MEETING SUMMARY

Region 6 Meeting

February 19, 2016

The UNOS Region 6 meeting was held on February 19, 2016 in Spokane, WA. Dr. Viken Douzdjian, Region 6 Councillor, convened the meeting and welcomed those in attendance. There were 40 individuals in attendance representing 93 percent of institutional voting members.

OPTN/UNOS Update

Dr. David Klassen, UNOS Chief Medical Officer, provided the OPTN/UNOS Update which included the following information:

Re-Balancing Resource Allocation based on the OPTN Strategic Plan

  • Increase transplants 40%
  • Provide equity 30%
  • Improve outcomes 15%
  • Promote safety 10%
  • 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
  • Alternate review paradigm under current flagging criteria for kidneys
  • Board Workgroup
  • Consider array of possible changes for all organs, including flagging criteria
  • COIIN Project
  • Develop and assess non-outcomes indicators
  • OPO study
  • 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 6 Vote: 47 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 6 Vote: 47 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 6 Vote: 47 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: .

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 6 Votes and Comments:

The region separated the portion of the proposal modifying Policy 8.7.A Mandatory Sharing from the other clarifications.

  • Mandatory share changes were not supported: 2 yes, 41 no, 7 abstentions
  • The OPOs agreed that using “other” bypass codes when there is a need for expedited placement raises red flags.Some were concerned that this modification could result in more discards.
  • Informed consent for KDPI >85%, Released Organs, and corrections for match classification labels/other clarifications:32 yes, 0 no, 1 abstention
  • Group supported informed consent prior to organ offer

Committee Response:

This proposal received comments primarily on the proposed changes to mandatory sharing and the

informed consent requirement for multi-organ candidates for kidneys based on KDPI greater than 85%.

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 (non-local CPRA 99-100 or 0MM) registrations on match run / KDPI ≤85%
1st 6 months
N (%) / KDPI ≤85%
2nd 6 months
N (%) / KDPI
>85%
1st 6 months
N (%) / KDPI
>85%
2nd 6 months
N (%)
0 / 1,458 (42.2) / 1,619 (45.0) / 342 (61.1) / 386 (65.1)
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 (100) / 3,597 (100) / 560 (100) / 593 (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-KAS (12/4/2014 – 6/3/2015) / 2nd 6 months Post-KAS (6/4/2015 – 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 used / 1.5% / 1.4%

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.
  • 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.