| Proposal |
Proposal pdf |
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| 1 |
Thoracic Organ Transplantation Committee - Proposal to add the factor 'change in bilirubin' to the lung allocation score (LAS) Policy affected: 3.7.6.1 - (Candidates Age 12 and Older)
This proposal would add 'change in bilirubin' as a factor to the waitlist survival model in the lung allocation score (LAS). An increase in a lung transplant candidate's bilirubin level that is 50% or higher than the value at listing, observed in a six-month period, increases this candidate's risk for dying on the waiting list. Analyses revealed the association between high bilirubin levels and waitlist mortality. This association was statistically significant only for candidates in diagnosis Group B (primarily candidates with pulmonary hypertension). This policy modification is expected to reduce lung transplant waitlist mortality, and create a more clinically comprehensive waitlist survival model that increases the sensitivity of the LAS in predicting a candidate's medical urgency for a lung transplant.
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(494 K) |
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6/30/2008 - 9/24/2008 |
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| 2 |
Ad Hoc International Relations Committee - Proposal to verify that foreign agencies importing organs to the United States, or receiving organs exported from the United States, are legitimate and test organs for transplant safety Policies affected: 6.4.2 (Developmental Protocols in Organ Exchange) and 6.4.3 (Ad Hoc Organ Exchange)
This proposal would clarify and strengthen the existing policy language on importing and exporting deceased donor organs to and from the United States. Specifically, this proposal would clarify the need to verify the clinical (laboratory) safety of imported organs, the application of ethical practices in recovering deceased donor organs imported for transplant, and the legitimacy of the foreign organization engaged in importing an organ to an OPTN member or receiving an organ exported from an OPTN member. The intent of these modifications is to promote the safety of the organ for transplant purposes, and insert measures in policy that verify the credibility of the foreign agency importing an organ to or receiving an organ exported from the United States.
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(251 K) |
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6/30/2008 - 9/24/2008 |
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| 3 |
Living Donor Committee - Proposal to improve the safety of living donation by restricting the acceptance and transplant of living donor organs to OPTN member institutions. Policy affected: add OPTN Policy 3.3.7 (Center Acceptance of Organs from Living Donors)
This proposal would require OPTN member transplant programs that perform living donor transplants to only transplant organs recovered at an OPTN member institution.
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(165 K) |
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6/30/2008 - 9/24/2008 |
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| 4 |
Membership and Professional Standards Committee - Proposal to modify the bylaws pertaining to conditional approval status for liver transplant programs that perform living donor transplants Bylaw affected: Attachment I, Appendix B, Section D, (4) Liver Transplant Programs that Perform Living Donor Liver Transplants of the OPTN/UNOS Bylaws
The proposed modification to the bylaws will clarify the expectation that the transplant center must inactivate or stop performing living donor liver transplants when transplant program personnel do not fully satisfy the criteria for full program approval by the end of the conditional approval period.
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(205 K) |
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6/30/2008 - 9/24/2008 |
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| 5 |
Membership and Professional Standards Committee - Proposal to change the OPTN/UNOS Bylaws to better define functional inactivity, voluntary inactive membership transplant program status, relinquishment of designated transplant program status, and termination of designated transplant program status Bylaw affected: Appendix B, Section II, C of the OPTN/UNOS Bylaws
This bylaw proposal clarifies the current definition of Functional Inactivity by including information about waiting list inactivation in UNetsm. The proposal defines short-term voluntary inactivation as inactivation of a program waiting list in UNetsm for 14 days or fewer; and long-term voluntary inactivation as inactivation of membership status based on the expectation the program will remain inactive for greater than 14 days. These modifications also specify exactly what a member must do in terms of notifying candidates when a program voluntarily inactivates or relinquishes its designated program status (long-term inactivation).
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(317 K) |
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6/30/2008 - 9/24/2008 |
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| 6 |
Historical Proposals Appear Below
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(43 K) |
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7/15/2008 - 7/16/2008 |
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| 7 |
Kidney Transplantation Committee - Proposal to Limit Mandatory Sharing of Zero Antigen Mismatch Kidneys to Children and Sensitized Adult Candidates
With few exceptions, current policy requires mandatory sharing of kidneys that are a zero antigen mismatch, regardless of other donor or candidate characteristics. The receiving organ procurement organization (OPO) then incurs an obligation to pay back a kidney. This modification would eliminate mandatory sharing at the regional and national levels for adult candidates who have a sensitization level (PRA or CPRA) less than 20%. The intent of this modification is to reduce the number of mandatory shares for unsensitized adult candidates, resulting in fewer payback debts, shorter cold ischemic times for kidneys, and improved efficiency of the OPTN kidney allocation system.
