Comments

Hume-Lee Transplant Center | 03/18/2023

Programs should be able to filter offers. It is unclear how age in this proposal is not already factored in.

Anonymous | 03/17/2023

I would also encourage UNOS to review how the data is currently entered into to Donornet by the OPO for the filters to be applied. It seems that the WIT, CIT, Biopsy information is not always consistently entered into the same location on a donor chart in donornet. At what point is the OPO required to enter the information? I have seen offers that have gone out without biopsy or clamp time being entered.

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

The UC San Diego Center for Transplantation applauds the Kidney Committee for their time and diligence in addressing the questions and concerns raised by the community following the last public comment cycle where this concept of Optimizing Usage of Kidney Offer Filters was shared.

Retaining the ability to opt out or modify the applicability of the offer filters at any time is essential given programs may adapt and change practices dependent on individual surgical provider’s preferences, availability of resources and/or the impact of certain events that may influence outcomes. Likewise retaining the ability to create exceptions for certain candidates or a certain population of candidates is critically important to avoiding unintended consequences.

We postulate that the three-month re-evaluation period may be too frequent, particularly when considering smaller or more rural transplant centers that are challenged by low volume. Additionally, we are concerned that this frequency may inadvertently create additional administrative burden for those centers that choose to opt out or modify the applicability of the filters.

Alternatively, we would recommend that UNOS create a quarterly report available to all centers denoting the current filters applied and summarizing both the observed acceptance practices and missed offer opportunities and apply the adjusted filters no more frequently than biannually. Given the recently approved policy to enhance transplant program performance monitoring, which includes a metric focused on center’s organ offer acceptance rate ratios, we are confident that programs will adopt accountable practices in the use of this tool.

With regards to the educational considerations that may be helpful for patients in understanding the processes related to offer filters, we do agree that patient friendly education be developed for programs to disseminate accordingly. These processes are very complex and tools to educate patients and communicate how these efforts will assist their programs in identifying appropriate organs for transplantation would have significant value to the community.

Shared decision-making is essential to patient-centered healthcare. Discussions around what type of organ offers a candidate is or is not willing to consider (HCV, + PHS risk factors, KDPI >85% etc) are a standard part of the informed consent process and programs should be transparent about their acceptance practices (restrictions on DCD for example). The organ offer filters should be explained simply as a tool programs may utilize to assist them in more efficiently reviewing organ offers; as such we do not believe that there is a need for any additional specific education necessary for patients.

Sierra Donor Services | 03/15/2023

Sierra Donor Services (SDS) supports optimizing organ offer filters as a critically important tool to drive much needed efficiencies in the organ allocation process to improve organ utilization. Inefficiencies in the allocation process are a contributing factor to non-use of organs resulting in ever increasing numbers of discarded organs. Organ offer filters were made available to all kidney transplant programs in January 2022, but the benefits of the filters are not fully realized due to lack of participation. The kidney discard rate remained above 25% for 2022; 28,310 kidneys were recovered by OPOs and offered to transplant programs, but only 20,765 kidneys were transplanted. We appreciate the proposal to provide default filters as a step in the right direction and understand the need to provide kidney transplant programs flexibility in implementing the filters. However, we are concerned that the potential wide-spread “opt-out” by transplant programs could undermine the policy goals of efficient allocation and increased utilization. In addition, an “opt-out” does not live up to the goal as stated in the proposal, to “standardize” the use of model-identified filters; instead, the policy will continue to rely on each individual transplant programs’ willingness to use the filters, with no incentive to participate or consequence for opting out. Requiring OPOs to continue to make unnecessary offers to transplant programs, of kidneys with donor factors a program has historically been unwilling to accept for any patient, undermines efforts to decrease discards and increase utilization of organs especially from more medically complex donors. Organs from medically complex donors present the most significant opportunity for increasing the pool of organs for transplantation and the National Academies of Science, Engineering and Medicine recommends a national goal for dramatically increasing recovery of these organs in its report Realizing the Promise of Equity in the Organ Transplantation System (2022), at p. 70. Mandatory filters based on program specific historical data would facilitate streamlined allocation to those centers more likely (and able) to accept these difficult to place kidneys, reducing ischemic time and increasing the likelihood of transplant. SDS recommends the OPTN develop a timeline for adoption of a policy for mandatory organ filters which would provide a pathway for transplant programs to opt out of specific filters for identified candidates based on candidate-specific medical criteria. Far too many kidney offers are provisionally accepted only to be declined at a later time, far too along in the process, for reasons known at the initial offer. Mandating use of the offer filters will help get the right kidneys to the right patient in the most efficient manner.

American Society of Nephrology | 03/15/2023

Dear Dr. McCauley and Dr. Doyle:

On behalf of the more than 37,000,000 Americans living with kidney diseases and the 21,000 nephrologists, scientists, and other kidney health care professionals who comprise the American Society of Nephrology (ASN), thank you for the opportunity to respond to provide comment regarding the Organ Procurement and Transplantation Network (OPTN) public comment proposal “Optimizing Usage of Kidney Offer Filters.”

Maximizing patients’ access to kidney transplant—and ensuring that access is equitably available to all patients—is of utmost priority for ASN. The society stands ready to work with OPTN, and the OPTN Operations and Safety Committee, to achieve this goal. As ample research demonstrates, many aspects of our nation’s kidney health ecosystem, including those related to kidney transplantation, are not equitably available to all patients. Significant disparities in transplant access and outcomes exist along racial/ethnic, socioeconomic, geographic, gender, and other lines, and ASN is dedicated to addressing these gaps and increasing health equity.

