Download MEETING SUMMARY Region 11 Meeting February 25, 2015 The

MEETING SUMMARY
Region 11 Meeting
February 25, 2015
The UNOS Region 11 meeting was held on February 25, 2015 in Charlotte, NC. Dr. David
Shaffer, Region 11 Councillor, convened the meeting and welcomed those in attendance. There
were 41 individuals in attendance representing 67 percent of institutional voting members.
OPTN/UNOS Update
Dr. Carl Berg, OPTN/UNOS President, provided the OPTN/UNOS Update which included the
following information:
 OPTN and UNOS Strategic Planning
o Updating the 2012 Strategic plan
o Planning for 2015-2018
 KAS implementation update
o “Out of the Gate” Data – so far the initial data shows changes predicted
 Redesigning liver distribution
o Town Hall Meeting Sept. 2014
o Ad Hoc Subcommittee meeting between Nov. 2014 – April 2015
o Develop recommendations to refine the concept of Redistricting
o Deliver to the committee and the public at a Public Forum in Spring 2015
 IT projects nearing completion
 2015 BOD project plan
 TransNet labelling and tracking app
 New public comment tool
o Blog-Style public comment
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 11 vote: 21 yes, 0 no, 2 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 11 vote: 21 yes, 2 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 11 vote: 21 yes, 0 no, 2 abstentions
This proposal was approved during the June 2015 OPTN/UNOS Board of Directors
meeting.
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 11 vote: 0 yes, 16 no, 0 abstentions
Comments:
The host OPO is unable to verify either the blood type of the intended recipient or compatibility
of blood type between the donor and recipient because the OPO has no actual source
documents for the recipient. It was suggested that 2.15.B table 2.2 be modified to eliminate the
table and replace it with a simple statement that the host OPO verifies that the recipient appears
on the donor match run. There was a concern about how the new process would fit into existing
processes around time outs. The additional ABO verification at "check-in" is unnecessarily
burdensome and redundant.
Committee Response:
Seven of the eleven regions approved this proposal. This proposal, however, was widely
debated. The ASTS, ASHI, and American Nephrology Nurses Association support the proposal.
AST opposes the proposal. AOPO commented that they appreciate the work but had several
concerns they would like addressed. The OPO, Transplant Administrators, Membership and
Professional Standards, Patient Affairs, Pediatric, Thoracic, Living Donor, and VCA Committees
reviewed this proposal. The Committees were generally supportive although several committees
did have suggestions or substantive comments that they wanted to be addressed.
Identified concerns and requests and subsequent OSC responses are summarized below and
organized by proposal goal.
Goal 1: Clarify requirements for ABO blood type determination, reporting, and verification and
better assist members in complying with the requirements.
The following issues were raised for proposed actions that address this goal:
1. Concerns over complexity
2. Concerns about documentation. Confusion or misunderstanding over acceptable
verification information sources. Concerns about site survey requirements.
3. Wait to adopt with TransNetsm/Phase in with TransNetsm
4. Concerns over time out fatigue, too many verifications, effort to implement
Goal 2: Align OPTN/UNOS and Centers for Medicaid and Medicare Services (CMS)
requirements
The following issues were raised for proposed actions that address this goal:
1. Concerns over living donor verification prior to anesthesia (versus prior to
incision)/verification in OR
2. Concerns over OPO requirements to perform verification at recovery
3. Only change to align with CMS
Goal 3: Strengthen current key safety components to ensure correct organ/correct recipient and
blood type compatibility or planned incompatibility
The following issues were raised for proposed actions that address this goal:
1. Need to focus on right organ/right recipient (not ABO)
2. Concerns about organ check-in
3. Concerns about adding verification if surgery starts prior to organ arrival
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. Wait to adopt with TransNetsm/Phase in with TransNetsm
While OPOs have started a voluntary national deployment, a beta testing version for transplant
hospitals will not be available until summer 2015. Approximately 15 transplant hospitals will test
but this number is less than 10% of all transplant hospitals. A voluntary national roll out for
transplant hospitals will not occur until perhaps late 2016. This would be too long to wait to
implement some of the proposal. By implementing these steps now, transplant hospitals can be
better prepared to implement TransNetsm when it is ready. Several requirements will not be
impacted by TransNetsm.
4. 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.
OSC will provide educational tools to assist with implementation.
Goal 2: Align OPTN/UNOS and Centers for Medicaid and Medicare Services (CMS)
requirements
1.
