Presentation on theme: "Legionellosis: Risk Management Planning"— Presentation transcript:
1Legionellosis: Risk Management Planning Indiana Chapter, Fall Conference of the:Association for Professionals in Infection Control and EpidemiologyMichael Coughlin, Ph.D.Weas Engineering, Inc.October 10, 2014
3Discussion TopicsLegionellaLegionellosisRisk Management Plan
4Philadelphia: July, 1976 Mysterious Illness Affects 221 People 147 Hospitalized34 DeathsPneumonia with Flu-like SymptomsFeverMuscle achesCoughPurulent sputumFluid in lungCould not visualize any micro-organisms from biopsyCould not culture any micro-organisms from biopsyDid not respond to conventional antibiotic therapy for pneumonia
5Legionella The “bug” Gram negative aerobic bacillus Intercellular parasiteAmoebaCiliated protozoaFastidious nutritional requirementsAmino Acid CysteineHigh Iron DemandVery slow growingHeat tolerantChlorine tolerant
6Legionellosis: The Disease The InfectionAcquired via inhalation of microscopic mist particles: < 5 micronsVery often found in alveoliNot spread person to person8,000 – 18,000 LD hospitalizations/year (CDC)85% Sporadic15% Outbreak8% of diagnosed pneumonias are LD> 90% are of serotype 1~ 10% serogroups 2-14, L. longbeachae, L. bozemanii
8Legionellosis: The Disease Legionnaires’ Disease (LD)Pontiac FeverDiseasePneumonia but with Flu-Like SymptomsFlu-LikeAt RiskImmunocompromisedHeavy drinkersSmokers and COPDAllTreatmentZithromaxLevoquinNone RequiredOrganismAll Legionella, especially L.p. serogroup 1All LegionellaFatality Rate15 – 80% (exacerbated by predisposing health risks, incorrect antibiotic therapy, delayed diagnosis)Zero
10Legionellosis: Diagnosis Four fold rise in antibodyOccurs in 70-80% of affected populationAntibody titer >250Can take up to 2 months to occurUrine antigen (lateral flow immunochromogenic test)Culture on BCYE….still the Gold StandardLp Sg 1&6Fisher ScientificLp Sg 1Alere
11Legionellosis: Diagnosis Compared to other pneumonias, LD presents same symptoms as other bacterial pneumonias, e.g., Steptococcus pneumoniae.Why then is it important to identify the causative agent?Correct antibiotic therapyPrevent outbreaksIdentify (and eliminate) the source of infection
12An Ideal Environment for Legionella Risk Factors = Ideal Growth ConditionsNutrientsHighly AerobicIdeal TemperatureHigh Surface AreaRetention TimeLow Chlorine LevelsPresence of Amoeba and Biofilm
14Biofilm: Control it and Control the Disease No fusion of lysosomeSome Legionella can not live in the absence of a host.
15Relative Significance of Legionellosis in US Data from: Morbidity and Mortality Weekly Report
16Relative Significance of Legionellosis in US US Waterborne Disease and Outbreak Surveillance SystemMMWR: September 6, 2013 / 62(35);58% from plumbing systems24% from untreated ground water12 % from community distributionLegionellosis
18Legionella in Hospital Potable Water Systems ReferenceLocationHospitals% with LegionellaIsolateHMSO, 1987UK4070L.p. Sg1Alary and Joly, 1992Quebec8468L.p. Sg 1-8Vickers et al, 1987PA1560L.p. Sg 1-6Patterson et al, 19976955Legionella Legionella sppMarrie et al, 1992Nova Scotia3923L.p.L. LongbeachaeLiu et al, 19961712L.p. Sg 1,4,6Kool et al, 1999Texas73Legionella1)Yu, V.L., "Resolving the Controversy on Environmental Cultures for Legionella: A Modest Proposal" Infection Control and Hospital Epidemiology, 19, pp , 1998.2)Texas Department of Health State Services Legionnaire's Disease(Legionellosis).ICD ; ICD-10 A48.1
19Seasonality of Legionellosis by Regions Data from: Morbidity and Mortality Weekly Report
20Incidence Rate of Legionellosis Urine TestMost cases of LD are from potable water and are sporadic.86.8% of LD cases are Community Acquired.Nosocomial pneumonias constitute an incidence rate of 4,200-7,700 per 100,000 patients
21Risk Management for Abatement of Legionellosis Risk: The probability of something going wrong.e.g., the chance of inhaling an infectious aerosol of LegionellaHazard: A process or parameter that increases a risk.e.g., biofilm containing Legionella in a cooling towerRisk Management is a process by which risk is controlled to an acceptable level by identifying and controlling the hazards.
