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8/21/2012 Welcome Cleaning and Monitoring Working together to manage risk Today’s Speakers Kathy Thompson, CIH Technical Service Specialist 3M Building & Commercial Services Division [email protected] Grace Thornhill, Ph.D. Technical Service Specialist 3M Infection Prevention Division [email protected] 1 8/21/2012 Cleaning and Monitoring for Risk Management • The importance of surface cleaning and disinfection – Breaking the environmental link in the chain of infection • Understanding non-critical surface disinfectants – Regulations, Guidelines and Standards for disinfection • Why process is just as important as product – Understanding process effects on disinfection • Applying Risk Assessment principles to surface disinfection – Managing the risk of infection by disinfecting surfaces – Considering other risks such as health and safety • Using monitoring to help manage the risk – Improving cleaning outcomes through monitoring • Understanding cleaning monitoring methods – Choosing a method based on your risk • Cleaning and Monitoring – working together The Importance of Surface Cleaning and Disinfection • • • The environment is a source of pathogens that can contribute to Healthcare Associated Infection (HAI) risk Certain microorganisms are more likely than others to be of environmental concern for HAIs – Some live longer in the environment – Some are more difficult to kill with low-level disinfectants – Some have low infectious dose or antibiotic resistance that makes them more likely to create HAI risk Appropriate surface disinfection is needed to reduce risk – Both product and process are important – Understanding both can help target disinfection resources and understand what products and processes you need Role of hospital surfaces in the transmission of emerging health care-associated pathogens: Norovirus, Clostiridum difficle, and Acinetobacter species. Weber, David J., and Rutala, William Al, et. al, Am J Infect Control 2010;38:S25-33 Disease Transmission Cycle Infectious Agent Susceptible Host Chain of Infection Reservoir Disinfection Portal of Entry Portal of Exit Mode of Transmission 2 8/21/2012 Chain of Infection Quiz • What breaks the link in the chain for measles? – Vaccination prevents you from being susceptible – Airborne mode of transmission • What breaks the link in the chain for tuberculosis? – Susceptibility, control the extent of inhalation exposure – Airborne mode of transmission • What breaks the link in the chain for hepatitis B? – OSHA Bloodborne Pathogens Standard • Vaccine for workers at risk, post-exposure evaluation • Needlestick prevention – sharps disposal • Work-practice controls – PPE, disinfecting contaminated surfaces • What breaks the link in the chain for norovirus? – Surface disinfection and other practices (hand hygiene, etc.) to minimize cross-contamination Factors that increase infection risk • Increasingly susceptible people – Older, immune-compromised population – Patients with catheters, IVs, open wounds or incisions • Microorganism characteristics – Resistant to antibiotics, live long and prosper • Increased microorganism exposure – Many people in smaller spaces (Cruise Ships, Hospitals) – Construction activities in healthcare facilities • Increased medical equipment cleaning challenges – More medical equipment in patient care area – More variety of sensitive surfaces on that equipment Understanding Disinfectants • Spaulding Classification based on risk • Regulatory framework for surface disinfectants – EPA Registration Requirements • Disinfectant Chemistries – Microbial Hierarchy for Disinfectant Susceptibility • Devices vs. formulated chemical substances – Room Decontamination Systems • Types of Disinfectants and Sanitizers – Professional or Healthcare Products – Consumer or Food-Service Products 3 8/21/2012 Spaulding's Classification: Disinfection Based on Use Level Definition Procedure Goal Example Critical Devices Objects which Sterilization enter sterile tissue or vascular system Kill all organisms, including spores killed Sterilization of Surgical Instruments Semi Critical Objects which touch mucous membranes or non-intact skin High Level Disinfection Kill all vegetative organisms, spores not killed High level disinfection of Endoscopes Noncritical Objects which touch only intact skin Low level