1. New Responsibilities Under ASHRAE Standard 188
Managing Legionella:
New Responsibilities Under ASHRAE Standard 188
Presented by

2. Topics for Today Legionella Bacteria Legionella in Our Water Systems
ASHRAE Standard 188
Legal Impact of ASHRAE
Standard 188
Sterilizers & Autoclave Steam Quality

3. Legionella Bacteria Family Legionellaceae
Aerobic Gram-negative, non-spore-forming
rod-shaped flagellated bacillus

4. First Reported Outbreak of Legionaries Disease
July 27, 1976 at the Bellevue Stratford Hotel in Philadelphia, Pennsylvania
34 people died
221 Sickened

5. 36 Years Latter, Where Are We in Controlling Legionnaires Disease?
Since the outbreak at the Bellevue Stratford Hotel in Philadelphia, there has been little uniformity in what actions, if any, either Regulatory or facility designers, owners or managers have taken to guard against the waterborne bacteria that cause Legionnaires’ disease.

6. Results of Improper Water Treatment

7. Results of Improper Water Treatment

8. Results of Improper Water Treatment

9. Results of Improper Water Treatment

10. U.S Legionellosis Cases Reported Annually
Increased 217% From 2000 to 2009

11. Legionella in Our Water System

12. Legionella makes a home in pipe slime
Legionella Finds a Home
Legionella makes a home in pipe slime

13. Legionella – Hiding in Plain Sight
New domestic water system clean piping

14. Stage 1- Biofilm forming bacteria enters domestic water system
Example, Pseudomonas aeruginosa (slime former), a very common and highly opportunistic pathogen

15. Stage 2- Bacteria creates active biofilm
Ability to create monolayer biofilm in 15 minutes
A functional population of 5x108 colonies in 4 days
The biofilm matrix is 15% cells and 85% polysaccharide

16. Stage 3- Legionella enters system with protozoan host

17. Stage 4- Active biofilm becomes habitat for protozoan & Legionella
Legionella and Protozoan host flourish in and are protected by biofilm matrix from external factors.

18. Stage 5- Initial attempts at controlling
Legionella: Heat & flush and hyperchlorination
Kill minor colonies of Legionella in bulk water system, has little affect on biofilm layer and therefore no impact on protozoan/Legionella colonies

19. Stage 6- System upset disrupts biofilm
Disrupted biofilm actively releases Protozoa and Legionella into bulk water system.

20. We Currently Have Lots of Guidance Documents

21. Lots of Legionella Guidance Documents

22. Lots of Legionella Guidance Documents

23. Guidance Documents have Not Controlled Legionnaires’ Disease -
Why?

24. Courts Do Not Look At Current Guidelines As Setting Industry Standards
The Lack of Uniformity Contributes to Your Exposure to Legal Liability When Illness or Death Occurs from Legionnaires’ Disease

25. Industry Trend - a Policy of Avoidance
Most wait to address the problem until after a case of Legionnaires’ disease is diagnosed

26. Industry Trend - a Policy of Avoidance

27. New ASHRAE Standard 188 - Prevention of Legionellosis in Building Water Systems

28. What is ASHRAE Standard 188?
Risk management approach for the
prevention of legionellosis associated with centralized industrial and commercial building water safety

29. Who is Responsible for Implementing
and Managing Building Water Safety

30. Core Elements of ASHRAE Standard 188
Requirement for Hazard Analysis (HACCP) Plan
• H = Hazard (Legionella)
• A = Analysis
• C = Critical
• C = Control
• P = Point

31. Annual Survey to Assess Risk
Facility owners and managers will be required to annually survey their buildings to determine risk characteristics using hazard analysis and critical control point (HACCP) methodology

32. Documented HACCP Plan HACCP team Flow diagrams Hazard summary
Monitoring/maintenance schedule
Validation summary
Verification schedule
Planned response to water service disruption

33. Your New HACCP Vocabulary
• Control Point
• Critical Control Point
• Critical Limit
• Validation
• Verification
• Monitoring
Courtesy Dr. Janet Stout
Special Pathogens Laboratory

34. Control Point (CP) Any step in the process at which
biological, chemical, or physical
factors can be controlled

35. Critical Control Point (CCP)
A step in a process at which control
can be applied and is essential to:
• Eliminate the hazard
• Prevent it from harming people

36. Critical Limit A maximum or minimum value to
which biological, chemical, or physical
factor must be controlled at a CCP to
prevent, eliminate, or reduce to an
acceptable level the occurrence of a
hazard.

37. Validation Verification
• Obtain evidence that the elements of the HACCP plan are effective
Determine compliance with the HACCP plan

38. Monitoring Measurements to assess whether a CCP is under control.
Monitoring refers to
measurements of the critical
Limits.

39. The Good, The Bad and The Ugly
ASHRAE Standard 188P is a Two-Way Street
It Imposes Burdens but it Also Offers Benefits

40. Your Rewards (The Good)
Compliance with ASHRAE 188 should
provide
Safer and healthier buildings
Fewer Legionnaires’ disease claims and lawsuits
Greater protection against allegations of negligence and wrongdoing if claims or
litigation are filed

41. Your Obligations (The Bad)
Performance of an Annual Building – by – Building Risk Assessment with an eye on the risk factors contained in the Standard
If risk factors are present – assembly of a Hazard Analysis and Critical Control Point (HACCP) Team and creation of a written HACCP Plan
Validation and documentation of compliance with the plan
If outbreaks or a suspected case of disease occurs then perform disinfection 11

42. virtually anyone anywhere (The Ugly)
Legionnaires’ disease can infect
virtually anyone anywhere (The Ugly)
You already have legal exposure if you design, own or manage water systems in commercial, institutional or industrial facilities

43. $20,000,000 Wrongful Death Legionnaires’
Disease Case Against Property Manager
Arising from the operation and maintenance of
centralized water system for a 12 story
Condominium building
The Plaintiffs alleged:
Negligence
Gross Negligence
Strict Liability

44. The Court Rejected the Plaintiff’s Contention that the OSHA and ASHRAE Guidelines Establish an Industry Standard of Care
“[s]uch guidelines and publications alone are not enough to establish the standard of care that professional management companies must exercise.”
“[p]laintiff has not produced any other evidence of the requisite standard of care, such as governmental regulations or industry standards, that could perhaps establish the requisite element of duty.”

