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National Webinar to Review
Non-Discussion Agenda
Spring 2014 Public Comment
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Objectives of Call
Non-Discussion Agenda Process Overview

Present and Discuss Non-Discussion Agenda
Proposals

Regional Meetings

Feedback to the Sponsoring Committees
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

17 proposals submitted for public comment

11 OPTN/UNOS committees with updates


Committee projects that require regional discussion and
feedback
1.5 additional hours to the standard 5 hour regional
meeting
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
 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
http://optn.transplant.hrsa.gov
Proposal to Allow Non-Substantive
Changes to the OPTN Policies and
Bylaws
Policy Oversight Committee
Stuart Sweet, MD
St Louis Children’s Hospital
Ann-Marie Leary
Ann-Marie Leary
The Problem

Sometimes we find obvious clerical (or nonsubstantive) 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

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

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?

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

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

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
Chair
Yolanda Becker, MD
[email protected]
Vice Chair
Susan Dunn, RN, BSN,
MBA
[email protected]
UNOS Staff
Liaison
Leigh Kades
[email protected]
Questions – Click hand button
Proposal to Modify ABO
Subtyping References for
Consistency
Operations and Safety Committee
Theresa Daly, MS, RN, FNP
New York-Presbyterian/Columbia
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 Proposal

Use consistent language for all subtype references
How the Proposal will Achieve its Goal

Pertinent references will read:
 Blood type A, non-A1
 Blood type AB, non-A1B
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 Do

Understand the meaning of the terms:
 Blood type A,non-A1
 Blood type AB,non-A1B,
Regional Representatives
Region
Name
Email
1
Sukru Emre, MD, FACS
[email protected]
2
Deborah Maurer, RN, MBA
[email protected]
3
Eric Gibney, MD
[email protected]
4
[email protected]
5
Diesa Samp, BSN, RN, CCTC
Kristin Mekeel, MD, FACS
[email protected]; [email protected]
6
Mark Menotti, RN, MBA
[email protected]
7
Colleen McCarthy, RN, BSN
[email protected]
8
Nancy Long, RN, BA, CCTC
[email protected]
9
Colleen O'Donnell-Flores, MHA
Colleen.O'[email protected]
10
Ladora Dils, BSN, MHA, CPTC
[email protected]
11
Laura Butler, NP-BC, MMHC
[email protected]
Questions – click hand button
Proposal to Clarify Data
Submission Reporting and
Documentation Obligations
Membership & Professional Standards Committee
Carl Berg, MD
Duke University Hospital
Ann-Marie Leary
Ann-Marie Leary
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 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 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 Representatives
Region
Name
Email
1
Heung Bae Kim, MD
[email protected]
2
David Reich, MD
[email protected]
3
Charles Wright, MD
[email protected]
4
W. Kenneth Washburn, MD
[email protected]
5
Richard Perez, MD
[email protected]
6
Viken Douzdjian, MD
[email protected]
7
Julie Heimbach, MD
[email protected]
8
Christie Thomas, MB, FRCP, FASN, FAHA
[email protected]
9
Lloyd Ratner, MD
[email protected]
10
Tim Taber, MD
[email protected]
11
Robert Stratta, MD
[email protected]
Questions – click hand button
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 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:


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 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 Representatives
Region
Name
Email
1
Heidi Yeh, MD
[email protected]
2
Silke Niederhaus, MD
[email protected]
3
Carlos R del Coro, MD
[email protected]
4
Jacqueline Lappin, MD
[email protected]
5
Fuad Shihab, MD
[email protected]
6
Ramasamy Bakthavatsalam, MD
[email protected]
7
Jon Odorico, MD
[email protected]
8
Zoe Stewart, MD, PhD
[email protected]
9
Pedro Sandoval, MD
[email protected]
10
Muhammad Mujtaba, MD, FASN
[email protected]
11
Douglas Hale, MD
[email protected]
Questions – click hand button
Proposal To Require the
Reporting of Aborted Living
Donor Recovery Procedures
Living Donor Committee
Christie Thomas, MD
University of Iowa
The Problem

Aborted living donor organ recovery
procedures may not be reported at time of
event and therefore may be under reported
Goals of the Proposal

Improve safety of living donation

Help quantify risk of living donation
How the Proposal will Achieve its Goal

Aborted procedures - new living donor
adverse event category added to UNetSM
Improving Patient Safety Portal
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 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 Representatives
Region
Name
Email
1
Sanjay Kulkarni, MD
[email protected]
2
Francis Weng, MD
[email protected]
3
George Therapondos, MD
[email protected]
4
Matthias Kapturczak, MD, PhD
[email protected]
5
Randolph Schaffer III, MD
[email protected]
6
Christian Kuhr, MD
[email protected]
7
J. Michael Millis, MD
Krista Lentine, MD, PhD
[email protected]
[email protected];
[email protected]
9
Carlos Marroquin, MD
[email protected]
10
Emilio Poggio, MD
[email protected]
11
Vinaya Rao, MD
[email protected]
8
Questions – click hand button
Non-Discussion Agenda

Process for moving a proposal to the Discussion
Agenda




15% of member institutions within a region submit a request
All requests must be received one week prior to the meeting
date
If the15% threshold is met:
 Proposal will be presented and discussed during Regional
Meeting
Regional Meeting


No Presentation or Discussion
Regional Vote
Providing Feedback to the Committee
Communicate directly with your Regional
Representative
Providing Feedback to the Committee
Online Individual Public Comment
Regional Meeting Information
http://transplantpro.org
Regional Administrator Contacts
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]