CSPT CSPT - Compounded Sterile Preparation Technician Infection Control and Microbiology Questions and Answers 5 — Questions and Answers
Question 1: Which hand hygiene technique is required immediately before donning sterile gloves for compounding Category 2 CSPs according to USP <797>?
- Washing hands with non-antimicrobial soap for 10 seconds
- Performing a surgical hand scrub or antiseptic hand rub for at least 30 seconds followed by a 30-second drying period (Correct answer)
- Using a 70% IPA wipe on the outer glove surface only
- Rinsing with sterile water without soap or sanitizer
Correct answer: Performing a surgical hand scrub or antiseptic hand rub for at least 30 seconds followed by a 30-second drying period
USP <797> requires a thorough hand-and-arm wash followed by an antiseptic hand rub before sterile gloving to minimize bioburden introduction.
Question 2: What is the role of the depyrogenation oven (dry heat oven) in sterile compounding as it relates to infection control?
- It sterilizes aqueous solutions using moist heat at 121°C
- It destroys bacterial endotoxins on glassware using temperatures of 250°C or higher (Correct answer)
- It provides a UV-irradiated environment for safe glassware storage
- It filters particulates from compounding components before use
Correct answer: It destroys bacterial endotoxins on glassware using temperatures of 250°C or higher
Dry heat depyrogenation at ≥250°C for validated time periods destroys pyrogens (endotoxins) on heat-stable items such as glass vials and syringes.
Question 3: A surface contact plate used for environmental monitoring in a cleanroom returns a count of 12 CFU on the ISO 7 anteroom floor. Which conclusion is MOST appropriate?
- The result is within acceptable limits and no action is required
- The result exceeds the USP <797> action level for ISO 7 surfaces and corrective action is required (Correct answer)
- The result is normal because floors are exempt from environmental monitoring standards
- The plate was improperly incubated and must be re-sampled immediately
Correct answer: The result exceeds the USP <797> action level for ISO 7 surfaces and corrective action is required
USP <797> sets action levels for surface monitoring; counts exceeding the threshold for the ISO class zone require investigation and corrective action.
Question 4: Which personal protective equipment (PPE) item must be sterile when used for compounding Category 2 CSPs in an ISO 5 direct compounding area?
- Shoe covers
- Sterile gloves (Correct answer)
- Fabric face mask
- Head cover (bouffant cap)
Correct answer: Sterile gloves
Sterile gloves are the only PPE component that must be sterile, as they directly contact critical sites; other garbing items are non-shed but not sterile.
Question 5: Biofilm formation in water systems used for compounding poses a significant infection control risk primarily because biofilms:
- Increase the electrical conductivity of purified water systems
- Protect embedded microorganisms from disinfection and can continuously shed viable organisms into the water supply (Correct answer)
- Are composed entirely of fungal hyphae resistant to UV treatment
- Reduce endotoxin levels by binding LPS to the biofilm matrix
Correct answer: Protect embedded microorganisms from disinfection and can continuously shed viable organisms into the water supply
Biofilms create a protective extracellular matrix that shields bacteria from disinfectants and antimicrobials, allowing continuous microbial shedding into water used for compounding.
Question 6: Which condition is the primary driver for requiring enhanced sterility testing and extended environmental monitoring under USP <797> for Category 2 CSPs?
- The preparation contains more than two active pharmaceutical ingredients
- The preparation is intended to be used beyond 12 hours for a high-risk patient population (Correct answer)
- The preparation is compounded in batches of more than 25 units
- The preparation is stored at refrigerated temperatures below 8°C
Correct answer: The preparation is intended to be used beyond 12 hours for a high-risk patient population
Category 2 CSPs intended for extended use periods in vulnerable populations require enhanced quality assurance measures including sterility testing and rigorous environmental monitoring.
Question 7: When a compounding technician experiences a needlestick injury during preparation of a hazardous CSP, what is the correct FIRST action per infection control and safety protocols?
- Complete the compounding batch before seeking treatment to avoid wasting the preparation
- Immediately remove gloves, wash the affected area thoroughly with soap and water, and report to occupational health (Correct answer)
- Apply a bandage and continue working with double-gloved hands
- Notify the pharmacy director via email at the end of the shift
Correct answer: Immediately remove gloves, wash the affected area thoroughly with soap and water, and report to occupational health
Immediate wound decontamination with soap and water followed by prompt reporting to occupational health is the first-line response to a needlestick to reduce infection risk and document exposure.
CSPT CSPT - Compounded Sterile Preparation Technician Infection Control and Microbiology Questions and Answers 5
Which hand hygiene technique is required immediately before donning sterile gloves for compounding Category 2 CSPs according to USP ?