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PROVIDERQUALITYASSURANCEUNITBUREAUOFIMMUNIZATIONNEWYORKCITYDEPARTMENTOFHEALTH&MENTALHYGIENEVACCINESFORCHILDREN(VFC)PROGRAMPage15/2020TEMPERATUREEXCURSIONINCIDENTREPORTNEWYORKCITYDEPARTMENTOFHEALTH&MENTALHYGIENE:VACCINESFORCHILDREN(VFC)PROGRAM347-396-2404(Phone)347-396-8841(Fax)PQAUnit@health.
nyc.
govIntheeventofatemperatureexcursion,contactthevaccinemanufacturers,completethisformandsubmitittotheVFCprogram.
Thisreportservesasarecordoftheincident,thestepstakentodeterminevaccineviability,andthedispositionoftheaffectedvaccines.
Keepthisreportforyourrecords.
VFCFacilityName:VFCPINDateReported:Reportedby(first&lastname)PhoneEmail:DateofExcursion:TimeofExcursion:OrderID(ifapplicable)IMMEDIATEACTIONTAKEN1.
WerethePhysician-in-Charge,VaccineCoordinatororBack-upVaccineCoordinatornotifiedofexcursionYESNO2.
Whatwastheexcursiontemperatureinsidetheaffectedstorageunit(s)atthetimetheproblemwasdiscoveredRefrigeratorTemperatureCor_______°FFreezerTemperature:Cor______°F*Pleasenotethatanytemperaturereadingoutsidetherecommendedranges(Refrigerator–between36°F[2°C]&46°F[8°C];Freezer–between-58°F[-50°C]&+5°F[-15°C])isconsideredatemperatureexcursion.
3.
HowlongwerethevaccinesexposedtoinappropriatestoragetemperaturesPleaserecordthetotalamountoftimeorcumulativetimeoutsideofrangeforeachunit.
Refrigerator:_____Days______Hours_____MinutesFreezer:______Days______Hours______Minutes4.
Whatwastheroomtemperaturesurroundingtheaffectedunitatthetimeoftheexcursion5.
WerewaterbottlesintherefrigeratoratthetimeoftheeventYESNOWerefrozencoolantpacksinthefreezeratthetimeoftheeventYESNO6.
WasaninventoryofthevaccineswithintheaffectedstorageunitconductedYESNO7.
Vaccinesintheaffectedstorageunitquarantinedwithintheunitandlabeled"DONOTUSE"pendingmanufacturer'sinputYESNO*Ifyourvaccinestorageunit(s)cannotberesettomaintaintheappropriatestorageconditions,followtheEMERGENCYPLANasdescribedwithintheVFCVaccineManagementPlan.
8.
HasthevaccinemanufacturerbeencontactedforfurtherguidanceYESNOCAUSEOFEXCURSION:PowerOutageUnit(s)notpluggedinornotturnedonProlongedopeningofrefrigerator/freezerdoorTemperatureMonitoringdevicemoved/misplacedUnit'stemperaturecontrolknobsettingisincorrectPooraircirculationinsideandoutsidetheunit(s)Operationalproblemswiththestorageunit(s)Other_Type&BrandNameofStorageUnitAffectedbyExcursion:SmallStand-AloneRefrigeratorPharmaceuticalGrade(Stand-AloneRefrigerator)SmallStand-AloneChestFreezerPharmaceuticalGrade(CombinedRefrigerator&Freezer)Stand-AloneFreezerSmallHouseholdRefrigerator&Freezer(RefrigeratorOnly)RegularStand-AloneRefrigeratorRegularHouseholdRefrigerator&Freezer(RefrigeratorOnly)RegularStand-AloneChestFreezerLargeHouseholdRefrigerator&Freezer(RefrigeratorOnly)PharmaceuticalGrade(Stand-AloneFreezer)StorageUnitBrandName:Model/SerialThermometerBrandName:Model/SerialPROVIDERQUALITYASSURANCEUNITBUREAUOFIMMUNIZATIONNEWYORKCITYDEPARTMENTOFHEALTH&MENTALHYGIENEVACCINESFORCHILDREN(VFC)PROGRAMPage25/2020TEMPERATUREEXCURSIONINCIDENTREPORTNEWYORKCITYDEPARTMENTOFHEALTH&MENTALHYGIENE:VACCINESFORCHILDREN(VFC)PROGRAM347-396-2404(Phone)347-396-8841(Fax)PQAUnit@health.
nyc.
govBASEDONMANUFACTURER'SREPSONSE:ManufacturerCodes:MSD=MerckandCo.