Concerns over living donor verification prior to anesthesia (versus prior to incision)/
verification in OR.
Several commenters were concerned that the timing proposed would not align with CMS and
cause confusion. Living donation is a well-planned, elective event. There should always be
adequate time to conduct this verification. Anesthesia is not without risk. These risks are
outlined in the supporting evidence section.
The OSC strongly feels that living donors should not be exposed to unnecessary risk, especially
for an elective case. Should an issue be discovered during a verification conducted after
administration of general anesthesia but prior to incision, then the living donor would be
exposed to unnecessary risk. The Committee continues to support keeping this timing at prior to
the induction of general anesthesia.
The Committee has dropped the requirement that the verification occur in the operating room
but has added that it must occur on the same day as surgery.
2. Concerns over OPO requirements to perform verification at recovery
Several commenters stated that they could not verify any recipient information because they do
not have access to source documents. It is acknowledged that the OPO will not have recipient
source documents. The OPTN computer system is named as an acceptable source. This allows
the OPO to use DonorNet and the match run to verify this information. A verification is a
confirmation of information and does not always require source documents. When source
documents are required, the table of acceptable sources will be specific. It is acknowledged that
the intended recipient might change. The information verified is what is known at the time of
recovery.
The proposal places the responsibility of conducting a verification at recovery with the OPO in
order to be congruent with CMS. The CMS rule, §486.344 Condition: Evaluation and
management of potential donors and organ placement and recovery, includes the following:
(d) Standard: Collaboration with transplant programs.
(1) The OPO must establish protocols in collaboration with transplant programs that define the
roles and responsibilities of the OPO and the transplant program for all activities associated with
the evaluation and management of potential donors, organ recovery, and organ placement,
including donation after cardiac death, if the OPO has implemented a protocol for donation after
cardiac death.
(2) The protocol must ensure that:
(i) The OPO is responsible for two separate determinations of the donor's blood type;
(ii) If the identity of the intended beneficiary is known, the OPO has a procedure to ensure that
prior to organ recovery, an individual from the OPO's staff compares the blood type of the donor
with the blood type of the intended beneficiary, and the accuracy of the comparison is verified
by a different individual;
(iii) Documentation of the donor's blood type accompanies the organ to the hospital where the
transplant will take place.
(3) The established protocols must be reviewed regularly with the transplant programs to
incorporate practices that have been shown to maximize organ donation and transplantation.
(e) Documentation of beneficiary information. If the intended beneficiary has been identified
prior to recovery of an organ for transplantation, the OPO must have written documentation from
the OPTN showing, at a minimum, the intended organ beneficiary's ranking in relation to other
suitable candidates and the recipient's OPTN identification number and blood type.
3. Only change to align with CMS
The OPTN and CMS will always have some differences in regulations due to varying areas of
focus such as the OPTN is responsible for allocation. Subtyping policy is to increase allocation
and therefore CMS will not address this area as it would be out of scope.
The other areas the OSC proposed to change that are different from CMS are based on findings
from the FMEA and are needed to address safety gaps. They will not cause anyone to be out of
alignment with CMS.
Goal 3: Strengthen current key safety components to ensure correct organ/correct recipient and
blood type compatibility or planned incompatibility
1. Need to focus on right organ/right recipient (not ABO)
The OSC agrees that this is the proper focus. This policy includes identification of the correct
organ and correct recipient as part of the process proposed as well as critical data such as
ABO.
2. Concerns about organ check-in
Some comments indicated that the organ check-in needed to be more specific or occur at the
operating room. The OSC has deliberately left the place of check-in up to the transplant hospital
to accommodate varying practices.
Some commenters mistakenly thought that the check-in required an ABO verification. This
check does not include ABO. It is a check of expected donor and actual donor ID on the
external label and organ type to make sure that the right organ has been sent to the correct
transplant hospital without accruing unnecessary cold ischemic time. The supporting evidence
section provides additional data in support of this step.
3. Concerns about adding verification if surgery starts prior to organ arrival
Some commenters felt this was an unnecessary step and that the universal precaution time out
required by the Joint Commission would take care of this need. This was seen as burdensome
by some and not adding value to the process.
The OSC suggests that this verification can be combined with the universal precaution time out.
The Joint Commission check requires that vital data be checked. Transplant hospitals can add
expected donor ID and ABO as well as recipient ID and ABO to this check. Conducting a
verification takes a very limited amount of time—an estimated 1 to 2 minutes. This was
suggested in a previous response.
