AGENDA
Region 4 Meeting
Marriott Suites Market Center, Dallas, Texas
September 25, 2015
(Note: All times except the start time are approximate. Actual times will be determined by the
amount of discussion.)
8:45- Registration and Continental Breakfast
10:15
9:00- Liver Program Directors meeting (Salon 1)
10:00 Thoracic Program Directors meeting (Austin room)
Histocompatibility Laboratory Directors meeting (San Antonio room)
10:15 Welcome/Opening Remarks (15 minutes)
Kenneth Washburn, MD
Region 4 Councillor
UTHSC at San Antonio
Non-Discussion Agenda (5 minutes)
Dr. Washburn
** As a reminder, the following proposals require a vote but will not be presented or discussed**
Proposal to Update the Human Leukocyte Antigen (HLA) Equivalency Tables (Histocompatibility Committee)
Policy 4.7: HLA Antigen Values and Split Equivalences, states; “The Histocompatibility Committee must
review and recommend any changes needed to the tables on or before June 1 of each year.” The Board of
Directors approved the most recent updates to the Equivalency Tables in November 2013. Since that time,
additional equivalencies have been proposed which should be incorporated into the tables in policy. This
proposal also adds alleles to the Human Leukocyte Antigen (HLA) dropdown options in UNetSM to increase
access to transplant for sensitized candidates. The Histocompatibility Committee (the Committee) also
proposes updating references to these HLA loci in policy to HLA-DPB1, HLA-DQA1, and HLA-DQB1 to
distinguish them from other similar HLA loci.
Revising Kidney Paired Donation Pilot Program Priority Points (Kidney Transplantation Committee)
This proposal seeks to improve how the OPTN Kidney Paired Donation Pilot Program (OPTN KPD)
prioritizes candidate-donor matches identified in KPD exchanges (2-way, 3-way, and chains) to increase the
likelihood of finding matches for difficult-to-match candidates. UNOS performs a match run on a regular
basis to identify all possible exchanges. The match run often identifies more than one possible exchange for
the same candidate-donor pair. Since each donor can only donate once, the OPTN KPD uses an
optimization algorithm to select a single set of exchanges in which no pair is included more than once. The
optimization algorithm searches for the combination of exchanges that maximizes the total number of
“priority points” according to current OPTN KPD policy (Table 13-2).
As of June 16, 2015, the OPTN KPD system consisted of 56% of candidates with a calculated panel
reactive antibody (CPRA) of greater than or equal to 80%, also known as highly sensitized candidates. A
candidate with a CPRA of 80% is immunologically incompatible with 80% of donors making it difficult to find
matches for these candidates. It is even more difficult to find matches for candidates with a CPRA of 98% or
higher because these candidates are only compatible with about 2% of donors. Current policy does not take
into account the vast difference in matching a candidate with a CPRA of 80% compared to one with a CPRA
of 98% or higher.
Furthermore, seemingly easy to match candidates (e.g., non-O blood type with low level of HLA
sensitization) that enter the OPTN KPD are often not receiving match offers. While these “easy to match”
candidates may match with many potential donors, matches are seldom or never found because the
candidate’s paired donor is difficult-to-match due to non-O blood type or other factors. Currently, the
optimization algorithm used to find OPTN KPD exchanges is based on a set of priority points that does not
include either the candidate or paired donor’s blood type, both of which affect the likelihood of a finding a
match. The proposed revisions to the priority points include both a sliding point scale for CPRA and
candidate and paired donor blood type to reflect the increased difficulty in matching candidates based on
these traits. The proposal also includes other changes to the priority points intended to update a system
developed in 2006.
As a part of the revision to the OPTN KPD priority points, the proposed policy changes will also provide a
remedy for OPTN KPD candidates that are part of a failed exchange. A failed exchange happens when a
KPD candidate does not receive a transplant after their paired donor has donated. This proposal refers to
these candidates as “orphan candidates.” The OPTN KPD does not currently have a remedy in place for
failed exchanges outlined in policy. Although the OPTN KPD has not had any failed exchanges as of June
2015, this proposal outlines a remedy for failed exchanges in the event that one occurs.
The Kidney Transplantation Committee (Kidney Committee) and KPD Work Group believe that these
changes will improve equity in access to highly sensitized candidates and pairs with difficult to match blood
types by increasing the number of priority points given to these pairs and increase the number of
transplants in the OPTN KPD by increasing the number of matches found.
