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TRANSCRIPT
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Department of Homeland Security
2IFHRI,QVSHFWRU*HQHUDO
DHS Has Not Effectively Managed Pandemic
Personal Protective Equipment and Antiviral
Medical Countermeasures
OIG-14-129 August 2014
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August 26, 2014
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OFFICE OF INSPECTOR GENERAL
Department of Homeland Security
TableofContents ExecutiveSummary............................................................................................................ 1 Background........................................................................................................................ 2 ResultsofAudit................................................................................................................... 3
NeedsAssessmentforPandemicPreparednessSupplies......................................3 PersonalProtectiveEquipmentPlanning...............................................................4 AntiviralMedicalCountermeasuresPlanning........................................................7 ManagementofPandemicPreparednessSupplies................................................8 PersonalProtectiveEquipmentOversight..............................................................9 AntiviralMedicalCountermeasuresInventoryManagement..............................10 InteragencyAgreementOversight........................................................................11 AntiviralMedicalCountermeasuresGuidanceandMonitoring...........................11 AdditionalObservation......................................................................................... 12 Recommendations................................................................................................ 13 ManagementCommentsandOIGAnalysis..........................................................15
Appendixes
AppendixA:Objectives,Scope,andMethodology............................................21 AppendixB: ManagementCommentstotheDraftReport..............................24 AppendixC: MajorContributorstoThisReport...............................................32 AppendixD: ReportDistribution.......................................................................33
Abbreviations
CBP U.S.CustomsandBorderProtection CDC CentersforDiseaseControlandPrevention COR contractingofficersrepresentative DHS DepartmentofHomelandSecurity ECD EstimatedCompletionDate FDA FoodandDrugAdministration FEMA FederalEmergencyManagementAgency FY fiscalyear HHS DepartmentofHealthandHumanServices IAA interagencyagreement ICE U.S.ImmigrationandCustomsEnforcement
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MCM medicalcountermeasures NCR NationalCapitalRegion NPPD NationalProtectionandProgramsDirectorate OHA OfficeofHealthAffairs OIG OfficeofInspectorGeneral PPE personalprotectiveequipment SLEP ShelfLifeExtensionProgram TSA TransportationSecurityAdministration USCG UnitedStatesCoastGuard USCIS U.S.CitizenshipandImmigrationServices USSS UnitedStatesSecretService
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ExecutiveSummary TheDepartmentofHomelandSecurity(DHS)supportseffortstodevelopandexecute pandemiccontingencyplansandpreparednessactionsaspartoftheUnitedStates Governmentspandemicpreparednessstrategy.Asevereinfluenzapandemicpresentsa tremendouschallenge,whichmayaffectmillionsofAmericans,causesignificant illnessesandfatalities,andsubstantiallydisruptoureconomicandsocialstability.Itis DHSresponsibilitytoensureitisadequatelypreparedtocontinuecriticaloperationsin theeventofapandemic. In2006,Congressappropriated$47millioninsupplementalfundingtoDHSfor necessaryexpensestoplan,train,andprepareforapotentialpandemic.DHSreported thatitspentthisfundingonpersonalprotectiveequipment,pandemicresearch, exercises,andmedicalcountermeasures.TheDepartmentandcomponentspurchased personalprotectiveequipmentandmedicalcountermeasures(specifically,antiviral medicalcountermeasures)toreducepotentialeffectsofapandemicandensurethe workforcecancontinueoperations.WeconductedanauditoftheDHSpandemic preparednesseffortstodetermineifDHSeffectivelymanagesitspandemic preparednesssupplyofpersonalprotectiveequipmentandantiviralmedical countermeasures. DHSdidnotadequatelyconductaneedsassessmentpriortopurchasingpandemic preparednesssuppliesandthendidnoteffectivelymanageitsstockpileofpandemic personalprotectiveequipmentandantiviralmedicalcountermeasures.Specifically,it didnothaveclearanddocumentedmethodologiestodeterminethetypesand quantitiesofpersonalprotectiveequipmentandantiviralmedicalcountermeasuresit purchasedforworkforceprotection.TheDepartmentalsodidnotdevelopand implementstockpilereplenishmentplans,sufficientinventorycontrolstomonitor stockpiles,adequatecontractoversightprocesses,orensurecompliancewith Departmentguidelines.Asaresult,theDepartmenthasnoassuranceithassufficient personalprotectiveequipmentandantiviralmedicalcountermeasuresforapandemic response.Inaddition,weidentifiedconcernsrelatedtotheoversightofantibiotic medicalcountermeasures. Wemade11recommendationsthatwhenimplementedshouldimprovetheefficiency andeffectivenessoftheDepartmentspandemicpreparations.TheDepartment concurredwiththeintentofall11recommendations.
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Background DHSpandemicpreparednessstrategyincludeseffortstodevelopandexecutepandemic contingencyplansandpreparednessactions.Asnewthreatsemerge,DHSmustplan andprepareforpossibledisastersbothnaturalandmanmade.Oneofthesethreatsis apandemicresultingfromanewinfluenzavirus.Asevereinfluenzapandemicpresents atremendouschallenge,whichmayaffectmillionsofAmericans,causesignificant illnessesandfatalities,andsubstantiallydisruptoureconomicandsocialstability. AccordingtotheCentersforDiseaseControlandPrevention(CDC),aninfluenza pandemiccanoccurwhenanonhumaninfluenzavirusisabletotransmitefficientlyand sustainablyfromhumantohumanandspreadglobally. Intheeventofanyemergency,Federalemployeeswillbeexpectedtocontinue operationstosustainagencyfunctions.Aninfluenzapandemicisnotasingularevent, butmaycomeinwavesthatlastweeksormonths.Itmayalsopassthrough communitiesofallsizesacrosstheNationandworldsimultaneously,asdemonstrated withthe2009H1N1influenzapandemic.Themountingriskofaworldwideinfluenza pandemicposesnumerouspotentiallydevastatingconsequencesforcritical infrastructureintheUnitedStates. DHSisresponsibleforensuringitisadequatelypreparedtocontinuecriticaloperations intheeventofapandemic.TheOfficeofHealthAffairs(OHA)servesasDHSprincipal authorityforallmedicalandpublichealthissues.OHAprovidesmedical,publichealth, andscientificexpertiseinsupportofDHSmissiontopreparefor,respondto,and recoverfromallthreats.OHAleadstheDepartmentsworkforcehealthprotectionand medicaloversightactivitiesandprovidesmedicalandscientificexpertisetosupportthe Department'spreparednessandresponseeffort.TheDirectorateforManagementis responsibleforimplementingtheDepartmentaloccupationalsafetyandhealth program,aswellasprocurement,property,equipment,andhumancapitalforthe Department.WithintheDirectorate,theDepartmentalOccupationalSafetyandHealth officeintegratessafetyandhealthprinciplesintothemanagementofDHSoperations, andprovidesdirectionandadvicetoDHSmanagementforoccupationalsafetyand healthmatters. BothOHAandtheDirectorateforManagementareresponsiblefororganizingpandemic preparationsfortheDepartment.TheseofficesprovideguidancetoDHScomponentsto enablemissionreadinessandtheprotectionofDHSpersonnelduringapandemicevent. Missionreadinessforapandemicincludeshavingpandemicpersonalprotection equipment(PPE)andantiviralmedicalcountermeasures(MCM)todistributeand dispenseduringapandemic.PandemicPPEisaworkplacecontrolmeasuretheDHS
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workforcemayusetopreventinfectionandreducethespreadofdisease.Inaddition, thedistributionanddispensingofantiviralMCMmayprotectDHSpersonnel,aswellas criticalcontractorsandthosewithinDHScareandcustodywhoarepotentiallyexposed inapandemic. In2006,Congressappropriated$47millioninsupplementalfundingtoDHSfor necessaryexpensestotrain,plan,andprepareforapotentialpandemic.DHSreported thatitspentthisfundingonPPE,pandemicresearch,exercises,andMCM.The DepartmentandcomponentspurchasedPPEandmedication(antiviralMCM)toreduce potentialeffectsofapandemicandensuretheworkforcecancontinueoperations. Usingtheappropriatedsupplementalfunding,DHShasmaintainedPPEandantiviral MCMstockpilesatboththedepartmentalandcomponentlevelsinpreparationfora pandemicresponse.Specifically,DHShasaPPEstockpileheldataFederalEmergency ManagementAgency(FEMA)distributioncenterandmultiplecomponentlocations. StockpilesofantiviralMCMareheldataDepartmentofHealthandHumanServices (HHS)facilityandmultiplecomponentlocations. WeconductedanauditoftheDHSpandemicpreparednesseffortstodetermineifDHS effectivelymanagesitspandemicpreparednesssupplyofPPEandantiviralMCM.As partofthisaudit,wealsoidentifiedconcernsrelatedtooversightofantibioticMCM, whichwasoutsideourauditscope. ResultsofAudit DHSdidnotadequatelyconductaneedsassessmentpriortopurchasingPPEandMCM forpandemicpreparedness.DHSdidnoteffectivelymanagetheinventoryofpandemic preparednesssuppliesitpurchased.Specifically,itdidnothaveclearanddocumented methodologiesforthetypesandquantitiesofPPEandMCMpurchasedforworkforce protection.TheDepartmentalsodidnotdevelopandimplementstockpile replenishmentplans,sufficientinventorycontrolstomonitorstockpiles,adequate contractoversightprocesses,orensurecompliancewithDepartmentguidelines.Asa result,theDepartmenthasnoassurancethatithassufficientPPEandMCMforDHS employeestocontinueoperations.DHSalsohasnoassurancethatthesuppliesonhand remaineffective.Aspartofourauditwork,wealsoidentifiedconcernsrelatedto oversightofantibioticMCM.
