BiomoniToring - APHL · 2016-05-16 · and asbestos with cancer, many other chemical...
Transcript of BiomoniToring - APHL · 2016-05-16 · and asbestos with cancer, many other chemical...
The Association of Public Health Laboratories
BiomoniToring AnAlysis of HumAn ExposurE to CHEmiCAls
UnmeT needs• Provide$25millioninFY2010tofundCDC’s
NationalBiomonitoringProgram> $15Mtofundstatestobuildlaboratory
capacityandcapabilitytomonitorchemicalsinpeople.
> $10MtofundCDCtosupportstateprograms,developmethods,conductstudiesandissuereportsonmonitoringdiseaseandchemicalexposuresinpeople.
BAckgroUndEverydaywecomeincontactwiththousandsofchemicals.Thoughyouwouldnotknowinglybreatheinairpollutedwithsulfurdioxideordrinkwatercontainingarsenic,chemicalsintheenvironmentoftengounnoticed.Whilepoorairqualityhasbeenlinkedwithasthma,andasbestoswithcancer,manyotherchemicalexposure-healthrelationshipsarenotknown.Approximately100,000chemicalsarecurrentlyregisteredforuseintheUS,yetweknowverylittleabouttheireffectsonhumanhealth.
AspartofitsNationalBiomonitoringProgram,CDC’sEnvironmentalHealthLaboratoryhasmeasuredlevelsofchemicalsinpeopleforthelast30years.ThedataareusedtoassessexposuretoenvironmentalchemicalsintheUSpopulationandprovidevaluableinformationwhenanalyzedinconjunctionwithhealthoutcomedata.
CDCcurrentlyhasbiomonitoringdataavailableforhundredsofchemicalsincludingperchlorate,bisphenolA(BPA)cotinine(ameasureof
secondhandtobaccosmoke),flameretardants,certainpesticidesandothercomplexchemicals.
Biomonitoringdataarecriticalinassessingpeople’sexposuretochemicalsfollowingbothunintentionalandintentionalchemicaleventsbyidentifyingthechemicalagentanddeterminingwhichpeoplewereandwerenotexposed.Additionally,informationfromCDCaboutbackgroundlevelsofexposurecanbeusedasareferencetodeterminewhenpeoplehaveelevatedlevelsofchemicalsintheirbodies.OngoingmonitoringofexposedpopulationsbyCDCensurespeoplereceivepropercareandtreatmentandhelpsdecisionmakersdeterminewhichchemicalsneedregulation.
ProgrAmAPHLsupportsfundingfortheNationalBiomonitoringProgramatCDC.Currently,theNationalCenterforEnvironmentalHealthatCDCusesbiomonitoringtomeasurespecimensfromparticipantsintheNationalHealthandNutrition
CDC FUNDING Environmental Health Laboratory (Dollars in millions)
FY 2009 $7.5 (Enacted)
FY 2010 $25 (APHL Required Amount)
8515 Georgia Avenue suite 700 silver spring, mD 20910 | phone: 240.485.2745 | fax: 240.485.2700 | Web: www.aphl.org
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ExaminationSurvey.Newfundingwouldbeusedtoprovideadequatetechnicalassistanceandtrainingtostates,supportstudiestoinvestigatethehealthimpactsofchemicalexposuresanddeveloplaboratorymethodsthatarereadilytransferrabletostates.
Atthestatelevel,thisfundingwouldexpandstatelaboratories’abilitiestoconducttargetedpopulation-basedbiomonitoringstudies,upgradefacilitiesandequipmentandbolstertheirworkforcetoensureproficiencyinlaboratorytechniques.
BiomoniToring And environmen-TAL PUBLic HeALTH TrAckingRatesofchronicdiseasessuchasallergies,asthma,obesity,diabetes,heartdiseaseandmetabolicsyndromeareallontheriseintheUS.Althoughtherearemanytheorieswithregardtocause,therearenodefinitiveanswersexplainingthesealarmingrates.Pastresearchhaslinkedsomeenvironmentalexposureswithspecificdiseases,suchasbenzeneexposuretoleukemia.However,muchworkremainstodeterminewhetherornotexposuretocertainchemicals,suchasflameretardants,causesillnessordisease.
TheEnvironmentalPublicHealthTracking
(EPHT)Networkwillallowexistingenvironmentalhazard,exposureanddiseasetrackingsystemstobelinkedtogether.Biomonitoringisessentialtosuchlinkagessinceitisthemostaccuratemethodofdetermininghumanexposuretoenvironmentalhazardsandisabetterwaytoassesstheimpactofanenvironmentalhazardonhumanhealth.
StatelaboratoriesshouldplayanimportantroleintheEPHTNetwork.TheConnecticutEPHTProgram,forexample,isworkingcloselywiththestate’spublichealthlaboratory,theMaineHealthandEnvironmentalTestingLaboratoryandtheVermontDepartmentofHealthLaboratorytoexamineumbilicalcordbloodfromnewbornsformercury,lead,cadmiumandrelatedbiomarkers.
Althoughsomestateshavemadetremendousstridesinbiomonitoring,currentlytherearenosystemsthatexistatthestateornationalleveltotrackmanyoftheexposuresandhealtheffectsthatmayberelatedtoenvironmentalhazards.
APHLsupportstheexpansionoftheEnvironmentalPublicHealthTrackingprogramtolinkenvironmentaldatawithbiomonitoringandhealthdatainallstates.Fundingshouldincreasethenumberofstatelaboratoriesdoingbiomonitoringanddeveloptheirabilitytosharedataelectronicallywithotheragencies.
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The Association of Public Health Laboratories
newBorn screening promotinG tHE HEAltH of AmEriCA’s futurE
UnmeT needs• FundtheprogramsauthorizedintheNewborn
ScreeningSavesLivesActof2007(S.1858/H.R.3825)tobuildthenecessaryinfrastructureandworkforceneededforeducation,outreach,follow-upcare,laboratoryqualityassuranceandcontingencyplanning.
• Provide$10milliontotheCDCEnvironmentalHealthLaboratory’sNewbornScreeningQualityAssuranceProgramtoensurethatlaboratorytestsusedtoscreennewbornsarehighqualityandthatnewonesaredevelopedconstantly.
BAckgroUndNewbornscreeningisavitalresponsibilitywithprofoundandlifelongconsequencesforthethousandsofinfantsdiagnosedeachyearwithheritableandgeneticconditions,suchassicklecellanemiaandcysticfibrosis.Inmanycases,earlyinterventioncanmeanthedifferencebetweenrelativehealthandsevereimpairment…orevenbetweenlifeanddeath.
APHLanditsmembersareacutelyawareoftheimportanceofnewbornscreening(NBS)andtheelementsofahigh-qualityscreeningprogram.StatepublichealthlaboratoriesareaccountablefortheNBStestresultsof97%ofallbabiesbornintheUnitedStates—morethan4millionbabieseachyear.
Inthepastdecade,theenvironmentfornewbornscreeningunderwentdrasticchange.Ontheonehand,newtechnologiesandgeneticdiscoveriesledtoamajorexpansionoftheNBStestingpanel,creatinggreateropportunityfor
interventionandalsoapressingneedfortechnicaltraining.
Ontheotherhand,unforeseencatastrophes—includinghurricaneKatrina—demonstratedthevulnerabilityofstatenewbornscreeningprograms,whicharealmostalwayssingle-siteoperations.
Oneofthemajormilestoneinnewbornscreeninglastyearwasthepassingofthe“NewbornScreeningSavesLivesActof2007,”whichwassignedintopubliclawbyPresidentBushonApril24,2008,withoutanyappropriatedfunds.
Newbornscreeningisanessential,life-savingandeffectivepreventivepublichealthprogramforearlyidentificationofmedicalconditionsthatcanleadtocatastrophichealthproblems.ItidentifiesthousandsofbabiesbornintheUSeachyearwithageneticormetabolicdisorder.Thecostoftheseconditionsifleftuntreatedisenormous,bothintermsofhumansufferingandineconomicterms.
