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APSIC CSSD Audit Guideline Web

This audit checklist contains questions to evaluate cleaning and sterilization processes across multiple sections. It includes questions about handling soiled instruments, cleaning and decontamination procedures, instrumentation inspection, sterilization monitoring, storage and documentation. The checklist contains both mandatory questions highlighted in each section as well as a total score out of 160 points for section A on handling soiled instruments. It aims to provide an accurate audit of practices for cleaning and sterilizing reusable medical equipment according to guidelines.

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gadhang dewangga
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100% found this document useful (1 vote)
162 views

APSIC CSSD Audit Guideline Web

This audit checklist contains questions to evaluate cleaning and sterilization processes across multiple sections. It includes questions about handling soiled instruments, cleaning and decontamination procedures, instrumentation inspection, sterilization monitoring, storage and documentation. The checklist contains both mandatory questions highlighted in each section as well as a total score out of 160 points for section A on handling soiled instruments. It aims to provide an accurate audit of practices for cleaning and sterilizing reusable medical equipment according to guidelines.

Uploaded by

gadhang dewangga
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 29

APSIC CSSD Center

of Excellence Program

Audit Checklist

!
Please make sure to answer
ALL questions to obtain a
more accurate audit.
Highlighted questions
are MANDATORY by
APSIC GUIDELINES
Audit Checklist
Table of Contents

• SECTION A: Handling, Collection and Transport


of Contaminated Instruments (pages 3-4)

• SECTION B: Cleaning and Decontamination Processes (pages 5-7)

• SECTION C: Instrumentation Inspection, Preparation and Packaging (pages 8-11)

• SECTION D: Sterilisation and Monitoring (pages 12-17)

• SECTION E: Sterile Storage and Distribution (pages 18-20)

• SECTION F: Documentation (pages 21-22)

• SECTION G: Facility Design (pages 23-25)

• SECTION H: Considerations (pages 26-27)

• Expert Feedback (page 28)

• Summary Scores (page 29)

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

Discarded appropriately all the time

Question 3:
Gross soil is removed from instruments at point Not removed
of use if immediate transportation not possible
Removed sometimes

Removed all the time

Question 4:
Soiled items should be kept moist Items are dry
(moist towel, enzyme foam or spray product)
Partially moist

Moist all the time

Question 5:
Secured, dedicated containers are provided Not available
for soiled instruments
Sometimes

All the time

Question 6:
Use of puncture resistant, leak-proof containers Not available
for soiled items
Sometimes

All the time

Question 7:
Soiled items must be contained during Not evident
transportation
Attempts made

Done all the time

3 SECTION A: HANDLING, COLLECTION AND TRANSPORT OF CONTAMINATED INSTRUMENTS continues >>>


APSIC CSSD Center of Excellence Program | Audit Checklist

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

Done all the time

Question 9:
Transportation carts should be covered and Not done
should prevent items from falling over or off
Occasionally done

Done all the time

Question 10:
Dedicated elevators (or lifts) with direct Not available
access to decontamination area
Dedicated but not used as
planned all the time

Dedicated and 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

Policy exists and complied


with all the time

TOTAL:
SECTION A:
Handling, 0 / 160 points
Collection and
Transport of
Contaminated MANDATORY ITEMS MARKED:
Instruments
0 / 100 (5 items)

I completed all questions in this section


especially the MANDATORY (highlighted) items.

Yes No

4
> Return to Table of Contents Proceed to Next Section
>
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

Both are available

Question 2:
Instrumentation is disassembled (according Not done
to manufacturer’s instructions) to expose all
surfaces for cleaning Done occasionally

Done all the time

Question 3:
Rigid container systems disassembled Not done
according to manufacturer instructions
(filters, valves and interior baskets) Done occasionally

Done all the time

Question 4:
Cleaning agents are used according to Not done
manufacturer’s instructions (dilution and
temperature, etc.) Done occasionally

Done all the time

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

Done all the time

Question 7:
Appropriate brushes/cleaning implements Not done
designed for use on medical devices
are used Done occasionally

Done all the time

5 SECTION B: CLEANING AND DECONTAMINATION PROCESSES continues >>>


APSIC CSSD Center of Excellence Program | Audit Checklist

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

Decontaminated at least daily

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

All 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

All 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

Frequency set and complied

SECTION B: CLEANING AND DECONTAMINATION PROCESSES continues >>>

6
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:

SECTION B: 0 / 180 points


Cleaning and
Decontamination
Processes MANDATORY ITEMS MARKED:

0 / 80 (4 items)

I completed all questions in this section


especially the MANDATORY (highlighted) items.

