Proposal |
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1 |
Proposal to Substantially Revise The National Kidney Allocation System (Kidney Transplantation Committee)
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
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Proposal (1.81 MB)
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9/21/2012 - 12/14/2012 |
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2 |
Proposal to Require Reporting of Every Islet Infusion to the OPTN Contractor within 24 Hours of the Infusion (Pancreas Transplantation Committee)
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.
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Proposal (337 K)
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9/21/2012 - 12/14/2012 |
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3 |
Proposal to Remove the OPTN Bylaw for the Combined Heart-Lung Transplant Program Designation (Thoracic Organ Transplantation and Membership and Professional Standards Committees (MPSC)
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.
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Proposal (236 K)
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9/21/2012 - 12/14/2012 |
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4 |
Proposal to Change the Composition of the OPTN Finance Committee (Executive Committee)
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.
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Proposal (332 K)
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9/21/2012 - 12/14/2012 |
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5 |
Proposal to Change the OPTN/UNOS Bylaws to Better Define Notification Requirements for Periods of Functional Inactivity (Membership and Professional Standards Committee (MPSC)
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.
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Proposal (531 K)
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9/21/2012 - 12/14/2012 |
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6 |
Proposal to Modify the Imminent and Eligible (I & E) Neurological Death Data Reporting Definitions (Organ Procurement Organization (OPO) Committee)
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.
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Proposal (544 K)
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9/21/2012 - 12/14/2012 |
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7 |
Proposal to Clarify Priority Status for Prior Living Organ Donors Who Later Require a Kidney Transplant (Kidney Transplantation Committee)
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.
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Proposal (313 K)
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3/16/2012 - 6/25/2012 |
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8 |
Proposal to Establish Kidney Paired Donation (KPD) Policy (Kidney Transplantation Committee)
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.
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Proposal (669 K)
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3/16/2012 - 6/25/2012 |
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9 |
Proposal to Include Bridge Donors in the OPTN Kidney Paired Donation (KPD) Program (Kidney Transplantation Committee)
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.
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Proposal (646 K)
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3/16/2012 - 6/25/2012 |
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10 |
Proposal to Allow Transplant Centers to Place Liver Candidates with HCC Exceptions on 'HCC Hold' Without Loss of Accumulated Exception Score (Liver and Intestinal Transplantation Committee)
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.
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Proposal (555 K)
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3/16/2012 - 6/25/2012 |
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11 |
Proposal to Revise the Lung Allocation Score (LAS) System (Thoracic Organ Transplantation Committee)
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.
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Proposal (1.14 MB)
Exhibit (2.03 MB)
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3/16/2012 - 6/25/2012 |
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12 |
Proposal to Require Reporting of Unexpected Potential and Proven Disease Transmission Involving Living Organ Donors (Living Donor Committee)
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.
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Proposal (464 K)
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3/16/2012 - 6/25/2012 |
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13 |
Proposal to Require Extra Vessel(s) Disposition to be Reported to the OPTN within Five Days of Transplant or Disposal (Operations and Safety Committee (OSC))
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.
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Proposal (497 K)
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3/16/2012 - 6/25/2012 |
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14 |
Proposal to Document All Locally Assigned Unique Identifiers in the Donor Record (OPO Committee)
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.
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Proposal (298 K)
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3/16/2012 - 6/25/2012 |
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15 |
Proposal to Update and Clarify Language in the DCD Model Elements (OPO Committee)
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.
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Proposal (522 K)
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3/16/2012 - 6/25/2012 |
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16 |
Proposal to Update Data Release Policies (Policy Oversight Committee)
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.
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Proposal (298 K)
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3/16/2012 - 6/25/2012 |
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17 |
OPTN Bylaws Substantive Rewrite of Appendix A: 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.
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Proposal (772 K)
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2/3/2012 - 4/6/2012 |
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18 |
Kidney Transplantation Committee: Proposal to Clarify Requirements for Waiting Time Modification Requests
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.
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Proposal (311 K)
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9/16/2011 - 1/12/2012 |
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19 |
Liver and Intestinal Organ Transplantation Committee: Proposal to Extend the "Share 15" Regional Distribution Policy to "Share 15 National"
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.