Worldwide,CDC’sNewbornScreeningQualityAssuranceProgramLaboratoryistheonly
CDC FUNDING Environmental Health Laboratory (Dollars in millions)
FY 2009 $8 (Enacted)
FY 2010 $10 (APHL Required Amount)
8515 Georgia Avenue suite 700 silver spring, mD 20910 | phone: 240.485.2745 | fax: 240.485.2700 | www.aphl.org
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newBorn screening promotinG tHE HEAltH of AmEriCA’s futurE
comprehensivesourceforensuringtheaccuracyofnewbornscreeningtests.FundingtheNewbornScreeningQualityAssuranceProgramat$8millionwillallowfor:1)Theresearchanddevelopmentofnew
laboratoryscreeningmethodsthatexpandthenumberofdisordersbabiescanbescreenedfor.
2)Population-basedpilottestingforconditions(e.g.,SevereCombinedImmuneDeficiency,PompeDisease,MetachromaticLeukodystrophy,etc.)notpresentlyincludedintestpanels.
3)Theprovisionoftechnicalassistanceandtechnologytransfertostatenewbornscreeninglaboratories,particularlywithregardtopromisingandsophisticatedtechniquescapableofidentifyingahostofdisorderscurrentlynotdiagnosableinnewborns.
4)Thetestingofnewscreeningtoolstoensurethehighestpossibleanalyticvalidityandutility.
coLLABorATion wiTH sTATe And LocAL HeALTH dePArTmenTs Duringthepastseveralyears,stateshave
experiencednewbornscreeningserviceinterruptionsduetobothnaturaldisastersandmanufacturerinabilitytoprovidetestingmaterials.Contingencyplanningisneededtolessentheeffectofdisastersthatinvolvenewbornscreeningprogramoperations.APHLcontinuestosupportthefundingfornewbornscreeningcontingencyplanningactivitiesthatwereoutlinedintheNewbornScreeningSavesLivesActtoensuretheavailabilityofnewbornscreeningduringanemergency.
oTHer criTicAL FUncTionsTheNewbornScreeningQualityAssuranceProgramLaboratoryatCDC:• Trainsstatelaboratoriansonthelatest
technologiesandprovidesproficiencystandardsfornewmaterials.
• Supportsstatelaboratoriesduringnewbornscreeningemergencysituations,suchastheaftermathofhurricanesKatrinaandRita.
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The Association of Public Health Laboratories
LABorATories mUsT Be ABLe To TrAnsmiTtEst AnD rEsult DAtA ElECtroniCAlly
UnmeT needs• Provide$112millioninannualCDCfundingfor
publichealthinformaticsinitiatives.• Provide$200millionannuallytodirectly
impactthestateandlocallaboratories’abilitytodevelopanddeployElectronicLaboratoryMessagingcapability.
• Increaselong-termfundingtostateandlocalpublichealthlaboratoriestoensurepurchaseandmaintenanceofastandards-compliant,interoperablelaboratoryinformationsystem.
• IncreasefundingfortheCDC’sNationalCenterforPublicHealthInformaticstosupportstateandfederaleffortsforelectronicdataexchange.
• Providefundingtosupportcommunity-buildingandcollaborationinitiativesamongallnationally-organizedpublichealthlaboratorynetworks.
BAckgroUndPublichealthlaboratoriesarekeyprovidersofpopulation-baseddiseasedatathatcanbeusedtoprotectthehealthofallAmericans.Theyprovidethemeanstorecognizeandalertofficialstooutbreaksofnewly-emergentandrecurrentdiseasebyservingastestingsitesforprivatephysicians,hospitalsandclinics,aswellasservingasadirectinterfacebetweenstateandfederalepidemiologists.Publichealthlaboratoriessafeguardentirecommunities.
Withouttheabilitytomanagelaboratorydatathemselves,labscannotdisseminateinformationtimelyandaccuratelytothoseresponsibleformanaging,controllingand
respondingtoanevent.Weneedsustainedfundingtoensureournation’slaboratorieshaveaccesstotechnologically-advancedinformationsystemsintimesofcrisis.
ALaboratoryInformationManagementSystem(LIMS)isavitalcomponentofthelaboratoryandsupportsallofitsfunctions—fromspecimenprocessingthroughsubsequenttestingandtestresultreporting.However,aLIMSisonlyonecomponentofthedailyworkandfunctionsofthelaboratorytoproducediseasedata.Theothercomponentistheelectronicexchangeofthepatient’stestordersandtestresultsamongthelaboratoryanditsprivate,local,stateandfederalpartners,whichisknownasElectronicLaboratoryMessaging(ELM).Toimplementonewithouttheotherwouldbetoimplementamarginallyusefulsystem.
ELMwouldpromoterapidinformationdisseminationandmitigationofexposure.Testordersandresultscannolongerbeinefficientlyreportedbytelephone,faxand
CDC FUNDING (Dollars in millions)
Public Health Informatics
FY 2009 $70 (Enacted)
FY 2010 $112 (APHL Required Amount) (with $32 million for public health laboratory data handling)
8515 Georgia Avenue suite 700 silver spring, mD 20910 | phone: 240.485.2745 | fax: 240.485.2700 | www.aphl.org
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email.Improvementsinhealthinformationtechnologymustincludethelaboratoriesthatperformtestingofpublichealthsignificance.
Virtuallyeverygovernmentagencyhascreatedaninformationnetworkwithinthepastfiveyearstotryandsupportweb-basedexchangeoflaboratorydata.Theproblemisthattheseeffortshavenotbeencoordinated,noradequatelyfunded,resultinginthemultitudeofsiloed,inefficient,oftenhomegrownsystemswehavetoday.
ModernizingthesesystemsandenablinginteroperabilityisahugechallengethatAPHLisstrivingtomeet.ThePublicHealthLaboratoryInteroperabilityProject(PHLIP)isacollaborationamongpublichealthlaboratory
scientistsandITexpertsfromAPHLmemberlaboratoriesandtheCentersforDiseaseControlandPrevention.ThePHLIPteamisdefiningthenecessaryinfrastructureandexpertisethatapublichealthlaboratorymusthavetoenabletwo-wayelectronicdatatransmissionwithpublichealthandclinicalpartnersinarecognizedstandardformat.
AsdocumentedinarecentreportfromAnalyticServices,Inc.,apanelofsubjectmatterexpertsidentifiedafundinglevelof$200millionannuallyasessentialtomovingforwardinasignificantway.“Withoutthisfunding,thefullbreadthofpublichealthlaboratoryresponsibilitiescannotbemet.”1
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1ElectronicLaboratoryReportingConsensus-BuildingMeeting.“FrameworkforElectronicLaboratoryReporting:
RecommendationstoPolicymakers.AReportoftheElectronicLaboratoryReportingConsensus-BuildingMeeting,”(Arlington,
VA:AnalyticServices,November2007)8.
The Association of Public Health Laboratories
ensUring THe eArLy deTecTion of fooDbornE DisEAsEs
BAckgroUndWhilesignificant,therecentnationaloutbreaksofgastrointestinaldiseaseassociatedwithfreshpeppersandpeanutbutterthatcapturednationalattentionaremerelythebest-knownexamplesofafarmoreextensiveburden.Foodiscapableoftransmittingmorethan200knowndiseases,andin1999,theCentersforDiseaseControlandPrevention(CDC)estimatedthatfoodbornediseasecausedapproximately76millionillnessesannually,including5,000deathsintheUS.Inthemajorityofoutbreaks,thecausesoftheillnessesremainunidentified.Theimprovedpublichealthlaboratory(PHL)capabilitythatwouldresultfromenactmentofCongresswomanRosaDeLauro’sbill,H.R.875,wouldallowfoodsafetyexpertstolinkcasesofillnessesmorerapidly,identifyingcommoncausesearlierinanoutbreakandpotentiallylimitingexposures.Frenzen,etal.estimatedin2005thatthepreventionofasinglefatalcaseofhemolyticuremicsyndromeinapatientinfectedwithShigatoxin-producingE. colimaysave$6.2milliondollars.
