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1 Monitoring(the(Switch(from( topv%to%bopv%%%% Guidelines)for)Developing) National(MonitoringPlans Versiondate:25August2015 1

2 TableofContents Acronyms...3 Introduction...4 Whatarethegeneralprinciplesofthisdocument?...6 Recap Monitoringonapage Plan DevelopaMonitoringStructure TimelineofActivities SwitchValidationIndicators IdentifyHumanandFinancialResources Prepare Developdatacollectiontools Developtrainingmaterials IdentifyFacilitiesforMonitoring DevelopMicroNPlans DevelopContingencyPlans Recruitsupervisorsmonitors Trainsupervisorsmonitors PreNpositionsupervisorsmonitors Validate Monitorsvisitcoldchainstoresandservicedeliverypoints DataReportedandAggregated Developvalidationreport Follow<Up topvwithdrawal ProblemsIdentifiedduringMonitoring...23 Annexes...24 AnnexA:MonitoringtOPVDisposal...24 AnnexB:CategorizingRiskoftOPVUse...26 RiskoftOPVStoredandUsedDuringtheSwitch...26 AnnexC:ExampleForms...27 SurveyFormforIndependentMonitors topvstoragesite...27 topvwithdrawaltallysheet...28 FormforTransferoftOPVfromHealthStructurestoDisposalSite...29 topvdisposalform DisposalSites...30 topvdisposalform Supervisors

3 Acronyms AFP bopv DPT3 DSO EPI IPV NGO NIP OPV3 topv UNICEF WHO AcuteFlaccidParalysis BivalentOralPolioVaccine ThirddoseofdiphtheriaNpertussisNtetanusvaccine DistrictSurveillanceOfficer ExpandedProgrammeonImmunization InactivatedPolioVaccine NonNgovernmentalOrganization NationalImmunizationProgram.SometimesusedinterchangeablywithEPI ThirddoseofOralPolioVaccine TrivalentOralPolioVaccine UnitedNationsChildren sfund WorldHealthOrganization 3

4 Introduction TheWorldHealthAssemblyhasendorsedtheSAGErecommendationforasynchronizedswitchfromtOPVto bopvinall156opvusingcountriesandregionsduringatwoweekperiodinapril2016(april17nmay1,2016,if endorsedbysageinoctober2015).akeycomponentofasuccessfulswitchinvolveseffectivemonitoringof health facilities after the national switch date in all countries to ensure that topv is no longer available for administration. Ensuring that topv is no longer being administered or in the cold chain is a country responsibility.thisdocumentoutlinesforcountriesgpei srecommendedmonitoringstrategyforwithdrawal of all topv from cold chain storage points. The document provides step by step guidance on planning, preparing,collectingandreportingdata,andcorrectiveactionsformonitoringtheswitch(box1). Thekeyobjectivesofthemonitoringstrategyareto: 1) Conductsitevisitsatallcoldchainstoresfromthenationaltothedistrictlevels(wherethelargest quantitiesoftopvwillgenerallybestoredatthetimeoftheswitch),aswellasselectedservice deliverypoints(healthfacilities),inordertoverifyremovalofthesestocksfromthecoldchain; 2) TakecorrectiveactiontoremovetOPVstocksfromthecoldchainiffoundandmarkthesestocks fordisposal; 3) Assessperformanceoftheswitch;and 4) AssessthestatusofbOPVandIPVdistributionatmonitoredfacilities. MonitoringthewithdrawaloftOPVfromcoldchainstoresandservicepointsisaseparateprocess from the certification of containment or destruction of poliovirus at laboratories and vaccine productionfacilities. Thedestructionandcontainmentofpoliovirusatlaboratoriesandvaccineproductionfacilitiesdescribedinthe Global Action Plan to Minimize Poliovirus Facility7associated Risk after Type7specific Eradication of Wild Polioviruses and Sequential Cessation of Routine OPV Use (known as GAPNIII) is a separate process from the withdrawal of topv. As a result, the requirements for the certification of the containment or destruction of poliovirusatlaboratoriesandvaccineproductionfacilitiesdonotapplytothemonitoringoftopvwithdrawal. However, switch monitoring activities may occur simultaneously with efforts to certify containment or destructionofpoliovirusatlaboratoriesandvaccineproductionfacilitiesandmayinvolvethesamekeystaff. 4

5 ObjectivesofSwitchMonitoring BOX1:MONITORINGOVERVIEW EnsureandvalidatewithdrawaloftOPV(primary) AssessintroductionofbOPV(secondary) AssessdistributionofIPV(secondary) IndependentMonitoringPeriod:completedwithin2weeksofthenationalswitchdateinApril2016 Planningandpreparingforthemonitoring: a. Conveneacommittee(e.g.,NationalSwitchValidationCommittee)thatis independentfromswitchimplementationactivitiestoprovidemonitoringoversight andvalidateswitch b. DevelopTORsfortheSwitchMonitors c. Developdatacollectiontoolsandreportingmechanismfortheindependent monitoring d. HireandtraintheSwitchMonitors Monitoringsiteselection: a. IndependentlymonitorALLfacilitiesdowntothedistrictlevel b. IndependentlymonitoraSAMPLEoftheservicepoints(healthcarefacilities)usinga risknbased,purposivestrategydescribedinsection3. Corrective action: All monitoring efforts should be linked with corrective action (in other words, removaloftopvfromthecoldchain). Reporting:MonitorsshouldreportdatatotheNationalSwitchValidationCommittee.TheNational SwitchValidationCommitteeshouldreportthevalidationresultstotheWorldHealthOrganization withintwoweeksofthenationalswitchdate. Additional monitoring: Supportive supervision visits can supplement independent monitoring of healthfacilities toprovideadditionalverification oftheadequatewithdrawaloftopvfromthecold chain.theseadditionalmonitoringactivitiesfortopvwithdrawalshouldbecompletedassoonas possible, while topv disposal should occur within 3 months of the switch; these activities can be conducted throughregularactivitiesofnationalimmunizationprograms.note:thedatacollected throughsupportivesupervisionvisitsarenotpartofthevalidationprocessthatshouldoccurwithin 2weeksofthenationalswitchdate. 5

