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Legionella: How to Protect Yourself 
and Your Clients 
• Janet E. Stout, PhD 
– Director, Special Pathogens Laboratory 
• ...
Introduction and What’s New? 
© Special Pathogens Laboratory 
JANET E. STOUT, PHD
© Special Pathogens Laboratory 
Introduction 
• What’s New in Legionnaires’ Disease? 
• What Protects You & Your Clients? ...
UPDATE ON LEGIONELLA 
© Special Pathogens Laboratory 
Notes from the Field
International Legionella Conferences 
© Special Pathogens Laboratory 
• Research 
highlights 
• Worldwide 
trends
International Legionella Conferences 
© Special Pathogens Laboratory 
• 8th International 
Conference, Melbourne 
• Europe...
Conference Highlights 
© Special Pathogens Laboratory 
• Clinical Aspects 
 Survivors of LD suffer PTSD syndrome 
 Fatal...
Cure One Disease, Cause Another 
• Biologic therapies widely used to treat 
inflammatory diseases increase the risk 
of in...
Antimicrobial Resistance? 
© Special Pathogens Laboratory 
• First report of 
a ciprofloxacin 
resistant 
Legionella 
pneu...
Conference Highlights 
© Special Pathogens Laboratory 
• Epidemiologic Trends 
 European Cases – Summer spikes, but earli...
2014 Report on Quebec Outbreak 
© Special Pathogens Laboratory
© Special Pathogens Laboratory 
Quebec Outbreak PFGE 
Figure 1. PFGE pattern and SBT types of Lp1 isolates involved in the...
© Special Pathogens Laboratory 
Outbreaks Continue: 
Cooling Towers Implicated 
• Warstein, Germany 
 165 cases, 12 ICU, ...
© Special Pathogens Laboratory 
Not The Beer! 
• “the Warsteiner brewery is not, for 
the time being, seen as the original...
© Special Pathogens Laboratory 
New Tools To Study 
Microbial Communities 
The 
Microbiome
Phylogenetic Methods for Studying 
Microbial Communities 
Feasel et al. PNAS September 22, 2009 vol. 106 no. 38 16393–1639...
© Special Pathogens Laboratory 
Pyrosequencing 
454 
Pyrosequencing: 
A Phylogenetic 
Method for 
Comparing 
Microbial 
Co...
Water Treatment Caused a Shift 
in Microbial Community 
© Special Pathogens Laboratory
© Special Pathogens Laboratory 
When We Add 
Disinfectants to Water… 
• We don’t eliminate bacteria, fungi 
and protozoa f...
PLoS ONE 2014 9(7):e102679.doi:10.1371/journal.pone.0102679 
© Special Pathogens Laboratory
MORE NEW FINDINGS: 
MOLECULAR METHODS 
© Special Pathogens Laboratory
© Special Pathogens Laboratory 
Molecular Methods 
• The CDC does not currently 
recommend the routine use of genetic 
pro...
© Special Pathogens Laboratory 
	 
Cross 
reactive 
by LAMP* 
Cross 
reactive 
by PCR* 
False positives may 
be due to 86%...
UPDATE ON LEGIONELLA 
© Special Pathogens Laboratory 
Guidelines and Standards
© Special Pathogens Laboratory 
Catalonia Outbreak
© Special Pathogens Laboratory 
Neonates at Risk 
Clinical Infectious Diseases 2013;57(1):48–56
Status of Proposed ASHRAE Standard 
© Special Pathogens Laboratory 
188P 
American Society of Heating, Refrigerating and A...
© Special Pathogens Laboratory 
Fourth Public Review 
September 26 - November 10
Why Another Public Review? 
• This document 
establishes minimum 
legionellosis risk 
management 
requirements for 
buildi...
© Special Pathogens Laboratory 
Changes 
• Removal of HACCP (Hazard Analysis and 
Critical Control Points) terminology 
(s...
