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Michael Coughlin, Ph.D. Weas Engineering, Inc. Legionellosis: Risk Management Planning October 10, 2014 Indiana Chapter, Fall Conference of the: Association.

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Presentation on theme: "Michael Coughlin, Ph.D. Weas Engineering, Inc. Legionellosis: Risk Management Planning October 10, 2014 Indiana Chapter, Fall Conference of the: Association."— Presentation transcript:

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

2  Legionella  Legionellosis  Hazard Assessment  Risk Mitigation  Plan Validation  Response to Outbreak Discussion Topics

3  Legionella  Legionellosis  Risk Management Plan Discussion Topics

4  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 Philadelphia: July, 1976

5 The “bug”  Gram negative aerobic bacillus  Intercellular parasite  Amoeba  Ciliated protozoa  Fastidious nutritional requirements  Amino Acid Cysteine  High Iron Demand  Very slow growing  Heat tolerant  Chlorine tolerant Legionella

6 The Infection  Acquired via inhalation of microscopic mist particles: < 5 microns  Very often found in alveoli  Not spread person to person Legionellosis: The Disease  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

7 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

8 Legionellosis: The Disease Legionnaires’ Disease (LD)Pontiac Fever DiseasePneumonia but with Flu-Like SymptomsFlu-Like At Risk Immunocompromised Heavy drinkers Smokers and COPD All Treatment Zithromax Levoquin None Required OrganismAll Legionella, especially L.p. serogroup 1All Legionella Fatality Rate15 – 80% (exacerbated by predisposing health risks, incorrect antibiotic therapy, delayed diagnosis) Zero

9 Legionellosis: The War Within

10 Legionellosis: Diagnosis  Four fold rise in antibody  Occurs in 70-80% of affected population  Antibody titer >250  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 Lp Sg 1&6 Fisher Scientific

11 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

12 Risk Factors = Ideal Growth Conditions Nutrients Highly Aerobic Ideal Temperature High Surface Area Retention Time Low Chlorine Levels Presence of Amoeba and Biofilm An Ideal Environment for Legionella

13 Visible Biofilms Spray Bars Air Washers Filter Screens Tap Aerators Condenser Tube Sheets

14 Biofilm: Control it and Control the Disease No fusion of lysosome Some Legionella can not live in the absence of a host.

15 Relative Significance of Legionellosis in US Data from: Morbidity and Mortality Weekly Report

16 Relative Significance of Legionellosis in US US Waterborne Disease and Outbreak Surveillance System 58% from plumbing systems 24% from untreated ground water 12 % from community distribution MMWR: September 6, 2013 / 62(35); Legionellosis

17 Location (Year)InfectedDeathsSource Toronto, Canada: Cooling Tower Fredrikstad, Norway: Air Washer Pamplona, Spain: Cooling Tower Elmira, NY: Potable Water Syracuse, NY: Potable Water Pittsburg, PA: Potable Water Quebec City, Canada: Cooling Tower Notable Recent Outbreaks

18 Legionella in Hospital Potable Water Systems ReferenceLocationHospitals% with Legionella Isolate HMSO, 1987UK4070L.p. Sg1 Alary and Joly, 1992Quebec8468L.p. Sg 1-8 Vickers et al, 1987PA1560L.p. Sg 1-6 Patterson et al, 1997UK6955Legionella Legionella spp Marrie et al, 1992Nova Scotia3923L.p. L. Longbeachae Liu et al, 1996UK1712L.p. Sg 1,4,6 Kool et al, 1999Texas1573Legionella 1)Yu, V.L., "Resolving the Controversy on Environmental Cultures for Legionella: A Modest Proposal" Infection Control and Hospital Epidemiology, 19, pp , )Texas Department of Health State Services Legionnaire's Disease(Legionellosis).ICD ; ICD-10 A48.1

19 Seasonality of Legionellosis by Regions Data from: Morbidity and Mortality Weekly Report

20 Incidence Rate of Legionellosis 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 Urine Test

21 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.

22 Risk Management: ASHRAE American Society of Heating Refrigeration and Air-Conditioning Engineers ASHRAE is accredited by the American National Standards Institute (ANSI) and follows ANSI's requirements for due process and standards development. ASHRAE is a professional association of engineers that establishes standards and guidelines of performance criteria for institutional and commercial buildings.

23 Risk Management Oversight: ASHRAE 188P Will supersede: Guideline Minimizing the Risk of Legionellosis Associated with Building Water Systems

24 Are ASHRAE Standards Binding?

25  OSHA  JCAHO/TJC  ASHE Who Are the AHJ’s?

26 Risk Management Oversight: OSHA 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. 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.”

