Redefining Provisional Yes and the Approach to Organ Offer and Acceptance At a glance Current policy Current OPTN policy defines provisional yes as when the transplant hospital notifies the OPTN or the host OPO that they have evaluated the offer and are interested in accepting the organ or receiving more information about the organ. Provisional yes is a tool used to manage organ offers; however, in the current system, it is not always effectively used. Because of a high number of offers received by transplant programs, provisional yes is potentially used without an evaluation of every offer. This concept paper discusses a potential solution that includes a three-tiered framework, and associated responsibilities, to standardize organ offer, review, and acceptance practices. Rather than a single provisional yes response with no associated responsibilities, each tier would represent the various stages of communication and responsibilities necessary between OPOs and transplant programs within the organ offer process. Supporting media Presentation View presentation Proposed concept Develop a tiered framework that will standardize organ offer, review and acceptance practices, and outline member responsibilities Recommend time limit on offers and number of offers that can be sent within tiers Increase efficiency and expedite organ placement Gather community feedback on framework Anticipated impact What it's expected to do Redefine “provisional yes” Limit the amount of organ offers sent out to manage offer burden Determine the appropriate time limits for organ offers Reduce overall organ allocation time Gather community feedback What it won't do This concept paper is intended to provide an update and solicit feedback; it will not result in a change in policy without additional public comment Terms to know Provisional yes: When the transplant hospital notifies the OPTN or the host OPO that they have evaluated the offer and are interested in accepting the organ or receiving more information about the organ. Organ offer acceptance: When the transplant hospital notifies the host OPO that it accepts the organ offer for an intended recipient, pending review of organ anatomy. For kidney, acceptance is also pending final crossmatch. Organ offer refusal: When the transplant hospital notifies the OPTN or the host OPO that they are declining the organ offer. Organ procurement organization (OPO): An organization authorized by the Centers for Medicare and Medicaid Services, under Section 1138(b) of the Social Security Act, to procure organs for transplantation. Primary potential transplant recipient: The first candidate according to match run sequence for whom an organ has been accepted. Backup Offer: An organ offer made to a lower ranked candidate on a deceased donor match run after a transplant hospital accepts an organ on behalf of a higher ranked candidate, but before the organ is transplanted. Transplant program: A component within a transplant hospital that provides transplantation of a particular type of organ. Click here to search the OPTN glossary Comments UC San Diego Health Center for Transplantation | 09/29/2022 The UC San Diego Health Center for Transplantation (CASD) appreciates the opportunity to provide public comment on the concept of Redefining Provisional Yes and the Approach to Organ Offer and Acceptance. We support more standardization for the organ evaluation and acceptance process and the redefining of the provisional yes to drive transplant center accountability and more transparency between OPOs and transplant centers, however we feel that the proposed tiered system does not adequately address the problems with the existing provisional yes system and will increase the burden on both OPOs and transplant centers attempting to navigate it. Regardless of approach, we must consider that Centers often entertain multiple offers simultaneously and expecting a thorough review and confirmation of willingness to accept a potential donor when a center is not primary is often not logistically feasible. Attachment OPTN Transplant Administrators Committee | 09/29/2022 The Transplant Administrators Committee thanks the Operations and Safety Committee for their efforts in developing this concept paper. A member stated she thinks push notifications from the OPTN Donor Data and Matching System would be extremely helpful if/when timeframe changes (i.e., time increases when the tier changes). A member asked when the tier process would require requesting additional information. She explained that, for example, when a split liver requires a CT scan with contrast it would not occur until the primary team declines the organ. The presenter explained this would occur in tier I or tier II when the offer is received. OPOs have stated ‘provisional yes’ is not as genuine a system as it could be, so programs give a ‘provisional yes’ and then hours later will explain they cannot accept until the CT scan is performed, which slows down the process. The member pointed out concern for when a program is the backup and diagnostics cannot be performed e performed in tier I and tier II, so efficiency would not be improved. American Nephrology Nurses Association (ANNA) | 09/29/2022 ANNA has concerns about this concept paper. We feel more details and information are needed about how the three tiers would increase efficiency. Region 6 | 09/28/2022 During the discussion there was feedback from several attendees that the tiered system is not intuitive and it was unclear how this system would improve on the current provisional yes. One attendee asked what metric the committee would follow to show that the change was successful. Another attendee asked how the transplant centers would be monitored to show they met the responsibilities in each tier, particularly if they get to tier 1 and then declined for a previously known quality issue. They went on to note that without monitoring, this is just another version of provisional yes. Another attendee commented that under the tiered system, it would be difficult to know what information is new when moving up a tier and this could create more work for the transplant centers. Several attendees were in support of the change and commented that the tiers in conjunction with offer filters will help expedite allocation. One attendee suggested that to inform the approach pre-recovery versus post-recovery there may be data we could learn the expedited liver wizard. Region 10 | 09/28/2022 Members of the region offered several suggestions for the committee. There is concern that this will substantially increase the burden on the transplant programs, which have already been stressed by the broader allocation. One member noted concern that the 3 tiers approach is premature and may possibly create more work for OPOs and transplant programs. The member believes that optimizing the utilization of offer filters through education and possibly mandates should precede reorganization of organ offer approach or redefining provisional yes. The committee should also consider if other operational initiatives could address these challenges, for example creating policy around limiting overnight offers to only those offers affecting urgent placement of organs. Several members expressed concern over the variability of donor information provided by OPOs at time of organ offer. In order for the tier approach to work, and to optimize offer efficiency, there needs to be a minimum set of donor information for OPOs to provide so that transplant programs can thoroughly evaluate an offer. Another member added that often times they are not allowed to request certain donor information until they are primary, which greatly slows down the allocation process. One member suggested that evaluating specific candidates should be moved to Tier 2. Another member noted concern that there will be an increase in virtual crossmatches for Histocompatibility labs, which will end up being wasted effort if the offer is not primary and is accepted by a candidate at a different program. One member suggested that there be transparency built into the tiered framework in regards to multi-visceral organ placement. When reviewing an offer a program should know if there are multi-visceral offers ahead of them. Others mentioned that for kidney offers in particular, organ recovery data like anatomy and biopsy are vital for offer evaluation and the tiered approach needs to incorporate that aspect. Another member suggested that there needs to be a time frame, like six hours before a scheduled organ recovery, that programs cannot accept another offer for the same patient. It may help reduce the number of late turndowns, which often times leads to organ discards. Another member suggested that OPOs should be allowed to determine how many offers they send out for a particular donor offer based on donor characteristics, like DCD organ offers. Another member inquired if there is data that suggests that this concept would result in less late declines after accepting an organ, if would be beneficial to evaluate such data. Additionally, a policy statement from the OPTN on the utility and need for on-call pay for coordinators to support management of organ offers would be helpful to have to review with hospital administration. Some members were in support of increasing the time frame for transplant programs to review organ offers as they move up the tiers, but others disagreed since that could slow down allocation. Lastly, there was a suggestion to create a tool for transplant programs to use that could predict how long they would have to wait for another offer to come to individual candidates. HonorBridge | 09/28/2022 HonorBridge appreciates the committee’s approach to addressing