Current Status of Proposals Submitted for Public Comment
Spring 2012
Proposed Changes to the Donation after Cardiac Death (DCD) Model Elements
The proposed changes to the Donation after Cardiac Death (DCD) Model Elements will clarify
and update language for the donation and transplantation community. These Model Elements
identify specific requirements that OPOs and transplant centers must include in their DCD
policies. As such, the name Model Elements has been changed to “Requirements.” DCD is
redefined as Donation after Circulatory Death (DCD) in order to accurately reflect the definition
of death determined by cardio-pulmonary criteria.
The OPO Committee has also added the following language that mirrors the Centers for
Medicare & Medicaid Services (CMS) requirements:
1) OPOs and transplant centers must establish protocols that define the roles and
responsibilities of the OPO and the transplant center for all activities associated with the DCD
donor and
2) OPOs must have a written agreement with Medicare and Medicaid participating hospitals
and critical access hospitals in its service area that describes the responsibilities of both the
OPO and hospital concerning DCD.
Additionally, other policies using the term “Donation after Cardiac Death" will be modified for
consistency. These proposed changes will help provide a common understanding of DCD
protocols for the transplant community and the public.
Final proposal was approved by the Board in November 2013 Board of Directors Meeting.
Implementation pending programming.
Proposal to Require Extra Vessel(s) Disposition to be Reported to the OPTN within Five Days of
Transplant or Disposal
The proposed policy language within section 5.10.2 (Vessel Storage) will require centers to
report disposition of extra vessels to the OPTN within five days of transplant or disposal. Five
working days was identified as a good option for this requirement because donor feedback is
required within five days and the proposed timeframe allows for validation of data.
Transmission of infectious diseases through organ transplantation is a patient safety issue and
can be a significant public health concern. Disease transmission via the use of deceased or
living donor organs and extra vessels can result in serious illness or death in recipients. The
proposed changes would provide the OPTN with appropriate information on the use of extra
vessels soon after they are transplanted and disposed of to assist in communicating information
about potential disease transmissions when reported for the extra vessel(s) donor.
Proposal was approved by the Board in November 2012. Implementation is pending
programming.
Proposal to Revise the Lung Allocation Score System
The Thoracic Committee proposes a revision to the Lung Allocation Score (LAS) system. This
revision includes modifications to the covariates in the waiting list and post-transplant survival
models, coefficients of the covariates, and the baseline waiting list and post-transplant survival
rates. The Committee intended for the LAS system to be dynamic to address disease severity
and post-transplant survival for a given current candidate population. Except for the addition of
partial pressure of carbon dioxide (PCO2) as a covariate to the LAS system’s waiting list model,
a thorough revision of the LAS system has not occurred since its implementation. The
proposed revisions to the LAS update the system to enable prioritization of candidates using
data derived from a population transplanted due to their LAS’s, instead of their waiting time.
Proposal was approved by the Board in November 2012. Implementation is pending
programming.
Fall 2012
Proposal to Substantially Revise the National Kidney Allocation System
This proposal seeks to substantially revise the national kidney allocation system by
incorporating new features such as an expanded definition of waiting time, a sliding scale for
assigning points to sensitized patients, expanded access for blood group B candidates who can
accept A2 or A2B kidneys, broader sharing for extremely highly sensitized candidates, longevity
matching of some kidneys, and regional sharing for kidneys with the highest risk of discard. The
proposed changes are estimated to result in an additional 8,380 life years achieved annually
from the current pool of deceased donor kidneys while improving access for sensitized
candidates and minority candidates.
Proposal was approved by the Board in June 2013. Implementation will occur in two
stages with the first phase in late May 2014 and the second in Dec 2014.
Proposal to Require Reporting of Every Islet Infusion to the OPTN Contractor within 24 Hours of
the Infusion
The goal of this proposal is to require the accurate and timely reporting of every islet infusion to
the OPTN Contractor and to update language in policies and bylaws to reflect current practice
for reporting islet infusions and outcomes information. Currently, islet Transplant Programs are
not required to report every islet infusion to the OPTN Contractor. Therefore, it is possible that
the OPTN Contractor may be unaware which islet recipients have received infusions, which
could have implications for patient safety or disease transmission. This proposal:
1. Requires islet programs to report each islet infusion to the OPTN Contractor within 24 hours
of the infusion, while still allowing islet candidates to retain their waiting time through three
consecutive islet infusions.
2. Removes outdated requirements in the bylaws for submitting islet logs.
3. Adds language in the bylaws to reflect current programming for when an additional
registration fee is generated after an islet candidate is removed from the waiting list for
transplant and immediately re-registered for another infusion.
Proposal was approved by the Board in June 2013. Policy was implemented on
September 1, 2013.
Proposal to Modify the Imminent and Eligible (I & E) Neurological Death Data Reporting
Definitions
The proposed changes clarify the data collection definitions for determining whether a death can
be classified as “imminent” or “eligible.” OPOs must classify a death as one of the following:
Imminent Neurologic Death (“imminent”), Eligible Death (“eligible”), or neither “eligible” nor
“imminent” (“neither”). The OPOs then report the “imminent” and “eligible” deaths to the OPTN.
