MEETING SUMMARY
Region 6 Meeting
Portland, Oregon
May 16, 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.
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 6 Vote: 35 yes, 4 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 6 Vote: 50 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.
Region 6 Vote: 50 yes, 0 no, 0 abstentions
This proposal was approved during the November 2014 OPTN/UNOS Board of Directors
meeting.
Effective Date: February 1, 201
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 6 Vote: 50 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.
Region 6 Vote: 50 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 6 Vote: 48 yes, 0 no, 0 abstentions
Region 6 Comments: There should be a check box added so that when a program is listing a
candidate, they can indicate whether or not they would accept an organ from an HCV Nat + donor.
Also, Living Donor recovery centers should not be required to screen for all transmissible diseases
within 28 days prior to organ recovery if the living donor is not high risk. The only requirement for
non-high risk donors should be HCV Nat.
Committee Response: The Committee appreciates this feedback. Programming is included in this
proposal to screen recipients not willing to receive NAT positive organs for transplant. This will be in
addition to screening already in place for serology positive organs.
The Committee appreciates concerns related to the decreased time period for final infectious disease
screening for living donors. Unfortunately, there have been window period infections in living donors
that were transmitted to recipients. For this reason, the Committee remains supportive of the 28 day
window proposed in the PHS Guideline. While potentially inconvenient for the living donor and the
organ recovery hospital, this will prevent scenarios where a donor is tested early in the evaluation
process and then may unknowingly become infected between screening and donation. Reducing the
opportunity for window period infection will enhance donor and recipient safety.
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
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 6 Vote: 4 yes, 53 no, 0 abstentions
Comments: Several members were concerned that the data did not support this being a wide-spread
problem and agreed that this issue should be addressed with individual centers and not put into
national policy. This would be burdensome for the centers and is already reported to the dialysis
centers through the nephrologists. If implemented, an annual letter would be more reasonable than a
letter at 90 days and then annually.
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 impleneted for six months and one year to see if there is any effect on the
inactive waiting list.
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 6 Vote: 55 yes, 0 no, 1 abstention
Comments: The members agreed that the unacceptable antigen fields should be added in UNet, so
that these organ offers are automatically screened off from candidates with antibodies to these types.
This is needed to do a virtual crossmatch.
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.
Region 6 Vote: 48 yes, 0 no, 0 abstentions
This proposal was approved during the November 2014 OPTN/UNOS Board of Directors
meeting.
Effective Date: Febraury 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 6 Vote: 46 yes, 2 no, 0 abstentions
Comments: There was some discussion about the need for HepBsAg testing for liver donors since
this is really not a problem for the recipient.
Committee Response: The Committee appreciates this response. All testing or screening
requirements in the proposal are based on recommendations from a Joint Societies Work Group and
the Disease Transmission and Advisory Committee.
This proposal was approved during the November 2014 OPTN/UNOS Board of Directors
meeting.
Effective Date: February 1, 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 6 Vote: 51 yes, 0 no, 0 abstentions
Comments: The region requested clarification of policy section 13.5.A, 2. to indicate that if a
candidate had antibody to on one HLA type, for example HLA C, they would only need to be typed for
HLA C not DR, DPB etc. The group did not come to consensus about screening all candidates every
90 days. The transplant programs thought this was not necessary and the Histo labs thought it was a
good idea because they would not be aware of a sensitizing event. There was no comment on having
the candidate inactivated automatically by UNOS versus having the center inactivate.
Committee Response: The Committee amended the proposal to make clear that the candidate’s
transplant program is only required to report the corresponding candidate HLA type if the candidate
reports unacceptable antigen. The Committee appreciates your question and attention to detail.
This proposal was approved during the November 2014 OPTN/UNOS Board of Directors
meeting.
Effective Date: 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.
Region 6 Vote: 58 yes, 0 no, 0 abstentions
Comments: There was general agreement that the MELD should be capped, but several of the
members thought that 34 was probably too high and asked that the committee look at data if the cap
was lower.
Committee Response: While the Subcommittee acknowledged that some members of the
community have voiced a concern that the cap should be lower than 34, the intent of the proposal was
to exclude patients with HCC Exceptions and a lower rate of drop-off from the regional sharing under
Share 35. Capping at any other particular MELD was not likely to be effective due to current regional
variation.
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 6months.
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 6 Vote: 50 yes, 0 no, 0 abstentions
Comments: There were questions about the dropout rate for HCC exceptions who meet criteria
versus those who do not and if this varied greatly by region. There was also concern that these
changes to policy would have an unknown effect on the goals of the re-districting.
Committee Response: 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 6 Vote: 47 yes, 0 no, 0 abstentions
Comments: The region supported this proposal unanimously but agreed that the training and
experience numbers should be higher. The pediatric members understood that the committee will
always get pushback that the numbers are either too high or too low and that this is probably as good
as we can get.
This proposal has been modified and will go out for public comment in January 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.
Region 6 Vote: 52 yes, 0 no, 0 absentions
This proposal was approved during the November 2014 OPTN/UNOS Board of Directors
meeting.
Effective Date: February 1, 2015
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 6 Vote: 0 yes, 38 no, 0 abstentions
Comments: In many cases OPOs do not have and cannot verify recipient information. Some of the
proposal is reasonable, but there is so much wrapped up into this one proposal there is no way to pull
out the good sections from the sections that are inconsistent with practice.
Committee Response: 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. The
Committee acknowledges that the proposal contains proposed changes to multiple sections. The
Committee is appreciative that the region acknowledges that the proposal contains good sections.
This policy proposal was tabled during the November 2014 OPTN/UNOS Board of Directors
meeting and will go back out for pubic comment in January 2015.
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 6 Vote: 33 yes, 0 no, 0 abstentions
This proposal was approved during the June 2014 OPTN/UNOS Board of Directors meeting.
Effective Date: July 1, 2014