lessons acquired from hcv outbreaks in hemodialysis units · 2019-07-18 · hcv outbreak in an...
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Lessons Acquired from HCV Outbreaks in Hemodialysis Units
JimmyTEO AssociateProfessor DivisionofNephrologyNationalUniversityofSingapore YongLooLinSchoolofMedicine NationalUniversityHospital
KDIGO
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DISCLOSURES
• Honoraria,consultingfeesfromMSD,Astellas,BoerhingerIngelheim,Novartis• Directandindirectownershipofstockinpharmaandbiotechcompanies,hospitals,
andclinicsaspartofretirementportfolio KDIG
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Outbreaks in Asia • Difficulttopullanyreportedeventsinliterature• CrudesurveyofMalaysia,Thailand,Taiwancontacts–noreports• Reportinliterature=Japan• SingaporeinlastfewyearsinRenalpatientward KDIG
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HCVOUTBREAKINANACUTEHOSPITALRENALUNIT • BetweenAprilandSeptember2015,22casesofacuteHCVinfectionwasidentifiedamongstpatientsadmittedtoWard64AorWard67atSGH
• ScreeningofthosewhohadbeenadmittedtothesewardsfromJanuarytoSeptember2015identifiedthreemorecases,givingatotalof25cases
• 20wererenaltransplantcases• Therewereeightdeathswithinthecluster
https://www.moh.gov.sg/docs/librariesprovider5/pressroom/current-issues/ircreport.pdf https://www.moh.gov.sg/docs/librariesprovider5/pressroom/current-issues/the-independent-review-committee-report-executive-summary.pdf
KDIGO
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HCVINFECTION • RenalWardwasoriginallyoperatinginWard64A,movedtoWard67on6April2015
whenWard64Awasunderrenovation,andbacktoWard64Aon28August2015• LaboratoryanalysisbySGH(andsubsequentlyconfirmedbyA*STAR)notedthe
presenceofastrainofHCV,ofgenotype1b,amongcases• ThusanoutbreakinvolvingacommonstrainofHCVwasestablished KDIG
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Independent Review Committee • Track1:
• Appointed two teams of international experts from the United States’ Centers for Disease Control (US CDC) and Prevention and Johns Hopkins University to strengthen its capabilities and to provide additional technical and scientific input to the committee’s review
• Track2:• Appointed three Resource Persons – Professor Tan Chorh Chuan,
President of NUS, Professor Chee Yam Cheng, Senior Advisor to National Healthcare Group, and Mr Ong Pang Thye, Deputy Managing Partner, KPMG to evaluate the various parties’ responses to the incident
• Included reviewing MOH’s role in the outbreak, IRC member Dr Jeffery Cutter (Director, Communicable Diseases Division, Ministry of Health) recused himself
KDIGO
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Four hypotheses were tested • Drugdiversion• Intentionalharm• Productcontamination• Breachesininfectioncontrol
KDIGO
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IRC findings • SusceptiblecasescomprisingmainlyimmunocompromisedkidneytransplantpatientsandtheintroductionofHCV(probablybythepatientidentifiedastheearliestinfectedcase)ledtoacuteinfectionswithextremelyhighquantitiesofvirusinthesepatients.
• Affectedpatientshadmanyexposurestointravenousmedicationsand/orlaboratoryteststhatrequiredbloodtaking,exacerbatingtherisksofHCVspreadthroughgapsininfectioncontrolpractices
• Gapsininfectioncontrolpractices(processesinvolvingintravenousprocedures),environmentalcleaning,andpreventionofenvironmentalcontamination.ThesepotentiallyfacilitatedHCVtransmissioninthetwoaffectedwards.
