AGENDA
Region 8 Meeting
Kansas City Airport Hilton
Kansas City, MO
February 12, 2016
(Note: All times except the start time are approximate. Actual times will be determined by the
amount of discussion.)
8:00
Registration and Continental Breakfast
9:00
Welcome/Opening Remarks
Christie Thomas, MB, FRCP, FASN,
FAHA
Region 8 Councillor
9:15
Non-Discussion Agenda
Dr. Thomas
** As a reminder, the following proposals require a vote but will not be presented or discussed**
Histocompatibility Committee
Adding HLA DQA1 Unacceptable Antigen Equivalences Table
This proposal intends to bridge a gap between the science and practice of human leukocyte antigen (HLA)
compatibility assessments and the realities of computer programming. Policy approved by the OPTN/UNOS
Board of Directors in November 2014 requires HLA typing for HLA-DQA1 for deceased donors to be
reported to the OPTN, and requires UNOS to change UNetSM programming to allow transplant programs to
report DQA1 as an unacceptable antigen. This proposal adds an HLA DQA1 equivalency table to policy that
identifies the relationship between parent antigens and corresponding allelic subtypes. The addition of the
table allows UNOS staff to program data entry for DQA1 unacceptable antigens/alleles, removing concerns
about patient safety due to human error and incorrect data entry.
Organ Procurement Organization Committee
Modifications to the Open Variance for the Recovery and Transplantation of Organs from HIV
Positive Donors
The HIV Organ Policy Equity Act (HOPE Act), enacted on November 21, 2013, allows research to be
conducted on the transplantation of organs from donors infected with HIV into individuals who are infected
with HIV before receiving such organ. The legislation required the OPTN to revise its policies “not later than
2 years after the enactment” to allow this research to begin. The HOPE Act also states that “not later than 4
years after the date of enactment and annually thereafter, the Secretary shall review the results of scientific
research in conjunction with the Organ Procurement and Transplant Network to determine whether the
results warrant revision of the standards of quality.”
Though the OPTN policies went into effect on November 21, 2015 creating a variance to permit the
research to be conducted, the policy does not explicitly address how the OPTN will work with the Secretary
to review the results of the research. UNOS leadership discussed the OPTN’s role in this review, and
recommended modifying the variance to require members participating in a HOPE Act research study to
provide periodic reports from their data safety monitoring boards to the OPTN. On October 19, 2015, under
the authority granted by OPTN Bylaw 11.7: Emergency Actions, the OPTN/UNOS Executive Committee
approved this requirement to meet the statutory deadline outlined in the HOPE Act. Bylaw 11:7 requires
policies adopted as an emergency action “to be distributed for public comment no more than 6 months after
approval.”
Vascularized Composite Allograft Transplantation Committee
List Covered Body Parts Pertaining to Vascularized Composite Allografts
The OPTN Final Rule requires the OPTN to implement policies related to VCAs and shall identify all
covered body parts in any policies specific to VCAs Current OPTN bylaws and policies do not consistently
specify these covered body parts. This proposal contains a list of covered body parts for OPTN/UNOS
Bylaws and Policies in order to meet the requirements of the Final Rule.
The list of covered body parts is not an endorsement of research on a new type of organ transplant by the
Department of Health and Human Services or the OPTN. The intent of these modifications is for the
OPTN/UNOS Bylaws and Policies to be compliant to federal regulation, to provide transparency in what
body parts are VCA transplants, and define the scope of oversight by the OPTN.
This list is intended to be inclusive of VCA transplants that are currently performed, as well as those VCA
types that may be performed in the near future. As such, the nomenclature is intended to be broad enough
to capture grafts that are anatomically linked and grafts that may fall under the umbrella of a surgical
specialty. Specific VCA types that an approved VCA transplant program may choose to register a
candidate for are explained in this document.
