Region 7 Meeting Notes
Chicago, IL
September 17, 2015
Julie Heimbach, MD, Regional Councillor, presented a regional update that included the goals for the
meeting, upcoming regional activities and shared regional data.
Members request that the following data elements be included in the data set for the spring 2016
regional meeting:
 Review a more in-depth analysis of discard rate
 Break down the regional and national living donor number by organ, kidney or liver
 Requested that the data include the raw number in additional too percent changes
 Review ECD by donor age
Brian Shepard, UNOS CEO, presented an update on the activities of the OPTN/UNOS which included
information on OPTN/UNOS new project initiatives, status of the OPTN/UNOS strategic plan, financial and
information technology update.
Non-Discussion Agenda
The region approves (21 yes, 0 no, 0 abstention) of all four non-discussion agenda proposals.
Proposal to Update the Human Leukocyte Antigen (HLA) Equivalency Tables (Histocompatibility Committee)
Revising Kidney Paired Donation Pilot Program Priority Points (Kidney Transplantation Committee)
Changes to Transplant Program Key Personnel Procurement Requirements (Membership and Professional Standards
Committee)
Proposal to Reduce the Documentation Shipped with Organs (Organ Procurement Organization
Committee)
Discussion Agenda
Sharon Bartosh, MD presented a proposal from Pediatric Transplantation Committee. The region opposes the
proposal as written (0 yes, 21 no, 0 abstentions), But approves the proposal with one amendment (13 yes, 8 no, 0
abstentions) and comments to the committee.
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Proposal to Establish Pediatric Training and Experience Requirements in the Bylaws
The National Organ Transplant Act (NOTA) requires that the OPTN “recognize the differences in health
and in organ transplantation issues between children and adults throughout the system and adopt criteria,
policies, and procedures that address the unique health care needs of children.” Although pediatric
transplantation is an accepted subspecialty within the field of transplantation, the current OPTN Bylaws do
not include any requirements in order for programs to be approved to perform pediatric transplants.
As early as 1993, the Membership and Professional Standards Committee (MPSC) has sought guidance
from the Pediatric Transplantation Committee in establishing pediatric requirements so it could better
assess key personnel applications. The Committee proposes that a designated transplant program must
have an approved pediatric component in order to perform transplants in patients less than 18 years old.
To be approved for a pediatric component, a program must identify a qualified primary pediatric surgeon
and a qualified primary pediatric physician to serve as key personnel. By establishing pediatric
membership requirements, this proposal contributes to the OPTN Strategic Goals of improving transplant
outcomes and promoting patient safety, while protecting access to transplantation.
Regional Amendment
The nomenclature in the heading needs to be modified to read “Primary Surgeon/Physician Caring
for Transplant Patients less Than 18 Years of Age.”
The region is concerned that the current heading could be interpreted to mean that the only appropriate
personnel to serve in this role is a board certified or trained pediatric clinician. When in actuality, a primarily
adult clinician who meets the requirements can serve in the role.
Regional Comment
The region agrees with necessity to have bylaws that safeguard the pediatric population. The region is
concerned that the proposal addresses only volume requirements without establishing performance
thresholds. Ultimately, the bylaw may restrict access to care for pediatric patients while not assuring that
they are cared for at a center with satisfactory graft or patient outcomes. Members request that the
committee consider a proposal that allows centers who currently care for pediatric patients and have good
graft and patient survival to receive automatic approval. New and currently under performing centers
should be required to meet minimum standards, submit an application and be under the review of the
MPSC before receiving full approval.
Dieder Mandelbrot, MD, presented an update on activities of the Kidney Committee and one proposal for
consideration. The region opposes the proposal as written (0 yes, 21 no, 0 abstentions) but approves a proposal with
amendments (21 yes, 0 no, 0 abstentions).
Regional Comments on the Committee Update:
Members want to see additional data to answer the following questions:
 If the current discard rates were mirrored in the pre KAS era, would the transplant rate be the same?
 What is the current donor profile of the 99% KDPI kidney?
The region discussed that the high KDPI kidneys should not be exempt from center outcomes. As part of the overall
analysis, poorer quality kidneys need to have weighted differently than higher quality kidneys.
