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Expedited liver placement

Proposal Overview

Status: Public Comment

Sponsoring Committee: Organ Procurement Organization Committee

Strategic Goal: Increase the number of transplants

Read the proposal (PDF; 8/2019)

Contact: Pete Sokol

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You may be interested in this proposal if

  • You work for an OPO
  • You work for a transplant hospital
  • You are currently on the liver waitlist

Here’s what we propose and why

Sometimes when OPOs are already in the operating room with the donor, they will hear from transplant centers that they no longer want to receive the liver they accepted for their candidate. When this happens, the OPO has to act quickly to try and place the organ elsewhere. Because we have no current policy in place that specifically addresses this situation, we are proposing an idea that would make it easier for OPOs to place these types of organs quickly and reduce the chance that they are discarded without being transplanted. If transplant centers are interested in receiving an offer of this type, this proposed policy would require them to report specific information in advance. It would also give OPOs specific guidance on how to conduct these cases, including the amount of time the transplant center has to respond, so that all expedited offers are handled consistently and uniformly across the country.

Why this may matter to you

This policy change would give OPOs early access to a list of transplant centers who are interested in accepting this type of offer for their candidate. This means OPOs could begin making back up plans before they ever enter the operating room.

Transplant hospitals would have the opportunity to indicate their willingness to accept an expedited liver offer, but in order to participate they would be required to enter specific acceptance criteria in advance.

Tell us what you think

  • Would this proposal help OPOs more quickly place livers that are turned down in the donor operating room?
  • During a previous public comment, many people were concerned that initiating expedited placement in the donor operating room was too late in the process. Does allowing OPOs to identify expedited liver candidates on the original liver match run address that concern?

Comments

Ryutaro Hirose | 08/06/2019

I commend the OPO in codifying the expedited placement process and making it a consistent practice. I personally would have pushed the process back to include a refusal or organ decline within 3 hours of the scheduled OR/withdrawal of support as these are also situations in which time pressure can make expedited placement may need to occur to prevent discard or to at least more efficiently identify a transplant center that will commit to accepting an organ that was declined late in the process and requires late re-allocation. Overall, I support this proposal and look forward to further refinement. I also plead with UNOS to capture all late declines and publish their findings with respect to center frequency or at least have that metric be a component of a transplant center report card that is shared with centers.

Indiana Donor Network | 08/08/2019

We strongly support this policy. This is a great first step for the OPOs to be able to place more livers for transplant under circumstances out of our control once we enter the OR. Having a list of true centers willing to accept livers from these cases is crucial to getting more organs transplanted. UNOS needs to ensure monitoring of this practice to limit abuse of every transplant center agreeing to be on the expedited list but not actually accepting these types of livers as all of the committee's work with be for nothing if the list isn't actually expedited.

LifeGift | 08/08/2019

We support this refined policy proposal as it takes into account the need for transplant program acceptance information prior to the actual decline of the offer to enable the OPO to act quickly in placing a transplantable organ, considered so by some programs and not considered so by others. It will be critical to use clear, consistent terms for monitoring this effort, and transparency in collecting and reporting effective practices to include successful utilization practices. If possible, proceed with some sort of testing the structure and process of the proposed policy to observe for impact before rolling out as a final policy. Thank your for the opportunity to comment.

OPTN Liver and Intestinal Organ Committee | 08/29/2019

The Liver Committee asked about the logistics of the expedited offers and acceptances. If there are several offers made at the same time, and several centers accept, but then turn down once the offer is certain, this could still result in slow placement. One Liver Committee member suggested that there be monitoring to ensure that the hospitals that accept the expedited placement and then later turn the organ down be discouraged from continuing that behavior. The Liver Committee also suggested having a different recorded message for expedited offers so that they could easily be distinguished by the center receiving the offer. The Liver Committee also asked about how many DCD livers were turned down late in the process.

OPTN Data Advisory Committee | 08/30/2019

The OPTN Data Advisory Committee (DAC) appreciates the opportunity to provide feedback on the public comment proposal. The DAC supports the proposal. However, the DAC is concerned with the availability of all data needed to make a well-informed acceptance decision once the expedited placement match run is initiated. It is necessary that all programs on the expedited placement match run have access to the same data, especially biopsy results. The reason that the organ was initially declined and the information supporting that decision should be shared with the programs on the expedited placement match run as well. The DAC also commented that standardizing how the appearance of each liver is documented and shared could help address the concerns noted above. The DAC noted that the acceptance criteria for the expedited placement list should be distinct from the acceptance criteria for primary offers.

