Questions and answers about OPTN member compliance actions
How does the OPTN assess compliance and patient safety?
Federal law (the National Organ Transplant Act [NOTA] of 1984, as amended, 42 U.S.C. § 274 et seq.) and federal regulation (the OPTN Final Rule, 42 C.F.R. part 121) establish the OPTN’s authority, structure and guiding principles. All transplant hospitals, organ procurement organizations and independent histocompatibility laboratories in the U.S. are OPTN members and must meet specified OPTN obligations.
The OPTN monitors member institutions for key performance indicators and compliance with OPTN requirements. If it identifies potential non-compliance with OPTN obligations, or potential issues affecting patient safety and/or the quality of transplant-related services the institution provides, the OPTN will investigate further under confidential medical peer review. The member review process, and the range of actions the OPTN may take based upon a review, are detailed in Appendix L of the OPTN Management and Membership Policies (PDF - 2 MB).
Two potential actions the OPTN may take are placing a member on Probation or designating the member a “Member Not in Good Standing.” In either case, the OPTN will provide public notice of the action and a summary of the issues that led to the designation. The OPTN will also provide public notice when either designation is rescinded. More information is listed below about Probation and Member Not in Good Standing.
Latest actions
- HHS moves to decertify Florida organ procurement organization LAORA (9/18/2025)
- OPTN Board Declares Memorial Hermann Hospital, University of Texas at Houston a Member not in Good Standing (2/26/2025)
Member not in good standing
Member Not in Good Standing is a public designation by the OPTN Board of Directors that an OPTN member institution has failed to comply with OPTN obligations. It could also apply to an OPTN member institution that could pose a risk to the health and safety of transplant patients, living donors or other members of the public. This could involve a single adverse event or a pattern of unresolved behavior. Member Not in Good Standing is the strongest possible designation the OPTN may impose.
Member Not in Good Standing does not affect the ability of an OPTN member institution to continue to provide services. A transplant hospital may continue to add candidates to the OPTN waiting list and receive organ offers for deceased donor organs; a laboratory may continue to provide transplant services; and an organ procurement organization may continue to recover organs from deceased donors. The OPTN does not have the authority to close a member institution, including any individual transplant program, or remove it from the OPTN membership.
The U.S. Department of Health and Human Services has sole authority to consider or take an action involving involuntary closure of an OPTN member, revocation of OPTN membership, or potential removal of the member’s ability to receive Medicare or Medicaid funding. The OPTN Board of Directors could make a recommendation to the Secretary of Health and Human Services regarding these potential additional actions but only the Secretary has the authority to impose those additional sanctions.
A Member Not in Good Standing must provide detailed corrective action plans to the OPTN to address the issue(s) of concern. It would also undergo enhanced monitoring of its activities and outcomes, as well as and onsite visits (announced or unannounced) by OPTN contractor staff and/or peer visitors representing the transplant profession.
A Member Not in Good Standing is not allowed to vote on OPTN matters, including approval of bylaws and election of the Board of Directors. Additionally, no representative from the member institution would be allowed to participate on the OPTN Board of Directors or any of the advisory committees that develop proposals for Board consideration as national transplant policy.
OPTN contractor staff investigate potential member institution non-compliance with OPTN obligations and forward the results of the investigation to the OPTN Membership and Professional Standards Committee (MPSC) for review. Appendix L to the OPTN Management and Membership Policies (PDF - 2 MB) addresses the review process.
The MPSC reviews the investigative findings and considers many factors when deciding what action, if any, is appropriate. Factors the MPSC considers include but are not limited to whether the institution’s actions were aligned with established medical practice, whether the member institution identified and resolved the issue, and whether a likelihood of recurrence exists. Appendix L to the OPTN Management and Membership Policies (PDF - 2 MB) addresses the range of actions the OPTN may take, including those which do not involve a public summary.
If the MPSC believes Member Not in Good Standing is warranted, it will first offer the member institution the opportunity for an interview. If after the interview the MPSC continues to believe Member Not in Good Standing is appropriate, it will offer the member institution the right to a formal hearing.
If after the hearing the committee continues to believe Member Not in Good Standing is appropriate, it will present this recommendation to the OPTN Board of Directors for final action. The member institution can request an appearance with the Board before a final vote is taken on the committee’s recommendation. A member institution may waive its right to due process at any time.
All steps in the investigation and review processes are conducted under confidential medial peer review to promote the fullest cooperation and sharing of information, which will lead to a stronger safer network for patients.
After the Board of Directors declares a member institution a Member Not in Good Standing, the OPTN will release a statement notifying the public. The statement, including a summary of the events or concerns that prompted the action, may be posted on the OPTN website. Additional details beyond the public summary remain part of the OPTN’s confidential record of the institution and are not subject to public disclosure.
