National Webinar to Review Non-Discussion Agenda

National Webinar to Review Non-Discussion Agenda

Fall 2014 Public Comment

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Share Non-Discussion Agenda development process

Present and Discuss Non-Discussion proposals

Review Regional Meeting voting procedures

Methods to submit feedback to the committee

Objectives of Call

Regional Meeting Goals

Discuss and comment on proposed policies and bylaws Collect feedback and provide to sponsoring committees Advisory to the councillor during Board deliberations

Executive Update on OPTN/UNOS activities

Receive updates on OPTN/UNOS committee activities and projects

Discuss regional business

Background

18 proposals submitted for public comment 2 VCA proposals

10 OPTN/UNOS committees with updates

Feedback Sessions

Fall 2014 Regional Meetings

Discussion Agenda Eleven proposals presented, discussed and voted on during

meeting

Non-Discussion Agenda Five proposals presented today No discussion at the regional meeting Regional Vote

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 Agenda

Proposal to Convert KPD Contact Responsibilities and Donor Pre-Select Requirements from the OPTN/UNOS Kidney Paired Donation Pilot Program Operational Guidelines into OPTN Policy (Kidney Committee)

Clarification of Multi-Organ Policies  (Policy Oversight Committee)

Proposal to Automatically Transfer Pediatric Classification for Registered Liver Candidates Turning (Pediatric Committee)

Proposal to Collect Extracorporeal Membrane Oxygenation (ECMO) Data upon Waitlist Removal for Lung Candidates(Thoracic Transplantation Committee)

Proposal to Reduce the Reporting Requirements for the Deceased Donor Registration Form(OPO Committee)

Non-Discussion Agenda Proposals

Fall 2014 Public Comment Proposals

September 23rd

Draft proposals posted to the OPTN website: http://optn.transplant.hrsa.gov/ContentDocuments/2014-09_Public_Comment.pdf

September 29th

Proposals officially released and posted to the OPTN website and open for comment

Proposal to Convert KPD Contact Responsibilities and Donor Pre-

Select Requirements from Operational Guidelines into OPTN

Policy

Kidney Transplantation Committee

Mark Aeder, MD

OPTN/UNOS KPD Pilot Program (KPDPP)

still governed by guidelines and policies

processes that help make program run efficiently are in guidelines

guidelines not enforceable, monitorable or transparent

The Problem

Facilitate efficient operations of OPTN/UNOS KPDPP Reduce match failures Reduce time from match offer to match acceptance and

transplant

Goal of the Proposal

Donor Pre-Select You may pre-accept or pre-refuse all potential donors for a

particular candidate System will not match candidates with pre-refused donors CPRA > 90% - donor pre-select is mandatory

potential donors not pre-accepted are treated as pre-refused

KPD Contact responsibilities Timelines for responses to match offers Ability to request extensions

How the Proposal will Achieve its Goal

For donor pre-select: If CPRA > 90%--pre-accept or pre-refuse all potential

donors If CPRA < 90%--pre-accept or pre-refuse is optional but

encouraged

Appoint a KPD contact and alternate Perform post-match offer responsibilities within timeframes

defined by policy

What Members will Need to Do

What Members Will Need to DoUpon receipt of a match offer, the following members:

Must: Within:

Transplant hospital receiving match offer

Report preliminary response to the OPTN (in the KPD application)

2 business days of receiving the match offer.

Transplant hospital with matched candidate

Give the matched donor’s transplant hospital: • required contents in the crossmatch kit• instructions for the donor • address for sending completed blood

samples to

2 business days of receiving notification of preliminary offer acceptance.

The matched donor transplant hospital

Send the completed blood samples to the address specified by the matched candidate’s hospital.

5 business days of receiving the required information (see middle column above) from the transplant hospital with the matched candidate

The matched donor transplant hospital

Records must include any updated serology and NAT testing results, and must indicate whether the matched donor is increased risk according to the PHS Guidelines.

2 business days of receiving notification of preliminary exchange acceptance.

The matched candidate transplant hospital

Report the results of the crossmatch to the OPTN (in the KPD application)

13 business days of receiving notification of preliminary exchange acceptance.

The matched candidate transplant hospital

Review the matched donor’s records and report a final acceptance or refusal of the match to the OPTN Contractor (in the KPD application)

13 business days of notification of preliminary exchange acceptance.

