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Public Comment Archive

Listed below is information about archived public comment proposals.

Looking for something else? Contact us at unoscommunications@unos.org or (804) 782-4800. We maintain an archive of historical OPTN documents.

September 2014 proposals

Public comment: 9/29/2014 - 12/5/2014

Convert kidney paired donation contacts from guidelines to policy

March 2014 proposals

Kidney Paired Donation Histocompatibility Testing Policies

Public comment: 3/14/2014 - 6/13/2014

This proposal includes requirements for histocompatibility testing on donors and recipients in the OPTN KPD Program. It includes required methods for HLA typing, antibody screenings, and crossmatching; a list of HLA types that must be reported for donors and candidates; and processes that must be followed for identifying unacceptable antigens and in the event of unacceptable positive crossmatches.

Cap the HCC Exception Score at 34

Public comment: 3/14/2014 - 6/13/2014

Candidates with a MELD/PELD score exception for HCC receive high priority on the liver waiting list, especially as their exception scores may increase automatically every three months. Increasingly, there are candidates with multiple HCC exception extensions who are now receiving regional offers under the "Share 35 Regional" policy implemented in June 2013. These candidates are likely to have a much lower risk of disease progression or dropout (i.e., removal from the waiting list for death or being too sick) than candidates with calculated MELD/PELD scores of 35 and higher. This proposal would cap the HCC exception score at 34, in effect giving candidates with calculated MELD/PELD scores of 35 and higher a better opportunity to receive regional offers under the new policy.

Delay HCC Exception Score Assignment

Public comment: 3/14/2014 - 6/13/2014

Candidates with a MELD/PELD score exception for HCC receive high priority on the liver waiting list, especially as their exception scores may increase automatically every three months. These candidates have significantly lower dropout rates (i.e., removal from the waiting list for death or for reasons related to the HCC) than non-HCC candidates, with the exception of those areas of the country with lengthy waiting times. The proposed solution to address the disparities in drop-out rates between patients with HCC exceptions and those without is to delay the score assignment by 6-months. Simulation modeling has shown that this would equalize the transplant and drop-out rates for those with and without HCC exceptions. In areas of the country with shorter waiting times to transplant, the delay will also allow a window of time for centers to observe candidates with rapidly growing tumors who may have very poor outcomes with a transplant. At least one study indicates that candidates with HCC exceptions in regions with shorter waiting times to transplant, where this "biologic test" is not met due to rapid transplantation, have worse post-transplant outcome.

Membership and Personnel Requirements for Intestine Transplant Programs

Public comment: 3/14/2014 - 6/13/2014

The proposed bylaw will define a designated intestine transplant program and establish minimum qualifications for primary intestine transplant surgeons and physicians. The proposal includes a full approval pathway and a conditional approval pathway to obtain the requisite experience to perform primary surgical and medical care. The intent is to set minimum standards where none currently exist without compromising quality or restricting new program formation.

Require the Collection of Serum Lipase for Pancreas Donors

Public comment: 3/14/2014 - 6/13/2014

This document proposes to make serum lipase a required field in Policy 2.8.E Required Information for Deceased Pancreas Donors, as well as required in DonorNet®, in order to make electronic pancreas offers. Currently, serum lipase is a listed field in DonorNet, but is not required in order to make electronic pancreas offers. Serum lipase level(s) in deceased donors are reliable indicators of pancreas function and quality. As such, the serum lipase values assist in making an informed clinical decisions regarding electronic pancreas offers. The proposal also proposes to create a new field in DonorNet where OPOs will report the upper limit of normal (i.e. maximum normal value or highest reference value) of the laboratory's normal serum lipase reference range. The reason for programming this new field is because laboratories' measurement ranges vary for serum lipase. As a result, a serum lipase value may have two different meanings at two different laboratories. This results in varying "normal" serum lipase values across the country. This new field will provide a reference point regarding the serum lipase value to the physician making the decision whether to accept the pancreas.

Align OPTN Policies with the 2013 PHS Guideline for Reducing Transmission of HIV, HBV, and HCV Through Solid Organ Transplantation

Public comment: 3/14/2014 - 6/13/2014

The Final Rule §121.4 (OPTN policies: Secretarial review and appeals.) notes that the OPTN Board of Directors is responsible for developing policies that are consistent with recommendations of the Centers for Disease Control and Prevention (CDC) to test potential organ donors and following transplant recipients to prevent the spread of infectious disease. The June 19, 2013, release of the PHS Guideline for Reducing Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) Through Organ Transplantation led to a systematic review of related OPTN policies. This proposal seeks to modify some existing policy language and also create new policies to reflect recommendations outlined in this updated PHS document.

Expanding Candidate and Deceased Donor HLA Typing Requirements to Provide Greater Consistency Across Organ Types

Public comment: 3/14/2014 - 6/13/2014

The proposed changes make the HLA typing methods and list of HLA loci to be reported consistent for deceased donors across all organ types. The required methods and list of HLA loci to be reported will apply both when OPTN policy requires HLA typing be performed and reported on the deceased donor prior to allocation (i.e. for kidney, kidney-pancreas, and pancreas allocation) and in instances where HLA typing is required only if requested by the candidate's transplant program (i.e. for heart, heart-lung, and lung allocation). The proposal includes new requirements for reporting HLA-DQA and HLA-DPB for deceased donors. The time period for reporting deceased donor HLA typing remains different by organ type to meet varying clinical requirements for timing of transplants. The proposal newly requires HLA typing to be performed and reported for deceased liver donors if requested by a transplant program and makes HLA typing requirements for deceased pancreas islet donors and candidates consistent with those for deceased pancreas donors and candidates.

Modify Existing or Establish New Requirements for the Informed Consent of all Living Donors

Public comment: 3/14/2014 - 6/13/2014

This proposal would modify existing policy and establish new policy requirements for the informed consent of all living donors. This proposal is in response to a directive from the Health Resources and Services Administration (HRSA) to develop such policy, and is 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. Policy to standardize the informed consent of living kidney donors has already been established. This proposal would modify some elements of exiting policy for the informed consent of living kidney donors and establish new requirements for all other categories of living organ donors.