NeedsAssessmentforPandemicPreparednessSupplies
DHSdidnoteffectivelydetermineitsneedforpandemicpreparednesssupplies priortopurchasingthosesupplies.Specifically,itdidnotidentifyitsPPEneedsor
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itsneedsforantiviralMCM,haveclearanddocumentedmethodologiesforthe typesandquantitiesofequipmentpurchased,havestockpilereplenishment plansforeitherPPEorMCM,orimplementsufficientinventorycontrolsto monitorthestockpiles.MuchofthePPEDHSpurchasedispastthe manufacturersdateofguaranteedusabilityandmostoftheMCMpurchasedis nownearingthemanufacturersexpirationdate.1Asaresult,DHSand componentsmaynothavesufficientPPEorMCMtoprovidetotheworkforce duringapandemic. PersonalProtectiveEquipmentPlanning PriortopurchasingPPE,theDepartmentdidnotidentifythetypeandquantity neededtocontinueoperationsduringapandemic.DHSreportedspending$9.5 milliononpandemicPPEbeginningin2006foritsheadquartersand components,yetdidnotdevelopalifecyclemanagementplan.2PPEpurchases includedrespirators,surgicalmasks,gloves,goggles,handsanitizer,andcoverall suits.DHSandcomponentsdidnothaveclearanddocumentedmethodologies fordeterminingthetypesandquantitiesofequipmenttheyneeded.Bynot identifyingitsneeds,theDepartmentcannotbesureitsPPEstockpilesare adequateordetermineifithasexcesssuppliesonhand.Forexample: x TheDHSNationalCapitalRegion(NCR)pandemicstockpilecontains
about350,000whitecoverallsuits.Nojustificationorrelated documentationwasavailabletosupportthatthisquantityandtypeof PPEwasnecessaryforpandemicresponse.
1Basedonthemanufacturersexperience,thefiltermediaintherespiratorsretainsitsfiltration performanceinaccordancetostatedNationalInstituteforOccupationalSafetyandHealthcertification for5yearsfromthedateofmanufacture. 2Alifecyclemanagementplanisadocumentedprocesstoacquire,maintain,andultimatelydisposeofa productorservice.
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Source:OIGphoto Oneof432palletsofcoverallsuitsattheDHSNCRPPEstockpile.
x TheDepartmenthasareportedinventoryofapproximately16million
surgicalmaskswithoutdemonstratinganeedforthatquantityofmasks.
AnaisleoftheDHSNCRPPEstockpilecontainingnitrilegloves,surgicalmasks, respirators,andcoverallsuits.
TheDepartmentalsodidnotdevelopalternativeuseorrotationplansfor headquartersandcomponentPPEstockpiles.TheDepartmentsentirerespirator
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stockpilehasreached,orwillsoonreach,themanufacturersdateofguaranteed usability.Infact,theDepartmentsownassessmentisthattheentirePPE stockpilewillnotbeusableafter2015.Duringsitevisits,weidentifiedthe following: x TheTransportationSecurityAdministrations(TSA)stockofpandemicPPE
includesabout200,000respiratorsthatarebeyondthe5year manufacturersguaranteedusability.TSAisconductingsamplingofits PPEtoidentifyanyspecificproblemswithitsusability.However,TSA officialssaidtheywillmaintainexistingstockandmayuseitfor employeecomfort.
Source:OIGphoto Therewere62,000surgicalmasksdesignatedforpandemicuseataTSAwarehouse.
x TheDepartmentsNCRandcomponentpandemicPPEstockpilesinclude
expiredhandsanitizer.Outof4,982bottles,4,184(84percent)are expired,somebyupto4years.
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Source:OIGphoto PalletinDHSNCRstockpileofhandsanitizerthatexpiredinFebruary2010.
AntiviralMedicalCountermeasuresPlanning Infiscalyear(FY)2009,OHApurchasedapproximately240,000coursesof antiviralMCMonbehalfoftheDepartment,withoutfirstdeterminingthe Departmentspandemicneeds.3Afteritsinitialpurchases,OHApreparedan acquisitionmanagementplanforantiviralMCM,whichestimatedits requirements.However,OHAdidnotfollowthisplan.Instead,OHAactedona seniorleveldecisionestablishing110percentcoverageoftheDHSworkforce.4 TheDepartmenthasnotprovidedanydocumentationdemonstratinghowthe currentstockpileofapproximately300,000coursesalignswithitspandemic needs. SinceFY2009,OHAhaspurchasedadditionalantiviralMCMswithout reevaluatingthestockpilequantityforreasonableness.OHAconductedperiodic datacallstocomponentstoidentifymissioncriticalemployees.However,OHA didnotdocumenthowtheinformationwasusedtoensureitsstockpileof antiviralMCMwouldbesufficienttomeetitsneeds.
3Acourseisaseriesofdosesadministeredtoasingleindividualoveradesignatedperiod.TheDHS antiviralMCMstockpilecontainsTamifluandRelenza. 4TheDHSworkforceincludescriticalcontractorsandpeopleunderDHScareandcustody.Itdoesnot includetheUnitedStatesCoastGuard(USCG)becausetheUSCGmaintainsitsownMCMprogramand stockpile.
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Withoutsufficientlydeterminingitsneeds,theDepartmenthasnoassuranceit willhaveanadequateamountofantiviralMCMtomaintaincriticaloperations duringapandemic.Also,itcannotensurepreviousandfuturepurchasesof antiviralMCMareanefficientuseofresources.DHSacquiredmostofits stockpileofantiviralMCMinFY2009,butdidnotimplementanacquisition managementplanthatincludedastrategyforreplenishment.Havingan acquisitionmanagementplanwouldensureitsstockpilecontinuedtomeetits needs.Asaresult,about81percentofitsstockpilewillexpirebytheendof2015 (shownintable1).DHSrecentlyspentabout$760,000onanadditionalpurchase of37,000antiviralMCMcourses,yethadstillnotdemonstratedhowthat purchasemetitsneeds. OHAisapplyingforashelflifeextensionwiththeFoodandDrugAdministration (FDA)toextendtheexpirationdatesontheantiviralMCMexpiringin2015, specificallyTamiflu,intheDHSstockpile.Weapplaudtheireffortandencourage thisprocess,asitreducestheresourcesneededtoreplaceexpiringdrugsand wouldextendtheirTamiflustockpileexpirationuntil2018.However,OHAhas notyetbeengrantedanextension.Evenwiththeextension,thismaynotfulfill theDHSrequirementsifapandemiceventoccurs. Table1.CoursesofDHSAntiviralMedicalCountermeasuresExpiringin2015 AntiviralMCM CurrentAntiviral
MCMStockpile AntiviralMCM Expiringin
2015
Percentof AntiviralMCM Expiringin2015
Tamiflu 192,272 192,272 100% Relenza 103,734 47,472 46%
Totals 296,006 239,744 81% Source:OIGanalysis ManagementofPandemicPreparednessSupplies DHSdidnoteffectivelymanageandoverseeitsinventoryofpandemic preparednesssupplies,includingPPEandantiviralMCM.Specifically,DHSdid notkeepaccuraterecordsofwhatitpurchasedandreceivedanddidnot implementsufficientcontrolstomonitoritsstockpiles.Asaresult,DHSmaynot beabletoprovidesufficientpandemicpreparednesssuppliestoitsemployeesto continueoperationsduringapandemic.
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PersonalProtectiveEquipmentOversight
DHSdidnothaveproperoversightofitspandemicPPEsupplies.Itdidnotkeep recordsofwhatitpurchasedandreceived,andithasnotaccuratelyaccounted forhowmuchPPEitcurrentlyhasinstock.Thereisdepartmentalguidanceon inventorymanagement;however,theDepartmentandcomponentsdidnot establishandmaintainaccurateinventoriesinaccordancewiththatguidance. ThisconditionmayhaveexistedbecausetheDepartmentandcomponentsdid notuseaninventorysystemtotrackandmonitorPPEorperformperiodic inventoriesoftheirPPEstockpiles.Forexample,theDepartmentlosta secondaryPPEstockpile,oncelocatedinWashington,DC,containing25,000 surgicalmasksandhandsanitizer.AFederalGovernmentofficebuildingin Washington,DCreceivedthisstockpilein2009,butofficialswereunableto locatethestockpileforthisauditandreporteditaslost.Additionally,atasite visittotheDHSNCRstockpileataFEMAdistributioncenter,wefoundinventory discrepanciesasseenintable2. Table2.AnalysisofDHSNationalCapitalRegionStockpile
PersonalProtective EquipmentItem
FEMADistribution CenterInventory
Aug.2013
OIGVerified CountAug.
2013
Discrepancy
Model9210Respirators NotonInventory 4,800 4,800 Model1860Respirators 919,080 928,320 9,240 CoverallSuits 367,800 356,400 11,400 HandSanitizer(8oz.) NotonInventory 784 784 ProtectiveGoggles 23,214 20,312 2,902
Source:OIGanalysis Wealsoidentifiedinaccurateinventoriesatcomponentoffices.UnitedStates ImmigrationandCustomsEnforcement(ICE),NationalProtectionandPrograms Directorate(NPPD),andTSAdidnotestablishaninventoryoftheinitialstock theyreceivedfromtheDepartment.Subsequentattemptstoinventorytheir pandemicPPEwerenotaccurate.ICEandTSAofficialsreportedunknown quantitiesofPPEmayhavebeendisposedof,butwecouldnotverifythisreport sincethecomponentshadnotperformedanearlierinventory.Infact,atsome ICEandUnitedStatesSecretService(USSS)locations,PPEwasdistributedto employeeswithoutanytrackingorrecordkeeping. ManagementoftheDepartmentspandemicPPEhasnotbeeneffectivebecause responsibilityatthedepartmentallevelhasnotbeenclearlydesignated.The DirectorateforManagementandOHAhavedifferentinterpretationsregarding
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therolesandresponsibilitiesforadministrationandoversightofDHSNCR stockpile.Bothofficesacknowledgedthatthereisnocleardelineationof responsibilitiesnecessarytoguaranteesuccessfulcoordinationofthe managementandoversightofpandemicPPE.Theyhaveagreedtoclarifytheir roles.Withoutdelineatedroles,propermanagement,accountability,and oversightoftheDepartmentspandemicPPEcannotoccur. AntiviralMedicalCountermeasuresInventoryManagement DHSdecidedtoprepositionsomeofitsstockpiletocomponentofficesin responsetotheH1N1influenzapandemicin2009.OHAprepositioned approximately32,000coursesofantiviralMCMstoU.S.CustomsandBorder Protection(CBP),ICE,USSS,andFEMAlocations.OHAdidnotmaintaincomplete oraccuraterecordsofthequantityandshippedlocationofMCMdistributed fromthestockpile,andcomponentsdidnotdocumentreceiptofMCM. In2010,OHArequestedcomponentinventories,butdidnotvalidatethe reportedinformation.OHAcannotaccountfornearly6,200coursesofantiviral MCMprepositionedwiththecomponents(seetable3).Duringourreview,we wereabletolocatemorethan4,000coursesofantiviralMCM;however,more than2,000coursesremainmissing. Table3.AnalysisofOHAandComponentAntiviralMedicalCountermeasures Inventories Component Courses
Shippedby HHS
Courses Reportedto OHAby
Components
Net Adjustments fromOIG Validation
Courses Missing
CBP 24,192 20,275 2,040 1,877 FEMA 144 144 0 0 ICE 6,240 5,496 696 48 USSS 1,536 0 1,406 130 GrandTotal 32,112 25,915 4,142 2,055 TotalUnknowntoOHA 6,197
Source:OIGanalysis BasedonouranalysisofantiviralMCMsenttocomponents,OHAand componentsdidnothavecompleteoraccurateinventoriesofprepositioned antiviralMCM.Specifically,weidentifiedthefollowing:
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x OHAsentmorethan1,500coursesofantiviralMCMtotheUSSS headquarters.OHAdidnothaverecordsofanyMCMatUSSSbecauseit didnotmaintainshipmentdocumentation.