Removal of Disinfection or pathogenic Cleaning organisms Patient Room Clean Rutala et. al. Clin. Inf. Dis. 2004;39:702-9 EPA, FIFRA and Non-Critical Surface Disinfectants • Sanitizers and Disinfectants (Antimicrobials) for non-critical surfaces are regulated by the EPA under FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act) – Office of Pesticide Programs (OPP) in the EPA regulates insecticides, antimicrobials, etc. – FDA regulates some products with similar chemistry for disinfection or sterilization of critical or semi-critical devices • Surface Disinfectants become EPA Registered when acceptable data for them is submitted to the EPA – Efficacy Data – threshold studies showing effectiveness • Efficacy test methods vary and are being revised – Toxicology Data – studies showing adequate safety – Chemistry Data – formula, manufacturing, analytical Disinfectants are regulated by the EPA as pesticides under FIFRA and have an EPA Registration Number Disinfectant claims on the product label should be consistent with EPA-approved claims listed on the EPA label • Several kill times and a general kill time may be listed for different microorganisms where test data has been obtained • A product may be approved as a disinfectant or a cleaner-disinfectant if it shows efficacy in the presence of organic soil • All disinfectants must have an EPA Registration Number displayed on their label, which can be used to retrieve the EPA information for that product • www.epa.gov/pesticides/PPLS/ • EPA Registered Disinfectants are required by law to be used according to their label 4 8/21/2012 Disinfectant Chemistries Common Disinfectants for “Non-critical” Surfaces Germicide Use Concentration Quat/Alcohol Combo RTU typically Quaternary Ammonium Compounds or “Quats” Mfg. use dilution and RTU Phenolic Mfg. use dilution and RTU Chlorine Bleach 500 PPM 5% or RTU 1:100 Dilution (sm. spills) 5000 PPM Hydrogen Peroxide Peracetic Acid 1:10 Dilution (lg. spills) Mfg. use dilution or RTU Devices vs. Formulated Disinfectants Formulated Disinfectants – EPA evaluates Have EPA Registration Numbers Efficacy data submitted to EPA EPA approves label claims Have EPA Establishment Numbers for manufacturing locations Devices – Buyer evaluates Can’t have EPA Registration Numbers as the requirements for efficacy data and EPA label approval do not apply Have EPA Establishment Numbers for manufacturing locations No EPA review of efficacy is part of the process of getting an Establishment No. Device manufacturer may have data Generated by third-party? Is data representative of field use? Room Decontamination Systems • Concern that conventional environmental disinfection is inadequate is a driver • May use airborne chemicals or UV devices • Studies showing effectiveness should be balanced against cost, other factors • Risk to human health? – Exposure to chemicals or physical hazards – HVAC balance, room leakage & re-entrapment – Occupational exposure limits are for workers 5 8/21/2012 Types of EPA Registered Antimicrobials • Sporicidal Disinfectants – Efficacy against Clostridium difficile spores • Intermediate Level Disinfectants (Tuberculocidal) - Kill mycobacteria, vegetative bacteria, most viruses, and most fungi but do not necessarily kill bacterial spores • Low Level Disinfectants - Kill most vegetative bacteria, some fungi, and some viruses (must be tested against certain organisms) – Staphylococcus aureus (gram pos), Salmonella choleraesuis (gram neg), and Pseudomonas aeruginosa to be considered Hospital-Grade Consumer and/or Food-Service Products • General Disinfectants – Efficacy against Staph and Salmonella • Limited Disinfectants – Efficacy against Staph or Salmonella • Food-Contact Sanitizer– Sanitizing efficacy against Staph and E coli in one minute with no potable water rinse Microbes and Susceptibility to Disinfectants Structure of the microorganism affects the level of disinfectant chemistry needed Bacterial Spores Hard to Kill C. difficile Mycobacterium Tuberculosis Non-enveloped viruses Sporicidal disinfectant e.g. chlorine 5000 ppm, peracetic acid Tuberculocidal disinfectant e.g. phenolic , quats, hydrogen peroxide, chlorine 1000 ppm (1:50) Norovirus as surrogate Feline calicivirus Fungi Athletes foot Vegetative Bacteria Easy to Kill Pseudomonas Staphylococcus Hospital grade disinfectant e.g.quats, alcohol, chlorine 