OPTN Membership Professional & Standards Committee | 08/30/2019

The Membership and Professional Standards Committee (MPSC) thanks the Organ Procurement Organization (OPO) Committee for presenting its proposal. MPSC members asked the OPO Committee’s Vice Chair several questions about the proposal. 1. Will OPOs be able to make more offers at one time than is currently allowed? Will OPOs also have a broader ability to see which programs have accepted the liver? Yes, OPOs will be able to send more offers at once. They will also be able to make the expedited offers from the original match run, so the process will follow the list. 2. Do transplant programs have to have accepted expedited offers previously, or can any program opt in? Any program can opt in at this point. 3. Is the OPO Committee concerned that the purpose is to expedite placement, and everyone will want to be involved? Did the Committee think about coming up with criteria for programs to meet in order to opt in? The OPO Committee will review the data 6 months after the policy is implemented to determine how many programs are opting in and how many are accepting offers. It’s hard to predict how that data will look, but the Committee is interested to see what will happen in practice. MPSC members who participated on the expedited placement workgroup added that the workgroup consciously decided to not be too prescriptive early on since the community had expressed concerns in previous public comment periods that programs wouldn’t have an opportunity to change acceptance practices. The first step is to let anyone opt in and then look at the data closely to see how many programs are actually accepting the livers. This proposal provides a structure and framework for something that currently happens inconsistently around the country.

OPTN Region 4 | 08/30/2019

Strongly support (7), Support (12), Neutral/Abstain (0), Oppose (1), Strongly Oppose (0)

OPTN Region 7 | 09/03/2019

Region & comments are as follows: Comments: Attendees acknowledged this was a complicated issue, but this policy was a good starting point. One of the circumstances that frequently results in late liver declines is inaccuracy of liver biopsy interpretation; this is sometimes due to the inexperience of pathologists at outlaying hospitals differentiating between macro and microsteatosis. They shared concerns regarding what type of monitoring and measures of “enforcement” may be included in the proposal (e.g.: of transplant programs that opted-in to the system but has frequent organ declines). A recommendation was shared for OPO staff involved in a donor case have direct contact with the surgeon considering the organ offer to avoid delay with intermediary discussions. Attendees shared the ideas of “blast electronic offers” to facilitate the placement of livers, and a requirement the recovery surgeon needed to stay in the donor OR for one hour for recovery. They also inquired to the scenario of two liver candidates with identical MELD scores and the mechanism for determining allocation order. The Regional Representative responded the OPTN policy on this was not changing, and is determined by waiting time at a particular MELD score or status. Region 7 voted as follows: 5 strongly support, 5 support, 1 abstention, 1 oppose, 2 strongly oppose

Alesha Luxon | 09/06/2019

I strongly support this proposal to develop a plan for expedited livers. CIT is critical for these organs and a backup plan for livers that are refused late in the process.

OPTN Region 3 | 09/07/2019

• Question: Is there any evidence to support that OPO’s will “opt-out”? o Concern: people will all opt-in  increase risks in OR; difficult for a liver to be placed in the OR o Response: there is no evidence, but now we will start to collect such data • Appreciate standards being implemented but backup offers should be addressed to ensure that they are honored and the OPO does not switch to expedited placement when declined in O.R. Strongly support (2), Support (12), Neutral/Abstain (4), Oppose (2), Strongly Oppose (4)

