Comments

OPTN Transplant Coordinators Committee | 09/29/2022

The OPTN Transplant Coordinators Committee thanks the Kidney Transplantation Committees for their work and for the opportunity to comment on this proposal. One member expressed support for the proposed changes. The member agreed that renal imaging should be required, and noted that many other KPD programs utilize an image uploader that allows programs to easily access and view that information and make informed offer decisions off the bat. The member added that having that information upfront can prevent last minute exchange failures, and noted that most surgeons want to review the actual images themselves. The member agreed that the renal images should be available within three business days from time of match offer. A member asked for clarification on the rationale to require centers to obtain a signature from bridge donors with a statement of willingness on how long they are willing to participate as a bridge donor. The member explained that this seems counterintuitive, as programs continuously educate donors on their right to change their mind at any time, and informed consent should be an ongoing process. The member added that operationally, requiring a written signature is outdated, and that electronic signature capture technology can be difficult for institutions to implement. The member shared that their program has maintained many of their telehealth services, particularly for donors farther away to reduce their travel and costs. The member expressed support for all other proposed changes. Several members remarked that 60 days from time of match offer to surgery seems too long, noting that the extended time before recovery and transplant is inefficient, and creates a window of opportunity for something to happen to the candidates or donors in the exchange. One member pointed out that, typically, an exchange can happen in a matter of weeks in most other paired donation programs, though most other programs frontload a lot of the patient information gathering and sharing. Members agreed that 60 days from time of match offer to scheduled surgery is too long. Members agreed that a lot can happen in 60 days, and noted that an extended window from time of match offer to surgery can increase the potential for something to happen with the candidate or the donor that could result in the exchange needing to be terminated. Another member pointed out that tighter deadlines could encourage participation in the OPTN KPD Program, as it makes the program more aggressive. One member recommended that the timeframe be shortened to 45 days to surgery, and others agreed that the timeframe could be tightened to 30 days to transplant and recovery. One member noted that 30 days could be difficult for smaller programs, but that it’s a good goal for programs to meet. One member expressed concern for including policy language that requires a surgery to happen within 60 days, noting that there could be potential for donors to sense an element of pressure or coercion. Another member agreed. The member explained that operationally, it makes sense to reduce the timeframe, but that the language should be mindful of that. One member recommended requiring the surgery to be scheduled within 60 days, to allow for necessary variations. The member provided a scenario, that a program schedules the surgery for 59 days after time of match offer, but a deceased donor kidney comes in and the surgeon needs to push the living donor surgery back a couple of days. The member added that wiggle room would be helpful, and that the language could instead require that the programs plan to have the surgery within 60 days. Another member recommended that the approach be instead requiring that all centers involved in an exchange need to agree upon a surgery date within a certain time frame, instead of requiring that surgery needs to happen within a certain date. The member added that this would be reasonable particularly with long chains. The member agreed that leaving this broad could potentially run the risk of the surgery not occurring for months, or something occurring with the candidate or donor that prevent the exchange. A member suggested whittling down the 60 day deadline and instead require programs to agree on a surgery date within 30 days of the offer, to keep the deadlines tight. The member reiterated their concern about requiring a surgery to occur within a specific timeframe. Members agreed that two business days is an appropriate amount of time for programs to review an offer and provide a preliminary response, keeping in mind smaller centers with fewer surgeons. Members agreed that programs could be required to provide a reason for their extension request, and that this could potentially reduce the overuse of extension requests. One member recommended providing a limit to how many times a program can request an extension. Another member pointed out that programs could be tracked on their use of the extension request, such that programs who are always extending or declining offers late could be identified. Members recommended potential reasons for extension request could include patient unavailability, surgeon unavailability, additional testing required, donor unavailability, and operating room unavailability. One member recommended an open text field be provided as well, for programs to provide a narrative. A member suggested that OPTN Policy differentiate between general KPD policy and OPTN KPD pilot program specific policy. The member asked if there was talk of the OPTN KPD Program dropping the “pilot” from the name, and the room agreed that the OPTN KPD program should no longer be considered a pilot. One member noted that the OPTN KPD Program needs to become a more competitive program, particularly in the context of other KPD programs. Another member agreed, noting that during Covid, matches were run once a month, which dis-incentivized programs to add more candidate and donor pairs. Members agreed that a lot of buy in is involved for programs to join a KPD program.