PHLsformthebackboneoftheresponsebyprovidinginformationthatcanassistepidemiologistsandotherfoodsafetyofficialsintheirinvestigation.LaboratoriesrespondtofoodborneemergenciesbydetectingandidentifyingoutbreaksthroughnetworkssuchasPulseNet,thenationalmolecularsubtypingnetworkformedbyPHLsandCDC.Withoutthesenetworks,largenationaloutbreaks,includingthe2008pepperoutbreakandthe2008-09peanutbutteroutbreak,mightneverbedetected.As
anexample,duringthenationalE. coliO157:H7outbreakin1993thatwastheimpetusforthedevelopmentofPulseNet,ittook39daystodeterminegroundbeefpattiesservedatanationalrestaurantchainwerethesourceoftheillness.In2006,duringthenationaloutbreakofE. coliO157:H7linkedtofreshspinach,ittookonly14daysfromthefirstcaseonsetofillnessuntiltheproductwasrecallednationally,preventinganuntoldnumberofcasesofillnesses.
PHLsserveanumberoffoodsafetyfunctions:• Disease Surveillance and PulseNet.Through
PulseNet,PHLsroutinelyperformDNAfingerprintingoncommonfoodbornebacteriaandtransmitthosedataelectronicallytoanationaldatabase,allowingmemberlaboratoriestoidentifyrelatedbacterialstrainsacrossstatebordersinatimelymanner.PulseNetcontinuestoexpandinscopeandutilitybyengagingnewfederalpartnersandtargetingemergingfoodpathogens.
• Outbreak Testing.Whenanoutbreakrelatedtofoodconsumptionoccurs,PHLsreceive
CDC FUNDING Food Safety (Dollars in millions)
FY 2009 $28 (Enacted)
FY 2010 $37* (APHL Required Amount) (*additional $9 million necessary to improve
food safety measures at the state level)
)
8515 Georgia Avenue suite 700 silver spring, mD 20910 | phone: 240.485.2745 | fax: 240.485.2700 | www.aphl.org
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ensUring THe eArLy deTecTion of fooDbornE DisEAsEs
bothhumanandfoodsamplesfrompublichealthnursesorhealthinspectorsandanalyzethemtodeterminethechemicalorbiologicalcontaminant.PHLs’contributionsallowforhumanillnesstobelinkedtoafoodsourcebyinvestigators.Foodsafetyinitiativesmaythenbepromotedtohelppreventfutureillness.
• Confirmatory Testing.PHLsalsotestsamplestoconfirmtheresultsofclinicalandhospitallaboratories.Thisroutinetestingisimportanttomonitoringtheincidenceandtypeoffoodbornediseaseinthepopulation.
PHL UnmeT needsOvertheyears,PHLshavebroughttheirfoodsafetylaboratorycapacitytoahigherlevelbasedonAPHLrecommendations.Theseeffortshaveyieldedtangibleresults:thenationallaboratorycapacityforfoodtestinghasgrownstronger.However,notablegapsremain:• Personnel.Withoutsteadyfundingforqualified
personnel,statesmaylacktheabilitytousetheirresourcesfully.AccordingtoarecentAPHLsurvey,64%ofstateswouldliketohiremorestaffbutdonothavesufficientfunding.
• Training.PHLpersonneltrainedforavarietyoftestmethodologiesarethelynchpinforsurgecapacity.Theknowledgegapinconventionallaboratorymethodsisincreasing,andstatesneedsufficientresourcestoadequatelytrainstafftoperformclassicalmicrobiologicalandchemicaltestingonbothfoodandhumansamples.However,81%ofstatelaboratorieshavecitedinadequatefundingastheprimarybarrierthatrestrictsthemfromprovidingfoodsafetytrainingtostaff.
• Reagents/Equipment.Whilemostlaboratoriesuseorhaveaccesstohighlytechnicalequipmentandsoftwarecapableofrapidly
detectinganddifferentiatingstrainsoffoodbornepathogens,maintenanceoflaboratoryequipmentisverycostly.Inaddition,reagentcostsareplacingasignificantfinancialburdenonmanyoftheselaboratories.
• Food Chemistry.EveryPHLshouldhavethecapabilitytoperformfoodchemistrytestingtodetectthepresenceofenvironmentalcontaminants,naturaltoxinsandotherchemicalagentsinfood.However,theaveragePHLhasonly1.6FTEsthatroutinelyperformfoodchemistrytesting.
cdc Food sAFeTy UnmeT needs• PulseNet—toallowimmediatetestingof
samples,expandPulseNettobeabletodetectadditionalpathogens,toevaluateandimplementnext-generationlaboratorytestingmethods,toimprovediagnosticmethodsandtrainingandtosupportnationalfoodbornediseasesurveillanceefforts.
• Improvements in sample shipping—toprovidestatesfundingtocombatrisingcostsofshippingclinicalisolatesand/orspecimenstoPHLsandassuretimelysubmissionofsamplesfromhealthcareprovidersandclinicallaboratoriestoPHLsperformingsurveilllance.
• Calicivirus/Norovirus—toexpandthenumberofstatesthathavecapacityformolecularNorovirusdetectionandsequencing,trainlaboratoriansinNorovirussequencingmethodsandsequenceanalysis,improveNorovirustypingmethodsandsupportnationalCalicivirus/Norovirussurveillance.
• Parasitic activities—todevelopnewtechnologies todetectthepresenceoffoodborneparasites
suchasCyclospora cayetanensisandtoprovidemolecular,conventionalandtele-diagnostictoolstoPHLs.
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The Association of Public Health Laboratories
environmenTAL LABorATories protECtinG our WAtEr from ContAminAtion
UnmeT needs• Support$20millioninFY2010forEPA’s
HomelandSecurityLaboratoryProgramto:> Buildcapacityandworkforceinthestatesto
analyzeenvironmentalsamplesforchemical,biologicalandradiologicalthreats.
> Expandthenumberofstatelaboratoriesparticipatingintheenvironmentalresponselaboratorynetwork(ERLN).
> Developandvalidatemethodsfortransfertostates.
> Expandthestateradiologicalgrantprogram.• ProvideEPAwith$10milliontobuilda
nationwidelaboratorynetworktoprotectourdrinkingwater(WaterLaboratoryAlliance).
BAckgroUndEverydayourair,waterandsoilareunderattackfromthetensofthousandsofchemicalspouringintothem.Mostpeopledon’tthinktwiceabouttheairtheybreatheorthewatertheydrink;theydependonourgovernmenttokeepthemcleanandsafe.Toensurethatthisimportantinfrastructureisindeedsafe,wemustensurethatlaboratoriesconductingregulartestingmaintaincertainqualityrequirements.Unfortunately,asdocumentedinarecentGAOreport,thisisnotthecase.EPAmustaddresslaboratoryqualityissuesthroughanationalstateenvironmentallaboratoryaccreditationprogram.
Terroristattacksendangernotonlyhumanlifeandhealth,butalsothenationaleconomyduetotheneedforevacuationandlaterremediation
oftheaffectedenvironment.EPAisresponsibleforconductingtheenvironmentalsamplingthatfeedsintothedecision-makingprocessfollowinganincidentofnationalsignificanceinvolvingtheenvironment,aswellastheremediationofaffectedareas.Stateandlocallaboratories,however,aretypicallythefirstreceiversduringanincident;thereforeEPAmustcoordinatewithenvironmentallaboratoriesaroundthecountry.
