MEETING SUMMARY
Region 9 Meeting
March 11, 2015
An OPTN/UNOS Region 9 meeting was held on March 11, 2015 at the New York Academy of
Medicine in New York, NY. Dr. Lloyd Ratner, Region 9 Councillor, convened the business
meeting and welcomed those in attendance. There were 67 individuals in attendance
representing 81 percent of UNOS institutional voting members. Those members present
unanimously approved the October 1, 2014 regional meeting summary.
OPTN/UNOS Update
Betsy Walsh, JD, MPH, OPTN/UNOS Vice-President, 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 9 vote: 14 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 9 vote: 14 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 9 vote: 14 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 9 vote: 18 yes, 1 no, 0 abstentions
Comments:
The region approved the proposal but commented that the current policy is confusing and
compliance is an issue and the proposed policy may not fix this. Also, requiring too many ABO
verifications diminishes the importance of the verification.
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.
Goal 1: Clarify requirements for ABO blood type determination, reporting, and verification and
better assist members in complying with the requirements.
1. Concerns over complexity
ABO policy touches over a dozen policies. The Committee did propose many non-substantive
changes to make each type of policy (e.g. determination) have the same structure and
terminology across donation types. Having all of these changes in one proposal may seem
complex. Details were added to address repeated transplant community questions (e.g.
acceptable sources). Basic steps already in policy for determination, reporting, and verification
remain. Core principles were also applied more uniformly to increase consistency.
OSC is committed to providing members with the tools needed to comply with these policies.
2. 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.
3. Concerns over time out fatigue, too many verifications, effort to implement
Many transplant hospital staff will not be doing any additional verifications. Various programs
have some type of check-in process already. The check-in is not a verification. It is similar to
when a package is received. A process exists where the receiver checks to see where it is from
and if it was expected. This is done for receipt of medical supplies and numerous other
procedures.
If transplant hospitals are performing the Joint Commission universal protocol time out prior to
the start of surgery, then they could incorporate or add elements such as ABO into this process
to reduce burden perceived for the proposed verification if surgery starts prior to organ arrival.
No one has spoken against the final pre-transplant verification. This verification remains in both
CMS and OPTN policy. Several have commented that they appreciate the spelling out of
requirements.
This proposal was approved during the June 2015 OPTN/UNOS Board of Directors
meeting.
Effective Date: early 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 9 vote: 19 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.
Committee Response:
This proposal was widely supported during public comment. It was approved in all regions. The
AST, ASTS, and AOPO all supported the proposal. Four Committees (MPSC, DTAC, TCC, and
OPO) deliberated and provided comment on this proposal.
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 9 Vote: 15 yes, 0 no, 1 abstention
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 9 Vote: 7 yes, 10 no, 2 abstentions
Comments:
The region made the following comments:


The committee should reexamine adding an exception clause for a very sick patient.
Access to care will be an issue for pediatric patients. The region is particularly
concerned about the 14-18 year age group. The data doesn’t show that adolescents are
not being served well currently.
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.
During its April 14, 2015 meeting in Chicago, the Committee considered all public comment
feedback. Its responses to each of the themes follows.
The proposal lacks evidence of a patient safety concern.
The National Organ Transplant Act (NOTA) requires that the OPTN “recognize the differences
in health and in organ transplantation issues between children and adults throughout the system
and adopt criteria, policies, and procedures that address the unique health care needs of
children.” Pediatric membership requirements are the most fundamental of criteria the OPTN
could adopt to recognize the unique needs of children in transplantation. As early as 1993, the
MPSC has sought guidance from the Pediatric Committee in establishing pediatric requirements
so it could better assess key personnel applications.
While centers not meeting the proposed criteria do not experience poor outcomes immediately
post-transplant, long-term patient and graft survival is significantly better at centers that meet
criteria. Some have suggested that this justifies excluding the surgeon from any pediatric
requirements. However, the primary surgeon is integral to the leadership of a program and
shares responsibility with the primary physician and medical director for its long-term outcomes.
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.
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 9 Vote: 18 yes, 0 no, 0 abstentions
Comments:
A member commented that HIV positive organs should only be allocated to HIV positive
candidates who appear on a match run and is supportive of the committee’s proposed
modification to policy 5.4.F.
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 (15 min)
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 9 Vote: 19 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
Vascularized Composite Allograft Committee
Membership Requirements for Vascularized Composite Allograft Transplant (15 min)
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 9 Vote: 19 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