6 Whatarethegeneralprinciplesofthisdocument? Whatisincludedinthisdocument? Thisdocumentprovidesaframeworkforcountriestoconsiderwhendevelopingandimplementingtheirplans formonitoringtheswitch.thisdocumentfocusesontheminimalrecommendationsformonitoringthe withdrawaloftopv,theintroductionofbopv,andthedistributionofipv(healthfacilitiesshouldhaveboth bopvandipvstocksonthenationalswitchday)duringthetwoweeksfollowingtheswitch.countriescango beyondtheserecommendationsbyaddingmoreactivitiesandindicatorsthatarespecifictotheirnational ImmunizationProgramgoals. Thisdocumentcanalsobeadaptedtoafieldguidefortrainingbasedonlocalneeds. Whoisthetargetaudience? MembersoftheNationalSwitchValidationCommittee,countrypolicymakers,programmanagers,logisticians, andconsultantswhoareinvolvedintheplanning,preparation,andimplementationoftheswitcharethe primarytargetaudience.thisdocumentexplainshowtoestablishasystemthatwillprovidetimelyanduseful dataforvalidatingtheswitch. 6

7 7 Recap Monitoringonapage Thetablebelowsummarizesthekeyactivitiesofthemonitoringactivities. IndependentMonitoringPeriod Plan BySeptember2015 Developmonitoringstructure Determinetimelineofactivities Developindicatorsforswitchvalidation Identifyhumanandfinancialresourcesneeded Prepare October2015 February2016 Developquestionnairesanddatacollectiontools Developtrainingmaterials Createrosteroffacilitiestomonitor Recruitsupervisorsandmonitors Trainsupervisorsandmonitors DevelopmicroNplans Developcontingencyplans National SwitchDay Adaychosenduringthelast2weeksofApril2016 (DatetobefinalizedbySAGEinOctober2015) Validate April2016<DuringthetwoweeksaftertheNationalSwitchDay Monitorsvisitcoldchainstoresandservicedeliverypoints Datareportedandaggregated Developvalidationreport Follow<up Monitoring Period Follow<Up 2<3monthsongoingaftertheswitch AdditionalmonitoringoftOPVwithdrawalasneeded Correctingidentifiedproblems MonitoringtOPVdisposalasdesired

8 1. Plan Plan Prepare Validate FollowNUp Developmonitoringstructure Determinetimelineofactivities Developindicatorsforswitchvalidation Identifyhumanandfinancialresourcesneeded 1.1. DevelopaMonitoringStructure Identifythestaffthatwillbeincludedinmonitoringactivitiesateachlevelofthehealthsystem.Reviewthe descriptions of each of the key players for the monitoring structure below and determine which National ImmunizationProgramstaffwillbeused,ifotherhealthworkerswillbeneeded,andifpartnerorganizations shouldalsobeincludedinthemonitoringactivities. National Switch Validation Committee: A body independent from switch implementation activities that is authorizedbythegovernmenttovalidatetheswitchandcertifythattopvhasbeenwithdrawnfromthecold chain.acountry snationalcertificationcommitteecouldbeusedforthispurposeifitisactive,ormembersof thenationalswitchvalidationcommitteecouldbedrawnfromthenationalcertificationcommitteeorother authoritiesnotpartoftheswitchmanagementcommittee. Monitoring Coordinators or Supervisors: Staff independent from switch implementation activities that are responsibleformanagingmonitorsandcollectingandrespondingtodata.coordinatorsandsupervisors: Identifycoldchainstorestobevisited Selectservicedeliverypointstobevisited Developandprovidetrainingmaterial Facilitatelogisticsforthetrainingandtransportationofindependentmonitors. Facilitatereproductionanddistributionofquestionnairesandguidelinesformonitors. DevelopamicroNplanforindependentmonitorsandtheirsupervisors.Theplanwillbeaccompaniedby amapandwillassigneachmonitortoareastobemonitoredeachday WHOorUNICEF CountryOfficesmay provide coordinators to manage switch monitoring. In larger countries, separateswitchmonitoringsupervisorsmaybeneededforindividualstates,provinces,ordistricts.however, 8

9 suchstateandlocalswitchmonitoringsupervisorsshouldultimatelyreporttoanationalswitchcoordinatorwho willworkwiththenationalswitchvalidationcommittee. Independent Monitors: Persons who will assess the cold chain storage sites and service points with a questionnaire.thesepersonsshouldnotbedirectlyinvolvedwiththeorganizationsimplementingtheswitch itselfbecausetheirindependencefromthoseorganizationsisimportantforallowingthemtoprovidehonest assessments. SwitchManagementCommittee(notpartofmonitoringstructure): Plans,manages,andoverseesallactivitiesrelatingtotheswitch,includingidentificationofthesitesto bemonitoredattheregionalandnationallevels Receivesupdatesonmonitoringactivitiesandfindings TakesappropriateprogrammaticactionincaselargeamountsoftOPVarefoundatcoldchainstoresor servicepointsand/oripvandbopvisnotavailable. Working groups used during SIAs could potentially serve as regional or national Switch Management Committees. Box2:Whatdoes independent mean? Formonitoringtheswitch, independent referstotheuseofcoordinators/supervisorsand monitorswhoarenotdirectlyinvolvedwithexecutingtheswitchandarethereforemore likelytoprovideunbiasedassessmentsoftheswitch simplementation.theseindividuals maycomefromthehealthsectorandmaybeemployedbythegovernmentorcomefrom localngosoruniversities.however,iftheseindividualsweredirectlyinvolvedwithswitch executionorplanningactivitiesinagivenregionordistrict,theyshouldnotparticipatein monitoringactivitiesintheseareas,butcanparticipateinotherregionsordistrictswhere theyhavenotbeendirectlyinvolvedwithexecutingtheswitch.independentcoordinators andmonitorsmaybefromothercountries,butitisnotnecessarytohaveinternational monitorsforswitchvalidation. Overall,individualswhocanprovideunbiased,credibleassessmentsofhowwelltheswitch hasbeenperformedarewellsuitedtobebeinginvolvedwithswitchmonitoring. 9