Visit These ASHRAE Websites 
© Special Pathogens Laboratory 
• ASHRAE Public Review Drafts: 
 https://www.ashrae.org/stan...
New VHA Legionella Directive 
© Special Pathogens Laboratory
Legionella: Don’t Let it Scare You! 
© Special Pathogens Laboratory
Legionella: How to Protect Yourself and Your 
© Copyright 2014 Saul Ewing LLP 
Clients 
October 31, 2014 
Presented to 
By...
© Copyright 2014 Saul Ewing LLP 2
© Copyright 2014 Saul Ewing LLP 
Because 
Legionnaires’ Disease is a 
Worldwide Problem 
3 
6
© Copyright 2014 Saul Ewing LLP 
In the United States 
Outbreaks Occur From 
East to West 
37
Legionnaires’ disease can infect virtually anyone 
where water can be inhaled or aspirated 
Like it or not, you already ha...
Surprisingly, there has been little uniformity in 
what actions designers, owners, facility managers 
and water treatment ...
Claims Typically Asserted in a 
Legionnaires’ Disease Lawsuit 
© Copyright 2014 Saul Ewing LLP 
 Typical Counts in Compla...
Most Legal Battles in 
Legionnaires’ Disease Cases 
are Fought Over the Allegation of 
© Copyright 2014 Saul Ewing LLP 
Ne...
The failure to exercise the standard of care that a 
reasonably prudent person would have exercised 
in a similar situatio...
Critical Elements a Plaintiff Must 
Demonstrate to Meet Their Burden of 
© Copyright 2014 Saul Ewing LLP 
Proof for Neglig...
In the Absence of Controlling Law 
or a Mandatory Standard, 
What Can the Water Treatment 
Industry Do For Protection From...
1. Become Familiar with Existing Industry 
Publications Addressing Legionnaires’ 
© Copyright 2014 Saul Ewing LLP 
Disease...
In the Health Care Industry 
•The Joint Commission for the Accreditation of Healthcare Organizations (JCAHO) 
published st...
© Copyright 2014 Saul Ewing LLP 
LEGIONELLA 2003: 
An Update and Statement by the 
Association of Water Technologies 
(AWT...
AWT Guidelines on Sampling and Testing 
© Copyright 2014 Saul Ewing LLP 
for Legionella 
Sampling and testing for Legionel...
AWT’s Position Statement on 
© Copyright 2014 Saul Ewing LLP 
Sampling and Testing 
AWT supports that Legionella sampling ...
2. Develop and Propose to your Clients 
Water Management Plans that Address 
Risks Posed by Legionella Bacteria 
• Customi...
3. After Adoption of Water Management 
Practices Be Sure They Are Consistently 
Applied and Document Your Compliance 
• It...
4. Have a Plan (or a Plan to Offer) if 
Legionella Bacteria is Detected in the 
Water System You Treat 
• Proactively cons...
5. Educate Your Clients That Managing 
Water Systems to Reduce the Risk of 
Legionnaires’ Disease is in Their 
© Copyright...
© Copyright 2014 Saul Ewing LLP 
Looking for Safe Harbors 
• Adopt sound water management practices, consistently 
apply t...
© Copyright 2014 Saul Ewing LLP 
FAQ 
Q. Should I educate my clients to Legionella bacteria and the risk presented? 
A: Ye...
© Copyright 2014 Saul Ewing LLP 
DISCLAIMER 
The content of this presentation has been prepared by Saul Ewing 
for informa...
Legionella Risk Management 
FRANK P. SIDARI, PE, BCEE 
© Special Pathogens Laboratory
Providing Risk Management 
© Special Pathogens Laboratory 
• Risk Management 
Overview 
• Providing Risk 
Management 
Serv...
Why Implement Risk Management? 
“It does not do to 
leave a live dragon 
out of your 
calculations, if you 
live near him....
Why Implement Risk Management? 
