1. Kidney Transplantation Committee Spring 2014

2. 1.Waiting time calculation - pre-registration dialysis time added 2.Candidate classification - Estimated Post Transplant Survival (EPTS) score 3.Kidney donor classification - replace SCD/ECD with Kidney Donor Profile Index (KDPI) 4.Priority for sensitized candidates - calculated panel reactive antibody (CPRA) sliding scale Allocation component changes

3. 5.Blood type eligibility - A 2 and A 2 B to B compatible 6.Pediatric kidney allocation – KDPI priority 7.Kidney payback policy – eliminated 8.Kidney variances – eliminated Allocation component changes

4. Get familiar with the EPTS calculator Begin Now Enter data in fields used to calculate EPTS Late May 2014 Editable data in the system Cross-references to OPTN and CMS dialysis dates Flags for data inconsistency System tools Action: Input and confirm data

5. Review listed candidates for criteria entered Discuss acceptance criteria for local versus import Determine candidates that may benefit from a shipped KDPI>85% organ Begin now Enter KDPI acceptance criteria Assess for KDPI and “other” criteria conflicts Late May 2014 Action: Update donor acceptance criteria

6.  Be mindful that other independent acceptance criteria may conflict with KDPI  Examples: o candidate opts out of DCD but selects KDPI max of 60% = will not see any DCD offers, even from KDPI 50% or less donors o candidate selects max donor age of 55 and KDPI of 60% = will not see offers from 56 y/o donor with KDPI 36% Acceptance criteria

7. Update consent forms - KDPI > 85% instead of ECD Begin now New candidates listed must be consented if willing to accept KDPI>85% Currently listed candidates - Willing to accept ECD? default to 0-100% KDPI Not willing to accept ECD? default to 0-85% KDPI At implementation Sample language for discussing KDPI with patients Patient brochure Tools available Summer 2014 Action: Update consent forms

8.  Prior living donors get 4 points Action: Assess candidates for prior living donation Check candidates for prior organ donation Retain documentation of prior donation Begin now

9. Review unacceptable antigens reported Begin now Enter any unacceptable antigens not previously entered (according to your center’s protocol) Prior to implementation Action: Update unacceptable antigens (UAs)

10. Reports will appear to allow Lab director and transplant physician/surgeon to approve unacceptable antigens for candidates already listed with CPRA greater than 98% Mid–2014 Message and printable form will display when CPRA 99-100% is reached Report listing candidates who require approvals System tools Action: Review and Approve UAs

11. Create a written protocol - maximum titer levels acceptable for blood type B candidates to blood type A2 or A2B donors Begin now Create consent forms for candidates in this category Enter whether candidate meets criteria - yes or no Retain documentation of titer levels Prior to Implementation (December 2014) Obtain consent from patients in this category Confirm eligibility in system every 90 days After implementation Action: Develop written policy for Blood Type B Candidates

12. Implementation Phase IPhase II Data updates begin New reports released Calculators available now New allocation rules applied Variances turned off Payback system turned off Spring/Summer 2014December 2014

13. Recorded webinars, podcasts, toolkits, etc. available on: OPTN web site - http://optn.transplant.hrsa.gov (click ‘Resources’ and ‘Professional Resources’)http://optn.transplant.hrsa.gov Transplant Pro* - http://transplantpro.org (click ‘I am Looking For’ and ‘Kidney Allocation System’)http://transplantpro.org *These are a service of United Network for Organ Sharing and are not produced under the OPTN contract. Subscribe to RSS feeds and a monthly newsletter at http://www.transplantpro.org More information

14. OPTN Kidney Paired Donation (KPD) Histocompatibility Testing Policies Kidney Transplantation Committee Spring 2014

15.  Kidney Committee distributed KPD policies for public comment in March 2012  A number of commenters had concern with histo section due to missing requirements  Professional societies brought together a KPD consensus conference around same time  This proposal incorporates  spring 2012 OPTN public comment feedback  findings from KPD consensus conference  recommendations from OPTN Histo Committee Background

16.  Low match success rate in KPD program  Antibody related issues and positive crossmatches continue to account for a number of match failures  Insufficient histocompatibility testing requirements to prevent match failure The Problem

17.  Increase match success rate in KPD program by preventing unexpected positive crossmatches that can break chains and prevent candidates and donors from accessing subsequent match runs and transplant opportunities  Promote transplant safety through more effective screening of kidney offers Goal of the Proposal

18.  Molecular HLA typing required for donors and candidates  Loci required for donors: HLA-A, B, Bw4, Bw6, C, DR, DR51, DR52, DR53, DPB, DQA, DQB  Loci required for candidates: HLA-A, B, Bw4, Bw6, DR  If candidate has unacceptable antigens, additional loci required: C, DR51, DR52, DR53, DPB, DQA, DQB  Candidate’s hospital must retype donor to confirm HLA type Proposed: HLA Typing

19.  Candidate’s transplant hospital must screen for antibodies at all of the following times:  every 90 days  when potentially sensitizing event occurs  if candidate reactivated after more than 90 inactive days  if unacceptable positive crossmatch occurs that prevents transplant with matched donor  Labs must use method at least as sensitive as crossmatch method  Physician/surgeon (or designee) and lab director (or designee) must review and confirm UA’s listed for candidate Proposed: Antibody Screenings

20.  Candidate’s transplant hospital must perform physical crossmatch before donor’s nephrectomy is scheduled and final crossmatch before surgery  Must report crossmatch results to donor’s transplant hospital and UNOS  If unacceptable positive crossmatch occurs between candidate and matched donor, candidate’s hospital must inactivate candidate before next match run, review the unacceptable antigens (UA), and report reason to UNOS w/in 7 days  Candidate can be reactivated once review and update (if applicable) of UAs is complete Proposed: Crossmatching

