MEETING SUMMARY Region 7 Meeting February 18, 2016

The UNOS Region 7 meeting was held on February 18, 2016 in Chicago, IL. Dr. Julie Heimbach, Region 7 Councillor, convened the meeting and welcomed those in attendance. There were 50 individuals in attendance representing 77 percent of institutional voting members.

OPTN/UNOS Update Stuart Sweet, MD, PhD, OPTN/UNOS Vice President, provided the OPTN/UNOS Update which included the following information: Re-Balancing Resource Allocation based on the OPTN Strategic Plan o Increase transplants 40% o Provide equity 30% o Improve outcomes 15% o Promote safety 10% o Promote efficiency 5%  2014 committee projects are heavy on promoting safety and efficiency  Projects approved at December 2015 Board meeting have a greater focus on increasing transplants Current Metrics Efforts  MPSC Workgroup o Alternate review paradigm under current flagging criteria for kidneys  Board Workgroup o Consider array of possible changes for all organs, including flagging criteria  COIIN Project o Develop and assess non-outcomes indicators  OPO study o Assess feasibility of better baseline for OPO metric IT releases – June to November 2015 Organ Offer Reports – Centers and OPOs  Review of recent organ offers: enhancement to current ROOT and DSA reports, updated weekly, includes offers from past 120 days, includes organs accepted and those refused by all programs  Located in the new data reports section in UNet Customer Input Channels for IT  Established an IT customer council  Regional meetings, industry conferences, OPO and transplant center visits, conversations with Board members OPTN Finance Update  FY 2015 slightly below budget projections, after years of registrations outpacing budget projections  After 3 straight years of the same registration fee, an increase is likely

Non-Discussion Agenda **Proposals not presented or discussed Adding HLA DQA1 Unacceptable Antigen Equivalences Table (Histocompatibility Committee) This proposal intends to bridge a gap between the science and practice of human leukocyte antigen (HLA) compatibility assessments and the realities of computer programming. Policy approved by the OPTN/UNOS Board of Directors in November 2014 requires HLA typing for HLA-DQA1 for deceased donors to be reported to the OPTN, and requires UNOS to change UNetSM programming to allow transplant programs to report DQA1 as an unacceptable antigen. This proposal adds an HLA DQA1 equivalency table to policy that identifies the relationship between parent antigens and corresponding allelic subtypes. The addition of the table allows UNOS staff to program data entry for DQA1 unacceptable antigens/alleles, removing concerns about patient safety due to human error and incorrect data entry. Region 7 Vote: 22 yes, 0 no, 0 abstentions This proposal was approved during the June 2016 OPTN/UNOS Board of Directors meeting. Effective date: Pending programming and notice to OPTN members

Modifications to the Open Variance for the Recovery and Transplantation of Organs from HIV Positive Donors (Ad Hoc Disease Transmission Advisory Committee) The HIV Organ Policy Equity Act (HOPE Act), enacted on November 21, 2013, allows research to be conducted on the transplantation of organs from donors infected with HIV into individuals who are infected with HIV before receiving such organ. The legislation required the OPTN to revise its policies “not later than 2 years after the enactment” to allow this research to begin. The HOPE Act also states that “not later than 4 years after the date of enactment and annually thereafter, the Secretary shall review the results of scientific research in conjunction with the Organ Procurement and Transplant Network to determine whether the results warrant revision of the standards of quality.”

Though the OPTN policies went into effect on November 21, 2015 creating a variance to permit the research to be conducted, the policy does not explicitly address how the OPTN will work with the Secretary to review the results of the research. UNOS leadership discussed the OPTN’s role in this review, and recommended modifying the variance to require members participating in a HOPE Act research study to provide periodic reports from their data safety monitoring boards to the OPTN. On October 19, 2015, under the authority granted by OPTN Bylaw 11.7: Emergency Actions, the OPTN/UNOS Executive Committee approved this requirement to meet the statutory deadline outlined in the HOPE Act. Bylaw 11:7 requires policies adopted as an emergency action “to be distributed for public comment no more than 6 months after approval.” Region 7 Vote: 22 yes, 0 no, 0 abstentions This proposal was approved during the June 2016 OPTN/UNOS Board of Directors meeting. Effective date: September 1, 2016

List Covered Body Parts Pertaining to Vascularized Composite Allografts (Vascularized Composite Allograft Transplantation Committee) The OPTN Final Rule requires the OPTN to implement policies related to VCAs and shall identify all covered body parts in any policies specific to VCAs Current OPTN bylaws and policies do not consistently specify these covered body parts. This proposal contains a list of covered body parts for OPTN/UNOS Bylaws and Policies in order to meet the requirements of the Final Rule.

The list of covered body parts is not an endorsement of research on a new type of organ transplant by the Department of Health and Human Services or the OPTN. The intent of these modifications is for the OPTN/UNOS Bylaws and Policies to be compliant to federal regulation, to provide transparency in what body parts are VCA transplants, and define the scope of oversight by the OPTN.

