have the luxury of simultaneous choice between two organs. However, I would not desire such a choice if there is an undue risk that another patient is not able to undergo a transplant as a result.

Region 5 | 09/13/2023

Sentiment: 7 strongly support, 7 support, 1 neutral/abstain, 5 oppose, 5 strongly oppose

Region 5 strongly supported the committee investigating the reasons for late declines and how to reduce or eliminate the late declines. While several members expressed support for the intention of the proposal they believed the real problem is with late declines. They explained that it is a huge problem for an OPO to have a late decline. To not allow a transplant center to accept two offers for the same recipient may result in candidate death because the offer may not come through for many reasons. They suggested to focus on how transplant centers can collaborate, be transparent, and increase communication. Late declines may result in someone far down the match run to receive an organ, but there are ways to mitigate this. They suggested to utilize the hard backup, and make transplant centers accountable for being a hard backup. This would mean that the transplant center has to communicate how likely or unlikely they are to accept the offer. If a simultaneous offer exists, then the transplant center should communicate that to the OPO. If the hard backup is because the first donor is questionable, if the OPO has not gotten a biopsy and that might not occur, the OPO should tell the transplant center hard backup why they’re a hard backup. They suggested the solution is more consistency across OPOs, more accountability and transparency, while also not limiting the clinician’s ability to provide the best patient care. An attendee requested the committee to define who are “higher status candidates”.

·Attendees expressed concern about DCD offers and suggested an exception pathway for pediatric candidates. An attendee suggested that the Committee investigate the details of the late decline, and even require more robust justification for the decline, and determine if certain centers are declining more than others and why. Several attendees pointed out that pediatric candidates may be impacted more severely by late declines and that the committee should investigate.

·A member suggested that an additional metric should be to see is how long it takes an OPO to deliver the final necessary data to determine acceptance, since one factor in late declines is delays in obtaining data (i.e. pathology).

·A member explained this proposal is the most equitable solution at this time. Whether late declines are related to multiple offers, this causes out of sequence allocations. This is a big problem and its disadvantaging patients right now. Patients are being bypassed because we can’t get these livers to the next appropriate patient on the list.

·An attendee said this will impact the sickest patients and suggested eliminating 2 offers going under 8 hours. Another suggestion, that policy should be modified to exclude donation after cardiac death (DCD) offers and patients who are extremely sick like status 1 candidates and candidates with MELD >35. Several attendees suggested an exception or alternate pathway for DCD donors since they may not end up donating and therefore are less of a "guaranteed" organ. Several attendees suggested to put late declined organs on a pump in order to offer additional time for re-allocation.

·A member suggested that UNOS and OPOs should document the frequency of late declines and publish data by center. The centers that participate in late declines frequently need to be examined. The ability to accept two livers for a very sick patient needs to be preserved (where it would be okay for lower MELD candidates but most simultaneous offer acceptances occur in candidates highest on the match run). The magnitude of the 'problem' of simultaneous offers is small. The problem of late declines is far larger than this population. As the MPSC has suggested, track and report rates of late declines by transplant centers: disseminate OPOs that do or do not do their best to avoid late declines (for example, some OPOs greatly facilitate pre procurement liver biopsies where as other OPOs never offer pre-procurement biopsies); increase transparency, and utilize “hard back-ups” (offer details about “hard back-ups” to all centers).

·Another attendee pointed out that accepting two donor offer simultaneously for a recipient is very reasonable. The attendee explained that historically, the acceptance limit was even greater than two donor offers. The attendee believed that OPOs should take more initiative and responsibility to inform the transplant centers who are below the primary recipient, that the primary recipient has two offers, and that the transplant centers should be ready to accept the 2nd organ if turned down by the primary candidate. 

