QUALITY CONTROL

IN
CENTRAL STERILE SUPPLY DEPARTMENT

S.SNIGDHA
MHA-II Year
CONCEPTS

Quality in Healthcare: A measure of the degree to which delivered services meet

established professional standards & judgment of value to the consumer.

Quality Control: The operational techniques and activities that are used to fulfill the
requirements of quality.

Quality Indicators: (QIs) are standardized, evidence-based measures of health

care quality that can be used with readily available hospital inpatient administrative data to
measure and track clinical performance and outcomes.
CSSD - Sterile Processing Department:

• The CSSD comprises the services within the hospital which receives, stores, processes,
sterilizes, distributes and controls professional supplies and equipments, both sterile
and non sterile to all departments of the hospital for the care and safety of patients –
Sharma

• To provide sterilized materials from a central department where sterilizing practices is

conducted under conditions which can be properly controlled thereby contributing to
reduction in the incidence of hospital infections.
FUNCTIONS

• To process, maintain and dispense supplies and equipment required by medical,

nursing, or paramedical personnel in designated departments for the care, diagnosis and
treatment of patients.

• To be equipped with modern equipment and use of the best known methods and
techniques of processing materials.

• To develop processing methods and supply control methods which will provide
supplies and equipments more efficiently and economically.

• To participate in supply and equipment research in an effort to provide the most suitable
material available for patient care.
STAFFING
• Manpower:

 Supervisor.

 Nursing Staff.

 Technicians.

Assistant Technicians.

 Clerical Staff.

 House Keeping - (Sakharker BM)

• Staff varies as per method of collection & delivery, work load, degree of
mechanization, number of shifts etc.. (Perkins, 1963)
DESIGNING DETAILS

• Location : In a delineated area where there is less or no external traffic movement,

should be either close to Operation Theatre(OT) or should be connected to OT with
safe & quick transfer mechanism, like dumbwaiters.

• Entry to CSSD should be restricted to only staff working in CSSD.

• Space : 7 sq.ft./bed (McGibony, 1969)

• Floor/Walls : Mosaic/Ceramics.

• The zones must lead to unidirectional movement of people and supplies.

WORK FLOW
LAYOUT: CSSD
Trolley
Wash
Reciving & Sorting

Washing , Cleaning Soiled

& Disinfecting Material

Office

Inspecting, Packing Store

& Sterilising

Staff
Autoclaves Changing room

Air Lock Staff toilet

Sterile
Issue counter
Sterile Store Materile
PROCESS PLANNING
• Initial inventory requirement: Five

1 in use.

1 in transit.

1 in processing in CSSD.

1 in storage.

1 in reserve.

• High use item : 5-7 times.

• Daily use item : 4-5 times.

• Slow use item : 3 times.

WORKING PRINCIPLES & FUCTIONAL ACTIVITIES :

• Sorting & Accounting: at CSSD for any breakage or loss.

• Cleaning & Washing:

 1st cleaning at the ward, removing blood stains & tissues.

 2nd cleaning at CSSD using detergents, hot & cold water.

 3rd Dip in Cidezyme Enzymatic Cleaner & Detergent Solution. (instruments kept as
open from clamped)

• Drying: Manual, Greasing & inspecting for sharpness or probable defect.

(Assembly line Technique)
WORKING PRINCIPALS & FUCTIONAL ACTIVITIES: Contd.

• Packaging: In porous material, linen and craft paper are commonly used(ISO 11607 and
EN 868 ). Paper wrapping - double layered linen.

 Pack size < 25 x 25 cm.

 Weight < 5 kg. (Owens)

• Labeling: Include the name of pack, number of articles, date of sterilization, initials/ sign.

• Sterilization Process: All packed items sent to the sterilization room & loaded sterilized.

• Storage: Sterilized packs - stored in sterile store, follow the clean room conditions.
STERILIZATION

• Their number is reduced to a probability, which is considered safe: the Sterility

Assurance Level (10^-6 ) or Spaulding protocol (achieving 99.99 per cent log kill
of bacterial spores).