10 1.2. TimelineofActivities Determinethemajoractivitiestoscheduleforswitchmonitoring.Theexactactivitiesandtheirtimingmayvary bycountry. April2016Calendar Sun Mon Tue Wed Thu Fri Sat StopuseoftOPVandremovetOPVfromthecold National SwitchDay chain.beginuseofbopvanddisposaloftopv TwoNweekwindowformonitoringcoldchain stores,collectingandreportingvalidationdata National ValidationDay CompletedisposaloftOPVassoonaspossible,butno laterthan3monthsafternationalswitchday Pre<SwitchActivities: IdentifymonitorsN1N2monthsbeforeswitch NotifymonitorsofswitchactivitiesN1monthbeforeswitch TrainmonitorsN2N4weeksbeforeswitch DevelopmonitoringplansforwhichcoldchainstoresorservicepointswillbevisitedbyeachmonitorN 1N2weeksbeforeswitch DistributedatacollectiontoolstomonitorsN1weekbeforeswitch 2weekSwitchValidationActivities: Monitorscollectinformationonswitchperformanceduringthe2weeksaftertheNationalSwitchDay MonitorswithdrawtOPViffoundatanysite MonitorsandtheirsupervisorsreportinformationtotheNationalSwitchValidationCommitteewithin3 daysoftheassessmentandnolaterthan2weeksafterthenationalswitchday DataaggregatedbyNationalSwitchValidationCommitteeandreportedtotheSwitchManagement Committee.NContinuousprocess,butshouldideallybecompletedwithin2weeksoftheNational SwitchDay Post<SwitchActivities: Aftervalidation,providesupportivesupervisionfor2N3monthstoincreaseconfidencethattOPVhas beenfullywithdrawnfromallservicepoints DisposeofalltOPVNAssoonaspossible,butnolaterthan3monthsaftertheNationalSwitchDay 1.3. SwitchValidationIndicators NationalImmunizationProgramandhealthsectorstaff,includingtheSwitchManagementCommittee,willneed todeterminethecoreindicatorstovalidatethattheswitchhasoccurredateachlevelofthecoldchain.the 10

11 followingindicatorsshouldbeconsideredtheminimumneededforswitchvalidation,withtheindicatorsrelated totopvbeingthemostimportant: ThenumberandpercentofcoldchainstoresandservicepointswheretOPVispresent AmongcoldchainstoresandservicepointswithtOPV,thenumberandpercentofsitesatwhichatleast onetopvvialwasfoundinsidethecoldchain AmongcoldchainstoresandservicepointswithtOPV,thenumberandpercentofsitesatwhichatleast onevialoftopvwasfoundoutsidethecoldchain ThenumberandpercentofcoldchainstoresandservicepointswithbOPV ThenumberandpercentofcoldchainstoresandservicepointswithIPV SeeAnnexCforanexampleofadatacollectionformthatcanbeusedtocollecttheinformationneededfor theseminimumindicatorsfromcoldchainstoresandservicepoints. AdditionalindicatorscanbeincludediftheNationalImmunizationProgramprogramisinterestedincollecting othertypesofinformation.datacollectionformsandthemonitoringstructurecanbeadaptedtotheneedsof thecountrynationalimmunizationprogramprogramandtheircurrentmanagementstructure IdentifyHumanandFinancialResources Basedontheplannedactivities,identifythehumanresourcesthatwillbeneededwithanyotherresourcessuch astransportation,supplies,datareportingtools,etc.thebudgettoolthatwasprovidedtothenationalswitch ManagementCommitteecanbeusedforestimations. 11

12 2. Prepare Plan Prepare Validate FollowNUp Developquestionnairesandcollectiontools Developtrainingmaterials Createrosteroffacilitiestomonitor DevelopmicroNplans Developcontingencyplans Recruitsupervisorsandmonitors Trainsupervisorsandmonitors 2.1. Developdatacollectiontools Monitorswillneedtousequestionnaires(foranexample,seeNote:Theformsincludedinthisguideincludethecore indicatorsthatareneededtovalidatetheswitch.additionalindicatorscanbeincludedifswitchmonitorsaretaskedwith collectinginformationonotherimmunizationactivities. 12

13 AnnexC:ExampleForms SurveyFormforIndependentMonitors topvstoragesite)inordertocapturealloftheinformationneededto validatetheswitch.dependingontherigorofthevalidationprocess,theformscanvaryinlengthanddepth. Theformsshouldincludeenoughquestionstocapturetheinformationneededfortheminimumindicatorsfor validatingtheswitch. TheformscanalsoincludeinstructionsforwhatmonitorsshoulddoiftheyfindtOPVatacoldchainstoreor servicepoint.forsomecountries,smsorotherelectronicmechanismscanbeusedtocollecttheinformation neededforswitchvalidation. Collection tools can be a simple paper based form that compiles the required information to compute the minimumindicatorsrequired(foranexampleseeannexc:topvwithdrawaltallysheet).foracompletereport on the switch, the collection tool can also be an Excel file that captures the all data issued from the questionnaire. Table1.Datafieldscollectedbytools Simplecollectiontool Completecollectiontool Facilitytype/name: Dateofthevisit NumberofvialsoftOPVfound topvkeptinoroutsideofthecoldchain: o Inthecoldchain o Outsideofthecoldchain bopvpresentatthefacility: o Yes o No IPVpresentatthefacility: o Yes o No Facilitytype/name: o National(name) o Regional(name) o District(name) o ServicePoint(name) Dateofthevisit Dateoftheswitchonsite topvpresentatthefacility: o Yes o No NumberofvialsoftOPVfound topvkeptinoroutsideofthecoldchain: o Inthecoldchain o Outsideofthecoldchain PlansfortOPV: o DestroyitonNsite o Keepitoutofthecoldchain o TransportittoatOPVdisposalsite o WaitforsomeonetopickupthetOPV Reasons for not disposing or transferring the topv o Unaware of need to dispose of or transfertopv o Didnotreceiveclearguidelines o Needadditionalassistance o Didnothavetimeyettodoit. DestinationfortOPVwithdrawn bopvpresentatthefacility: 13

