Quiz for Competency Testing in Aseptic Manipulation: An Introduction

Which of the following best describes the purpose of an Ishikawa (fishbone) diagram in sterile compounding?

To document batch record deviations

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To map potential causes of contamination leading to a specific effect

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To assign staff responsibilities during compounding shifts

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To calculate the Beyond-Use Date (BUD) of sterile preparations

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Which of the following is NOT one of the six common categories of contamination causes?

Personnel (Manpower)

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Raw Materials

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Environmental (Mother Nature / Facility)

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Marketing and Sales

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Match each contamination category with the most appropriate example:

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Wearing artificial nails during compounding
Failing to disinfect the compounding surface between uses
Dirty vial crimper not cleaned properly
HEPA filter not certified within 6 months

Personnel (Manpower)

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Methods / Process

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Equipment (Machinery)

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Facility (Mother Nature)

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Why is competency testing in aseptic manipulation directly linked to contamination causes?

It serves primarily as a legal requirement for pharmacies.

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It is designed to evaluate and control for root causes of contamination.

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It focuses on maximizing efficiency in compounding workflows.

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It is primarily used to calculate costs of sterile compounding.

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Which of the following is NOT one of the four primary USP <797> aseptic competency testing activities?

Hand hygiene and gowning

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Gloved fingertip sampling

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Surface sampling

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Sterility testing of finished compounded batches

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A new technician completes hand hygiene and gowning but consistently fails gloved fingertip sampling. Based on the fishbone categories, which “root causes” are most likely contributing?

Personnel and Training

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Materials and Machinery

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Facility and Cleaning

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Process and Sales

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Competency Testing in Aseptic Manipulation

Video 1 – Introduction

Quiz for Competency Testing in Aseptic Manipulation: An Introduction

Seth DePasquale, R.Ph., BCSCP September 4, 2025

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