National Webinar to Review Non-Discussion Agenda

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