Activities Meaning

O Observation
CSSD - Infection Control Audit Tool - 2022 SI Staff Interview
D Documents
PF Personal files
Name of Visit Date MR Medical Records
Hospital
Region Auditor 1 Name Scoring Explanation

City Audit Information Auditor 1 Email 2 Fully Met (80% or more Compliance)
Audited Facility
Information Partially Met (from 50% to less than 80%
Tel Auditor 2 Name 1
Compliance)
Email Auditor 2 Email 0 Not Met (less than 50% Compliance)
Head of
NA Not Applicable
Infection
 1 CSSD Policies and Procedures Weight Activities Score Comments
1.01 Updated Written policies & procedures are available, and approved by the Infection Control Committee. Critical D O 0 2

2 National Criteria for CSSD Staffing Level Weight Activities Comments

Hospitals with bed capacity ≤ 100 beds : 1 CSSD staff for every 20 beds, an additional 1 CSSD staff per average of 100
2.01 Medium D O 0 2
Surgical Procedures done per month.The minimum required numbers is 3 CSSD staff at least.

Hospitals with bed capacity > 100 beds : 1 CSSD staff for every 50 beds, an additional 1 CSSD staff per average of 100
2.02 Medium D O 0 2
Surgical Procedures done per month. The minimum required numbers is 5 CSSD staff at least.

3 CSSD Staff Qualifications Weight Activities Comments

Staff files are available for every CSSD staff including: qualification record (either CSSD education certification or CSSD
3.01 training certification)، Orientation records, updated Job Description, valid Saudi commission registration, BLS High D PF SI 0 1 2
certification, annual competency assessment records, Immunization records.

4 CSSD Infrastructure / Unit Design Weight Activities Comments

The healthcare facility provides central sterilization services and none of the cleaning, disinfecting, or sterilizing
4.01 activities are carried out by individual departments outside of the CSSD. Not allowed for prepack the surgical Critical O SI 0 2
instrument/ready for sterilization to be send for CSSD.
CSSD should be divided into 3 areas with complete physical separation between these areas (Receiving and
4.02 Decontamination area), (Inspection, Assembly, Packaging, and Sterilization area), (Sterile Storage, and Dispatching Critical O 0 2
areas). (Minimum 2 areas, dirty and clean)

4.03 All surgical instruments processed in unidirectional workflow from dirty to clean area. Medium O 0 1 2

The decontamination area is maintained under negative pressure, with 10 air changes per hour, temperature ranges
4.04 Critical D O SI 0 1 2
from 18°C to 23°C and relative humidity from 30% to 60%.
The IAP area is maintained under positive pressure, with 10 air changes per hour at least, temperature ranges from
4.05 Critical D O SI 0 1 2
20°C to 23°C and relative humidity from 30% to 60%. sterile storage area not exceed 70%
The sterile storage area is maintained under positive pressure, with 4 air changes per hour at least, temperature
4.06 Critical D O SI 0 1 2
ranges from 20°C to 23°C and relative humidity with limit of 70%

5 Point of Use, Transportation of Surgical Instruments From/To CSSD Weight Activities Comments
Point of use treatment procedure is applied in all hospital departments with the MOH approved spray solution,
5.01 High O SI 0 2
Received dried soiled instruments are reported by CSSD staff to the intended department.
Contaminated instrument securely contained in its rigid containers or biohazard bags and transported inside (a closed
5.02 Critical O SI 0 2
cart) or (locked transportation box delivered on an open trolley) with biohazard tag sign.
Transportation carts/transportation boxes used for contaminated instruments must be dedicated for its use unless
5.03 Critical O SI 0 2
disinfected manually or mechanically in the CSSD to transport sterile items.
sterile items are arranged properly in the transportation cart/box, Not allowed for overloaded or stack inside it, even
5.04 High O SI 0 1 2
throw while handling.
 6 Decontamination Area Weight Activities Comments
The manufacturer's instructions for use (IFU) of complex instruments are available in hard/soft copies for proper
6.01 Medium D O 0 1 2
disassembling, cleaning, assembling, and sterility option.

Manual cleaning is mandatory, it is performed before loading in the washer disinfectors, Ultrasonic cleaners or manual
6.02 Critical O SI 0 1 2
disinfection. Brushes in a different sizes\shapes for cleaning soiled instrument, are available.