Modify Existing or Establish New Requirements for the Psychosocial and Medical Evaluation of all Living Donors

Public comment: 3/14/2014 - 6/13/2014

This proposal would modify existing policy and establish new policy requirements for the psychosocial and medical evaluation of all types of living donors. This proposal is in response to a directive from the Health Resources and Services Administration (HRSA) to develop such policy, and is 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. Policy to standardize the medical evaluation of living kidney donors has already been established. This proposal would modify some elements of existing policy for the psychosocial and medical evaluation of living kidney donors and establish new requirements for the psychosocial and medical evaluation for all living organ donors.

Require the Reporting of Aborted Living Donor Organ Recovery Procedures

Public comment: 3/14/2014 - 6/13/2014

Promoting patient safety is a critical component of the OPTN's mission. The OPTN seeks to protect the safety of transplant candidates, recipients, and living donors, but living donors are unique in that they put themselves at risk without any potential benefit to their own health. Due to a variety of reasons, including last minute recipient or donor health problems and unforeseen donor anatomy issues, living donor organ recovery procedures occasionally need to be aborted after anesthesia has been administered, but before the recovery of the organ. Monitoring the safety of these prospective donors is an important part of the OPTN's goal of promoting living donor safety. The OPTN relies on the UNetSM Improving Patient Safety Portal for notification of patient safety concerns and living donor adverse events. Under this proposal, an aborted living donor organ recovery procedure would become a new category of living donor adverse event that recovery hospitals would need to report through the UNet Improving Patient Safety Portal. Additionally, the proposal would clarify current living donor adverse event reporting requirements by eliminating some redundant sections of policy.

Clarify Data Submission and Documentation Requirements

Public comment: 3/14/2014 - 6/13/2014

Policy 18.1 (Data Submission Requirements) requires members to submit data to the OPTN through the use of standardized forms. However, Policy 18.1 does not explicitly state that the data submissions must be accurate or that members must be able to provide documentation to verify the accuracy of their data submissions. The MPSC historically has agreed that the need for accurate data is implied within Policy 18.1, as is the member's obligation to provide documentation to verify the data's accuracy. This proposal's goal is to amend Policy 18.1 to explicitly state that the data must be accurate and that members must provide documentation to support their data.

Approval Consideration of a Non Qualifying Transplant Program Applicant Located in a Prescribed Geographically Isolated Area

Public comment: 3/14/2014 - 6/13/2014

The proposed bylaw language makes available a mechanism by which the MPSC may make a recommendation to the Board, and the Board may consider and approve the designation of transplant programs who currently cannot meet key personnel qualifying criteria because the applicant is located in a geographically isolated area. Currently, if an applicant cannot meet the program requirements, then the application is closed by the MPSC as rejected, leaving the applicant to appeal to the HHS Secretary for any further approval consideration of the closed application.

ABO Blood Type Determination, Reporting, and Verification Policy Changes

Public comment: 3/14/2014 - 6/13/2014

Member feedback has long noted the complex phrasing and requirements related to ABO blood type determination and verification. These requirements are a fundamental step in safe and successful organ transplantation. The Committee is proposing clarifications and improvements to these requirements. These recommendations are based, in part, from a Failure Modes and Effects Analysis (FMEA) conducted to proactively identify areas of risk related to ABO processes in deceased donation. This policy proposal is only one facet in the Committee's approach to improving ABO blood type determination and verification. Other strategies to minimize identified risks and maximize human factors engineering include member education and competency training, programming changes to UNet, and collaboration with the Electronic Tracking and Transport (ETT) project to improve technological capabilities. This policy proposal contains the following features: Clarified existing requirements related to commonly asked questions Strengthened safety components to ensure the correct organ is transplanted into the correct recipient and that the match is ABO compatible or intended incompatible Modified the timing of deceased donor blood type determinations and reports prior to executing the match run with an exception for accelerated donor cases Modified the timing and scope of verifications for deceased and living donor organ recoveries Clarified specific verification elements and sources Better aligned OPTN and Centers for Medicare and Medicaid Services (CMS) requirements Added conditional requirements to check in organs upon arrival and to perform a pre-transplant verification Added a requirement for qualified health care professionals to perform ABO reporting and verification functions Made deceased and living donor standards more consistent.

ABO Subtyping Consistency Policy Modifications

Public comment: 3/14/2014 - 6/13/2014

This proposal seeks to make all ABO subtype references consistent throughout OPTN policies. Current references use different terms, such as A2 and non-A1, which are intended to mean the same thing but may be confusing. The more technically accurate description uses the "non" preface as routine testing only detects the presence or absence of A1 and other rare subtypes other than A2 do exist. In 2011, the OPTN published guidance on this issue. The proposed changes will align references with this guidance using the terms blood type A, non-A1 and blood type AB, non-A1B.

Allow Non-substantive Changes to the OPTN Policies and Bylaws

Public comment: 3/14/2014 - 6/13/2014

On occasion, clerical errors are identified in the Policies and Bylaws. These clerical errors are non-controversial things like obvious misspellings and mis-numbering of lists. There is nothing in the Bylaws or Policies that allow staff to make these non-substantive changes. This proposal would allow staff to make non-substantive changes without needing approval by the Executive Committee or Board of Directors. The Executive Committee would review these changes retrospectively.

Notify Patients Having an Extended Inactive Status

Public comment: 3/14/2014 - 6/13/2014

The goal of this proposal is to promote effective and safe care for organ candidates by increasing awareness of their inactive waiting list status. Published literature suggest that the longer candidates wait for an organ while in an inactive status, the less likely they are to receive a transplant. In addition, the Committee is concerned that candidates are not consistently informed of their status nor do they understand what it means to have an inactive status. The new policy will require transplant hospitals to provide written notification to candidates with an inactive waiting list status when the candidate has been inactive for: 90 consecutive days 365 consecutive days Annually, thereafter, for as long as the candidate remains inactive The notification must include all of the following: The most recent date they became inactive, That the candidate cannot receive organ offers for transplant while inactive, and a telephone number at the candidate's transplant center to contact for more information.

