Hospital Pharmacy - July/August 2019 - 259

788841
research-article2018

HPXXXX10.1177/0018578718788841Hospital PharmacyLoomis et al

Original Article

Development and Implementation of
a Standardized Sterile Compounding
Training Program

Hospital Pharmacy
2019, Vol. 54(4) 259-265
© The Author(s) 2018
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https://doi.org/10.1177/0018578718788841
DOI: 10.1177/0018578718788841
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Meagan Loomis1, Tracy Kosinski1,2, and Stacy Wucherer1

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 inperson 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.
Keywords
compounding, education, technicians, staff development

The United States Pharmacopeia (USP) General Chapter 797
was first introduced in 2004 to provide guidance to pharmacies on quality standards for compounding sterile preparations.1 The purpose of the chapter is to promote safety and
prevent patient harm by ensuring sterility and accuracy of all
compounded sterile preparations (CSPs). Failure of compounding personnel to follow quality standards and best
practice recommendations introduces the greatest risk of
contamination and therefore appropriate training of personnel is of high importance.1-4 With increased scrutiny and
focus on sterile compounding training with the anticipated
release of updated USP Chapter 797 and USP Chapter 800,1,5
sterile compounding facilities are required to develop and
implement robust tools, processes, and assessments to ensure
safe and adequate training of compounding personnel. A
critical component of any sterile compounding operation is
the design and implementation of a comprehensive, didactic,
and hands-on instruction and assessment of personnel
involved in compounding sterile preparations.4

Background
Published reports describe fatal and nonfatal consequences
resulting from contamination or accuracy errors during compounding of sterile preparations.6-9 Trissel and colleagues
found the contamination rate of media-fill simulations done by
pharmacists and technicians was 4.4% and 6.2%, respectively,
likely through inadvertent touch contamination.10 Flynn and
colleagues conducted an observational study of the accuracy of
intravenous (IV) admixture compounding at 5 US hospital
pharmacies which resulted in a mean overall error rate of 9%.11
From this study, a CSP was deemed to have been prepared in
1

Aurora Health Care, Milwaukee, WI, USA
Concordia University Wisconsin School of Pharmacy, Mequon, USA

2

Corresponding Author:
Meagan A. Loomis, Aurora Sheboygan Memorial Medical Center, 2629
North 7th Street, Sheboygan, WI 53083-4998, USA.
Email: meagan.loomis@aurora.org
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