ID

6372

Description

Hematopoietic Stem Cell Transplant (HSCT) Infusion ISO Date Format Version 1 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=

Keywords

  1. 12/18/14 12/18/14 - Martin Dugas
Uploaded on

December 18, 2014

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Treatment - Hematopoietic Stem Cell Transplant (HSCT) Infusion ISO Date Format Version 1 - 2894050v2.0

This form must be completed for all recipients who receive a HSCT product. If multiple HSCT products are infused it must be reported separately. A series of collections should be considered a single product when they are all from the same donor and use the same collection method and technique (and mobilization, if applicable), even if the collections are performed on different days.

Registry Use Only
Description

Registry Use Only

Sequence number:
Description

ClinicalDataFormSequenceNumber

Data type

double

Date received:
Description

ClinicalDataFormReceivedDate

Data type

date

Identification Data
Description

Identification Data

CIBMTR Center Number:
Description

HematopoieticStemCellTransplantationRecipientInstitution::CenterforInternationalBloodandMarrowTransplantResearchFacilityNumber

Data type

double

CIBMTR Recipient ID:
Description

HematopoieticStemCellTransplantationRecipientIdentificationNumber

Data type

double

Donor ID:
Description

HematopoieticStemCellTransplantationTissueDonorIdentificationNumber

Data type

double

NMDP Cord Blood Unit ID:
Description

HematopoieticStemCellTransplantationUmbilicalCordBloodTypeInstitution::NationalMarrowDonorProgramIdentifier

Data type

double

Non-NMDP Cord Blood Unit :
Description

HematopoieticStemCellTransplantationUmbilicalCordBloodTypeNotInstitution::NationalMarrowDonorProgramIndicator

Data type

text

Today's date:
Description

ClinicalDataFormTodayDate

Data type

date

Date of hematopoietic stem cell transplantation (HSCT) for which this form is being completed:
Description

HematopoieticStemCellTransplantationOccurrenceDate

Data type

date

Hsct Type
Description

Hsct Type

What source was used for the hematopoietic stem cell transplantation?
Description

HematopoieticStemCellGraftSourceName

Data type

text

Was a particular hematopoietic stem cell source used?
Description

HematopoieticStemCellGraftSourceTherapyInd-2

Data type

text

Product Type
Description

Product Type

What type of hematopoietic stem cell transplant was used?
Description

HematopoieticStemCellGraftTypeName

Data type

text

Was a particular hematopoietic stem cell transplant type used?
Description

HematopoieticStemCellGraftTypeTherapyInd-2

Data type

text

Specify the other hematopoietic stem cell transplant type: (Answer only if the value for 2730912 is "Other". )
Description

HematopoieticStemCellGraftOtherTypeSpecify

Data type

text

Pre-collection Therapy
Description

Pre-collection Therapy

Did the donor receive treatment, prior to any stem cell harvest, to enhance the product collection for this HSCT?
Description

HematopoieticStemCellTissueDonorPriorHarvestProcedureEnhanceCollectionTreatIndicator

Data type

text

Chemotherapy (autologous only)
Description

PriorHarvestProcedureTissueDonorTreatChemotherapyIndicator

Data type

text

Anti-CD20(rituximab,Rituxan) (autologous only)
Description

PriorHarvestProcedureTissueDonorTreatCD20AntigenIndicator

Data type

text

Growth factor(s)
Description

PriorHarvestProcedureTissueDonorTreatHematopoieticGrowthFactorIndicator

Data type

text

G-CSF
Description

PriorHarvestProcedureTissueDonorTreatG-CSFIndicator

Data type

text

GM-CSF
Description

PriorHarvestProcedureTissueDonorTreatGM-CSFIndicator

Data type

text

Other growth factor(s)
Description

PriorHarvestProcedureTissueDonorTreatOtherHematopoieticGrowthFactorIndicator

Data type

text

Specify (Answer only if the value for 2772114 is "Yes")
Description

PriorHarvestProcedureTissueDonorTreatOtherHematopoieticGrowthFactorTherapiesSpecify

Data type

text

Other treatment
Description

PriorHarvestProcedureTissueDonorOtherTreatIndicator

Data type

text

Specify treatment: (Answer only if the value for 2773751 is "Yes")
Description

PriorHarvestProcedureTissueDonorOtherTreatSpecify

Data type

text

Product Collection
Description

Product Collection

Date of product collection:
Description

HematopoieticStemCellGraftCollectionDate

Data type

date

Was more than one collection required for this HSCT?
Description

MultipleHematopoieticStemCellGraftCollectionRequiredIndicator

Data type

text

Specify the number of subsequent days of collection in this episode: (Complete a separate product form for each subsequent collection that was not part of this mobilization.)
Description

