APSIC CSSD Audit Guideline Web
APSIC CSSD Audit Guideline Web
of Excellence Program
Audit Checklist
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APSIC GUIDELINES
Audit Checklist
Table of Contents
2
APSIC CSSD Center of Excellence Program | Audit Checklist
SECTION A:
Handling, Collection and Transport of Contaminated Instruments
Question 1:
Reusable items separated from waste at Not separated
point of use
Partial separation
Clear separation
Question 2:
Contaminated disposable items are discarded Not discarded appropriately
appropriately (including sharps)
Partial compliance
Question 3:
Gross soil is removed from instruments at point Not removed
of use if immediate transportation not possible
Removed sometimes
Question 4:
Soiled items should be kept moist Items are dry
(moist towel, enzyme foam or spray product)
Partially moist
Question 5:
Secured, dedicated containers are provided Not available
for soiled instruments
Sometimes
Question 6:
Use of puncture resistant, leak-proof containers Not available
for soiled items
Sometimes
Question 7:
Soiled items must be contained during Not evident
transportation
Attempts made
SECTION A:
Handling, Collection and Transport of Contaminated Instruments (continued)
Question 8:
Transportation of soiled instruments avoids Not evident
high (public) traffic areas
Attempts made
Question 9:
Transportation carts should be covered and Not done
should prevent items from falling over or off
Occasionally done
Question 10:
Dedicated elevators (or lifts) with direct Not available
access to decontamination area
Dedicated but not used as
planned all the time
Question 11:
Policy and procedure in place for Not available
transportation of contaminated items
between buildings, if applicable Policy exists but not followed
TOTAL:
SECTION A:
Handling, 0 / 160 points
Collection and
Transport of
Contaminated MANDATORY ITEMS MARKED:
Instruments
0 / 100 (5 items)
Yes No
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APSIC CSSD Center of Excellence Program | Audit Checklist
SECTION B:
Cleaning and Decontamination Processes
Question 1:
Written policies and procedures in place for Both not available
all cleaning and decontamination processes
One is available
Question 2:
Instrumentation is disassembled (according Not done
to manufacturer’s instructions) to expose all
surfaces for cleaning Done occasionally
Question 3:
Rigid container systems disassembled Not done
according to manufacturer instructions
(filters, valves and interior baskets) Done occasionally
Question 4:
Cleaning agents are used according to Not done
manufacturer’s instructions (dilution and
temperature, etc.) Done occasionally
Question 5:
Appropriate manual and mechanical cleaning Not done
methods are used according to manufacturer’s
instructions and IFU’s are accessible to Done occasionally
decontamination staff Done all the time
Question 6:
Appropriate personal protective equipment Not evident
(PPE) are used
Occasionally practiced
Question 7:
Appropriate brushes/cleaning implements Not done
designed for use on medical devices
are used Done occasionally
SECTION B:
Cleaning and Decontamination Processes (continued)
Question 8:
Brushes/cleaning implements are either Not evident
disposable or if reusable, are decontaminated
at least daily Decontaminated irregularly
Question 9:
Monitoring of mechanical cleaning equipment Not done
should be done upon installation and then weekly Done on installation but not
(preferably daily) and recorded monitored subsequently
Done on installation and monitored
with documentation weekly/daily
Question 10:
Appropriate manual and mechanical rinsing Staffs are unaware of these
methods are understood and are done according
to manufacturer’s instructions Some understood and complied
Question 11:
Cleaning agent (enzymatic cleaner) should No evidence of compatibility
be compatible with the medical device to
be cleaned Some are compatible
Question 12:
Chemical for disinfectants and terminal sterilisation Not done
are used according to manufacturer’s instructions
Partial compliance
Full compliance
Question 13:
Ultrasonic cleaner solution is changed at specified No frequency set
frequency or sooner if needed
Frequency set but not complied
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APSIC CSSD Center of Excellence Program | Audit Checklist
SECTION B:
Cleaning and Decontamination Processes (continued)
Question 14:
Final rinse in washer disinfector is done Final rinse with untreated water
with treated water (deionized, distilled,
or RO water) Final rinse with treated water
TOTAL:
0 / 80 (4 items)
Yes No
7
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APSIC CSSD Center of Excellence Program | Audit Checklist
SECTION C:
Instrumentation Inspection, Preparation and Packaging
Instrument inspection
Question 1:
Ensure instruments are cleaned and dried Not evident
before packaging
Partial compliance
Full compliance
Question 2:
Inspect instruments for flaws or damage. Lighted magnifying glass
Check for rust, pitting, corrosion, burrs, nicks, not available
cracks, chipping of plated surfaces. Lighted Occasional inspection with
magnifying glass available for instrument lighted magnifying glass done
inspection.
