Development and Implementation of a Standardized Sterile Compounding Training Program

Abstract

Purpose: The purpose of the study is to develop and implement a standardized sterile compounding training program in a multihospital system that incorporates sterile compounding best practice recommendations and ensures compliance with United States Pharmacopeia (USP) Chapters 797 and 800 standards. Methods: Baseline sterile compounding training data were collected and reviewed for sterile compounding facilities across a multihospital health system, which included 37 distinct sterile compounding operations. Current sterile compounding personnel across the system completed preintervention assessments consisting of a written, knowledge-based exam; media-fill challenge test; and an observed assessment of aseptic technique. The personnel then completed refresher training of sterile compounding concepts by completing online and in-person courses. A postintervention assessment was then conducted to evaluate training methods and topics. Based on the intervention data, a training program for new sterile compounding personnel was developed and implemented. A program to provide annual, ongoing training to existing sterile compounding personnel was also developed and implemented. Results: There was a statistically significant improvement in sterile compounding written exam scores (P < .0001) and aseptic technique observation scores (P < .0001) after implementation of refresher training. The validated training program was then included in the development and implementation of standardized training for all new and existing sterile compounding personnel across a multihospital health system. Conclusion: A standardized and consistent, sterile compounding training program was developed for all new and existing sterile compounding personnel incorporating a live, in-person training course, as well as online and hands-on training.