1. Proposal to Modify Existing or Establish New Requirements for the Psychosocial and Medical of Living Donors (Resolution 17) Living Donor Committee Mary Amanda Dew, PhD

2.  OPTN policy has inconsistent requirements for psychosocial and medical evaluation of living donors  Kidney donor recovery hospitals must follow OPTN policies  Liver donor recovery hospitals must develop and follow center-specific protocols  Hospitals performing living lung, pancreas or intestine donor recovery are not required to follow OPTN policy or develop and follow center-specific protocols The Problem

3. #5- Promote Living Donor Safety Minimize risk to living organ donors Properly evaluate potential living donors Strategic Plan

4.  Establish standardized psychosocial and medical evaluation requirements for living liver, lung, pancreas and intestine donors that mirror existing requirements for living kidney donors  Improve the medical evaluation process for future living liver, lung, pancreas and intestine donors Goal of the Proposal

5.  Standardization of the psychosocial and medical evaluation process for living liver, lung, pancreas and intestine donors How the Proposal will Achieve its Goal

6. Proposed requirements are based on recommendations from a Joint Societies Steering Committee and early comment from 5 OPTN Committees Joint Societies Committee representation from: American Society of Transplantation (AST); American Society of Transplant Surgeons (ASTS); North American Transplant Coordinators Organization (NATCO) Background

7. Product Policy Target Population Impact: Living Donors Total IT Implementation Hours 0/10,680 Total Overall Implementation Hours 20/17,885 Overall Project Impact

8. TypeTotalSupportSupport as Amended OpposedNo vote/ No comment/ Did not consider Committee195 (26.3%) 0014 (73.7%) Regional1111 (100%) 000 Individual2720 (74.1%) 02 (7.2%) 5 (18.5%) Public Comment Results

9.  June 2014 – Board approved VCA policies  Early September – Living Donor Committee leadership asked to extend proposed policy to include living VCA donors  September 8, 2014 – Committee heard presentation from VCA Committee Chair. Committee discussed and did not support extending proposed policy to VCA donors Post Public Comment Considerations

10. Reasons for Committee decision: SUMMARY 1.VCA not considered in policy development/public comment 2.Elements of policy are not justifiable in the context of VCA 3.Different types of VCA donors will require different evaluation elements, none of which have received deliberation 4.It took years to implement consent policies for kidney donors despite large donation volume; no clear emergent problem for VCA requiring action without deliberation 5.Delaying passage of policy for liver, lung, pancreas and intestine donors in order to deliberate about VCA donors will not promote safety of these non-VCA donors

11.  Policy 14.4 E Living Donor Exclusion Criteria  Table 14-9 Living Donor Exclusion Criteria Additional Exclusion Criteria for Living Kidney Donors Uncontrollable hypertension or history of hypertension with evidence of end stage organ damage See page 28 of the Board book Recommended Amendment

12.  Policy 14.4 B Living Donor Medical Evaluation Requirements  Conform Policy 14.4.B, Table 14-2, row (Transmissible Disease Screening) to match the same table and row in Resolution 13 as adopted by the Board on November 12, 2014.  See Page 27 of your Board book. Necessary Amendment

13. RESOLVED, that the following new or modified Policies 14.1 (Required Protocols for Recovery Hospitals), 14.5 (Psychosocial Evaluations Requirements for Living Donors), 14.4 (Medical Evaluation Requirements for Living Donors), 14.6 (Registration and Blood Type Verification of Living Donors Before Donation), 14.7.A (Prospective Crossmatching Prior to Kidney Placement, 14.7.B (Placement of Non-directed Living Donor Kidneys, 14.7.C (Transplant Hospital Acceptance or Living Donor Organs), 14.8 (Packaging, Labeling, and Transporting of Living Donor Organs, Vessels, and Tissue Typing Materials as set forth below are effective February 1, 2015 *Page 61 of Board book Resolution 17

14. Proposed requirements are based on recommendations from a Joint Societies Steering Committee and early comment from 5 OPTN Committees Joint Societies Committee representation from: American Society of Transplantation (AST); American Society of Transplant Surgeons (ASTS); North American Transplant Coordinators Organization (NATCO) Additional Background

15.  DTAC recommended minor changes to the required infectious disease testing  All references to “potential living donor” would be changed to read “living donor”  The majority of existing psychosocial and medical evaluation requirements for living kidney donors would be extended to living liver, lung, pancreas and intestine donors  No new requirements for living kidney donors Proposal Summary

16.  New living liver donor medical evaluation requirements are provided in Table 14-8  liver-specific family history; general lab and imaging tests; liver-specific tests; anatomic assessment  New living liver donors exclusion criteria include:  HCV RNA positive, HBsAg positive  Donors with ZZ, Z-null, null-null and S-null alpha-1- antitrypsinphenotypes and untype-able phenotypes  Expected donor remnant volume less than 30% of native liver volume  Prior living liver donor Proposal Summary