OPTN Region 5 | 09/11/2019

Strongly support (6), Support (22), Neutral/Abstain (3), Oppose (0), Strongly Oppose (0) • One member asked if there is a consideration on the quality of the liver regarding allocation o It was stated there are really two scenarios, and this policy as written will not address both:  Good livers turned down for logistical reasons etc.  Marginal liver turndowns • It was suggested the OPTN should monitor liver programs that are not accepting livers but have opted to participate in expedited placement. Members discussed the importance of monitoring to ensure that the proposed process is appropriately being performed by institutions that are opting in. A member stated that there should be a way to monitor if transportation was offered. Some programs are unable to accept offers due to being at a farther distance and unable to access transportation to recover the organ. Transportation is really underestimated in broader distribution process and this should be heavily considered when discussing broader distribution. A member stated that it would be interesting to know if the percentage of procurement surgeons not being a part of the primary center or if the primary center having local procurement or not plays a role in higher turndown rates. Another member stated that programs are more likely to offer organs to surgeons they have a strong relationships with. A member asked what logistics were being referred to for this proposal. It was clarified that this policy is to address when a transplant hospital turns down an organ late in the allocation process.

OPTN Operations and Safety Committee | 09/11/2019

The Operations and Safety Committee (OSC) thanks the OPTN Organ Procurement Organization (OPO) Committee for their efforts in developing this public comment proposal for expedited liver placement. The Committee voiced the need to address the challenges of recovery teams completing a procurement (after the operating recovery team declines the liver) and question how this would be enforced. It is believed that entrance to the OR is still too late in initiating expedited placement and that it should be done before the OR. The Committee acknowledged the policy addressing the cases where turndown occurs in the OR, and suggests extending this policy to address cases where patients are becoming unstable or have time constraints. In addition, it would be helpful to establish guidelines/recommendations for the appropriate workup of potentially "marginal" donors where imaging and/or biopsy is done PRIOR to entering the operating room. This would allow more thorough evaluation of the donors and potentially allow OPOs to have a better idea of the size and quality of donor livers. Finally, the running of the expedited list could occur prior to the OR in the event that it is likely, based on the pre-operative workup, that intra-operative declines might occur. The Committee indicated the following sentiments for the proposal: Strongly Support- 31%, Support- 69%

Abigail Martin | 09/16/2019

I am writing in support of the proposal because it allows transplant centers to opt in or opt out at the patient level at the time a patient is placed on the waitlist. Being able to opt in or out at an individual patient level, rather than at a program level, is extremely important for pediatric programs that offer split liver transplants to their smaller, younger patients. There are some patients, such as a small infant who would most likely require a split segment or lobe, who will likely never be a good candidate for an expedited liver because there is no reasonable way to have a team available to split the liver on short notice. However, there are cases, such as a teenager with fulminant liver failure, for whom a pediatric center may be extremely interested in an expedited liver. Allowing the center to make these decisions on an individual patient basis allows the most flexibility for pediatric centers to ensure that pediatric patients continue to have access to these potential donors. There was a suggestion at the Region 2 meeting that opting in or out for expedited livers should be decided at a program level, such as has been proposed for pancreas transplant. Making the decision at a program level would likely force pediatric programs to opt out in all cases because many of their listed patients may require a split graft, even though there are some patients for which opting in would be appropriate. If the policy were to change to opting in or out at the program level I would strongly oppose it for this reason.

OPTN Region 2 | 09/20/2019

Region 2 voted as follows and had the following comments: Strongly support (1), Support (9), Neutral/Abstain (2), Oppose (4), Strongly Oppose (5) Members of the region had concerns with what is being proposed. The region feels that expedited placement should not be an opt-in system. Without qualifications every center will opt-in and the expedited list will not function properly. One member suggested the OPO Committee learn from the experience of the Pancreas Committee and facilitated pancreas placement. At first, there were no qualifying criteria and facilitated placement was not efficient. Facilitated placement is working better now that there are criteria for qualifying as a facilitated pancreas program. A suggestion was made to utilize the organ offer filters to identify centers that are already accepting livers late in the allocation process, and use that as qualifying criteria. The members of the region think that initiating expedited placement in the OR is too late. It does not give transplant centers enough time to figure out the logistics before accepting an expedited liver offer. There was a comment that doing pre-OR diagnostics on livers (ultrasound) will greatly benefit transplant centers as they evaluate expedited placement offers.