MultipleHematopoieticStemCellCollectionNextDayCount

Data type

double

Were anticoagulants added to the product during collection?
Description

DuringHematopoieticStemCellGraftCollectionAnticoagulantAgentAdministrationIndicator

Data type

text

Product Collection
Description

Product Collection

What anticoagulants were added to the product during collection?
Description

DuringCollectionHematopoieticStemCellGraftCombinedAnticoagulantAgentAdditiveType

Data type

text

Were particular anticoagulants added to the product during collection?
Description

DuringCollectionHematopoieticStemCellGraftCombinedAnticoagulantAgentAdministrationIndicator

Data type

text

Specify the other anticoagulants (Answer only if the value for 2741578 is "Other")
Description

DuringCollectionHematopoieticStemCellGraftCombinedOtherAnticoagulantAgentAdministrationTherapiesSpecify

Data type

text

Product Transport And Receipt
Description

Product Transport And Receipt

Was this product collected off-site and shipped to your facility?
Description

ExternalCollectionHematopoieticStemCellGraftAtFacilitySendIndicator

Data type

text

Date of receipt of product at your facility:
Description

HematopoieticStemCellGraftAtFacilityReceivedDate

Data type

date

Time of receipt of product: (24-hour clock)
Description

HematopoieticStemCellGraftReceivedHourMinuteTime

Data type

time

Is time of receipt of product standard time or daylight savings time?
Description

HematopoieticStemCellGraftReceivedTimeUnitofMeasure

Data type

text

Specify the shipping environment of the product(s):
Description

HematopoieticStemCellGraftArrivalFacilityShippingEnvironmentType

Data type

text

Specify shipping environment:
Description

HematopoieticStemCellGraftArrivalFacilityShippingEnvironmentSpecifyText

Data type

text

Were the secondary containers (e.g., insulated shipping containers and unit cassette) intact when they arrived at your center? (Cord blood product only)
Description

UmbilicalCordBloodSecondaryContainerArrivalFacilityIntactIndicator

Data type

text

Was the cord blood unit completely frozen when it arrived at your center? (Cord blood product only)
Description

UmbilicalCordBloodArrivalFacilityCompleteFrozenIndicator

Data type

text

Was the cord blood unit stored at your center prior to thawing? (Cord blood product only)
Description

UmbilicalCordBloodPriorThawAtFacilityStorageIndicator

Data type

text

Specify the storage method used for the cord blood unit:
Description

UmbilicalCordBloodPriorThawAtFacilityStorageMethodType

Data type

text

Temperature during storage:
Description

UmbilicalCordBloodPriorThawAtFacilityStorageCelsiusScaleValue

Data type

double

Date storage started:
Description

UmbilicalCordBloodPriorThawAtFacilityStorageBeginDate

Data type

date

Product Processing / Manipulation
Description

Product Processing / Manipulation

Was a fresh product received, then cryopreserved at your facility prior to infusion?
Description

ReceivedNewHematopoieticStemCellGraftPriorInfusionProcedureAtFacilityCryopreservationIndicator

Data type

text

Was the product thawed from a cryopreserved state prior to infusion?
Description

PriorInfusionProcedureHematopoieticStemCellGraftFromCryopreservationThawIndicator

Data type

text

Was the entire product thawed?
Description

PriorInfusionHematopoieticStemCellGraftEntireThawIndicator

Data type

text

Was a compartment of the bag thawed?
Description

PriorInfusionHematopoieticStemCellGraftPartBagDosingUnitThawIndicator

Data type

text

Were there multiple product bags?
Description

PriorInfusionHematopoieticStemCellGraftMultipleBagDosingUnitThawIndicator

Data type

text

Specify number of bags thawed:
Description

PriorInfusionHematopoieticStemCellGraftMultipleBagDosingUnitThawCount

Data type

double

Date thawing process initiated:
Description

HematopoieticStemCellGraftThawPriorInfusionBeginDate

Data type

date

Time at initiation of thaw: (24-hour clock)
Description

HematopoieticStemCellGraftThawPriorInfusionBeginTime

Data type

time

Is the thawing begin time standard time or daylight savings time?
Description

HematopoieticStemCellGraftThawPriorInfusionBeginTimeUnitofMeasure

Data type

text

Time at completion of thaw : (24-hour clock)
Description

HematopoieticStemCellGraftThawPriorInfusionEndTime

Data type

time

Is the thawing end time standard time or daylight savings time?
Description

HematopoieticStemCellGraftThawPriorInfusionEndTimeUnitofMeasure

Data type

text

Was the primary container (e.g.,cord blood unit bag) intact upon thawing?
Description

