Membership & Professional Standards Committee

1. Membership & Professional Standards Committee Fall 2012

2. Bylaw Implementation Dates September 1: • OPTN Bylaws Rewrite – Appendices A-K and M (Phase 1 – Plain language) • OPTN Bylaws, Appendix L, addressing reviews, actions, and due process (substantive and plain language changes)

3. Ongoing Committee Initiatives • Modified Outcomes Flagging Methodology • Goal: Better identify transplant programs that could truly benefit from intervention • Outcomes data using existing and new methodology studied in parallel for several CSR cycles and reviewed by MPSC • Modified flagging methodology will be recommended by the MPSC as the sole flagging method • Proposal will be distributed for public comment during Spring 2013

4. New Committee Initiatives • Bylaws Rewrite – Phase 2 • Procedures for reviewing applications • Process for submitting letters of reference • Primary surgeon/physician currency requirements • Clarification of reporting requirements for changes in key personnel at OPO’s and Histo Labs • Intestinal Transplant Program Requirements (led by Liver/Intestine Committee)

5. Questions? • Ken Andreoni MD, Committee Chair Kenneth.Andreoni@surgery.ufl.edu • Alan Reed, MD, Vice Chair alan-reed@uiowa.edu • Sally Aungier, MPSC Liaison Sally.aungier@unos.org

6. Proposal to Remove the OPTN Bylaw for the Combined Heart-Lung Transplant Program Designation Co-Sponsors: MPSC and Thoracic Committees Fall 2012 Public Comment Cycle

7. The Problems • Only combined transplant that requires separate program approval status • Inconsistent with other combined organ transplants • Computer system development and programming challenges

8. Goals • Align program requirements for all combined organ transplants • Reduce application burden • Simplify • Make more efficient

9. Achieving These Goals Remove bylaw = problems solved

10. Impact Programs • 50 heart/lung programs • Potential for 125 more Patients • 54 heart/lung transplant candidates • Candidates not affected

11. Expected Implementation • Anticipated Board Consideration: June 2013 • Anticipated Effective Date: September 1, 2013

12. Member Action None!

13. NOT Controversial Feedback • Very few objections • “makes sense”

14. Contacts Thoracic Chair: Steven A. Webber, MD Thoracic Vice Chair: Joe Rogers, MD Staff Liaison Liz Robbins 804-782-4068 Elizabeth.Robbins@unos.org

15. Contacts MPSC Chair: Kenneth Andreoni, MD MPSC Vice Chair: Alan Reed, MD Staff Liaison Sally Aungier 804-782-4812 sally.aungier@unos.org

16. Proposal to Change the OPTN/UNOS Bylaws to Better Define Notification Requirements for Periods of Functional Inactivity Membership and Professional Standards Committee Fall 2012

17. The Problem • Bylaws do not clearly outline Member actions for functional inactivity, including: • Periods of waiting list inactivation • Cessation of a transplant program component (e.g. Living Donor/adult-peds) • Since the Bylaws do not specifically address notification content or timing, programs have been inconsistent in how they notify patients

18. Goal of the Proposal • Detailed, timely patient information regarding periods when organ offers will not be made on their behalf • More guidance for MPSC to monitor functional inactivity

19. Goal of the Proposal (cont.) • Clearly define Member responsibilities: • Clarify patient notification content and timing requirements for periods of waiting list inactivation in UNetsm • Specify Member actions for notifying patients when a program voluntarily ceases performing a specific type of transplant

20. How the Proposal will Achieve its Goal WL Inactivation • Current bylaw requires programs to provide written notice to potential candidates and candidates of waiting list inactivity • Proposed modifications: waiting list inactivity notifications must contain the following: • Reason • Expected length • Explanation organs cannot be accepted during this time

21. How the Proposal will Achieve its Goal WL Inactivation II • Notification content requirements (cont): • Options available to the candidates, including multiple listing/transfer • Mechanism for notifying candidates when WL is reactivated or if the expected length of inactivation is extended • Copy of Patient Information Letter • Cumulative notice must include dates for each instance of WL inactivation

22. How the Proposal will Achieve its Goal WL Inactivation III • When to send notifications:

23. How the Proposal will Achieve its Goal WL Inactivation IV • Example: Program reaching cumulative waiting list inactivation of 28 days or more in one 365 day Period

24. How the Proposal will Achieve its GoalProgram Component Cessation • Members must: • Notify all patients affected by the cessation at least 30 days prior to, but no later than 7 days after cessation

25. How the Proposal will Achieve its GoalProgram Component Cessation (cont.) • Patient notifications must include: • Reason for cessation • Explanation that organs cannot be accepted on the candidate’s behalf during period of cessation • Patient options • Phone number for the transplant program’s administrative office

26. Impact • 12 programs met WL inactivation thresholds in 2011 • 4 programs ceased a component in 2011 • Proposed requirements could result in additional financial burden to send notifications, increase in patient calls/questions, submission of responses to MPSC inquiries

27. Expected Implementation • Anticipated Date of Board Consideration: June 2013 • Anticipated Effective Date: September 1, 2013

28. What Members Will Need to Do • WL inactivation: • Include required elements in patient notifications • Send within specified timeframe • Cessation: • Include all required elements • Send within specified timeframes • MPSC will continue to monitor periods of WL inactivation and will request confirmation that you notified patients

29. Specific Requests for Comment • Questions refer to Appendix K, section A (program component cessation bylaw), page 94 in the public comment document • Is the term ‘affected patients’ clear enough? Proposed language includes these groups: • Potential Candidates • Waitlisted Candidates • Potential Living Donors

31. Questions? MPSC Chair: Kenneth Andreoni, MD MPSC Vice Chair: Alan Reed, MD Staff Liaisons Jacqui O’Keefe 804-782-4867 jacqueline.okeefe@unos.org Sally Aungier 804-782-4812 sally.aungier@unos.org