HomeLAnd secUriTy LABorATory ProgrAmGovernmentallaboratoriesreceivewhitepowdersorothersamplesthatmaycontainradiological,biologicalorchemicalwarfareagentseveryday.Theselaboratoriestestunknownsamplestoidentifycontaminantsandassessdangers.
Themajorityofstateandlocalenvironmentallaboratories,however,lacktheproperresourcestoadequatelyrespondsuchevents.Theyneedfederalguidancesuchasvalidatedmethods,standardsandproficiencytestingprograms.
EPA LAboRAtoRY FUNDING (Dollars in millions)
FY 2009 $6.1 (Enacted)
FY 2010 $39.6 (APHL Required Amount) (additional $20 million for the ERLN and $10
million for Water Laboratory Alliance)
8515 Georgia Avenue suite 700 silver spring, mD 20910 | phone: 240.485.2745 | fax: 240.485.2700 | www.aphl.org
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Withoutthissupport,stateswillbedelayedintheirresponseorunabletorespondatall,puttingthelivesofmillionsindanger.
Tomeetthisneed,APHLrequestsfundingforEPAtoadvancethedevelopingEnvironmentalResponseLaboratoryNetwork.Thisnetworkshouldprovideamechanismforstateandfederalenvironmentallaboratoriestocollaborateandleveragecapabilities.TheERLNwillalsoprovideamechanismtofundstateenvironmentallaboratoriestoincreasecapacitytorespondtoemergenciesandensurehigh-qualityresultstosupportdecisionmaking.
rAdioLogicAL PrePAredness gAPsIfaterroristweretoattacktheUSwitharadiologicalagent,federalandstatelaboratorieswouldbeverylimitedintheirabilitytorespond.DuringanOctober2007CongressionalhearingonUSlaboratorycapacitytoeffectivelyrespondtoaradiologicalattack,experttestimoniesrevealedthatvalidatedmethodstotestclinicalspecimensinaradiologicalemergencyexistforonly6ofthe13highestpriorityradioisotopesmostlikelytobeusedinaterroristevent.Thescreeningof100,000clinicalsamplesforisotopes(forwhichvalidatedmethodsdoexist)wouldtakemorethanfouryears,whileanalysisofenvironmentalsamplescouldtakeaslongassixyearstocomplete.
Accordingtoa2007APHLsurvey,55%ofrespondingstateenvironmentallaboratories
havetheabilitytotestdrinkingwaterforthepresenceofradiation.Inalarge-scaleevent,theselaboratorieswouldbequicklyoverwhelmedduetothehighsamplecount.Thesameisprobablytrueforothersampletypes.
Fundingisneededtoenhancethecapabilityandcapacityofstateandlocalenvironmentalandradiochemistrylaboratoriesbyupgradingequipment,providingtrainingandbolsteringtheworkforce.
wATer LABorATory PrePArednessTwohundredandfiftymillionAmericansgettheirdrinkingwaterfrompublicwatersystems.AterroristattackonalargemunicipalwatersupplycouldendangerthelivesofmillionsofAmericans.
Duringaterroristincident,stateandlocallaboratorieswouldbehardpressedtoanalyzethethousandsofwatersamplesforcontaminants.Laboratoriesneedanetworkofotherlaboratoriestocallonforhelp;otherwise,decisionsaffectinglifeanddeathmaybedisastrouslydelayed.
EPAhasmanagedtopartiallymeetthisneedthroughtheWaterLaboratoryAlliance(WLA).DedicatedfundingshouldbedirectedtowardtheWLA’sDrinkingWaterLaboratoryResponsePreparednessProjectforcoordinationofstateenvironmentallaboratories’planningandforbuildingcapacityinthestatestoanalyzethreats(forexampleasdirectedbyHSPD-9).
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The Association of Public Health Laboratories
LAck oF FUnds JeoPArdizes DisEAsE DEtECtion
UnmeT needs• Enhancethenation’sabilitytorespondto
emergingdiseaseoutbreaksby:> IncreasingCDC’scapacitytotestsamples.> Developinganddeployingdiagnostictests
tostateandlocalpublichealthlaboratories(PHLs).
> ProvidingtechnicalassistanceandtrainingtostateandlocalPHLprofessionals.
• IncreasesupportfortheEpidemiologyand LaboratoryCapacityProgram,acriticalsourceof fundingandtechnicalassistanceforinfectious diseasedetectioninstatelaboratories,
providing:> Capacitytorespondtoemergingdiseases.> Geneticfingerprintingforfoodbornediseases
throughPulseNet,whichmakesrapiddetectionofoutbreaksoffoodborneillnesses(forexample,Salmonellacontaminationinpeanutbutter)possibletoexpeditepublichealthinterventions.
> Detectionofvirusesthatcauseseriousintestinaldistressinhumans.
> Laboratorydetectionofdrugresistantbacteria(suchasMRSA),virusesandparasites.
• Enhanceinfluenzapandemicpreparednessandexpandearlywarninglaboratorysurveillancewithyear-roundtestingtorapidlydetectvariationsofinfluenzaviruses,especiallythedeadlyavianinfluenzaviruses,inaccordancewiththeDepartmentofHealthandHumanServices’“FederalGuidancetoAssistStatesInImprovingState-LevelInfluenzaOperatingPlans.”Continuedadditionalfundswillenhance
moleculardetectioncapacityusingCDC’snewprotocolthatreceivedFDA510(k)clearance,provideneededreagents,allowforstaffrecruitmentandprovidetraining.
• Developandimplementelectroniclaboratorymessagingsystemsthatcantransferappropriatedataforbetterdiseasecontrol.
• Preparethenextgenerationoflaboratoryleadersthrougheducationandmanagementtrainingprograms.
• EnhancenationalcapacitytodetectandpreventoutbreaksofnewinfectiousdiseasesthroughtheEmergingInfectionsProgram.
CDC FUNDING (Dollars in millions)
Preparedness, Detection and Control of Infectious DiseasesFY 2009 $157 (Enacted)FY 2010 $167 (APHL Required Amount) (additional $10 million for responding to emerging infectious diseases)
Pandemic InfluenzaFY 2009 $156 (Enacted)FY 2010 $166 (APHL Required Amount) (additional $10 million for state and local surveillance capacity)
Vector-borne Diseases, including West Nile VirusFY 2009 $26 (Enacted)FY 2010 $46 (APHL Required Amount) (additional $20 million for surveillance and detection of vector-borne diseases, including West Nile Virus)
8515 Georgia Avenue suite 700 silver spring, mD 20910 | phone: 240.485.2745 | fax: 240.485.2700 | www.aphl.org
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LAck oF FUnds JeoPArdizes DisEAsE DEtECtion
PrePAredness, deTecTion And conTroL oF inFecTioUs diseAsesTheCDCInfectiousDiseasesControlProgramfundscriticallaboratoryimprovementsthatallowfederalandstateprogramstomaintainearlywarningdetectioncapabilitiesforknowndiseasesandprovidequickidentificationofunknowndiseases.Increasedfundingisessentialtopreserveexistingcapacity,enhancesurveillancefornewstrainsofinfluenzaandprovideimprovedresponsivenesstothegrowingproblemofemergingdiseases.ArecentoutbreakofchikungunyavirusinItalydemonstrateshowonepersoncanacquirethediseasewhiletravelingabroadandtransmitthevirustomosquitovectorsintheirhomecountry.Theinitialintroductionintothemosquitopopulationresultedin334suspectedcasesinageographicalregionthathadnotpreviouslybeenexposedtothedisease.LaboratorycapacityinItalywascriticaltoconfirminfectioninmorethan200people.
