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Legionellosis: Risk Management Planning Indiana Chapter, Fall Conference of the: Association for Professionals in Infection Control and Epidemiology Michael Coughlin, Ph.D. Weas Engineering, Inc. October 10, 2014 Discussion Topics Legionella Legionellosis

Hazard Assessment Risk Mitigation Plan Validation Response to Outbreak Discussion Topics Legionella Legionellosis Risk Management Plan Philadelphia: July, 1976

Mysterious Illness Affects 221 People 147 Hospitalized 34 Deaths Pneumonia with Flu-like Symptoms Fever Muscle aches Cough Purulent sputum Fluid in lung Could not visualize any micro-organisms from biopsy

Could not culture any micro-organisms from biopsy Did not respond to conventional antibiotic therapy for pneumonia Legionella The bug Gram negative aerobic bacillus Intercellular parasite Fastidious nutritional requirements

Amoeba Ciliated protozoa Amino Acid Cysteine High Iron Demand Very slow growing Heat tolerant Chlorine tolerant Legionellosis: The Disease

The Infection Acquired via inhalation of microscopic mist particles: < 5 microns Very often found in alveoli Not spread person to person 8,000 18,000 LD hospitalizations/year (CDC) 85% Sporadic 15% Outbreak 8% of diagnosed pneumonias are LD > 90% are of serotype 1 ~ 10% serogroups 2-14, L. longbeachae, L. bozemanii Legionellosis: The Disease Infectious Sources

Cooling Towers Ornamental Ponds Vegetable Misters Cooling Misters Nebulizers Stand Alone Humidifiers Shower Heads Tap Aerators Spas Misting Tents Birthing Baths

Ice Machines Compost Legionellosis: The Disease Legionnaires Disease (LD) Pontiac Fever Disease Pneumonia but with Flu-Like Symptoms Flu-Like At Risk Immunocompromised Heavy drinkers Smokers and COPD All

Treatment Zithromax Levoquin None Required Organism All Legionella, especially L.p. serogroup 1 All Legionella Fatality Rate 15 80% (exacerbated by predisposing health Zero risks, incorrect antibiotic therapy, delayed diagnosis) Legionellosis: The War Within

Legionellosis: Diagnosis Four fold rise in antibody Antibody titer >250 Lp Sg 1&6 Fisher Scientific Occurs in 70-80% of affected population Can take up to 2 months to occur

Urine antigen (lateral flow immunochromogenic test) Culture on BCYE.still the Gold Standard Lp Sg 1 Alere Legionellosis: Diagnosis Compared to other pneumonias, LD presents same symptoms as other bacterial pneumonias, e.g., Steptococcus pneumoniae. Why then is it important to identify the causative agent? Correct antibiotic therapy Prevent outbreaks Identify (and eliminate) the source of infection An Ideal Environment for Legionella Risk Factors = Ideal Growth Conditions Nutrients Highly Aerobic Ideal Temperature High Surface Area Retention Time

Low Chlorine Levels Presence of Amoeba and Biofilm Visible Biofilms Condenser Tube Sheets Filter Screens Spray Bars Air Washers Tap Aerators Biofilm: Control it and Control the Disease No fusion of lysosome Some Legionella can not live in the absence of a host. Relative Significance of Legionellosis in US Cases in 2010 12000 10000 8000

6000 4000 2000 0 Eq n ui e E e nc p l ha

s iti ol h C a er sle ea M s t Bo ism ul

Ty o ph id v Fe er io er t Li s sis W

Ni t es le v Fe er um M ps L i eg on

lo el sis Data from: Morbidity and Mortality Weekly Report c er b Tu o ul sis Relative Significance of Legionellosis in US US Waterborne Disease and Outbreak Surveillance System MMWR: September 6, 2013 / 62(35);714-720

Legionellosis 58% from plumbing systems 24% from untreated ground water 12 % from community distribution Notable Recent Outbreaks Location (Year) Infected Deaths Source Toronto, Canada: 2005 127 21

Cooling Tower Fredrikstad, Norway: 2005 53 10 Air Washer Pamplona, Spain: 2006 139 0 Cooling Tower Elmira, NY: 2008