Anonymous | 09/29/2022

The UC San Diego Health Center for Transplantation (CASD) appreciates the opportunity to provide public comment on the proposal to Update Kidney Paired Donation Policy. While we generally support this proposal and appreciate the Committee’s dedication to improving the KPD program’s efficiency, we would strongly recommend that the Committee consider removing the 60 day deadline from the time of match offer to facilitate recovery and transplant. While we completely understand the intent is to ensure the system is not bogged down with tentative acceptances that later fall out, we believe that a recovery and transplant date is best left determined by the programs engaging in the exchange based on their donor and recipient needs. By imposing this deadline we risk creating undue pressure for donors, who in turn may simply decide not to proceed if they cannot decide a surgery date that works best for them. We have similar concerns regarding the proposed requirement for the donor to state how long they are willing to wait for a match as a bridge donor. While it is appropriate for programs to have this discussion with donors on an ongoing basis, requiring a donor to formally attest may discourage their participation longer term when and if needed. This also seems an unnecessary added documentation element for programs when donors retain the right to change their mind at any time, for any reason. • Do the deadlines provide sufficient time to perform the required tasks and review the match offer? With the exception of the proposed 60-day deadline to facilitate the recovery and transplant, the deadlines seem reasonable. The recovery and transplant date is best left determined by the programs engaging in the exchange based on their donor and recipient needs. We would propose alternatively that centers involved in the exchange be required to schedule (as opposed to complete) the procedures within 30 days. • Is the 60 day deadline from time of match offer to recovery and transplant surgery appropriate? See above. • Should the deadline for the provision of a preliminary response be shortened to one business day from receipt of match offer, or is two business days more appropriate? If so, why? Two business days is more appropriate, particularly for smaller programs that may have limited staff. Reducing this timeframe is likely to result in issues similar to the provisional yes we see on the deceased donor match run. • How can overuse of extension requests be discouraged? How can better performance be incentivized in the program? Generally, we agree that tightening the deadlines as proposed here will incentivize better performance however, the OPTN could certainly become more competitive by offering similar benefits as other external KPD programs. • Should clinical donor information, such as renal images, be specified as required donor information made accessible to the matched candidate’s transplant hospital within the three business day deadline? If so, why? We agree this is reasonable and would help centers to more effectively determine if they are interested in pursuing a donor while pending HLA results. It will likely decrease the opportunity for later declines in the process. • Should the donor’s entire evaluation record, including renal images, be made available in the OPTN KPD System at time of match offer? If so, what is the rationale? See above. • Should policy specify that transplant programs obtain a signature from bridge donors confirming informed consent and the estimated period of willingness to be a bridge donor? If so, why? See comments above re: a donor’s statement of period of willingness. While we do agree that programs should fully educate their potential bridge donors, requiring a signature to this effect seems an antiquated practice in 2022. Informed consent is an ongoing process spanning the donation journey based on each donor’s needs and level of understanding. Further, while there are some electronic signature services available, the pandemic highlighted this as an operational pain point for many programs attempting to otherwise implement telehealth practices.

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Anonymous | 09/29/2022

ANNA supports.

National Kidney Foundation | 09/28/2022

The National Kidney Foundation thanks OPTN for the opportunity to comment on this policy proposal. Please see our attached comment letter. Thank you.

View attachment from National Kidney Foundation

Anonymous | 09/28/2022

The Living Donor Committee thanks the OPTN Kidney Transplantation Committee for their efforts in developing this public comment proposal, Update Kidney Paired Donation Policy. The Committee supports the updates to kidney paired donation policy. The Committee suggests that standardizing clinical kidney paired donor information may increase efficiency. The Committee suggests that policy should clearly state that bridge donors who choose not to continue in a kidney paired donation chain may choose instead to donate directly to the deceased donor waitlist, as a non-KPD non-directed donor. The Committee agrees that it may be difficult to standardize an individual’s estimated period of willingness to be a bridge donor because an individual’s period of willingness may change depending on when the question is asked and giving the opportunity to donate to the waitlist will always allow for the intended donation to take place.

Anonymous | 09/28/2022

Sentiment: 3 strongly support, 17 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose

Anonymous | 09/28/2022

Sentiment: 2 strongly support, 10 support, 3 neutral/abstain, 1 oppose, 0 strongly oppose | This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. One member noted their support for attempts to improve efficiencies in KPD and other organ allocation initiatives, but the coordination of KPD is inherently cumbersome, and holding this component of organ allocation to a strict timeline could have unintended consequences when dealing with multiple centers, multiple donors and recipients, surgical/OR scheduling restrictions, etc. Hence, we do not support the proposed timeline revisions. Another member expressed support for Bridge donors being able to tolerate a period of time to wait before being offered out to the list. The member noted that the timelines in the new KPD offer process seem appropriate.

