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Expedited placement of livers

Proposal Overview

Status: Review

Sponsoring Committee: Organ Procurement Organization Committee

Strategic Goal: Increase the number of transplants

Read the proposal (PDF; 1/2019)

Contact: Robert Hunter

Executive summary

Expedited organ placement has been an important part of organ allocation for many years. Organ procurement organizations (OPOs) utilize this method to quickly place organs that are at risk of not being used for transplant. OPTN policy does not currently address expedited placement with the exception of Policy 11.6: Facilitated Pancreas Allocation. Consequently, during recent discussions about broader distribution and system optimization, the community expressed the desire to better understand expedited placement, its impact on transplant candidates, and to maximize utilization of transplantable organs. Therefore, the goal of this proposal is to address the following issues:

  1. Lack of transparency with the current system
  2. Lack of guidance for OPOs and transplant hospitals
  3. Lack of consistent practice across the country
  4. Inconsistent access to organs for candidates in need of transplant

The OPO Committee is proposing policy language that will allow for the quick identification of transplant candidates willing to accept an expedited offer when a liver has been declined late in the process. This will be accomplished by requiring transplant hospitals to enter candidate-level acceptance criteria that will allow for additional screening on an expedited liver match run. As part of this proposal, OPOs will be permitted to make expedited offers if the donor has entered the operating room and the OPO is notified of a liver turndown. These offers will be sent out with an abbreviated time limit of 20 minutes to identify those candidates willing to accept an expedited liver offer. At the end of this time limit, the liver will be placed with the candidate that appears highest on the match run.

Comments

OPTN Transplant Coordinators Committee | 09/20/2019

The OPTN Transplant Coordinators Committee heard a presentation on the OPO Committee’s proposal during a conference call on August 21, 2019. Committee members expressed their surprise at the number of occurrences when liver donation is authorized but the accepting transplant program declines the organ offer during procurement. The members agreed this proposal would 1) increase transparency, 2) increase equity in access to liver transplantation, 3) decrease the instances that donation is authorized but an organ not transplanted, and 4) increase liver transplants. They held a discussion inclusive of operational details of this proposal, the clinical and logistical circumstances that may lead to expedited liver placement (e.g: visual inspection in-situ, liver pathology results, donor/potential transplant size mismatch that is more apparent in the donor operating room, or a liver from another deceased donor was accepted for the same potential transplant recipient), the need for guidance from the OPO Committee on managing logistical and communications issues for successful liver placement through this mechanism, and the intended post-implementation monitoring plan. The Committee supports this proposal, including monitoring of program acceptance practices at 12 months following implementation. The Committee appreciates the opportunity to provide feedback on this impactful proposal to the organ donation and transplantation community.

The Living Legacy Foundation of Maryland | 01/30/2019

MDPC is not in favor as written. I would ask that the committee consider pushing advancements in DonorNet and other allocation strategies rather than propose this "emergency allocation" practice from the OR of donors. The time frames outlined in this proposal are not reasonable, and the likelihood of liver placement with a 20 minute acceptance buffer is problematic. If expedited placement were to be considered it should include a reasonable time frame pre-OR (2 hours?) where difficult to place livers, or high likelihood of intra-operative decline livers (criterion could be established to define this) should be considered for expedited placement to transplant centers that are known to accept and transplant these organs. At the same time, to improve utilization we should consider a mandatory reporting of all cases of intra-operative declines of livers that are subsequently transplanted by another center during this "emergency allocation" practice. It is useful to build accountability for all in the system to ensure the greatest use of transplantable organs.

LifeGift | 01/30/2019

LifeGift supports the intent and efforts to address an ongoing problem of coordinating the placement of livers in time constrained scenarios in ways that comply with commitment to stewardship of the donor's gift, equity for candidates waiting and the need to optimize recipient outcomes. While the early work of this policy proposal is very important, we oppose the policy as written for two reasons: 1) there is wide variability in the field in how both OPO and transplant center professionals label, describe and otherwise quantify what is actually occurring in these situations, and 2) we believe it would be most beneficial to collect the data on experiences for a period or 6 months or perhaps longer to know specifically what is happening and why. This will inform a better practice and policy. An example is the use of 20 minute period for decision. We believe this is too constrained in situations where a liver may be declined due to unanticipated intended recipient clinical factors. Another example is the likelihood that ALL centers will opt in ALL their candidates for acceptance of expedited offers, much like the unintended behaviors that occurred with the release of DonorNet (and the incorrect assumption that centers would use clinically relevant reasons to screen off candidates to help reduce offer volume where the offer would obviously be outside a center's acceptance experience). We support the effort but oppose the current written document. Thank you for chance to comment.