This check is important as no candidate should start surgery and then have a verification past
the point where harm could have been avoided. Anesthesia is not without risk. There has been
a case where the intended recipient surgery started prior to organ arrival. The patient was put
on a heart-lung bypass machine and then ABO incompatibility was discovered. The transplant
was not performed, however, organ removal had taken place and the patient later died. The pretransplant verification check is a step to protect the patient from unnecessary risks.
This proposal was approved during the June 2015 OPTN/UNOS Board of Directors
meeting.
Effective Date: February 1, 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 11 vote: 16 yes, 0 no, 1 abstention
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 11 vote: 18 yes, 1 no, 1 abstention
This proposal was approved during the June 2015 OPTN/UNOS Board of Directors
meeting.
Effective Date: September 1, 2015
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 11 vote: 2 yes, 14 no, 1 abstention
Comments:
The data is limited and should be stratified by age group ( e.g. 0 to 5 6 to 10 11 to 15 16 to 18).
There should be an exception for the larger adolescent urgent cases. Concerns were raised
about medical judgement being removed out of the hands of the adult program. The committee
should reconsider using weight as the criteria.
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 cannot define a pediatric patient as less than 18 years old.
For the purposes of addressing the unique health care needs of children throughout the
transplantation system, NOTA states that “the term ‘children’ refers to individuals who are under
the age of 18.” Defining a pediatric patient as less than 18 years old is also consistent with CMS
and the American Academy of Pediatrics. Any alternative to the definition of a pediatric patient
as less than 18 years old in the Bylaws could have implications for allocation policy, where
currently most candidates registered prior to 18 years old receive pediatric priority.
The proposal lacks evidence to support the proposed caseload requirements.
Many have asked the Committee to produce evidence to support the proposed case volume
requirements for the primary pediatric surgeon. As with all OPTN membership requirements
involving case volume, the proposed case volume requirements were developed through clinical
consensus. None of the OPTN membership requirements, alone, are predictive of good
program outcomes. Many factors contribute to the success of a program. However, qualified key
personnel are important contributors to a program’s success, and case volume is the most basic
way a surgeon demonstrates requisite experience.
The purpose of these requirements is to establish criteria for membership; therefore, the
Committee does not have to demonstrate improved outcomes associated with these
requirements. However, in an effort to build consensus, the Committee investigated outcomes
data. A descriptive analysis of OPTN data showed significantly better unadjusted Kaplan-Meier
graft and patient survival for pediatric transplants performed at high versus low volume kidney,
liver, and heart programs from 1995-2010 (Exhibits B-D). High volume programs were
determined using the proposed case volume requirements for each organ, i.e., at least 12
kidney transplants, 18 liver transplants, 8 heart transplants, and 4 lung transplants. While highvolume lung transplant programs also experienced better patient survival outcomes, the
difference was not statistically significant (Exhibit E). Additionally, adjusted analyses that were
performed independently by UNOS showed that as a group, centers performing <18 pediatric
liver transplants during 2000-2010 had an increased risk of graft loss and death within 5 years
(i.e., worse outcomes) as compared to centers performing 18+ pediatric liver transplants during
that period; and centers that performed <12 pediatric kidney transplants during 2000-2010 had
an increased risk of graft loss and death within 5 years (i.e., worse outcomes) as compared to
centers that performed 12+ pediatric kidney transplants during that period (Exhibit F-G).
The proposal limits access to transplantation for pediatric patients.
In response to feedback from the Regions, the Committee made major comprises in the
development of these proposed Bylaws in the interest of access to transplantation for pediatric
patients. The resulting proposal better balances the competing interests of quality of care,
including patient safety, and access to transplantation for pediatric candidates. In fact, from
January 1, 2005 through July 31, 2014, 97.7% of pediatric transplants were performed at
centers that would have met the proposed pediatric volume criteria. Again, because of the
limitations of OPTN data, center volume is being used as a proxy for primary surgeon volume. A
low volume center could still be approved for a pediatric component so long as a surgeon that
has performed the required number of pediatric surgeries over the history of his or her career
can serve as key personnel. Programs may also take advantage of a 24-month conditional
pathway to establish a new pediatric component or accommodate a change in key personnel.
The Committee continues to receive requests for an exception that would allow programs
without a pediatric component to perform a pediatric transplant in an emergency, such as acute
fulminant liver failure. The Committee has thoroughly considered and decided against proposing
such an exception, which would represent a departure from the current standard that OPTN
members must fully meet program and program component requirements in order to perform
transplants. In these exceedingly rare instances, patients can be safely transported to qualified
pediatric component program.
