AGENDA
Region 8 Meeting
Kansas City Airport Hilton
Kansas City, MO
April 4, 2014
8:30
Registration and Continental Breakfast
9:00
Welcome/Opening Remarks
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9:15
Harvey Solomon, MD
Region 8 Councillor
Fall 2013 Regional meeting summary
Committee nominations
Fall 2014 meeting date
Non-Discussion agenda process
OPTN/UNOS Update (30 minutes)
Kenneth Andreoni, MD
OPTN/UNOS President
9:45 OPTN/UNOS Committee Reports and Voting on Public Comment Proposals
Moderator:
Harvey Solomon, MD
Transplant Coordinator Committee
Andrew Webb, RN, BSN
Proposal to Notify Patients Having an Extended Inactive Status (10 minutes)
The goal of this proposal is to promote effective and safe care for organ candidates by increasing awareness of
their inactive waiting list status. Published literature suggest that the longer candidates wait for an organ while in an
inactive status, the less likely they are to receive a transplant. In addition, the Committee is concerned that
candidates are not consistently informed of their status nor do they understand what it means to have an inactive
status.
Thoracic Transplantation Committee
Scott Silvestry, MD
Committee Update (5 minutes)
Proposal to Continue the Adolescent Classification Exception for Pediatric Lung Candidates
(10 minutes)
On June 10, 2013, the OPTN/UNOS Executive Committee approved a temporary policy permitting lung candidates
less than 12 years old to request an exception from the Lung Review Board (LRB) to be classified as an adolescent
candidate for the purposes of prioritization by lung allocation score (LAS) for lung offers from donors 12 years of
age and older. Unless further action is taken by the Board of Directors, the “adolescent classification exception” will
expire on July 1, 2014. Because the temporary policy permits young pediatric lung candidates who may be suitable
for lung offers from larger donors to apply for an exception, the Thoracic Committee proposes removing the July 1,
2014, deadline from the policy making this a permanent policy change. The Thoracic Committee also proposes
additional language to clarify the data reporting requirements for candidates with approved adolescent classification
exceptions.
Operations and Safety Committee
Committee Update
(5 minutes)
Nancy Long, RN, BA, CCTC
Proposed ABO Blood Type Determination, Reporting, and Verification Policy Modifications
(15 minutes)
Member feedback has long noted the complex phrasing and requirements related to ABO blood type
determination and verification. These requirements are a fundamental step in safe and successful organ
transplantation. The Committee is proposing clarifications and improvements to these requirements.
These recommendations are based, in part, from a Failure Modes and Effects Analysis (FMEA)
conducted to proactively identify areas of risk related to ABO processes in deceased donation. This
policy proposal is only one facet in the Committee’s approach to improving ABO blood type
determination and verification. Other strategies to minimize identified risks and maximize human factors
engineering include member education and competency training, programming changes to UNet℠, and
collaboration with the Electronic Tracking and Transport (ETT) project to improve technological
capabilities.
This policy proposal contains the following features:
 Clarified existing requirements related to commonly asked questions
 Strengthened safety components to ensure the correct organ is transplanted into the correct
recipient and that the match is ABO compatible or intended incompatible
 Modified the timing of deceased donor blood type determinations and reports prior to executing
the match run with an exception for accelerated donor cases
 Modified the timing and scope of verifications for deceased and living donor organ recoveries
 Clarified specific verification elements and sources
 Better aligned OPTN and Centers for Medicare and Medicaid Services (CMS) requirements
 Added conditional requirements to check in organs upon arrival and to perform a pre-transplant
verification
 Added a requirement for qualified health care professionals to perform ABO reporting and
verification functions
 Made deceased and living donor standards more consistent
Membership and Professional Standards Committee
Christie Thomas, MB, FRCP, FASN,
FAHA
Committee Update (5 minutes)
Proposal to Allow a MPSC Recommendation to the Board of Directors for Approval Consideration
of a Non Qualifying Transplant Program Applicant Located in a Prescribed Geographically
Isolated Area (10 minutes)
The proposed bylaw language makes available a mechanism by which the MPSC may make a recommendation to
the Board, and the Board may consider and approve the designation of transplant programs who currently cannot
meet key personnel qualifying criteria because the applicant is located in a geographically isolated area. Currently,
if an applicant cannot meet the program requirements, then the application is closed by the MPSC as rejected,
leaving the applicant to appeal to the HHS Secretary for any further approval consideration of the closed
application.
Living Donor Committee
Krista Lentine, MD, PhD
Proposal to Modify Existing or Establish New Requirements for the Informed Consent of all
Living Donors (10 minutes)
This proposal would modify existing policy and establish new policy requirements for the informed consent of all
living donors. This proposal is in response to a directive from the Health Resources and Services Administration
(HRSA) to develop such policy, and is based on recommendations from a Joint Societies Steering Committee
composed of representatives of the American Society of Transplantation (AST); the American Society of Transplant
Surgeons (ASTS) and the North American Transplant Coordinators Organization (NATCO) to the Living Donor
Committee. Policy to standardize the informed consent of living kidney donors has already been established. This
proposal would modify some elements of exiting policy for the informed consent of living kidney donors and
establish new requirements for all other categories of living organ donors.