OPTN Region 1 | 09/24/2019

Region 1 voted and had the following comments: Strongly support (2), Support (5), Neutral/Abstain (3), Oppose (0), Strongly Oppose (1) Region 1 generally supported the proposal. Some members commented that transplant centers need more than 30 minutes to review all their candidates and determine if any are suitable for a liver. There was a recommendation that the committee identify donors that are at high risk for late turndowns and for those donors offer the liver to expedited placement programs in parallel with offers to centers on the primary match. This would give the centers more time to make a decision in the event of a late turn down. There was a comment that the biopsy is the most important piece of information to get to centers so they can make a decision on whether or not to accept the organ. Some members recommended the expedited offer of a liver at risk of not being placed should go to a center and not an individual candidate.

OPTN Ethics Committee | 09/24/2019

The OPTN Ethics Committee thanks the Organ Procurement Organization Committee for its effort in developing this proposal and presenting a method for expedited placement for livers. The Committee supports the proposal and the focus of the committee on increasing utilization of these organs. The Committee supports the approach the Committee has taken and the proposed solution. The Committee members indicated 29% strong support, 50% support and 21% neutral/abstain on the proposal.

LifeShare Transplant Donor Services of Oklahoma | 09/26/2019

LifeShare (OKOP) strongly supports this policy proposal. Currently, there are no guidelines for placing a liver in an expedited fashion. While ideally, and most commonly, the liver is place prior to the surgical recovery beginning, our experience in the broader sharing era of Share 35 is that the number of livers being turned down intraoperatively by both the primary center and the backup centers is increasing. This results in the need to place the liver rapidly to prevent losing a transplantable graft. The policy proposal will provide a structure which in turn will allow consistency, transparency, and monitoring. As a product of the OPO Committee and a work group that included MPSC, the policy is well thought out and represents an important first step as we anticipate allocation being broadened still further in months and years to come.

OPTN Region 11 | 09/26/2019

Strongly support (1), Support (9), Neutral/Abstain (3), Oppose (1), Strongly Oppose (1) Region 11 supported the proposal.

Donor Alliance | 09/26/2019

Donor Alliance supports the proposed policy of expedited liver placement. We are pleased to see the expanded details regarding the application of match list filters when expedited placement is chosen. The policy outlines very clear, concise steps to take when liver recovery is underway and the receiving center backs out. It would be beneficial to continue to track & trend the reasons centers decline late in the allocation / recovery process.

James Sharrock | 09/26/2019

Guidelines for expedited liver placement are increasingly important as broader sharing creates more circumstances in which such placement is critical to minimize discards. A policy that is consistent and transparent and which allows for monitoring is critical to acceptance. The proposed policy has been developed over time by a broad based work group and will provide appropriate guidance where applicable.

Region 8 | 09/27/2019

Members of region 8 supported the proposal. The following comments and questions were discussed: • For opt-in criteria, maximum distance from donor hospital means different things in different parts of the country. • Some organ turndowns in the OR are because the organ is not suitable for transplant, while some are still suitable for transplant. It will be important to know why the organ was turned-down in the OR. • It would be helpful to have standardized information; labs and picture of liver is pretty much all that is needed to make a decision • Decision to do expedited placement should be before cross-clamp • There is concern that programs will turn down liver for “size” once brought back to transplant hospital. You should not be allowed to turn-down liver in transplant OR unless for certain conditions (i.e. HCC, intended recipient no longer able to accept transplant) • Fibrosis should be added to the opt-in criteria list • One member clarified that the proposed expedited placement option is in addition to backup offers. Vote: Strongly support (10), Support (10), Neutral/abstain (2), Oppose (1), Strongly oppose (0)

