• Document No.

  • CMHS Sterile Processing Audit - DNV-ISO

  • Client / Site

  • Conducted on

  • Prepared by

  • Location
  • Personnel

Section 1: Purchasing, Validation, Monitoring and Maintenance of Sterilizers and Associated Equipment.

  • Daily the floor of the sterilizer is checked and free of debris, chamber drain and filters are clear, recording devices are functioning correctly and the door gasket is undamaged.

  • The sterilizer chamber is cleaned routinely and the cleaning documented.

  • On Pre vacuum sterilizers there is a daily Bowie Dick test performed.

  • Every package has an external chemical indicator.

  • Every cycle has an electric printout of sterilization parameters.

  • A comprehensive and documented preventative maintenance program is established including calibration.

  • On Pre vacuum sterilizers Bowie Dick testing is done after return to service.

  • Filters on sterilizers are checked and recorded by engineering dept. every 6 months.

  • When recommissioning and performance requalification is performed the process is documented and a copy filed in the facility.

  • Staff competency is completed annually and as needed for individual training/ retraining.

  • There is a contract with a trained, competent maintenance contractor, equipment manufacturer or trained organization staff for preventative maintenance of sterilizer equipment.

  • Drying cabinets have a daily visual temperature check.

  • Drying cabinets are calibrated routinely.

  • Biological indicator incubators are checked for temperature accuracy.

Section 2: Quality Management

  • The person in charge of the processing facility has specific qualifications and experience in sterilizing technology.

  • There are documented policies and procedures for all activities involved in the processing of items

  • Records are maintained in a designated storage area for a period of time not less than defined by regulatory authorities.

  • There are written job descriptions for each category of staff in the facility.

  • There is formal orientation program.

  • Each item intended for use as a sterile item has a label with batch control identification which indicates sterilizer, date of sterilization and cycle or load number.

  • All sterilizing records are maintained and include date of cycle, sterilizer number, cycle number, exposure time temperature and pressure, identification of the loading operator, the specific contents of the load and the results of physical, chemical and biological tests used.

  • All sterilizers have automatic parameters recorders.

  • A record of all mechanical testing, repairs and preventative maintenance is kept for each sterilizer.

  • There is a policy and procedure for recall.

  • All items to be processed have external chemical indicators on them.

  • There is written information from the biological/enzymatic indicator supplier on the storage, handling, use, microbial testing and correct incubation processes.

  • Each day biological indicators are used, an additional unexposed indicator from the same batch is incubated to verify pre sterilization viability of test spores.

  • Staff wear clean, hospital laundered attire.

  • All hair is secured and covered while preparing items for sterilization.

  • Plastic aprons, fluid repellent masks, gloves and eye protection are worn when handling used / soiled items.

Section 3: Storage and Handling of Sterile Items

  • The facility has documented policies and procedures for storage, handling and issuing of sterile stock.

  • All items are stored above floor level by at least 8 inches.

  • All items are stored at least 18 inches from ceiling.

  • Storage containers, carts and cupboards are clean, dry and in good condition.

  • All surfaces including walls, floors and ceiling lights are easy to clean, non porous and smooth.

  • All batch information is on the sterilized package and not on the dust cover.

  • Sterile items intended for distribution outside the health facility are securely packed and protected against damage and contamination during transportation.

Section 4: Cleaning of the Sterile Processing Department

  • Surfaces that could be soiled by blood and body fluids are impervious and intact to allow for effective cleaning.

  • Waste is placed into appropriate containers.

  • Sharps containers are available for use if necessary and are exchanged when 3/4 full.

Section 5: Selection and Care of Instruments

  • All instruments with dull edges are sent for sharpening.

  • Any stopcocks move freely and are left in the open position for processing.

  • Fine instruments and their tips are protected in a manner that does not inhibit the sterilization process.

  • Microsurgical instruments are not placed on top of one another during sorting, cleaning or any other part of the packaging and sterilization process.

  • Insulated instruments are tested to ensure the integrity of insulations.

  • All loaner sets and instruments undergo complete routine cleaning and processing prior to sterilization. Perceived lack of time does not permit the cleaning process to be bypassed.

  • Following use all loan equipment is subjected to the full cleaning process and decontaminated prior to return.

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