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Expedited placement of livers

Proposal Overview

Status: Public Comment

Sponsoring Committee: Organ Procurement Organization Committee

Strategic Goal 1: Increase the number of transplants

Read the proposal (PDF; 1/2019)

Contact: Robert Hunter


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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

Charlie Alexander | 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.

Kevin Myer | 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.

Richard Hasz | 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

Region 7 | 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-1 strongly support, 4 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.