Gift of Life Donor Program | 01/31/2019

GLDP is not in support of the expedited liver allocation following OR turndown policy as it is currently written. GLDP believes more attention needs to be focused on improving Donornet through dynamic screening and allocation tools and development of new rules to assist OPOs and transplant centers in primary allocation and the identification of adequate back up candidates prior to the scheduled OR in anticipation of an intraoperative liver turn down. The policy as developed places an incredible amount of burden to begin this reallocation process on the OPO coordinator in the operating room under adverse conditions for information sharing, connectivity, and other operational restraints. The policy also places an unrealistic 20 minute burden for a transplant center to review all the donor information, identify an appropriate candidate, contact that candidate regarding the offer, speak to the OPO coordinator in the OR and develop complex logistical plans to transport the organ from the donor hospital to the transplant center after organ acceptance. This “expedited” process as defined by the policy can only be initiated from the donor OR by policy and only after certain donor information is available (i.e. liver biopsy etc.). Additionally, the proposed policy places a significant burden on other organ recovery teams who will know be forced to wait for reallocation and may be adversely effected due to donor hemodynamic stability, logistical issues with pilot duty times etc. Over the past two years, 37 % of donor livers GLDP has recovered with the intent to transplant are turned down intraoperatively by a transplant center for the initially intended recipient. (see data below) We have been successful in re-allocating 44 % of these livers that were turned down intraoperatively to another candidate. We attribute this reallocation success to having a proactively developed back-up plan for each donor which includes pre-identification of centers willing to accept an “expedited” offer from the OR. The back -up plan currently includes a rank order of all candidates from the DSA and region’s 18 liver transplant centers followed by transplant centers who are willing to a) consider the donor information pre-recovery b) be willing to accept the liver if called from the OR c) have identified and contacted candidate and d) are prepared to arrange organ transportation in an expedited manner. Additionally our OPO coordinator discuss conditions of potential acceptance with all the back up centers prior to the OR, should the liver offer come to them from the operating room (i.e. biopsy results, images, pictures, size, waivers, etc.) . Relationships have been established to facilitate direct and effective communication from the OPO coordinator in the OR to the transplant centers. (i.e. the transplant surgeon directly to onsite TC via cell phone) If the rank order of local and regional back up candidates decline when called from the operating room, calls will be made to transplant centers who have previously considered the donor information and are prepared for the liver offer. This allows for quick sharing of vital clinical information on why the primary center is refusing and allows for the transplant center to review the intraoperative donor information directly with the transplant coordinator and recovery surgeon. (not through an electronic offer). In our experience few transplant centers are willing to take the steps to be in this expedited back up position. Transplant center’s often refuse to even evaluate a liver offer or contact their transplant surgeon until they are made a primary offer. We do support the policy’s proactive identification of patients and centers willing to take an “expedited” offer and the attempt for a quick response, however we believe this all has to occur in advance of the operating room setting to be effective. (2-3 hours in advance depending on donor conditions and travel logistics) Also, intra-OR declines of livers that are ultimately transplanted elsewhere should be monitored/reported so that we can assess the prevalence of this behavior by a particular center. Centers who never use organs should be excluded from the expedited list process. Also centers who routinely turn down livers intraoperatively when they are the primary center should be held accountable if their turn down rate is above established thresholds. Liver allocation should not be a “surprise” event from the operating room and any policy that requires OPO’s to use this process may lead to unnecessary wastage of livers for transplantation. The committee should consider piloting any expedited liver allocation policy prior to promulgating it for national utilization. GLDP would be happy to participate in such a pilot should the committee consider this option. Any “expedited” policy should require centers who want to be contacted by an OPO for an expedited offer be in a position to screen the donor and identify a patient prior to the donor going to the operating room. This process could be made easier and more efficient for OPO’s and transplant center’s if the donornet and allocation electronic system could be dynamic. Currently when a match run is generated it evaluates a current set of clinical data to screen a center or candidate off the list. The system doesn’t allow for additional screening of the list when new clinical information becomes available or for a center to electronically provide clinical “conditions” for acceptance and rescreen as this donor data becomes available. A dynamic system could also allow the transplant center to accept pending certain donor conditions and when those conditions became known the system could automatically update the match run with declinations or acceptances. A dynamic donornet system could also evaluate laboratory trends for screening instead of using a point in time laboratory value. Additional donor and recipient data fields should also be considered to more efficiently match donor and recipient candidates and provide the transplant center with a more complete picture of a donor’s condition. These examples and other dynamic screening algorithms should be evaluated by a UNOS/OPTN group dedicated to this work. The donornet system could be enhanced to allow OPO’s and center’s to have a transparent view of all the area’s (however defined) donation activity in order to better make the acceptance and offer process more transparent. Donornet could be programmed to more effectively pursue marginal donors by prescreening potential donors using a donornet “donor suitability” tool which would identify transplant centers who may be willing to accept an offer from this type of donor. Centers who are willing to consider these types of notifications would allow OPOs to look beyond their local DSA definition of medical suitability and could potentially increase availability of organs. UNOS needs to urgently focus on creating state of the art donornet tools for allocation and matching to make our current system more efficient. The donation and transplant matching system is at its capacity it currently causes significant delays from authorization until an operating room can be scheduled. Currently, OPOs have been incredibly effective at managing a donor family’s expectations on how long the allocation process takes, however we believe this extended time burden on the family is unnecessary and harmful to improving overall donation efforts in the future. While we understand the intent of the policy it is an attempt to improve the utilization of livers, based on our considerable experience we believe it may actually lead to increased liver discards. Wholesale changes should be made to improve the tools we use and not place a band aid on the current system. We hope our comments and experience with liver reallocation from the operating is helpful to the committees deliberation. GLDP DATA from 953 liver donors over the past two years: Jan 1 2017- Dec 31 2018 Primary Liver Center Local Ctrs. Non-local Ctrs. All Ctrs. Primary @ OR 685 268 953 Txplanted to Intended Pt. 418 61% 182 68% 600 63% OR Turn-Down 267 39% 86 32% 353 37% OR Turn-Down Re-allocated to another pt. 126 47% 29 34% 155 44% OR Turn-Down not Txplanted 141 53% 57 66% 198 56% Txplanted to intended pt or back up pt. 544 79% 211 79% 755 79%