,Inc.
,PMC=SanofiPasteur,SEQ=Seqirus,SKB=GlaxsoSmithKlineQualityofVFCvaccineshasnotbeencompromisedandmaycontinuetobeused.
YESNO[SKIPTOMANUFACTURERCASENUMBER(S)SECTION/SIGNFORMONPAGE3]VFCvaccineswasnotapprovedforfurtheruseandshouldbeidentifiedas"spoiled".
YESNO[CONTINUETOMANUFACTURERCASENUMBER(S)SECTION/IDENTIFYSPOILEDDOSES/SIGNFORM]ManufacturerCaseNumber(s):MSD_PMC_SKB_SEQ_Wyeth_Pfizer_*PLEASEATTACHCOPIESOFALLDOCUMENTSFROMTHEMANUFACUTERSTATINGTHEVIABILITYSTATUSOFALLVACCINES.
*DONOTDISCARDVACCINESUNLESSDIRECTEDBYTHEMANUFACTURER(S).
PediatricInfluenzaVaccines,Manufacturer&LotNumber(s)affectedduetotemperatureexcursion:(NP)=NoPreservative,(PF)=PreservativeFree,&Quad=QuadrivalentManufacturerCodes:MSD=MerckandCo.
,Inc.
,PMC=SanofiPasteur,SEQ=Seqirus,SKB=GlaxsoSmithKlineVaccine(Manufacturer)Placean'X'inboxnexttospoiledvaccinesVaccineTypeLotNumber(s)LotExpirationDateNewExpirationDate(ifapplicable)NumberofDosesAfluria(SEQ)FluAfluria(NP)(SEQ)FluFluarix(PF)(SKB)FluFluMist(NP)Quad(SKB)FluFluvirin(SEQ)FluFluvirin(PF)(SEQ)FluFluzone(PMC)FluFluzone(NP)(PMC)FluFluzonePedDose(NP)(PMCFluDescribetheincidentandcorrectiveactionstaken:PROVIDERQUALITYASSURANCEUNITBUREAUOFIMMUNIZATIONNEWYORKCITYDEPARTMENTOFHEALTH&MENTALHYGIENEVACCINESFORCHILDREN(VFC)PROGRAMPage35/2020TEMPERATUREEXCURSIONINCIDENTREPORTNEWYORKCITYDEPARTMENTOFHEALTH&MENTALHYGIENE:VACCINESFORCHILDREN(VFC)PROGRAM347-396-2404(Phone)347-396-8841(Fax)PQAUnit@health.
nyc.
govVFCVaccines,Manufacturer,LotNumber(s)&dosesaffectedduetotemperatureexcursion:ManufacturerCodes:MSD=MerckandCo.
,Inc.
,PMC=SanofiPasteur,SEQ=Seqirus,SKB=GlaxsoSmithKlineVaccine(Manufacturer)Placean'X'inboxnexttospoiledvaccinesVaccineTypeLotNumber(s)LotExpirationDateNewExpirationDate(ifapplicable)NumberofDosesActHIB(PMC)HibAdacel(PMC)TdapBoostrix(SKB)TdapCervarix(SKB)HPVDaptacel(PMC)DTaPEngerixB(SKB)HepBGardasil(MSD)HPVHavrix(SKB)HepAInfanrix(SKB)TdapIPOL(PMC)e-IPVKinrix(SKB)DTaP-IPVMenactra(PMC)MCV4Menveo(SKB)MCVM-M-RII(MSD)MMRPediarix(SKB)DTap-HepB-IPVPedvaxHIB(MSD)HIBPentacel(PMC)DTap-IPVPneumovax23(MSD)PneumoPrevnar13TM(Wyeth)PneumoProQuad(MSD)MMR-VRecombivaxHB(MSD)HepBRotarix(SKB)ROTARotaTeq(MSD)ROTATenivac(PMC)TdTwinrix(SKB)HepA-BVaqta(MSD)HepAVarivax(MSD)VARICELLANAME:SIGNATURE:DATEREPORTED:VACCINEMANUFACTURERCONTACTINFORMATIONMANUFACTURERCONTACTINFOVFCVACCINECSL1-888-435-8633or1-855-358-8966www.
biocsl.
comInfluenza(Age9yearsandolder)(AfluriaNoPreservative)Influenza(Age9yearsandolder)(Afluria)GlaxoSmithKline1-877-356-836https://www.
gskusmedicalaffairs.
com/stability-calculator.
htmlvaccine.
service-center@gsk.
