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Quality Assurance Systems Questions and Answers Flashcards

6 cards from real CIS practice questions. Tap to flip, then mark Knew It or Still Learning โ€” missed cards come back until you master them.

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

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

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

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

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

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

  3. What is the purpose of documenting sterilizer cycle printouts?

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

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

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

    Answer: At least weekly and with every load containing implantable devices

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

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

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

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

  6. What role does competency testing play in sterile processing quality assurance?

    Answer: Ongoing verification that staff can correctly perform critical processes, typically annually

    Competency testing provides documented verification that all staff can correctly perform duties, conducted during orientation, annually, and when procedures change.