PrimaryHematopoieticStemCellGraftContainerUponThawIntactIndicator

Data type

text

What method was used to thaw the product?
Description

HematopoieticStemCellGraftThawMethodHematopoieticStemCellGraftThawMethodType

Data type

text

Specify other thaw method: (Answer only if the value for 2789998 is "Other method")
Description

HematopoieticStemCellGraftOtherThawMethodTypeSpecify

Data type

text

Did any adverse events or incidents occur while thawing the product?
Description

AdverseEventDuringThawOccurrenceIndicator

Data type

text

Product Processing / Manipulation - Part 2
Description

Product Processing / Manipulation - Part 2

Was the product manipulated prior to infusion?
Description

HematopoieticStemCellGraftPriorInfusionProcedureManipulationIndicator

Data type

text

Specify portion manipulated:
Description

HematopoieticStemCellGraftPriorInfusionProcedurePartManipulationType

Data type

text

ABO incompatibility (RBC depletion)
Description

ErythrocyteCountReducedMethodPerformedIndicator

Data type

text

Buffy coat preparation
Description

ErythrocyteCountReducedMethodBuffyCoatPreparationPerformedIndicator

Data type

text

Cell separator (i.e., COBE Spectra)
Description

ErythrocyteCountReducedMethodCellSortingPerformedIndicator

Data type

text

Density gradient separation (i.e., Ficoll)
Description

ErythrocyteCountReducedMethodDensityGradientCentrifugationPerformedIndicator

Data type

text

Plasma removal
Description

ErythrocyteCountReducedMethodPlasmaRemovedPerformedIndicator

Data type

text

Sedimentation (i.e., hetastarch)
Description

ErythrocyteCountReducedMethodSedimentationPerformedIndicator

Data type

text

Other
Description

ErythrocyteCountReducedMethodOtherPerformedIndicator

Data type

text

Specify: (Answer only if the value for 2774524 is "Yes" )
Description

ErythrocyteCountReducedMethodOtherPerformedSpecify

Data type

text

Ex-vivo expansion
Description

IncreaseexvivoHematopoieticStemCellGraftManipulationTechniqueIndicator

Data type

text

Genetic manipulation (gene transfer / transduction)
Description

TransductionGeneHematopoieticStemCellGraftManipulationTechniqueIndicator

Data type

text

Volume reduction
Description

VolumeReducedHematopoieticStemCellGraftManipulationTechniqueIndicator

Data type

text

CD34+ selection
Description

HematopoieticProgenitorCellAntigenCD34PositiveSelectionMethodPerformedIndicator

Data type

text

Specify cell selection system used:
Description

HematopoieticProgenitorCellAntigenCD34PositiveSelectionHematopoieticStemCellGraftManipulationDiagnostic,Therapeutic,andResearchEquipmentName

Data type

text

Specify system: (Answer only if the value for 2786700 is "Other" )
Description

HematopoieticProgenitorCellAntigenCD34PositiveSelectionHematopoieticStemCellGraftManipulationOtherDiagnostic,Therapeutic,andResearchEquipmentTherapiesSpecify

Data type

text

T-cell depletion
Description

T-CellDepletionMethodPerformedIndicator

Data type

text

antibody affinity column
Description

T-CellDepletionMethodAntibodyAffinityPerformedIndicator

Data type

text

antibody coated plates
Description

T-CellDepletionMethodAntibodyCoatedPlatePerformedIndicator

Data type

text

antibody coated plates and soybean lectin
Description

T-CellDepletionMethodAntibodyCoatedPlateSoybeanLectinAgglutinationPerformedIndicator

