This proposal seeks to substantially revise the national kidney allocation system to enhance post-transplant survival benefit, increase utilization of donated kidneys and increase transplant access for biologically disadvantaged candidates. The proposal incorporates new features such as an expanded definition of waiting time, a sliding scale for assigning points to sensitized patients, expanded access for blood type B candidates who can accept kidneys from subtypes of blood type A donors, 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. Kidney Proposal Video Part 1 Kidney Proposal Video Part 2

The proposed change removes an OPTN bylaw for designating a single combined heart-lung transplant program. There are no such bylaws for designating other single combined organ transplant programs. A combined heart-lung transplant program must concurrently have both an approved heart transplant program and an approved lung transplant program. The requirement needlessly burdens the transplant hospital to obtain approval for an additional organ transplant program designation to transplant organs for which the transplant hospital has already been approved. Aside from submitting often duplicative key personnel information, there are no additional requirements a transplant program must meet in order to qualify for the designation. The combined heart-lung transplant program designation also creates unnecessary programming work for the OPTN Contractor.

The purpose of this proposal is to better define the notification requirements for periods of functional inactivity. Currently, the Bylaws do not clearly outline the actions a Member must take when it becomes functionally inactive. This Bylaw proposal clarifies the current notification requirements for functional inactivity by including specific requirements for notification of functional inactivity, including waiting list inactivation in UNetsm. These modifications also specify what a member must do in terms of notifying patients when a program voluntarily ceases performing a specific type of 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.

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.

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.

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.

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 patients 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.

This rewrite affects the current Appendix A: Application and Hearing Procedures for Members and Designated Transplant Programs. This represents a substantive rewrite of the process and procedures for reviewing potential violations of and non-compliance with OPTN obligations. All content of the former Appendix A also underwent a plain language rewrite and reorganization for clarity and usability, and will be presented as the new Appendix L: Reviews, Actions, and Due Process.

The Committee is proposing an extension of the current "Share 15 Regional" policy so that deceased donor livers (age 18 and higher) would be offered to all candidates with MELD/PELD scores of 15 or higher locally, regionally, and nationally before being offered to candidates with lower MELD/PELD scores.

The OPTN contractor's policy evaluation plan requires that heart transplant programs record in UNet changes to a heart transplant candidate's status or criterion within 24 hours, but this requirement is not written in Policies 3.7.3 (Adult Candidate Status) and 3.7.4 (Pediatric Candidate Status). The two policies state that the OPTN contractor will notify "a responsible member of the transplant team" prior to downgrading a candidate's Status, but the OPTN contractor does not notify such personnel in addition to displaying the candidate's status in UNet. The proposed modification includes the 24-hour requirement, removes of the notification clause, and includes edits for plain language. For consistency, the modifications also include language about potential referral of pediatric heart status exception case decisions to the Thoracic Organ Transplantation Committee.

The purpose of this proposal is to update CPRA so it can better reflect current lab practices as well the current donor pool. These revisions include updating the HLA frequencies used to calculate CPRA, the addition of the antigen C to the calculation and the removal of zero (0) as a default value.

This proposal would establish policy requirements for the informed consent of living kidney donors. This proposal is in response to a directive from the Health Resources and Services Administration (HRSA) and based on recommendations from a Joint Societies Steering Committee composed of representatives of the American Society of Transplantation (AST); the American Society of Transplant Surgeons (ASTS); and the North American Transplant Coordinators Organization (NATCO) to the OTPN/UNOS Living Donor Committee.

This proposal would establish policy requirements for the medical evaluation of living kidney donors. This proposal is in response to a directive from the Health Resources and Services Administration (HRSA), and based on recommendations from a Joint Societies Steering Committee composed of representatives of the American Society of Transplantation (AST); the American Society of Transplant Surgeons (ASTS) and the North American Transplant Coordinators Organization (NATCO) to the Living Donor Committee.

The proposed modification will change the term "consent" to "authorization" throughout policy when used in reference to deceased organ donation. Currently, OPTN policy uses the term "consent" to describe the act of making an anatomical gift. However, the public associates "consent" with the medico-legal concept of "informed consent" through which physicians must give patients all the information they need to understand the risks, benefits, and costs of a particular medical treatment. In the context of organ/tissue/eye donation after death, this blending of terms leads to misunderstandings about the act of donation that could hinder our national goal of increasing organ/tissue/eye donation and transplantation. The OPO community has responded to this circumstance by changing the donation terminology from "consent" to "authorization". This change focuses attention on the altruistic act of donation and reinforces the fact that donation after death does not involve medical treatment.