the complex organ offer acceptance process. We would encourage the committee to consider any areas of opportunity for automation and consideration for expedited processes when organs are being allocated post cross clamp. The tiered framework attempts to address the concern of volume of offers through standardization but does not account for hard to place/complex organs where a larger number of offers is needed to get an organ accepted. This concept paper also does not address how organizations will be held accountable to this new process. Lastly, we ask how offer filters will impact this system and whether filters will make some of the components of the tiered system redundant. Until filters are mandatory, and continuous distribution (CD) is implemented, it is difficult to address the provisional yes problem without creating more inefficiencies or complex, cumbersome processes. OPTN Liver & Intestinal Organ Transplantation Comm | 09/28/2022 The OPTN Liver & Intestinal Organ Transplantation Committee thanks the OPTN Operations & Safety Committee for their efforts on developing the concept paper for Redefining Provisional Yes and the Approach to Organ Offer and Acceptance. The Committee notes that the concept of a tiered system may work better for kidney offers compared to liver offers. The Committee suggests that being able to indicate which transplant candidates the transplant program would consider the offer for would be helpful because responding to an organ offer for one transplant candidate is limiting. The Committee adds that it additionally may be beneficial for the OPO to see which transplant candidates the transplant programs would consider for the organ offer. The Committee suggests various criteria or thresholds to be established to aid in a more expedited and efficient placement of marginal organs. The Committee suggests creating the ability for the system to notify transplant programs of a ‘pre-offer’. This ‘pre-offer’ may operationalize as the OPO notifying a transplant program that an organ offer may be impeding, which would then allow the transplant program more time to evaluate their transplant candidates. The Committee notes that a tiered system to organ offers and acceptance may be difficult due to call teams changing during the process which sometimes hinders the ability to accept an organ offer because there are different acceptance practices among various staff within a transplant program. The Committee suggests that OPOs should standardize how they evaluate a deceased donor and provide available information. The Committee notes that some inefficiencies result from the various OPO practices of donor evaluation. Region 8 | 09/27/2022 The majority of the regional members supported a change and provided substantive feedback. There was support for the tier system and eliminating the usage of provisional yes. (And support for offer filters where filters will assist with organ offers.). One member explained that his center does not support project and believes it will make an inefficient process more inefficient. A member asked the committee to provide the community with a timeline for this project. A member suggested the OPTN use A.I. modeling to program the following, “we know this organ will likely take x number of offers to place” to dynamically shift how many offers can be sent. A member emphasized the need to continue to implement the offers filters process at all centers in order to improve the allocation process. The member suggested to enhance the listing criteria per candidate. For example, in the liver candidate, add distance maximums for DCD donors (these criteria are available for expedited donors but not for standard DCD donors). The member explained that this programming change will eliminate the need for transplant centers to review unnecessary offers. Further, the member explained that there is a general concern that the tiered offer process will increase the number of notifications received for a viable offer if her center is not initially the primary. Also, the member commented that most of the concepts seem to pertain to offers that occur prior to procurement, and inquired if the same time limits and tier process will apply to offers occurring after procurement. A member strongly supported the need to redefine the provisional yes and create more efficiency in the system. The member explained that the number of transplant centers in each tier needs to be evaluated and potentially increased to reach more transplant centers, and that each transplant center is currently allowed to accept two organs offers for each recipient - and that this should be considered as this work continues. A member supported the concept but thought the logistics need to be carefully worked out, and pointed out that there needs to be more than one offer and one backup per organ. A member’s center strongly encouraged implementation of a "chat" function that would allow programs to let the OPO know the specific information or interventions that would be needed to make a final decision. A member commented that mandatory offer filters have the potential to eliminate the need for tier 3 offers, and should be the first step to improving the efficiency and transparency of kidney allocation. A member commented that the current 'automatic' provisional yes appears to be meaningless and needs to be changed. But, further commented that the three-tiered system may be overly complex and burdensome leading to the unintended consequence of reducing efficiency and increasing organ discards. The member suggested that holding programs accountable based on provisional yes versus refusal rates would be more effective in increasing organ placement efficiency. A member commented that enacting this proposal seems like it will increase the number of notifications/alerts sent to a program since they typically receive three notifications per organ offer. This directly opposes the rationale to reduce the number of organ offers. It may also lead to increased calls/interruptions to the surgeon staff and increase fatigue, especially if the offers occur in the middle of the night. Association of Organ Procurement Organizations | 09/27/2022 Please see the attached comment from the Association of Organ Procurement Organizations Attachment International Society for Heart and Lung Transplantation | 09/27/2022 Please see attachment for comment from AHFTX IDN. Attachment New England Donor Services | 09/27/2022 The current process for organ allocation could be significantly more efficient to improve utilization and reduce discards. There are no policy obligations on transplant programs when receiving an organ offer unless they are primary to confirm that the organ is in fact acceptable and suitable for the candidate it is being offered for, or that their candidate is ready and available to receive a transplant. As a result, “Provisional Yes” has become meaningless. It creates inefficiency in the process when the organ is turned down for the primary candidate and the other programs that entered a provisional yes have not actually evaluated the offer for their candidate. Policies are needed to require that certain steps be taken by a program when receiving a primary or backup organ offer. Far too often an organ is declined late in the process after initially entering a provisional yes, due to donor information known by the center at the time of the initial notification, candidate unavailability that could have been realized sooner, or a lack of involvement by the transplant center clinician decision maker in reviewing the donor-specific information about an offered organ. Allocation delays such as this negatively impact the next candidates on the list and can result in avoidable discards. NEDS supports development of policy to reduce these wasteful and inefficient practices that have put organs at risk of non-use or, as has happened, resulting in non-use. A tiered approach would obligate centers in the top tier (primary and a backup) to ensure candidates are ready/available, that the organ is suitable for them and that the key transplant decision maker is involved. The 2nd tier of candidates would be obligated to only undertake a subset of these tasks unless and until their candidate moves to the top tier, at which point the additional steps would be required. This is to ensure that organs are appropriately considered for candidates and in an efficient timeframe. NEDS suggests that the Committee consider fully implementing mandatory offer filters before implementing a provisional yes policy – if offer filters are in place, the provisional yes approach will be simpler to operationalize. Region 7 | 09/27/2022 Members of the region feel that this is a very important topic and are appreciative of the Operations & Safety efforts on this project. The region offered several suggestions in response to the concept paper. Many in attendance were skeptical that the three tier system would help with improving organ offer efficiency. The number of phone calls necessary to move through the tiers seems burdensome and would increase allocation time. It was noted that the increase in phone calls would be very problematic for smaller programs. As it is currently described, Tier 3 could be completed through universal use of organ offer filters. It was also noted that the current inefficiencies with Provisional Yes could be solved with Offer Filters. One member voiced support that the tiers do seem to place responsibility on both sides of the process, but the time limits for each tier seems unrealistic. It would be helpful to have more time when it comes to patient evaluation. Another member noted that a comprehensive crossmatch can take up to 48 hours which does