This list is intended to be inclusive of VCA transplants that are currently performed, as well as those VCA types that may be performed in the near future. As such, the nomenclature is intended to be broad enough to capture grafts that are anatomically linked and grafts that may fall under the umbrella of a surgical specialty. Specific VCA types that an approved VCA transplant program may choose to register a candidate for are explained in this document. Region 7 Vote: 22 yes, 0 no, 0 abstentions This proposal was approved during the June 2016 OPTN/UNOS Board of Directors meeting. Effective date: Several bylaw changes will be implemented pending programming and notice to members. Other bylaw changes will be implemented on September 1, 2018. Review the June 2016 Board policy notice for additional details: https://optn.transplant.hrsa.gov/governance/policy-notices/.

Discussion Agenda

Kidney Transplantation Committee Kidney Allocation System (KAS) Clarifications & Clean Up The OPTN implemented the revised kidney allocation system (KAS) on December 4, 2014. Since the OPTN/UNOS Board of Directors approved the policy in June 2013, the Kidney Committee and UNOS staff have identified areas in which changes and clarifications are needed in the policy language. This proposal focuses on five areas for changes to kidney allocation policy:  Changing policy on mandatory shares  Clarifying informed consent requirements for multi-organ candidates for kidneys based on KDPI greater than 85%  Maintaining consistency throughout kidney allocation policy with regard to Policy 5.9: Released Organs  Correcting redundant match classifications in Table 8-5: Allocation of Kidneys from Deceased Donors with KDPI Less Than or Equal to 20%  Clerical changes The Committee believes that the changes outlined in this proposal will provide clarification on kidney allocation policy and increase equitable access to very highly sensitized candidates. Other clarifications will improve the overall efficiency of KAS. Region 7 Vote: 0 yes, 22 no, 3 abstentions, separate votes on sections of the proposal with amendments are located below in the comment section Comments: The proposal needs to strike a balance between fairly allocating kidneys according to the match run to the most highly sensitized candidates, and concern over increasing the discard rate due to prolonged allocation time.  OPOs that are routinely using the bypass code may have a higher utilization rate. The region would like to see the data on utilization rate for OPOs with a high use of the bypass code. Mandatory share vote with amendment: 23 yes, 0 no, 0 abstentions  Retain the mandatory share policy only for KDPI> 85 which requires the OPO to make at least 5 offers over 3 hours from cross clamp, and then they can use a local bypass code, as it is currently being used. The region supports eliminating this option for KDPI kidneys <85.  Eliminating this policy will extend the CIT on marginal kidneys and increased the discard rate, since kidney programs accept a very low number (1 year post-KAS implementation, 34 (2%)of the 1,528 transplants going to CPRA 99-100% recipients were with a KDPI>85% kidney) of high KDPI kidneys for 99-100% CPRA patients. Extending more offers to the high CPRA candidates will not make these kidneys more likely to be accepted by high CPRA candidates, and may increase the discard rate.

Informed consent for multi-organ candidates willing to accept offers of >85% KDPI kidneys vote: 9 yes, 12 no, 1 abstention  Data exists for consenting kidney candidates for high KDPI kidneys, not for multi-organ candidates. The community needs to know what the risk is for multi-organ candidates in order to provide true informed consent. Is a high KDPI kidney of similar risk for failure in a multi-organ candidate as a kidney alone recipient, what is the risk to the multi-organ candidate if the primary organ is successful but the kidney is not, and what is the outcome if the multi-organ candidate does not accept this offer and stay on the list?  The region is generally supportive of consenting multi-organ candidates for >85% KDPI kidneys, but not “prior to receiving offers” as stated in the policy. Transplant programs should have the ability to decide when the appropriate time is to consent these candidates. Clerical changes and proposed modifications to policy 5.9: 22 yes, 0 no, 1 abstention Committee Response: The Committee’s considerations on mandatory sharing and the informed consent Requirement are outlined below.

Mandatory Sharing The majority of the regions (7 of 11) supported the proposed changes. Several committees, including the OPO Committee, also expressed support for these changes.

Comment Theme: Increase in Cold Ischemia Time (CIT) and Discard Rate Multiple groups (including those that supported the proposed changes) expressed concern that a prolonged allocation time will increase CIT and the discard rate.

Response: Despite concerns expressed during public comment, subcommittee members reiterated that although there may be many candidates on the match run in these classifications, this may be the only (“once in a lifetime”) offer for a very highly sensitized candidate in these classifications. An OPO could still use other currently available bypass codes to place the kidney in the event that the kidney becomes at risk for discard. In addition to discussing this comment theme, the Subcommittee and Committee also reviewed additional data post-public comment. As shown by the bolded numbers in Table 4, during the 12 months post-KAS implementation:  about 6-7% of match runs included more than 10 registrations for a kidney with a KDPI 0-85%  about 3%-5% of match runs included more than 5 registrations for a kidney with a KDPI greater than 85% Table 4: Kidney Match Runs by Number of Mandatory Share Registrations # mandatory share KDPI KDPI KDPI KDPI (non-local CPRA ≤85% ≤85% >85% >85% 99-100 or 0MM) 1st 6 2nd 6 1st 6 months 2nd 6 months registrations on months months N (%) N (%) match run N (%) N (%) 0 1,458 1,619 342 (61.1) 386 (65.1) (42.2) (45.0) 1 700 (20.3) 710 (19.7) 99 (17.7) 103 (17.4)

2-5 825 (23.9) 829 (23.0) 89 (15.9) 87 (14.7)

6-10 239 (6.9) 227 (6.3) 18 (3.2) 11 (1.9) >10 233 (6.7) 212 (5.9) 12 (2.1) 6 (1.0) All 3,455 3,597 560 (100) 593 (100) (100) (100)

For “easy-to-match” donors, there may be dozens or even hundreds of candidates in the mandatory share classifications on a match run. However, histocompatibility testing requirements, implemented on January 21, 2016, take into account HLA-DQA1 and HLA-DPB1 as unacceptable antigens to automatically avoid those donors if these unacceptable antigens are listed. These measures may further refine the number of candidates that appear in the mandatory share classifications.

