CSSD Performance Quality Analysis at a Super

Speciality Hospital

NAME : D. Gandhiraj
DESIGNATION : Microbiologist
DEPARTMENT : Institurte of Laboratory Medicine
HOSPITAL : Royal Care Super Speciality Hospital
DATE : 14/03/2018
 Background: (about hospital)
• RoyalCare super specality hospital Inaugrated on 14th,Nov,2016 as a 750 bedded
project at Neelambur, Coimbatore, Tamilnadu

• Current bed strength - 270

• The hospital is provided with State of Art CSSD.

• The study choosen to implement systematic workflow, sterilization performance and

Quality Assurance.
 Objective:
• To impliment and monitor the necessary systems to ensure efficient functioning
and support of the sterile service in the hospital.

• To assess the effectiveness of sterilisation methods and turn-around by

implementing Quality in CSSD performance.

• To maintain record of effectiveness of cleaning, disinfection and sterilization

process by physical and biological controls.
 Audit case type (Descriptive)
• Area Audited - CSSD

• A checklist of APSIC used to analyse the performance quality (PQ) of CSSD and to
impliment the necessary requirements.

• Some of these questions have forced options and some are open ended questions
regarding CSSD.

• Project started on 18/12/2017 to 27/02/2018

• Data collected through Observation and interaction with CSSD personnel.

 Checklist content
1. Handling,Collection and transportation of contaminated instruments
2. Cleaning and decontamination processes
3. Instrumentation inspection,preparation & Packaging
4. Sterilization and monitoring
5. Sterile storage and distribution
6. Documentation
7. Facility Design
8. Personnel Considerations
 NON COMPLIANCE OBSERVED
Handling,Collection and transportation of contaminated
instruments:
ITEM REVIEVED PROCESS

Secured,dedicated containers are provided for soiled instruments Not practiced

Use of puncture resistant leak proof containers for soiled items Not practiced

Policy and procedure in place for transportation of contaminated items between buildings Not Applicable

Transportation carts should be covered and should prevent items from falling over or off Not practiced
Cleaning and decontamination processes

ITEM REVIEVED PROCESS

Written policies and procedures in place for all cleaning and decontamination process Policy available but
not practiced

Appropriate brushes or cleaning implements designed for use on medical devices are used Partial practice

Brushes/cleaning implemented are either disposable or if reusable ,are decontaminated atleast Partial practice
daily
Instrumentation inspection,preparation & Packaging
ITEM REVIEVED PROCESS
Cleaning verification by users should include visual inspection combined with other verification ( ATP) Partial Practice
methods that allow assessment of instrument surfaces
Deligate/ sharp instruments are protected while being handled / assembled for sterilization (may use Not practiced
special holder ,tip guards, or foam sleeves).
Tip protectors should be sterilant permiable
Basins : Partial practice
• graduated basins sholuld differ in diameter by one inch
• use non lining absorbant material between nested basins.
• wraped basin sets should not exceed 11.3 kg ( 7 pounds)
Ridged container system instructions are being followed regarding weight and density of instrument sets. Not practiced

• Packing materials are held for a min.of 2 hours . prior to use at room temp (20 degree C - 23 Degree Not practiced
C) at a relative humidity ranging from 30-60%
 Sterilization and monitoring
ITEM REVIEVED PROCESS
1.Paper - plastic pouches - use baskets to facilitate placing pouches on edge Not practiced

Sterilization and monitoring

2.Implant loads : Monitor with a BI PCD containing a class 5 integrating indicator.Implants should be Not practiced
quarantined until BI results are known,except in emergency situations

3.Non implant loads:optional monitoring with a PCD containing either : a class 5 integrating indicator Not practiced

4.Routine sterilizer efficacy testing testing with a BI PCD is done daily Not practiced

5.Use appropriate BI PCD depending on type of sterilizer Not practiced

6.Qualification testing :For sterilization process failures where the cause is not immediately identifiable and Not practiced
after majorsteam or sterilizers repairs,run 3 empty cycles BI PCD followed by 3 empty cycles with a Bowie -
Dick test oif prevaccum sterilizer.
7. Sterilizer maintenance :-drain strainers are inspected daily for debris Not practiced
-sterilizer external and internal surfaces are routinely cleaned
Sterile storage and distribution
ITEM REVIEVED PROCESS
• Transport carts should have a physical barrier between the bottom shelf and the floor. Not practiced
• Reusable covers should be cleaned after each use.

