AGENDA
Region 1 Meeting
Beechwood Hotel, 363 Plantation St, Worcester, MA
February 8, 2016
(Note: All times except the start time are approximate. Actual times will be determined by the
amount of discussion.)
9:00
Registration and Continental Breakfast
10:00 Welcome/Opening Remarks (20 minutes)
Heung Bae Kim, MD
Region 1 Councillor
Children’s Hospital Boston
Non-Discussion Agenda (5 minutes)
Dr. Kim
** 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.
10:25 OPTN/UNOS Update (25 minutes)
Betsy Walsh, JD, MPH
OPTN/UNOS President
10:50 OPTN/UNOS Committee Reports and Voting on Public Comment Proposals
Moderator: Heung Bae Kim, MD
**Lunch will be served at 12:30**
Kidney Transplantation Committee
Committee Update (20 min)
Reginald Gohh, MD
Rhode Island Hospital
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)
Richard Formica, MD
Yale-New Haven Hospital
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:
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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 liver-kidney candidates.”
Patient Affairs Committee Update (5 min)
Anna Zitnay, RN, CCTC
Yale-New Haven Hospital
Thoracic Organ Transplantation Committee
Francis Fynn-Thompson, MD
Children’s Hospital Boston
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 post-transplant mortality rates overall or
increasing waiting list mortality rates for candidates in lower urgency statuses.
Liver and Intestinal Organ Transplantation Committee
Michael Schilsky, MD
Yale-New Haven Hospital
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.
Histocompatibility Committee Update (5 min)
Indira Guleria, PhD
Brigham and Women’s Hospital, Tissue
Typing Laboratory
Membership and Professional Standards Committee
Transplant Performance Measures Presentation (30 min)
David Axelrod, MD, MBA
Dartmouth-Hitchcock Medical Center
Ad Hoc Disease Transmission Advisory Committee
Chris Curran, CPTC, CTBS, CTOP
New England Organ Bank
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 donorderived 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 donor-derived
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, over-reporting 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 Update (5 min)
Jill Stinebring, RN, BSN, MBA, CPTC
New England Organ Bank
Operations and Safety Committee
Amy Evenson, MD
Beth Israel Deaconess Medical Center
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.
3:00
Adjournment