Adolescent Classification Exception for Pediatric Lung Candidates

Public comment: 3/14/2014 - 6/13/2014

On June 10, 2013, the OPTN/UNOS Executive Committee approved a temporary policy permitting lung candidates less than 12 years old to request an exception from the Lung Review Board (LRB) to be classified as an adolescent candidate for the purposes of prioritization by lung allocation score (LAS). Unless further action is taken by the Board of Directors, the "adolescent classification exception" will expire on July 1, 2014. Because the temporary policy permits young pediatric lung candidates who may be suitable for lung offers from larger donors to apply for an exception, the Thoracic Committee proposes removing the July 1, 2014 deadline from the policy, making some modifications to the temporary policy, and making a permanent policy change. The Thoracic Committee also proposes additional language to clarify the data reporting requirements for candidates with approved adolescent classification exceptions. The Thoracic Committee hopes to continue increased access to organs by providing an opportunity for uniquely situated pediatric candidates to gain increased priority for an older and larger donor pool, thereby reducing the rate of waiting list mortality for pediatric candidates.

September 2013 proposals

Modify Deceased Donor Testing Requirements

Public comment: 9/6/2013 - 12/6/2013

This proposal seeks to modify current deceased donor testing requirements in policy based upon updated testing kit availability and laboratory practice, and also clarify any points of confusion for the OPO community. Current test requirements stemmed from changing test kit availability and a widely publicized transmission event in 2007. Over the years, there have been a number of questions regarding the application of this language from OPOs that do not understand the terminology or wish to use tests outside of the current requirements.

Histocompatibility Policy Rewrite

Public comment:9/6/2013 - 12/6/2013

This proposal reflects recommendations from the Histocompatibility Committee ('the committee') following a comprehensive review of the OPTN policies governing histocompatibility testing. The committee is proposing several changes in order to align OPTN testing requirements with those in federal regulations. Some changes are in response to requests from UNOS staff to resolve issues with policies identified as difficult to monitor. Finally, the committee is proposing to eliminate numerous sections of the current policies because they are outdated or adequately addressed in the standards required by histocompatibility accrediting agencies (ASHI and CAP). In recognition of the fact that testing methods and technology continue to evolve and clinical practice for histocompatibility testing often varies among patients, the committee intends to move most of the sections proposed for elimination from policy into a guidance document that will be developed at the conclusion of this process.

Establish Minimum Requirements for Living Liver Donor Follow-Up

Public comment: 9/6/2013 - 12/6/2013

This proposal would require transplant programs to report required fields on the Living Donor Follow-Up (LDF) form at required post-operative reporting periods (6, 12, and 24 months). The OPTN currently relies on Living Donor Follow-Up (LDF) forms to collect data on the short-term health status of living donors. Data on living donors who donated since 2006 demonstrate that many programs do not report meaningful living donor follow-up information at required reporting intervals. Consequently, to allow for meaningful analyses to objectively study the short-term effects of living donation, the transplant community must collectively improve reporting of patient information on the LDF form. The proposed minimum reporting requirements are based on recommendations from the Joint Society Work Group, which is composed of representatives from the American Society of Transplantation (AST), the American Society of Transplant Surgeons (ASTS), and the North American Transplant Coordinators Organization (NATCO) to the OPTN/UNOS Living Donor Committee.

Require Registration of all Living Donor Organ Candidates Before Transplant

Public comment: 9/6/2013 - 12/6/2013

Under this proposal, all candidates for living donor transplants would be required to be added to the waiting list before their transplant. All living donor organ recipients are already reported to UNetsm and are charged a registration fee, just like candidates for deceased donor organs. Most transplant programs add living donor organ transplant candidates to the waiting list prior to the transplant procedure via Waitlistsm, while other programs may report a living donor organ transplant recipient after the transplant occurs via Tiedism. Patient safety benefits associated with registering a candidate prior to transplant, include improved blood type verification prior to the transplant procedure, providing unique identifiers for comparing donor and candidate information, and the accrual of wait time. Please note that this proposal would not change the registration fees paid to the OPTN contractor.

Revise the Current Method for Flagging for Transplant Program Post-transplant Performance Reviews

Public comment: 9/6/2013 - 12/6/2013

The purpose of this proposal is to better identify those transplant programs that may be underperforming in the area of patient and graft survival. The Bylaw proposal adopts the new Bayesian methodology that will be utilized by the SRTR in the production of the public transplant program performance metrics and establishes new flagging thresholds that maximize the true positive flags while minimizing false positive flags. In doing so, the transplant programs most in need of MPSC review and assistance in improving outcomes will be flagged.

Patient Notification of Lack of Transplant Functional Inactivity

Public comment: 9/6/2013 - 12/6/2013

The purpose of this proposal is to provide, through a requirement for patient notification, candidates and potential candidates with information about the program's activity levels that will allow the patient to make informed decisions about whether to move to another more active program or multiply list at another program. In addition, the proposed Bylaw revision may provide an incentive for a low volume program to develop ways to increase transplant activity thereby positively impacting the program personnel's experience and currency. In the alternative, it may spur a functionally inactive program to examine whether there is sufficient need in the community to justify the maintenance of the functionally inactive program resulting in the inactivation or withdrawal of a low volume program with the resultant referral of candidates to a higher volume program.

March 2013 Proposals

Add Serum Sodium to the MELD Score

Public comment: 3/15/2013 - 6/15/2013

The Committee is proposing to add serum sodium to the MELD score equation. Based on simulation modeling results, this change could reduce waiting list mortality by 50-60 deaths per year without adversely affecting post-transplant survival or negatively impacting any group of candidates (e.g., age, gender, ethnicity, diagnosis) ERRATA notice accompanies this proposal correcting information therein.

