National Webinar to Review Non-Discussion Agenda Spring 2014 Public Comment If you are logged into the webinar, please enter the audio PIN Please put your phone on MUTE and do not place this call on HOLD

 Non-Discussion Agenda Process Overview  Present and Discuss Non-Discussion Agenda Proposals  Regional Meetings  Feedback to the Sponsoring Committees Objectives of Call

Regional Meeting Goals  Discuss and comment on proposed policies and bylaws  Collect feedback and provide to sponsoring committees  Receive updates on OPTN/UNOS committee activities and projects  Discuss regional business Background

 17 proposals submitted for public comment  A majority of OPTN/UNOS committees with updates (11)  Several didn’t report during Fall 2013  Committee projects that require regional discussion and feedback  1.5 additional hours to the standard 5 hour regional meeting Spring 2014 Regional Meetings

 Divide the agenda into two sections  Discussion  Non-Discussion  Discussion agenda format is the same as previous meetings  Presentation at the regional meeting  Discussion at the regional meeting  Regional Vote  Non-Discussion agenda format  Items discussed today  No discussion at the regional meeting  Regional Vote Regional Meeting Agenda

Proposal to Require the Reporting of Aborted Living Donor Organ Recovery Procedures (Living Donor Committee) Proposal to Allow Non-substantive Changes to the OPTN Policies and Bylaws (Membership and Professional Standards Committee) Proposed ABO Subtyping Consistency Policy Modifications (Operations and Safety Committee) Proposal to Require the Collection of Serum Lipase for Pancreas Donors (Pancreas Transplantation Committee) Proposal to Clarify Data Submission and Documentation Requirements (Policy Oversight Committee) Non-Discussion Agenda Proposals

Public Comment Proposals

Regional Meeting Information

Proposal to Allow Non-Substantive Changes to the OPTN Policies and Bylaws Policy Oversight Committee Mark Aeder, MD University Hospitals of Cleveland Ann-Marie Leary

 Sometimes we find obvious clerical (or non- substantive) errors in the OPTN Policies and Bylaws  Currently, nothing in the Bylaws or Policies allows staff to make these changes  The Executive Committee or Board of Directors must approve these simple changes The Problem

 Allow staff to make non-substantive changes immediately, without Board approval  Executive Committee would review these changes later Goal of the Proposal

 This proposal adds language to the OPTN Bylaws that will permit staff to make clerical changes:  OPTN Bylaws Article X: Amendment of Charter and Bylaws  OPTN Bylaws Article XI: Adoption of Policies How the Proposal will Achieve its Goal

 Capitalization or punctuation, as needed to maintain consistency with current policy  Typographical, spelling, or grammatical errors  Lettering and numbering of a rule or the subparts of a rule, according to style conventions in current policy  Cross-references to rules or sections that are cited incorrectly because of subsequent repeal, amendment, or reorganization of the sections cited What’s a “non-substantive” change?

 Many legislative and regulatory bodies have procedures that provide authority for making minor changes to their policies and legislation:  § Authority for minor changes to the Code of Virginia  North Carolina General Statutes § 150B (Codifier's Authority to Revise Form of Rules)  Washington Revised Code § (Codification and Revision of Laws – Scope of Revision) Supporting Evidence

 This proposal will not require that members do anything or change their procedures  If members print out copies of the Bylaws or Policies, they should periodically print out new, corrected versions What Members will Need to Do

Contacts for Feedback ChairYolanda Becker, MD Vice Chair Susan Dunn, RN, BSN, MBA UNOS Staff Liaison Leigh Kades

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Proposal to Modify ABO Subtyping References for Consistency Operations and Safety Committee Theresa Daly, MS, RN, FNP New York-Presbyterian/Columbia

 Current OPTN policy contains different terms that have the same intended meaning  Policy 2.6.B: “found to be non-A1 or non-A1B”  Policy 13.7.B: “to a blood type A2 or A2B”  Policy 14.4.A.i: “donor to be non-A1 (negative for A1) or non-A1B (negative for A1B)”  Inconsistency may create confusion The Problem

 Use consistent language for all subtype references Goal of the Proposal

 Pertinent references will read:  Blood type A, non-A 1  Blood type AB, non-A 1 B How the Proposal will Achieve its Goal

 June 2011, OPTN published guidance based on work of ABO subtyping committee  “It is important to know that the technically accurate term for A2 and A2B donors is ‘A1-negative’ or ‘A, non-A1’ because A2 is not directly tested for and many other rare subtypes exist (e.g. A3, Aint, etc.)”.  Some OPOs reluctant to report “A2” subtypes due to this issue Supporting Evidence

