Comments

OPTN Heart Transplantation Committee | 02/05/2024

The OPTN Heart Transplantation Committee thanks the OPTN Executive Committee for presenting the Expedited Placement Variance proposal to the Committee during their January 16, 2024 meeting. The Committee confirmed that future protocols would not go through the OPTN public comment process, but they would be published online. They were also informed that the OPTN Executive Committee has asked for a mechanism for the public to comment on such protocols. The Committee asked how transplant programs will be notified about future protocols and how programs might be able to participate? The Committee was told that a communication plan will be developed to ensure OPTN members are aware of approved protocols and how they might participate.

LiveOnNY (NYRT) | 02/05/2024

The following is submitted on behalf of LiveOnNY (NYRT) as a public comment regarding the proposed Expedited Placement Variance proposed by the OPTN:

LiveOnNY has identified through experience that the implementation of an expedited organ placement process is critical in improving the utilization of organs that would otherwise be at an increased risk for non-utilization or discard. Although standard sequential allocation is always the primary goal; LiveOnNY has identified factors including but not limited to donor stability, family time constraints, donor hospital/OR availability, cold ischemic time, organ function and late organ declines as factors that most profoundly impact the ability to effectively and efficiently place transplantable organs with recipient centers for their patients.

Acknowledging that there are equitability concerns when placing an organ out of sequence, LiveOnNY believes that organs are considered a national, rather than a local or regional, resource. Geographical priorities in the allocation of organs should be prohibited except when transportation timelines of organs would threaten their suitability for transplantation. Increased transportation methods and distance leads to increased cold ischemic time and is associated with greater risk for graft failure and organ discard. 

Each Organ Procurement Organization (OPO) is presented with unique challenges, whether it be geography, weather patterns, distance between donor and recipient hospital, population density, number of local transplant programs, access to pulsatile preservation devices, etc. LiveOnNY believes that each OPO should be able to operate within a framework to develop and utilize an expedited placement protocol that is a best fit for the unique challenges presented to their respective Donation Service Areas. LiveOnNY has developed an expedited placement protocol that provides the following: 

• A clear framework as to when and in what situations it is appropriate to begin the utilization of customized expedited placement protocols.

• A standardized practice to maintain consistent messaging when speaking to each different transplant center.

• A comprehensive review of each match run to ensure that offers are being made equitably while also ensuring the highest chance of utilization is achieved. 

• A framework that was created based on existing OPTN policies. 

OPO’s are being measured on their ability to place life-saving organs for transplant. Transplant centers often, unintentionally place the OPO in a situation where expedited placement is necessary as they hold offers far beyond policy stated time limits and/or by accepting multiple organs for the same recipient and waiting for extended periods prior to ultimately declining. 

For expedited organ placement to be truly successful and limit inequity when utilizing expedited placement, there needs to be support from transplant centers and their coordinators. The increasing experience of LiveOnNY is that individual recipient coordinators, rather than transplant programs, are deciding not to participate in expedited placement practices. When decisions like this are made, many recipients are left without an opportunity to receive a life-saving organ. 

In conclusion, LiveOnNY fully supports the endeavor by the OPTN to explore practices and policies surrounding expedited organ allocation, and with reservation welcome recommendations from the MPSC and OPTN contractor to achieve a zero-recipient waitlist through creative customizable allocation variances to ensure no transplantable organ is ever discarded. The option to pursue these open variances should occur concurrently to ensure that a final decision is made expeditiously while removing variables such as time of year, insurance mediated decisions, medical education cycles, and more.

OPTN Liver & Intestinal Organ Transplantation Committee | 02/05/2024

The OPTN Liver & Intestinal Organ Transplantation Committee thanks the OPTN Executive Committee for their efforts on the Expedited Placement Variance proposal.

While the Committee is interested in innovative approaches to policy development, they are concerned with the ability to account for ensuring enough community feedback is gathered as it helps develop more rigorous proposals. The Committee does not support any expedited process that would enable the OPTN Executive Committee to forgo public comment on any future variance proposals.

The Committee emphasizes their concern on the lack of involvement by their Committee members in the review and approval processes for proposed protocols as well as on the OPTN Expeditious Taskforce. The Committee expresses the importance of having multiple representatives, specifically in surgery and hepatology, involved in processes that affect the entire country in order to ensure that all perspective and feedback is accounted for especially when reviewing protocols specific to expedited liver placement.

The Committee recommends that the policy language for the variance should include specific language that expedited placement protocols are for the purposes of decreasing non-use and not increasing ease of placement. This could have unintended consequences including increasing disparities and potentially violating the Final Rule. 

The Committee supports the monitoring of the variance and the protocols that will be tested.

OPTN Pediatric Transplantation Committee | 02/05/2024

The OPTN Pediatrics Transplantation Committee would like to thank the OPTN Executive Committee and the Expeditious Task Force for their work on this proposal. Although the Committee supports increasing utilization and decreasing non-use, it is very concerned about unintended consequences. The Committee feels this proposal as written is vague and lacks critical guardrails to ensure that this variance is effective and efficient at achieving its stated goals and preserves equity and access to transplant for children and other hard-to-match populations. Specifically, the Committee is concerned about the impact these protocols will have on access for pediatric candidates and other hard-to-match populations by granting permission for organ procurement organizations to increasingly allocate out of sequence. To accomplish the Task Force’s stated goals, we would recommend the following:

• Specify that variances are required to focus on organs at high-risk for non-use and demonstrate that they are increasing transplants by reducing non-use, not just shifting transplants from one population to another. The proposal as written would allow variances to allocate any organs out-of-sequence for any reason, instead of focusing on organs that the proposing group has identified as likely to be non-used. 
• Ensure that all protocols are data driven.  All proposals should include a background section providing data showing that the organs included in the protocol are at high risk of non-use and that the included population is equitable and appropriate.
• Ensure that all proposed protocols are feasible, having a reasonable chance of showing meaningful results. This would require a sample size calculation for each protocol, demonstrating how many centers/transplants/candidates would need to be involved to demonstrate statistically meaningful improvements. This could also include stopping rules, which could include early identification of both benefits as well as harms.
• Add specific safeguards to protect the pediatric population from losing access to organs. Children and other hard-to-match populations often rely on broader geographic sharing, which can be “less efficient” because it requires communication between OPOs and transplant centers less used to working together, more travel and logistics. However, data repeatedly shows that this broader geographic sharing has been essential to prevent pediatric waitlist deaths and increasing transplant rates. It is critical that variances not undermine this sharing. Therefore, the variance should explicitly exclude kidneys with a KDPI of 0-35% and pediatric donor livers, hearts, and lungs from any proposed protocols. Allowing allocation out-of-sequence for these organs would back pedal on important policy changes made in the last 2-3 years to direct particularly pediatric donors to pediatric candidates.
• Ensure expedited placement does not result in worse patient outcomes by tracking the outcomes. Patients who receive transplants under a variance protocol should have their outcomes tracked even after the variance has ended to provide important information for future policy development.
• Increase transparency for this variance by making all protocols that are submitted publicly available; this includes approved and non-approved submissions. It would be particularly helpful to include at least an assessment of why the Executive Committee did/did not approve each protocol; this would help future submitting entities understand how to make their protocols.