22Risk Management: ASHRAE American Society of Heating Refrigeration and Air-Conditioning EngineersASHRAE is a professional association of engineers that establishes standards and guidelines of performance criteria for institutional and commercial buildings.ASHRAE is accredited by the American National Standards Institute (ANSI) and follows ANSI's requirements for due process and standards development.
23Risk Management Oversight: ASHRAE 188P Will supersede: Guideline Minimizing the Risk of Legionellosis Associated with Building Water Systems
26Risk Management Oversight: OSHA Section 5(a)(1) of the Occupational Safety and Health Act:“Each employer shall furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees.”Several conditions must be met for OSHA to issue a General Duty Clause violation:The hazard was recognized.The employer failed to keep the workplace free of a hazard to which his or her employees were exposed.A feasible and useful method was available to correct the hazard.The hazard was causing or likely to cause death or serious injury.
27Risk Management Oversight: JCAHO The Joint Commission for the Accreditation of Healthcare OrganizationsStandard EC 1.7, requires a management program to:Reduce the potential for organizational-acquired illness.Manage pathogenic biological agents in cooling towers, domestic hot water, and other aerosolizing water systems.
28Risk Management Oversight: ASHE The American Society for Healthcare EngineeringAll health care facilities:Conduct a risk assessment of potential sources of Legionella.Develop a management plan for maintenance and operation of water systems.
29Hazard Analysis and Critical Control Point HACCP Risk Management PlansHazard Analysis and Critical Control Point HACCPA Risk Management Program developed by Pillsbury for NASA in 1957.
30Hazard Analysis and Critical Control Points HACCPA Risk Management Program developed by Pillsbury for NASA in 1957because“There’s no room for poop in a NASA suit”
31Essentials of a HACCP Plan: “The 7 Principles of HACCP” Assess the Hazards.*Identify the Critical Hazard and its Critical Control Point (CCP).Establish CCP parameters.Establish monitoring frequency and procedure of CCP.Establish corrective actions when CCP limit is exceeded.Establish record keeping system.Validate the HACCP plan.*A CCP is the final step in the process wherein the hazard can be eliminated or adequately mitigated.
32Risk Management Plan by the “Team” Hazard Assessment.Mitigate Management.Establish risk mitigation parameters.Establish test frequency for mitigation procedures.Establish corrective actions when mitigation procedures are not achieved.Establish record keeping system fro mitigation procedures and actions.Plan Validation.
33Risk Management Plan Legionellosis Legionella Remediation Surveillance Plan ValidationHazard AssessmentRisk ManagementRemediationSurveillanceLegionellosisLegionella
34Validation by Legionella Testing: PCR Detects:Non-culturable LegionellaDead LegionellaLegionella in biofilmLegionella in amoebaSpecific for L. pneumophilaHighly Sensitive0.002 cell/ml for potable water0.004 cell/ml for tower waterRapid (Same Day)PCR cannot test for all serotypes
35Validation by Legionella Testing: Culture Culture MethodsDetects only “healthy” LegionellaSample must be fresh.Must suppress growth of competitive heterotrophs.No differentiation of Legionella speciesLow Sensitivity0.05 cell/ml potable water1 cell/ml tower waterSlow amplification (growth)= 3-4 day incubation done twiceStill the CDC Gold Standard
37Hazard Analysis: Potable Water AssessmentTap AeratorsShower Head AerosolsFaucet AerosolsDead LegsHot Water Tanks Sediment
38Risk Mitigation: Secondary Disinfection Chemical OxidationChlorineChorine DioxideMonochloramineTemperature Control> 140°F< 68°FChemical ReductionCu: 400 ppbAg: 40 ppbPoint of UseFiltration0.22 micron