Amy Evenson | 09/13/2023

I appreciate the concerns from the OPOs and interested parties in addressing this potential inefficiency in our allocation system. As a surgeon who advocates for my patients' best interests, I feel the need to represent their perspective. Patients at the top of the list (Status 1, MELD >35) often have a very limited window to receiving an organ prior to becoming too sick for transplant. If any version of this policy is adopted, there should be an exception for these patients to have more than one organ accepted. For example, our center is aggressive in considering offers and often accept DCD offers. If I have accepted a DCD that then does not progress, my patient will have missed out on any potential offers that have been made between the acceptance and knowledge of the ultimate usability of the DCD organ -- possibly 24-36 hours later. Further, under this policy, to hedge against the risk that the DCD may not progress, I may end up declining the DCD if another offer comes up leading to a late decline and possible non-use of the DCD. This goes against the overall goal of the entire transplant community to increase the number of organs transplanted. Allowing 2 acceptances, especially for high MELD/Status 1 patients, would avoid this issue.

I have always tried to be very upfront in my communications with OPOs when I have 2 acceptances for a patient to allow the system to be as efficient as possible and decrease the risk of non-use of organs. Finding ways for OPOs and transplant centers to work together will likely go further than imposing this restriction on our patients' opportunities for transplant.

OPTN Pediatric Transplantation Committee Meeting | 09/13/2023

The OPTN Pediatric Transplantation Committee thanks the OPTN OPO Committee for the presentation and opportunity to provide feedback. While the Committee shares the OPO Committee’s concern about out of sequence allocation and the connection to concurrent acceptances (especially for liver), it is hesitant to support this proposal without additional data. The Committee urges the OPO Committee to look at additional metrics in the data analysis, especially those that provide information about impact on pediatric candidates. 

First, the Committee suggests looking at how many of the multiple acceptance events were for pediatric candidates and for pediatric donors. This is important to take into account because reducing the offer acceptance limit may impair access for highly sick and hard to match pediatric patients. Second, the Committee suggests investigating the mean time between first and second acceptances, as this may yield helpful information about the intent behind the concurrent acceptance. Depending on this timeframe, it also may be possible to put a time cap for a period in which programs are allowed to have multiple acceptances out. Similarly, data about whether the first or second organ is being turned down should be taken into account, as this may provide important information about intent of the transplant program. For example, the first organ was turned down, this may be indicative of a center having a back-up plan for a difficult to match candidate. However, it could also be indicative of centers using out of sequence allocation in an inappropriate manner. Also, information about whether concurrent acceptances are creating delays in procurement of other organs would be useful. The Committee agrees that if there is strong evidence that concurrent acceptances benefit very sick or hard to match patients, the Committee should consider allowing concurrent acceptances for these populations only. Additional data in these areas would be helpful in determining the appropriate fix for concurrent acceptances. 

The Committee notes that while the data on concurrent acceptances and out of sequence is concerning from an efficiency standpoint, it is very difficult to evaluate the impact of this proposal on pediatric candidates because they were not taken into account specifically in the analysis. Members suggested also looking into this across organs and ask the OPO Committee to consider developing a set of best practices. Overall, members were hesitant to provide support of this proposal without the additional suggested data analysis and pediatric-specific metrics.

Anonymous | 09/12/2023

Multiple organ offers slows down allocation, decreases placement efficiency as well as makes arranging donor OR much more difficult. The ripple effect this has extends beyond the OPO and allocation but also transplant programs ability to schedule appropriately for backup patients, increases recipients hospitalization which in turn may increase medical costs, extends donor case timing which in turn affects the donor family as they wait for an OR to be set.

Region 11 | 09/12/2023

Sentiment: 5 strongly support, 3 support, 1 neutral/abstain, 3 oppose, 3 strongly oppose

