OPTN response to HRSA data directive available for viewing

Published on: Wednesday, December 18, 2024

Richard Formica, M.D., President of the Organ Procurement and Transplantation Network (OPTN) Board of Directors, sent the following update to OPTN members regarding the HRSA data directive.

Last month I informed you of a call for public comment, as published in the Federal Register, regarding the HRSA directive that calls for new OPTN data collection on patients prior to waitlisting registration and ventilated patients referred to an organ procurement organization. The Organ Procurement and Transplantation Network (OPTN) has now prepared and sent a response to HRSA. The text of the OPTN response is available here. In addition, the OPTN website houses a resource section that contains additional information about the data directive.

The OPTN Data Advisory Committee (DAC) led the process of gathering feedback from two workgroups, sponsored by the DAC and the Membership and Professional Standards Committee (MPSC), to assess the new data collection. The summarized feedback was presented for approval by the DAC Chair to the OPTN Executive Committee, on behalf of the OPTN Board of Directors, on December 12, 2024. We thank everyone who has graciously volunteered considerable time and expertise into developing the response.

The OPTN supports collection of new data and the goals HRSA outlined in the directive. We have offered detailed feedback on both sets of proposed data to ensure that the data fields provide meaningful insights for improvement, are clear in intent, and result in minimal increase in data burden to OPTN member institutions.

Individually or on behalf of your organization, you may be planning to submit your own commentary. Written comments must be submitted on or before January 3, 2025, via e-mail to paperwork@hrsa.gov or by mail to the HRSA Information Collection Clearance Officer, Room 14NWH04, 5600 Fishers Lane, Rockville, MD 20857. HRSA will review comments and will subsequently post another document, including any proposed revisions, for an additional 30-day public comment period.

Thank you for your attention to this important matter, which will have lasting effect in improving the fields of organ donation and transplantation.