Data type

text

antibody and complement
Description

T-CellDepletionMethodAntibodyComplementPerformedIndicator

Data type

text

antibody and toxin
Description

T-CellDepletionMethodAntibodyToxinPerformedIndicator

Data type

text

immunomagnetic beads
Description

T-CellDepletionMethodCellSortingImmunomagneticColumnPerformedIndicator

Data type

text

elutriation
Description

T-CellDepletionMethodElutriativeCentrifugationPerformedIndicator

Data type

text

CD34 affinity column plus sheep red blood cell rosetting
Description

T-CellDepletionMethodCD34AntigenImmunoaffinityChromatographySheepRedBloodCellRosettingPerformedIndicator

Data type

text

Other (Other T-cell depletion)
Description

T-CellDepletionMethodOtherPerformedIndicator

Data type

text

Specify: (Answer only if the value for 2774740 is "Yes" )
Description

T-CellDepletionMethodOtherPerformedTherapiesSpecify

Data type

text

Other manipulation
Description

HematopoieticStemCellGraftManipulationOtherTechniqueIndicator

Data type

text

Specify: (Answer only if the value for 2744934 is "Yes" )
Description

HematopoieticStemCellGraftManipulationOtherTechniqueTherapiesSpecify

Data type

text

Were antibodies used during product manipulation?
Description

DuringHematopoieticStemCellGraftManipulationAntibodyAdministeredIndicator

Data type

text

anti CD2
Description

DuringHematopoieticStemCellGraftManipulationCD2AntigenAdministeredIndicator

Data type

text

anti CD3
Description

DuringHematopoieticStemCellGraftManipulationCD3ComplexAdministeredIndicator

Data type

text

anti CD4
Description

DuringHematopoieticStemCellGraftManipulationCD4AntigenAdministeredIndicator

Data type

text

anti CD5
Description

DuringHematopoieticStemCellGraftManipulationT-CellSurfaceGlycoproteinCD5AdministeredIndicator

Data type

text

anti CD6
Description

DuringHematopoieticStemCellGraftManipulationT-CellDifferentiationAntigenCD6AdministeredIndicator

Data type

text

anti CD7
Description

DuringHematopoieticStemCellGraftManipulationT-CellAntigenCD7AdministeredIndicator

Data type

text

anti CD8
Description

DuringHematopoieticStemCellGraftManipulationCD8Antigen,BetaPolypeptide1AdministeredIndicator

Data type

text

anti CD34
Description

DuringHematopoieticStemCellGraftManipulationHematopoieticProgenitorCellAntigenCD34AdministeredIndicator

Data type

text

anti TCR alpha / beta (T10-B9)
Description

DuringHematopoieticStemCellGraftManipulationT-CellReceptor,Alpha-BetaAdministeredIndicator

Data type

text

OKT-3
Description

DuringHematopoieticStemCellGraftManipulationMuromonab-CD3AdministeredIndicator

Data type

text

other CD3
Description

DuringHematopoieticStemCellGraftManipulationOtherCD3ComplexAdministeredIndicator

Data type

text

Specify (Answer only if the value for 2746342 is "Yes" )
Description

DuringHematopoieticStemCellGraftManipulationOtherCD3ComplexAdministeredSpecify

Data type

text

anti CD52
Description

DuringHematopoieticStemCellGraftManipulationAnti-CD52MonoclonalAntibodyAdministeredIndicator

Data type

text

campath-NOS
Description

DuringHematopoieticStemCellGraftManipulationAlemtuzumabNotOtherwiseSpecifiedAdministeredIndicator

Data type

text

campath-1G
Description

DuringHematopoieticStemCellGraftManipulationCampath-1GAdministeredIndicator

Data type

text

campath-1H
Description

DuringHematopoieticStemCellGraftManipulationAlemtuzumabAdministeredIndicator

Data type

text

other antibody
Description

DuringHematopoieticStemCellGraftManipulationOtherAntibodyAdministeredIndicator

Data type

text

Specify: (Answer only if the value for 2746486 is "Yes" )
Description

DuringHematopoieticStemCellGraftManipulationOtherAntibodyAdministeredTherapiesSpecify

Data type

text

Autologous Products Only - Part 1 / 2
Description

Autologous Products Only - Part 1 / 2

Were tumor cells detected in the recipient or autologous product prior to HSCT?
Description

WithinRecipientOrAutologousGraftNeoplasticCellPriorHematopoieticStemCellTransplantationDetectedIndicator