Multiple members commented that high MELD and status 1 candidates should be able to have more than one acceptance to improve their chance of receiving a timely transplant as a delay, such as length of time to O.R., could be life threatening. Multiple members agreed there should also be exceptions in the case of an offer from a DCD donor as only 50% of DCD cases proceed to donation and also to avoid discouraging programs from accepting DCD offers and potentially lead to increased non-utilization. Multiple members commented that because there is often an extended time period between acceptance and OR time, the official acceptance of the organ should occur at some standardized timestamp before OR. Some members commented that 4 hours before OR would be acceptable and others thought that was too close to OR time and recommended 6 hours to allow time for reallocation. A member commented that because of the time between offer acceptance and a scheduled OR time, there should be a backup plan for the organ, including expeditated placement or machine perfusion to ensure the liver is transplanted. A member commented that because lungs can deteriorate over time, they support the idea of being able to accept two offers for higher status patients. A member commented that a program should only be able to hold one primary acceptance and gave an example in which a liver is turned down late because the program was holding onto two primary acceptances and by the time the second offer is turned down, the organ has too much cold time to reallocate. A member commented that holding more than one offer for a patient increases the risks for non-utilization especially in areas where local transplant programs are unable or unwilling to recover organs with short notice; a program should accept the organ with the best chance of successful transplantation for their patient but should not keep other organs from utilization for other recipients.

university of iowa | 09/12/2023

based on the data presented- organs being allocated to less sick recipients and higher organ discard rates following dual primary acceptances, to align with the goals of equity and improved organ utilization it seems that the current policy allowing a center to hold two primary offers should be abandoned.

Midwest Transplant Network | 09/12/2023

This causes huge strain to not only OPOs and the allocation process but also to other incoming teams that are trying to schedule around this. Data shows this is not effective for anyone other than allowing cushion to the liver programs but the overall effectiveness in transplantation is not there

OPTN Pancreas Transplantation Committee | 09/12/2023

The OPTN Pancreas Transplantation Committee thanks the OPTN Organ Procurement Organization Committee for their work and the opportunity to comment on this proposal.

Overall, the Committee supports the proposal and provided the following feedback for consideration:

•Time limit to accept an offer - if an organ recovery is scheduled and the program receives another offer less than 2-3 hours before the scheduled organ recovery time, they can turn down the offer and accept another one, which may impact late turndown. 

•If a program is being offered a donor after cardiac death (DCD) and a brain-dead donor, and the DCD is the preferred organ but does not progress, then a patient who is high on the waiting list may miss out on the opportunity with the other donor. 

The Committee suggests consideration for DCD exceptions as well as clarifying that the policy applies when programs accept offers from two OPOs.

OPTN Operations and Safety Committee | 09/11/2023

The OPTN Operations and Safety Committee thanks the OPTN Organ Procurement Organization Committee for their work and for the opportunity to comment on this proposal.

Committee members provided the following feedback:

•There was a question about how often the second liver that is declined goes to a lower status patient at the same center. 

•There was a comment about how the liver transplant community is outspoken about the need to accept two offers, but that has a salutary effect on multi-organ allocation where the kidney is being held while waiting for multi-organ placement.

•There was a comment about last-minute declines and the need for a time limit. If an OPO is waiting for a recovery team to arrive and then they accept another offer, there really needs to be a time limit for transplant programs to decide on which offer to accept. Organ allocation is complex and when one organ is declined it can impact the recovery and placement of all organs. There is also a transparency component and the need for communication between the OPO and transplant programs.

•There was a comment that this is a behavioral issue that needs to be tracked. If this is a behavioral issue for certain transplant centers, the community should better understand why it is happening so that other centers won’t have to be penalized by having policies that might be detrimental to their patients.

•There was a comment that backup offers exist because if an OPO requests a transplant center serve as a backup when there are two acceptances, that center should take it seriously.

•There were several comments in support of an exception for donation after circulatory death (DCD) because the number of DCD donors is increasing each year. 

•There was a comment in support of an exception for high MELD patients because those patients benefit from having two acceptances. 

