ABSTRACT
PURPOSE: Interventions to improve the safety and efficiency of manual sterile compounding are needed. This study evaluated the impact of a technology-assisted workflow system (TAWS) on sterile compounding safety (checks, traceability, and error detection), and efficiency (task time). METHODS: Observations were conducted in an oncology pharmacy transitioning from a manual to a TAWS process for sterile compounding. Process maps were generated to compare manual and TAWS checks and traceability. The numbers and types of errors detected were collected, and task times were observed directly or via TAWS data logs. RESULTS: Analysis of safety outcomes showed that, depending on preparation type, 3 to 4 product checks occurred in the manual process, compared to 6 to 10 checks with TAWS use. TAWS checks (barcoding and gravimetric verification) produced better traceability (documentation). The rate of incorrect-drug errors decreased with technology-assisted compounding (from 0.4% [5 of 1,350 preparations] with the manual process to 0% [0 of 1,565 preparations] with TAWS use; P < 0.02). The TAWS increased detection of (1) errors in the amount of drug withdrawn from vials (manual vs TAWS, 0.4% [5/1,350] vs 1.2% [18/1565]; P < 0.02), and (2) errors in the amount of drug injected into the final container (manual vs TAWS, 0% [0/1,236] vs 0.9% [11/1,272]; P < 0.002). With regard to efficiency outcomes, TAWS use increased the mean mixing time (manual vs TAWS, 275 seconds vs 355 seconds; P < 0.001), had no significant impact on average visual checking time (manual vs TAWS, 21.4 seconds vs 21.6 seconds), and decreased average physical checking time (manual vs TAWS, 58.6 seconds vs 50.9 seconds; P < 0.001). CONCLUSION: In comparison to manual sterile compounding, use of the TAWS improved safety through more frequent and rigorous checks, improved traceability (via superior documentation), and enhanced error detection. Results related to efficiency were mixed.