x OHAsent590coursesofantiviralMCMtoeightCBPfieldoffices,of whichCBPheadquarterswasunawarebecauseitdidnotmonitor antiviralMCMuntil2012.
x AttwoCBPlocations,wefoundinventorydiscrepanciesincludingone locationthatreported90courses,butactuallyhad1,344;andanother locationreported330,butactuallyhad528.
x AtthreeICEfieldofficelocations,720coursesofantiviralMCMwere incorrectlyreportedtoICEheadquartersasdestroyed;yet,weidentified theywerestillinpossessionoftheseMCMcourses.
InteragencyAgreementOversight OHAhadinteragencyagreements(IAA)withHHSforthestorageandlogisticsof themajorityofitsantiviralMCM.However,OHAdidnotensurepropercontract administrationandoversight.Specifically,therewasnodocumentationthatthe contractperformancewasroutinelymonitored.Onlyoneinspectionwas documentedduringtheentirecontractperiod.Themostrecentcontracting officersrepresentative(COR)wasunawareofhisappointmentanddidnotfulfill hisdutiesformorethan7months.Thisoccurredbecausetheprogramoffice responsiblefordesignatingtheCORdidnotnotifytheCORofhisappointment andresponsibilities. CORoversightisessentialtoensuringthatgoodsarereceivedandservicesare performedinaccordancewiththestatementofwork.However,OHAhaspaid HHSwithoutensuringitreceivedgoodsandservices.WenotifiedOHAofthis problem,andOHAhassincedesignatedaCORandissuedanappointmentletter outliningCORdutiesandresponsibilities. AntiviralMedicalCountermeasuresGuidanceandMonitoring OHAissuedguidancethatprepositionedantiviralMCMwastobesecurely storedinremotelocationswithlimitedornoimmediateaccesstomedicalcare, properlydispensed,andkeptinatemperaturecontrolledenvironment. However,CBP,ICE,andUSSSdidnotfollowOHAsguidanceonprepositioning antiviralMCMinremotelocations,andOHAdidnotenforcethisrequirement. Instead,OHAallowedcomponentstostoreantiviralMCMinmajormetropolitan areaslikeBoston,MA;Chicago,IL;Denver,CO;Miami,FL;andWashington,DC. Forexample,ICErequestedthatOHAsendanequalamountofantiviralMCMto
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locationsnationwide,regardlessofthesizeoftheofficeorofitsremote location. NeitherOHAnorcomponentsprovideddocumentedguidanceregardinghowto properlysecuretheantiviralMCM.Thiscontributedtotheineffective managementoftheantiviralMCManddiminishedtheDepartmentsabilityto continuecriticaloperationsduringapandemic.Forexample,ICEwasmissing48 coursesofantiviralMCMattwoofitslocations.ICEheadquarterscannot accountforwhathappenedtothemissingcoursesofantiviralMCM.Wevisited oneoftheseofficesandfoundthatthemedicationwasinanunsecuredoffice storageroom. InadditiontomissingantiviralMCM,USSSmayhaveimproperlydispensed130 coursesofantiviralMCMtoitsemployeestotreatinfluenzain2009.USSScould notprovideanydocumentation,asrequired,toshowtheyweredispensed.OHA officialssaidcomponentswerenotauthorizedtodispensetheantiviralMCM. OHAdidnotmaintainrecordsofMCMatUSSS,anditmaynothaveprovided guidanceonproperdispensingprotocolstoUSSS.
OHAalsohadnoassurancethatcomponentsstoredantiviralMCMattheproper temperatureanddidnotmonitorcomponentstoensureMCMswerestoredin continuouslytemperaturecontrolledenvironments.OHAs2009guidancefor antiviralMCMsoutlinedtherequirementsforstoragetemperature,butitdidnot havemonitoringrequirementsforcomponentstoensuretheantiviralMCM werestoredproperly. Additionally,componentheadquartersdidnotissueguidancefortheirfield officesorensurepropercontrolswereinplacetoaccountfortheantiviralMCM afteritwasprepositioned.Specifically,componentsdidnotensureantiviral MCMwereconsistentlystoredatthecorrecttemperatures.Forexample,at multiplesiteswevisited,officialssaidthebuildingswhereantiviralMCMwere beingstoredwerenottemperaturecontrolledduringeveningsandweekends. OHAspentapproximately$600,000ontheantiviralMCMsenttocomponent fieldoffices.OHAdoesnothaveassurancethattheprepositionedantiviralMCM havebeenproperlystored.Therefore,itisintheprocessofrecalling approximately32,000coursesofantiviralMCMforpossibledestructiondueto concernsaboutsafetyandefficacy. AdditionalObservation AlthoughantibioticMCMwasoutsidethescopeofouraudit,wehavesimilar concernsregardingtheeffectivenessofCBPsmonitoringofitsantibioticMCM.
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DuringfourofourCBPsitevisits,weobservedantibioticMCMstoredalongside antiviralMCM.CBPMCMmonitoringreliesontheselfreportedinventories, whichdonotcontainstorageconditionsatfieldoffices.Thismonitoringis insufficienttoensureprepositionedantibioticMCMarebeingstoredaccording torequirements.Asaresult,theusabilityofitsstockpileofmorethan88,000 coursesofantibioticMCM,valuedat$5million,maybequestionable. OHAhasagreementsinplacewithmostcomponentsgivingthemthe responsibilitytoproperlystoreantibioticsandoutliningrequirementsto maintaintheantibiotics.Duringouraudit,weobservedinadequatemonitoring ofstorageconditionsonlyatCBP.However,weurgeOHAtoensurethereis propermanagementandoversightoftheDepartmentsprepositionedantibiotic MCMandthatcomponentscomplywithallstoragerequirements. Recommendations WerecommendthattheDeputySecretary:
Recommendation#1: Identifyanddesignateanofficeresponsibleforthemanagementand accountabilityofpandemicPPE. Werecommendtheofficedesignatedforthemanagementandaccountabilityof pandemicPPE: Recommendation#2: Developastrategyformanagement,storage,anddistributionofpandemicPPE. Recommendation#3: Implementaninventorysystemforthecurrentinventoryandfutureinventories ofpandemicPPE. Recommendation#4: Workwithcomponentstoestablishamethodologyfordeterminingsufficient typesandquantitiesofpandemicPPEtoalignwiththedepartmentwide pandemicplan.
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Recommendation#5: Havecomponentsimplementinventorycontrolproceduresforprepositioned pandemicPPEtomonitorstockpiles,trackshipments,andensurecompliance withdepartmentalguidance.
WerecommendtheDHSMCMWorkingGroupandOHA: Recommendation#6: DeterminerequirementsofantiviralMCMfortheDepartmenttomaintain criticaloperationsduringapandemic. WerecommendOHA: Recommendation#7: CreateanantiviralMCMAcquisitionManagementPlantoinclude:
a) amethodologyfordeterminingtheidealquantityofantiviralMCM OHAwillstockpileandhowfrequentlyitwillbereevaluated;
b) areplenishmentplan;and c) inventorytracking,reporting,andreconciliationproceduresfor
existingstockpileandnewantiviralpurchases.
Recommendation#8: Reviseprocedurestoensurepropercontractoversightbygovernment employeesformanagementofitsMCMsupportservicecontractsandensure thecontractingofficersrepresentativesfollowprocedures. Recommendation#9: FinalizeandissueantiviralMCMguidanceonthestorageconditions,security, anddistributionforantiviralMCMforallcomponents. Recommendation#10: FinalizetheantiviralMCMrecallithasinitiatedontheCBP,ICE,FEMA,andUSSS inventories.