The Committee reiterates its recommendation to add safeguards to the policy for pediatric and consider other hard-to-match candidates, as well as provide a mechanism for members of the community to report any observed adverse outcomes as a result of protocols approved under the variance.

OPTN Patient Affairs Committee | 02/05/2024

The OPTN Patient Affairs Committee appreciates the opportunity to comment on this proposal. The Committee supports efforts to increase the number of transplants and reduce organ non-use and supports iterating on potential solutions to address problems rapidly. However, the Committee has some concerns regarding this proposal. A member noted that there is no requirement for transplant hospitals or OPOs to participate in the variance or protocols and expressed concern that transplant hospitals and OPOs may not actually be interested in participating. Members noted that 18 months does not seem like an expedited timeline and recommended shortening the variance to 30, 60, or 90 days to create a greater sense of urgency, and recommended working with OPOs who are already doing expedited placement effectively to implement their processes into the system faster. Additionally, while there are patient representatives on the task force, the Committee is concerned that the patient representation is not sufficient and that members of the Committee were not included in the task force. The Committee requests to be more involved as proposals and protocols are developed and recommends including additional people on the task force who have not previously had leadership roles in the OPTN.

OPTN Membership & Professional Standards Committee | 02/05/2024

The Membership and Professional Standards Committee (MPSC) thanks the Executive Committee for their time and effort in developing and presenting this proposal. A member noted the time constraints associated with policy changes and the public comment and Board approval process. A member inquired about the data collection process and to what extent data will be collected through the OPTN to monitor and evaluate the variance. A member wondered how the variances will be tracked through the match run to ensure the consenting programs are participating and the protocol is followed appropriately. Given the role of the MPSC, members discussed how the variances will be monitored and some members recommended excluding the variance from allocations monitoring. Members are not supportive of excluding the variance from performance monitoring. A member voiced concern over the Executive Committee approving variance protocols since not every organ type is represented clinically on the Executive Committee. The member emphasized the importance of having the variances reviewed and approved by those with clinical expertise of the specific organ type the variance will apply to. A member also recommended the release of the Kidney Minimum Acceptance Criteria (KiMAC) screening tool that is used by the OPTN to aid in allocation.

Mid-America Transplant | 02/04/2024

Mid-America Transplant (MT) appreciates the opportunity to provide feedback to the OPTN regarding Expedited Placement Variance. As a high-performing organ procurement organization (OPO), MT is committed to its mission of saving lives through excellence in organ and tissue donation, and we are grateful for OPTN’s efforts to improve efficiency in the organ transplant system. We offer the following recommendations around variances and the OPTN’s governance thereof.
1. Mid-America Transplant is dedicated to saving as many lives as possible and has a systematic process governing expedited placement variance. The two critical factors governing its decision to move to expedited placement are cold ischemic time and transplant center relationships. Specifically, when allocating kidneys for transplant, MT moves to expedited placement once six hours of cold ischemic time has been reached. This timeframe is sufficient to begin expedited placement while allowing time to transport the organ, thus mitigating the likelihood of discard. Once this six-hour cold ischemic time mark is reached, MT begins to reach out to transplant centers who have a history of aggressive acceptance practices and with whom we have developed a relationship. MT considers transplant centers “aggressive” when there is a demonstrated practice of accepting high creatinine and high KDPI kidneys. For non-renal organs, MT begins expedited placement twelve hours prior to anticipated organ recovery time.
MT recommends that Artificial Intelligence (AI) models be included in the expedited placement protocols that the OPTN considers as it conducts PDSA pilots and other process improvement initiatives. Over the past three years, researchers at the Missouri University of Science and Technology (Missouri S&T) have built AI models that support expedited kidney allocation. This project, in partnership with UNOS, is currently receiving funding from the NSF and the initial model has been shared publicly in multiple forums. The AI models identify over 20 donor characteristics that accurately predict the risk of kidney non-utilization and over 10 recipient characteristics that accurately predict the likelihood of placement at specific transplant centers. MT believes that incorporating AI models like the ones developed by Missouri S&T into the expedited placement protocols may be an effective way to address the significant complexities of the organ allocation system and provide the best way to optimize utility and equity. It is certainly worth exploring and assessing during the proposed 18-month variance period.

2. MT recommends the OPTN run multiple concurrent trials to enable more organs transplanted, to expedite and expand opportunities for maximizing organ donation. MT supports variance models that dismantle barriers which contribute to health inequities, and that have appropriate measures of success which consider how to equitably and efficiently transplant as many organs as possible. Models that allow enough time to allocate from an expedited list can enable the consideration of transportation and other logistics which might otherwise serve as a barrier to a successful transplant.

3. Concerns. Although MT is supportive of efforts to identify optimal expedited placement processes, MT would respectfully raise the following concerns to OPTN for consideration as it refines policies related to expedited placement.
First, MT would request a clearer understanding of the impact of an OPO’s participation in a variance protocol on an OPO’s performance metrics during the 2024 CMS performance year. An OPO that is voluntarily participating in an experimental protocol with the intent to save more lives could determine that a particular process is inefficient and may end up decreasing its transplant rate. Similarly, the OPTN Executive Committee discusses the randomizing of normal allocation vs. expedited allocation when evaluating protocols. It is unclear why an OPO would agree to conduct normal allocation if the intervention is expected to improve outcomes, and thus bolster CMS performance metrics.

Sommer Gentry and Allan Massie | 02/04/2024

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NY Center for Liver Transplantation | 02/04/2024

The organ donation and transplant community agree that the use of donated organs for transplantation must be maximized. Deceased donor organs are sometimes “hard to place” and may end up being unused. Expedited placement of these organs has been utilized to reduce non-use. However, a lack of standardized protocols for expedited placement has resulted in a patchwork approach by OPOs to “bypass” patients on the rank list in order to efficiently place the organs. This raises ethical questions for patients bypassed without the opportunity to receive the organ offer. A lack of transparency and effective oversight of bypassed organs increases the potential for criticism of the OPTN as unfair and prevents the transplant community from learning which practices work best.

If done well, the current proposal to create a variance to govern the expedited placement (or “bypass”) protocols is a step in the right direction. There is certainly a need to quickly identify ways to make use of these unused organs. However, the proposal as written has a number of issues that need to be addressed prior to adoption:

1 - The stated purpose is too broad for the proposed outcome measures. If the intent is to transplant unused organs, the purpose should be rewritten to say, “to create a variance to pilot and assess different expedited organ placement protocols to increase organ utilization” and outcome measures may stay as is, “successful variances will demonstrate an increase in the utilization rate and/or decrease in non-use rate.” It is important the proposed variance specifically targets unused organs; or the OPTN risks gains made in equitable access to transplantation and may cause harm to patients on the waitlist. How will the Committee ensure that utilization increases do not result from decreased patient equity?

2 - It is unclear how the OPTN will evaluate the impact of newly approved variances. The proposal states, “because the OPTN does not know which OPOs are using protocols right now, it will be challenging to establish a proper control group for this analysis…One option is to require participating members to submit their existing expedited placement protocols as a condition of participation in this variance. This will allow the OPTN to understand when a member is changing their expedited placement protocols due to this variance.”

