Current policy requires anti-HTLV-1/2 antibody testing on all potential donors. Most OPOs currently use an enzyme immunoassay test system. This system will no longer be manufactured effective 12/31/2009. This leaves a high throughput testing platform as the only FDA-licensed commercially available alternative, which may not be amenable to the time constraints and logistics associated with prospective testing for organ donation at most OPOs. Based on the extremely low incidence (0.035-0.046% of blood donors) of HTLV-1/2 confirmed in donors, and the fact that there are no reported cases in the U.S. of transplant recipients infected with HTLV-1 that actually develop the disease, the OPTN/UNOS Board of Directors voted to discontinue the requirement to perform prospective screening of deceased donors during its June 22-23, 2009 meeting. In response, the Ad Hoc Disease Transmission Advisory Committee recommends that retrospective HTLV-1/2 screening tests be required for all deceased donors, and that all screen positive tests be followed with confirmatory testing to differentiate between HTLV-1 and HTLV-2

This policy proposal improves the safety of living donation through an improved ABO verification and matching process. Currently, the ABO verification and matching requirements for living donors are less stringent than the requirements for deceased donors.

The purpose of this bylaw modification is to clarify member responsibilities with regard to OPTN notification of adverse actions taken by regulatory agencies that would impact the organizations ability to serve transplant patients. The Committee modified existing language within the bylaws to clarify material submission and extend time periods for action.

This proposal adds language to the bylaws stipulating that members are obligated to follow their respective state laws regarding anatomical gifts. This bylaw will ultimately help preserve public trust in the national organ transplant system by preventing conflicts of interest associated with having the same person declare death and perform organ procurement and transplantation. The ultimate goal of this proposed change is to prohibit the same physician from declaring a patients death and participating in the removal or transplant of organs from that decedent.

This proposal would set minimum criteria for candidates listed for simultaneous liver-kidney (SLK) transplantation. The intent of this proposal is first to identify candidates who are unlikely to regain renal function following liver transplantation. These proposed policy changes would provide priority for these candidates to receive a SLK transplant. The goal of this proposal is to improve patient and renal graft survival following SLK transplant.

This proposal will create regional distribution of livers for MELD/PELD candidates. This proposal should provide those in most need of a liver transplant greater access to organs.

This proposal adds the following two factors to the LAS to better predict a lung transplant candidates waiting list urgency: 1) current bilirubin (for a candidate in any diagnosis group); and 2) change in bilirubin of at least 50% (for a candidate in diagnosis Group B only). Analyses revealed the association between high bilirubin levels and waitlist mortality. The association between current bilirubin of at least 1.0 mg/dL and waiting list mortality has statistical significance. An increase in a lung transplant candidates bilirubin level of 50% or more during a six-month period, when the higher bilirubin value is at least 1.0 mg/dL, increases a diagnosis Group B candidates risk for dying on the waiting list. This association between change in bilirubin of at least 50% and waiting list mortality for candidates in diagnosis Group B (largely candidates diagnosed with pulmonary hypertension) has statistical significance. The Thoracic Committee anticipates that this policy modification will reduce waitlist mortality for a lung transplant candidate, and improve the ability of the LAS to predict a candidates medical urgency for a lung transplant.

This proposal to change the bylaws will clarify when notification of changes in key personnel should be submitted and will further clarify the expectation that member institutions that cannot comply should voluntarily inactivate or withdraw the affected transplant program. This proposed language places greater emphasis on the submission of complete applications. Additionally, it clarifies the steps that will be taken if the member fails to inform the OPTN Contractor of key personnel changes.

Policy currently states that each candidate registered on the Pancreas Waiting List must be diagnosed as a diabetic or have pancreatic deficiency. The proposed revision would allow candidates who require the procurement or transplantation of the pancreas for technical reasons as part of a multiple organ transplant to be placed on the pancreas waiting list.

The revision to Policy 3.1 will incorporate the definition of a directed donation into OPTN policy. The revision to Policy 3.2.4 will require the Transplant Center to: determine why the candidate does not appear on the organ match run for the donor, and verify that the donor organ is safe and appropriate for the candidate by comparing donor information and candidate information available in UNetSM before the transplant. The revision to Policy 3.9.3 will clarify that when multiple organs are allocated to a single recipient, the term on a match run means that the recipient must appear on the heart, lung, or liver match run. This clarification does not alter the organ allocation sequence defined by organ allocation policy.

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.

This proposal would require OPTN member transplant programs that perform living donor transplants to only transplant organs recovered at an OPTN member institution.

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).

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.

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.

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.

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.

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.