Changes to the OPTN Bylaws Governing Histocompatibility Laboratories

Public comment: 3/15/2013 - 6/15/2013

This proposal represents the first phase of a comprehensive review of the OPTN Bylaws governing histocompatibility laboratories being conducted by the Histocompatibility Committee. This proposal contains several proposed changes, including an expanded definition of an OPTN histocompatibility laboratory, new required elements for agreements between histocompatibility laboratories and transplant programs or OPOs, a requirement that histocompatibility laboratories maintain the standards of the American Society for Histocompatibility and Immunogenetics (ASHI) or the requirements listed in the College of American Pathologists (CAP) checklists as of a date certain, a requirement that histocompatibility laboratories submit a Laboratory Coverage Plan to the OPTN Contractor, additional requirements for documentation when notifying the OPTN Contractor of changes in key personnel, and a separate, elevated performance standard for HLA typing performed for graded proficiency testing. Please note that the Committees comprehensive review of the Bylaws is ongoing and will continue throughout the upcoming year. This is the first of two proposals to be released as a result of the review.

Proposed Update to the HLA Equivalency Tables

Public comment: 3/15/2013 - 6/15/2013

The Committee is recommending several changes to the HLA equivalency tables, the majority of which are intended to reflect the OPTN policy requiring molecular HLA typing for deceased kidney, pancreas, and kidney-pancreas donors. Current OPTN Policy 3.5.14 requires the Histocompatibility Committee to update, on an annual basis, the HLA equivalency tables found in Appendix 3A of OPTN policies. The proposed changes to the tables referencing Matching Antigen Equivalences are intended to eliminate certain equivalences to better define a zero-HLA mismatch and an HLA-DR mismatch level for kidney, pancreas, and kidney-pancreas candidates in deceased donor allocation. The proposed changes in the tables referencing Unacceptable Antigen Equivalences eliminate certain equivalences for unacceptable antigens that are unnecessarily disadvantaging candidates in the screening process. In addition, the Committee is proposing changes to the section entitled Additional Unacceptable Antigen Equivalences to be used in Calculated PRA Only. These changes are intended to reverse previously approved policy changes that, if implemented, would have negative and unintended consequences for sensitized patients. Finally, the Committee is proposing a new, more user friendly format for displaying the tables in OPTN policy.

Clarify Requirements for Independent Donor Advocates at Living Kidney Donor Recovery Centers

Public comment: 3/15/2013 - 6/15/2013

This proposal would clarify existing requirements for independent donor advocates at living kidney donor programs, and would require living kidney donor programs to develop and follow new hospital-specific protocols addressing the qualifications, training and responsibilities of their independent donor advocates.

Change Pediatric Heart Allocation Policy

Public comment: 3/15/2013 - 6/15/2013

The primary goal of this proposal is to improve waiting list mortality for pediatric heart candidates by modifying the pediatric heart allocation policy. To do so, this proposal includes four recommendations: 1) redefine Status 1A and Status 1B criteria; 2) increase the qualifying isohemagglutinin titer to 1:16 or less for candidates who are one year of age or older but registered before their second birthday and willing to accept ABO-incompatible heart offers; 3) change the allocation priority of urgent potential transplant recipients younger than one year of age and potential transplant recipients eligible to receive ABO-incompatible heart offers; and 4) eliminate the option to register heart candidates as in utero. Redefining pediatric heart Status 1A and Status 1B criteria will decrease waiting list mortality as the proposed changes yield an allocation system that is more dependent on a candidates medical urgency, rather than the candidates waiting time. Expanding the criteria to qualify for an ABO-incompatible heart transplant and increasing the prioritization of these candidates should also improve pediatric heart candidates waiting list mortality rate by safely increasing their access to donor hearts, and potentially increasing the number of transplants. Lastly, eliminating in utero registrations will save time and resources needed to allocate and procure donor hearts for pediatric candidates.

Redefine the Role of the Vice-President of the Board of Directors

Public comment: 3/15/2013 - 6/15/2013

This proposal would separate the roles of the Vice-President of the Board of Directors and the Chair of the Membership and Professional Standards Committee (MPSC). The bylaws currently require the Vice-President to serve as the Chair of the MPSC. As the responsibilities of the MPSC Chair have increased over time, it can be challenging for the Vice-President to get sufficient exposure to the broader governance issues that he or she will encounter as President. Separating the roles will allow for the Vice-President to spend that year involved in Board governance and preparing for his or her Presidential year, and will allow the MPSC Chair to serve a more traditional two-year term, providing more stability in that Committees leadership.

September 2012 proposals

Substantially Revise The National Kidney Allocation System

Public comment: 9/21/2012 - 12/14/2012

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.

Require Reporting of Every Islet Infusion to the OPTN Contractor within 24 Hours of the Infusion

Public comment: 9/21/2012 - 12/14/2012

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.

Remove the OPTN Bylaw for the Combined Heart-Lung Transplant Program Designation

Public comment: 9/21/2012 - 12/14/2012

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.

Change the Composition of the OPTN Finance Committee

Public comment: 9/21/2012 - 12/14/2012

To improve the efficient management of the OPTN, this proposal recommends changing the composition of the OPTN Finance Committee so that it is consists of members of the OPTN Board of Directors. Currently, the OPTN Finance Committee is a permanent standing committee with regional and at-large appointments, and it reports to the OPTN Board of Directors. For most organizations, financial governance begins with a finance committee that resides at the board level.

Change the OPTN/UNOS Bylaws to Better Define Notification Requirements for Periods of Functional Inactivity

Public comment: 9/21/2012 - 12/14/2012

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.

Modify the Imminent and Eligible (I & E) Neurological Death Data Reporting Definitions

Public comment: 9/21/2012 - 12/14/2012

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.

March 2012 proposals

Clarify Priority Status for Prior Living Organ Donors Who Later Require a Kidney Transplant

Public comment: 3/16/2012 - 6/25/2012

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.

Establish Kidney Paired Donation (KPD) Policy

Public comment: 3/16/2012 - 6/25/2012

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.

