National Webinar to Review
Non-Discussion Agenda
Fall 2015 Public Comment
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1
Webinar Objectives
 Review
non-discussion agenda process
 Present
and discuss proposals on the non-discussion
agenda
 Review
methods to submit feedback to sponsoring
committees
2
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 committee activities and projects

Discuss regional business
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Regional Meeting Agenda

Discussion Agenda


Non-Discussion Agenda




8 proposals presented, discussed, and voted on during meeting
4 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 regional meeting date
If the 15% threshold is met, proposal will be presented and discussed during
regional meeting
4
Non-Discussion Agenda Proposals

Proposed Changes to Transplant Program Key Personnel Procurement
Requirements (Membership and Professional Standards Committee)

Revising Kidney Paired Donation Pilot Program Priority Points (Kidney
Transplantation Committee)

Proposal to Update the Human Leukocyte Antigen (HLA) Equivalency
Tables (Histocompatibility Committee)

Proposal to Reduce the Documentation Shipped with Organs (Organ
Procurement Organization Committee)
5
Changes to Transplant Program Key
Personnel Procurement Requirements
Membership and Professional Standards Committee
Fall 2015
6
What is the goal of the proposal?
 Update




key personnel procurement Bylaws to:
Correct unexplained inconsistencies
Clearly establish requirements that are currently viewed as optional
Remove unnecessary specificity
Accommodate applications that the MPSC generally believes are acceptable,
but that it must reject due to current Bylaws requirements
 Thereby,

Simplifying the key personnel application process for members and the MPSC
7
What problem will the proposal solve?
 Inconsistent
primary surgeon procurement requirements
 Solution:


Delete primary kidney transplant surgeon multi-organ procurement
requirement
Delete primary liver transplant surgeon donor selection and management
requirement
8
What problem will the proposal solve?
 The
word “should” means Primary transplant physician aren’t
required to observe organ procurements
 Solution:

Use the word “must”
9
What problem will the proposal solve?
 Questionable
necessity of specifying primary transplant
physicians must observe multi-organ donor procurements
 Solution:

Delete primary transplant physician multi-organ procurement
observation requirement

Exposure to multi-organ donors will likely occur without an explicit OPTN
Bylaws requirement considering:
 Proposed change that primary transplant physicians must observe at
least three organ procurements
 Multiple organs procured from the overwhelming majority of donors
10
What problem will the proposal solve?
 Surgeons
applying through fellowship pathway sometimes
meet all requirements, but didn’t perform the requisite
number of procurements during fellowship
 Solution:


Allow applying surgeons to cite procurements performed both
during their fellowship and 2 years after completion
Otherwise, must apply through clinical experience pathway
11
Supporting Evidence
 Proposal
stems directly from recommendations
developed by a Joint Societies Working Group
(JSWG)
 Collaborative effort between:
 American Society of Transplantation (AST)
 American Society of Transplant Surgeons (ASTS)
 North American Transplant Coordinators Organization (NATCO)
 MPSC
12
How will members implement this proposal?

No immediate action required of members upon implementation

Membership and key personnel change applications submitted on
or after the implementation date will be evaluated based on these
requirements

Anticipated board review date – December 2015

Anticipated implementation date – March 2016
13
How does this proposal support the OPTN
Strategic Plan?
 Promote
the efficient management of the OPTN
 Proposal
addresses key personnel procurement
requirements that are:



