AGENDA

Region 6 Meeting

The W Seattle

Seattle, Washington

May 4, 2012

8:45Check-in for OPTN/UNOS Kidney Paired Donation Pilot Program Meeting

9:00Kidney Paired Donation Pilot ProgramRuthanne Hanto, RN, MPH

Program Manager, OPTN/UNOS Kidney Paired Donation Pilot Program

9:00Region 6 Liver Workgroup meetingLinda Wong, MD

9:30Main Meeting Registration and Continental Breakfast

10:00Welcome/Opening RemarksKaren Nelson, PhD, D(ABHI)

Region 6Councillor

  • September 2011 regional meeting summary
  • November 2011OPTN/UNOS Board meeting summary
  • Committee appointments
  • Fall meeting dates/Portland, OR
  • Spring Educational Forum Update
  • Nomination process for Regional Councillor

10:15 UNOS Update John Lake, MD

OPTN/UNOS President

11:00 Workplace Partnership for Life (WPFL) UpdateTBD

11:05OPTN/UNOS Committee Reports and Voting on Public Comment Proposals

Moderator: Karen Nelson, PhD, D(ABHI)

Region 6 Councillor

***A Working Lunch will be provided at 12:30***

EthicsLisa Florence, MD, FACS

Kidney Transplantation Viken Douzdjian, MD

Proposal to Clarify Priority Status for Prior Living Organ Donors who Later Require a Kidney Transplant

This proposal seeks to clarify the allocation priority assigned to prior living organ donors who later require a kidney transplant. Current policy is unclear as to whether the priority is to be assigned in the event that a prior living donor requires a second or third transplant. This proposal would clarify that the priority is to be assigned with each kidney transplant registration for prior living organ donors.

Proposal to Establish Kidney Paired Donation (KPD) Policy

This proposal converts the existing OPTN Kidney Paired Donation (KPD) Pilot Program rules, housed in the OPTN KPD Pilot Program Operational Guidelines, into OPTN policy. The full range of adverse actions will be available to the MPSC for violations of KPD policy, up to and including designation of member not in good standing.

The policy also includes additional elements of potential donor informed consent that are specific to KPD and requirements for how the OPTN Contractor will conduct matching in the OPTN KPD Program.

The proposed changes would consolidate all rules for the OPTN KPD Program into a single location and allow the MPSC to follow its standard processes for potential violations of KPD policy.

Proposal to Include Bridge Donors in the OPTN Kidney Paired Donation (KPD Program)

The goal of this proposal is to increase matching opportunities in the OPTN KPD Program by allowing bridge donors (a donor who does not have a match identified during the same match run as his paired candidate) in the OPTN KPD Program. Currently, the OPTN KPD Pilot Program requires that donor chains end with a donation to a candidate on the deceased donor waiting list. As a result, donor chains could end when there may be the potential to extend the chain and transplant more candidates. Additionally, many transplant hospitals have expressed a desire for the OPTN KPD Program to include bridge donors. A secondary goal of this proposal is to increase participation in the OPTN KPD Program by providing more options for participating transplant hospitals. These policies are being proposed as new policies in the Proposal to Establish KPD Policy, which is also out for public comment in Spring 2012. The proposed changes would allow potential donors who are not matched in the same match run as their paired candidates to enter a later match run to find a KPD match rather than donating to the deceased donor waiting list.

Finance Susan Marx, MBA

Liver and Intestinal Organ Transplantation Jorge Reyes, MD

Proposal to Allow Centers to Place Liver Candidates with HCC Exceptions on ‘HCC Hold’ Without Loss of Accumulated MELD Exception Score

This proposal would allow transplant programs to voluntarily place well-compensated candidates with stable or well-treated HCC in inactive status (“HCC Hold”, where no livers will be offered) without losing accumulated exception points. These candidates may then be reactivated at the discretion of the transplant center if the tumor shows growth or other concerning features. Candidates listed with an HCC exception continue to receive additional points every three months regardless of whether the HCC tumors have changed in size or have responded to ablative therapy. In some cases, a center may wish to put a candidate with an HCC exception ‘on hold’ (in inactive status) at a particular MELD score until the tumor(s) show growth or change if the tumor is stable or if there has been a successful response to therapy. Currently, the UNet℠application does not allow this without loss of exception points. If an exception expires while a candidate is inactive, the application must be resubmitted as an initial application with loss of accumulated points, or the case must go to the Regional Review Board (RRB) for prospective review.

