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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. Objectives of Call. Non-Discussion Agenda Process Overview

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National webinar to review non discussion agenda

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


Objectives of call

Objectives of Call

  • Non-Discussion Agenda Process Overview

  • Present and Discuss Non-Discussion Agenda Proposals

  • Regional Meetings

  • Feedback to the Sponsoring Committees


Background

Background

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


Spring 2014 regional meetings

Spring 2014 Regional Meetings

  • 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


  • Regional meeting agenda

    Regional Meeting Agenda

    • 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


    Non discussion agenda proposals

    Non-Discussion Agenda Proposals

    • 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)


    Public comment proposals

    Public Comment Proposals

    http://optn.transplant.hrsa.gov


    Regional meeting information

    Regional Meeting Information

    http://transplantpro.org


    Proposal to allow non substantive changes to the optn policies and bylaws

    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

    Ann-Marie Leary


    The problem

    The Problem

    • 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


    Goal of the proposal

    Goal of the Proposal

    • Allow staff to make non-substantive changes immediately, without Board approval

    • Executive Committee would review these changes later


    How the proposal will achieve its goal

    How the Proposal will Achieve its Goal

    • 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


    What s a non substantive change

    What’s a “non-substantive” change?

    • 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


    Supporting evidence

    Supporting Evidence

    • Many legislative and regulatory bodies have procedures that provide authority for making minor changes to their policies and legislation:

      • § 30-149. Authority for minor changes to the Code of Virginia

      • North Carolina General Statutes § 150B-21.20 (Codifier's Authority to Revise Form of Rules)

      • Washington Revised Code § 1.08.015 (Codification and Revision of Laws – Scope of Revision)


    What members will need to do

    What Members will Need to Do

    • 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


    Contacts for feedback

    Contacts for Feedback


    Questions

    Questions

    • Through the webinar, please indicate you have a question by clicking the hand icon

    • We will open the phone line for all callers


    Proposal to modify abo subtyping references for consistency

    Proposal to Modify ABO Subtyping References for Consistency

    Operations and Safety Committee

    Theresa Daly, MS, RN, FNP

    New York-Presbyterian/Columbia


    The problem1

    The Problem

    • 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


    Goal of the proposal1

    Goal of the Proposal

    • Use consistent language for all subtype references


    How the proposal will achieve its goal1

    How the Proposal will Achieve its Goal

    • Pertinent references will read:

      • Blood type A, non-A1

      • Blood type AB, non-A1B


    Supporting evidence1

    Supporting Evidence

    • 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


    What members will need to do1

    What Members will Need to Do

    • Understand the meaning of the terms:

      • Blood type A,non-A1

      • Blood type AB,non-A1B,


    Regional representatives

    Regional Representatives


    Questions1

    Questions

    • Through the webinar, please indicate you have a question by clicking the hand icon

    • We will open the phone line for all callers


    Proposal to require the reporting of aborted living donor recovery procedures

    Proposal To Require the Reporting of Aborted Living Donor Recovery Procedures

    Living Donor Committee

    Mary Amanda Dew, PhD

    University of Pittsburgh


    The problem2

    The Problem

    • Aborted living donor organ recovery procedures may not be reported at time of event and thereforemay be under reported


    Goals of the proposal

    Goals of the Proposal

    • Improve safety of living donation

    • Help quantify risk of living donation


    How the proposal will achieve its goal2

    How the Proposal will Achieve its Goal

    • Aborted procedures - new living donor adverse event category added to UNetSM Improving Patient Safety Portal


    Supporting evidence2

    Supporting Evidence

    • Reliable count of aborted living donor organ recovery procedures does not exist

    • Since 2003 - only 12 cases reported where a donation surgery was aborted after anesthesia was administered because of a threat to donor’s health


    What members will need to do2

    What Members will Need to Do

    • Recovery hospitals will report aborted living donor recovery procedures within 72 hours of the event as Living Donor Adverse Events through the UNetSM Improving Patient Safety Portal


    Regional representatives1

    Regional Representatives


    Questions2

    Questions

    • Through the webinar, please indicate you have a question by clicking the hand icon

    • We will open the phone line for all callers


    Proposal to clarify data submission reporting and documentation obligations

    Proposal to Clarify Data Submission Reporting and Documentation Obligations

    Membership & Professional Standards Committee

    Ann-Marie Leary

    Compliance Operations Analyst, UNOS

    Ann-Marie Leary

    Ann-Marie Leary


    The problem3

    The Problem

    • 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


    Goal of the proposal2

    Goal of the Proposal

    • 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


    What members will need to do3

    What Members will Need to Do

    • 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


    Regional representatives2

    Regional Representatives


    Questions3

    Questions

    • Through the webinar, please indicate you have a question by clicking the hand icon

    • We will open the phone line for all callers


    Proposal to require the collection of serum lipase for pancreas donors

    Proposal to Require the Collection of Serum Lipase for Pancreas Donors

    Pancreas Transplantation Committee

    Jonathan Fridell, MD

    Indiana University Health

    Ann-Marie Leary

    Ann-Marie Leary


    The problem4

    The Problem

    • Serum lipase is a direct indicator of pancreas quality

    • Serum lipase is not reported for all potential pancreas donors


    Goal and achieving the goal

    Goal and Achieving the Goal

    • 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


  • What members will need to do4

    What Members will Need to Do

    • 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


    Regional representatives3

    Regional Representatives


    Questions4

    Questions

    • Through the webinar, please indicate you have a question by clicking the hand

    • We will open the phone line for all callers


    Non discussion agenda

    Non-Discussion Agenda

    • 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


    Providing feedback to the committee

    Providing Feedback to the Committee

    Communicate directly with your Regional Representative


    Providing feedback to the committee1

    Providing Feedback to the Committee

    Online Individual Public Comment


    Regional administrator contacts

    Regional Administrator Contacts


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