Previously, the Subcommittee had reviewed the bypass code usage during the first six months following the implementation of KAS. The Subcommittee compared the bypass code utilization to the second six months of KAS. Although there were fewer candidate registrations bypassed, Table 5 shows that some OPOs, but not all of the 58 OPOs are using this bypass code. This further supports the Committee’s belief that very highly sensitized candidates may not be treated equitably across the country. Table 5: Usage of Bypass Code Refusal Reason 881 – Mandatory Sharing Offer Requirements Met 1st 6 months Post- 2nd 6 months Post- KAS (12/4/2014 – KAS (6/4/2015 – 6/3/2015) 12/3/2015) N of candidate registrations bypassed 902 537 % bypassed with CPRA 99-100 52% 61% % bypassed other 0-ABDR mismatch 48% 39% N of donors 52 49 N of OPOs using bypass code 22 28 Total number of donors with match runs 3,404 3,583 % of donor match runs with bypass code 1.5% 1.4% used Note: Only match runs with final acceptance are included. Due to the overall level of support for the proposed changes, the Subcommittee did not recommend any changes to the proposal. The Committee agreed with the Subcommittee’s recommendation and did not make any changes to this portion of the policy proposal (18 yes, 0 no, 1 abstention). The Committee maintains that KAS was intended to make the system more equitable for highly sensitized patients and not just those patients that are in the first 10 or first 5 on the match run. Committee members also noted that concerns about discard rate and CIT may be better addressed through other projects such as the system optimization project sponsored by the OPO Committee which will look at the organ offer process as a whole. The IT Customer Council (created by UNOS IT comprised of Transplant Coordinators, Surgeons, Lab Directors, etc.) is also considering leading a project to collaborate with the committees and UNOS staff to identify and create more definitive bypass and refusal codes to identify issues that may affect organ placement.

Comment Theme: Changes Will Need to Be Monitored The OPO Committee and ASTS noted that the impact of the proposed changes should be monitored and evaluated.

Response: The proposal’s evaluation plan does not outline additional evaluation outside of the ongoing monitoring for KAS. UNOS already tracks discard rates by KDPI on a monthly basis. If approved by the OPTN/UNOS Board of Directors, the Kidney Committee could request a deeper analysis if there was an increase in discards or CIT post-implementation.

Informed Consent for Multi-Organ Candidates for Kidneys Based on KDPI Greater than 85% OPTN Committees: In general, most of the OPTN committees that commented on the proposal favored obtaining consent as proposed in the public comment document. The Thoracic, Liver, and Patient Affairs Committees supported obtaining informed consent prior to transplant. The Pancreas Transplantation Committee did not believe there should be a requirement due to the rarity of using a high KDPI kidney for a simultaneous pancreas-kidney transplant. The Pancreas Committee also expressed concern that the requirement would put policy in place of medical judgement.

Regions: The regions were split on this clarification with six regions either in favor of the proposed clarification as written or changing the timeframe to prior to transplant. Five of the regions did not believe this informed consent requirement should apply to multi-organ candidates.

Comment Theme: Maintaining Consistency with Kidney-Alone Policy and Consent for Other High-Risk Designations The Membership and Professional Standards Committee (MPSC) and the American Society for Transplant Surgeons (ASTS) supported obtaining consent as proposed to maintain consistency with both kidney-alone policy and other issues that patients need to be informed on (such as potential infections or other high-risk designations).

Comment Theme: Lack of Data on Risks/Outcome for Multi-Organ Candidates The main theme among the regions was that without the data on risks/outcomes for multi-organ candidates, transplant programs cannot inform on the risks. However, the American Society for Transplantation (AST) also noted that without data we do not know that KDPI does not impact outcomes. Response: Subcommittee members noted that it would be difficult to determine the impact of the KDPI score on a SLK recipient that accounts for all factors. However, a subsequent, post- public comment literature review identified two papers that demonstrated poorer renal outcomes in simultaneous liver-kidney recipients with extended criteria donor (ECD) kidneys.1 The Subcommittee reviewed the KDPI distribution among deceased donor kidney transplants in 2015, as shown in Table 6. This data showed multi-organ candidates receive kidneys with a high KDPI, but they are rare. In 2015, 31 of approximately 1,500 multi-organ transplants used a kidney with a KDPI greater than 85%.