Simultaneous Liver Kidney (SLK) Allocation Policy (25 min)
Current OPTN policy prioritizes candidates seeking a simultaneous liver kidney (SLK) transplant before
pediatric and adult transplant candidates who are listed only for a kidney (“kidney alone candidates”) when
the liver candidate and the deceased donor are in the same Donation Service Area (DSA). Unlike kidney
alone allocation, in SLK allocation, the kidney is not allocated based on medical criteria assessing the
kidney function of the candidate. Instead, geographic proximity between the liver-kidney candidate and the
donor is the single factor for allocating the kidney with the liver. Organ Procurement Organizations (OPOs)
are not required to allocate the kidney with the liver to a regional SLK candidate, although they have the
discretion to do so.
The Kidney Transplantation Committee (“the Committee”), has identified several problems with this current
policy:
 The current policy for SLK allocation is counter to requirements in the OPTN Final Rule (“Final
Rule”) specifying that organ allocation policies be based on sound medical judgment and
standardized criteria. These requirements are in place to ensure equity and efficiency in the U.S.
organ allocation system—to promote a system where all candidates are assessed and organs are
allocated equitably based on some level of medical need.
 The lack of medical criteria results in the allocation of high quality kidneys to liver candidates who
may regain renal function after liver transplant and decreased access for kidney alone candidates
who would otherwise be highly prioritized in deceased donor kidney allocation.
 The lack of consistency for regional SLK allocation has been a tremendous concern for the liver
transplant community, as deceased donor liver allocation prioritizes candidates with a certain
medical urgency status or Model End Stage Liver Disease Score (MELD) score or Pediatric End
Stage Liver Disease (PELD) score for regional allocation but regional SLK allocation is not required.
In order to provide more clarity and consistency in the rules for SLK allocation, the Committee is proposing
the following new policies:
 Establish medical eligibility criteria for candidates seeking an SLK transplant. Because there is
somewhat limited data to establish new rules, the Committee has relied on clinical consensus and
feedback from experts in kidney and liver transplantation to establish the criteria.
 Establish a “safety net” (some match classification priority on the kidney alone waiting list for liver
recipients with continued dialysis dependency or kidney dysfunction in the first year after liver
transplant) as an added element to address concerns about limitations associated with the SLK
medical eligibility criteria.
This proposal reflects feedback from the 11 OPTN regions, several professional transplant societies, patient
advocacy groups, and various OPTN/UNOS committees. The proposal is intended to further the OPTN
strategic goal to “provide equity in access to transplants” by addressing the objective to “establish clearer
rules for allocation of multiple organs to a single candidate, especially liver-kidney candidates.”
Because there is a tremendous amount of transplant community interest in the development of this policy
and a need to ensure a high level of consensus for the final product, the Committee may utilize the Fall
2015 and Spring 2016 public comment periods to receive input on these changes, with an expectation that
the OPTN/UNOS Board of Directors will consider final adoption at the June 2016 Board meeting.
Regional Amendments
 Inclusion of mandatory regional kidney sharing with liver candidates who meet medical eligibility and
have a MELD > or equal to 35
 Exclusion of pediatric candidates
 Inclusion of mandatory local kidney sharing with liver candidates who meet medical eligibility
Regional Comments
The region requests clarification on the following:
 Does the verification of eligibility have to be completed by the Primary Transplant Physician
(Nephrologist) or can any Transplant Nephrologist associated with the program complete the
verification requirement?
 Under the safety net, proposed policy states that the candidate must meet the GFR standard prior to
kidney listing. This language may preclude currently registered candidates from using the safety net
unless they are removed from the waitlist and relisted. Was this the intention of the committee?
In regards to the safety net requirement the proposal has a huge data burden. The region requests that the
committee review the proposal and provide clear guidance as to how often and when a test must be
performed in order to qualify.
The region requests that UNOS committees continue to work on better defining multiple organ placement.
Current policy language does not provide clear direction as to order of allocation priority and therefore this is
left up to each OPO to determine. Nationally there is no consistency to how this is done.
Beth Plahn, RN, provided an update on the activities of the Transplant Administrators Committee.
