医療施設コンプライアンス 15項目
Sterile Processing Department (SPD) AAMI ST79 Audit
このチェックリストは英語版です。
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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