not fit well into the proposed tiers. One member suggested that it may be more efficient to allow transplant programs to look at all of the donors offers available and make their initial decisions during their own evaluation, instead of having OPOs make offers first before a transplant program can evaluate the donor offer. It was also suggested that the committee explore the idea of a targeted list of candidates for a given donor. Several programs within Region 7 have participated in a targeted list of hard to match candidates that the programs can get early access to evaluate an organ offer and decide if it would be a possible match for their candidate. Another member noted that the proposed names, Tier 1-3, are too ambiguous and non-directional. Instead, the committee should consider giving more direction in the tier names, such as, Initial Offer tier, Continued Evaluation tier, and Final tier. American Society of Transplantation | 09/27/2022 The American Society of Transplantation (AST) offers the following comments in response to the concept paper “Redefining Provisional Yes and the Approach to Organ Offers:” The AST has significant concerns that, without creating parallel allocation processes to improve efficiency, the concepts outlined in this paper will add significant complexity without achieving the stated goal of expediting organ placement. It is not clear how these changes would be operationalized or whether the changes outlined in the concept paper will result in unintended consequences that could diminish rather than improve the efficiency of organ placement. The AST recommends that the OPTN implement changes ultimately resulting from the “Optimizing Usage of Kidney Offer Filters” concept paper first, before approving any changes to provisional yes policy. To improve efficiency as much as possible, objective "internal refusal reasons" envisioned in this paper to comprise the Tier III decision making criteria should be incorporated into the organ specific offer filter criteria as well. If or when provisional yes policy changes are implemented, Tier III decision making behavior could inform future changes to offer filters. The proposed chat feature and ability of programs to view their sequence if the intended organ is part of a multi-organ offer would be a welcomed change and could be implemented prior to or independent of changes to provisional yes policy. As allocation progresses, to remain in a position to accept an offer, transplant centers must provide increased specificity regarding what is needed to make a final decision. This prompts a few questions and concerns: -More detail is needed about how the “tier” system will work. i.e., will centers be notified that they are now in a higher tier and be required to enter additional information? -How will the current practice of potential recipient blood being sent out to OPOs for highly sensitized patients be considered? We believe it should be maintained and centers should not be penalized for this practice. -For this practice to work, centers should be expected to confirm a candidate's medical suitability no later than Tier II to ensure that there have been no interval changes that would lead to organ decline. For Tier II, OPOs should not be constrained to a single offer per organ. Regarding the number of Tier III notifications that could be sent down a match run, consider using the mean Number of Programs Needed until Final Acceptor on Each Match by Organ Type across All OPOs (Table 1 in the concept paper). Currently, OPOs determine how many centers to offer an organ on the match run. The functionality to remove a transplant program from a match run if the organ is declined by the program for quality should be implemented with the exception that a marginal donor may be declined for one candidate but may be suitable for an alternate candidate further down the list. It is important that a tiered match run maintains priority for dual organ candidates per OPTN allocation criteria. The number of offers that proceed to a “Tier I” should be limited to primary and back up offer. Otherwise, patients will be notified of organs that will never come to them. Consider additional offers for marginal, DCD, high KDPI, etc. organs. Programs should be held accountable for provisionally accepting organs that are later declined based on information provided initially. These avoidable late declines should be reported and routinely reviewed, and if a trend is identified, subject to a quality improvement process. In response to specific questions posed in the paper, the following feedback was provided: What should happen if the first program refuses the organ offer (in Tier I)? The organ should be offered to candidates listed at the next center with one exception. If an organ is declined for quality for one candidate (e.g., a pediatric patient), it very well may be suitable for an alternate candidate further down the list. The system should allow for patient-level decision-making while improving efficiency by allowing the OPO to move on to candidates at another center quickly when an organ will be declined for all candidates by the first program. Consider organ quality decline process that automatically allows a program to differentiate whether a decline is for all versus for one patient. What information should OPOs be required to complete for a Tier III offer evaluation? With broader sharing, a greater level of standardization between OPOs should be a priority. This includes standardizing to the extent feasible the donor data that is available at offer such as imaging, hemodynamics, and neurological status for DCD donors. Are there tools that should be considered that could help facilitate this three-tiered model? Current real-time donor data including hemodynamics (pressors), ventilatory status, blood and urine results, and access to imaging. Each match run should also include how many different programs are ahead of a potential transplant recipient, in addition to providing each individual candidate’s ranking. As an example, the likelihood of receiving an organ is different if there are 50 potential transplant recipients from one program ahead of your patient versus 50 potential transplant recipients from 10 different programs; additional information to assess this during organ allocation would be helpful. Are the requirements within each tier reasonable? Tier III will become the provisional yes and accepted offers will likely increase. Ideally, virtual crossmatch information will be available at the time the Tier III offer is made. Should OPOs limit offers based on tiers? Should this be based on the number of organ offer responses that are confirmed? This is a must and should be implemented independently of this proposal. The number of offers is currently determined by OPOs but should be based on an algorithm that incorporates the likelihood of acceptance based on donor and organ factors. Harder to place organ offers could have a different and larger limitation that is organ specific (the data provided show differences between kidney and liver). Should there be expectations outlined that are specific to offers sent pre- and post-recovery? Exceptions may be needed for dual organ offers, sensitized patients, and DCD cases. Do you agree with the recommended thresholds for each tier? These thresholds will require careful review for each organ type. The tier thresholds should not be left up to the individual OPO. There is too much variability. Thresholds may differ between organs. What threshold should be considered for Tier III for when should a program receive the initial notification? The number of programs needed until a final acceptor on each match by organ across all OPOs (Table 1) is a good starting point. Do you agree with the recommendations on time limits on offers for Tier I and Tier II? Members expressed support for the proposed time frames for Tier I and Tier II. Strictly enforcing the time limit will significantly improve the current process. Should there be different considerations for offers sent pre- and post-recovery? If so, what should those considerations be? Yes, time limits should be modified for offers post-recovery as any delay at that time will prolong the ischemia time and can lead to non-utilization of an organ. Approaching these scenarios similarly could result in the discard of organs allocated post-recovery that could otherwise be transplanted. Should there be a time limit for Tier III to respond to a notification on an organ offer? Yes, this would facilitate efficient organ allocation. Attachment OPTN Histocompatibility Committee | 09/27/2022 The Histocompatibility Committee would like to thank the OPTN Operations and Safety Committee for bringing this concept paper forward, and for all their work on this subject. Members of our committee do have concerns regarding the timing in tier I. Physical crossmatch and antibody testing at a rapid rate can take hours to perform, and the 1.5 hours may not be enough time for centers to perform the necessary testing. Our members feel that this timeline is especially restrictive for cases requiring a physical crossmatch. This time would also complicate justifications for refusals because there is no time for additional testing, the time allowed to input refusal codes is based on risk assessment you have at that moment. Some centers with a limited number of cases will need a physical crossmatch while organs are already allocated, there must be enough time for those centers to perform those tests. There are questions around the backup selection process, who identifies the backups, and must they come from the match run? We are also concerned about the impact this will have on highly sensitized patients