OPTN should require that OPOs submit existing expedited placement protocols, not only as a condition of this variance, but in all cases where bypass codes are regularly used to expedite placement. The dearth of written expedited placement protocols is not well explained, nor is the lack of uniformity in the way these cases are captured in the OPTN dataset. A cursory review of the existing data reveals approximately 15 different codes used to capture these bypass situations, few of which are used consistently. Some are codes specifically for expedited placement (799, 863, 887); others identify the reason for going out of sequence on the list - such as for donor medical instability, or for OPO or transplant center operational constraints (751-53, 760-63, 765, 861-2); and other bypasses have simply been captured in open text boxes (898) and can be called bypass, open offer, expedited offer, out of sequence, OoS or any abbreviation of the same.

3 – Until the above is clarified – only one expedited placement protocol per organ type should be allowed.

4 - In the interest of demonstrating clear transparency, all proposals for expedited placement that are considered by the Executive Committee should be posted to the OPTN website, including those that are not approved.

Joe Brownlee | 02/04/2024

Overall, I support innovation through pilots and creative thinking. It is apparent this variance proposal is providing an avenue for innovation while evaluating results quickly (a “fail fast” mentality). I am supportive of a well-created game plan to execute with clear directions, anticipate results, and sharing lessons learning QUICKLY. While the proposal is a step in the right direction, it appears hurried and not well defined.

Please accept my feedback as a parent of a 2x heart transplant recipient, a newer member of the Pediatric Transplantation Committee (whose feedback is due very soon), a professional in the tax-exempt arena who implemented pilot tests globally, and a significant supporter of helping improve the US transplant system to reduce the likelihood that any organ with life-saving value does not reach a well-suited recipient.

• Better definition of the problem using validated data of historical unutilized/discarded organs by organ, region, and reason
• Better structure and details in the Expedited Placement Variance document
• Clarify reviewing body is the Task Force before the Exec Committee considers their suggestion—strengthen representation on the Task Force.
• ALL submitted expedited organ placement protocol (approved/not approved) be published for awareness by all.
• Pilot one organ (kidney due to its volume) as recommended by many to learn, innovate, “succeed/fail fast”, and implement lessons learned to other organ populations. For example, some noted that proposed variances should focus solely on kidneys, more specifically those with a KDPI of > than a certain % determined by data analytics.
• Emphasize key metrics, including, but not limited to: increasing utilization of at-risk/underutilized/significant chance of non-use donations, improving longer-term outcomes of survival, increasing utilization in targeted demographics (higher-risk populations)
• Fully support the feedback by the International Society for Heart and Lung Transplantation on 01/17/2024
• Exempt all pediatric donations (those received from under 18 years of age) from use in expedited placement and follow normal protocols (major concern voiced by many, including the Pediatric Transplantation Committee).
• A specific focus should be given to anticipated long-term outcomes (life expectancy) and ensure Expedited Placement Variance doesn’t increase “futile” transplants
• Fully support the following excerpts from the Pediatric Families and Engaged Partners, The Society of Liver Transplantation
o distribute organs to pediatric patients and the most vulnerable is requiring OPOs to offer organs to children on PTR (or other hard-to-match recipients) prior to activating the expedited placement protocol.
o stronger representation of pediatrics on the committee changing these protocols

Hospital Espanol Auxilio Mutuo | 02/04/2024

Transplant Center Hospital Auxilio Mutuo

Our Transplant Center supports that the OPTN develops initiatives to improve organ utilization. The Expedited Placement Variance Policy objective is to address this issue by allowing OPOs and Transplant Centers to propose expedited organ placement protocols that aim to implement efficient processes to allocate and utilize “marginal organs that are hard to place.” As written in this Proposal, these protocols: (1) will be approved by the Executive Committee for 18 months, after which the Board may recommend extension, modification, or termination of the variance; (2) the approved protocols will be made publicly available for review and (3) evaluation of success will include outcome measures, such as increase in the utilization rate and/or decrease in the non-use rate.



Our main concerns with this Policy are:

1. For Transplant Centers that do not participate in an expedited placement proposal: how will “hard-to-place organ” or “marginal organ” be defined? Not having a clearly established definition may lead to the unintended consequence of exporting organs that may have been used locally.

2/ For Transplant Centers that participate in an expedited placement proposal: how will it affect the SRTR Program-specific outcomes?


We would appreciate clarifications on these concerns before fully supporting this Policy.

American Society of Nephrology | 02/04/2024

Maximizing patients’ access to kidney transplant—and ensuring that access is equitably available to all patients—is of utmost priority for the American Society of Nephrology (ASN). The society stands ready to work with OPTN, including the OPTN Executive Committee and the Expeditious task force, to achieve this goal. In particular, the increasing organ nonuse rate is a troubling trend the society agrees should be urgently addressed through policy change. In this context, the society is particularly appreciative of the chance to weigh in on the December 2023 proposal developed by the Expeditious task force and sponsored by the OPTN Executive Committee.

Please refer to the attached PDF for ASN’s complete comments on this proposal.

In summary, ASN is strongly supportive of policy changes to decrease organ nonuse rates and increase both patient access and system efficiency—and believes testing an approach to expedited placement is a reasonable endeavor. However, the society has several concerns and recommendations regarding the proposed approach, particularly:

• As OPTN pursues increasing efficiency and decreasing nonuse, the values of utility, equity and transparency can and should be advanced simultaneously in a balanced fashion.
• The current match run allocation process is flawed: OPTN should prioritize improving this process over expanding and making permanent workarounds (expedited placement practices) that attempt to compensate for the current allocation algorithm’s apparent shortcomings.
• Should expedited placement pilots proceed under a variance as proposed, an increasing number of patients at transplant centers that do not participate may not receive a fair opportunity in terms of access to transplant, and these changes in access may not be transparent to patients, referring nephrologists, and researchers: ensuring transparency about these changes is essential if this variance moves ahead.
• Any pilots or protocols that are approved should be rigorously designed, including controls, clear and transparent monitoring strategies and implementation plans, and predefined end points (including to assess effects on equity in access), and be planned, resourced, and implemented by OPTN in order to obtain data that will yield meaningful lessons and inferences from the expedited placement variance.
• The OPTN, the Centers for Medicare and Medicaid Services (CMS), and the Health Resources and Services Administration (HRSA), must work together collaboratively as they craft expectations and metrics for organ procurement organizations (OPOs) and transplant centers (as well as other stakeholders, such as nephrologists and dialysis organizations) so that all stakeholders are aligned towards the same end—increased, equitable patient access to transplant.

ASN recommends that the Committee issue another round of public comment building on this initial proposal, such as during the 2024 summer comment period. Ideally, it would provide more detail related to plans for patient engagement and transparency, equity, and study design and evaluation and monitoring methods. Again, ASN also strongly urges the Committee to consider tackling the root cause drivers of the growth in expedited placement practices by optimizing the current match run allocation algorithm, as well as advancing complementary approaches to increasing system efficiency and decreasing organ nonuse in ways that balance utility, equity, and transparency and enhance collaborative growth amongst all stakeholders in the transplant ecosystem.