• Thesecouldhavebeenaccentuatedbytheshifttoanotherwardwherethelayoutwasdifferentfromthewardthatstaffwerefamiliarwith
KDIGO
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Recommendations • Tominimisetheriskofinfectiontransmission:• Reviewstandardoperatingproceduresandpracticesoninfectioncontrol,withaviewtoreduceriskofenvironmentalcontamination,andtoensureadequateenvironmentalcleaninganddisinfection
• Adheretostandardprecautionsforinfectioncontrol,aslaidoutinUSCDCguidelines• Strengthentheframeworkforsupervisionandmonitoringofstafftoensurecompliancewithstandardoperatingprocedures
US Centers of Disease Control and Prevention. 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings
KDIGO
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Key actions and responses on 5 items • (a)recognitionofaninfectiousdiseaseoutbreak• (b)notificationstoMOH• (c)outbreakmanagementandcontainment• (d)communicationsandescalation• (e)rolesandresponsibilitiesofkeyplayersduringtheoutbreak.• SurveillancesystemworkswellforcommunityoutbreaksofknowninfectiousdiseasesandhospitalshaverobustframeworkstohandlecommonHealthcare-AssociatedInfections(HAIs),theHCVoutbreakhighlightedagap
KDIGO
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Recognition • TheRenalUnitdidnotrecognisetheoutbreakinatimelymannerandtherewasadelayinreportingtoInfectionControlforhelpincontainment
KDIGO
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Notifications • MOHwasnotnotifiedbydoctorsandlaboratoriesofallthecasesinthecluster• MOH-CDDdidnotclassifytheinitialcommunicablediseasesnotificationsasacuteHCVinfectionsdespitesomecaseshavingabnormalliverfunctiontests,asthecaseswereassessednottomeetthecasedefinitionofanacuteinfectionatthetime
KDIGO
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Outbreak management and containment • StartedinvestigationsintotheHCVclusterfrommid-May2015,andenhancedinfectioncontrolmeasuresfromearly-June,investigationsperformedwereincomplete
• SeveralelementsofoutbreakinvestigationsuchasassessingtheseverityandextentoftheoutbreakweredoneaftermeetingwiththeDirectorofMedicalServices(DMS)on3September,suchasappointinganexternalpartytochairMedicalReviewCommitteetodetermineiftherewererelateddeathsduetotheHCVinfectionandsettingupaQualityAssuranceCommitteetodoarootcauseanalysis
KDIGO
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Communications and escalation • Withinthehospital,communicationwithseniormanagementtookplaceearly• However,intheabsenceofanestablishedframeworkfortheunusualandunfamiliareventoftheHCVoutbreak,therewasadelayinescalationfromthehospitaltoMOH
• Inaddition,withinMOH,therewasnosingledivisionwithclearresponsibilityandcapabilitytodealwiththeissue,resultinginagapinownership,untilthematterwasescalatedtotheDMS KDIG
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Roles and responsibilities • Withinthehospital,theredidnotappeartobeclearrolesandresponsibilitiesforthemanagementofunusualhospitaloutbreaks
• WithinMOH,theDMSassessedon3September2015thatmoreinformationwasneededtodeterminetheseverityandextentoftheoutbreak,andrequestedthehospitaltocompletekeypiecesofworkwithintwoweeks
• TheMinisterwasthereforeonlyinformedoftheissueon18September,andbriefedon25September,afterthehospitalsubmittedtheirinvestigationreporton24September KDIG
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Conclusions • Unusualoutbreakofablood-borneinfectionwithlowprevalenceratesinSingaporewaslikelyduetoacombinationofmultipleoverlappingfactorsconcentratedduringtheperiodofApriltoJune2015intheRenalWards
• Inparticular,theconcentrationofveryillpatientsandgapsininfectioncontrolpracticesprovidedanenvironmentfortheinfectiontospread
• WhileexistingsurveillanceandresponsesystemslendthemselveswelltoknowncommunityoutbreaksandHAIs,thesystemresponsetotheincident,whichisconsideredanunusualone,revealedsomegapsinthesystem
• RecommendedimprovingthenotificationandsurveillancesystemforacuteHCV;designatingasingleteamwithinMOHtooverseesurveillance,investigationandmanagementofoutbreaksandensureadequateexpertisetofacilitateoutbreakinvestigation;andstrengtheningescalationprocessesforHAIsandunusualrisks
KDIGO
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Key practical problems • Acutehospitalsurveillance• Nostandardreportinganddatacollectionwithinhospital• Changingmedicalteamsandinabilitytoidentifytrends
KDIGO
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Singapore MOH guidelines 2019
KDIGO
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Reported HCV outbreaks • Consideredpaperspublishedbetween1992and2015• 5parameters
• Total number of cases • Duration of the outbreak (number of months between the day of onset and
the day of end of the outbreak or as reported by the authors) • Attack rate (AR) (number of cases/number of susceptible individuals) • Fatality rate (FR) (number of deaths/number of cases) • Time to publication
• Consideredasmolecularepidemiologytechniquesonlytheanalysisofinfectioncluster(s)throughPCRof1ormoreselectedregion(s)oftheviralgenome
