Infection Prevention in the Outpatient Setting

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1 Infection Prevention in the Outpatient Setting Lynn Skelton, BSN, RN, CIC Manager Epidemiology and Infection Prevention Advocate Medical Group and Advocate Dreyer Kelli Heisner, BSN, RN, CIC Infection 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 Manager of Infection Prevention and Epidemiology RN hired July Infection Preventionist RN hired August Infection Preventionist MT hired 1

2 Cleaning, Sterilization, & High Level Disinfection (HLD) Objectives At 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 Formal education completed 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 2

3 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. 3

4 Patient Contact Device Classification Examples Recommended Level of Processing Low Level Disinfection (LLD) High Level Disinfection (HLD) Sterilization Intact Skin Noncritical Items LLD Mucous membranes or non-intact skin Semi critical Items At a minimum HLD Sterilization acceptable for surgical instruments Sterile areas of the body, Critical Items including contact with Vascular System Sterilization Cleaning, Disinfecting and Sterilizing Easy Process?? Cleaning of Instruments 4

5 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 5

6 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 6

7 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. 7

8 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 there Plating/metal finish can chip off Paper Test determines unstable finish - Rub with gloved hands 8

9 Instrument Inspection Example Instrument Teeth Inspection This is what they should look like Examples of Damaged Teeth 9

10 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 10

11 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 11

12 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 12

13 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 13

14 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 Biological Indicators (BI) AMG Tiered Risk Assessment Tier Site Recommended Time for BI Tier 1 Tier 2 Tier 3 Ambulatory Surgery Center (ASC) Treat like a hospital operating room High Volume Sites Sites that use the sterilizer daily 1 hour BI 3 hour BI daily Tuttnauer only 1 hour BI daily Low Volume Sites 48 hour BI weekly Sites that use the (CDC and AAMI minimum sterilizer 1-4 times/week standard) or less 14

15 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 15

16 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 16

17 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 inches from the ceiling 2 inches from an outside wall Closed shelving/storage is preferred First in, First out stock rotation system 17

18 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 18

19 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 19

20 Associate Education & Audits Education Classes Mandatory for all associates who perform cleaning, HLD, and/or sterilization Held 17 classes from 10/2015 to 11/ 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 20

21 Pre/Post Test Results AMG Pre/Post Test Results Q: AMG is using a tiered approach for biological indicators. What tier would a site be in that uses their autoclave 3 times per week? A: Tier 3 40% 72% Q: Where is the correct place to label a pouch? A: Lower right hand corner of plastic side 41% 83% Q: Instruments are pouched correctly when. A: All the above Q: Instruments with hinges should be in the position when cleaned, packaged, and sterilized. A: Open 97% 99% 93% 99% Q: What is the appropriate enzymatic solution to water ratio? A: 1 pump of enzymatic solution to 1 gallon water 51% 81% 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 42% 71% Q: Sterilization is defined as. A: Killing/removing of all organisms, including bacteria, viruses, spores, and fungi 92% 99% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Pre-Test Post-Test Pouching Job Instruction Biological Indicator Job Instruction 21

22 Audits Develop audit tool based on standardized process to monitor your sites for compliance Infection Prevention Plan and Risk Assessment Development Objectives At 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 22

23 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 23

24 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 24

25 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 25

26 Goal Example Lynn Skelton, BSN, RN, CIC Manager Epidemiology Infection Prevention Kelli Heisner, BSN, RN, CIC Infection Preventionist

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