RISK ASSESSMENT: Compliance with AS/NZS 4187:2003

Transcription

1 RISK ASSESSMENT: Compliance with AS/NZS 4187:2003 Sterilising Services Department AS/NZS 4187:2003 Section 2: Cleaning and Handling Used Items SCORING CRITERIA 0 = No evidence of compliance FOLLOW-UP REVIEW CRITERIA 90% compliance = 1 year 1 = Some evidence of compliance 80 90% compliance = 6 months 2 = Full evidence of compliance 70 80% compliance = 3 months Less than 70% compliance = 1 month EXPECTED OUTCOME CLEANING AND HANDLING OF USED ITEMS IF THE ITEM IS NOT CLEAN, STERILIZATION MAY BE COMPROMISED. 1. Is gross residual soil removed as close to the point of use prior to return to SSD? RATING Best Practice RATING/COMMENTS Is weekly testing of water hardness documented? (Is there good quality water?) Is there is a copy of AS/NZS 4187: Are Standard Precautions used at all stages of handling used items? (PPE is used) in the sterilising area? 3. Are written procedures for handling of used Does the cleaning area have separate equipment available in all areas? (including wards) hand washing facilities? 4. Are single use items discarded at point of use? Is only single use tubing used? 5. Are there separate procedures for the collection of used items and delivery of sterile stock? 6. Are collection containers puncture resistant, leak proof and lidded? 7. Is the container / trolley cleaned at the end of each collection round? 8. Are all instruments that have been unwrapped for use considered contaminated whether used or not and subjected to a full cleaning process? 9. Are there are written procedures for handling specialized items including loan equipment? Is there efficient ventilation with minimum of 10 air changes per hour with pressure being negative to the sterilizing area? Does the facility have smooth surfaces without crevices? (Non porous surfaces) Is there good lighting? Is the directed traffic flow from receipt to final distribution of clean products? (dirty to clean, no cross over) Do cleaning procedures document measures to minimize risk of instrument damage?

2 EXPECTED OUTCOME 10 Cleaning agents or other chemicals are not allowed to come into direct contact with personnel. 11. Abrasive cleaners (steel wool, abrasive powders and pastes) are not used. 12. Material Safety Data Sheets have been obtained and read prior to introduction of chemicals. 13. Common household detergents are not used as they have high foaming properties and are difficult to rinse free of residue. 14. Ultrasonic is degassed after each fill before instruments are processed. 15. Ultrasonic is tested daily to establish efficiency of transducers. This is documented. 16. Ultrasonic is fitted with a lid and is always operated with the lid closed. 17. The ultrasonic is emptied and cleaned at least daily or more frequently depending upon use. 18. Cleaning equipment is thermally disinfected or sterilized at the end of each session. It is stored clean and dry. 19 The functions of the washer/disinfector and the detergent dispenser are checked daily and documented. 20. Is the batch washer final rinse between 80 and 90C? 21. Do cycles, which require thermal disinfection, meet the time-temperature combinations as outlined in ? (anaesthetic / respiratory equipment) 22. Is there a process to ensure that the internal cleanliness of the washer is maintained? (ie. Descaling or routine self disinfection cycles) 23. All anaesthetic equipment is placed into a drying cabinet after cleaning. 24 Tubing and other items with lumens are placed over appropriate connectors in drying cabinets to ensure hot air dries all surfaces. 25. The drying cabinet operates between 65C and 75C RATING Best Practice COMMENTS Do suppliers of chemicals provide evidence of compliance with Appendix D Have chemical suppliers provided training for staff? Do chemical suppliers provide test kits for Ph, chlorine content, chlorine residue, presence of iron and water hardness? Are there daily checks performed to check for detergent and rinse additive residue? Is cleaning performed with a mechanical washer? Are soil tests performed to verify the cleaning efficiency of the washer/disinfector? Is the Drying cabinet is used for drying instruments and hollowware?

3 ASSESSMENT AS 4187:2003 Section 2 Cleaning and Handling of Used Items MANDATORY CRITERIA Name of Facility: Total Possible Score = Date of Assessment: Performed By: Reassessment Required (Circle Applicable) 1 Year 6 Months 3 Months 1 Month BEST PRACTICE Total Possible Score = Action Required: References for further reading: AS/NZS 4187:2003 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and the maintenance of associated environments in health care facilities. Audit Tool compiled by P. Woodburn / J.Hellsten Loddon Mallee Region Infection Control Resource Centre 2003.

