Comments

UC San Diego Center for Transplantation | 03/15/2023

UCSD Center for Transplantation appreciates the efforts of the Living Donor Committee focused on improving the UNOS Paired Kidney Donation Pilot Program; although we largely agree with the proposal we do not support the requirement for programs to re-obtain the donor’s signature upon re-evaluation confirming that they have been re-informed that they may withdraw from participation in the OPTN KPDPP program at any time, for any reason. While we do agree that ongoing education is important across the donation continuum of care, requiring multiple signatures re-attesting the same fact is not only administratively burdensome but is beyond the minimum necessary standards for safe and effective practices. We would argue that ensuring re-education is documented is sufficient for the purposes the Committee is seeking to serve.

Region 6 | 03/15/2023

1 strongly support, 10 support, 2 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 attendee commented that this would improve patient safety. 

OPTN Living Donor Committee | 03/15/2023

The OPTN Living Donor Committee thanks the OPTN Kidney Transplantation Committee for their efforts in developing this public comment proposal, Align OPTN KPD Blood Type Matching Policy and Establish Donor Re-Evaluation Requirements. The Committee suggests adding Hepatitis B Virus and Hepatitis C Virus as additional infectious disease retesting exceptions for living donors that have previously tested positive for these diseases. Additionally, the Committee suggests that the re-evaluation deadline of a living donor be based on the initial evaluation date. The Committee agrees that 60-days prior notice to the living donor’s re-evaluation date is sufficient. The Committee agrees that a 90-day timeframe is sufficient between notification and potential ineligibility of a living donor for a re-evaluation to occur.

Region 11 | 03/15/2023

3 strongly support, 19 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose

Anonymous | 03/14/2023

I am more alarmed that this policy is not already in place. Further evidence that UNOS is severely lacking in the role they exist to play.

Donor Network of Arizona | 03/14/2023

Donor Network of Arizona supports this proposal.

Region 7 | 03/14/2023

3 strongly support, 10 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

A member commented that administrative requirements are kept to a minimum for potential donors as the more intrusive the requirements are, the more likely it might be that those volunteering become disconnected over time, especially if they are a non-directed donor.

Region 1 | 03/14/2023

0 strongly support, 7 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose

Region 1 supported the proposal with no comments. 

American Society of Transplant Surgeons | 03/14/2023

The UNOS KPD program is one of the smallest KPD exchanges in the US, and currently addresses less than 50 transplants per year. Larger exchanges such as NKR facilitate more than 1000 KPD exchanges, so any changes to UNOS KPD policy will not be significantly impactful to the KPD patient population at large. The psychosocial and medical re-evaluation requirements are reasonable given the current program performance – it takes almost 6 months to run the first crossmatch for the first patient. If 20-30 programs that are involved with UNOS KPD as their KPD conduit, this is not an undue burden. There are very few patients in the UNOS KPD, so the number of patients per program are few as well. Medical and psychosocial elements collected should reflect the safety of the living donor to go forward with surgery in a timely manner. The donor reevaluation should be related to the first date the donor has been active in the OPTN KPDPP system. The 60-day prior notice is reasonable as is the 90-day interval between notification and potential donor eligibility related to donor ineligibility. Blood type alignment requirements are appropriate. The reality of this proposal is that it does make some of the processes around UNOS KPDPP better, but the program itself has inherent operational inefficiencies that are evident from the data compared to other exchanges. These changes are unlikely to be transformative in facilitating many more UNOS KPD exchanges.

View attachment from American Society of Transplant Surgeons

American Society of Transplantation | 03/14/2023

The American Society of Transplantation (AST) supports in concept the public comment proposal, “Align OPTN Kidney Paired Donation Blood Type Matching Policy and Establish Donor Re-Evaluation Requirements,” and offers the following comments for consideration:

