department of homeland security 2iÀfh ri ,qvshfwru … · medical countermeasures) to reduce...

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

August 26, 2014

OFFICE OF INSPECTOR GENERAL


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

www.oig.dhs.gov OIG-14-129

http:www.oig.dhs.gov



MCM medicalcountermeasures NCR NationalCapitalRegion NPPD NationalProtectionandProgramsDirectorate OHA OfficeofHealthAffairs OIG OfficeofInspectorGeneral PPE personalprotectiveequipment SLEP ShelfLifeExtensionProgram TSA TransportationSecurityAdministration USCG UnitedStatesCoastGuard USCIS U.S.CitizenshipandImmigrationServices USSS UnitedStatesSecretService

www.oig.dhs.gov OIG-14-129

http:www.oig.dhs.gov



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.

www.oig.dhs.gov 1 OIG14129

www.oig.dhs.gov



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


www.oig.dhs.gov



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


www.oig.dhs.gov



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.


www.oig.dhs.gov



Source:OIGphoto Oneof432palletsofcoverallsuitsattheDHSNCRPPEstockpile.

x TheDepartmenthasareportedinventoryofapproximately16million

surgicalmaskswithoutdemonstratinganeedforthatquantityofmasks.

AnaisleoftheDHSNCRPPEstockpilecontainingnitrilegloves,surgicalmasks, respirators,andcoverallsuits.

TheDepartmentalsodidnotdevelopalternativeuseorrotationplansfor headquartersandcomponentPPEstockpiles.TheDepartmentsentirerespirator


Source:OIGphoto

www.oig.dhs.gov



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.


www.oig.dhs.gov



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.


www.oig.dhs.gov



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.


www.oig.dhs.gov



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


www.oig.dhs.gov



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:


www.oig.dhs.gov



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


www.oig.dhs.gov



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.


www.oig.dhs.gov



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.


www.oig.dhs.gov



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.


www.oig.dhs.gov



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


www.oig.dhs.gov



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


www.oig.dhs.gov



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.


www.oig.dhs.gov



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


www.oig.dhs.gov



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


www.oig.dhs.gov



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.


www.oig.dhs.gov



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,


www.oig.dhs.gov



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


www.oig.dhs.gov



performedphysicalverificationbysamplinginventoriesattheheadquarterslevel,as wellasatcomponentheadquartersandfieldofficelocationsselected.Wealso comparedoriginalorderandshipmentinformationforantiviralMCMwithOHAand componentinventoriesandwereabletoidentifyquantitiesthatwereinundocumented locationsormissing.Theevidencefromtestingtheinventoriesthroughourphysical verificationduringsitevisitsandanalysisofdatawassufficientandadequateforthe purposesofmeetingourauditobjectiveandsupportingourauditfindings. WeconductedthisperformanceauditbetweenJuly2013andApril2014pursuanttothe InspectorGeneralActof1978,asamended,andaccordingtogenerallyaccepted governmentauditingstandards.Thosestandardsrequirethatweplanandperformthe audittoobtainsufficient,appropriateevidencetoprovideareasonablebasisforour findingsandconclusionsbaseduponourauditobjectives.Webelievethattheevidence obtainedprovidesareasonablebasisforourfindingsandconclusionsbaseduponour auditobjectives.


www.oig.dhs.gov

OFFICE OF INSPECTOR GENERAL Department of Homeland Security

AppendixB ManagementCommentstotheDraftReport


www.oig.dhs.gov



www.oig.dhs.gov



AppendixC MajorContributorstoThisReport BrookeBebow,Director StephanieChristian,AuditManager GaryCrownover,ProgramAnalyst RuthGonzalez,ProgramAnalyst MatthewNoll,ProgramAnalyst MarkA.Phillips,Auditor MelissaPrunchak,ProgramAnalyst KevinDolloson,CommunicationsAnalyst PriscillaCast,Referencer


www.oig.dhs.gov



AppendixD ReportDistribution DepartmentofHomelandSecurity Secretary DeputySecretary ChiefofStaff DeputyChiefofStaff GeneralCounsel ExecutiveSecretary Director,GAO/OIGLiaisonOffice AssistantSecretaryforOfficeofPolicy AssistantSecretaryforOfficeofPublicAffairs AssistantSecretaryforOfficeofLegislativeAffairs ChiefPrivacyOfficer OfficeofManagementandBudget Chief,HomelandSecurityBranch DHSOIGBudgetExaminer Congress CongressionalOversightandAppropriationsCommittees,asappropriate


www.oig.dhs.gov

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:


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.

OIG-14-129 OIG-14-129 www.oig.dhs.gov

OIG-14-129 www.oig.dhs.gov

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.


Figure. FigureFigure26. OIG14129. 26. OIG14129. 26. OIG14129. www.oig.dhs.gov.



Figure. Figure. FigureFigure29. OIG14129. 29. OIG14129. 29. 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

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) programPLink

PLink

PLink

department of homeland security 2iÀfh ri ,qvshfwru … · medical countermeasures) to reduce...

Documents