Manual cleaning sinks (minimum 2 deep sinks) are available, dilutions measurement tool is available, cleaning
6.03 detergent and cleaning efficiency test must be MOH approved product. Decontamination sink are cleaned frequently High O SI 0 1 2
as needed, Not allowed to observe any blood, dirty objects, scale
Automated washer disinfector function properly, the strainers and chambers are free of soil. Loading and unloading
6.04 Medium O SI 0 1 2
procedures of the washer disinfector are performed properly.

7 Inspection, Assembly, Packaging, and Sterilization Area Weight Activities Comments

High level disinfected items must be passed through the hatch window to the IAP area. Backflow only allowed in case
7.01 Medium O SI 0 1 2
of soil after cleaning or moist after sterilizing through the secured hatch window in tray or basket for reprocessing.

Drying procedures are performed by using the appropriate drying tools such as dry cabinet or lint free wipes,
7.02 Medium O SI 0 1 2
prohibited to use lint towels.

7.03 All Instruments are inspected for cleanliness, function, completeness and lubricate when necessary. Critical D SI O 0 1 2

7.04 Chemical indicators class 6 or 5 must present inside each package. Critical O SI 0 2

All pouches, wrapped packages, sets are labeled before sterilization including: Sterilization date, sterilizer number,
7.05 High O SI 0 1 2
Cycle load number, Department / Unit name, Item Description, Technician initials.

7.06 Loading and unloading of the surgical instruments into/out of the sterilizers rack is performed accurately. High O SI 0 2

8 Sterile storage and Dispatch Area Weight Activities Comments

Sterile storage shelves are free from dust & away from the sprinklers and air vents. The lighter items on the top
8.01 High O SI 0 1 2
shelves & heavier items on bottom shelves (Not allowed to use the tape indicator on the rigid container)

Storage shelves are clearly labelled with approved label material, placed 40 cm from the ceiling, 20 cm from the floor
8.02 Medium O SI 0 1 2
and at least 5 cm away from wall.
 9 Infection Prevention and Control Standards Weight Activities Comments
9.01 Hand washing station is mandatory in the decontamination area. hand rub dispensers are available in all CSSD areas. High O 0 2

CSSD staff can demonstrate the difference between hand washing and hand rubbing, and its appropriate techniques.
9.02 Critical O SI 0 2
Staff appropriately perform the donning and doffing of the PPE.

9.03 Clean areas dress code are(Surgical scrub, hair covering, dedicated shoes) and for dirty area full PPE. Critical O SI 0 1 2

9.04 Visitors dress code in the clean area are (yellow-gown, head-cover, dedicated shoes) and for dirty area full PPE High O SI 0 2

9.05 Staff changing rooms are available, clean, arranged for CSSD staff to change before going inside the working areas Medium O SI 0 1 2

Emergency eyewash safety station or emergency eyewash bottle is available, functioned, and tested at least weekly in
9.06 High D SI O 0 1 2
decontamination area.

10 Environmental Cleaning and Disinfection Weight Activities Comments

Housekeeping staff use appropriate PPE during their routine cleaning activities. Cleaning equipment are separate and
10.01 High O SI 0 1 2
dedicated for each area.(mops and bucket etc). Housekeeping equipment is kept clean and dry after use.

10.02 Floors are mopped after each decontamination process in the dirty area and once in each shift in the clean area. High O SI 0 2

High touch surfaces are disinfected more frequently (e.g. worktables, countertops, light switches, door knobs, rack
10.03 High O SI 0 1 2
handles, display screen buttons, etc).

10.04 CSSD staff spray and wipe the work station with approved disinfectant before starting the Inspection work . High O SI 0 2

10.05 Shipping boxes, damaged utilities, foods and drinks are not allowed in the CSSD areas. High O SI 0 2
11 Waste Management Weight Activities Comments
11.01 All used PPE and regular waste should be disposed of inside regular black containers. High D 0 2

Sharp object like single used instrument, or disposable needles delivered by mistake to CSSD should be reported and
11.02 High O SI 0 2
disposed in to sharp container.

11.03 Hazardous waste like Biological Indicator (BI) vials should be disposed in to yellow biohazard bag. High O SI 0 2

12 CSSD Documentation Weight Activities Comments

Cleaning efficiency test files include: ultrasonic tests, protein efficiency tests for washer disinfectors, manual cleaning
12.01 High D SI 0 1 2
detergent efficiency tests are kept for one year.

Sterilization loading logbook for each sterilizer including information of sterilization date, sterilizer number, Cycle load
12.02 Critical D SI 0 1 2
number, Department name, Item Description, items quantity, Technician initials are documented and kept for one year.

