Canadian Entry To Practice Canadian Entry To Practice Sterile Products 2 — Questions and Answers
Question 1: Which garbing step must be performed LAST before entering an ISO Class 5 primary engineering control?
- Shoe covers
- Head cover
- Sterile gloves (Correct answer)
- Face mask
Correct answer: Sterile gloves
Sterile gloves are donned last to prevent contamination from other garbing steps before manipulating sterile products.
Question 2: What is the correct direction of cleaning swabs when disinfecting an IV bag injection port?
- Back-and-forth multiple times
- Circular motion inward
- Single unidirectional stroke, then discard swab (Correct answer)
- Random overlapping strokes
Correct answer: Single unidirectional stroke, then discard swab
A single unidirectional stroke with a fresh alcohol swab prevents recontamination of the disinfected surface.
Question 3: Which of the following is a high-alert medication requiring extra verification in sterile compounding?
- Vitamin B12 injection
- Concentrated potassium chloride (Correct answer)
- Normal saline flush
- Heparin flush 10 units/mL
Correct answer: Concentrated potassium chloride
Concentrated potassium chloride is a high-alert medication because errors in its preparation or administration can cause fatal cardiac arrhythmias.
Question 4: Total parenteral nutrition (TPN) solutions must be prepared in which environment?
- ISO Class 8 cleanroom
- ISO Class 7 buffer room
- ISO Class 5 laminar airflow workbench (Correct answer)
- General pharmacy preparation area
Correct answer: ISO Class 5 laminar airflow workbench
TPN solutions must be compounded in an ISO Class 5 laminar airflow workbench to maintain sterility of this high-risk preparation.
Question 5: What is the significance of a positive environmental monitoring result in the cleanroom?
- It confirms the room is functioning correctly
- It triggers investigation and corrective action (Correct answer)
- It extends the BUD of current preparations
- It indicates filters need replacement only
Correct answer: It triggers investigation and corrective action
A positive environmental monitoring result indicates potential contamination and requires immediate investigation, corrective action, and possible product quarantine.
Question 6: Which solution is considered isotonic and compatible with red blood cells for IV infusion?
- 0.45% sodium chloride
- 0.9% sodium chloride (Correct answer)
- 5% dextrose in water
- 10% dextrose in water
Correct answer: 0.9% sodium chloride
0.9% sodium chloride (normal saline) is isotonic with blood and does not cause hemolysis or crenation of red blood cells.
Canadian Entry To Practice Canadian Entry To Practice Sterile Products 2
Which garbing step must be performed LAST before entering an ISO Class 5 primary engineering control?