MEETING SUMMARY
Region 1 Meeting
March 2, 2015
An OPTN/UNOS Region 1 meeting was held on March 2, 2015 at the Beechwood Hotel in
Worcester, MA. Dr. Heung Bae Kim, Region 1 Councillor, convened the business meeting and
welcomed those in attendance. There were 62 individuals in attendance representing 79
percent of UNOS institutional voting members. Those members present unanimously approved
the November 3, 2014 regional meeting summary.
OPTN/UNOS Update
Dr. Heung Bae Kim, Region 1 Councillor, provided the OPTN/UNOS Update which included the
following information:
 OPTN and UNOS Strategic Planning
o Updating 2012 Strategic Plan
 Clarified goal #2, access to transplant
 Broadened goal #3, survival goal
 Combined patient and living donor safety goals
o Planning for 2015-2018
 Member review of proposed plan – spring 2015
 Board review and approval – June 2015
 KAS Implementation Update
o “Out of the Gate” Data
 Monthly monitoring reports posted to OPTN wesbite
 Redesigning Liver Distribution
o Further refining the metrics of access, disparity and ways to optimize distribution
o Identify financial implications of alternative sharing methods
o Address transportation and logistical issues
o Public Forum June 2015
 IT Projects Nearing Completion
 New public comment tool on OPTN website
o Blog-style public comment
 Promote trust and transparency
 Publish all comments received
Non-Discussion Agenda **Proposals not presented or discussed
Proposal to Improve UNetsm Reporting of Aborted Procedures and Non-Transplanted
Organs (Living Donor Committee)
This proposal is intended to clarify and simplify reporting requirements for aborted living donor recovery
procedures and incidents when a living donor organ is recovered but not transplanted and to ensure that
follow-up forms are generated so no living donor is lost to follow-up.
Region 1 Vote: 12 yes, 0 no, 0 abstentions
This proposal was approved during the June 2015 OPTN/UNOS Board of Directors
meeting.
Effective Date: Pending implementation and notice to members
Clarify Policy Language and Process for Individual Wait Time Transfer (Patient Affairs
Committee)
Policy 3.6.C: Waiting Time Transfer does not completely and accurately describe the process that occurs
when a candidate transfers primary waiting time from one transplant program to another. The Patient
Affairs Committee (hereafter, the Committee) proposes modifications to Policy 3.6.C so that it details the
current process and defines waiting time that is eligible for transfer. This proposal promotes the efficient
management of the OPTN by describing the responsibilities of both transplant programs and the OPTN
Contractor in the individual waiting time transfer process. By defining waiting time that is eligible for
transfer, this proposal also ensures that the waiting time transfer calculations are accurate and that the
process is fair for all candidates.
Region 1 Vote: 12 yes, 0 no, 0 abstentions
This proposal was approved during the June 2015 OPTN/UNOS Board of Directors
meeting.
Effective Date: September 1, 2015
Proposal to Collect Ex Vivo Lung Perfusion (EVLP) Data for Transplant Recipients
(Thoracic Organ Transplantation Committee)
Ex vivo lung perfusion (EVLP) is an emerging technology that can be used during transport, and to
preserve and condition lungs prior to transplantation. The utilization of EVLP is not currently reported to
the OPTN, so the OPTN cannot determine how many lungs have been perfused or transplanted. In the
spring of 2015, the OPTN will implement changes to the OPTN Tiedi forms, including the Deceased
Donor Registration form (DDR). Through the modified DDR, Organ Procurement Organizations (OPOs)
will report whether an accepting transplant program intends to perfuse the lungs prior to transplant.
However, there is no corresponding field on the Transplant Recipient Registration form (TRR) for
transplant programs to report whether lungs were perfused prior to transplant. The Thoracic Committee
believes it is important to capture this information to monitor lung allocation, recipient safety, and organ
and patient outcomes. This information will also be important for future policy development and risk
adjustment for member-specific performance measures.
Region 1 Vote: 12 yes, 0 no, 0 abstentions
This proposal was approved during the June 2015 OPTN/UNOS Board of Directors
meeting.
