Public Comment Items Proposed During Spring 2014
Following is a summary of the region’s comments on each proposal submitted for public
comment during the spring of 2014, the sponsoring committee’s response to regional
comments, if applicable, and the OPTN/UNOS Board of Directors action on each proposal. The
region met on May 5, 2014 in Worcester, MA.
Non-Discussion Agenda **Proposals not presented or discussed
Proposal to Require the Collection of Serum Lipase for Pancreas Donors (Pancreas
Transplantation Committee)
This document proposes to make serum lipase a required field in Policy 2.8.E Required
Information for Deceased Pancreas Donors, as well as required in DonorNet ®, in order to make
electronic pancreas offers. Currently, serum lipase is a listed field in DonorNet®, but is not
required in order to make electronic pancreas offers. Serum lipase level(s) in deceased donors
are reliable indicators of pancreas function and quality. As such, the serum lipase values assist
in making an informed clinical decisions regarding electronic pancreas offers. The proposal also
proposes to create a new field in DonorNet® where OPOs will report the upper limit of normal
(i.e. maximum normal value or highest reference value) of the laboratory’s normal serum lipase
reference range. The reason for programming this new field is because laboratories’
measurement ranges vary for serum lipase. As a result, a serum lipase value may have two
different meanings at two different laboratories. This results in varying “normal” serum lipase
values across the country. This new field will provide a reference point regarding the serum
lipase value to the physician making the decision whether to accept the pancreas.
Region 1 Vote: 13 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.
Region 1 Vote: 13 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)
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.
Region 1 Vote: 13 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.
Region 1 Vote: 13 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
non-controversial things like obvious misspellings and mis-numbering of lists. There is nothing
in the Bylaws or Policies that allow staff to make these non-substantive changes. This proposal
would allow staff to make non-substantive changes without needing approval by the Executive
Committee or Board of Directors. The Executive Committee would review these changes
retrospectively.
Region 1 Vote: 13 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 Agenda
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.
Region 1 Vote: 14 yes, 1 no, 0 abstentions
Comments:
The region approved the proposal with the following comments:
 If PCR based testing is in compliance with OPTN policy, the policy needs to be updated
to include this information.
 The region suggested that the committee develop guidance as to how to proceed with a
positive NAT result as the false positive rate for NAT is so high.
 Patients tend to be risk averse and it would be helpful for the committee to develop
guidance that the public can understand concerning the risk of disease transmission and
best practices for informed consent discussions.
Committee Response:
Review of feedback on the proposal highlighted the following themes:
 Concerns related to NAT requirements
o Desire for standardization of NAT across platforms
o Guidance on how to proceed with initial positive (eg. Triplex)
o How to rule out potential false positive NAT results (and how to manage
repeat testing)
o Concerns related to access to NAT in some donor service areas. Could a
NAT requirement lead to delayed donation or lost donors?
 Effects on some sub-populations (e.g. pediatric donors, living donors) and the
potential for organ wastage.
 Plan for implementation of these changes, as time will be needed for OPOs and
transplant hospitals to develop new internal procedures and testing protocols.
 Hemodialysis as an increased risk factor for HCV
 Education materials for patients considering increased risk organs
 How to handle recipient consent if potential living donor meets increased risk criteria
Education Materials for Candidates Considering Increased Risk Donor Organs
The Committee understands and appreciates the longstanding desire of the transplant
community to receive guidance on the topic of informed consent, especially in relation to
informed consent of increased risk donor organs. This is a topic that has come up frequently
over the years.
While the Committee is happy to partner in the development of guidance or best practices, it
believes that this task may best be addressed by the professional societies rather than the
OPTN. It may be outside of the purview of the OPTN, and might best be developed with
additional input from transplant social workers and independent advocates who could assist in
providing plain-language comparisons to frame the risk of potential donor-derived disease
transmission risk related to increased risk donor organ offers in a tangible way.
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
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.
Region 1 Vote: 0 yes, 8 no, 2 abstentions
Comments:
Under the current policy and this proposal, young pediatric candidates (less than 12 years old)
receive priority for two categories of donors, pediatric and adolescent (if approved by the lung
review board). Adolescents only receive priority for adolescent donors. The committee should
consider allowing adolescent candidates to apply for a pediatric classification exception or
young pediatric candidates with an approved adolescent classification exception to receive
priority for adolescent donors only.