Table 6: KDPI Distribution Among Deceased Donor Kidney Transplants in 2015

Because the majority of the responses supported obtaining informed consent, the Subcommittee decided to keep the requirement, but ultimately recommended changing the timeframe for obtaining the consent up until the time of transplant. This decision was largely driven by the idea that a multi-organ candidate’s circumstances may change from the time of registration to the time of transplant. A multi-organ candidate that may not initially consent prior to receiving organ offers for a kidney with a KDPI greater than 85%. However, as the need for a transplant becomes more urgent, the candidate may be willing to accept these kidneys. This change will allow the greatest degree of flexibility for obtaining consent, but it would not prevent transplant programs from creating more stringent standards for their particular program if they chose (i.e. to obtain consent at the time of listing or prior to receiving offers). The Committee reviewed this recommendation and reiterated many of the same concerns expressed during the development of this proposal. Namely that the other organ drives the offer. Several committee members also agreed with the concerns over the limited data to explain adequately the risks to a multi-organ candidate. Conversely, other committee members agreed that there should be consistency with kidney-alone policy. Individual committee members also expressed the following:  While candidates must consent for a higher risk kidney, they do not have to consent for a higher risk liver.

1  Because the other organ drives the offer, the consent may not be explained by a member of the renal community who is familiar with the risks of accepting a high KDPI kidney.  Committee members were concerned that this was pro forma formality rather than a true understanding of the scope of the risks. Ultimately, committee members agreed that the majority of the public comment responses supported obtaining informed consent. While some might find it ideal to obtain consent prior to receiving offers, allowing up until the time of transplant gives programs the most flexibility and is patient-centric. The Committee approved the post-public comment change (17 yes, 0 no, 2 abstentions). This proposal was approved during the June 2016 OPTN/UNOS Board of Directors meeting. Effective date: September 1, 2016, with the exception of Policy 8.5.H (Allocation of Kidneys from Deceased Donors with KDPI Scores less than or equal to 20%) and Policy 8.7.A (Mandatory Sharing), which will be implemented pending programming and notice to OPTN members.

Simultaneous Liver Kidney (SLK) Allocation Current OPTN policy prioritizes candidates seeking a simultaneous liver kidney (SLK) transplant before pediatric and adult transplant candidates who are listed only for a kidney (“kidney alone candidates”) when the liver candidate and the deceased donor are in the same Donation Service Area (DSA). Unlike kidney alone allocation, in SLK allocation, the kidney is not allocated based on medical criteria assessing the kidney function of the candidate. Instead, geographic proximity between the liver-kidney candidate and the donor is the single factor for allocating the kidney with the liver. Organ procurement organizations (OPOs) are not required to allocate the kidney with the liver to a regional SLK candidate, although they have the discretion to do so.

The Kidney Transplantation Committee has identified several problems with this current policy:  The current policy for SLK allocation is counter to requirements in the OPTN Final Rule (“Final Rule”) specifying that organ allocation policies be based on sound medical judgment and standardized criteria.  The lack of medical criteria results in the allocation of high quality kidneys to liver candidates who may regain renal function after liver transplant and decreased access for kidney alone candidates who would otherwise be highly prioritized in deceased donor kidney allocation.  The lack of consistency for regional SLK allocation has been a tremendous concern for the liver transplant community, as deceased donor liver allocation prioritizes candidates with a certain medical urgency status or Model End Stage Liver Disease Score (MELD) score or Pediatric End Stage Liver Disease (PELD) score for regional allocation but regional liver-kidney allocation is not required for these candidates.

This proposal seeks to:  Establish medical eligibility criteria for adult candidates seeking an SLK transplant.  Provide greater clarity for the rules around liver-kidney allocation and fix the inconsistency that exists between deceased donor liver allocation policy and liver-kidney allocation policy.  Establish a “safety net” (new match classification priority on the kidney alone waiting list) for liver recipients with continued dialysis dependency or kidney dysfunction in the first year after liver transplant as an added element to address concerns about limitations associated with the SLK medical eligibility criteria.

This proposal is the result of two consensus conferences and two rounds of public comment and incorporates feedback from the OPTN/UNOS Board of Directors, 11 OPTN regions, several professional transplant societies, patient advocacy groups, and various OPTN/UNOS committees. The proposal is intended to further the OPTN strategic goal to “provide equity in access to transplants” by addressing the objective to “establish clearer rules for allocation of multiple organs to a single candidate, especially liver-kidney candidates.” Region 7 Vote: 7 yes, 12 no, 3 abstentions Comments:  The primary reason for dissent is the region thinks that it should be mandatory for OPOs to share a kidney with a liver regionally for all SLK candidates, and not just candidates with a MELD score ≥ 35.  One member expressed concern that the medical eligibility criteria specify that a transplant nephrologist must confirm a diagnosis, and the focus was on CKD, specifically. CKD is defined as having a GFR less than or equal to 60 for greater than 90 consecutive days. Since this diagnosis is defined by numbers, it eliminates the need for medical judgment, and therefore, no reason that the decision requires a transplant nephrologist. Committee Response: Because the proposal represents over 10 years of work and compromises from groups representing the many different perspectives and received overwhelming support from the OPTN regions in the Spring 2016 public comment cycle, the SLK working group and the Kidney Committee voted unanimously to recommend that the proposal move forward to the Board with no post-public comment changes. However, the Committee did consider and discuss changes based on public comment.

