Healthcare Facility Compliance 12 items
Flexible Endoscope Reprocessing Compliance Audit
Multi-society compliance audit of flexible endoscope reprocessing covering precleaning, leak testing, manual cleaning, high-level disinfection, drying, storage, and traceability.
ANSI/AAMI ST91SGNA StandardsFDA Reprocessing GuidanceCMS Infection Control
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Precleaning & Transport
- Is bedside precleaning performed immediately after the procedure before biofilm can form? *
- Are soiled endoscopes transported to reprocessing in a closed, labeled, leak-proof container? *
Leak Testing & Manual Cleaning
- Is a leak test performed on each flexible endoscope before manual cleaning? *
- Is manual cleaning performed following the manufacturer's IFU, including brushing all channels and ports? *
- Is cleaning verified using a residual soil test (e.g., ATP or protein) before disinfection? *
High-Level Disinfection / Sterilization
- Is high-level disinfection or sterilization performed with an FDA-cleared agent compatible with the scope's IFU? *
- Are minimum effective concentration (MEC) test strips and solution temperature verified and logged for each cycle? *
Drying & Storage
- Are channels dried with forced instrument air (e.g., 70% alcohol flush then air) before storage? *
- Are endoscopes stored hanging vertically in a ventilated or drying cabinet that prevents recontamination? *
- Is a maximum storage interval defined before reprocessing is repeated? *
Traceability & Competency
- Is each reprocessing cycle documented with scope serial number, patient, operator, and equipment to enable traceability? *
- Are reprocessing staff trained and competency-verified at hire and at least annually? *
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