American Society of Transplantation | 09/30/2019

The American Society of Transplantation is supportive of the proposal for expedited placement of livers. We agree that this proposal has the potential to decrease the disparity that currently exists with expedited placement of organs by increasing transparency and allowing more transplant centers to participate in the process. The patient opt-in process would help OPOs place livers that are turned down in the donor operating room more quickly and identifying these patients on the original liver match run would help the OPO prepare for the expedited placement. Specific comments relating to this proposal offered by our constituencies include; • To limit ischemic times and avoid organ discards, it is imperative that each transplant center that opts-in patients for expedited placement must be logistically and operationally prepared to accept such organs • Review of participating center acceptance practice within this policy as planned would be crucial in avoiding unnecessary organ discards. • This proposal requires close monitoring and audits of how quickly and often OPOs initiate the expedited placement, as well as the specific triggers for expedited placement so as to not disadvantage or inadvertently bypass viable back-up recipients on the existing match run who may not have been designated for expedited placement by their transplant centers. • Was consideration given to machine perfused livers which could affect both the time availability to reallocate, and the decision of the transplant centers to accept? • Prioritization for pediatric donor livers to be offered using expedited algorithm to pediatric recipients first. Expedited placement attempts should not bypass pediatric patients that meet the criteria for inclusion on the expedited match list. • Livers meeting criteria for ex-situ split should still be offered to pediatric patients that met the expedited placement criteria, with allocation of the remnant segment in expedited fashion to a center close to the pediatric center. • Consideration be given to exclusion of donor weight in the expedited center information as this variable is redundant with donor height and BMI which are more predictive of potential risk factors for recipient complications. • Consideration of additional provision and language inclusion for alternative expedited placement algorithms for livers to centers performing hepatocyte transplantation.

Association of Organ Procuremement Organizations | 09/30/2019

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 makes progress toward enhanced organ allocation, recovery and transplantation, AOPO believes it can be strengthened and would support the proposal with the following revisions or clarifications: 1. AOPO supports a defined process for expedited placement, but we do want to emphasize that this proposal does not establish a requirement that OPOs initiate expedited placement if they can continue efforts to place the liver according to the match run. However, the proposal does establish policy requirements that address when OPOs can initiate expedited placement. 2. It is critical that 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 that opt-in for expedited placement are processing these offers within the mandatory 30-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. 3. The proposal should consider the timing for expedited placement. The trigger of expedited placement is in the operating room, which is late in the allocation process and poses a 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 to minimize the possibility of the liver being discarded. We understand the committee agreed that it would be difficult to justify an arbitrary timeframe based on the scheduled donor organ recovery, which can change for a variety of reasons. AOPO asks that this be monitored and considered as a future policy change if supported by data. 4. 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 to monitor centers that have not responded to the expedited placement offers within the 30-minute time frame. 5. 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 thoracic organs, as well as those organs that are difficult to place. Thank you for the opportunity to comment.

NATCO | 10/01/2019

NATCO commends the committee’s effort to address the placement of livers when an organ is declined in the operating room. We support the proposal which creates much needed guidelines to enable OPOs to act quickly, reducing the chance that organs are discarded without being transplanted. We were pleased to see that the proposal allowed for 30 minutes to respond to the offer. Some concern has been expressed over the possibility for frequent declines by some transplant centers after opting into the expedited list. We agree with those in the community who have also expressed a desire to include some form of monitoring and measures of enforcement in the proposal to help address this concern. As the community has previously agreed that children should be prioritized for pediatric deceased donor livers, we believe this should remain true if pediatric donor livers go through an expedited placement process. The Board and members of NATCO appreciate the committee’s work on this proposal and the opportunity to provide comments.

Region 10 | 10/01/2019

The members of the region supported the proposal, but raised some concerns that the committee needs to address. The policy needs to be clear about when an OPO switches from placing a liver with a backup center on the original match and when and OPO can switch over to expedited placement. Doing so will make the process more efficient. There was also a suggestion to have a field in DonorNet to note the reason for why the liver was turned down in the OR, that information will be paramount for accepting an expedited liver. Additionally, there should be more descriptive decline codes in DonorNet. Members were also concerned about how expedited placement will be monitored by the MPSC. If this proposal is to pass then those specifications need to be clearly defined for both OPOs and transplant centers. One member suggested that the committee model expedited placement of livers after facilitated pancreas allocation. Having an opt in system by patient is better than having an opt in system by program, however there needs to be requirements for centers to qualify as an expedited liver program. Like pancreas, the qualifications should be importing a set number of imported livers. The proposal mentions that there are four transplant centers that currently accept over half of the expedited livers and it would be helpful to have those four centers represented on the workgroup that is developing this policy proposal. The workgroup can incorporate the lessons learned from those centers. Lastly, a member said that fee waivers are going to be an integral piece in accepting expedited liver offers. It would be helpful if the OPTN developed policies around fee waivers for organ offers.

