Infection Prevention in the Outpatient Setting...11/7/2016 2 Cleaning, Sterilization, & High Level...
Transcript of Infection Prevention in the Outpatient Setting...11/7/2016 2 Cleaning, Sterilization, & High Level...
11/7/2016
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Infection Prevention in the Outpatient Setting
Lynn Skelton, BSN, RN, CICManager Epidemiology and Infection Prevention Advocate Medical Group and Advocate Dreyer
Kelli Heisner, BSN, RN, CICInfection Preventionist
Advocate Medical Group and Advocate Dreyer
Advocate Medical Group & Advocate Dreyer• Advocate Medical Group (AMG)
– More than 350 locations throughout Chicagoland and Central
Illinois
• Including 56 Advocate Clinics at Walgreens
– More than 1,500 physicians and advanced practice clinicians
• Primary Care, Family Medicine, Immediate Care, and more than 50
medical and surgical specialties
• Advocate Dreyer
– 13 locations
– More than 230 physicians and advanced practice clinicians
• Primary Care, Family Medicine, Immediate Care, and more than 28
medical and surgical specialties
Infection Prevention• No dedicated Infection Prevention Program
prior to January 2015
• Currently 3.0 FTE
– January 2015 - Manager of Infection Prevention
and Epidemiology RN hired
– July 2015 - Infection Preventionist RN hired
– August 2016 - Infection Preventionist MT hired
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Cleaning, Sterilization, & High Level Disinfection (HLD)
ObjectivesAt the conclusion of this presentation, participants will be
able to:
• Explain the difference between cleaning, disinfection,
and sterilization
• Match the Spaulding Classification for Medical Devices
with the required level of disinfection for medical
equipment
• Translate the process of cleaning, sterilization, and high
level disinfection in your own setting
• Develop an instrument Recall Procedure
• Develop a cleaning, sterilization and high level
disinfection competency
Background• 2014 - Formal education completed
• 2015 - Leadership and Infection Prevention audits
identified inconsistent practices
• Several new sites acquired since 2014 education
• Several cleaning and sterilization products not on
contract with the health system
• Physician practice sites primarily staffed by medical
assistance (MA) who are expected to perform sterile
processing duties amongst their other duties– Variability in sterile processing education
– High turn over
• 9/11/15: CDC/FDA Health Advisory Issued– Immediate Need for Healthcare Facilities to Review Procedures for
Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices
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How did we start?• Identified the following:
– Outpatient sites that have sterilizers
– Types of sterilizers
– Products being used for cleaning, high level
disinfection, and sterilization
– Procedures being performed
– Instruments being used
– Instructions For Use (IFU) of instruments, products,
and autoclave
• Completed education needs assessment
• Standardized, educated, and audited our
process
What is the difference between cleaning, disinfection, and sterilization?• Cleaning
– General removal of debris (dirt, food, feces, blood, saliva and other body secretions)
– Reduces amount of organic matter that contributes to proliferation of bacteria and viruses
• Disinfection– Removes most organisms present on surfaces that can cause
infection or disease• Low Level Disinfection (LLD) – kills some viruses and bacteria
• Intermediate Level Disinfection (ILD) – kills mycobacteria, most viruses, and bacteria
• High Level Disinfection (HLD) – kills all organisms, except high levels of bacterial spores
• Sterilization– The killing or removal of all organisms, including bacteria,
viruses, spores, and fungi
Spaulding Classification for Medical Devices and Levels of Disinfection• Noncritical Items:
Devices that do not ordinarily touch the patient or touch only intact
skin. These devices should be cleaned by low-level disinfection.
• Semi critical Items:A device that comes into contact with intact mucous membranes and
does not ordinarily penetrate sterile tissue. These devices should
receive at least high-level disinfection.
• Critical Items:A device that enters normally sterile tissue, the vascular system, or
through which blood flows. Such devices should be sterilized.
