CIS Quality Assurance Systems Questions and Answers 2

Question 1

What is the primary purpose of biological indicators in sterilization quality assurance?

Accepted Answer

To verify that sterilization conditions were sufficient to kill highly resistant bacterial spores

Answer

Biological indicators contain highly resistant bacterial spores and serve as the gold standard for verifying sterilization lethality.

Question 2

What does a positive biological indicator result require the department to do?

Accepted Answer

Immediately recall all items from the suspect load, quarantine remaining loads, and investigate

Answer

A positive BI triggers immediate recall of affected items, quarantine of subsequent loads, root cause investigation, and retesting before returning the sterilizer to service.

Question 3

What is the purpose of documenting sterilizer cycle printouts?

Accepted Answer

To provide a permanent record of sterilization parameters for verification, traceability, and compliance

Answer

Cycle printouts provide objective records of time, temperature, and pressure parameters, enabling verification and providing traceability for regulatory purposes.

Question 4

How often should biological indicator testing be performed for standard loads?

Accepted Answer

At least weekly and with every load containing implantable devices

Answer

AAMI recommends BI testing at least weekly for routine loads and with every implant load, as implants pose the highest infection risk.

Question 5

What is a corrective action plan in sterile processing quality assurance?

Accepted Answer

A documented response identifying root cause of a quality deviation and steps to prevent recurrence

Answer

A corrective action plan formally identifies root cause, details immediate corrective steps, defines preventive measures, and assigns responsibility and timelines.

CIS - Certified Instrument Specialist Practice Test

CIS - Certified Instrument Specialist Practice Test

CIS Quality Assurance Systems Questions and Answers 2