Please refer to ASN’s complete comments in the attached PDF.

Ample research also demonstrates that there is significant untapped potential to maximize the use of procured organs to increase survival and quality of life for people with kidney failure, particularly as compared to dialysis. As this proposal outlines, two critically important aspects of increasing organ use are minimizing cold ischemia time and expediting organ placement—among other crucial policy and practice changes outside the scope of this proposal. Accordingly, ASN perceives numerous potentially positive outcomes deriving from this proposal, if finalized.

The society also believes are several unintended consequences that may occur because of its implementation as currently proposed, described in the complete response, that give the society pause in supporting this proposal outright. At present, the society has some reservations regarding the implementation of opt-out filters and maintains serious concerns regarding an eventual move to adoption of mandatory filters. Please contact ASN Strategic Policy Advisor Rachel Meyer at rmeyer@asn-online.org with any questions or to discuss this letter in more detail.

Sincerely, Michelle A. Josephson, MD, FASN President

View attachment from American Society of Nephrology

New England Donor Services | 03/15/2023

NEDS strongly supports the use of organ offer filters as a critically important tool to drive much needed efficiencies in the organ allocation process to improve organ utilization. Inefficiencies in the current allocation process are a contributing factor to non-use of organs. In the 5 month period from 10/1/2022-2/28/23, NEDS coordinated a total of 200 kidney donors and made over 210,000 organ offers to kidney transplant programs. Out of the 397 kidneys recovered by NEDS and offered for transplant, ultimately 78 kidneys were not used. Too many offers are being made to programs who are unlikely to accept and transplant medically complex kidneys negatively impacting the efficient placement of kidneys to programs who may seriously consider these organs for their candidates. Over 57,000 refusals for “actual or projected cold ischemic time too long” were entered by kidney transplant programs during this time period. This projected or actual cold time accrues because programs that would never consider medically complex kidneys delay placement to those centers that would.

NEDS recommends the OPTN develop a timeline for adoption of a policy for mandatory use of organ offer filters that would provide a pathway for transplant programs to opt-out of specific filters for identified candidates based on candidate-specific medical criteria. The OPTN could monitor transplant center acceptance data, as described in the proposal, and remove filters as appropriate based on acceptance patterns, balancing the need for organ placement efficiency and preserving transplant program medical-decision making.

LifeShare Transplant Donor Services of Oklahoma | 03/15/2023

Our OPO strongly supports requiring and optimizing the use of offer filters. With organ non-utilization (previously commonly referred to as "discard") rates rising both in our own donor population and nationally, we have experienced an every-increasing number of offers that are declined by centers for known donor variables which could have filtered the center off the match run.

Use of offer filters should, in theory, optimize efficiency of organ allocation and more quickly get the organ offered to a center comfortable with using it, whether it be high KDPI, an older donor, or DCD with extended warm ischemic time. Trials of offer filters in which willing centers have voluntarily participated have demonstrated that offer filters are effective in decreasing unnecessary offers while not impacting the actual transplant numbers of centers applying them. Simultaneously, fewer offers are required to get the organ placed with a center and patient willing to accept the characteristics of the donor/organ. We strongly support requiring and optimizing usage of offer filters.

Infinite Legacy | 03/15/2023

Offer filters provide efficiency to the organ offer process by those transplant centers who have voluntarily instituted them. Increases in cold ischemic time can lead to delayed graft function, and efforts to minimize cold ischemic time with offer filters is a positive variable to the kidney transplant system. OPOs should have access to the OPTN system to visualize transplant center’s offer filters which gives the OPO an opportunity to quickly bypass disinterested programs and place organs more quickly. Minimum offer filters should be based on the actual acceptance criteria, while maintaining the center’s ability to turn offer filters off for specific recipients to address any patient specific needs. There is great concern that transplant programs often list their broadest criteria in order to receive every available offer but rarely, if ever, accept organs within that criteria which makes it challenging for OPOs to expeditiously get kidneys to the centers that will transplant them.

Region 6 | 03/15/2023

3 strongly support, 10 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose

During the discussion one attendee supported notification to patients about the filters being used by their center. Another attendee supports the default filters as long as centers have the ability to change the filters as needed and are able to opt out for an individual patient. One attendee recommended having a website where patients can see the various filters that are applied and could use the information to advocate which filters they would like to apply.  

Region 11 | 03/15/2023

5 strongly support, 17 support, 1 neutral/abstain, 1 oppose, 0 strongly oppose

A member stated three months is not enough time to make changes in acceptance criteria. A member questioned the inclusion of maximum age as a filter as they believe it to be arbitrary and it is already calculated into KDPI. Another member recommended adding minimum height and weight as well as a creatinine cut off filters. A member stated decreasing the number of offers made to centers who have no intention of accepting a given organ will help to improve the efficiency of the system and ultimately improve satisfaction for anyone taking organ offers. A member concluded that offer filters are nice in theory, much more difficult to implement in practice.

National Kidney Foundation | 03/15/2023

See attachment.

View attachment from National Kidney Foundation

OPTN Pancreas Transplantation Committee | 03/15/2023

The Pancreas Committee thanks the OPTN Operations and Safety Committee for the opportunity to review their Optimizing Usage of Offer Filters proposal.

The Committee is in support of this proposal. There was a question regarding clarification on if the default filters are specific to individual transplant programs or if they would be applied across all programs. There was agreement in the proposed automatic exclusion criteria.