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Patient ContactDevice
ClassificationExamples
RecommendedLevel of
Processing• Low Level Disinfection
(LLD)• High Level Disinfection
(HLD)• Sterilization
Intact Skin Noncritical Items LLD
Mucousmembranes ornon-intact skin
Semi critical Items
• At a minimumHLD
• Sterilization acceptable for surgical instruments
Sterile areas ofthe body,including contact with Vascular System
Critical Items Sterilization
Cleaning, Disinfecting and Sterilizing… Easy Process??
Cleaning of Instruments
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Clean vs. Soiled Utility Rooms
• Current State: All practice sites are space
constrained
– Many sites are performing cleaning of soiled
instruments in the same room with sterilization and
high level disinfection
– Physician practice buildings were not built with
infection prevention in mind
• Ideal State: Each practice site has a separate
clean and soiled utility room
– Sterilization and HLD should take place in a clean
room
IF IT IS
NOT
CLEAN
IT CAN
NOT BE
STERILE
Transporting Soiled Instruments
“Approved container – a rigid container
with a cover will be used if dirty instruments
or equipment need to be transported to a
soiled utility area for cleaning and
sterilization”
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Instrument Transport Spray
• Surfactant-based gel with corrosion inhibitors
which allows instruments to stay moist so
blood and body fluid don’t dry on
• Spray on instruments at point of use prior to
transferring to the soiled utility room
Enzymatic Detergent
• A detergent that removes soil and debris from
instruments prior to sterilization.
• Dual protease enzyme that attacks blood and fat
• Excellent cleaning properties
• Safe for surgical and endoscopic instruments
• Follow manufacturer guidelines for:
– Dilution
– Soaking time
Enzymatic Detergent PPE• Use PPE including fluid resistant gown, gloves,
face shield or facemask with eye shield every
time you use this product.
– Enzymatic detergents can cause skin irritation and eye
damage if they come in contact with your skin or eyes
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Brushes• Scrub instruments, as needed, below
surface of enzymatic solution using a
non-metal scrub brush
• Brushes shall be changed when brush
bristles are frayed
• Follow manufacturer guidelines related to
cleaning of brushes
• Brushes should be available for all
instruments including lumen instruments
Instrument Lubrication
• Instrument lubrication is used to:
– Prevent rusting
– Keep surgical instruments operating freely and
easily
• Follow lubricant manufacturer guidelines
Instrument Cleaning Process• Don PPE
• Place instruments in the enzymatic solution.
– *Important* - Instruments must be in the open unlocked
position while soaking
– Take apart instruments that come apart for effective cleaning
• Scrub instruments, as needed, below the surface of
enzymatic solution using a non-metal scrub brush
• Soak instruments in the enzymatic solution per
manufacturer recommendations
• Rinse instruments in warm tap water
– Be aware of possible sharp objects in soaking solution –
remove instruments with caution
– Inspect instrument to be sure that all debris and blood or
body fluids are removed
• Dip hinged instruments in lubrication solution
• Allow instruments to air dry
*Important* - Instruments must be completely dry before you
can package and place in sterilizer.
