(Management Case Study) Utilization of a Dashboard for Tracking and Trending Environmental Sampling Data Across Multiple Sterile Compounding Sites

Purpose: The currently enforceable version of the United States Pharmacopeia (USP) < 797> outlines more frequent environmental monitoring in facilities preparing compounded sterile products. These practice changes have resulted in a larger quantity of data for leaders to collect and review. This case describes one method for collating and assessing this larger volume of data and developing data-driven action steps based on environmental sampling across multiple sterile compounding sites.

Methods: Monthly surface sampling and biannual air sampling was outsourced to an external vendor. Data from sampling were collected across nine compounding areas, composed of cleanroom suites and segregated compounding areas. The information was collated in a spreadsheet each month after sampling results were obtained. A dashboard was developed to display the collected samples and results, including location sampled, colony forming unit (CFU) count, and organism speciation. The dashboard was reviewed on a recurring basis with members of the departments of pharmacy, infection prevention and control, and environmental care.

Results: The dashboard contained several views to track and trend environmental monitoring data. This included review of sampling locations for all compounding areas, allowing for standardization of environmental sampling plans and adjustments in sampling locations. The dashboard also supported trending specific organisms. This information was reviewed with members of the departments of pharmacy, infection prevention and control, and environmental care and allowed for discussions about action steps related to cleaning, garbing, and facilities.

Conclusion: The development of a dashboard allowed for review and assessment of increased quantity of data to support best practice and procedures for cleanroom maintenance and environmental sampling.