OPTN Data Advisory Committee | 03/15/2023

The Data Advisory Committee (DAC) thanks the Operations and Safety Committee for presenting their public comment proposal. The Committee raised two concerns. First, establishing a review period of every three months appears to be too frequent. Transplant program staff, especially smaller programs, have limited administrative bandwidth to review the filters as proposed. Second, the reliance on past practices to establish future operations may limit the autonomy programs want to achieve, and instead find themselves receiving offers that cast them as either too aggressive or too conservative. What opportunities do programs have to break out of such molds in the future, if they want to change their behavior? Restricting the types of offers programs want to receive could be a disservice to patients. The Committee asked if there is a way to use existing data related to transplant program acceptance behavior that could be used to make broader determinations of what offers an individual program might accept or not accept.

Association of Organ Procurement Organizations | 03/14/2023

Thank you for the opportunity to submit comments on the Organ Procurement and Transportation Network’s (OPTN’s) policy development process on behalf of the Association of Organ Procurement Organizations (AOPO). AOPO collectively represents 48 federally designated, non-profit Organ Procurement Organizations (OPOs) in the United States, which together serve millions of Americans. As an organization, AOPO is dedicated to providing education, information sharing, research, technical assistance, and collaboration with OPOs, other stakeholders, and federal agencies to continue this nation’s world-leading transplantation rates while consistently improving towards the singular goal of saving as many lives as possible. We offer the following comments for your consideration:

AOPO supports optimizing organ offer filters as a critically important tool to drive much needed efficiencies in the organ allocation process to improve organ utilization. Inefficiencies in the allocation process are a contributing factor to non-use of organs resulting in higher and higher numbers of discarded organs. Organ offer filters were made available to all kidney transplant programs in January 2022, but the benefits of the filters are not fully realized due to lack of participation. The kidney discard rate remained above 25% for 2022; 28,310 kidneys were recovered by OPOs and offered to transplant programs, but only 20,765 kidneys were transplanted.

We appreciate the proposal to provide default filters as a step in the right direction and understand the need to provide kidney transplant programs flexibility in implementing the filters. However, we are concerned that the potential wide-spread “opt-out” by transplant programs could undermine the policy goals of efficient allocation and increased utilization. In addition, an “opt-out” does not live up to the goal as stated in the proposal, to “standardize” the use of model-identified filters; instead, the policy will continue to rely on each individual transplant programs’ willingness to use the filters, with no incentive to participate or consequence for opting out.

Requiring OPOs to continue to make unnecessary offers to transplant programs, of kidneys with donor factors a program has historically been unwilling to accept for any patient, undermines efforts to decrease discards and increase utilization of organs especially from more medically complex donors. Organs from medically complex donors present the most significant opportunity for increasing the pool of organs for transplantation and the National Academies of Science, Engineering and Medicine recommends a national goal for dramatically increasing recovery of these organs in its report Realizing the Promise of Equity in the Organ Transplantation System (2022), at p. 70. Mandatory filters based on program specific historical data would facilitate streamlined allocation to those centers more likely (and able) to accept these difficult to place kidneys, reducing ischemic time and increasing the likelihood of transplant.

AOPO recommends the OPTN develop a timeline for adoption of a policy for mandatory organ filters which would provide a pathway for transplant programs to opt out of specific filters for identified candidates based on candidate-specific medical criteria. The OPTN could monitor transplant center acceptance data, as described in the proposal, and remove filters as appropriate based on acceptance patterns, balancing the need for organ placement efficiency and preserving transplant program medical decision making.

AOPO also encourages the OPTN to improve the available filters by including additional donor factors, e.g., creatinine and whether the donor underwent dialysis. Improved filters would increase transplant center confidence in the effectiveness and accuracy of the filters in only eliminating offers the center would not consider.

Donor Network of Arizona | 03/14/2023

Donor Network of Arizona supports this proposal. We believe this will improve efficiency of organ allocation and lead to increased utilization of donor kidneys. We further believe that centers which choose to modify their model-identified filters should be subject to increased scrutiny to see if they accept offers that the model-identified filters would have screened off and should be subject to sanctions if they continue to receive and decline such offers.

Region 7 | 03/14/2023

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

Several members commented that it is important for patients to understand the filters and how transplant hospitals use them. One attendee added that this is the type of thing that would be helpful when comparing hospitals or considering multi-listing. Another recommended that patients be involved in the creation of educational offerings, which need to be more robust than a brochure. Several attendees commented on the three month timeframe and there was not agreement if it was the right cadence. There were comments that three months is too soon, and resetting would be a burden, especially on a small center. Others commented that three months is too long and does not support optimizing organ utilization and changes to practice. A member recommended that OPOs should have access to this information, especially the offer explorer. Several members voiced support for the use of offer filters to improve efficiency and reduce cold ischemic time and are interested in learning more, including how it can impact their organ acceptance rate. One member commented that this is a good warm up to mandatory filters and supports mandatory filters as long as there is an option to apply for a change in the case of personnel changes.

Region 1 | 03/14/2023

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

Region 1 supported this proposal. An attendee suggested that if the committee considers minimum acceptance criteria to be different from offer filters, maybe they could integrate the two. A member suggested that six months would be a more appropriate evaluation timeframe. A couple attendees said that this is an important project and should be applied to other organs as well. A member stated making the filters “opt-out” is a great idea that has the potential to get programs who are not serious about an offer out of the way, so a program who really wants the organ can get it to their candidate faster. Another member commented that the filter options need to be more specific and have more specific execptions, for example, filter out for factor X plus KDPI > 85 except if HCV +. An attendee asked that the committee consider making the filters mandatory instead of opt-out, to fulfill their promise to deliver a more efficient system. 

