Membership & Professional Standards Committee Fall 2012

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) During its June meeting the Board of Directors approved two MPSC proposals that had completed the public comment process. These changes will be effective on September 1: The OPTN Bylaws Plain Language Rewrite was undertaken to rewrite the Bylaws in plain language and to reorganize the Bylaws for better clarity and usability. This rewrite did not make any substantive changes to the content of the current Bylaws, but only changes the current language to make it easier to understand with more consistent terminology, better organization, and new usability features, including a table of contents. At that same meeting, the Board approved both a substantive and plain language rewrite to the bylaws pertaining to Reviews, Actions, and Due Process.  The new Appendix L represents a substantive rewrite of the procedures for reviewing potential violations of and non-compliance with OPTN obligations. <Speaker Notes> The OPTN Bylaws Substantive Rewrite of the bylaws addressing reviews, actions, and due process accomplishes the following objectives:   Outlines the three possible review pathways for potential violations of OPTN obligations and requirements. Clarifies the role of Secretary of the U.S. Department of Health and Human Services (HHS) in reviewing and acting on potential violations, particularly those that may pose a threat to patient health and public safety. Clarifies when the Secretary may request that the OPTN Contractor perform special reviews of a Member for non-compliance. Adds a new monitoring tool to aid Members who may need time and assistance from the OPTN to come into compliance. Clarifies notice requirements after an adverse action is taken by the OPTN. Provides information to Members about their rights in plain language with logical organization.

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 The MPSC has proposed modifications to the post-transplant outcomes flagging methodology to better identify transplant programs that could truly benefit from intervention. Outcomes data using existing and new methodology were studied in parallel for several Center Specific Report (CSR) cycles and reviewed by the Performance Analysis and Improvement Subcommittee (PAIS) and MPSC. In March 2012, the MPSC recommending adopting the modified flagging methodology as the sole flagging method. Bylaw language was approved in July 2012, and the proposal will be distributed for public comment in the Spring 2013.

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) The Committee will also be reviewing issues that were identified during Phase I of the Bylaws rewrite that were too substantive in nature to be amended then. Some of these projects were identified by the staff and others were brought up by the transplant community during the public comment process for Phase I. For example, the bylaws listed on this slide need to be updated to reflect current practices. The Committee and staff will begin working on these rewrites this fall. <Note for speaker. Primary personnel at OPO’s = executive director and medical director. Primary personnel at labs = lab director/technical supervisor>

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