Presente d by

I.
Legionella Bacteria
II.
Legionella in Our Water Systems
III. ASHRAE Standard 188
IV. Legal Impact of ASHRAE
Standard 188
V.
Sterilizers & Autoclave Steam Quality

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

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

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.

Results of Improper Water Treatment

Results of Improper Water Treatment

Results of Improper Water Treatment

Results of Improper Water Treatment

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

Legionella Finds a Home
Legionella makes a home in pipe slime

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

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

Stage 2- Bacteria creates active biofilm
• Ability to create monolayer biofilm in 15 minutes
• A functional population of 5x10 8 colonies in 4 days
• The biofilm matrix is 15% cells and 85% polysaccharide

Stage 3- Legionella enters system with protozoan host

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

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

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

Lots of Legionella Guidance Documents

Lots of Legionella Guidance Documents

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

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

Industry Trend - a Policy of Avoidance

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

Who is Responsible for Implementing and Managing Building Water Safety

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

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

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

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

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

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

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.

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

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

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

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

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

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

$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

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.”

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

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

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

The Key to Success (Use the kiss principal)
1. 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.
2. Meet as often as necessary to ensure and enable each task is accomplished in a Timely
Manner.
3. 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.

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

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

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

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 "highvac" 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

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.

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.

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

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.

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

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.

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.