4 RISK ASSESSMENT: Compliance with AS/NZS 4187:2003 Sterilising Services Department AS/NZS 4187:2003 Section3: Packaging and wrapping of items prior to sterilization SCORING CRITERIA 0 = No evidence of compliance FOLLOW-UP REVIEW CRITERIA 90% compliance = 1 year 1 = Some evidence of compliance 80 90% compliance = 6 months 2 = Full evidence of compliance 70 80% compliance = 3 months Less than 70% compliance = 1 month EXPECTED OUTCOME Provide an effective barrier against potential contamination 1. Combinations of hollowware, instruments, dressings, drapes or tubing are not incorporated into a single pack. 2. Packs have been validated to ensure efficiency of air elimination so that the sterilising agent can penetrate the load. 3. All packs are labelled prior to sterilisation. 4. Each package is labelled with batch control information. (steriliser identification number / date of sterilization / cycle or load number) 5. Instruments with hinges or ratchets remain open or unlocked during sterilisation. 6. Multi-part instruments are disassembled prior to packaging to permit effective sterilisation. 7. Hollowware sets are packaged so that all openings face the same direction. 8. The colour change of the sterilising indicator tape following exposure is distinct and uniform and markedly different to the unprocessed tape. RATING Best Practice COMMENTS/RATING Flexible packaging (peel packs) is positioned on its side for sterilisation. There is a procedure to link steriliser cycle information to items that have been sterilised, to the patient. Hollowware is placed with the opening against the paper. All trays used for packaging instrument sets are perforated to allow for penetration of sterilising agent and efficient drying. Flexible packaging is sealed by a heat sealer. The use of sterilising indicator tape for sealing bags and pouches is only used in the event of a breakdown of heat sealing equipment

5 ASSESSMENT AS 4187:2003 Section 3 Packaging and wrapping of items prior to Sterilization. Name of Facility: Total Possible Score = Date of Assessment: Performed By: Reassessment Required (Circle Applicable) 1 Year 6 Months 3 Months 1 Month The purpose of packaging and wrapping of items for sterilisation is to provide an effective barrier against sources of potential contamination in order to maintain sterility and to permit aseptic removal of the contents of the pack. BEST PRACTICE Total Possible Score = Action Required: References for further reading: AS/NZS 4187:2003 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and the maintenance of associated environments in health care facilities. Audit Tool compiled by P. Woodburn / J.Hellsten Loddon Mallee Region Infection Control Resource Centre 2003.

6 RISK ASSESSMENT: Sterilising Services Department AS/NZS 4187:2003 Section 5: Loading of Sterilisers. SCORING CRITERIA 0 = No evidence of compliance FOLLOW-UP REVIEW CRITERIA 90% compliance = 1 year 1 = Some evidence of compliance 80 90% compliance = 6 months 2 = Full evidence of compliance 70 80% compliance = 3 months Less than 70% compliance = 1 month EXPECTED OUTCOME Correct loading of sterilisers is essential to ensure sterilisation. 1. Hollowware is tilted on edge in a draining position so that only minimal resistance to removal of air, the passage of steam and condensate will be met. 2. Packs of drapes are loaded in layers vertical to allow air to be removed rapidly from packs. 3. Items are loaded within boundaries of the loading trolley so that they do not touch the chamber walls or fall off the trolley. 4. Flexible packaging materials are loaded on edge with paper to laminate or flat with the paper surface downwards. 5. Hollowware in flexible packaging is packed with the opening against the paper, not the laminate/plastic. 6. Loading trolleys are loosely loaded to capacity with only a single layer of packs placed on each tray. 7. The department has clear written procedures on the loading of sterilisers and all staff performing this task have had formal training to do so. 8. If flash sterilisation is used the items are placed onto a perforated mesh tray (or flash pack) and placed flat on the steriliser shelf to allow for easy access. RATING Best Practice COMMENTS/RATING Loads are not preheated as there is a risk of altering the physical characteristics of the packaging. Packs of hollowware and trays of instruments are not placed above textile packs. Load configuration is validated and documented and staff follow the procedure.

7 ASSESSMENT AS 4187:2003 Section 5 Loading of Sterilizers. Name of Facility: Total Possible Score = Date of Assessment: Performed By: Reassessment Required (Circle Applicable) 1 Year 6 Months 3 Months 1 Month BEST PRACTICE Total Possible Score = Action Required: References for further reading: AS/NZS 4187:2003 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and the maintenance of associated environments in health care facilities. Audit Tool compiled by P. Woodburn / J.Hellsten Loddon Mallee Region Infection Control Resource Centre 2003.

8 RISK ASSESSMENT: Compliance with AS/NZS 4187:2003 Sterilising Services Department AS/NZS 4187:2003 Section 6: Unloading of sterilisers. SCORING CRITERIA 0 = No evidence of compliance FOLLOW-UP REVIEW CRITERIA 90% compliance = 1 year 1 = Some evidence of compliance 80 90% compliance = 6 months 2 = Full evidence of compliance 70 80% compliance = 3 months Less than 70% compliance = 1 month EXPECTED OUTCOME Directly after the sterilising process, items are very vulnerable to contamination by moisture or improper handling. 1. On completion, the load is immediately removed from the sterilizer and visually inspected to ensure it is dry and that sterilising indicators have made the required colour change. 2. On removal of the load from the steriliser the operator checks printouts and signs that the parameters have been met. 3. The load is quarantined and the supervisor is notified immediately, if any deviation from the parameters is detected. 4. Steriliser trolleys containing cooling items are kept away from high activity areas. 5. Cooling items are not force cooled by fans or boosted air conditioning. 6. Cooling items are never placed onto solid surfaces as condensation may result. 7. Items that have been dropped on the floor, placed onto a dirty surface, torn, have broken seals or are wet are considered non sterile and reprocessed. RATING Best Practice RATING/COMMENTS