27 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: JCAHO

28 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 Oversight: ASHE

29 Hazard Analysis and Critical Control Point HACCP A Risk Management Program developed by Pillsbury for NASA in Risk Management Plans

30 HACCP A Risk Management Program developed by Pillsbury for NASA in 1957 because “There’s no room for poop in a NASA suit” Hazard Analysis and Critical Control Points

31 1. Assess the Hazards. 2. *Identify the Critical Hazard and its Critical Control Point (CCP). 3. Establish CCP parameters. 4. Establish monitoring frequency and procedure of CCP. 5. Establish corrective actions when CCP limit is exceeded. 6. Establish record keeping system. 7. Validate the HACCP plan. Essentials of a HACCP Plan: “The 7 Principles of HACCP” A CCP is the final step in the process wherein the hazard can be eliminated or adequately mitigated. *

32 1. Hazard Assessment. 2. Mitigate Management. I. Establish risk mitigation parameters. II. Establish test frequency for mitigation procedures. III. Establish corrective actions when mitigation procedures are not achieved. IV. Establish record keeping system fro mitigation procedures and actions. 3. Plan Validation. Risk Management Plan by the “Team”

33 Risk Management Plan LegionellaLegionellosis Plan Validation Hazard Assessment Risk Management RemediationSurveillance

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

35 Culture Methods DDetects only “healthy” Legionella SSample must be fresh. MMust suppress growth of competitive heterotrophs. NNo differentiation of Legionella species LLow Sensitivity 00.05 cell/ml potable water 11 cell/ml tower water SSlow amplification (growth)= 3-4 day incubation done twice SStill the CDC Gold Standard Validation by Legionella Testing: Culture

36 Risk Management Plan: Potable Water

37 Hazard Analysis: Potable Water Assessment Tap Aerators Shower Head Aerosols Faucet Aerosols Dead Legs Hot Water Tanks Sediment

38 Chemical Oxidation ChlorineChorine DioxideMonochloramine Temperature Control > 140°F< 68°F Chemical Reduction Cu: 400 ppb Ag: 40 ppb Point of Use Filtration 0.22 micron Risk Mitigation: Secondary Disinfection

39 Risk Mitigation: Chemical Oxidation ChlorineChlorine DioxideChloramine (can not be used in dialysis) Maximum Limit4 ppm0.8 ppm as ClO 2 4 ppm StableSpontaneously degrades to chlorate Volatile gas and spontaneously degrades to chlorite Yes CorrosiveNot at 1.0 ppm Copper and Lead Penetrates BiofilmNoYes AmoebicidalNoYesNo Ease of ApplicationEasyOn Site Blending Raw Material HazardsCausticCaustic, Gas Disinfection By-ProductsTHM’sChlorite (<0.8 ppm)THM’s, NDMA Cost/ ppm

40 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

41 Current Validation Strategies in Hospitals TX 2002 MD 2000 Dept. of VA 2008 CDC 2000 Routine Surveillance Based on  LD history  Patient risk  System risk YesBased on  NH 2 Cl  LD history  Patient risk Based on  LD history  Patient risk Frequency and Number Risk Based 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 SitesShower heads, faucets, hot water tanks Shower heads, faucets, hot water tanks Shower heads, faucets, hot water tanks Sample Size10-50 ml and Swab ml and Swab 100 ml and Swab 1000 ml and Swab

42 Validation: Test Strategies Potable WaterCooling Towers SwabWaterSwabWater Surveillance Faucets Shower Heads 100 ml of first purge from cold and hot water taps or shower heads Optional100 ml Remediation Faucets Shower Heads One liter of first purge from cold and hot water taps or shower heads and one liter from storage tanks. Optional100 ml

43 Validation Mitigation Nebulizers and HumidifiersPotable Water On Line Disinfection≥1≥10 Off Line Disinfection≥10≥100 OSHA Guideline for Legionella Limits: CFU/ml 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.”

44 Validation Mitigation Nebulizers and HumidifiersPotable Water USAUKUSAUK On Line Disinfection≥10.1≥100.1 Off Line Disinfection≥101.0≥ Comparative Guideline for Legionella Limits: CFU/ml

45 Risk Management: Validation StageMethodSensitivity Surveillance SwabPresence/Absence Purge CFU/ml Remediation SwabPresence/Absence Purge CFU/ml Staged Validation for Potable Water

46 Risk Management Plan: Potable Water Assess HazardMitigate RiskValidate Plan *Tap AeratorsRemove *Dead LegsRemove or Flush Weekly *Shower Heads in Cancer Wards Replace with Sterile Disposable Shower Heads Ice MachinesPlace in High use AreasQuarterly testing with swabs and/or water samples *Hot Water DHW Return: >120 °F (check state code) DHW Supply: > °F (check state code) *Cold WaterSecondary Disinfection *EWGLI: 2011 European Working Group for Legionella Infections