ASN appreciates OPTN’s and the Committee’s interest in reducing organ nonuse and increasing system efficiency and is grateful for the opportunity to provide input on this proposal. The society stands ready to work with OPTN and the Committee to address the recommendations and concerns included in this letter.

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American Society of Transplant Surgeons | 02/04/2024

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Leslie Wyers | 02/03/2024

Thank you for allowing for public comment; however, we need to include ALL stakeholders in such an important decision making processes- and this includes the pediatric population. I respectfully request extension of the comments AND inclusion of feedback from the UNOS Pediatric Committee and experts in Pediatric Transplantation have a "seat at the table". Given OPTN's renewed commitment to transparency, it only makes sense to ensure all members of our transplant community are included- especially our transplant children whose voices need to be heard through their adult advocates.

Penn Transplant Institute - Penn Medicine | 02/03/2024

Penn Transplant Institute appreciates the efforts of the OPTN Expeditious Task Force to improve allocation efficiency and organ utilization. As written, the proposed policy grants the OPTN Executive Committee authorization to allocate deceased donor organs out of sequence without oversight or a transparent process to assess match run variances. To improve this policy, the Taskforce should establish a formal mechanism to monitor deviations or variations in organ allocation.

The OPTN should create consensus-driven guidelines to safeguard the integrity and equity of the organ allocation process. Efforts to mitigate non-utilized organs should only commence after a thorough examination of data-driven trends for expedited allocation, including practice variations, deviations, and associated root causation.

The proposed policy also lacks uniform criteria for out-of-sequence deceased donor organ allocation. Without clear guidelines on which organs qualify for expedited placement, the policy may inadvertently legitimize the out-of-sequence allocation of organs that could and should be offered to potential recipients based on the standard match run.

The simultaneous implementation of multiple variance protocols, without defining organs at risk of non-utilization, may lead to unintended consequences and potentially exacerbate inequity. In addition, we strongly recommend transparency and data collection around the use of industry contracts and organ perfusion device utilization by OPO's for thoracic and abdominal transplant.
This information and associated data must be monitored for routine allocation and for future expedited placement variances.

As continuous distribution expands, we recommend that the Expeditious Task Force formalize a mechanism to evaluate the effectiveness of expedited allocation and any unintended impact to waitlisted patients bypassed during expedited allocation. Thank you for the opportunity to comment and for your consideration.

Esther A Torres | 02/03/2024

As Medical Director of LifeLink of Puerto Rico, it is my mission to work to recover and transplant as many organs as is possible to save the lives of those waiting in the island and in the mainland. The distance and travel logistics between Puerto Rico and the mainland challenge the placement of organs that are not used locally. Improved efficiency in allocation will help these organs find a home. The OPTN expedited task force proposal addresses this issue with the goal of finding solutions. I enthusiastically support this proposal and am hopeful that it will result in more lives saved.

Association of Organ Procurement Organizations | 02/02/2024

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LifeLink Foundation (FLWC, GALL, PRLL) | 02/02/2024

The OPOs of the LifeLink Foundation (LifeLink of Florida, Georgia, and Puerto Rico) support the ongoing efforts of the OPTN to improve efficiencies within the organ transplant system with a focus to increase organ utilization. The improvement methodologies described within the OPTN proposal have been implemented in healthcare for many years with demonstrated success. We fully support and applaud the OPTN’s willingness to adopt the use of these improvement methodologies for evaluation and quick iterative changes. This is an important progressive step within the transplant system. We support the Task Force’s efforts to examine the systems and work directly with the OPTN executive committee to allow for a rapid turnaround and decision-making process to launch these events. With all of this in mind, the LifeLink OPOs would support the OPTN to run multiple, concurrent voluntary expedited placement protocols to maximize organ utilization.

NATCO | 02/02/2024

NATCO thanks the Executive Committee and the Expeditious Task Force as it works to improve efficiency in the organ transplant system. We support the Expedited Placement Variance proposal and its aim to use quick, iterative PDSA’s, pilots, and other process improvement initiatives to improve the system in a rapid, flexible, and responsive manner. We appreciate that the task force is seeking effective practices from within the community to address the growing number and percentage of organs allocated out of sequence. NATCO supports the requirements to determine explicit clinical criteria for organs eligible for expedited placement as well as explicit criteria for candidates eligible to receive expedited placement offers and believe this will further the efforts to help OPO’s and Transplant Centers work together to improve organ utilization. We appreciate the recognition regarding the challenges that may be present with respect to operating multiple, simultaneous expedited protocols and encourage more discussion regarding ways to overcome any potential bias that might result from not randomly assigning protocols during the study. Overall, we believe that standardizing the protocols for expedited placement will improve overall utility and equity impacts of expedited placement.

Anonymous | 02/02/2024

As a parent of 2 daughters with liver transplants, I believe expediting the process could have adverse affects for the pediatric community. It is extremely important that the right match is found for the best possible outcome, with hope of long term transplantation. The hope is for life and accuracy in matching in extremely important. At minimum, I believe it would be beneficial to have more time for Pediatric Specialists to weigh in on this proposal so pediatric transplants are not inadvertently put at risk.

HonorBridge | 02/02/2024

HonorBridge supports the proposal to create a variance to test expedited protocols. Efforts to increase the utilization of hard to place organs which prevent nonuse has been a challenge in the transplant community. Conducting rapid PDSAs will allow the OPTN to review multiple protocols for effectiveness. We do support the concurrent running of PDSAs as this will provide the most efficient and timely way to test multiple protocols. OPOs should have the opportunity to remove themselves at any time from a variance should the PDSA demonstrate any negative impacts to placement success. Additionally, out of sequence allocations should continue to be an option when an OPO is not participating in an approved protocol. These would, of course, continue to be reviewed by the Membership and Professional Standards Committee.

Rebecca Baranoff | 02/02/2024

As a kidney transplant recipient I feel requesting a new variance to allow for the creation of pilot programs involving transplant programs and OPOs in the process of improving transplant is a very good idea. This hopefully can give the task force data to learn how to improve efficiency , increase organ distribution and increase the transplant rate for all of the candidates waiting.

OPTN Pancreas Transplantation Committee | 02/02/2024

The Pancreas Transplantation Committee thanks the OPTN Executive Committee for their efforts on the Expedited Placement Variance proposal.

The Committee is in support of this proposal and agreed that this structured approach provides benefits to expedite placement and reduce non-utilization of organs. The Committee provided some feedback for consideration:

·      Monitoring: The Committee suggests that there be various ways to monitor the variances received as well as the evaluation of the variances once implemented. As variances are being received, it should be determined what variances are similar and could be combined. Acknowledging that regions vary, if variances submitted are similar to specific regions, those variances should be available for those respective regions to work on together. Additionally, monitoring should also include identifying variances that may not be working for some programs. Data on allocations out of sequence and non-utilization should be evaluated to determine the causes of these instances. There should be acknowledgement that the timeline in monitoring changes/impacts of these variances can vary by organ type. For example, variances related to kidney may accumulate more data in a faster timeframe than a variance related to pancreas due to the sample size evaluated.

·      Collaboration with organ specific Committees: The Committee suggests consultation with organ specific Committees to review and have the opportunity to provide their expertise/input early on in the process. This would also give Committees an idea of what protocols could be utilized in the future.