© Special Pathogens Laboratory 
• How does a facility… 
 demonstrate proactive approach t...
Risk Management Approaches 
© Special Pathogens Laboratory 
• Water Safety Plans 
 Risk management method developed by 
W...
Components of Risk Management 
• Assemble a team 
• Develop flow diagrams 
• Assess risks / identify hazards 
• Define con...
Water Safety Plan Implementation 
© Special Pathogens Laboratory
Risk Management/Water Safety Plan 
© Special Pathogens Laboratory 
Assemble a Team 
• Titles 
 Administrator 
 Facilitie...
Risk Management/Water Safety Plan 
Develop Flow Diagrams 
• Potable and Non-Potable Systems 
• Block diagrams (high level)...
© Special Pathogens Laboratory
Risk Management/Water Safety Plan 
© Special Pathogens Laboratory 
Assess Risks 
• The targeted hazard is… 
 Legionella b...
Examples of Where to Assess Risk 
© Special Pathogens Laboratory 
Hot Water Heaters and Tanks
Examples of Where to Assess Risk 
© Special Pathogens Laboratory 
Hot Water Mixing and Circulation
Examples of Where to Assess Risk 
© Special Pathogens Laboratory 
Water Treatment
Examples of Where to Assess Risk 
© Special Pathogens Laboratory 
Distal Outlets and Points of Exposure
Risk Management/Water Safety Plan 
© Special Pathogens Laboratory 
Control Risk 
• Control Measure 
 A means to minimize ...
Risk Management/Water Safety Plan 
© Special Pathogens Laboratory 
Intervention 
• Intervention or Corrective Action: 
 P...
Risk Management/Water Safety Plan 
© Special Pathogens Laboratory 
Establish Monitoring 
• Successful monitoring program 
...
Risk Management/Water Safety Plan 
© Special Pathogens Laboratory 
Document 
• Maintain records to demonstrate plan 
is be...
Example Documentation 
© Special Pathogens Laboratory 
• Daily 
monitoring logs 
• Building automation 
• Laboratory repor...
Risk Management/Water Safety Plan 
© Special Pathogens Laboratory 
Verify 
• Verification 
 Confirmation that the plan is...
Risk Management/Water Safety Plan 
© Special Pathogens Laboratory 
Plan Validation 
• Validation 
 Evidence that confirms...
Risk Management/Water Safety Plan 
© Special Pathogens Laboratory 
Plan Audit 
• Audit 
 Review of the plan to determine ...
© Special Pathogens Laboratory 
WORKING WITH CLIENTS
© Special Pathogens Laboratory 
Who Is Responsible? 
• Facility managers are on the front line 
of water safety 
• Water t...
© Special Pathogens Laboratory 
Be Proactive 
• Explain risk management benefits 
and risk to your client
© Special Pathogens Laboratory 
Prepare Yourself 
• Assemble Your Team 
 Water System Experts 
 Risk Management 
 Legio...
© Special Pathogens Laboratory 
Assist Your Client 
• Demonstrate Your Understanding 
 Proactive Approach 
 Team of Expe...
© Special Pathogens Laboratory 
Thank You 
Garry R. Boehlert, Esq. 
Partner, Saul Ewing LLP 
gboehlert@saul.com 
Janet E. ...
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Legionella: How to Protect Yourself and Your Clients

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Presentation delivered at AWT 2014 by Dr. Janet Stout, Frank Sidari, and Garry Boehlert

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Legionella: How to Protect Yourself and Your Clients

  1. 1. Legionella: How to Protect Yourself and Your Clients • Janet E. Stout, PhD – Director, Special Pathogens Laboratory • Garry R. Boehlert, Esq. – Partner, Saul Ewing LLP • Frank P. Sidari III, PE, BCEE – VP, SPL Consulting Services
  2. 2. Introduction and What’s New? © Special Pathogens Laboratory JANET E. STOUT, PHD
  3. 3. © Special Pathogens Laboratory Introduction • What’s New in Legionnaires’ Disease? • What Protects You & Your Clients? • What’s Involved In Risk Management?