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Recommendation#11: CollaboratewithCBPtodeterminethesafetyandeffectivenessoftheantibiotic MCMthathavebeenstoredalongsidetheirantivirals. ManagementCommentsandOIGAnalysis Initsresponsetoourdraftreport,theDepartmentconcurredwiththeintentof all11recommendations.Itidentifiedissuesitbelievedwerenotappropriately characterized,whichareaddressedbelow.TheDepartmentexpressedconcern thatweoveremphasizedtheroleofPPEandMCM,whichtheyviewasthelastin ahierarchyofcontrols.Duringtheaudit,wedidreviewthehierarchyofcontrols includingengineeringcontrols,administrativecontrols,PPE,andMCM.Theaudit focusesonPPEandMCMduetotheextensivegovernmentalresources dedicatedtopurchasingmaterialsanddrugsinbothareas.Inaddition,according totheDHSChiefMedicalOfficer,theMCMProgramplaysavitalrolein protectingourworkforceandensuresthattheDepartment'soperationaland headquarterscomponentshavethecapabilityandtheresourcestocontinueto fulfillourmissionduringamajorincident.Wewereunabletoinclude informationonengineeringcontrolsbecausetheDepartmentcouldnotprovide documentationtodemonstratethiscontrolwasused.AccordingtoDHSofficials, nofundinghasbeenallocatedforengineeringcontrols,suchasphysicalbarriers. Wealsoconsideredthepotentialimpactofadministrativecontrols,specifically telework.Atthetimeofouraudit,lessthan5percentofDHSemployeesactually teleworkedandapproximately30percentofDHSemployeeswereinpositions thatarecapableoftelework.ManyofDHSemployeesconductoperations,such aspassengerscreening,thatarenotsuitablefortelework.Therefore,whilethere arealternativecontrols,wechosetofocusonwhereDHShasinvestedits resourcesandonthecontrolswithinthehierarchythatwouldbecriticalin allowingDHSoperationstocontinueduringapandemic. InauditingPPEandMCM,theOIGreliedonHHS,FDA,CDC,manufacturer information,andDHSsmedical,safetyandhealthprofessionalsasoutlinedin thereport.TheDepartmentheadquartersentirerespiratorstockpilehas reached,orwillsoonreach,themanufacturersdateofguaranteedusability. AccordingtoaDepartmentalsafetyandhealthofficial,althoughperiodic samplingbyDHSprofessionaloccupationalsafetyandhealthpersonnelcould establishwhetheritremainedusable,Managementhasdeterminedthebest alternativeistostandardizethepandemicPPEsupplychainanddiscontinue headquartersrelianceoncurrentstockpilesanddisposeofthembytheendof 2015.Atthetimeoftheaudit,DHSprovidednodocumentationonplansto replacetheircurrentPPEstockpileby2015andthefundingtoaccomplishsucha
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task.TheauditfoundthatDHSandcomponentsdonotknowwherePPEis located,howmuchithas,andtheusabilityofthestockpilesthatexist.Although DHShasidentifiedPPEandMCMastheleasteffectivecontrols,ithasinvested millionsinpurchasingtheseresourceswithoutdeterminingthequantities neededforapandemicresponse.AccordingtoDHS,itisnotrequiredunderthe OccupationalSafetyandHealthAdministrationtoprovidePPEsuppliestoits personnel;however,ithaselectedtodosoinitsownplanningrequirements. DHSshouldensureithassufficientsuppliestofulfillitsrequirementsandthat thesuppliesareinworkingcondition. InaddressingMCM,OHAhastakenstepswiththeFDAtousetheShelfLife ExtensionProgram(SLEP),whichcansavevaluableresourcesbyextending expirationdatesondrugsstillfoundtobeeffective.Weapplaudtheireffortand encouragethisprocess,asitreducestheresourcesneededtoreplaceexpiring drugs.However,OHAneedstoensurethatitproperlyidentifiesthedrugsthat receivesuchanextension.OHAimproperlyidentifiedinitsresponsethatithad beengrantedanFDAextensionforitsantiviralMCM.TheFDAhasnotapproved thespecificdrugsOHAhasinitsstrategicstockpilethatareduetoexpirenext year.DuringmeetingswiththeDepartment,theyconfirmedtheydidnothave anFDAextensionfortheirstockpile. Theplansinplacewhentheauditwasinitiatedwerethe2009H1N1plansfor boththeDepartmentandthecomponents.TheDepartmentwasintheprocess ofupdatingitspandemicplans,sowewereunabletoreviewthoseaspartofthis initialaudit.TheDepartmentspandemicplanningeffortswillbeaddressedinan upcomingaudit. Recommendation#1:Concur.TheOfficeoftheUnderSecretaryfor ManagementdesignatedtheDHSOfficeoftheChiefReadinessSupportOfficer asbeingresponsibleforthemanagementandaccountabilityofpandemicPPE effectiveJanuary2014.WerequestthatOIGconsiderthisrecommendation resolvedandclosed. OIGAnalysis:TheDepartmentsresponsetothisrecommendationaddressesthe intentoftherecommendation.Thisrecommendationisresolvedandwillremain openuntiltheDepartmentprovidesevidencethattheChiefReadinessSupport Officerhasbeendesignatedasbeingresponsibleforthemanagementand accountabilityofpandemicPPEeffectiveJanuary2014.TheDepartmentshould alsoprovideacopyofthenewpolicymemo,onceimplemented.
Recommendation#2:Concur.TheDHSChiefReadinessSupportOfficerissueda PandemicLogisticsSupportPlanCharteronMay30,2014.Thischarter
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establishestheframeworkforthedevelopmentofaDepartmentpandemic logisticssupportplanforpandemicPPE.APandemicLogisticsIntegrationTeam (iTeam)hasalsobeenestablishedwithrepresentationfromDHSComponents andpandemicPPErequirementshavebeendrafted.EstimatedCompletionDate (ECD):September30,2014. OIGAnalysis:TheDepartmentsresponsetothisrecommendationaddressesthe intentoftherecommendation.Thisrecommendationisresolvedandwillremain openuntiltheDepartmentprovidesacopyofthestrategyformanagement, storage,anddistributionofpandemicPPEdevelopedbythePandemicLogistics IntegrationTeam.Wewillclosethisrecommendationupondeterminingthatthe evidenceprovidedmeetstheintentofthisrecommendation. Recommendation#3:Concur.MembersofthePandemicLogisticsiTeamare reviewingtheapplicationoftheDepartment'sexistingpersonalproperty inventorymanagementsystemsforestablishingmanagementandinventory controlsforpandemicPPE.ThecurrentpandemicPPEinventoriesarebeing distributedwithinDHSwhereoperationalrequirementscanbeaugmented; remainingitemswillbesurplusedinaccordancewithFederalandDepartment requirementsandstandards.ECD:September30,2014. OIGAnalysis:TheDepartmentsresponsetothisrecommendationaddressesthe intentoftherecommendation.Thisrecommendationisresolvedandwillremain openuntiltheDepartmentprovidesacopyoftheimplementationplanincluding theinventorysystemforthecurrentinventoryandfutureinventoriesof pandemicPPEdevelopedbythePandemicLogisticsIntegrationTeam.Wewill closethisrecommendationupondeterminingthattheevidenceprovidedmeets theintentofthisrecommendation. Recommendation#4:Concur.Workisunderway.Aworkgrouphasbeen establishedunderthePandemicLogisticsiTeamtodevelopPPErequirements usinganemployeeriskbasedapproachsupportingworkplacecontrols.ECD: September30,2014. OIGAnalysis:TheDepartmentsresponsetothisrecommendationaddressesthe intentoftherecommendation.Thisrecommendationisresolvedandwillremain openuntiltheDepartmentprovidesacopyoftheworkgroupsplanestablishing amethodologyfordeterminingsufficienttypesandquantitiesofpandemicPPE toalignwiththedepartmentwidepandemicplan.Wewillclosethis recommendationupondeterminingthattheevidenceprovidedmeetstheintent ofthisrecommendation.
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Recommendation#5:Concur.Thisisintheplanningstage.Apolicyand standardsworkgroupisbeingestablishedunderthePandemicLogisticsiTeamto establishPPEcontrolproceduresandstandards.ECD:September30,2014. OIGAnalysis:TheDepartmentsresponsetothisrecommendationaddressesthe intentoftherecommendation.Thisrecommendationisresolvedandwillremain openuntiltheDepartmentprovidesacopyoftheworkgroupsplan implementinginventorycontrolproceduresforprepositionedpandemicPPEto monitorstockpiles,trackshipments,andensurecompliancewithdepartmental guidance.Wewillclosethisrecommendationupondeterminingthatthe evidenceprovidedmeetstheintentofthisrecommendation. Recommendation#6:Concur.Concur.OHAcontinuestosolicit,receive,and addressDHScomponentMCMneedsandrequirementsasastandingagenda itemduringthemonthlyMCMWorkingGroupmeeting,andasakeyelementof theMCMQuarterlyReports,OHApreparesanddistributesaspartoftheMCM program.Additionally,DHSisworkingwithCDConaninteragencyprocessto defineantiviralstockpilingneedsonbehalfoftheentireFederalGovernment. WerequestthatOIGconsiderthisrecommendationresolvedandclosed. OIGAnalysis:TheDepartmentsresponsetothisrecommendationaddressesthe intentoftherecommendation.Thisrecommendationisresolvedandwillremain openuntiltheDepartmentprovidesacopyoftheworkgroupsplanoutliningthe determinationofrequirementsofantiviralMCMfortheDepartmenttomaintain criticaloperationsduringapandemic.Wewillclosethisrecommendationupon determiningthattheevidenceprovidedmeetstheintentofthis recommendation. Recommendation#7:Concur.AnMCMIntegratedLogisticsSupportProgram hasbeendraftedandiscurrentlyinDHSclearance.CompletionoftheMCM IntegratedLogisticsSupportProgramwilladdressallthreeelementsofthis recommendation.ECD:September30,2014. OIGAnalysis:TheDepartmentsresponsetothisrecommendationaddressesthe intentoftherecommendation.Thisrecommendationisresolvedandwillremain openuntiltheDepartmentprovidesacopyoftheIntegratedLogisticsSupport Programaddressingallthreeelementsofthisrecommendation.Wewillclose thisrecommendationupondeterminingthattheevidenceprovidedmeetsthe intentofthisrecommendation. Recommendation#8:Concurinprinciple.Existingproceduresasdescribedin theHomelandSecurityAcquisitionRegulation,HomelandSecurityAcquisition
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Manual,theDHSOfficeofProcurementOperationscontractingofficer's representativeguidebookandcomponentspecificproceduresaddressing contractingofficersrepresentativedutiesandresponsibilitiesareadequatefor ensuringpropercontractoversight,buttheseprocedureswerenotfollowed consistentlyintheadministrationofMCMsupportservicecontracts.SinceOIG identifiedfindingsconcerninginadequateoversight,OHAhastakenstepsto ensurethathighlyqualifiedcontractingofficer'srepresentativesareassignedto allMCMsupportservicecontracts.Theseemployeesprovidedirectand comprehensiveoversightofeachaspectoftheMCMprojectincludingdetailed governanceoverallrelatedcontractsupport.WerequestthatOIGconsiderthis recommendationresolvedandclosed. OIGAnalysis:TheDepartmentsresponsetothisrecommendationaddressesthe intentoftherecommendation.Thisrecommendationisresolvedandwillremain openuntiltheDepartmentprovidesacopyoftherevisedprocedurestoensure propercontractoversightbygovernmentemployeesformanagementofits MCMsupportservicecontractsandensurethecontractingofficer's representativesfollowprocedures.Wewillclosethisrecommendationupon determiningthattheevidenceprovidedmeetstheintentofthis recommendation. Recommendation#9:Concur.StorageandsecurityguidanceMCMstandard operatingproceduresinitiallyreleasedin2010havebeenupdatedand expanded,andprovidedtocomponentMCMplanners.Theyhavealsobeen postedtotheDHSConnectIntranetMCMpage.WerequestthatOIGconsider thisrecommendationresolvedandclosed. OIGAnalysis:TheDepartmentsresponsetothisrecommendationaddressesthe intentoftherecommendation.TheDepartmentprovidedsupporting documentationonstorageandsecurityguidanceMCMstandardoperating proceduresthathavebeenupdatedandexpanded,andprovidedtocomponent MCMplanners.Thisdocumentationwassufficienttoclosethisrecommendation. Thisrecommendationisresolvedandclosed.