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Instrument Inspection
Instrument Inspection• Instrument inspection is a key step in safety
• Instruments will wear over time and if not
inspected on a regular basis can cause harm
to patients and/or frustration for your provider
• Key things to look for when inspecting your
instruments are:
– Stains, rust, dried on blood or tissue debris
– Cracks, wear, missing pieces, finish damage
The larger the crack the
longer it has been therePlating/metal finish can chip off
Paper Test determines unstable
finish - Rub with gloved hands
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Instrument Inspection Example
Instrument Teeth Inspection
This is what they should look like
Examples of Damaged Teeth
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How to inspect an instrument• Inspect instrument for cleanliness:
– If blood or debris still present, re-wash in enzymatic detergent
utilizing scrub brush
• Inspect instrument for damage and sharpness:
– Remove from service any instruments with any defects
– Place appropriate tag on instrument:
• Red Tag = Repair of Instrument
• Yellow Tag = Sharpening of Instrument
– Schedule appointment with instrument repair company
• Inspect instrument for wetness:
– Visually inspect instrument for any signs of wetness
– If wet, allow instrument to dry longer
Instrument Pouching
Pouching 101
Do not fold over to fit item
Improper gap
The fold line is in the wrong place
Always fold at the perforation with
no gaps
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Packaging Instruments in Pouches• Place sharp instrument tips in approved tip
protectors
• Place dry clean instruments, handles in first, in a
pouch appropriate to the size of the instrument
• Instruments are to be in the open unlocked position
• Place a chemical indicator in pouch
Packaging Instruments in Wrapping• Use only one step wrap in appropriate size - Do not cut
the wrap
• Heavier instruments are placed in the tray first
• Curved tips are always positioned in the same direction
• Cupped or concaved instruments are positioned to avoid
water/condensation collection
• Place a chemical indicator in tray and optional outside of
tray
• Secure wrap with a maximum of 3 strips steam indicator
tape
Labeling – Our Process• Label the outside of wrapped packages and the
lower right hand corner plastic side of pouches
with an alcohol based marker (e.g. Scripto or
Sharpie) if label gun not available.
• Include the following:
– Date sterilized
– Load number
– Initials of person performing the sterilization process
– Department if it is a shared autoclave
– Sterilizer name or number, if more than one sterilizer
at the site
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Autoclaves
Methods of Sterilization• Steam Flush Pressure Pulse - a repeated sequence consisting of
a steam flush and a pressure pulse system that removes air from
the sterilizing chamber and processed materials using steam at
above atmospheric pressure (no vacuum is required).
– No approved biological indicator for Ritter MidMark
Methods of Sterilization• Gravity - steam is pumped into a chamber containing ambient air.
Because steam has a lower density than air, it rises to the top of the
chamber and eventually displaces all the air. As steam fills the
chamber, the air is forced out through a drain vent. By pushing the
air out, the steam is able to directly contact the load and begin to
sterilize it
Amsco
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Methods of Sterilization• Pre-Vacuum - a series of alternating steam pressure injections and
vacuum draws (also called pulses) to dynamically remove the air
from the chamber
Gettinge Steris
Loading a Sterilizer• Pouches:
– Standing on edge with paper side of one pouch next to plastic
side of the other – must be able to put your hand between
pouches
• This cannot be done unless you have the correct tray
– Lying flat with paper side down
• Single layer, may overlap but not stack on each other
• Wrapped Packs:– Solid tray: Loosely loaded and positioned on edge so that all
fabric layers are perpendicular to the shelf
– Perforated or Mesh tray: Load with tray bottom down
Sterilization Quality Controls
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Monitoring Sterilization • Mechanical Indicators
– Not indicator of sterility
– Gauges, displays, printouts
– Indicates if device working properly
• Chemical Indicators – Not indicator of sterility
– Change color with timed exposure to heat, steam
– Used to show items have gone through sterilization process
– Class 1 thru 5
• Biological Indicators – Indicator of sterility
– Demonstrates bacterial spores on test strips or in vials/containers have all been killed
Chemical Indicator/Integrator (CI)
• EVERY pouch and tray EVERY time
• Ensure that a CI is placed where it is visible
in each pouch
• Confirm that the strip change passes when
removing pouch from the autoclave
Tier Site Recommended Time for BI
Tier 1 Ambulatory Surgery Center (ASC)
• Treat like a hospital operating room
• 1 hour BI
Tier 2 High Volume Sites• Sites that use the
sterilizer daily
• 3 hour BI daily• Tuttnauer only – 1 hour
BI daily
Tier 3 Low Volume Sites• Sites that use thesterilizer 1-4 times/week
or less
• 48 hour BI weekly(CDC and AAMI minimum standard)
Biological Indicators (BI)AMG Tiered Risk Assessment
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AMG Biological Indicator QC• Select 2 BI ampules with the same lot number
• Label BI ampules as follows:
– BI ampule #1 – “P”, date, load #, autoclave #, initials
– BI ampule #2 – “C”, date, initials
• Crush the control “C” BI ampule and incubate
• Create a challenge pack
– Pouch: “P” ampule and chemical integrator/indicator
– Wrapped pack: old instruments, “P” ampule, and chemical
integrator/indicator
• Place challenge pack in the most difficult area inside the
sterilizer (i.e. next to the drain, in the center of multiple
pouch/pack load)
– Place other pouches that need to be sterilized in your BI test load but they
cannot be released for use until your biological testing has passed.