 Understand the meaning of the terms:  Blood type A,non-A 1  Blood type AB,non-A 1 B, What Members will Need to Do

Regional Representatives RegionName 1 Sukru Emre, MD, 2 Deborah Maurer, RN, 3 Eric Gibney, 4 Diesa Samp, BSN, RN, 5 Kristin Mekeel, MD, FACS 6 Mark Menotti, RN, 7 Colleen McCarthy, RN, 8 Nancy Long, RN, BA, 9 Colleen O'Donnell-Flores, 10 Ladora Dils, BSN, MHA, 11 Laura Butler, NP-BC,

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Proposal To Require the Reporting of Aborted Living Donor Recovery Procedures Living Donor Committee Mary Amanda Dew, PhD University of Pittsburgh

 Aborted living donor organ recovery procedures may not be reported at time of event and therefore may be under reported The Problem

 Improve safety of living donation  Help quantify risk of living donation Goals of the Proposal

 Aborted procedures - new living donor adverse event category added to UNet SM Improving Patient Safety Portal How the Proposal will Achieve its Goal

 Reliable count of aborted living donor organ recovery procedures does not exist  Since only 12 cases reported where a donation surgery was aborted after anesthesia was administered because of a threat to donor’s health Supporting Evidence

 Recovery hospitals will report aborted living donor recovery procedures within 72 hours of the event as Living Donor Adverse Events through the UNet SM Improving Patient Safety Portal What Members will Need to Do

Regional Representatives RegionName 1 Sanjay Kulkarni, 2 Francis Weng, 3 George Therapondos, 4 Matthias Kapturczak, MD, 5 Randolph Schaffer III, 6 Christian Kuhr, 7 J. Michael Millis, 8 Krista Lentine, MD, PhD 9 Carlos Marroquin, 10 Emilio Poggio, 11 Vinaya Rao,

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Proposal to Clarify Data Submission Reporting and Documentation Obligations Membership & Professional Standards Committee Ann-Marie Leary Compliance Operations Analyst, UNOS Ann-Marie Leary

 Policy does not specify what has always been implied  Data submitted through OPTN forms must be accurate  Members must provide documentation to verify data accuracy  Other policies explicitly state members must maintain or provide certain documentation The Problem

 Clarify policy to alleviate confusion  Reduce resources required to obtain documentation and review potential noncompliance issues  Only applies to standardized forms required by Policy 18 Goal of the Proposal

 Should not have to change policies or procedures  Will not be required to provide additional documentation during routine site surveys  UNOS will not change how it monitors compliance  May be asked to gather and provide relevant documentation upon request for MPSC review What Members will Need to Do

Regional Representatives RegionName 1Heung Bae Kim, MD 2 David Reich, 3 Charles Wright, 4 W. Kenneth Washburn, 5 Richard Perez, 6 Viken Douzdjian, 7 Julie Heimbach, 8 Christie Thomas, MB, FRCP, FASN, 9 Lloyd Ratner, 10 Tim Taber, 11 Robert Stratta,

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Proposal to Require the Collection of Serum Lipase for Pancreas Donors Pancreas Transplantation Committee Jonathan Fridell, MD Indiana University Health Ann-Marie Leary

 Serum lipase is a direct indicator of pancreas quality  Serum lipase is not reported for all potential pancreas donors The Problem

 Goal:  Provide transplant professionals with critical information about the quality of the pancreas offered  Change:  Require collection of serum lipase for all pancreas donors  Report lab’s upper limit of normal value for serum lipase test Goal and Achieving the Goal

 OPOs will be required to report serum lipase values for all pancreas donors  A new field gives OPOs ability to report the upper limit of normal value What Members will Need to Do

RegionName 1 Heidi Yeh, 2 Silke Niederhaus, 3 Carlos R del Coro, 4 Jacqueline Lappin, 5 Fuad Shihab, 6 Ramasamy Bakthavatsalam, 7 Jon Odorico, 8 Zoe Stewart, MD, 9 Pedro Sandoval, 10 Muhammad Mujtaba, MD, 11 Douglas Hale, Regional Representatives

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 Moving an Item to the Discussion Agenda  15% of member institutions within a region submits requests  All requests must be received one week prior to the meeting date  If 15% request:  Proposal will be presented and discussed during Regional Meeting  Regional Meeting  Councillor Moderates Voting  No Presentation or Discussion  Regional Vote Non-Discussion Agenda

Communicate directly with your Regional Representative Providing Feedback to the Committee

Online Individual Public Comment Providing Feedback to the Committee

RegionRegional AdministratorPhone Number 1,4,9Shannon 2,6,8Betsy 3,11Cliff 5,7,10Chrystal Regional Administrator Contacts