Gift of Life Michigan | 03/14/2023

Inefficiencies in the allocation process are a contributing factor to the non-use of organs resulting in higher and higher numbers of unutilized organs. Organ offer filters were made available to all kidney transplant programs in January 2022 but the benefits of the filters are not fully realized due to lack of participation. The kidney non-utilization rate remained above 25% for 2022; And for Gift of Life Michigan, it exceeded 35%. 28,310 kidneys were recovered by OPOs and offered to transplant programs, but only 20,765 kidneys were actually transplanted. The “opt-out” policy for organ offer filters is unlikely to result in the widespread use of filters and therefore will not adequately support the policy goals of efficient allocation and increased utilization. By continuing to allow transplant programs to choose NOT to apply organ filters, the proposed policy maintains the status quo – and does not live up to the goal as stated in the proposal, to “standardize” the use of model-identified filters; instead, the policy will continue to rely on each individual transplant programs’ willingness to use the filters, with no incentive to participate or consequence for opting out.

Requiring OPOs to continue to make unnecessary offers to transplant programs, of kidneys with donor factors a program has historically been unwilling to accept for any patient, undermines efforts to increase utilization of organs, especially from more medically complex donors. Organs from medically complex donors present the most significant opportunity for increasing the pool of organs for transplantation and the National Academies of Science, Engineering, and Math recommends a national goal for dramatically increasing the recovery of these organs in its report Realizing the Promise of Equity in the Organ Transplantation System (2022), at p. 70. Mandatory filters based on program-specific historical data would facilitate streamlined allocation to those centers more likely (and able) to accept these difficult to place kidneys, reducing ischemic time and increasing the likelihood of transplant.

A timeline for adoption of a policy for mandatory organ filters should be developed. The OPTN could monitor transplant center acceptance data, as described in the proposal, and add additional filters as appropriate based on acceptance patterns, balancing the need for organ placement efficiency and preserving transplant program medical decision making. Programs should be required to apply to have filters removed with rationale as to why and if they continue to decline those offers the filters should be turned back on within a matter of months. We also encourage the OPTN to improve the available filters by including additional donor factors, e.g., creatinine and whether the donor underwent dialysis. Improved filters would increase transplant center confidence in the effectiveness and accuracy of the filters in only eliminating offers the center would not consider.

Center for Organ Recovery and Education | 03/14/2023

Strongly Support

OPTN Patient Affairs Committee | 03/14/2023

The OPTN Patient Affairs Committee supports this proposal and, more broadly, efforts to promote increased organ utilization and efficiency by getting offers to transplant programs that will accept them as quickly as possible. The Committee recognizes that offer filters may reduce non-utilization of kidneys by allowing OPOs to bypass transplant programs who do not accept marginal kidneys and thereby reducing cold time. Accordingly, the Committee supports mandating use of offer filters.

The Committee supports the automatic exclusions listed in the proposal. A member suggests including living donors in the automatic exclusions as well. While members support the 90-day reset for the filters, members also have concerns that transplant programs may become too “comfortable” with their offer filters and may not make an effort to accept kidneys that would be screened by the filters, even if their patients are willing to accept those kidneys. Members are concerned that transplant program may only choose to accept organs that are expected to provide good outcomes and will reflect well in the transplant program’s performance metrics. This would negatively impact patients who would be willing to accept organs that fall outside of the program’s filters.

The Committee emphasizes the importance of shared decision-making between candidates and their transplant programs. This proposal could serve as a springboard for empowering patients to have more say in what organs they are willing to accept, perhaps by allowing the patient to set their own personal offer filters, in conjunction with their transplant team. The Committee supports all efforts to empower patients during their transplant journey.

For the patient education and outreach, the proposal mentions a brochure for patients to review. The Committee does not think that will be adequate. Candidates should be educated directly by the physician, transplant center, or transplant coordinator on how offer filters could impact them personally, for example, in terms of the quality of the kidney they may receive; how long they may wait for transplant; and the length of time the transplanted kidney is expected to function. This information may impact where a patient chooses to list for transplant. The Committee notes that patient education must be ongoing, as candidates can be overwhelmed by information at the beginning of their transplant journey. Patients often only see their doctors when they sick and not processing information well, which is why it is critical to have ongoing conversations about transplant options, particularly since a patient’s preference regarding an acceptable organ may change the longer they wait for transplant. Information should also be made available so that patients can review outside the doctor’s office, when they may be feeling better.

The Committee holds that there should be mandatory education on offer filters for transplant programs. Additionally, transplant programs must look at the data on the organs they have accepted and use that information to broaden their acceptance criteria and improve access to transplant for their candidates. A transplant program that has a tendency to either remove offer filters or stick to default filters without critical review is doing a disservice to their patients. Members also support making data public to allow patients to see the types of organs their centers are accepting.

The Committee was surprised not to receive more detailed projections about the potential for offer filters to reduce the non-utilization rate and requests to stay apprised of updates and whether offer filters are significantly improving organ utilization. Additional comments from Committee members are submitted as an attachment.

