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Strengthening Organ Donation and Procurement Safety

What is the difference between organ donation and organ procurement?

According to national data, more than 90% of Americans support organ donation, which is reflected in the more than 170 million Americans who have registered their intention to donate organs after their death. A national system that serves all organ donors and more than 100,000 patients in need of a transplant must be safe, fair, and effective. Without a strong record of safety, people may not want to register as donors in the future.

Donating organs requires getting that life-saving gift from the donor patient to the waitlist patients in need. There are specialized medical providers, called organ procurement organizations (OPOs), that are the link between donation and transplantation through providing organ procurement clinical care. Organ procurement is the “the surgical procedure of removing an organ, corneas or other tissue(s) from a donor.” Organ procurement organizations interact with more than 1 million patients who are evaluated to donate organs every year— in 2024, nearly 40,000 waitlisted patients received a donated organ from a deceased organ donor.

Improving Organ Procurement Safety to Strengthen Public Trust and Patient Outcomes

The Organ Procurement and Transplantation Network (OPTN) creates, implements, and monitors national policies for organ procurement organizations (OPOs), transplant hospitals, and other OPTN members. As the OPTN modernizes, HRSA and the OPTN are committed to improving procurement safety to protect potential donor patients and strengthen public trust in organ donation. Everyone who chooses to be an organ donor deserves a process that is safe, high-quality, and respectful. When the time comes, getting organ procurement right is essential—because it's not just a procedure, it's the gift of life.

What actions are being taken to address organ procurement safety?

HRSA and the OPTN are actively engaged in ensuring that organ procurement is safe for the over one million patients referred to OPOs annually. Recent actions include:

  • Strengthened reporting of allegations of misconduct: HRSA instituted a new process to report allegations of misconduct related to organ donation, organ procurement, or organ transplantation. Under the new process, as reports are received, HRSA directs oversight action, triages the complaint to the appropriate investigative body, multiple bodies, or as appropriate, to the OPTN.
  • New OPO data for improved oversight: HRSA has proposed novel federal data collection that requires OPOs to describe how, when, and where OPO providers interact with patients referred for possible organ donation by hospitals. This data collection is currently in a public comment period, and stems from an HHS Secretarial Data Directive.
  • More comprehensive data files: HRSA notified the OPTN to include patient records in data and analytic files for those patients from whom OPOs attempted to procure organs to increase transparency and inform system oversight and quality improvement.
  • New policies to safeguard innovative procurement techniques: HRSA issued a critical comment to the OPTN concerning the practice of normothermic regional perfusion (NRP), especially as it relates to the safety of patients who may donate their organs.
  • Investigating allegations and creating responsive policies for OPOs: HRSA and the OPTN conducted a special review of allegations of potential preventable harm to a patient under the care of a specific OPO. Additionally, HRSA identified a concerning pattern of risk across OPOs, often linked to staff practices, which included inconsistent assessments, coordination of care, data collection, and lack of clarity on roles and responsibilities within the care team. In response, HRSA directed the OPTN to develop a corrective action plan for the specific OPO and directed the OPTN to develop safety standards and policies for the protection of all patients who may donate organs across the nation.

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