Quality Assurance and Documentation
This domain tests whether you can prove that reprocessing and infection prevention are working: records, audits, monitoring, recall procedures, competency, and corrective action. Items ask what a complete record contains or what to do when monitoring fails.
Core rules
- Traceability links every item to its load and sterilizer. A complete load record includes sterilizer identification, cycle number and type, physical parameters, chemical and biological indicator results, operator, date, and load contents.
- Sterile storage and release follow written criteria; a load is held until the required indicators are read and accepted.
- Recall procedure: when a BI or other monitor fails, quarantine the load, trace all items to the point of use, retrieve and reprocess, and extend the recall to the last negative BI in that sterilizer.
- Quality monitoring includes water quality testing for endoscope reprocessing, environmental cleaning verification, hand hygiene audits, and equipment maintenance records.
- Competency is documented initially and at least annually, with direct observation rather than a signature alone.
- Corrective action includes root cause analysis, a documented fix, and re-audit to confirm effectiveness.
Worked example
A steam BI turns positive on a Friday evening load. Reasoning: do not release the load. Quarantine it, notify infection prevention and the supervisor, identify every item from that load, recall back to the last documented negative BI, review packaging and loading, and document the investigation and corrective action before resuming.
Traps that cost marks
Recording parameters after the fact; missing operator or load contents; documenting a recall without retrieval evidence; annual competency completed as paperwork only; and closing a corrective action without verifying that the problem stopped.