Inspection done with lighted
magnifying glass for all instruments
Question 3:
Cleaning verification by users should include Only visual inspection
visual inspection combined with other Other verification methods included
verification methods (ATP) that allow but without fixed schedule and plan
assessment of instrument surfaces
Other verification method included
and channel
with fixed schedule and plan
Question 4:
Instruments: Not evident
– Cutting edges are sharp
– Moving parts move freely, without sticking Done occasionally
– Instruments needing repair are taken out Done all the time
of service for repair or replacement
Question 5:
Follow MDMs instructions for instruments Not evident
requiring lubrication after cleaning or prior
to sterilisation Done occasionally
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APSIC CSSD Center of Excellence Program | Audit Checklist
SECTION C:
Instrumentation Inspection, Preparation and Packaging (continued)
Question 6:
Delicate/sharp instruments are protected while Not evident
being handled/assembled for sterilisation (may
use special holders, tip guards, or foam sleeves) Done occasionally
– Tip protectors should be sterilant-permeable Done all the time
Question 7:
Instruments that open (e.g. scissors, haemostats) Not evident
are held in unlocked, open positions
Done occasionally
Question 8:
Multi-part instruments are disassembled Not evident
prior to sterilisation, ensuring all parts are
easily accessed for aseptic assembly Done occasionally
Question 9:
Lumened devices: Not evident
– Remove stylets/plugs, such as catheters,
needles, tubings Done occasionally
– Moistening of the lumen may be Done all the time
recommended; consult device manufacturer
Question 10:
Complex instruments (eg, air-powered, Not evident
endoscopes, having lumens or channels)
are prepared according to written IFU from Done occasionally
device manufacturer Done all the time
Question 11:
Non-linting absorbent material may be placed Not evident
in trays to help facilitate drying. Tray liners or
other absorbent materials may be used to Done occasionally
alleviate drying problems. Done all the time
SECTION C: INSTRUMENTATION INSPECTION, PREPARATION AND PACKAGING: Preparation and assembly continues >>>
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APSIC CSSD Center of Excellence Program | Audit Checklist
SECTION C:
Instrumentation Inspection, Preparation and Packaging (continued)
Question 12:
Basins: Not evident
– Graduated basins should differ in diameter
by one inch Done occasionally
– Use non-linting absorbent material between Done all the time
nested basins
– Wrapped basin sets should not exceed 3kg (7 lbs)
Question 13:
Containerized instrument sets do not Not evident
exceed 11kg (25 lbs)
Occasionally comply
Packaging
Question 14:
Packaging materials are held for a min. of 2 hrs. Not evident
prior to use at room temp (21°F-24°F) and at a
relative humidity ranging from 30-60%. [This is One factor complied with
needed to permit steam sterilisation and prevent
Both factors complied with
superheating.]
