MEETING SUMMARY
Region 2 Meeting
Pittsburgh, PA
March 28, 2014
Public Comment Items Proposed during fall 2013
Following is a summary of the region’s comments on each proposal out for public comment during the
spring of 2014, the sponsoring committee’s response to regional comments, if appropriate, and the
OPTN/UNOS Board of Directors action on each proposal.
Non-Discussion Proposals
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.
Vote: 27 yes, 0 no, 0 abstentions
This proposal was approved during the November 2014 OPTN/UNOS Board of Directors meeting.
Effective Date: Upon implementation and notice to members
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.
Vote: 27 yes, 0 no, 0 abstentions
This proposal was approved during the November 2014 OPTN/UNOS Board of Directors meeting.
Effective Date: Upon implementation and notice to members
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.
Vote: 27 yes, 0 no, 0 abstentions
This proposal was approved during the November 2014 OPTN/UNOS Board of Directors meeting.
Effective Date: February 1, 2015
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.
Vote: 27 yes, 0 no, 0 abstentions
This proposal was approved during the November 2014 OPTN/UNOS Board of Directors meeting.
Effective Date: May 1, 2015
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 noncontroversial 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.
Vote: 27 yes, 0 no, 0 abstentions
This proposal was approved during the November 2014 OPTN/UNOS Board of Directors meeting.
Effective Date: February 1, 2015
Discussion Proposals
Histocompatibility Committee
Expanding Candidate and Deceased Donor HLA Typing Requirements to Provide Greater
Consistency Across Organ Types
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.
Vote: 22 yes, 4 no, 0 abstentions
Comments: During the discussion there was concern that there is no standardized method to identify
unacceptable antigens and MFI cutoffs. This variation is a problem when sharing for high PRA patients.
The variation makes it difficult to interpret the clinical importance of a positive crossmatch. One member lab
asked if the committee had considered including the alpha chain and if so, would there be a benefit to
implementing both the alpha and beta at the same time.
Committee Response: The Committee met in person on August 11-12, 2014 to review public comments
received on this proposal. During review of the public comments, members agreed that HLA-DPA should be
included in the list of loci, however, this change was considered outside the scope of this proposal and
would need to be addressed through the development of a new project.
As a result of favorable public comment, the Committee voted unanimously to recommend approval of the
proposal, without changes, to the Board of Directors. In response to specific public comment feedback on
whether to include HLA-DQA and HLA-DPB fields in DonorNet® only or to DonorNet® and WaitlistSM, the
Committee unanimously agreed with the majority of commenters that the proposal should be programmed
to include HLA-DQA and HLA-DPB fields in DonorNet® and HLA-DQA and HLA-DPB fields in WaitlistSM as
unacceptable antigens.
This proposal was approved during the November 2014 OPTN/UNOS Board of Directors meeting.
Effective Date: Upon programming and notice to members
Living Donor Committee
Proposal to Modify Existing or Establish New Requirements for the Informed Consent of all Living
Donors
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.
Vote: 26 yes, 0 no, 0 abstentions
No comments
This proposal was approved during the November 2014 OPTN/UNOS Board of Directors meeting.
Effective Date: February 1, 2015
Proposal to Modify Existing or Establish New Requirements for the Psychosocial and Medical
Evaluation of all Living Donors
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.
Vote: 25 yes, 2 no, 0 abstentions
Comments: There was some concern about UNOS policy dictating medical decision making and a
suggestion that these requirements should be guidelines and not policies. There were also several
members who had gone through a living donor program site survey and wanted “phosphate” to be removed
from the list of requirements.
Committee Response: On June 16, 2006, the Health Resources and Services Administration (HRSA)
published a notice in the Federal Register in which the Secretary of Health and Human Services directed
the Organ Procurement and Transplant Network (OPTN) to develop policies regarding living organ donors
and living organ donor recipients, including policies for the equitable allocation of living donor organs (in
accordance with section 121.8 of the Final Rule). The notice directed the OPTN to develop such policies in
the same manner, and with the same public comment process, that is done for policies on deceased organ
donors and deceased donor organ recipients. The notice stipulated that noncompliance with such policies
will subject OPTN members to the same consequences as noncompliance with OPTN policies regarding
deceased donor transplantation.
This proposal was approved during the November 2014 OPTN/UNOS Board of Directors meeting.
Effective Date: February 1, 2015
Transplant Coordinator Committee
Proposal to Notify Patients Having an Extended Inactive Status
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.
Vote: 0 yes, 24 no, 2 abstentions
Comments: The region did not approve this proposal and had the following concerns:
o There committee should consider alternatives to a written letter. Some centers call their patients
and document the call in the patients chart.
o The retrospective data is misleading because many inactive patients are inactive due to being sick
and their deaths are not preventable.
o If implemented this would be an unfunded mandate and the centers would have to come up with
substantial resources to comply with the policy.
o In many areas candidates are listed with the understanding that they will remain on the list as
inactive for years until they gain enough waiting time to receive organ offers.
o The data does not support the stated goal of the proposal.
Based on public comment, the committee decided not to submit the proposal to the Board in
November. Instead, they will explore ways to inform the transplant community of effective patient
notification practices. The committee will also review the data and revisit the proposal after KAS
has been implemented for six months and one year to see if there is any effect on the inactive
waiting list.
Kidney Transplantation Committee
Kidney Paired Donation (KPD) Histocompatibility Testing Policies
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.