because of the testing they require, this change might push programs to move on to different candidates because the lab cannot meet the timeframe. We understand that the offer cannot wait forever, but one hour is too short. There were no further comments from the committee. American Society of Transplant Surgeons | 09/27/2022 The American Society of Transplant Surgeons (ASTS) is generally in favor of reforming the approach to organ offer and acceptance to improve efficiency of placement. Redefining the Provisional Yes is certainly a part of it, but fundamental revisions beyond this are needed to modify/improve processes within the organ offer/placement pathway to optimize this ecosystem. This includes but is not limited to, incentives for programs and OPOs to promote efficiency, establishing standard criteria for conduct of organ procurements, establishing criteria for procurement surgeons, and optimizing safety/efficiency of organ transport. The three-tiered system proposed adds granularity to understand where in the placement process the centers are, in addition to increasing the accountability of responding programs somewhat. The drawbacks include potential micromanagement of the placement pathway when practices vary around the country, leading to programs feeling locked into pathways that don’t fit into their optimal workflow. Tiered Framework • What should happen if the first program refuses the organ offer (in Tier I)? In the first version of this endeavor, it would be best not to penalize programs that turn down after Tier 1. Rather, it would be considered valuable to assess the success of this new system and should be used for evaluating at periodic intervals. • What information should OPOs be required to complete for a Tier III offer evaluation? OPOs should have the donor record completed and ready as with the current system prior to sending out offers. • Are there tools that should be considered that could help facilitate this three-tiered model? Transparency would be critical for success of any model. Therefore, the proposal to not white out OPO information is welcomed. In addition, there may not be a need to white out center information as well, as this will likely not impact confidentiality. Associated Requirements within Tiers • Are the requirements within each tier reasonable? Generally, yes, with the caveat that there is a risk of overprescribing the requirements for each tier. For example, it may not be reasonable for the tiers to determine when candidate availability should be determined. The proposal suggests Tier 1, but many programs do that much earlier in the process. • Should OPOs limit offers based on tiers? Should this be based on the number of organ offer responses that are confirmed? Yes, this will be a key element to improving efficiency and getting center buy-in. The initial number of offers should be based on the number within which the organ has a reasonable chance of getting placed. This may need a sophisticated algorithm which should be developed based on donor factors, organ characteristics, and other variables such as geography, time to procurement, etc. The number of offers should come down as the tiers move up to 1. • Should there be expectations outlined that are specific to offers sent pre- and post-recovery? Rather than having a dichotomous plan for pre- vs. post-procurement, a continuous variable based on proximity to clamp time (on either side pre- or post-), in combination with other factors could be used for decisions on number of offers (as stated in the response to the previous question) Tier Thresholds (number of offers sent) • Do you agree with the recommended thresholds for each tier? Generally, yes. Each tier should incrementally increase the accountability for provisionally accepting the organ. • What threshold should be considered for Tier III for when should a program receive the initial notification? If the program has expressed an interest in receiving such organ offers as the one being offered (during the listing process), they should not be bypassed. Time Limit on Offers • Do you agree with the recommendations on time limits on offers for Tier I and Tier II? Yes. • Should there be different considerations for offers sent pre- and post-recovery? If so, what should those considerations be? Yes. • Should there be a time limit for Tier III to respond to a notification on an organ offer? Yes, and it should be consistent with current standards for the Provisional Yes. Attachment Live On Nebraska | 09/27/2022 After reviewing the proposed policy, it is Live On Nebraska’s position that this is a step backwards in an effort to improve the efficiency and effectiveness of allocating organs and will potentially lead to more organs not being transplanted. As mentioned in some of the comments from transplant programs, this proposed change is overly burdensome. Until offer filters are mandatory, and continuous distribution is implemented, it is difficult to address the provisional yes problem without creating more inefficiencies. The primary focus of the OPTN should be to reduce the use of “provisional yes” in a manner that results in late organ declines. Live On Nebraska strongly encourages the OPTN to work on policies and procedures around transplant program use of “provisional yes” and their ability to decline previously accepted organs late in the allocation process without transplant center accountability. Region 11 | 09/26/2022 An attendee suggested that multi-organ offers be addressed to reduce the time between offer and transplant. Another attendee commented that kidney placement is not prioritized in multi-organ offers. Several attendees voiced dissatisfaction with how many offers are made in the current system and gave examples of receiving offers when they are 100 or more in sequence on the list and there are much higher primary offers. Gift of Life Donor Program (PADV) | 09/26/2022 Gift of Life Donor Program (PADV) thanks the Operations and Safety Committee for their efforts on this proposal and the opportunity to comment. Gift of Life strongly agrees that the provisional yes no longer suits its intended purpose and decreases organ allocation efficiency. We support more standardization for the organ evaluation and acceptance process and the redefining of the provisional yes to drive transplant center accountability and more transparency between OPOs and transplant centers. We feel that the proposed tiered system does not adequately address the problems with the existing provisional yes system and will increase the burden on both OPOs and transplant centers attempting to navigate a tiered system. Currently, the entry of a provisional yes is essentially meaningless as there are no requirements for entry and it does not indicate any particular action by the center. A provisional yes means something different at each center. While some centers proactively review offers and thoroughly vet patients ahead of time, many centers who have third party services enter a provisional yes for every offer, without looking at any of the donor information. For this reason, the provisional yes does not help an OPO adequately prepare for organ acceptance, nor does it help transplant centers understand their true place on a match run (i.e., what actions have been taken by centers ahead and how likely they are to receive a primary offer.) Furthermore, for those centers that enter a provisional yes without reviewing the offer, or worse, claim interest when contacted by the OPO without reviewing the offer, there are currently no consequences or formalized way to hold these centers accountable. Actions like this directly contribute to the discard of otherwise useable kidneys and severely decrease efficiency of organ placement. The proposal does not address these issues and in fact, further complicates the current system. Rather than a tiered system of offers, Gift of Life proposes a multifactorial and/or conditional provisional yes. The provisional yes should clearly indicate what actions have been taken by the center: surgeon/decision maker review of donor information, confirmation of candidate medical suitability and availability, virtual crossmatch performed/not needed, serological crossmatch needed, final crossmatch compatible, etc. Gift of Life proposes that centers who reach primary or first back-up position be held accountable to meet all these expectations pre-recovery or be subject to bypass. However, any transplant center can proactively perform any or all these steps and clearly communicate this to the OPO on the match run. If a center documents on the match run that they met a certain requirement yet later declines for that reason, a notification should be sent to OPTN for tracking and follow up. Ultimately data related to these types of declines could be displayed on the match run for each center, increasing transparency between OPOs and transplant centers and better inform decision making by OPOs and transplant centers on the match run. Gift of Life proposes that transplant centers should be able to enter further conditions of acceptance on each offer. For example, when evaluating a DCD donor, a center may indicate on the match run they will not accept if warm ischemic time exceeds 30 minutes. This would be visible to all centers on the match. Post-recovery, these conditions would allow the OPO to quickly move through any centers whose requirements are not met. We support the proposal that the transplant center should also have a way to indicate on the match that more information is needed from the OPO, and what that information is. However, a chat feature would not be a responsible solution as it could be easily missed or lost during change of shift of both OPO and