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 timetemperature combination
Surface T°
Time
90° C
1min
80° C
10min
75° C
30min
70° C
100min SOP1.10 & SOP5.4
ADEQUATE
(100%)

OVERALL COMMENTS FOR THIS SECTION:


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


REQUIRES IMPROVEMENT
(>70% = 4/6)

INADEQUATE
(<70%)

STERILISING SERVICES AUDIT

CRITERIA
RISK RATING &
ACTIONS REQUIRED
REVIEW
DATE
BY WHOM
2. QUALITY ASSURANCE cont.
2.2 MINIMUM 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%)

OVERALL COMMENTS FOR THIS SECTION:




REQUIRES IMPROVEMENT
(>70% = 3/4)

INADEQUATE
(<70%)

STERILISING SERVICES AUDIT
CRITERIA

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
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
RISK RATING &
ACTIONS REQUIRED
REVIEW
DATE
BY WHOM
STERILISING SERVICES AUDIT

CRITERIA
RISK RATING &
ACTIONS REQUIRED
REVIEW
DATE
BY WHOM
2. QUALITY ASSURANCE cont.
2.3 PACKAGING & WRAPPING
ADEQUATE
(100%)

REQUIRES IMPROVEMENT
(>70% = 4/6)

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
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


INADEQUATE
(<70%)

STERILISING SERVICES AUDIT

CRITERIA
ADEQUATE
(100%)

RISK RATING &
ACTIONS REQUIRED
REQUIRES IMPROVEMENT
(>70% = 3/4)

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
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

REVIEW
DATE
BY WHOM
INADEQUATE (<70%)

STERILISING SERVICES AUDIT

CRITERIA
RISK RATING &
ACTIONS REQUIRED
REVIEW
DATE
BY WHOM
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 Endoscopy & QH 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 Endoscopy
& QH ICG Section 3
ADEQUATE
(100%)

OVERALL COMMENTS FOR THIS SECTION:





REQUIRES IMPROVEMENT
(>70% = 6/8)

INADEQUATE
(<70%)

STERILISING SERVICES AUDIT
CRITERIA

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
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
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

RISK RATING &
ACTIONS REQUIRED
REVIEW
DATE
BY WHOM
STERILISING SERVICES AUDIT
CRITERIA

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
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

RISK RATING &
ACTIONS REQUIRED
REVIEW
DATE
BY WHOM
STERILISING SERVICES AUDIT

CRITERIA
RISK RATING &
ACTIONS REQUIRED
REVIEW
DATE
BY WHOM
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%)

OVERALL COMMENTS FOR THIS SECTION:





REQUIRES IMPROVEMENT
(>70% = 4/5)

INADEQUATE
(<70%)
