Implementation and Evaluation of a Standard Operating Procedure for Pediatric Infliximab Infusions

BACKGROUND: The purpose of this quality improvement project was to decrease care variation regarding infliximab delivery at a pediatric inflammatory bowel disease (IBD) center. This variation was driven by differences in provider and nurse practices within 2 distinct infliximab administration units in our center. Following the development of an infusion protocol, the primary project goal was to assess improvement in the submission and completion of a protocol-specific preinfusion safety checklist. METHODS: The infusion protocol was developed based on the standard of care and expert physician opinion. A safety checklist was created to screen for active IBD symptoms and infection. We utilized continuous quality improvement to evaluate and guide the implementation of this preinfusion checklist. Checklist completion was assessed monthly over 15 months. We also conducted focus group interviews with infusion nurses and physicians to solicit qualitative protocol feedback. RESULTS: We used standard run chart rules and identified a shift in the median completion rate for both units, with no trends or astronomical points. The baseline period was defined as the 6-month post-checklist implementation. The median baseline completion rate for 1 unit was 46%, and during the subsequent 9 months, the rate increased to 81%. In the other unit, the median baseline completion rate was 91%, and during the succeeding 9 months, the rate was 95%. Focus group feedback included themes of quality, communication, safety, and efficiency and helped improve the protocol. CONCLUSIONS: Feasibility was established for a standardized protocol to improve completion of a preinfusion safety checklist in children with IBD who receive infliximab. Nurse and physician focus group feedback was important for guiding protocol refinements.