Recommendation#10:Concur.Therecalliscomplete.OHArecentlyreceiveda confirmationletter,datedJuly7,2014,fromtheHHSstoragefacilityadvising thatallantivirallotshadbeenreturned.WerequestthatOIGconsiderthis recommendationresolvedandclosed. OIGAnalysis:TheDepartmentsresponsetothisrecommendationaddressesthe intentoftherecommendation.Thisrecommendationisresolvedandwillremain openuntiltheDepartmentprovidesacopythatallantiviralMCMshippedtothe
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fieldlocationshasbeenreturned.Therearestill1,071coursesofantiviralMCM sentfromthefieldthathavenotbeenreturnedtotheHHSfacility.Therewere fivelocationsthatdidnotreturnanyoftheantiviralMCMtheywereshipped, andtherewereeightlocationsthatdidnotreturnthefullamountoftheMCM thatwasoriginallyshipped.ThisrecommendationcannotbecloseduntilOHA locatestheremainingcoursesordocumentsthatthosecourseshavebeenlost andprovidesdocumentationineithercase.Wewillclosethisrecommendation upondeterminingthattheevidenceprovidedmeetstheintentofthis recommendation. Recommendation#11:Concur.OHAcontinuestocollaboratewithallDHS ComponentstoincludeU.S.CustomsandBorderProtection,throughtheMCM WorkingGroup,tovalidatethesafetyandeffectivenessofMCM.DHSemploys theapprovedSLEPinclosecoordinationwiththeFDAandtheU.S.Department ofDefense.Todate,tenlotsofantibioticMCMhavebeensubmittedtoSLEPfor testingandofthoseforwhichtestinghasbeencompletedallhavebeenfoundto remainefficaciousresultinginacostavoidanceof$5.1milliontothe Department. Inadditiontoextendingtheshelflife,theSLEPtestingverifiesthesafety/efficacy ofMCMthatmayhavebeenstoredimproperly(outsideofthemanufacturer's temperaturerange).Inoneinstance,5,450bottlesofantibioticswereexposed toatemperaturespikeover100degreesFahrenheitforanunknownduration. ThelotwassubmittedtoSLEPtotestforcontinuedefficacy.Itwasfoundtobe stillsafeandeffectiveforuse,anditwasreturnedtotheDHSstockpile. Additionally,onJuly7,2014,OHAprovidedproceduralguidancetoDHS ComponentsregardingMCMonmeasurestoensurethesafetyandeffectiveness ofmedications,includingantibiotics,intheMCMProgram.WerequestthatOIG considerthisrecommendationresolvedandclosed. OIGAnalysis:TheDepartmentsresponsetothisrecommendationaddressesthe intentoftherecommendation.Thisrecommendationisresolvedandwillremain openuntiltheDepartmentprovidesdocumentationonhowitisvalidatingthe safetyandeffectivenessoftheMCM.Wewillclosethisrecommendationupon determiningthattheevidenceprovidedmeetstheintentofthis recommendation.
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AppendixA Objectives,Scope,andMethodology TheDHSOIGwasestablishedbytheHomelandSecurityActof2002(PublicLaw107 296)byamendmenttotheInspectorGeneralActof1978.Thisisoneofaseriesofaudit, inspection,andspecialreportspreparedaspartofouroversightresponsibilitiesto promoteeconomy,efficiency,andeffectivenesswithintheDepartment. WeconductedanauditoftheDHSpandemicpreparednesseffortstodetermineifDHS effectivelymanagesitspandemicpreparednesssupplyofPPEandantiviralMCM.To achieveourauditobjective,weidentifiedandreviewedapplicableFederallaws, regulations,andDHSpoliciesandproceduresregardingpandemicpreparedness.The auditcoveredDHSpandemiceffortsfromFY2006throughApril2014. WeinterviewedDHSofficialswithintheDirectorateforManagement,theOfficeof OperationsCoordinationandPlanning,OHA,andsomecomponentsresponsiblefor pandemicpreparednessplanning,administration,oversight,andmanagement. Specifically,wemetwithcomponentofficialsfromCBP,FEMA,ICE,TSA,USCG,NPPD, U.S.CitizenshipandImmigrationServices(USCIS),andUSSS.Wealsointerviewed personnelatHHS. WemetwithDepartmentofficialstodeterminewhichofficeswereresponsiblefor pandemicpreparednessplanning,management,andoversighttoensureworkforce protection.WeinterviewedDHSofficialswithintheDirectorateforManagement,the OfficeofOperationsCoordinationandPlanning,andOHAresponsibleforpandemic preparednessplanning,administration,oversight,andmanagement.Wealsometwith HHSpersonnelwhoconductthestorageandlogisticsoftheDHSantiviralMCMstockpile aspartoftheIAA.Finally,weinterviewedDHSemployeesfromcomponent headquartersandfieldofficesofCBP,FEMA,ICE,TSA,theUSCG,NPPD,USCIS,and USSS. TodetermineifDHSeffectivelymanagesitspandemicPPE,wereviewedwhatplansand guidanceDHShadforthetypesandquantitiesofPPE,forthealternativeuseorrotation oftheequipment,andfordistributionofPPEtocomponents.Weassessedtheaccuracy ofDHSinventoriesbyconductingajudgmentalsampleofsitevisitsandaphysical verificationofonsiteequipment.Specifically,wevisitedpandemicPPEstockpilesforthe NCRataFEMAdistributioncenterandatICE,USSS,TSA,andNPPDlocationsand documentedstorageconditionsanddiscrepanciesbetweeninventoriesandquantities onsite.WeassessedDHSoversightofitspandemicPPEstockpilebydetermininghow DHStrackedandmonitoredPPE,conductedperiodicinventoriesoftheirPPEstockpiles,
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anddelineatedtherolesandresponsibilitiesbetweenDHSoffices.Seetable4forthe officeswevisitedthatpossessedPPE.
Table4.PersonalProtectiveEquipmentSiteVisits Component NumberofLocations
FEMA 4 ICE 5
NPPD 2 TSA 5
USSS 3 Source:OIG
TodetermineifDHSeffectivelymanagesitspandemicpreparednesssupplyofantiviral MCM,wedeterminedwhetherOHAcreatedplansforitsacquisitionandinventory management.WeevaluatedtheguidanceOHAissuedonappropriatestorageand distributionofantiviralMCM.WeassessedOHAoversightofitsantiviralMCMstockpile bydetermininghowOHAtrackedandmonitoredantiviralMCM,conductedinventories oftheantiviralMCMstockpiles,andensuredperformanceofCORresponsibilities.We assessedtheaccuracyofOHAandcomponentantiviralMCMinventoriesbycomparing theirinventorieswiththeshippingdatafromHHS.Inaddition,wereviewedthe accuracyofcomponentheadquartersinventoriesofantiviralMCMstockpiledattheir officesbyconductingajudgmentalsampleofsitevisitsandaphysicalverificationofthe medicationonsite.Specifically,wevisitedantiviralMCMstockpilesatanHHSstorage facilityandatICE,CBP,NPPD,andUSSSlocations,anddocumentedstorageconditions anddiscrepanciesbetweeninventoriesandquantitiesonsite.Seetable5fortheoffices andlocationswevisited.
Table5:MedicalCountermeasuresSiteVisits Component NumberofLocations
CBP 14 FEMA 1
ICE 12 NPPD 1 TSA 1
USCG 1 USCIS 1 USSS 2
Source:OIG WereliedoncomponentsandDHSheadquarterstoprovideuscountsoftheirpandemic PPEandantiviralMCMstockpiles,whichwerenotcompleteandaccurate.We
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performedphysicalverificationbysamplinginventoriesattheheadquarterslevel,as wellasatcomponentheadquartersandfieldofficelocationsselected.Wealso comparedoriginalorderandshipmentinformationforantiviralMCMwithOHAand componentinventoriesandwereabletoidentifyquantitiesthatwereinundocumented locationsormissing.Theevidencefromtestingtheinventoriesthroughourphysical verificationduringsitevisitsandanalysisofdatawassufficientandadequateforthe purposesofmeetingourauditobjectiveandsupportingourauditfindings. WeconductedthisperformanceauditbetweenJuly2013andApril2014pursuanttothe InspectorGeneralActof1978,asamended,andaccordingtogenerallyaccepted governmentauditingstandards.Thosestandardsrequirethatweplanandperformthe audittoobtainsufficient,appropriateevidencetoprovideareasonablebasisforour findingsandconclusionsbaseduponourauditobjectives.Webelievethattheevidence obtainedprovidesareasonablebasisforourfindingsandconclusionsbaseduponour auditobjectives.