9 EXPECTED OUTCOME 8. There is a documented procedure for unloading of any items processed unwrapped. 9. When plastic dust covers are used the items are cool before placing into the cover. 10. Dust covers are placed onto cooled items within two hours of sterilising. 11. If dust covers are used they are labelled Dust Cover Only 12. Theatre staff wear a surgical face mask and sterile attire when transferring flash sterilised items to the point of use. 13. Procedures for unloading each type of steriliser at the facility are documented and ongoing compliance with these procedures are monitored. RATING Best Practice COMMENTS ASSESSMENT AS 4187:2003 Section 6: Unloading of Sterilisers. MANDATORY CRITERIA Name of Facility: Total Possible Score = Date of Assessment: Performed By: Reassessment Required (Circle Applicable) 1 Year 6 Months 3 Months 1 Month Action Required: References for further reading: AS/NZS 4187:2003 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and the maintenance of associated environments in health care facilities. Audit Tool compiled by P. Woodburn / J.Hellsten Loddon Mallee Region Infection Control Resource Centre 2003

10 RISK ASSESSMENT: Compliance with AS/NZS 4187:2003 Sterilising Services Department AS/NZS 4187:2003 Section 7: Purchasing, Validation, Monitoring and Maintenance of Sterilisers and Associated Equipment. SCORING CRITERIA 0 = No evidence of compliance FOLLOW-UP REVIEW CRITERIA 90% compliance = 1 year 1 = Some evidence of compliance 80 90% compliance = 6 months 2 = Full evidence of compliance 70 80% compliance = 3 months Less than 70% compliance = 1 month EXPECTED OUTCOME All stages of the sterilisation process shall be developed and documented to ensure the items can be sterilised.. 1. The cleaning process is developed, documented and monitored to ensure that the items can be sterilised. 2. The inspection process is developed, documented and monitored to ensure that the items can be sterilised. 3. The assembly process is developed, documented and monitored to ensure that the items can be sterilised. 4. The packaging process is developed, documented and monitored to ensure that the items can be sterilised. 5. The loading process is developed, documented and monitored to ensure that the items can be sterilised. 6. The sterilising cycle process is developed, documented and monitored to ensure that the items can be sterilised. 7. The calibration, routine monitoring and recording process is developed, documented and monitored to ensure that the items can be sterilised. RATING Best Practice COMMENTS/RATING There is documented policy which states that the facility releases processed items by either parametric release or non parametric release.

11 EXPECTED OUTCOME 8. The unloading process is developed, documented and monitored. 9. The storage process is developed, documented and monitored. 10. The distribution process is developed, documented and monitored. 11. The validation process is developed, documented and monitored. (see attached notes or section 7) 12. Daily the floor of the steriliser is checked and free of debris, chamber drain and filters are clear, recording devices are functioning correctly and the door gasket is undamaged. 13. The loading trolley and external surfaces of the steriliser are cleaned daily. 14. The steriliser chamber is cleaned weekly when it is cold and the cleaning is documented. 15. On Pre vacuum sterilisers there is a daily leak rate test conducted or it is done weekly if an air detector is fitted. 16. On pre vacuum sterilisers there is a daily Bowie Dick test performed. 17. Every package has an external chemical indicator. 18. Every cycle has an electric printout of sterilisation parameters. 19. A comprehensive and documented preventative maintenance program is established. 20. On Pre vacuum sterilisers Air detector function and performance testing is done at recommissioning and performance re-qualification. 21. Calibration of measuring devices is performed 3/6/12 monthly depending upon history and on IQ, OQ and PQ. 22. Filters on sterilisers are checked and this is recorded every six months. 23. When recommissioning and performance requalification is performed the process is documented and a copy filed in the processing facility. 24. Performance requalification is performed at least annually and whenever there is a change made to steriliser load configuration. RATING Best Practice COMMENTS/RATING The facility has a signature register for the staff authorising release of processed loads. Internal chemical indicators are used in all packages.

12 EXPECTED OUTCOME Validation is considered as a total process, which consists of commissioning and performance qualification 25. Responsibility for determining the necessity and extent of repeating parts of performance requalfication is assigned to the designated person who is trained in this specialty. 26. All associated equipment used to process sterile items has established, documented and validated processes in place. 27. There is a contract with a trained, competent maintenance contractor, equipment manufacturer or trained organisation staff for preventative maintenance of associated equipment. 28. Drying cabinets have a documented daily visual temperature check, check of door seals and filters and a daily surface clean. 29. Drying cabinets are on a preventative maintenance schedule at least quarterly. 30. Drying cabinets are calibrated at least annually and following repair. They also have an annual thermocouple temperature check. 31. Batch washers have calibration checks at least annually and following repair. 32. Batch washers have quarterly thermocouple temperature checks. 33. Batch washers have preventative maintenance scheduled at least quarterly. 34. There is a process which checks daily and documents jets, filters, door gaskets, external surfaces, detergent and rinse dispensers on batch washers 35. Batch washers have documented time at temperature records and cycles which require thermal disinfection are checked.(anaesthetic equip) 36. Biological indicator incubators are checked annually for temperature. 37. Rapid attest autoreaders have the florescent globes changed 6/12 monthly and records are kept. 38. Ultrasonic washers have documented daily performance testing. 39. Ultrasonic washers have annual electrical safety checks performed and documented. RATING Best Practice COMMENTS/RATING There is a documented procedure for descaling of batch washers. There is a documented daily test for chemical residue from batch washers.