Effective Date: Pending implementation and notice to members
Discussion Agenda
Operations and Safety Committee
Proposed ABO Blood Type Determination, Reporting, and Verification Policy
Modifications
This proposal seeks to:
1. Clarify requirements related to ABO blood type determination, reporting, and verification for
donors and candidates
2. Strengthen current key system safety components to ensure the correct organ is transplanted
into the correct recipient and that the match is ABO compatible or planned incompatible
3. Align OPTN/UNOS and Centers for Medicaid and Medicare Services (CMS) blood type
requirements more closely
This proposal was originally released in the spring 2014 public comment cycle and has been
modified to address concerns raised by the transplant community.
Region 1 Vote: 11 yes, 3 no, 0 abstentions
Comments:
The region approved the proposal with a comment that the additional pre-recovery verification
requirements when the intended recipient is known prior to organ recovery be removed from the
proposal. Safeguards are built into current policy and the proposal such as deceased donors
and candidates being blood typed twice and a requirement that two individuals make an
independent report of the blood type in UNet. Matching is performed based on blood type
results (and other factors) by a highly sophisticated computer system. Confirming the intended
recipient prior to organ recovery isn't necessary and the proposed source to use when
performing the verification is the OPTN computer system. The OPTN computer system is not a
source document.
Committee Response:
Seven of the eleven regions approved this proposal. This proposal, however, was widely
debated. The ASTS, ASHI, and American Nephrology Nurses Association support the proposal.
AST opposes the proposal. AOPO commented that they appreciate the work but had several
concerns they would like addressed. The OPO, Transplant Administrators, Membership and
Professional Standards, Patient Affairs, Pediatric, Thoracic, Living Donor, and VCA Committees
reviewed this proposal. The Committees were generally supportive although several committees
did have suggestions or substantive comments that they wanted to be addressed.
Identified concerns and requests and subsequent OSC responses are summarized below and
organized by proposal goal.
1. Concerns about documentation. Confusion or misunderstanding over acceptable verification
information sources. Concerns about site survey requirements.
The OSC will provide education about acceptable sources. A verification is a confirmation of
information. Because two people are required independently to enter blood type in UNet for both
donors and candidates, the OPTN computer system is allowed to be the verification source in
some cases. While some people disagreed with that philosophy and had concerns they could
not trust the data, the OSC believes if it is strong enough to be used for the match run then this
data can be used in some verification areas. The final pre-transplant verification does require
that source documents be used.
2. Concerns over OPO requirements to perform verification at recovery
Several commenters stated that they could not verify any recipient information because they do
not have access to source documents. It is acknowledged that the OPO will not have recipient
source documents. The OPTN computer system is named as an acceptable source. This allows
the OPO to use DonorNet and the match run to verify this information. A verification is a
confirmation of information and does not always require source documents. When source
documents are required, the table of acceptable sources will be specific. It is acknowledged that
the intended recipient might change. The information verified is what is known at the time of
recovery.
The proposal places the responsibility of conducting a verification at recovery with the OPO in
order to be congruent with CMS. The CMS rule, §486.344 Condition: Evaluation and
management of potential donors and organ placement and recovery, includes the following:
(d) Standard: Collaboration with transplant programs.
(1) The OPO must establish protocols in collaboration with transplant programs that define the
roles and responsibilities of the OPO and the transplant program for all activities associated with
the evaluation and management of potential donors, organ recovery, and organ placement,
including donation after cardiac death, if the OPO has implemented a protocol for donation after
cardiac death.
(2) The protocol must ensure that:
(i) The OPO is responsible for two separate determinations of the donor's blood type;
(ii) If the identify of the intended beneficiary is known, the OPO has a procedure to ensure that
prior to organ recovery, an individual from the OPO's staff compares the blood type of the donor
with the blood type of the intended beneficiary, and the accuracy of the comparison is verified
by a different individual;
(iii) Documentation of the donor's blood type accompanies the organ to the hospital where the
transplant will take place.
(3) The established protocols must be reviewed regularly with the transplant programs to
incorporate practices that have been shown to maximize organ donation and transplantation.
