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Member Actions

Questions and answers about OPTN member actions

Member not in good standing

Probation

What is the OPTN?

The Organ Procurement and Transplantation Network (OPTN) is a national transplant network established by federal law (the National Organ Transplant Act of 1984) and federal regulation (the OPTN Final Rule). Currently, every transplant hospital, organ procurement organization and transplant histocompatibility laboratory in the U.S. is an OPTN member. Membership means that their institution meets OPTN requirements and that it plays an active role in forming the policies that govern the transplant community.

Other OPTN members include: voluntary health organizations, such as the National Kidney Foundation; general public members, such as ethicists and donor family members; and medical professional/scientific organizations, such as the American Society of Transplantation. Key functions of the OPTN include the following:

  • Establishment of policies for the allocation of transplantable organs nationwide

  • Collection of clinical data on all transplant candidates (patients accepted by a transplant center for a transplant operation), organ donors (living and deceased), and transplant recipients (people who have received an organ transplant) in the United States

  • Establishment of key network membership requirements for transplant hospitals, organ procurement organizations and independent histocompatibility laboratories, as well as monitoring of these institutions for compliance with established standards, policies and key measures of transplant quality

United Network for Organ Sharing (UNOS), based in Richmond, Va., operates the OPTN under contract with the Health Resources and Services Administration of the U.S. Department of Health and Human Services.

The authority, structure and overall processes of the OPTN are established by federal law (the National Organ Transplant Act of 1984) and federal regulation (the OPTN Final Rule). All transplant centers, organ procurement organizations and independent histocompatibility laboratories in the U.S. are OPTN members and are subject to the OPTN’s authority.

Member not in good standing

What is “Member Not in Good Standing?”

Member Not in Good Standing is a public designation of an OPTN member institution that has failed to meet key expectations for compliance with OPTN requirements. It could also apply to a member institution with a current situation 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.

What does Member Not in Good Standing mean?

Member Not in Good Standing does not directly affect the ability of an OPTN member institution to continue to provide services. A transplant hospital or laboratory may continue to provide transplant services; an organ procurement organization may continue to recover organs from deceased donors. The OPTN does not have the authority to close a member institution or remove it from the OPTN network.

The U.S. Department of Health and Human Services 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. Under the OPTN Final Rule, the OPTN/UNOS Board of Directors could make a recommendation to the Secretary of Health and Human Services regarding these potential additional actions.

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, including OPTN reviews of data and onsite visits (announced or unannounced) by UNOS 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.

How does the OPTN reach a finding of Member Not in Good Standing?

UNOS staff investigate potential member institution non-compliance with OPTN obligations and forward the results of the investigation to the OPTN/UNOS Membership and Professional Standards Committee (MPSC) for review. Investigations often include review of relevant data and documents and reports from UNOS staff visits and/or visits by teams of transplant professionals to member institutions. As a part of the investigative process, the MPSC may also participate in informal discussions directly with the member institution.

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. Based on its findings, the MPSC may take actions that would not involve public notice, such as a issuing a notice of uncontested violation or a letter of warning or reprimand. These actions are generally issued for events or concerns that the member institution acknowledges and that, in the committee’s assessment, the institution is able to resolve on its own through corrective action.

If the MPSC believes Member Not in Good Standing is warranted, the committee will first offer the member institution the opportunity for an interview with the MPSC. If after the interview the MPSC continues to believe Member Not in Good Standing is appropriate, the MPSC will offer the member institution the right to a formal hearing with the MPSC. If after the hearing the committee continues to believe Member Not in Good Standing is appropriate, it will present this recommendation to the OPTN/UNOS 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.

What public notices are given?

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, is 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 cause 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 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.

Can a Member Not in Good Standing regain full standing in the OPTN?

Yes, if the member institution 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. 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 becoming a member in good standing. 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

What is 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. This could involve issues including a pattern of unresolved noncompliance with OPTN policies or bylaws, a sustained length of time where patient or graft survival is substantially below statistically expected outcomes, or a lengthy period of program inactivity.

What does Probation mean?

Probation does not directly affect the ability of an OPTN member institution to continue to provide services. A transplant hospital or laboratory may continue to provide transplant services; an organ procurement organization may continue to recover organs from deceased donors.

The OPTN does not have the authority to close a member institution or remove it from the OPTN network. The U.S. Department of Health and Human Services 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. Under the OPTN Final Rule, the OPTN/UNOS Board of Directors could make a recommendation to the Secretary of Health and Human Services regarding these potential additional actions.

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 UNOS staff and/or peer visitors representing the transplant profession.

How does the OPTN determine probationary status?

UNOS staff investigate potential member institution non-compliance with OPTN obligations and forward the results of the investigation to the OPTN/UNOS Membership and Professional Standards Committee (MPSC) for review. Investigations often include review of relevant data and documents and reports from UNOS staff visits and/or visits by teams of transplant professionals to member institutions. As a part of the investigative process, the MPSC may also participate in informal discussions directly with the member institution.

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. Based on its findings, the MPSC may take actions that would not involve public notice, such as a issuing a notice of uncontested violation or a letter of warning or reprimand. These actions are generally issued for events or concerns that the member institution acknowledges and that, in the committee’s assessment, the institution is able to resolve on its own through corrective action.

If the MPSC conducts an initial review and believes probation is warranted, the committee will first offer the member institution the opportunity for an interview with the MPSC. If after the interview the MPSC continues to believe probation is appropriate, the MPSC will offer the member institution the right to formal hearing. If after the hearing the committee continues to believe probation is appropriate, it will present this recommendation to the OPTN/UNOS 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.

What public notices are given?

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, is 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 cause 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.

Can a member under probation regain full standing in the OPTN?

A member institution under probation may not regain full standing in the OPTN for at least 12 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.