Question 15:
Packaging materials are examined regularly Not evident
for defects (i.e. holes, warn spots, stains)
Done occasionally
Question 16:
Wrappers should be kept snug, but not wrapped Not evident
too tightly or strike-through could occur
Done occasionally
Question 17:
Paper/plastic pouches: No labeling
– Labeling is done on plastic side only
– Double peel pouch only if pouch is Labeling but not on plastic side
validated for this use Labeling on plastic side
SECTION C:
Instrumentation Inspection, Preparation and Packaging (continued)
Packaging (continued)
Question 18:
Wrapped packs: No labeling
– Write only on indicator tape or affixed labels
Labeling done inappropriately
Question 19:
Perforated, wire-mesh-bottom trays, and rigid Not evident
organizing trays are inspected prior to each use
to ensure there are no sharp edges, nicks, or Done occasionally
loose wire-mesh Done all the time
Question 20:
Tape (other than sterilisation indicator tape) Not evident
should not be used to secure packages, nor
should safety pins, ropes, paper clips, staples, Done occasionally
or other sharp objects Done all the time
Question 21:
Validation test to be done for heat sealer Not done
at set frequency
Frequency set but not followed
TOTAL:
SECTION C: 0 / 260 points
Instrumentation
Inspection,
Preparation MANDATORY ITEMS MARKED:
and Packaging
0 / 100 (5 items)
Yes No
11
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APSIC CSSD Center of Excellence Program | Audit Checklist
SECTION D:
Sterilisation and Monitoring
Question 1:
Steriliser manufacturers: Not available
– Written instructions for cycle parameters
are available Some are available
Question 2:
Rigid container manufacturers: Not evident
– Instructions for cycle parameters
are followed Done occasionally
Question 3:
Medical device manufacturers: Not available
– Written instructions for sterilisation cycle
parameters are available/accessible for items Available but not easily accessible
to be sterilised, including loaner sets
Available and easily accessible
Question 4:
Group together similar items requiring same Not evident
cycle parameters
Done occasionally
Question 5:
Steriliser cart: Not evident
–A llow space between packs
–D o not overload Overloading seen occasionally
–P ackages should not touch chamber walls Complied with all the time
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APSIC CSSD Center of Excellence Program | Audit Checklist
SECTION D:
Sterilisation and Monitoring (continued)
Question 6:
Mixed loads: Not evident
– Place metal items on the loading cart below
textiles and paper-plastic pouches (to prevent Done occasionally
condensate from dripping onto lower packs) Done all the time
Question 7:
Solid-bottom pans, bowls, and trays are tilted Not evident
on edge and oriented in the same direction
Done occasionally
Question 8:
Paper-plastic pouches: Not evident
– Use baskets to facilitate placing pouches
on edge Done occasionally
Question 9:
Rigid containers: Not evident
– Stacking could interfere with air evacuation;
follow container’s manufacturer’s instructions Done occasionally
Question 10:
Open steriliser door properly Not evident
– Door may be opened slightly at the end
of the cycle (for some time) prior to Done occasionally
removing the load Done all the time
Question 11:
Load contents: Not evident
–T here should be no visible signs of liquid, or
water droplets. (Wet items are considered Wetness seen occasionally
contaminated even if not touched.) Dry for all items
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APSIC CSSD Center of Excellence Program | Audit Checklist
SECTION D:
Sterilisation and Monitoring (continued)
Question 12:
Sterilised items remain on the cart to cool for Not evident
a minimum of 30 minutes, and are not touched
during the cooling process Done occasionally
Question 13:
Place cart in a low traffic area without proximity Carts placed in close proximity to vents
to air-conditioning or cold-air vents
Some carts are placed in close
proximity to vents
Question 14:
Immediate use “Flash” items: Not used immediately
– Are used immediately and not stored
for later use (assume condensate will Occasionally used immediately
be present)
Used immediately always
Question 15:
Verify parameters of the cycle have been Not evident
met by reviewing cycle printout tapes.
Circle minimum temperature and exposure Reviewed but not documented regularly
time, initial/sign, and date. Reviewed and documented all the time
Question 16:
Bowie-Dick Testing is done daily in pre-vacuum Not evident
sterilisers before first processed load.
Process Bowie-Dick at 132°-134ºC for 3.5 to Done occasionally
4 minutes. One pack per load in an empty Done daily
chamber. Record results.
Question 17:
External process indicators (indicator tape, Not evident
labels) are affixed to hospital-sterilised packages
and containers Affixed on some
14 SECTION D: STERILISATION AND MONITORING: Physical monitors, chemical indicators and biological indicators continues >>>
APSIC CSSD Center of Excellence Program | Audit Checklist
SECTION D:
Sterilisation and Monitoring (continued)
Question 18:
Internal chemical indicator(s) (Type 4, 5, 6) Not evident
are placed inside every package in the most
challenging location for sterilant to reach Placed in some items/not in most
(refer to Rigid Container Manufacturers’ challenging location
Instructions for CI placement) Complied with for all items
Question 19:
Implant loads: Not evident
– Monitor with a BI PCD containing a Type 5
Integrating Indicator. Implants should be Monitored but not quarantined
quarantined until BI results are known,
Monitored and quarantined
except in emergency situations.
