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

lynn.skelton@advocatehealth.com

224-783-1468

Kelli Heisner, BSN, RN, CIC

Infection Preventionist

kelli.heisner@advocatehealth.com

224-783-1332