STERILISING SERVICES AUDIT CRITERIA 4. MANAGEMENT 4.1 There is a copy of AS 4187: 2003, AS 4815:2006 and associated relevant standards such as: AS 1410- Pre vacuum Sterilisers AS 1079- Packaging of items (sterile) for patient care AS 1079.2 Part 2 Non-reusable papers- For wrapping of goods undergoing sterilisation in HCF AS 1079.4- Part 4- Flexible packaging systems – for single use in hospitals AS 1079.5- Part 5: Non-reusable, non-woven wrapping materialsfor goods undergoing sterilising in HCF AS 2182- Sterilisers- Steam-Benchtop AS 2192- Sterilisers-Steam-Downward displacement AS 2437- Flushers/sanitisers for bed pans & urine bottles AS 2478- Dry heat sterilisers AS 2514- Drying cabinet for medical equipment AS 2773.1- Ultrasonic cleaner-non portable AS 2773.2- Ultrasonic cleaner- benchtop AS 2774- Drying cabinet for respiratory apparatus AS 2945- Batch-type washer/disinfector AS 3789- Textiles for healthcare facilities and institutions AS 3789.2- Part 2- Theatre linen and pre-packs AS 3789.6- Part 6- fabric specifications AS 3789.8- Part 8 – recyclable barrier fabrics AS3836- Rack conveyor type washers AS4021- Non-reusable containers for the collection of sharp medical items used in health care areas AS3816- Management of clinical and related wastes AS4146- Laundry practice AS4261- Reusable containers for the collection of sharp items used in human and animal medical applications Disinfection & Sterilization Infection Control Guidelines 4.2 CHRISP Standard Operating Procedures are operationalised to meet the needs of the department Disinfection & Sterilization Infection Control Guidelines 4.3 Standard Precautions and Workplace Health and Safety protocols are applied during all stages of the cleaning, disinfection and sterilising process Disinfection & Sterilization Infection Control Guidelines & SOP RISK RATING & ACTIONS REQUIRED REVIEW DATE BY WHOM STERILISING SERVICES AUDIT CRITERIA 4. MANAGEMENT cont. 4.4 Items designed to be reprocessed are processed to a level for their intended use eg cleaning followed by sterilisation for all Semi-critical and critical items Disinfection & Sterilization Infection Control Guidelines 4.5 Manufactures instructions are provided and available to staff for the processing of reusable medical devices Disinfection & Sterilization Infection Control Guidelines and Easi-Sterilise Cleaning of Complex Instruments 4.6 Material Safety Data Sheets (MSDS) are available for all cleaning agents and chemicals which have been read and understood by staff prior to initial use SOP1.3 & Disinfection & Sterilization Infection Control Guidelines 4.7 Labelling on cleaning agents are to comply with any statutory obligations and includes the following information: name of product name and addresses of manufacturer description & purpose of the product directions for dilution and use batch number expiry date advice not to mix cleaning agent with other chemicals safety & first aid instructions specific storage requirements SOP1.3 & Chem Alert 4.8 Chemicals used within the department are registered with the Therapeutic Goods Association Disinfection & Sterilization Infection Control Guidelines 4.9 Manufacturers instructions are followed in relation to load content Disinfection & Sterilization Infection Control Guidelines 4.10 Process in place for the notification of the manager or shift supervisor for all faults or failed processes (e.g. cleaning cycles, sterilising loads) SOP RISK RATING & ACTIONS REQUIRED REVIEW DATE BY WHOM STERILISING SERVICES AUDIT CRITERIA 4. MANAGEMENT cont. 4.11 The sterilising processing facility has standard operating procedures for the following: collection of used reusable items for areas outside the sterilising processing facility eg ward, other facilities cleaning items, equipment and the environment inspection of cleaned items assembly and disassembly of items handling and processing of specialised items packaging of items loading of items for processing sterilisation cycle process for linking steriliser cycle batch information to items that have been sterilised to the patient calibration, routine monitoring and recording of sterilising equipment and cycles unloading of sterilisers storage of sterile items validation of process for sterilisers management of deviations and faults associated with processing of items distribution of sterile items recall of supplies or stored loads complaints procedure Disinfection & Sterilization Infection Control Guidelines & SOP 4.12 Staffing profile is reviewed annually and meets the needs of the unit Business Planning Framework 4.13 Clear professional and operational reporting structure within the facility is evident Disinfection & Sterilization Infection Control Guidelines 4.14 Incidents relating to the processing of reusable medical equipment are reported, risk rated and actioned within corporate and facility policy and the unit is provided with a summary of incidents regularly Disinfection & Sterilization Infection Control Guidelines RISK RATING & ACTIONS REQUIRED REVIEW DATE BY WHOM STERILISING SERVICES AUDIT CRITERIA ADEQUATE (100%) OVERALL COMMENTS FOR THIS SECTION: RISK RATING & ACTIONS REQUIRED REQUIRES IMPROVEMENT (>70% = 10/14) REVIEW DATE BY WHOM INADEQUATE (<70%)