  4. 4. UPDATE ON LEGIONELLA © Special Pathogens Laboratory Notes from the Field
  5. 5. International Legionella Conferences © Special Pathogens Laboratory • Research highlights • Worldwide trends
  6. 6. International Legionella Conferences © Special Pathogens Laboratory • 8th International Conference, Melbourne • European Study Group on Legionella Infections, Barcelona
  7. 7. Conference Highlights © Special Pathogens Laboratory • Clinical Aspects  Survivors of LD suffer PTSD syndrome  Fatality highest in immunocompromised persons with community-acquired infection  Atypical presentation of symptoms in the elderly  Legionella longbeachae cases in Europe
  8. 8. Cure One Disease, Cause Another • Biologic therapies widely used to treat inflammatory diseases increase the risk of intracellular infections including legionellosis. © Special Pathogens Laboratory
  9. 9. Antimicrobial Resistance? © Special Pathogens Laboratory • First report of a ciprofloxacin resistant Legionella pneumophila isolated from a clinical specimen. J. Antimicrob. Chemother.-2014-Bruin-2869-71 Cipro resistance in Legionella-1
  10. 10. Conference Highlights © Special Pathogens Laboratory • Epidemiologic Trends  European Cases – Summer spikes, but earlier and longer • 38% of cases between August to October  Urine antigen principal diagnostic tool – 88% of all cases  Use of typing methods to link outbreak strains • Sequence-based typing & pulsed field gel electrophoresis • New – use of whole genome sequencing for typing
  11. 11. 2014 Report on Quebec Outbreak © Special Pathogens Laboratory
  12. 12. © Special Pathogens Laboratory Quebec Outbreak PFGE Figure 1. PFGE pattern and SBT types of Lp1 isolates involved in the 2012 Québec City outbreak. Lévesque S, Plante P-L, Mendis N, Cantin P, et al. (2014) Genomic Characterization of a Large Outbreak of Legionella pneumophila Serogroup 1 Strains in Quebec City, 2012. PLoS ONE 9(8): e103852. doi:10.1371/journal.pone.0103852 http://www.plosone.org/article/info:doi/10.1371/journal.pone.0103852
  13. 13. © Special Pathogens Laboratory Outbreaks Continue: Cooling Towers Implicated • Warstein, Germany  165 cases, 12 ICU, 2 deaths  Legionella pneumophila, serogroup 1, monoclonal subtype Knoxville, sequence type 345.  Outbreak strain found in 2 cooling towers + other sources – including wastewater from brewery!
  14. 14. © Special Pathogens Laboratory Not The Beer! • “the Warsteiner brewery is not, for the time being, seen as the original source.” Whether or not the Warsteiner brewery is found to be the breeding ground for the Legionella bacteria, officials have been making it clear that the beer is completely safe to drink.
  15. 15. © Special Pathogens Laboratory New Tools To Study Microbial Communities The Microbiome
  16. 16. Phylogenetic Methods for Studying Microbial Communities Feasel et al. PNAS September 22, 2009 vol. 106 no. 38 16393–16399 © Special Pathogens Laboratory
  17. 17. © Special Pathogens Laboratory Pyrosequencing 454 Pyrosequencing: A Phylogenetic Method for Comparing Microbial Communities • Julianne Baron, J. Kirk Harris, Eric P. Holinger, Norman R. Pace, Janet E. Stout  University of Pittsburgh, Pittsburgh, PA, USA.  University of Colorado, Boulder, CO, USA.