International Society for Heart and Lung Transplantation | 09/11/2023

The International Society for Heart and Lung Transplantation (ISHLT) appreciates the opportunity to provide feedback on the “Modify Organ Offer Acceptance Limit” OPTN Public Comment proposal. Feedback was solicited from the ISHLT Advocacy Committee, the ISHLT Advanced Lung Failure and Transplant Interdisciplinary Network Steering Committee and the ISHLT Advanced Heart Failure and Transplant Interdisciplinary Network Steering Committee

Although ISHLT recognizes the critical need to reduce organ non-utilization, members raised concerns about the impact on waiting list mortality, particularly for critically ill and difficult to match thoracic organ transplant candidates. ISHLT believes that this blanket proposal restricting all candidates to a single primary offer acceptance is not appropriate unless mechanisms are put in place to allow exceptions. Moreover, ISHLT believes that considering criteria and exception pathways separately by organ will be needed to strike an appropriate balance between non-utilization and waiting list mortality. ISHLT recommends that the committee develop organ specific exception criteria for difficult to match, critically ill candidates. Recognizing that backup recipients for DCD donors may be a particular challenge, ISHLT encourages the committee to consider including explicit conversations between transplant centers and OPOs when exceptions are needed to ensure that adequate backup candidates are in place.

View attachment from International Society for Heart and Lung Transplantation

American Nephrology Nurses Association (ANNA) | 09/11/2023

ANNA supports this proposal as it pertains to kidney transplant allocation.

Region 2 | 09/05/2023

Sentiment: 11 strongly support, 8 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose

Overall members of the region are supportive of this proposal. Attendees noted concern with OPOs facing late declines just prior to the surgery, resulting in out-of-sequence allocation or non-utilization. There was agreement that establishing mandatory guidelines could contribute to a smoother processes and better outcomes. One attendee did express concern for the need to understand the definitive reasons behind the non-utilization rates discussed in the proposal. The committee should ensure that non-utilization was not based on factors such as biopsies or other considerations that might not have been taken into account initially. Another attendee also noted the necessity of still allowing two acceptances for high panel reactive antibody (PRA) patients. It was suggested that these patients might need to be given special consideration given their specific medical needs.

Assad Hassoun | 08/31/2023

Often times we get an offer, especially liver, for a high MELD and very sick patients and accept a borderline acceptable quality organ and having a chance to get a better offer in the interim to avoid morbidity, long hospital say and ICU cost, definitely worth having that chance.

sara clark | 08/30/2023

The goal is to save as many lives as possible through organ transplant. The possibility of an organ going to waste and not being used because transplant centers are being greedy is wrong on so many levels and contradicts the entire purpose of organ donation.

Region 4 | 08/30/2023

Sentiment: 4 strongly support, 10 support, 3 neutral/abstain, 3 oppose, 3 strongly oppose

Region 4 was split in their support of this proposal and had substantiative feedback for the committee. Several attendees agreed that the proposal was needed and would improve placement efficiency and organ utilization. They went on to comment that late turndowns sometimes result in the loss of an organ, which is unacceptable. There were several attendees who did not support the proposal due to concern about how this would impact pediatric candidates who are already limited in the organs they can accept due to size matching, organ suitability and travel distances.  There were also several attendees who were concerned about how this policy would impact adult liver candidates with high MELD scores. This practice is needed for these high MELD candidates who have high mortality without a transplant and need to have access to appropriate quality organs. Another attendee added that highly sensitized candidates need to be allowed to have more than one offer acceptance. One attendee commented that late turndowns are often due to late biopsy results and if OPOs were able to get biopsy results earlier in the process, centers could make decisions earlier. One attendee supported limiting acceptances for liver candidates but commented that this should not apply to kidney acceptance since there is no perceived problem with late turn downs for kidneys.

Catherine Kling | 08/29/2023

I strongly oppose this proposal. As a Region 6 member, we are geographically isolated and don't always have access to frequent liver offers for our high MELD candidates. Limiting candidates access to offers, will be detrimental and potentially dangerous for our patients.

This is policy is being offered a solution to out of sequence allocation, however data provided in this proposal showed that only 15% of late turn downs in the setting of simultaneous acceptances for liver are allocated out of sequence. The vast majority (85%) follow the match run. This is in the comparison of 10-12% of all livers being allocated out of sequence (and some months up to 16%).

An intermediary solution is to provide better information sharing. Transplant programs are currently unaware when a liver has been accepted by a candidate who has another simultaneous acceptance. Sharing this information readily through the match run would allow transplant programs to prepare with a backup candidate.