Data type

text

Autologous Products Only
Description

Autologous Products Only

What tumor cell detection method was used ?
Description

PriorHematopoieticStemCellTransplantationNeoplasticCellDetectionMethodType

Data type

text

Were particular tumor cell detection method used prior to HSCT?
Description

PriorHematopoieticStemCellTransplantationNeoplasticCellDetectionMethodOccurrenceIndicator

Data type

text

Were tumor cells detected in circulating blood cells prior to HSCT?
Description

CirculatingTumorCellPriorHematopoieticStemCellTransplantationDetectionIndicator

Data type

text

Were tumor cells detected in bone marrow, in the interval between last systemic therapy and collection prior to HSCT?
Description

WithinBoneMarrowIntervalLastSystemicTherapyAndCollectionNeoplasticCellPriorHematopoieticStemCellTransplantationDetectionIndicator

Data type

text

Were tumor cells detected in collected cells, before purging prior to HSCT?
Description

PriorHematopoieticStemCellTransplantationNeoplasticCellWithinGraftPriorRemovableDetectionDetectionIndicator

Data type

text

Specify method (Answer only if the value for 2775544 is "Other molecular technique" OR "Other technique" )
Description

PriorHematopoieticStemCellTransplantationNeoplasticCellDetectionOtherMethodOccurrenceTherapiesSpecify

Data type

text

Autologous Products Only - Part 3 / 5
Description

Autologous Products Only - Part 3 / 5

Was the product treated to remove malignant cells (purged) ? (autologous product only)
Description

HematopoieticStemCellGraftRemovedMalignantCellTreatIndicator

Data type

text

Autologous Products Only - 3 / 4
Description

Autologous Products Only - 3 / 4

What malignant cell removal method was used to treat the product?
Description

MalignantCellRemovedMethodType

Data type

text

Was a particular malignant cell removal method used for product treatment?
Description

MalignantCellRemovedMethodOccurrenceIndicator

Data type

text

Specify the other malignant cell removal method: (Answer only if the value for 2748795 is "Monoclonal antibody","Other drug", "Toxin","Positive stem cell selection" or "Other method".)
Description

MalignantCellRemovedOtherMethodOccurrenceTherapiesSpecify

Data type

text

Autologous Products Only Part 4 / 4
Description

Autologous Products Only Part 4 / 4

What kind of method was used to detect tumor cells after purging?
Description

PostMalignantCellRemovedNeoplasticCellDetectionMethodType

Data type

text

Was a particular tumor cell detection method used after purging?
Description

PostMalignantCellRemovedNeoplasticCellDetectionMethodOccurrenceIndicator

Data type

text

Specify the other tumor cells detection method (Answer only if the value for 2778929 is "Other")
Description

PostMalignantCellRemovedNeoplasticCellDetectionOtherMethodOccurrenceTherapiesSpecify

Data type

text

Product Analysis (all Products)
Description

Product Analysis (all Products)

Specify the time point in the product preparation that the product was analyzed:
Description

HematopoieticStemCellGraftLaboratoryProcedureTimepointType

Data type

text

Date of product analysis:
Description

HematopoieticStemCellGraftLaboratoryProcedureDate

Data type

date

Total volume of product: (one decimal place)
Description

HematopoieticStemCellGraftLaboratoryProcedureTotalVolumeValue

Data type

double

What was the unit of measure for the total volume of the product being analyzed?
Description

HematopoieticStemCellGraftLaboratoryProcedureSpecimenUOM

Data type

text

Nucleated cells: (Report the total number of cells not cells per kilogram)
Description

NucleatedBloodCellLaboratoryProcedureCellTotalInteger::2DecimalPlaceCount

Data type

double

Nucleated cells exponent value:
Description

NucleatedBloodCellLaboratoryProcedureExponentValue

Data type

double

Not tested (Not tested for nucleated cells)
Description

NucleatedBloodCellLaboratoryProcedureMissingValueReasonIndicator

Data type

text

Mononucleated cells: (Report the total number of cells not cells per kilogram)
Description

MononucleatedBloodCellLaboratoryProcedureCellTotalInteger::2DecimalPlaceCount

Data type

double

Mononucleated cells exponent value:
Description

MononucleatedBloodCellLaboratoryProcedureExponentValue

Data type

double

Not tested (Not tested for mononucleated cells)
Description

MononucleatedBloodCellLaboratoryProcedureMissingValueReasonIndicator

Data type

text

Nucleated red blood cells: (Report the total number of cells not cells per kilogram)
Description