The proposal needs to stratify caseload requirements by age, weight, and other clinical
factors.
At the Regional Meetings in the fall of 2013, the Committee presented initial requirements that
were stratified by age, weight, and other relevant clinical factors in an effort to build consensus
prior to public comment. Among the initial requirements, the primary pediatric kidney surgeon
must have performed 6 transplants in patients weighing 20 kilograms or less at time of
transplant, and the primary pediatric liver surgeon must have performed 9 transplants in patients
less than 12 years old and 5 technical variants, including split, reduced, or living donor liver
transplants. This experience had to be achieved over a recent five year period. As mentioned
above, the Committee received overwhelming feedback to modify the requirements to preserve
access to transplantation for pediatric patients. In response, the Committee eliminated
stratifications from the pediatric caseload requirements and proposed that the requisite
surgeries could be performed over an entire career, so long as the surgeon demonstrates
currency of experience as currently defined in the Bylaws. Informed by the development
process, the Committee knows it cannot achieve consensus for stratified caseload requirements
and recognizes its responsibility to balance quality of care with access to transplantation for
pediatric patients.
This proposal was not approved during the June 2015 OPTN/UNOS Board of Directors
meeting. 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. The Board directed that the interested parties collaborate to develop an
acceptable proposal that could be distributed for public comment in the fall 2015.
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 11 vote: 18 yes, 0 no, 0 abstentions
This proposal was approved during the June 2015 OPTN/UNOS Board of Directors
meeting.
Effective Date: Pending programming
Ad Hoc Disease Transmission Advisory Committee
Proposal to Require Re-Execution of the Match Run when a Deceased Donor’s Infectious
Disease Results Impact Potential Recipients based upon Screening Preferences
The purpose of Policy 2.9 (Required Deceased Donor Infectious Disease Testing) is to determine
whether deceased organ donors have evidence of infection with a number of potentially transmissible
pathogens. For some of these specific pathogens, organ transplant candidates may choose not to receive
offers from positive donors. In this case, these candidates do not appear on a match run. Current policy
does not require the host OPO to re-execute the match run if new results become available after
execution of the initial match run. This updated donor information could screen certain candidates from
receiving organ offers. Review of OPTN data indicates that a large number of organ allocations take
place using match runs executed prior to receipt of all test results. This presents a potential patient safety
concern, as organs could unintentionally be allocated to a candidate who is not willing to accept offers
from organs who are positive for a specific infectious disease. This could result in unintended donorderived disease transmission. Better defining in policy the processes that should be followed when new
results are learned after the initial match run will reduce the opportunity for error and enhance patient
safety.
Region 11 vote: 9 yes, 12 no, 0 abstentions
Comments:
This proposal would lead to an increase in costs and create logistical issues that would delay
the organ offer and acceptance process. Members shared concerns that there could be other
changes to the donor like oxygen levels and blood cultures. Is this proposal justified by the
number of inadvertent transmissions? Some members suggested that the problem could be
better addressed if there was a requirement that serology be completed before the match run is
executed.
Committee Response:
Public comment generated little concern from individuals, groups, or committees and received
support from 10 of the 11 regions in support. The American Society of Transplantation
submitted substantial comments. Overall comments were grouped into four themes:

How should back up organ offers be handled or addressed?
Committee members discussed these concerns and agreed that while the originally
proposed policy clearly states that only the primary offer may be honored on the original
match run, it does not clearly outline what to do with back up offers. After consideration,
the Committee approved post-public comment language changes that require the reexecuted match run be used for back up offers in these instances. The Committee
believes that this change will resolve confusion regarding which match run to use in this
circumstance. Committee members recognized that OPOs already face circumstances
where organ offers may be rescinded based upon new information, and do not see any
need to outline specific requirements on how to address this in policy. The Committee
favored allowing OPOs to determine their own practices in this area rather than being
prescriptive in this area.

This may increase OPO time and expense and create added logistics for
transplant hospitals
Region 11 raised concerns that this proposal, as written, may increase costs and create
logistical issues that may delay the organ offer and acceptance process. Members
asked if there could be other changes to the donor information outside of these
infectious disease results that may also require re-execution of the match run.