• The AST agrees with aligning blood type A, non-A1 and AB, non-A1B matching requirements.
• The suggested requirements for medical and psychosocial evaluation are appropriate; however, it is important to acknowledge that annual reevaluation requirements may add additional barriers to donation. The AST agrees with the underlying principle of this policy proposal but there is a need to balance donor readiness with the cost, time, energy, and inconvenience that comes with annual evaluations. We appreciate that the policy gives the program discretion regarding repeating anatomic assessments and 24-hour urine collection. We propose that flexibility for annual donor evaluations using telemedicine and home lab draws would increase ease and efficiency for donors and evaluating teams and translate into improved compliance.
• The infectious disease retesting at time of reevaluation should be limited to conditions that could potentially be treated prior to surgery, such as positive RPR or TB, and those that are relevant in matching, i.e., in some cases, CMV serostatus. Other serological testing can be updated at the time of pre-operative visit. Alternatively, the policy could require only testing for serologies that were previously negative as positive serologies are unlikely to change over time in an otherwise healthy individual.
• The proposed policy details that, “The donor’s reevaluation deadline is based on donor’s date of registration in the OPTN KPD program or the date of the donor’s re-evaluation, whichever is most recent.” The AST recommends modifying this detail of the policy to minimize any possible burden on donors registered in the OPTN KPDPP system. The policy should assure that no donor is required to be evaluated more than once a year, unless there is a medically supported reason that necessitates more frequent testing. Additionally, for greater consistency across programs and minimize confusion, the due date should be more specifically defined. The AST recommends that the anniversary of the date the donor is registered in the OPTN KPDPP system serve as the first revaluation due date, and each subsequent due date should be one year from the date of the previous reevaluation.
• Notice 60 days prior to the donor re-evaluation date is adequate; however, extending this notice to 90 days would likely better accommodate donors’ schedules and benefit those programs with fewer resources. All donor candidates should be informed about annual reevaluation requirements in case a match is not identified within the first year. Providing 90 days between notification and the potential donor ineligibility date is sufficient to complete the donor’s reevaluation.
• The AST does not support the proposed requirement that programs reconsent potential donors annually, as evidenced by the donor’s signature. Informed consent is an iterative and evolving process, and while there is agreement that programs should do their due diligence to ensure their donors understand and are actively participating in shared decision-making, we do not see the benefit of this additional administrative requirement. Documentation that the donor has been reeducated, remains engaged, and agrees to proceed with reevaluation in the electronic medical record should be sufficient. Further, it should be noted that this proposed requirement is not aligned with the current requirement in OPTN policy 14.3 which only requires obtaining the signature acknowledging informed consent prior to organ recovery, not prior to initiation of the evaluation process.
• The Committee should consider mirroring the National Kidney Registry’s (NKR) requirements. By aligning the core requirements of system participation, the OPTN will reduce the burden on centers and the opportunity for unintentional non-compliance from members attempting to keep up with different requirements.

American Society for Histocompatibility and Immunogenetics (ASHI) | 03/14/2023

This proposal is not pertinent to ASHI or its members.

NATCO | 03/14/2023

NATCO appreciates the opportunity that the OPTN Kidney Committee has provided to review the proposal to “Align OPTN KPD Blood Type Matching Policy and Establish Donor Re-Evaluation Requirements.” We provide the following feedback to the Committee’s specific questions:

1. Are the proposed psychosocial and medical re-evaluation requirements appropriate? Do any of the proposed re-evaluation requirements pose a burden on transplant programs, and if so, which? The proposed requirements are appropriate and should not pose an undue burden on transplant programs.

2. Are there other additional medical or psychosocial elements that should be included for re-evaluation? Updating the ILDA evaluation, as well as the medical and psychosocial evaluation, would be recommended. This update will ensure that the patient continues to understand their rights and resources as a potential donor, demonstrates understanding of the evaluation and informed consent process, as well as to ensure continued availability of the ILDA.

3. Should the infectious disease retesting exception apply to other tests that the donor has previously tested positive for, or just CMV antibodies and EBV antibodies? If so, which? Agree with repeating all of the infectious disease testing, and keeping the exception only for previously-positive CMV and EBV antibodies.

4. Should the donor’s re-evaluation deadline be based on the date the donor was first registered in the OPTN KPDPP system, or the first date that the donor had an active status in the OPTN KPDPP system? The recommendation is to use the registration date. A significant period of time could pass between registration and activation, and using the activation date in that situation could lead to many of the initial evaluation components being outdated.

5. Is 60 days prior notice to the donor re-evaluation date sufficient, or should the notification be sent out earlier? Yes, 60 days should be sufficient.

6. Is 90 days between notification and potential donor ineligibility date provide a sufficient amount of time to complete the donor’s re-evaluation? Should this timeframe be shortened or extended? Yes, 90 days should be sufficient. This timeframe provides a 30-day “grace period” from the anniversary of the donor’s registration.

7. Implementation of the donor re-evaluation requirement will include an initial implementation period in which donor eligibility will not be impacted. How long should this initial implementation period be? The recommended timeframe is 6 months.

8. Do you agree that aligning blood type A, non-A1 and AB, non-A1B matching requirements is appropriate? Yes, this proposal is appropriate and fully-supported. In summary, NATCO supports the proposed changes and agrees that each is necessary for improved efficacy of, and match success rate within, the OPTN KPD program. Having updated donor evaluations is imperative to donor safety as well the success of a KPD program.

Region 8 | 03/14/2023

2 strongly support, 12 support, 5 neutral/abstain, 2 oppose, 0 strongly oppose

Region 8 mostly supports this proposal, but some members were in opposition. An attendee said that its’ institution supports the alignment of blood type matching and annual re-evaluation (the latter in concept). And recommends the committee consider reducing the burden of re-evaluation on both potential donors and transplant centers by performing virtual re-evaluation, rather than in-person. It also recommends deferring any ID testing that is unlikely to change.

OPTN Transplant Coordinators Committee | 03/14/2023

The Transplant Coordinators Committee thanks the Kidney Committee for their work on this proposal. 

A member expressed support for the timeframes being proposed in the policy. She did express concern about the donor testing portion being confusing. There are other infectious disease testing being tested for and her center just repeats all the testing at the same time. 

