Audience
- Transplant programs
- OPOs
- Histocompatibility labs (for awareness)
- The OPTN Membership and Professional Standards Committee
Implementation date
Jan. 10, 2024
At-a-glance
Effective Jan., 10, 2024, OPTN Policy 18.5: Reporting of Living Donor Events, will be updated to require members to report certain patient safety events within 72 hours of becoming aware of the event. In addition, members will now be required to report if a living donor is placed on the waiting list for any organ regardless of the organ that was donated.
What you need to do
Members should familiarize themselves with the patient safety events listed below that will be required to be reported to the OPTN within 72 hours of becoming aware of the event.
Events transplant programs will be required to report:
- A transplant of the incorrect organ into an organ recipient occurs
- A transplant of an organ into the incorrect organ recipient occurs
- A donor organ is identified as incorrect during pre-transplant processes conducted according to either OPTN Policy 5.8.A: Pre-Transplant Verification Prior to Organ Receipt or OPTN Policy 5.8.B: Pre-Transplant Verification Upon Organ Receipt
- The potential transplant recipient is identified as incorrect during pre-transplant processes conducted according to either OPTN Policy 5.8.A: Pre-Transplant Verification Prior to Organ Receipt or OPTN Policy 5.8.B: Pre-Transplant Verification Upon Organ Receipt
- An organ was delivered to the incorrect transplant hospital and resulted in non-use of the organ
- The incorrect organ was delivered to the transplant hospital and resulted in non-use of the organ
- An ABO typing error or discrepancy is caught before or during pre-transplant processes conducted according to either OPTN Policy 5.8.A: Pre-Transplant Verification Prior to Organ Receipt or Policy 5.8.B: Pre-Transplant Verification Upon Organ Receipt
Events organ procurement organizations (OPO) will be required to report:
- An ABO typing error or discrepancy is caught after the OPO’s deceased donor blood type and subtype verification process, as outlined in OPTN Policy 2.6.C: Reporting of Deceased Donor Blood Type and Subtype, and after the OPO has executed a match run
The requirement for OPOs to report when “transplant hospital procurement staff leave the operating room without allowing the host OPO to package and label deceased donor organs and tissue typing specimens as required” has been moved from OPTN Policy 16.2 Packaging and Labeling Responsibilities to 18.5: Reporting of Living Donor Events.
Additional details
These updates aim to ensure that the OPTN Membership and Professional Standards Committee (MPSC) and the Health Resources and Services Administration (HRSA) are aware of all of these serious patient safety events. These events can be investigated to determine if there is an ongoing patient safety concern, and guidance can be provided to the transplant community to limit risk to transplant candidate, recipient and living donor safety.
Please note, while this update specifies certain safety events members must report to the OPTN, the proposal does not absolve members from informing the OPTN of other types of potential non-compliance with OPTN Obligations when they become aware of the issue. This proposal, developed by the MPSC, was approved by the OPTN Board of Directors on Dec. 4, 2023.
Education and resources
Educational resources for members on these changes will be available upon release.
Patient safety instructions in the OPTN Patient Safety Reporting Portal will be updated at a later date. An additional communication will be sent when these instructions have been updated.
For additional details, please see the policy notice.
Questions?
If you have questions relating to implementation, contact UNOS Customer Service at [email protected], or call 800-978-4334 from 8 a.m. to 7 p.m. ET.
For policy-related questions, contact [email protected].
The Organ Center is available 24 hours a day at 800-292-9537.