100 ppm (1:500) Enveloped viruses HIV/AIDS Hepatitis B Russell, Hugo, Ayliffe. Principles and practice of disinfection, preservation and sterilization. John Wiley & Sons, 2004. Are Disinfectants Effective Against Different Strains? • • • • • Not every genotypic strain of S. aureus has been tested (it would not be possible) When antibiotic-susceptible and antibiotic-resistant bacteria were tested, there was no demonstrated correlation between antibiotic resistance and resistance to disinfectants Because disinfectants destroy microorganisms by disrupting multiple cellular processes, they are immune to the effects of resistance seen against antibiotics, which typically target single cellular processes CDC recommends the use of an EPA-registered disinfectant with a claim against S. aureus to prevent the spread of community associated MRSA Should claims be pathogen specific or can activity against the test organism of any group be used as claim for all of the group Registration of Disinfectants Based on Relative Microbicidal Activity •Author(s): William A. Rutala , PhD, MPH and David J. Weber , MD, MPH, Source: Infection Control and Hospital Epidemiology, Vol. 25, No. 4 (April 2004), pp. 333-341 6 8/21/2012 Six Factors that Influence Cleaning and Disinfection • Number of organisms • Organism soil • Resistance of the microorganism • Surface design • Concentration/dilution • Contact time Friction, detergent and attention to details are key to effective environmental disinfection—Process, Not Product Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008. Rutala, W, Weber, D. Healthcare Infection Control Advisory Committee Recommendations, CDC. Product vs. Process • Both are important • Product is no good if the right process isn’t used • How are you making sure all necessary surfaces are cleaned • How are you verifying that you have obtained and maintained the right disinfectant concentration Verifying and Maintaining Disinfectant Concentration Disinfectant levels can be tested to verify the solution contains the necessary amount of active ingredient(s) • • Check disinfectant level after dilution to verify accuracy of system Check disinfectant level in ready-to-use container to verify correct concentration is maintained during surface application – Quat test paper, titration kits preferred for accuracy – Bleach (Chlorine) test paper to verify dilution and freshness Use practices to maintain disinfectant levels and prevent contamination – Use new cleaning cloths and mops for each patient room – Do not contaminate the disinfectant – Avoid dipping dirty cleaning cloths into basins of disinfectant – Do not rinse and wring out mop heads in the bucket of disinfectant 7 8/21/2012 Norovirus Norovirus (Norwalk Virus) • Common cause of human gastroenteritis • Highly contagious – low infectious dose • Disinfectant claims are for surrogate – Feline Calicivirus or FCV CDC Guideline for the Prevention and Control of Norovirus Gastroenteritis Outbreaks in Healthcare Settings – Routine cleaning and disinfection of high-touch surfaces and equipment in isolation, cohort, and high-traffic clinical areas – Clean and disinfect shared equipment between patient uses – Increase frequency of cleaning and disinfection during outbreaks to twice daily at the unit level and three times a daily for high-touch surfaces – Use bleach or disinfectant with Norovirus or surrogate claims Contact Time on Non-Critical Surfaces • Use EPA-registered disinfectant per manufacturer recommendations • Many EPA-registered hospital disinfectants still have a general label contact time of 10 minutes, though a few organisms have shorter contact times specifically listed • Multiple scientific studies have demonstrated the efficacy of hospital disinfectants against pathogens with a contact time of at least 1 minute • Surveyors will expect label contact time to be followed • Use a Risk Assessment approach to determining disinfectant choices and process steps (www.disinfectionandsterilization.org – APIC 2011) Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008. Rutala, W, Weber, D. Healthcare Infection Control Advisory Committee Recommendations, CDC. What is Appropriate Surface Disinfection? • Disinfectant Claims – – – – Types and Chemistry Microorganisms and Kill Time Formulated vs. Devices Critically evaluate claims • Product vs. Process – Can the