Allow 'HCC Hold' for Liver Candidates with HCC Exceptions

Public comment: 3/16/2012 - 6/25/2012

Without Loss of Accumulated 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.

Revise the Lung Allocation Score (LAS) System

Public comment: 3/16/2012 - 6/25/2012

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.

Require Reporting of Unexpected Potential and Proven Disease Transmission Involving Living Organ Donors

Public comment: 3/16/2012 - 6/25/2012

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.

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

Public comment: 3/16/2012 - 6/25/2012

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.

Document All Locally-Assigned Unique Identifiers in the Donor Record

Public comment: 3/16/2012 - 6/25/2012

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.

Update and Clarify Language in the DCD Model Elements

Public comment: 3/16/2012 - 6/25/2012

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.

Update Data Release Policies

Public comment: 3/16/2012 - 6/25/2012

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: 1) Allow the OPTN Contractor to release more data than is currently released. 2) Provide an appeals process if the OPTN denies a data request. 3) Set requirements for the release of confidential information. 4) Allow the OPTN contractor to release non-confidential data by institution to any requester. 5) Eliminate the list of data elements that can be released in special circumstances out of policy to allow for greater flexibility in data release. 6) 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.

February 2012 proposal

OPTN Bylaws Substantive Rewrite of Appendix A

Public comment: 2/3/2012 - 4/6/2012

Application and Hearing Procedures for Members and Designated Transplant Programs

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.

September 2011 proposals

Clarify Requirements for Waiting Time Modification Requests

Public comment: 9/16/2011 - 1/12/2012

Current OPTN/UNOS policies for submitting waiting time modification requests are not clear, leading to wasted time for the transplant centers that submit requests, for OPTN Contractor staff who process requests, and for the Committees that review requests. Required documentation is often missing and results in delays for transplant candidates to receive the waiting time that they may be entitled to receive under OPTN policy. With these proposed clarifications, the Committee expects to see fewer submissions of incomplete requests and faster time to implementation of approved requests.

Extend the "Share 15" Regional Distribution Policy to "Share 15 National"

Public comment: 9/16/2011 - 1/12/2012

Note: The board approved this proposal in June 2012. View the policy notice

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.

Regional Distribution of Livers for Critically Ill Candidates

Public comment: 9/16/2011 - 1/12/2012

This proposal would offer livers to combined local and regional candidates with MELD/PELD scores of 35 or higher ("tiered regional sharing").

Plain Language Modifications to the Adult and Pediatric Heart Allocation Policies

Public comment: 9/16/2011 - 1/12/2012

Note: The board approved this proposal in June 2012. View the policy notice

Including the Requirement of Transplant Programs to Report in UNet a Change in Criterion or Status within 24 Hours of that Change

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.

Changes to the Non-Resident Alien Transplant Audit Trigger Policy

and Related Definitions

Public comment: 9/16/2011 - 1/12/2012

This proposal clarifies the data collected about the citizenship and residency of donors and recipients. The proposal also amends the audit trigger policy, allowing the Ad Hoc International Relations Committee to review the circumstances of any transplant of non-US residents/non-US citizens and make a public report. The proposal also contains technical amendments and removal of requirements that are not enforceable.

Update to the Calculated PRA (CPRA)

Public comment: 9/16/2011 - 1/12/2012

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.

Revision of the Bylaws and Policies that Govern HLA Laboratories

Public comment: 9/16/2011 - 1/12/2012

This proposal revises the UNOS Bylaws and Policies that apply to histocompatibility laboratories to more closely align OPTN/UNOS requirements for member laboratories with current laboratory practices.

Establish Requirements for the Informed Consent of Living Kidney Donors

Public comment: 9/16/2011 - 1/12/2012

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.

Establish Minimum Requirements for Living Kidney Donor Follow-Up

Public comment: 9/16/2011 - 1/12/2012

This proposal would require transplant programs to report required fields on the Living Donor Follow-up (LDF) form at required post-operative reporting periods (6, 12, and 24 months). The OPTN currently relies on Living Donor Follow-up (LDF) forms to collect data on the short-term health status of living donors. Data on living donors who donated in 2006 through 2009 demonstrate that many programs do not report meaningful living donor follow-up information at required reporting intervals. Consequently, to allow for meaningful analyses to objectively study the short-term effects of living donation, the transplant community must collectively improve patient information on the LDF form. The proposed minimum reporting requirements are based on recommendations from the Joint Society Work Group, which is composed of representatives from the American Society of Transplantation (AST), the American Society of Transplant Surgeons (ASTS), and the North American Transplant Coordinators Organization (NATCO) to the OPTN/UNOS Living Donor Committee.

Establish Requirements for the Medical Evaluation of Living Kidney Donors

Public comment: 9/16/2011 - 1/12/2012

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.

Require the OPTN Distributed Standardized Label

Public comment: 9/16/2011 - 1/12/2012

Eliminate the Use of an "Alternate" Label when Transporting Organs on Mechanical Preservation Machines

This proposal would make labeling of these machines consistent for all deceased and living donor organs that are transported outside of donor hospitals. Current policy allows the use of an "alternate" label, or a label other than the OPTN standardized label, when transporting organs on a mechanical preservation machine. OPOs create their own alternate labels resulting in inconsistent labeling. The proposed policy changes eliminate the use of alternate shipping labels on mechanical preservation machines and require OPOs to use a new standardized label that is part of the current color-coded labeling system distributed by the OPTN contractor.

Change the Term "Consent" to "Authorization" Throughout Policy

Public comment: 9/16/2011 - 1/12/2012

When Used in Reference to Organ Donation

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.