Brian Shepard presented one proposal from the Data Advisory Committee. The region approves the
proposal (21 yes, 0 no, 0 abstentions) with no comment.
Proposal to Revise OPTN/UNOS Data Release Policies
Current OPTN/UNOS policy restricts the release of organ procurement organization (OPO)- and hospitalidentified data, even though the OPTN Final Rule (the Final Rule) requires the OPTN to release data in
response to “reasonable requests from the public for data needed for bona fide research or analysis
purposes” and “reasonable requests from the public for data needed to assess the performance of the
OPTN or Scientific Registry, to assess individual transplant programs, or for other purposes.” The Health
Resources and Services Administration (HRSA) clarified that this portion of the Final Rule applies to release
of data that is identified by transplant hospital or OPO, and therefore OPTN/UNOS policy is not consistent
with the Final Rule. The OPTN/UNOS Data Advisory Committee (DAC) is proposing changes in response to
this interpretation of the Final Rule.
This proposal revises the OPTN/UNOS Data Release policy to better align with the Final Rule by removing
restrictions on the release of OPTN data. This will allow the OPTN contractor to release more data than are
currently released, including any non-confidential data by institution (e.g., data identifiable by transplant
hospital, histocompatibility lab, or OPO). As allowed in the Final Rule, UNOS staff will still evaluate data
requests for reasonableness, but the process for doing so will not reside in OPTN policy.
Meg Rogers provided a summary of current activity and an update on the new Work Partners for Life initiative
Mary Francois provided an update on the activities of the Thoracic Organ Transplantation Committee.
Carrie Stephen presented one proposal from the committee. The region approves of the proposal (20 yes,
0 no, 0 abstentions) and expresses strong support of the Thoracic Committee’s work.
Proposal to Modify Pediatric Lung Allocation Policy (15 min)
On May 31, 2013, former Secretary of Health and Human Services, Kathleen Sebelius, requested that the
OPTN review lung allocation policy, with “particular attention to the age categories used in allocation” and
the “intent of identifying any potential improvements to this policy that would make more transplants
available to children, consistent with the requirements of the OPTN final rule.” As an immediate measure,
the OPTN/UNOS Board of Directors approved the Adolescent Classification Exception for Pediatric
Candidates, which allowed lung candidates less than 12 years old to request an exception from the Lung
Review Board to be classified as an adolescent candidate for the purposes of prioritization by Lung
Allocation Score (LAS). Following its passage, the Thoracic Organ Transplantation Committee conducted a
more comprehensive review of lung allocation policy and identified two additional opportunities for
improving access to transplant for all pediatric candidates less than 18 years old.
The Committee proposes broader geographic sharing of pediatric donor lungs. This will give candidates
less than 18 years old better access to properly sized donors, which aligns with Goal 2 of the OPTN
Strategic Plan. The Committee also proposes establishing eligibility criteria for candidates registered prior to
their second birthday to receive a deceased donor lung of any blood type. This will increase utilization of the
smallest donor lungs and decrease waiting list mortality among infants, which supports Goals 1 and 3 of the
OPTN Strategic Plan.
Julie Heimbach presented one proposal from the Policy Oversight Committee. The region approves with a
very close vote (10 yes, 8 no, 0 abstentions) and comment to the committee.
Proposal to Increase OPTN/UNOS Committee Terms to Three Years
Most OPTN/UNOS committee members currently serve terms of two years, with the exception of the Patient
Affairs (PAC), Transplant Administrators (TAC), and Ethics committees, who serve three-year terms.
Committee members and committee leadership have expressed that it would be beneficial for all committee
members to serve three-year terms to decrease committee turnover, enable members to continue work on
long-term projects, and retain needed historical knowledge and expertise for a longer period.
Regional Comment
Regional members were concerned that the proposal does not provide a mechanism to remove non-participating
committee members. They are aware that UNOS has an internal process for requesting that members step down, but
they suggest that if this proposal moves forward it include clearly defined committee member expectations and the
ramifications if those expectation are not met. Members also discussed that regionally we have an initiative to increase
the number of centers who participate in the nominating process. This proposal will limit the number of individuals who
are submitting nominations. Overall the region did appreciate that the work of the committee is complicated and that
having the same group work on a project from start to finish would benefit the overall work product.
