Managing Legionella

Managing Legionella:
New Responsibilities Under
ASHRAE Standard 188
Presented by
Topics for Today
Legionella Bacteria
Legionella in Our Water Systems
ASHRAE Standard 188
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 in Our Water System
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 5x108 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.
We Currently Have Lots of
Guidance Documents
Lots of Legionella Guidance Documents
Lots of Legionella Guidance Documents
Guidance Documents have Not
Legionnaires’ Disease Why?
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’
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
New ASHRAE Standard 188
- Prevention of Legionellosis
in Building Water Systems
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
Your New HACCP Vocabulary
Control Point
Critical Control Point
Critical Limit
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
• Obtain evidence that
the elements of the
HACCP plan are
Determine compliance
with the HACCP plan
Measurements to assess whether
a CCP is under control.
Monitoring refers to
measurements of the critical
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
 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
 If outbreaks or a suspected case of disease occurs then
perform disinfection
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
• “[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
 Performance standards (limits)
 Corrective actions
7. Establish documentation, verification, and validation
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
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
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.
Sterilizer & Autoclave
Steam Quality
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
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
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
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.
Thank You
Questions ?

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