A transplant hospital designated as a Member Not in Good Standing is obligated to provide notification of its status to all of the transplant individuals that it serves. For example, if noncompliance at a transplant hospital’s kidney transplant program causes the designation, the transplant hospital would need to notify transplant candidates as well as recipients undergoing follow up care and monitoring at all of its organ transplant programs. Organ procurement organizations (OPOs) are obligated to notify all hospitals with whom they have a contractual relationship, and laboratories are required to notify all members with whom they have a contractual relationship.
Yes, if the member institution demonstrates needed improvements to the satisfaction of the MPSC and the Board of Directors. A Member Not in Good Standing may not regain full standing in the OPTN for at least nine months. The committee and the Board would consider the result of additional monitoring and the member’s corrective actions. A member institution might be placed on Probation (also requiring public notice and enhanced monitoring, but with fewer member restrictions) for a period of time before having their status of Good Standing restored. The review process associated with restoration of privileges is conducted under confidential medical peer review. The OPTN would give public notice for a member institution’s full status reinstatement, just as it does when it initially applies the designation of Member Not in Good Standing.
Probation
Probation is a public designation indicating that an OPTN member institution is undergoing extensive corrective action for compliance with OPTN requirements, or for a situation that, if left uncorrected, could pose a risk to the health and safety of transplant patients, living donors, or other members of the public.
Probation does not affect the ability of an OPTN member institution to continue to provide services. A transplant hospital may continue to add candidates to the OPTN waiting list and receive organ offers for deceased donor organs; a laboratory may continue to provide transplant services; and an organ procurement organization may continue to recover organs from deceased donors.
The OPTN does not have the authority to close a member institution, including any individual transplant programs, or remove it from the OPTN network. The U.S. Department of Health and Human Services (HHS) has sole authority to consider or take an action involving involuntary closure or suspension of an OPTN member institution or potential removal of the member’s ability to receive Medicare or Medicaid funding. The OPTN Board of Directors could make a recommendation to the Secretary of Health and Human Services regarding these potential additional actions, but only the Secretary has the authority to impose those additional sanctions.
A member institution on Probation must provide detailed corrective action plans to the OPTN to address the issue(s) of concern. It will also undergo enhanced monitoring of its activities and outcomes, including OPTN reviews of data and onsite visits by OPTN contractor staff and/or peer visitors representing the transplant profession.
OPTN contractor staff investigate potential member institution non-compliance with OPTN obligations and forward the results of the investigation to the MPSC for review. Appendix L to the OPTN Management and Membership Policies (PDF - 2 MB) addresses the review process.
The MPSC reviews the investigative findings and considers many factors when deciding what action, if any, is appropriate. Factors the MPSC considers include but are not limited to whether the institution’s actions were aligned with established medical practice, whether the member institution identified and resolved the issue, and whether a likelihood of recurrence exists. Appendix L to the OPTN Management and Membership Policies (PDF - 2 MB) addresses the range of actions the OPTN may take, including those which do not involve a public summary.
If the MPSC conducts an initial review and believes Probation is warranted, it will first offer the member institution the opportunity for an interview. If after the interview the MPSC continues to believe Probation is appropriate, the MPSC will offer the member institution the right to a formal hearing. If after the hearing the committee continues to believe Probation is appropriate, it will present this recommendation to the OPTN Board of Directors for final action. The member institution can request an appearance with the Board before a final vote is taken on the committee’s recommendation. A member institution may waive its right to due process at any time.
All steps in the investigative and review processes are conducted under confidential medical peer review.
After the Board of Directors places a member institution on Probation, the OPTN will release a statement notifying the public. The statement, including a summary of the events or concerns that prompted the action, may be posted on the OPTN website. Additional details beyond the public summary remain part of the OPTN’s confidential record of the institution and are not subject to public disclosure.
A transplant hospital under Probation is obligated to provide notification of its status to the transplant patients of the designated transplant program that is the cause of the probationary status. For example, if non-compliance at a kidney transplant program causes the designation, the transplant hospital would need to notify all kidney transplant candidates as well as kidney recipients undergoing follow-up care and monitoring at the hospital. Organ procurement organizations are obligated to notify all hospitals with whom they have a contractual relationship, and laboratories are required to notify all members with whom they have a contractual relationship.
A member institution under Probation may not regain full standing in the OPTN for at least nine months. After the required time has passed, the member institution can regain full standing if it demonstrates needed improvements to the satisfaction of the MPSC and the Board of Directors. The committee and the Board would consider the result of additional monitoring and the member’s corrective actions. The review process associated with restoration of privileges is conducted under confidential medical peer review. The OPTN would give public notice for a member’s full status reinstatement, just as it does when it initially applies the designation of Probation.