The Implementation of a Personnel Training and Assessment Program for New Standards in the US Pharmacopeia General Chapter Pharmaceutical Compounding of Sterile Preparations

Purpose: The US Pharmacopeia (USP) general Chapter sets standards for personnel training and assessment of aseptic manipulation skills. We describe the implementation of a training and assessment program to meet these standards at an academic medical center.Methods: Exempt approval by the University of Kentucky Institutional Review Board was granted. All pharmacy personnel responsible for compounding sterile preparations were included. Participants completed three computer-based learning modules (CBLs) related to mathematics skills, aseptic manipulations, and USP . Participants were given an online test, prior to viewing a CBL (pretest) and after completion of a CBL (posttest). Mean pre- and posttest scores were analyzed using a paired Student’s t-test. A proctored practical examination involved manipulations of sterile fluid culture media (media-fill challenge) to assess aseptic manipulation skills. Culture media were incubated at room temperature for 14 days and monitored for growth.Results: ...