9:20
OPTN/UNOS Update
Stuart Sweet, MD, PhD
OPTN/UNOS Vice President
9:45 OPTN/UNOS Committee Reports and Voting on Public Comment Proposals
Moderator: Dr. Thomas
Thoracic Organ Transplantation Committee
Andrew Kao, MD
Proposal to Modify the Adult Heart Allocation System (30 min)
The Thoracic Organ Transplantation Committee (the Committee) proposes modifications to the adult heart
allocation system to better stratify the most medically urgent heart transplant candidates, reflect the
increased use of mechanical circulatory support devices (MCSD) and prevalence of device complications,
and address geographic disparities in access to donors among heart transplant candidates. Though
changes to the adult heart allocation system implemented in 2006 were successful, candidates with
disparate waiting list mortalities are currently grouped together in the most urgent classification, Status 1A,
causing waiting time to be the primary factor in stratifying candidates. Additionally, the current geographic
sharing scheme creates potential inequities in access to transplant for the most urgent candidates.
The Committee proposes two significant changes to the adult heart allocation system:
1) Develop additional urgency stratifications based on relative waiting list mortality rates for all adult
heart candidates
2) Modify the geographic sharing scheme to provide the most medically urgent candidates access to
donors from a broader geographic area
The Committee’s proposal is largely supported by modeling analysis performed by the Scientific Registry of
Transplant Recipients (SRTR). The proposed changes are expected to achieve lower waiting list morality
rates overall and higher transplant rates for the most medically urgent candidates without increasing posttransplant mortality rates overall or increasing waiting list mortality rates for candidates in lower urgency
statuses.
Patient Affairs Committee
(5 min)
Ann Grosscup, MS
Ad Hoc Disease Transmission Advisory Committee
Marilyn Levi, MD
Improving Post-Transplant Communication of New Donor Information (15 min)
Communication delays or failures regarding new donor information learned post-transplant have led to
transplant recipient morbidity and mortality. A statistically significant association between having a proven or
probable donor-derived transmission event and the presence or absence of a communication gap has been
documented in a recent 2015 published article.
The Ad Hoc Disease Transmission Advisory Committee has been reviewing cases of potential donorderived transmission events since 2006 to learn and share the science behind these transmissions and
recommend processes to prevent unnecessary transmissions.
Policy implemented in 2011 implemented reporting guidelines and established patient safety contacts.
Reporting behaviors since that implementation have demonstrated increased reporting, yet wide variation in
practices. Data analyzed suggest that some of these reporting behaviors have not led to overall system
improvements.
Current policy does require OPOs to report results received post-transplant. OPO interpretations of what
must be reported to transplant hospital patient safety contacts and the OPTN varies greatly. An unintended
consequence has been a shift away from recipient disease to wide variations and, in some areas, overreporting of results with little benefit to the system goal. Over-reporting and under-reporting may also lead to
reporting fatigue thus taking away from the critical and important intent of the system. Communication
delays or failures can also occur in this process with negative consequences for patients.
This proposal adds clarity and specifics to reporting policy. Specifying what conditions are to be reported
and how they are to be reported should add more reliability and consistency to the process. This proposed
policy will aim to reduce unnecessary reporting to both the OPTN and transplant hospital patient safety
contacts. By triaging reporting requirements, fatigue from over-reporting can be reduced and help focus
time and energy on reporting and following relevant and critical results.
Organ Procurement Organization Committee
Diane Brockmeier, RN, BSN, MA
Committee Update (5 min)
Operations and Safety Committee
Timothy Schmitt, MD, FACS
Standardize an Organ Coding System for Tracking of Organs: Requirements for OPO TransNet Use
(15 min)
The Operations and Safety Committee is proposing a requirement for organ procurement organizations
(OPOs) to use TransNetsm for deceased donor organ labeling and packaging. The proposal also requires
OPOs to transmit case data to the OPTN to allow for web-based tracking while organs are in transit.
TransNet, a service of the OPTN, is a new system that uses barcode scanning technology at the point of
organ recovery to help label, package, and track organs and other biologic materials being shipped for
transplantation.
TransNet involves using an application developed for either Android or iOS tablets and a portable barcode
printer that interacts with DonorNet® to supplement the current UNOS labeling system. During organ
recovery, OPO procurement coordinators will use the system in the operating room to print on-demand
labels and scan information on all organs and materials to be transported. Currently, 35 out of 58 OPOs
have been trained to use TransNet on a voluntary basis. This proposal will make use of the system a
requirement for all OPOs.
This effort started in 2012 as a Health Resources and Services Administration (HRSA) project awarded
funding through the U.S. Health and Human Services (HHS) Innovations program. It was one of four HHS
programs intended to drive innovation in the government and healthcare. The project goals were to reduce
incorrect transplantation, minimize transport errors, accelerate organ information transfer, and capture
organ procurement/transport data.
