Monitoring compliance with organ transplant policy in the United States

Background

To ensure that life-saving organs are distributed fairly, there are a number of 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 maintain the highest standards in patient safety 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 swift action to bring members back into compliance fosters a high level trust among transplant professionals.

The policy compliance process

The OPTN provides the most comprehensive health-care oversight program in the country. Transplantation is the only field of medicine in which every case is monitored.

• UNOS' Evaluation and Quality Department employs more than 20 staff members to ensure policies are followed. They examine every patient's listing status and every organ placement offer from a deceased donor (for more than 18,000 transplants in 2002)
• Because heart and liver policy are largely based on the medical urgency of patients, UNOS routinely conducts on-site audits of patient records of all heart and liver programs at least once every three years to verify that all policies are followed.
• When problems are detected, an on-site review is scheduled immediately. In order to protect all patients and the integrity of the transplant system, the policy compliance system utilizes a confidential review process designed to correct deviations as quickly as possible.
• Potential issues of non-compliance were detected at only five percent of the more than 330 centers reviewed since September 2000, the beginning of the current three-year audit cycle. Each issue was referred to the OPTN/UNOS MPSC for investigation. This is a fact-finding phase during which information is collected. An even smaller percentage merited action by the committee.

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

• Requiring corrective action plans
• Issuing warning letters
• Issuing letters of reprimand
• Recommending that the board of directors declare the member "Not in Good Standing"

Based on MPSC findings, members may take additional actions. Changes that have come about as a result of MPSC action include:

• Internal audits have been conducted.
• Transplant programs have been closed, both temporarily while corrections are made and permanently.
• Personnel changes have been made.
• Millions of dollars have been spent on improving medical record-keeping

Other potential implications of MPSC actions could include:

• Loss of Medicare certificate for hospital (not just 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.

Last updated: October 7, 2004