Legionellosis: Risk Management Planning

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

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

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 LpSg 1 Alere LpSg 1&6 Fisher Scientific

11. Legionellosis: Diagnosis Compared to other pneumonias, LD presents same symptoms as other bacterial pneumonias, e.g., Steptococcuspneumoniae. • 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);714-720 • 58% from plumbing systems • 24% from untreated ground water • 12 % from community distribution Legionellosis

17. Notable Recent Outbreaks

18. Legionella in Hospital Potable Water Systems 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

19. Seasonality of Legionellosis by Regions • 2000-2009 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 12-2000 -- 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 Allhealth care facilities: • Conduct a risk assessment of potential sources of Legionella. • Develop a management plan for maintenance and operation of water systems.

29. 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. • MitigateManagement. • 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 Remediation Surveillance Legionellosis Legionella

34. Validation by Legionella Testing: PCR 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

38. Risk Mitigation: Secondary Disinfection

39. Risk Mitigation: Chemical Oxidation

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

42. Validation: Test Strategies

43. Validation 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 Comparative Guideline for Legionella Limits: CFU/ml

45. Risk Management: Validation Staged Validation for Potable Water

46. Risk Management Plan: Potable Water *EWGLI: 2011 European Working Group for Legionella Infections

47. Risk Management Plan:Spas 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 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. Absence of Disease and Low Risk Areas

50. 2003 CDC Response to Legionella Detection • 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 Absence of Disease and High Risk Areas