13 1 Potable Water Syracuse , NY: 2008 13 1 Potable Water Pittsburg, PA: 2011-2012 21 5 Potable Water

Quebec City, Canada: 2012 180 13 Cooling Tower Legionella in Hospital Potable Water Systems Reference Location Hospitals HMSO, 1987 Alary and Joly, 1992 Vickers et al, 1987 Patterson et al, 1997

UK Quebec PA UK 40 84 15 69 % with Legionella 70 68 60 55 Marrie et al, 1992 Nova Scotia

39 23 Liu et al, 1996 Kool et al, 1999 UK Texas 17 15 12 73 Isolate L.p. Sg1 L.p. Sg 1-8 L.p. Sg 1-6 Legionella

Legionella spp L.p. L. Longbeachae L.p. Sg 1,4,6 Legionella 1)Yu, V.L., "Resolving the Controversy on Environmental Cultures for Legionella: A Modest Proposal" Infection Control and Hospital Epidemiology, 19, pp. 893-897, 1998. 2)Texas Department of Health State Services Legionnaire's Disease(Legionellosis).ICD-9 482.8; ICD-10 A48.1 Seasonality of Legionellosis by Regions 2000-2009 Data from: Morbidity and Mortality Weekly Report Incidence Rate of Legionellosis 1.6 1.4 Urine Test

Incidence per 100,000 1.2 1 0.8 Incidence 0.6 0.4 0.2 0 78 80 8 2 84 86 88 9 0 92 94 96 98 00 02 04 0 6 08 10 1 2 19 1 9 19 19 1 9 1 9 19 19 1 9 19 1 9 2 0 20 2 0 20 20 2 0 20 Most cases of LD are from potable water and are sporadic. 86.8% of LD cases are Community Acquired. Nosocomial pneumonias constitute an incidence rate of 4,200-7,700 per 100,000 patients Risk Management for Abatement of Legionellosis Risk: The probability of something going wrong. e.g., the chance of inhaling an infectious aerosol of Legionella

Hazard: A process or parameter that increases a risk. e.g., biofilm containing Legionella in a cooling tower Risk Management is a process by which risk is controlled to an acceptable level by identifying and controlling the hazards. Risk Management: ASHRAE American Society of Heating Refrigeration and Air-Conditioning Engineers ASHRAE is a professional association of engineers that establishes standards and guidelines of performance criteria for institutional and commercial buildings. ASHRAE is accredited by the American National Standards Institute (ANSI) and follows ANSI's requirements for due process and standards development. Risk Management Oversight: ASHRAE 188P

Will supersede: Guideline 12-2000 -Minimizing the Risk of Legionellosis Associated with Building Water Systems Are ASHRAE Standards Binding? Who Are the AHJs? OSHA JCAHO/TJC ASHE Risk Management Oversight: OSHA Section 5(a)(1) of the Occupational Safety and Health Act: Each employer shall furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause

death or serious physical harm to his employees. Several conditions must be met for OSHA to issue a General Duty Clause violation: 1. The hazard was recognized. 2. The employer failed to keep the workplace free of a hazard to which his or her employees were exposed. 3. A feasible and useful method was available to correct the hazard. 4. The hazard was causing or likely to cause death or serious injury. Risk Management Oversight: JCAHO The Joint Commission for the Accreditation of Healthcare Organizations Standard EC 1.7, requires a management program to: Reduce the potential for organizational-acquired illness. Manage pathogenic biological agents in cooling towers, domestic hot water, and other aerosolizing water systems.

Risk Management Oversight: ASHE The American Society for Healthcare Engineering All health care facilities: Conduct a risk assessment of potential sources of Legionella. Develop a management plan for maintenance and operation of water systems. Risk Management Plans Hazard Analysis and Critical Control Point HACCP A Risk Management Program developed by Pillsbury for NASA in 1957. Hazard Analysis and Critical Control Points HACCP A Risk Management Program developed by Pillsbury for NASA in 1957 because

Theres no room for poop in a NASA suit Essentials of a HACCP Plan: The 7 Principles of HACCP 1. 2. 3. 4. 5. 6. 7. * Assess the Hazards. *Identify the Critical Hazard and its Critical Control Point (CCP). Establish CCP parameters. Establish monitoring frequency and procedure of CCP. Establish corrective actions when CCP limit is exceeded.