• Carts are3 decontaminated/ dried before reused for transporting sterile supplies Not practiced
Documentation
ITEM REVIEVED PROCESS
PRODUCT RECALLS: Partial
• Policies &procedures are clear and concise record maintened
• lot control label are used to include : sterilizer ID , lot number, sterilization date
,expiration date, name of pack and initials.

• Sterilization process failure : when cannot immediately identify cause of failure ( eg . Not practiced
selected incorrect cycle setting ), reprocess the load and recall / reprocess all items
dating back to last load in sterilizer with negative BI results
Facility Design
ITEM REVIEVED PROCESS

If centralized reprocessing is not possible , consistant policies and procedures between locations Not applicable
are in place

Emergency eyewash stations ( required by OSHA) located within 10 seconds travel time of all Not practiced
chemical usage locations , with a continuous flush for at least 15 minutes . E.g.,
Decontamination area

Temperature and Humidity monitoring controls in decontamination and clean areas and daily Not practiced
record

Appropriate positive and negative pressure ventilation system in place Not practiced
 Personnel Consideration
ITEM REVIEVED PROCESS
All CS Personnel recieve a minimum annual training on department policies and procedures All Partial
CS personnel demonstrate comprtency annually
Wriiten policy on personal hygiene Not practiced

Written policy on adherence to appropriate CS personnel attire Partial

Written policy on adherence to appropriate PPE in decontamination area Partial

Pre - Audit Outcome
 Deployment Chart
PRIMARY
PROBLEM SECONDARY MEANS FEASIBILITY ACTION TAKEN
MEANS
Policies and Standard operating protocols
CSSD manual implemented
Procedures are not created
there is seperate lift for
transportation of but not
Facility Dedicated elevators provided
having divider contaminated
items
Instrument
Improper assembling of
Handling Regular instrrument sets weight
multipart instruments &
Pre - Audit and Preventable monitoring and proper assembling
overweight
Outcome Packaging
Proper usage of PPE,
Manpower Training on PPE usage is given
Absenteesam
Equipment Cleaning Checklist implemented
Process Failure & Improper
Documetation done for process failure
cleaning

Quality
Assurance PCD not implemented PCD Initiated for every cycle
Monitoring
 POST AUDIT COMPLIANCES
Handling,Collection and transportation of contaminated
instruments:
ITEM REVIEVED PROCESS
Secured,dedicated containers are provided for soiled instruments Implemented, yet to
practice

Use of puncture resistant leak proof containers for soiled items implemented

policy and procedure in place for transportation of contaminated items between buildings Implemented, yet to
practice

transportation carts should be covered and should prevent items from falling over or off yet to implement

dedicated elevators with direct access to decontamination area practicing

Cleaning and decontamination
processes
ITEM REVIEVED PROCESS
written policies and procedures in place for all cleaning and decontamination process Implemented

appropriate brushes or cleaning implements designed for use on medical devices are used Implemented

brushes/cleaning implement are either disposable or if reusable ,are decontaminated atleast daily Implemented
 Instruments
Receiving and
Cleaning
Instrumentation inspection,preparation & Packaging
ITEM REVIEVED PROCESS
Cleaning verification by users should include visual inspection combined with other verification ( ATP) On discussion
methods that allow assessment of instrument surfaces
-Deligate/ sharp instruments are protected while being handled / assembled for sterilization (may use Implemented
special holder ,tip guards, or foam sleeves).
- Tip protectors should be sterilant permiable
complex instruments (air-powered, endoscopes, having lumens or channels) are prepared according to Implemented
written instructions from device mfr.
basins : Implemented and
• graduated basins sholuld differ in diameter by one inch nested basins are
• use non lining absorbant material between nested basins. yet to impliment
• wraped basin sets should not exceed 11.3 kg ( 7 pounds)
Ridged container system instructions are being followed regarding weight and density of instrument sets. Yet to practice

• Packing materials are held for a min.of 2 hours . prior to use at room temp (20 degree C - 23 Degree Implemented
C) at a relative humidity ranging from 30-60%
Instrument preperartion
and sterilization
 Sterilization and monitoring
ITEM REVIEVED PROCESS
1.Paper - plastic pouches - use baskets to facilitate placing pouches on edge implemented