The region does not support removing the expiration date from the policy. The Thoracic
Committee should continue to review data and determine how to allocate lungs based on size
matching, not age.
Committee Response:
The Thoracic Committee met on June 17, 2014 to discuss public comment feedback. First, the
Committee discussed whether the proposal should be assigned a different expiration date, as
suggested by some of the Regions and commenters, rather than continuing on permanently.
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.
The Committee noted feedback suggesting that it is unfair to allow pediatric candidates to apply
for adolescent classification, without permitting adults or adolescents to apply for a pediatric
classification. Though not statistically significant, the Committee recognized the trend for slightly
worse access to donor lungs for young pediatric candidates. Thus, the adolescent classification
helps even the playing field, rather than tipping it in favor of pediatric candidates. Additionally,
the fact that only one candidate received adult donor lungs is indicative of surgeons’ motivation
to do what is best for the patient. This exception did not create an atmosphere in which
surgeons began to accept lungs of all sizes for their young pediatric candidates. Young pediatric
donor lungs are still offered to and accepted by adolescent and adult candidates. Therefore,
even if there is a perception that the adolescent classification policy discriminates against
adolescents and adults, in practice such inequities do not exist. The Committee will
nevertheless continue to monitor the effects of the policy.
This proposal was approved during the June 2014 OPTN/UNOS Board of Directors
meeting.
Effective Date: July 1, 2014
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.
Region 1 Vote: 15 yes, 0 no, 0 abstentions
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.
Region 1 Vote: 15 yes, 0 no, 0 abstentions
Comments:
The region requested that a sample consent form and checklist be developed for members to
review to ensure that their consent forms include all required elements.
This proposal was approved during the November 2014 OPTN/UNOS Board of Directors
meeting.
Effective Date: February 1, 2015
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.
Region 1 Vote: 12 yes, 0 no, 2 abstentions
Comments:
The region supports the proposal, but a couple members commented that capping at a MELD
score of 34 is still too high.
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 post-transplant outcomes.
Region 1 Vote: 8 yes, 2 no, 6 abstentions
Comments:
Candidates that have one small well-treated tumor are not likely to drop off the waiting list due
to death or too sick, with a larger tumor the circumstances are very different.
Committee Response:
Public comment revealed general opposition focused on:
 Concern for lack of data to support the proposal
 Concern this would limit access to patients when transplant is appropriate and a proven
cure for HCC
 Suggestions that a six month delay is too long, with a recommendation of a 3 month
delay
 Concern that minorities and the poor who do not have the same access to healthcare
and were not diagnosed early may be disadvantaged
 Concern this policy would penalize high performing centers/OPOs due to the poor
performance of others, Need for policy focused on OPO accountability
 Concern patients will be dissatisfied having to live with cancer for a longer time
 Concern centers may “game the system” & early list to “get 6 months under their belt”
 Suggestion that patients should be observed for lifestyle and demonstrated healthcare
management
 Concern that this proposal does not alleviate geographic disparity.
General support focused on:
 Concern that other non-HCC patients may still be disadvantaged despite these proposed
changes
 The need for a mechanism to override the system for ablated tumors.
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.
Additionally, concerns were voiced that bad tumor biology was unlikely to manifest in any
obligatory waiting period. The Committee felt this to be an inaccurate statement citing that in
regions where wait times are substantially longer, bad tumor biology does in fact have time to
manifest. As mentioned above, the option for RRB appeal remains intact for those candidates
who demonstrate a need for higher priority.
Some commented that this proposal would not alleviate the current geographic disparity. This
proposal is intended to reduce the disparity in waiting list drop-out rates (removals for death/”too
sick”/other removals due to HCC) between HCC and non-HCC candidates, not to reduce the
national geographic disparity. The Committee is currently pursuing other projects to address the
national geographic disparity. Likewise, this policy proposal was not intended to address OPO
performance.
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.
