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 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.
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 5x108 colonies in 4 days • The biofilm matrix is 15% cells and 85% polysaccharide
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.
Guidance Documents have Not Controlled 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 WhenIllness 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
New ASHRAE Standard 188 - Prevention of Legionellosis in Building Water Systems
What is ASHRAE Standard 188? Risk management approach for the prevention of legionellosisassociated 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 Determine compliance with the HACCP plan • Obtain evidence that the elements of the HACCP plan are effective
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 • 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
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) 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.
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.