Changes to Transplant Program Key Personnel Procurement Requirements (Membership and Professional
Standards Committee)
Some transplant program key personnel requirements in OPTN/UNOS Bylaws involving organ procurement
experience stand to be updated. Specifically, the Bylaws addressed in this proposal are unnecessary due to
the evolution of transplantation, unenforceable as currently written, inconsistent across the different
transplant programs, or include periods to obtain necessary procurement experience that have been
restrictive and problematic for some members. This proposal recommends Bylaws changes that address
these issues and update transplant program key personnel procurement requirements. Proposed changes
include deleting multi-organ procurement requirements for all key personnel, requiring that all primary
transplant physicians must (as compared to “should”) observe three procurements of the organ that
corresponds to the transplant program they are applying to be the primary physician of, removing “selection
and management of the donor” requirements from the primary liver transplant surgeon pathways, and
extending the time period for performing the requisite number of procurements in each primary transplant
surgeon training pathway. Clarifying and updating these Bylaws primarily supports the OPTN strategic plan
key goal of promoting the efficient management of the OPTN.
Proposal to Reduce the Documentation Shipped with Organs (Organ Procurement Organization
Committee)
OPTN/UNOS Policy 16.5.A (Organ Documentation) states that members must send the complete donor
record in the container with each transported organ. These requirements originated prior to the availability
of electronic medical records and the functionality to upload information into DonorNet®. The OPO
Committee discussed strategies to reduce the amount of documentation that is packaged and shipped with
each organ, to allow OPO transplant coordinators more time to focus on donor management. The OPO
Committee proposes limiting the required documentation to blood type source documentation and infectious
disease testing results. OPOs will continue to provide all other pertinent donor information electronically.
10:35 OPTN/UNOS Update (20 minutes)
Stuart Sweet, MD, PhD
OPTN/UNOS Vice-President
10:55 OPTN/UNOS Committee Reports and Voting on Public Comment Proposals
Moderator: Kenneth Washburn, MD
** Lunch will be served at 12:30**
Data Advisory Committee
Dr. Sweet
Proposal to Revise OPTN/UNOS Data Release Policies (15 min) page 99
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.
Pediatric Transplantation Committee
Gregory Abrahamian, MD
UTHSC at San Antonio
Proposal to Establish Pediatric Training and Experience Requirements in the Bylaws (15 min) page 9
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.
Thoracic Organ Transplantation Committee
Mark Drazner, MD, MSC
UT Southwestern Medical Center
Committee Update (10 min)
Proposal to Modify Pediatric Lung Allocation Policy (10 min) page 200
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.
Transplant Administrators Committee Update (5 min)
Susan Zylicz, MHA, BSN, RN, CCTC
The Methodist Hospital
Kidney Transplantation Committee
Steven Potter, MD, FACS
East Texas Medical Center
Committee Update (15 min)
Simultaneous Liver Kidney (SLK) Allocation Policy (20 min) page 236
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.
HRSA Workplace Partnership for Life Hospital Campaign
(5 min)
Beth Hannan
LifeShare Transplant Donor Services of
Oklahoma
Donate Life America Update (5 min)
Suzy Miller
Donate Life Texas
Membership and Professional Standards Committee
Adam Bingaman, MD, PhD
Methodist Specialty and Transplant Hospital
Committee Update (5 min)
Addressing the Term “Foreign Equivalent” in OPTN/UNOS Bylaws (15 min) page 127
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.
Pancreas Transplantation Committee
Richard Ruiz, MD
Baylor-Simmons Transplant Institute
Committee Update (5 min)
Proposal to Revise Facilitated Pancreas Allocation Policy (10 min) page 225
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.
Operations and Safety Committee Update (5 min)
Nicole Johnson, MBA, BS, RN
Baylor-Simmons Transplant Institute
Policy Oversight Committee
Jeffrey Orlowski, MS, CPTC
LifeShare Transplant Donor Services of
OKlahoma
Proposal to Increase OPTN/UNOS Committee Terms to Three Years (10 min) page 191
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.
Living Donor Committee
Shannon Edwards
UNOS Regional Administrator
Proposal to Establish and Clarify Policy Requirements for Therapeutic Organ Donation (10 min) page 114
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.
Liver and Intestine Committee Update (5 min)
Vivek Kohli, MD, FACS
INTEGRIS Baptist Hospital
Histocompatibility Committee Update (5 min)
Chantale Lacelle, PhD
UT Southwestern Medical Center
3:00
Adjournment