Proposal to Modify Existing or Establish New Requirements for the Psychosocial and Medical
Evaluation of all Living Donors (10 minutes)
This proposal would modify existing policy and establish new policy requirements for the psychosocial and medical
evaluation of all types of living donors. This proposal is in response to a directive from the Health Resources and
Services Administration (HRSA) to develop such policy, and is based on recommendations from a Joint Societies
Steering Committee composed of representatives of the American Society of Transplantation (AST); the American
Society of Transplant Surgeons (ASTS) and the North American Transplant Coordinators Organization (NATCO) to
the Living Donor Committee. Policy to standardize the medical evaluation of living kidney donors has already been
established. This proposal would modify some elements of existing policy for the psychosocial and medical
evaluation of living kidney donors and establish new requirements for the psychosocial and medical evaluation for
all living organ donors.
Kidney Transplantation Committee
Clifford Miles, MD
Committee Update (10 minutes)
Kidney Paired Donation (KPD) Histocompatibility Testing Policies (15 minutes)
This proposal includes requirements for histocompatibility testing on donors and recipients in the OPTN KPD
Program. It includes required methods for HLA typing, antibody screenings, and crossmatching; a list of HLA types
that must be reported for donors and candidates; and processes that must be followed for identifying unacceptable
antigens and in the event of unacceptable positive crossmatches.
Histocompatibility Committee
Brian Freed, PhD, D(ABHI)
Committee Update (5 minutes)
Expanding Candidate and Deceased Donor HLA Typing Requirements to Provide Greater
Consistency Across Organ Types (15 minutes)
The proposed changes make the HLA typing methods and list of HLA loci to be reported consistent for deceased
donors across all organ types. The required methods and list of HLA loci to be reported will apply both when OPTN
policy requires HLA typing be performed and reported on the deceased donor prior to allocation (i.e. for kidney,
kidney-pancreas, and pancreas allocation) and in instances where HLA typing is required only if requested by the
candidate’s transplant program (i.e. for heart, heart-lung, and lung allocation). The proposal includes new
requirements for reporting HLA-DQA and HLA–DPB for deceased donors. The time period for reporting deceased
donor HLA typing remains different by organ type to meet varying clinical requirements for timing of transplants.
The proposal newly requires HLA typing to be performed and reported for deceased liver donors if requested by a
transplant program and makes HLA typing requirements for deceased pancreas islet donors and candidates
consistent with those for deceased pancreas donors and candidates.
Pediatric Transplantation Committee Update (10 minutes)
Richard Hendrickson, MD
12:00 Lunch (provided)
**There will be a breakout during lunch for liver programs to meet and discuss regional and national liver
issues**
Ad Hoc Disease Transmission Advisory Committee
Scott Biggins, MD
Proposal to Align OPTN Policies with the 2013 PHS Guideline for Reducing Transmission of
Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV)
Through Solid Organ Transplantation. (15 minutes)
The Final Rule §121.4 (OPTN policies: Secretarial review and appeals.) notes that the OPTN Board of
Directors is responsible for developing policies that are consistent with recommendations of the Centers
for Disease Control and Prevention (CDC) to test potential organ donors and following transplant
recipients to prevent the spread of infectious disease.
The June 19, 2013, release of the PHS Guideline for Reducing Human Immunodeficiency Virus (HIV),
Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) Through Organ Transplantation led to a systematic
review of related OPTN policies. This proposal seeks to modify some existing policy language and also
create new policies to reflect recommendations outlined in this updated PHS document.
Liver and Intestinal Transplantation Committee
Ruben Quiros, MD
Committee Update (15 minutes)
Proposal to Cap the HCC Exception Score at 34 (15 minutes)
Candidates with a MELD/PELD score exception for HCC receive high priority on the liver waiting list, especially as
their exception scores may increase automatically every three months. Increasingly, there are candidates with
multiple HCC exception extensions who are now receiving regional offers under the “Share 35 Regional” policy
implemented in June 2013. These candidates are likely to have a much lower risk of disease progression or
dropout (i.e., removal from the waiting list for death or being too sick) than candidates with calculated MELD/PELD
scores of 35 and higher. This proposal would cap the HCC exception score at 34, in effect giving candidates with
calculated MELD/PELD scores of 35 and higher a better opportunity to receive regional offers under the new policy.
Proposal to Delay HCC Exception Score Assignment (15 minutes)
Candidates with a MELD/PELD score exception for HCC receive high priority on the liver waiting list, especially as
their exception scores may increase automatically every three months. These candidates have significantly lower
dropout rates (i.e., removal from the waiting list for death or for reasons related to the HCC) than non-HCC
candidates, with the exception of those areas of the country with lengthy waiting times. The proposed solution to
address the disparities in drop-out rates between patients with HCC exceptions and those without is to delay the
score assignment by 6-months. Simulation modeling has shown that this would equalize the transplant and dropout rates for those with and without HCC exceptions. In areas of the country with shorter waiting times to transplant,
the delay will also allow a window of time for centers to observe candidates with rapidly growing tumors who may
have very poor outcomes with a transplant. At least one study indicates that candidates with HCC exceptions in
regions with shorter waiting times to transplant, where this “biologic test” is not met due to rapid transplantation,
have worse post-transplant outcomes.