A member noted that they re-evaluate their donors past one year for other KPD programs, so it is acceptable to retest for infectious diseases. She also supported not retesting for CMV and EBV if the donor previously tested positive.  

A member noted that her only concern with this proposal is regarding the written consent requirement. She acknowledged that informed consent is a necessary part of patient centered healthcare, and healthcare providers should be having ongoing discussions with all patients based on their needs and when education is required. However, she believes that what is being proposed is not consistent with Policy 14.3, which requires signatures prior to organ recovery, not initiation of evaluation. Additionally, requiring a signature at the time of evaluation is not feasible when evaluating donors outside of the local area of the transplant center and creates an administrative burden that provides no clear benefit. 

A member added that patients should not be required to drive from far away just to provide a signature. Another member agreed and added there is a potential for losing donors if they don’t want to travel. 

A member noted there are no informed consent signature requirements for listing, other than for blood type or for high KDPI kidneys. She added that some states might require an actual signature for informed consent, but overall informed consent is more than simply getting a signature, especially in the age of a pandemic and telehealth options. Another member added that a signature does not mean a patient understands or reads a document. Another member asked if the National Kidney Registry (NKR) requires an annual informed consent and the response was that only an annual re-evaluation is required. 

A member noted that reassessment requirements should be what is clinically appropriate. Members agreed that every year is appropriate because so much can change. Weight, blood pressure, and other medical history can change over the course of the year. A member noted that reassessment should be based from time of registration. 

A member noted that as a living donor representative, re-evaluation at time of listing or anniversary of last testing should be considered. This is because a donor could be registered before completing the evaluation. Members agreed that the registration and active date should be the same following the completion of the donor evaluation. A member noted there could be recipient factors that could impact the timing of this. Lastly, a member noted that the OPTN requirements should strive to align with the NKR requirements.

Members discussed what the appropriate date should be and recommended the registration date. This will allow the evaluation to be completed, as currently required in policy. A member asked if the program is responsible for entering the re-evaluation date.

Rebecca Brown | 03/13/2023

I strongly support requiring LD re-evalution on an annual basis. This is important to minimize risk to the potential living donor and ensure on-going candidacy for living donation. It is also imperative to streamline the KPD process when potential match offers are made. I also support the proposal to align Blood type matching for KPD participants with the OPTN Kidney policy.

Genene Wiebe | 03/12/2023

I am a living donor and I know that the things that I thought about would my family be taken care of if they needed a kidney. That wasn’t a problem then I would like to stress the importance of keeping living donors at the top of the priority list for organ transplants. A living donor is someone who saves the lives of strangers by giving a piece of their own body. These living donors do not ask for anything in return, not even a thank you. These living donors also take the risk of endangering themselves, when they give away a part of their body. We should be doing everything we can to protect living donors. It is not that we expect to be on the list, it takes the stress as a parent for my family. It is also a way to help donors that may want to give - give with the fact that they can be at rest. Please do not take away allowing the living donors that donated to save a life be taken off the top of list. Let’s not politician or what’s best for UNOS and donation organizations that get caught up in the wrong things but remember those that gave. If you as a person in these organizations gave to someone I bet this would not be a question for you. You would have expectations to protect your family. You become a donor and then ask yourself what the standards should be

Stephen Johnson | 03/10/2023

There was only ONE reason some 25 years ago, that I allowed my brother to donate one of his kidneys to me and that was knowing should he ever need a kidney transplant himself, he’d go to the front of that line! Having been an advocate for over 20 years, keeping the process in place is mandatory!

Region 9 | 03/09/2023

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

Region 9 supported this proposal. This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. One member stated they don’t want to see this become a barrier. 

American Nephrology Nurses Association (ANNA) | 03/08/2023

See Attachment

View attachment from American Nephrology Nurses Association (ANNA)

Region 5 | 03/03/2023

8 strongly support, 19 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

Region 5 supports the proposal. A member commented that there are many requirements for donor re-evaluation, and pointed out there have been potential KPD chains broken due to donor issues, and that this will significantly increase costs associated with KPD. A members’ institution explained that it supports the concept but opposes the requirement that centers obtain a written signature from the donor for every annual re-evaluation. It explained that informed consent is an evolving process that occurs over the course of the donation journey and should be documented by providers. And noted that requiring a signature is an antiquated and burdensome practice with little positive impact on patient safety.

Region 10 | 02/28/2023

1 strongly support, 12 support, 8 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 that the committee is encouraged to review what would be required for re-evaluation.

Region 3 | 02/24/2023

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

Anonymous | 02/23/2023

By having annual procedures, I believe these new requirements will increase organ transplants since the donor will be required to stay up to date in order to better match with people in need.

Region 2 | 02/21/2023

9 strongly support, 12 support, 2 neutral/abstain, 1 oppose, 0 strongly oppose

Region 4 | 02/21/2023

2 strongly support, 19 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose

Katherine Szucs | 01/31/2023

It is extremely important to update all active donors in the OPTN KPD program yearly. Keeping the donors updated will greatly decrease the amount of swap failures and result in more successful swaps.