NucleatedRedBloodCellLaboratoryProcedureCellTotalInteger::2DecimalPlaceCount

Data type

double

Nucleated red blood cells exponent value:
Description

NucleatedRedBloodCellLaboratoryProcedureExponentValue

Data type

double

Not tested (Not tested for nucleated red blood cells)
Description

NucleatedRedBloodCellLaboratoryProcedureMissingValueReasonIndicator

Data type

text

CD34+ cells: (Report the total number of cells not cells per kilogram)
Description

HematopoieticProgenitorCellAntigenCD34PresentCellLaboratoryProcedureCellTotalInteger::2DecimalPlaceCount

Data type

double

CD34+ cells exponent value:
Description

HematopoieticProgenitorCellAntigenCD34PresentCellLaboratoryProcedureExponentValue

Data type

double

Not tested (Not tested for CD34+ cells)
Description

HematopoieticProgenitorCellAntigenCD34PresentCellLaboratoryProcedureMissingValueReasonIndicator

Data type

text

CD3+ cells: (Report the total number of cells not cells per kilogram)
Description

CD3ComplexPresentCellLaboratoryProcedureCellTotalInteger::2DecimalPlaceCount

Data type

double

CD3+ cells exponent value:
Description

CD3ComplexPresentCellLaboratoryProcedureExponentValue

Data type

double

Not tested (Not tested for CD3+ cells)
Description

CD3ComplexPresentCellLaboratoryProcedureMissingValueReasonIndicator

Data type

text

CD4+ cells: (Report the total number of cells not cells per kilogram)
Description

CD4AntigenPresentCellLaboratoryProcedureCellTotalInteger::2DecimalPlaceCount

Data type

double

CD4+ cells exponent value:
Description

CD4AntigenPresentCellLaboratoryProcedureExponentValue

Data type

double

Not tested (Not tested for CD4+ cells)
Description

CD4AntigenPresentCellLaboratoryProcedureMissingValueReasonIndicator

Data type

text

CD8+ cells: (Report the total number of cells not cells per kilogram)
Description

CD8-PositiveT-LymphocytePresentCellLaboratoryProcedureCellTotalInteger::2DecimalPlaceCount

Data type

double

CD8+ cells exponent value:
Description

CD8-PositiveT-LymphocytePresentCellLaboratoryProcedureExponentValue

Data type

double

Not tested (Not tested for CD8+ cells)
Description

CD8-PositiveT-LymphocytePresentCellLaboratoryProcedureMissingValueReasonIndicator

Data type

text

Viability of cells
Description

LaboratoryProcedureViableCellSpecimenOutcomePercentageValue

Data type

double

Not tested (The cell viability not tested)
Description

LaboratoryProcedureViableCellSpecimenOutcomeMissingValueReasonIndicator

Data type

text

Method of testing cell viability:
Description

LaboratoryProcedureViableCellSpecimenOutcomeType

Data type

text

Specify other method: (Answer only if the value for 2760530 is "Other method")
Description

LaboratoryProcedureViableCellSpecimenOutcomeSpecify

Data type

text

Were the colony-forming units (CFU) assessed after thawing? (cord blood product only)
Description

ColonyFormingUnitPostThawAssessmentIndicator

Data type

text

Was there growth?
Description

ColonyFormingUnitPostThawGrowthIndicator

Data type

text

Total colonies per product: (One decimal place with exponent "x10E5")
Description

LaboratoryProcedurePostThawColonyFormingUnitOutcomeTotalColonyCount

Data type

double

Unknown (Total colonies per productunknown )
Description

LaboratoryProcedurePostThawColonyFormingUnitOutcomeMissingValueReasonIndicator

Data type

text

Total CFU-GM: (One decimal place with exponent "x10E5")
Description

ColonyFormingUnitLaboratoryProcedurePostThawPerformedTotalColony-FormingUnit-GranulocyteMacrophageAssayCount

Data type

double

Unknown (Total CFU-GMUnknown )
Description

ColonyFormingUnitLaboratoryProcedurePostThawPerformedMissingValueReasonIndicator

Data type

text

Were cultures performed before infusion to test the product(s) for bacterial or fungal infection? (complete for all cell products)
Description

PriorInfusionProcedureCultureProcedureBacteriaFungiInfectiousDisorderIndicator

Data type

text

Specify results:
Description

PriorInfusionProcedureCultureProcedureBacteriaFungiInfectiousDisorderLaboratoryFindingResult