Jon Odorico | 02/04/2019

A policy such as this exists for facilitated pancreas transplantation and could work for livers. However, the triggering of this expedited placement during the intraoperative phase may be late enough that centers will have difficulty scrambling to identify a recipient or could force centers to have backup patients in house. Furthermore, the opt in program proposed did not work efficiently for the pancreas and the facilitated pancreas policy was recently changed to include in a dynamic and changing fashion those centers that imported pancreata which has worked well.

Srinath Chinnakotla | 02/05/2019

As transplanting surgeon, we all recognize that "marginal livers" and/or "steatotic livers" are better utilized in patients low MELD and can yeild comparable outcomes to "standard liver" donors. Higher biologic MELD patients do not tolerate "marginal or steatotic livers". The committee shoudl consider the following ammendent for common good and provide better patient outcomes. 1. Centers should opt in to receive the expedited liver offers. 2. The center accepting the liver should have the opportunity to transplant the most suitable recipient with that liver. 3. The time limit should be 30 min. 20 min is too short. Many thanks

Anonymous | 02/08/2019

Region 7 vote-1 strongly support, 4 support, 1 abstention, 4 oppose, 2 strongly oppose There was concern that if a DSA/region has an efficient system in place for expedited placement, implementation of a national policy would eliminate their ability to use the system they have in place. One member recommended having a system like pancreas where you can only opt in if you have imported a certain number of expedited livers per year. There was also concern about programs who use 3rd party call center to take their calls. How would the proposal hold programs accountable when they accept a liver.

Steve Zanders DO FCCP | 02/17/2019

As an Intensivist who manages potential donors I am opposed to this proposal. My largest concern is the significant potential for further decrease in transplantation given the restrictions imposed. The proposal addresses these 4 items: 1. Lack of transparency about how organs are placed using expedited placement 2. Lack of guidance for OPOs and transplant hospitals when there is a need to utilize expedited placement 3. Lack of consistent practice across the country because there are no current requirements 4. Inconsistent access to organs for candidates in need of transplant because candidates on the match run might be bypassed during expedited placement. If the goal is to create a transparent system and provide guidance for uniform practice then my suggestion would be to improve the inefficient methods and procedures that are caused by OPO’s first. While I am very much in agreement that allocation to the most needed recipients is a worthy goal, “how” this is done cannot create frenetic roadblocks which would further diminish transplant potential. The proposal and 20 minute restricted time frame will only lead to less transparency and chaos. Time is already of essence and safe allocation will be the casualty of this new proposal. Would it be possible to first propose a way to “fix” the 4 concerns by working singly on those concerns before imposing a catastrophic rule? A proposal based on anecdotal evidence is not sufficient to justify what would amount to a substantial loss of transplantable livers. Might the concerns be better addressed by utilizing and taking advantage of OPO’s with high performance and self- imposed standards as a foundation for development of policy?

Region 1 | 02/18/2019

Region 1 vote-4 strongly support, 5 support, 2 abstentions, 2 oppose, 1 strongly oppose Comments: Members of Region 1 generally support this proposal from the Organ Procurement Organization Committee, but provided suggestions regarding the process for the Committee to consider about the proposed expedited placement process. Some members questioned how back up offers under the initial allocation would be handled. There was also a recommendation that there should be additional criteria for OPOs to run an expedited list beyond a turndown in the OR so that there is a standard across OPOs for running the list. Executing a separate match while in the OR could be difficult; it was suggested that if the proposal is approved, members of Region 1 would want to work with UNOS for effective programming. The registration for expedited placement would need to be as accurate as possible to be effective. There was opposition to the proposed 20 minutes timeframe to consider an organ and a recommendation that it be longer. Some members agreed that any “expedited” policy should require centers who want to be contacted by an OPO for an expedited offer be in a position to screen the donor and identify a patient prior to the donor going to the operating room.