Establish record keeping system. Validate the HACCP plan. A CCP is the final step in the process wherein the hazard can be eliminated or adequately mitigated. Risk Management Plan by the Team Hazard Assessment. Mitigate Management. 1. 2. I. II. III. IV. 3.

Establish risk mitigation parameters. Establish test frequency for mitigation procedures. Establish corrective actions when mitigation procedures are not achieved. Establish record keeping system fro mitigation procedures and actions. Plan Validation. Risk Management Plan Risk Management Remediation Legionellosis Hazard Assessment

Plan Validation Surveillance Legionella Validation by Legionella Testing: PCR PCR Detects:

Specific for L. pneumophila Highly Sensitive Non-culturable Legionella Dead Legionella Legionella in biofilm Legionella in amoeba 0.002 cell/ml for potable water 0.004 cell/ml for tower water Rapid (Same Day) PCR cannot test for all serotypes Validation by Legionella Testing: Culture Culture Methods

Detects only healthy Legionella Sample must be fresh. Must suppress growth of competitive heterotrophs. No differentiation of Legionella species Low Sensitivity 0.05 cell/ml potable water 1 cell/ml tower water Slow amplification (growth)= 3-4 day incubation done twice Still the CDC Gold Standard

Risk Management Plan: Potable Water Hazard Analysis: Potable Water Assessment Tap Aerators Shower Head Aerosols Faucet Aerosols Dead Legs Hot Water Tanks Sediment Risk Mitigation: Secondary Disinfection Chemical Oxidation Chlorine Chorine Dioxide Monochloramine Chemical

Reduction Cu: 400 ppb Ag: 40 ppb Temperature Control < 68F > 140F Point of Use Filtration 0.22 micron Risk Mitigation: Chemical Oxidation Chlorine Chlorine Dioxide

Chloramine (can not be used in dialysis) Maximum Limit 4 ppm 0.8 ppm as ClO2 4 ppm Stable Spontaneously degrades to chlorate Volatile gas and Yes

spontaneously degrades to chlorite Corrosive Not at 1.0 ppm Not at 1.0 ppm Copper and Lead Penetrates Biofilm No Yes Yes Amoebicidal

No Yes No Ease of Application Easy On Site Blending On Site Blending Raw Material Hazards Caustic Caustic, Gas Caustic, Gas

Disinfection By-Products THMs Chlorite (<0.8 ppm) THMs, NDMA Cost/1000 gal. $1.63 @1.0 ppm $3.45 @ 1.0 ppm $2.33 @ 1.0 ppm Risk Mitigation: Point of Use Filtration 0.2 micron pore size 31 day maximum use

Quick connect/disconect adaptors 3 gpm for tap and 5 gpm for shower at 43 psi Current Validation Strategies in Hospitals TX 2002 Routine Surveillance Based on LD history Patient risk System risk MD 2000 Dept. of VA 2008 CDC

2000 Yes Based on NH2Cl LD history Patient risk Based on LD history Patient risk Frequency Risk Based and Number 2/100 beds (min. 10) 2x/yr 2/100 beds (min. 10)

History of LD: 2x/yr No History of LD 1x/yr 2/100 beds (min. 10) >400 beds: Quarterly <400 beds: 2x/Yr Number not stated Sample Sites Shower heads, faucets, hot water tanks Shower heads, faucets, hot water tanks Shower heads, faucets,

hot water tanks Shower heads, faucets, hot water tanks Sample Size 200-1000 ml 100 ml and Swab and Swab 10-50 ml and Swab 1000 ml and Swab Validation: Test Strategies Potable Water Swab

Water Surveillance Remediation Cooling Towers Swab Water Faucets Shower Heads 100 ml of first purge from cold and hot water taps or shower heads Optional 100 ml

Faucets Shower Heads One liter of first purge from cold and hot water taps or shower heads and one liter from storage tanks. Optional 100 ml Validation OSHA Guideline for Legionella Limits: CFU/ml Nebulizers and Humidifiers Potable Water On Line Disinfection

