Assessment of the Quality of Finished Intravenous Infusions Using Failure Mode and Effects Analysis.

BACKGROUND

The post-dispensing process of Pharmacy Intravenous Admixture Services (PIVAS), including verification, packaging, transportation, nurse receipt and verification, and clinical administration, involves multiple high-risk steps associated with intravenous medication safety. However, existing risk management studies have primarily focused on internal preparation procedures within PIVAS, with limited attention to the external circulation processes after admixture preparation.

METHODS

Failure mode and effects analysis (FMEA) was applied to systematically identify, evaluate, and prioritize potential risks in the post-dispensing workflow of finished intravenous infusions. Risk priority numbers (RPNs) were calculated based on severity, occurrence, and detectability scores. High-risk failure modes were defined as those with an RPN ≥120 or a severity score ≥8. Targeted corrective interventions were subsequently implemented for these high-risk processes.

RESULTS

A total of six high-risk failure modes were identified across the post-dispensing workflow. Following FMEA-based interventions, the total RPN score of these six high-risk failure modes decreased from 707 to 394, representing a 44.3% reduction. In addition, the incidence of real-world risk events decreased significantly between 2020 and 2022 (p < 0.001), indicating substantial improvements in medication safety and process quality.

CONCLUSION

FMEA is an effective and practical tool for extending quality control from internal admixture preparation to the complete post-dispensing process in PIVAS. The implementation of FMEA facilitated the establishment of a closed-loop risk management framework and improved the safety of intravenous medication administration.