The Committee asked for more clarity on the process of the proposed expedited placement variances:

·      How will this proposal differ to current practices of out of sequence allocation?

·      How many variances would be developed from this proposal?

·      What is the timeline for reviewing protocols?

·      How is the Executive Committee planning to address potential IT resources in their evaluation?

The Committee acknowledges the merits of the variances by providing a structured approach in studying how these systems could work and making efforts to avoid unintended consequences.

Piedmont Transplant Institute | 02/02/2024

Piedmont Transplant Institute fully supports the OPTN expedited task force proposal, recognizing its crucial role in streamlining processes to improve utilization of challenging organ offers for transplantation. This initiative aligns with our commitment to safely utilize every possible organ for transplant in the patient that would gain the most benefit, ultimately increasing the number of patients receiving life-saving transplants.

Ensuring transparency in the process of expedited offers is crucial to allow equitable opportunities for transplant centers to help in the efforts to decrease organ non-utilization rates.

We encourage the OPTN to require that each OPO's expedited organ placement protocol be published for review by transplant centers.

Piedmont Transplant Institute is excited for future opportunities to participate in this extremely important initiative to improve the efficiency of organ allocation to help save more lives while focusing on balancing the interests of patients on the waiting lists, OPOs and transplant centers.

OPTN Operations and Safety Committee | 02/02/2024

The Operations and Safety Committee thanks the OPTN Executive Committee for their efforts on the Expedited Placement Variance proposal.

The Committee is in support of the proposal and provided some questions and feedback for consideration. The Committee asked for more clarity on the process of the proposed expedited placement variances:

·      How long will it take to test an individual variation?

·      Does the Expeditious Task Force have a goal as to how many protocols would be tested during the time the variance is in place?

·      If an OPO were to sign up for a variance, does this mean an OPO is committed to trying out a variance no matter what it is regardless of implications for themselves, or signing up for the opportunity to be involved in variances that they still get an option for?

The Committee noted that OPOs are currently under high scrutiny and cautioned that OPOs not having the opportunity to evaluate the impact of success on their organ placement that a variance would have would be detrimental. The Committee suggested there being some room for that willingness or there would be challenges to have members sign up for this effort.

Pediatric Families and Engaged Partners, The Society of Liver Transplantation | 02/02/2024

Pediatric Families and Engaged Partners (PFEP) of The Society of Pediatric Liver Transplantation (SPLIT) is grateful for the chance to comment on the proposed Expedited Placement Variance, thank you for all your hard work on this. As a group, we are concerned that the proposal has the potential to create disparities that are not entirely predictable - especially for the possible impacts on children who are a small sample size and depend on broader geographic sharing for adequate access to organs. We would like to see better requirements for the changes, and their evaluation plans, to ensure that expedited placement protocols are not diverting organs from vulnerable populations that are harder to match and more dependent on broader geographic sharing - in particular, pediatric patients. Like our parent organization (SPLIT) stated, if the goal is to minimize non-use of organs, then proposed changes should be focusing on organs that are high-risk for non-use, we agree that there should be a redesign on how organs are being distributed in order to avoid diverting organs from children and other vulnerable populations that depend on broader geographic sharing. One suggestion to distribute organs to pediatric patients and the most vulnerable is requiring OPOs to offer organs to children on PTR (or other hard-to-match recipients) prior to activating the expedited placement protocol. There is also a concern that these policy changes would have a consequential impact on pediatric patients who currently are not being prioritized in the name of this expedited placement. We would also like to see a stronger representation of Pediatrics on the committee changing these protocols, since those voices can be negatively impacted by quick decisions based on adult patient data. We agree with our parent organization (SPLIT) and ask for an open discussion of this policy and inclusion of safety checks for each specific new variant protocol, rather than just requiring Executive Committee approval.

Nicole Oates | 02/01/2024

As a member of an organ allocation team, I often experience the difficulties faced by OPOs attempting to place "high risk" for discard organs more specifically kidneys. I am in full support of the OPTN Expeditious Task Force variance proposal and champion the bold aim of 60K transplants by 2026. I believe the proposed variances should focus solely on kidneys, more specifically those with a KDPI of > 60%. OPOs and Transplant Centers who volunteer to participate (trialing the protocol and the subsequent data collection) should be involved in this proposal. Transplant centers when offered expedited organ offers, should have the ability to choose any recipient that is most suitable for the case. Running multiple protocols concurrently vs consecutively would expedite the data collection phase; identifying potential solutions earlier in the process and save more lives. The task force should trial 3-5 protocols and assign an equal number of OPOs (from different regions) to test each protocol. This data can provide a broader outlook of which protocols may work in differing regions. Thank you OPTN Task Force for leading the charge, effecting major change in our industry, and allowing time for public comment on the proposal.

OPTN Transplant Coordinators Committee | 02/01/2024

The OPTN Transplant Coordinators Committee appreciated the opportunity to comment on the Expedited Placement Variance proposal. 

The Committee confirmed that this alternate allocation process does not fall under research protocols that require communication and additional consent from potential recipients. This is a way of allocating organs differently to test efficient placement. A member commented that while this focuses on hard-to-place organs, the protocols could also address allocation following a late turndown. There was also a suggestion to define hard-to-place organs.

The Committee appreciates the novel approach to endorse quick PDSAs (Plan, Do, Study, Act) to test expedited placement protocols. However, the members agreed there needs to be operational clarity for how these will be approved, managed, and evaluated. Additionally, there is concern about unintended consequences because these PDSAs will primarily be OPO protocols that will impact transplant programs. If different OPOs are using different variances, it might cause confusion for transplant hospitals who receive offers from multiple OPOs. Therefore, there needs to be some level of consistency for how these are operationalized as well as a communication strategy to keep the community informed about this work.

The Committee recommends minimal thresholds for data collection to best evaluate the use of the test protocols. Additionally, it was recommended that a clear definition of what a rapid variance means be established. Lastly, there was a suggestion to limit the expedited placement variances to kidneys since there are offer filters available to kidney transplant programs.

The Committee recommends the use of specific bypass codes so that transplant programs are not penalized for the use of decline codes. For example, if a transplant program enters a provisional yes within the first 30 sequence numbers and the expedited placement variance is activated before that, then bypass codes should be automatically entered.

Anonymous | 02/01/2024

As the parent of a pediatric transplant recipient I am concerned that children will be disadvantaged by the Expedited Placement Variance. Children should receive the best possible transplanted organ to allow them to live a long-lasting life. Before approval of this variance, I agree with all those who are urging for: 1. a longer public comment period on this variance, and 2. a pediatric-focused workgroup the opportunity to evaluate the implications related to this important change.

OPTN Organ Procurement Organization Committee | 02/01/2024

The OPTN Organ Procurement Organization (OPO) Committee appreciated the opportunity to comment on the Expedited Placement Variance proposal. The Committee suggested that OPOs be guaranteed exemption from Member and Professional Standards Committee (MPSC) review for existing practices that they share related to this proposal. There was also a recommendation to create a form so that whoever is developing a protocol could make sure they cover the criteria that are being proposed. The Committee also raised concerns about how OPOs will enforce the filters to be utilized, as they may find it challenging to write a protocol that complies with the Final Rule when they are only going to call certain centers willing to accept the organs. The Committee notes that each area of the country has different definitions of aggressive centers, thus deciding on which criteria make a center “aggressive” may pose a challenge.

