STERILISING SERVICES AUDIT

CRITERIA

/  / RISK RATING &
ACTIONS REQUIRED / REVIEW DATE / BY WHOM
2. QUALITY ASSURANCE
2.1 CLEANING PROCESS & EQUIPMENT
2.1.1 The water supply is potable and good quality SOP5.1 & QH ICG Section 3 / 
2.1.2 The detergents and drying agents used in instrument cleaning are compatible with the quality of clean water supply SOP1.3 & QH ICG Section 3 / 
2.1.3 Cleaning agents are used as recommended by the manufacturer for their intended purpose: acid-based agents are only used for stainless steel surfaces; enzymatic cleaners used for sensitive equipment; household detergents are not used SOP1.3 & QH ICG Section 3 / 
2.1.4 All mechanical cleaning equipment have daily checks of washer/disinfector function and detergent and rinse additives SOP1.9 to SOP1.12 & SOP5.2 / 
2.1.5 There are specific program cycles for anaesthetic equipment and instruments; and the manufactures recommendations for processing are followed:
pre rinse 40°-50°C
wash 50°-60°C
disinfect 70°-95°C
final rinse 80°C to 90° SOP1.10 & SOP%.4 / 
2.1.6 Automated washers disinfectors used to process semi-critical items intended for immediate use achieve the following time-temperature combination
Surface T° Time
90° C 1min
80° C 10min
75° C 30min
70° C 100min SOP1.10 & SOP5.4 / 
ADEQUATE
(100%)
 / REQUIRES IMPROVEMENT
(>70% = 4/6)
 / INADEQUATE
(<70%)

OVERALL COMMENTS FOR THIS SECTION:
2. QUALITY ASSURANCE cont.
2.2MINIMUM STANDARDS FOR MONITORING OF MECHANICAL CLEANING EQUIPMENT
2.2.1 Automated washer disinfector machines-
  • documented time at temperature
  • check every cycle if thermal disinfection required
  • continuous performance checks for - T° and cleanliness of items to be checked after each load
  • documented daily test for chemical residue SOP5.4
/ 
2.2.2 Ultrasonic cleaner-
  • daily performance testing – aluminium foil test or pencil load or other test methods as per manufacturers instructions SOP5.3
/ 
2.2.3 Drying cabinet-
  • daily visual temperature check SOP1.15
/ 
2.2.4 Monitoring item cleaning and daily routine cleaning, checking cleaning equipment
  • cleaning efficiency test
  • daily surface cleaning
  • checking and cleaning filters, door seals, jets, doors, door gaskets, base plates
  • detergent and rinse dispensers are clear and functioning
  • detergent and rinse additives are checked daily and replenished as necessary
  • continuous checks of switches, gauges and lights SOP5.2 & SOP5.9
/ 
ADEQUATE
(100%)
 / REQUIRES IMPROVEMENT
(>70% = 3/4)
 / INADEQUATE
(<70%)

OVERALL COMMENTS FOR THIS SECTION:
2. QUALITY ASSURANCE cont.
2.3 PACKAGING & WRAPPING
2.3.1 Each packaging and wrapping material used has been tested to establish penetration rates and drying characteristics QH ICG Section 3 / 
2.3.2 All packaging and wrapping materials selected are compatible with the item being sterilised and the sterilising process QH ICG Section 3 / 
2.3.3 Sterilising indicator tape used for packaging has the following properties:
  • is compatible with the selected wrapping material used
  • when processed changes colour which is uniform
  • distinctly different from the unprocessed tape
  • has the name of the manufacturer, batch number and date of manufacturer clearly marked on its core
  • is heat, moisture stable and permeable to sterilising agents
  • only used to seal bags or laminating pouches in the event of breakdown of heat sealing equipment as per figure 3.3 page 34 AS/NZS 4187 SOP2.5 & QH ICG Section 3
/ 
2.3.4 Heat sealer-
  • daily check for seal integrity pre and post sterilising SOP2.6
/ 
2.3.5 The rigid containers used to pack items for sterilisation allows for steam penetration and the removal of sterilising agents plus has the ability to ensure sterility QH ICG Section 3 / 
2.3.6 Rigid packs have the following properties-
  • all components are easily disassembled for cleaning, drying and storage
  • for downward displacement and benchtop steam sterilisers, the base and lids are perforated
  • containers are compatible with cleaning and sterilisation methods and equipment
  • adequate trails have been undertaken to assess use of the container system
  • onsite testing using physical and biological testing, and efficiency of drying cycle have been established during Performance Qualification
  • containers are not damaged QH ICG Section 3
/ 
2. QUALITY ASSURANCE cont.
2.3 PACKAGING & WRAPPING
ADEQUATE
(100%)
 / REQUIRES IMPROVEMENT
(>70% = 4/6)
 / INADEQUATE
(<70%)