Changes considered but not adopted: SLK medical eligibility criteria The SLK medical eligibility criteria being recommended to the Board of Directors enjoys wide ranging support from the 11 OPTN regions, the AUA, NKF, and the many OPTN/UNOS committees that reviewed and provided comment on the proposal. However, a review of the comments from the American Society of Nephrology (ASN) and ASTS highlight the difficulty the working group faced in achieving wide ranging clinical consensus on these criteria. The ASN suggests that the medical criteria for CKD and sustained acute kidney injury are too liberal, while the ASTS suggests they are too conservative. The ASTS and Region 9 suggested that the Committee consider revising the duration of time (from 6 weeks to 4 weeks) that a liver-kidney candidate must be on dialysis or have continued GFR ≤25 to meet the SLK eligibility standard for sustained acute kidney injury. The ASTS comments reflect that there were differing opinions and practices among their own membership about the appropriate duration. During policy development, the working group and Committee actively debated the duration of dialysis. It was generally, although not universally, felt that 12 weeks was too long. Much of the debate centered around 6 versus 8 weeks. In the end, the Kidney Committee representatives compromised and agreed to 6 weeks because of concerns that candidates for SLK have MELD scores that portend a poor 3 month survival and 6 weeks duration was more favorable to the patient. In the end, the Committee decided on the six week duration as a reasonable compromise, since there were strong voices arguing for both more and less dialysis time prior to SLK eligibility. The Committee discussed that the implementation of the safety net should address concerns expressed about the duration being too strict. There were also comments debating whether the GFR threshold (30 mL/min) for the CKD criteria is too liberal. These comments were received from the American Society of Nephrology (ASN) and an individual commenter. The Committee, along with the working group, has debated this point at length. The Committee believes it has arrived at the medical criteria that is well supported by the transplant community and the best evidence that exists at this time.

Board Amendment: SLK medical eligibility criteria Subsequent to the committee’s April 18, 2016 vote on the proposal, a Board member requested a draft amendment to be considered by the Board at the June meeting. The amendment would change the GFR threshold criteria for the CKD category from 30 mL/min to 20 mL/min in order to make SLK eligibility criteria for CKD consistent with the criteria used to assign waiting time points in kidney alone allocation. The leadership of the Kidney and Liver Committees discussed the amendment and are requesting that the Board not adopt the amendment. The Kidney Committee’s regional representatives raised this specific question for feedback at the regional meetings. The feedback was overwhelmingly against lowering the GFR threshold for this category. The change would significantly restrict candidate eligibility and the Committee is concerned that making such a change without the consensus of the transplant community will jeopardize the trust that the working group and Committee have gained in the development of this proposal. Changes considered but not adopted: SLK allocation The proposed new SLK allocation rules were also widely supported by the OPTN regions, the AUA, NKF, and other OPTN/UNOS committees (including the OPO and Liver and Intestinal Organ Committees). However, the ASTS and Region 7 expressed concerns about whether the expanded requirements for regional liver-kidney allocation go far enough. The ASTS suggested that the OPO should be required to allocate the kidney with the liver to regional candidates with MELD at least 30. Region 7 (the only region to vote to oppose the proposal) offered that the OPO should be required to share the kidney with the liver to all regional candidates, regardless of MELD. The working group and the Committee discussed these comments and agreed that it is not appropriate to make either of these changes for the below reasons:  The proposal is designed to align the new liver-kidney allocation policy with the current liver alone allocation policy. The current liver-kidney allocation policy does not require sharing beyond the local DSA, although the current liver alone allocation policy mandates regional liver sharing for candidates with MELD score of at least 35. Making this rule consistent also decreases complexity in implementing any new rules by ensuring that liver-kidney offers will still be made using the liver match run and a consistent allocation scheme.  Using the addition of MELD score for regional liver-kidney sharing acknowledges that there must be a balance in access for liver-kidney and kidney alone candidates and that kidney alone candidates face a large supply/demand mismatch for organs and additional time on dialysis results in worse outcomes. Changes considered but not adopted: Safety net for liver recipients The safety net element of this proposal enjoys the most support and consensus of any other element of the proposal. However, there was feedback concerning the placement of safety net priority among the deceased donor kidney allocation sequences. This is also an area where the Committee has received conflicting feedback throughout the public comment cycles. Some commenters have suggested that there should be no additional priority for liver recipients in sequence B (the allocation sequence when the donor’s KDPI score is 20-34%), even though local adult liver recipients would only be prioritized within this sequence after the highly sensitized and local pediatric candidates. Others (notably the ASTS and Region 9) expressed concern that there is no additional safety net priority in sequence A of kidney allocation. The working group and the Kidney Committee discussed this concern and decided against recommending additional priority in sequence A for the following reasons:  While liver recipients will not receive additional safety net priority for kidneys in sequence A, they are not excluded from receiving these offers altogether. For instance, a liver recipient who is highly sensitized would still appear in the highly sensitized match classification in sequence A. A liver recipient with an EPTS in the top 20% would still appear in this classification within the sequence. And, liver recipients in the OPO’s DSA will still appear in the “all local adults” match classification in sequence A.  The main goal of sequence A is to provide more life years from kidney transplantation. In previous public comment periods, the regions and other commenters have expressed concern that the new safety net classification may act as a disincentive for a liver recipient to find a living kidney donor. The Committee contends that sequence A kidneys perform similar to living donor kidneys, and exempting a special classification for liver recipients in this sequence may provide incentives for liver recipients to seek a living kidney donor. This proposal was approved during the June 2016 OPTN/UNOS Board of Directors meeting. Effective date: Pending programming and notice to OPTN members

Thoracic Organ Transplantation Committee Proposal to Modify the Adult Heart Allocation System The Thoracic Organ Transplantation Committee (the Committee) proposes modifications to the adult heart allocation system to better stratify the most medically urgent heart transplant candidates, reflect the increased use of mechanical circulatory support devices (MCSD) and prevalence of device complications, and address geographic disparities in access to donors among heart transplant candidates. Though changes to the adult heart allocation system implemented in 2006 were successful, candidates with disparate waiting list mortalities are currently grouped together in the most urgent classification, Status 1A, causing waiting time to be the primary factor in stratifying candidates. Additionally, the current geographic sharing scheme creates potential inequities in access to transplant for the most urgent candidates.