transplant center staff, and instead recommend follow-up continue to occur by phone. Organs that must be re-allocated post-recovery are already at high risk of discard and notification limits only serve to add cold ischemic time to these already challenged gifts. Furthermore, notifications for post-recovery organs should be clearly marked as such to aid transplant centers in prioritizing workload. Post-recovery, centers should be able to indicate on the match run that they would accept an organ if given a primary offer and have prepared to do so i.e., performed a crossmatch, and cleared the candidate. We do feel that the current time limits for offer evaluation are appropriate and would not impose further specific time limits for centers to meet previously discussed pre-recovery requirements. Gift of Life urges the committee to ensure that in whatever manner these increased responsibilities are implemented, they are enforceable with a clear process and consequences for non-compliance. In conclusion, Gift of Life does not support the concept of tiered offers but instead advocates for a more dynamic and conditional provisional yes that would indicate what steps a center has taken for a given offer/candidate and include acceptance parameters such as warm ischemic time, lab values, and/or biopsy results. Within this system, a program whose candidates reach a given rank on the match should be required to meet certain requirements or be subject to bypass. Post-recovery offers should not be limited, and transplant centers must have greater responsibility to evaluate post-recovery offers expeditiously and indicate interest in real time. OPTN Lung Transplantation Committee | 09/26/2022 The Lung Transplantation Committee thanks the Operations and Safety Committee for their concept paper. Members said that the concepts make sense for kidney allocation but are concerned that the tiered framework would not work well for lung allocation. A member expressed concern that programs would take too long in accepting these offers, which would limit the number of candidates that could serve as backups. The member noted that sequences would need to be reflected in the tiers. A member explained that lung offers should be sent to a very limited number of candidates to avoid wasting time, so Tier III should have some limits, like only sending notifications to ABO identical candidates within 250 nautical miles. Members stated lung organ acceptance is much more dynamic than kidney, and emphasized the importance of having updated donor information like chest X-rays within 6 hours, a CT scan within a day or two, and updated blood gas information to assess organ quality. Members suggest addressing inefficiencies in lung offers by requiring OPOs to complete all testing before organs are offered, and by expanding acceptance criteria to reflect conditions for which the transplant program would not accept an organ (e.g. indications of emphysema via CT scan). Members felt that Tier II would become the “new provisional yes” for lung and noted that about 70% of all matches occur in sequence numbers less than 10. Since most lungs are placed early in the allocation process, lung may not have the same challenges as other organs in trying to place organs far down the match run. Additionally, lung transplant centers have tight waiting lists of candidates that are closely monitored so when an organ is offered, these candidates are ready to go for transplant. OPTN Transplant Coordinators Committee | 09/23/2022 The OPTN Transplant Coordinators Committee thanks the Operations and Safety Committee for their work and for the opportunity to comment on this concept paper. Several Committee members agreed that offer filters and mandatory offer filters will address many of the same issues that the provisional yes concept attempts to address. One member noted that offer filters could eliminate the need for a tier 3 offer. Another member recommended rolling out offer filters for all organs before pursuing any major system changes to the allocation process, noting that the provisional yes concept would be expensive to implement, and that there may be cheaper and more effective ways to address remaining concerns. Some Committee members emphasized that policy already describes specific allocation and evaluation timeframes meant to improve efficiency of offer acceptance and evaluation, but that there is nothing in the system to enforce those timeframes or monitor their adherence. One member recommended that any updates to the allocation system include efforts to enforce and monitor compliance to the timeframes, both to encourage efficiency and to give insight as to whether the current timeframes are reasonable and feasible for transplant programs. A member noted that automated timeouts and bypasses could be tricky, particularly in cases where a transplant center’s provisional yes is pending additional information from the OPO. The member added that transplant programs should not be bypassed while awaiting information that is reasonable to evaluating the offer. A member asked if the Operations and Safety Committee would consider shortening the timeframe for evaluation for organs being allocated after a late turn down or in-OR decline. The member recommended that the provisional yes concept makes special consideration for reallocation after late turn downs. One member recommended requiring virtual crossmatch early in the evaluation process, such as tier 3, or at least requiring programs to identify which candidates need physical specimen sent for cross match. The member noted that physical crossmatches can be time consuming, particularly when materials take time to ship. A member recommended expanding the number of offers that can be sent out in tier 1, such that tier 1 encompasses both the primary offer and the first back up to the primary offer. The member explained that the first back up offer essentially needs to be ready to accept the organ at any moment, in case the primary recipient falls through. Additional back up offers could be considered tier 2. A member recommended utilizing simulation modeling before implementation of this concept. One member noted that there is need for clarification on how tier 1 functions when allocating lungs, particularly as it applies to double lung allocation. Region 1 | 09/21/2022 An attendee stated we all agree that there is a problem. The proposal, as written, is complex and creates more work for the transplant center staff. We should be focus on existing tools (kidney acceptance criteria, candidate listing forms, and organ offers filter) before embarking on additional projects. I would not support the proposal as written. An attendee commented this is necessary. This should be a focus on decreasing time post cross clamp to final acceptance. These changes are more critical in placing more marginal kidneys. An attendee asked about the timing of cross matching and another advocated for a dynamic match run. Another attendee shared their concern with the thirty minutes from tier II to tier I, and several attendees brought up that whether the offer is pre or post clamp would have to be considered. There was discussion about lower KDPI kidneys being accepted higher up on the match run and that there should be a focus on higher KDPI kidney allocation that already have 12-14 hours cold ischemic time. Attendees suggested pairing this with offer filters to increase efficiency. An attendee commented that the increase in structure will turn a parallel process into a linear process and may require more time. If not coupled with offer filters this may not be successful. Another attendee asked how multi-organ offers would be factored into this in terms of primary and back up offers. Another attendee thinks a 3 tier system makes things even more complex and could slow allocation down. Region 3 | 09/20/2022 Many attendees supported the committee’s effort to improve the current provisional yes system. During the discussion there was concern raised that the three tier to acceptance concept seems to run the risk of increased work load and burnout for physicians and transplant center coordinators without establishing sufficient accountability for the transplant centers toward their offer acceptance practices. One attendee added that generally, centers acceptance practices need greater transparency to patients and the general public. There was a recommendation to put a limit on how many offers can have a provisional yes before the OPO is able to send out more offers. They noted that doing this would give transplant centers time to evaluate the offer fully since there would be fewer offers at once and the candidates would be higher in the offer sequence. Another attendee commented that in assessing candidate medical suitability for all Tier II offers would be difficult since it would mean bringing the patient into the hospital. They added that instead of a tier system, it would be better to have an electronic alert when your candidate is 2-3 behind the first ranked candidate so you could reopen the offer and take more time to evaluate the donor (give 30 minutes at this time point instead of when you're primary). This concept was supported by other attendees. Another attendee commented that as a patient, they were required to notify their transplant program about any changes in medical status or availability. Other attendees commented that patients should be responsible for contacting their center if their medical status changes or if they are temporarily unavailable due to travel. One added that this process should be automated so it is easy for the patient to report the information. Another attendee suggested that requiring an outline of information