1. Improving Dual Kidney Allocation
Kidney Transplantation Committee
As you may recall, the Committee circulated a concept paper in the spring 2017 public comment cycle asking for feedback on three different policy solutions developed by the Dual Kidney Work Group. This proposal contains the policy that received the most support from the community during the last cycle.

2. What problem will the proposal solve?
Discard rates for high KDPI kidneys is at or above 50%
Policy 8.6: Dual Kidney Allocation needs to be updated to promote efficient placement
As many of you know, discard rates for high KDPI kidneys is at or above 50%. However, the graft survival advantage of dual kidney transplantation, in which both kidneys from an older or otherwise non-ideal donor are transplanted into the same patient have been widely published.
Members have also indicated current dual kidney allocation policy is ambiguous, needs to be updated, and does not allow OPOs to identify and allocate kidneys suitable for dual transplantation in a timely manner. Specifically, current policy 8.6: Dual Kidney Allocation, implemented over 2 decades ago, does not give OPOs direction on how and when to allocate dual kidneys. 
By revising the policy, the Kidney Committee sees this project as one step to addressing the problem of the increased numbers of discarded high KDPI kidneys post-KAS.

3. What are the proposed solutions?
Sequence C
KDPI 35-84%
Sequence D
KDPI > 85%
Highly Sensitized
0-ABDRmm
Prior living donor
Local SLK safety net
Local
Regional
National
Local (Dual Opt-In)
Regional (Dual Opt-In)
National (Dual Opt-In)
Local + Regional
Sequences C & D include single and dual opt-in allocation
Combined Local + Regional classification removed
This solution relies on donor KDPI to allocate dual kidneys. The Committee felt that KDPI is an appropriate measure to use on its own since it incorporates multiple donor factors, encompasses most of the criteria in current double kidney allocation policy, and is how organs are currently classified for allocation.
In this proposal, the allocation sequences for kidneys with KDPIs 35% and above have been amended to include single and dual allocation, and the combined Local + Regional classification has been removed. These amendments should ensure that the kidneys at increased risk for discard are offered earlier to the nearest center that will use them. This policy provides OPOs with concrete direction on how to allocate high KDPI kidneys, allowing them to make offers much more quickly, and allows a transplant program to list a candidate to receive offers for both single and dual kidneys on the same match run.

4. Supporting Evidence: Donors KDPI >85% with at least One Match Acceptance of En Bloc or Dual Kidneys,
98.6% transplanted at accepting center
4.8% (31) pairs were split, and 5 of 31 left the accepting center
1.4% (9 of 645) at least one kidney transplanted at different center
(N=645)
As described in the public comment proposal, the Dual Allocation project also includes the provision that allows surgeons to split dual kidneys should they be deemed suitable for single transplant, based on medical judgment. Since I went into detail about the released organs provision during the en bloc portion of this presentation, I won’t repeat it here, but the Committee did want to share data about splitting high KDPI dual kidney pairs. Similar to en bloc, it is rare that split duals leave their accepting transplant center and with this allocation sequence we expect it to become even more rare.
OPTN data show that, for donors with a KDPI 85% and above, only 1.4% had at least one kidney leave the original accepting center for transplant elsewhere in the last six years. Coupled with implementation of this amended allocation sequence, the Committee anticipates that this scenario will become even more rare as the original match run will clearly indicate the nearest single recipient.
Ultimately, the Committee found that alignment with current OPTN Policy 5.9 is the most transparent and patient-centered method to managing released kidneys, even if rare. The Committee feels that every effort should be made to follow the OPTN’s established allocation sequences.
NOTES ON COLD ISCHEMIA: None of the transplanted kidneys from the 9 donors who had at least 1 kidney transplanted outside the accepting center left the accepting candidate’s DSA. For split kidneys, the mean CIT for the first kidney was 25 hours, and the second was 30 hours, for a difference of 5 hours for split units.