Questions – Click hand button

Questions?Committee Chair Richard Formica, MD richard.formica@yale.edu

Committee Liaison Gena Boyle, MPA gena.boyle@unos.org

Region 1 Rep Reginald Gohh, MD rgohh@lifespan.org

Region 2 Rep Alexander Gilbert, MD Alexander.J.Gilbert@gunet.georgetown.edu

Region 3 Rep Nicole Turgeon, MD nturgeo@emory.edu

Region 4 Rep Steven Potter, MD, FACS srpotter@etmc.org

Region 5 Rep Jonathan Fisher, MD, FACS fisher.jonathan@scrippshealth.org

Region 6 Rep Eric Langewisch, MD langewis@ohsu.edu

Region 7 Rep Arjang Djamali, MD axd@medicine.wisc.edu

Region 8 Rep Clifford Miles, MD cdmiles@unmc.edu

Region 9 Rep Liise Kayler, MD, MS, FACS lkayler@montefiore.org

Region 10 Rep Dean Kim, MD dkim3@hfhs.org; DKim3@dmc.org

Region 11 Rep Titte Srinivas, MD srinivat@musc.edu

Clarification of Multi-Organ Policies

Policy Oversight Committee (POC)

Mark Aeder, MD

Plain language rewrite project revealed OPTN multi-organ policies as unclear and inconsistent

Required substantive changes - out of scope of plain language rewrite

Organ-specific committees need to address multi-organ allocation issues

The Problem

Clarification and better readability of these policies

Improvements in organization

Deletion of duplicated policy language

Goal of the Proposal

Multi-committee work group:

drafted proposed policy language

provided input to ensure that changes are in-line with clinical practice

How the Proposal will Achieve its Goal

Changes to policy language:

2.15.F (Multiple Organ Procurement) – edited for clarity and to explain requirements for organ recovery

3.4.C (Candidate Registrations) – Moved the multi-organ candidate registration requirements to this section

5.4.D (Multiple Organ Procurement and Offers) – deleted, since it has the same information as 2.15.F

How the Proposal will Achieve its Goal

Changes to policy language (cont.):

New sections 5.8.A (Allocation of Heart-Lungs) and 5.8.B (Other Multi-Organ Combinations) clarifies current language and eliminates payback recommendation

Moved Current 6.4.A (Waiting Time for Multi-organ Candidates – Heart, Lung, and Heart/Lung) to 3.7 (Waiting Time Modifications) for better organization

How the Proposal will Achieve its Goal

Board review – June 2015 If approved, effective Sept. 1, 2015

Transplant programs and OPOs - familiarize yourselves with revised policies

Current way of compliance monitoring won’t change

What Members will Need to Do

Questions – click hand button

Yolanda Becker, MDChair, Policy Oversight Committee

ybecker@surgery.bsd.uchicago.edu

Leigh A. Kades, MA Liaison, Policy Oversight Committee

leigh.kades@unos.org

Questions?

Proposal to Automatically Transfer Pediatric Classification for Registered Liver Candidates

Turning 18

Pediatric Transplantation Committee

Eileen Brewer, MD

Liver inconsistent with most other organ allocation policy for pediatrics: Pediatric classification not automatically

retained when a liver candidate turns 18 Exception: Status 1A and 1B candidates

rogram can apply to RRB for pediatric classification for adult candidates (age 18 and older) to return to the waitlist if ever registered prior rograms not aware of this exception process.

The Problem

Retain pediatric classification for all liver candidates who turn 18 while waiting

Eliminate pediatric classification exception process for adults ever listed before age 18 but since removed and relisted

Goal of the Proposal

RRBs consistent in decision-making in decision-making

38 MELD candidates that would qualify for automatic ped classification (as of June 20) 71% (27) were 15-17 years old at listing Age 18-33, only 11% (4) older than 25 Wait time <1-17 years Most MELD scores <13 (5 with past due re-certifications) No previous liver transplants Most had received at least one offer No prevalent diagnosis

Bs consistent in decision-making

Supporting Evidence

If approved by the Board, proposal will be implemented without any action from liver programs

Will require UNetSM programming to fully automate

What Members will Need to Do

Questions – click hand button

Questions?Committee Chair Eileen Brewer, MD ebrewer@bcm.edu

Committee Liaison Christine Flavin, MPH christine.flavin@unos.org

Region 1 Rep Nancy Rodig, MD nancy.rodig@Childrens.harvard.edu

Region 2 Rep Kenneth Lieberman, MD klieberman@hackensackumc.org

Region 3 Rep Jayme Locke, MD, MPH jlocke@uabmc.edu; jayme.locke@va.gov

Region 4 Rep Dev Desai, MD, PhD dev.desai@utsouthwestern.edu

Region 5 Rep Linda Book, MD linda.book@imail.org

Region 6 Rep Patrick Healey, MD patrick.healey@seattlechildrens.org

Region 7 Rep Srinath Chinnakotla, MD, MCh

schinnak@umn.edu; chinni@umn.edu

Region 8 Rep Steven Kindel, MD skindel@childrensomaha.org

Region 9 Rep Nadia Ovchinsky, MD novchins@montefiore.org

Region 10 Rep Julia Steinke, MD julia.steinke@spectrumhealth.org

Region 11 Rep Andrew Savage, MD savageaj@musc.edu

Proposal to Collect Extracorporeal Membrane

Oxygenation (ECMO) Data When Removing Lung Candidates from

Waitlist

Thoracic Transplantation Committee

Joseph Rogers, MD

Insufficient data to analyze effect of ECMO on candidates listed for lung transplant