(e) Documentation of beneficiary information. If the intended beneficiary has been identified
prior to recovery of an organ for transplantation, the OPO must have written documentation from
the OPTN showing, at a minimum, the intended organ beneficiary's ranking in relation to other
suitable candidates and the recipient's OPTN identification number and blood type.
This proposal was approved during the June 2015 OPTN/UNOS Board of Directors
meeting.
Effective Date: Pending OPTN/UNOS Executive Committee meeting, likely 2nd quarter
2016
Proposal to Modify the Sterile Internal Vessels Label
This proposal seeks to modify the requirements for the sterile internal vessels label. The amount of
information required on this label will be reduced. Currently all infectious disease results are required by
policy to be handwritten on a “2 x 4” or “2 x 5” label in a sterile field. This process is difficult for OPOs to
complete and prone to transcription errors. Infectious disease results on this label will be reduced to
whether the donor is positive for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or
Hepatitis C Virus (HCV) and whether the donor is at increased risk in accordance with US Public Health
Service Guidelines for HIV, HBV, or HCV. Requirements for the hangtag poly-plastic internal label
attached to the outermost layer of the triple sterile barrier will not change and all infectious disease results
still must be completed on this label.
Region 1 Vote: 12 yes, 0 no, 0 abstentions
Comments:
The region requested that the committee delineate the Hepatitis B results on the vessel label.
Otherwise OPO coordinators may mark the HIV HBV or HCV question as “yes” when the donor
is positive for Hepatitis B surface antibody. The region would like for the committee to consider
adding a field for the match run ID so that the transplant center can easily find information in
DonorNet.
Committee Response:
The OSC specifically asked for feedback on whether the positive indication for HBV should be
for any positive HBV testing result or solely for HBsAg positive results as storage of these
vessels is prohibited by policy.
The majority of commenters, including the AST and three OPTN Committees, did want
information about the different types of HBV results and requested that the label distinguish
between different types of HBV test results.
This proposal was approved during the June 2015 OPTN/UNOS Board of Directors
meeting.
Effective Date: September 1, 2015
Liver and Intestine Committee
Proposed Membership and Personnel Requirements for Intestine Transplant Programs
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 serve as the
primary surgeon or primary physician. The intent is to set minimum standards where none currently exists
without compromising quality or restricting new program formation.
Region 1 Vote: 10 yes, 0 no, 1 abstention
Comments:
The region commented that the proposal strikes a balance between access and programs
having some experience. It was also noted that intestine programs listed on the OPTN website
is not up to date as many of the programs perform very few if any intestine transplants and this
effort will establish an accurate list for patients to access. The region does have concerns about
the 4 month application period. Programs may need additional time. Another concern is
regarding the transition plan. Programs that will no longer perform intestine transplants will need
to transfer candidates to other programs. During this transition period programs will be pending
approval. How will an intestine program that is closing know where to transfer its candidates if
programs have not yet been approved?
Committee Response:
This proposal lacks a detailed plan for application, transition and implementation.
The plan for application, transition and implementation was established in collaboration with the
UNOS Membership and Quality Department.
Expected Implementation Plan:
These Bylaws will be implemented pending approval of the new membership application for
intestinal transplant programs by the Office of Management and Budget (OMB), programming
and notice to members.
All transplant hospitals with intestine programs with a current status of “Active, Approval Not
Required” will receive an OPTN intestine transplant program application, along with a deadline
for submission of the application. The application will be structured similarly to other current
transplant program application forms. Transplant hospitals that receive this packet will be asked
to complete all requisite information to apply for an intestine transplant program and submit the
application within 120 days. Transplant hospitals that receive this application but do not intend
to apply for an intestine transplant program will be asked to document this in writing and submit
that documentation to UNOS. Transplant hospitals that do not receive an application but wish to
apply for an intestine transplant program should contact the UNOS Membership Analyst for their
region to obtain an application and the necessary instructions once the application period is
announced.
The proposed Bylaws will be slated for implementation following the 120-day application
submission period. Every application received during the submission period will be acted on
prior to implementation. Applications received after the deadline will be processed in the order
they are received. Processing of applications received after the deadline cannot be guaranteed
prior to the implementation date. Members will be alerted of the status of applications before the
implementation date.