product make up for a poor process? – Maintaining disinfectant concentration – Quality Assurance methods • Balancing all the Factors – Efficacy and Process – Worker and Patient Safety – Use a risk assessment process to get the most infection reduction out of your disinfection resources with acceptable safety margins Balancing the factors that influence appropriate surface disinfection to reduce risk 8 8/21/2012 What is a Risk Assessment? • Structured process to analyze the risk in terms of consequences and their probabilities • Provides a basis for decision about the most appropriate approach to be used • Process depends on the application – Worker Health Risk using Formalin in Lab = Hazard x Exposure – Formaldehyde exposure limits based on intrinsic toxicological hazards (0.75 ppm as 8 hour TWA, 2 ppm as 15 min STEL) – OSHA requires evaluation (e.g. air sampling) to verify inhalation exposure is below limits and other activities to manage health risk – Air Sampling data is used to analyze the risk and decide if inhalation exposure controls (e.g. ventilation) are needed ISO/IEC 31010:2009, OSHA Formaldehyde Standard 29 CFR 1910.1048 Risk Assessments and GHS (Globally Harmonized System) • What is GHS? – A system of classifying and labeling hazardous chemicals that will now be used in the US for HazCom 2012 • The MSDS is a resource for chemical safety information used in worker risk assessments – Information on the (M)SDS will change with GHS • Understanding the difference between old and new OSHA Hazard Communication Standard requirements and information will be useful for managing worker and patient safety risk – May see new hazard information US Federal Register, March 26, 2012, US Government Printing Office, Washington, DC. Infection Control Risk Assessment (ICRA) • Risk Assessment is part of The Joint Commission Infection Control Standards (IC.01.03.01) • A comprehensive risk assessment becomes the basis for establishing program goals (IC.01.04), implementation (IC.02) and evaluation (IC.03) • The Joint Commission Environment of Care Standards require an ICRA for healthcare construction activities to minimize infection risk • Consider implementing Surface Disinfection Risk Assessments as a multidisciplinary process with EVS, Infection Prevention, including Employee Health and Safety The Joint Commission: The Source, February, Volume 8, Issue 2, 2010 9 8/21/2012 Cleaning and Monitoring for Risk Management • The importance of surface cleaning and disinfection – Breaking the environmental link in the chain of infection • Understanding non-critical surface disinfectants – Regulations, Guidelines and Standards for disinfection • Why process is just as important as product – Understanding process effects on disinfection • Applying Risk Assessment principles to surface disinfection – Managing the risk of infection by disinfecting surfaces – Considering other risks such as health and safety • Using monitoring to help manage the risk – Improving cleaning outcomes through monitoring • Understanding cleaning monitoring methods – Choosing a method based on your risk • Cleaning and Monitoring – working together What is the greatest risk to patients? Admission to a room previously occupied by a patient who was colonized or infected with a multi-drug resistant organism. Underlying Elements that Contribute to Risk • MDRO and their persistence in the environment • Suboptimal Cleaning Performance • The environment is harder to clean 10 8/21/2012 MDRO Survival in the Environment MDRO Duration of Survival Acinetobacter Days to 5 months Clostridium difficile Weeks to years Enterococcus (VRE) Days to 4 months Staphylococcus aureus (MRSA) Weeks to months Hepatitis B virus 7 days Norovirus 12-14 days Kramer A et al. BMC Infect Dis 2006, 6:130 Hota B Clin Infect Dis 2004; 39:1182 Performance: How are we doing? • • • • Are protocols being followed? Is cleaning efficacious? Is performance consistent? Who cleans what? Studies show that there is room for improvement Monitoring Daily Cleaning Practices Using an ATP Bioluminescence Assay Boyce JM et al. ICHE 2009;30:678 • Objective - To evaluate the usefulness of an adenosine triphosphate (ATP) bioluminescence assay for assessing the efficacy of daily hospital cleaning practices. • Conclusions - Suboptimal cleaning practices were documented by determining aerobic colony counts and by use of an ATP bioluminescence assay. ATP readings provided quantitative evidence of improved cleanliness of high-touch surfaces after the implementation of an intervention program. 