TransLife | 02/19/2019

TransLife does not support the policy as proposed for the reasons already provided by other OPOs. Efforts to expedite allocation that are based on transplant program indicators of what they say they will accept are not practical in a non-urgent situation. So this certainly isn't a practical approach in an expedited situation. In emergent situations, allocation priority should be focused on identifying the programs most likely to accept an organ in a challenging situation. The OPTN should focus more effort on an organ distribution system based on actual acceptance practices of transplant programs.

Anonymous | 02/21/2019

Region 5 Vote: 4 strongly support, 12 support, 3 abstention, 7 oppose, 3 strongly oppose Questions included how long a surgeon, especially in the case where they believe it is not a transplantable liver, would be expected to sit in the operating room waiting on placement and what will this do to backup offers in place? It was suggested that triggers for going to expedited placement be well defined and should include factors such as reason for turn down (recipient issue vs donor issue) and how far down the backup list offers are made. Other suggestions were made such as sending expedited offers from a different number to indicate the time sensitivity, creating a “transportation available” button in UNet, and filtering out programs who have never accepted the type of liver offered. Feedback was given that policy language needs to be very clear that the OPO does not have to go to an expedited list and can preserve backup offers. One member stated that there are three scenarios: the perfect liver turned down for recipient reasons, the in-between liver declined for a variety of reasons, and the non-transplantable liver and that this is a blanket proposal to meet the need of the in-between livers declined. A member pointed out the importance of good waitlist management and that when a program has backup(s) in place, the OPO should not be able to move to the expedited list. It was also stated that this is putting a policy in place to a practice that is already happening.

Anonymous | 02/21/2019

Region 2 Vote: 6 strongly support, 6 support, 3 neutral/abstain, 5 oppose, 4 strongly oppose One member noted that instead of having patients select at time of listing their willingness to accept a split liver, a patient should have that opportunity at time of offer. It is hard to assess for each patient at time of listing. Several members voiced concerns about the efficiency of allocating after the liver is turned down in the OR. There are too many logistical hurdles to overcome while in the OR. The expedited placement should be able to start several hours before the schedule OR in order to successfully allocate the liver. Their argument is that twenty minutes is not enough time to make a decision. The proposed expedited list has the potential to be as large as the regular waiting list because there will be centers that will opt into the expedited list so as to not miss out on any offer, but will never accept an expedited offer. Acceptance history needs to be incorporated into the criteria to join the expedited list.

Anonymous | 02/25/2019

Region 8 vote: 7 strongly support, 12 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose A member suggested the Committee consider developing rules of engagement in the operating room. For example, establishing that the liver recovery team must decide if they will accept the liver within one hour of cross clamp. Late turndowns in the operating room lead to increased cold ischemic times and possibly discards. The committee should also consider establishing distance parameters for steatosis. A program might be willing to accept a higher percentage of steatosis if the donor hospital is close in proximity to the transplant hospital. A member also urged the committee to consider logistics with expediting liver offers such as plane availability and getting the liver to the accepting center in a timely manner.

Anonymous | 02/28/2019

Region 10 Vote: 5 strongly support, 9 support, 2 neutral/abstain, 2 oppose, 5 strongly oppose Members expressed several concerns with the proposal. The twenty minute time limit in which to accept an expedited liver is not enough time to adequately prepare. It was mentioned that it is not enough time to have a plane ready to go retrieve the liver. Everyone will end up opting into the expedited list, therefore making the list very cumbersome and defeating the purpose of an expedited list. There needs to be some sort of criteria to be able to qualify for the expedited list. A member also expressed concern over centers that use third party call centers for their organ offers. To ensure that the surgeon sees the expedited offer with enough time to evaluate the offer, it should be sent directly to the surgeon and not the call center. Ultimately, the region fears that this will increase the number of liver discards and does not do a good job of solving the problem of late turndowns.

Southwest Transplant Alliance | 03/05/2019

While STA is in favor of a new policy to assist with expediting liver placement in the event of a decline in OR, we do not believe this policy (as written) will address the need.

Anonymous | 03/15/2019

Region 4 vote-8 strongly support, 9 support, 1 abstentions, 2 oppose, 2 strongly oppose Comments: Some members raised the issue of what happens when a liver is procured and not placed. There was also concern that 20 minutes was too short a timeframe to make a decision on an expedited liver. There was some question about the OPOs ability to extend the time limit if they though it was warranted. There was some support for having something in the policy about delaying cross-clamp until the liver is allocated. The concern was that without policy language, other procurement teams may not be willing to wait. A member asked if this would replace backup livers. It does not.