  18. 18. Water Treatment Caused a Shift in Microbial Community © Special Pathogens Laboratory
  19. 19. © Special Pathogens Laboratory When We Add Disinfectants to Water… • We don’t eliminate bacteria, fungi and protozoa from the water, we change the proportions
  20. 20. PLoS ONE 2014 9(7):e102679.doi:10.1371/journal.pone.0102679 © Special Pathogens Laboratory
  21. 21. MORE NEW FINDINGS: MOLECULAR METHODS © Special Pathogens Laboratory
  22. 22. © Special Pathogens Laboratory Molecular Methods • The CDC does not currently recommend the routine use of genetic probes or PCR for detection of Legionella.  “Use of PCR for the identification of Legionella spp. is not recommended until more data regarding sensitivity and specificity of procedures are available”
  23. 23. © Special Pathogens Laboratory Cross reactive by LAMP* Cross reactive by PCR* False positives may be due to 86% 16S rRNA sequence similarity with Legionella and common organisms like Aeromonas, Pseudomonas, Mycobacteria
  24. 24. UPDATE ON LEGIONELLA © Special Pathogens Laboratory Guidelines and Standards
  25. 25. © Special Pathogens Laboratory Catalonia Outbreak
  26. 26. © Special Pathogens Laboratory Neonates at Risk Clinical Infectious Diseases 2013;57(1):48–56
  27. 27. Status of Proposed ASHRAE Standard © Special Pathogens Laboratory 188P American Society of Heating, Refrigerating and Air-conditioning Engineers
  28. 28. © Special Pathogens Laboratory Fourth Public Review September 26 - November 10
  29. 29. Why Another Public Review? • This document establishes minimum legionellosis risk management requirements for building water systems. • This document includes major changes in response to comments on the last full public review. © Special Pathogens Laboratory
  30. 30. © Special Pathogens Laboratory Changes • Removal of HACCP (Hazard Analysis and Critical Control Points) terminology (some of the principles of the HACCP process are consistent with the process utilized in the document) • Provides a normative appendix for health care facilities meeting specific requirements that provides an alternate compliance path that is more stringent than other facilities. • Requirements for design, construction, installation, commissioning, operation, maintenance and service are given more emphasis.
  31. 31. Visit These ASHRAE Websites © Special Pathogens Laboratory • ASHRAE Public Review Drafts:  https://www.ashrae.org/standards-research-- technology/public-review-drafts • ASHRAE Standards Actions:  https://www.ashrae.org/standards-research-- technology/standards-actions (and select the September 26, 2014 edition)
  32. 32. New VHA Legionella Directive © Special Pathogens Laboratory
  33. 33. Legionella: Don’t Let it Scare You! © Special Pathogens Laboratory
  34. 34. Legionella: How to Protect Yourself and Your © Copyright 2014 Saul Ewing LLP Clients October 31, 2014 Presented to By: Garry R. Boehlert, Esq.
  35. 35. © Copyright 2014 Saul Ewing LLP 2
  36. 36. © Copyright 2014 Saul Ewing LLP Because Legionnaires’ Disease is a Worldwide Problem 3 6
  37. 37. © Copyright 2014 Saul Ewing LLP In the United States Outbreaks Occur From East to West 37
  38. 38. Legionnaires’ disease can infect virtually anyone where water can be inhaled or aspirated Like it or not, you already have legal exposure if you treat or manage water systems in commercial, institutional or industrial facilities © Copyright 2014 Saul Ewing LLP 38
  39. 39. Surprisingly, there has been little uniformity in what actions designers, owners, facility managers and water treatment companies should take to guard against the waterborne bacteria that cause Legionnaires’ disease © Copyright 2014 Saul Ewing LLP Current Law 3 9
  40. 40. Claims Typically Asserted in a Legionnaires’ Disease Lawsuit © Copyright 2014 Saul Ewing LLP  Typical Counts in Complaint  Negligence  Gross Negligence  Res Ipsa Loquitur  Breach of Warranty of Merchantability  Strict Liability 40 COMPLAINT
  41. 41. Most Legal Battles in Legionnaires’ Disease Cases are Fought Over the Allegation of © Copyright 2014 Saul Ewing LLP Negligence 41
  42. 42. The failure to exercise the standard of care that a reasonably prudent person would have exercised in a similar situation © Copyright 2014 Saul Ewing LLP Eighth Edition 42