comDTap(Infanrix)DTap-IPV(Kinrix)DTaP-HepB-IPV(Pediarix)HepatitisAPediatric(Havrix)HepatitisA-HepatitisB18only(Twinrix)HepatitisBPediatric/Adolescent(EngerixB)HIBMENCY(MENHIBRIX)HPV-BivalentHumanPapillomavirusTypes16and18(Cervarix)Influenza(Age36monthsandolder)(FluarixQuadrivalentPreservativeFree)Influenza(Age36monthsandolder)(FluLavalQuadrivalent/FluLavalTrivalent)MENB–MeningococcalGroupB(Bexsero)MeningococcalConjugate(GroupsA,C,YandW-135)(Menveo)Rotavirus,Live,Oral,Oral(Rotarix)TetanusToxoid,ReducedDiphtheriaToxoidandAcellularPertussis(Boostrix)MedImmune1-877-633-4411www.
medimmune.
comInfluenza[5]Live,Intranasal(Age2-49years)(FluMistQuadrivalentNoPreservative)Merck1-877-829-6372www.
merckvaccines.
comHepatitisAPediatric(Vaqta)HepatitisBPediatric/Adolescent(RecombivaxHB)Hib(PedvaxHIB)HPV-QuadrivalentHumanPapillomavirusTypes6,11,16and18Recombinant(Gardasil)Measles,MumpsandRubella(MMR)(M-M-RII)MMR/Varicella(ProQuad)PneumococcalPolysaccharide(23Valent)(Pneumovax23)Rotavirus,Live,Oral,Pentavalent(RotaTeq)Varicella(Varivax)Novartis1-855-358-8966www.
novartis.
comInfluenza(Age4yearsandolder)(Fluvirin)Influenza(Age4yearsandolder)(FluvirinPreservativeFree)Pfizer1-800-505-4426www.
pfizer.
comPneumococcal13-valent(Prevnar13TM)MENB–MeningococcalGroupB(Trumenba)SanofiPasteur1-800-822-2463www.
sanofipasteur.
usDTap(Daptacel)DTaP-IP-HI(Pentacel)e-IPV(IPOL)Hib(ActHIB)Influenza(Age36monthsandolder)(FluzoneNo-Preservative/QuadrivalentNoPreservative)MeningococcalConjugate(GroupsA,C,YandW-135)(Menactra)Tetanus&DiphtheriaToxoids(Tenivac)TetanusToxoid,ReducedDiphtheriaToxoidandAcellularPertussis(Adacel)Influenza(Age6monthsandolder)(Fluzone/FluzoneQuadrivalent)
nyc.
govIntheeventofatemperatureexcursion,contactthevaccinemanufacturers,completethisformandsubmitittotheVFCprogram.
Thisreportservesasarecordoftheincident,thestepstakentodeterminevaccineviability,andthedispositionoftheaffectedvaccines.
Keepthisreportforyourrecords.
VFCFacilityName:VFCPINDateReported:Reportedby(first&lastname)PhoneEmail:DateofExcursion:TimeofExcursion:OrderID(ifapplicable)IMMEDIATEACTIONTAKEN1.
WerethePhysician-in-Charge,VaccineCoordinatororBack-upVaccineCoordinatornotifiedofexcursionYESNO2.
Whatwastheexcursiontemperatureinsidetheaffectedstorageunit(s)atthetimetheproblemwasdiscoveredRefrigeratorTemperatureCor_______°FFreezerTemperature:Cor______°F*Pleasenotethatanytemperaturereadingoutsidetherecommendedranges(Refrigerator–between36°F[2°C]&46°F[8°C];Freezer–between-58°F[-50°C]&+5°F[-15°C])isconsideredatemperatureexcursion.
3.
HowlongwerethevaccinesexposedtoinappropriatestoragetemperaturesPleaserecordthetotalamountoftimeorcumulativetimeoutsideofrangeforeachunit.
Refrigerator:_____Days______Hours_____MinutesFreezer:______Days______Hours______Minutes4.
Whatwastheroomtemperaturesurroundingtheaffectedunitatthetimeoftheexcursion5.
WerewaterbottlesintherefrigeratoratthetimeoftheeventYESNOWerefrozencoolantpacksinthefreezeratthetimeoftheeventYESNO6.
WasaninventoryofthevaccineswithintheaffectedstorageunitconductedYESNO7.
Vaccinesintheaffectedstorageunitquarantinedwithintheunitandlabeled"DONOTUSE"pendingmanufacturer'sinputYESNO*Ifyourvaccinestorageunit(s)cannotberesettomaintaintheappropriatestorageconditions,followtheEMERGENCYPLANasdescribedwithintheVFCVaccineManagementPlan.