Donor Alliance | 03/15/2019

Donor Alliance supports the transparency and guidance this proposed policy offers to OPOs when liver teams decline livers intraoperatively. With the process suggested by this proposal, the time factor for secondary allocation should be reduced. The required shortened evaluation time aids in placement of an organ that oftentimes goes unrecovered, or is discarded.

Anonymous | 03/15/2019

This proposal provides no opportunity for aggressive centers to review donor information until the offer is made in OR- this would put centers in a position of being notified- calling to speak with the surgeon (if there is someone other than the physician taking call), calling to see if there is a recipient available, if they are able to arrange transport and then accepting all within the 20 minute time frame with little to no time to review the organ offer to evaluate who the liver is best suited for. Also, with needing to see if the recipient is able to come in and if there is transport available consuming the time allowed for response and minimizing the time offered to review the donor information will force acceptance on organs that have not been thoroughly assessed. Limited time to review/contact candidates/see if transport can be arranged within a short window to accept will cause livers to be declined by aggressive centers due to something that was discovered in the organ offer (when liver is already en route to the hospital) that makes that liver unsuitable for a candidate being brought in, but would of been suitable for a different candidate at the right center if the full picture was known prior to wasted cold ischemic time being added on an organ on its way to an unsuitable candidate who was notified to come in, and arranging/transporting the organ to a center unable to ultimately use it for a candidate it was accepted for with no time to left to get a suitable recipient in and the liver ultimately being discarded-this could potentially happen if it is an increased risk donor and the candidate in house refuses an increased risk organ. Another issue with a cold expedited offer in regards to this limited time frame for offer review is that information that would of been seen if there were not some many other pressing things to do to evaluate if at that moment a candidate was able come into the center and liver could get there prior to accepting, is that skimming through all the information in the offer will cause something to be missed by the center and a liver that is unsuitable for a candidate will be transplanted and cause detrimental outcomes for the recipient. If there is a suspicion by the opo coordinator that the liver may be turned down in the OR either due to labs, med/soc, donor size/weight, etc by the Primary team and regular backups, aggressive backup liver offers should be able to be made to centers that regularly accept higher fat content on biopsies, or have a more aggressive hep C program or centers that accept >75 year old donor liver- this aggressive backup offer allows donor information to be reviewed completely as in a regular offer for a complete picture of the donor and if all primary and regular backup teams decline intraop the aggressive center has already had time to plan what candidate would be best to receive that liver and the time from official offer to the aggressive center can be appropriately used to call candidate in and arrange transport for the right person for the right liver without causing an unreasonable delay for the team/teams actively in OR recovering, wasted resources for a liver that cannot be transplanted for only candidate available, or unnecessary additional cold ischemic time. This proposal seems to have good intentions but limits the efficiency of being able to place the organs quickly and poses a huge safety risk to recipients- which expedited placement's purpose is to quickly but safely facilitating transplant of an organ with the right center who has a suitable candidate for a liver that otherwise would be discarded.

Association of Organ Procurement Organizations (AOPO) | 03/17/2019

The Association of Organ Procurement Organizations (AOPO) believes a fair, equitable and transparent process for placement of livers under emergent time constraints is critical to safeguard transplantable livers and protect the impartiality of the transplantation system. While the proposed Expedited Placement of Liver policy is progress toward enhanced organ allocation, recovery and transplantation, AOPO believes it can be strengthened and would support the proposal with the following revisions: 1. It is critical those transplant centers that opt-in to consider an expedited liver for their patient have a process within the liver program that can rapidly respond to these specific types of offers. The OPTN must develop a monitoring system to track the timing and response to these liver offers and ensure that centers which opt-in for expedited placement are processing these offers within the mandatory 20-minute time limit. A transplant center opting-in to the system without having the effective processes in place to truly consider and utilize these livers will make the expedited placement process valueless. The monitoring system should be designed to assess the overall effectiveness of the expedited liver placement policy to increase liver utilization. 2. The proposal should consider the timing for expedited placement. The trigger of expedited placement is in the operating room and this is late in the allocation process and there is significant risk of non-utilization of transplantable livers. AOPO suggests that the committee back-up the trigger for expedited placement to three hours prior to the scheduled operating room time. If the liver is not placed or if a center declines at that point, then expedited placement can be triggered. 3. The DonorNet System should also be upgraded to increase transparency to indicate when a transplant center has accepted multiple organs for the same patient and monitor centers that have not responded to the expedited placement offers within the 20-minute time frame. 4. Finally, the primary purpose of this policy is to provide an expedited placement system for livers that are turned down after the donor has entered the operating room. While this policy is currently limited to livers from donors that have entered the OR, AOPO would encourage the OPO Committee and the OPTN to also consider exploring expedited placement for the thoracic organs, as well as those organs that are difficult to place. Thank you for the opportunity to comment.