Anonymous | 02/01/2024

As the mother of a pediatric transplant recipient I would like to advocate for an extended public comment period in which pediatric experts can weigh in to help make this variance the best it can be.

Gift of Life Michigian | 02/01/2024

We appreciate a more flexible approach to allocation, mindful that conflict inevitably arises when something in short supply is in question.

We realize that innovation can originate from a variety of sources. We are also aware of several other initiatives launched by other entities (e.g., Health Resources and Service Administration's (HRSA) Health Services Advisory Group (HSAG) Organ Procurement Organization (OPO) Performance Improvement project, the United Network for Organ Sharing (UNOS) Donation after Circulatory Death (DCD) project, the End-state disease Treatment Choices Learning Collaborative (ETCLC) for kidneys, and individual projects by OPOs and transplant centers). We encourage forums in which various entities can share their ideas with the community at large.

We are aware of the deficiencies of policy driven ability to place organs expeditiously. While the transplant community is unified in efforts to get more patients transplanted, balanced with access and equity challenges, the complexities of managing medical acuity, race, distance, transplant access, and other variables has resulted in policies designed to accomplish those goals, but have presented many obstacles to efficient organ placement.

We support the OPTN's efforts to improve organ allocation, especially in instances of expedited placement caused by several factors. We generally support exploration of creative and evidence-based approaches to problem solving.

The proposed variance is a bold approach to serious challenges to efficient placement and utilization of donated organs. The proposal appears to define guidelines that allow for innovation and flexible testing and adjustments of protocols designed to improve organ utilization, especially for organs that are difficult to place.

We support this opportunity to try new ways to place more organs. Many, possibly all, OPOs have adjusted allocation practices in response to under utilization of organs and some of the complexities of broader sharing, such as time and travel and transportation. We hope these efforts will contribute to continued efficiency and success in transplantation.

OPTN Kidney Transplantation Committee | 02/01/2024

The OPTN Kidney Committee (the Committee) thanks the Executive Committee and OPTN Task Force for their work on this proposal and the opportunity to comment. The Committee asked for increased clarity around how these variances will be evaluated, how data will be collected on the variances, and how the variances will be monitored for unintended consequences. The Committee appreciates the Executive Committee and Task Force’s commitment to transparency in sharing monitoring reports regarding the variance and the flexibility provided by the proposed variance to test potential expedited placement pathways. The Committee noted that expedited placement protocols may preference certain populations that may be easier to transplant, and emphasized the importance of ensuring these protocols and related outcomes are closely monitored to ensure disparities do not increase.

Society of Pediatric Liver Transplantation (SPLIT) | 01/31/2024

The Society of Pediatric Liver Transplantation (SPLIT) appreciates the opportunity to comment on the proposed Expedited Placement Variance. The proposal as written is incredibly broad and could under-mine many existing policies, with little recourse for those negatively impacted. Specifically, we ask the following to be addressed:

-- More narrow definition of what variances will be considered - if the stated goal is to reduce non-use of organs, then proposed variances should be (1) REQUIRED to focus on organs at high-risk of non-use and (2) designed explicitly to avoid diverting organs from children and other vulnerable populations that depend on broader geographic sharing. One way to achieve #2 is to require that OPOs must offer organs to children on PTR (or other hard-to-match recipients) prior to activating the expedited placement protocol.

--Clearer explanation of requirements for the variances, and their evaluation plans, to ensure that expedited placement protocols are not diverting organs from vulnerable populations that are harder to match and more dependent on broader geographic sharing - in particular from children and young people.

--A requirement that these expedited placement protocols include "stopping rules" - what unanticipated negative impacts should require halting the variance.

--More specifics about number of expedited placement protocols that could be simultaneously running-would consider limiting to 3-5 per organ - to avoid excessive fracturing of the system and which rules are applied to which people. Again, this proposal as written seems to have potential to create disparities that are not entirely predictable - especially in terms of impact on children who are a small sample size and depend on broader geographic sharing for adequate access to organs

-- There is a risk that the impact on these policy changes on pediatric patients would not be considered, in the name of expediated placement. The Executive Committee is OPTN leadership but given the limited number of people on this Committee, may not be able to represent comprehensive expertise on the potential impact of a specific expedited placement protocol. If these variances will change policy temporarily then they should also be vetted by those with relevant expertise -e.g. the organ-specific committees and the Pediatric Committee

--Clearer justification for why this requires expedited approval

--We ask for a greater open discussion of this policy and inclusion of safety checks for each specific new variant protocol, rather than just requiring Executive Committee approval.

Anonymous | 01/30/2024

I concur with the comments and ideas set forth by BARE Inc. and Transplant Families. Please allow for an extended comment period and include pediatric specialists to ensure the expedited placement variance does not inadvertently negatively impact pediatric transplant recipients.

BARE Inc | 01/30/2024

BARE echoes the sentiments conveyed in earlier comments on the Expedited Placement Variance related to pediatrics. Our main concern is on the potential unintended consequences for children, and we emphasize the importance of extending the public comment period. Furthermore, we suggest establishing a specialized workgroup comprising pediatric experts or leveraging the pediatric committee to provide its guidance. This collaborative approach will facilitate a thorough assessment and contribute to molding this variance into the most advantageous form for pediatric recipients.

Christopher Thome | 01/30/2024

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Transplant Families | 01/30/2024

Transplant Families would like to thank the Executive Committee and the Task Force for their work. While Transplant Families strongly supports greater utilization of viable organs, we are concerned that this Expedited Placement Variance will have unintended negative consequences for children. We strongly advocate for an extended public comment period to allow for a more comprehensive consideration of this variance. Additionally, we propose the formation of a dedicated workgroup consisting of pediatric experts OR utilization of the pediatric committee for guidance. This collaborative effort will ensure a comprehensive evaluation and contribute to shaping this variance into the most beneficial form possible for all recipients. We would also like to echo sentiment advocating for systematic collection and analysis of data so that we can truly be agile in our decision making going forward. We appreciate the opportunity to give comments on behalf of the community we represent, children and their caregivers.

OPTN Policy Oversight Committee | 01/30/2024

The Policy Oversight Committee (the Committee) thanks the Executive Committee for their work on this proposal and the opportunity to comment. Committee members urged the Executive Committee to think about checks and balances as the main reviewers and approvers of the potential variances. Members further suggested adding a maximum limit to variance timelines. Members commented it will be challenging to track multiple variances at once and the Executive Committee will need to ensure they can be measured in a clear and transparent manner. Members also cautioned pilots in certain areas of the country may not be reflective of how they would work nationwide due to regional differences.

OPTN Transplant Administrators Committee | 01/30/2024

The OPTN Transplant Administrators Committee (the Committee) thanks the Executive Committee for their work on this proposal and the opportunity to comment. The Committee recommends that further clarity be provided about which organs the variance could apply to, as the perception is the variance and the subsequent proposals should only apply to kidney. The Committee also seeks further clarification on how OPOs should continue to operate once the public comment period ends, during the period of time proposals are being considered by the Executive Committee.