OPTN Transplant Coordinators Committee | 08/28/2023

The OPTN Transplant Coordinators Committee thanks the OPTN Organ Procurement Organization Committee for their work and for the opportunity to comment on this proposal.

 A member asked if transplant programs are only allowed one organ offer acceptance, will the timeframe and parameters around holding the provisional yes on the other offers be strengthened? Response timeframes are established by policy and OPOs and transplant center processes for those should not be impacted. A member commented that once operating room times are set, transplant centers should be required to decide on an offer and commit to it to ensure fairness to other transplant centers.

A member suggested having an exception to encourage centers to accept donation after circulatory death (DCD) organs, although it was recognized that DCD donors make up a relatively small proportion of these concurrent acceptances. The member also recommended, if this policy change is approved, that the Committee be prepared to take action if there are unintended consequences when it comes to DCD donors, specifically waitlist deaths. The member said overall the proposal helps address logistical issues with rapid organ placement and is asking transplant centers to remain accountable to their decisions.

Anonymous | 08/28/2023

This is a solution looking for a problem. Changing this does not address the many issues in play with late declines and potentially could be disastrous for very sick patients when the first offer falls through.

Harish Mahanty | 08/28/2023

I do agree that late declines of liver allografts can lead to graft discards. We all need to be better stewards of the process and that includes accepting centers as well as the opo’s. However limiting the number of concurrent offers to a recipient may inhibit these sick patients from being transplanted and is likely not the answer to limit organ discards. It is unclear to me if multiple acceptances for a single recipient is the major cause for late declines . More data is needed to determine if acceptance of this proposal will make a significant difference in the late decline rate.

Robert Osorio | 08/27/2023

I know the frustration of late declines in liver allocation however to prohibit center from accepting more than one offer when they have a sick patient awaiting transplantation could threaten that recipient's life.

We are all trying to use as many grafts as possible; thus, it is common that the first offer one accepts is unsuitable for transplantation (may be a DCD that does not expire or a marginal graft that is too fatty). Without the ability to back up with an alternative offer will place that recipient at risk of not getting another offer in time.

More effort should be placed on publicly publishing centers last minute decline rates. Thus, identifying why these centers have such high rates and potentially,
improving individual practices. OPOs also need to facilitate as much data as possible to evaluate grafts prior to procurement (such as pre-procurement liver biopsies).

I strongly oppose a modification to organ acceptance limits.

James Pomposelli | 08/26/2023

It is certainly understandable where the support for this proposal comes from. Late turn down of organ offers creates confusion and delay. However, are there better ways to avoid this problem? Some solutions have been suggested in other comments. More aggressive use of pre donation biopsy, use of emerging technologies such as cold and normothermic perfusion, better communication and coordination between OPO’s and transplant programs will relieve much of the stress on the system.

Not uncommonly, unrealistic time constraints are placed on transplant programs to procure organs within narrow time windows which contributes to the problem that this proposal seeks to fix. Conversely, when there is a “perfect donor,” abdominal organs such as liver can be offered literally days before thoracic organs are placed and the procurement time set. This is understandable as the OPO wishes to maximize utility. But in such a scenario, I have used a less desirable donor (second offer) that was offered to my recipient later but proceeded to the operating room sooner (no thoracic organs) so I could save their life before they died. With this proposal, a single offer that is drawn out over days could be the difference between life or death. This “one size fits all” approach is fool hardy and dangerous for our patients.

Ryutaro Hirose | 08/25/2023

While well-intentioned, this is not the solution to late declines.

Late declines are definitely problematic and a challenge to OPOs. We as a community can do better. OPO directors have said we have tried and have made no progress. I contest that we have REALLY actually 'tried'. We need to capture the data and disseminate it . Late declines undoubtedly lead to more expeditied placement. Some OPOs refuse to or do not offer pre-procurement biopsies under any circumstances. Some transplant centers participate in late declines in a large %age of livers the accept. There are areas for improvement on both sides. The data should be collected and made transparent. The reasons for late declines need to be collected in a systematic fashion, and outliers should potentially be examined by the MPSC.