5. How will members implement this proposal?
Transplant Programs
Must report to UNOS that they are willing to accept dual kidneys to receive dual offers
Must document the reason for not transplanting the kidneys as duals if the surgeon splits the kidneys
OPOs
Allocate dual kidneys from donors according to the match run
This proposal impacts transplant centers and OPOs.
Transplant centers:
This proposal requires transplant centers to report to UNOS that they are willing to accept dual kidneys if they want to receive offers for those organs. This proposal will allow transplant centers to manage acceptance of dual kidneys at the candidate or center level using listing defaults. This option should mitigate administrative burden and help ensure that only those candidates and centers willing to consider accepting a dual kidney offer appear on the match run.
Current practice of charging one acquisition fee for dual kidneys is not expected to change in light of this proposal.
OPOs
OPOs will allocate kidneys from donors to those centers indicating they will transplant as duals.
If a surgeon opts to split dual kidneys, the OPO may be asked to allocate a single kidney.

6. How will the OPTN implement this proposal?
Dec. 2017
Board of Directors
Requires programming in UNetSM IT
Policy notices, system notices
Communications
Requires an education program
Education
Reviewed at 6 months, 1 year, and 2 years
Evaluation
Monitoring will not change
Compliance monitoring
This proposal will require programming in UNet. Changes are required in both WaitList and DonorNet.
The OPTN will follow established protocols inform members and educate them on any policy changes through Policy and Systems Notices posted on the OPTN website and Transplant Pro.
This proposal will require an instructional program and will be monitored for specific needs throughout implementation to determine the appropriate modality for educating members.
Any data entered in UNet may be subject to OPTN review. Members are required to provide documentation as requested. UNOS will continue to review deceased donor match runs that result in a transplanted organ to ensure that allocation was carried out according to OPTN requirements.

7. Questions? Nicole Turgeon, MD Kidney Committee Chair nturgeo@emory.edu
Chelsea Rock Haynes, MPA
Kidney Committee Liaison
I’m happy to take any final questions you have on the Dual Kidney proposal. You’re also welcome to reach out to our Committee Chair or our Liaison from UNOS. Thank you.

8. Extra Dual/En Bloc Slides

9. What does it mean to “release” per 5.9?
Releasing organs is current practice. The risk of accepting an organ that can’t be transplanted into the originally intended recipient is always present. 
In these scenarios, the organ is “released” to the OPO to determine whether and how the organ can be reallocated. It rarely means physically shipping it back to the host OPO.
If implemented, new functionality in DonorNet will streamline this process for en bloc kidneys.
OPTN Policy 5.9 states programs must:
“…Release the…organs back to and notify the host OPO…for further distribution. The host OPO must then allocate the organ to other candidates...”
It is important to note that this proposal does not require any changes to current practice regarding Policy 5.9. As with any allocation, the risk of accepting an organ that can’t be transplanted into the originally intended recipient is always present.  Per Policy 5.9 those organs must be released back to the OPO for reallocation.  Reallocation typically follows the original match run for local offers and requires a back-up run for import offers.  The same practice will apply for en bloc allocation.
As I mentioned earlier, the Committee is also recommending adding IT functionality in DonorNet such that all en bloc match runs automatically include both en bloc and single allocation – one after the other – so a match run generated by KDPI for single kidneys is ready should the surgeon decide to split the pair.
IF ASKED:
Q: What if the en blocs are imported to another DSA? The original match run will no longer apply since it was run for the originating OPO.
A: The host OPO must first grant local backup. If granted, the importing OPO will need to run a local backup match run, which is standard practice for most OPO’s. Should the surgeon decide to split after the import has taken place, the local backup match run would have already been generated.

