OPTN Bylaws Substantive Rewrite of the Bylaws Addressing Review, Actions, and Due Process

1. OPTN BylawsSubstantive Rewrite of the Bylaws Addressing Review, Actions, and Due Process Sponsored by the Membership and Professional Standards Committee (MPSC) Public Comment Period February 3, 2012 – April 6, 2012

2. The Rewrite Process This rewrite represents Part 2 of Phase I: • Part 1: Plain language changes and re-organization WITHOUT any changes to substance • Part 2: Plain language and reorganization WITH substantive changes to the due process section (current Appendix A)

3. Project Overview • Started March 2011 • Review Teams with Extensive Collaboration • MPSC Bylaws Due Process Substantive Rewrite work group • HRSA representatives • UNOS staff, including legal & subject matter experts

4. Project Goals The goals of the substantive rewrite were to: • Rewrite in plain language • Reorganize the bylaws logically • Clarify Members’ rights and responsibilities • Clarify OPTN responsibilities and actions

5. Project Goals – continued (2) • Define three possible review pathways for potential violations, including an option that allows for the speedy, agile handling of threats to patient health and public safety • Imminent Threat Review • Expedited Review (New!) • Routine Review

6. Project Goals – continued (3) • Clarify the period in which the Secretary of HHS should be notified of a potential violation or non-compliance issue • Clarify when potential violations will be referred to the Secretary of HHS • Clarify when and how the OPTN Contractor will perform special Secretary-directed reviews as permitted under the Final Rule, especially in cases where there is no OPTN policy violation

7. Project Goals – continued (4) • Add a monitoring tool to aid Members who may need time and assistance to come into compliance • Provide increased opportunities to Members for quality improvement

8. Public Comment Comments on this proposal were received through • Online survey • Live Meeting presentations to the Regions • Approved by 10 regions. • 1 region did not comment. • Education sessions to OPTN/UNOS Committees

9. Public Comment Tally

10. Post Public Comment Changes • Please refer to the full language for the new Appendix L: Reviews, Actions, and Due Process (Exhibit K). • Based on comments received from ASTS and AOPO, several revisions were made that changed responsibility and authority given to the Executive Director and correctly assigns it to the MPSC Chair or the OPTN. • Clarified language regarding hearing panel members and their responsibility to avoid conflicts of interest.

11. Post Public Comment Changes (2) • Clarified notification requirements by adding definition for Transplant Hospital Patients. • Corrected typos and formatting errors where found. • In response to numerous requests, will work with staff to provide concrete examples and diagrams to be included in the OPTN Evaluation Plan for Member guidance.

12. Questions? Comments?