  43. 43. Critical Elements a Plaintiff Must Demonstrate to Meet Their Burden of © Copyright 2014 Saul Ewing LLP Proof for Negligence • Establish that you breached an applicable Industry Standard of Care • Establish causation between your Acts and Omissions and the Plaintiff’s Injury 43
  44. 44. In the Absence of Controlling Law or a Mandatory Standard, What Can the Water Treatment Industry Do For Protection From the © Copyright 2014 Saul Ewing LLP Risks Presented by Legionella Bacteria? 44
  45. 45. 1. Become Familiar with Existing Industry Publications Addressing Legionnaires’ © Copyright 2014 Saul Ewing LLP Disease 45
  46. 46. In the Health Care Industry •The Joint Commission for the Accreditation of Healthcare Organizations (JCAHO) published standard EC 1.7, which requires all JCAHO accredited facilities to have a management program to "reduce the potential for organizational-acquired illness." It holds the health care facility responsible for "managing pathogenic biological agents in cooling towers, domestic hot water, and other aerosolizing water systems.“ •The American Society for Healthcare Engineering (ASHE) recommends that health care facilities conduct a risk assessment of potential sources of Legionella Bacteria and develop a management plan for maintenance and operation of water systems. © Copyright 2014 Saul Ewing LLP 46
  47. 47. © Copyright 2014 Saul Ewing LLP LEGIONELLA 2003: An Update and Statement by the Association of Water Technologies (AWT) 47 Another Valuable Resource is
  48. 48. AWT Guidelines on Sampling and Testing © Copyright 2014 Saul Ewing LLP for Legionella Sampling and testing for Legionella can be useful in helping assess risks and in determining whether or not preventive and corrective measures are working. Having an action plan based on results of Legionella sampling can alert you to increased risks and whether or not disinfection procedures should be implemented. Not sampling tells you nothing about a system – until a case of LD occurs. With those quite logical and simple statements made, it may be assumed that Legionella sampling should be and is routine for any monitored system. Such is not the case (p. 23). 4 8
  49. 49. AWT’s Position Statement on © Copyright 2014 Saul Ewing LLP Sampling and Testing AWT supports that Legionella sampling and testing should be considered for all potential Legionella-source water systems. An ultimate decision to test or not should be determined and based upon an assessment and review of the specific water system (site and operations) for LD risks. This includes having an understanding of relevant facts on Legionella sampling and testing, Legionella and Legionnaires’ disease, and having an action plan for test results. Accordingly, AWT does not recommend the routine sampling and testing of all systems without appropriate assessments (emphasis in the original) (p. 31). 49
  50. 50. 2. Develop and Propose to your Clients Water Management Plans that Address Risks Posed by Legionella Bacteria • Customized on a building by building basis with an eye on risk factors such as:  General health and age of users of the facility  Quality and level of disinfectant in incoming water © Copyright 2014 Saul Ewing LLP 50
  51. 51. 3. After Adoption of Water Management Practices Be Sure They Are Consistently Applied and Document Your Compliance • It does little good to have a water management plan if it is not followed • When it comes to a legal defense, reliable written documentation can by very valuable © Copyright 2014 Saul Ewing LLP 51
  52. 52. 4. Have a Plan (or a Plan to Offer) if Legionella Bacteria is Detected in the Water System You Treat • Proactively consider what to do if Legionella bacteria is present © Copyright 2014 Saul Ewing LLP 52
  53. 53. 5. Educate Your Clients That Managing Water Systems to Reduce the Risk of Legionnaires’ Disease is in Their © Copyright 2014 Saul Ewing LLP Economic Best Interest • Well managed water systems have fewer repairs, longer useful lives and save energy • Risk of claims and litigation is reduced • Guarding against the risks posed by Legionella bacteria may result in savings on insurance premiums 53