10. Policy 5.9 Released Organs
The transplant surgeon or physician responsible for the care of a candidate will make the final decision whether to transplant the organ.
The transplant program must transplant all accepted, deceased donor organs into the originally designated recipient or release the deceased donor organs back to and notify the host OPO or the OPTN Contractor for further distribution. If a transplant program released an organ, it must explain to the OPTN Contractor the reason for refusing the organ for that candidate. The host OPO must then allocate the organ to other candidates according to the organ-specific policies. The host OPO may delegate this responsibility to the OPTN Contractor or to the OPO serving the candidate transplant program’s DSA.
If deceased donor organs cannot be transplanted into the originally intended recipient, Policy 5.9: Released Organs requires the transplant program to release the organs back to the host OPO and notify the host OPO or the OPTN Contractor for further allocation. The host OPO must allocate the organ to other candidates according to the organ-specific policies (i.e., according to a match run), or can opt to let the OPTN Contractor or the OPO serving the candidate transplant program’s designated service area (i.e. the “importing OPO”) allocate the organ instead. This policy applies to all organ allocation
Reallocation of the kidney to other candidates would still be according to the kidney allocation policies whether it was allocated by the host OPO, the importing OPO, or the Organ Center.

11. Deceased Donor Kidney Transplants 12/4/2014-11/30/2016 by OPTN Region and Kidney Transplant Type
Kidney Procedure Type
Total
LEFT KIDNEY
RIGHT KIDNEY
EN-BLOC
Sequential Kidney N %
OPTN Region
459
50.44
446
49.01 5
0.55
910
100.00 1 2
1585
48.77
1611
49.57 41
1.26 13
0.40
3250 3
1683
47.09
1798
50.31 83
2.32 10
0.28
3574 4
1161
46.59
1261
50.60 57
2.29
0.52
2492
2130
47.36
2235
49.70 95
2.11 37
0.82
4497 6
48.32
463
50.16 14
1.52
923 7
873
48.31
905
50.08 21
1.16 8
0.44
1807
783
49.28
767
48.27 35
2.20
0.25
1589 9
797
46.39
870
50.64
1.22 30
1.75
1718
899
46.77
983
51.14 33
1.72
0.36
1922 11
1250
47.26
1353
51.15
1.32
0.26
2645
12066
47.64
12692
50.11
440
1.74
129
0.51
25327
Sequential = Dual Kidneys

12. KDPI and risk adjustment
The PSRs currently include “procedure type” as a factor:
Left kidney
Right kidney
Double kidney
En bloc kidney
There is no extra risk (or reduction of risk) associated with procedure type
The risk-adjustment model will not harm or reward programs for completing en bloc transplants
For questions surrounding center PSRs (primarily in Region 3)
The Committee did not receive many comments regarding their proposal to mask the KDPI score in DonorNet to mitigate the artificially high KDPI scores of en bloc kidneys. A single commenter felt omitting the KDPI takes away predictive information from coordinators and surgeons to consider when evaluating offers, but others from that region agreed that masking the KDPI is an appropriate compromise, as en bloc KDPI scores are too skewed to serve as a meaningful data point. There were two commenters that suggested a risk adjustment for en bloc kidney transplants in the same way that high KDPI kidney transplants will be excluded from outcomes monitoring.
Committee leadership discussed this feedback with SRTR. SRTR advised that in their PSRs, the KDPI equation is used exactly how it is programmed in UNet to estimate the risk of graft failure, i.e. without the en bloc coefficient. Currently, small donor en bloc kidneys reflect a relatively high KDPI score. The higher the KDPI of an organ, the higher its estimated risk of graft failure. However, this may not be an accurate reflection of the true risk for en bloc transplants. Furthermore, the PSRs include “procedure type” as a factor: for example, left kidney, right kidney, double kidney, or en bloc kidney. In the 1-year deceased donor graft survival models as of April 2017, there is no extra risk (or reduction of risk) associated with procedure type, aside from a very small protective effect for using the left kidney. The risk-adjustment model (i.e., outcomes calculations) will not harm or reward programs for completing en bloc transplants because both KDRI and en bloc are included in the model and can capture the potential effect of en bloc on one-year post-transplant outcomes. Committee leadership were satisfied with this explanation and did not have any concerns.