12.03 Bowie Dick test for steam sterilizers must be performed on daily basis, after maintenance. records are kept for 1 Year. Critical D SI 0 1 2

Biological indicator test file is available. Biological tests result for steam sterilizers must be performed minimally
12.04 weekly preferable daily, with the implants load, and after maintenance. Biological test result for plasma sterilizers is Critical D SI 0 1 2
performed daily, and after maintenance. All records are kept for 1 year

Sterilizers physical parameters printout records hard/soft copy must be kept for one year. These parameters are: leak
12.05 Critical D SI 0 1 2
test cycle, temperature, pressure, sterilization duration, etc.
Receiving and dispatching logbook are available and must include: Sender/Receiver ID, department's name, sets and
12.06 Medium D SI 0 1 2
packages names, Date, Time and quantities.
CSSD Environmental monitoring file are available. Temperature, Humidity, Pressure must be recorded daily and air
12.07 Critical D SI 0 1 2
exchange quarterly. Documentation is kept for 1 year.

12.08 Planned Preventive Maintenance (PPM) file must be available. Medium D SI 0 1 2

Incident file must be available and include reports if any: large scale of chemical spill, staff stick injury, biological
12.09 Critical D SI 0 1 2
indicator recall incidents, lost or damaged surgical instruments, environmental disaster incidents are happened.

12.10 Machine Operation file are available, all machines checked daily, out of service machines have posted sign. Medium D SI 0 1 2

12.11 Materials safety data sheets of all chemicals used in the department must be available and updated. Critical D SI 0 1 2
13 Endoscopy Unit Weight Activities Comments
Written policies and procedures are available & implemented for reprocessing of flexible endoscopes (cleaning, and
13.01 High O D SI 0 1 2
disinfection in-between patients)

13.02 Staff are qualified by certification, education or training and able to explain all procedures of endoscopes reprocessing. Critical O SI PF 0 2

The procedure room(s) and the decontamination area are physically separated and access is allowed for authorized
13.03 Critical O SI 0 2
personnel only.
Procedure & Decontamination room are equipped with a separate, dedicated hand washing sink with hand free
13.04 High O SI 0 1 2
controls.

13.05 Reprocessing area is well ventilated and under negative pressure. High O SI 0 1 2

13.06 Appropriate personal protective equipment (respirator, gloves: nitrile or butyl rubber, goggles and gowns) are used. Critical O SI 0 2

Emergency eyewash safety station is available in decontamination area and accessible within 30 meters or 10 seconds
13.07 Medium O 0 1 2
of potential chemical exposure.
All channels of endoscope are flushed & external surfaces are wiped with a detergent solution immediately at the
13.08 High O SI 0 1 2
point of use.
Soiled endoscopes are transported safely to the reprocessing area in a suitable closed container with a clearly visible
13.09 Critical O SI 0 2
biohazard label.
Leak testing is performed according the manufacturer’s requirements before manual cleaning and the result is
13.10 High D O SI 0 1 2
documented.
Endoscopes are manually cleaned (brushed and flushed) with detergent solution. Disposable single use brushes should
13.11 High D SI 0 1 2
be used. If not available, reusable brushes that are sterilized after every use are considered as acceptable alternative.
Reusable heat-stable accessories that break the mucosa (e.g., biopsy forceps) are cleaned mechanically and sterilized
13.12 Critical O SI D 0 2
after each use.
High level disinfectants used should be approved by MOH and routinely tested to ensure Minimum Effective
13.13 Concentration MEC of the active ingredient (test strips are used and results recorded).SDS should be available & High D O SI 0 1 2
followed.
13.14 Endoscopes that are stored in cabinets & not used are reprocessed as per manufacturer's Instructions for use (IFU) High O SI D 0 1 2
Validated AER (Automated Endoscope Reprocesser) should be used and a successful cycle is confirmed before the use
13.15 High D O SI 0 1 2
of the endoscope.
13.16 Endoscopes are stored uncoiled, hanging vertically in a clean, dry, and well ventilated storage cabinet. High D O SI 0 1 2
There is a tracking and tracing system that records different stages of decontamination, the persons involved, storage
& subsequent patient use. (Records should include patient name, medical record number, the endoscopies, date and
13.17 High D O SI 0 1 2
time of the clinical procedure, identification number and type of endoscope and AER, results of inspection and leak
test and name of the person reprocessing the endoscope).