14 Simplecollectiontool 2.2. Developtrainingmaterials Completecollectiontool o Yes o No Staff started to administer the bopv or distributeitforadministration o Yes o No,butplantostartadministeringor distributingthevaccinesoon o No, and have no plans to start administering or distributing the vaccine IPVpresentatthefacility: o Yes o No Staff started to administer the IPV or distributeitforadministration o Yes o No,butplantostartadministeringor distributingthevaccinesoon o No, and have no plans to start administering or distributing the vaccine Thetrainingmaterialshouldcoverthefollowingtopics: Informationabouttheswitch Purposeofthemonitoringactivity,itsobjectivesandtheroleofindependentmonitors Timelineoftheindependentmonitoring Descriptionofthebehaviourandprofileofanindependentmonitorandhis/herinteractionwithhealth workers Descriptionofthetasksoftheindependentmonitor Reviewoftools(forms)used:exerciseandexamples Addressingconcerns,previousmistakesandhandlingmisleadinginformation DevelopingindependentmonitoringmicroNplanandhowtofollowit PlansfortOPVdisposalactivities IdentifyFacilitiesforMonitoring ThegoalhereistoidentifywhichfacilitiesinthecoldchainneedtobevisitedfortheefficientvalidationoftOPV withdrawal and bopv introduction. The recommended risknbased purposive (in other words, nonnrandom) sampling monitoring strategy is intended to rapidly identify the cold chain stores and service points possibly holdingthelargeststocksoftopvaftertheswitchandfacilitateimmediatecorrectiveaction. Steps: 14

15 1. GeneratealineNlistofcoldchainstoresthatstocktOPVfromthenationaltothedistrictlevel(inother words,allnational,regional,anddistrictcoldchainstores)alongwiththeirlastknowntopvstocklevels (ifpossible).monitorsshouldvisitallofthesestores. 2. GeneratealineNlistoftheservicepointsthatcanstoretOPVinaworkingrefrigeratororfreezerformore than 1 night. The monitors, based on standardized criteria set by the national level, should visit a sampleoftheseservicepoints.select10%oftheservicepointswiththehighestpopulation.prioritize facilitiesthathave: topvreceivedjustbeforetheswitch AhistoryofnonNcompliancewithimmunizationprogrampolicies DPT3coverage<80% Managementissues Otherhighriskcharacteristics(seeAnnexB) Thisstrategywillprovidecompleteinformationonallcoldchainstoresfromthenationaltothedistrictleveland willprovideinformationonmanyservicepoints.thesedatawillprovidereasonableassuranceofasuccessful nationalswitchwithintwoweeksofthenationalswitchdate. Resultsfromthesampledservicepointswillnotbegeneralizabletoallservicepoints.Therefore,countriesare encouragedtoensuretopvwithdrawalfromallservicepointsthroughsupportivesupervisionduring the2n3 monthsthatfollowthecompletionofindependentmonitoring. Figure1belowfurtherillustrateshowthepurposivesamplingshouldbeconductedattheservicepoint(health facility)level. 15

16 2.4. DevelopMicroNPlans Usingthelistofstoresthatneedtobemonitored(allstoresfromthenationaltothedistrictlevel)aswellasthe listofservicepointsthatneedtobevisitedbasedonthepurposivesamplingstrategy;micronplansshouldbe developedforeachindependentmonitor(ormonitoringteam,ifdistrictorregionislarge).thesemicronplans shouldincludethefollowing: ScheduleofstorestobevisitedoverthemonitoringperiodaftertheNationalSwitchDay Mechanismsandproceduresforreportingtosupervisors ProtocolformopNupwithstoresiftheycannotbevisitedonschedule PoliciesforwhattodoiftOPVisfound Contactinformationforallstorestobevisited Contactdetailsofcoordinatorsandsupervisors(tobeaddedwhenrecruited). 16

17 Next, determine the modes of communication and data flow for each of the key participants. Consider the following: Isthereamechanismalreadyinplaceforinformationsharing? Howfrequentlywillinformationbesharedbetweenswitchmonitoringparticipants?Whatinformation? Isthemechanismusedtoshareinformationupthemonitoringsystem(forexample,frommonitorsto supervisorsorcoordinators)aswellasdownthemonitoringsystem(forexample,fromthenational SwitchValidationCommitteetothecoordinators)? Howwillinformationbesharedwiththeindividualsimplementingtheswitch? Howquicklycaninformationbepassedfromoneparticipanttothenext? 2.5. DevelopContingencyPlans Considerdevelopingcontingencyplansforswitchmonitoring.Forexample: Whatwillbedoneifnotallofthecoldchainstoresandtheselectedservicepointsarevisitedduringthe monitoringperiodfollowingthenationalswitchday? Whatwillbedoneifthenumberofservicepointsthatneedvisitsincreasesbecausemanyoftheinitial servicepointvisitsindicatethattherehavebeenproblemswithtopvwithdrawal? ManyproblemscanbedealtwithduringthemopNupmonitoringperiod,butsomeproblemsmayneedtobe dealtwithduringtheindependentmonitoringphase Recruitsupervisorsmonitors Itisrecommendedthatonesupervisorberecruitedperregion.Theindependentmonitorsshouldnotbedirectly involved with implementing the switch itself so that they can provide unbiased assessments of the implementation of the switch. InNcountry partner organizations, such as nonngovernmental organizations, universities,orprofessionalgroups,maybeabletoassistwithprovidingpeopleorotherresources. Mainresponsibilitiesforthesupervisors: Providetheindependentmonitorswithlistsofsitestobeassessed Providetrainingtoindependentmonitors Ensurethattheindependentmonitorsareabletotraveltotheirassignedsitesandmovefromoneto anotherasrequired. Visitindependentmonitorsinthefieldtocheckonthequalityofwork. Observe performances of independent monitors and provide adequate feedback with corrective measuresasneeded. Beavailableforindependentmonitorstocontactbyphoneatalltimesduringmonitoringperiod. Arrange periodic debriefings with independent monitors, including at the end of the independent monitors periodofwork Collecttheformsfromindependentmonitors,reviewqualityandreliabilityofdatacollectionprocess, andcorrectifrequired Compiledataandanalysethedata Sendsummariesoffindingstoindividualscoordinatingtheimplementationoftheswitchintheareaof thesupervisors responsibility. 17