47 Risk Management Plan: Spas Assess HazardMitigate RiskValidate Plan Aerosols ppm Cl 2 or ppm Br 2 No Standard ParticulatesFiltration Dissolved Solids1.5 x TDS 1) Guidelines for the Surveillance, Investigation, and Control of Legionnaires’ Disease in Florida

48 Risk Management Plan: Humidifiers and Nebulizers Nebulizers: Use only sterile water Humidification: Use only steam

49 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 140°F 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. Remediation of Legionella Contaminated Potable Water

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

51 2003 CDC Response to Nosocomial Legionellosis When Legionellosis is Confirmed 1. 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.

52 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 CDC Response to Nosocomial Legionellosis

53 Remediation Primary Remediation: Flush hot water tanks. Maintain hot water temperature to 160°F-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 ppm. Circulate the water for at least 2 hours and maintain the water pH between 7.0 and CDC Response to Nosocomial Legionellosis

54 If these measures are unsuccessful, seek expert consultation for review of decontamination procedures and assistance with further efforts. Retest every 2 weeks for Legionella every 3 months. If negative after 3 months, continue monthly testing for 3 more months. Maintain all records CDC Response to Nosocomial Legionellosis Plan Validation

55 Hazard Analysis: Cooling Water System

56 Gilpin, 1995, The Analyst: 1336 Samples, 472 Cooling Towers. Legionella in Cooling Towers

57  Excessive drift  Sediment in basin  Visible corrosion  Visible biofilm  Planktonic bacteria  Filled with water but not operating Cooling Tower: Hazard Analysis

58 Risk Mitigation: Air Filtration New Slide Air Solution Co.

59 Risk Mitigation: High Efficiency Drift Eliminators < 0.001% of Circulation = High Efficiency

60 Risk Mitigation: Minimize Suspended Solids

61

62 Risk Management Plan: Bio-Loading Mitigate Risk Assess Hazard BiocideTest Method Test Frequency Planktonic BacteriaOxidizing Biocide ppm as Cl 2 DPDDaily BiofilmNon Oxidizing Biocide Monthly Addition N. Ap European Working Group for Legionella Infections

63 Validation Mitigation Cooling Towers On Line Disinfection100 Off Line Disinfection1000 OSHA Guidelines for Legionella Limits: CFU/ml

64 Validation Mitigation Cooling Towers Reassess Risk Mitigation Program Disinfection≥1.0 UK Standards for Legionella Limits: CFU/ml Best to strive for no detectable Legionella. Many sites have no detectable Legionella, why should yours be an exception?

65 Risk Management Plan: Cooling Towers and Water Features Mitigate RiskValidate Plan Assess Hazard Control ParameterFrequency BiofilmNon Oxidizing Biocide AdditionQuarterly 100 mL sample Planktonic BacteriaOxidizing Biocide DriftHigh Efficiency Drift Eliminators Sediment in BasinFiltration Soluble IronCorrosion control

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

67 1. Power down cooling tower fan 2. Close bleed valve. 3. Close air intakes within 100 ft of the cooling tower. * Use a 3M™ Disc Filter 2125 P2 respirator or equivalent 4. Discontinue regular chemical treatment. 5. Adjust pH to Add chlorine to initially establish 50 ppm free chlorine. 7. Add a dispersant or low foaming surfactant. 8. Maintain 10 ppm of free chlorine for 24 hours. 9. Confirm the residual at least every 2 hours. 10. Drain, refill and repeat steps 5-9 until tower is visually clean 11. Mechanically clean all cooling tower surfaces and components 12. *Refill and bring free chlorine to 10 ppm for 1 hour. 13. Test and confirm absence of Legionella. If still present, repeat procedure. “Wisconsin Protocol” Remediation of Legionella Contaminated Tower Water Cooling Tower Associated with Disease

68  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. Risk Management Plan Summary

69 Questions?

70 1. Guidelines for the Surveillance, Investigation, and Control of Legionnaires’ Disease in Florida. environments/indoor.../Legionella.pdfwww.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 ww.hseni.gov.uk/l8_legionnaires__disease_the_control_of_legionella_bacteria_in _water_systems.pdf 3. Guidelines for Preventing Health-Care--Associated Pneumonia, Texas Department of State Health Services Report of the Texas Legionnaires’ Disease Task Force. 5. ASHRAE Legionellosis Position Statement E_PD_Legionellosis_2012.pdf 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 Bibliography


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