17.  DTAC recommended minor changes to the required infectious disease testing  All references to “potential living donor” would be changed to read “living donor”  The majority of existing psychosocial and medical evaluation requirements for living kidney donors would be extended to living liver, lung, pancreas and intestine donors  No new requirements for living kidney donors Proposal Summary

18.  New living liver donor medical evaluation requirements are provided in Table 14-8  liver-specific family history; general lab and imaging tests; liver-specific tests; anatomic assessment  New living liver donors exclusion criteria include:  HCV RNA positive, HBsAg positive  Donors with ZZ, Z-null, null-null and S-null alpha-1- antitrypsinphenotypes and untype-able phenotypes  Expected donor remnant volume less than 30% of native liver volume  Prior living liver donor Proposal Summary

19. Two organizations responded with concerns:  National Catholic Bioethics Center  National Catholic Partnership on Disability The Committee leadership prepared a detailed written response to address their concerns, met with representatives from both groups by conference call, and sent another written response as follow-up. Public Comment Results

20. Primary concerns of Catholic organizations included:  Use of term “all,” as short-hand reference to kidney, liver, lung, pancreas, intestine donation, opens the door to donation of all tissues, not just those listed, and no matter how great the potential for donor harm, mutilation, and permanent disfigurement  Exclusion criteria for living donors  Should refer to any, rather than high, suspicion of coercion  Psychiatric conditions, even if controlled, should lead to exclusion  Mental incapacity at any age should be an exclusion  Incomplete monitoring plan for living donor recovery hospitals Public Comment Results: Individual

21.  June 2014 – The Board approved VCA policies which do not exclude potential living VCA donation  The Living Donor Committee leadership was asked to consider extending this psychosocial and medical evaluation policy to include living VCA donors  September 2014 – The VCA Committee Chair and vice Chair presented the VCA policies and proposals during a full Living Donor Committee meeting, and responded to questions Post Public Comment Considerations

22.  Request by the VCA Committee Chair to Living Donor Committee to extend this psychosocial and medical evaluation policy proposal to include living VCA donors to prevent “unregulated vacuum and to protect public safety and preserve the public trust.”  The Committee did not support extending this proposal to include living VCA donation for multiple reasons. Post Public Comment Considerations

23.  Reasons for lack of Committee support for including living VCA donation:  The Committee had specifically referred only to kidney, liver, pancreas, intestine, and lung donors in policy drafts and background supporting information  Psychosocial and medical evaluation requirements for living VCA donors were not considered a) by the JSWG during development of their policy recommendations, b) by the Committee during policy development, or c) during public comment Post Public Comment Considerations

24.  Reasons for lack of Committee support for including living VCA donation:  The policy contains elements that cannot be justified when applied to living VCA donors. Example:  The policy excludes individuals who are both <18 and mentally incapable of making an informed decision.  It thus allows donors ≥ 18 who are mentally incapable under rationale that under rare circumstances this is in donor’s best interest (preserve life of caretaker of donor).  But VCA transplantation is a life-enhancing, not life-saving procedure. Post Public Comment Considerations

25.  Reasons for lack of Committee support for including living VCA donation:  The policy does not contain elements essential for psychosocial and medical evaluation of living VCA donors.  Different categories of living VCA donation will require separate evaluation considerations, namely 1) limb and face, 2) multi-visceral as a composite (e.g., uterus+ovaries), and 3) other non-visceral organs. Post Public Comment Considerations

26.  Reasons for lack of Committee support for including living VCA donation:  It has taken years to develop, gain approval and implement psychosocial and medical evaluation policies for living kidney donation, which has the longest history and greatest volume. Absence of such policies should not be considered an emergent problem.  Developing psychosocial and medical evaluation policy for living VCA donation needs careful consideration due to unique issues.  In the meantime, there is no clear rationale for delaying policy approval process for psychosocial and medical evaluation policies for liver, lung, pancreas and intestine donors. Post Public Comment Considerations

27.  Reasons for lack of Committee support for including living VCA donation: SUMMARY  No consideration of VCA during policy development/public comment  Elements of policy are not justifiable in the context of VCA  Different types of living donor VCA will require different psychosocial and medical evaluation elements, none of which have received any deliberation  It took years to implement similar policies for living kidney donors despite large volume of donations; no clear emergent problem for VCA requiring action without deliberation  Delaying passage of policy to cover liver, lung, pancreas and intestine donors in order to deliberate about VCA will not promote safety of these non-VCA donors Post Public Comment Considerations

28. RESOLVED, that the following new or modified Policies 14.1 (Required Protocols for Recovery Hospitals), 14.5 (Psychosocial Evaluations Requirements for Living Donors), 14.4 (Medical Evaluation Requirements for Living Donors), 14.6 (Registration and Blood Type Verification of Living Donors Before Donation), 14.7.A (Prospective Crossmatching Prior to Kidney Placement, 14.7.B (Placement of Non-directed Living Donor Kidneys, 14.7.C (Transplant Hospital Acceptance or Living Donor Organs), 14.8 (Packaging, Labeling, and Transporting of Living Donor Organs, 36, 37, 75 and 76, as set forth below are effective February 1, 2015 *Page 61 of Board book Resolution 17