View attachment from OPTN Patient Affairs Committee

American Society of Transplant Surgeons | 03/14/2023

The ASTS strongly supports the OPTN Proposal: Optimizing Usage of Offer Filters. This proposal is an excellent step towards increasing efficiency in organ placement and utilization. We strongly support the additional filter criteria that are being proposed by the committee. These criteria are commonly utilized current offers and will likely improve efficiency. We suggest that the committee consider the following additional filter options: 1. Candidate EPTS (this would allow centers to exclude lower EPTS patients from higher KDPI kidneys with additional risk factor combinations); 2. Normothermic reperfusion as a factor in addition to DCD (NRP can affect a center’s threshold for acceptable warm time); 3. Donor dialysis or CVVH within 24 or 48 hours of death. Additionally, the committee should consider excluding centers with less than 2 years of data (new transplant centers) prior to automatic filtering or providing those centers more frequent data. When educating patients, it may be beneficial to provide sufficient background in the variability of current organ acceptance practices, both between centers and even within centers (based on call team); this background may help reassure patients that the proposal is a move towards improved transparency and efficiency. Additionally, patients will need reassurance that underserved groups cannot be filtered out through this system. A complicating factor in education is that the patient likely has little control over these filters, particularly if filters become mandatory. It should be clear that this proposal does not offer the patient individual selection of which filters will apply to them. Thank you to the OPTN and the Operations and Safety Committee for their work on this important proposal.

View attachment from American Society of Transplant Surgeons

Region 8 | 03/14/2023

4 strongly support, 15 support, 0 neutral/abstain, 0 oppose, 1 strongly oppose

Region 8 supports this proposal. An attendee said that his kidney program uses the filters and has had positive results. He expressed concern that this proposal, as written, is not clear on whether programs will have notification when filters reapply. He suggested that programs should be told what the suggested filters are, before they’re implemented so they can be involved in the decision of whether to apply them or not. Regarding timeline for review, he suggested somewhere between a week and a month. And he emphasized that programs need to have the right of refusal. An attendee questioned whether a program could feasibly manage a 90 day re-set; and noted that human behavior doesn’t change that fast. An attendee pointed out that depending on the system, there is a possibility for human error to limit the organs available to recipients. The member believes programs should have the ability to determine the filters for its program. From the OPO perspective, this proposal will increase allocation efficiency. An attendee suggested that the committee consider periodic re-evaluation or reset to ensure the filters are not impairing change in acceptance criteria. An attendee explained that centers who manage their filters well and have strong offer acceptance outcomes should not be penalized in terms of maintenance mandates. An attendee suggested that it might be useful to offer more granular filters in order to accurately identify which donors a candidates might accept. 

OPTN Histocompatibility Committee | 03/14/2023

The Histocompatibility Committee supports the usage of offer filters and supports education for candidates on center-specific practices related to offer filters. This proposal seems likely to increase allocation efficiency, decrease cold ischemic time, and decrease the burden on labs for evaluating organ offers which a program is unlikely to ultimately accept.

The Committee is strongly supportive of the automatic exclusions for highly sensitized and zero antigen mismatch candidates. The Committee is also supportive of the ability to exclude individual candidates from offer filters, as some candidates may be more difficult to match.

Six months may be a better re-evaluation period than three months, due to staffing resource limitations. 

American Society of Transplantation | 03/14/2023

The American Society of Transplantation (AST) is generally supportive of the public comment proposal, “Optimizing Usage of Kidney Offer Filters,” as an important measure to create the efficiencies in the system needed to increase utilization of organs, particularly from older and more medically complex donors where the non-use rate has continued to be unacceptably high, and offers the following comments for consideration:

• Retaining the ability to opt out or modify the applicability of the offer filters at any time is essential given programs may adapt and change practices dependent on individual surgical provider’s preferences, availability of resources, and the impact of certain events that may influence outcomes. Likewise, retaining the ability to create exceptions for certain candidates or a certain population of candidates is critically important to avoiding unintended consequences.
• The AST agrees with excluding programs that exclusively transplant pediatrics from this proposal. For those programs that transplant both adult and pediatric patients, the OPTN should monitor the impact of these changes to evaluate whether pediatric patients at these programs are disproportionately impacted by the proposed offer filters. The three-month reevaluation period may be too frequent, particularly when considering smaller or more rural transplant centers that are challenged by low volume. The AST suggests a quarterly report available to all centers denoting the current filters applied and summarizing both the observed acceptance practices and missed offer opportunities, and applying the adjusted filters no more frequently than biannually.
• With regards to the educational considerations that may be helpful for patients to understand processes related to offer filters, we agree that patient friendly education should be developed for programs to disseminate. A simple brochure or online guide should be sufficient, and it should be distributed broadly and directly by the OPTN (such as a resource always available on the website or handed to recipients during their visits).
• When a program modifies the default filters applied to specific candidates, it is critical that those modifications are not changed by subsequent generations of the model-identified filters. The changes in this proposal will create a significant administrative burden if programs are required to adjust the filters for those candidates every three months upon the generation of new model-identified filters.

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

This proposal is not pertinent to ASHI or its members.

OPTN Transplant Administrators Committee | 03/14/2023

The Transplant Administrators Committee thanks the Operations and Safety Committee for their efforts in developing this proposal.

TAC members offer the following comments and questions:

TAC members appreciate the Operations and Safety Committee taking the feedback provided during the previous public comment period and identifying candidates that should be excluded from the offer filters. 

Several members expressed concern about the 90-day period to re-evaluate the offer filters. 90 days may not be enough time to establish a pattern of acceptance behavior.

Concern about impact on pediatric programs. For example, if a pediatric patient turns 18, would the offer filters be applied to them. 

Recommendation to create a “smart feature” for when a transplant program declines an offer for a patient so it auto applies filters for that patient moving forward. 