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AppendixB ManagementCommentstotheDraftReport
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AppendixC MajorContributorstoThisReport BrookeBebow,Director StephanieChristian,AuditManager GaryCrownover,ProgramAnalyst RuthGonzalez,ProgramAnalyst MatthewNoll,ProgramAnalyst MarkA.Phillips,Auditor MelissaPrunchak,ProgramAnalyst KevinDolloson,CommunicationsAnalyst PriscillaCast,Referencer
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AppendixD ReportDistribution DepartmentofHomelandSecurity Secretary DeputySecretary ChiefofStaff DeputyChiefofStaff GeneralCounsel ExecutiveSecretary Director,GAO/OIGLiaisonOffice AssistantSecretaryforOfficeofPolicy AssistantSecretaryforOfficeofPublicAffairs AssistantSecretaryforOfficeofLegislativeAffairs ChiefPrivacyOfficer OfficeofManagementandBudget Chief,HomelandSecurityBranch DHSOIGBudgetExaminer Congress CongressionalOversightandAppropriationsCommittees,asappropriate
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ADDITIONAL INFORMATION To view this and any of our other reports, please visit our website at: www.oig.dhs.gov. For further information or questions, please contact Office of Inspector General (OIG) Office of Public Affairs at: [email protected], or follow us on Twitter at: @dhsoig. OIG HOTLINE To expedite the reporting of alleged fraud, waste, abuse or mismanagement, or any other kinds of criminal or noncriminal misconduct relative to Department of Homeland Security (DHS) programs and operations, please visit our website at www.oig.dhs.gov and click on the red tab titled "Hotline" to report. You will be directed to complete and submit an automated DHS OIG Investigative Referral Submission Form. Submission through our website ensures that your complaint will be promptly received and reviewed by DHS OIG. Should you be unable to access our website, you may submit your complaint in writing to:
Department of Homeland Security
Office of Inspector General, Mail Stop 0305
Attention: Office of Investigations Hotline
245 Murray Drive, SW
Washington, DC 20528-0305
You may also call 1(800) 323-8603 or fax the complaint directly to us at (202) 254-4297. The OIG seeks to protect the identity of each writer and caller.
http:www.oig.dhs.govmailto:[email protected]:www.oig.dhs.gov
Structure BookmarksDepartment of Homeland Security.2IFH.RI.,QVSHFWRU.*HQHUDO. DHS Has Not Effectively Managed Pandemic .Personal Protective Equipment and Antiviral .Medical Countermeasures .Department of Homeland Security.2IFH.RI.,QVSHFWRU.*HQHUDO. DHS Has Not Effectively Managed Pandemic .Personal Protective Equipment and Antiviral .Medical Countermeasures .SectFigureOIG-14-129 August 2014. OIG-14-129 August 2014. August 26, 2014 FigureTable.of.Contents.. . Executive.Summary...............................................................................................................1. . Background...........................................................................................................................2. . Results.of.Audit.....................................................................................................................3. . Needs.Assessment.for.Pandemic.Preparedness.Supplies..............................Table.of.Contents.. . Executive.Summary...............................................................................................................1. . Background...........................................................................................................................2. . Results.of.Audit.....................................................................................................................3. . Needs.Assessment.for.Pandemic.Preparedness.Supplies..............................
Appendix.A:....Objectives,.Scope,.and.Methodology..............................................21.. Appendix.A:....Objectives,.Scope,.and.Methodology..............................................21.. Appendix.B:. Appendix.B:. Appendix.B:. Management.Comments.to.the.Draft.Report................................24.
Appendix.C:. Appendix.C:. Major.Contributors.to.This.Report.................................................32.
Appendix.D:. Appendix.D:. Report.Distribution.........................................................................33.
. .
Abbreviations.. Abbreviations..
. .
CBP. CBP. U.S..Customs.and.Border.Protection.
CDC. CDC. Centers.for.Disease.Control.and.Prevention.
COR. COR. contracting.officers.representative.
DHS. DHS. Department.of.Homeland.Security..
ECD. ECD. Estimated.Completion.Date.
FDA. FDA. Food.and.Drug.Administration.
FEMA. FEMA. Federal.Emergency.Management.Agency.
FY. FY. fiscal.year.
HHS. HHS. Department.of.Health.and.Human.Services.
IAA. IAA. interagency.agreement.
ICE. ICE. U.S..Immigration.and.Customs.Enforcement.
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FigureTableTRMCM. medical.countermeasures.
TRNCR. National.Capital.Region.
TRNPPD. National.Protection.and.Programs.Directorate.
TROHA. Office.of.Health.Affairs.
TROIG. . Office.of.Inspector.General.
TRPPE. personal.protective.equipment.
TRSLEP. ShelfLife.Extension.Program.
TRTSA. Transportation.Security.Administration.
TRUSCG. United.States.Coast.Guard.
TRUSCIS. U.S..Citizenship.and.Immigration.Services.
TRUSSS. United.States.Secret.Service.
TR.
. .
. .
Figure
Executive.Summary... . The.Department.of.Homeland.Security.(DHS).supports.efforts.to.develop.and.execute. pandemic.contingency.plans.and.preparedness.actions.as.part.of.the.United.States. Governments.pandemic.preparedness.strategy..A.severe.influenza.pandemic.presents.a. tremendous.challenge,.which.may.affect.millions.of.Americans,.cause.significant. illnesses.and.fatalities,.and.substantially.disrupt.our.economic.and.social.stability..It.is. DHS.responsibility.to.ensure.it.is.adequately.prepared.to.contiExecutive.Summary... . The.Department.of.Homeland.Security.(DHS).supports.efforts.to.develop.and.execute. pandemic.contingency.plans.and.preparedness.actions.as.part.of.the.United.States. Governments.pandemic.preparedness.strategy..A.severe.influenza.pandemic.presents.a. tremendous.challenge,.which.may.affect.millions.of.Americans,.cause.significant. illnesses.and.fatalities,.and.substantially.disrupt.our.economic.and.social.stability..It.is. DHS.responsibility.to.ensure.it.is.adequately.prepared.to.contiExecutive.Summary... . The.Department.of.Homeland.Security.(DHS).supports.efforts.to.develop.and.execute. pandemic.contingency.plans.and.preparedness.actions.as.part.of.the.United.States. Governments.pandemic.preparedness.strategy..A.severe.influenza.pandemic.presents.a. tremendous.challenge,.which.may.affect.millions.of.Americans,.cause.significant. illnesses.and.fatalities,.and.substantially.disrupt.our.economic.and.social.stability..It.is. DHS.responsibility.to.ensure.it.is.adequately.prepared.to.conti
SectPLink
Figure
Background.. . DHS.pandemic.preparedness.strategy.includes.efforts.to.develop.and.execute.pandemic. contingency.plans.and.preparedness.actions..As.new.threats.emerge,.DHS.must.plan. and.prepare.for.possible.disastersboth.natural.and.manmade..One.of.these.threats.is. a.pandemic.resulting.from.a.new.influenza.virus..A.severe.influenza.pandemic.presents. a.tremendous.challenge,.which.may.affect.millions.of.Americans,.cause.significant. illnesses.and.fatalities,.and.substantially.disrupt.our.economic.and.sociaBackground.. . DHS.pandemic.preparedness.strategy.includes.efforts.to.develop.and.execute.pandemic. contingency.plans.and.preparedness.actions..As.new.threats.emerge,.DHS.must.plan. and.prepare.for.possible.disastersboth.natural.and.manmade..One.of.these.threats.is. a.pandemic.resulting.from.a.new.influenza.virus..A.severe.influenza.pandemic.presents. a.tremendous.challenge,.which.may.affect.millions.of.Americans,.cause.significant. illnesses.and.fatalities,.and.substantially.disrupt.our.economic.and.sociaPLink
Figureworkforce.may.use.to.prevent.infection.and.reduce.the.spread.of.disease..In.addition,. the.distribution.and.dispensing.of.antiviral.MCM.may.protect.DHS.personnel,.as.well.as. critical.contractors.and.those.within.DHS.care.and.custody.who.are.potentially.exposed. in.a.pandemic... . In.2006,.Congress.appropriated.$47.million.in.supplemental.funding.to.DHS.for. necessary.expenses.to.train,.plan,.and.prepare.for.a.potential.pandemic..DHS.reported. that.it.spent.this.funding.on.PPE,.pandemic.research,.exercisesworkforce.may.use.to.prevent.infection.and.reduce.the.spread.of.disease..In.addition,. the.distribution.and.dispensing.of.antiviral.MCM.may.protect.DHS.personnel,.as.well.as. critical.contractors.and.those.within.DHS.care.and.custody.who.are.potentially.exposed. in.a.pandemic... . In.2006,.Congress.appropriated.$47.million.in.supplemental.funding.to.DHS.for. necessary.expenses.to.train,.plan,.and.prepare.for.a.potential.pandemic..DHS.reported. that.it.spent.this.funding.on.PPE,.pandemic.research,.exercises
SectSectPLink
Figureits.needs.for.antiviral.MCM,.have.clear.and.documented.methodologies.for.the. types.and.quantities.of.equipment.purchased,.have.stockpile.replenishment. plans.for.either.PPE.or.MCM,.or.implement.sufficient.inventory.controls.to. monitor.the.stockpiles..Much.of.the.PPE.DHS.purchased.is.past.the. manufacturers.date.of.guaranteed.usability.and.most.of.the.MCM.purchased.is. now.nearing.the.manufacturers.expiration.date.1.As.a.result,.DHS.and. components.may.not.have.sufficient.PPE.or.MCM.to.provide.to.the.wor4. OIG14129. www.oig.dhs.gov.
Figure. Source:.OIG.photo. One.of.432.pallets.of.coverall.suits.at.the.DHS.NCR.PPE.stockpile.. . x The.Department.has.a.reported.inventory.of.approximately.16.million. surgical.masks.without.demonstrating.a.need.for.that.quantity.of.masks.. An.aisle.of.the.DHS.NCR.PPE.stockpile.containing.nitrile.gloves,.surgical.masks,. respirators,.and.coverall.suits.. . The.Department.also.did.not.develop.alternative.use.or.rotation.plans.for. headquarters.and.component.PPE.stockpiles..The.Departments.entire.respirator. www.oig.dhs.gov. 5. OIG14129. . Source:.OIG.photo. PLink
Figurestockpile.has.reached,.or.will.soon.reach,.the.manufacturers.date.of.guaranteed. usability..In.fact,.the.Departments.own.assessment.is.that.the.entire.PPE. stockpile.will.not.be.usable.after.2015..During.site.visits,.we.identified.the. following:.. . x The.Transportation.Security.Administrations.(TSA).stock.of.pandemic.PPE. includes.about.200,000.respirators.that.are.beyond.the.5year. manufacturers.guaranteed.usability..TSA.is.conducting.sampling.of.its. PPE.to.identify.any.specific.problems.with.its.uemployee.comfort... . Source:.OIG.photo. There.were.62,000.surgical.masks.designated.for.pandemic.use.at.a.TSA.warehouse.. . x The.Departments.NCR.and.component.pandemic.PPE.stockpiles.include. expired.hand.sanitizer..Out.of.4,982.bottles,.4,184.(84.percent).are. expired,.some.by.up.to.4.years.. 6. OIG14129. www.oig.dhs.gov.