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Proposal (544 K)
Exhibit (381 K)
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9/16/2011 - 1/12/2012 |
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20 |
Liver and Intestinal Organ Transplantation Committee: Proposal For Regional Distribution of Livers for Critically Ill Candidates
This proposal would offer livers to combined local and regional candidates with MELD/PELD scores of 35 or higher ("tiered regional sharing").
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Proposal (643 K)
Exhibit (376 K)
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9/16/2011 - 1/12/2012 |
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21 |
Thoracic Organ Transplantation Committee: Plain Language Modifications to the Adult and Pediatric Heart Allocation Policies, Including the Requirement of Transplant Programs to Report in UNet a Change in Criterion or Status within Twenty-Four 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.
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Proposal (389 K)
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9/16/2011 - 1/12/2012 |
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22 |
Ad Hoc International Relations and Ethics Committees: Proposed Revisions to and Reorganization of Policy 6.0 (Transplantation of Non-Resident Aliens), Which Include Changes to the Non-Resident Alien Transplant Audit Trigger Policy and Related Definitions
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.
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Proposal (621 K)
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9/16/2011 - 1/12/2012 |
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23 |
Histocompatibility Committee: Proposed Update to the Calculated PRA (CPRA)
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.
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Proposal (416 K)
Exhibit (2.55 MB)
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9/16/2011 - 1/12/2012 |
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24 |
Histocompatibility Committee: Revision of the UNOS Bylaws, the OPTN Bylaws and the OPTN Policies that Govern HLA Laboratories
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.
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Proposal (498 K)
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9/16/2011 - 1/12/2012 |
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25 |
Living Donor Committee: Proposal to Establish Requirements for the Informed Consent of Living Kidney Donors
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.
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Proposal (556 K)
Exhibit (448 K)
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9/16/2011 - 1/12/2012 |
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26 |
Living Donor Committee: Proposal To Establish Minimum Requirements for Living Kidney Donor Follow-Up
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.
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Proposal (547 K)
Exhibit (399 K)
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9/16/2011 - 1/12/2012 |
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27 |
Living Donor Committee: Proposal To Establish Requirements for the Medical Evaluation of Living Kidney Donors
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.
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Proposal (569 K)
Exhibit (560 K)
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9/16/2011 - 1/12/2012 |
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28 |
Organ Procurement Organization (OPO) Committee: Proposal to Eliminate the Use of an "Alternate" Label when Transporting Organs on Mechanical Preservation Machines and to Require the OPTN Distributed Standardized Label Organ Procurement Organization (OPO) Committee
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.
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Proposal (456 K)
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9/16/2011 - 1/12/2012 |
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29 |
Organ Procurement Organization (OPO) Committee: Proposal to Change the Term "Consent" to "Authorization" Throughout Policy 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.
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Proposal (684 K)
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9/16/2011 - 1/12/2012 |
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30 |
Organ Procurement Organization (OPO) Committee: Proposal to Modify the Imminent and Eligible (I & E) Neurological Death Data Reporting Definitions
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.
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Proposal (582 K)
Exhibit (462 K)
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9/16/2011 - 1/12/2012 |
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31 |
Policy Oversight Committee (POC): Proposal to Clarify and Improve Variance Policies
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.
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Proposal (636 K)
Exhibit (580 K)
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9/16/2011 - 1/12/2012 |
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32 |
Test document
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Proposal (13 K)
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12/12/2010 - 12/12/2011 |
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33 |
Liver and Intestinal Transplantation Committee: Proposal for Improved Imaging Criteria for HCC Exceptions
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.
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Proposal (594 K)
Exhibit (287 K)
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3/11/2011 - 6/10/2011 |
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34 |
Liver and Intestinal Transplantation Committee: Proposal to Reduce Waiting List Deaths for Adult Liver-Intestine Candidates
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.
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Proposal (415 K)
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3/11/2011 - 6/10/2011 |
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35 |
Liver and Intestinal Transplantation Committee: Proposed Committee-Sponsored Alternative Allocation System (CAS) for Split Liver Allocation
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.