Question 20:
Non-implant loads: Not used immediately
– Optional monitoring with a PCD containing
either: a BI, a BI and Type 5, a Type 5 integrating Done for some loads
indicator, or a Type 6 emulating indicator
Done for all loads
Question 21:
Routine steriliser efficacy testing with a BI PCD Not evident
is done daily (if steriliser run daily):
Sterilisers larger than 60 liter: Done sometimes
– Place BI PCD in first load of items to be sterilised, Done daily when used
on bottom shelf of steriliser cart over drain
Table top sterilisers:
– BI PCD is run with first load of the day and
generally placed in centre of load
Question 22:
Steam: Used weekly
– Daily (each day the steriliser is used)
Used daily
SECTION D: STERILISATION AND MONITORING: Use appropriate BI PCD depending on type of steriliser continues >>>
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APSIC CSSD Center of Excellence Program | Audit Checklist
SECTION D:
Sterilisation and Monitoring (continued)
Question 23:
Gaseous sterilization (e.g. EO, H2O2): Not evident
– BI should be used every load
Done but no regular recording
Question 24:
Sterilisers larger than 60 liter: Used weekly
– Use commercially available FDA-cleared
BI PCD or AAMI 16-towel pack (M) Used daily
Question 25:
Table top sterilisers: Used weekly
– BI PCD is a user assembled challenge test pack,
which creates the greatest challenge (e.g., BI in Used daily
peel pouch, BI in wrapped set) and contains
Used every load
items normally processed
Question 26:
Control BI: Not evident
– Incubate a positive BI control each day a test
vial is incubated and in each auto-reader or Done but no regular recording
incubator. The Control BI needs to be from the Done with good recording always
same lot number as the Test BI. Record results.
Question 27:
Test BI: Not evident
– Incubate Test BI according to BI
Manufacturers’ Instructions. Done but no regular recording
Record results.
Done with good recording always
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APSIC CSSD Center of Excellence Program | Audit Checklist
SECTION D:
Sterilisation and Monitoring (continued)
Qualification testing
Question 28:
For sterilisation process failures where the cause is Not evident
not immediately identifiable, and after major steam
or steriliser repairs, run 3 empty cycles with a BI PCD Done but not as full procedure
followed by 3 empty cycles with a Bowie-Dick test if Done as in standard
prevacuum steriliser
Steriliser maintenance
Question 29:
Steriliser “drain strainers” are inspected Not evident
daily for debris
Occasionally done
Inspected daily
Question 30:
Steriliser external and internal surfaces Not evident
are routinely cleaned
Occasionally cleaned/
some parts cleaned only
Routinely cleaned for external
and internal surfaces
TOTAL:
0 / 460 points
SECTION D:
Sterilisation
and Monitoring MANDATORY ITEMS MARKED:
Yes No
17
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APSIC CSSD Center of Excellence Program | Audit Checklist
SECTION E:
Sterile Storage and Distribution
Sterile storage
Question 1:
Written policies and procedures are Not available
available for storage, handling, rotation,
and labelling of sterile packs Some are available
Question 2:
Traffic in the sterile storage area is Not controlled
controlled to limit access to sterile items Controlled but not fully complied
by staffs
Controlled and full compliance
Question 3:
Outside shipping containers and corrugated Not using appropriate containers
cartons are not used as containers in sterile
storage areas Partial compliance
Full compliance
Question 4:
Storage area temperature is generally less Both not complied with
than 24°C and relative humidity should not
exceed 70% One of them is complied with
Question 5:
Sterile items are stored at least 20-25cm (8-10") Non-compliance
above the floor, at least 45cm (18") below the
ceiling or sprinkler heads, and at least 5cm (2") One of them is compliant
from outside walls Full compliance
Question 6:
Shelving and storage carts have a physical No barrier
barrier between the bottom shelf and the floor
Partial barrier
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APSIC CSSD Center of Excellence Program | Audit Checklist
SECTION E:
Sterile Storage and Distribution (continued)
Question 7:
Medical/surgical items, including rigid Non-compliant throughout area
containers, are not stored next to or under sinks,
under exposed water/sewer pipes, or in any Partial compliance
location where they may become wet Full compliance in all areas
Question 8:
Supplies are stored only on designated Non-compliant throughout area
shelving, counters, and carts (not on