18 InvestigatetoidentifyreasonsforleftovertOPVand/ornointroductionofbOPVand/orIPV. AdviseswitchimplementationstaffoncorrectiveactionsincasetOPVisfoundatcoldchainstoresor servicepointsand/oripvandbopvisnotavailable. Providethemonitoringcoordinatorwithanyinformationneededtowritethereportforvalidation. FacilitatethepaymentoftheIndependentmonitors MainresponsibilitiesfortheIndependentSwitchMonitors: Carryoutthefieldmonitoringactivity Completethemonitoringformsprovided. Submitthecompletedformsdailytothesupervisors ReporttosupervisordetailsaboutleftoveroftOPVand/ornointroductionofbOPVand/orIPV. Recordanyadditionalobservationthatmaybehelpfulinidentifyingproblemswiththeimmunization program Remove any topv found on visits to cold chain stores and service points unless the amount of topv found is so large as to make this impractical. Hand over topv removed to supervisor or deliver to disposalsiteasspecifiedinthemicronplan. Suggestedcriteriaforselectingindependentmonitors Education: o Completedatleastahighschoolorsecondaryschoollevel(BEPC) o Haveagoodmasteryoftheofficiallanguageofthecountry o Beabletospeakthelocallanguageandbeabletooperateinthelocalculture. Behaviour: o Behaveinlinewiththecustomsofthecommunityvisited o Observebasicpolitenessrules:greetings,givingreasonsforthevisit o Havetheabilitytoworkinateamandunderpressure o Know how to reformulate questions to make them more understandable without losing the substance Experience: o Somefamiliaritywithlogisticsorthehealthcaresystem o More experience will likely be needed for inspecting larger cold chain store facilities such as nationalorregionalcoldchainstores Culturalaspects: o Befamiliarwiththecountry sculturesandthelanguagesandabletointerviewcoldchainand healthfacilitystaff o Same ethnic and religious group as members of communities who may not cooperate with membersofdifferentethnicorreligiousgroups 2.7. Trainsupervisorsmonitors Thetrainingshouldbeconductedimmediatelypriortotheswitchinordertocompletetheentiremonitoring activitywithintheshortesttimepossible. Trainers ThenationalindependentmonitoringcoordinatorwiththeassistanceofWHO/UNICEFstaffshoulddo aninitialtrainingoftrainers. 18

19 Following the national training of trainers, local training should be conducted by trained persons includingconsultantswhereneeded. Organizationoftraining Amaximumof30traineesatonetimeisdesirable.Themethodshouldfocusonpracticaloperational issueswithexercisesandrolenplaytoensuretheparticipationandinvolvementoftheparticipants. Supervisorsmustattendthetrainingandhaveadditionalsessionstotrainthemonqualitysupervision andtohighlighttheirrolesandresponsibilitiesduringtheactivity. Themonitorsshouldbetrainedon: Rolesandresponsibilities UsingmicroNplans VerifyingtheabsenceoftOPVatselectedfacilities RemovaloftOPVifanyresidualtOPVisfoundinfacilities Completingrecordingformstoavoiddataqualityproblems Communicatingandreportingoutcomeoffacilityvisitstosupervisor Ifappropriate,confirmingthatthereisaplanfortOPVdisposalateachfacility,ifdisposalhasnotbeen completed 2.8. PreNpositionsupervisorsmonitors Supervisorsandmonitorsmusttraveltotheirrespectivelocationsaccordingtotheplanandbereadytostart theindependentmonitoringintheirdesignatedsitesonthenationalswitchday. Suppliesrequiredforindependentmonitorsandsupervisors: IDcardsandreferenceletter; Phonecredit; Questionnaires; Guidelines; PlasticbagandstickersincasetOPVisfound; Notepad; Pens. 19

20 3. Validate Plan Prepare Validate FollowNUp Monitorsvisitcoldchainstores Datareportedandaggregated Developvalidationreport Thevalidationprocessshouldincludealltasksfromthestartofmonitoringactivityuntilthevalidationreportis developed,approvedbythenationalswitchvalidationcommittee,senttotheministryofhealth,andreported tothewhocountryoffice.thefigurebelowshowsatimelinewithmilestones,whichcanvaryfromcountryto countrywiththegoalofthevalidationprocessbeingcompletedwithintwoweeksofthenationalswitchday. Figure2:Exampletimelinetovalidatetheswitch Begin Monitoring SwitchDayNDay0 CompleteData Collec_on Day5 CompileData andshare Report Day11 Switch Validated 3.1. Monitorsvisitcoldchainstoresandservicedeliverypoints Day14 Beginning on the day after the National Switch Day, all independent monitors should systematically monitor vaccinecoldchainstoresandservicepointsasdescribed: NationaltoDistrictlevelstores:Independentmonitorswillvisit100%ofthevaccinecoldchainstoresfromthe nationaltothedistrictlevel.iftopvisfound,themonitorwillbeexpectedtoremovethevial(s)fromthecold chainandfacilitatedeliverytodisposalsiteasdescribedinthecollectionplandevelopedbytheswitchlogistics WorkingGrouppriortotheswitch,documenthis/herfindings,andreporttothesupervisor.Iftheamountof 20