RecentdomesticinfectiousdiseasethreatsincludeCA-MRSAandotherantibiotic-resistantbacteria,Tamiflu-resistantandavianinfluenza,SARS,monkeypox,HepatitisA,bacterialmeningitis,WestNileVirus,malariaanddenguefever.Thethreatforpandemicinfluenzaisatanunprecedentedlevelduetohighlypathogenicavian(H5N1)influenzaco-circulatingwithhumaninfluenzainsettingswithhighriskofexposure(birdmarkets),resultingingreaterpotentialforadaptationtohumanhostsorre-assortmentwithcirculatinghumanviruses.Therehavebeenatleast360confirmedcasesofavianinfluenzaresultingin226deathsworldwide.Wemustalsobepreparedforanunexpectedstrainofinfluenzatoemergeasapandemicstrain.Arecommendationfromthe“FederalGuidancetoAssistStatesinImprovingState-LevelInfluenza
OperatingPlans”(http://www.pandemicflu.gov/news/guidance031108.pdf)hasidentified“PandemicIntervals,Triggers,andActions”toassiststatesandlocalsinupdatingtheirpandemicplans.Laboratorytestingtoconfirmintroductionandspreadofanovelstrainisacrucialcomponenttotriggerappropriatemitigationandcontrolstrategiesforeachinterval.
Overthepastfewyears,therehavebeenseverallarge,multi-stateoutbreaksofpertussis(whoopingcough),mumpsandmeasles,diseasesnowre-emerginginchildrenandadults.Inadditiontothehumanimpactofthesediseases,thereisatremendouseconomicimpact.EstimatesindicatethatinfectiousdiseaseshaveaneconomiccostintheUSofmorethan$120billioneachyear.Aninfluenzaoutbreakonthescaleof1918wouldcauseanestimatedonemilliondeathsintheUS.
vecTor-Borne diseAses, incLUding wesT niLe virUsFederalWestNileVirusfundingsupportssurveillancethatdeterminesthelevelofdiseaserisktopeopleandgetsthismessageouttoproviders,respondersandthepublictoallowforimplementationofappropriateinterventions.
Withthisfunding,manystatesarealsoabletoperformthesameactivitiesforothervirusesthatcauseencephalitis,whichisimportanttomonitorforoutbreaksofSt.LouisencephalitisorevendengueifitemergesintheUS.Proposedfundingreductionswillforcesomestatestochoosebetweenkeepinglaboratorystafftoperformtestsandthematerialsneededtoconductthosetests.Otherstatesmayberequiredtofundamentallychangethescopeoftheirtestingprogramsandreducetheinformationthatisnecessaryforsuccessfulinterventionstrategies—whichwillleadtoincreasedillnessinhumansandanimals.
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The Association of Public Health Laboratories
rEvitAlizinG DomEstiC Hiv/Aids eFForTs
UnmeT needs• ProvideHIV/AIDSfundingconsistentwiththe
CentersforDiseaseControlandPrevention(CDC)ProfessionalJudgmentBudget.
• SupportHIVsurveillancesothatfundscanbeallocatedwheretheyareneededmost.
• ProvideresourcessothatnewHIVdiagnosticandscreeningtechnologiescanbevalidatedandimplementedinpublichealthlaboratories.
• EnablelaboratoriestodetectHIVinfectionsintheirearliest(andmostinfectious)stagesbysupportingthenewestandmostadvancedtestingtechnologies,includingnucleicacidamplificationtestingandfourth-generationimmunoassays.
• ImprovelaboratorycapacitytomonitorandconfirmHIV-2infections.
• EvaluatethenewlyproposedalternativeHIVtestingalgorithmstoimprovethespeed,accuracyandefficiencyofHIVdiagnosisandsurveillance.
• FacilitateHIVdiseasemanagementbyenablinglaboratoriestoconductviralloadtesting,genotypingandantiretroviralresistancemonitoring.
BAckgroUndMorethan25yearsafterthefirstdocumentedcases,HIV/AIDScontinuestobeamajorpublichealthburdenintheUnitedStates.TherearemorethanonemillionpeoplelivingwithHIVin
theUStoday,andthisnumberisgrowing.WhileHIVaffectsallracial,socio-economic,regionalandagegroups,African-Americans,Latinosandmenwhohavesexwithmenhavebeendisproportionatelyaffectedbytheepidemic.
RecentadvancesinsurveillancetechnologyhaveallowedCDCtomoreaccuratelyestimatetheincidence(ornumberofannualnewinfections)ofHIV.Therewere56,300newHIVinfectionsin2006,40%greaterthanthe40,000thatwaspreviouslyestimated.CDCestimatesthatforevery100peoplelivingwithHIV,fivenewinfectionswilloccurperyear.EarlydiagnosisofHIViscrucialtolimitingthenumberofnewinfections.
CDChasdevelopedanambitiousplantocombatHIV/AIDSintheUS.By2020,theyhopetoreducetheHIVtransmissionratefrom5%to2.5%andtoreducetheproportionofinfectedindividualswhoareunawareoftheirstatus.Currentdatashowthatin2006,21%ofHIV-infectedindividuals(more
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CDC FUNDING Preparedness (Dollars in millions)
FY 2009 $691 (Enacted)
FY 2010 $1,578 (APHL Required Amount)
rEvitAlizinG DomEstiC Hiv/Aids eFForTs
than200,000people)don’tknowtheyareHIVpositive,andCDCwantsthisnumbercutinhalf.
Toachievethesegoals,CDCdevelopedaprofessionaljudgmentbudgetthatoutlinedtheidealapproachtofightingHIV/AIDSintheUS.AvitalpartofthisplanincludesscalingupHIVtestinginitiatives,improvingHIVmonitoringsystemsanddevelopingnewtoolstoaggressivelyfightHIV/AIDS.Stateandlocalpublichealthlaboratorieswouldplayakeyroleinthisinitiative,andanincreaseinlaboratoryresourceswouldbenecessaryinorderforittosucceed.
Currently,publichealthlaboratoriesprovideservicescrucialtothediagnosisofHIVinfections.PublichealthlaboratoriesserveasreferralandreferencelaboratoriesforHIVtestingandsupporttheworkofotherpublicandprivatesectorlaboratories.TheselaboratoriesareinstrumentalinconductingdiseasesurveillanceandprovidethedatanecessarytomonitortrendsinHIVinfection.WiththeincreasingnumberofpeoplelivingwithHIV/AIDSinthepublichealthcaresystem,publichealthlaboratorieswillhaveanincreasingroleindiseasemanagementaswell.Developingthiscapacitybyprovidingviralloadtesting,antiretroviralresistancemonitoringandCD4/CD8cellcounts,willimprovebothpatientcareandpublichealthsurveillance.HIV-2,alesscommon
butcloselyrelatedstrainofHIV,posesanotherchallengetopublichealthlaboratories.Atpresent,thereislimitedcapacityfortheconfirmationandmanagementofHIV-2infections.InfectionsbythisstrainaremostlylimitedtoWestAfrica,butthisgapmustbeaddressedtoimprovepublichealthlaboratorypreparedness.
Inrecentyears,newtechnologieshavearisenthathavegreatlyimprovedthespeedandaccuracyofHIVscreeninganddiagnosis.MostHIVtestsrelyonthedetectionofantibodiesagainstHIV,whichcansometimestakemonthstodevelop.Unfortunately,itisduringthissameperiodthatHIV-infectedindividualsaremostinfectious.Newtechnology,suchasnucleicacidamplificationtestsandfourth-generationimmunoassaysarecapableofdetectinginfectionmuchearlierthanwaspreviouslypossibleandcouldbecrucialinbreakingthetransmissioncycle.WhilethesetestsaremoreexpensivethantraditionalHIVtests,theirabilitytodetectinfectionatthemosttransmissiblestagecouldsignificantlyimproveourabilitytopreventnewinfections.
APHLhasbeenworkingwithCDCandstateandlocalpublichealthlaboratoriestodevelopnewtestingalgorithmsthatincorporatethemostadvancedHIVdiagnostictools.
