MEETING SUMMARY
Region 4 Meeting
December 2, 2011
A UNOS Region 4 meeting was held on December 2, 2011 at the Houston Marriott at the Texas Medical
Center in Houston, Texas. Dr. David Nelson, MD, Region 4 Councillor, convened the business meeting
and welcomed those in attendance. There were 98 individuals in attendance representing 73 percent of
UNOS institutional voting members. Those members present unanimously approved May 2011 regional
meeting summary.
Dr. Nelson encouraged members to submit nominations for Region 4 representative vacancies on
OPTN/UNOS Committees and the Associate Councillor position. He also asked the group if it is
reasonable for UNOS to decrease the number of public comment booklets provided for the regional
meeting. The members did not object to this. Several booklets will be available at each table during
future meetings for members to share.
A spring regional meeting date of March 30th was proposed and a notice will be sent to the region with
this tentative date. If this date is not acceptable to the majority, then a new date will be selected and
circulated by e-mail.
OPTN/UNOS Update
Jack Lake, MD, OPTN/UNOS President provided the OPTN/UNOS Update which included the following
information:
 Living Donor Site Audits
o Site survey process
o Most common policy and bylaws violations
o Living donor follow-up
 Incident Reporting
o Reportable events
o How and where to report an event
o What happens after an event is reported
o Living Donor adverse outcomes review process
 Reporting Extra Vessel Disposition to the OPTN
o Policy background
o OPO and transplant center responsibilities
o How to submit the report
o How to access your centers process for reporting
 OPTN Kidney Paired Donation Pilot Program Update
o Match run results as of August 2011
 Center for Transplant System Excellence
o OPTN Deceased Donor Potential Study
 UNOS Communication Resources
o Web sites
o Member information archive
o Patient Safety Newsletter
o UNOS member survey
 Ad Hoc Disease Transmission Advisory Committee Update
o Potential disease transmissions reported nationally and by region
o For guidance on reporting potential donor-derived disease transmissions, refer to OPTN
policy 4.5 and Guidance for Reporting Potential Donor-Derived Disease Transmission
Events document approved by the OPTN/UNOS Board of Directors during its June 2011
meeting.
National Committee Reports
Those regional representatives in attendance presented synopses of national committee deliberations.
The participants actively discussed many of the issues raised during these reports. Fourteen items
recently circulated for public comment were considered and the following recommendations agreed
upon:
Kidney Transplantation
Eileen Brewer, MD
Proposal to Clarify Requirements for Waiting Time Modification Requests
Current OPTN/UNOS policies for submitting waiting time modification requests are not clear, leading to
wasted time for the transplant centers that submit requests, for OPTN Contractor staff who process
requests, and for the Committees that review requests. Required documentation is often missing and
results in delays for transplant candidates to receive the waiting time that they may be entitled to
receive under OPTN policy. With these proposed clarifications, the Committee expects to see fewer
submissions of incomplete requests and faster time to implementation of approved requests.
Region 4 Vote: 26 yes, 0 no, 0 abstentions
Kidney Committee Presentation: Dr. Brewer presented a brief summary of the proposed components
of a new kidney allocation system. The region unanimously approved a motion to write a memorandum
to the Kidney Committee indicating Region 4’s disapproval of the use of dialysis time prior to listing in a
new kidney allocation system. Dr. Osama Gaber will submit a letter on behalf of the region.
Liver and Intestinal Organ Transplantation
Kenneth Washburn, MD
Proposal to Extend the “Share 15” Regional Distribution Policy to “Share 15 National”
The Committee is proposing an extension of the current “Share 15 Regional” policy so that deceased
donor livers (age 18 and higher) would be offered to all candidates with MELD/PELD scores of 15 or
higher locally, regionally, and nationally before being offered to candidates with lower MELD/PELD
scores.
Region 4 Vote: 23 yes, 2 no, 1 abstention
Proposal for Regional Distribution of Livers for Critically Ill Candidates
This proposal would offer livers to combined local and regional candidates with MELD/PELD scores of 35
or higher (“tiered regional sharing”).