21 topvfoundislarge(wouldrequireanothervehicletotransport),themonitormaynotbeabletoremoveallof thetopvandafollownupvisitmaybeneededtoconfirmthattopvhasbeencorrectlywithdrawn. Servicepoints:Independentmonitorswillmonitorasampleofthefacilitiesasdescribedabove.FindingtOPVin thecoldchainshouldpromptcorrectiveaction(removaloftopv)andmaytriggervisitstoadditionalsitesfor verificationoftopvwithdrawal. IncaseoneormoretOPVvials(openedorunopened)arefoundinthecoldchainoftheservicepoints: Themonitorwillremovethevialsfromthecoldchainandtransportthemtothenearestdistrictor regiondisposalsiteaccordingtothedisposalplan.themonitormaywaittotransportthetopvtothe disposalsiteuntilafterheorshehascompletedhisorherothermonitoringactivities. Thesupervisorwillselectanadditional5%ofhealthfacilitiesformonitorstovisit. IfoneormoretOPVvialscontainingvaccine(openedorunopened)arefoundintheadditional5%ofvisited facilities, a sweep of all service points should be conducted for the wholedistrict. Sweeping would mean an intensifiedmonitoringexercisewithinvolvementofmoredistrict,regionalandnationalstaff,etc. ThisstrategyshouldcontinueuntilsupervisorsandcoordinatorsfeelalltOPVhasbeenwithdrawnfromthecold chain, even if this extends beyond the country validation date. If the visits to the service points will extend beyond the two weeks following the National Switch Day, then they should fall under the usual National ImmunizationProgram ssupervision. The graphic below further illustrates how the purposive sampling would be conducted at the service point (healthfacility)level. Figure3:SiteVisitsandCorrectiveActionbyIndependentMonitors 21

22 DecisiontoSweepaDistrictorRegion Sweepingdistrict:IftOPVisfoundafterthesecondroundofmonitoring(i.e.,additional5%ofsites), themonitoringcoordinatorwiththesupportofdistrictimmunizationstaffisresponsibleforoverseeing asweepofentiredistrict Sweepingregion:If2ormoredistrictsrequiresweeps,theninvolveregionalandnationalstaffto conductabroaderassessmentoftheentireregion 3.2. DataReportedandAggregated Independentmonitors o Hand over all questionnaires to their supervisors on a daily basis or discuss findings of questionnairesoverthephone. Coordinators/Supervisors o Collectquestionnairesandreviewthequalityofinformation o Compilequestionnairesintocollectiontool o FollowNup with monitors who have not turned in questionnaires for their assigned facilities, accordingtotheirmicronplans o Senddatatocoordinator o Collectallsummarysheetsandmonitoringforms o AggregateresultsforNationalSwitchValidationCommitteetoreview o DetermineifanyprogrammaticactionisneededtoremovetOPVifitisfoundinnumerouscold chainstores,and,ifso,whatactionisneeded NationalSwitchValidationCommittee o Willdeclaremonitoringcompletedonceitissatisfiedthatallnationaltodistrictlevelcoldchain storeshavewithdrawntopvandthatnofurtherassessmentsorsweepsofservicepointsare neededundertheguidelinesdescribedabove. o Willmaketheultimatedecisionaboutwhetherornotthecountrycanvalidatethatthereisno longertopvbeingadministeredorpresentinthecoldchainafterthenationalswitchday. o MayrequesttheSwitchManagementCommitteetogatheradditionalinformationiftheyfeel theydonothaveenoughdatatovalidatetheswitch. o Willreportfindingsoftheswitchtonationalgovernment,whoshouldthensendthereportto thewho Developvalidationreport After the National Switch Validation Committee has concluded whether or not the country can validate that there is no longer topv being administered or present in the cold chain after the National Switch Day, the committeeshouldreportitsfindingstothenationalgovernment.thenationalgovernmentshouldinturnreport onthestatusoftheswitch,includingavalidationoftheswitch,tothecountryandregionalofficeoftheworld HealthOrganization. 22

23 4. FollowNUp Plan Prepare Validate FollowNUp Althoughthevastmajorityoftheswitchmonitoringactivitiesshouldtakeplaceduringthe2weeksimmediately followingthenationalswitchday,countriesareencouragedtoconductmopnupactivitiesthroughsupportive supervisioninordertoensurethattopvhasbeensufficientlyremovedfromthecoldchainandthattheriskof topvadministrationaftertheswitchislow.themopnupactivitieswillalsoaddressproblemswithbopvandipv introduction identified during the initial two weeks of monitoring. National Immunization Program staff can carryoutthismopnupactivityduringroutinesupervision.themopnupshouldoccurassoonaspossibleafterthe switchandlastnolaterthan2n3monthsafterthenationalswitchday. CountriesmayalsoconsiderdevelopingaplanformonitoringtOPVdisposal,whichwouldbecarriedoutovera longerperiodthanthe2weeksofindependentmonitoringfocusedontopvwithdrawal.disposaloftopvmay not be completed within the first two weeks following the National Switch Day, but disposal of topv and monitoringofthatdisposalshouldbecompletedalsowithin2n3monthsafterthenationalswitchday(seethe wastemanagementsectionofthelogisticsguideline) topvwithdrawal AdditionalmonitoringoftOPVwithdrawal Correctingidentifiedproblems MonitoringtOPVdisposal Futureactivities Whileindependentmonitoringdatacollectedduringthefirsttwoweeksaftertheswitchdateareneededfor validation, mopnup activities through supportive supervision will further increase confidence in successful withdrawaloftopv.astheinformationontopvwithdrawalcollectedfromsampledservicepointswillnotbe generalizabletoallservicepoints,visitsbynationalimmunizationprogramsupervisorsordistrictsurveillance officerstothesesitesisanimportantcomponentofasuccessfulswitch. NationaltoDistrictlevelcoldchainstores:IftheamountoftOPVfoundataspecificcoldchainstorewastoo largetopicknupduringthemonitoringperiod,afollownupvisitmaybeneededtoconfirmthattopvhasbeen correctlywithdrawn.thisfollownupvisitmayhappenfollowingthetwoweeksofindependentmonitoringbut shouldbeprioritizedandconductedassoonaspossible. 23