13 EXPECTED OUTCOME There shall be evidence that the process has complied with all established specifications prior to release of processed items. 40. Daily the ultrasonic tanks are emptied (more frequently if necessary), external surfaces are wiped and filters and base plates are checked. 41. Heat sealers are calibrated at least annually and after repairs. 42. Heat sealers have external surfaces wiped daily, and continuous checks for correct functioning of switches gauges and lights Heat sealers have documented check of seal integrity pre and post sterilisation daily. 44. Heat sealers have maintenance at least quarterly RATING Best Practice COMMENTS/RATING Validation is considered a total process, which consists of commissioning and performance qualification. Validation is performed to evaluate the reliability of the sterilisation process. Careful attention should be given to assuring that physical parameters throughout the entire sterilization cycle (not just the sterilization stage) are comparable to those set during installation qualification and operational qualification. Commissioning consists of two activities, installation qualification and operational qualification. Installation Qualification demonstrates that the sterilizer and the area in which it is installed comply with manufacturers instructions. Operational Qualification demonstrates that the installed equipment operates within the predetermined limits when used with its operational procedures. (calibration of gauges, recording equipment and indicators, parameter monitoring, sterilizer performance tests etc) Performance Qualification shall demonstrate the attainment of the required sterilising conditions throughout the specified steriliser loads. This is achieved through verification of physical parameters (thermocouple testing) and demonstration of microbiological lethality (biological/enzymatic indicators). Each sterilisation process and each type of steriliser load and loading pattern for the process shall be specified and documented. Performance Qualification shall be performed at least annually and whenever a change is made to the sterilizer load. Parametric release can only be used when there is objective evidence that items have met all processing specifications achieved during Performance Qualification. Process records show compliance with specifications for cleaning, loading, unloading and all cycle parameters. There is evidence that any monitoring devices have recorded all stages of the cycle and these results comply with specifications. All calibration and maintenance schedules on the equipment is current. Non Parametric Release involves the use of biological/chemical indicators to determine that the sterilisation process has met all processing specifications achieved during Performance Qualification. The load is released once the indicators are interpreted as a pass result. The release documentation shall record identification of items processed, identification of the cycle or process, time of release and the name of the person authorising the release.

14 ASSESSMENT AS/NZS 4187:2003 Section 7: Purchasing, validation, monitoring and maintenance of sterilizers and associated equipment. MANDATORY Name of Facility: Total Possible Score = Date of Assessment: Performed By: Reassessment Required (Circle Applicable) 1 Year 6 Months 3 Months 1 Month All stages of the sterilisation process shall be developed and documented to ensure that the items can be sterilized. The process shall be reliably reproduced and routinely monitored to the desired probability of a sterile item. BEST PRACTICE Total Possible Score = Action Required: References for further reading: AS/NZS 4187:2003 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and the maintenance of associated environments in health care facilities. Audit Tool compiled by P. Woodburn / J.Hellsten Loddon Mallee Region Infection Control Resource Ce

15 RISK ASSESSMENT: Compliance with AS/NZS 4187:2003 Sterilising Services Department AS/NZS 4187:2003 Section 8: Quality Management SCORING CRITERIA 0 = No evidence of compliance FOLLOW-UP REVIEW CRITERIA 90% compliance = 1 year 1 = Some evidence of compliance 80 90% compliance = 6 months 2 = Full evidence of compliance 70 80% compliance = 3 months Less than 70% compliance = 1 month EXPECTED OUTCOME 1. The person in charge of the processing facility has specific qualifications and experience in sterilising technology. 2. The person in charge has the authority to implement the requirements of the standard. 3. There are documented policies and procedures for all activities involved in the processing of items. (see 8.2) 4. Records are maintained in a designated storage area for a period of time not less than that defined by regulatory authorities. ** 5. There are written job descriptions for each category of staff in the facility. 6. There is a formal orientation program as set out in There are protocols for stock control to manage stock levels. 8. Sterile supplies are handled and stored in a manner that maintains integrity and prevents contamination, from any source. RATING Best Practice COMMENTS/RATING The sterilising services line of responsibility is directly to the executive director to ensure neutrality of service. Instrument tracking records are kept for at least 7 years. There is a system of assessing staff performance after orientation and at regular intervals. Procedures are in place to link steriliser cycle batch information to the patient.

16 EXPECTED OUTCOME 9. Each item intended for use as a sterile item has a label with batch control identification, which indicates the steriliser, date of sterilisation and cycle or load number. 10. All sterilising cycle records are maintained and include date of cycle, steriliser number, cycle number, exposure time temperature and pressure, identification of the loading operator, identification of the person authorising release of the load, the specific contents of the load and the results of physical, chemical and biological tests used. 11. All sterilisers have automatic parameter recorders. 12. A record of all mechanical testing, repairs and preventative maintenance is kept for each steriliser. 13. Maintenance records are stored in a designated area with other records. 14. There is a procedure established and documented for the review of deviation reports, quality indicators or procedural problems. 15. There is policy and procedure for recall as per Monitoring of physical parameters include time, temperature and pressure. 17. The operator examines the record chart to verify that correct cycle parameters were met and sign to allow identification of who released the load. 18. The chemical indicators sterilising tape are examined after sterilisation to ensure colour change indicating items have been exposed to a sterilising process. 19. All items to be processed have external chemical indicators on them. 20. Internal chemical indicators are retrieved and interpreted by the user of the sterile item at the time of use. 21. Chemical indicators are used with each unwrapped load, during operational qualification, performance qualification, recommissioning and performance requalification. RATING Best Practice COMMENTS/RATING

