Abstract
Purpose
The US Pharmacopeia (USP) general Chapter <797> 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 <797>. 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
A significant increase was found in mean percentage of correct answers for pre- and posttest scores for the aseptic manipulation (85% vs 93%; P < 0.05) and USP <797> (78% vs 90%; P < 0.001) CBLs. The mean percentage of correct answers on the mathematics test was 92%. The results of the media-fill challenge revealed that 4 of the 84 (4.2%) proctored assessments were contaminated.
Conclusion
This personnel training and assessment program meets the requirements of USP <797>. The use of CBLs was effective in teaching and assessing participants on the theoretical and practical principles of aseptic manipulations. The proctored practical assessment meets USP <797> requirements for medium-risk level media-fill challenge tests.
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