21.  Crossmatch-related refusals (positive crossmatch or unacceptable antigens) account for ~30% of failed matches  61 programs had accepted at least one match offer for which the entire exchange fell through  Some programs may have had a disproportionately high number of crossmatch-related refusals  39 programs refused at least one match offer due to a crossmatch-related reason Supporting Evidence

22.  If unacceptable positive crossmatch occurs between candidate and matched donor, candidate’s hospital must inactivate candidate in the KPD program before next match run  If this change is approved, is it less burdensome for transplant programs if the inactivation is automatic (completed by UNOS)? Specific Feedback Request

23.  Is it burdensome to require antibody screenings every 90 days for ALL candidates (even if not sensitized?)  Should longer timeframe between screenings apply for non-sensitized candidates?  180 days? Specific Feedback Request

24.  Donor’s transplant hospital responsible for reporting donor HLA info, arranging shipment of donor blood sample to candidate’s hospital or histo lab  Candidate’s transplant hospital responsible for reporting candidate HLA info, confirming donor HLA info, antibody screening requirements, crossmatching requirements What Members will Need to Do

25.  Richard Formica, MD Committee Chair  Name Region # Representative Email  Gena Boyle Committee Liaison gena.boyle@unos.org Questions?

26. Backup Slides

27. KDPI

28. Point changes: Sensitization CPRA 0 00 0.08 0.21 0.34 0.48 0.81 1.09 1.58 2.46 4.05 6.71 10.82 12.17 17.30 0 2 4 6 8 10 12 14 16 18 20 0102030405060708090100 Points CPRA Sliding Scale (Allocation Points) (CPRA<98%) Current New CPRA

29. Summary: Member responsibilities Communicate importance of early referral Establish protocols for A 2 and A 2 B donors to B candidates Report/update data to calculate EPTS and waiting time Review candidates to identify prior living organ donors Establish KDPI acceptance criteria and update consents for KDPI>85% Review waiting list for unacceptable antigens Review “other” donor screening criteria Educate candidates and potential candidates on changes

30. Q: Will patients in the current system who have begun accruing waiting time based on GFR or CrCl criteria lose the waiting time they have accrued thus far? A: No, these candidates will not lose the waiting time already accrued. FAQ-Waiting Time Eligibility Criteria

31. Q: Does the new KAS also allow credit if the GFR/CrCl criteria was met prior to registration? A: No, this remains unchanged in the new policy. The patient will begin accruing waiting time at or after registration when the GFR or CrCl criteria are met. FAQ-Waiting Time Eligibility Criteria

32. Q: Will programs now have the ability to edit the dialysis start date for the candidates on their list? A: Yes. The dialysis start date (and other waiting time eligibility criteria) is now an editable field on the candidate record in UNet. Programs no longer have to submit a work order to UNOS in order to change it. FAQ-Dialysis Start Date

33. Q: What documentation will UNOS accept as sufficient for the dialysis start date? A: For candidates listed prior to KAS Phase 1 (summer 2014), UNet℠ will display references to CMS data on dialysis start date (if a reliable date was found based on SSN). If the program confirms or updates a dialysis start date that matches the CMS date provided in UNet℠, the program does not need to provide additional documentation. If the program selects a different date or enters one when no reference date is provided, the program will need to provide additional documentation (list of acceptable documents is the same as with current monitoring plan. The list includes 2728 form, H&P, progress notes, etc in the medical record) FAQ-Dialysis Start Date

34. Q: If a candidate currently listed did not consent to accept an ECD offer, but would like to set a max KDPI greater than 85% in the new system, does the program need to obtain informed consent from the candidate? A: Yes. While programs do not need to obtain additional consent from candidates who previously consented to accept an ECD offer, any candidate who has not previously consented and newly added candidate willing to accept offers from kidneys with KDPI greater than 85% needs to provide consent. FAQ-KDPI and Consent

35. Q: Are these signatures required each time the unacceptable antigens change? A: No. Once the approvals have been obtained, the program is not required to obtain any additional documentation or re-enter the names in the system. The system will continue to provide access to greater sharing priority as long as the CPRA is greater than 98% and the approver names have been entered previously. FAQ-CPRA Approvals

36. Q: When making national offers to candidates with CPRA 100%, can OPOs require the transplant program to perform a crossmatch and ensure that it is negative prior to shipping the kidney? A: OPOs can request that the crossmatch be performed prior to shipping the kidney. However, if the transplant program accepts the offer and refuses this condition, the OPO must still ship the kidney to the transplant program. FAQ-Placement Issues for CPRA 100% Candidates

37. Q: What allocation sequence is used if the kidney is shipped nationally and the intended recipient cannot be transplanted? A: Per OPTN policy, the transplant program must release the organ back to the host (originating) OPO. The host OPO may allocate the kidney according to its own match or delegate to the importing OPO. Similarly, the host OPO can backup the organ offer according to its match list prior to shipping the kidney or allow the importing OPO to back up the offer according to its match sequence. The decision lies with the host OPO. FAQ-Placement Issues for CPRA 100% Candidates

38. Q: When will the Committee consider new variances? A: The Committee will need to allow some time to pass after the policy is fully operational in order to establish a baseline from which to assess any new variance. The Committee has decided that no variances will be considered until the policy has been operational for at least one year. FAQ-Variances

39. Q: How will dual kidney allocation work in the new system? A: The same kidneys that were eligible for dual allocation under the current system will be eligible under the new KAS. In both the current and new KAS, programs will not have the ability to differentiate donor criteria between dual v. single offers. Programs should consider this when selecting the maximum KDPI for each candidate. Other FAQs