1 10 Off Line Disinfection 10 100 Mitigation OSHA Guidelines applies only to water systems being used by healthy individuals. numbers are only guidelines, the goal is zero detectable. guidelines are subject to change. Validation Comparative Guideline for Legionella Limits: CFU/ml Nebulizers and Humidifiers

Potable Water Mitigation USA UK USA UK On Line Disinfection 1 0.1 10

0.1 Off Line Disinfection 10 1.0 100 1.0 Risk Management: Validation Staged Validation for Potable Water Stage Surveillance Remediation Method Swab Purge

Swab Purge Sensitivity Presence/Absence 0.5-300 CFU/ml Presence/Absence .05-30 CFU/ml Risk Management Plan: Potable Water Assess Hazard *Tap Aerators *Dead Legs *Shower Heads in Cancer Wards Ice Machines *Hot Water *Cold Water Mitigate Risk

Remove Remove or Flush Weekly Replace with Sterile Disposable Shower Heads Place in High use Areas DHW Return: >120 F (check state code) DHW Supply: >140-145 F (check state code) Secondary Disinfection Validate Plan Quarterly testing with swabs and/or water samples *EWGLI: 2011 European Working Group for Legionella Infections Risk Management Plan: Spas

Assess Hazard Mitigate Risk Validate Plan Aerosols 3.0 -8.0 ppm Cl2 or 4.0- 8.0 ppm Br2 No Standard Particulates Filtration Dissolved Solids 1.5 x TDS

1) Guidelines for the Surveillance, Investigation, and Control of Legionnaires Disease in Florida Risk Management Plan: Humidifiers and Nebulizers Nebulizers: Use only sterile water Humidification: Use only steam Remediation of Legionella Contaminated Potable Water Absence of Disease and Low Risk Areas Primary Remediation: Post signs at each outlet to be flushed warning of potential scald injury. Flush hot water tanks. Maintain hot water temperature at 140F and purge outlets for a minimum of 5 minutes. Secondary Remediation: Flush hot water tanks. Maintain a free chlorine residual of 50 ppm for 1 hr or 20 ppm for 2 hrs.

2003 CDC Response to Legionella Detection Absence of Disease and High Risk Areas Decontaminate the water supply. Do not turn on showers or faucets until systems test negative for Legionella Use Sterile water for: 1. 2. 3. i. ii. iii. iv. Sponge baths Showers

Tooth brushing Rinsing of nasogastric tubes 2003 CDC Response to Nosocomial Legionellosis When Legionellosis is Confirmed Contact the local or state health department or CDC. 2. Determine source of Legionella with using Infection Control and Engineering resources. Review historical water records. Conduct walk-thru and observe personnel duties and operation of equipment. 3. Assess all relevant medical and engineering data. 4. Determine if clinical and environmental samples are a perfect match. 5. Disinfect contaminated systems. 1. 2003 CDC Response to Nosocomial Legionellosis Diagnosis of Hospital Acquired Legionellosis

Confirmed LD: diagnosed after 10 days of a continuous inpatient stay. Suspected LD: diagnosed between 2-9 days of an inpatient stay. Suspected LD: diagnosed in >2 patients within 6 months of each other and after having visited an outpatient transplant unit during part of the 2-10 day period before illness onset. 2003 CDC Response to Nosocomial Legionellosis Remediation Primary Remediation: Flush hot water tanks. Maintain hot water temperature to 160F-170 F and purge outlets for a minimum of 5 minutes. Post warning signs at each outlet being flushed to prevent scald injury to patients, staff, or visitors. Secondary Remediation: Flush hot water tanks. Maintain a free chlorine residual of >2 ppm with or without supplemental heating throughout the system. This might require chlorination of the water heater or tank to levels of 20-50 ppm. Circulate the water for at least 2

hours and maintain the water pH between 7.0 and 8.0. 2003 CDC Response to Nosocomial Legionellosis Plan Validation Retest every 2 weeks for Legionella every 3 months. If negative after 3 months, continue monthly testing for 3 more months. Maintain all records. If these measures are unsuccessful, seek expert consultation for review of decontamination procedures and assistance with further efforts. Hazard Analysis: Cooling Water System Legionella in Cooling Towers