Anonymous | 03/18/2019

The Operations and Safety Committee (OSC) discussed this proposal and offer the following responses: o The Committee voiced concern about the proposed 20 minute timeframe for responding to an expedited liver offer. The Committee recommends that the timeframe be expanded to 30 minutes. o The Committee would like the OPO Committee to consider the following criteria for initiating expedited liver offers:  For donation after cardiac death (DCD) donors, add language allowing OPOs to initiate expedited liver offers within one hour of the expected withdrawal of support.  If the liver has not been placed when the donor is going into the operating room (OR), add language allowing OPOs to initiate expedited liver offers. Vote: 6 Strongly Support, 4 Support, 1 Neutral/Abstain, 0 opposed, 0 strongly opposed.

Anonymous | 03/18/2019

Until this guarantees more transplants I find it difficult to support. What communities need are the following: high performing OPOs, transplant centers with good practices and an educated community about organ, eye and tissue donation. If these three factors are in place a higher donor rate will occur. I am very tired of hearing the voices of the coast where donor rates are low. Sharing organs from parts of the country that are doing all three aspects, I feel is not fair. What about the patients that now will die in the areas that are now going to lose up to 45% of the organs that now need to be shared. I ask it that fair? I do not understand how you could answer that question with a yes! And cost! It is simply not true that hospitals write off the portion for a transplant that is not paid by the insurance company. I know several patients that are making payments to their hospitals after their transplant. Please think this through...a law suit must not be the reason to make such a quick change...you are impacting lives forever...please be careful, mindful and thoughtful regarding all individuals this will impact.

American Society of Transplantation | 03/19/2019

The American Society of Transplantation is supportive of this proposal and offers the following recommendations and comments for consideration: • Extension of the acceptance time limit to 30 minutes to allow programs to reassess the resources currently at hand to support the expedited placement at their centers • Incorporation into the policy consideration of distance to the transplant center (e.g., smaller circle first) to shorten ischemic time. • Exemption of expeditiously placed livers from the mMAT calculation given that expedited placement of livers may result in placement of the organ into lower MELD patients, and as such may decrease the mMAT score of that transplant center. • Monitoring and transparency with regard to: -acceptance rates for each transplant center that opts into this allocation -outcomes of the livers that are transplanted under these circumstances -OPO performance in terms of time of notification, number of expedited placements per donors, etc. • Clarification of how the current common practice of having back-up recipients will be handled within the premise of the current proposal.

American Society of Transplant Surgeons | 03/21/2019

The American Society of Transplant Surgeons (ASTS) appreciates the work of the OPTN/UNOS Organ Procurement Organization Committee. While the ASTS supports quick placement of organs at risk of discard, we are also concerned with the potential for unintended consequences as the community adjusts to the new liver allocation policy. With a wider radius of 250-500 miles to distribute organs, the process proposed may encourage centers to compete for organs. ASTS encourages the OPTN/UNOS to defer this proposal until the community has more data to analyze the new allocation system’s performance.

Anonymous | 03/21/2019

The Transplant Administrators Committee (TAC) shares several concerns regarding unintended consequences which may occur with the implementation of a nationwide system or expedited placement: • Surgeons may be unwilling to conduct procurements outside of their home center. There is also no protocol for organs arriving damaged that may have been procured by a separate team. • Monitoring practices are inconsistent. It is important that this proposal carries out fair and accurate practices in such a time-sensitive situation. It would be important to know which OPOs and transplant centers accept many of the expedited livers. • Reasoning for late turned down livers should be descriptive and explicit, not just represented by a generic code • Thirty minutes, instead of twenty, allows a more suitable amount of time for acceptance to ensure hospitals do not miss an expedited opportunity. • Some centers accept a large number of expedited placements. What is the outcome data? Why do these center accept more expedited placements than others? It would be helpful to have this information so that we can better understand the practice. • If new participating centers begin to accept livers, but without experience in expedited placement, there is concern they may not be used.

Anonymous | 03/21/2019

The Liver and Intestinal Organ Transplantation Committee (the Liver Committee) commends the Organ Procurement Organization (OPO) Committee for their work in creating this public comment proposal and thanks them for presenting the document. The Liver Committee was concerned that the proposal might encourage late turn-downs by the procurement team in the operating room and suggested that late-turn downs are tracked as part of the proposed policy. The Liver Committee also suggested that the OPO Committee consider how long the procurement team in the operating room will wait to cross-clamp after the organ is accepted off the expedited match run because it may take more than the allotted 20 minutes to organize logistics.