Proposed Membership and Personnel Requirements for Intestine Transplant Programs (in
collaboration with the Membership and Professional Standards Committee) (15 minutes)
The proposed bylaw will define a designated intestine transplant program and establish minimum qualifications for
primary intestine transplant surgeons and physicians. The proposal includes a full approval pathway and a
conditional approval pathway to obtain the requisite experience to perform primary surgical and medical care. The
intent is to set minimum standards where none currently exist without compromising quality or restricting new
program formation.
Minority Affairs Committee Update (5 minutes)
Christie Gooden, MD
Pancreas Transplantation Committee Update (5 minutes)
Zoe Stewart, MD, PhD
Patient Affairs Committee Update (5 minutes)
Corrie Wright, MS
Transplant Administrators Committee Update (5 minutes)
Katie Evers, RN, BSN, MBA
Non-Discussion Agenda
Harvey Solomon, MD
(5 minutes)
** As a reminder, these items require a vote but will not be presented or discussed**
Proposal to Require the Collection of Serum Lipase for Pancreas Donors (Pancreas
Transplantation Committee)
This document proposes to make serum lipase a required field in Policy 2.8.E Required Information for Deceased
Pancreas Donors, as well as required in DonorNet®, in order to make electronic pancreas offers. Currently, serum
lipase is a listed field in DonorNet®, but is not required in order to make electronic pancreas offers. Serum lipase
level(s) in deceased donors are reliable indicators of pancreas function and quality. As such, the serum lipase
values assist in making an informed clinical decisions regarding electronic pancreas offers.
The proposal also proposes to create a new field in DonorNet ® where OPOs will report the upper limit of normal
(i.e. maximum normal value or highest reference value) of the laboratory’s normal serum lipase reference range.
The reason for programming this new field is because laboratories’ measurement ranges vary for serum lipase. As
a result, a serum lipase value may have two different meanings at two different laboratories. This results in varying
“normal” serum lipase values across the country. This new field will provide a reference point regarding the serum
lipase value to the physician making the decision whether to accept the pancreas.
Proposal to Require the Reporting of Aborted Living Donor Organ Recovery Procedures (Living
Donor Committee)
Promoting patient safety is a critical component of the OPTN’s mission. The OPTN seeks to protect the safety of
transplant candidates, recipients, and living donors, but living donors are unique in that they put themselves at risk
without any potential benefit to their own health. Due to a variety of reasons, including last minute recipient or donor
health problems and unforeseen donor anatomy issues, living donor organ recovery procedures occasionally need
to be aborted after anesthesia has been administered, but before the recovery of the organ. Monitoring the safety of
these prospective donors is an important part of the OPTN’s goal of promoting living donor safety. The OPTN
relies on the UNetSM Improving Patient Safety Portal for notification of patient safety concerns and living donor
adverse events. Under this proposal, an aborted living donor organ recovery procedure would become a new
category of living donor adverse event that recovery hospitals would need to report through the UNetSM
Improving Patient Safety Portal. Additionally, the proposal would clarify current living donor adverse
event reporting requirements by eliminating some redundant sections of policy.
Proposal to Clarify Data Submission and Documentation Requirements (Membership and
Professional Standards Committee (Membership and Professional Standards Committee)
Policy 18.1 (Data Submission Requirements) requires members to submit data to the OPTN through the use of
standardized forms. However, Policy 18.1 does not explicitly state that the data submissions must be accurate or
that members must be able to provide documentation to verify the accuracy of their data submissions. The MPSC
historically has agreed that the need for accurate data is implied within Policy 18.1, as is the member’s obligation to
provide documentation to verify the data’s accuracy. This proposal’s goal is to amend Policy 18.1 to explicitly state
that the data must be accurate and that members must provide documentation to support their data.
Proposed ABO Subtyping Consistency Policy Modifications (Operations and Safety Committee)
This proposal seeks to make all ABO subtype references consistent throughout OPTN policies. Current references
use different terms, such as A2 and non-A1, which are intended to mean the same thing but may be confusing. The
more technically accurate description uses the “non” preface as routine testing only detects the presence or
absence of A1 and other rare subtypes other than A2 do exist. In 2011, the OPTN published guidance on this issue.
The proposed changes will align references with this guidance using the terms blood type A, non-A1 and blood type
AB, non-A1B.
Proposal to Allow Non-substantive Changes to the OPTN Policies and Bylaws (Policy Oversight
Committee)
On occasion, clerical errors are identified in the Policies and Bylaws. These clerical errors are non-controversial
things like obvious misspellings and mis-numbering of lists. There is nothing in the Bylaws or Policies that allow
staff to make these non-substantive changes. This proposal would allow staff to make non-substantive changes
without needing approval by the Executive Committee or Board of Directors. The Executive Committee would
review these changes retrospectively.
3:30
Adjournment