OPTN Bylaws Rewrite Appendix L: Reviews, Actions, and Due Process

1. OPTN Bylaws Rewrite Appendix L: Reviews, Actions, and Due Process John Lake, MDPresident, OPTN/UNOS Board of Directors Co-chair, Appendix L Substantive Rewrite MPSC Work Group lakex009@umn.edu Sharon L. Shepherd, JD, MSN, RN Compliance Analyst sharon.shepherd@unos.org

2. What is Appendix L? Appendix L: Reviews, Actions, and Due Process outlines: • Rights and responsibilities of OPTN Members • Requirement that OPTN Members must comply with OPTN obligations • Definition of OPTN obligations OPTN

3. OPTN Obligations Members agree to comply with all OPTN obligations. OPTN obligations include all the applicable provisions of the National Organ Transplant Act (NOTA), OPTN Final Rule, OPTN Charter, OPTN Bylaws, and OPTN Policies. OPTN

4. What is Appendix L? Appendix L: Reviews, Actions, and Due Process outlines: • How the OPTN Contractor and the MPSC will review and act on potential violations or non-compliance issues • Members’ rights when a potential violation is being reviewed • The role of the Secretary of Health and Human Services (HHS) in these reviews OPTN

5. Why Rewrite Appendix L? The goals of the rewrite were to: • Rewrite in plain language • Reorganize the bylaws logically • Clarify Members’ rights and responsibilities • Clarify OPTN responsibilities and actions • 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 OPTN

6. Why Rewrite Appendix L? • 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 OPTN

7. Why Rewrite Appendix L? • 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 OPTN

8. Current Bylaws • Category I : Fast track review for substantial, time sensitive threat to patient health or public safety • Category II and III: Defined based on MPSC action OPTN

9. How Is an Issue Reviewed? • MPSC review • Letter of Reprimand or recommendation of adverse action (probation or member not in good standing) entitles Member to an interview • If after interview, the MPSC recommends an adverse action, then the Member is entitled to a hearing • Continued recommendation for an adverse action goes to the Board of Directors for final decision. OPTN

10. Three New Review Pathways • Imminent Threat Review pathway (Former Category I) • Expedited Review pathway (New!) • Routine Review pathway OPTN

12. The Imminent Threat Review Pathway • Former Category I – NOT new! • Extremely egregious or urgent and severe risks to patient health or public safety • Very, very few cases will continue through the Imminent Threat Review Pathway OPTN

13. The Imminent Threat Review Pathway • MPSC Chair will determine what action the Member needs to take to mitigate the threat to patient health and public safety • Executive Director may then request that the Member take the determined action immediately (within 24 hours) • If threat is mitigated, the potential violation may then proceed through the Expedited or Routine Review pathway OPTN

14. The Imminent Threat Review Pathway • The Executive Director will provide notice to the Secretary within 24 hours of the MPSC Chair’s determination of an Imminent Threat Review • No interview is offered • Instead, the Executive Committee reviews the Imminent Threat Review Committee recommendation • Any adverse action will become effective immediately, before the Member is offered a hearing OPTN

15. The Expedited Review Pathway • This is a new pathway. • Provides an expedited timeframe for review of investigation results by committee. • Interview is granted in an expedited manner, either in-person or through teleconference, instead of waiting until the next MPSC meeting. • Completion of Hearing Panel report and Board review are both expedited. OPTN

16. The Routine Review Pathway A Routine Reviewwill be conducted for any potential violation of OPTN obligations when the MPSC determines that an Expedited Review or an Imminent Threat Review is not warranted. OPTN

17. Secretarial Reviews and Actions • Provides an avenue to notify the Secretary within 7 days when there is no violation of OPTN obligations but a threat to patient health and public safety exists. • Clarifies that the Secretary may request that the OPTN Contractor perform a special review of a potential violation “in the manner and within the period specified by the Secretary” as provided for in the Final Rule. OPTN

18. Deferred Disposition • If the MPSC is considering a recommendation to impose an adverse action against a Member, the MPSC may vote to delay further consideration of the matter for a Deferred Disposition period. • Deferred Disposition is an assessment and improvement period provided to the Member to demonstrate compliance with OPTN obligations. • May be offered after the Member has had an interview. • Very specific limitations on when this option can be used; looks at Member’s compliance and MPSC review history OPTN

19. Appendix L Schedule • Public Comment Period February 3 through April 6, 2012. • Three Live Meeting education sessions: 2/22, 3/9, and 3/13. • The substantive rewrite of Appendix L and the entire Bylaws Phase I Plain Language Rewrite will go to the Board for approval in June 2012, but as separate proposals. • Subsequent release of the entire “new and improved” OPTN Bylaws. OPTN

20. Questions? Comments? You may also send your questions or comments to: bylawsrewrite@unos.org OPTN