the OPO must provide in the Donor highlight section would help with donor selection. Several attendees agreed that there are inefficiencies in the allocation system but is concerned that the Tier system is adding another layer to a very complicated system. They went on to comment that the community should focus on offer filters and the match needs to be dynamic, not static. Organ Procurement Organization Committee | 09/20/2022 The OPTN Organ Procurement Organization Committee thanks the Operations and Safety Committee for their work and for the opportunity to comment on this concept. The Committee expressed several concerns with this concept, including that the tier system models the current system too closely and that this concept does not sufficiently ensure accountability between transplant programs and OPOs. The Committee emphasized the importance of transplant program accountability, and expressed support for automated bypasses based on offer time limits. Members of the Committee highlighted that the most effective aspect of this concept is the automatic bypass based on offer time limits, as this will bolster the evaluation expectations and reduces negotiation between the program and the OPO. Furthermore, the automatic bypass will hold transplant programs accountable for these time limits. One member also noted that including a method for transplant programs to request additional information through the OPTN Donor Data and Matching System would also be helpful. The member emphasized that programming an area in the match run for the program to specify which information they need would significantly help streamline communication. One member pointed out that both the additional information request and the automatic bypasses based on offer time limits could be implemented without a tier system. Several members expressed concern that the tier system is practically similar to current offer and evaluation practices. Members noted that programs will likely default to accepting tier 3 offers, and not being evaluation until the offer becomes a tier 2 offer. One member expressed concern for prolonged decision making in Tier 2 and Tier 3, noting issues that many OPOs are experiencing with late turn downs, particularly those due to recipient issues or recipients receiving a better offer. The member added that every patient with a Tier 1 offer and the first few back up patients need to be prepared to go to the operating room, in case the primary acceptance falls through. Another member noted that the tier concept not only models the current system, but creates an additional buffer layer between the offer and the decision makers with the 3rd tier. One member expressed concerns for additional time to allocation, noting that there are issues with programs coding offers patient by patient as each of those offers become primary, instead of evaluating the offer as a whole and determining which patients they would accept the offer for. Another member noted that, while 90 minutes may seem insignificant for a program to consider an offer, 90 minutes multiplied by the thousands of patients on the kidney match equals a lot of time spent trying to place an organ, resulting in high cold ischemic times and non-utilization. Several members agreed that accountability for transplant programs needs to be clearly defined and enforced. Some members agreed that this concept does not ensure transplant center accountability for the current rules of allocation. One member continued, explaining several key issues with the current offer evaluation and acceptance practices, including: programs not adhering to offer time limits, programs refusing to thoroughly evaluate back up offers as if they were primary, and programs not properly checking in on their patients when evaluating an offer. The member elaborated on the last point, noting that this causes issues when the organ has to be shipped and is declined mid-flight due to patient insurance or unavailability. One member expressed concerns for additional time to allocation, noting that there are issues with programs coding offers patient by patient as each of those offers become primary, instead of evaluating the offer as a whole and determining which patients they would accept the offer for. Members agreed that accountability for transplant programs needs to be built into the system, and that OPOs should not be responsible for holding transplant centers accountable. One member recommended that allocation analysts, who typically hold OPOs accountable for appropriate allocation, could similarly address transplant program behaviors that delay allocation. One member recommended giving consideration to limiting the number of provisional yes responses that a transplant program can provide on an offer, explaining that the provisional acceptances are not genuine when a program enters a provisional yes for all of their patients on a match run. A member pointed out that policy doesn’t address the “Notify Back-up” and “Notify Primary” buttons within the match run, and that policy should clarify when the clock starts on an offer. The member explained that some programs don’t consider the clock to start until the OPO and transplant program have discussed the offer via phone call, and that this can create issues and delay allocation when coordinators don’t answer offer calls. The member noted that this problem can be exacerbated by contract coordinators, who act as an additional buffer between OPOs and decision makers at transplant programs. The member noted that automated bypasses can provide a neutral, standardized timer for all organ offers. Several members emphasized the importance of ensuring that any offer policy provides clarity and accountability as to when the offer clock starts, and that the offer clock is not tied to a phone call. One member noted that the addition of an electronic notification while relying on a telephone call to start the clock doubled expectations for OPOs. Members agreed that offer filters will significantly improve allocation efficiency, and would have positive effects on the tiered system concept. Some members noted that offer filters could effectively replace tier 3 offers, if used correctly. One member noted that offer filters are critical to more efficient allocation practices. A member noted that the holding of account needs to be shared equally between transplant programs and OPOs, and that lack of patient insurance or historical center acceptance behaviors are information available ahead of time that can be used to improve allocation efficiency. A member noted that between offer filters and acceptance criteria, a tiered offer system is not necessary. Anonymous | 09/20/2022 I agree with the need for efficiency in the organ offer notification process. As a Transplant Center staff member that covers on-call for organ offers for an adult kidney program, our team prioritizes organ offers according to recovery date/time, as well as other factors. Though our process is very similar to the proposal, the 3-tiered concept appears overly cumbersome, and may actually increase inefficiencies by expanding the workload for the transplant centers. The booming increase in match run notifications since the implementation of the new kidney allocation system (eliminating DSAs) has made this prioritization workflow essential. However, one of our biggest challenges is from OPOs that are not entering the planned or tentative OR time into the dedicated field in DonorNet prior to organ recovery. Some will enter the information into the Donor Highlights narrative (not ideal, but still helpful), while others never enter an OR time at all. In addition, Cross-clamp date/time is often not entered/flowing into the distinct field in DonorNet—even hours after surgery—so there is no way to recognize at a glance that the recovery surgery has already taken place. (Only a search through the attachments to see that post-recovery documents have been posted—or worse, an unexpected call from the OPO with a primary organ offer). What I would propose for OPOs to help Transplant Centers efficiently prioritize: • Utilize the distinct field in DonorNet to post the OR Date/Time (scheduled or tentative) as early as possible • Complete the documentation required to allow cross clamp data to post to the proper fields in DonorNet immediately after organ recovery Other suggestions: • Some OPOs will ‘lock down’ the case after the initial match run notification responses, thereby disabling the ability for Transplant Centers to enter an updated response (after further review of the information by a Transplant Physician or Surgeon, and/or review of the candidate’s chart). If we are facing a time crunch with multiple offers, it is not always feasible to call the OPO representative to request the offer be ‘unlocked’, and will simply skip this step. • If a DCD does not pass within the allotted time, it is extremely helpful for the OPO to enter *DCD Did Not Pass* at the top of the Donor Highlights narrative. By removing that donor from our priority list, it enables the transplant center to put more focus on other offers. And for the UNOS Technology Team: • In the mobile version of DonorNet, the list of Refused offers is in a separate tab from those ‘In Progress’. Can this concept be created for the full web version? Could there be a ‘favorites’ option to create our own worklist? • A ‘dashboard’ in the opening page of DonorNet that would include scheduled/tentative OR date/time, cross-clamp date/time, and current sequence # of a center’s top candidate for all active organ offers. Region 2 | 09/13/2022 Members of the region expressed concern that the tiered approach may not have the intended purpose and may result in further