The Committee proposes two significant changes to the adult heart allocation system: 1) Develop additional urgency stratifications based on relative waiting list mortality rates for all adult heart candidates 2) Modify the geographic sharing scheme to provide the most medically urgent candidates access to donors from a broader geographic area

The Committee’s proposal is largely supported by modeling analysis performed by the Scientific Registry of Transplant Recipients (SRTR). The proposed changes are expected to achieve lower waiting list morality rates overall and higher transplant rates for the most medically urgent candidates without increasing post-transplant mortality rates overall or increasing waiting list mortality rates for candidates in lower urgency statuses. Region 7 Vote: 21 yes, 2 no, 2 abstentions Comments: The committee was asked to consider looking at LVAD candidates with complications and infections differently rather than lumping all LVAD candidates not using 30 day time into Status 4. The concern is that the committee has not appropriately differentiated risk and urgency for these patients in the modified proposal. There was concern expressed about possibly "gaming the system”. The fact that any candidate with a cardiac index <2.2 and the presence of a balloon is granted status 2 was an example brought forward. Also since there are differences between the patient on ECMO or with a femoral IABP compared to a patient with a subclavian balloon pump who may be ambulatory (partially a device subcategory issue and partially a possible “manipulation" for urgency issue).

Did the thoracic committee consider the intravenous inotropes candidates versus the non- intravenous supported in the wait list mortality scoring?

The slide set presented at the regional meeting indicates that pediatric candidates will not be affected by this proposal, but the modeling shows possible increased mortality.

The modeling performed for the current version of the proposal does not reflect the pediatric heart allocation changes that will be implemented in March. This needs to be carefully monitored once enough data is available to determine if the proposed changes will negatively affect pediatric candidates.

VAD MCS candidates are sometimes transplanted at adult centers and these candidates are not being addressed in this proposal.

An OPO representative asked about the possible impact on the actual allocation process. Could it possibly negatively affect the utilization rate of hearts (increased allocation time which may lead a donor family to say no, damaging the OPO’s relationship with the hospital staff)? This proposal was not presented at the June Board Meeting. A modified version takes into account the public comments received has been submitted for public comment in August 2016.

Liver and Intestinal Organ Transplantation Committee National Liver Review Board Currently there is not a national system that provides equitable access to transplant for liver candidates whose calculated MELD or PELD score does not accurately reflect the severity of their disease. Each OPTN region has its own review board that evaluates exception requests submitted by the liver transplant programs in its region. Most regions have adopted independent criteria used to request and approve exception requests, commonly referred to as “regional agreements.” Some have theorized that regional agreements may contribute to regional differences in exception submission and award practices, even among regions with similar organ availability. The current system also has some inefficiencies which can lead to delays in candidates being awarded exception points. In November 2013, the OPTN/UNOS Board of Directors (Board) charged the Liver and Intestinal Organ Transplantation Committee (the Committee) with developing a conceptual plan and timeline for the implementation of a national liver review board.

Through policy and revised operational guidelines, this proposal establishes a national structure for review of MELD and PELD exception cases in which all liver transplant programs have an equal opportunity for representation. The National Liver Review Board (NLRB) seeks to mitigate regional differences in award practices by establishing new voting procedures and giving the Committee the ability to develop national guidance for assessing common requests. This proposal improves the efficiency of the review board system by reducing the workload for reviewers and eliminating unnecessary delays in awarding exception points when appropriate. Region 7 Vote: 18 yes, 4 no, 2 abstentions Comments: The region supports the concept of a NLRB. There is concern that a national review board will not have a regional perspective and won’t be aware of region specific issues and disease. The number of exceptions differs by region and these cases will be reviewed by a national group. Currently through an appeal, a program in the region can appeal to the RRB and talk via conference call with the representatives in the region to make their case, and this process can work in the candidates favor since the local practitioners have a rapport with one another and can “find a way to get the patient transplanted” by awarding a score that will allow that to happen. Another comment was raised that this proposal is about uniformity, not equity. This proposal was not presented at the June Board Meeting. Guidance for adult MELD exception review was submitted for public comment in August 2016, and a third proposal will be submitted for public comment in January with revised exception scores. Depending upon public comment feedback, the three proposals will be submitted to the Board during the June 2017 meeting.

Ad Hoc Disease Transmission Advisory Committee Improving Post-Transplant Communication of New Donor Information Communication delays or failures regarding new donor information learned post-transplant have led to transplant recipient morbidity and mortality. A statistically significant association between having a proven or probable donor-derived transmission event and the presence or absence of a communication gap has been documented in a recent 2015 published article.

The Ad Hoc Disease Transmission Advisory Committee has been reviewing cases of potential donor-derived transmission events since 2006 to learn and share the science behind these transmissions and recommend processes to prevent unnecessary transmissions.