This proposal streamlines and clarifies requirements for review and approval of variances, including gathering all requirements into one policy category for the variance application, review, approval, modification, dissolution, and appeal processes; detailing the process for appealing a variance decision of the Committee or Board of Directors; eliminating redundancy in existing variance policies; and rewriting the variance policies using plain language.

Patients awaiting a liver transplant who are diagnosed with hepatocellular carcinoma (HCC) are eligible for additional priority through MELD/PELD exceptions. Under this proposal, HCC lesions would be classified more precisely according to newly-defined imaging criteria, with only Class 5 potentially eligible for automatic upgrades. Currently, HCC exceptions are based on diagnostic criteria that rely on imaging characteristics rather than liver biopsy. The attendees of a multi-disciplinary HCC Consensus Conference held November 2008 made specific recommendations regarding the appropriate imaging criteria to properly determine HCC staging. The Committee is proposing to incorporate these recommendations into Policy 3.6.4.4. A survey of all U.S. liver transplant programs in October 2010 indicated strong support for these changes.

This committee-sponsored AAS (CAS) is intended to increase the number of transplants and reduce waiting list deaths by transplanting the right lobe into an adult patient and the remaining lobe/segment into a second candidate. The CAS will potentially reduce waiting times for liver candidates overall, because the liver pool would be expanded by splitting livers that otherwise would not be split. In November 2010, the Board of Directors approved two alternative allocation systems (AAS) to Policy 3.6.11 (Allocation of Livers for Segmental Transplantation). At that time, the Board asked that the Liver Committee consider developing a committee-sponsored AAS (CAS) that would allow other Regions and OPOs to participate in a split liver AAS. This proposed CAS is based on the approved Region 2 and OneLegacy AASs, but will provide one standard model for all participants to follow. In summary, if an adult candidate is offered a liver through the standard policy or an approved-AAS (i.e., via the match run) who has been determined to be suitable for a segmental liver transplant (known as the index patient), the candidate's transplant center may transplant the right lobe into the index patient. The center may then transplant the left lobe/segment into any other medically suitable listed patient at that institution or an affiliated pediatric institution (if applicable), in order of the match run.

The Thoracic Committee proposes that Policy 3.7.6.3.2 require transplant programs to update in no less than 14 days, any observed changes in clinical values most important to determining a candidate's Lung Allocation Score for candidates whose scores are 50 or higher. The proposal would require transplant programs to update candidate data for high-LAS candidates whenever changes occur to assisted ventilation, supplemental oxygen, or current PCO2. Policy 3.7.6.3.2 requires a transplant program to update its candidates' clinical data in UNetSM values every six months. A candidate whose lung allocation score is 50 or higher is likely receiving therapeutic interventions that may decrease her or his score, but does not currently require more frequent updates if the candidate's health improves.

The OPTN currently relies on Living Donor Follow-up (LDF) forms to collect data on the short-term health status of living donors. The transplant community must collectively improve patient information on the LDF form to allow for meaningful analyses to objectively study the short-term effects of living donation. Data on living donors who donated in 2006 through 2008 demonstrate that many programs do not report the status of their living donors at required reporting intervals. Under this proposal, transplant programs would be required to accurately report if the living donor is alive or dead at the required post operative reporting periods (6, 12 and 24 months). Follow-up information on donors is especially important in the current climate where the public and the media seek data on the safety of living donation. Without accurate and comprehensive living donor follow-up data, it will not be possible to answer questions and address concerns.

This proposal would require confirmatory subtype testing of blood group A and AB deceased or living donors when subtyping is used for the placement of organs, and the donor is identified to be subtype non-A1 (e.g A2) or non-A1B (e.g A2B). Blood samples for the initial and confirmatory subtype testing will be required to be taken on two separate occasions and be pre-transfusion specimens only.

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 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 have to be modified for consistency.

The purpose of this proposal is to improve consistency in listing Status IA and IB pediatric liver candidates. The current requirement that a patient be located in the ICU uses location as a surrogate for severity of illness. Since the criteria for admission to an ICU varies from institution to institution across the country, the use of this surrogate creates inequality in Status 1A and 1B listings. In reviewing the other criteria for listing a Status 1A or 1B pediatric candidate, the Pediatric Transplantation Committee believes that these criteria are a stringent enough indicator of severity of disease that the ICU requirement may be eliminated without giving undue advantage to this subset of patients.