8.
HasthevaccinemanufacturerbeencontactedforfurtherguidanceYESNOCAUSEOFEXCURSION:PowerOutageUnit(s)notpluggedinornotturnedonProlongedopeningofrefrigerator/freezerdoorTemperatureMonitoringdevicemoved/misplacedUnit'stemperaturecontrolknobsettingisincorrectPooraircirculationinsideandoutsidetheunit(s)Operationalproblemswiththestorageunit(s)Other_Type&BrandNameofStorageUnitAffectedbyExcursion:SmallStand-AloneRefrigeratorPharmaceuticalGrade(Stand-AloneRefrigerator)SmallStand-AloneChestFreezerPharmaceuticalGrade(CombinedRefrigerator&Freezer)Stand-AloneFreezerSmallHouseholdRefrigerator&Freezer(RefrigeratorOnly)RegularStand-AloneRefrigeratorRegularHouseholdRefrigerator&Freezer(RefrigeratorOnly)RegularStand-AloneChestFreezerLargeHouseholdRefrigerator&Freezer(RefrigeratorOnly)PharmaceuticalGrade(Stand-AloneFreezer)StorageUnitBrandName:Model/SerialThermometerBrandName:Model/SerialPROVIDERQUALITYASSURANCEUNITBUREAUOFIMMUNIZATIONNEWYORKCITYDEPARTMENTOFHEALTH&MENTALHYGIENEVACCINESFORCHILDREN(VFC)PROGRAMPage25/2020TEMPERATUREEXCURSIONINCIDENTREPORTNEWYORKCITYDEPARTMENTOFHEALTH&MENTALHYGIENE:VACCINESFORCHILDREN(VFC)PROGRAM347-396-2404(Phone)347-396-8841(Fax)PQAUnit@health.
nyc.
govBASEDONMANUFACTURER'SREPSONSE:ManufacturerCodes:MSD=MerckandCo.
,Inc.
,PMC=SanofiPasteur,SEQ=Seqirus,SKB=GlaxsoSmithKlineQualityofVFCvaccineshasnotbeencompromisedandmaycontinuetobeused.
YESNO[SKIPTOMANUFACTURERCASENUMBER(S)SECTION/SIGNFORMONPAGE3]VFCvaccineswasnotapprovedforfurtheruseandshouldbeidentifiedas"spoiled".
YESNO[CONTINUETOMANUFACTURERCASENUMBER(S)SECTION/IDENTIFYSPOILEDDOSES/SIGNFORM]ManufacturerCaseNumber(s):MSD_PMC_SKB_SEQ_Wyeth_Pfizer_*PLEASEATTACHCOPIESOFALLDOCUMENTSFROMTHEMANUFACUTERSTATINGTHEVIABILITYSTATUSOFALLVACCINES.
*DONOTDISCARDVACCINESUNLESSDIRECTEDBYTHEMANUFACTURER(S).
PediatricInfluenzaVaccines,Manufacturer&LotNumber(s)affectedduetotemperatureexcursion:(NP)=NoPreservative,(PF)=PreservativeFree,&Quad=QuadrivalentManufacturerCodes:MSD=MerckandCo.
,Inc.
,PMC=SanofiPasteur,SEQ=Seqirus,SKB=GlaxsoSmithKlineVaccine(Manufacturer)Placean'X'inboxnexttospoiledvaccinesVaccineTypeLotNumber(s)LotExpirationDateNewExpirationDate(ifapplicable)NumberofDosesAfluria(SEQ)FluAfluria(NP)(SEQ)FluFluarix(PF)(SKB)FluFluMist(NP)Quad(SKB)FluFluvirin(SEQ)FluFluvirin(PF)(SEQ)FluFluzone(PMC)FluFluzone(NP)(PMC)FluFluzonePedDose(NP)(PMCFluDescribetheincidentandcorrectiveactionstaken:PROVIDERQUALITYASSURANCEUNITBUREAUOFIMMUNIZATIONNEWYORKCITYDEPARTMENTOFHEALTH&MENTALHYGIENEVACCINESFORCHILDREN(VFC)PROGRAMPage35/2020TEMPERATUREEXCURSIONINCIDENTREPORTNEWYORKCITYDEPARTMENTOFHEALTH&MENTALHYGIENE:VACCINESFORCHILDREN(VFC)PROGRAM347-396-2404(Phone)347-396-8841(Fax)PQAUnit@health.
nyc.
govVFCVaccines,Manufacturer,LotNumber(s)&dosesaffectedduetotemperatureexcursion:ManufacturerCodes:MSD=MerckandCo.