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The Association of Public Health Laboratories
TUBercULosis A sErious rE-EmErGinG tHrEAt
UnmeT needs• Providefederalfundingof$210million
asauthorizedinPublicLaw110-392.HHSSecretary’sAdvisoryCouncilfortheEliminationofTuberculosishasrecommended$252.4milliontomeettheCDCgoaloftuberculosis(TB)eliminationintheUS.> Developgovernment/privatepartnerships
designedtoencouragethedevelopmentofnewtuberculosisassays.
• Increasefundingforlaboratoriestoimplementnewandexistingdiagnosticteststhatcanidentifytuberculosisandscreenfordrugresistance.
• StandardizedrugsusceptibilitytestingmethodsintheUSforfirst-andsecond-linedrugsusedtotreatTBpatientstoimproveclinicaloutcome.
• ProvidefundingforCDCtoconductan assessmentoflaboratorytuberculosistesting capacity.• Developaplanofactionthatwilladdress
extensivelydrugresistanttuberculosis(XDR-TB)topreventitfrominvadingtheUS.
• DirectCDCtodevelopastrategicplanforimplementingandmaintainingasystemsapproachtoTBcontrolthatincludeslaboratorysystems.
• AssessthetruecostsofprovidingTBlaboratoryservicesbecausethecosttoidentifyindividualcasesrisesasthenumberofcasesdeclinesandthecostofserviceswillvaryfromonejurisdictiontoanother.
• Developrecommendedtestingmethodsfordifferentpatientpopulations,aswellas
guidelinestohelpjurisdictionsselecttheappropriatelevelofservice.
• Improvelaboratorystaffproficiencyincomplextuberculosistestingproceduresinlightoffewerspecimensbeingtestedinrelationtothedeclineintuberculosis.
• Trainnewlaboratorystaffintuberculosistestingproceduresinlightofarapidlyagingworkforce.
BAckgroUndTuberculosisisaseriousre-emerginginfectiousdiseasethataffectsthelungsandrespiratorysystemaswellasotherorgansandcanleadtodeathifleftuntreated.Thisillnessistransmittedperson-to-personviatheairbycoughing,sneezingandeventalking.Tuberculosishasre-emergedasaco-infectionwithHumanImmunodeficiencyVirus(HIV)becauseHIVweakenstheimmunesystemandmakesthepatientmoresusceptibletoinfectionandsevereTBdisease.
Today,despiteanoveralldeclineincases,tuberculosiscontinuestoincursignificantsocial,publichealthandeconomiccostsintheUS.
CDC FUNDED (Dollars in millions)
FY 2009 $143 (Enacted)
FY 2010 $210 (APHL Required Amount)
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TUBercULosis A sErious rE-EmErGinG tHrEAt
Approximatelyone-thirdoftheworld’spopulationislatentlyinfectedwiththebacteriumthatcausestuberculosis.Anestimated10millionto15millionUScitizenshavelatenttuberculosisinfection,andabout10%oftheseindividualswilldeveloptuberculosisatsomepointintheirlives.Approximately13,500newcasesoftuberculosisdiseasewerediagnosedin2007intheUS.Costlytuberculosisoutbreaksstilloccur,andmulti-drugresistanttuberculosiscontinuestospread.Nowthenationisfacinganewtuberculosisthreat,extensivelydrugresistanttuberculosis(XDR-TB),aformoftuberculosisthatisresistanttothetwomostimportantfirst-linedrugsandatleasttwoofthemostimportantsecond-linedrugsavailablefortreatment.XDR-TBisadeadlyformoftuberculosisthatcanbeincurable,especiallytopeoplewithHIV/AIDS,andisswellingtoepidemicproportionsinsouthernAfrica.AnumberoflaboratorieshavealreadyreportedthisdeadlynewformoftuberculosisintheUS.TheCDCprovisionallyestimatesthatthedirectmedicaltreatmentcostsofanXDR-TBpatient($132,000)areonaverage2.5timeshigherthanthoseofamulti-drugresistanttuberculosis(MDR-TB)patient($53,000)andmaybemuchhigherdependingonhospitalizationlengthandlocationoftreatment.Altogether,tuberculosis-relatedcostsapproach$1billioneachyearintheUS.
ToreachthegoaloftheeliminationoftuberculosisintheUS,improvementsinlaboratorytestingmustbemaintainedandtranslatedintoimprovementsinthetreatment,preventionandcontroloftuberculosis.Despiteadvancesinlaboratorymethods,lackofcoordinationfor
referralofspecimensandculturescontinuestoleadtounnecessarydelaysinlaboratorytesting,reportingandinitiationoftreatment.
Currentlyall50statepublichealthlaboratoriesperformsomeleveloftuberculosistestingandserveasreferralandreferencelaboratoriesforcultureidentificationandtuberculosisdrugsusceptibilitytestinginsupportofotherpublicandprivatesectorlaboratories.StatepublichealthlaboratorieshaveusedCDCfundingoveraperiodofmanyyearstocreatemodernlaboratorieswiththelatestdiagnosticequipmentapprovedfortuberculosisisolationandidentification,biosafetyequipmenttoprotectlaboratorystaffandpremises,personnelsufficienttomeettheneedforrapidlaboratoryconfirmationoftuberculosisandongoingstafftrainingintheuseofstate-of-the-artdiagnosticequipmentandrapidtestingprocedures.Aslaboratorieshavebecomebetterequippedandpersonnelbettertrained,federalfundshavebeenusedlesstoupgradetuberculosislaboratoriesandmoretomaintaincoretuberculosiscapabilitiesandinfrastructure.
Ofthe$140millionallocatedfortuberculosiscontrol,only$8milliongoestosupportingpublichealthlaboratorytesting.Thisnumberhasbeenstagnantat$8millionannuallysince1995.Withinflationfactoredin,thefundinghasexperienceda25%decreaseinrealdollars.Althoughitistemptingtothinkthatfundingcandecreaseinproportiontothedecreaseinthenumberoftuberculosiscases,belowacertainpointthisreasoningfallsapart,sinceabaseleveloffunding(inrealdollars)isnecessarytomaintainthetuberculosiscontrolinfrastructure.
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The Association of Public Health Laboratories
BioLogicAL PrePAredness must bE mAintAinED
UnmeT needs• EnsureCDCreceivesfundingcomparableto
theFY2005levelstoexpandprograms,developmethods,providetrainingandensureadequatestaffinglevelsatstateandlocalpublichealthlaboratoriesthataremembersoftheLaboratoryResponseNetwork(LRN)forbiological,chemicalandradiologicalterrorismpreparedness.
• IncreasedirectfundingforCDCtosupportarapidlydeployablereagentstockpilefortheLRNlaboratoriestoassurethatrapidandaccuratelaboratorytestingcanoccur.
• Buildsafeandsecurefacilitiesforintaketriageandtestingofunknownsamplesandprovidenationalguidelinesonthetriagingofunknownsamples.
• Developandimprovemethodsforrapidconfirmationofbioterrorism,chemicalandradiologicalthreatagentsinhuman,food,animalandenvironmentalsamples.
• Expandpublichealthlaboratoryoutreach,trainingandcoordinationwithhospital,veterinary,foodandenvironmentallaboratorieswhereterrorismagentsmayfirstbedetected.
• Provideaminimumof$10millionfundingtotheDHSOfficeofHealthAffairstocoordinatewithotherfederalagenciesandpartnerstodeveloparobustvalidationprocessforhand-heldassaysandotherfieldassays.
Continuedfederalfundingatappropriatelevelswillpreservethestateandlocalcapacitythathas
beenbuilt,whichallowslaboratoriesto:• Respondrapidlyandeffectivelytoaterrorist
eventorpublichealthemergency.• Purchasenewinstrumentation,adoptnew
technologiesanddevelopelectronicdatamessaging.
• Recruitandretainhighlyskilledlaboratorypersonnel.
• Maintainoutreachprogramstohospitalandclinicallaboratoriesandfirstresponders.