Concern that acceptance behavior will be based on the type of offers a transplant program is receiving, such as one with increased cold ischemic time. 

How will transplant centers be sure that the application of the computer model is clinically relevant and based on what offers are being accepted. Some transplant centers do not want to miss offers if the system is selecting offer filters based on behavior. Lastly, does the community really understand how offer filters work.

Offer filters could be an unnecessary burden for some centers. He added that it probably won’t change center practice as some surgeons have been practicing for 20 years at some programs.

Comment about how beneficial offer filters have been for one center. Offer filters have led to more kidneys being accepted because staff has less “offer fatigue” and able to focus on offers that will lead to an acceptance. 

Offer acceptances are probably different in New York City than Colorado. Some centers are never accepting organs from certain donors, and offer filters force important and challenging conversations with surgical and medical teams.

Concern about requiring transplant programs to review their offer filters every 90 days, even if it is simply turning them off. Recommendation to provide the ability for a transplant program to check a box stating they will do their own filtering since some centers know how to work the process. Recommendation that transplant centers that routinely “opt out” of offer filters be required to re-evaluate every three months. 

Suggestion to make offer filters only mandatory for those transplant programs with lower offer acceptance rates.  

Mandating default offer filters is not the right approach to increase adoption, but instead suggested creating a system that is smarter and more usable.

Question about how to get transplant centers to adopt offer filters to improve the allocation system as the committee weighs the optional versus mandatory approach. 

Question about how transplant centers would be notified that offer filters will be turned on or modified. Recommendation to avoid sending notifications on weekends and holidays.

Recommendation to allow transplant centers to compare their current filters with any upcoming changes and allowing transplant programs the option to accept or decline the new filters. 

Question about selection bias with later sequence numbers. Offer filters might improve acceptance rates, although some surgeons might still be reluctant to use filters due to lack of trust in the system. 

Suggestion to review the correlation between a transplant center’s offer acceptance practices and waitlist mortality.

NATCO | 03/14/2023

NATCO would like to thank the Organ Procurement and Transplant Network (OPTN) for the opportunity to offer public comment on optimizing the use of organ filters, presented by the Operations and Safety Committee. NATCO strives to support initiatives that benefit both OPOs and the transplant centers they serve. Further optimization of organ filters can increase kidney utilization, improve offer acceptance, and decrease the time these life-saving organs spend outside the body. Having the ability to filter out organs that a transplant center would never accept will cut down significantly on time spent allocating organs. Furthermore, this would help alleviate unneeded phone calls or unwanted communication during overnight hours. The current “opt-in” model of filter usage is not widely used and therefore not as helpful as originally intended. Changing to an “opt-out” model would likely improve filter usage and cause transplant programs to further clarify their acceptance criteria. We also agree with the exclusion of special characteristics such as high PRA and zero antigen mismatches. Although overall support exists, there should be pause or caution in making organ filters mandatory. This does not seem to be widely supported in the community. There is also concern that re-evaluating the filters every three months may be too soon and could represent a burden to smaller centers with less staff.

OPTN Transplant Coordinators Committee | 03/14/2023

The Transplant Coordinators Committee thanks the Operations and Safety Committee for their work on this proposal. 

Several members expressed concern about the filters being applied every three months as this will create more work for transplant centers, especially aggressive centers that do not want any offer filters. 

A member complimented the Committee on taking the feedback from the previous public comment period and applying it to this proposal. She recommended retaining the ability for transplant programs to modify the filters but expressed concern about the three-month period and recommended six months. Applying the filters every three months would be burdensome for transplant programs. She also recommended that the OPTN create a report on the types of offers accepted or missed by transplant programs. Lastly, she suggested adding the ability to apply filters based on which surgeon is on call.  

A member supported the exclusion of certain patient types from the default filters. She also suggested looking at a certain threshold of offers instead of a strict timeframe to reduce the burden on smaller programs. 

A member commented about the potential impact of the new Membership and Professional Standards Committee (MPSC) metrics on offer acceptances. For example, offers that are filtered off are excluded from the acceptance model. And if a transplant center removes all the filters and then does not accept offers, they are at risk of being identified for MPSC review. 

A member thought it was great having the ability to select yes or no to DCD donors. She added that it would be nice to apply a combination of filters at the candidate level, such as an age or distance for DCD.

Lorrinda Gray-Davis | 03/13/2023

The reliance on offer filters can lead to organ shortages, as some potential donors may be filtered out without careful consideration of their eligibility. The patient loses their voice of acceptance of a high risk organ. It comes down to the risk a transplant program is willing to take. I understand filters are reset and data is mined to make better decisions, during this time how many waiting patients miss their chance to accept a high risk organ?

OPTN Membership & Professional Standards Committee | 03/13/2023

The Membership and Professional Standards Committee (MPSC) thanks the Operations and Safety Committee for the opportunity to review and comment on the Optimizing Usage Offer Filters proposal. Members are supportive of the proposal and see it as a natural progression of the MPSC’s offer acceptance metric and an opportunity to ensure the optimization of transplantable organs. Members felt this proposal was the first step to eventually mandating offer filters, noting that mandating offer filters now would likely receive pushback from the community. If the offer filters do eventually become mandatory, it is recommended to develop some type of transition period when new personnel join the team to allow for changes in acceptance practices. A member recommended reviewing the quantity of HIV transplants for potential future inclusion in the offer filters system as the number of these transplants increases. 