Sterilization and monitoring

2.Implant loads :Monitor with a BI PCD containing a class 5 integrating indicator.Implants should be implemented
quarantined until BI results are known,except in emergency situations

3.Non implant loads:optional monitoring with a PCD containing either : a class 5 integrating indicator implemented

4.Routine sterilizer efficacy testing testing with a BI PCD is done daily implemented

5.Use appropriate BI PCD depending on type of sterilizer implemented

6.Qualification testing :For sterilization process failures where the cause is not immediately identifiable and implemented
after majorsteam or sterilizers repairs,run 3 empty cycles BI PCD followed by 3 empty cycles with a Bowie -
Dick test oif prevaccum sterilizer.
7. Sterilizer maintenance :-drain strainers are inspected daily for debris implemented
-sterilizer external and internal surfaces are routinely cleaned
Sterile storage and distribution
ITEM REVIEVED PROCESS
• Transport carts should have a physical barrier between the bottom shelf and the floor. implemented
• Reusable covers should be cleaned after each use.

• Carts are3 decontaminated/ dried before reused for transporting sterile supplies implemented
Storage and Monitoring
Documentation
ITEM REVIWED PROCESS
PRODUCT RECALLS: implemented
• Policies &procedures are clear and concise
• record maintened
• lot control label are used to include : sterilizer ID , lot number, sterilization date
,expiration date, name of pack and initials.

• Sterilization process failure : when cannot immediately identify cause of failure ( eg . implemented
selected incorrect cycle setting ), reprocess the load and recall / reprocess all items
dating back to last load in sterilizer with negative BI results
Facility Design
ITEM REVIEVED PROCESS
If centralized reprocessing is not possible , consistant policies and procedures between locations implemented
are in place

Emergency eyewash stations ( required by OSHA) located within 10 seconds travel time of all implemented
chemical usage locations , with a continuous flush for at least 15 minutes . E.g.,
Decontamination area
Functional workflow pattern clear distinction (ie physical wall) between dirty and clean implemented

Temperature and Humidity monitoring controls in decontamination and clean areas and daily implemented
record
Appropriate positive and negative pressure ventilation system in place implemented
Floors and walls are constructed from materials that can withstand frequent cleaning implemented
Ceilings are flush surfaces and not of materials that are of particulate or fiber- shedding implemented
composition
 Personnel Consideration
ITEM REVIEVED PROCESS
All CS Personnel recieve a minimum annual training on department policies and procedures All Implemented, yet to
CS personnel demonstrate comprtency annually practice
Written policy on personal hygiene Implemented, yet to
practice

Written policy on adherence to appropriate CS personnel attire Implemented, yet to

practice

Written policy on adherence to appropriate PPE in decontamination area Implemented, yet to

practice
 Conclusions
• CSSD is an independent department with facilities to receive, clean, pack, disinfect, sterilizes, store and distribute
instruments as per well-delineated protocols. Thus it provides all the departments of a hospital with guaranteed
sterile equipment ready and available for immediate use in patient care – a step towards the prevention of hospital
acquired infections(HAI’s).
• Implementation of standard protocols can reduce loss of surgical instruments, reduce instrument damage and
reduce repair costs, automate many tedious training and reporting tasks and reduce the cost spent on investigations
for infection control issues.
• The problems faced in the audit are all common- missing instruments, proper trolleys, infection control issues, lack
of training, monitoring reporting leading to delay in surgeries, procedures. Along with issues like requirement of
adequate staff, regular training, better communication between departments is must to streamline the process and
make it tailor made for individual departments.
• To bring about continuous improvement and update procedures one needs to recommend tools like end user
satisfaction questionnaires and Infection control team audit and feedback.
• End users need to be trained and make them aware of the techniques used. All the reusable medical devices must
be decontaminated following each episode of use.
 References or Bibliography
• William A Rutala, David J. Weber(Health Infection Control Practices Advisory Committee),
Guidelines for disinfection and sterilization in healthcare facilities, 2008.
www.cdc.gov/hipac/disinfectionsterilization.

• The APSIC guidelines for Disinfection and Sterilization of Instruments in healthcare facilities,
Revised Jan 2017.

• ‘Decontamination and Reprocessing Manual for Healthcare Facilities’ WHO Revised CSSD
Manual and Guidelines.