• Types of Sterilization:

 Dry Heat.

 Steam Sterilization – Autoclaves. (Common and Safe method)

 Heat Chemical Vapor Sterilizers.

 Gas Sterilizers.
QUALITY CONTROL IN CSSD
• Mechanical Indicators:

 Routine Temperature, Pressure and Time testing.

 Inspection of packing.

 Shelf life of items.

• Chemical Indicators:

 Signaloc tapes.

 Thermo tapes.
• Biological Indicators:
 Culture of Bacillus Stereo Thermophillus.
 Random sampling of sterilized items.
 Bowie Dick test.
 Process Challenge Device.

Bowie Dick Test Culture of Bacillus Stereo Thermophillus

Quality of Loading:

• Loosely packed to permit air passage.

• Packed in the same direction to avoid air pockets.

• Metal items to be placed in bottom racks, instrument trays or sterilizing containers

should be placed upright and packs & peel pouches should be placed on the sides.
Quality Control of Wrapping Material:

• Medical grade kraft paper.

• Laminated paper (3 layers) suitable for both ETO & steam.

• Non-glazed butter paper can also be used steam sterilizer but bad tensile strength

• Crepe paper is good.

• Linen wrapper should be muslin of 140 thread count in two layers.

• Unbleached muslin is 10% more stronger than bleached muslin.

• Linen can be used for both ETO & steam sterilizer.

Quality Control for Dry Sterilizer:

• Temperature -160°C/hour or 180°C/30 minutes.

• Chemical indicators & Bacillus Subtilis – weekly.

Quality Control of Steam Sterilizer:

• Quality of steam - 3% moisture, dryness fraction 0.9 - 0.95

• Downward displacement type sterilizer

 Temperature -121°C / 20 minutes.

• Pre-vaccum type sterilizer

• Temperature -134 °C / 3 minutes or 121 °C / 20 minutes.

• Leak Rate Test - indicates that the evacuated chamber is adequately sealed for the entry of
steam.

• Air Detector Test - performance test.

• Bowie Dick Test - indicates the penetration of steam into the load, PCD for hollow lumen.

• Biological Indicator - sterilizing parameters have reached.

Quality Control of Ethylene oxide (ETO) :

• Specified limits of gas concentration, 37 °C - 60 °C temperature, relative humidity

45-75%, for 105-300 mts to be maintained.

• Dry packing.

• Preferable for single use plastic devices, optical instruments.

• Inappropriate for soiled items, ventilators.

• Plastic wrapping (ethyl cellulose, PVC, Cellophane) is not indicated.

• Preferred wrapping is spun bound poly olefin or sterilisation paper.

• Baccilus Subtilis to ensure sterilization - Sterility Assurance Level(SAL) of 10.

Gas Plasma Sterilizer Systems:

• Plasma is the 4th state of matter.

• Applying Radio Frequency to a gas causes it to form plasma.

• Generally used is hydrogen peroxide (most well known – STERRAD)

Record Maintenance

Machine load book - Individual loading, maintenance and complaint.

Workload book - Of all machines.

Stock register - Linen, Surgical and General.

Loan register - Trays loaned to different departments.

Staff linen register - Dressing and Linen.

Indent book - Surgical, Medicine and General.

Attendance register.

Exchange book.
Feedback:

• From the user end - wet pack, torn pack, loosely packed, mismatch of instrument.

• From the Infection control Team - Swab Culture test Positive.

• From the CSSD Technician - Daily reporting regarding the Autoclave machine
functionality as per laid down parameter(Engineering aspect).

• From the Company Engineer at the time of Inspection(AMC).

• From an Independent regularity body by surprise check.

Economic Implication

• Centralization helps in Standardization & uniformity.

• Reduced use of higher antibiotics.

• Reduced use of disposables.

• Reduced nosocomial infection - Reduced Average Length of Stay.

Thank you
Behind the scenes:

• https://www.youtube.com/watch?v=TfqT-QiKOqE