  54. 54. © Copyright 2014 Saul Ewing LLP Looking for Safe Harbors • Adopt sound water management practices, consistently apply those practices, document and be able to verify compliance (Read and understand AWT Position Papers) • Be cognizant of water temperature in the context of your activities (be aware of at risk populations) • If you use a biocide, determine whether Legionella bacteria in its kill spectrum • Perform appropriate start up and routine and preventative maintenance and cleaning of equipment and systems and document those activities • Comply with the operation and maintenance recommendations of the manufacturer of the equipment utilized in your water systems, cooling towers, water features, etc. 54
  55. 55. © Copyright 2014 Saul Ewing LLP FAQ Q. Should I educate my clients to Legionella bacteria and the risk presented? A: Yes, education of your client offers you a level of protection. An educated client is in the best position to make informed decisions. Q. How should I raise the topic? A: In writing, and optimally, as part of the proposal process. Q. Should I document my client’s response? A: Yes -- the services you end up providing will generally be governed by a written contract. It could help if you can show you offered Legionella related services. Q. Should I test for Legionella without my client’s knowledge or consent? A: Generally, no. Water Treatment Companies are service providers. No law, rule or regulation mandates testing. Let your educated client contract for the services they select. 55
  56. 56. © Copyright 2014 Saul Ewing LLP DISCLAIMER The content of this presentation has been prepared by Saul Ewing for information purposes only. The provision and receipt of the information and presentation materials should not be considered legal advice, does not create a lawyer-client relationship, and should not be acted on without seeking professional counsel who have been informed of the specific facts. Should you wish to contact the presenter to obtain more information regarding your company's particular circumstances, it may be appropriate to enter into an attorney/client relationship. 56
  57. 57. Legionella Risk Management FRANK P. SIDARI, PE, BCEE © Special Pathogens Laboratory
  58. 58. Providing Risk Management © Special Pathogens Laboratory • Risk Management Overview • Providing Risk Management Services
  59. 59. Why Implement Risk Management? “It does not do to leave a live dragon out of your calculations, if you live near him.” J.R.R. Tolkien, The Hobbit © Special Pathogens Laboratory
  60. 60. Why Implement Risk Management? © Special Pathogens Laboratory • How does a facility…  demonstrate proactive approach to control of Legionella?  operate, monitor, document its water systems to minimize risk associated with Legionella? • Have a plan in place that…  documents proactive efforts  uses evidence based decisions  follows an accepted risk management approach
  61. 61. Risk Management Approaches © Special Pathogens Laboratory • Water Safety Plans  Risk management method developed by WHO specifically for safe drinking water • Hazard Analysis and Critical Control Point (HACCP)  Preventative risk management system used by the food manufacturing industry • Proposed ASHRAE Legionella Standard 188P
  62. 62. Components of Risk Management • Assemble a team • Develop flow diagrams • Assess risks / identify hazards • Define controls and interventions • Establish monitoring • Document and verify • Plan validation © Special Pathogens Laboratory
  63. 63. Water Safety Plan Implementation © Special Pathogens Laboratory
  64. 64. Risk Management/Water Safety Plan © Special Pathogens Laboratory Assemble a Team • Titles  Administrator  Facilities manager  Infection control  Water treatment professional  Risk manager  Legionella expert • Abilities  Power to make decisions  Understanding of facility  Knowledge of water systems  Ability assess facility risk tolerance  Expertise in Legionella
  65. 65. Risk Management/Water Safety Plan Develop Flow Diagrams • Potable and Non-Potable Systems • Block diagrams (high level) • Show major points in system © Special Pathogens Laboratory