• Assureacoordinatedresponseeffortwithfederalpartners.
BAckgroUndFormedin1999bytheCentersforDiseaseControlandPrevention(CDC),theFederalBureauofInvestigation(FBI)andAPHL,theLRNisthenation’spremiersystemforidentifying,testingandcharacterizingpotentialagentsofbiologicalandchemicalterrorism.Stateandlocalpublichealthlaboratoriescompriseapproximately70%of
CDC FUNDING (Dollars in millions)
FY 2009 $700 (Enacted)
FY 2010 $919 (APHL Required Amount) (plus $20 million for EPA’s ERLN)
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BioLogicAL PrePAredness must bE mAintAinED
the165LRNBiologicalReferenceLaboratoriesandalmost100%oftheLRNChemicalLaboratories.Theselaboratoriesproducehigh-confidencetestresultsthatarethebasisforthreatanalysisandinterventionbybothpublichealthandlawenforcementauthorities.
TheLRNforBiologicalTerrorismpreparednessisorganizedasathree-tieredpyramid.Atthefoundationarethousandsofsentinelclinicallaboratories,whichperforminitialscreeningforpotentialpathogens.Whensentinelclinicallaboratoriescannotruleoutthepresenceofabiologicalterrorismagent,theyreferspecimensandisolatestoanLRNreferencelaboratory.Morethan160stateandlocalpublichealth,military,international,veterinary,agriculture,foodandwatertestinglaboratoriesserveasreferencelaboratories,performingcomplexanalysesandprovidingsupporttolawenforcementforthreatinvestigations.InadditiontolaboratorieslocatedintheUS,facilitieslocatedinAustralia,CanadaandtheUnitedKingdomserveasreferencelaboratories.Attheapexofthepyramidarenationallaboratories,suchasthoseattheCDCandtheDepartmentofDefense(DoD).Theselaboratoriestestandcharacterizesamplesthatposechallengesbeyondthecapabilitiesofreferencelaboratories,andprovidesupportforotherLRNmembersduringaseriousoutbreakorterroristevent.
In2001,theLRNperformedmorethan1millionanthraxtests.Sincethen,publichealthlaboratorieshavebeenregularlytestingsamplestoruleoutbioterrorisminsupportoflawenforcementandpublichealthagencies.Ina12-monthperiod(CDCPublicHealthEmergencyPreparednessCooperativeAgreementFY07),statepublichealthlaboratoriesreceivedmorethan
5,000unknownsamplesandperformedmorethan9,000testslookingforsuspectedterrorismagents.
BioLogicAL TerrorismThepublichealthlaboratoriesof50statesandtheDistrictofColumbia(DC)receivedabout$49millionforbioterrorismpreparednessinFY2007,whichisapproximately$24millionlessthanFY05fundingand$56millionlessthanFY02funding.
Duetothesefundingissues,severalproblemsplaguepublichealthlaboratories,includingseverestaffingshortages,lackofintegratedlaboratoryinformationmanagementsystemsforelectronicdatamessagingandaging,non-securefacilities.Despitetheseconstraints,expectationsofLRNpublichealthlaboratoriescontinuetoexpandduetotheimplementationofnewtechnologies;additionofnewtestsforadditionalagentsofbioterrorismandotherinfectiousdiseasethreats;increasedcoordinationwithfood,veterinaryandenvironmentallaboratories;andanamplifieddemandoftrainingforsentinelclinicalandhospitallaboratorypartners.
LRNpublichealthlaboratoriescontinuetoreachouttosentinellaboratoriesandhavetrainedthousandsoflaboratorians.FromAugust2007toAugust2008,statepublichealthlaboratoriessponsoredsentinel(clinical)laboratorytrainingandoffered233rule-outtestingclassestomorethan2,100laboratorians;about250packagingandshippingclassestomorethan3,500laboratorians;about530biosafetyguidelinesclassestoapproximately2,300laboratories;andmorethan250classesonbroadlaboratorypracticestomorethan2,700laboratorians.Increasedfundingforstaffatthestatepublichealthlaboratoriesisneededtoensurecontinuationofthesecriticaltrainingclasses.
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The Association of Public Health Laboratories
cHemicAL PrePAredness WE’rE STILL not rEADy
UnmeT needs• DirectCDCtodedicatefundingforallLaboratory
ResponseNetworklaboratoriesintheirPublicHealthEmergencyPreparednesscooperativeagreement.
• RestorefundingtoCDC’schemicalterrorismlaboratorytoFY2007levelstosupportmethodtransfertostatesfordrugsofabuse,incapacitatingagentsandothertoxicants.
• Provide$10milliontofullyfundall10Level1chemicalterrorismlaboratoriestoensureournation’sabilitytorespondtolarge-scalechemicalevents.
BAckgroUndWhenmostpeoplethinkofterrorismevents,theythinkaboutbioterrorism,suchastheanthraxattacksof2001.However,chemicalterrorismposesanequallysignificantthreat,andtherearetensofthousandsoftoxicchemicalsthatcouldfallintothewronghands.AlthoughthecreationofthechemicalsideoftheLaboratoryResponseNetwork(with46publichealthlaboratoriesandCDC)in2003dramaticallyincreasedcapabilityandcapacitytorespondtochemicalterrorismincidents,manygapsandchallengesremaintoday.Akeybarrierhasbeenthesteadydownwardspiraloffunding.Ofthe$746millionenactedforpreparednessactivitiesin2008,onlyabout$24millionofthiswasdirectedtopublichealthlaboratoriesforchemicalterrorismpreparednessactivities.Ifthiscontinues,millions
ofdollarsoftheinvestmentsmadeintheseuniquelaboratorieswillbewastedastheinstrumentssitidlebecausethereisnotrainedstafftooperatethem.Inaddition,wewillfallshortinmeetingcriticalchemicalpreparednessneeds.
Throughdeterminationanddedication,oftendespitethelackofdedicatedfunding,chemicallaboratorieshavemadeprogress:• In2003,onlyeightstatelaboratoriesreported
havingachemicalterrorismresponseplaninplace.By2006,35reportedhavingawrittenplanforachemicalincident.
• Publichealthlaboratoriesnotonlydraftedplansforachemicalincident,buttheyalsopracticedforone.In2007,statepublichealthlaboratoriesconductedonaverage3.5drillsorexercisesforchemicalterrorismpreparedness.In2008,CDCandthe10Level1surgecapacitylaboratoriesconductedanexerciseinvolvingtherapidanalysisof5,000samples,thesamenumberastherewerepatientsintheMarch10,1995,Tokyo
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PREPAREDNESS (Dollars in millions)
FY 2009 $700 (Enacted)
FY 2010 $919 (APHL Required Amount)
subwaySarinattack.Morethanhalf(56%)oflaboratorieswithacontinuityofoperationsplanincludedchemicalthreatpreparednessactivitiesinthisplan.
• Moststates(31)reportedhavingafull-timestaffpersontocoordinatethechemicalterrorismlaboratoryin2007,althoughthisisarequirementofthePublicHealthEmergencyPreparednesscooperativeagreement.
• In2007,92%ofstatepublichealthlaboratorieswerecapableofconductingsomechemicalthreatagentanalysesonclinicalsamplesusingstandardizedmethodsandtrained,dedicatedstaff,anincreasefrom10%in2003.
However,majorgapsstillexist:• Workforceshortagespersist.In2003,fivestates
hadchemistsdedicatedtochemicalemergencyresponseonstaff.In2007,46laboratorieshaddedicatedanalystsbutonlyhadanaverageof2.8full-timechemistsonstaff.Laboratorieswithoneortwochemistswouldnotbeabletomaintain24/7response,whichisoftenneededduringalargeevent.
