national webinar to review non-discussion agenda
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National Webinar to Review Non-Discussion Agenda. Fall 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. Objectives of Call. Share Non-Discussion Agenda development process - PowerPoint PPT PresentationTRANSCRIPT
National Webinar to Review Non-Discussion Agenda
Fall 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
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 [email protected]
Committee Liaison Gena Boyle, MPA [email protected]
Region 1 Rep Reginald Gohh, MD [email protected]
Region 2 Rep Alexander Gilbert, MD [email protected]
Region 3 Rep Nicole Turgeon, MD [email protected]
Region 4 Rep Steven Potter, MD, FACS [email protected]
Region 5 Rep Jonathan Fisher, MD, FACS [email protected]
Region 6 Rep Eric Langewisch, MD [email protected]
Region 7 Rep Arjang Djamali, MD [email protected]
Region 8 Rep Clifford Miles, MD [email protected]
Region 9 Rep Liise Kayler, MD, MS, FACS [email protected]
Region 10 Rep Dean Kim, MD [email protected]; [email protected]
Region 11 Rep Titte Srinivas, MD [email protected]
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
Leigh A. Kades, MA Liaison, Policy Oversight Committee
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 [email protected]
Committee Liaison Christine Flavin, MPH [email protected]
Region 1 Rep Nancy Rodig, MD [email protected]
Region 2 Rep Kenneth Lieberman, MD [email protected]
Region 3 Rep Jayme Locke, MD, MPH [email protected]; [email protected]
Region 4 Rep Dev Desai, MD, PhD [email protected]
Region 5 Rep Linda Book, MD [email protected]
Region 6 Rep Patrick Healey, MD [email protected]
Region 7 Rep Srinath Chinnakotla, MD, MCh
[email protected]; [email protected]
Region 8 Rep Steven Kindel, MD [email protected]
Region 9 Rep Nadia Ovchinsky, MD [email protected]
Region 10 Rep Julia Steinke, MD [email protected]
Region 11 Rep Andrew Savage, MD [email protected]
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 [email protected]
Committee Liaison Liz Robbins Callahan [email protected]
Region 1 Rep Todd Astor, MD, FCCP [email protected]
Region 2 Rep Ryan Davies, MD [email protected]
Region 3 Rep Parag Patel, MD [email protected]
Region 4 Rep Mark Drazner, MD, MSC [email protected]
Region 5 Rep David Weill, MD [email protected]
Region 6 Rep Erika Lease, MD [email protected]
Region 7 Rep Christopher Wigfield, MD, FRCS, (C/Th)
Region 8 Rep Scott Silvestry, MD [email protected]; [email protected]
Region 9 Rep Maryjane Farr, MD [email protected]
Region 10 Rep Thomas Wozniak, MD [email protected]
Region 11 Rep Mark Steele, MD [email protected]
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 [email protected]
Committee Liaison
Robert Hunter [email protected]
Region 1 Rep Helen Nelson, RN, BSN, CCTC, CPTC
Region 2 Rep Debbie Williams, MBA, BSN, RN [email protected]
Region 3 Rep Ram Subramanian, MD [email protected]
Region 4 Rep Tammie Peterson, MSH/MPH, RN, CPTC
Region 5 Rep Sindhu Chandran, MD [email protected]
Region 6 Rep Stephen Kula, PhD, NHA [email protected]
Region 7 Rep J. Kevin Cmunt, BS, MS [email protected]
Region 8 Rep Diane Brockmeier, RN, BSN, MA [email protected]
Region 9 Rep Rebecca Milczarski, MSN, MBA, CPTC
Region 10 Rep Ellen Blair, RN, CPTC [email protected]
Region 11 Rep Paul O’Flynn [email protected]
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 [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