The proposed policy change requires OPOs to provide HLA typing at the time of making a thoracic organ offer to a transplant program. Clinical practice and review of the literature suggest that knowledge of donor HLA allows for the most suitable candidate to receive a thoracic organ offer. Policy 3.7.12.1 (Essential Information) does not currently require the provision of HLA Class I and II data on deceased donor thoracic organs, nor do Policies 3.7.12.1.1 (Essential Information for Lung Offers), 3.7.12.2 (Desirable Information for Heart Offers), and 3.7.12.3 (Desirable Information for Lung Offers) recommend provision of HLA data for deceased donor thoracic organs. Coupled with recently developed techniques to determine HLA antibody specificity and perform virtual crossmatching, donor HLA data at the time of a thoracic organ offer will allow centers to consider offers for sensitized candidates in circumstances where prospective crossmatch is not practical. Enabling virtual cross matching for thoracic organs also has the potential to reduce post-transplant morbidity and mortality by preventing unanticipated positive crossmatches.

The intended goal of this policy is to protect the health of living organ donors by shifting the responsibility for living donor follow-up to the hospital that has an established relationship with the living donor. The proposal clarifies and, in some cases, changes which transplant program is responsible for the living donation process. Under this proposal, the transplant program that operates on the living donor will be responsible for the consent, medical and psychosocial evaluations, perioperative care, and required follow-up reporting for that donor. Additionally, the revisions require that OPTN member transplant hospitals only accept living donor organs from transplant programs that are approved by the OPTN for recovering that type of living donor organ.

The goal of this proposal is to provide an additional means for open donor nephrectomy qualification now that laparoscopic nephrectomy is more commonplace than it was when this bylaw was originally adopted. The proposal recognizes surgeons who are qualified to perform laparoscopic living donor nephrectomies as qualified to perform open donor nephrectomies as well. The revisions also eliminate the requirement for kidney transplant programs to be specifically designated to perform open donor nephrectomies since the majority of donor surgeries are performed laparoscopically.

Three Donation Service Areas (LifeBanc, Life Connection of Ohio and LifeCenter Organ Donor Network) are requesting a single, combined new Alternative Local Unit in the State of Ohio. There will be a single waiting list within the ALU for liver allocation. This will allow for better and more efficient allocation of organs to those on the waiting list with the most urgent need over a larger geographic area.

Region 2 is proposing a variance, or Alternative Allocation System (AAS), to Policy 3.6.11 (Allocation of Livers for Segmental Transplantation). Under this AAS, if a candidate in Region 2 is suitable for a segmental transplant, the transplant center may accept a liver offer and transplant the right lobe of that liver into that suitable candidate (known as the index patient). Then center would then be allowed to transplant the left segment of that liver into another medically suitable patient listed at the same center or at an affiliated pediatric institution. The index patient is defined as the first candidate for whom a deceased door liver is offered and accepted, in accordance with the match run, who is medically suitable and willing to accept a segmental liver. This AAS should increase the number of transplants, allowing a single liver to be divided into two segments for transplantation, and thus removing two patients from the waiting list instead of one.

The proposed modifications are meant to clarify and/or improve current OPO and transplant center requirements for screening for, communicating and reporting all potential or confirmed donor-related disease and malignancy transmission events. These changes are expected to: Help improve patient safety and recipient outcomes by making policy consistent with current clinical testing practices in the organ recovery transplant communities and creating a Patient Safety Contact; Place all content related to donor evaluation and screening into one policy section; Further define and standardize the elements of informed consent and the communication of clinically significant information regarding potential disease transmission events; and Provide a clear, plain language policy format that will be easier for members and other readers to understand and follow

This proposal would require that OPOs and their associated laboratories perform HLA typing of deceased donors by DNA methods and identify the HLA-A, -B, -Cw, -DR and -DQ antigens before making any kidney, kidney-pancreas, pancreas, or pancreas islet offers.

These proposals require that the organ recovery center report all instances of: living donor organs recovered but not utilized for transplant; living donor organs recovered but then redirected and transplanted into a recipient other than the intended recipient. These events would be reported through the UNetSM Patient Safety System. If a living donor organ is transplanted into a recipient other than the intended recipient, all required donor and recipient information must still be submitted through Teidi.

All OPTN forms must be reviewed and approved by the Office of Management and Budget (OMB) every three years. The OPTN initiated a review of the data elements in order to identify any necessary changes. . This proposal will outline the recommended modifications to the data elements in Tiedi. These recommendations follow a comprehensive review of all the data elements by OPTN Committees, the Ad Hoc Data Management Group, an Expert Panel on Cardiovascular Risk Factors in Renal Candidates/Recipients, and the Policy Oversight Committee. The purpose of the changes is to add important variables that are not currently collected, clarify or modify questions on the forms, and eliminate variables that are redundant or no longer needed

Under this proposal, transplant centers would be required to document that potential living organ donors have been informed that the sale or purchase of human organs (kidney, liver, heart, lung, pancreas and any other human organ) is a federal crime.

