Quality Assurance and Documentation Flashcards
6 cards from real MDRAO practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Quality Assurance and Documentation flashcards as text
What is the purpose of a preventive maintenance (PM) program for CSSD equipment?
Answer: To systematically schedule and document regular equipment inspections, calibrations, and servicing to prevent failures and ensure consistent performance
A PM program proactively schedules regular equipment servicing, calibration, and inspection to prevent failures, maintain performance within validated parameters, and ensure regulatory compliance.
What must be documented when a sterilizer load record is completed for each sterilization cycle?
Answer: Sterilizer ID, cycle type, date and time, load contents, operator ID, physical parameter printout results, and chemical indicator results
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.
What is the purpose of an infection control risk assessment (ICRA) when planning renovations to a CSSD?
Answer: To identify and mitigate infection risks to patients and staff from dust, debris, and disruption of airflow patterns during construction
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.
How should a CSSD respond to a complaint or concern raised by a clinical user about a reprocessed instrument set?
Answer: Accept the returned set, quarantine it, document the complaint in a quality event report, investigate, and implement corrective action as needed
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.
What does 'traceability' mean in sterile instrument reprocessing, and why is it important?
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
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.
What is the role of audits and competency assessments in a CSSD quality program?
Answer: Regular audits and competency assessments verify that staff are following established procedures, identify gaps in practice, and drive continuous quality improvement
Regular audits and competency assessments are proactive quality tools that verify practice adherence, identify deviations from standards, and support continuous improvement — not just reactive responses to incidents.