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: OPTNComplaints@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.
- Reporting allegations of misconduct: Any individual or entity may file a complaint reporting an allegation of misconduct. Visit the Reporting allegations of misconduct page for more information.
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 (PDF - 170 KB) 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.
- The OPTN provided the following response (PDF - 265 KB) on October 8, 2024.
- HRSA provided the OPTN with the following response (PDF - 238 KB) to this critical comment on March 5, 2025.
- The OPTN provided a draft plan in response (PDF - 410 KB) on April 30, 2025. This plan is under review by HRSA.
- HRSA provided the OPTN with initial action items for implementation (PDF - 464 KB) on September 26, 2025.
- The OPTN and HRSA issued a safety notice (PDF) related to NRP on November 21, 2025.
HRSA provided the following critical comment letter (PDF - 92 KB) 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.
- The OPTN provided the following response (PDF - 340 KB) on September 9, 2024.
- HRSA provided the OPTN with the following response (PDF - 1 MB) to this critical comment on November 27, 2024.
- The OPTN provided the following response (PDF - 266 KB) on December 13, 2024.
- HRSA provided the OPTN with the following response (PDF - 102 KB) to this critical comment on February 21, 2025.
- The OPTN provided a draft AOOS Plan (PDF - 400 KB) to HRSA on March 31, 2025. This plan is under review by HRSA.
- HRSA provided an initial response (PDF - 155 KB) to the OPTN on May 13, 2025, directing them to develop a definition of AOOS. HRSA will provide additional comments and edits to the OPTN’s AOOS Plan.
- HRSA provided a second response (PDF - 156 KB) to the OPTN on May 30, 2025, directing them to 1) develop an AOOS website , 2) assess member compliance in the aggregate by member, and 3) promote awareness and allocation policy compliance.
- The OPTN provided an analytic definition of AOOS (PDF - 100 KB) to HRSA on June 3, 2025.
- HRSA provided a response to the OPTN, accepting their proposed AOOS (PDF - 127 KB) definition on June 6, 2025.
- HRSA provided feedback (PDF - 152 KB) on the OPTN’s AOOS Remediation Plan on July 10, 2025, and directed them to 1) Form an AOOS Workgroup composed of representatives from multiple OPTN committees, including the Patient Affairs Committee; and 2) Develop a 90-day action plan for implementing the most critical components of the Plan.
HRSA directs OPTN to develop a policy that requires OPOs to designate patient safety officers – September 18, 2025 (PDF - 286 KB)
HRSA direction to expand OPTN data files for transparency – July 11, 2025 (PDF - 202 KB)
OPO Corrective Action Plan – May 28, 2025 (PDF - 2 MB)
HRSA directs the OPTN to review and ensure the integrity of match run data – December 2, 2025 (PDF)
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