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National Webinar to Review Non-Discussion Agenda
Spring 2014 Public Comment
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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
http://optn.transplant.hrsa.gov
Regional Meeting Information
http://transplantpro.org
Proposal to Allow Non-Substantive Changes to the OPTN Policies and
Bylaws
Policy Oversight Committee
Mark Aeder, MDUniversity Hospitals of Cleveland
Ann-Marie LearyAnn-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:
§ 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)
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
Chair Yolanda Becker, MD [email protected]
Vice Chair Susan Dunn, RN, BSN, MBA [email protected]
UNOS Staff Liaison Leigh Kades [email protected]
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Questions
Proposal to Modify ABO Subtyping References for
Consistency
Operations and Safety Committee
Theresa Daly, MS, RN, FNPNew 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-A1
Blood type AB, non-A1B
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-A1
Blood type AB,non-A1B,
What Members will Need to Do
Regional Representatives
Region Name Email1 Sukru Emre, MD, FACS [email protected] Deborah Maurer, RN, MBA [email protected] Eric Gibney, MD [email protected] Diesa Samp, BSN, RN, CCTC [email protected]
5 Kristin Mekeel, MD, FACS [email protected]; [email protected]
6 Mark Menotti, RN, MBA [email protected] Colleen McCarthy, RN, BSN [email protected] Nancy Long, RN, BA, CCTC [email protected] Colleen O'Donnell-Flores, MHA Colleen.O'[email protected]
10 Ladora Dils, BSN, MHA, CPTC [email protected] Laura Butler, NP-BC, MMHC [email protected]
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Questions
Proposal To Require the Reporting of Aborted Living Donor Recovery Procedures
Living Donor Committee
Mary Amanda Dew, PhDUniversity 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 UNetSM Improving Patient Safety Portal
How the Proposal will Achieve its Goal
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
Supporting Evidence
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
What Members will Need to Do
Regional Representatives
Region Name Email
1 Sanjay Kulkarni, MD [email protected] Francis Weng, MD [email protected] George Therapondos, MD [email protected] Matthias Kapturczak, MD, PhD [email protected] Randolph Schaffer III, MD [email protected] Christian Kuhr, MD [email protected] J. Michael Millis, MD [email protected]
Krista Lentine, MD, [email protected];
[email protected] 9 Carlos Marroquin, MD [email protected]
10 Emilio Poggio, MD [email protected] Vinaya Rao, MD [email protected]
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Questions
Proposal to Clarify Data Submission Reporting and Documentation Obligations
Membership & Professional Standards Committee
Ann-Marie Leary Compliance Operations Analyst, UNOS
Ann-Marie LearyAnn-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
Region Name Email1 Heung Bae Kim, MD [email protected] David Reich, MD [email protected] Charles Wright, MD [email protected] W. Kenneth Washburn, MD [email protected] Richard Perez, MD [email protected] Viken Douzdjian, MD [email protected] Julie Heimbach, MD [email protected] Christie Thomas, MB, FRCP, FASN, FAHA [email protected] Lloyd Ratner, MD [email protected]
10 Tim Taber, MD [email protected] Robert Stratta, MD [email protected]
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Questions
Proposal to Require the Collection of Serum Lipase for
Pancreas Donors
Pancreas Transplantation Committee
Jonathan Fridell, MD Indiana University Health
Ann-Marie LearyAnn-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
Region Name Email
1 Heidi Yeh, MD [email protected] Silke Niederhaus, MD [email protected] Carlos R del Coro, MD [email protected] Jacqueline Lappin, MD [email protected] Fuad Shihab, MD [email protected] Ramasamy Bakthavatsalam, MD [email protected] Jon Odorico, MD [email protected] Zoe Stewart, MD, PhD [email protected] Pedro Sandoval, MD [email protected]
10 Muhammad Mujtaba, MD, FASN [email protected] Douglas Hale, MD [email protected]
Regional Representatives
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Questions
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
Region Regional Administrator Phone Number E-mail
1,4,9 Shannon Edwards 804-782-4759 [email protected]
2,6,8 Betsy Gans 804-782-4814 [email protected]
3,11 Cliff McClenney 804-782-4742 [email protected]
5,7,10 Chrystal Graybill 804-782-4631 [email protected]
Regional Administrator Contacts