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(451 K) |
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2/8/2008 - 4/30/2008 |
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| 8 |
Pancreas Transplantation Committee - Proposal to Allow an Additional Method for Waiting Time Reinstatement for Pancreas Recipients
This modification would change Policy 3.8.8- Waiting Time Reinstatement for Pancreas Recipients to allow the Organ Center to reinstate waiting time if:
• A pancreas graft has failed within 2 weeks of transplant,
• The recipient needs a second pancreas transplant,
• The transplant center submits a completed waiting time reinstatement form,
• The transplant center submits a statement of intent to perform a pancreatectomy, and
• The transplant center maintains radiographic evidence of graft failure and will submit this documentation upon request.
The goal of this policy change is to allow surgeons to remove a failed pancreas graft and transplant another pancreas during the same surgery.
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(287 K) |
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2/8/2008 - 4/30/2008 |
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| 9 |
Living Donor Committee - Proposal to Change the OPTN/UNOS Bylaws to Require Written Notification (or Disclosures) to Living Donors from the Recipient Transplant Programs
The goal of this proposal is to provide living donors with the same information and protections given to candidates on the national transplant waiting list. Under the proposed change, recipient transplant centers must provide written notification to living organ donors within ten business days following their donation date to include the following:
• the telephone number that is available for living donors to report concerns or grievances through the OPTN;
• disclosure that the recipient transplant center is required to submit Living Donor Follow-up (LDF) forms to the OPTN for a minimum of two years; and
• the plan for obtaining living donor data for completion of follow-up forms.
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(372 K) |
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2/8/2008 - 4/30/2008 |
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| 10 |
Membership and Professional Standards Committee (MPSC) - Proposal to the OPTN and UNOS Bylaws: Restoration of Membership Privileges Following an Adverse Action
The OPTN/UNOS has taken adverse actions against several members including the action of “Member Not in Good Standing.†The bylaws do not presently provide a clear mechanism or pathway to restore full membership privileges to a member that has received an adverse action such as “Member Not in Good Standing†or “Probation.†These proposed modifications to Section 5.05A “Restoration of Unrestricted Membership†will further describe the circumstances under which the MPSC can consider restoring a member’s full privileges. These modifications will also provide OPTN members with clear expectations for time periods before restoration of full membership privileges may be requested.
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(421 K) |
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2/8/2008 - 4/30/2008 |
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| 11 |
Membership and Professional Standards Committee (MPSC) - Proposal to Change the Elector System for Histocompatibility Lab Members and Medical/Scientific Members
This bylaw proposal eliminates the current elector system for voting privileges and responsibilities for histocompatibilty laboratory members and medical/scientific organizations. This bylaw proposal permits each histocompatibilty laboratory and each medical/scientific member a single vote in the affairs of the OPTN/UNOS and removes the need for separate national elections for both the histocompatibility member and medical/scientific member electors.
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(155 K) |
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2/8/2008 - 4/30/2008 |
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| 12 |
Operations Committee - Proposal to Change Organ Time Limits to Organ Offer Limits for Zero Antigen Mismatched Kidneys, Pancreata, and Kidney/Pancreas Combinations
These policy modifications allow OPOs to make zero antigen mismatched organ offers through UNetsm instead of requiring OPOs to use the Organ Center to place all zero antigen mismatched organs. The modifications state that OPOs and the Organ Center must make a specified number of zero antigen mismatched organ offers instead of offering the zero antigen mismatched organs for a specified number of hours. The goal of these changes is to implement a process that can be applied consistently across OPOs, that is in line with DonorNet® advances, and that is monitorable by UNOS staff. Additionally, these modifications will bring policy in line with the Executive Committee’s May 2007 resolution to allow OPOs to make offers for zero antigen mismatched organs rather than using the Organ Center to make such offers. These policy modifications are intended to change how zero antigen mismatched offers are measured, not the amount or number of zero antigen mismatched offers that are made.
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(667 K) |
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2/8/2008 - 4/30/2008 |
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| 13 |
OPTN/UNOS Executive Committee - Proposal to Require Transplant Centers to Inform Potential Recipients about Known High Risk Donor Behavior
In December 2007, the Executive Committee approved policy language to require that transplant centers inform potential organ recipients about any known high risk behavior (as defined by CDC Guidelines) by the donor. This policy was approved prior to public comment to address potential patient safety issues. While this policy is currently in effect, the Executive Committee is seeking comment and will reconsider policy language during its June 2008 Board of Directors meeting. The intent of this policy is to clarify the criteria for high risk behavior that requires transplant professionals to notify potential organ recipients prior to implantation.