Modify the Imminent and Eligible (I & E) Neurological Death Data Reporting Definitions

Public comment: 9/16/2011 - 1/12/2012

The proposed policy changes clarify the definitions for determining whether a death can be classified as "imminent" or "eligible". OPOs are responsible for reporting data that classify a death as either an Imminent Neurologic Death ("imminent") or Eligible Death ("eligible") or neither "eligible" nor "imminent" ("neither"). The OPOs then report the "imminent" and "eligible" deaths to the OPTN. There are inconsistencies in the data reporting which have been primarily attributed to: OPOs interpreting the definitions in Policy 7.1 (Reporting Definitions) differently, and Brain death laws varying from state to state affecting the way the deaths are reported. The Committee eliminated Multi-system organ failure as an exclusionary criteria for classifying a death as "eligible", and identified a list of organ specific exclusionary criteria that has been added to provide more detailed guidance. The Committee also made changes to the definition of "imminent" so that it is restricted to those deaths that would most likely be classified as "eligible" had brain death been legally declared. This could allow the combination of "eligible" and "imminent" deaths to mitigate the effect of the variation in brain death laws.

Clarify and Improve Variance Policies

Public comment: 9/16/2011 - 1/12/2012

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.

March 2011 proposals

Improved Imaging Criteria for HCC Exceptions

Public comment: 3/11/2011 - 6/10/2011

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.

Reduce Waiting List Deaths for Adult Liver-Intestine Candidates

Public comment: 3/11/2011 - 6/10/2011

The proposal is intended to reduce the death rate on the waiting list for adult combined liver-intestine candidates by providing broader access to donor organs. Waiting list death rates in adult candidates awaiting a combined liver-intestine transplant are nearly three times higher than those waiting for a liver alone. This is a numerically small patient population with high waiting list mortality rates due to the need for two organs and donor organ size constraints.

Committee-Sponsored Alternative Allocation System (CAS) for Split Liver Allocation

Public comment: 3/11/2011 - 6/10/2011

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.

Encourage OPOs to Provide CT Scan if Requested

Public comment: 3/11/2011 - 6/10/2011

Modify Language in 3.7.12.3 for Currency and Readability

The Thoracic Committee proposes the addition of CT scan to Policy 3.7.12.4 (Desirable Information for Lung Offers). An OPO is encouraged to provide this information if it is requested to do so by a transplant program. The proposed policy does not require a transplant program to request a CT scan. Deceased donor lung or lungs may have contusions or infiltrates or malignant nodules, which may not be visible in a chest x-radiation (CXR). A computed tomography (CT) scan can identify these contusions, preventing the transplant of a damaged lung. The CT scan can also identify nodules which may be malignant, preventing the transmission of cancer or tumors to the recipient.

Require Updates of Certain Clinical Factors Every 14 Days for Lung Transplant Candidates with Lung Allocation Scores (LAS) of at Least 50

Public comment: 3/11/2011 - 6/10/2011

Modify Policy 3.7.6.3 for Currency and Readability

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.

Allow Outpatient Adult Heart Transplant Candidates Implanted with Total Artificial Hearts (TAH) 30 Days of Status 1A Time

Public comment: 3/11/2011 - 6/10/2011

This interim policy is in effect , and will expire on December 1, 2011 without further action by the Board of Directors. The Thoracic Committee will consider public comment and make a recommendation to the Board of Directors before the expiration date. On November 9, 2010, the OPTN/UNOS Board of Directors approved an interim policy, concurrent with public comment, for adult heart transplant candidates implanted with a TAH and discharged from the hospital. These candidates may now be listed as Status 1A for 30 days. When this 30-day time period ends, if these candidates do not qualify for Status 1A by other existing criteria, they must be downgraded; and, they may be Status 1B. Recent availability of a portable driver has allowed some candidates with TAHs to await heart transplantation as outpatients. Prior to the availability of this new instrument, all candidates with TAHs remained inpatients. Policy allows all inpatient TAH candidates to be classified as Status 1A for 14 day periods; however, policy previously prevented outpatient candidates implanted with TAHs to be listed as Status 1A unless they qualified by other criteria. There are no data to suggest that the medical urgency of an inpatient candidate with a TAH implant is different from an outpatient candidate with a TAH implant.

Improve the Reporting of Living Donor Status

Public comment: 3/11/2011 - 6/10/2011

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.

Improve the Packaging, Labeling and Shipping of Living Donor Organs, Vessels and Tissue Typing Materials

Public comment: 3/11/2011 - 6/10/2011

The majority of living donor organs recovered for transplant are not shipped or transported outside the recovery center, and therefore would not be affected by this proposal. However, the packaging and shipping of living donor organs is increasing, especially as "kidney paired" donation increases throughout the country. Changes to the policies for the packaging and shipping of deceased donor organs, vessels, and tissue typing materials were approved by the OPTN/UNOS Board in November 2010, and took effect in January 2011. The implementation of these new policies has created a situation where the rules for packaging, labeling and shipping deceased donor organs are more stringent than policies for the packaging, labeling and shipping of living donor organs. In response, this proposal would update living donor policy to more closely align with recent changes to the policy requirements for the packaging, labeling and shipment of deceased donor organs, vessels and tissue typing materials. The proposal also clarifies procedures when the living donor organ is not packaged, shipped or transported. The Committee anticipates both transplant centers and Organ Procurement Organizations (OPOs) would benefit from the standardization of packaging and shipping requirements for all organs. The Committee further expects that applying the existing requirements for the packaging and shipping of deceased donor organs to living donor organs, vessels and tissue typing materials will increase the safety of living donor organs that are packaged and transported outside the recovery facility. The proposal would not preclude transplant centers from entering into an agreement with an OPO to coordinate the packaging and shipping of living donor organs, vessels and tissue typing materials.

Require Confirmatory Subtyping of Non-A1 and Non-A1B Donors

Public comment: 3/11/2011 - 6/10/2011

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.

Standardize Label Requirements for Vessel Storage and Vessel Transport

Public comment: 3/11/2011 - 6/10/2011

This proposed change makes the labeling requirements for vessel storage consistent with those for vessel transport. Recent Policy 5.0 changes eliminated the requirement that a label be placed directly on the vessel container for transport and require that the vessel label distributed by the OPTN contractor be attached to the outer barrier of the triple sterile barrier. Policy 5.10.2, currently requires the labeling of the vessel container when vessels are stored and requires the OPO to complete the labeling in the donor OR. As such, there is an inconsistency in vessel labeling requirements. This proposed policy modification will not affect the labeling requirements for vessel transport, and will clarify that containers for vessel storage do not require the vessel container itself to be labeled. The vessels must be placed in a triple sterile barrier, one of which is the rigid container, and labeled with the OPTN distributed label.