  66. 66. © Special Pathogens Laboratory
  67. 67. Risk Management/Water Safety Plan © Special Pathogens Laboratory Assess Risks • The targeted hazard is…  Legionella bacteria and risk of transmission • Identify Risks:  Locations where the hazard may occur  Likelihood of occurrence  Potential severity of hazard occurrence  Hazard controls (if present)
  68. 68. Examples of Where to Assess Risk © Special Pathogens Laboratory Hot Water Heaters and Tanks
  69. 69. Examples of Where to Assess Risk © Special Pathogens Laboratory Hot Water Mixing and Circulation
  70. 70. Examples of Where to Assess Risk © Special Pathogens Laboratory Water Treatment
  71. 71. Examples of Where to Assess Risk © Special Pathogens Laboratory Distal Outlets and Points of Exposure
  72. 72. Risk Management/Water Safety Plan © Special Pathogens Laboratory Control Risk • Control Measure  A means to minimize Legionella risk or comply with regulatory requirements  Must be validated • Scientific literature • Professional standards • Test results • Regulatory requirement
  73. 73. Risk Management/Water Safety Plan © Special Pathogens Laboratory Intervention • Intervention or Corrective Action:  Procedures followed when a deviation of a critical limit occurs • Properties:  Specific  Immediate and comprehensive  Documented
  74. 74. Risk Management/Water Safety Plan © Special Pathogens Laboratory Establish Monitoring • Successful monitoring program includes:  Identification of Responsible Parties  Data Recording Documentation/Forms  Equipment/Methods for Testing  Frequency (Schedule)  Staff Training
  75. 75. Risk Management/Water Safety Plan © Special Pathogens Laboratory Document • Maintain records to demonstrate plan is being used and is effective • Store all information collected as part of the plan for future reference • Record keeping can have significant legal implications
  76. 76. Example Documentation © Special Pathogens Laboratory • Daily monitoring logs • Building automation • Laboratory reports • Maintenance records • Intervention records
  77. 77. Risk Management/Water Safety Plan © Special Pathogens Laboratory Verify • Verification  Confirmation that the plan is being implemented and followed properly. • Is monitoring being completed correctly and according to schedule? • Have control measures been violated? • Have interventions been properly performed for any violations of critical limits?
  78. 78. Risk Management/Water Safety Plan © Special Pathogens Laboratory Plan Validation • Validation  Evidence that confirms the effectiveness of the plan • How do you know the hazard (Legionella) is being controlled?  Establish validation measures
  79. 79. Risk Management/Water Safety Plan © Special Pathogens Laboratory Plan Audit • Audit  Review of the plan to determine if the plan is still valid for the facility  Have there been… • Gaps in documentation, monitoring, validation • Changes to the facility or water systems • Positive Legionella culture results • Diagnosis of case
  80. 80. © Special Pathogens Laboratory WORKING WITH CLIENTS
  81. 81. © Special Pathogens Laboratory Who Is Responsible? • Facility managers are on the front line of water safety • Water treatment providers often expected to assume responsibility
  82. 82. © Special Pathogens Laboratory Be Proactive • Explain risk management benefits and risk to your client
  83. 83. © Special Pathogens Laboratory Prepare Yourself • Assemble Your Team  Water System Experts  Risk Management  Legionella Experts  Legionella Laboratory • Have Confidence in Your Team  Demonstrated excellence  Industry experts
  84. 84. © Special Pathogens Laboratory Assist Your Client • Demonstrate Your Understanding  Proactive Approach  Team of Experts • Educate Your Client  Training • Propose a Program  Documented Effort
  85. 85. © Special Pathogens Laboratory Thank You Garry R. Boehlert, Esq. Partner, Saul Ewing LLP gboehlert@saul.com Janet E. Stout, PhD Director, Special Pathogens Laboratory jstout@specialpathogenslab.com Frank P. Sidari III, PE, BCEE VP, SPL Consulting Services fsidari@specialpathogenslab.com

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