Intravenous iron staining: real-world incidence, preventability, and mitigation tools from a long-term quality improvement project.

Background: Iron deficiency is the leading cause of anaemia worldwide and is increasingly treated with intravenous (IV) iron therapy. Staining from IV iron therapy is a rare but significant and preventable adverse event. To mitigate patient harm, a health-service-wide quality improvement project was implemented. This study aimed to determine the real-world impact of a quality improvement project on IV iron staining incidents and preventability.

Methods: A retrospective chart audit was undertaken for all IV iron staining episodes reported in a directorate-wide clinical incident reporting database (RiskMan) between 2016 and 2022. Incidence rates of IV iron staining, preventability, and stain severity were compared pre- and post-implementation of a standardized IV iron procedure.

Results: Over 7 years, 103 IV iron stains were identified, resulting in a staining rate of 0.31 stains per 100 infusions (pre 0.27% and post 0.34%, P = .25). Implementation of the standardized IV iron procedure resulted in improvements in pharmacist review of the medication order (61.8% versus 89.7%, P < .01), use of the statewide IV iron infusion consent form (27.3% versus 76.9%, P < .01), and appropriate cannula site (14.3% versus 52.5%, P < .01). Smaller stain sizes were associated with cessation of the infusion at identification of extravasation (312 cm2 versus 35 cm2) (P = .04). Preventability was assigned to 86% of stains.

Conclusion: The incidence rate of IV iron staining in a real-world clinical setting is 0.31%. There was increased compliance with several best practice principles and 86% of stains were preventable. Early identification and intervention of potential staining incidents results in smaller iron stains for patients. Quality improvement tools developed for this project can contribute to patient outcomes internationally.