Managing Legionella: New Responsibilities Under ASHRAE Standard 188 Presented by Topics for Today I. II. III. IV. 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 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 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 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 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 • Obtain evidence that the elements of the HACCP plan are effective Verification 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. 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 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. Thank You Questions ?