Designing a microbiological monitoring program for compounding facilities

We describe the evolution of a large multicenter health system's microbiological monitoring program to improve standardization of viable sample collection practices; results review, interpretation, and response; and record keeping. We also describe lessons learned and considerations for other organizations considering microbiological monitoring program enhancements.

Developing a robust microbiological monitoring program requires policy and procedure development; training and education of staff involved in viable sample collection, results interpretation, and investigations; establishing a robust sampling plan; reviewing trend data; reviewing systems data; and conducting investigations. Well-defined policies and procedures ensure consistent response to "out of level" (ie, violative) sampling results. Staff education ensures staff involved in microbiological monitoring are educated on adequate sampling techniques and microbial contamination sources and mitigation strategies. Thorough record keeping is essential for microbiological monitoring sampling activities and ongoing systems monitoring. The records should include results, investigations, assessments, recommendations, and records of completed follow-up actions.

Facilities management requires a comprehensive microbiological monitoring and systems monitoring plan. In health systems with multiple sites, a centralized oversight and management program may be beneficial to standardize records, response planning, and overall control of controlled compounding environments.