To limit acceptances to one liver for a sick status 1a or high MELD patient, when we all know that a DCD may not pass, or there may be intraoperative findings that make a donor an unproductive donor or an unusable liver occurs with some frequency. To not allow a program to accept a second liver simultaneously may likely result in the death of that patient if another offer does not come in time after that discovery.,

This proposal is not the right solution to the very real problem of late declines - which occur with frequency without simultaneous offers being a factor. The late decline of a liver offered to a candidate with simultaneous offers may indeed lead to other patients at a lower MELD getting a transplant. This may or may not even be a problem. If a center who was indeed a hard back up feels that the liver turned out to be one that they did not feel was right for a patient at the top of the list, a patient further down may be an appropriate patient to receive that liver.

The data that suggests that the magnitude of this problem (simultaneous offers accepted by a single recipient) is outsized is not convincing.

Overall, we should adopt many other previously suggested interventions (at the system optimization meeting etc). This includes 1) better documentation of all late declines - long overdue and being addressed in MPSC 2) transparency and reporting of transplant programs' practice patterns and reasons for late declines e.g patient detioration vs 'size', etc. 3) examination of different OPO practices that prevent, ameliorate and accomodate (OR promote and contribute to) late declines. 4) mandate and encourage good communication between transplant programs and OPOs when a center has more than one accepted offer to coordinate timing (even between OPOs) when simultaneous offers are being accepted 5) encourage pumping of livers with normothermic pumps to extend the time that would be available to place organs that have potential for a late declines. Lastly, we could allow 2 offers to status 1, higher MELD patients, and only limit to one acceptance to those candidates with lower MELD scores. These would at least not threaten the lives of very sick patients who may need the flexibility to be in for two livers until one is shown to be useable for that candidate.

Joseph Magliocca | 08/24/2023

I have significant concerns that this policy change will negatively impact several patient populations on the list that are also the most vulnerable. I am speaking from the perspective of a liver transplant surgeon.
In the most critically ill patients, it is unpredictable when they will receive a suitable offer. Very often we will accept the "best available" option of two non-ideal options. In that case, our procurement teams will go to assess an organ, and if there is an issue, will turn it down and opt for the second organ. With good communication, I don't believe it is unduly burdensome for an OPO to have a backup center that is willing to accept the organ should the first back out.

The second population is the pediatric population since it is always challenging to find appropriately sized organs with favorable anatomy for a child. Very often these issues are not clearly evident until actual visualization of the organ. Once again, with good, honest communication between transplant centers and OPOs, having a backup center does not seem to be particularly onerous.

I have personally been on both sides of this scenario as primary center and backup center. I can see the potential for abuse, but we need to act in good faith and not put vulnerable patients at risk. Should this policy be considered, specific exceptions or conditions need to be included.

Caroline Jadlowiec | 08/17/2023

I support the proposal. The current OPTN policy, which allows for a transplant program to accept two organ offers for any one candidate, leads to unnecessary late declines and allocation changes. Exceptions to this rule should, however, be made for high acuity and high MELD patients.

Robert Cannon | 08/15/2023

This proposal would likely be highly detrimental to the sickest patients in whom any delay in transplant could mean the difference between life and death. The ability to accept two offers at any given time allows such patients to have a backup organ in place should the originally accepted organ turn out to be unsuitable for them. The proposed policy would increase the amount of time required to find another organ, and during this period the patient may deteriorate to the point where transplant is no longer possible. The problem of late reallocation and wasted organs would be ideally addressed if the accepting transplant center makes it clear they have another offer accepted for the patient so the OPO can seek a strong backup. I am not so naive to think that this always happens, so an alternative policy to address this problem would be to alert OPOs within donornet when a candidate who has accepted an organ from them enters another acceptance. Such a policy would allow a backup recipient to be sought. This would need to be accompanied by oversight to ensure that OPOs do not bypass such candidates to avoid seeking a backup candidate.