James Anderson presented and update on the activities of the Operations and Safety Committee.
Ty Dunn presented an update on the activities of the Pancreas Committee and one proposal for consideration.
The region opposes the proposal as written (3 yes, 14 no, 1 abstention) but approves with an amendment (16 yes, 0
no, 2 abstentions).
Proposal to Revise Facilitated Pancreas Allocation Policy
The Pancreas Transplantation Committee offer a proposal that will expedite organ placement by updating
the mechanics of facilitated pancreas allocation. Such changes will combat a troubling trend of growing
pancreas underutilization rates by shifting facilitated pancreas allocations from a list of volunteer programs
to one of programs with a recent record of frequently importing pancreata external to their Donation Service
Area (DSA). This proposal calls for the revision of Policy 11.7 by splitting it into two subsections; Policy
11.7.A: Transplant Program Qualifications outlines eligibility requirements for programs to participate while
11.7.B: Facilitated Pancreas Offers explains the process by which an organ procurement organization
(OPO) or the Organ Center can use facilitated pancreas allocation. This proposal coincides with the first
goal of the Organ Procurement and Transplantation Network’s (OPTN) Strategic Plan to increase the
number of transplants by offering imported pancreata to those programs most likely to use them.
Regional Amendment
To extend the requirement of inclusion on the facilitated list to centers who have accepted 5 pancreas within
a two year period.
David Cronin, MD provided an update on the activities of the Membership and Professional Standards Committee and
the region approves the proposal (16 yes, 0 no, 2 abstentions) with comments to the committee.
Addressing the Term “Foreign Equivalent” in OPTN/UNOS Bylaws
OPTN/UNOS Bylaws’ transplant program key personnel requirements use the term “foreign equivalent.”
Specifically, transplant program key personnel are required to have current American board certification or
the “foreign equivalent,” and cited experience must have been obtained at a designated transplant program
or the “foreign equivalent.” This term is unclear for members when assessing if certain staff are qualified to
serve as transplant program key personnel and for the OPTN/UNOS Membership and Professional
Standards Committee (MPSC) when evaluating membership applications and determining if a board
certification or case experience performed outside the United States should be considered equivalent. To
address this problem, and after consideration by a Joint Societies Working Group, the MPSC proposes
deleting the term “foreign equivalent” from the Bylaws (except for vascularized composite allograft (VCA)
program key personnel); permitting board certification by the Royal College of Physicians and Surgeons of
Canada in addition to American board certification; and establishing a new process for those individuals
who are not American or Canadian board certified to qualify as transplant program key personnel. These
proposed changes are anticipated to advance the OPTN Strategic Plan key goals of promoting living donor
and transplant recipient safety and the efficient management of the OPTN. Changing the Bylaws to better
reflect the training and experience expected of transplant program key personnel should contribute
positively to increased transplant recipient safety. Additionally, removing the ambiguous term “foreign
equivalent” and providing a detailed option to qualify as key personnel for those who do not possess
American board certification should help promote the efficient management of the OPTN.
Regional Comment
The region requests that the committee confirm that the CME requirement included in the proposal are
equal to those that are required to for Board Certification.
Kymberly Watt, MD presented an update on the activities of the Liver and Intestine Committee.
Michael Millis, MD presented one proposal from the Living Donor Committee. The region opposes the proposal as
written (4 yes, 13 no, 0 abstentions) but approves with an amendment (14 yes, 2 no, 1 abstention) and comments to
the committee.
Proposal to Establish and Clarify Policy Requirements for Therapeutic Organ Donation
This policy proposal would establish or clarify which policy requirements apply for the informed consent,
psychosocial and medical evaluation and follow-up reporting for therapeutic donors.
Regional Amendment
To limit the proposal to only include domino donors.
Regional Comment
The region is concerned about creating a new classification of donors (therapeutic donors). They surmise
that this is a very small population of candidates and that the OPTN should not create policy for such a
small population.
The following committees did not report at the regional meeting. The committee update is posted on line for
review: Histocompatability Committee.