windowsills, floors, etc.) Partial compliance
Question 9:
When stacking container systems, ensure Non-compliant throughout area
they are firmly seated on one another
Partial compliance
Distribution
Question 10:
Supplies are distributed on a Not done
First In First Out (FIFO) basis
Occasionally done
Question 11:
Packaging is inspected visually for Both not complied with
integrity, and labelling, prior to
One of them is complied with
using items
Coth complied with
Question 12:
Transport carts should have a physical barrier Both not complied with
between the bottom shelf and the floor
One of them is complied with
– Reusable covers should be cleaned
after each use Both complied with
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APSIC CSSD Center of Excellence Program | Audit Checklist
SECTION E:
Sterile Storage and Distribution (continued)
Distribution (continued)
Question 13:
Carts are decontaminated/dried before Not done
reused for transporting sterile supplies
Occasionally done
TOTAL:
0 / 140 points
SECTION E:
Sterile Storage
and Distribution MANDATORY ITEMS MARKED:
0 / 20 (1 item)
Yes No
20
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APSIC CSSD Center of Excellence Program | Audit Checklist
SECTION F:
Documentation
Question 1:
Documentation for each mechanical washer Not done
is maintained:
– Monitor and verify cleaning processes Some are monitored and documented
(e.g. digital readouts, and cycle printouts) All are monitored and documented
Question 2:
Documentation for each steriliser is Not done
maintained, and includes results from
Documentation done occasionally
each load (e.g. monitoring results;
steriliser repair records) Documentation done always
Question 3:
For each cycle printout tape: Not evident
– Verify cycle start was initiated
– Ensure cycle selected was appropriate Printout tape done occasionally
for load contents Printout tape done for each cycle
– Verify correct Time & Temp. was met
– Ensure there were no cycle aborts
or warnings
Question 4:
Record for each cycle: Not evident
– Lot number
– Load contents Records done occasionally
– Exposure time/temp; *Name/initials Records available for each cycle
of steriliser operator
– Results of BI testing, if applicable
– Results of Bowie-Dick testing, if applicable
– Results of CIs in test packs; reports
of non-conclusive or non-responsive
CIs found in the load
Question 5:
An instrument tracking system or other No system available
type of computer system is used
Manual
Electronic
SECTION F:
Documentation (continued)
Product recalls
Question 6:
– Policies & Procedures are clear and concise No product recall policy
– Records are maintained
– Lot control labels are used, to include: Policy exists but records not
maintained regularly
Steriliser ID, lot number, sterilisation date,
expiration date, name of pack and initials Policy exists and records
available for all items
Question 7:
Sterilisation Process Failure: Not done
– When cannot immediately identify cause of
failure (e.g. selected incorrect cycle setting), Occasionally done
reprocess the load and recall/reprocess all Done all the time
items dating back to last load in steriliser with
negative BI results
TOTAL:
0 / 120 points
SECTION F:
Documentation
MANDATORY ITEMS MARKED:
0 / 100 (5 items)
Yes No
22
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APSIC CSSD Center of Excellence Program | Audit Checklist
SECTION G:
Facility Design
Question 1:
All instrumentation reprocessing Not centralized
is centralized
Centralized
Question 2:
If centralized reprocessing is not possible, No policy
consistent policies and procedures between
locations are in place Inadequate policy
Question 3:
CSSD department size is appropriately Not done
designed with regard to anticipated volume
Attempts to do so and has clear
plans to modify and improve
Yes
Question 4:
Decontamination area facilitates proper Poor workflow and inadequate space
workflow and provides adequate space
for necessary equipment Inadequate space but good workflow
Question 5:
Decontamination area has space No dedicated space
dedicated to donning and removal
of PPE Dedicated space but inadequate
Question 6:
Decontamination sink is of adequate size Inappropriate design
and has three compartments (for soaking,
cleaning and rinsing) Adequate size but < 3 compartments
Question 7:
Handwashing sinks/hand hygiene facilities No sinks/hand hygiene facilities
are appropriately located in department
Inappropriately located
Appropriately located
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APSIC CSSD Center of Excellence Program | Audit Checklist
SECTION G:
Facility Design (continued)
Question 8:
Emergency eyewash stations (required by Not available