Vote: 27 yes, 0 no, 1 abstention
Region 2 Comments: The region did not have any comments about the proposal, but responded to the
request for feedback. In cases where an unacceptable positive crossmatch breaks a chain, there was
support for having UNOS automatically inactivate a candidate and automatically reactivate them once the
review is complete. There was also consensus that screening every 90 days for all candidates was
reasonable.
Committee Response: The proposal now reflects both of the region’s recommendations.
This proposal was approved during the November 2014 OPTN/UNOS Board of Directors meeting.
Effective Date: Upon programming and notice to the members.
Ad Hoc Disease Transmission Advisory Committee
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.
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.
Vote: 25 yes, 0 no, 0 abstentions
No Comments
This proposal was approved during the November 2014 OPTN/UNOS Board of Directors meeting.
Effective Date: February 1, 2015 except NAT requirements
NAT requirements will be implemented upon programming and notice to members
Liver and Intestinal Transplantation Committee
Proposal to Cap the HCC Exception Score at 34
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.
Vote: 14 yes, 6 no, 3 abstentions
Comments: This could disadvantage candidates waiting in regions with a high average MELD/PELD at
transplant
Committee Response: It was suggested that this policy may inadvertently disadvantage candidates in
regions with a high average MELD/PELD at transplant and may potentially prolong waiting times for HCC
patients. The intent of this proposal is to give candidates who reach a true laboratory MELD/PELD score an
opportunity to receive organ offers, especially in regions with high average MELD/PELD scores at
transplant. HCC candidates demonstrating a need for higher priority may be referred to the Regional
Review Board (RRB) for consideration.
This proposal was approved during the November 2014 OPTN/UNOS Board of Directors meeting.
Effective Date: Upon programming and notice to members
Proposal to Delay HCC Exception Score Assignment
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 drop-out 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 posttransplant outcomes.
Vote: 4 yes, 12 no, 4 abstentions
Comments: Those who did not support the proposal were concerned that there was not enough data to
support the proposal.
Committee Response: Several commenters stated that there was a perceived lack of data presented in
support of the proposal. The Committee agreed that rather than a lack of data there had been a lack of
proper communication which likely contributed to the lack of support. Modeling data included in the proposal
showed that a 6 month delay would not disadvantage this population but would reduce the disparity in the
transplant and drop-out 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. HCC
candidates demonstrating a need for higher priority may be referred to the Regional Review Board (RRB)
for consideration.
This proposal was approved during the November 2014 OPTN/UNOS Board of Directors meeting.
Effective Date: Upon programming and notice to members
Proposed Membership and Personnel Requirements for Intestine Transplant Programs (in
collaboration with the Membership and Professional Standards Committee)
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.
Vote: 23 yes, 0 no, 1 abstention
Comments: There was some concern raised that for currently approved programs who will be terminated,
120 days may not be enough time for the program to get their application approved.
This proposal was not submitted to the Board of Directors for review and is out for public comment
until March 27, 2015.
Membership and Professional Standards Committee
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
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.
Vote: 11 yes, 11 no, 2 abstentions
Comments: The members who opposed this proposal commented that a program should not be approved
if they do not have a qualified surgeon. Allowing this could result in a patient safety issue.
Committee Response: The MPSC is sensitive to potential patient safety concerns. As such, it should be
noted that programs seeking this exception are not absolved of all expectations included in the OPTN
Bylaws. The proposed Bylaws set up a process for the OPTN Board of Directors to consider approving
programs in these geographically isolated areas. Before the Board would even be asked to consider
approving these programs, the proposed Bylaws require geographically isolated applicants to “demonstrate
to the MPSC that the proposed key personnel have both a satisfactory level of transplant experience and an
established history of transplant success for the specific organ type indicated in the application for
designated transplant program status.” If the MPSC had any concerns about geographically isolated
applicant, then these applications would not be sent to the Board for its consideration.
This proposal was approved during the November 2014 OPTN/UNOS Board of Directors meeting.
Operations and Safety Committee
Proposed ABO Blood Type Determination, Reporting, and Verification Policy Modifications
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
Vote: 16 yes, 1 no, 5 abstentions
Comments: There was concern that there was too much redundancy in this policy and that the additional
requirements may go too far given the frequency of any problems.
Committee Response: The Committee received several comments to this effect. Redundancy is a key
part of the safety checks in current and proposed ABO policy. The redundancy however occurs at critical
checkpoints when there is a hand-off or transition. These are times susceptible to error. Each determination,
reporting, and verification step involves different persons participating in the transplantation process. The
Committee conducted a proactive, not reactive exercise with the FMEA. The areas identified for change are
supported by both general health care data and concepts as well as transplant-specific data. Please see the
Primary Public Comment Concerns/Questions section above for a full response.
This policy proposal was tabled during the November 2014 OPTN/UNOS Board of Directors meeting.
Thoracic Transplantation Committee
Proposal to Continue the Adolescent Classification Exception for Pediatric Lung Candidates
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.
Vote: 18 yes, 0 no, 5 abstentions
Comments: There was some concern that removing the sunset date would also remove any urgency the
committee has to review and revise the policy.
Committee response: The Committee noted that if they proposed an expiration date, it would have to be
well into the future because so little data were collected over the one year since this policy’s
implementation. Though some feedback suggested that adopting an expiration date would pressure the
Committee to continue examining this policy, the Committee determined that such “pressure” is not
necessary. The Committee already committed to evaluating pediatric lung transplant policy holistically with
a view towards many different solutions, which not only includes the adolescent classification exception, but
also broader geographic sharing of pediatric lungs and the potential for ABO-incompatible lung transplants.
This proposal was approved during the June 2014 OPTN/UNOS Board of Directors meeting.