MDRAO Quality Assurance and Documentation 2

Question 1

What is the purpose of a preventive maintenance (PM) program for CSSD equipment?

Accepted Answer

To systematically schedule and document regular equipment inspections, calibrations, and servicing to prevent failures and ensure consistent performance

Answer

A PM program proactively schedules regular equipment servicing, calibration, and inspection to prevent failures, maintain performance within validated parameters, and ensure regulatory compliance.

Question 2

What must be documented when a sterilizer load record is completed for each sterilization cycle?

Accepted Answer

Sterilizer ID, cycle type, date and time, load contents, operator ID, physical parameter printout results, and chemical indicator results

Answer

A complete sterilizer load record includes: sterilizer identification, cycle type and number, date/time, load description, operator ID, physical parameter results, and chemical indicator pass/fail — providing full traceability for each cycle.

Question 3

What is the purpose of an infection control risk assessment (ICRA) when planning renovations to a CSSD?

Accepted Answer

To identify and mitigate infection risks to patients and staff from dust, debris, and disruption of airflow patterns during construction

Answer

An ICRA before CSSD renovations identifies risks from construction dust, microbial contamination from disrupted surfaces, and airflow changes — implementing controls to prevent HAIs from construction activities near clean zones.

Question 4

How should a CSSD respond to a complaint or concern raised by a clinical user about a reprocessed instrument set?

Accepted Answer

Accept the returned set, quarantine it, document the complaint in a quality event report, investigate, and implement corrective action as needed

Answer

User complaints about reprocessed instruments must be formally documented, the item quarantined and investigated, a root cause determined, and corrective action implemented — this is a quality management requirement in CSA Z314.

Question 5

What does 'traceability' mean in sterile instrument reprocessing, and why is it important?

Accepted Answer

The ability to link a specific processed item through all stages of reprocessing (patient use, cleaning, sterilization, storage, and reuse) for recall and quality investigation purposes

Answer

Traceability in CSSD means linking each instrument or set through every reprocessing step — enabling rapid identification, recall, and investigation when a sterilization failure or HAI cluster is suspected.

MDRAO - Medical Device Reprocessing Association of Ontario Practice Test

MDRAO - Medical Device Reprocessing Association of Ontario Practice Test

MDRAO Quality Assurance and Documentation 2