Policy implemented in 2011 implemented reporting guidelines and established patient safety contacts. Reporting behaviors since that implementation have demonstrated increased reporting, yet wide variation in practices. Data analyzed suggest that some of these reporting behaviors have not led to overall system improvements.

Current policy does require OPOs to report results received post-transplant. OPO interpretations of what must be reported to transplant hospital patient safety contacts and the OPTN varies greatly. An unintended consequence has been a shift away from recipient disease to wide variations and, in some areas, over-reporting of results with little benefit to the system goal. Over-reporting and under-reporting may also lead to reporting fatigue thus taking away from the critical and important intent of the system. Communication delays or failures can also occur in this process with negative consequences for patients.

This proposal adds clarity and specifics to reporting policy. Specifying what conditions are to be reported and how they are to be reported should add more reliability and consistency to the process. This proposed policy will aim to reduce unnecessary reporting to both the OPTN and transplant hospital patient safety contacts. By triaging reporting requirements, fatigue from over- reporting can be reduced and help focus time and energy on reporting and following relevant and critical results. Region 7 Vote: 19 yes, 0 no, 1 abstention Comments: The region approved the proposal and made the following comments:  Sputum cultures: the region would like for the committee to review data to determine if reporting gram negative results in the sputum to all organ specific programs is important and necessary for recipient care.  There is concern that sometimes the staff member at the OPO making the decision about what to report does not have a clinical background and this was not addressed in the proposal.  Toxoplasmosis testing: concerns was raised over fact that there is no FDA approved test available for organ donors at present, unknown amount of time, availability, and expense for this testing to be completed, OPOs and other region members need more information regarding implications of toxoplasmosis testing before committing to providing it. Committee Response: This proposal was well received and supported within the transplant community.

All eleven regions approved the proposal. Every region unanimously voted in favor except in region 2 where there was only one “no” vote. The Kidney, Living Donor, Membership and Professional Standards, OPO, Operations and Safety, Thoracic, Transplant Administrators, Transplant Coordinators, and Vascularized Composite Allograft (VCA) Committees all expressed support for the proposal. In addition, the American Society of Transplantation (AST), American Society for Transplant Surgeons (ASTS), American Society for Histocompatibility and Immunogenetics (ASHI), and NATCO all commented in support of the proposal. AOPO did not formally comment but has been a collaborator in the development of the proposal.

Several themes that emerged during public comment and the DTAC made several post-public comment changes in response to comments. 1. Toxoplasmosis testing for all deceased donors The DTAC sought specific public comment regarding toxoplasmosis testing on all deceased donors due to recent data showing morbidity and mortality in non-cardiac transplant recipients from this disease. The transplant community overall supported toxoplasmosis testing for all deceased donors. The DTAC has changed this proposal to require toxoplasmosis testing for all deceased donors.

Several commenters asked about testing when no specific tests have been approved, licensed, or cleared by the US Food and Drug Administration (FDA) specifically for donor screening. The FDA was consulted and responded that they had no concerns with this requirement. They provided a list of cleared FDA tests that can be used.

Some members in one region expressed concern about the cost of testing and another region commented that it might add roughly $25,000 per year but that the cost could be absorbed. Multiple OPOs also indicated that they were already conducting toxoplasmosis testing in all donors.

The ASTS, ASHI, International Society for Heart and Lung Transplantation (ISHLT), and NATCO all supported routine toxoplasmosis testing. The AST requested more evidence to expand toxoplasmosis testing beyond donors involving heart allocation. The DTAC has an abstract being presented at the upcoming 2016 American Transplant Congress on a retrospective review of proven and probable toxoplasmosis reports from January 2008 through September 2015. The data show proven or probable transmissions in 11 recipients. Nearly half (45%) were in non-heart recipients (heart recipients = 6; non-heart recipients = 5). Five of the 11 recipients died. To exclude non-cardiac cases would miss an opportunity to prevent morbidity and mortality.

The MPSC, OPO, Operations and Safety, Thoracic, and VCA committees all expressed support for toxoplasmosis testing in all deceased donors. Several commenters explained that the current system for either testing or sending a tube of blood to the transplant hospital for testing was problematic due to lost tubes, laboratories not accepting the specimens, and gaps in communicating results to all transplant hospitals.

2. VCA specific requirements The DTAC sought specific feedback on the need for VCA specific requirements. In response to comments from the VCA Committee and the AST, the DTAC and VCA Committees will be forming a work group to explore specific testing and reporting needs regarding VCA donors.

The proposal was amended to require 24 hour reporting of positive results for genitourinary cultures, respiratory samples (bacterial or Candida species) to transplant programs receiving lungs or head and neck VCAs, and urine cultures (bacterial or Candida species) to transplant programs receiving kidneys or genitourinary VCAs.

3. Specific requirements for reporting positive results In response to comments to concerns of potential over reporting regarding negative histopathology results, the DTAC amended this requirement to include only relevant findings.

In response to concern for including positive tissue cultures and the possibility of confusion with tissue recovery, the DTAC amended the language to exclude a specific statement on positive tissue cultures as the organ transplantation needs are actually covered in the requirement to report positive serologic, NAT, or antigen results indicating presence of parasites, virus, or fungi.

