3304 - Sterile Compounding: Findings and Lessons Learned

Session Description: Opportunities were identified in the Fiscal Year (FY) 2020 Joint Commission Mock Survey in relation to Pharmacy Sterile Compounding. A gap analysis was performed at the sterile compounding areas of a 500+ bed hospital. The purpose of this gap analysis was to evaluate sterile compounding areas for compliance with United States Pharmacopeia (USP) 797 and The Joint Commission elements of performance. The assessment consisted of an evaluation of both environmental controls and operational elements. Upon completion of the assessment, notable gaps were identified regarding employee competency, sterile compounding technique, and environmental quality control.

External consultants were utilized to identify aforementioned gaps and develop action plans to achieve a state of compliance. Internally, a multidisciplinary team was assembled to implement and sustain any changes recommended by external parties. There were twice weekly meetings conducted, weekly rounding in sterile compounding areas, and follow up with executive leadership to support the needs of the department and provide accountability. Additionally, electronic files were created for better documentation and management of staff education. There was also an evaluation of the Certification Services Program coupled with the search for new vendors. As it was determined that there was a deficiency of well-qualified technicians performing certification services. The processes were implemented to ensure the facility practices aligned with USP 797. To track progress, a workgroup was established to review the status of each survey opportunity that was identified.

The major outcome that resulted from the improvement strategies was in November of 2021 Pharmacy Sterile Compounding had zero Joint Commission survey findings. To maintain the success of our efforts and ensure sustainability, a sterile compounding coordinator was hired. This individual serves as the designated person for all sterile compounding activities. Additionally, bi monthly compliance monitoring is conducted by infection prevention to identify trends and opportunities.