CRCST Quality Assurance 2 — Questions and Answers
Question 1: Which document provides written evidence that a sterilization process has been validated to consistently produce a sterile product?
- Sterilization process challenge device record
- Biological indicator log
- Process qualification report (Correct answer)
- Chemical indicator batch record
Correct answer: Process qualification report
A process qualification report provides written evidence that the sterilization cycle consistently delivers the required lethality and produces sterile products.
Question 2: A sterility assurance level (SAL) of 10⁻⁶ means there is no more than a 1 in how many chance that a single item remains non-sterile after processing?
- 100,000
- 1,000,000 (Correct answer)
- 10,000
- 100
Correct answer: 1,000,000
SAL 10⁻⁶ means there is a 1 in 1,000,000 (one in a million) probability that a viable microorganism is present on a processed item.
Question 3: Which type of sterilization monitoring detects the presence of living spores after a sterilization cycle?
- Chemical indicator monitoring
- Biological indicator monitoring (Correct answer)
- Mechanical monitoring
- Physical parameter monitoring
Correct answer: Biological indicator monitoring
Biological indicator monitoring uses highly resistant bacterial spores (e.g., Geobacillus stearothermophilus) to directly challenge and confirm sterilization efficacy.
Question 4: In quality management, what does the term 'corrective action' refer to?
- Preventive steps taken before a problem occurs
- Steps taken to eliminate the cause of a detected nonconformity (Correct answer)
- Routine equipment maintenance procedures
- Documentation of acceptable product deviations
Correct answer: Steps taken to eliminate the cause of a detected nonconformity
Corrective action involves identifying the root cause of a detected nonconformity and implementing steps to prevent its recurrence.
Question 5: Which organization publishes the ANSI/AAMI standards most commonly referenced for sterilization quality assurance in U.S. healthcare facilities?
- CDC
- OSHA
- AAMI (Correct answer)
- The Joint Commission
Correct answer: AAMI
AAMI (Association for the Advancement of Medical Instrumentation) publishes ANSI/AAMI standards such as ST79, which govern steam sterilization and sterility assurance.
Question 6: A Class 5 integrating indicator is designed to react to all critical parameters of sterilization. How does it differ from a Class 6 emulating indicator?
- Class 5 indicators are cycle-specific; Class 6 is not
- Class 5 reacts to all critical variables; Class 6 is calibrated to specific cycle parameters (Correct answer)
- Class 5 is a biological indicator; Class 6 is chemical
- Class 5 is placed outside packages; Class 6 is placed inside
Correct answer: Class 5 reacts to all critical variables; Class 6 is calibrated to specific cycle parameters
Class 5 integrating indicators react to all critical sterilization variables across a range, while Class 6 emulating indicators are calibrated to specified values of a particular sterilization cycle.
Question 7: What is the primary purpose of conducting a Bowie-Dick test in prevacuum steam sterilizers?
- To verify the sterility of instrument sets
- To test air removal and steam penetration in the chamber (Correct answer)
- To monitor the temperature throughout the entire cycle
- To validate the cooling and drying phase
Correct answer: To test air removal and steam penetration in the chamber
The Bowie-Dick test is performed daily in prevacuum sterilizers to verify that air is adequately removed and steam can fully penetrate porous loads.
CRCST Quality Assurance 2
Which document provides written evidence that a sterilization process has been validated to consistently produce a sterile product?