• Run load
• Remove challenge pack.
– Allow to cool for 10 min
AMG Biological Indicator QC• Crush the processed (P) BI ampule and incubate
– Let BI ampule incubate for the specified amount of time according to
your tier level.
• Read BI Results– Tier 2: Read auto reader display screen
• Processed (P) ampule should display a negative (-) sign.
• Control (C) ampule should display a positive (+) sign indicating spores are
detected
– Tier 3: Observe BI ampule for color change
Processed (P) ampule
should remain purple and
clear
Control (C) ampule
should turn yellow and
cloudy
Failed Biological Indicators
• Repeat BI test in the next load
– Failure could be due to human error
• If repeat BI passes, the sterilizer can continue
to be used
• If repeat BI fails, follow the “AMG Recall of
Sterilized Items due to Positive Biological
Indicator” Procedure
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AMG Recall of Sterilized Items due to Biological Indicator Failure• Notify your immediate supervisor
• Identify and remove from stock, all items that have been
sterilized since last negative BI
• Record the positive BI result in the logbook in “Red” ink
• Remove sterilizer from service, apply red tag for
nonconforming products, and contact ACE.
• Report incident per protocol
• Notify providers in office,
Infection Prevention, Quality,
and Risk Management
AMG Recall of Sterilized Items due to Biological Indicator Failure• Record on the Sterilization Instrument Recall Log the
items retrieved, items not retrieved in the recall, and
actions taken on recalled items
AMG Recall of Sterilized Items due to Biological Indicator Failure• If recalled items have been used, identify what patient(s)
the items were used on. Complete the Instrument Recall
– Patient Log and send to infection prevention
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Additional BI Testing
• 3 consecutive cycles should be run, 1 right
after the other with a challenge pack when
the following occurs:
– After repair or replacement of a sterilizer
– Upon relocation of the sterilizer
– After new sterilizer installation
• 1 BI shall be run with each load containing an
implant
Instrument Storage
Storage of Sterilized Instruments (CDC)
• 8-10 inches from the floor
• 18-20 inches from the ceiling
• 2 inches from an outside wall
• Closed shelving/storage is preferred
• “First in, First out” stock rotation
system
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Event Related Sterility
• Once instruments are
sterilized, they are
considered sterile unless:
– Package is opened, damaged,
or wet
• Always inspect packaging
prior to use.
If opened, damaged or wet
Do not use
High Level Disinfection
Disinfection Soak Container/Station
• Containers used for HLD
• Different types of systems based on air
exchanges
• Less than 10 air exchanges per hour requires
special system with filter to effectively
neutralized and clean air is returned to the
room
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High Level Disinfection Process• Don PPE per manufacturer recommendations
• Test HLD poured solution in covered container with the
test strips
• Check temperature of HLD solution to ensure solution is
in acceptable range per manufacturer guidelines
• Immerse clean item in HLD solution
• Soak per manufacturer specified time frame
• Following soak, rinse HLD solution off per manufacturer
guidelines
• Allow to item to dry
• Cover item to prevent recontamination
High Level Disinfection – Logs
High Level Disinfection – Testing and Disinfection Log
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Associate Education & Audits
Education Classes• Mandatory for all associates who perform
cleaning, HLD, and/or sterilization
• Held 17 classes from 10/2015 to 11/2016
• 162 associates attended
• 4 hour class
– 2 hour presentation
– 2 hour hands on competency with vendors
• Pre/Post Test
Competency• Created a step by step competency outlining
the procedure
• Developed case scenarios and required
demonstration for hands on portion of class.