Yes No

7
> Return to Table of Contents Proceed to Next Section
>
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

Done all the time

SECTION C: INSTRUMENTATION INSPECTION, PREPARATION AND PACKAGING continues >>>

8
APSIC CSSD Center of Excellence Program | Audit Checklist

SECTION C:
Instrumentation Inspection, Preparation and Packaging (continued)

Preparation and assembly

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

Done all the time

Question 8:
Multi-part instruments are disassembled Not evident
prior to sterilisation, ensuring all parts are
easily accessed for aseptic assembly Done occasionally

Done all the time

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 >>>

9
APSIC CSSD Center of Excellence Program | Audit Checklist

SECTION C:
Instrumentation Inspection, Preparation and Packaging (continued)

Preparation and assembly (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

Full compliance all the time

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

Done all the time

Question 16:
Wrappers should be kept snug, but not wrapped Not evident
too tightly or strike-through could occur
Done occasionally

Done all the time

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

10 SECTION C: INSTRUMENTATION INSPECTION, PREPARATION AND PACKAGING: Packaging continues >>>


APSIC CSSD Center of Excellence Program | Audit Checklist

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

Labeling on indicator tape or


affixed labels

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

Frequency set and followed

TOTAL:
SECTION C: 0 / 260 points
Instrumentation
Inspection,
Preparation MANDATORY ITEMS MARKED:
and Packaging
0 / 100 (5 items)

I completed all questions in this section


especially the MANDATORY (highlighted) items.

Yes No

11
> Return to Table of Contents Proceed to Next Section
>
APSIC CSSD Center of Excellence Program | Audit Checklist

SECTION D:
Sterilisation and Monitoring

Follow manufacturers’ guidelines

Question 1:
Steriliser manufacturers: Not available
– Written instructions for cycle parameters
are available Some are available

Available for all sterilisers

Question 2:
Rigid container manufacturers: Not evident
– Instructions for cycle parameters
are followed Done occasionally

Done all the time

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

Loading the steriliser (follow steriliser manufacturers’ written instructions)

Question 4:
Group together similar items requiring same Not evident
cycle parameters
Done occasionally

Done all the time

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

SECTION D: STERILISATION AND MONITORING: Loading the steriliser continues >>>

12
APSIC CSSD Center of Excellence Program | Audit Checklist

SECTION D:
Sterilisation and Monitoring (continued)

Loading the sterilizer (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

Done all the time

Question 8:
Paper-plastic pouches: Not evident
– Use baskets to facilitate placing pouches
on edge Done occasionally

Done all the time

Question 9:
Rigid containers: Not evident
– Stacking could interfere with air evacuation;
follow container’s manufacturer’s instructions Done occasionally

Done all the time

Unloading the steriliser

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

SECTION D: STERILISATION AND MONITORING: Unloading the steriliser continues >>>

13
APSIC CSSD Center of Excellence Program | Audit Checklist

SECTION D:
Sterilisation and Monitoring (continued)

Unloading the sterilizer (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

Done all the time

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

Complied with always

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

Physical monitors, chemical indicators and biological indicators

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

Affixed on all items

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)

Physical monitors, chemical indicators and biological indicators (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

Use appropriate BI PCD depending on type of steriliser

Question 22:
Steam: Used weekly
– Daily (each day the steriliser is used)
Used daily

Used every load

SECTION D: STERILISATION AND MONITORING: Use appropriate BI PCD depending on type of steriliser continues >>>
15
APSIC CSSD Center of Excellence Program | Audit Checklist

SECTION D:
Sterilisation and Monitoring (continued)

Use appropriate BI PCD depending on type of steriliser (continued)

Question 23:
Gaseous sterilization (e.g. EO, H2O2): Not evident
– BI should be used every load
Done but no regular recording

Done with good recording always

Question 24:
Sterilisers larger than 60 liter: Used weekly
– Use commercially available FDA-cleared
BI PCD or AAMI 16-towel pack (M) Used daily

Used every load

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

BI test/control and results

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

SECTION D: STERILISATION AND MONITORING continues >>>

16
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:

0 / 320 (16 items)

I completed all questions in this section


especially the MANDATORY (highlighted) items.

