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Presentation on theme: "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."— Presentation transcript:

1 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

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

3 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

4  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 Spring 2014 Regional Meetings

5  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

6 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

7 Public Comment Proposals http://optn.transplant.hrsa.gov

8 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

9  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

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

11  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

12  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?

13  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

14  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

15 Contacts for Feedback ChairYolanda Becker, MD ybecker@surgery.bsd.uchicago.edu Vice Chair Susan Dunn, RN, BSN, MBA sdunn@donoralliance.org UNOS Staff Liaison Leigh Kades leigh.kades@unos.org

16 Questions – Click hand button

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

18  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

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

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

21  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

22  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

23 Regional Representatives RegionNameEmail 1 Sukru Emre, MD, FACSsukru.emre@yale.edu 2 Deborah Maurer, RN, MBAmaurerd@upmc.edu 3 Eric Gibney, MDeric.gibney@piedmont.org 4 Diesa Samp, BSN, RN, CCTCdsamp@sleh.com 5 Kristin Mekeel, MD, FACS kmekeel@ucsd.edu; kmekeel@rchsd.org 6 Mark Menotti, RN, MBAmenotti@ohsu.edu 7 Colleen McCarthy, RN, BSNcolleen.mccarthy@bcw.edu 8 Nancy Long, RN, BA, CCTCnlong@saint-lukes.org 9 Colleen O'Donnell-Flores, MHAColleen.O'Donnell@nyumc.org 10 Ladora Dils, BSN, MHA, CPTCddils@lifelineofohio.org 11 Laura Butler, NP-BC, MMHClaura.butler@vanderbilt.edu

24 Questions – click hand button

25 Proposal to Clarify Data Submission Reporting and Documentation Obligations Membership & Professional Standards Committee Carl Berg, MD Duke University Hospital Ann-Marie Leary

26  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

27  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

28  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

29 Regional Representatives RegionNameEmail 1Heung Bae Kim, MD heung.kim@childrens.harvard.edu 2 David Reich, MDDavid.Reich@DrexelMed.edu 3 Charles Wright, MDCharles.wright@lifelinkfound.org 4 W. Kenneth Washburn, MDwashburn@uthscsa.edu 5 Richard Perez, MDrichard.perez@ucdmc.ucdavis.edu 6 Viken Douzdjian, MDvdouzdji@lhs.org 7 Julie Heimbach, MDheimbach.julie@mayo.edu 8 Christie Thomas, MB, FRCP, FASN, FAHAchristie-thomas@uiowa.edu 9 Lloyd Ratner, MDlr2182@cumc.columbia.edu 10 Tim Taber, MDtetaber@iupui.edu 11 Robert Stratta, MDrstratta@wakehealth.edu

30 Questions – click hand button

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

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

33  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

34  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

35 RegionNameEmail 1 Heidi Yeh, MDhyeh@partners.org 2 Silke Niederhaus, MDsniederhaus@smail.umaryland.edu 3 Carlos R del Coro, MDdelcoro14@gmail.com 4 Jacqueline Lappin, MDjlappin@sw.org 5 Fuad Shihab, MDfuad.shihab@hsc.utah.edu 6 Ramasamy Bakthavatsalam, MDbaktha@uw.edu 7 Jon Odorico, MDjon@surgery.wisc.edu 8 Zoe Stewart, MD, PhDzoe-stewart@uiowa.edu 9 Pedro Sandoval, MDprs2109@columbia.edu 10 Muhammad Mujtaba, MD, FASNmmujtaba@iupui.edu 11 Douglas Hale, MDdouglas.a.hale@vanderbilt.edu Regional Representatives

36 Questions – click hand button

37 Proposal To Require the Reporting of Aborted Living Donor Recovery Procedures Living Donor Committee Christie Thomas, MD University of Iowa

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

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

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

41  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

42  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

43 Regional Representatives RegionNameEmail 1 Sanjay Kulkarni, MDsanjay.kulkarni@yale.edu 2 Francis Weng, MDfweng@barnabashealth.org 3 George Therapondos, MDgtherapondos@ochsner.org 4 Matthias Kapturczak, MD, PhDmkapturczak@sakdc.com 5 Randolph Schaffer III, MDschaffer.randolph@scrippshealth.org 6 Christian Kuhr, MDchristian.kuhr@vmmc.org 7 J. Michael Millis, MDMmillis@surgery.bsd.uchicago.edu 8 Krista Lentine, MD, PhD lentinek@slu.edu; krista.lentine@tenethealth.com 9 Carlos Marroquin, MDCarlos.Marroquin@vtmednet.org 10 Emilio Poggio, MDpoggioe@ccf.org 11 Vinaya Rao, MDvrao3@uthsc.edu

44 Questions – click hand button

45  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 Non-Discussion Agenda

46 Communicate directly with your Regional Representative Providing Feedback to the Committee

47 Online Individual Public Comment Providing Feedback to the Committee

48

49 Regional Meeting Information http://transplantpro.org

50 RegionRegional AdministratorPhone NumberE-mail 1,4,9Shannon Edwards804-782-4759Shannon.Edwards@unos.org 2,6,8Betsy Gans804-782-4814Betsy.Gans@unos.org 3,11Cliff McClenney804-782-4742Clifton.McClenney@unos.org 5,7,10Chrystal Graybill804-782-4631Chrystal.Graybill@unos.org Regional Administrator Contacts


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