17 EXPECTED OUTCOME 22 If the chemical indicator suggests inadequate processing the contents of the package is not used. 23. There is written information from the biological/enzymatic indicator supplier on the storage, handling, use, microbial testing and correct incubation processes. 24. Biological indicators are used during performance and operational qualification, for loads not previously validated, as part of recommissioning and performance requalification and weekly for Sterrad and Steris systems. 25. Each day biological indicators are used, an additional unexposed indicator from the same batch is incubated to verify pre-sterilisation viability of the test spores 26. When using a prevacuum steriliser leak rate tests are performed daily prior to the bowie dick test. (Leak rate performed weekly if an air detector is fitted.) 27. On prevacuum sterilisers a daily bowie dick test is performed. It is also done on operational qualification, calibration and recommissioning. 28. If prevacuum sterilisers have air detectors fitted they have air detector performance and function tests during operational qualification, calibration and recommissioning. 29. There are documented results of commissioning of the sterilisers, which forms part of the validation process. 30. Performance qualification has been documented to form part of the validation process. 31. The person responsible for releasing loads has full knowledge of the validated process and is satisfied that the monitoring and control of the entire process has met specifications. 32. A full validation process has been undertaken regardless of parametric release or non parametric release policy at the facility. 33. All release of loads is documented with identification of process or cycles, the time of the release and the name of the person authorising the release. RATING Best Practice COMMENTS/RATING

18 EXPECTED OUTCOME 34. All packaging is monitored following sterilisation as per Staff are immunised as per immunisation guidelines and records are kept including refusals. 36. All staff accidents are recorded and reported. RATING Best Practice COMMENTS/RATING Staff suffering from dermatitis, skin infections or infected lesions are examined by a medical practitioner. 37. Staff wear clean attire for the duration of each shift Uniforms used in the SSD should not be worn out of the Health Care Facility. 38. All hair is secured and covered whilst preparing items for sterilisation. 39. Plastic aprons, fluid repellent masks, gloves and eye protection are worn when handling used/soiled items. Nail polish and acrylic nails should not be used and nails should be kept short. Hand and wrist jewellery, including plain wedding bands, should not be worn. 40. All staff have had education on hand hygiene and follow procedures as per Staff do not wear hand creams while on duty. 42. The working environment is maintained in a hygienic state at all times 43. Attention is given to minimizing lint production to prevent recontamination of clean instruments. 44. Regular audits are conducted to evaluate procedures and processes.

19 ASSESSMENT AS 4187:2003 Section 8: Quality Management. MANDATORY Name of Facility: Total Possible Score = Date of Assessment: Performed By: Reassessment Required (Circle Applicable) 1 Year 6 Months 3 Months 1 Month BEST PRACTICE Total Possible Score = Action Required: References for further reading: AS/NZS 4187:2003 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and the maintenance of associated environments in health care facilities. Audit Tool compiled by P. Woodburn / J.Hellsten Loddon Mallee Region Infection Control Resource Centre 2003.

20 RISK ASSESSMENT: Sterilising Services Department AS/NZS 4187:2003 Section 9: Storage and handling of Sterile Stock. SCORING CRITERIA 0 = No evidence of compliance FOLLOW-UP REVIEW CRITERIA 90% compliance = 1 year 1 = Some evidence of compliance 80 90% compliance = 6 months 2 = Full evidence of compliance 70 80% compliance = 3 months Less than 70% compliance = 1 month EXPECTED OUTCOME Sterile items shall be stored and handled in a manner that maintains the integrity of packs and prevents contamination from any source. 1. The facility has documented policies and procedures for storage, handling and issuing of sterile stock 2. Critical medical items, which are stored unwrapped are subjected to the full cleaning process and sterilised before being stored. 3. Critical medical items stored unwrapped are cleaned and resterilised immediately prior to use. 4. There is a dedicated sterile storage area, which is controlled to prevent contamination. 5. The storage area is free of dust, insects and vermin. 6. All items are stored above floor level by at least 250mm. 7. All items are stored at least 440mm from ceiling fixtures. 8. All stock is protected from direct sunlight. 9. Storage containers, trolleys and cupboards are clean, dry and in good condition. 10. Commercial dispenser boxes are not topped up or reused. 11. All surfaces including walls, floors and ceiling lights are easy to clean, non porous and smooth. RATING Best Practice COMMENTS/RATING Cardboard boxes should not be used as storage containers as they cannot be cleaned and may harbour organisms.