OPTN Pancreas Committee | 10/01/2019

The Pancreas Committee thanks the OPO Committee for its work on this proposal. The Chair commented that there could be logistical challenges with the volume of centers that are included in the expedited placement of liver process and suggested the OPO Committee consider some of the ideas of the facilitated pancreas program as the two policies both share a goal of more efficient placement. However, the Chair acknowledged that the organs are very different in terms of procurement and overall they supported the proposal’s approach. The Committee overall supported the proposal. A sentiment vote showed the following results: 50% strongly support, 17% support, and 33% neutral/abstain.

Society for Pediatric Liver Transplant | 10/02/2019

The Society for Pediatric Liver Transplant (SPLIT) believes that the proposal put forth by the OPTN Organ Procurement Organization (OPO) Committee will provide a more equitable and transparent process for distributing these livers to children in need of transplantation and help avoid preventable discard of potentially life-saving organs. It is essential that expedited placement of livers declined by the primary transplant center be offered for expedited placement in a transparent and need-based method that provides equal access to all wait-listed candidates. We agree that centers should opt-in to accept expedited placement livers on a per-patient basis. SPLIT continues to support and advocate for prioritizing pediatric deceased donor organ allocation to the most medically urgent status pediatric recipients. As a point of clarification, however, SPLIT requests more specific language on: 1. The plan for evaluating the impact of this practice change on children and adolescent liver transplant candidates. This evaluation should be required. We could not find previous analyses, by UNOS or otherwise in the literature, that describes whether children are ever offered these expedited placement livers. The UNOS community has agreed previously that children should be prioritized for pediatric deceased donor livers, and this should remain true if pediatric donor livers go through an expedited placement process. 2. Post-implementation tracking of whether children are offered these expedited placement livers should be required, and particularly pediatric donor livers should be preferentially offered to pediatric recipients if they had indicated willingness to accept an expedited liver. 3. The standardized decision algorithm that OPO’s will use to initiate the expedited placement process, and the number of centers that will be notified for time-efficient allocation could be more specified to ensure that this process will be equitable and transparent across OPOs. The UNOS community has agreed previously that children should be prioritized for pediatric deceased donor livers, and this should remain true if pediatric donor livers go through an expedited placement process.

American Society of Transplant Surgeons | 10/02/2019

The American Society of Transplant Surgeons (ASTS) supports this proposal overall and thanks the OPTN Organ Procurement Organization Committee for continuing to examine the issue of timely organ placement. However, we are concerned that the policy does not address the relatively common practice of transplant programs procuring a liver for their respective hospitals, then refusing it a few hours later for size or anatomy incompatibility. This results in the expedited process starting after the liver has several hours of cold time. At that point, the liver will most likely be refused by everyone except the procuring program, who often will have their own backup recipient in the hospital. This practice is known as creating an “open offer.” Policy should dictate that the procuring program decide to accept or decline the liver in the donor operating room. In another scenario, when a case involves a high-risk recipient where problems with the transplant can occur prohibiting liver implantation and the liver is still in the donor hospital. It should be the responsibility of the accepting program to alert the OPO so as to create a back-up list based on expedited offer policy to incorporate programs willing to accept a liver within 3-hours of cross clamp. In these cases, the liver can’t leave the procuring operating room/hospital without that decision. OPO’s should implement a policy of not allowing cross clamping to occur until the accepting team has accepted for a specific recipient on the match run. We also recommend that later refusals resulting in open offers should be tracked and reviewed. If a pattern or repeat practice is noted with a particular program, this should be referred to the OPTN’s Membership and Professional Standards Committee (MPSC). Lastly, we support expedited placement of designated high-risk livers, such as those with significant steatosis or recovered from older or DCD donors. This will likely decrease the discard rate as well.

Carolina Donor Services | 10/02/2019

Carolina Donor Services supports the proposed policy for expedited liver placement. The committee is encouraged to monitor center acceptance rates of expedited livers and make future policy recommendations that further refine the center opt-in process if warranted.

OPTN Region 9 | 10/02/2019

Strongly support (3), Support (7), Neutral/Abstain (0), Oppose (0), Strongly Oppose (0) One of the “opt-in” criteria to accept an expedited placement is to agree to allow any procurement team to recover the liver, if necessary. A member asked who would decide when it is necessary for another procurement team to recover the liver. Members also agreed that it would be helpful to have guidelines for what constitutes an appropriate donor screening process. There would be fewer late turn-downs if there were better assessments of donor organs.