,Inc.
,PMC=SanofiPasteur,SEQ=Seqirus,SKB=GlaxsoSmithKlineVaccine(Manufacturer)Placean'X'inboxnexttospoiledvaccinesVaccineTypeLotNumber(s)LotExpirationDateNewExpirationDate(ifapplicable)NumberofDosesActHIB(PMC)HibAdacel(PMC)TdapBoostrix(SKB)TdapCervarix(SKB)HPVDaptacel(PMC)DTaPEngerixB(SKB)HepBGardasil(MSD)HPVHavrix(SKB)HepAInfanrix(SKB)TdapIPOL(PMC)e-IPVKinrix(SKB)DTaP-IPVMenactra(PMC)MCV4Menveo(SKB)MCVM-M-RII(MSD)MMRPediarix(SKB)DTap-HepB-IPVPedvaxHIB(MSD)HIBPentacel(PMC)DTap-IPVPneumovax23(MSD)PneumoPrevnar13TM(Wyeth)PneumoProQuad(MSD)MMR-VRecombivaxHB(MSD)HepBRotarix(SKB)ROTARotaTeq(MSD)ROTATenivac(PMC)TdTwinrix(SKB)HepA-BVaqta(MSD)HepAVarivax(MSD)VARICELLANAME:SIGNATURE:DATEREPORTED:VACCINEMANUFACTURERCONTACTINFORMATIONMANUFACTURERCONTACTINFOVFCVACCINECSL1-888-435-8633or1-855-358-8966www.
biocsl.
comInfluenza(Age9yearsandolder)(AfluriaNoPreservative)Influenza(Age9yearsandolder)(Afluria)GlaxoSmithKline1-877-356-836https://www.
gskusmedicalaffairs.
com/stability-calculator.
htmlvaccine.
service-center@gsk.
comDTap(Infanrix)DTap-IPV(Kinrix)DTaP-HepB-IPV(Pediarix)HepatitisAPediatric(Havrix)HepatitisA-HepatitisB18only(Twinrix)HepatitisBPediatric/Adolescent(EngerixB)HIBMENCY(MENHIBRIX)HPV-BivalentHumanPapillomavirusTypes16and18(Cervarix)Influenza(Age36monthsandolder)(FluarixQuadrivalentPreservativeFree)Influenza(Age36monthsandolder)(FluLavalQuadrivalent/FluLavalTrivalent)MENB–MeningococcalGroupB(Bexsero)MeningococcalConjugate(GroupsA,C,YandW-135)(Menveo)Rotavirus,Live,Oral,Oral(Rotarix)TetanusToxoid,ReducedDiphtheriaToxoidandAcellularPertussis(Boostrix)MedImmune1-877-633-4411www.
medimmune.
comInfluenza[5]Live,Intranasal(Age2-49years)(FluMistQuadrivalentNoPreservative)Merck1-877-829-6372www.
merckvaccines.
comHepatitisAPediatric(Vaqta)HepatitisBPediatric/Adolescent(RecombivaxHB)Hib(PedvaxHIB)HPV-QuadrivalentHumanPapillomavirusTypes6,11,16and18Recombinant(Gardasil)Measles,MumpsandRubella(MMR)(M-M-RII)MMR/Varicella(ProQuad)PneumococcalPolysaccharide(23Valent)(Pneumovax23)Rotavirus,Live,Oral,Pentavalent(RotaTeq)Varicella(Varivax)Novartis1-855-358-8966www.
novartis.
comInfluenza(Age4yearsandolder)(Fluvirin)Influenza(Age4yearsandolder)(FluvirinPreservativeFree)Pfizer1-800-505-4426www.
pfizer.
comPneumococcal13-valent(Prevnar13TM)MENB–MeningococcalGroupB(Trumenba)SanofiPasteur1-800-822-2463www.
sanofipasteur.
usDTap(Daptacel)DTaP-IP-HI(Pentacel)e-IPV(IPOL)Hib(ActHIB)Influenza(Age36monthsandolder)(FluzoneNo-Preservative/QuadrivalentNoPreservative)MeningococcalConjugate(GroupsA,C,YandW-135)(Menactra)Tetanus&DiphtheriaToxoids(Tenivac)TetanusToxoid,ReducedDiphtheriaToxoidandAcellularPertussis(Adacel)Influenza(Age6monthsandolder)(Fluzone/FluzoneQuadrivalent)
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