NATCO | 09/28/2022

NATCO thanks the Kidney Transplantation Committee for its efforts to provide clarity, align policy language with other OPTN policies and to improve efficiency of the OPTN KPDPP program. NATCO supports the proposed changes to Kidney Paired Donation Pilot Program. We agree with increasing communication and consent around bridge donation to improve the donor’s understanding, and to help with timelines. We believe that two business days for preliminary response to match offer is reasonable and gives the programs enough time to review with teams and respond. The additional shortened deadlines for donor information, crossmatch, and donor records are also reasonable to help with efficiencies. We believe that the donor records and images should be made available in the OPTN KPD system at the time of match offer as this will allow for a much more streamlined process for review and may result in less changed acceptances later.

Anonymous | 09/27/2022

Sentiment: 3 strongly support, 12 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose

Anonymous | 09/27/2022

Sentiment: 3 strongly support, 7 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose | This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. One member voiced strong support for this initiative as it should increase speed of decisions and usage of organs. This proposal will reduce action timelines by days. Additionally, there is support for the modification of donor (bridge donor) informed consent to allow donors to make a determination on their match waiting time thus empowering them and increasing their investment in the process. The 60-day time from match to surgery is appropriate and realistic. Keep the preliminary response to the offer at two days as this should prevent requests for more time. Lastly, to keep administrative burden on donors to a minimum, allow for electronic signatures for bridge donor willingness and informed consent.

American Society of Transplantation | 09/27/2022

The American Society of Transplantation (AST) generally supports the changes outlined in the public comment proposal, “Update Kidney Paired Donation Policy.” We offer the following comments for consideration: The AST agrees with setting a 60-day deadline from the time of match offer to transplant surgery. As identified by the committee, this reduces the risk of the exchange breaking while providing enough time for centers to facilitate the transplant. Deadlines are appropriate to improve program efficiency, but language should be changed to “should” instead of “must” when referring to the timing of recovery and transplant surgery. Two business days to provide a provisional response is appropriate; shorter time may be challenging for the lower volume programs with less personnel. Extension requests may be minimized by registering transplant candidates and donors after the complete evaluation and only if they are ready to proceed with transplant. We suggest that the committee explores the use of system alerts, liaison communications, and automated emails as reminders of an outstanding offer. Reminders should be throughout the day and then programs can be alerted to an expiring offer. The incentive is for programs to respond quickly on behalf of their patients. Punitive measures are used by other registries but there is no greater penalty than a lost opportunity for a patient. Expanded language regarding financial risk and potential resources available to defray donation related costs, as well as increasing bridge donors autonomy, is appropriate. The AST recommends that clinical donor information/evaluation records and images be made available to the receiving centers at the time of preliminary offer so that transplant teams can make a quick but informed decision. This avoids late declines due to donor anatomy, etc., which reduces the efficiency of the KPD process. We think this can be accomplished within the 2-business day deadline for a preliminary response. The AST agrees with the OPTN committee’s proposal to shorten the final acceptance/refusal to 10 days. The AST agrees with the committee that breaking exchanges due to administrative reasons is unfair for the patient and granting automatic extension in case of non-response from participating centers is reasonable. We recommend that the committee consider specifying a maximum duration for extension (e.g., 60 days) and a maximum number of extension requests. This will prevent overuse and aligns with the overarching goal of making the KPD process more efficient. The AST agrees with aligning the OPTN KPDPP informed consent with OPTN Policy 14.3. The AST agrees that transplant programs should obtain a signature from bridge donors confirming consent and a period of willingness to become a bridge donor. Although donors are allowed to drop-out of the process at any time, this gives the bridge donor more autonomy. There is agreement that bridge donors should be consulted about informed consent and the estimated period of willingness to be a bridge donor; however, there were differing perspectives on whether the bridge donor’s signature should be required. It was suggested that a signature may be interpreted as a binding agreement, and not altruistic and voluntary. Instead, an alternative recommendation is for transplant programs to confirm assessment of and education to the donor on bridge donation and document these conversations occurred. The AST recommends requiring transplant centers to disclose the presence of multiple KPD programs in the country, including the OPTN KPDPP. This will allow donor-candidate pairs to explore all their options, including multi-listing, to gain access to different KPD programs (included in 13.4.C the last statement). The AST urges the committee to consider a policy for requirements for testing active pairs/donors. Many offers are declined or not viable because patient testing is outdated. Instituting a requirement for patients active in the registry to be clinically ready and suitable for transplantation and donation would result in increased registry efficiency and decrease time to transplant/donation.