24 Service points: Identification of topv remaining in the cold chain at sampled service points should prompt monitoringvisitsto5%additionalservicepoints,asweepofservicepointsinadistrict,orboth.someorallof theseadditionalvisitsorsweepactivitiesmayneedtooccurfollowingthetwoweeksofindependentmonitoring butneedstohappenassoonaspossible. AstheinformationontOPVwithdrawalcollectedfromsampledservicepointswillnotbegeneralizabletoall service points, visits by National Immunization Program supervisors or district surveillance officers to service points,particularlyonesnotvisitedbyindependentmonitors,isanimportantcomponentofasuccessfulswitch. These supportive supervision visits should occur as soon as possible after the switch and no later than 2N3 monthsaftertheswitchdate ProblemsIdentifiedduringMonitoring ProblemswithbOPVandIPVdistribution identifiedthroughswitchmonitoringshouldhavebeen reportedto NationalImmunizationPrograms staff,butmaynothavetriggeredfurtherassessmentsbyswitchmonitorsor immediatelytriggeredsweepsofadditionalservicepoints.allactivitytofollownuponproblemswithbopvand IPV distribution and to assess the effectiveness of that follownup will be handled through a National ImmunizationProgram sexistingmethodsoftrackingvaccinedistributionandcoverage. 24

25 Annexes AnnexA:MonitoringtOPVDisposal See the Waste Management section in the Logistics Guide for additional information on disposal and definitionsoftypesofdisposalsites. InadditiontomonitoringtOPVwithdrawal,bOPVintroduction,andIPVdistribution,countriesmayalsowantto develop efficientmechanismsforassessing iftopvisbeingpromptlydisposedof.dependingonacountry s resources and preferences, some disposal activities may happen during the two weeks following the switch, simultaneouslywiththeindependentmonitoringoftheswitch,whileothersmayoccurmorethantwoweeks after the switch. Disposal of topv should occur as soon as possible, but no longer than 3 months after the National Switch Day. Planners should refer to the waste management section of the Logistics Guideline to developadisposalmonitoringplan. AsexplainedintheLogisticsGuideline,priortotheswitchitwillbeimportant: Toconductaninventoryofalldisposalequipment,recordingifequipmentisworkingandthevolumeof material(vials,ifpossible)thattheequipmentcandisposeofin1day. To develop a topv collection plan in sufficient detail that the movement of topv from collection to disposal sites can be predicted and monitored. Individual plans may need to be developed at the national,regional,anddistrictlevelsofthehealthsystemandwithineachdistrict. TheLogisticsGuidelinealsodescribesoptionsforcollectionandhandingoftOPV,including: SupervisorspickuptOPVfromcoldchainstoresandtaketodisposalsite StafffromcoldchainstoresdropNofftOPVatadisposalsite topv can be amassed from multiple health structures at district level and then can be moved to a regionalornationaldisposalsiteanddisposedof Acollection/disposalplanshouldshowtheschedulefortheplannedmovementanddisposaloftOPV,whichis usefulforplanningsupervisoryvisits.forexample,allcoldchainstoresusingaparticulardisposalsitecould movetheirtopvtothatsiteonthesamedayorcouldmovetheirtopvtothedisposalsiteondifferentdays. Duetothetwoweektimelimitontheoperationsoftheindependentmonitors,theycanhelpidentifythattOPV has been removed from a cold chain store or service point and confirm that plans are in place for disposal. However,itisunlikelythatthemonitorswillbeabletoconfirmthattOPVhasbeendisposed,whereithasbeen disposed of, and when. However, information collected in the independent monitoring questionnaires, along withinformationcollectedduringsupportivesupervisionvisits,canbeusedtohelptrackwhetherornotthe coldchainstoresandservicepointshavereturnedtheirtopvandwhereithasbeensentfordisposal. MonitoringtOPVdisposal 1. MonitoringoftOPVdisposalshouldfocusondisposaloftOPVfromnational,regional,anddistrictcold chainstoresbecausethevolumesoftopvstoredatthosefacilitiesispotentiallymuchgreaterthanthe volumeoftopvstoredatservicepoints. 2. ColdchainstoreandservicepointsshouldfillashortformorstickerlistingthenumberofvialsoftOPV thatarebeingsentfordisposalalongwiththetopvvials(seeforexampleformfortransferoftopv 25

26 fromhealthstructurestodisposalsite).preferably,thesameinformationwillbeprintedonthesticker thatgoesonthebagswhenwithdrawingthetopvfromthecoldchain. 3. DisposalsitescanuseaformtocheckoffwhentOPVfromagivencoldchainstoreoraservicepointhas beenreceivedanddisposedof(seeforanexampletopvdisposalform DisposalSites). i. Alternativesolutions,suchaselectronicdatamanagementsystems,couldalsobeused torecordvialsofdisposedtopv 4. Supervisors shouldvisittopvdisposalsitestomakesurethattopvhasbeencollectedandpromptly disposedof.therecordskeptbythedisposalsitestaffmaybeveryhelpfultothesupervisors. a. If the supervisor visits a disposal site and finds that it either has not received topv from all expected stores or has not finished disposing of the topv it has received, he or she should schedulearepeattrip.multiplerepeattripsmaybeneededbeforeallexpectedtopvhasbeen collectedanddisposedof. 5. SupervisorsrecordtheamountoftOPVthatacoldchainstoreoraservicepointsendsfordisposaland thesiteofdisposalusingaquestionnaireduringvisitstocoldchainstoresandservicepoints(seeforan exampletopvdisposalform Supervisors) 6. SupervisorsshouldideallycrossNchecktheamountoftOPVreportedashavingbeensentfordisposalby cold chain stores with the amount of topv that disposal sites record as having been received and destroyedtoensurethatallvialsweredestroyed 7. Information collected on questionnaires by supervisors should be compiled and sent to the Switch ManagementCommittee. 26

