1. CSSD Performance Quality Analysis at a Super
Speciality Hospital
NAME : D. Gandhiraj
DESIGNATION : Microbiologist
2. 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.
3. 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.
4. 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.
5. 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
6. Handling,Collection and transportation of contaminated
instruments:
NON COMPLIANCE OBSERVED
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
7. 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
daily
Partial practice
8. Instrumentation inspection,preparation & Packaging
ITEM REVIEVED PROCESS
Cleaning verification by users should include visual inspection combined with other verification ( ATP)
methods that allow assessment of instrument surfaces
Partial Practice
Deligate/ sharp instruments are protected while being handled / assembled for sterilization (may use
special holder ,tip guards, or foam sleeves).
Tip protectors should be sterilant permiable
Not practiced
Basins :
• 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)
Partial practice
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
C) at a relative humidity ranging from 30-60%
Not practiced
9. Sterilization and monitoring
Sterilization and monitoring
ITEM REVIEVED PROCESS
1.Paper - plastic pouches - use baskets to facilitate placing pouches on edge Not practiced
2.Implant loads : Monitor with a BI PCD containing a class 5 integrating indicator.Implants should be
quarantined until BI results are known,except in emergency situations
Not practiced
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
after majorsteam or sterilizers repairs,run 3 empty cycles BI PCD followed by 3 empty cycles with a Bowie -
Dick test oif prevaccum sterilizer.
Not practiced
7. Sterilizer maintenance :-drain strainers are inspected daily for debris
-sterilizer external and internal surfaces are routinely cleaned
Not practiced
10. Sterile storage and distribution
ITEM REVIEVED PROCESS
• Transport carts should have a physical barrier between the bottom shelf and the floor.
• Reusable covers should be cleaned after each use.
Not practiced
• Carts are3 decontaminated/ dried before reused for transporting sterile supplies Not practiced
11. Documentation
ITEM REVIEVED PROCESS
PRODUCT RECALLS:
• 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.
Partial
• Sterilization process failure : when cannot immediately identify cause of failure ( eg .
selected incorrect cycle setting ), reprocess the load and recall / reprocess all items
dating back to last load in sterilizer with negative BI results
Not practiced
12. Facility Design
ITEM REVIEVED PROCESS
If centralized reprocessing is not possible , consistant policies and procedures between locations
are in place
Not applicable
Emergency eyewash stations ( required by OSHA) located within 10 seconds travel time of all
chemical usage locations , with a continuous flush for at least 15 minutes . E.g.,
Decontamination area
Not practiced
Temperature and Humidity monitoring controls in decontamination and clean areas and daily
record
Not practiced
Appropriate positive and negative pressure ventilation system in place Not practiced
13. Personnel Consideration
ITEM REVIEVED PROCESS
All CS Personnel recieve a minimum annual training on department policies and procedures All
CS personnel demonstrate comprtency annually
Partial
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
15. PROBLEM
PRIMARY
MEANS
SECONDARY MEANS FEASIBILITY ACTION TAKEN
Pre - Audit
Outcome
Policies and
Procedures
Standard operating protocols
are not created
Preventable
CSSD manual implemented
Facility
there is seperate lift for
transportation of but not
having divider contaminated
items
Dedicated elevators provided
Instrument
Handling
and
Packaging
Improper assembling of
multipart instruments &
overweight
Regular instrrument sets weight
monitoring and proper assembling
Manpower
Proper usage of PPE,
Absenteesam
Training on PPE usage is given
Equipment Process Failure & Improper
cleaning
Cleaning Checklist implemented
Documetation done for process failure
Quality
Assurance
Monitoring
PCD not implemented PCD Initiated for every cycle
Deployment Chart
16.
17. Handling,Collection and transportation of contaminated
instruments:
POST AUDIT COMPLIANCES
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
18. 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
20. Instrumentation inspection,preparation & Packaging
ITEM REVIEVED PROCESS
Cleaning verification by users should include visual inspection combined with other verification ( ATP)
methods that allow assessment of instrument surfaces
On discussion
-Deligate/ sharp instruments are protected while being handled / assembled for sterilization (may use
special holder ,tip guards, or foam sleeves).
- Tip protectors should be sterilant permiable
Implemented
complex instruments (air-powered, endoscopes, having lumens or channels) are prepared according to
written instructions from device mfr.
Implemented
basins :
• 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)
Implemented and
nested basins are
yet to impliment
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
C) at a relative humidity ranging from 30-60%
Implemented
22. Sterilization and monitoring
Sterilization and monitoring
ITEM REVIEVED PROCESS
1.Paper - plastic pouches - use baskets to facilitate placing pouches on edge implemented
2.Implant loads :Monitor with a BI PCD containing a class 5 integrating indicator.Implants should be
quarantined until BI results are known,except in emergency situations
implemented
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
after majorsteam or sterilizers repairs,run 3 empty cycles BI PCD followed by 3 empty cycles with a Bowie -
Dick test oif prevaccum sterilizer.
implemented
7. Sterilizer maintenance :-drain strainers are inspected daily for debris
-sterilizer external and internal surfaces are routinely cleaned
implemented
23. Sterile storage and distribution
ITEM REVIEVED PROCESS
• Transport carts should have a physical barrier between the bottom shelf and the floor.
• Reusable covers should be cleaned after each use.
implemented
• Carts are3 decontaminated/ dried before reused for transporting sterile supplies implemented
25. Documentation
ITEM REVIWED PROCESS
PRODUCT RECALLS:
• 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.
implemented
• Sterilization process failure : when cannot immediately identify cause of failure ( eg .
selected incorrect cycle setting ), reprocess the load and recall / reprocess all items
dating back to last load in sterilizer with negative BI results
implemented
26. Facility Design
ITEM REVIEVED PROCESS
If centralized reprocessing is not possible , consistant policies and procedures between locations
are in place
implemented
Emergency eyewash stations ( required by OSHA) located within 10 seconds travel time of all
chemical usage locations , with a continuous flush for at least 15 minutes . E.g.,
Decontamination area
implemented
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
record
implemented
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
composition
implemented
27. Personnel Consideration
ITEM REVIEVED PROCESS
All CS Personnel recieve a minimum annual training on department policies and procedures All
CS personnel demonstrate comprtency annually
Implemented, yet to
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
28. 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.
29. 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.