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American Society of Transplant Surgeons | 09/27/2022

The American Society of Transplant Surgeons (ASTS) is pleased to provide the following feedback to the OPTN Kidney Transplantation Committee. The recent OPTN proposal on kidney paired donation aims to modernize and update OPTN Policy 13 which has provided a framework for the OPTN Kidney Paired Donation Pilot Program, which has been operational as a national offering since 2010. As of July 6, 2022, there are approximately 60 programs participating in UNOS KPDPP. There have been considerable changes in modern KPD practice, most of which have evolved in the practice of other larger paired exchanges. Do the deadlines provide sufficient time to perform the required tasks and review the match offer? Is the 60-day deadline from time of match offer to recovery and transplant surgery appropriate? The deadlines outlined in the policy proposal do allow for completion of required tasks and match offer review within a reasonable time frame for most kidney transplant programs. There may be some limitations to meeting the deadlines for smaller programs. The 60-day deadline from match offer to recovery and transplant surgery is also a reasonable timeline, but smaller or rural programs may contest this related to issues surrounding operating room availability. Programs will need to respond by only entering donors into the KPDPP if they are ready to go to surgery in the immediate term. This timeframe will also implicitly increase communication between the donor and the donor recovery hospital to ensure effective KPD practice. Should the deadline for the provision of a preliminary response be shortened to one business day from receipt of match offer, or is two business days more appropriate? If so, why? The deadline for provision of a preliminary response for match offer receipt should be two business days How can overuse of extension requests be discouraged? How can better performance be incentivized in the program? Better performance can be incentivized through a points-based system that could, as an example, provide centers with priority for end-of-chain kidneys. Should clinical donor information, such as renal images, be specified as required donor information made accessible to the matched candidate’s transplant hospital within the three-business day deadline? If so, why? Yes, this promotes a best practice in KPD by optimizing the decision-making process by transplant hospitals. It supports transplant professionals and transplant recipients. Transplant surgeons and other providers must have the right clinical information to truly understand the offers they are accepting and denying. This type of approach is utilized in other kidney exchanges. Should the donor’s entire evaluation record, including renal images, be made available in the OPTN KPD System at time of match offer? If so, what is the rationale? The availability of the entire donor evaluation record at the time of offer provides the hospitals and clinical staff (surgeons and nephrologists) with the full picture to facilitate rapid and safe offer decision-making. While there may be some additional burden to programs to get images uploaded for review, UNOS has existing technology that they use in the deceased donor system in DonorNet that could help transplant hospitals with this task. Should policy specify that transplant programs obtain a signature from bridge donors confirming informed consent and the estimated period of willingness to be a bridge donor? If so, why? Transplant programs should be aware of the best practices related to bridge donors, and UNOS should serve as a conduit for dissemination of that information. However, additional policy requirements will not necessarily increase patient safety in anyway. Rather, transplant programs should be encouraged to establish and maintain a bridge donor policy that works for their program, patients, and providers. Adherence to their own policy should be expected for the purposes of regulation. This model mirrors what is in place for multiple other UNOS policies. ASTS would like to note that this program is only one of many paired exchanges that programs can use; UNOS should be careful about being too proscriptive in creating rules. This may act as a disincentive for programs to participate in the UNOS KPDPP, which would be an unintended consequence.

View attachment from American Society of Transplant Surgeons

Anonymous | 09/26/2022

Sentiment: 6 strongly support, 13 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose Comments: An attendee suggested that it might be reasonable to have a mechanism to upload donor imaging and workup in a similar way as deceased donor information.

Anonymous | 09/21/2022

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

Anonymous | 09/20/2022

Sentiment: 3 strongly support, 10 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose

Region 2 | 09/13/2022

Sentiment: 6 strongly support, 16 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. One member recommended that the proposal require patients to maintain updated testing while active in the registry. This will decrease cancelled matches and facilitate cases. It was also noted that KPD programs should be aligned with OPTN policies.

Anonymous | 09/12/2022

Sentiment: 1 strongly support, 6 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

Anonymous | 09/08/2022

Sentiment: 9 strongly support, 21 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

Anonymous | 08/26/2022

Sentiment: 2 strongly support, 17 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

Rebecca Baranoff | 08/07/2022

Yes, the policy should specify that transplant programs obtain a signature from bridge donors confirming informed consent and the estimated period of willingness to be a bridge donor. The transplant program should also continue to provide the bridge donor with a timeline for their surgery and maintain ongoing communication with the donor if there is a long delay.

Kidney Donor Conversations | 08/04/2022

Support policies that decrease wait time, and improve communication & transparency for KPD and living donors.