Kidney Transplantation Committee Spring 2014 Allocation component changes 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 5. Blood type eligibility - A2 and A2B to B compatible 6. Pediatric kidney allocation – KDPI priority 7. Kidney payback policy – eliminated 8. Kidney variances – eliminated Action: Input and confirm data Begin Now Late May 2014 System tools • Get familiar with the EPTS calculator • Enter data in fields used to calculate EPTS • Editable data in the system • Cross-references to OPTN and CMS dialysis dates • Flags for data inconsistency Action: Update donor acceptance criteria Begin now Late May 2014 • Review listed candidates for criteria entered • Discuss acceptance criteria for local versus import • Determine candidates that may benefit from a shipped KDPI>85% organ • Enter KDPI acceptance criteria • Assess for KDPI and “other” criteria conflicts Acceptance criteria 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% Action: Update consent forms Begin now • Update consent forms - KDPI > 85% instead of ECD At implementation • 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 Tools available Summer 2014 • Sample language for discussing KDPI with patients • Patient brochure Action: Assess candidates for prior living donation Prior living donors get 4 points Begin now • Check candidates for prior organ donation • Retain documentation of prior donation Action: Update unacceptable antigens (UAs) Begin now Prior to implementation • Review unacceptable antigens reported • Enter any unacceptable antigens not previously entered (according to your center’s protocol) Action: Review and Approve UAs Mid–2014 • Reports will appear to allow Lab director and transplant physician/surgeon to approve unacceptable antigens for candidates already listed with CPRA greater than 98% System tools • Message and printable form will display when CPRA 99-100% is reached • Report listing candidates who require approvals Action: Develop written policy for Blood Type B Candidates Begin now • Create a written protocol - maximum titer levels acceptable for blood type B candidates to blood type A2 or A2B donors Prior to Implementation (December 2014) • Create consent forms for candidates in this category • Enter whether candidate meets criteria - yes or no • Retain documentation of titer levels After implementation • Obtain consent from patients in this category • Confirm eligibility in system every 90 days Implementation Phase I • Data updates begin • New reports released • Calculators available now Spring/Summer 2014 Phase II • New allocation rules applied • Variances turned off • Payback system turned off December 2014 More information Recorded webinars, podcasts, toolkits, etc. available on: OPTN web site - http://optn.transplant.hrsa.gov (click ‘Resources’ and ‘Professional Resources’) Transplant Pro* - http://transplantpro.org (click ‘I am Looking For’ and ‘Kidney Allocation System’) *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 OPTN Kidney Paired Donation (KPD) Histocompatibility Testing Policies Kidney Transplantation Committee Spring 2014 Background 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 The Problem 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 Goal of the Proposal 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 Proposed: HLA Typing 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: Antibody Screenings 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: Crossmatching 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 Supporting Evidence 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 Specific Feedback Request 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 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? What Members will Need to Do 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 Questions? Richard Formica, MD Committee Chair Name Region # Representative Email Gena Boyle Committee Liaison [email protected] Backup Slides KDPI Point changes: Sensitization Points CPRA Sliding Scale (Allocation Points) 20 18 16 14 12 10 8 6 4 2 0 0 0 (CPRA<98%) 17.30 New 12.17 10.82 Current 0 0 10 0.21 0.08 20 30 0.48 0.34 40 50 CPRA CPRA 0.81 1.09 60 70 6.71 1.58 4.05 2.46 80 90 100 Summary: Member responsibilities Communicate importance of early referral Establish protocols for A2 and A2B 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 Review waiting list for unacceptable and update consents for KDPI>85% antigens Review “other” donor screening criteria Educate candidates and potential candidates on changes FAQ-Waiting Time Eligibility Criteria 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 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-Dialysis Start Date 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 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-KDPI and Consent 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-CPRA Approvals 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-Placement Issues for CPRA 100% Candidates 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 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-Variances 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. Other FAQs 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.