45. Expected Legal Significance of ASHRAE Standard 188P After Adoption
It will apply equally to new and existing facilities
If, as expected, Standard 188 is adopted into city, county and state building codes, it will have the force of law
Even if not formally made part of a code, plaintiffs are expected to argue that the new standard sets best practices for your industry

46. How to Start A HACCP Plan
Form a team and appoint a leader
Construct a water systems flow diagram
Perform a hazard analysis
Establish critical control points (CCPs)
Establish control measures
Monitoring
Frequency
Performance standards (limits)
Corrective actions
Establish documentation, verification, and validation procedures

47. Implementing a Risk Management Plan Based on ASHRAE Standard 188 Does Not Have To Be As Complicated as Some May Suggest!

48. The Key to Success (Use the kiss principal)
Like eating an elephant, it’s all in the planning and execution. Form the team, assign small doable tasks
to each team member based on HACCP.
Meet as often as necessary to ensure and enable each task is accomplished in a Timely
Manner.
It is critical That each
Forward step (improvement)
is held! The Japanese call it
Kaizen, a philosophy of
continuous improvement
coupled with holding the gain.

49. Sterilizer & Autoclave
Steam Quality

50. Importance of Steam Quality
From the earliest sterilizers (autoclaves)
Wet packs and specks on instruments have
often been blamed on poor
Steam quality.

51. Operating Principles of Steam Sterilization
There are four basic steps to operating a steam
Sterilizer (autoclave).
loading the items to be sterilized
Removal of air from the chamber
Sterilization at the necessary temperature and pressure
Drying.

52. Operating Principles of Steam Sterilization - Loading
Materials are typically wrapped in a
reusable cloth or disposable material. Once
wrapped, these are called "packs." Step 1, the loading
of the items to be sterilized, usually involves arranging
the packs vertically on a loading cart. Sufficient room
is allowed between packs to permit air removal, direct
steam contact, and proper drying

53. Operating Principles of Steam Sterilization – Air Removal
the removal of air from the chamber is often
accomplished by drawing a vacuum on the chamber. If this is the case, the unit is referred to as operating in a "pulse," "pre-vac," or "high-vac" mode.
Sometimes air is removed simply by gravity, with steam injected at the top and the air forced out through the bottom of the unit. The unit is operating in a "gravity" mode. It is important to remember complete air removal is essential for proper sterilization

54. Operating Principles of Steam Sterilization – Sterilization
Sterilization takes place at temperatures of 250 to 275 °F (120 to135 °C) for approximately 15 minutes. This corresponds to a steam pressure of 15 to 30 psi. The steam should be saturated but have a steam quality of at least 0.97.

55. Operating Principles of Steam Sterilization – Drying
The drying process, is typically carried out
under vacuum. Sterilizers are steam jacketed so that the walls of the unit are kept hot to prevent condensation at the walls during the drying process. To verify proper sterilization conditions, indicator tape is often used to show that air is being adequately removed from the chamber and that the sterilization
has been successful.

56. Steam Quality *Steam Quality is defined as the amount of
Liquid traveling with the steam vapor expressed
as a weight percentage. For example, if 100 pounds
Flows through the steam line, and
5 pounds is liquid water , then 95
Pounds is steam vapor. It is 95%
Steam quality.
*Courtesyy Walt Deacon - Thermo Diagnostics

57. What Causes Poor Quality Steam
Boiler carryover
All boilers carryover to some degree. The key is to minimized it with good steam separating equipment and maintaining proper drum water level.
Non-insulated steam pipes
Condensation in hot steam pipes against cooler pipes and/or walls forms liquid water. Pipe insulation plays a big part in minimizing condensation and maintaining steam quality.

58. Water droplets forming on uninsulated steam pipe
What Causes Poor Quality Steam
Steam line corrosion byproducts
Water in the system is a major cause of specks on
instruments. Low pH condensate (and liquid
water from carryover) corrodes metal piping.
In addition, high velocity water scrubs steel
or copper oxidation off pipe walls causing
specks and wet packs.
Water droplets forming on uninsulated steam pipe

59. What Causes Poor Quality Steam
Steam line corrosion byproducts Cont
The FDA has established limits on the amount
of amine which can be fed in food applications
which is also applicable for autoclaves. limits are listed below:
Morpholine 10 ppm (mg/L)
DEAE 15 ppm (mg/L)
Cyclohexylamine 10 ppm (mg/L)
Octadecylamine 3 ppm (mg/L)
Note: When a combination neutralizing amine product is used, the total amine concentration cannot exceed 25 ppm (mg/L) in the steam.

60. What Causes Poor Quality Steam
Poor functioning steam-traps
A steam trap is an automatic valve that drains liquid water and vents air, but keeps (traps) steam in the system. The internal mechanism senses condensate and air, and opens the valve to drain the system. Steam pressure pushes the undesired fluid out.
When the liquid water is not removed, it can add to specks on instruments and wet packs.

61. Thank You
Questions ?