1. Ad Hoc Disease Transmission Advisory Committee Spring 2015

2.  Board approved proposal to align OPTN Policy with PHS Guideline in Nov. 2014  Most policies effective Feb. 1, 2015  NAT requirements -- not effective until programming for data collection fields and screening is complete (watch for System Notice, expected late Summer 2015)  PHS Guideline education available!  Recorded town hall meeting on applying increased risk criteria on TransplantPro  February 3, 2015 webinar covered policy changes passed by Board in Nov.  FAQ sheet on OPTN website DTAC Update

3.  Improving Patient Safety Portal Update  Upgrading portal for reporting potential donor-derived disease transmission events  Easier to use  less free text  more pull down menus  Programming scheduled for completion this spring DTAC Update

4. Proposal to Require Re-Execution of the Match Run when a Deceased Donor’s Infectious Disease Results Impact Potential Recipients based upon Screening Preferences Ad Hoc Disease Transmission Advisory Committee Spring 2015

5.  Large number of organ allocations take place based on match runs executed before receiving certain infectious disease results  Presents a potential patient safety concern  Organs could unintentionally be allocated to a candidate who is not willing to accept offers from specific diseased donors  Increases opportunity for unintended donor-derived disease transmission! The Problem

6.  Enhance patient safety by outlining specific requirements for when a match run must be re- executed  prevents unintentional allocation that may lead to unintended donor-derived disease transmission Goal of the Proposal

7. If the donor tests positive for…Then candidates may choose not to receive offers on the following match runs: Cytomegalovirus (CMV) Intestine Hepatitis B core antibody (HBcAb) Heart, Intestine, Kidney, Liver, Lung, Pancreas, Heart-Lung, Kidney-Pancreas Hepatitis B Nucleic Acid Test (NAT)* Heart, Intestine, Kidney, Liver, Lung, Pancreas, Heart-Lung, Kidney-Pancreas Hepatitis C (HCV) Antibody Heart, Intestine, Kidney, Liver, Lung, Pancreas, Heart-Lung, Kidney-Pancreas Hepatitis C Nucleic Acid Test (NAT)* Heart, Intestine, Kidney, Liver, Lung, Pancreas, Heart-Lung, Kidney-Pancreas Current Infectious Disease Screening Options *approved by the Board in Nov 2014, but not yet implemented

8.  The DTAC requested data to better understand how often match runs are executed without the relevant infectious disease results  Reviewed all donor matches executed from January 2012-December 2013 Supporting Evidence

9. Deceased Donor Matches 2012-2013 Percent with Ambiguous Results

10. Percent of Deceased Donor Matches with Result of Pending: 2009-2013

11. Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO (Region 1 Highlighted)

12. Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO (Region 2 Highlighted)

13. Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO (Region 3 Highlighted)

14. Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO (Region 4 Highlighted)

15. Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO (Region 5 Highlighted)

16. Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO (Region 6 Highlighted)

17. Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO (Region 7 Highlighted)

18. Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO (Region 8 Highlighted)

19. Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO (Region 9 Highlighted)

20. Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO (Region 10 Highlighted)

21. Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO (Region 11 Highlighted, One OPO with 0%))

22. No Elimination of Pathway for Urgent Allocation  WHEN test results are received plays a roll in executing the match run  Stringent requirements preventing match run execution could lead to loss of potential organ donors or organ discard REQUESTED: OPO community feedback on appropriate expectations in this area

23. STOP allocation on original match run Report updated donor result in DonorNet SM Re-execute the match run Allocated organ using updated match run Host OPOs: For new positive HBV, HCV, or CMV results without pending organ acceptance How the Proposal will Achieve its Goal

24. Host OPOs: For new positive HBV, HCV, or CMV results with (provisional) organ acceptance Report new test result to first tx hospital on match that accepted each organ as soon as possible, but within 1 hr of receiving result Report updated donor result in DonorNet SM Re-execute match run if potential recipient declines the offer after learning this new information Re-allocate the organ using the updated match run

25. How the Proposal will Achieve its Goal TX Hospitals with (provisional) organ acceptance, once notified by Host OPO of positive HBV, HCV, or CMV result: Inform potential recipient (or agent) of the positive donor test result Notify the host OPO whether organ will be accepted or declined within an hour of receipt of this new information If accepted, meet requirements for informed consent in Policy 15.3.A: Deceased Donors with Additional Risk Identified Pre-Transplant

26. How the Proposal will Achieve its Goal Host OPOs: For new positive HIV result with or without (provisional) organ acceptance for a potential recipient STOP allocation on original match run Report updated donor result in DonorNet SM Re-execute only kidney and liver match runs to include only HIV-pos candidates at centers participating in IRB approved research protocol that meet OPTN Final Rule requirements Allocate organs using updated match run Withdraw all pending offers to candidates who are not HIV pos and on new match runs

27. The Solution- a recap  Enhance patient safety without eliminating or limiting options for match run execution  With the exception of HIV, honor primary offer and allow opportunity for medical judgment and informed consent based upon new test result

28.  Review requirements for when re-execution of a match run is required based upon new donor infectious disease results  Report new donor information in DonorNet SM before re-executing match to appropriately screen candidates from appearing on match run  Communicate with first accepting transplant hospital for an organ regarding these new findings within an hour of receiving positive test result What OPOs will Need to Do

29.  Review new requirements for OPOs to re-execute the match run (some back up offers may be withdrawn based upon new information)  Inform potential recipient (or agent) of new positive donor test results  Notify host OPO if organ will be accepted or declined within an hour of receiving new donor information  If accepting organ, meet requirements for informed consent in Policy 15.3.A What Transplant Hospitals will Need to Do

30.  Dan Kaul, MD Committee Chair kauld@med.umich,edu  Presenter name (RA will complete) email address  Shandie Covington Committee Liaison shandie.covington@unos.org shandie.covington@unos.org Questions?

31. Extra slides… if needed

32. Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO

33. Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) CMV Serology Results for Intestine Matches Run 2012-2013 By OPO