inconsistent
unnecessarily specific
needing additional flexibility
14
Questions
15
Questions – click hand button
16
Questions?
Committee Chair
Jonathan Chen, MD
jonathan.chen@seattlechildrens.org
Committee Liaison
Chad Waller
Chad.Waller@unos.org
Region 1 Rep
David Axelrod, MD, MBA
david.a.axelrod@hitchcock.org
Region 2 Rep
Matthew Cooper, MD
matthew.cooper@medstar.net
matthew.cooper@gunet.georgetown.edu
Region 3 Rep
Thomas Pearson, MD, D.Phil.
tpearso@emory.edu
Region 4 Rep
Adam Bingaman, MD, PhD
adam.bingaman@mhshealth.com
Region 5 Rep
Lisa Stocks, RN, MSN, FNP
lstocks@ucsd.edu
Region 6 Rep
Christian Kuhr, MD
christian.kuhr@vmmc.org
Region 7 Rep
David Cronin II, MD, PhD, MHCM
dcronin@mcw.edu
Region 8 Rep
Timothy Schmitt, MD, FACS
tschmitt@kumc.edu
Region 9 Rep
Lewis Teperman, MD
lewis.teperman@nyumc.org
Region 10 Rep
Todd Pesavento, MD
todd.pesavento@osumc.edu
Region 11 Rep
Kenneth Brayman, MD, PhD, FACS
klb9r@hscmail.mcc.virginia.edu
17
Revising Kidney Paired
Donation Pilot Program Priority
Points
Kidney Transplantation Committee
Fall 2015
18
What problem will the proposal solve?
Problem 1
Solution
• OPTN KPD system does not fully consider:
• Increased difficulty in matching some pairs (i.e.
high CPRA and certain blood types)
• Certain data to identify matches more likely to be
accepted
• Revise optimization algorithm’s priority points to
identify matches to optimize the pair pool for
“difficult to match” pairs and consider potentially
relevant data
19
What problem will the proposal solve?
Problem 2
Solution
• KPD informed consent policies will require
programs to inform on remedies for failed
exchanges (if one exists)
• OPTN policy does not provide a remedy for
candidates in failed exchanges in the OPTN
KPD
• Award high point value to “orphan candidates”
(1,000,000 points)
• Ensures that NDD chain will end with “orphan
candidate” if possible
• Only applies to candidates “orphaned” in the
OPTN KPD
20
How does the proposal address the problem
statement?
Maintain
Remove
Revise
• Base points for
all matches
(100 pts)
• Points for prior
living donors
and pediatric
candidates
• Waiting time
• Points for same
region and
same DSA
• Negative points
for “all other
antibody
specificities”
• Adopt a sliding
scale CPRA
• Increase points
for same
hospital
matches
• Reduce points
for 0-ABDR
mismatches
Add Points
Categories
• Candidate and
paired donor
ABO
• Previous
negative or
positive but
acceptable
crossmatches
(with or without
desensitization)
• Orphan
candidates
21
Supporting Evidence
Sensitivity Study
Design
• Re-optimized 136
historical OPTN
KPD match runs
using 24 scenarios
Evaluation
Limitations
• # and % of matches
by candidate and
pair characteristics
• Match rate
• Change in total # of
matches found
• Impact of potential
changes on
equitable access
for patients
• Focus on # of
matches, not
transplants
• Static study
• Limited ability to
evaluate small
subpopulations (i.e.
living donors)
22
Supporting Evidence – Overall Trends
 Increased
the # of matching opportunities for 99% and
100% CPRA candidates
 Prioritizing
by pair characteristics increased the # of
matching opportunities for hard to match pairs
 Blood type O candidates
 Candidate’s whose paired donor is non-O
23
How will members implement this proposal?
 Members
participating in KPDPP will need to communicate
the changes as a part of informed consent, particularly about
the remedy for a failed exchange
 Proposal
 No
does not require additional data collection
changes to current routine site surveys
 Anticipated
Board Date: December 2015
 Implementation
Date: Pending programming
24
How does this proposal support the OPTN
Strategic Plan?
 Increase the number of transplants
 Increase # of matches found
 Incentivize transplant hospitals to participate
 Use data to improve chance of timely offers to candidates most
likely to accept
 Improve equity in access to transplants
 Addresses increased difficulty in matching certain blood types and
CPRA levels
 Improves access for candidates in failed exchanges
25
Questions
26
Questions – click hand button
27
Questions?
Committee Chair
Mark Aeder, MD
mark.aeder@uhhospitals.org
Committee Liaison
Melinda Woodbury
Melinda.Woodbury@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
Truman Earl, MD, MSCI
tearl@umc.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
Didier Mandelbrot, MD
damandel@medicine.wisc.edu
Region 8 Rep
Clifford Miles, MD
cdmiles@unmc.edu
Region 9 Rep
Vinay Nair, DO
vinay.nair@msnyuhealth.org;
vinay.nair@mountsinai.org
Region 10 Rep
Joshua Augustine, MD
joshua.augustine@uhhospitals.org
Region 11 Rep
Vincent Casingal, MD
vincent.casingal@carolinashealthcare.org
28
Proposal to Update the HLA
Equivalency Tables
Histocompatibility Committee
Fall 2015
29
What problems will the proposal solve?
 Some

equivalences have changed since last update
Proposed solution - update equivalency tables based on:
 advances in HLA typing
 the frequencies of antigens reported for donors and antigens and unacceptable
antigens reported for candidates
HLA antigen dropdowns in UNetSM disadvantage
candidates with antibodies against some alleles but not all of
them
 Some

Proposed solution - update dropdowns in UNet
 Policy

references to HLA DPB, DQA, and DQB are out of date
Proposed solution – change policy references to these loci to DPB1, DQA1, and DQB1
30
What is the goal of the proposal?
 Increase

opportunities for candidates to receive offers
Compatible donors will not be excluded based on outdated or broad
HLA typing constraints of prior equivalency tables
 Reduce
risk of positive crossmatch after shipping kidneys
nationally and regionally
31
Supporting Evidence
Broad antigens reported for deceased donors (2013-2014)
* C3 was reported by 33 labs for 264 donors.
Note: Labels show the number of labs for each broad antigen.
32
How will members implement this proposal?
 Transplant