Region 4 Vote: 16 yes, 9 no, 2 abstentions
Regional Comments: Region 4 was supportive of this proposal but several members were of the
opinion that a sharing threshold needs to be incorporated into the proposed policy. Following are
comments brought forward during a lengthy discussion:
 How many livers can be expected to leave each DSA in Region 4 based on this policy? Several
members commented that livers will be criss-crossing the region for a difference of one
MELD point. Finances are also something to consider.
 The committee may find unintended consequences of this proposal during its review post
implementation, and in order to modify liver allocation computer programming will need to
occur which will be a lengthy process while candidates continue to be disadvantaged.
 This proposal may disenfranchise small liver programs. Cities with larger populations will
draw livers away from smaller geographic areas.
 The committee needs to account for exceptions in this proposal.
The region voted to approve an amendment to add a sharing threshold to the proposal (vote: 16 yes,
2 no, 1 abstention).
Thoracic Organ Transplantation
Dan Meyer, MD
Plain Language Modifications to the Adult and Pediatric Heart Allocation Policies, Including the
Requirement of Transplant Programs to Report in UNet a Change in Criterion or Status within TwentyFour Hours of that Change
The OPTN contractor’s policy evaluation plan requires that heart transplant programs record in UNetSM
changes to a heart transplant candidate’s status or criterion within 24 hours, but this requirement is not
written in Policies 3.7.3 (Adult Candidate Status) and 3.7.4 (Pediatric Candidate Status). The two policies
state that the OPTN contractor will notify “a responsible member of the transplant team” prior to
downgrading a candidate’s Status, but the OPTN contractor does not notify such personnel in addition
to displaying the candidate’s status in UNet℠. The proposed modification includes the 24-hour
requirement, removes of the notification clause, and includes edits for plain language. For consistency,
the modifications also include language about potential referral of pediatric heart status exception case
decisions to the Thoracic Organ Transplantation Committee.
Region 4 Vote: 20 yes, 0 no, 0 abstentions
Ad Hoc International Relations and Ethics
Marian O’Rourke, RN, CCTC
Proposed Revisions to and Reorganization of Policy 6.0 (Transplantation of Non-Resident Aliens),
Which Include Changes to the Non-Resident Alien Transplant Audit Trigger Policy and Related
Definitions
This proposal clarifies the data collected about the citizenship and residency of donors and recipients.
The proposal also amends the audit trigger policy, allowing the Ad Hoc International Relations
Committee to review the circumstances of any transplant of non-US residents/non-US citizens and make
a public report. The proposal also contains technical amendments and removal of requirements that are
not enforceable.
Region 4 Vote: 16 yes, 5 no, 0 abstentions
Regional Comments: The region supported this proposal but a couple members commented that this
proposal introduces increased oversight in this area and that centers will be under increased scrutiny
regarding international patients that they decide to list.
Histocompatibility
Geoffrey Land, PhD, HCLD
Proposed Update to the Calculated PRA (CPRA)
The purpose of this proposal is to update CPRA so it can better reflect current lab practices as well the
current donor pool. These revisions include updating the HLA frequencies used to calculate CPRA, the
addition of the antigen C to the calculation and the removal of zero (0) as a default value.
Region 4 Vote: 19 yes, 0 no, 0 abstentions
Regional Comments: The region approved the proposal but noted that UNOS should consider adding
HLA-DPB1 frequencies to the CPRA calculation and that it should be programmed with the proposed
changes as it is inevitable that those frequencies will also be included eventually. DPB1 antibodies
occur in sensitized renal patients as often, if not more often, than HLA-C antibodies and are
responsible for both acute and accelerated graft rejection. The failure to include those specificities in
the CPRA creates a situation that is inequitable for those sensitized patients in comparison with other
sensitized patients in the same way that the failure to include HLA-C antibodies has been.
The committee should also consider requiring HLA laboratories to type potential deceased donors for
their DPB1 types and subsequently provide HLA laboratories the opportunity to enter donor DPB1
types in UNet. Currently, transplant programs that receive offers for patients with known strong
antibodies to DPB1 have to obtain donor tissue and DPB1 type the donors in their own HLA
laboratories, thus delaying allocation in some cases.
