1. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com Waterborne Pathogens Risk Assessment – Role of the IP Presented by: Megan Canright, MPH, CIH Karen Trapane, MS, HEM March 9, 2016 (San Diego APIC meeting)

2. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com 2 Meeting Objectives Understand what could be present in the hospital’s potable water systems that could contribute to HAIs. Understand what is your role on the water management team and identifying risks. Identify elements of the ASHRAE 188 standard for water management plan as it relates to hospitals.

3. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com 3 Meeting Objectives Understand the risks associated with unmanaged water systems Learn about water management plan key elements and controlling risk Understand what actions can be taken to mitigate issues with water quality

4. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com 4 The Infection Preventionist The link between patients and hospital water systems Under pressure to accomplish objectives surrounding insurance reimbursement and reducing HAIs May not always be included in engineering functions or water systems but should be Has great influence over processes and process changes

5. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com Waterborne Pathogens and Risk for HAIs 5

6. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com Waterborne Pathogens Bacteria Viruses Protozoa Helminths 6

7. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com Legionella species Gram-negative rod Most motile – 1-3 flagellae 50+ species, 70+ serogroups –19+ pathogenic (pneumophila, longebeachae, bozemanii, micdadei, etc.) Water (surface, ground) and soil Commonly found in [low] in water systems 7

8. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com Legionella Growth Conditions Water (potable, industrial, lakes, etc.) Temperature 68-120°F (20-49°C) –Ideal growth range 96-115°F (35-46°C) Commensal organisms (amoebae) Biofilms Sediment, scale, algae 8

9. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com Biofilms 9

10. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com Legionella – Associated Illness Nosocomial v. community Hotels, hospitals, long-term care, cruises... Exposure: mists and aerosols, aspiration Elderly, children, immunocompromisation HAI susceptibility –recent surgery, assisted ventilation, NICU, immunosuppresion/therapy, transplant… Agent: L. Pneumophila serogroup 1?? 10

11. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com Legionella – Associated Illness Infectious dose unknown Legionnaire’s Disease (pneumonia) Pontiac Fever (not an infection) Incubation period –2-14 days: Legionnaire’s Disease –1-2 days: Pontiac Fever 1-2% of all pneumonia cases? 11

12. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com Diagnostic Tests Legionnaire’s Disease diagnosis by: –Urinary antigen test –Blood, sputum culture –Chest x-ray –Lung biopsy Pontiac Fever diagnosis by: –Urinary antigen test –Blood culture –False negative rate high 12

13. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com 13 Diagnostic Tests

14. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com 14 Hospital-Acquired Legionella Infections Hospital-Acquired Pneumonia (HAP) accounts for 15-20% of all HAIs Nosocomial Legionnaire’s Disease accounts for 20-30% of HAPs –10 days hospitalization before onset = HAI Mortality rate approaches 50% for HA Legionellosis Statistics Reported by CDC: http://www.cdc.gov/legionella/index.html

15. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com 15 Hospital-Acquired Legionella Infections First hospital-associated outbreak in 1965 –Psychiatric hospital in Washington, DC –81 illnesses, 15 deaths –Antibody seroconversion – 85% patients Largest hospital-associated outbreak 1977-1982 –VA hospital, Los Angeles –218 confirmed cases

16. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com 16 Hospital-Acquired Legionella Infections Miami Valley Hospital, 2011 (new hospital) –10 confirmed cases, 1 death –Within weeks of opening Oxygen dehumidifier identified in 2009 outbreak (hospital not identified) Known outbreaks worldwide: India, Turkey, Poland, Italy, Taiwan, etc.

17. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com Liability and Risks Increased length of stay Decreased or eliminated insurance reimbursement Increased level of care for patient Reporting requirements may lead to CMS inspection ASHRAE 188-2015 may establish a “duty of care” for use in litigation 17

18. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com Liability Considerations Two or more cases epidemiologically linked Often no “smoking gun”, multiple sources are common Difficult to “prove” patient and environmental sample match An implemented plan can help to prevent “negligence” or “at-will” claims 18

19. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com Financial Ramifications Preventable with Water Management Plan 19

20. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com What is ASHRAE 188-2015? 20

21. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com 21 Who is ASHRAE? American Society of Heating, Refrigeration, and Air-Conditioning Engineers (ASHRAE) Published voluntary standards and guidelines Publications are peer-reviewed by panel of experts, public comment periods, iterations/revisions Not enforceable, but….

22. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com 22 Purpose Establish minimum Legionellosis risk management requirements for building water systems. Applies to human-occupied commercial, institutional, multiunit residential, and industrial buildings. …intended for use by owners and managers of human-occupied buildings, excluding single-family residential buildings. … is also intended for those involved in the design, construction, installation, commissioning, operation, maintenance, and service of centralized building water systems and components. Annex: denotes special requirements for healthcare facilities Scope

23. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com ASHRAE 188/IH Paradigm Anticipation, Recognition Evaluation Control Prevention, Management 23

24. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com Key Standard Elements Requires a Team of Experts Risk Assessment Management Plans Contingency plans Verification Validation Courtesy of: ASHRAE 24

25. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com Key Elements – The Team Requires a Team of Experts Plumbing systems design expertise Facility Operations Expert Treatment and Control measures Expert Validation Expert Response Action Expert 25

26. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com Key Elements – Risk Assessment Risk Assessment Health of Supply (Municipal, Wells) Function of System Occupants and users Aerosolization potential Control Measures –Chemistry, heat, flow –Impact to systems and existing biofilms –Short and long term 26

27. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com Key Elements – The Plans Management Plans (Simple) Drawings Control measures Critical Control Points Control values Contingency plans Verification & Validation –Establish “safe” range –Chemistry, temperature, bacteria 27

28. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com Key Elements – The Annex Designated Team –Designated responsibility/leadership –Decision maker, Facilities, IP membership required Water Diagrams –All key water service points –Water treatment, processing, control –Hazardous conditions (clinical support, patient care) Water Management Plan –Documented risk assessment, assigned responsibility –Areas with higher risk of infection, likelihood assessment –Disease surveillance 28

29. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com Key Elements – The Annex Risk Assessment –Repeated with changing processes, maintenance, or disruption –Proactive risk assessment with new construction/renovation –Commissioning plan, Legionella management plan Water Systems Procedures –Systems start-up and shut-down –System maintenance –Water treatment –Cooling tower maintenance/disinfection –Backflow prevention 29

30. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com Risk Assessment & Management 30

31. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com 31 Risk Assessment & Management Assemble Water Management TeamDocument and Records ReviewBuilding WalkthroughIdentification/Implementation of ControlsVerification and Validation

32. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com Water Systems with Potential Risk Domestic water and fixtures Industrial water Cooling towers Therapeutic spas Decorative features Emergency equipment 32

33. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com 33 Common Conditions of Risk Low Occupancy Uncontrolled Dead Legs Construction Projects Unused/Unexercised Fixtures Inadequate Temperature, Flow Low Oxidant Residual

34. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com 34 Common Areas of Risk Potable Water Systems –Showers, sink fixtures (automatic) –Hoppers –Hot water tanks/boilers –Emergency showers/eyewashes –Historical dead legs –Ice machines –Emergency tanks –Thermal mixing valves

35. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com 35 Areas of Risk - Hospitals Non-Potable Water Systems –Cooling towers –Decorative water features –Humidification systems –Backflow/cross-connections Low flow/use –Low occupancy wings –Future build outs –Unmanaged bypasses

36. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com 36 Areas of Risk - Hospitals Construction Projects –Water shut-offs –Stubbed piping –Tie-ins –Chlorination Reliance on –Municipal treatment –Incoming treatment (e.g., UV)

37. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com System Control Plans Control Gap Analysis –Residual Oxidant –Temperature Management –Flushing & Flow –Filtration –Dead Leg Prevention & Management –Preventive Maintenance Water Treatment –Primary as needed –Secondary ongoing 37

38. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com Monitoring Verification –Recordkeeping –Oversight Validation/Environmental Assessment –Sample collection Temperature, oxidant Surrogates (HPC), specific pathogens Response –Preventive action plan 38

39. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com 39 Role of the Infection Preventionist Integral part of Water Management Team Provide feedback regarding patient risk –Patients at high risk –Departments with exposure risk –Assignment of qualitative risk (L, M, H) Help determine need for sampling –Confirmation of risk areas –Validation of risk control –Feedback on specific testing locations

40. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com 40 Role of the Infection Preventionist Review sampling plan, provide feedback –Sampling objectives –Type of sampling (water, swabs, bulk) –Analytes –Analytical methods –Number of samples –Locations of samples –Frequency of sampling

41. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com 41 Role of the Infection Preventionist Review sampling data, provide feedback –Interpretation of data, “thresholds” –Historical context –Patient context Assist with selection of controls –Feasibility of implementation –Specifications review –Evaluation and review of data

42. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com 42 Role of the Infection Preventionist Outbreak response support –Identification of HAI cases –Regulatory reporting –Collaborate with Public Health Management of surveillance –Determine when to start/stop –Surveillance methods –Data management

43. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com 43 Summary A water management plan is the best way to prevent waterborne HAIs You are an integral and very necessary stakeholder in the program Liability and Risks are too great for status quo It will compliment your TJC management plans

44. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com 44 Selected References Legionellosis: Risk Management for Building Water Systems. ANSI/ASHRAE 188-2015 Evaluation, Recognition, and Control of Legionella in Building Water Systems. AIHA. 2015 Guidelines for Environmental Infection Control in Health- Care Facilities: Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC). Centers for Disease Control. 2003. Legionella and the prevention of legionellosis. World Health Organization. 2007.

45. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com 45 Selected References Legionnaire’s disease, the control of legionella bacteria in water systems: Approved Code of Practice and guidance. 3 rd ed. Health and Safety Executive (HSE). 2000 OSHA Technical Manual (OTM) Section III: Chapter 7: Legionnaires’ Disease. Occupational Safety and Health Administration. 1999 CDC. [Increasing incidence of] Legionellosis in the United States, 2000-2009. MMWR 2011;60:1083-1086. Beer KD, Gargano JW, Roberts VA, et al. Surveillance for waterborne disease outbreaks associated with drinking water — United States, 2011–2012. MMWR. 2015;64(31):842–8

46. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com Questions? Megan Canright Director Scientific Operations mcanright@forensicanalytical.com 858-859-3322 Karen Trapane Director, San Diego ktrapane@forensicanalytical.com 858-247-1051 46

47. Copyright © Forensic Analytical Consulting Services, Inc. www.ForensicAnalytical.com Thank You! Forensic Analytical Consulting Services, Inc. Right People. Right Perspective. Right Now. 47