inefficiencies. The region made several comments and suggestions for the committee to consider as they continue with the project. One member noted that tools they have implemented at their program look like the tiers in the concept paper. The problem is that it takes too long to get offers to the decision makers due to system inefficiencies. It would be more efficient to limit the number of offers an OPO can send out for a given organ or establish a system where transplant centers are able to see all active organ donors and select which donors they may be interested in receiving offers from. Another member agreed that this would add time to the current allocation process given the limitation to the number of offers going out. Tier 3 can be accomplished with offer filters and shouldn’t be a tier. Tiers 1 and 2 could be collapsed together and use histocompatibility and other factors to consider. Additionally, have OPOs post information and give transplant centers the chance to respond. The approach may need to be different for each organ, specifically in Region 2. Number of centers in 250 NM should be taken into consideration. With seventy kidney centers in the area going two offers at a time would be extremely difficult. However, that approach may have less of an impact on transplant centers out west. Another member suggested the histocompatibility be moved to Tier 2. It was also noted that offer filters are a good first draft to consider age, body size, but the key to efficiency is to limit the number of calls in the middle of the night that aren’t going to be accepted. Instead of redefining Provisional Yes the committee should focus more on effective offer filtering to increase efficiency and timeliness of organ placement. Another member suggested using tiers at the patient level so that if a program has gone through all of the steps their patient would be considered Tier 1. For example, if a candidate at sequence #20 has completed all of the offer evaluation steps they would receive the offer ahead of a candidate at sequence #5 who had not gone through all of the offer evaluation steps. Another member that this project is much overdue and it has been a known error to broaden organ sharing with no concern for OPO/transplant center relations or responsibilities. It was also noted that Tier 3 could be accomplished through Offer Filters and Tiers 1 and 2 should be combined to limit complexity and hopefully decrease time to final acceptance. Another member noted that the tiers appear complex and will create more work for transplant centers. Adherence may be challenging due to organ offer logistics and time to get a live crossmatch. Additionally, all donor imaging and data should be available directly in DonorNet to increase efficiency. Another member stated that the concept will cause a significant delay with an already slow allocation process. This concept is attempting to place a Band-Aid on a process that isn't so much a process problem but more of a people problem. The transplant centers need to have staff available to review and decide on organ offers in real time and make a genuine decision for their center or for specific candidates. Declining offers one candidate at a time is delaying allocation. The committee needs to address the following issues: surgeons who are in the operating room and can't make a decision for 3+ hours, programs that don't look at offers until they are primary, programs that don't make sure their candidates are available and ready for transplant then code out once the organ is on its way because the candidate doesn't have insurance coverage. In response, it was noted that anything that impairs the transplant surgeon's ability to give an offer its full consideration in a timely fashion will slow the allocation process down. The layers that have been placed in front of transplant surgeon notification have been enacted by transplant programs with the intent of actually shielding the surgeons from the noise in the system which can be overwhelming and might even further impair the surgeon's ability to fully consider each real offer. Increasing the number of transplant surgeons across the nation may help alleviate this issue. In general, OPO's have responded to the pressures to increase the numbers of deceased donors. Transplant centers have likely lagged behind in hiring more surgeons, because surgeons are costly and are a huge investment. There are enough transplant surgeons trained but programs mostly have not truly considered expanding their surgical group in light of the pandemic and the financial strain the hospital systems have faced. Region 9 | 09/12/2022 One attendee commented that the proposal was redundant given that many similar components are already in place. Another attendee commented that their institution does not support this proposal and don’t agree that this approach will meet the intended outcome. Another attendee commented that they liked the idea of a tiered system. Region 5 | 09/08/2022 Several members suggested that the system needs to document, preserve, and analyze important time stamps for each of the important events, such as: What time an OPO makes a primary and back up offer, What time an acceptance is first entered or acknowledge, When a 'final acceptance ' is then declined later - close to or after operating room or cross-clamp, Late declines after final acceptance A member commented that the tiered approach doesn't resolve the issue of centers accepting an organ and subsequently declining with no change in donor information; there's concern that the proposed process will add even more organ offers to an already inefficient system. The member explained that their institution supports the idea of some form of auction-style allocation where blast offers go out and the highest on the list gets it after a certain period of time. We should focus our efforts on better documentation of offer process and identifying late declines/declines with no change in donor information. The member suggested that the committee study the findings from the recent liver expedited allocation process to consider a path forward. Several members suggested that for hard to place kidneys the committee should consider an auction style placement - put out offers to more centers and for them to identify their highest patient they would take it for, and then the highest bidder gets the next offer. Then, mandatory offer filters should be used for offers from further away. The center would then have the opportunity to widen the filters by demonstrating accepting use of suboptimal organs for local candidates. The opportunity should be given to the centers by showing actual acceptance. Another member suggested to monitor and report the donor evaluation to organ offer process and include the time-frames in order to develop best practice and standards. A member commented that the existing system is unacceptable for everyone involved. The efficiencies which could be gained from the system are lost when transplant centers can "stop the clock" by entering a provisional yes and refuse to truly evaluate the offer until it's primary. This also disadvantages transplant centers who do use the system appropriately. The tier system will only be effective if OPTN enforces it. Several members expressed support for redefining provisional yes for organ offers. A member suggested that the current plan will be a burden to OPOs, slow down allocation and will not likely increase transplantation. Glyn Morgan | 09/07/2022 This concept paper offers suggestions that would complicate an already burdensome process for those who respond to organ offers. We should concentrate on the existing organ offers filters tool. In short - the filters work - they are easy to apply and simple to modify. Too few program have made the effort to use filters. We applied filters the very first day they were activated and have seen a 60% reduction in offers - all of which would have been declined by our center. During the same time we have performed more deceased donor kidney transplants with no increase in DGF rates. Most importantly our team is better rested, less stressed and can concentrate on the suitable offers made to our list. The proposal put forth in the concept paper cannot be considered or supported until there is widespread adoption of offer filters. Anonymous | 09/02/2022 I agree with the need for efficiency in the organ offer notification process. As a Transplant Center staff member that covers on-call for organ offers for an adult kidney program, our team prioritizes organ offers according to recovery date/time, as well as other factors. Though our process is very similar to the proposal, the 3-tiered concept appears overly cumbersome, and may actually increase inefficiencies by expanding the workload for the transplant centers. The booming increase in match run notifications since the implantation of the new kidney allocation system (eliminating DSAs) has made this prioritization workflow essential. However, one of our biggest challenges is from OPOs that are not entering the planned or tentative OR time into the dedicated field in DonorNet prior to organ recovery. Some will enter the information into the Donor Highlights narrative (not ideal, but still helpful), while others never enter an OR time at all. In addition, Cross-clamp date/time is often not entered/flowing into the distinct field in DonorNet—even hours after surgery—so there is no way to recognize at a glance that the recovery surgery has already taken place. (Only a search through the attachments to see that post-recovery documents have been posted—or worse, an unexpected call from the OPO with a primary organ offer). What I would propose for OPOs to help