OVERALL COMMENTS FOR THIS SECTION:
2.4 STERILISING EQUIPMENT
2.4.1 Dryness fraction of the sterilisers is 97% or above (a dryness fraction below 97% is associated with wet packs in steam sterilisation) QH ICG Section 3 / 
2.4.2 Steam is not superheated i.e. not heated beyond 2°C above the sterilising temperature QH ICG Section 3 / 
2.4.3 Penetration times have been established and added to the holding times (121°C - 15mins, 132°C – 4 mins, 134°C – 3 mins) see page 36, AS/NZS 4187 QH ICG Section 3 / 
2.4.4 On completion of the steriliser drying stage the load is immediately removed from the steriliser and the following actions occur:
  • visual inspection of load occurs noting that the load is dry, seals are intact, correct labelling of the items and the sterilising indicators have changed to the required colour
  • recording charts and print outs are checked and the sterilisers recording sheets are signed
  • loading cars with cooling items are not placed in a high activity area
  • recently processed items are not assisted to cool by means such as fans or boosted air-conditioning SOP3.4
/ 
ADEQUATE
(100%)
 / REQUIRES IMPROVEMENT
(>70% = 3/4)
 / INADEQUATE (<70%)

2. QUALITY ASSURANCE cont.
2.4 STERILISING EQUIPMENT
OVERALL COMMENTS FOR THIS SECTION:
2.5 STERILISER MONITORING & RECORDS
2.5.1 Daily routine checking and cleaning program for each type of steriliser-
  • floor of steriliser is free of debris
  • recording devices are functioning correctly
  • door gasket is undamaged
  • air filter is clean- if applicable
  • chamber drain (if present and applicable)
  • humidity reservoir, if externally fitted and applicable
  • distilled water container, if fitted- and applicable
  • lid seal and carrier undamaged
  • vaporizer system (if applicable) SOP5.9
/ 
2.5.2 Records are kept for each sterilising cycle, which includes
  • date of cycle
  • steriliser number or code
  • exposure time, temperature and pressure
  • name or identification of loading operator
  • name or identification of person authorised to release load contents form the sterilising processing facility
  • specific contents of load
  • readout results of physical, chemical or biological/enzymatic indicators used SOP3.2 & SOP3.4
/ 
2.5.3 Pre-vacuum steriliser-
  • every pack has an external chemical indicator
  • each cycle has an electronic printout
  • daily leak rate test where no air detector
  • daily Bowie Dick test
  • weekly leak rate test if air detector SOP5.5, SOP5.6, SOP5.7 & SOP5.8
/ 
2. QUALITY ASSURANCE cont.
2.5 STERILISER MONITORING & RECORDS
2.5.4 Downward displacement (Jacketed) and portable bench-top sterilisers with drying cycle-
  • every pack has an external chemical indicator
  • every cycle has an electronic printout QH ICG Section 3
/ 
2.5.5 Downward Displacement (Non-Jacketed) Flash steriliser-
  • every cycle electronic printout
  • every cycle chemical indicator – class 4,5, or 6 QH ICG Section 3
/ 
2.5.6 Peracetic acid liquid chemical sterilisation system;
  • every cycle the chemical indicator strip is checked or colour change
  • every cycle electronic load printout is checked to confirm sterilising parameters are met & every cycle attachments for the purging of the chemical steriliant have remained correctly attached to the instrument throughout the cycle
  • daily diagnostic cycle
  • weekly biological indicator EndoscopyQH ICG Section 3
/ 
2.5.7 Hydrogen Peroxide Plasma-
  • every pack external chemical indicator
  • every cycle electronic printout
  • weekly biological/enzymatic indicator SOP5.5
/ 
2.5.8 Automated endoscope reprocessor in CSD-
  • for every pack there is a need to check process recorder for critical process parameters- time, T°, chemical concentration, and if possible flow rate and pressure
  • daily check of the chemical level
  • monthly microbial monitoring of rinse water quality EndoscopyQH ICG Section 3
/ 
ADEQUATE
(100%)
 / REQUIRES IMPROVEMENT
(>70% = 6/8)
 / INADEQUATE
(<70%)