The DTAC also clarified language regarding reporting of bacterial, mycobacterial, and fungal results including requirements for reporting Candida species. This proposal was approved during the June 2016 OPTN/UNOS Board of Directors meeting. Effective date: September 1, 2016, except changes to policies 2.9 (required deceased donor infectious disease testing) and 2.11.C (required information for deceased heart donors). Review the June 2016 Board policy notice for additional details: https://optn.transplant.hrsa.gov/governance/policy-notices/.

Operations and Safety Committee Standardize an Organ Coding System for Tracking of Organs: Requirements for OPO TransNet Use The Operations and Safety Committee is proposing a requirement for organ procurement organizations (OPOs) to use TransNetsm for deceased donor organ labeling and packaging. The proposal also requires OPOs to transmit case data to the OPTN to allow for web-based tracking while organs are in transit.

TransNet, a service of the OPTN, is a new system that uses barcode scanning technology at the point of organ recovery to help label, package, and track organs and other biologic materials being shipped for transplantation.

TransNet involves using an application developed for either Android or iOS tablets and a portable barcode printer that interacts with DonorNet® to supplement the current UNOS labeling system. During organ recovery, OPO procurement coordinators will use the system in the operating room to print on-demand labels and scan information on all organs and materials to be transported. Currently, 35 out of 58 OPOs have been trained to use TransNet on a voluntary basis. This proposal will make use of the system a requirement for all OPOs.

This effort started in 2012 as a Health Resources and Services Administration (HRSA) project awarded funding through the U.S. Health and Human Services (HHS) Innovations program. It was one of four HHS programs intended to drive innovation in the government and healthcare. The project goals were to reduce incorrect transplantation, minimize transport errors, accelerate organ information transfer, and capture organ procurement/transport data.

Requiring OPOs to use TransNet will reduce packaging and labeling errors. Packaging and labeling organs were done in the past entirely by hand, partially by hand, or by using pre-printed labels. Automating the process with TransNet will greatly reduce transcription errors and mistakes due to illegible handwriting. It will allow for one time data entry of donor information and a consistent validation process across all OPOs. Peer-reviewed literature has shown that this type of system eliminates transcription errors. TransNet will also accelerate information transfer and improve real-time communication regarding organ package contents and location thus enabling transplant hospitals to prepare for impending organ transplants more efficiently.

This proposal primarily supports OPTN/UNOS Strategic Goal 4: Promote living donor and transplant recipient safety by reducing labeling, packaging, and communication errors that can result in wrong recipient, wrong patient transplant, or organ wastage. Region 7 Vote: 18 yes, 0 no, 0 abstentions Comments: A question was asked about OPOs that package living donor organs (usually for a KPD exchange) for transplant hospitals. Since living donor recovery hospitals are not required to use TransNet, presumably OPOs will not be required to use TransNet when packaging living donor organs. Committee Response: Several major themes arose in public comment with several post-public comment changes that clarified use. Some additional non-substantive style, consistency, and clarity edits were also made. 1. Overall support for the proposal The proposal was well received in public comment. All regions unanimously supported the proposal except Region 5. Region 5 passed the proposal but had two “no” votes.

American Society of Transplantation (AST), American Society of Transplant Surgeons (ASTS), American Society for Histocompatibility and Immunogenetics (ASHI), and NATCO all support the proposal. AOPO sent in a letter of support after the end of public comment.

The OPO Committee supports the proposal.

Two individual OPOs also made comments of support.

2. Request to extend TransNet usage to transplant hospitals Eight comments were made urging the development and use of TransNet by transplant hospitals in order to gain the full benefits of the system. ASTS requested “a timeline for the development and implementation of the “complete” electronic tracking system that will facilitate tracking from donor to recipient (and not just a simple inventory system)”.

The OSC wholeheartedly agrees and is committed to working on this next step.

Region 6, AST and ASTS requested that this development include performing required verifications (e.g. ABO) using TransNet.

The OSC wholeheartedly agrees and is committed to working on this next step.

3. Request to clarify TransNet usage in specific situations The Living Donor Committee requested that functionality be developed for use with living donor organs. Requirements gathering has started for living donor organs.

It was requested that clarification be made on whether OPOs who package living donor organs on behalf of living donor recovery hospitals would be required to use TransNet in this situation. Because functionality does not currently exist for use with living donor organs, a post-public comment clarification was made to the policy proposal that exempts mandatory use for living donor organs. As this functionality is developed, OPOs and living donor recovery hospitals will be able to test TransNet without violating the proposed policy language.

It was also requested that language be clarified regarding the repackaging of organs and TransNet use. The Committee also developed post-public comment exclusionary language for the repackaging of organs as this function may be performed by transplant hospitals. Currently the functionality for transplant hospitals to repackage organs using TransNet does not exist.

The Committee also considered special situations such as third-party organizations that may perform organ perfusion such as ex-vivo lung perfusion. Current OPTN policy does not specifically address these types of organizations in general and therefore specific policy regarding TransNet usage for these groups is not proposed. If a third-party organization were to perfuse on behalf of an OPO, it would be required to use TransNet by delegation of responsibility. If a third party organization were to perfuse on behalf of a transplant hospital, then use of TransNet would not be required at this time due to the repackaging exemption.

This proposal was approved during the June 2016 OPTN/UNOS Board of Directors meeting. Effective date: June 1, 2017