Transplant Centers efficiently prioritize: • Utilize the distinct field in DonorNet to post the OR Date/Time (scheduled or tentative) as early as possible • Complete the documentation required to allow cross clamp data to post to the proper fields in DonorNet immediately after organ recovery Other suggestions: • Some OPOs will ‘lock down’ the case after the initial match run notification responses, thereby disabling the ability for Transplant Centers to enter an updated response (after further review of the information by a Transplant Physician or Surgeon, and/or review of the candidate’s chart). If we are facing a time crunch with multiple offers, it is not always feasible to call the OPO representative to request the offer be ‘unlocked’, and will simply skip this step. • If a DCD does not pass within the allotted time, it is extremely helpful for the OPO to enter *DCD Did Not Pass* at the top of the Donor Highlights narrative. By removing that donor from our priority list, it enables the transplant center to put more focus on other offers. And for the UNOS Technology Team: • In the mobile version of DonorNet, the list of Refused offers is in a separate tab from those ‘In Progress’. Can this concept be created for the full web version? Could there be a ‘favorites’ option to create our own worklist? Kidney Transplantation Committee | 08/31/2022 The OPTN Kidney Transplantation Committee thanks the Operations and Safety Committee for their work and for the opportunity to comment on this proposal. The Committee expressed several concerns with this concept, with members noting particularly that tier III as proposed could become the new provisional yes. One member explained that, if too many tier III offers are sent out, programs will just automatically input provisional acceptances, and the offers will flood into tier II. Some members agreed that the current system is already reflective of what is presented in the tiered framework. Members expressed concerns that this concept will apply differently for programs of different sizes, and could particularly be burdensome for smaller programs, as compared to larger, better-resourced programs. Members agreed that the provisional yes concept needs to work for all types of programs. Some members expressed concern that requiring users to log on and click into offers throughout the night could be logistically complicated and burdensome. Members emphasized that programs will need to be held accountable to these responsibilities, and some members recommended increase program accountability by making provisional decisions more binding. Members noted that there could be issues in defining time limits in each tier, as 30 minutes could be insufficient to perform all of the tasks and responsibilities presented. Members also recommended performing simulation modeling as this moves forward, to help inform time limits and avoid creating preventable delays to allocation. Members also recommended including some language where OPOs can prioritize day time offers, as middle of the night provisional yes responses in particular contribute to increased cold ischemic time, as people forget about the offers and provide late, post-cross clamp declines. Members further suggested batched offering, such that the kidney is offered a certain number of candidates on a match run, and if those candidate’s programs don’t respond, they would be bypassed and the next group of candidates would be offered to, rather than the current sequential offerings. Region 4 | 08/26/2022 One attendee urged the committee to address extra renal, post recovery open offers. They added that this methodology will delay getting the organs placed if there is not a pathway to extend open offers. The commenter also recommended that for Tier 1 offers, the individuals representing the transplant team be clear with the surgeons doing the transplant so that there is no miscommunication. Clear communication limits time to place an organ and also prevents organ wastage. Another attendee commented that they are unsure how this approach would reduce the notifications since Tier 3 offers seem similar to the initial notification with a similar option to decline for the whole center. One attendee noted that final candidate suitability needs to be assessed when the candidate is seen at the transplant hospital. Another attendee commented that this project and the offer filters project are intertwined and they would support the provisional yes concept provided offer filter participation is required. One attendee commented that fixing the offer process is only half of the equation. They added that making the list more manageable is also part of the equation so that candidates who appear on the list would actually be considered for the type organ being offered. Another attendee commented that the 3-tiered framework has potential to improve efficiency of the process. They added that starting with refusals rather than a provisional yes may more quickly eliminate offers rather than the provisional yes which is almost a universal response. An attendee commented that there should be a pilot project with volunteer programs so that we can identify any problems with this system. Anonymous | 08/24/2022 While I agree there is a serious need to address the offer acceptance process, this plan does not at all address the root cause of the problem which is OPO coordinator sending out too many offers at one time. There is no benefit to either the OPO or the transplant center if offers are sent out into the 100s, 200s and there are still provisional yeses at the beginning of the match. The fastest way to improve this issue is to limit how many can have a PY in before the OPO is able to send out more offers. This would give the transplant center a better ability to evaluate the offer fully by there being fewer offers at once and it actually being a possibility because the rank in the match is closer. Anonymous | 08/22/2022 I agre with the suggested modification UPMC | 08/16/2022 The feedback from our center regarding the framework to eliminate 'provisional yes' is around the suggested timeframes between the tiers. Our observation is that there is significant variation between OPOs presenting and displaying donor data. Is it possible to standardize the donor data and imaging visibility directly through the donor net link rather than sometimes having to copy and paste into the browser outside of donor net? This leads to time delays that will be significant given the tight timeframes proposed. Thank you. LifeGift | 08/11/2022 Thank you for the good effort here to address the serious abuse of the provisional yes original goal. While the effort is laudable, when thinking about this set of tiered responses in isolation (for a single offer), it seems practical and useful, However, when thinking about this in the context of a huge outflow and inflow of offers per OPO and a center, it seems overwhelmingly complex and may have unintended consequences of increasing complexity. Suggest starting first with addressing capacity issues by employing offer filters and addressing the problem at its core before moving to adding 3 levels of offer types. Thank you Harvey Solomon | 08/11/2022 I suggest that in Tier 3 there is an affirmation from the implanting surgeon or their approved representative that the donor quality, data have been discussed and agreed upon. This will hopefully limit miscommunication and discard of organs. Any occurrence will be recorded and result in corrective action plan. Anonymous | 08/10/2022 The proposed system seems complex as outlined in presentation. I worry about increased physician and coordinator burnout as organ offers require substantial scrutiny in Phase II or Phase I offer when in reality you would rarely scrutinize an organ unless you were in a favorable sequence number to preserve sleep and sanity. It seems like it will increase provider work and time awake, which is not sustainable for this profession. Anonymous | 08/09/2022 I don't think this proposal deals with the root causes of organ placement inefficiency. 1. OPO's send too many offers at once because they fear the provisional yes has not really been well screened 2. Transplant centers are not really screening offers at the time they receive them. 3. The exponential increase in mandatory multivisceral placements has led to the inability to allocate more than one organ at a time. I must place the heart before placing the lungs. I must place the lungs before placing the liver. Each of these things adds considerable time to the process. The tier 3 option already exists, centers can already decline for their entire center and/ or begin selectively declining for individual candidates. I don't see how adding more levels of provisional yes adds efficiency. Additionally it is likely that centers will want more time to consider offers already received as we progress from Tier 3 to 2 to 1. This also does not address the practice of centers declining when the sun comes up, based on information that was available when the offer was received 6 hours prior I would certainly support limiting the number of centers to which an OPO can offer an organ (e.g. not being able to offer if more than "x" centers with provisional yes), but this proposal as it stands does little to address the underlying issues Rebecca Baranoff | 08/07/2022 I agree with the concept of the 3-tiered framework to remove the provisional yes and provide a more structured format for accepting or denying organs. I do think the suggested time limit on offers is too short; I suggest 2 hours as the length of time. Kidney Donor Conversations | 08/04/2022 Support changes to increase efficiencies and decrease the time for organ transplants.