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The Health Resources and Services Administration (HRSA) wishes to inform the community of opportunities for interested stakeholders to provide comments on upcoming OPTN policy and data collection changes:
1. HRSA has published two notices in the Federal Register to solicit public comments regarding new Organ Procurement and Transplantation Network (OPTN) data collection.
The first notice announces a revision of the Office of Management and Budget (OMB) package No. 0915-0157. This package collects data on potential organ donor patients and potential organ transplant recipients. This revision includes adding data collection forms for candidates listed in the OPTN electronic organ matching system to the existing OMB-approved information collection. These forms contain information the OPTN electronic organ matching system uses to match potential organ recipients with available deceased donor organs. They also allow a transplant center to add, change, or remove candidates from the OPTN waiting list after a transplant center completes the patient evaluation. These modifications aim to improve the OPTN’s organ matching, allocation processes, and OPTN member compliance with OPTN requirements.
The second notice announces a new OMB package (No.0906-xxxx– New) resulting from the HRSA directive for the OPTN to collect additional data on patients prior to waitlist registration and referrals of potential deceased donor patients to organ procurement organizations (OPOs). These data will facilitate the OPTN’s ability to address disparities in processes of care, improve access to organ transplantation, and assess overall system performance. These data will also provide a more objective source of information on procurement practices, the management of potential donor patients, and how these practices inform the supply of deceased donor organs available for transplant. These data may also help to improve monitoring of OPO performance and will facilitate quality assurance and performance improvement efforts to reduce the variation in the quality-of-care OPOs provide to potential donor patients and donor families.
These efforts are part of HRSA’s ongoing commitment to maximizing patients’ access to safe, equitable, and efficient care, and to improving the transparency and accountability of our system for all stakeholders.
2. A special OPTN public comment period to raise awareness of HRSA’s directive to separate two previously-combined classes of OPTN requirements for the OPTN and its membership.
As of July 23rd, requirements relevant to OPTN governance (OPTN Bylaws) have been separated from policies relevant to day-to-day transplant and procurement care and member operations (Management and Membership Policies). This is currently in effect on an interim basis and will be formalized at the OPTN Board of Directors meeting in December.
Separation of the two types of requirements does not affect any other OPTN policies, and specifically does not affect organ allocation or individual patient care.
Clarification of governance and oversight through this step is part of HRSA’s ongoing OPTN Modernization Initiative. This includes the previously announced separation of the OPTN Board of Directors from the legacy contractor board, as well as the selection of vendors for Board support and OPTN operations. As we help the transplant and procurement system move forward with focus on increased patient-centricity, transparency and accountability, we welcome the community’s feedback and input.
The OPTN president, Dr. Richard Formica, recently hosted a town hall to address community member questions and a recording is available HERE.
Thank you for your continued support of the OPTN and HRSA’s OPTN Modernization Initiative. For more information and updates on the OPTN Modernization, please visit www.hrsa.gov/optn-modernization.
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