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Legionellosis: Risk Management Planning

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1 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

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

3 Discussion Topics Legionella Legionellosis Risk Management Plan

4 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

5 Legionella 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

6 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

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 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 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&6 Fisher Scientific Lp Sg 1 Alere

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 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

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

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 MMWR: September 6, 2013 / 62(35); 58% from plumbing systems 24% from untreated ground water 12 % from community distribution Legionellosis

17 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 Elmira, NY: 2008 13 1 Potable Water Syracuse , NY: 2008 Pittsburg, PA: 5 Quebec City, Canada: 2012 180

18 Legionella in Hospital Potable Water Systems
Reference Location Hospitals % with Legionella Isolate HMSO, 1987 UK 40 70 L.p. Sg1 Alary and Joly, 1992 Quebec 84 68 L.p. Sg 1-8 Vickers et al, 1987 PA 15 60 L.p. Sg 1-6 Patterson et al, 1997 69 55 Legionella Legionella spp Marrie et al, 1992 Nova Scotia 39 23 L.p. L. Longbeachae Liu et al, 1996 17 12 L.p. Sg 1,4,6 Kool et al, 1999 Texas 73 Legionella 1)Yu, V.L., "Resolving the Controversy on Environmental Cultures for Legionella: A Modest Proposal" Infection Control and Hospital Epidemiology, 19, pp , 1998. 2)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
Urine Test 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

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 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.

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

26 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: The hazard was recognized. The employer failed to keep the workplace free of a hazard to which his or her employees were exposed. A feasible and useful method was available to correct the hazard. The hazard was causing or likely to cause death or serious injury.

27 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.

28 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.

29 Hazard Analysis and Critical Control Point HACCP
Risk Management Plans Hazard Analysis and Critical Control Point HACCP A Risk Management Program developed by Pillsbury for NASA in 1957.

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

31 Essentials of a HACCP Plan: “The 7 Principles of HACCP”
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.

32 Risk Management Plan by the “Team”
Hazard Assessment. Mitigate Management. 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.

33 Risk Management Plan Legionellosis Legionella Remediation Surveillance
Plan Validation Hazard Assessment Risk Management Remediation Surveillance Legionellosis Legionella

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

35 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

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

39 Risk Mitigation: Chemical Oxidation
Chlorine Chlorine Dioxide Chloramine (can not be used in dialysis) Maximum Limit 4 ppm 0.8 ppm as ClO2 Stable Spontaneously degrades to chlorate Volatile gas and spontaneously degrades to chlorite Yes Corrosive Not at 1.0 ppm Copper and Lead Penetrates Biofilm No Amoebicidal Ease of Application Easy On Site Blending Raw Material Hazards Caustic Caustic, Gas Disinfection By-Products THM’s Chlorite (<0.8 ppm) THM’s, NDMA Cost/1000 gal. ppm 1.0 ppm 1.0 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 Routine Surveillance Based on LD history Patient risk System risk Yes NH2Cl Frequency and Number Risk Based 2/100 beds (min. 10) 2x/yr 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 Sample Size 10-50 ml and Swab ml and Swab 100 ml and Swab 1000 ml

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

43 Validation OSHA Guideline for Legionella Limits: CFU/ml
Mitigation Nebulizers and Humidifiers Potable Water On Line Disinfection ≥1 ≥10 Off Line Disinfection ≥100 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 Comparative Guideline for Legionella Limits: CFU/ml
Mitigation Nebulizers and Humidifiers Potable Water USA UK On Line Disinfection ≥1 0.1 ≥10 Off Line Disinfection 1.0 ≥100

45 Risk Management: Validation
Staged Validation for Potable Water Stage Method Sensitivity Surveillance Swab Presence/Absence Purge CFU/ml Remediation CFU/ml

46 Risk Management Plan: Potable Water
Assess Hazard Mitigate Risk Validate Plan *Tap Aerators Remove *Dead Legs Remove or Flush Weekly *Shower Heads in Cancer Wards Replace with Sterile Disposable Shower Heads Ice Machines Place in High use Areas Quarterly testing with swabs and/or water samples *Hot Water DHW Return: >120 °F (check state code) DHW Supply: > °F (check state code) *Cold Water Secondary Disinfection *EWGLI: 2011 European Working Group for Legionella Infections

47 Risk Management Plan: Spas
Assess Hazard Mitigate Risk Validate Plan Aerosols ppm Cl2 or 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

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

49 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 140°F and purge outlets for a minimum of 5 minutes. Secondary Remediation: Maintain a free chlorine residual of 50 ppm for 1 hr or 20 ppm for 2 hrs.

50 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: Sponge baths Showers Tooth brushing Rinsing of nasogastric tubes

51 2003 CDC Response to Nosocomial Legionellosis
When Legionellosis is Confirmed Contact the local or state health department or CDC. 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. Assess all relevant medical and engineering data. Determine if clinical and environmental samples are a perfect match. Disinfect contaminated systems.

52 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.

53 2003 CDC Response to Nosocomial Legionellosis
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 8.0.

54 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.

55 Hazard Analysis: Cooling Water System

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

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

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 Risk Mitigation: Minimize Suspended Solids

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

63 Validation OSHA Guidelines for Legionella Limits: CFU/ml Mitigation
Cooling Towers On Line Disinfection 100 Off Line Disinfection 1000

64 Validation UK Standards for Legionella Limits: CFU/ml Mitigation
Cooling Towers Reassess Risk Mitigation Program Disinfection ≥1.0 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 Risk Validate Plan Assess Hazard Control Parameter Frequency Biofilm Non Oxidizing Biocide Addition Quarterly 100 mL sample Planktonic Bacteria Oxidizing Biocide Drift High Efficiency Drift Eliminators Sediment in Basin Filtration Soluble Iron Corrosion control

66 Remediation of Legionella Contaminated Tower Water
Absence of Disease 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.

67 Remediation of Legionella Contaminated Tower Water
“Wisconsin Protocol” Cooling Tower Associated with Disease 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 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.

68 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.

69 Questions?

70 Bibliography Guidelines for the Surveillance, Investigation, and Control of Legionnaires’ Disease in Florida. environments/indoor.../Legionella.pdf 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 Guidelines for Preventing Health-Care--Associated Pneumonia, 2003 Texas Department of State Health Services Report of the Texas Legionnaires’ Disease Task Force. ASHRAE Legionellosis Position Statement E_PD_Legionellosis_2012.pdf OSHA Technical Manual https://www.osha.gov/dts/osta/otm/otm_iii/otm_iii_7.html#app_iii:7_3


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