Figure. Source:.OIG.photo. Pallet.in.DHS.NCR.stockpile.of.hand.sanitizer.that.expired.in.February.2010.. .. Antiviral.Medical.Countermeasures.Planning... . In.fiscal.year.(FY).2009,.OHA.purchased.approximately.240,000.courses.of. antiviral.MCM.on.behalf.of.the.Department,.without.first.determining.the. Departments.pandemic.needs.3.After.its.initial.purchases,.OHA.prepared.an. acquisition.management.plan.for.antiviral.MCM,.which.estimated.its. requirements..However,.OHA.did.not.follow.this.plan..Instead,.OHA.acted.PLink
FigureWithout.sufficiently.determining.its.needs,.the.Department.has.no.assurance.it. will.have.an.adequate.amount.of.antiviral.MCM.to.maintain.critical.operations. during.a.pandemic..Also,.it.cannot.ensure.previous.and.future.purchases.of. antiviral.MCM.are.an.efficient.use.of.resources..DHS.acquired.most.of.its. stockpile.of.antiviral.MCM.in.FY.2009,.but.did.not.implement.an.acquisition. management.plan.that.included.a.strategy.for.replenishment..Having.an. acquisition.management.plan.would.ensure.its.stockpileTable.1..Courses.of.DHS.Antiviral.Medical.Countermeasures.Expiring.in.2015. Antiviral.MCM. Antiviral.MCM. Antiviral.MCM. Current.Antiviral. MCM.Stockpile. Antiviral.MCM. Expiring.in. 2015. Percent.of. Antiviral.MCM. Expiring.in.2015.
Tamiflu. Tamiflu. 192,272. 192,272. 100%.
Relenza. Relenza. 103,734. 47,472. 46%.
Totals. Totals. 296,006. 239,744. 81%.
TableTRSource:.OIG.analysis.
TR.
TRManagement.of.Pandemic.Preparedness.Supplies.
TR.
TRDHS.did.not.effectively.manage.and.oversee.its.inventory.of.pandemic.
TRpreparedness.supplies,.including.PPE.and.antiviral.MCM..Specifically,.DHS.did.
TRnot.keep.accurate.records.of.what.it.purchased.and.received.and.did.not.
TRimplement.sufficient.controls.to.monitor.its.stockpiles..As.a.result,.DHS.may.not.
TRbe.able.to.provide.sufficient.pandemic.preparedness.supplies.to.its.employees.to.
TRcontinue.operations.during.a.pandemic...
TR.
. .
. .
. .
8. OIG14129. www.oig.dhs.gov.
Figure
Personal.Protective.Equipment.Oversight. Personal.Protective.Equipment.Oversight. . DHS.did.not.have.proper.oversight.of.its.pandemic.PPE.supplies..It.did.not.keep. records.of.what.it.purchased.and.received,.and.it.has.not.accurately.accounted. for.how.much.PPE.it.currently.has.in.stock..There.is.departmental.guidance.on. inventory.management;.however,.the.Department.and.components.did.not. establish.and.maintain.accurate.inventories.in.accordance.with.that.guidance.. This.condition.may.have.existed.because.the.Department.and.components.did. not.use.an.inventory.system.to.track.and.monitPersonal.Protective. Equipment.Item. Personal.Protective. Equipment.Item. Personal.Protective. Equipment.Item. FEMA.Distribution. Center.Inventory. Aug..2013. OIG.Verified. Count.Aug.. 2013. Discrepancy.
Model.9210.Respirators. Model.9210.Respirators. Not.on.Inventory 4,800. 4,800
Model.1860.Respirators. Model.1860.Respirators. 919,080 928,320. 9,240
Coverall.Suits. Coverall.Suits. 367,800 356,400. 11,400
Hand.Sanitizer.(8.oz.). Hand.Sanitizer.(8.oz.). Not.on.Inventory 784. 784
Protective.Goggles. Protective.Goggles. 23,214 20,312. 2,902
Source:.OIG.analysis. . We.also.identified.inaccurate.inventories.at.component.offices..United.States. Immigration.and.Customs.Enforcement.(ICE),.National.Protection.and.Programs. Directorate.(NPPD),.and.TSA.did.not.establish.an.inventory.of.the.initial.stock. they.received.from.the.Department..Subsequent.attempts.to.inventory.their. pandemic.PPE.were.not.accurate..ICE.and.TSA.officials.reported.unknown. quantities.of.PPE.may.have.been.disposed.of,.but.we.could.not.verify.this.report. since.the.components.h9. OIG14129. www.oig.dhs.gov.
Figurethe.roles.and.responsibilities.for.administration.and.oversight.of.DHS.NCR. stockpile..Both.offices.acknowledged.that.there.is.no.clear.delineation.of. responsibilities.necessary.to.guarantee.successful.coordination.of.the. management.and.oversight.of.pandemic.PPE..They.have.agreed.to.clarify.their. roles..Without.delineated.roles,.proper.management,.accountability,.and. oversight.of.the.Departments.pandemic.PPE.cannot.occur.. . Antiviral.Medical.Countermeasures.Inventory.Management. . DHS.decided.to.pre
Component. Component. Component. Component. Courses. Shipped.by. HHS. Courses. Reported.to. OHA.by. Components. Net. Adjustments. from.OIG. Validation. Courses. Missing.
CBP. CBP. 24,192. 20,275. 2,040. 1,877.
FEMA. FEMA. 144. 144. 0. 0.
ICE. ICE. 6,240. 5,496. . 696. 48.
USSS. USSS. 1,536. 0. 1,406. 130.
Grand.Total. Grand.Total. 32,112. 25,915. 4,142. 2,055.
Total.Unknown.to.OHA. Total.Unknown.to.OHA. 6,197.
Source:.OIG.analysis. . Based.on.our.analysis.of.antiviral.MCM.sent.to.components,.OHA.and. components.did.not.have.complete.or.accurate.inventories.of.prepositioned. antiviral.MCM..Specifically,.we.identified.the.following:. . www.oig.dhs.gov. 10. OIG14129. PLink
Figurex OHA.sent.more.than.1,500.courses.of.antiviral.MCM.to.the.USSS. headquarters..OHA.did.not.have.records.of.any.MCM.at.USSS.because.it. did.not.maintain.shipment.documentation.. x OHA.sent.590.courses.of.antiviral.MCM.to.eight.CBP.field.offices,.of. which.CBP.headquarters.was.unaware.because.it.did.not.monitor. antiviral.MCM.until.2012.. x. At.two.CBP.locations,.we.found.inventory.discrepancies.including.one. location.that.reported.90.courses,.but.actually.had.1,344;.and.another. location.reported.330,.but.aPLink
Figurelocations.nationwide,.regardless.of.the.size.of.the.office.or.of.its.remote. location.. . Neither.OHA.nor.components.provided.documented.guidance.regarding.how.to. properly.secure.the.antiviral.MCM..This.contributed.to.the.ineffective. management.of.the.antiviral.MCM.and.diminished.the.Departments.ability.to. continue.critical.operations.during.a.pandemic..For.example,.ICE.was.missing.48. courses.of.antiviral.MCM.at.two.of.its.locations..ICE.headquarters.cannot. account.for.what.happened.to.the.missing.couPLink
FigureDuring.four.of.our.CBP.site.visits,.we.observed.antibiotic.MCM.stored.alongside. antiviral.MCM..CBP.MCM.monitoring.relies.on.the.selfreported.inventories,. which.do.not.contain.storage.conditions.at.field.offices..This.monitoring.is. insufficient.to.ensure.prepositioned.antibiotic.MCM.are.being.stored.according. to.requirements..As.a.result,.the.usability.of.its.stockpile.of.more.than.88,000. courses.of.antibiotic.MCM,.valued.at.$5.million,.may.be.questionable... . OHA.has.agreements.in.place.with.most.coPLink
Figure
Recommendation.#5:... .. Have.components.implement.inventory.control.procedures.for.prepositioned. pandemic.PPE.to.monitor.stockpiles,.track.shipments,.and.ensure.compliance. with.departmental.guidance.. . We.recommend.the.DHS.MCM.Working.Group.and.OHA:. . Recommendation.#6:... . Determine.requirements.of.antiviral.MCM.for.the.Department.to.maintain. critical.operations.during.a.pandemic... . We.recommend.OHA:. . Recommendation.#7:... . Create.an.antiviral.MCM.Acquisition.Management.Plan.to.include:.. a) aRecommendation.#5:... .. Have.components.implement.inventory.control.procedures.for.prepositioned. pandemic.PPE.to.monitor.stockpiles,.track.shipments,.and.ensure.compliance. with.departmental.guidance.. . We.recommend.the.DHS.MCM.Working.Group.and.OHA:. . Recommendation.#6:... . Determine.requirements.of.antiviral.MCM.for.the.Department.to.maintain. critical.operations.during.a.pandemic... . We.recommend.OHA:. . Recommendation.#7:... . Create.an.antiviral.MCM.Acquisition.Management.Plan.to.include:.. a) a
SectPLink
Figure
Recommendation.#11:... . Collaborate.with.CBP.to.determine.the.safety.and.effectiveness.of.the.antibiotic. MCM.that.have.been.stored.alongside.their.antivirals... . Management.Comments.and.OIG.Analysis. . In.its.response.to.our.draft.report,.the.Department.concurred.with.the.intent.of. all.11.recommendations..It.identified.issues.it.believed.were.not.appropriately. characterized,.which.are.addressed.below..The.Department.expressed.concern. that.we.overemphasized.the.role.of.PPE.and.MCM,.which.they.view.as.tRecommendation.#11:... . Collaborate.with.CBP.to.determine.the.safety.and.effectiveness.of.the.antibiotic. MCM.that.have.been.stored.alongside.their.antivirals... . Management.Comments.and.OIG.Analysis. . In.its.response.to.our.draft.report,.the.Department.concurred.with.the.intent.of. all.11.recommendations..It.identified.issues.it.believed.were.not.appropriately. characterized,.which.are.addressed.below..The.Department.expressed.concern. that.we.overemphasized.the.role.of.PPE.and.MCM,.which.they.view.as.t