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Proposal (456 K)
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3/11/2011 - 6/10/2011 |
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36 |
Thoracic Organ Transplantation Committee: Proposal to Encourage Organ Procurement Organizations (OPO) to Provide Computed Tomography (CT) Scan if Requested by Transplant Programs, And to 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.
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Proposal (338 K)
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3/11/2011 - 6/10/2011 |
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37 |
Thoracic Organ Transplantation Committee: Proposal to Require Updates of Certain Clinical Factors Every 14 Days for Lung Transplant Candidates with Lung Allocation Scores (LAS) of at Least Fifty, And to 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.
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Proposal (424 K)
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3/11/2011 - 6/10/2011 |
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38 |
Thoracic Organ Transplantation Committee: Proposal to Allow Outpatient Adult Heart Transplant Candidates Implanted with Total Artificial Hearts (TAH) Thirty Days of Status 1A Time
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.
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Proposal (394 K)
Exhibit (375 K)
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3/11/2011 - 6/10/2011 |
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39 |
Living Donor Committee: Proposal to Improve the Reporting of Living Donor Status
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.
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Proposal (152 K)
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3/11/2011 - 6/10/2011 |
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40 |
Living Donor Committee: Proposal to Improve the Packaging, Labeling and Shipping of Living Donor Organs, Vessels and Tissue Typing Materials
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.
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Proposal (582 K)
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3/11/2011 - 6/10/2011 |
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41 |
Operations and Safety Committee: Proposal to Require Confirmatory Subtyping of Non-A1 and Non-A1B Donors
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.
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Proposal (616 K)
Exhibit (130 K)
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3/11/2011 - 6/10/2011 |
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42 |
Organ Procurement Organization (OPO) Committee: Proposal to Standardize Label Requirements for Vessel Storage and Vessel Transport
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.
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Proposal (440 K)
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3/11/2011 - 6/10/2011 |
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43 |
Organ Procurement Organization (OPO) and Organ Availability Committees: Proposal to Update and Clarify Language in the DCD Model Elements
The proposed changes to the Donation after Cardiac Death (DCD) Model Elements will clarify and update language for the donation and transplantation community. These Model Elements 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.
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Proposal (653 K)
Exhibit (475 K)
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3/11/2011 - 6/10/2011 |
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44 |
Pediatric and Liver and Intestinal Organ Transplantation Committees: Proposal to List All Non-Metastatic Hepatoblastoma Pediatric Liver Candidates as Status 1B
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.
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Proposal (549 K)
Exhibit (169 K)
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3/11/2011 - 6/10/2011 |
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45 |
Pediatric Transplantation Committee: Proposal to Eliminate the Requirement that Pediatric Liver Candidates Must be Located in a Hospital's Intensive Care Unit to Qualify as Status 1A or 1B
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.
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Proposal (479 K)
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3/11/2011 - 6/10/2011 |
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46 |
Membership and Professional Standards Committee (MPSC), Organ Procurement Organization (OPO) Committee - Proposed Model for Assessing the Effectiveness of Individual OPOs in Key Measures of Organ Recovery and Utilization
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.
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Proposal (1.07 MB)
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1/21/2011 - 3/29/2011 |
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47 |
Thoracic Organ Transplantation Committee - Proposal to Require Collection of Human Leukocyte Antigen (HLA) Type for Thoracic Organs
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.
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Proposal (277 K)
Exhibit (1.66 MB)
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10/1/2010 - 2/5/2011 |
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48 |
Thoracic Organ Transplantation Committee - Proposal to Clarify Adult Heart Status 1A Language to Enable Consistent Interpretation of Policy and Reflect Current Programming in UNetSM
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.
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Proposal (219 K)
Exhibit (1.12 MB)
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10/1/2010 - 2/5/2011 |
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49 |
Living Donor Committee and Membership and Professional Standards Committee - Proposal to Clarify which Transplant Program has Responsibility for Elements of the Living Donation Process 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.
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Proposal (210 K)
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10/1/2010 - 2/5/2011 |
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50 |
Membership and Professional Standards Committee - Proposal to Establish Qualifications for a Director of Liver Transplant Anesthesia in the OPTN Bylaws
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.
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Proposal (178 K)
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10/1/2010 - 2/5/2011 |
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51 |
Membership and Professional Standards Committee - Proposal to Modify the Requirements for Transplant Hospitals that Perform Living Donor Kidney Recoveries
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.