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(187 K) |
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2/8/2008 - 4/30/2008 |
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| 14 |
Pediatric and Liver and Intestinal Organ Transplantation Committees - Proposal to Change How 0-10 Year-Old Donor Livers and Combined Liver-Intestines are Allocated
In July 2006, the Pediatric Transplantation Committee was charged with developing a plan to reduce the number of deaths on the pediatric organ transplant waiting lists. This proposal is one of a series of organ specific proposals resulting from this charge. In keeping with the principles of the Final Rule, the common theme of these proposals is to allocate organs from pediatric donors more broadly to ensure they are offered first to candidates at highest risk of waiting list mortality, without negatively impacting adults or adolescents. The following policy recommendation specifically addresses allocation of young pediatric donor livers (defined here as age 0-10 yrs). The intent of the current policy modification is to build upon the 2005 policy improvements (pediatric Status 1A/1B definitions and regional sharing of pediatric livers) by creating a new allocation algorithm specifically for young pediatric donor livers and intestines that will allow for broader sharing to the sickest pediatric candidates on a national level. The 0-10 age group was specifically chosen because, historically, only 1% of adults received a liver transplant from donors less than 12 years of age. The Pediatric and Liver-Intestine Committees propose extending offers nationally to all 0-11 year-old Status 1A pediatric liver and combined liver-intestine candidates before making local adult Status 1A offers for the 0-10 donor age group. This proposal is expected to reduce waiting list mortality for the children at highest risk of death without negatively impacting adult candidates. 
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(6.86 MB) |
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2/8/2008 - 4/30/2008 |
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| 15 |
Pediatric and Thoracic Organ Transplantation Committee - Proposal to Change Allocation of Pediatric Lungs and Allow Creation of a Stratified Allocation System for 0-11 year-old Candidates
In July 2006, the Pediatric Transplantation Committee was charged with developing a plan to reduce the number of deaths on the pediatric organ transplant waiting lists. This proposal is one of a series of organ specific proposals resulting from this charge. In keeping with the principles of the Final Rule, the common theme of these proposals is to allocate organs from young pediatric donors more broadly to ensure they are offered first to candidates at highest risk of waiting list mortality, without negatively impacting adults or adolescents. The following policy recommendation specifically addresses allocation to young pediatric lung candidates (defined here as age 0-11 yrs). In order to improve allocation to the sickest young pediatric candidates, two policy changes are proposed. The first would create a simple status system for young pediatric candidates (based on objective medical characteristics) to direct donor lungs to the sickest of these candidates first. The second component would improve access to organs for the sickest patients by more broadly sharing young pediatric donor lungs, allocating first to combined local, Zone A and Zone B young pediatric candidates, and then to combined local and Zone A adolescents before local offers are made to adults. Because historically, only 0.4% of adults received a lung transplant from young pediatric (<12) donors (size matching limits suitability of these donors for adults), we anticipate that these proposed changes will have a limited impact on adults while reducing pediatric waiting list mortality 
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(748 K) |
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2/8/2008 - 4/30/2008 |
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| 16 |
Pediatric and Thoracic Organ Transplantation Committee - Proposal to Allocate Pediatric Donor Hearts More Broadly
In July 2006, the Pediatric Transplantation Committee was charged with developing a plan to reduce the number of deaths on the pediatric organ transplant waiting lists. This proposal is one of a series of organ specific proposals resulting from this charge. In keeping with the principles of the Final Rule, the common theme of these proposals is to allocate organs from pediatric donors more broadly to ensure they are offered first to candidates at highest risk of waiting list mortality without negatively impacting adults or adolescents. In current policy, the allocation of young pediatric donor hearts (defined here as age 0-10 years old) follows the adult algorithm. In contrast, adolescent (11-17 year-old) donor hearts are allocated preferentially to pediatric candidates before adult candidates within each of the status categories and geographic zones. The intent of this policy is to incorporate all pediatric donor hearts into the current adolescent algorithm and share all pediatric donor hearts more broadly to the sickest candidates by combining local and Zone A offers for Status 1A pediatric candidates and for Status 1B candidates respectively. For adolescent donor hearts, this policy proposal will not change the existing prioritization of pediatric candidates ahead of adults. Now, for younger pediatric donor hearts (from 0-10 year old donors), pediatric candidates will also be prioritized ahead of adults within each status and allocation zone. Because historically only 0.5% of adults have received hearts from donors less than 12 years old, this proposal should have a limited impact on adults while reducing pediatric waiting list mortality. 
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(725 K) |
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2/8/2008 - 4/30/2008 |
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