39Risk Mitigation: Chemical Oxidation ChlorineChlorine DioxideChloramine(can not be used in dialysis)Maximum Limit4 ppm0.8 ppm as ClO2StableSpontaneously degrades to chlorateVolatile gas and spontaneously degrades to chloriteYesCorrosiveNot at 1.0 ppmCopper and LeadPenetrates BiofilmNoAmoebicidalEase of ApplicationEasyOn Site BlendingRaw Material HazardsCausticCaustic, GasDisinfection By-ProductsTHM’sChlorite (<0.8 ppm)THM’s, NDMACost/1000 gal.ppm1.0 ppm1.0 ppm
40Risk Mitigation: Point of Use Filtration 0.2 micron pore size31 day maximum useQuick connect/disconect adaptors3 gpm for tap and 5 gpm for shower at 43 psi
41Current Validation Strategies in Hospitals TX2002MD2000Dept. of VA2008CDCRoutine SurveillanceBased onLD historyPatient riskSystem riskYesNH2ClFrequency and NumberRisk Based2/100 beds(min. 10)2x/yrHistory of LD: 2x/yrNo History of LD 1x/yr2/100 beds (min. 10)>400 beds: Quarterly<400 beds: 2x/YrNumber not statedSample SitesShower heads, faucets, hot water tanksShower heads,faucets,hot water tanksSample Size10-50 mland Swabml and Swab100 mland Swab1000 ml
42Validation: Test Strategies Potable WaterCooling TowersSwabWaterSurveillanceFaucetsShower Heads100 ml of first purge from cold and hot water taps or shower headsOptional100 mlRemediationOne liter of first purge from cold and hot water taps or shower heads and one liter from storage tanks.
43Validation OSHA Guideline for Legionella Limits: CFU/ml MitigationNebulizers and HumidifiersPotable WaterOn Line Disinfection≥1≥10Off Line Disinfection≥100OSHA Guidelines“…applies only to water systems being used by healthy individuals.”“…numbers are only guidelines, the goal is zero detectable.”“…guidelines are subject to change.”
44Validation Comparative Guideline for Legionella Limits: CFU/ml MitigationNebulizers and HumidifiersPotable WaterUSAUKOn Line Disinfection≥10.1≥10Off Line Disinfection1.0≥100
45Risk Management: Validation Staged Validation for Potable WaterStageMethodSensitivitySurveillanceSwabPresence/AbsencePurgeCFU/mlRemediationCFU/ml
46Risk Management Plan: Potable Water Assess HazardMitigate RiskValidate Plan*Tap AeratorsRemove*Dead LegsRemove or Flush Weekly*Shower Heads in Cancer WardsReplace with Sterile Disposable Shower HeadsIce MachinesPlace in High use AreasQuarterly testing with swabs and/or water samples*Hot WaterDHW Return: >120 °F (check state code)DHW Supply: > °F (check state code)*Cold WaterSecondary Disinfection*EWGLI: 2011 European Working Group for Legionella Infections
47Risk Management Plan: Spas Assess HazardMitigate RiskValidate PlanAerosolsppm Cl2 orppm Br2No StandardParticulatesFiltrationDissolved Solids1.5 x TDS1) Guidelines for the Surveillance, Investigation, and Control of Legionnaires’ Disease in Florida
48Risk Management Plan: Humidifiers and Nebulizers Nebulizers: Use only sterile waterHumidification: Use only steam
49Remediation of Legionella Contaminated Potable Water Absence of Disease and Low Risk AreasPrimary Remediation:Post signs at each outlet to be flushed warning of potential scald injury.Flush hot water tanks.Maintain hot water temperature at 140°F and purge outlets for a minimum of 5 minutes.Secondary Remediation:Maintain a free chlorine residual of 50 ppm for 1 hr or 20 ppm for 2 hrs.
502003 CDC Response to Legionella Detection Absence of Disease and High Risk AreasDecontaminate the water supply.Do not turn on showers or faucets until systems test negative for LegionellaUse Sterile water for:Sponge bathsShowersTooth brushingRinsing of nasogastric tubes
512003 CDC Response to Nosocomial Legionellosis When Legionellosis is ConfirmedContact the local or state health department or CDC.Determine source of Legionella with using Infection Control and Engineering resources.Review historical water records.Conduct walk-thru and observe personnel duties and operation of equipment.Assess all relevant medical and engineering data.Determine if clinical and environmental samples are a perfect match.Disinfect contaminated systems.