Anonymous | 03/21/2019

The MPSC thanks the Organ Procurement Organization (OPO) Committee for presenting its proposal. MPSC members asked the OPO Committee Chair several questions about the implications of intra-operative expedited placement of livers and had a few comments for consideration when drafting the final policy language. 1. What happens when the initial recovery team wants to leave after declining the liver? Why doesn’t policy require them to stay and help with the procurement in order to protect the procurement process? The policy’s current language does not require the initial recovery team to stay and procure the liver for the accepting center of the expedited liver. The OPO committee felt that if the donor became unstable or other circumstances arose that would require cross clamp to occur, the OPO needs to have the ability to do so without breaking policy. They were also unsure if they could make this mandatory and were concerned that this requirement would not make it through the policy-drafting phase. However, the OPO Committee felt that making a recommendation or training document with the following, would be appropriate: a. Recommend that cross-clamp be held for up to one hour if the donor and recipient are stable b. Transportation be in process by the OPO during the expedited placement process c. The local team to hold and be available for the accepting center 2. When identifying expedited placement recipients, will there be a new match run or is the original match run used? The transplant center may not be familiar with the case and donor prior to receiving the offer and 20 minutes is a very short turnaround time. This project will require programming prior to implementation and discussions surrounding requirements are ongoing. Re-executing the match run, from an OPO perspective, is not appropriate logistically. Discussions have been around programming an expedited placement button in the match run that would gray out PTRs that previously declined as well as recipients that are not listed as willing to accept an expedited placement liver. OPOs are still able to utilize backup offers from the original match run. 3. Acceptance of marginal livers or turndowns in the OR has nothing to do with the patients in most cases; it is largely a center issue. Most centers say they are willing to accept these organs and later decline. In order to utilize these livers, we should identify the 10 centers that actually utilize these organs and make direct offers to them. The policy is a culmination of 24 months of work for the committee and early on, the data reviewed showed that only five centers were receiving 60% of these livers from the OR, which is a very small number. The challenge of reaching out to only those select centers is that it creates no transparency. Other centers may use these organs but are not getting the offers because we do not have a system in place to allow this. 4. Is there a cap on how many offers an OPO can push out at once? Once the expedited placement pathway is chosen, there is no cap for OPO on how many centers can receive the offer. That design is intentional since the liver is at risk of not being transplanted. The MPSC offered two additional comments about the proposal: • The OPO Committee should gather data quickly on which programs are accepting and transplanting these organs in order to start refining the criteria for which programs can accept expedited offers. This has to be an iterative process where centers are re-evaluated to receive these offers on an on-going basis. • There need to be guidelines on when the OPO should move to the expedited list versus offering down the original run.

Carolina Donor Services | 03/22/2019

Carolina Donor Services supports policy that facilitates quick and efficient placement of organs that are at risk of being discarded. The OPTN must monitor for trends in acceptance (then refusal) patterns that drive late declines and assure there are consequences and actions taken to minimize occurrence. It is critical that the centers that opt-in to receive expedited offers demonstrate effective practices to review, accept and transplant these organs. Additionally, the Committee should consider expedited placement in some circumstances prior to OR when there is a late decline of the organ and/or donor quality factors that make organ placement difficult.

Anonymous | 03/22/2019

12 strongly support, 11 support, 7 abstention, 1 oppose, 0 strongly oppose One member expressed concern regarding the need to preserve backup offers and others echoed this with a suggestion that the policy should include a default for backup offers so they are not bypassed. Another member stated that often these are donors that require careful evaluation and 20 minutes may not be enough time. A shared OPO perspective was that when OPOs currently expedite placement they are in violation of policy and have to provide rationale and justify the placement to the MPSC – this policy would give them a way to expeditiously place livers without violating policy.

Anonymous | 03/22/2019

1 strongly support, 4 support, 2 abstention, 6 oppose, 11 strongly oppose Comments: Multiple people expressed concern that the 20-minute time limit is not enough time and that it really won’t save time because of the additional evaluation that would need to be done after the initial acceptance. Additionally, members feel this could negatively impact centers that are under-resourced due to staffing requirements to respond to offers. Feedback included a recommendation that OPOs standardize operating procedures and standardize how they categorize increased risk patients since some OPOs use criteria not aligned with PHS Guidelines and this adds time to evaluation. Another member stated that the reason for turn down should be a factor in the process. And someone else shared concern that the requirements penalize anyone who wants to put a large percentage of their list for consideration even if they intend to go through the list quickly to find the best patient. It was suggested that not enough data has been collected to inform this proposal and it should be pulled to gather more data.

Anonymous | 03/22/2019

24 strongly support, 10 support, 3 abstain, 0 oppose, 1 strongly oppose Comments: Members generally welcomed having a clear policy on expedited placement, however voiced several concerns. Some members felt that having the first unit of distribution be a national share is too large a catchment area, and the match will be too long, resulting in organs needing to travel farther distances. Furthermore, members voiced concern that there will be an increase in the number of transplant hospitals saying “yes” to an organ offer, and then backing-out at the last minute due to not thoroughly reviewing the offer. Many members agreed that third-party call centers should not be involved when an organ goes for expedited placement, because this would allow the surgeon to directly view the offer. There was general consensus that criteria for when OPOs switch to an expedited list needs to be more stringent, and there should be punitive actions if a program accepts an organ and then backs out (e.g. no longer included on expedited list). There were questions around whether the policy included required timeframes for delaying cross-clamp in the O.R. Overall, the region felt that the proposal needs to further address fair organ placement and the impact on organ discard rate prior to implementation.

