Impact of technology-assisted versus manual sterile compounding on safety and efficiency in a Canadian community hospital.

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 The TAWS increased detection of (1) errors in the amount of drug withdrawn from vials (manual vs TAWS, 0.4% [5/1,350] vs 1.2% [18/1565]; P 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.

Use of failure modes and effects analysis to mitigate potential risks prior to implementation of an intravenous compounding technology.

PURPOSE: The purpose of this study was to identify potential failure points in a new chemotherapy preparation technology and to implement changes that prevent or minimize the consequences of those failures before they occur using the failure modes and effects analysis (FMEA) approach. METHODS: An FMEA was conducted by a team of medication safety pharmacists, oncology pharmacists and technicians, leadership from informatics, investigational drug, and medication safety services, and representatives from the technology vendor. Failure modes were scored using both Risk Priority Number (RPN) and Risk Hazard Index (RHI) scores. RESULTS: The chemotherapy preparation workflow was defined in a 41-step process with 16 failure modes. The RPN and RHI scores were identical for each failure mode because all failure modes were considered detectable. Five failure modes, all attributable to user error, were deemed to pose the highest risk. Mitigation strategies and system changes were identified for 2 failure modes, with subsequent system modifications resulting in reduced risk. CONCLUSION: The FMEA was a useful tool for risk mitigation and workflow optimization prior to implementation of an intravenous compounding technology. The process of conducting this study served as a collaborative and proactive approach to reducing the potential for medication errors upon adoption of new technology into the chemotherapy preparation process.

Comparison of IV oncology infusions compounded via robotics and gravimetrics-assisted workflow processes.

PURPOSE: A study was conducted to compare an intravenous (IV) gravimetric technology-assisted workflow (TAWF) platform to an IV robotic system. In the study we reviewed both IV technology platforms using the same gravimetric quality assurance system, which allowed for direct comparison. METHODS: All oncology preparations compounded from January 2016 through December 2018 using either system were included in our retrospective analysis. Final preparation accuracy, IV system precision, and workflow throughput (analyzed using lean process methodologies) were evaluated. RESULTS: Data analysis indicated that use of the IV gravimetric TAWF system was associated with a significantly lower percentage of accuracy errors compared to the IV robotics system (1.58% vs 2.47%, P < 0.001), with no significant difference in absolute precision (1.12 vs 1.12 P = 0.952). Lean analysis demonstrated that overall completion time (17:49 minutes vs 24:45 minutes) and compound preparation time (2:39 minutes vs 6:07 minutes) were less with the IV gravimetric TAWF vs the IV robotics system. CONCLUSION: Implementation of either an IV gravimetric TAWF system or IV robotics system will result in similar compounding accuracy and precision. Preparation time was less with use of the IV gravimetric TAWF vs the IV robotic system, but the IV robotic system required less human intervention. Both systems ensure medication safety for patients, although the IV robotic system has increased safeguards in place. Therefore, the primary driver for implementing these systems is alternative factors such as cost of systems implementation and maintenance, employee safety, and drug waste.