• Standardepidemiologyincludedserologicalanalysis,genotyping,orsub-typing
Fabrizi F, Messa P. Transmission of hepatitis C virus in dialysis units: a systematic review of reports on outbreaks. Int J Artif Organs. 2015 Sep;38(9):471-80. doi: 10.5301/ijao
KDIGO
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Fabrizi F, Messa P. Transmission of hepatitis C virus in dialysis units: a systematic review of reports on outbreaks. Int J Artif Organs. 2015 Sep;38(9):471-80. doi: 10.5301/ijao
KDIGO
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Fabrizi F, Messa P. Transmission of hepatitis C virus in dialysis units: a systematic review of reports on outbreaks. Int J Artif Organs. 2015 Sep;38(9):471-80. doi: 10.5301/ijao
KDIGO
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KDIGO
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Summary of findings from Tables • Adefinitepatient-to-patienttransmissionpathwaywasnotrecordedinanumberofoutbreaks(n=11,24%)
• Internalcontaminationofmachinewasmentionedorsuspectedasasource(n=8,18%)
• Epidemiologicalinvestigationscoupledwiththeapplicationofmoleculartechniquesinmanyoutbreaks(n=31;69%)
• Sharingofcontaminatedmultidosevials(heparinorsalinesolution)wasthesuspectedlapseconsidered(n=6;13%)
• Themostfrequenttransmissionpathwaywasmultipledeficienciesinapplyingstandardproceduresordialysisspecificprecautions(n=29;64%)
Fabrizi F, Messa P. Transmission of hepatitis C virus in dialysis units: a systematic review of reports on outbreaks. Int J Artif Organs. 2015 Sep;38(9):471-80. doi: 10.5301/ijao
KDIGO
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Contaminated dialysis and space • DatasupportingtransmissionofHCVbyHDmachinesarecontroversial• Findingssuggestthatthisrouteisuncommonandplaysaminortransmissionrole• Intheabsenceofvisibleblood,HCVRNAwasfoundontheexternalsurfacesofthedialysate(inlet-outlet)connectorofadialysismachineandonawastecart
• Bloodcontaminationhasbeenseenonenvironmentalsurfacesandequipmentbutalsoonitemsandsurfacesoutsidethetreatmentarea
Fabrizi F, Messa P. Transmission of hepatitis C virus in dialysis units: a systematic review of reports on outbreaks. Int J Artif Organs. 2015 Sep;38(9):471-80. doi: 10.5301/ijao
KDIGO
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Patient-care practices • Afteradjustingfornondialysis-relatedHCVriskfactors,patient-carepracticesindependentlyassociatedwithhigherprevalenceofHCVinfectionincluded
• reusing priming receptacles without disinfection (OR, 2.3, 95% CI, 1.4; 3.9) • handling blood specimens adjacent to medications and clean supplies (OR,
2.2; 95% CI, 1.3; 3.6) • using mobile carts to deliver injectables (OR, 1.7; 95% CI, 1.0-2.8)
Shimokura G, Chai F, Weber DJ, Samsa GP, Xia GL, Nainan OV, Tobler LH, Busch MP, Alter MJ. Patient-care practices associated with an increased prevalence of hepatitis C virus infection among chronic hemodialysis patients. Infect Control Hosp Epidemiol. 2011 May;32(5):415-24
KDIGO
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Summary • Manyreportssuggestthatanexactmodeofpatient-to-patienttransmissionofHCVintheHDsettingcouldnotbeascertained
• Theputativemechanismofpatient-topatienttransmissionwasmostlyunsatisfactorycompliancetostandard/specificinfectionpreventionpractices
• FulladherencetocontrolproceduresagainstthediffusionofHCVwithindialysisunitsandappropriatescreeningforanti-HCVantibodyareencouraged
Fabrizi F, Messa P. Transmission of hepatitis C virus in dialysis units: a systematic review of reports on outbreaks. Int J Artif Organs. 2015 Sep;38(9):471-80. doi: 10.5301/ijao
KDIGO
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KIDGO 2018 guidelines • >50%ofhealthcare–associatedHCVoutbreaksfrom2008to2015reportedtotheCDCoccurredinhemodialysissettings
Kidney International Supplements (2018) 91-165
KDIGO
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Kidney International Supplements (2018) 91-165
KDIGO
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Kidney International Supplements (2018) 91-165
KDIGO
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A few notes • Isolationnotrecommended
• Not much evidence, only 1 RCT • Isolate room, patient, machine, staff ?
• Controlmeasuresareeffective• TreatmentofHCV(reduceactiveprevalence,reduceincidence)• Auditsanduseofsurveillancedata
• Any new HCV positivity in HD patients = HD associated infection until proven otherwise
• Screeningofallpatientsbeforedialysisplacement,androutinesurveillance• Infrastructure/space
• Physical separation of patients, medication preparation areas, etc. Kidney International Supplements (2018) 91-165
KDIGO
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Answering my brief • ExamplesfromAsia• Betterinfrastructuredesign• Betterauditingmeasures• Bettersystemdesign(lowerpatient/staffratio)• Betterstafftraining/education• AttitudewhenfacingseroconversionsinHDKDIG
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