Background
On September 18, 2025, the Health Resources and Services Administration (HRSA) directed the Organ Procurement and Transplantation Network (OPTN) to develop a new policy that requires organ procurement organizations (OPOs) to designate a Patient Safety Officer (PSO) to support patient safety and compliance with applicable OPTN obligations.
Sponsoring Committee: OPTN Board of Directors
Public Comment Period: Nov. 13 - Dec. 28, 2026
Board Approved: TBD
Effective Date: TBD
Summary of proposed policy changes
The proposed changes establish requirements related to the PSO role and associated reporting requirements, including:
- Definition of the PSO as the OPO’s central patient safety point of contact for patients, families, hospitals, third-party contractors, and other OPO personnel to address acute patient safety issues
- Inclusion of the PSO as key OPO personnel
- Identification of eligibility, qualifications, responsibilities, and organizational requirements for the PSO role
- Identification of OPOs’ responsibilities for reporting safety events to PSOs, including the types of events or points when OPO personnel and other individuals must report safety events to PSOs and the types of events PSOs are required to report
The proposed changes also include the following:
- Revision of references to the Patient Safety Contact in OPTN Policies 15.1, 15.4.A, 15.4.B, and 15.5.B with Transmissible Disease Reporting Contact to delineate this contact’s role and responsibilities from those of the PSO
- Removal of requirements for an OPO to notify the Membership and Professional Standards Committee (MPSC) if it has not filled a vacant administrative or medical director position within six months, as well as the suggestion that the MPSC could recommend that the Board notify the Health and Human Services (HHS) Secretary of the OPO’s failure to fill the position
Anticipated impact
- What it’s expected to do
- Establish centralized point of contact for addressing acute patient safety issues
- Provide continuous coverage within the OPO for real time oversight, identification, mitigation, escalation, and documentation of patient safety risks
- Offer direct clinical escalation access to the OPO Medical Director and other OPO executives
- Provide facilitation, guidance, education, and support to OPO personnel for preventing similar events in the future
- What it won’t do
- Replace existing Patient Safety Contacts established under OPTN Policy 15
Terms to know
Patient Safety Officer: An OPO’s central patient safety point of contact for patients, families, hospitals, third-party contractors, and other OPO personnel to address acute patient safety issues
Resources
- Proposed Policy (PDF - 774 KB)
- OPTN OPO Patient Safety Officer (PSO) Policy Presentation (PDF - 472 KB)
Public comments open
The public may submit comments on this policy proposal from November 13 through December 28, 2026. HRSA staff will review the comments and post them on this page within two to three business days.