OVERALL COMMENTS FOR THIS SECTION:
2. QUALITY ASSURANCE cont.
2.6 STERILISER COMMISSIONING & VALIDATION
2.6.1 On commissioning of a steriliser the following tests and checks are performed-
  • instillation qualification
  • operational qualification
  • performance qualification of the steriliser
  • certification of performance qualification of the steriliser QH ICG Section 3
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2.6.2 Recommissioning is performed when
  • engineering work that may have altered the performance of the steriliser
  • when routine monitoring records, testing and performance prequalification indicates data outside the original parameters determined during validation QH ICG Section 3
/ 
2.6.3 Performance qualification (PQ) is performed when-
  • after commissioning
  • whenever change to product, package to be processed or changes to loading pattern
  • 3, 6 or 12 moths (depending on calibration history) QH ICG Section 3
/ 
2.6.4 Instillation qualification consists of -
  • environmental temperature and humidity is maintained within specified limits
  • there is no evidence of interference from or to other equipment during the sterilising cycle
  • accuracy of T° and/or pressure measurement are within specified limits when verified by calibration QH ICG Section 3
/ 
2.6.5 Operational qualification consists of-
  • when operated with an empty chamber, the T° and pressures recorded and indicated throughout the sterilising cycle on instrumentation permanently fitted to the steriliser, compare with specified limits determined for that process
  • air detector is functioning
  • bowie dick tests are run for air removal (pump function)
  • microbiological lethality is determined via placement of biological/enzymatic indicators in identified cold spots QH ICG Section 3
/ 
2. QUALITY ASSURANCE cont.
2.6 STERILISER COMMISSIONING & VALIDATION
2.6.6 Performance Qualification consists of-
  • achieve the minimum sterilising assurance level (SAL) 10-6
  • documentation of heat distribution
  • date and time when each of the three performance qualification cycles were run
  • identification of steriliser & cycle and process parameters selected- T°, time and pressure
  • description of loads to be processed (over page)
  • location and position of all temperature sensors and biological/enzymatic indicators
  • performance of heat penetration studies into each nominated type of steriliser load
  • for reusable oblong or square based rigid containers the placement of physical, chemical and biological/enzymatic indicators into each corner of the container
  • investigations and corrective actions taken if any cycle fails
  • name and signature of person undertaking the PQ
  • the name and signature of the person confirming the results QH ICG Section 3
/ 
2.6.7 There is documentary evidence of commissioning and recommissioning performance qualifications reports QH ICG Section 3 / 
2.6.8 Certification of validation records include-
  • copy of the original specification of the steriliser and subsequent changes
  • location and unique identification of the steriliser
  • documentation to demonstrate safety specifications compliance
  • pressure vessel certificates
  • operating instructions
  • copies of test certificates
  • verification of calibration of all instruments fitted to the steriliser
  • instillation instructions
  • approved test report of validation QH ICG Section 3
/ 
2.6.9 A system is evident for the routine calibration of the steriliser by a trained competent person QH ICG Section 3 / 
2. QUALITY ASSURANCE cont.
2.6 STERILISER COMMISSIONING & VALIDATION
ADEQUATE
(100%)
 / REQUIRES IMPROVEMENT
(>70% = 7/9)
 / INADEQUATE
(<70%)

OVERALL COMMENTS FOR THIS SECTION:
2.7 STORAGE STERILE STOCK
2.7.1 Storage areas for sterile items are –
  • dedicated for sterile storage only
  • are dust, insect and vermin free
  • have open shelving that is 250mm above floor level and 440mm from ceiling fixtures
  • protected from sunlight SOP4.2
/ 
2.7.2 Temperatures and humidity within the sterile storage areas are constant between 18°C to 22°C and 35% to 68% humidity SOP4.2 / 
2.7.3 All equipment used to transport sterile items are to be clean, dry and in good condition SOP4.5 / 
2.7.4 There is a system in place for stock rotation and checking for sterile stock which is non-conforming SOP4.4 & SOP4.6 / 
2.7.5 There is a system in place to record items released from sterile stock area which includes identification of item, cycle item has undergone, time of release and name of person authorising release SOP3.4 / 
ADEQUATE
(100%)
 / REQUIRES IMPROVEMENT
(>70% = 4/5)
 / INADEQUATE
(<70%)

OVERALL COMMENTS FOR THIS SECTION: