Clarify Informed Consent of Transmittable Conditions

1. Clarify Informed Consent of Transmittable Conditions Ad Hoc Disease Transmission Advisory Committee (DTAC)

2. What problem will the proposal solve? • Current informed consent policy prior to transplant is vague • Specific consent required prior to transplant “when the donor has a known medical condition that may, in the transplant hospital’s medical judgment, be transmissible to the recipient” • MPSC concerned policy implies need for individual consent for every positive test result • “Might not be reasonable and cause undue burden” for programs • Difficult to monitor and enforce

3. What are the proposed solutions? • Rearrange policy order to emphasize the education requirement of potential candidates at the time of listing • Add clause to general consent policy at time of wait listing that results can affect post-transplant care and management • Tie the consent process to conditions screened by UNetsm • Tests named in current OPTN policy 5.3.B • Provides clear and enforceable policy • Keep other informed consent requirements when using donor organs:

4. What is currently in Candidate Screening and Re-Execute the Match Policies?

5. Supporting Evidence

6. EBV and CMV positive donors are the norm not the exception Out of 10,326 deceased donors from whom at least one organ was recovered for transplant: • 9,205 (89%) tested positive for EBV (IgG or IgM) • 6,283 (61%) tested positive for CMV Data Source: UNet data from October 1, 2016 and September 30, 2017

7. EBV and CMV are standard EBV Mismatches: • 85% of EBV-negative recipients received an EBV-positive donor organ • 2,289 out of 2,691 EBV-negative recipients CMV Mismatches: • 57% of CMV-negative recipients received a CMV-positive donor organ • 5,687 out of 10,003 CMV-negative recipients Data Source: UNet data from October 1, 2016 and September 30, 2017

8. HCV and HBV positive donors Out of 10,326 deceased donors from whom at least one organ was recovered for transplant: • 744 (7.2%) tested positive for HCV antibody • 495 (4.8%) tested positive for HCV NAT • 478 (4.6%) tested positive for HBV core antibody • 15 (0.1%) tested positive for HBV NAT Data Source: UNet data from October 1, 2016 and September 30, 2017

9. What about other conditions? • Can still obtain informed consent if warranted • Transplant hospitals must still meet applicable informed consent requirements for: • State laws • CMS Conditions of Participation

10. How will members implement this proposal? Transplant hospitals will need to: • Examine and possibly revise their consent protocols and practices to comply with the revised policies • Examine practices at both time of listing a potential transplant recipient & at the time of organ offer • Provide staff training to understand and comply with the revised policies • Possibly revise their current informed consent form or documentation

11. Specific Feedback • Two questions • Should policy specify patient signature or documentation of discussion in medical record? • Are conditions named in policy for candidate screening and re-executing the match run still applicable and complete?

12. How will the OPTN implement this proposal? • Anticipated Board Review date: June 11-12, 2018 • Anticipated Implementation date: September 1, 2018 • No programming in UNetSM

13. How will the OPTN implement this proposal? • Evaluation for compliance (site survey new): • Medical record documentation that a potential recipient or recipient’s agent gave consent before transplant when: • An organ was accepted from a donor who tested positive for: • Hepatitis B core antibody (HBcAb) • Hepatitis B nucleic acid test (NAT) • Hepatitis C (HCV) antibody • Hepatitis C nucleic acid test (NAT) • An intestine was accepted from a donor who tested positive for cytomegalovirus (CMV)

14. Questions? Cameron Wolfe, MBBS(Hons), MPH, FIDSA Ad Hoc Disease Transmission Advisory Committee Chair cameron.wolfe@duke.edu Susan Tlusty Ad Hoc Disease Transmission Advisory Committee Liaison Susan.tlusty@unos.org

15. Extra Slides

16. Reporting table

17. Timeline of policy Listing Organ Offer Evaluation Transplant Policy 15.3.A General Consent Before Transplant • Policy required tests for deceased and living donors • We cannot test for everything • Malignancy and disease might be found after transplant • Donor testing can impact post-transplant care Policy 15.3.C Post-Transplant Testing Policy 15.3.B Informed Consent Donors w/ Additional Risk • Increased Risk Donor • Hemodiluted donor for HIV, HBV, HCV Tests • Donor positive for conditions in Policy 5.3.B • Must have protocol • Must test for HIV, HBV, and HCV if had to consent for Policy 15.3.B

18. Tie Informed Consent to Existing Policy

19. Willingness to accept HBV or HCV positive organs varies Out of 116,350 patients on the waitlist, the following would accept an organ: • 71,318 (61.3%) from a HBV core positive donor; • 8,021 (6.9%) from a HBV NAT positive donor; • 8,083 (6.9%) from a HCV antibody positive donor; • 1,931 (1.7%) from a HCV NAT positive donor. Out of 272 patients registered as waiting for an intestine: • 159 (58.5%) would accept an intestine from a CMV antibody positive donor. Data Source: UNet data as of September 30, 2017

20. Increasing use of HBV and HCV positive organs • HBV Mismatches: 774 HBV-negative recipients received an organ from a donor with at least one positive HBV test (among 24,883 HBV-negative recipients) • HCV Mismatches: 342 HCV-negative recipients received an organ from a donor with at least one positive HCV test (among 23,879 HCV-negative recipients) • CMV Mismatches (Intestines only): 21 CMV-negative recipients received donated intestines from a CMV-positive donor (among a total of 57 CMV-negative intestine recipients and a total of 110 intestine recipients)

21. OPTN Bylaws Appendix L.15. OPTN Determinations and Actions OPTN actions may be imposed when a member: • Fails to comply with OPTN Obligations as described in L.1. Member Compliance. • Fails to submit or follow a corrective action plan or plan for quality improvement. • Fails to meet personnel requirements. • Acts in a way that poses a risk to patient health or public safety. • Fails to act as necessary to avoid risk to patient health or public safety.