CRCST Quality Assurance 2

Question 1

Which document provides written evidence that a sterilization process has been validated to consistently produce a sterile product?

Accepted Answer

Process qualification report

Answer

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?

Accepted Answer

1,000,000

Answer

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?

Accepted Answer

Biological indicator monitoring

Answer

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?

Accepted Answer

Steps taken to eliminate the cause of a detected nonconformity

Answer

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?

Accepted Answer

AAMI

Answer

AAMI (Association for the Advancement of Medical Instrumentation) publishes ANSI/AAMI standards such as ST79, which govern steam sterilization and sterility assurance.

(CRCST) Certified Registered Central Service Technician Exam Practice Test

(CRCST) Certified Registered Central Service Technician Exam Practice Test

CRCST Quality Assurance 2