Presentation on theme: "New Responsibilities Under ASHRAE Standard 188"— Presentation transcript:
1 New Responsibilities Under ASHRAE Standard 188 Managing Legionella:New Responsibilities Under ASHRAE Standard 188Presented by
2 Topics for Today Legionella Bacteria Legionella in Our Water Systems ASHRAE Standard 188Legal Impact of ASHRAEStandard 188Sterilizers & Autoclave Steam Quality
3 Legionella Bacteria Family Legionellaceae Aerobic Gram-negative, non-spore-formingrod-shaped flagellated bacillus
4 First Reported Outbreak of Legionaries Disease July 27, 1976 at the Bellevue Stratford Hotel in Philadelphia, Pennsylvania34 people died221 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.
12 Legionella makes a home in pipe slime Legionella Finds a HomeLegionella 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 minutesA functional population of 5x108 colonies in 4 daysThe 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 hyperchlorinationKill 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.
27 New ASHRAE Standard 188 - Prevention of Legionellosis in Building Water Systems
28 What is ASHRAE Standard 188? Risk management approach for theprevention 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 scheduleValidation summaryVerification schedulePlanned response to water service disruption
33 Your New HACCP Vocabulary • Control Point• Critical Control Point• Critical Limit• Validation• Verification• MonitoringCourtesy Dr. Janet StoutSpecial Pathogens Laboratory
34 Control Point (CP) Any step in the process at which biological, chemical, or physicalfactors can be controlled
35 Critical Control Point (CCP) A step in a process at which controlcan 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 physicalfactor must be controlled at a CCP toprevent, eliminate, or reduce to anacceptable level the occurrence of ahazard.
37 Validation Verification • Obtain evidence that the elements of the HACCP plan are effectiveDetermine compliance with the HACCP plan
38 Monitoring Measurements to assess whether a CCP is under control. Monitoring refers tomeasurements of the criticalLimits.
39 The Good, The Bad and The Ugly ASHRAE Standard 188P is a Two-Way StreetIt Imposes Burdens but it Also Offers Benefits
40 Your Rewards (The Good) Compliance with ASHRAE 188 shouldprovideSafer and healthier buildingsFewer Legionnaires’ disease claims and lawsuitsGreater protection against allegations of negligence and wrongdoing if claims orlitigation 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 StandardIf risk factors are present – assembly of a Hazard Analysis and Critical Control Point (HACCP) Team and creation of a written HACCP PlanValidation and documentation of compliance with the planIf outbreaks or a suspected case of disease occurs then perform disinfection11
42 virtually anyone anywhere (The Ugly) Legionnaires’ disease can infectvirtually 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 ManagerArising from the operation and maintenance ofcentralized water system for a 12 storyCondominium buildingThe Plaintiffs alleged:NegligenceGross NegligenceStrict 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 facilitiesIf, as expected, Standard 188 is adopted into city, county and state building codes, it will have the force of lawEven 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 leaderConstruct a water systems flow diagramPerform a hazard analysisEstablish critical control points (CCPs)Establish control measuresMonitoringFrequencyPerformance standards (limits)Corrective actionsEstablish 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 tasksto each team member based on HACCP.Meet as often as necessary to ensure and enable each task is accomplished in a TimelyManner.It is critical That eachForward step (improvement)is held! The Japanese call itKaizen, a philosophy ofcontinuous improvementcoupled with holding the gain.
50 Importance of Steam Quality From the earliest sterilizers (autoclaves)Wet packs and specks on instruments haveoften been blamed on poorSteam quality.
51 Operating Principles of Steam Sterilization There are four basic steps to operating a steamSterilizer (autoclave).loading the items to be sterilizedRemoval of air from the chamberSterilization at the necessary temperature and pressureDrying.
52 Operating Principles of Steam Sterilization - Loading Materials are typically wrapped in areusable cloth or disposable material. Oncewrapped, these are called "packs." Step 1, the loadingof the items to be sterilized, usually involves arrangingthe packs vertically on a loading cart. Sufficient roomis allowed between packs to permit air removal, directsteam contact, and proper drying
53 Operating Principles of Steam Sterilization – Air Removal the removal of air from the chamber is oftenaccomplished 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 outunder 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 sterilizationhas been successful.
56 Steam Quality *Steam Quality is defined as the amount of Liquid traveling with the steam vapor expressedas a weight percentage. For example, if 100 poundsFlows through the steam line, and5 pounds is liquid water , then 95Pounds is steam vapor. It is 95%Steam quality.*Courtesyy Walt Deacon - Thermo Diagnostics
57 What Causes Poor Quality Steam Boiler carryoverAll 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 pipesCondensation 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 SteamSteam line corrosion byproductsWater in the system is a major cause of specks oninstruments. Low pH condensate (and liquidwater from carryover) corrodes metal piping.In addition, high velocity water scrubs steelor copper oxidation off pipe walls causingspecks and wet packs.Water droplets forming on uninsulated steam pipe
59 What Causes Poor Quality Steam Steam line corrosion byproducts ContThe FDA has established limits on the amountof amine which can be fed in food applicationswhich 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-trapsA 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.