21 EXPECTED OUTCOME Sterile items shall be stored and handled in a manner that maintains the integrity of packs and prevents contamination from any source. 12. The light fittings in the sterile store are flush with the ceiling. RATING Best Practice COMMENTS/RATING 13 Temperatures in the storage area are maintained from 18 to 22 Degrees Celsius. 14 Access to the sterile store is restricted to those who have been trained in the handling of sterile items, do not have any skin disorders and have washed and dried their hands prior to entry. Traffic area is controlled to minimize the movement of airborne contaminants. 15. Items are placed in plastic dust covers immediately they are cool. Plastic dust covers are used to protect sterilised items from contamination during prolonged storage and transport. 16. Dust covers are sealed. Plastic bags are sealed by hermetic means. (heat seal) 17. All batch information is on the sterilised package and not the dust cover. 18. Sterile items intended for distribution outside the health facility are securely packed and protected against damage and contamination during transportation. 19. All transport equipment is maintained in a clean and dry state and in good working order. Hoists, trolleys and containers used for the delivery of sterile items are dedicated to that purpose, kept clean and not used for the collection of used items, transport of food or garbage. 20. When commercially prepared items are delivered dust is wiped from the store pack prior to it being opened. Sterile items are removed from the store pack before being brought into the clean area. 21. Sterile items from external suppliers are inspected for cleanliness and damage prior to being accepted. 22. The facility has a system of stock rotation based on the date of sterilisation. There is a management system in place which ensures maintenance of adequate stock levels.

22 ASSESSMENT AS 4187:2003 Section 9: Storage and handling of sterile stock. MANDATORY Name of Facility: Total Possible Score = Date of Assessment: Performed By: Reassessment Required (Circle Applicable) 1 Year 6 Months 3 Months 1 Month BEST PRACTICE Total Possible Score = Action Required: References for further reading: AS/NZS 4187:2003 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and the maintenance of associated environments in health care facilities. Audit Tool compiled By: P. Woodburn / J.Hellsten Loddon Mallee Region Infection Control Resource Centre 2003.

23 RISK ASSESSMENT: Compliance with AS/NZS 4187:2003 Sterilising Services Department AS/NZS 4187:2003 Section11: Cleaning of the sterilising processing facility. SCORING CRITERIA 0 = No evidence of compliance FOLLOW-UP REVIEW CRITERIA 90% compliance = 1 year 1 = Some evidence of compliance 80 90% compliance = 6 months 2 = Full evidence of compliance 70 80% compliance = 3 months Less than 70% compliance = 1 month EXPECTED OUTCOME A clean environment will assist in the prevention of cross contamination. 1. There is a documented cleaning procedure and good cleaning practices to ensure the environment is clean. 2. There is a policy, which documents the areas and equipment to be cleaned, the methods and frequency and who is responsible. RATING Best Practice COMMENTS/RATING The Victorian Cleaning Standards audits (internal and external) consistently achieve greater than 85 percent pass. 3. Cleaning activities are documented and records kept. 4. Surfaces that could be soiled by blood and body fluids are impervious and intact to allow for effective cleaning. 5. Waste generated is placed into the appropriate containers. 6. Sharps containers, which comply with Australian Standards are available for use if necessary. 7. Sharps are placed into sharps containers by the users at the point of generation and not sent to SSD. 8. All waste is removed from the sterilising facility via designated disposal exits.

24 ASSESSMENT AS 4187:2003 Section 11: Cleaning of the Sterilising Processing Facility and Associated equipment. MANDATORY Name of Facility: Total Possible Score = Date of Assessment: Performed By: Reassessment Required (Circle Applicable) 1 Year 6 Months 3 Months 1 Month BEST PRACTICE Total Possible Score = Action Required: References for further reading: AS/NZS 4187:2003 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and the maintenance of associated environments in health care facilities. Cleaning Standards for Victorian Hospitals, Victorian Government Publishing, 2005 Audit Tool compiled by P. Woodburn / J.Hellsten Loddon Mallee Region Infection Control Resource Centre 2003

25 RISK ASSESSMENT: Compliance with AS/NZS 4187:2003 Sterilising Services Department AS/NZS 4187:2003 Section12: Selection and care of instruments. SCORING CRITERIA 0 = No evidence of compliance FOLLOW-UP REVIEW CRITERIA 90% compliance = 1 year 1 = Some evidence of compliance 80 90% compliance = 6 months 2 = Full evidence of compliance 70 80% compliance = 3 months Less than 70% compliance = 1 month EXPECTED OUTCOME Unnecessary tissue trauma will occur from poorly maintained instruments, and operative procedures may be unnecessarily prolonged. 1. The person in charge of the processing facility responsible for reprocessing of reusable instruments and equipment is involved in the selection process prior to the purchase of the instruments. 2. Where manufacturers have made claims or recommendations for processing of their equipment you have written details from them. 3. All staff working in the processing facility has had education and training on the correct handling of instruments. 4. Instrument repairs are only performed by a qualified tradesperson. RATING Best Practice COMMENTS/RATING Instruments are etched not engraved. 5. Colour coding tapes are not used. A system for identifying instruments is established. 6. During procedures in the operating room, the removal of soils from instruments is continuous using a sponge with sterile water. Saline is not used to rinse or wipe instruments. 7. Cannulated instruments are not allowed to become dry 8. Light and delicate instruments are kept separate from heavy instruments that could cause damage. Sorting and inspection of instruments takes place as soon as possible after use.