– Autoclave
– Cleaning
– Instrument Inspection and Instrument Lubrication
– Tip Protectors, Chemical Integrators, and
Pouching
– Biological Indicators
– High Level Disinfection
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Pre/Post Test Results
99%
71%
81%
99%
99%
83%
72%
92%
42%
51%
93%
97%
41%
40%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Q: Sterilization is defined as___ .A: Killing/removing of all organisms, including bacteria, viruses, spores, and
fungi
Q: According to Spaulding’s classification, a device that comes into contact with mucus membranes and does not ordinarily penetrate sterile tissue needs
to be A: High Level Disinfection
Q: What is the appropriate enzymatic solution to water ratio?A: 1 pump of enzymatic solution to 1 gallon water
Q: Instruments with hinges should be in the ___ position when cleaned,packaged, and sterilized.
A: Open
Q: Instruments are pouched correctly when____.A: All the above
Q: Where is the correct place to label a pouch?A: Lower right hand corner of plastic side
Q: AMG is using a tiered approach for biological indicators. What tier would asite be in that uses their autoclave 3 times per week?
A: Tier 3
AMG Pre/Post Test Results
Pre-Test Post-Test
Pouching Job Instruction
Biological Indicator Job Instruction
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AuditsDevelop audit tool based on standardized
process to monitor your sites for compliance
Infection Prevention Plan and Risk Assessment
Development
ObjectivesAt the conclusion of this presentation, participants will
be able to:
• Assess scope of services for each specialty, the
community served, county specific communicable
diseases, high risk patient/services, and employee
risks
• Identify the components for the development of the
Infection Prevention Plan
• Construct measurable goals with actionable steps
• Develop a comprehensive risk assessment and
Infection Prevention Plan
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Where do I start?
• Obtain an comprehensive list of all practice
sites including location and specialty
• Group practice locations by county
• Develop map
Map Examples
County Communicable Disease Report
• Obtain each county communicable disease
report
– County Website
– Contact County
• Review for the top 5 communicable disease
for each county
• Review the sexually transmitted infections
(STI) for each county
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Additional Data to Collect• High risk patients seen
– Transplant
– Cystic Fibrosis
– Immunocompromised
– Oncology
• High risk procedures preformed
• Risk Management trends
– Bed bugs
• Employee Health trends
– Needle stick injuries
– Communicable disease exposures
Risk Assessment Example
Components of an Infection Prevention Plan• Purpose
• Geographic Location and Community/Patient
Population
• Authority
• Infection Prevention Program
– Responsibility of the Infection Prevention Committee
– Scope
• Program Risk Assessment
• Program Goals and Strategies
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Components of an Infection Prevention Plan• Infection Prevention and Control Policies and
Guidelines
• Regulatory Accreditation
• Surveillance Definition
• Surveillance Activities and Patient Surveillance
– Microbiology Surveillance
– Environmental Surveillance
– Employee Surveillance
• Benchmarking
Components of an Infection Prevention Plan• Medical Equipment, Devices, and Supplies
• Outbreak Investigation
• Communication and Education
• Influx of Potentially Communicable Patients
• Influenza Vaccinations
• Construction and Design
• Hand Hygiene
• Annual Program and Policy Review
• References
Goals• Identify areas for improvement based of risk
assessment and practice site visits
• Create goals that are specific, measurable,
action oriented, realistic, and time based
(SMART)
• For each goal, identify actionable steps to
achieve goal
• Monitor ongoing progress of each goal
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Goal Example
Lynn Skelton, BSN, RN, CIC
Manager Epidemiology Infection Prevention
224-783-1468
Kelli Heisner, BSN, RN, CIC
Infection Preventionist
224-783-1332