Region 10 Meeting Notes
Dayton, OH
September 10, 2015
Tim Taber, MD, Regional Councillor, presented a regional update that included the goals for the meeting,
upcoming regional activities and shared regional data.
Stuart Sweet, MD, Incoming UNOS President, presented the UNOS Update which included information on
OPTN/UNOS new project initiatives, status of the OPTN/UNOS strategic plan, financial and information
technology update.
The region approves (23 yes, 0 no, 1 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)
Stuart Sweet presented one proposal submitted by the Data Advisory Committee for consideration. The
regional approves (18 yes, 3 no, 0 abstentions) of the proposal with comments to the committee.
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.
Regional Comment:
The region requests that the committee review the safeguards against using data for purposes not
disclosed in the data use agreement. If the proposal is approved by the OPTN/UNOS Board, the region
asks that UNOS include as part of the operational guidelines that the member whose data is being provided
receive a copy of the data.
Joshua Augustine provided an update on the activities of the Kidney Transplantation Committee
and one proposal for consideration. The region opposes the proposal as written (0 yes, 18 no, 4
abstention) but approves with amendments (15 yes, 0 no, 8 abstentions) and comments to the
committee.
Regional Comments on Committee Report:
Several members in the region request that UNOS provide early outcome data or projections on graft
outcome for high CPRA recipients. In addition, they would like to have data on final disposition of PHS high
risk donors allocated to high CPRA candidates. Anecdotally they are experiencing a higher discard rate in
this donor population.
Simultaneous Liver Kidney (SLK) Allocation Policy
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
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Pediatric candidates be excluded from the proposal. The committee needs to collaborate with the
Pediatric and Liver committee to develop policy for when a pediatric patient receives a local, regional or
national SLK offer.
The addition of policy language requiring the OPO to offer the kidney to a regional candidate with a
MELD equal or greater than 35 who meets medical eligibility.
The addition of policy language requiring the OPO to offer the kidney to a local candidate who meets
medical eligibility.
Regional Comments
The region requests that the committee consider including guidance to encourage programs to consider
living donation as an option prior to listing for the safety net. The committee needs to collaborate with the
MPSC to develop an alternate approach for how kidney outcomes would be monitored in this patient
population. Under the current review process, centers hesitate to perform a living kidney transplant post
liver transplant because of the potential negative impact on their living donor graft rates and subsequent
MPSC scrutiny.
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Anne Murphy provided an update on the ongoing activities of the Transplant Administrators
Committee.
Jules Lin provided an update on the ongoing activities of the Thoracic Organ Transplantation
Committee and presented one proposal for consideration. The region approves of the proposal (22
yes, 0 no, 2 abstentions) with no comment.
Proposal to Modify Pediatric Lung Allocation Policy
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.
Stuart Sweet presented a proposal from the Policy Oversight Committee for consideration. The
region approves the proposal (24 yes, 0 np, 2 abstentions) with no comment.
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.
Andi O’Malley provided an update on the current activities of Donate Life America.
Erica Reed provided an update on the current activities of the HRSA sponsored Work Partners for Life
campaign.
Todd Pesavento, MD provided an update on the current activities of the Operations and Safety Committee.
Eileen Brewer, MD presented one proposal for consideration from the Pediatric Committee. The regional
approves of the proposal (25 yes, 0 no, 2 abstentions) with comments to the committee.
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 Comments:
Members in the region are concerned that the final proposal was not adequately vetted through members of
the thoracic community. There is concern that the requirements will ultimately restrict access to lung
transplant for 16-18 patients. Members request that the committee consider adding an additional approval
pathway for adolescent lung.
Regional Question
Members request verification that the only notification requirement is: (1) if the center currently has pediatric
candidates on their list and the center would not be applying for pediatric center approval (2) if a center
does not ultimately receive approval as a pediatric transplant center. Response: Yes, that is the intention.
Sam Ho, PhD, D(ABHI) provided an update on the current activities of the Histocompatability Committee.
Todd Pesavento, MD provided an update on the current activities of the Membership and Professional
Standard Committee and one proposal for consideration. The region opposes the proposal
(0 yes, 16 no, 9 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 Comments:
The regional opposes the proposal due to the bylaw restriction that only allows for foreign candidates to
receive approval through the experience pathway and excludes the ASTS fellowship pathway. Several
members request that the goal statement be revised to remove the statement that this proposal is aimed at
making transplant safer for patients. They feel that there are many foreign trained individuals successfully
practicing within the region and are not supportive of the characterization that requiring US training or
experience ensures that patients receive better care.
Amer Rajab, MD, provided an update on the current activities of the Pancreas Committee and
one proposal for consideration. The region approves of the proposal (16 yes, 0 no, 6 abstentions)
with no comment.
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.
Randee Bloom presented on one proposal from the Living Donor Committee for consideration. The
region approves of the proposal (14 yes, 2 no, 7 abstentions) with 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 Comment:
The region requests that these donors be added to the drop down list in DonorNet. The collection of data is
essential to looking at outcomes for this type of donor. Second, that the committee conduct a thorough
review of the current policies and bylaws to assess the circumstances where this new sub-set of living
donation need to be specifically mentioned in policy/bylaws. Lastly, the region requests clarification about
therapeutic donor status post donation. If a therapeutic donor does not receive a kidney at the time of
donation and later is placed on the waitlist do they receive priority as a prior living donor?
Regional Question:
The region requests clarification on the reporting timeline for these donors.
Answer: According to the chart reference (Table 8.1), reporting is restricted to the Living Donor Feedback
(at the time of donation) and the LDR (at the time of discharge). Therapeutic donors are excluded from
submitting the LDF (from discharge to two years post donation)
Recovery Hospitals
Living donor feedback
The time prior to
For each potential
donation surgery
Recovery Hospitals
Living donor
registration (LDR)
Recovery Hospitals
Living donor follow-up
(LDF)
60 days after the
Recovery Hospital
submits the living
donor feedback form
60 days after the sixmonth, 1-year, and 2year anniversary of
the donation date
living donor organ
recovered at the
hospital
For each living donor
organ recovered at the
hospital
For each living donor
organ recovered at the
hospital
The following committees did not report at the regional meeting. The committee update is posted on line for
review: Liver and Intestine Committee.