Kidney Transplantation Committee Fall 2014

Recent Public Comment Proposals OPTN KPD Histocompatibility Testing Requirements If approved: 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 In the Spring, we presented proposed new histocompatibility testing requirements for kidney programs participating in the OPTN KPD program. We recently voted to send an amended version of the proposed requirements to the Board of Directors for approval on November 12. If the Board approves the proposal, all of the new changes would become effective with IT programming and notice to the membership. If approved, the OPTN KPD donor hospital will be responsible for reporting the required HLA information on the donor, as well as arranging shipment of the donor’s blood sample to the candidate’s hospital or affiliated histo lab. The OPTN KPD candidate hospital will be responsible for reporting the candidate’s HLA information, confirming the donor’s HLA information, meeting all antibody screening requirements, as well as the crossmatching requirements.

Recent Public Comment Proposals OPTN KPD Histocompatibility Testing Requirements, post-public comment changes: UNOS will make candidate ineligible when unacceptable positive crossmatch occurs Candidate’s program will be required to confirm that the candidate’s physician and the histo lab director have performed a review of the unacceptable antigens in order to be eligible Added (+/- 20 days) to the requirement for antibody screenings every 90 days We decided to make three changes post-public comment: The public comment proposal required programs to inactivate their candidate in the OPTN KPD program if an unacceptable positive crossmatch occurred that precludes transplant with a matched donor. We asked for specific feedback about whether or not the program should be required to inactivate the candidate or if UNOS should automatically make the candidate ineligible. The overwhelming feedback we received was that UNOS should automatically make the candidate ineligible. So, we have included this change in the proposal. We also removed the requirement that someone from the histocompatibility laboratory verify the accuracy of the unacceptable antigens each time they are entered. We felt like this was going to be a very burdensome requirement, because programs were going to have to document the verification in the medical record. Instead, we are recommending that the physician or surgeon (or their designee) and the histocompatibility laboratory director (or their designee) review any unacceptable antigens listed for the candidate before the candidate appears on their first KPD match run. This seemed like a more reasonable requirement from our standpoint. Finally, we discussed the proposed requirement that all candidates be tested for antibodies every 90 days. We wanted to allow programs some flexibility in this requirement, so we added a plus or minus 20 day window to this requirement. This is consistent with the KAS policy to confirm that Blood Type B candidates are still eligible for access to A2/A2B kidney offers.

December 4, 2014 KAS Implementation The new kidney allocation system will take effect on December 4, 2014. I want to quickly revisit some important things that transplant programs, OPOs, and histocompatibility laboratories need to do now to prepare. In the interest of time, I am going to focus on the areas where we’ve received the most questions.

New Mandatory Fields in Waitlist Current diabetes status Prior solid organ transplants Maximum acceptable KDPI On May 27, UNOS released several new fields in UNet℠ to allow transplant programs to begin preparing for implementation of the system. On December 4, these new fields will become required. This will mean that transplant programs will have to enter this information for candidates being newly registered and when making an edit to a candidate’s record who was registered prior to December 4. The current diabetes status and prior solid organ transplants field will be used in conjunction with the dialysis start date and the date of birth to calculate the new Estimated Post-Transplant Survival (EPTS) score. Programs will also be required to select a maximum acceptable KDPI for each candidate who is registered on or after December 4. When the new maximum KDPI fields were released in May, the system automatically assigned a maximum KDPI for any candidates previously added based on their prior SCD/ECD selections (if the candidate was willing to accept ECD offers, the max was set to 100% KDPI—if not, the max was set to 85%). On the morning of December 4, the system will again assign max values based on SCD/ECD for any candidates added after the May 27 release who do not have a maximum KDPI selected. The program can change the maximum for each candidate.

% of Kidney Registrations % of Kidney Registrations* with Verified EPTS Data, by Transplant Program 73 programs have verified EPTS data for 100% of their candidates 18 programs have not verified EPTS data for any candidates Overall, more than half of all candidates on the list have newly entered and/or verified data fields for calculating an EPTS score. Seventy-three programs are done, having an EPTS for 100% of their candidates. 18 programs haven’t started yet, and the remaining approximately 150 kidney programs have made some progress. Programs have until December 4th to provide this information; otherwise, candidates will be assumed to be outside the Top 20% in terms of EPTS and will not receive priority for the highest-longevity kidneys. * Includes Registrations on the Waitlist May 27, 2014 with Verification Status as of Sep 23, 2014.