Update and Clarify Language in the DCD Model Elements

Public comment: 3/11/2011 - 6/10/2011

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.

List All Non-Metastatic Hepatoblastoma Pediatric Liver Candidates as Status 1B

Public comment: 3/11/2011 - 6/10/2011

The Pediatric and Liver & Intestinal Organ Transplantation Committees propose that non-metastatic hepatoblastoma pediatric liver candidates should be listed immediately as Status 1B with elimination of the requirement to be listed at a MELD/PELD 30 for 30 days. Hepatoblastoma is the most common primary liver malignancy in children. Optimal management of these patients usually includes a combination of chemotherapy and complete tumor resection. In some cases, a non-metastatic tumor may not be resectable by conventional means and may require a liver transplant to achieve a complete resection. In order to allow children with non-metastatic hepatoblastoma to be transplanted in a timely fashion, current UNOS policy allows these children to be assigned a MELD/PELD score of 30 at the time of listing. If the candidate is not transplanted within 30 days, the candidate may then be listed as Status 1B. The current Children's Oncology Group protocol for treatment of hepatoblastoma calls for no more than four of six rounds of chemotherapy prior to transplant, reserving two rounds for use following transplant. Since these patients must undergo chemotherapy while awaiting transplant, the optimal window for transplant is very small.

Eliminate the Requirement that Pediatric Liver Candidates Must be Located in a Hospital's Intensive Care Unit to Qualify as Status 1A or 1B

Public comment: 3/11/2011 - 6/10/2011

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.

January 2011 proposal

Model for Assessing the Effectiveness of Individual OPOs in Key Measures of Organ Recovery and Utilization

Public comment: 1/21/2011 - 3/29/2011

The Organ Procurement Organization (OPO) Committee and the Membership and Professional Standards Committee (MPSC) propose the use of a statistical model to analyze OPO performance. This model utilizes a comparison of observed (actual) to expected organs transplanted per donor (yield) based upon donor specific characteristics in each Donation Service Area. The model will be used in aggregate (for all organs) in addition to organ specific performance measures, and predicts how many organs would have been recovered and transplanted if the OPO performed at the level of the national average for donors with similar characteristics. The MPSC will use the model to monitor OPO performance, similar to existing practices for monitoring transplant program performance. Through this approach, the MPSC will identify opportunities for improvement at OPOs whose observed organ yield falls below expected levels by more than a threshold. The bylaw proposal provides information regarding the model's intended use by the MSPC as well as the threshold that will result in MPSC inquiry.

October 2010 proposals

Require Collection of Human Leukocyte Antigen (HLA) Type for Thoracic Organs

Public comment: 10/1/2010 - 2/5/2011

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.

Clarify Adult Heart Status 1A Language

Public comment: 10/1/2010 - 2/5/2011

to Enable Consistent Interpretation of Policy and Reflect Current Programming

This proposal clarifies language about Status 1A requirements in thoracic policy 3.7.3. (Adult Candidate Status) The revised Status 1A language clarifies that clinicians requesting Status 1A for candidates who do not meet criteria may only do so for candidates who are admitted to their listing hospital. Revised language in criterion (b) clarifies that clinicians may enter a mechanical circulatory support device complication other than the examples provided, and that UNOS staff will process such an entry as a request for Status 1A by criterion (b). Finally, revised language clarifies that a request for Status 1A by criterion (b) does not require that the candidate be an inpatient. This proposal will not require programming in UNetSM.

Clarify Responsibility for Elements of the Living Donation Process

Public comment: 10/1/2010 - 2/5/2011

and to Reassign Reporting Responsibility for Living Donation from the Recipient Transplant Program to the Transplant Program Performing the Living Donor Nephrectomy or Hepatectomy

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.

Establish Bylaws Qualifications for a Director of Liver Transplant Anesthesia

Public comment: 10/1/2010 - 2/5/2011

This proposal will protect patient safety by ensuring that all Liver Transplant programs employ an anesthetist who meets minimum experience and training requirements specific to transplantation. Transplant programs will be required to designate a Director of Liver Transplant Anesthesia with expertise in the area of perioperative care of liver transplant patients who could serve as an advisor to other members of the team. The new bylaw language will: Designate the appropriate board certification for the position Delineate certain administrative and clinical responsibilities that should be handled by the Director; and Determine the minimum qualifications needed for the position.

Modify the Requirements for Transplant Hospitals that Perform Living Donor Kidney Recoveries

Public comment: 10/1/210 - 2/5/2011

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.

Prohibit Storage of Hepatitis C Antibody Positive and Hepatitis B Surface Antigen Positive Extra Vessels

Public comment: 10/1/2010 - 2/5/2011

The proposed addition of policy is meant to improve patient safety and recipient outcomes related to the storage and transplant of extra vessels. The Operations and Safety Committee is proposing revised policy language for OPTN policy 5.10.2 (Vessel Storage) prohibiting the storage of Hepatitis C antibody positive and Hepatitis B surface antigen positive extra vessels. This proposal also includes modifications to policy 5.10.1 requiring transplant centers to verify the donor extra vessels ABO, all serology results, container contents, date of expiration and the UNOS Donor ID with the ABO and all serology results of the intended recipient prior to implantation. This change is expected to reduce the risk of disease transmission from transplant of extra vessels into secondary recipient(s) when the vessels are not transplanted into the recipient for whom the donors organ was originally procured.

March 2010 proposals

Ohio Alternative Local Unit (ALU)

Public comment: 3/19/2010 - 7/16/2010

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.