OPTN Histocompatibility Committee | 01/30/2024

The OPTN Histocompatibility Committee received a presentation and had no concerns about the proposal. The Committee appreciates the work the Executive Committee put into the proposal’s development and had no objections or comments. 

liise kayler | 01/29/2024

The OPTN should put a process in place to better understand current expedited organ placements. That way, when variances are improved, it might be possible to separate the effect of the approved variance vs nonprotocol rescue placements taking place.

Anonymous | 01/26/2024

Before variances are developed and implemented, we need a thorough and transparent assessment of organs discarded so that the solution actually addresses the problem. To date, there has been no comprehensive assessment of reasons for discard of procured organs and anything short of this may lead to further chaos without addressing the root causes of the problem. Once a variance is proposed, it needs to be specific based on clear and reproducible data and definitions and should be assessed by a 3rd party for impact on allocation and equity to be sure that it does not disadvantage further already marginalized or disadvantaged groups.

Legacy of Hope | 01/26/2024

As an OPO, Legacy of Hope supports a proposed plan for the OPTN to run concurrent expedited placement protocols. Over the last few years, there has been an increase in expedited placement of multiple organs, resulting in year-after-year increase of lives saved. The development of multiple expedited placement protocols by OPOs, specifically around kidneys, reinforces that no single solution would improve organ utilization for every OPO. Concurrent expedited placement protocols create a “protocol marketplace” allowing for interested OPOs to review multiple protocols and select one based on similarities between the creating OPO and their own.

OPTN Lung Transplantation Committee | 01/25/2024

The OPTN Lung Transplantation Committee appreciates the opportunity to comment on the Expedited Variance Placement proposal. The Committee supports the development of a new variance to govern pilot studies related to expedited placement protocols and commends the Executive Committee’s efforts to provide equal access to participate in these protocols. The Lung Committee asks the Executive Committee to consider the importance of maintaining transparency throughout the process of reviewing and implementing proposed protocols for expedited placement of hard-to-place organs. Key terms associated with a given protocol should also be clearly defined to ensure consistency in execution. The Committee raised concerns regarding potential interactions between approved protocols and members noted that approving multiple variances involving the same organs in the same locale could make it difficult to discern the impact of each protocol independently. It was discussed that each approved variance should assume neutral impact on the allocation of other organs. Members urged the OPTN Executive Committee to provide more detailed information about the approval process, monitoring, and evaluation plans for these pilot studies, including specific key metrics to measure success and potential downstream effects. Members also suggested that proposed pilot studies be reviewed and monitored by a patient safety board.

Neeraj Sinha | 01/24/2024

Creation of variances is a powerful tool to advance the field. In the context of lung transplantation, commonest reasons for needing expedited placement are last minute turn-downs and lengthy assessment times (often they exist together). The above two issues need collaborative QI studies. Unrelated to topic, it would be worthwhile to consider a provision for variances allowing transplant of high-risk candidates (data carve-outs, reporting of results).

Iowa Donor Network | 01/23/2024

We are in favor of testing strategies that will lead to a decrease in organ nonuse and an increase in organs transplanted. Given all of the computational, scientific prowess the US Organ Transplant System possesses, we can quickly determine if an intended strategy has met its targets of success. If it has not, we should be able to quickly pivot in another direction that appears more likely to propel us to our desired end of increased organ utilization for transplantation. OPOs have successfully employed PDSAs (Plan-Do-Study-Act) for many years to tackle challenging family authorization and complex donor hospital notification issues. We can lead the way on this.

St. Louis Children's Hospital | 01/21/2024

MOCH strongly supports the concept of using the OPTN Variance policy to accelerate efforts to address organ non-utilization by developing and testing expedited placement protocols. However, MOCH has the following concerns regarding the proposal:

•The proposal, as written, fails to provide sufficient justification for the special, shortened public comment period. Although the proposed changes in variance policy language are reasonable, the specific open proposal (5.4.G) provides insufficient operational details for how the new variance will be implemented. The OPTN may wish to consider extending the comment period through the upcoming Winter 2024 regional meeting cycles to allow time for more operational specificity to be provided and to gather more community feedback on this proposal. MOCH supports comments previously provided by AST and ISHLT in this regard.

•Given the complexity of implementing the proposed expedited placement protocols, an initial pilot using kidney allocation to demonstrate feasibility may be appropriate (kidney allocation has both the highest incidence of donor organ non-utilization and the highest volume to support data collection for a rapid PDSA). Once efficacy, safety and transparency have been achieved, moving on to protocols involving expedited placement of other organs and operating concurrent expedited placement protocols would be reasonable.

Jonathan Miller | 01/19/2024

I believe it would be possible to test multiple protocols at once. I would be very supportive of adopting a strong experimental design for the evaluation, including if possible randomizing match runs to which protocol is used to be able to get the strongest support for conclusions.

LifeShare Transplant Donor Services of Oklahoma | 01/17/2024

The following is submitted on behalf of LifeShare Transplant Donor Services, (LifeShare) as public comment regarding the proposed Expedited Placement Variance. As an organization, we endorse the introduction of the Expedited Placement Variance as approved for comment by the OPTN Executive Committee. Our experience suggest that, when warranted by individual donor and logistic consideration, expedited placement of organs can significantly enhance donated organ utilization. This not only maximizes the legacy of the donor but also respects their selfless gift by ensuring that each donated organ has the highest chance of successful transplantation.

In our practice, expedited organ placement has proven to be a critical factor in improving organ utilization rates for organs at increased risk of non-utilization. We have observed that addressing uncontrollable time constraints prior to donation, managing cold ischemic time effectively, and optimizing logistical timing enhances the efficiency and success of organs donated being successfully transplanted. We encourage the integration of these aspects into the proposed policy to ensure the best outcomes for donated organs.

We also advocate for the systematic collection and analysis of data across all Organ Procurement Organizations (OPOs) and transplant programs who may take different approaches to expedited placement. So doing will facilitate a deeper understanding of the factors that most significantly impact organ utilization for organ offers that require expedited placement pathways. By gathering comprehensive data, the OPTN can develop informed, data-driven strategies for continuous refinement of a national expedited allocation system.

Recognizing the wide variance in donation service areas, we cannot emphasize enough the need for policies that are adaptable and responsive to the unique challenges faced in different locales. Geographic variance, resource availability, variation of transplant centers acceptance practices, and transportation resources are factors that require tailored strategies. Understanding these diverse challenges is crucial for shaping future policies to optimize the invaluable gift of organ donation.

In light of these considerations, we recommend that future policy development should:

1) Incorporate flexibility to accommodate varying regional needs and challenges.

2) Focus on data collection that reflects the diverse realities of different donor service areas.

3) Prioritize strategies that enhance efficiency in organ allocation, especially in areas with unique logistical challenges, and demonstrate increased organ utilization of organs at risk for non-utilization.

In conclusion, LifeShare firmly believes that the Expedited Placement Variance is a step in the right direction towards optimizing organ utilization and honoring the generous gifts of organ donors. We appreciate the opportunity to provide our input on this significant proposal.