ECMO use currently only reported at time of registration at time of transplant

The Problem

Collect ECMO data from a contemporary cohort of lung transplant candidates

Analyze ECMO data

Determine if ECMO should be a variable in the LAS calculation

Goal of the Proposal

Modify candidate removal page in WaitlistSM to include fields for ECMO/mechanical ventilatory support data Dates of cannulation/intubation and

decannulation/extubation Site of cannulation Ambulation status Type of ECMO (VA or VV)

How the Proposal will Achieve its Goal

Growing use of ECMO as bridge to transplant

Correlation between high LAS at transplant and ECMO use

Conflicting retrospective studies regarding relationship between ECMO use and post-transplant outcomes

Supporting Evidence

Transplant Programs must:

Report whether a candidate was supported by invasive mechanical ventilation or ECMO

If yes, report information for additional data fields for each lung candidate you remove from WaitlistSM

What Members will Need to Do

Questions – click hand button

Questions?Committee Chair Joe Rogers, MD joseph.rogers@duke.edu

Committee Liaison Liz Robbins Callahan liz.robbins@unos.org

Region 1 Rep Todd Astor, MD, FCCP tastor@partners.org

Region 2 Rep Ryan Davies, MD Rdavies@nemours.org

Region 3 Rep Parag Patel, MD patel.parag@mayo.edu

Region 4 Rep Mark Drazner, MD, MSC mark.drazner@utsouthwestern.edu

Region 5 Rep David Weill, MD dweill@stanford.edu

Region 6 Rep Erika Lease, MD elease@medicine.washington.edu

Region 7 Rep Christopher Wigfield, MD, FRCS, (C/Th)

cwigfield@surgery.bsd.uchicago.edu

Region 8 Rep Scott Silvestry, MD silvestrys@wustl.edu; silvestrys@wudosis.wustl.edu

Region 9 Rep Maryjane Farr, MD maf2171@columbia.edu

Region 10 Rep Thomas Wozniak, MD twozniak@iuhealth.org

Region 11 Rep Mark Steele, MD mark.p.steele@vanderbilt.edu

Proposal to Reduce the Reporting Requirements for the Deceased Donor Registration

(DDR) Form

Organ Procurement Organization Committee

Jennifer Prinz and Patti Niles

Inconsistent data reporting on potential deceased donors that do not proceed to donation

Policy: Host OPO must complete deceased donor registration (DDR) for all deceased donors and authorized but not recovered potential deceased donors DDR never intended to be used for non-donors DDR contains basic demographic information and

detailed clinical information that only applies to actual donors

The Problem

Remove policy requirement to complete the DDR for non-donors Current requirement provides minimal information

Goals of the Proposal

Complete the donor feedback form

DDR will not be generated if you check the “no organs were transplanted for the purpose of transplantation” box (currently labeled as “referral only”)

Requirements for completing Death Notification Registration won’t change

Routine monitoring of OPTN members won’t change

UNet data subject to OPTN review-members must provide documentation as requested

What Members will Need to Do

Questions?Committee Chair Sean Van Slyck svanslyck@ctdn.org

Committee Liaison

Robert Hunter robert.hunter@unos.org

Region 1 Rep Helen Nelson, RN, BSN, CCTC, CPTC

helen_nelson@neob.org

Region 2 Rep Debbie Williams, MBA, BSN, RN dwilliams@thellf.org

Region 3 Rep Ram Subramanian, MD rmsubra@emory.edu

Region 4 Rep Tammie Peterson, MSH/MPH, RN, CPTC

tammie.peterson@baylorhealth.edu

Region 5 Rep Sindhu Chandran, MD sindhu.chandran@ucsf.edu

Region 6 Rep Stephen Kula, PhD, NHA skula@legacyoflifehawaii.org

Region 7 Rep J. Kevin Cmunt, BS, MS kcmunt@giftofhope.org

Region 8 Rep Diane Brockmeier, RN, BSN, MA dbrockmeier@mts-stl.org

Region 9 Rep Rebecca Milczarski, MSN, MBA, CPTC

rebecca_milczarski@urmc.rochester.edu

Region 10 Rep Ellen Blair, RN, CPTC eblair@lcodro.org

Region 11 Rep Paul O’Flynn poflynn@kodaorgan.com

Questions – click hand button

Submit comments on the OPTN website beginning 9/29 http

://optn.transplant.hrsa.gov/governance/public-comment/

Communicate with your regional representative

Webinar scheduled for October 20th at 2pm ET for members not attending today’s webinar Registration Link:

https://attendee.gotowebinar.com/register/4113117229163803394

Providing Feedback

Regional Meeting Information

http://transplantpro.org

Region Regional Administrator Phone Number E-mail

1,4,9 Shannon Edwards 804-782-4759 Shannon.Edwards@unos.org

2,6,8 Betsy Gans 804-782-4814 Betsy.Gans@unos.org

3,11 Cliff McClenney 804-782-4742 Clifton.McClenney@unos.org

5,7,10 Chrystal Graybill 804-782-4631 Chrystal.Graybill@unos.org

Regional Administrator Contacts