Healthcare Facility Compliance 15 items
Sterile Processing Department (SPD) AAMI ST79 Audit
Audit of the sterile processing department covering decontamination, cleaning, sterilization monitoring, and sterile storage in line with AAMI ST79.
ANSI/AAMI ST79CMS 42 CFR 482.42AORN Guidelines
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Decontamination Area
- Does workflow move unidirectionally from dirty (decontamination) to clean areas with physical separation? *
- Is the decontamination area maintained under negative pressure relative to adjacent areas? *
- Do staff wear appropriate PPE (fluid-resistant gown, gloves, face protection) in the decontamination area? *
- Are instruments kept moist and transported to decontamination promptly after use? *
Cleaning & Inspection
- Are manufacturer instructions for use (IFU) available and followed for each instrument's cleaning? *
- Are cleaning verification tests performed on washer-disinfectors and ultrasonic cleaners? *
- Are instruments inspected for cleanliness and function under magnification/lighting before assembly? *
Sterilization & Monitoring
- Is a biological indicator (BI) run in each sterilizer at least daily, and with every implant load? *
- Is a chemical indicator placed inside each package and a Class 5 or 6 integrator used per policy? *
- Is a Bowie-Dick test performed daily on dynamic-air-removal steam sterilizers? *
- Are load records documenting contents, cycle parameters, and monitoring results retained? *
- Is immediate use steam sterilization (IUSS) minimized and documented with rationale? *
Sterile Storage
- Is sterile storage located in a clean, controlled area with temperature and humidity monitoring? *
- Are sterile packages stored at least the required distance from floor, ceiling, and exterior walls? *
- Is the integrity of package seals and wraps inspected before use with an event-related shelf-life policy? *
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