• Although36SPHLsreportedthattheyprovidedtrainingtofirstrespondersin2007,laboratoriesreportalackofstaffandinstrumentationtoprovidesufficienttrainingandoutreach.Furthermore,thereisstillalackofnationalguidanceforthesetrainings.
• Laboratoriesreceivedmorethan5,200threatsamplesin2007andtestedmorethan1,800forachemicalthreat.Ofthe5,200,morethan1,200wereenvironmentalsamplesthatcouldhavecontainedachemicalorradiologicalthreat.
cHemicAL LABorATory resPonse neTworkTheChemicalLaboratoryResponseNetwork(LRN-C)isanationwidenetworkoffederal,stateandlocallaboratoriescapableofconfirmingthepresenceofchemicalterrorismagentsandothertoxicsubstancesinclinicalsamples(bloodandurine).Theselaboratorieshavedesignated“levels”thatcorrelatewiththeircapacitytoperformcertaintasksduringemergencyevents.
Chemicallaboratoriesinthisnetworkhavemadegreatstridesinpreparednesssincetheyfirstreceivedfundingin2003.However,bothCDCandthestatesarenolongerreceivingthenecessaryfundingtosustainthelevelofpreparednesstheyhaveworkedsohardtobuild.CDChasandiscurrentlydevelopingmethodsthatwillenablelaboratoriestotestmoresamplesinashortertime.However,thesemethodsrequireexpertise,trainingcoursesandlaboratorians’time,allofwhichrequireadequatefunding.
In2006,fivenewlaboratoriesweredesignatedasLevel1,whichisthelevelcapableofprovidingsurgecapacitytoCDCformorerapiddetectionofthemostdangerouschemicalagents.StudiesbytheIntegratedConsortiumofLaboratoryNetworkshaveshownthatournationneedsatleast10Level1laboratoriesinordertohandlethenumberofsamplesanticipatedduringachemicaleventofnationalsignificance.Yet,thefundingforthesenationalassetshasnotincreasedtoreflecttheincreasednumberoflaboratoriesandtheincreasednumberofsamplesthatareprojectedtobeneededtorespondtoamajorincident.
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The Association of Public Health Laboratories
rAdioLogicAL PrePAredness
UnmeT needs• Provide$10milliontoCDC,asrequestedby
theFY09proposedPresidentialbudget,tobuildaradiologicalcomponentoftheLaboratoryResponseNetwork.
• DirectCDCtoincludefundinginthePublicHealthEmergencyPreparednessgrantforradiochemistryactivities.
• ProvideadditionalfundingtoCDCtodevelopmethodsandtoprovidetechnologytransfertostateandlocallaboratorians.
Sincethe1950s,thethreatofaradiologicaleventevokesfearinheartsaroundtheworld.However,radiologicalpreparednessinlaboratorieshaslongbeenignored.ItwasnotuntilarecenthearingintheHouseCommitteeonScienceandTechnologythatmostpeopleunderstoodthereisacompletelackofcapacitytoscreenandtestforradionuclides.Duringthishearing,membersofCongressexpressedconcernaboutthelackofreadinessforaradiologicalevent.However,theyhaveyettoappropriatefundingtoimprovethis.
CDCisdevelopinguniquelaboratorymeasurementsinurinetodeterminewhetherpeoplehaveradionuclidesintheirbodiesand,ifso,howmuch.Thisinformationwillidentifyexposedindividuals,assesstheirhealthriskanddetermineeffectivetreatment.Withtheexceptionofafewradionuclides,itisnotpossibletodeterminethisexposurewithoutthesenewtechniquesbeingdevelopedatCDC.
CDC’sdevelopmentoftheUrineRadionuclideScreen(URS)willneedthisforidentifyingwhichradionuclideapersonisexposedtoandthe
levelofexposureorcontamination.TheURSistargetingmorethan20high-priorityradionuclidesonthebasisoflikelyradiologicterrorismscenarios.Currently,CDCisworkingtocompletetheURS,whichwouldprovideresultswithin24hoursofreceivingasample.
Almostallstatepublichealthlaboratorieslackthecapabilitytotesthumansamplesforthepresenceofradionuclides.Thisisduetoalackoffundingandtheworkforceshortageaffectingtheradiochemistryfield.Fewnewscientistsarebeingtrainedonradiologicalanalyticalmethods.Mostlaboratoriesdonothavesupportforaradiologicalprogramand,therefore,therearefewjobsforfutureradio-analyticalscientists.• Onaverage,statepublichealthlaboratories
havefewerthantwotrainedstaffforradiologicalactivities.
• Nostatepublichealthlaboratoryhadhigh-resolutionequipmentforradiologicalanalysesandonlyfivelaboratorieshaveonethatcouldbeusedformeasuringradionuclidesinFiscalYear2007.
CDC FUNDING Preparedness (Dollars in millions)
FY 2009 $0 (Enacted)
FY 2010 $10 (APHL Required Amount)
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rAdioLogicAL PrePAredness
• Only15statepublichealthlaboratoriescanmeasurehumanspecimensforradionuclides.Seventy-fivepercentofthoselaboratoriescanonlymeasureforoneradionuclide(Uranium).
TherecentassassinationofAlexanderLitvinenkoillustratesjusthowquicklyaradiationeventcanescalate.Onlyoneperson,Litvinenko,wastargeted,buttensofthousandsofpeoplewerepotentiallyexposed.Morethan1,000peopleneededtobetested,andseveralbuildingsintheUKwillbesealedforthenextfiveyears,duetocontamination.
rAdioLogicAL LABorATory resPonse neTworkAfteraradiologicalevent,therewillbeamyriadofquestions:whowasexposed,towhatsubstanceandtowhatextent.Experts’opinionsvaryastomedicaltreatmentbut,ingeneral,thetreatmentwindowvariesbetweenonedaytotwoweeks.Thecurrentlaboratorymethodscanreturnresultswithin3–21days,assumingamethodevenexists.Inanefforttoimprovestatepublichealthlaboratorycapacity,CDChasproposedaddingaradiologicalcomponenttotheLaboratoryResponseNetwork(LRN-R.)Inthisnetwork,fivestatepublichealthlaboratorieswouldprovidesurgecapacitytoCDCtoanalyzesamplesforpriorityradionuclidesusingtheURS.Havingthiscapabilitywilldrasticallyreduceresponsetimeforprovidinglocal,stateandfederaldecisionmakerswithhigh-quality,interpretableanalyticalresultsintheimmediateresponsephaseofaradiologicornuclearattack.Thisessentialnationalradioanalyticallaboratorycapacityshouldmarkedlyreducemorbidityandmortalityresulting
fromaradiologicalornuclearevent.Tohelpaddressgapsinthenation’sability
torespondtoradiologicterrorism,APHLisrequesting:• $6.3 millionfordevelopingandexpanding
CDC’sURStomeasure22high-priorityradionuclides.Thisextensiveresearcheffortincludes:• Researchonthebestmeasurement
approachesforapproximately11ofthe22targetedradionuclidesinhumanurine.
• SupportingessentialextramuralresearchwithDepartmentofEnergynationallaboratories.
• Purchasingspecializedequipmentandsupplies,includinginstrumentscapableofmeasuringalpha,betaandgammaradiation,inadditiontotwohigh-resolutionmassspectrometers.
• Developingradiologicreferencematerialsformethodvalidationandproficiencytesting.
• Developingandmaintainingbothaclinicalradiologicalproficiencytestingprogramandatrainingandtechnology-transferprogram.
• $4 millionforestablishingandmaintainingfiveLRNlaboratoriestocreateandmaintainregionalradiologicalLRNcapability.Fundingwouldbeusedto:• Purchasespecializedinstruments,including
thosethatcanmeasurealpha,betaandgammaradiation,andhigh-resolutionmassspectrometers.
• Hireradiologiclaboratorystaffinstates.• Supporttrainingfortheradiologiclabstaff.• SupportparticipationinCDC’sproficiency
testingprogram.
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