Background: 50% of SOT centers are cited by CMS for inadequate review of adverse events (AE)s. AE reviews are inconsistently performed, rarely cover near misses (NM), rarely identify improvement opportunities and actionable changes are inconsistently applied. We aimed to create a system to capture all AEs/NMs, review events for improvement opportunities and use learnings for quality improvement (QI).

Methods: Using regulatory requirements as the scaffold, operational definitions, AER forums and follow up plans were standardized across programs. March 2016: the system was implemented and included 1) 3 ways to communicate an AE/NM 2) Standard AER presentation template/forum with factor analysis 3) Improvement identification process 4) Database development to trend across programs 5) Feedback with hospital safety/legal 6) Learnings used for QI metrics.

Results: Since implementation, AEs reported to transplant increased from 2 to 37/month and the number receiving an intensive review doubled. Events reviewed included patient death/graft loss, handoff/communication issues, surgical complications and infections. 107 specific opportunities were identified, categorized and trended (figure) with 40 individual action items resulting, and 9 structured QI projects were launched.

Summary: An AE system at a large pediatric SOT center was implemented to identify, review, trend and learn from AEs/NMs to improve patient safety. This system meets regulatory requirements, guides improvement strategy and changed the culture across SOT programs.

CITATION INFORMATION: Gossett J, Lake M, Bucuvalas J, Basu A, Burkhart L, Danziger-Isakov L, Lorts A. We Wish This Would Never Happen Again! Implementation of an Adverse Event Review System to Improve the Safety of Pediatric Solid Organ Transplant (SOT) Patients. Am J Transplant. 2017;17 (suppl 3).

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