Currently, the Kidney Paired Donation (KPD) Pilot Program only allows potential living donors with incompatible potential recipients to participate. Potential non-directed (or altruistic) living donors (those who are not linked to an incompatible potential recipient) have no way to enter the program. Also, candidate/ donor pairs can only be matched in groups of two or three, and all donor nephrectomies in the group must occur simultaneously. This proposal would allow potential non-directed living donors (NDDs) to participate in the KPD Pilot Program and add donor chains as an option in the system. A donor chain occurs when a NDD gives a kidney to a recipient whose living donor in turn gives a kidney to another recipient and continues the chain. This proposal would allow two types of donor chains: open and closed. Closed chains start with a NDD and end with a donation to a recipient on the deceased donor waiting list. Open chains start with a NDD and end with a potential bridge donor who will start another segment in the open chain. In open chains, the bridge donor nephrectomy does not occur at the same time as the other living donor nephrectomies. Donor chains have the potential to increase the number of transplants in a KPD system.

This resource is a voluntary set of recommendations for OPTN member transplant hospitals to use when developing their program-specific living liver donor medical evaluation protocols. This resource is not a policy or a bylaw. The OPTN contractor will not monitor adherence to these guidelines.

This proposal will reconcile the current patient volume discrepancies between the requirements for full and conditional OPTN/UNOS program approval when qualifying primary physicians at kidney, liver and pancreas transplant programs. The bylaws currently permit programs to propose and qualify primary physician candidates for conditional program approval without meeting the MPSC desired 50% of full approval primary care volume requirements when submitting their application. The primary physician at the conditionally approved program can then qualify that program for full approval status after one year at conditional approval without ever having met the same total patient volume requirements as the primary physician originally qualifying at a fully approved program. The proposed language does not change any prior Board approved total patient volume requirements used to qualify for full program approval as the primary physician at kidney, liver and pancreas transplant programs when using either experience or training pathways. Additionally, it clarifies the initial minimum required patient volume to qualify a candidate for consideration as the primary kidney, liver or pancreas physicians at a program seeking conditional approval.

The Committee is seeking comment on two proposed modifications to Policy 5.0. Current policy assigns responsibility for packaging and labeling of organs to the OPO. In certain situations, recovery teams may arrive from transplant centers to procure hearts and lungs. Due to the effects of prolonged cold ischemic time on these organs, these recovery teams sometimes forgo the labeling procedure, which leaves the OPO out of compliance with Policy 5.0. The proposed modification to Policy 5.0 transfers the responsibility of packaging and labeling of organs to the transplant center when its recovery team elects to recover organ(s) and transport the organ(s) directly to their transplant center for transplant. This should be done in collaboration with the OPO. Additionally, current policy requires that tissue-typing material containers be labeled with one unique identifier. The Joint Commission (JC) requirements for accreditation stipulate that tissue-typing material be labeled with two unique identifiers. This proposal seeks to realign OPTN policy with JC requirements by changing the requirement from one to two unique identifiers. This modification is anticipated to enhance patient safety while reducing the confusion that members face when attempting to comply with several requirements from different regulatory bodies.

This proposal will create regional distribution of livers for Status 1 candidates. This proposal should give the most urgent candidates waiting for a liver transplant more access to organs.

This proposal will establish criteria and MELD/PELD scores for candidates with hepatopulmonary syndrome, cholangiocarcinoma, cystic fibrosis, familial amyloidosis, primary hyperoxaluria, and portopulmonary hypertension. This proposal should provide consistency in scores assigned to liver transplant candidates with these diagnoses.

All patients must have their health information protected. If the policy is applied in its current form, potential living donors might not be offered an opportunity to discontinue the donation process rather than have their high risk status disclosed. Modification of this policy will protect the health information of high risk potential living donors.

The proposed modifications to Policy 5 will clarify the policy requirements, eliminate redundancy and provide guidance to OPOs and transplant centers when packaging, labeling and shipping organs, vessels and tissue typing materials. The entire content has been reorganized in order to promote clarity. Types of organ packaging are defined, labeling and documentation requirements are clearly delineated for solid organs, tissue typing materials and vessels. Vessel recovery and storage requirements are listed, as is transportation responsibilities for renal, non renal and tissue typing materials. The goal is to prevent organ wastage, to define terms and responsibilities to promote safe and efficient packaging and labeling, and to clearly list the requirements for recovering, storing and using vessels in solid organ transplant recipients. The responsibility for packaging and labeling deceased donor organs is assigned to the Host OPO while the responsibility for packaging and labeling living donor organs is assigned to the transplant center.