SectPLink
Figuretask..The.audit.found.that.DHS.and.components.do.not.know.where.PPE.is. located,.how.much.it.has,.and.the.usability.of.the.stockpiles.that.exist..Although. DHS.has.identified.PPE.and.MCM.as.the.least.effective.controls,.it.has.invested. millions.in.purchasing.these.resources.without.determining.the.quantities. needed.for.a.pandemic.response..According.to.DHS,.it.is.not.required.under.the. Occupational.Safety.and.Health.Administration...to.provide.PPE.supplies.to.its. personnel;.however,.it.has.elected.to.doPLink
Figureestablishes.the.framework.for.the.development.of.a.Department.pandemic. logistics.support.plan.for.pandemic.PPE..A.Pandemic.Logistics.Integration.Team. (iTeam).has.also.been.established.with.representation.from.DHS.Components. and.pandemic.PPE.requirements.have.been.drafted..Estimated.Completion.Date. (ECD):.September.30,.2014.. . OIG.Analysis:.The.Departments.response.to.this.recommendation.addresses.the. intent.of.the.recommendation..This.recommendation.is.resolved.and.will.remain. open.until.the.DepartmPLink
FigureRecommendation.#5:.Concur..This.is.in.the.planning.stage..A.policy.and. standards.workgroup.is.being.established.under.the.Pandemic.Logistics.iTeam.to. establish.PPE.control.procedures.and.standards..ECD:.September.30,.2014.. . OIG.Analysis:.The.Departments.response.to.this.recommendation.addresses.the. intent.of.the.recommendation..This.recommendation.is.resolved.and.will.remain. open.until.the.Department.provides.a.copy.of.the.workgroups.plan. implementing.inventory.control.procedures.for.prepositionedRecommendation.#5:.Concur..This.is.in.the.planning.stage..A.policy.and. standards.workgroup.is.being.established.under.the.Pandemic.Logistics.iTeam.to. establish.PPE.control.procedures.and.standards..ECD:.September.30,.2014.. . OIG.Analysis:.The.Departments.response.to.this.recommendation.addresses.the. intent.of.the.recommendation..This.recommendation.is.resolved.and.will.remain. open.until.the.Department.provides.a.copy.of.the.workgroups.plan. implementing.inventory.control.procedures.for.prepositioned
PLink
FigureManual,.the.DHS.Office.of.Procurement.Operations.contracting.officer's. representative.guidebook.and.componentspecific.procedures.addressing. contracting.officers.representative.duties.and.responsibilities.are.adequate.for. ensuring.proper.contract.oversight,.but.these.procedures.were.not.followed. consistently.in.the.administration.of.MCM.support.service.contracts..Since.OIG. identified.findings.concerning.inadequate.oversight,.OHA.has.taken.steps.to. ensure.that.highly.qualified.contracting.officer's.rePLink
Figurefield.locations.has.been.returned..There.are.still.1,071.courses.of.antiviral.MCM. sent.from.the.field.that.have.not.been.returned.to.the.HHS.facility..There.were. five.locations.that.did.not.return.any.of.the.antiviral.MCM.they.were.shipped,. and.there.were.eight.locations.that.did.not.return.the.full.amount.of.the.MCM. that.was.originally.shipped..This.recommendation.cannot.be.closed.until.OHA. locates.the.remaining.courses.or.documents.that.those.courses.have.been.lost. and.provides.documentation.in.eithPLink
Figure
Appendix.A.. Objectives,.Scope,.and.Methodology........ . The.DHS.OIG.was.established.by.the.Homeland.Security.Act.of.2002.(Public.Law.107 296).by.amendment.to.the.Inspector.General.Act.of.1978..This.is.one.of.a.series.of.audit,. inspection,.and.special.reports.prepared.as.part.of.our.oversight.responsibilities.to. promote.economy,.efficiency,.and.effectiveness.within.the.Department.. . We.conducted.an.audit.of.the.DHS.pandemic.preparedness.efforts.to.determine.if.DHS. effectively.manages.its.pandemic.prepAppendix.A.. Objectives,.Scope,.and.Methodology........ . The.DHS.OIG.was.established.by.the.Homeland.Security.Act.of.2002.(Public.Law.107 296).by.amendment.to.the.Inspector.General.Act.of.1978..This.is.one.of.a.series.of.audit,. inspection,.and.special.reports.prepared.as.part.of.our.oversight.responsibilities.to. promote.economy,.efficiency,.and.effectiveness.within.the.Department.. . We.conducted.an.audit.of.the.DHS.pandemic.preparedness.efforts.to.determine.if.DHS. effectively.manages.its.pandemic.prepPLink
Figureand.delineated.the.roles.and.responsibilities.between.DHS.offices..See.table.4.for.the. offices.we.visited.that.possessed.PPE.. . Table.4..Personal.Protective.Equipment.Site.Visits. Component. Component. Component. Number.of.Locations.
FEMA. FEMA. 4.
ICE. ICE. 5.
NPPD. NPPD. 2.
TSA. TSA. 5.
USSS. USSS. 3.
Source:.OIG. . To.determine.if.DHS.effectively.manages.its.pandemic.preparedness.supply.of.antiviral. MCM,.we.determined.whether.OHA.created.plans.for.its.acquisition.and.inventory. management..We.evaluated.the.guidance.OHA.issued.on.appropriate.storage.and. distribution.of.antiviral.MCM..We.assessed.OHA.oversight.of.its.antiviral.MCM.stockpile. by.determining.how.OHA.tracked.and.monitored.antiviral.MCM,.conducted.inventories. of.the.antiviral.MCM.stockpiles,.and.ensured.performance.of.COR.responsibilities..We. assessedComponent. Component. Component. Number.of.Locations.
CBP. CBP. 14.
FEMA. FEMA. 1.
ICE. ICE. 12.
NPPD. NPPD. 1.
TSA. TSA. 1.
USCG. USCG. 1.
USCIS. USCIS. 1.
USSS. USSS. 2.
.........Source:.OIG. . We.relied.on.components.and.DHS.headquarters.to.provide.us.counts.of.their.pandemic. PPE.and.antiviral.MCM.stockpiles,.which.were.not.complete.and.accurate..We. www.oig.dhs.gov. 22. OIG14129. PLink
Figureperformed.physical.verification.by.sampling.inventories.at.the.headquarters.level,.as. well.as.at.component.headquarters.and.field.office.locations.selected..We.also. compared.original.order.and.shipment.information.for.antiviral.MCM.with.OHA.and. component.inventories.and.were.able.to.identify.quantities.that.were.in.undocumented. locations.or.missing..The.evidence.from.testing.the.inventories.through.our.physical. verification.during.site.visits.and.analysis.of.data.was.sufficient.and.adequate.for.the. puPLink
Figure
Appendix.B.. Appendix.B.. Management.Comments.to.the.Draft.Report.. . . . . . . . . 24. OIG14129. 24. OIG14129. www.oig.dhs.gov.
25. OIG14129. www.oig.dhs.gov.
Figure. FigureFigure26. OIG14129. 26. OIG14129. 26. OIG14129. www.oig.dhs.gov.
27. OIG14129. www.oig.dhs.gov.
28. OIG14129. www.oig.dhs.gov.
Figure. Figure. FigureFigure29. OIG14129. 29. OIG14129. 29. OIG14129. www.oig.dhs.gov.
30. OIG14129. www.oig.dhs.gov.
31. OIG14129. www.oig.dhs.gov.
Figure. . Figure. . Figure
Appendix.C. Major.Contributors.to.This.Report. . Brooke.Bebow,.Director. Stephanie.Christian,.Audit.Manager. Gary.Crownover,.Program.Analyst. Ruth.Gonzalez,.Program.Analyst. Matthew.Noll,.Program.Analyst. Mark.A..Phillips,.Auditor. Melissa.Prunchak,.Program.Analyst. Kevin.Dolloson,.Communications.Analyst. Priscilla.Cast,.Referencer.. . . . www.oig.dhs.gov. 32. OIG14129. Appendix.C. Major.Contributors.to.This.Report. . Brooke.Bebow,.Director. Stephanie.Christian,.Audit.Manager. Gary.Crownover,.Program.Analyst. Ruth.Gonzalez,.Program.Analyst. Matthew.Noll,.Program.Analyst. Mark.A..Phillips,.Auditor. Melissa.Prunchak,.Program.Analyst. Kevin.Dolloson,.Communications.Analyst. Priscilla.Cast,.Referencer.. . . . www.oig.dhs.gov. 32. OIG14129. PLink
Figure
Appendix.D.. Report.Distribution. . Department.of.Homeland.Security...... . Secretary.. Deputy.Secretary. Chief.of.Staff.... Deputy.Chief.of.Staff. General.Counsel. Executive.Secretary.. Director,.GAO/OIG.Liaison.Office. Assistant.Secretary.for.Office.of.Policy. Assistant.Secretary.for.Office.of.Public.Affairs. Assistant.Secretary.for.Office.of.Legislative.Affairs. Chief.Privacy.Officer. . Office.of.Management.and.Budget.... . Chief,.Homeland.Security.Branch... DHS.OIG.Budget.Examiner. . Congress.... . CongAppendix.D.. Report.Distribution. . Department.of.Homeland.Security...... . Secretary.. Deputy.Secretary. Chief.of.Staff.... Deputy.Chief.of.Staff. General.Counsel. Executive.Secretary.. Director,.GAO/OIG.Liaison.Office. Assistant.Secretary.for.Office.of.Policy. Assistant.Secretary.for.Office.of.Public.Affairs. Assistant.Secretary.for.Office.of.Legislative.Affairs. Chief.Privacy.Officer. . Office.of.Management.and.Budget.... . Chief,.Homeland.Security.Branch... DHS.OIG.Budget.Examiner. . Congress.... . CongPLink
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