Luke Masha | 08/15/2023

I strongly support this proposal. As a transplant physician, the current practice leads to situations where transplant centers have uncertainty about the eventual availability of an organ. We have found that some centers when they are entertaining two organs offers for the same patient, wait till the very last minute to make a decision which leads to organ non-use as such last minute decisions do not allow other centers to scramble a team in time to procure an organ. Some centers even simply run into issues with assembling their procurement team and thus at the last minute cancel the earlier procurement and take the organ with the later procurement, leaving no time for other centers to go acquire the other viable due to the last minute cancellation. Furthermore, centers that are told they are backup for such organs have to act on that information in a timely manner which could mean things like bringing patients in to reverse their warfarin. If the organ ends up falling through, a recipient then has to manage a long lovenox/warfarin bridge (where they are refractory to warfarin for weeks potentially) due to receipt of high dose vitK.

I have been extremely frustrated by the current practice because almost with certainty some organs never end up being used as a result. Logistically transplant centers need a certain minimum amount of time to procure and organ and the current practice gives no cutoff time or limitation to how long a center can wait before finally giving up the other viable organ. I fully support limiting centers to the acceptance of just one organ at a time and see no positive benefit from the current practice as it stands.

Mississippi Organ Recovery Agency | 08/10/2023

Thank you for the opportunity to comment on this modification to the current policy on organ offers. Every year the Mississippi Organ Recovery Agency works extremely hard to increase the number of organs available for transplantation. One of the biggest challenges is the current policy allowing a transplant program to accept two organ offers for the same patient at the same time. The recent presentation on July 20,2023 by PJ Geraghty, Vice President of Clinical Services for Donor Network of Arizona, provided data that supports this statement of the challenges faced by organ procurement organization. On average, concurrently accepted livers are turned down 1.5 hours prior to crossclamp and lungs five hours prior to crossclamp.

Our experience at MORA echoes the information shared during this webinar. We repeatedly have seen where a transplant program will accept two organs for the same patient and then try to manipulate the organ recovery to occur at the same time. They will then send out two recovery teams and pick the best organ for their recipient and leave the other organ to be frantically placed by the organ procurement organization. Sometimes this is even after they have recovered the organ, they will decline it and leave it behind for the organ procurement organization to hopefully place with the other transplant centers who have agreed to be a backup. Unfortunately, sometimes those centers back out for timing based on when the originally accepting center declines the organ they accepted. This manipulation of the organ allocation system by a group of transplant programs is detrimental to the system and a dishonor to donor families. Too many organs have already not been transplanted because of this practice.

Sincerely,
Kevin Stump
President / CEO
Mississippi Organ Recovery Agency

Anonymous | 08/06/2023

In general, I don't oppose limiting multiple offer limits, however there should definitely be exceptions made for high MELD and DCD as these high MELD recipients need expeditious treatment and DCD donors have only 50% chance of progressing. Additional exclusions should include offers from an OPO that has not yet set an OR time, especially in the case where a recipient is a high acuity recipient where time is of the essence. These patients may die without transplant waiting for some OPO's to move the donor to the OR for procurement. For some OPO's this time frame can be quite prolonged between initial organ offer and donor organ procurement.

Texas Children’s Hospital | 08/03/2023

This would be a huge detriment to the pediatric population. These patients face the extra burden of size matching as well as the logistical complexities of longer travel distances. They are often the recipients of technical variants which is limited by clinical constraints and quality of the allograft. This means that every opportunity they have to potentially find a match is vital. It is not unheard of for a child and their family to come in for >10 “dry runs” before they are successfully transplanted. Limiting the chances for a potential match makes a challenging problem even more difficult in a population that is already disadvantaged and underrepresented. We highly oppose this policy proposal on behalf of the pediatric patients though the life-threatening implications for high MELD adult liver patients also exists.

Anonymous | 08/01/2023

With so many people waiting on organs, it seems a travesty that this would not have been the policy all along. One unused organ is one too many. This action should help in the drive to increase the donor base if the public is assured organs will not be wasted.