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Proposal (182 K)
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10/1/2010 - 2/5/2011 |
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52 |
Operations and Safety Committee - Proposal to Prohibit Storage of Hepatitis C Antibody Positive and Hepatitis B Surface Antigen Positive Extra Vessels
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.
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Proposal (251 K)
Exhibit (3 MB)
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10/1/2010 - 2/5/2011 |
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53 |
Liver and Intestinal Organ Transplantation Committee - Proposed Ohio Alternative Local Unit (ALU)
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.
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Proposal (339 K)
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3/19/2010 - 7/16/2010 |
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54 |
Liver and Intestinal Organ Transplantation Committee - Proposed OneLegacy Split Liver Alternative Allocation System
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.
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Proposal (370 K)
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3/19/2010 - 7/16/2010 |
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55 |
Liver and Intestinal Organ Transplantation Committee - Proposed Region 2 Split Liver Alternative Allocation System
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.
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Proposal (369 K)
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3/19/2010 - 7/16/2010 |
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56 |
Pancreas Transplantation Committee - Proposal to Develop an Efficient, Uniform National Pancreas Allocation System
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.
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Proposal (1.77 MB)
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3/19/2010 - 7/16/2010 |
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57 |
Ad Hoc Disease Transmission Advisory Committee (DTAC) - Proposal to Modify OPO and Transplant Center Requirements for Screening, Communicating and Reporting All Potential or Confirmed Donor-Related Disease and Malignancy Transmission Events.
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
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Proposal (1.55 MB)
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3/19/2010 - 7/16/2010 |
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58 |
Histocompatibility Committee - Proposal to Update HLA Equivalences Tables
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).
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Proposal (1.45 MB)
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3/19/2010 - 7/16/2010 |
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59 |
Histocompatibility Committee - Proposal to Require that Deceased Donor HLA Typing be Performed by DNA Methods 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.
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Proposal (4.21 MB)
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3/19/2010 - 7/16/2010 |
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60 |
Living Donor Committee - Proposal for the Placement of Non-Directed Living Donor Kidneys
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.
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Proposal (445 K)
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3/19/2010 - 7/16/2010 |
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61 |
Living Donor Committee - Proposal to Require Reporting of Non-utilized and Redirected Living Donor Organs
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.
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Proposal (354 K)
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3/19/2010 - 7/16/2010 |
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62 |
Organ Procurement Organization (OPO) Committee - Proposal to Require Use of a Standardized, Internal Label 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
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Proposal (6.95 MB)
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3/19/2010 - 7/16/2010 |
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63 |
Proposed Modifications to Data Elements on the following Tiedi forms : 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
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Proposal (4.37 MB)
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3/5/2010 - 4/16/2010 |
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64 |
Policy Oversight Committee - Proposal to Improve the Variance Appeal Process Affected Policy: 3.4 (Organ Procurement, Distribution and Alternative Systems for
Organ Distribution or Allocation)
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.
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Proposal (665 K)
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10/15/2009 - 2/5/2010 |
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65 |
Proposal to Add a Valuable Consideration Disclosure to the Bylaws - Appendix B, Attachment I, Section XIII, C (2) Kidney Transplant Programs that Perform Living Donor Kidney Transplantation and Appendix B, Attachment I, Section XIII, C (4) Liver Transplant Programs that Perform Living Donor Liver Transplantation
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.