522003 CDC Response to Nosocomial Legionellosis Diagnosis of Hospital Acquired LegionellosisConfirmed LD: diagnosed after 10 days of a continuous inpatient stay.Suspected LD: diagnosed between 2-9 days of an inpatient stay.Suspected LD: diagnosed in >2 patients within 6 months of each other and after having visited an outpatient transplant unit during part of the 2-10 day period before illness onset.
532003 CDC Response to Nosocomial Legionellosis RemediationPrimary Remediation: Flush hot water tanks. Maintain hot water temperature to 160°F-170 °F and purge outlets for a minimum of 5 minutes. Post warning signs at each outlet being flushed to prevent scald injury to patients, staff, or visitors. Secondary Remediation: Flush hot water tanks. Maintain a free chlorine residual of >2 ppm with or without supplemental heating throughout the system. This might require chlorination of the water heater or tank to levels of ppm. Circulate the water for at least 2 hours and maintain the water pH between 7.0 and 8.0.
542003 CDC Response to Nosocomial Legionellosis Plan ValidationRetest every 2 weeks for Legionella every 3 months.If negative after 3 months, continue monthly testing for 3 more months.Maintain all records.If these measures are unsuccessful, seek expert consultation for review of decontamination procedures and assistance with further efforts.
62Risk Management Plan: Bio-Loading Mitigate RiskAssess HazardBiocideTest MethodTest FrequencyPlanktonic BacteriaOxidizing Biocideppm as Cl2DPDDailyBiofilmNon Oxidizing BiocideMonthly AdditionN. Ap.2011 European Working Group for Legionella Infections
63Validation OSHA Guidelines for Legionella Limits: CFU/ml Mitigation Cooling TowersOn Line Disinfection100Off Line Disinfection1000
64Validation UK Standards for Legionella Limits: CFU/ml Mitigation Cooling TowersReassess Risk Mitigation ProgramDisinfection≥1.0Best to strive for no detectable Legionella. Many sites have no detectable Legionella, why should yours be an exception?
65Risk Management Plan: Cooling Towers and Water Features Mitigate RiskValidate PlanAssess HazardControl ParameterFrequencyBiofilmNon Oxidizing Biocide AdditionQuarterly100 mL samplePlanktonic BacteriaOxidizing BiocideDriftHigh Efficiency Drift EliminatorsSediment in BasinFiltrationSoluble IronCorrosion control
66Remediation of Legionella Contaminated Tower Water Absence of DiseaseClose bleed valve.Dose the cooling tower sump with a minimum of 180 ppm of C-992 and allow the product to circulate for 6 hours.Restart the bleed of the cooling tower.
67Remediation of Legionella Contaminated Tower Water “Wisconsin Protocol”Cooling Tower Associated with DiseasePower down cooling tower fanClose bleed valve.Close air intakes within 100 ft of the cooling tower.Use a 3M™ Disc Filter 2125 P2 respirator or equivalentDiscontinue regular chemical treatment.Adjust pH toAdd chlorine to initially establish 50 ppm free chlorine.Add a dispersant or low foaming surfactant.Maintain 10 ppm of free chlorine for 24 hours.Confirm the residual at least every 2 hours.Drain, refill and repeat steps 5-9 until tower is visually cleanMechanically clean all cooling tower surfaces and components*Refill and bring free chlorine to 10 ppm for 1 hour.Test and confirm absence of Legionella. If still present, repeat procedure.
68Risk Management Plan Summary Make your Risk Management Plan relevant and simple.There are few standards; guidelines are the norm.All guidelines are steered by validation.Risk Management is an iterative process of continuing improvement.So long as the process of assessment, mitigation and validation is followed, presence of Legionella is simply an opportunity for improvement.Risk Management can be your friend.
70BibliographyGuidelines for the Surveillance, Investigation, and Control of Legionnaires’ Disease in Florida. environments/indoor.../Legionella.pdfLegionnaires’ disease. The control of Legionella bacteria in water systems. Approved Code of Practice and guidance. ww.hseni.gov.uk/l8_legionnaires__disease_the_control_of_legionella_bacteria_in _water_systems.pdfGuidelines for Preventing Health-Care--Associated Pneumonia, 2003Texas Department of State Health Services Report of the Texas Legionnaires’ Disease Task Force.ASHRAE Legionellosis Position Statement E_PD_Legionellosis_2012.pdfOSHA Technical Manual https://www.osha.gov/dts/osta/otm/otm_iii/otm_iii_7.html#app_iii:7_3