Programs:
Request updated HLA typing using molecular methods for existing
candidates who may be affected by the changes to the
equivalences tables
Review/modify unacceptable antigens reported for candidates with
antibodies against alleles that are being added
 Labs:
 Assign split (not broad) antigens to candidates
33
How does this proposal support the OPTN
Strategic Plan?
Strategic Goal
Impact
Increase the number of transplants Improve efficiency of allocation for sensitized
candidates
Improve equity in access to
transplants
Allow members to enter more specific data to ensure
candidates are not excluded from donors against
whom they don’t have UAs
Improve waitlisted patient, living
donor, and transplant recipient
outcomes
• Table updates will lead to better compatibility and
decrease probability of post-transplant rejection
• Allocation to candidates less likely to have a
positive crossmatch reduces cold ischemia time
Promote living donor and
transplant recipient safety
Reduce risk of organ discards due to futile shipments
34
Questions
35
Questions – click hand button
36
Questions?
Committee Chair
Dolly Tyan, PhD
dtyan@stanford.edu
Committee Liaison
Geoffrey Zindren
Geoffrey.Zindren@unos.org
Region 1 Rep
Indira Guleria, PhD
iguleria@partners.org
Region 2 Rep
Julie Houp, MS
jgraz@jhmi.edu; juliehoup@jhmi.edu
Region 3 Rep
Gabriella Wheeler, PhD
gabriella.henel@piedmont.org
Region 4 Rep
Chantale Lacelle, PhD
chantale.lacelle@utsouthwestern.edu
Region 5 Rep
Dolly Tyan, PhD
dtyan@stanford.edu
Region 6 Rep
Diane Kumashiro, MS, CHS, CLS dkumashiro@hcttl.org
Region 7 Rep
Manish Gandhi, MD
gandhi.manish@mayo.edu
Region 8 Rep
Brian Freed, PhD, D(ABHI)
brian.freed@ucdenver.edu
Region 9 Rep
Allen Norin, PhD
allen.norin@downstate.edu
Region 10 Rep
Sam Ho, PhD, D(ABHI)
sho@giftoflifemichigan.org
Region 11 Rep
Peter Lalli, PhD, D(ABHI)
peter.lalli@carolinashealthcare.org
37
Proposal to Reduce the
Documentation Shipped with
Organs
Organ Procurement Organization Committee
Fall 2015
38
What problem will the proposal solve?

Current policy requires OPOs to send complete donor record with
each organ

Requirement originated before OPOs could upload information into
DonorNet®

During the TransNetsm project, UNOS staff members observed
attempts to make copies of documentation, often interrupting donor
management
39
What is the goal of the proposal?
 Free
up OPO staff to concentrate on donor management and
packaging and shipping quality by eliminating requirements
to include documentation they have already provided to
transplant centers
40
How does the proposal address the problem
statement?

Reduces the need to copy and ship documentation already provided to
transplant programs



Blood type documentation (including subtype if used for allocation) and
infectious disease testing results will still be packaged with each organ
Death pronouncement source documentation, authorization for donation source
documentation, human leukocyte antigen (HLA) type, donor evaluation and
management, donor medical and behavioral history, and organ intraoperative
findings will be provided in DonorNet upon receipt
Transplant programs can accurately and completely evaluate donor
suitability using information provided in DonorNet
41
How will members implement this proposal?

OPOs must:



Transplant hospitals must:


Submit deceased donor information to UNOS upon receipt so transplant
programs can evaluate donor suitability
Still include source documentation for blood type and infectious disease testing
with each organ
Be aware that deceased donor information is available in DonorNet and can
print copies if necessary
The proposed language will not change the way UNOS conducts its
routine site surveys
42
How does this proposal support the OPTN
Strategic Plan?
 Strategic
Goal: Promote the efficient management of
the OPTN

Allow for more efficient and timely communication of donor
information using DonorNet instead of paper documentation that
gets packaged and shipped with each organ.
43
Questions
44
Questions – click hand button
45
Questions?
Committee Chair
Sean Van Slyck, MPA, HAS, CPTC
svanslyck@dnwest.org
Committee Liaison
Robert Hunter
Robert.Hunter@unos.org
Region 1 Rep
Jill Stinebring, RN
jill_stinebring@neob.org
Region 2 Rep
Debbie Williams, MBA, BSN, RN, CPTC
dwilliams@thellf.org
Region 3 Rep
Giridhar Vedula, MD
giridhar.vedula.md@flhosp.org
Region 4 Rep
Janice Whaley, MPH, CPTC
jwhaley@lifeshareok.org
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
Daniel Lebovitz, MD
danl@lifebanc.org; dlebovitz@lifebanc.org
Region 11 Rep
Dwayne Jolly
d.jolly@kodaorgan.org
46
Fall 2015 Public Comment

Opened August 14

Closes October 14

Proposals are posted on the OPTN website under “Governance” tab
http://optn.transplant.hrsa.gov/governance/public-comment/
47
Providing Feedback

Submit comments on the OPTN website


http://optn.transplant.hrsa.gov/governance/public-comment/
Communicate with your regional representative

http://optn.transplant.hrsa.gov/converge/members/committees.asp
48
Regional Meeting Information
http://transplantpro.org
49
Regional Administrators Contacts
Region
Regional Administrator
Phone Number
Email
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
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