Anonymous | 03/22/2019

The American Society for Histocompatibility and Immunogenetics (ASHI) supports this proposal.

Anonymous | 03/22/2019

The Transplant Coordinators Committee reviewed the proposal during a meeting on February 19, 2019. Members expressed their overall support for this proposal, and understand this proposal is not in lieu of the prudent practice of “back-up” offers. Rather, this proposal outlines a policy-based alternative in the event that back-up offers decline. Members verbalized concerns about: • The need for standardized information about donor livers before an offer is made through this expedited mechanism to ensure optimal assessment of the liver by a transplant program. This may include percentage of steatosis, digital images, anatomical measurements, ischemia time, available transportation alternatives, etc… • The potential for “offer congestion” as a result of large volumes of expedited offers, or notifications to transplant programs that have history of not accepting expedited offers. • Accountability for transplant programs with patterns of declining expedited liver offers. • Displaying meaningful information to transplant programs to understand the number of potential recipients and transplant programs ahead of potential recipients at their program. • The need to emphasize robust communication between involved OPO and transplant program staff to avoid confusion or delays in cross clamp. The Committee appreciates the opportunity to provide feedback to the OPO Committee.

Jeffrey Trageser | 03/22/2019

I support this proposal, but feel more details need to be clarified. Whenever a liver is declined late (during or after surgical recovery), OPOs (and transplant centers) lose precious time trying to find an appropriate recipient. Any effort to streamline allocation once cold ischemic time is accruing will enable more recipients to be transplanted. Allocating the liver one recipient at a time can cause enough cold-ischemic time (CIT) to accumulate to a level that can render the organ not-suitable for transplant. Currently, many OPOs bypass transplant centers to find "aggressive" centers that can find a good match for the liver quickly, and can mange the added CIT. Other OPOs may determine the liver is not suitable for transplant, based on CIT and the number of centers that have already declined, and subsequently discard the organ. This proposal seems to be addressing the reality that to effectively find an appropriate candidate for a liver that has already been recovered, and already has CIT, OPOs routinely bypass centers that do not typically accept organs in this scenario. The proposal will allow all transplant centers to participate in this expedited allocation system while simultaneously allowing them to not receive these offers if they can't realistically utilize these these organs in a rapid fashion. I believe that that having the choice to offer the liver from the original list or the new expedited list is causing some confusion and stress for some OPO and transplant professionals. Additional guidance and/or an algorithm for defining which allocation system to use would be helpful.

New England Donor Services | 03/22/2019

NEDS supports the goal of this proposal and suggests the following to increase the effectiveness: 1. DonorNet (DN) should be programmed to allow centers that will accept an expedited liver for a particular patient, to have that patient flagged on the original match run. If the liver is turned down in the OR, a button in DN could activate expedited placement so notifications can be sent to only those candidates listed for expedited offers and others can be bypassed. There shouldn’t be a second, separate match run generated. Having these patients flagged on the original match run would give the allocating OPO the ability to see which centers they could identify prior to the OR. 2. In order to achieve “expedited” placement of the liver, the offer should go to the final decision maker at the Transplant center (versus an agent of the decision-maker) to efficiently determine final actual acceptance. 3. Transplant centers must appropriately list candidates that they will accept an expedited liver for otherwise it will slow down the process and could lead to the liver being discarded. UNOS should monitor acceptance/turn downs in OR and for expedited placements and incorporate a review and corrective action process for programs if indicated by acceptance patterns (see #5 below). 4. If the organ is turned down in the OR, the surgeon recovering for the primary center should be required to continue the recovery for back-up programs. 5. Data Monitoring should include: (a) op liver turn downs that are ultimately transplanted elsewhere; (b) All cases where expedited placement is activated, the outcome of the liver being transplanted or not and (c) Liver utilization pre- and post-implementation of this policy. 6. The policy should also address expedited placement in those circumstances where there is no primary program as the donor enters the OR in the case of instability or family time constraints.

Anonymous | 03/26/2019

Vote: 0 strongly support, 10 support, 5 abstain, 1 oppose, 5 strongly oppose Comments: Members were generally supportive but has concerns about getting the offer to the decision maker within the 20 minute time frame. One suggestion was to have expedited placement notifications set up to go directly to the decision maker. This would require IT to program different notification systems for expedited and standard allocations. Some members were concerned that this system would be less efficient than the current practice resulting in more discarded organs. The committee will need to evaluate discards post-implementation. There was also some concern about bypassing candidates who had a provisional “yes” on the initial match when running an expedited match. There was a recommendation to include language that would require an OPO to offer to a certain number of these back-up offers prior to running an expedited match.