Revision of the UNOS Bylaws, the OPTN Bylaws and the OPTN Policies that Govern HLA Laboratories
This proposal revises the UNOS Bylaws and Policies that apply to histocompatibility laboratories to more
closely align OPTN/UNOS requirements for member laboratories with current laboratory practices.
Region 4 Vote: 19 yes, 2 no, 0 abstentions
Regional Comments: The region supported the proposal but a couple members commented that it
seems unnecessary to delete the standards relating to chimerism solely because it is not routinely
used in many UNOS laboratories. That testing is not only used in UNOS laboratories to occasionally
document the donor-source of cells causing graft versus host disease after organ transplant, but also
to document chimerism that may be related to the induction of donor-specific tolerance either by
chance or because of protocols that deliberately try to create chimerism by infusing donor bonemarrow derived cells.
Being that it takes years to obtain approval for new policies and bylaws it seems very short-sighted to
delete important standards now simply because they are only used in a few laboratories; it is
certainly possible that if specific tolerance inducing protocols are found to be very successful such
testing will be far more widely used in the future. Chimerism testing is also routinely used after
composite tissue (e.g., hand) transplants since that type of transplant almost always also includes
transplant of bone containing donor hematopoietic stem cells.
Living Donor
Steven Potter, MD, FACS
Proposal to Establish Requirements for the Informed Consent of Living Kidney Donors
This proposal would establish policy requirements for the informed consent of living kidney donors. This
proposal is in response to a directive from the Health Resources and Services Administration (HRSA) and
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 OTPN/UNOS Living Donor
Committee.
Region 4 Vote: 20 yes, 0 no, 0 abstentions
Proposal to Establish Minimum Requirements for Living Kidney Donor Follow-up
This proposal would require transplant programs to report required fields on the Living Donor Follow-up
(LDF) form at required post-operative reporting periods (6, 12, and 24 months). The OPTN currently
relies on Living Donor Follow-up (LDF) forms to collect data on the short-term health status of living
donors. Data on living donors who donated in 2006 through 2009 demonstrate that many programs do
not report meaningful living donor follow-up information at required reporting intervals. Consequently,
to allow for meaningful analyses to objectively study the short-term effects of living donation, the
transplant community must collectively improve patient information on the LDF form. The proposed
minimum reporting requirements are based on recommendations from the Joint Society Work Group,
which is composed of representatives from the American Society of Transplantation (AST), the American
Society of Transplant Surgeons (ASTS), and the North American Transplant Coordinators Organization
(NATCO) to the OPTN/UNOS Living Donor Committee.
Region 4 Vote: 0 yes, 16 no, 0 abstentions
Regional Comments: The region did not support this proposal as the members think that a 90%
threshold is not a realistic target. Another member commented that the data shared on compliance
rates was from 2008 and that kidney programs have improved regarding submission of living donor
follow-up forms since that time and this needs to be taken into consideration. Several members also
noted that some donors don’t wish to be followed post donation.
The region overall strongly believes that following living donors is the right thing to do, but that
attaining the 90% threshold is not realistic. The region approved an amendment to document the
attempts that were made to contact living donors. In the event that a center falls below the 90%
threshold, the center could provide the OPTN with documentation of attempts to contact each living
donor who does not have the required follow-up information (vote: 23 yes, 0 no, 0 abstentions).
Proposal to Establish Requirements for the Medical Evaluation of Living Kidney Donors
This proposal would establish policy requirements for the medical evaluation of living kidney donors.
This proposal is in response to a directive from the Health Resources and Services Administration
(HRSA), and 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.