Upon implementation of these proposed Bylaws, any transplant hospital without an approved
intestine transplant program that has intestine or liver-intestine candidates on its waiting list
must follow the patient notice and transition plan requirements described in OPTN Bylaws
Appendix K (Transplant Program Inactivity, Withdrawal, and Termination).
This proposal was approved during the June 2015 OPTN/UNOS Board of Directors
meeting.
Effective Date: Pending implementation and notice to members
Pediatric Transplantation Committee
Proposal to Establish Pediatric Training and Experience Requirements in the Bylaws
Pediatric transplantation is a subspecialty within the field of transplantation. In the current OPTN Bylaws,
the primary surgeon and primary physician are not required to have pediatric training or experience in
order to serve as key personnel at programs that perform pediatric transplants. The Bylaws’ silence on
pediatric program requirements means that there is not a universal standard of quality in pediatric care,
which, in the most rare and serious of circumstances, could pose a risk to patient safety. In 2012, the
Board of Directors included developing separate program requirements for pediatric programs as a key
initiative under Goal 4: Promote Patient Safety of the OPTN/UNOS Strategic Plan and charged the
Pediatric Transplantation Committee with developing Bylaws that fulfill this key initiative. 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.
Region 1 Vote: 6 yes, 5 no, 2 abstentions
Comments:
The region generally supports the concept of the OPTN establishing pediatric program
requirements. Below are comments made by those who opposed the proposal as written:
 The statement that low volume centers have worse outcomes than high volume centers
is not backed up with data. It was noted during that meeting that this statement was
generated by a statistically valid analysis of the SRTR data.
 The committee should reexamine adding an exception clause for a very sick patient.
 Looking at volume alone is not enough survival rates need to be part of the proposal.
However UNOS has never used this as a standard for program approval. If used no new
programs would ever be approved.
 Some concern regarding the number of transplants being proposed specifically for liver
and kidney programs but it was noted that conditional approval is an option.
 The KM curves imply that surgical expertise is not the issue rather that medical care
after one year is an issue.
Committee Response:
The Committee received support for this proposal from pediatric specialists, including
organizations such as the American Society of Nephrology (ASN), the American Society of
Pediatric Nephrology (ASPN), the North American Pediatric Renal Trial and Collaborative
Studies, the Studies of Pediatric Liver Transplantation (SPLIT), as well as parents and family
members of pediatric transplant patients. Transplant professionals supportive of the proposal
voiced appreciation for defining the widely-accepted subspecialty of pediatrics in the Bylaws, as
well as for establishing a standard of quality and safety for all pediatric patients. Parents
expressed an expectation that these quality and safety standards exist, as well as a desire for
all children to receive care from highly-qualified individuals who understand their unique needs.
However, despite the Committee’s efforts to build consensus for proposed requirements, many
recurrent themes emerged from public comment. These include that the proposal:
 Lacks evidence of a patient safety concern
 Cannot define a pediatric patient as less than 18 years old
 Lacks evidence to support the proposed caseload requirements
 Limits access to transplantation for pediatric patients
 Needs to stratify caseload requirements by age, weight, and other clinical factors.
The proposal lacks evidence to support the proposed caseload requirements.
Many have asked the Committee to produce evidence to support the proposed case volume
requirements for the primary pediatric surgeon. As with all OPTN membership requirements
involving case volume, the proposed case volume requirements were developed through clinical
consensus. None of the OPTN membership requirements, alone, are predictive of good
program outcomes. Many factors contribute to the success of a program. However, qualified key
personnel are important contributors to a program’s success, and case volume is the most basic
way a surgeon demonstrates requisite experience.