The MPSC identified educating transplant programs as essential for the successful implementation and utilization of offer filters by the community. Members felt that transplant programs would be more inclined to use the offer filters if they correctly understood the intent of the filters and dispel the assumption that filters would cause transplant programs to miss offers that they may accept. The MPSC suggested connecting the offer filters with the new offer acceptance ratio metric to show that programs may not have been flagged for low acceptance ratios if they were using offer filters.

Members felt this proposal would increase efficiency for both OPOs and transplant programs and reduce the number of offers for organs that the transplant program would never accept while getting harder to place organs to programs that will use them more expeditiously. This would also reduce the burden on the MPSC to evaluate instances of OPOs offering organs out of sequence in an attempt to match hard-to-place organs. Alternatively, the filters would allow OPOs to identify programs in sequence that will accept and transplant them in an evidence-based manner.

A member recommended developing a report where programs are able to review the organ offers that were within their filtered criteria but were not accepted and the offers that were filtered off and never seen on a 3-6 month cadence. Members suggested that this review could allow transplant programs to analyze their acceptance practice and consider if their filters need to be modified. This data could also serve to develop trust in the offer filters system by showing transplant programs how their offers have shifted since its implementation. However, it would be beneficial to have an offer filter system that learned from program practice so if a program were more aggressive the filters would learn and adjust to this behavior, as opposed to manually modifying the filters on a regular basis. Overall, the MPSC supports this proposal.

Region 9 | 03/09/2023

1 strongly support, 8 support, 3 neutral/abstain, 2 oppose, 1 strongly oppose

Region 9 was generally supportive of offer filters. An attendee remarked that while this proposal is great for efficiency, it’s not great for transparency for patients, and operationalizing notifying patients is going to be a heavier lift. Several members commented that three months is too quick to update the filters and six months would be a better timeframe. A member added that we wouldn’t want the filter update to impact individual patients where a program has established an opt out for them. An attendee said the committee needs to be more transparent about the reasoning for filters, and if the goal is to increase utilization, voluntary filters are the way to go. The attendee continued to say their program’s acceptance criteria are constantly changing, and they would be restricted by unchangeable model-identified filters. An attendee stated that this proposal is a workaround for a non-functional allocation system, and that a better option would be to offer underutilized kidneys to patients who do not show up at the top of match runs. Another attendee agreed that patients that would rather take a kidney, even for a short time, versus not getting transplanted at all. A member shared that some centers may not have capacity to field excessive offers that they previously opted out from receiving, especially those that don’t use offer vendors. An attendee stated that CPRA cutoff changes from program to program and that 90% across programs is not the same. A couple members expressed concern for mandatory offer filters and that the OPTN is overstepping its bounds. A member cautioned that this could result in minority or underrepresented populations to be automatically bypassed. Another member said that filters should be determined by each transplant center, not imposed, and that default parameters should be used for centers that don’t populate their filters.

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

See Attachment

View attachment from American Nephrology Nurses Association (ANNA)

Bhavna Chopra | 03/06/2023

Support

Region 5 | 03/03/2023

8 strongly support, 21 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose

Region 5 supports the proposal. A member commented that mandatory offer filters will be a big improvement for OPO efficiency in organ placement. A member noted her support for the offer filters as long as programs retain the right to opt out/modify the filters at any time. As a suggestion, a member said that centers should receive continuous feedback on filter modifications that could help increase allocation of hard to place kidneys.

Alyssa Ketron | 02/28/2023

The introduction of optional filters as a tool was welcomed by our center. We have successfully applied several filters and seen improvement in acceptance rate ratios, thus helping to expedite placement of organs. We generally support the application of mandatory filters which are able to be modified by transplant centers as they see fit, and as their acceptance practices and/or decision-making personnel may change with time. As a small conservative center, our minimum acceptance criteria applied to candidates upon listing has relatively low maximum peak and final creatinine values. We have received offers that fall outside these parameters, as the creatinine has risen after the initial match run was made. Since filters are applied using data available at the time of the offer, adding creatinine as a filter option is essential to absorb these offers which are outside our acceptance criteria. Additionally, we have expanded our candidate acceptance to include individuals with higher BMIs/muscle mass for whom a larger donor graft is necessary. With the current system, there is no option for us to apply size parameters to either the candidate waitlist registration or a filter. Adding a BMI or height/weight/sex mismatch category could help bypass our larger candidates and place the organs more quickly to an appropriate candidate. Finally, many conservative centers are unlikely to accept an offer that has already been refused by other centers for hundreds of other candidates. The addition of an option to filter out offers for candidates beyond a certain sequence number in the match run (IE if an offer is made for a candidate beyond sequence 200 or 500) would be hugely beneficial to filtering out offers our center has historically not accepted. As offers already refused for several hundred candidates are typically difficult to place, facilitating offering these organs to appropriate candidates/centers has the capacity to have a positive impact on decreasing organ non-use.