26 EXPECTED OUTCOME 9. Instruments which can be disassembled are taken apart prior to terminal cleaning. 10. Any instrument that appears defective is cleaned, dried and sterilised prior to being sent for repairs. 11. All instruments are free from soil, rust or lint. 12. Lumens, grooves and articulations are free of debris and stillettes are passed through lumens. 13. Joints are free of debris and move freely. 14. All instrument surfaces are smooth, well finished, unpitted and free of burrs. 15. The tips of instruments do not have hooks or snags and approximate accurately. 16. Any instruments with worn areas in jaw serrations are sent for repair. 17. Stiff or loose instruments are sent for repair. 18. All instruments with cutting edges are sharp or are sent for sharpening. 19. Any valves move freely and are left in the on position for processing. 20. Instruments are tested to ensure they are functioning prior to processing. 21. Fine instruments and their tips are protected in a manner that does not inhibit the sterilisation process. 22. Microsurgical instruments are not placed on top of one another during sorting, cleaning or any other part of the packaging and sterilisation process. 23. Insulated instruments are tested to ensure the integrity of the insulation. 24. All loan sets and instruments undergo complete routine cleaning and processing prior to sterilisation. Perceived lack of time does not permit the cleaning process to be bypassed. 25. If soil or debris is found on loan equipment on receipt this is reported to the supplier. 26. Following use all loan equipment is subjected to the full cleaning process and sterilised prior to being returned to the source. RATING Best Practice COMMENTS/RATING Cleaned items are not flash sterilised prior to further processing. When lubricant is used, the lubricant solution is discarded after each use. There is a procedure in place where theatre alerts SSD if instruments are blunt. Single use tubing is not used. Trays with lids are used for the sterilisation and storage of microsurgical instruments. Staff with responsibility for testing insulated equipment, are appropriately trained. There should be a contractual agreement in place to define responsibilities of the parties for loan instruments.

27 EXPECTED OUTCOME 27. Handpieces are cleaned and sterilised after each use. 28. Sterilisation of handpieces is done in a steam steriliser. 29. Sheaths /sleeves for instruments and equipment are not used as a substitute for cleaning, disinfection or sterilisation procedures. RATING Best Practice COMMENTS/RATING Specific instructions are documented in relation to the cleaning of instruments, which have motors. If a motor or its flexible lead is not sterilisable and is likely to be contaminated by aerosols, body fluids or debris emanating from a patient the motor is barrier wrapped and the lead protected with a plastic sleeve.

28 ASSESSMENT AS 4187:2003 Section 12: Selection and care of instruments. MANDATORY Name of Facility: Total Possible Score = Date of Assessment: Performed By: Reassessment Required (Circle Applicable) 1 Year 6 Months 3 Months 1 Month Unnecessary tissue trauma will occur from poorly maintained instruments, and operative procedures may be unnecessarily prolonged. BEST PRACTICE Total Possible Score = Action Required: References for further reading: AS/NZS 4187:2003 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and the maintenance of associated environments in health care facilities. Audit Tool compiled by P. Woodburn / J.Hellsten Loddon Mallee Region Infection Control Resource Centre 2003.

29 RISK ASSESSMENT: Compliance with AS/NZS 4187:2003 Sterilising Services Department AS/NZS 4187:2003 Section13: Use of operating room textiles SCORING CRITERIA 0 = No evidence of compliance FOLLOW-UP REVIEW CRITERIA 90% compliance = 1 year 1 = Some evidence of compliance 80 90% compliance = 6 months 2 = Full evidence of compliance 70 80% compliance = 3 months Less than 70% compliance = 1 month EXPECTED OUTCOME Textiles for patient draping and operator gowns for use in surgical procedures shall comply with AS and If the health care facility has a laundry which processes operating room textiles, the area set aside for inspection, folding and assembly of these textiles is under the direction of the person responsible for sterilising at that facility. 2. Inspection, folding and assembly of linen is performed in a dedicated area which is physically separated from others. 3. There is air conditioning and air extractors to assist in the removal of airborne lint in the environment in which linen packs are prepared. 4. Linen is discarded if patched areas exceed more than 1% of the total garment or there are visible signs of deterioration. 5. Linen is relaundered if there are visible signs of dirt, stains, grease or oil. (Also after repairs.) 6. Goods such as gauze swabs and abdominal sponges are not incorporated into linen packs. 7. Linen required to be sterile is carefully inspected over an illuminated linen inspection table to detect the presence of holes or other damage. 8. All holes are marked with tailors chalk and sent for repair. 9. There is hand washing facilities in the area. RATING Best Practice COMMENTS/RATING Dry cleaning is performed for stains which cannot be removed by laundering.

30 ASSESSMENT AS 4187:2003 Section 13: Use of operating room textiles. MANDATORY Name of Facility: Total Possible Score = Date of Assessment: Performed By: Reassessment Required (Circle Applicable) 1 Year 6 Months 3 Months 1 Month BEST PRACTICE Total Possible Score = Action Required: References for further reading: AS/NZS 4187:2003 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and the maintenance of associated environments in health care facilities. Audit Tool compiled by P. Woodburn / J.Hellsten Loddon Mallee Region Infection Control Resource Centre 2003.