Requiring OPOs to use TransNet will reduce packaging and labeling errors. Packaging and labeling organs
were done in the past entirely by hand, partially by hand, or by using pre-printed labels. Automating the
process with TransNet will greatly reduce transcription errors and mistakes due to illegible handwriting. It
will allow for one time data entry of donor information and a consistent validation process across all OPOs.
Peer-reviewed literature has shown that this type of system eliminates transcription errors. TransNet will
also accelerate information transfer and improve real-time communication regarding organ package
contents and location thus enabling transplant hospitals to prepare for impending organ transplants more
efficiently.
This proposal primarily supports OPTN/UNOS Strategic Goal 4: Promote living donor and transplant
recipient safety by reducing labeling, packaging, and communication errors that can result in wrong
recipient, wrong patient transplant, or organ wastage.
Membership and Professional Standards Committee Update
Transplant Performance Measures Presentation (30 min)
Timothy Schmitt, MD, FACS
Liver and Intestinal Organ Transplantation Committee
Scott Biggins, MD
Committee Update (5 min)
National Liver Review Board (20 min)
Currently there is not a national system that provides equitable access to transplant for liver candidates
whose calculated MELD or PELD score does not accurately reflect the severity of their disease. Each
OPTN region has its own review board that evaluates exception requests submitted by the liver transplant
programs in its region. Most regions have adopted independent criteria used to request and approve
exception requests, commonly referred to as “regional agreements.” Some have theorized that regional
agreements may contribute to regional differences in exception submission and award practices, even
among regions with similar organ availability. The current system also has some inefficiencies which can
lead to delays in candidates being awarded exception points. In November 2013, the OPTN/UNOS Board of
Directors (Board) charged the Liver and Intestinal Organ Transplantation Committee (the Committee) with
developing a conceptual plan and timeline for the implementation of a national liver review board.
Through policy and revised operational guidelines, this proposal establishes a national structure for review
of MELD and PELD exception cases in which all liver transplant programs have an equal opportunity for
representation. The National Liver Review Board (NLRB) seeks to mitigate regional differences in award
practices by establishing new voting procedures and giving the Committee the ability to develop national
guidance for assessing common requests. This proposal improves the efficiency of the review board system
by reducing the workload for reviewers and eliminating unnecessary delays in awarding exception points
when appropriate.
Kidney Transplantation Committee
Clifford Miles, MD
Committee Update (20 min)
Kidney Allocation System (KAS) Clarifications & Clean Up (15 min)
The OPTN implemented the revised kidney allocation system (KAS) on December 4, 2014. Since the
OPTN/UNOS Board of Directors approved the policy in June 2013, the Kidney Committee and UNOS staff
have identified areas in which changes and clarifications are needed in the policy language. This proposal
focuses on five areas for changes to kidney allocation policy:
 Changing policy on mandatory shares
 Clarifying informed consent requirements for multi-organ candidates for kidneys based on KDPI
greater than 85%
 Maintaining consistency throughout kidney allocation policy with regard to Policy 5.9: Released
Organs
 Correcting redundant match classifications in Table 8-5: Allocation of Kidneys from Deceased
Donors with KDPI Less Than or Equal to 20%
 Clerical changes
The Committee believes that the changes outlined in this proposal will provide clarification on kidney
allocation policy and increase equitable access to very highly sensitized candidates. Other clarifications will
improve the overall efficiency of KAS.
Simultaneous Liver Kidney (SLK) Allocation (20 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 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.
 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 liver-kidney allocation is not
required for these candidates.
This proposal seeks to:
 Establish medical eligibility criteria for adult candidates seeking an SLK transplant.
 Provide greater clarity for the rules around liver-kidney allocation and fix the inconsistency that exists
between deceased donor liver allocation policy and liver-kidney allocation policy.
 Establish a “safety net” (new 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 is the result of two consensus conferences and two rounds of public comment and
incorporates feedback from the OPTN/UNOS Board of Directors, 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 liverkidney candidates.”
Histocompatibility
Committee Update (5 min)
3:00
Estimated Adjournment
Brian Freed, PhD, D(ABHI)