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Proposal (532 K)
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11/13/2009 - 2/5/2010 |
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66 |
Ad Hoc Disease Transmission Advisory Committee - Proposal to Modify Requirements for Mandatory HTLV-1/2 Testing for All Potential Deceased Donors
Affected/Proposed Policy: Policy 2.2.3.1 (For All Potential Donors)
Current policy requires anti-HTLV-1/2 antibody testing on all potential donors. Most OPOs currently use an enzyme immunoassay test system. This system will no longer be manufactured effective 12/31/2009. This leaves a high throughput testing platform as the only FDA-licensed commercially available alternative, which may not be amenable to the time constraints and logistics associated with prospective testing for organ donation at most OPOs. Based on the extremely low incidence (0.035-0.046% of blood donors) of HTLV-1/2 confirmed in donors, and the fact that there are no reported cases in the U.S. of transplant recipients infected with HTLV-1 that actually develop the disease, the OPTN/UNOS Board of Directors voted to discontinue the requirement to perform prospective screening of deceased donors during its June 22-23, 2009 meeting. In response, the Ad Hoc Disease Transmission Advisory Committee recommends that retrospective HTLV-1/2 screening tests be required for all deceased donors, and that all screen positive tests be followed with confirmatory testing to differentiate between HTLV-1 and HTLV-2
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Proposal (549 K)
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8/17/2009 - 9/30/2009 |
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67 |
Kidney Transplantation Committee - Proposal to Include Non-Directed Living Donors and Donor Chains in the Kidney Paired Donation Pilot Program (Affected Program: Kidney Paired Donation Pilot Program)
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.
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Proposal (772 K)
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7/10/2009 - 9/14/2009 |
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68 |
Living Donor Committee - Proposal to Improve the ABO Verification Process for Living Donors (Affected Policies: Policy 12.3.1 - ABO Identification; Policy 12.8.1. - Reporting Requirements)
This policy proposal improves the safety of living donation through an improved ABO verification and matching process. Currently, the ABO verification and matching requirements for living donors are less stringent than the requirements for deceased donors.
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Proposal (365 K)
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7/10/2009 - 9/14/2009 |
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69 |
Living Donor Committee - Proposed Guidance for the Medical Evaluation of Living Liver Donors )
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.
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Proposal (514 K)
Exhibit (407 K)
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7/10/2009 - 9/14/2009 |
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70 |
Membership and Professional Standards Committee - OPTN Notification Requirements for OPOs, Transplant Hospitals, and Histocompatibility Labs When Faced with an Adverse Action Taken by Regulatory Agencies (Affected Bylaws: Appendix B (Sections I, II, III): Criteria for OPO, Transplant Hospital, and Histocompatibility Laboratory Membership)
The purpose of this bylaw modification is to clarify member responsibilities with regard to OPTN notification of adverse actions taken by regulatory agencies that would impact the organizations ability to serve transplant patients. The Committee modified existing language within the bylaws to clarify material submission and extend time periods for action.
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Proposal (880 K)
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7/10/2009 - 9/14/2009 |
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71 |
Membership and Professional Standards Committee - Proposal to Change the UNOS Bylaws to Reconcile Discrepancies in Patient Volume Requirements for Full and Conditional Program Approval When Qualifying Kidney, Liver and Pancreas Primary Transplant Physicians (Affected Bylaw: Appendix B, Attachment I)
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.
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Proposal (649 K)
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7/10/2009 - 9/14/2009 |
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72 |
Membership and Professional Standards Committee - Proposal to Add Language to the OPTN/UNOS Bylaws Requiring Transplant Center and OPO Members to Follow State Law Regarding Anatomical Gifts (Affected Bylaws/Policy: Article I, Sec 1.10, Appendix B, Section I and II, and Policy 3.4: Organ Procurement, Distribution and Alternative Systems for Organ Distribution or Allocation)
This proposal adds language to the bylaws stipulating that members are obligated to follow their respective state laws regarding anatomical gifts. This bylaw will ultimately help preserve public trust in the national organ transplant system by preventing conflicts of interest associated with having the same person declare death and perform organ procurement and transplantation. The ultimate goal of this proposed change is to prohibit the same physician from declaring a patients death and participating in the removal or transplant of organs from that decedent.
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Proposal (673 K)
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7/10/2009 - 9/14/2009 |
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73 |
Organ Procurement Organization (OPO) Committee - Proposal to Change Requirements for Labeling and Packaging Organs Procured by Visiting Transplant Center Teams and for OPO Labeling of Tissue Typing Materials (Affected Policy: Policy 5.0 Standardized Packaging, Labeling and Transporting of Organs, Vessels and Tissue Typing Materials (Organ Procurement Organization) (OPO) Committee)
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.
