Комплаенс медицинских учреждений Пунктов: 15

Sterile Processing Department (SPD) AAMI ST79 Audit

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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? *

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? *

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? *

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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