Percent Population Density Distribution (CFU/ml) 7.00% 3.00% 46.00% <10 10-200 201-1000 >1000 44.00% Gilpin, 1995, The Analyst: 1336 Samples, 472 Cooling Towers. Cooling Tower: Hazard Analysis

Excessive drift Sediment in basin Visible corrosion Visible biofilm Planktonic bacteria Filled with water but not operating Risk Mitigation: Air Filtration New Slide Air Solution Co. Risk Mitigation: High Efficiency Drift Eliminators < 0.001% of Circulation = High Efficiency Risk Mitigation: Minimize Suspended Solids Risk Mitigation: Minimize Suspended Solids

Risk Management Plan: Bio-Loading Assess Hazard Planktonic Bacteria Biofilm Mitigate Risk Biocide Test Method Oxidizing Biocide DPD Daily @ 0.2-0.5 ppm as Cl2 Non Oxidizing Biocide Monthly Addition N. Ap. 2011 European Working Group for Legionella Infections

Test Frequency Daily N. Ap. Validation OSHA Guidelines for Legionella Limits: CFU/ml Cooling Towers Mitigation On Line Disinfection 100 Off Line Disinfection 1000 Validation

UK Standards for Legionella Limits: CFU/ml Cooling Towers Mitigation Reassess Risk Mitigation Program Disinfection 0.1-1.0 1.0 Best to strive for no detectable Legionella. Many sites have no detectable Legionella, why should yours be an exception? Risk Management Plan: Cooling Towers and Water Features Mitigate Risk Validate Plan Control Parameter

Frequency Assess Hazard Biofilm Non Oxidizing Biocide Addition Planktonic Bacteria Oxidizing Biocide Quarterly 100 mL sample Drift High Efficiency Drift Eliminators Sediment in Basin Filtration

Soluble Iron Corrosion control Remediation of Legionella Contaminated Tower Water Absence of Disease 1. 2. 3. Close bleed valve. Dose the cooling tower sump with a minimum of 180 ppm of C-992 and allow the product to circulate for 6 hours. Restart the bleed of the cooling tower. Remediation of Legionella Contaminated Tower Water

Wisconsin Protocol Cooling Tower Associated with Disease 1. 2. 3. * 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. Power down cooling tower fan Close bleed valve. Close air intakes within 100 ft of the cooling tower. Use a 3M Disc Filter 2125 P2 respirator or equivalent

Discontinue regular chemical treatment. Adjust pH to 7.5-8.0. Add chlorine to initially establish 50 ppm free chlorine. Add a dispersant or low foaming surfactant. Maintain 10 ppm of free chlorine for 24 hours. Confirm the residual at least every 2 hours. Drain, refill and repeat steps 5-9 until tower is visually clean Mechanically clean all cooling tower surfaces and components *Refill and bring free chlorine to 10 ppm for 1 hour. Test and confirm absence of Legionella. If still present, repeat procedure. Risk Management Plan Summary

Make your Risk Management Plan relevant and simple. There are few standards; guidelines are the norm. All guidelines are steered by validation. Risk Management is an iterative process of continuing improvement. So long as the process of assessment, mitigation and validation is followed, presence of Legionella is simply an opportunity for improvement. Risk Management can be your friend. Questions? Bibliography 1. Guidelines for the Surveillance, Investigation, and Control of Legionnaires Disease in Florida. www.floridahealth.gov/healthy-environments/indoor.../Legionella.pdf 2.

Legionnaires disease. The control of Legionella bacteria in water systems. Approved Code of Practice and guidance. ww.hseni.gov.uk/l8_legionnaires__disease_the_control_of_legionella_bacteria_in _water_systems.pdf 3. Guidelines for Preventing Health-Care--Associated Pneumonia, 2003 www.cdc.gov/mmwr/preview/mmwrhtml/rr5303a1.htm 4. Texas Department of State Health Services Report of the Texas Legionnaires Disease Task Force. www.dshs.state.tx.us/idcu/disease/legionnaires/taskforce/ 5. ASHRAE Legionellosis Position Statement www.ashrae.org/File%20Library/docLib/About%20Us/PositionDocuments/ASHRA E_PD_Legionellosis_2012.pdf

6. OSHA Technical Manual https://www.osha.gov/dts/osta/otm/otm_iii/otm_iii_7.html#app_iii:7_3

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