Because OPOs interpret reporting definitions differently and because brain death laws vary from
state to state, OPOs are inconsistent in the way they report death data. The changes proposed
by the Committee eliminate multi-system organ failure (MSOF) as an exclusionary criterion for
classifying a death as “eligible” and add a list of organ-specific exclusionary criteria to give
OPOs more guidance. The Committee also changed the definition of “imminent” to restrict it to
those deaths that would most likely be classified as “eligible” had brain death been legally
declared. This change could allow the combination of “eligible” and “imminent” deaths to
mitigate the effect of the variation in brain death laws.
roposal was approved by the Board in June 2013. Implementation is slated for January 1,
2015.
Proposals that have been submitted to the Executive Committee for approval post
November board meeting
Aprils 2014 Executive Committee Decision
Policy Affected: 3.6.C (Waiting Time Transfers)
Problem Statement Under the new kidney allocation system (KAS), waiting time transfers will
not be necessary for candidates who accrue waiting time due to being on chronic maintenance
dialysis prior to listing, since the dialysis start date will be the same for each registration.
However, UNOS staff recently caught a policy drafting error that would have the effect of
eliminating the option for kidney candidates accruing waiting time based on GFR or CrCl to
transfer primary waiting time once KAS is fully programmed and implemented. This option
needs to be retained for candidates once the new KAS is implemented, and this policy change
ensures kidney candidates can continue to accrue waiting time based on GFR or CRCl once
KAS is implemented.
Changes This proposal eliminates language in order to ensure that kidney transplant
candidates can continue to transfer primary waiting time once the new kidney allocation system
is in effect. Member Actions No member action is required as these are changes to policies
that were approved in June 2013 but have not been implemented.
March 2014 Executive Committee Decision
Policy Affected: OPTN Policies 1.2, 3.4.D.i, 5.3.B, 5.3.C, 5.3.D, 5.3.E, 8.2.A, 8.4.B,
10.1.E, 14.2.A, and 16.1
Problem Statement
After the release of the rewritten OPTN Policies on February 1, 2014, UNOS staff discovered
some inadvertent changes were made that substantively changed the Policies or made them
less clear. The corrections approved by the Executive Committee on March 5, 2014 will restore
the requirements in the OPTN Policies that existed before the plain language rewrite.
Changes
1. Delete Policy 5.3.B: Informed Consent for Kidneys Based on KDPI Greater than 85%. This
language is part of the new Kidney Allocation System (KAS) changes and is not yet
implemented and should not be included in the rewrite version that shows only approved
and implemented language.
2. Reinstatement of old Policy 3.5.3.2 requiring pre-procurement tissue typing for ECD kidney
donors. This was mistakenly deleted in the rewrite and is reinstated as Policy 8.2.A: Tissue
Typing Requirements for Expanded Criteria Donors.
3. Reinstatement of language from old Policy 3.5.11.3 that explains that sensitized candidates
with a CPRA of 80% or greater are assigned 4 points. This language was added to 8.4.B:
Time of Waiting Points for Standard Donors.
4. Reinstatement of language from old Policy 3.8.4 that candidate unacceptable antigens must
be reported to receive priority in the allocation of pancreas based on CPRA. This language
was added as 3.4.D.i: Reporting Unacceptable Antigens for Pancreas Candidates.
5. Reinstate the preposition “in” instead of “at” in section 16.1: Organs Not Requiring Transport
to retain clarification that the timeout must occur in the operating room rather than directly
outside the operating room.
6. Correct the following cross-references:

To tables of values used to calculate LAS values in section 10.1.E: LAS Values and
Clinical Data Update Schedule for Candidates at Least 12 Years Old.
 In section 14.2.A: ILDA Requirements for Kidney Recovery Hospitals.
7. Reinstate definitions that were included in the public comment draft and then accidentally
deleted.
Action Required
The rewritten Policies can be viewed here. Members should familiarize themselves with the
rewritten OPTN Policies.
January 2014 Executive Committee Decisions
Policies Clarification regarding DonorNet® Documentation for Public Health Service (PHS)
Guideline
Problem Statement
On November 12, 2013, the Board approved a proposal regarding the PHS Guideline. The
proposal:
®
for each specific donor what version of the PHS Guideline was used to determine
increased risk of disease transmission.
At the end of this same meeting, a comprehensive plain language rewrite of all OPTN
policy was approved by the Board. This rewrite was meant to include all of the changes to
policies approved prior to and at that Board meeting. While it updated the PHS Guideline
definition to only permit the use of the 2013 Guideline, it did not remove the requirement to
document in the Donor Highlights section of DonorNet®, which version of the Guideline was
used. This created an unnecessary requirement for OPOs.
Changes
This policy change removes the requirement that OPOs must report to the OPTN
Contractor which version of the PHS Guideline was used to evaluate a particular donor.
Member Actions
Beginning February 1, 2014, the policy references to PHS Guideline applies to only the
2013 version, and will include increased risk for HBV and HCV. OPOs are not required to
document in the Donor Highlights section that the 2013 PHS Guideline was used to
evaluate a donor for increased risk of disease transmission.
If a donor meets increased risk criteria based upon the current