31 RISK ASSESSMENT: Compliance with AS/NZS 4187:2003 Sterilising Services Department AS/NZS 4187:2003 Appendix C: Care and handling of flexible endoscopes, accessory items and associated equipment. SCORING CRITERIA 0 = No evidence of compliance FOLLOW-UP REVIEW CRITERIA 90% compliance = 1 year 1 = Some evidence of compliance 80 90% compliance = 6 months 2 = Full evidence of compliance 70 80% compliance = 3 months Less than 70% compliance = 1 month EXPECTED OUTCOME There is increased risk of tissue trauma, infection and surgical complications if a damaged or contaminated endoscope / accessory is used. 1. Flexible endoscopes and accessory items inserted into sterile body cavities are sterile at the time of use. 2. All accessory items, which penetrate the mucosal barrier are sterile at the time of use. 3. Flexible endoscopes are inspected, tested and processed according to their function and design using standard precautions. 4. Extreme care is taken when handling endoscopic equipment in order to prevent damage to lenses, fibre-optic and other delicate components. 5. There is a well ventilated, adequately sized processing area. 6. The processing area has designated clean and dirty areas. 7. There are adequate plumbing facilities and equipment to enable proper processing. 8. The ventilation system complies with workplace Australia and OH@S legislation. RATING Best Practice COMMENTS/RATING It is recognised that once an accessory item is placed into a disinfected endoscope the accessory item itself is no longer sterile.

32 EXPECTED OUTCOME 9. Only staff trained and assessed in the care, handling and processing of endoscopes do so. 10. The flexible endoscope insertion tube is wiped using clean water and an enzymatic cleaning solution immediately the procedure is finished. 11. The operator also aspirates the enzymatic cleaning solution through the suction channel. 12. All endoscopes are leak tested prior to immersion including in between each patient use. 13. The flexible endoscope and accessory items are disassembled as far as possible. 14. Taps are opened and the channels/lumens of the endoscopes and the joints of the accessories are brushed to remove any adherent debris. 15. The cleaning process continues until completely clean and flush-rinsing has removed any traces of enzyme/detergent. 16. Accessory items are placed into an ultrasonic washer in order to ensure joints and spiral coils are completely free of debris. 17. Brushes used for cleaning the channels / lumens of each endoscope are cleaned and thermally disinfected following each use. 18. After flush rinsing, flexible endoscopes and accessory items are thoroughly dried. Internal lumens are purged with air to remove residual moisture. 19. Internal and external surfaces of endoscopes are dried prior to immersion in liquid disinfectants or sterilants to prevent dilution of the agent. 20. Flexible endoscopes are processed with the buttons and valves removed. RATING Best Practice COMMENTS/RATING There is provision of single use accessory items if the lumens are too small or fine to be adequately cleaned. Cleaning brushes used for cleaning the channels/lumens of each endoscope are cleaned and sterilised after each use. Non-linting cloths are used for endoscopes and accessory items as residual lint can cause foreign body reactions. Endoscopes, which are soaked prior to use in an instrument grade disinfectant, are not considered to be sterile and thus are not used for procedures where sterile items are required. 21. Accessory items are only used if sterile. The concentration of chemical disinfectants is monitored at least daily or immediately prior to use. 22. Endoscope processing machines are routinely cleaned and maintained to prevent colonization and formation of biofilms. Care is taken to ensure that activation has been effected and the results recorded where activators are required.

33 EXPECTED OUTCOME 23.. Endoscope processing machines are routinely monitored microbiologically and if the machine is contaminated will not be used until cleaned and proven microbiologically safe. 24. Instruments intended for use in sterile cavities, in immuno-compromised patients, or for invasive procedures are rinsed with sterile or µm filtered water 25. Accessories capable of withstanding steam sterilisation are processed by this method. Chemical disinfection is not used as a convenient alternative. 26. Prior to storage the endoscopes are dried with 70% alcohol. Methylated spirits is not used for drying as it can damage components. 27. Endoscopes are stored without their valves and buttons attached. 28. Endoscopes, which are not being used immediately following processing, are stored in a well-ventilated cupboard with full length hanging space. 29. Records are kept with date of procedure, patients name and DOB, instrument used, order of patients on the list, name of the person who processed instrument, daily records of concentration of chemical disinfectant and name of person who connected the instrument to the processor. 30. Endoscopes to be sent for repair are cleaned and processed. If the endoscope is unable to go through the process due to its damage it is packaged and sealed and labelled with a hazardous warning. 31. Documentation of all policies and procedures is kept in accordance with 8.2. RATING Best Practice COMMENTS/RATING Instrument cases should not be used to routinely store endoscopes, as there is a significant risk of contamination.

34 ASSESSMENT AS 4187:2003 Appendix C: Care and Handling of flexible endoscopes, accessory items and associated equipment. MANDATORY Name of Facility: Total Possible Score = Date of Assessment: Performed By: Reassessment Required (Circle Applicable) 1 Year 6 Months 3 Months 1 Month Endoscopic accessory, items which break the mucosal barrier have been linked to disease transmission between patients. BEST PRACTICE Total Possible Score = Action Required: References for further reading: AS/NZS 4187:2003 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and the maintenance of associated environments in health care facilities. Audit Tool compiled by P. Woodburn / J.Hellsten Loddon Mallee Region Infection Control Resource Centre ntre 2003.