This information has been provided by OPTN and is presented by NFT as a public service.
The OPTN is seeking feedback on initiatives impacting organ donation and transplantation in the U.S. The public comment period for the proposals below will be open from August 2, 2019 to October 2, 2019. You can review proposals and submit your approval, disapproval, support, lack of support or suggestions on the OPTN website. To learn more about how your voice matters, register for a webinar to learn about OPTN’s policy proposals.
According to their website, “The Organ Procurement and Transplantation Network (OPTN) is a unique public-private partnership that links all professionals involved in the U.S. donation and transplantation system. Also crucial to the system are individuals who sign organ donor cards, people who comment on policy proposals and countless volunteers who support donation and transplantation, among many others.
The National Organ Transplant Act (NOTA) established the OPTN in 1984. In 2000, The U.S. Department of Health and Human Services (HHS) implemented a final rule establishing a regulatory framework for the structure and operations of the OPTN.
The goals of the OPTN are to increase the number of and access to transplants, improve survival rates after transplantation, and to promote patient safety and efficient management of the system.”
Synopsis of Initiatives
Proposal: Modify Appointment Process for the Histocompatibility Vice Chair
Sponsoring Committee: OPTN Histocompatibility Committee
The Vice President of the OPTN Board of Directors appoints the Chair and Vice Chair of the nearly all OPTN standing committees. The Vice Chair of the Histocompatibility Committee is the only exception to this practice; the Histocompatibility Committee Vice Chair is appointed by a national election of histocompatibility laboratories. This proposal intended to establish consistency in the Vice Chair appointment process across all OPTN Committees.
Proposal: Update to the Definition of Pre-existing Liver Disease
Sponsoring Committee: OPTN Liver Transplantation Committee
Current OPTN policy allows patients meeting specific criteria for fulminant hepatic failure to be eligible for listing as Status 1A when patients are “without pre-existing liver disease.” The policy is ambiguous regarding whether or not receipt of a prior liver transplantation constitutes a “pre-existing liver disease.” The goal of this proposal is to:
• Clarify policy language so that pre-existing liver disease does not include a prior liver transplant.
Proposal: Modify Data Submission Policies
Sponsoring Committee: OPTN Data Advisory Committee
OPTN Policy 18 policy includes conflicting timelines for data submission with OPTN members report is confusing. Furthermore, the policy does not preclude members from changing data that has been officially submitted and is considered final. This proposal attempts to:
• Clarify when data elements found on the Transplant Information Electronic Data Interface (TIEDI) data collection instruments are required.
• Limit member’s ability to change data that have been officially submitted using the TIEDI data collection instruments.
• Revise certain policy language to make it more consistent with members’ data entry experiences.
Concept Paper: Continuous Distribution of Lungs
Sponsoring Committee: OPTN Thoracic Organ Transplantation Committee
In December 2018, the OPTN Board of Directors approved a continuous distribution system as the preferred organ distribution framework. This concept paper intends to educate/inform the transplantation community about this distribution framework, and consider:
• A move toward a framework for organ distribution might best be described as “a points based system”, rather than a disease “a classification based system”.
• Modeling that can mitigate existing disease classifications that always prioritize some candidates over others.
• The proximity of candidates to a donor through an algorithm designed to account for certain principles such as outcomes, discards, and efficiency, rather than their location inside or outside a boundary.
This is the first organ system to move to this new framework, which will ultimately result in greater efficiency and transparency for the OPTN.
Proposal: Remove DSA and Region from Pancreas Allocation Policy
Sponsoring Committee: OPTN Pancreas Transplantation Committee
This proposal will remove DSA and region from pancreas distribution policy in order to create an allocation system more aligned with the OPTN Final Rule and improve patient access to transplant.
• Replace the Donation Service Area (DSA) and regional boundaries used in the current system with a 500 nautical mile (NM) circle around the donor hospital. Pancreas and kidney-pancreas would first be allocated to all eligible candidates inside the 500 NM circle. If the organ has not been accepted by those candidates, it would then be offered to other eligible candidates.
Proposal: Remove DSA and Region from Kidney Allocation Policy
Sponsoring Committee: OPTN Kidney Transplantation Committee
This proposal will remove DSA and region from Kidney allocation policy in order to create an allocation system more aligned with the OPTN Final Rule.
• Replace DSA and region with a 500 NM circle around the donor hospital, with up to 4 proximity points inside the circle and up to 8 proximity points outside the circle. The Committee believes a fixed-distance circle of 500 NM and implements proximity point can reduce disparities in access by the greatest amounts while still accounting for operation and system efficiencies.
• The Committee also proposes increased access for pediatric candidates and prior living donors to fall just below 100% highly sensitized candidates.
Proposal: Data Collection to Evaluate the Logistical Impact of Broader Organ Distribution
Sponsoring Committee: OPTN Operations and Safety Committee
Several members of the Board, OPTN committees, and the community have asked for more information about the mode of transportation. Currently, analysis of this issue is limited due to the lack of national data on the “mode of transportation” for organs. The proposed data collection will:
• Provide additional information to the community on the logistical impacts of broader distribution, specifically as it pertains to modes of transportation.
These data will provide opportunities for transplant programs and OPOs to evaluate and discuss effective practices and potential policies.
Proposal: Expedited Placement of Livers
Sponsoring Committee: OPTN Organ Procurement Organization (OPO) Committee
Current OPTN policy does not address the expedited placement of organs. This gap creates a lack of:
• Transparency with the current system
• Guidance for OPOs and transplant hospitals on how to expedited offers
• Consistent practice across the country which impacts access to organs
The goal of this proposal is to develop an expedited placement system that allows
1. Transplant hospitals to opt-in at the candidate level, and
2. OPOs to identify potential candidates on the match run and send electronic offers to these candidates based on additional screening applied to the current liver match run.
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