11 8/21/2012 Rooms are harder to clean! Increase in Complexity • • • • • Beds Electronics Mobile Equipment Personal items Who cleans what??? Strategy to Manage Risk Hospital Hygiene Bundle “Interventions that are critical and effective for assuring a clean and disinfected environment” Ruth Carrico, Ph.D, RN, FSHEA, CIC Lead Clinical Advisor AHE Clean Spaces Healthy Patients http://cleanspaces.site.apic.org/tools-and-resources/tools-and-resources/ Proposed Bundle Elements • • • • • • • • • • Disinfectant: Selection and Proper Use Identification of surfaces and items to be cleaned/disinfected PPE: Selection and Use Clean/Disinfect Surfaces and items using correct techniques Identify and report breaches in Infection Prevention Follow Infection Prevention Practices Proper Hand Hygiene Monitoring effectiveness of cleaning/provide feedback Develop clear policies and procedures Effective education program Ruth Carrico, Ph.D. Clean Spaces, Healthy Patients Nancy Havill, CIC, Hosp. of St. Raphael, CT. APIC 2012 Clean Spaces, Healthy Patients 12 8/21/2012 Environmental Monitoring Program EVS and IP share responsibility • • • • • • • Ensure compliance to established protocols Identify problems and assess risk Define what “clean” means in your facility Ensure your process is under control Focus and drive process improvement Assess staff competency Confirm staff training Monitoring means: Check, supervise, watch, keep track of…. How do we monitor environmental cleaning? • • • • Visual Inspection Aerobic Colony Counts (ACC) Fluorescent Dyes/Powders/Gel ATP Bioluminescence Current Standard Practice: Visual Examination Visual assessment is not an accurate measure of surface cleanliness nor of microbial contamination. It can be a misleading measure of cleaning efficacy. Boyce et al. Monitoring the Effectiveness of Hospital Cleaning Practices by Use of an Adenosine Triphosphate Bioluminescence Assay Infection Control and Hospital Epidemiology. July 2009, 30: 678-684. 13 8/21/2012 Aerobic Colony Counts (ACC) • Environmental surfaces are cultured for the presence of aerobic bacteria. – Swab surface and culture on nutrient media – Dip slides or RODAC plates –nutrient agar is pressed directly onto the environmental surface • Results are quantitative: CFU/ area tested • Pathogens are identified in some cases. Fluorescent Powders/Lotions/Gels “Enhanced” Visual Inspection • UV fluorescent molecules are incorporated into water soluble gels , powders or lotions and used to mark an environmental surface. • The surface is cleaned and then re-inspected by using a UVA light. The removal or partial removal of the fluorescent marker indicates if a surface has been wiped. • Generates Qualitative Results: • Has the surface been wiped? Yes/No • Does not tell you if a surface is clean. Adenosine Tri-phosphate (ATP) Bioluminescence • ATP is present in all living organisms – animal, plant, microorganisms, human secretions and excretions. • Contaminated surfaces show high levels of ATP, clean surfaces show low ATP levels. • The surface is swabbed and the ATP levels measured in a luminometer • Results are quantitative: Measured in Relative Light Units (RLU) • Benchmark RLU levels used to define “clean” 14 8/21/2012 Methods for Assessing Cleaning Practices Method Advantages Disadvantages Visual inspection •Simple •Not reliable measure of cleanliness Fluorescent marker system •Inexpensive •Minimal equipment needed •Can improve practices •Must mark surfaces before cleaning, and check them after cleaning •Does not provide quantitative measures Aerobic colony counts •Relatively simple •Detects presence of pathogens •More expensive •Results not available for 48 hrs later ATP bioluminescence assay systems •Provides quantitative measure of cleanliness •Quick results •Can improve practices •More expensive •Requires special equipment John M. Boyce, MD, APIC 2010 , Improving Cleaning and Disinfection and How to Monitor the Effectiveness of Surface Disinfection. Working Together to Manage Risk • Common goals – Patient Safety – Clean and Safe Environment • EVS policies and procedures • IP Bundle • Common language – Data from Monitoring Program Questions ??? 15