The purpose of these requirements is to establish criteria for membership; therefore, the
Committee does not have to demonstrate improved outcomes associated with these
requirements. However, in an effort to build consensus, the Committee investigated outcomes
data. A descriptive analysis of OPTN data showed significantly better unadjusted Kaplan-Meier
graft and patient survival for pediatric transplants performed at high versus low volume kidney,
liver, and heart programs from 1995-2010 (Exhibits B-D). High volume programs were
determined using the proposed case volume requirements for each organ, i.e., at least 12
kidney transplants, 18 liver transplants, 8 heart transplants, and 4 lung transplants. While highvolume lung transplant programs also experienced better patient survival outcomes, the
difference was not statistically significant (Exhibit E). Additionally, adjusted analyses that were
performed independently by UNOS showed that as a group, centers performing <18 pediatric
liver transplants during 2000-2010 had an increased risk of graft loss and death within 5 years
(i.e., worse outcomes) as compared to centers performing 18+ pediatric liver transplants during
that period; and centers that performed <12 pediatric kidney transplants during 2000-2010 had
an increased risk of graft loss and death within 5 years (i.e., worse outcomes) as compared to
centers that performed 12+ pediatric kidney transplants during that period (Exhibit F-G).
The proposal limits access to transplantation for pediatric patients.
In response to feedback from the Regions, the Committee made major comprises in the
development of these proposed Bylaws in the interest of access to transplantation for pediatric
patients. The resulting proposal better balances the competing interests of quality of care,
including patient safety, and access to transplantation for pediatric candidates. In fact, from
January 1, 2005 through July 31, 2014, 97.7% of pediatric transplants were performed at
centers that would have met the proposed pediatric volume criteria. Again, because of the
limitations of OPTN data, center volume is being used as a proxy for primary surgeon volume. A
low volume center could still be approved for a pediatric component so long as a surgeon that
has performed the required number of pediatric surgeries over the history of his or her career
can serve as key personnel. Programs may also take advantage of a 24-month conditional
pathway to establish a new pediatric component or accommodate a change in key personnel.
The Committee continues to receive requests for an exception that would allow programs
without a pediatric component to perform a pediatric transplant in an emergency, such as acute
fulminant liver failure. The Committee has thoroughly considered and decided against proposing
such an exception, which would represent a departure from the current standard that OPTN
members must fully meet program and program component requirements in order to perform
transplants. In these exceedingly rare instances, patients can be safely transported to qualified
pediatric component program.
The proposal needs to stratify caseload requirements by age, weight, and other clinical
factors.
At the Regional Meetings in the fall of 2013, the Committee presented initial requirements that
were stratified by age, weight, and other relevant clinical factors in an effort to build consensus
prior to public comment. Among the initial requirements, the primary pediatric kidney surgeon
must have performed 6 transplants in patients weighing 20 kilograms or less at time of
transplant, and the primary pediatric liver surgeon must have performed 9 transplants in patients
less than 12 years old and 5 technical variants, including split, reduced, or living donor liver
transplants. This experience had to be achieved over a recent five year period. As mentioned
above, the Committee received overwhelming feedback to modify the requirements to preserve
access to transplantation for pediatric patients. In response, the Committee eliminated
stratifications from the pediatric caseload requirements and proposed that the requisite
surgeries could be performed over an entire career, so long as the surgeon demonstrates
currency of experience as currently defined in the Bylaws. Informed by the development
process, the Committee knows it cannot achieve consensus for stratified caseload requirements
and recognizes its responsibility to balance quality of care with access to transplantation for
pediatric patients.
A majority of the directors present voted in favor of this proposal, however the Bylaws
require that a majority of the entire Board must vote to approve changes to the bylaws.
Therefore, these proposed modifications to the Bylaws were not approved. The Board
directed that the interested parties including the Pediatric Committee and
representatives of the professional societies including the ASTS collaborate to develop
an acceptable proposal that could be distributed for public comment in the fall 2015
cycle.
Organ Procurement Organization Committee
Proposal to Address the Requirements Outlined in the HIV Organ Policy Equity Act
Current federal rules and OPTN policy prohibit the recovery and transplantation of organs from deceased
donors infected with the human immunodeficiency virus (HIV). The HIV Organ Policy Equity Act, enacted
on November 21, 2013, will allow for the development and publication of criteria for the conduct of
research relating to transplantation of organs from donors infected with HIV into individuals who are
infected with HIV before receiving such organ. The goal of this proposal is to continue to amend OPTN
policies to allow members to participate in the research study in accordance with upcoming changes to
the Final Rule and criteria developed by the Secretary of Health and Human Services (HHS).
