OPTN critical comments
To promote greater transparency, HRSA has directed the OPTN to publish critical comments submitted to the OPTN as well as the OPTN responses. The critical comment process is described in 42 C.F.R. part 121, the federal regulations governing the operations of the OPTN, as noted below. Under regulation, any individual or entity may submit written critical comments to HRSA related to the way the OPTN is carrying out its duties and/or OPTN policies. Written submissions may be submitted to HRSA at: askDoT@hrsa.gov for consideration. Upon review, HRSA, on behalf of the Secretary of HHS, will consider the critical comments.
The process for critical comments is different from other feedback processes for the OPTN, including:
- Proposed OPTN Policy - The public comment process is a critical forum for national discussion on proposed organ procurement and transplant policy. For guidelines on how to submit public comments on proposed OPTN policies, please visit the Public Comment page.
- Patient Safety Concerns - OPTN Members are required to report a wide range of patient safety concerns through the OPTN Patient Safety Reporting Portal. Additionally, any individual or entity may submit information on patient safety concerns via the OPTN contractor at: patientservices@unos.org or HRSA at: askDoT@hrsa.gov.
The critical comment process is defined in the OPTN Final Rule.
"Any interested individual or entity may submit to the Secretary in writing critical comments related to the manner in which the OPTN is carrying out its duties or Secretarial policies regarding the OPTN. Any such comments shall include a statement of the basis for the comments. The Secretary will seek, as appropriate, the comments of the OPTN on the issues raised in the comments related to OPTN policies or practices. Policies or practices that are the subject of critical comments remain in effect during the Secretary's review, unless the Secretary directs otherwise based on possible risk to the health of patients or to public safety. The Secretary will consider the comments in light of the National Organ Transplant Act and the regulations under this part and may consult with the Advisory Committee on Organ Transplantation established under § 121.12."
After this review, the Secretary may:
- Reject the comments;
- Direct the OPTN to revise the policies or practices consistent with the Secretary's response to the comments; or
- Take such other action as the Secretary determines appropriate.
OPTN critical comments
HRSA has provided the following critical comments to the OPTN.
HRSA provided the following critical comment letter to the OPTN, as well as a data request to the OPTN contractor, on Sept. 27, 2024. The critical comment letter has been redacted for confidentiality.
HRSA provided the following critical comment letter to the OPTN, as well as a data request to the OPTN contractor, on Aug. 30, 2024. The critical comment letter has been redacted for confidentiality.