International Society for Heart and Lung Transplantation | 01/17/2024

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Aleksandr Prokofev | 01/11/2024

How is it that a single organ transplant, as a complete and accomplished event A to Z, generates a total cash flow of millions of dollars.
Doctors and nurses received good salaries, Pharmacologists are happy, The recipient remained alive, this is also wonderful. This reflects the value of that unique (histocompatibility) transplanted organ. But why is it free for the donor (his family, most of whom also have children)? What's so shameful about it if the family receives part of this gigantic cash flow, which would have happened with any team of doctors. But not with any donor as the person you need. Do some donors need money during their lifetime? They even made a movie about it, how donors are grown for one Main Recipient.

American Society of Transplantation | 01/11/2024

The American Society of Transplantation (AST) supports the goals of the proposed variance policy changes to facilitate more rapid exploration and implementation of system improvements; however, the proposed open variance for expedited placement (5.4.G) is missing key operational details. The AST offers the following comments in response to this proposal:

The proposal as written fails to provide sufficient justification for the special, shortened public comment period (it is stated explicitly that the proposal does not meet criteria for “Emergency Action” or “Expedited Action”). Although the proposed policy language changes are reasonable, the open variance for expedited placement proposal needs more specificity to ensure that protocols can be implemented safely, transparently, and equitably, meaningful data will be collected to evaluate the protocols, and that concurrent protocols can be operated effectively. The AST recommends that the OPTN update this proposal with additional operational details and extend the comment period through the upcoming winter 2024 regional meeting cycle to allow time for additional community discussion on this important topic.

Although alluded to in the policy proposal, it should be made clear in the variance operational guidelines that the Executive Committee’s role is to review and approve protocols that have been proposed by those with appropriate content expertise within the Expeditious Task Force or OPTN committees. The operational guidelines should also clarify the analysis of results will include committees with appropriate content expertise.

Lastly, the proposed policy language references the “Executive Transplantation Committee” in line 41. It is assumed that line 41 is referring to the OPTN Executive Committee. If this assumption is correct, the AST recommends editing this reference to align with the nomenclature found elsewhere in the OPTN Bylaws and the proposed policy to avoid possible confusion.

Ryan Helmick | 01/10/2024

Overall, expedited placement is one which should be encouraged to better utilize organs. A point of significant concern is that limited specification in the "explicit criteria" that will allow for expedited placement may not account for all scenarios where expedited placement makes sense from a practical sense. For example, if there is a center procuring a liver from a young donor, and they have a recipient become too sick to transplant, it would be unfortunate if the heart and lung teams also had to hold on crossclamp in order to go through re-allocation vs allowing for an expedited placement.

It will be important to ensure OPOs are allotted a degree of freedom and flexibility to expedite placement in unforseen circumstances.

LifeGift | 12/27/2023

LifeGift strongly supports the Task Force, the proposed variance for more rapid organ acceptance and encourages the OPTN to continue using this more iterative and simultaneous performance improvement approach. The project is well thought out and described and concerns for unintended consequences are addressed. We hope more projects like this will follow in subsequent years.

Nancy Marlin | 12/26/2023

After years of requests that the process be expedited, it is gratifying to see that serious discussions - and actions - are being proposed. Keep going!

ConnectLife | 12/26/2023

I am in strong support of evaluation of expedited placement variances. It is very difficult in this environment to provide placement on organs that have been declined in OR, or just prior to OR. While OPO's are being measured on their ability to place organs and questioned when organs are not utilized, the same standards do not seem to be weighed for transplant centers who hold offers for extended periods of time while stating that they are accepting, then declining due to a multitude of reasons just prior to the OR. This leaves coordinators to struggle with expedited placement or have difficult conversations with families requesting additional time to facilitate organ placement when they have already given extended periods of time to allow the gift of life for others. Late declines and extended TXC evaluation times have a large impact on organ non-utilization.

Amanda Bailey | 12/22/2023

I support the OPTN proposal.
Further proposals regarding expedited placement criteria, recipients, and allocation pattern should be very specific and be able to be universally applied to all OPOs. Organ allocation is only fair to the recipients if the match run is used in an expeditious manner without favoritism of one transplant hospital over another. I look forward to reviewing the expedited criteria.

Steven Weitzen | 12/22/2023

I want to start by stating that I am a current member of the Patient Affairs Committee of OPTN (PAC), but I am making this statement in my individual capacity.

I support the Proposal, in general; however, I have a few questions and suggestions.

1. Certain OPTN Policy provisions are proposed to be amended. I would just ask, if not done so already, that counsel for OPTN ensure that all proposed changes would be made within the law, rules and regulations which govern OPTN.
2. As a member of PAC and as a heart transplant recipient, I know, first hand, that patients have insight into the transplant process that is often missed by others – even transplant professionals. I suggest that PAC be intrinsically involved in the variance and protocol process. I did not note any specific reference to patient involvement in the Proposal, and I believe this is a significant weakness in the Proposal.
3. This might seem to be an obvious starting point before the Proposal was initiated, but, since there is no requirement that OPOs or transplant hospitals participate, does OPTN have the reasonable belief that a significant number of OPOs and/or hospitals will participate to the point that the Proposal will have a chance to result in success?
4. We are all aware of the OPTN Modernization Initiative which is in process. Since we are heading toward a time when the Initiative is expected to gain critical mass, has there been thought as to if the Proposal will in any way interfere with the Initiative or vice versa?
5. As to one of the “Considerations for the Community”, I would think it would make sense for OPTN to run limited, multiple, concurrent expedited protocols. I do not have any practical experience with this concept, but it would seem to be the most efficient, as explained in the Proposal.

Craig Pressley, LICSW | 12/21/2023

I am writing to express my strong support for the recent proposal by the OPTN to introduce a new variance for expedited organ placement and to modify the existing variance process. This initiative represents a significant step forward in enhancing the efficiency and effectiveness of the organ donation and transplant system.

The creation of a specific variance to govern pilot projects related to expedited organ placement is a commendable move. It acknowledges the urgent need for innovative solutions in the field of organ transplantation. By granting the OPTN Executive Committee the authority to develop protocols for expedited organ placement, the proposal paves the way for a more flexible and responsive system. This adaptability is crucial for meeting the dynamic demands of organ transplantation and ensuring that organs are utilized to their fullest potential.

The anticipated impact of these changes is profound. By improving the efficiency of the organ donation and transplant system, we can expect an increase in organ utilization and, consequently, a higher transplantation rate. This not only saves more lives but also optimizes the use of available resources.

The concept of a variance, as defined in this proposal, is an effective tool for piloting and studying specific changes in organ allocation. It ensures that all protocols adhere to the stringent requirements of the OPTN, thereby maintaining the highest standards of safety and efficacy. The focus on expedited organ placement is particularly noteworthy as it addresses a critical challenge in the field – the timely allocation of organs that are at risk of not being used for transplant.

In conclusion, I strongly support the proposed changes to the OPTN's governance structure and the introduction of a new variance for expedited organ placement. These changes are not only necessary but vital for the evolution of our organ transplant system. They reflect a commitment to continuous improvement and a responsiveness to the needs of patients awaiting life-saving transplants.

Thank you for considering my support for this crucial initiative.

Sincerely,

Craig Pressley, LICSW