OSHA) located within 10 seconds travel time
of all chemical usage locations, with a Inappropriately located
continuous flush for at least 15 minutes Appropriately located
(e.g. decontamination area)
Question 9:
Functional workflow pattern: No distinction
– Clear distinction (i.e. physical wall)
between dirty and clean Unclear distinction
Clear distinction
Question 10:
Functional workflow pattern: Not available
– Pass–through window available
to avoid hallways, and is not Available but open
propped open Available and not propped open
Question 11:
Temperature and humidity monitoring Not available
controls in decontamination and clean areas
Only one monitor
Question 12:
Temperature and humidity monitoring is Not done
recorded daily
Irregular monitoring
Question 13:
Appropriate traffic control. Written policy and No policy
procedure in place for authorized entry and
movement and attire. Policy available but not complied with
Question 14:
Floors and walls are constructed from Poor materials
materials that can withstand frequent cleaning
One of them can withstand frequent cleaning
SECTION G:
Facility Design (continued)
Question 15:
Ceilings are flush surfaces and not of Did not meet standard
materials that are of a particulate or
fibre-shedding composition Only fulfill one criteria
Question 16:
Doors close freely and do not No doors
have thresholds
Doors have thresholds/don’t close freely
Question 17:
Appropriate positive (clean areas) No clear pressure differences
and negative (soiled areas) pressure
ventilation systems in place Only one area meets standard
Question 18:
Appropriate air-change in decontamination Both area does not meet
and storage area
Only one area meets standard
Question 19:
Lighting adequate for all work areas Poor lighting throughout
TOTAL:
0 / 200 points
SECTION G:
Facility Design
MANDATORY ITEMS MARKED:
0 / 20 (1 item)
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APSIC CSSD Center of Excellence Program | Audit Checklist
SECTION H:
Considerations
Question 1:
CS supervisory personnel meet No recognized qualifications
minimum recommended qualifications
Local training only
Question 2:
CS supervisory personnel maintain Not done
competency and participate in departmental
continuing education Sporadically done
Question 3:
CS technicians meet minimum No recognized qualifications
recommended qualifications
Local training only
Question 4:
All new CS personnel receive initial Not done
and comprehensive facility and
department orientation Some received it
Question 5:
All CS personnel receive a minimum Not done
annual training on department policies
and procedures All CS personnel demonstrate Not regularly done
competency annually All received it and documented
Question 6:
Written policy on personal hygiene No policy
Inadequate policy
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APSIC CSSD Center of Excellence Program | Audit Checklist
SECTION H:
Considerations (continued)
Question 7: No policy
Written policy and adherence to
appropriate CS personnel attire Inadequate policy/partial compliance
Question 8:
Written policy and adherence to No policy
appropriate PPE in decontamination area Inadequate policy/partial compliance
Question 9:
Written policy and schedule No police or schedule
for housekeeping Has police but no schedule
Question 10:
Written policy and schedule No policy
for instrument and sterilizer Inadequate policy/partial compliance
machine maintenance
Clear comprehensive policy with
full compliance
Question 11:
Products used for any/all stages in reprocessing No collaboration
(cleaning, disinfection, sterilization) must be
approved by the committee responsible for Partial collaboration
product selection, by an individual with Full collaboration
reprocessing expertise and by an individual
with infection prevention and control expertise
TOTAL:
0 / 120 points
SECTION H:
Considerations
MANDATORY ITEMS MARKED:
0 / 20 (1 item)
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APSIC CSSD Center of Excellence Program | Audit Checklist
Expert Feedback
Comments:
Impressive elements:
Expert 1 name:
Expert 2 name:
Date:
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APSIC CSSD Center of Excellence Program | Audit Checklist
Summary Scores
Facility name:
Country:
Cleaning and
B 0 / 180 0 / 80 (4 items)
Decontamination Processes
Instrumentation Inspection,
C 0 / 260 0 / 100 (5 items)
Preparation and Packaging
Sterilisation
D 0 / 460 0 / 320 (16 items)
and Monitoring
Sterile Storage
E 0 / 140 0 / 20 (1 item)
and Distribution
0 / 760
Grand total 0 / 1640
(38 items)
EMAIL FORM
RESET FORM
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