OPTN Transplant Coordinators Committee | 10/02/2019

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.

OneLegacy | 10/02/2019

OneLegacy supports the proposal, provided more detailed language on when the requirement to run and expedited placement match run. Our support is contingent on ensuring the requirements to run an expedited placement list is only effective under the following circumstances: • The donor has entered OR, or initiation of withdrawal of life support (DCD) • The in-OR logistics can accommodate a delay in crossclamp (at the discretion of the OPO) • Crossclamp has NOT occurred If any of those three are not valid then the OPO should be able to use its discretion to manage the allocation of the liver to maximize the potential for transplant.

UW Organ & Tissue Donation | 10/02/2019

UW Organ & Tissue Donation (UW OTD) appreciates the efforts of the OPTN to increase liver transplants and decrease organ wastage. We offer the following feedback for measures to prevent organ wastage, ensure equity and decrease opportunities for system gaming, and close evaluation of the system. 1. Preventing wastage: o We support the proposal’s recommendation to require transplant hospitals to agree to allow any procurement team to recover the liver if necessary. However, we suggest the recovery surgeon for the declined liver be required to remain available at the donor hospital to recover the liver until and unless other arrangements have been made for the recovery surgery. o We strongly recommend requiring the declining surgeon to speak directly to OPO staff in the event of a decline that will lead to initiating the expedited liver protocol. o We support the Committee’s recommendation of “transportation logistics,” specifically that “the host OPO assists the accepting transplant hospital with additional air and ground transportation if needed” be included as a rule not a suggestion. 2. Equity and preventing “gameification” of the system: o Transplant centers that opt in to receive expedited liver offers must demonstrate the necessary infrastructure and services to support expedited transplants in order to ensure organs are transplanted into the intended recipient and avoid organ wastage. Transplant centers should be required to renew recipient information such as MELD scores and acceptance criteria in order to prevent expedited livers being accepted for an unsuitable recipient and resulting in unfair allocation or organ wastage. o Late refusals should be tracked and monitored, as well as situations when transplant centers accept a liver for one patient and then hours later decline for the original patient and subsequently transplant into a different recipient. As noted by the Liver Committee, if there are several offers made at the same time, and several centers accept, but then turn down once the offer is certain, this could still result in slow placement; there be monitoring to ensure that the hospitals that accept the expedited placement and then later turn the organ down be discouraged from continuing that behavior. o As noted by the DAC, all programs on the expedited match run must have access to the same data. 3. Evaluation: o The OPTN must monitor for policy adherence and performance outcomes. o Declines should be monitored and those centers with frequent declines be addressed by the MPSC. o If the volume of centers opt-ing in for expedited livers becomes burdensome, OPTN should strongly consider implementing parameters similar to those in the facilitated pancreas program.

New England Donor Services - CTOP and MAOB | 10/02/2019

NEDS appreciates the efforts of the OPO committee and supports this proposal to increase the efficiency of the placement process and ultimately serve more patients in need. Not having to run a second match run and implementing programming that allows the original match run to be used, will be very helpful. Extending the response time for the transplant programs seems reasonable. However, we note that the expedited offer needs to go the final decision maker at the transplant program because to work efficiently, this needs to be a final acceptance and not a provisional yes. In addition, this system will only be effective if the transplant centers list patients that they will actually accept an expedited liver for. This must be seen as an “opt in” for specific patients where clinically appropriate and not a way to list all patients in order to get more offers. Finally, there needs to be close monitoring by UNOS to look for late turn downs, and the reason, that result in delays or the loss of an organ, trends by transplant programs and when expedited placement is activated, the outcome of the liver being transplanted or not.

UC San Diego Center for Transplantation | 10/02/2019

Support, as this will bring transparency to the process of late reallocations and may reduce discards of otherwise acceptable livers. This may also be the first step in addressing the “bad habits” some centers practice. While we understand that time is of the essence, we do have some reservations about being required to allow “any procurement team” to recover the liver. There should be clarification on what the allowable timeframe for Center’s to send their own teams for recovery or some structure for mutually agreed upon recovery partnerships.