OneLegacy Split Liver Alternative Allocation System

Public comment: 3/19/2010 - 7/16/2010

OneLegacy and the five liver transplant programs in its donation service area (DSA) are proposing a variance, or alternative allocation system (AAS), to Policy 3.6.11 (Allocation of Livers for Segmental Transplantation). This AAS would permit the institution to accept a liver for an acceptable candidate at their institution, split that liver and transplant one lobe into that candidate (known as the index patient) and then transplant the other lobe into any other medically suitable patient listed at the same 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. The AAS is intended to increase the donor pool by providing an incentive to the institution receiving a liver offer to split a good-quality organ and transplant it in two recipients rather than transplanting the entire organ in one recipient.

Region 2 Split Liver Alternative Allocation System

Public comment: 3/19/2010 - 7/16/2010

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.

Develop an Efficient, Uniform National Pancreas Allocation System

Public comment: 3/19/2010 - 7/16/2010

The purpose of this proposal is to improve the national pancreas allocation system. This improvement is consistent with the OPTN long-range strategic goals and priorities:

  • to increase geographic equity in access and waiting time to deceased donor organs for transplantation;
  • to maximize capacity of deceased donor organ transplantation;
  • to achieve operational efficiency and cost-effectiveness of implementing and maintaining the organ allocation system.

Specific objectives of the proposed allocation system for pancreas transplantation:

  • reduce geographic inequities of pancreas utilization, access to transplantation, and transplant waiting time;
  • maximize capacity by improving the opportunity for pancreas candidates to receive a transplant;
  • enhance efficiency and cost-effectiveness, and minimize complexity of implementing and maintaining the operational requirements of a new pancreas allocation system; and
  • optimize pancreas transplant access without adversely affecting kidney transplantation.

Specifically, the Committee evaluated the transplant volume for adult and pediatric kidney recipients as well as ethnicity, age, and gender of recipients. Methodology to achieve these objectives: combine pancreas-alone (PA) and simultaneous pancreas-kidney (SPK) candidates onto a single match run list; allow local candidates who are allocated a pancreas from the combined list but who also require a kidney transplant, to receive a kidney independently of the kidney-alone match run if they meet specific qualifying criteria; institute objective medical qualifying criteria relating to renal dysfunction and diabetes for SPK candidates to accrue waiting time; allocate deceased donor pancreata separately from the current kidney allocation system so that pancreas candidates are allocated organs that precede kidney paybacks and pediatric and adult kidney-alone (KI) recipients monitor allocation of standard criteria deceased donor kidneys for pediatric and adult KI recipients and SPK recipients with respect to donor ages 35 and >35 years, as well as ethnicity, age and gender.

Modify OPO and Transplant Center Requirements for Screening, Communicating and Reporting All Potential or Confirmed Donor-Related Disease and Malignancy Transmission Events

Public comment: 3/19/2010 - 7/16/2010

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.

Update HLA Equivalences Tables

Public comment: 3/19/2010 - 7/16/2010

The purpose of this proposal is to update the tables in Appendix 3A to reflect changes in HLA typing practice and to improve the utility of the unacceptable antigens. Appendix 3A includes 2 tables, one listing HLA antigen designations that should be considered equivalent for purposes of matching kidney candidates and donors for the HLA-A,-B, and DR antigens (HLA Antigen Values and Split Equivalences) and a second for determining which donor HLA antigens are unacceptable based on the unacceptable HLA-antigens listed for a sensitized candidate (HLA A, B, C, DR, and DQ Unacceptable Antigen Equivalences).

Require that Deceased Donor HLA Typing be Performed by DNA Methods

Public comment: 3/19/2010 - 7/16/2010

and Identify Additional Antigens for Kidney, Kidney-pancreas, Pancreas, and Pancreas Islet Offers

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.

Placement of Non-Directed Living Donor Kidneys

Public comment: 3/19/2010 - 7/16/2010

This proposal would establish procedures for the placement of non-directed living donor kidneys. Under the proposal, transplant centers would select the recipient of non-directed living donor kidneys based on a match run.

Require Reporting of Non-utilized & Redirected Living Donor Organs

Public comment: 3/19/2010 - 7/16/2010

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 Tiedi.

Require Use of a Standardized, Internal Label

Public comment: 3/19/2010 - 7/16/2010

that is Distributed by the OPTN and that Transplant Centers Notify the Recovering OPO when they Repackage an Organ

Current OPTN policy only requires that the external label distributed by the OPTN contractor be used for transporting organs and vessels. This proposed policy change would require OPOs and transplant centers to also use standardized, internal labels that are distributed by the OPTN contractor for organ and vessel transport and for vessel storage. This change will make both internal and external labeling consistent throughout the U.S. The proposal also: requires transplant centers to notify the recovering OPO when they repackage an organ; makes the language consistent by changing the term - provided by the OPTN contractor- to the term -distributed by the OPTN contractor-; moves Policy 2.5.6.1 which lists the required documentation that accompanies an organ or vessel to policy 5.5.1. clarifies labeling requirements for vessel storage The goal of this proposed change is to improve patient safety and reduce the number of wasted organs by reducing the number of labeling errors.

Modifications to Data Elements on Tiedi forms

Public comment: 3/5/2010 - 4/16/2010

Transplant Candidate Registration (TCR), Transplant Recipient Registration (TRR), Transplant Recipient Follow-up (TRF), Living Donor Registration (LDR), Living Donor Follow-up (LDF), Deceased Donor Registration (DDR), Histocompatibility Form (HF), and approval of a new Explant Pathology Form for Liver Recipients.

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.

October 2009 proposal

Improve the Variance Appeal Process

Public comment: 10/15/2009 - 2/5/2010

A variance is a policy experiment conducted by a member of the OPTN to improve organ procurement and allocation. For ease in reading, this proposal uses the term variance to describe it and its types. A review of variance policies revealed that most are silent on the process for appealing decisions of the committee or Board of Directors. This proposal attends to this deficiency. As such, the proposed modifications describe how an OPTN member may appeal a variance decision, and the role of the relevant committee and POC in the appeal process. Note: The modifications do not impact the current operation of existing variances.