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Proposal (390 K)
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7/10/2009 - 9/14/2009 |
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74 |
Kidney Transplantation Committee and Liver and Intestinal Organ Transplantation Committee -Proposed listing requirements for simultaneous liver-kidney transplant candidates (Policy proposed: 3.5.10 - Simultaneous Liver-Kidney Transplantation)
This proposal would set minimum criteria for candidates listed for simultaneous liver-kidney (SLK) transplantation. The intent of this proposal is first to identify candidates who are unlikely to regain renal function following liver transplantation. These proposed policy changes would provide priority for these candidates to receive a SLK transplant. The goal of this proposal is to improve patient and renal graft survival following SLK transplant.
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Proposal (1.17 MB)
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2/6/2009 - 4/24/2009 |
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75 |
Liver and Intestinal Organ Transplantation Committee - Proposal to create regional distribution of livers for Status 1 liver candidates (Policy affected: 3.6 - Allocation of Livers)
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.
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Proposal (530 K)
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2/6/2009 - 4/24/2009 |
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76 |
Liver and Intestinal Organ Transplantation Committee - Proposal to create regional distribution of livers for MELD/PELD candidates (Policy affected 3.6 - Allocation of Livers)
This proposal will create regional distribution of livers for MELD/PELD candidates. This proposal should provide those in most need of a liver transplant greater access to organs.
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Proposal (581 K)
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2/6/2009 - 4/24/2009 |
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77 |
Liver and Intestinal Organ Transplantation Committee - Proposal to standardize MELD/PELD exception criteria and scores (Policy affected: 3.6.4.5 - Liver Candidates with Exceptional Cases)
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.
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Proposal (532 K)
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2/6/2009 - 4/24/2009 |
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78 |
Thoracic Organ Transplantation Committee - Proposal to add the factors current bilirubin and change in bilirubin to the lung allocation score (LAS) (Policy affected: 3.7.6.1 (Candidates Age 12 and Older)
This proposal adds the following two factors to the LAS to better predict a lung transplant candidates waiting list urgency: 1) current bilirubin (for a candidate in any diagnosis group); and 2) change in bilirubin of at least 50% (for a candidate in diagnosis Group B only). Analyses revealed the association between high bilirubin levels and waitlist mortality. The association between current bilirubin of at least 1.0 mg/dL and waiting list mortality has statistical significance. An increase in a lung transplant candidates bilirubin level of 50% or more during a six-month period, when the higher bilirubin value is at least 1.0 mg/dL, increases a diagnosis Group B candidates risk for dying on the waiting list. This association between change in bilirubin of at least 50% and waiting list mortality for candidates in diagnosis Group B (largely candidates diagnosed with pulmonary hypertension) has statistical significance. The Thoracic Committee anticipates that this policy modification will reduce waitlist mortality for a lung transplant candidate, and improve the ability of the LAS to predict a candidates medical urgency for a lung transplant.
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Proposal (635 K)
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2/6/2009 - 4/24/2009 |
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79 |
Living Donor Committee - Proposal to modify the high risk donor policy to protect the confidential health information of potential living donors (Policy affected: 4.1.1 - Communication of Donor History)
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.
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Proposal (346 K)
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2/6/2009 - 4/24/2009 |
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80 |
Membership and Professional Standards Committee - Proposal to change the OPTN/UNOS Bylaws to clarify the process for reporting changes in key personnel (Bylaw affected: Appendix B, Section II,E (Key Personnel); Appendix B, Attachment 1, Section III (Changes in Key Personnel)
This proposal to change the bylaws will clarify when notification of changes in key personnel should be submitted and will further clarify the expectation that member institutions that cannot comply should voluntarily inactivate or withdraw the affected transplant program. This proposed language places greater emphasis on the submission of complete applications. Additionally, it clarifies the steps that will be taken if the member fails to inform the OPTN Contractor of key personnel changes.
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Proposal (630 K)
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2/6/2009 - 4/24/2009 |
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81 |
Organ Procurement Organization (OPO) Committee - Proposal to clarify, reorganize and update OPTN policies on OPO and transplant center packaging, labeling and shipping practices (Policy affected: 5.0 (Standardized Packaging, Labeling and Transporting of Organs, Vessels and Tissue Typing Materials)
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.
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Proposal (538 K)
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2/6/2009 - 4/24/2009 |
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