27 AnnexB:CategorizingRiskoftOPVUse SuggestedcriteriaforidentifyingHighRiskdistricts/subdistricts: AFPsurveillance: o Recent or onngoing wild poliovirus circulation, either suspected or confirmed from AFP surveillanceorenvironmentalsurveillance. o ClustersofAFPcases. o Recentpoliocompatiblecases o Silentorunderreportingareas o Localitywherethesupervisionisweak Immunization: o LowroutineimmunizationcoveragewithDTP3orOPV3 o UnderNperformanceinpreviouscampaigns o Discrepancies in numbers of children vaccinated between administrative data and coverage surveys o HistoryofstockNouts o PoorcommunicationswithorreportingtoNationalImmunizationProgramorEPI Demographicandgeographiccharacteristic: o Denselypopulatedareas o Slums, displaced populations, refugee camps, crowded and highly populated urban area with dense highnrise buildings, mobile communities including nomads and seasonal workers, conservative communities, areas with administrative instability, management problems or insecurity,etc. o Borderandhardtoreachdistricts/areas RiskoftOPVStoredandUsedDuringtheSwitch LevelofSupply Chain District and higher storelevels Service points Short term Long term Use of scavenged topv HypotheticalscenariooftOPVstorageanduse StorageoflargestocksoftOPVinthecoldchainatdistrictleveland subsequent distribution to service points after the switch either intentionally (for example, in response to stockout of bopv) or unintentionally(forexample,becauseofconfusionwithbopv) ServicepointscontinuetousetOPVduringthefirstmonthfollowing theswitch. Service points store topv after the switch and use it months after the switch, either accidentally or intentionally during a bopv stockout. If cold chain stores or service points withdraw topv from the cold chainbutdonotpromptlydisposeofit,thattopvmaybescavenged andusedforimmunizationornonnimmunizationpurposes. Likelihoodof occurrence LowNMedium Low LowN Medium Note: The forms included in this guide include the core indicators that are needed to validate the switch. Additional indicatorscanbeincludedifswitchmonitorsaretaskedwithcollectinginformationonotherimmunizationactivities. Low 27

28 AnnexC:ExampleForms SurveyFormforIndependentMonitors topvstoragesite Facilitytype: National Regional District ServicePoint Region: District: Facility: Dateofthevisit: Dateoftheswitchonsite: Monitorname: Monitorphonenumber: Supervisorname: Supervisorphonenumber: ID Question Options 1. IstOPVpresentatthe facility? YesGotoquestion2 NoGotoquestion6 2. HowmanyvialsoftOPV? 3. IsthetOPVkeptinor outsideofthecoldchain? Inthecoldchain Outsideofthecoldchain 4. Whatarethefacilitystaff planningtodowiththe topv? DestroyitonNsite Keepitoutofthecoldchain TransportittoatOPVdisposalsite WaitforsomeonetopickupthetOPV 5. Whyhasthefacilitynot alreadydisposedoftopvor transferredittoadisposal site? 6. WherehasthetOPVbeen sentordestroyed? 7. IsbOPVpresentatthe facility? 8. Havethefacilitystaff startedtoadministerthe bopvordistributeitfor administration? UnawareofneedtodisposeofortransfertOPV Didnotreceiveclearguidelines Needadditionalassistance Didnothavetimeyettodoit. Yes NoGotoquestion9 Yes No,butplantostartadministeringordistributingthevaccinesoon No,andhavenoplanstostartadministeringordistributingthevaccine 9. IsIPVpresentatthefacility? Yes NoStop 10. Havethefacilitystaff startedtoadministerthe IPVtochildrenordistribute itforadministration? Yes No,butplantostartadministeringordistributingthevaccinesoon No,andhavenoplanstostartadministeringordistributingthevaccine Anycomments?(forexample,ifyoufoundanytOPV,wheredidyoufindit?)Mayuseothersideofpaper 28

29 topv%withdrawal%tally%sheet% Tobecompletedbyindependentmonitor Region: District: Supervisorname:Supervisorphonenumber: HealthFacilityName Date of oftopvvials In/outofthe bopv IPVpresent? FollowEup Visit found coldchain? present? needed? 1 In Out Yes No Yes No Yes No Comments if followeup is necessary Totalnumberofhealthfacilitiesmonitored: NumberofhealthfacilitieswithtOPVnotwithdrawnfromcoldchain: NumberofhealthfacilitieswithnoIPV: Additionalcomments: In Out Yes No Yes No Yes No In Out Yes No Yes No Yes No In Out Yes No Yes No Yes No In Out Yes No Yes No Yes No In Out Yes No Yes No Yes No In Out Yes No Yes No Yes No In Out Yes No Yes No Yes No In Out Yes No Yes No Yes No In Out Yes No Yes No Yes No NumberofhealthfacilitiesthatneedfollowEup: NumberofhealthfacilitieswithnobOPV: 29

30 Form%for%Transfer%of%tOPV%from%Health%Structures%to%Disposal%Site% Date: ColdChainStoreorServicePointsendingtOPV: DisposalSiteReceivingVaccine: VialsoftOPVbeingsent: 30

31 topv%disposal%form% %Disposal%Sites% (Disposal)site)fills)out)) DisposalSiteName:DisposalSiteSupervisor sname:disposalsitesupervisorphonenumber: Region:District: To)be)completed)when)cold)chain)store)(facility))delivers)or)sends)tOPV)to)disposal)site) To)be)completed)as)disposal)site) destroys)topv)from)each)facility) FacilitynameE Facility Region District Date topv received of topv vials Date topv of topv vials returningtopv Type* bydisposalsite fromfacility vialsdestroyed destroyed Total *Writeoneofthefollowingtypesoffacilities:Nationalstore,Regionalstore,Districtstore,ServicePoint(SP) Formmaybemodifiedasneededtosuitneedsofcountry. % 31

32 topv%disposal%form% %Supervisors% (Monitor)fills)out)) DisposalSiteName:Supervisorname:Supervisorphonenumber: Region:District: Disposal Site Name Level of Disposal Site* Region District Date ofvisit topv Disposal Completed? of topv vials disposed oftodate Date ofvisit topv Disposal Completed? of topv vials disposed oftodate Date ofvisit topv Disposal Completed? Total *Writeoneofthefollowingtypesoffacilities:Nationalstore,Regionalstore,Districtstore,ServicePoint(SP). Formmaybemodifiedasneededtosuitneedsofcountry. of topv vials disposed oftodate 32