Greater than 98% CPRA Approvals Physician/ surgeon and HLA lab director review Reviewers provide written documentation in candidate’s medical record Program staff enter approver names in UNet℠ Candidates with a CPRA greater than 98% will have access to regional and national priority if the candidate’s physician or surgeon and the HLA laboratory director review and approve the unacceptable antigens for the candidate. UNetSM is now programmed to alert programs when a candidate’s CPRA is over 98% and also allows the program to report that the required CPRA approvals have been obtained for the candidate. Programs need to know that this a multiple step process:   The candidate’s physician or surgeon and the HLA laboratory director must review the unacceptable antigens listed. Written approval from both individuals must be documented in the candidate’s medical record along with the unacceptable antigens that are approved; and The approver names must be manually entered into UNetSM so that the system will recognize that the candidate is eligible for regional or national sharing. In order to help with documenting the approvals in the patient’s medical record, UNet℠ is now programmed to allow you to access a printable CPRA approver form. If you access this through the patient’s waitlist record, the form will populate with the unacceptable antigens listed for the candidate and the CPRA. This allows the program to print the form, obtain both signatures, and place it in the patient’s medical record as documentation.

Greater than 98% CPRA Approvals Once process is complete, UNet℠ will recognize regional/national priority any time the CPRA score is above 98% No additional review required, even if unacceptable antigens change and the score fluctuates If one or both approver names are missing in UNet, the candidate will continue to receive offers and points for CPRA The candidate will not receive regional/national priority One of the questions we’ve received frequently is whether or not the review and approval is needed every time the unacceptable antigens change. It is not. Once you have completed the process outlined on the previous slide (including the manual entry of the approver names in UNetSM, the system will continue to recognize the regional or national priority any time the score is above 98%. This is the case even if the candidate’s score fluctuates below and then above 98% again. It’s also the case if a candidate moves from 99% to 100%. If one or both approver names are missing in UNetSM, the candidate will continue to receive offers and all CPRA points. However, the candidate will not receive regional or national priority.

Additional Access for Blood Type B Candidates Develop written protocol regarding maximum titer levels Obtain written, informed consent from candidate Confirm candidate’s eligibility every 90 days in UNet℠ The new system will also provide greater access to deceased donor kidneys for blood type B candidates who can safely accept a kidney from an A2 or A2B blood type donor. To accomplish this, transplant programs will be responsible for developing their own written protocol regarding maximum titer levels and obtaining written informed consent from each blood type B candidate regarding their willingness to accept a blood type A2 or A2B kidney.   Although programs will not be required to report titer levels in UNetSM, they will have to indicate whether the candidate is eligible by entering “yes” or no” in the system. They will be required to confirm the candidate’s eligibility in the system per their protocol every 90 days to continue these offers. UNetSM will alert programs when a candidate’s eligibility is about to expire.

Access for Blood Type B Candidates Programs not required to participate in A/2/A2B to blood type B transplants Only required to complete process if participating Policy does not specify the frequency of testing for titer levels Programs only required to confirm eligibility based on program specific protocol for testing To be clear, programs are not required to participate in transplanting A2/A2B kidneys into B candidates. The process I just described is only required if the program does want to receive these offers for Blood Type B candidates. The policy does not specify how often the program must test for titer levels. It is designed to let programs establish and follow their own criteria.

All variance fields will be removed from DonorNet® Impact on OPOs All variance fields will be removed from DonorNet® OPOs must follow existing policies regarding backup offers and release of organs OPOs will be impacted by the new system. On December 4, DonorNet will no longer display any variance related fields. References to SCD and ECD will be removed and kidney allocation will be based on the donor’s KDPI. We’ve received some questions from OPOs about the order of allocation when a kidney is shipped and the intended recipient cannot be transplanted (either regionally or nationally to a highly sensitized candidate or for high KDPI kidneys which will be offered on a combined local/regional list). The allocation rules in this instance are no different from those that apply in the current system for kidneys shared as zero mismatches. Per OPTN Policy 5.7 Released Organs, 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 allocation to the importing OPO. Similarly, the host OPO can backup the organ offer according to its match 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.

New Additions to the Toolkit Updated FAQs Draft OPTN Evaluation Plan New policy language Patient e-learning module We’ve added several new resources to the KAS toolkit on the OPTN website. This includes an updated list of frequently asked questions, a draft UNOS evaluation plan that will be used to assess compliance, the new policy language that becomes effective December 4, 2014, and a new patient e-learning module.

Questions? Richard Formica, Jr., MD Committee Chair richard.formica@yale.edu Regional Rep name (RA will complete) Region X Representative email address Gena Boyle, MPA Committee Liaison gena.boyle@unos.org