Yes No

17
> Return to Table of Contents Proceed to Next Section
>
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

All 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

Both 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

Full physical barrier

SECTION E: STERILE STORAGE AND DISTRIBUTION: Sterile storage continues >>>

18
APSIC CSSD Center of Excellence Program | Audit Checklist

SECTION E:
Sterile Storage and Distribution (continued)

Sterile storage (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

Full compliance in all areas

Question 9:
When stacking container systems, ensure Non-compliant throughout area
they are firmly seated on one another
Partial compliance

Full compliance in all areas

Distribution

Question 10:
Supplies are distributed on a Not done
First In First Out (FIFO) basis
Occasionally done

All the time

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

SECTION E: STERILE STORAGE AND DISTRIBUTION: Distribution continues >>>

19
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

Done all the time

TOTAL:

0 / 140 points
SECTION E:
Sterile Storage
and Distribution MANDATORY ITEMS MARKED:

0 / 20 (1 item)

I completed all questions in this section


especially the MANDATORY (highlighted) items.

Yes No

20
> Return to Table of Contents Proceed to Next Section
>
APSIC CSSD Center of Excellence Program | Audit Checklist

SECTION F:
Documentation

Equipment and cycling 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 continues >>>


21
APSIC CSSD Center of Excellence Program | Audit Checklist

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)

I completed all questions in this section


especially the MANDATORY (highlighted) 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

Clear comprehensive 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

Proper workflow and adequate space

Question 5:
Decontamination area has space No dedicated space
dedicated to donning and removal
of PPE Dedicated space but inadequate

Good adequate dedicated area

Question 6:
Decontamination sink is of adequate size Inappropriate design
and has three compartments (for soaking,
cleaning and rinsing) Adequate size but < 3 compartments

Adequate size with 3 compartments


and connectors

Question 7:
Handwashing sinks/hand hygiene facilities No sinks/hand hygiene facilities
are appropriately located in department
Inappropriately located

Appropriately located

SECTION G: FACILITY DESIGN continues >>>

23
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

Monitors present for both

Question 12:
Temperature and humidity monitoring is Not done
recorded daily
Irregular monitoring

Daily documented 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

Policy available with full compliance

Question 14:
Floors and walls are constructed from Poor materials
materials that can withstand frequent cleaning
One of them can withstand frequent cleaning

Both items fulfilled

24 SECTION G: FACILITY DESIGN continues >>>


APSIC CSSD Center of Excellence Program | Audit Checklist

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

Meet both criteria

Question 16:
Doors close freely and do not No doors
have thresholds
Doors have thresholds/don’t close freely

Meet both standards

Question 17:
Appropriate positive (clean areas) No clear pressure differences
and negative (soiled areas) pressure
ventilation systems in place Only one area meets standard

Both areas are of appropriate


pressure ventilation

Question 18:
Appropriate air-change in decontamination Both area does not meet
and storage area
Only one area meets standard

Both areas are of appropriate


meet standard

Question 19:
Lighting adequate for all work areas Poor lighting throughout

Some have adequate lighting

Adequate lighting in all work areas

TOTAL:

0 / 200 points
SECTION G:
Facility Design
MANDATORY ITEMS MARKED:

0 / 20 (1 item)

I completed all questions in this section


especially the MANDATORY (highlighted) items.
Yes No

25
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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

Trained with relevant regional/


international qualifications

Question 2:
CS supervisory personnel maintain Not done
competency and participate in departmental
continuing education Sporadically done

Regular documented programs

Question 3:
CS technicians meet minimum No recognized qualifications
recommended qualifications
Local training only

Has recognized training regionally/


internationally

Question 4:
All new CS personnel receive initial Not done
and comprehensive facility and
department orientation Some received it

All received it and documented

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

Clear comprehensive policy

SECTION H: CONSIDERATIONS continues >>>

26
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

Clear comprehensive policy with


full compliance

Question 8:
Written policy and adherence to No policy
appropriate PPE in decontamination area Inadequate policy/partial compliance

Clear comprehensive policy with


full compliance

Question 9:
Written policy and schedule No police or schedule
for housekeeping Has police but no schedule

Has police and 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)

I completed all questions in this section


especially the MANDATORY (highlighted) items.
Yes No

27
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>
APSIC CSSD Center of Excellence Program | Audit Checklist

Expert Feedback

Comments:

Impressive elements:

Areas for improvement:

Expert 1 name:

Expert 2 name:

Date:

28
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>
APSIC CSSD Center of Excellence Program | Audit Checklist

Summary Scores

Facility name:

Country:

Section Item Score MANDATORY items

Handling, Collection and


A Transport of Contaminated 0 / 160 0 / 100 (5 items)
Instruments

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

F Documentation 0/ 120 0 / 100 (5 items)

G Facility Design 0 / 200 0 / 20 (1 item)

H Considerations 0 / 120 0 / 20 (1 item)

0 / 760
Grand total 0 / 1640
(38 items)

EMAIL FORM

RESET FORM

29
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