The Committee pointed to the wide variation in current practice for when to re-execute
the match run. While some OPOs never execute a match run until all infectious disease
test results are available, others always execute the match run prior to receipt. The
Committee agrees that waiting until all infectious disease tests results is most practical
and the safest practice, but recognizes that some OPOs do not have immediate access
to testing and that some donors may require an expedited approach. For this reason, the
Committee was not supportive of requiring that a match run only be executed when all
results are in hand.

The Committee respects the OPOs’ need for flexibility related to when to execute a
match run, but stands beside the requirement to re-execute based only upon positive
infectious disease results as specifically outlined. It worked closely with the OPO and
Operations & Safety Committee in developing this concept, and does not anticipate
substantial increases in time or expense related to the proposal beyond what already
happens in the transplant community when this scenario arises currently. Requiring reexecution of the match run only reduces the opportunity for human error in
communicating this information to transplant hospitals.
This proposal does not go far enough- all match runs should be re-executed when
this information is received.
The Committee was originally supportive of a requirement to always require re-execution
of the match run in these circumstances. Upon discussion in the larger joint
subcommittee, including representation from both the Operations & Safety and OPO
Committees, the Committee grew to appreciate the transplant surgeon perspective of
honoring the primary potential transplant recipient’s acceptance when seen as an
appropriate organ by the surgeon and upon obtaining informed consent of the potential
recipient. While in most cases, the joint subcommittee believes that this provisionally
accepted organ will be declined based upon this new information, the group felt strongly
that it was an appropriate compromise to make in light of the logistics of sometimes
having a potential recipient admitted, consented, and cleared for transplant.
Several commenters noted that OPOs should put more effort on completing tests before
executing a match run, while others raised concerns that OPO should not wait for all
information to generate a match run- as this could impact donor stability and organ
quality.
For all of these reasons, the Committee is confident that this compromise approach
outlined in the three separate pathways is a reasonable way to enhance patient safety
while not removing the ability for the potential recipient’s care team to exercise medical
judgment as appropriate.

Potential recipient notification as proposed is more restrictive than current
requirements in Policy 15.3.A: Deceased Donors with Additional Risk Identified
Pre-Transplant.
Concerns that the proposed language for specific informed consent related to the new
infectious disease result in addition to the requirements of Policy 15.3.A were shared
post public comment by Operations & Safety Committee as well as the Regional
Administrators, after fielding a number of questions from members. Upon review of the
language, the Committee agreed that current language in Policy 15.3.A addresses this
issue without the need to specifically state these additional requirements. This language
was removed as part of the Committee’s post-public comment review.
In summary, the Committee’s post-public comment actions included:
 The addition of a new definition in Policy 1.1 for “primary potential transplant recipient” to
clearly define that only the first candidate according to match run sequence for whom an
organ has been accepted may still consider an offer when one of these specific
infectious diseases is found to be present after execution of the match run on which the
organ was allocated.
 Clarification in Policy 5.5.B to include that new positive HBV and HCV results apply to all
organs, while a positive CMV result applies only to the intestine match run.
 Restructuring Policy 5.5.B for the purposes of clarity to aid members in understanding
the policy requirement.
 Removal of the more prescriptive language about requiring the transplant hospital to
notify the potential recipient of the donor’s new positive infectious disease result.
Existing language in Policy 15.3.A addresses the informed consent requirement.
 Additional stylistic edits suggested by staff for clarity.
The Committee appreciated the thoughtful feedback and was unanimous in its support for these
post-public comment modifications to its proposal.
This proposal was approved during the June 2015 OPTN/UNOS Board of Directors
meeting.
Effective Date: Pending programming and notice to OPTN membership
Vascularized Composite Allograft Committee
Membership Requirements for Vascularized Composite Allograft Transplant
Vascularized Composite Allografts (VCAs) were included in the OPTN Final Rule (42 CFR part 121) as
covered human organs effective July 3, 2014. In response to this change, the OPTN Board of Directors
approved minimal VCA membership requirements that will expire on September 1, 2015. Under the
current rules, there are no specific membership requirements with regard to VCA transplant experience
for the primary physician and surgeon at a VCA program. The VCA Committee is proposing minimal
certification, training, and experience for individuals serving as VCA primary physicians and surgeons. If
approved, these new requirements will replace those requirements that will expire in September 2015.
Region 11 vote: 11 yes, 0 no, 0 abstentions
This proposal was approved during the June 2015 OPTN/UNOS Board of Directors
meeting.
Effective Date: Pending programming and notice to members