Region 10 | 02/28/2023

3 strongly support, 13 support, 2 neutral/abstain, 3 oppose, 1 strongly oppose

Overall, members of the region were supportive of the proposal but there was some opposition. An attendee noted their full support of all avenues that result in more efficient organ acceptance and placement. The offer filters have been underutilized, and there has to be tough decisions made to use the filters as intended. There also has to be consequences for those who do not use the filters properly. In those instances, the OPTN should have the leeway to adjust a program’s filters if the acceptance data does not support the range of filters the transplant program inputs itself. There is too much time wasted in placing organs due to not using the filters in the proper way. Others noted their support in offer filters for adult programs but would oppose mandatory filters for pediatric programs. Pediatric programs should be educated about the offer filters but allow them the choice to turn on offer filters. Others suggested changing the re-evaluation period from three months up to six months. Another attendee noted that they are not in favor of mandatory filters. Instead, they support better scrutiny/oversight of organ offer acceptance, as is occurring, which hopefully will drive use of filters and associated behavior change. Another attendee added before moving to mandatory filters, please consider requirements based on offer acceptance rates. If above a certain threshold, filters would be optional. If below the threshold, mandate certain minimum filters, and if rates are in the lowest percentiles, mandate stronger filters. An attendee requested access for OPOs in the OPTN computer system to see the full list of available filters. Another attendee noted that their program was an early adopter of offer filters, but mandating usage may not be the right direction to go. With the large number of offers programs are receiving, as well as increased scrutiny of organ offer acceptance rates, programs will start using filters organically. For those programs that have moved to third-party vendors to handle organ offers, there is a financial incentive to use offer filters and stop paying for the third-party vendors. Another attendee added that by using filters, it decreases the workload and allows the importing coordinator the opportunity to focus on offers the program is more likely to accept. It also provides an opportunity for OPOs to bypass programs not interested, so that after cross clamp they are able to get to programs willing to accept an organ more quickly. 

OPTN Kidney Transplantation Committee | 02/27/2023

The Kidney Committee thanks the Operations and Safety Committee for the presentation and the opportunity to provide a public comment on the proposal. The Committee supports the proposal in general. Committee members commented the proposed three month re-evaluation period is too short and suggested six months as an alternative. The Kidney Committee also strongly encourages the sponsoring Committee to carefully consider education and messaging on the purpose and functionality of offer filters, especially for the patient community. 

Region 3 | 02/24/2023

6 strongly support, 5 support, 0 neutral/abstain, 4 oppose, 0 strongly oppose

Region 3 was generally supportive of offer filters. During the discussion, one attendee commented that they supported the use of offer filters and the benefits to the system. They went on to recommend more patient education about what filters a center has in place, as choice and transparency of care continues to be a priority. Another attendee commented that the patient education should be focused on transplant rates and offer acceptance rates and not on specific organ offers. One attendee commented that they use filters and find them helpful. They went on to recommend the inclusion of candidates Estimated Post-Transplant Survival (EPTS) as a filter option, particularly for high Kidney Donor Profile Index (KDPI) kidneys. This would help centers match EPTS and KDPI. Another attendee commented that there should be continued improvements on extended organ offers that a center would not accept for any of their patients.  

LifeGift | 02/21/2023

Strongly Support

Region 2 | 02/21/2023

6 strongly support, 12 support, 3 neutral/abstain, 3 oppose, 0 strongly oppose

Overall, the region supports the proposal, with some noting that offer filters need to be required at all kidney programs. It was also noted that programs should retain the ability to modify their filters. An attendee suggested the need to add more granular filters for the process to be effective. Offer filters need to be expanded before mandating usage by transplant programs. The attendee suggested adding filters for donor/recipient age or EPTS/KDPI parity. Lastly, an attendee suggested that the committee should determine a minimum set of filters that transplant programs must use.

Region 4 | 02/21/2023

5 strongly support, 11 support, 4 neutral/abstain, 3 oppose, 1 strongly oppose

Region 4 generally supported this proposal. Several attendees supported default filters but had concerns about moving to mandatory filters. One attendee commented that programs should proactively manage their acceptance patterns and filters.  They added that automatically applying default offer filters for kidney transplant programs based on their previous acceptance puts undue burden on transplant programs to have to go and make sure the filters are correct every 3 months. They recommended that alternatively, data should be provided to help programs choose their own filters. One attendee recommended that patients should have the ability to update preferences and communicate to their programs what type of kidney they are willing to accept.  Another attendee commented that centers should be required to report to patients what filters are in place and if they change. They added that the re-evaluation window should be no more than 90 days. Another attendee commented that they did not think adding filters helps with transparency and could be confusing to patients. Another attendee commented that programs are not being good stewards of the freedom their allowed under the current system. They added that programs often list with the broadest criteria, but never accept organs within those criteria and OPOs can’t get kidneys to the centers who will transplant them. One attendee commented that the committee should look at the possibility of developing centralized labs and pair them with donor procurement centers to allow calls to centers knowing which recipients cross match negative and allowing the center to accept or decline. Another attendee recommended the committee take into consideration the expanding use of NRP and extended warm ischemic times under current definitions.  

Anonymous | 02/02/2023

Support

Lorrindas Gray-Davis | 02/02/2023

I would like to know how the education for patients would take place? Would patients be able to decide they want a different filter? I think more patient engagement needs to take place.

Anonymous | 02/01/2023

If used properly, and with the AI discussed, filters are incredibly helpful and would better facilitate transplantation if used.

Steven Weitzen | 01/29/2023

I support this project as long as it is done with care and modifying the process with time -- e.g., perhaps ensure that offer filters being used are not too stringent or otherwise inappropriate.

Anonymous | 01/19/2023

I have ran into significant issues trying to place kidneys when NRP has been implemented and it looks as though WIT is astronomical. The use of filters auto-rules out centers that may actually be interested, since the agonal phase is cut substantially shorter than what is calculated on the DCD flowsheet that transfers over to UNET. This is a misrepresentation of what the actual WIT is, and while we can place a note in DonorHighlights, and do other things to give a accurate representation of WIT, the calculation is still there and the filter still bypasses centers.