Region 1 Vote: 0 yes, 4 no, 11 abstentions
Comments:
The committee should consider eliminating the timeframe in which experience can be obtained
for both the surgeon and physician requirements. Otherwise programs that are actively
transplanting intestines may not qualify. Has the committee looked at training programs to
determine if the proposed requirements are realistic?
This proposal was not submitted to the Board of Directors for review and is out for public
comment until March 27, 2015.
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.
Region 1 Vote: 11 yes, 0 no, 3 abstentions
Comments:
The region supports typing the donor at the donor’s transplant hospital. Retyping the donor at
the candidate’s hospital is burdensome and unnecessary.
Committee Response:
The proposal places the requirement on the candidate’s hospital to ensure a second and
separate typing verifies the donor HLA type.
This proposal was approved during the November 2014 OPTN/UNOS Board of Directors
meeting.
Effective Date: Upon programming and notice to members
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.
Region 1 Vote: 0 yes, 15 no, 1 abstention
Comments:
The region did not support the proposal. While the proposal is well intentioned, it is too
prescriptive. The discussion included the following comments:
 Transplant hospitals should develop their own protocols regarding the notification of
inactive candidates. Specifically how (verbal vs. written communication) and when
candidates are notified.
 Written notification may not assist with patient education regarding inactive status.
Transplant hospitals struggle with educating candidates about their status on the waiting
list, and many think that this proposal will not help achieve this goal.
 Instead of a policy proposal, this could be an education initiative. Perhaps the
committee should survey programs that are effectively managing their waiting lists and
share best practices with the community.
 Alternatively, the committee should focus on transplant hospitals that have a large
number of inactive patients and reach out to them.
 Under the proposal, a transplant hospital can re-activate candidates just prior to the
notification timeframes and inactivate shortly thereafter, negating the intent of the
proposal.
This proposal was not submitted to the Board of Directors for review.
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 pretransplant verification
 Added a requirement for qualified health care professionals to perform ABO reporting
and verification functions
 Made deceased and living donor standards more consistent
Region 1 Vote: 0 yes, 13 no, 2 abstentions
Comments:
The region did not approve the proposal and provided the following comments:

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The region recommends that the committee define anesthesia by adding the word
“general”.
Source documentation definition – the committee should consider defining when an
original handwritten medical note is acceptable.
If the policy is approved, the region requested that the Living Donor and Recipient OR
Verification Templates be updated to include the new requirements.
Policy 5.6.A,Table 5.1: The region identified a couple issues with this requirement as
currently written:
o The policy requires the host OPO in conjunction with the on-site surgical
recovery team to perform a deceased donor organ recovery verification which
requires the verification of a recipient unique identifier, recipient blood type and
that the donor and recipient are blood type compatible, in addition to other
elements.
What process does the host OPO follow when the intended recipient is unknown
while the on-site surgical recovery team and OPO are conducting the
verification? This does occur, particularly with kidney allocation.
Secondly, when the on-site surgical recovery team is recovering an organ for
another transplant center, how can the OPO and surgical recovery team perform
the verification without having the required documentation? Is the on-site
recovery team expected to take responsibility for a potential recipient that is listed
at another transplant center?
Committee Response:
The Committee agrees with the terminology comment regarding anesthesia and has added the
word "general" prior to the word "anesthesia" for clarification.
The Committee has removed the examples from the proposed policy definition. The Committee
plans to work on a guidance document regarding source documents. DEQ will put some
additional information in the evaluation plan.
The Committee agrees with the suggestion to provide updated verification templates and will
work with CMS to update these tools.
The Committee has received multiple comments concerning the ability to perform a verification
at deceased donor organ recovery when the intended recipient is not known. The Committee
has proposed post-public comment changes in response to these comments.
This policy proposal was tabled during the November 2014 OPTN/UNOS Board of
Directors meeting.
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.
Region 1 Vote: 12 yes, 0 no, 0 abstentions
This proposal was approved during the November 2014 OPTN/UNOS Board of Directors
meeting.
Effective Date: February 1, 2015
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.
Region 1 Vote: 10 yes, 0 no, 1 abstention
This proposal was approved during the November 2014 OPTN/UNOS Board of Directors
meeting.
Effective Date: Upon programming and notice to members