The proposed change would facilitate more appropriate timing of liver transplantation for candidates with HCC based on the size and number of their tumors, as well as encourage alternative therapies for HCC besides transplantation.

Living Donor Jordana Gaumond, MD

Proposal to Require Reporting of Unexpected Potential or Proven Disease Transmission Involving Living Organ Donors

Under this proposal, existing policy would be modified to require members to report to the OPTN Contractor any unexpected potential or proven living donor-derived disease transmission, including infections or malignancies. Current OPTN/UNOS policy requires specific infectious disease testing for all deceased organ donors. It also requires that any unexpected potential or proven disease transmission, including infections and malignancies, discovered after donation be reported to the OPTN Contractor.

Although rare, unexpected potential or proven disease transmissions involving a living donor have occurred. The types of events reported to date include small renal cell carcinomas (RCC) found in the living donor during recovery and malignancies and viral infections identified in the recipient or the donor after donation. This policy change is being proposed to help improve the reporting of disease transmissions involving living donors.

Minority Affairs Stephen Kula, PhD, NHA

Operations and Safety Kathy Jo Freeman, RN, MSN

Proposal to Require Extra Vessel(s) Disposition to be Reported to the OPTN within Five Days of Transplant or Disposal

The Operations and Safety Committee is proposing policy language within section 5.10.2 (Vessel Storage) to require transplant centers to report the disposition of extra vessels to the OPTN within five days of transplant or disposal. This proposal will enhance patient safety and recipient outcomes in cases where extra vessels are transplanted by providing timely information on the disposition of extra vessels that could be part of an investigation by the OPTN/UNOS ad hoc Disease Transmission Advisory Committee’s (DTAC) review of a potential disease transmission event. It is expected that this proposal can reduce the risk of disease transmission when the donor of the extra vessel is potentially at risk for transmitting disease a primary or secondary recipient.

Organ Procurement Organization (OPO) Casey Kickertz, BSN, CPTC

Proposal to Require Documentation of Second Unique Identifier

This proposal will require OPOs and living donor recovery centers to document all unique identifiers used to label any tissue typing specimen in the donor record. This will allow transplant centers to validate the unique identifier information.

Proposal to Update and Clarify Language in the 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 do not change any current level of oversight by the donor hospital to ensure that appropriate practices are following for a patient’s end of life care, and that hospital approved practitioners follow hospital palliative care policies and guidelines involving the withdrawal of life sustaining medical treatment/support. 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 committees 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 that have the terms “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.

Note: This proposal was distributed for public comment during the March 11, 2011 to June 10, 2011 period. Prior to the Nov. 14-15, 2011 Board of Directors meeting, several letters were submitted to the OPTN contractor requesting that the public comment period be reopened to allow the requesting organizations to provide comments. The Executive Committee directed the OPO Committee to review the comments outlined in the letters, revise the proposal if necessary, and resubmit the proposal for public comment during the spring 2012 cycle.

Policy Oversight (POC) TBD

Proposal to Update Data Release Policies

The proposed revisions to the OPTN Data Release Policies will combine Policy 9 and Policy 10 into a single policy (Policy 9 – Release of Data). The proposed changes will:

  • Allow the OPTN Contractor to release more data than is currently released
  • Provide an appeals process if the OPTN denies a data request
  • Set requirements for the release of confidential information
  • Allow the OPTN contractor to release non-confidential data by institution to any requester
  • Eliminate the list of data elements that can be released in special circumstances out of policy to allow for greater flexibility in data release.
  • The process for release of person-identified data will not change.

During the evaluation of the policies as part of the Plain Language Rewrite Project, it was noted that the data release policies contained outdated elements that required substantive changes. The proposed revisions align these policies with current practice and present the information in a simpler format.

Patient Affairs John Fallgren RN, BS

Pediatric Transplantation Andre Dick, MD

Thoracic Organ Transplantation Nahush Ashok Mokadam, MD

Proposal to Revise the Lung Allocation Score System

The Thoracic Organ Transplantation 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 baseline waiting list and post-transplant survival rates used in the LAS calculation. The Thoracic Organ Transplantation Committee intended for the LAS system to be dynamic so that it addresses 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 in 2005.

The LAS system prioritizes candidates who are at least 12 years of age for allocation of deceased donor lung offers. The revisions to the LAS system will enable prioritization of candidates using data derived from a candidate population transplanted due to their LASs, instead of their waiting time.

Transplant Administrators Pamela Hester, RN, BSN, CCTC

HistocompatibilityPaul Warner, PhD, D(ABHI)

2:55Old/ New Business

3:00 Adjournment