Region 1 Vote: 11 yes, 0 no, 0 abstentions
This proposal was approved during the June 2015 OPTN/UNOS Board of Directors
meeting.
Effective Date: Pending programming and notice to members
Ad Hoc Disease Transmission Advisory Committee
Proposal to Require Re-Execution of the Match Run when a Deceased Donor’s Infectious
Disease Results Impact Potential Recipients based upon Screening Preferences
The purpose of Policy 2.9 (Required Deceased Donor Infectious Disease Testing) is to determine
whether deceased organ donors have evidence of infection with a number of potentially transmissible
pathogens. For some of these specific pathogens, organ transplant candidates may choose not to receive
offers from positive donors. In this case, these candidates do not appear on a match run. Current policy
does not require the host OPO to re-execute the match run if new results become available after
execution of the initial match run. This updated donor information could screen certain candidates from
receiving organ offers. Review of OPTN data indicates that a large number of organ allocations take
place using match runs executed prior to receipt of all test results. This presents a potential patient safety
concern, as organs could unintentionally be allocated to a candidate who is not willing to accept offers
from organs who are positive for a specific infectious disease. This could result in unintended donorderived disease transmission. Better defining in policy the processes that should be followed when new
results are learned after the initial match run will reduce the opportunity for error and enhance patient
safety.
Region 1 Vote: 10 yes, 1 no, 0 abstentions
Comments:
One member made the comment that the OPO should always rerun the match when positive
infectious disease results become available even with a provisional yes. This ensures that only
candidates willing to accept CMV HBV and HCV positive will appear on a match for a donor with
a positive test result.
Committee Response:
Public comment generated little concern from individuals, groups, or committees and received
support from 10 of the 11 regions in support. The American Society of Transplantation
submitted substantial comments. Overall comments were grouped into four themes:

This proposal does not go far enough- all match runs should be re-executed when
this information is received.
The Committee was originally supportive of a requirement to always require re-execution
of the match run in these circumstances. Upon discussion in the larger joint
subcommittee, including representation from both the Operations & Safety and OPO
Committees, the Committee grew to appreciate the transplant surgeon perspective of
honoring the primary potential transplant recipient’s acceptance when seen as an
appropriate organ by the surgeon and upon obtaining informed consent of the potential
recipient. While in most cases, the joint subcommittee believes that this provisionally
accepted organ will be declined based upon this new information, the group felt strongly
that it was an appropriate compromise to make in light of the logistics of sometimes
having a potential recipient admitted, consented, and cleared for transplant.
Several commenters noted that OPOs should put more effort on completing tests before
executing a match run, while others raised concerns that OPO should not wait for all
information to generate a match run- as this could impact donor stability and organ
quality.
For all of these reasons, the Committee is confident that this compromise approach
outlined in the three separate pathways is a reasonable way to enhance patient safety
while not removing the ability for the potential recipient’s care team to exercise medical
judgment as appropriate.
This proposal was approved during the June 2015 OPTN/UNOS Board of Directors
meeting.
Effective Date: Pending programming and notice to membership
Vascularized Composite Allograft Committee
Membership Requirements for Vascularized Composite Allograft Transplant
Vascularized Composite Allografts (VCAs) were included in the OPTN Final Rule (42 CFR part 121) as
covered human organs effective July 3, 2014. In response to this change, the OPTN Board of Directors
approved minimal VCA membership requirements that will expire on September 1, 2015. Under the
current rules, there are no specific membership requirements with regard to VCA transplant experience
for the primary physician and surgeon at a VCA program. The VCA Committee is proposing minimal
certification, training, and experience for individuals serving as VCA primary physicians and surgeons. If
approved, these new requirements will replace those requirements that will expire in September 2015.
Region 1 Vote: 9 yes, 0 no, 1 abstention
This proposal was approved during the June 2015 OPTN/UNOS Board of Directors
meeting.
Effective Date: Pending programming and notice to members