Monitoring compliance with organ transplant policy in the United States

To ensure that life-saving organs are distributed fairly, there are many detailed policies governing the nation’s organ transplant system. These policies are developed by a consensus of organ transplant and procurement professionals, patients and donor families.

Adherence to transplant policy is ensured through a comprehensive, systematic auditing and monitoring process. The policy compliance process is designed to maximize the safety of patients and living donors and foster public trust in the transplant network. Any deviation from policy is corrected quickly and thoroughly to protect patients and ensure that their treatment is not interrupted.

The United Network for Organ Sharing (UNOS) is the non-profit organization that operates the Organ Procurement and Transplantation Network (OPTN) under contract with the U.S. Department of Health and Human Services. In this role UNOS coordinates organ transplant policy development and compliance, maintains the nation's waiting list, matches donated organs with transplant candidates and collects data on every transplant patient and donor in the United States.

UNOS plays an important role in bringing together the transplant community to protect patients and the public trust by ensuring that organ allocation policies are followed by all transplant centers and organ procurement organizations in the United States.

Transplantation is the only field of medicine in which actions in one area of the country affect people in another. The collaborative nature of transplantation therefore necessarily extends to organ allocation policy oversight.

This oversight is accomplished through UNOS' Evaluation and Quality Department, based in Richmond, and through the OPTN/UNOS Membership Professional Standards Committee (MPSC), comprised of medical professionals from the field of transplantation who volunteer their time to ensure the integrity of the nation's transplant system. Strict monitoring and appropriate action to bring members back into compliance fosters a high level trust among transplant professionals.

The policy compliance process

The OPTN is among the most comprehensive health-care oversight programs in the country. Every organ allocation is subject to monitoring.

  • UNOS' Department of Evaluation and Quality employs more than 40 staff members to ensure policies are followed. They examine patients’ listing status and organ placement offers from deceased donors.
  • UNOS routinely conducts on-site audits of patient records of all deceased donor transplant programs at least once every three years to verify that they follow OPTN bylaws and policies and the requirements of the OPTN Final Rule. If a situation is discovered that poses an imminent threat to patient safety or public health, an on-site review is scheduled immediately.
  • In order to protect all patients and the integrity of the transplant system, the OPTN/UNOS MPSC utilizes a confidential, peer review process designed to correct deviations as quickly as possible.
  • Compliance with organ allocation policy exceeds 95 percent. In the rare number of incidents where potential issues of non-compliance are identified, an even smaller percentage merit action by the committee following a thorough review of the circumstances.

Although the main goal of the process is to protect patients by bringing members into compliance, MPSC actions may include:

  • Requiring corrective action plans and member self-assessments
  • Issuing warning letters
  • Issuing letters of reprimand
  • Recommending that the board of directors place the member on Probation or declare the member "Not in Good Standing"

Based on MPSC findings, members may take additional process improvement actions. Changes that have occurred as a result of MPSC action include the following:

  • Member institutions have conducted internal audits to verify improvements.
  • Transplant programs have closed, either temporarily while corrections are made, or permanently.
  • Transplant institutions have made personnel changes to provide additional expertise and increase patient access to transplant services.

Other potential implications of MPSC actions could include:

  • Loss of Medicare certificate for an entire hospital (not just its transplant center)
  • Requirement to notify state department of health and patients
  • Loss of professional reputation/standing for either a transplant institution or senior transplant professionals

Organ donation is dependent upon the public's trust that the nation's transplant system is operated fairly. Organ transplant policy is based on the latest medical and scientific findings and continually refined to be as equitable as possible given the severe shortage. Because patient safety is the primary goal, compliance with transplant policy is carefully monitored and stringently controlled.