Region 4 Vote: 15 yes, 2 no, 2 abstentions
Organ Procurement Organization
Patrick Giordano, FACHE
Proposal to Eliminate the Use of an “Alternate” Label when Transporting Organs on Mechanical
Preservation Machines and to Require the OPTN Distributed Standardized Label
This proposal would make labeling of these machines consistent for all deceased and living donor organs
that are transported outside of donor hospitals. Current policy allows the use of an “alternate” label, or
a label other than the OPTN standardized label, when transporting organs on a mechanical preservation
machine. OPOs create their own alternate labels resulting in inconsistent labeling. The proposed policy
changes eliminate the use of alternate shipping labels on mechanical preservation machines and require
OPOs to use a new standardized label that is part of the current color-coded labeling system distributed
by the OPTN contractor.
Region 4 Vote: 23 yes, 0 no, 0 abstentions
Proposal to Change the Term “Consent” to “Authorization” Throughout Policy When Used in
Reference to Organ Donation
The proposed modification will change the term "consent" to "authorization" throughout policy when
used in reference to deceased organ donation. Currently, OPTN policy uses the term “consent” to
describe the act of making an anatomical gift. However, the public associates “consent” with the
medico-legal concept of “informed consent” through which physicians must give patients all the
information they need to understand the risks, benefits, and costs of a particular medical treatment.
In the context of organ/tissue/eye donation after death, this blending of terms leads to
misunderstandings about the act of donation that could hinder our national goal of increasing
organ/tissue/eye donation and transplantation. The OPO community has responded to this
circumstance by changing the donation terminology from “consent” to “authorization.” This change
focuses attention on the altruistic act of donation and reinforces the fact that donation after death does
not involve medical treatment.
Region 4 Vote: 23 yes, 0 no, 0 abstentions
Proposal to Modify the Imminent and Eligible (I & E) Neurological Death Data Reporting Definitions
The proposed policy changes clarify the definitions for determining whether a death can be classified as
“imminent” or “eligible.” OPOs are responsible for reporting data that classify a death as either an
Imminent Neurologic Death (“imminent,”) or Eligible Death (“eligible,”) or neither “eligible” nor
“imminent” (“neither.”) The OPOs then report the “imminent” and “eligible” deaths to the OPTN.
There are inconsistencies in the data reporting which have been primarily attributed to:
 OPOs interpreting the definitions in Policy 7.1 (Reporting Definitions) differently, and
 Brain death laws varying from state to state affecting the way the deaths are reported.
The Committee eliminated Multi-system organ failure as an exclusionary criteria for classifying a death
as ”eligible”, and identified a list of organ specific exclusionary criteria that has been added to provide
more detailed guidance. The Committee also made changes to the definition of “imminent” so that it is
restricted to those deaths that would most likely be classified as “eligible” had brain death been legally
declared. This could allow the combination of “eligible” and “imminent” deaths to mitigate the effect of
the variation in brain death laws.
Region 4 Vote: 16 yes, 3 no, 0 abstentions
Regional Comments: Region 4 supported the proposal, but a member offered the following comment:

This proposal may lead to increased costs for the OPO as the OPO conducts additional tests to
place organs from a marginal donor who by definition is an eligible donor. For example, when
an OPO persues an eligible donor and places one organ and after the organ is recovered the
transplant center who initially accepted it now declines and with increased cold ischemic time
the organ cannot be allocated. This donor remains an eligible donor yet no organs were
allocated.
Policy Oversight
Meelie DebRoy, MD
Proposal to Clarify and Improve Variance Policies
This proposal streamlines and clarifies requirements for review and approval of variances, including
gathering all requirements into one policy category for the variance application, review, approval,
modification, dissolution, and appeal processes; detailing the process for appealing a variance decision
of the Committee or Board of Directors; eliminating redundancy in existing variance policies; and
rewriting the variance policies using plain language.
Region 4 Vote: 21 yes, 0 no, 0 abstentions
Committee reports:
Transplant Administrators
Katherine Stark, MHSA
Pancreas
John Duffy, MD
Operations and Safety
Dean Henderson, MHA
Minority Affairs
Sherilyn Gordon Burroughs, MD
Membership and Professional Standards
Marlon Levy, MD, FACS
Finance
Stephan Moore, MHA
New Business
With no further business, the meeting was adjourned.