Data type

text

Specify organism names: (1st Organism Name)
Description

PriorInfusionProcedureCultureProcedureBacteriaFungiInteger::1InfectiousDisorderOrganismName

Data type

text

Specify organism names: (2nd Organism Name)
Description

PriorInfusionProcedureCultureProcedureBacteriaFungiInteger::2InfectiousDisorderOrganismName

Data type

text

Specify organism names: (3rd Organism Name)
Description

PriorInfusionProcedureCultureProcedureBacteriaFungiInteger::3InfectiousDisorderOrganismName

Data type

text

Specify organism names: (4th Organism Name)
Description

PriorInfusionProcedureCultureProcedureBacteriaFungiInteger::4InfectiousDisorderOrganismName

Data type

text

Specify organism names: (5th Organism Name)
Description

PriorInfusionProcedureCultureProcedureBacteriaFungiInteger::5InfectiousDisorderOrganismName

Data type

text

Specify organism names: (6th Organism Name)
Description

PriorInfusionProcedureCultureProcedureBacteriaFungiInteger::6InfectiousDisorderOrganismName

Data type

text

If codes 198, 209, 219, or 259, specify organism: (Answer only if the value for 2784429, 2784431,2784433,2784435,2784437 and 2784439 is "Other bacteria, specify","Other Candida, specify",Other Aspergillus, specify" or "Other fungus, specify".)
Description

PriorInfusionProcedureCultureProcedureBacteriaFungiInfectiousDisorderOtherOrganismSpecify

Data type

text

Product Infusion
Description

Product Infusion

Was more than one product infused? (e.g., marrow and PBSC,PBSC and cord blood, two different cords, etc.)
Description

MultipleHematopoieticStemCellGraftInfusionProcedureIndicator

Data type

text

Was the product infusion described on this insert intended to produce hematopoietic engraftment?
Description

HematopoieticStemCellGraftInfusionProcedureHematopoieticEngraftmentIntentIndicator

Data type

text

Date of this product infusion:
Description

MultipleHematopoieticStemCellGraftInfusionProcedureDate

Data type

date

Time product infusion initiated (24-hour clock):
Description

HematopoieticStemCellGraftInfusionProcedureBeginTime

Data type

time

Is it the standard time or daylight savings time?
Description

HematopoieticStemCellGraftInfusionProcedureBeginTimeUnitofMeasure

Data type

text

Time product infusion completed (24-hour clock):
Description

HematopoieticStemCellGraftInfusionProcedureEndTime

Data type

time

Is it the standard time or daylight savings time?
Description

HematopoieticStemCellGraftInfusionProcedureEndTimeUnitofMeasure

Data type

text

Total volume of product plus additives infused: (One decimal place with Unit of Measure "ml")
Description

HematopoieticStemCellGraftCombinedAdditiveInfusionProcedureTotalVolumeValue

Data type

double

Measurement units
  • ml
ml
Specify the route of product infusion:
Description

HematopoieticStemCellGraftInfusionProcedureRouteofAdministrationType

Data type

text

Specify route of infusion:
Description

HematopoieticStemCellGraftInfusionProcedureOtherRouteofAdministrationTherapiesSpecify

Data type

text

Did the volume of infused product include any added agents?
Description

WithinHematopoieticStemCellGraftInfusionProcedureAdditiveAgentOccurrenceIndicator

Data type

text

Product Infusion - Part 2 / 3
Description

Product Infusion - Part 2 / 3

What kind of additives are included in volume of infused product?
Description

WithinHematopoieticStemCellGraftInfusionProcedureVolumeAdditiveType

Data type

text

Were particular additives included in volume of infused product?
Description

WithinHematopoieticStemCellGraftInfusionProcedureAdditiveAdministeredIndicator

Data type

text

Specify agent: (Answer only if the value for 2740356 is "Other")
Description

WithinHematopoieticStemCellGraftInfusionProcedureOtherAdditiveAdministeredTherapiesSpecify

Data type

text

Product Infusion
Description

Product Infusion

Was the entire volume of product infused?
Description

HematopoieticStemCellGraftEntireVolumeInfusionProcedureIndicator

Data type

text

Specify what happened to the reserved portion:
Description

ReservationPartEndPointType

Data type

text

Specify: (Answer only if the value for 2769592 is "Other fate")
Description

ReservationPartEndPointSpecifyText

Data type

text

Were there any adverse events or incidents associated with the stem cell infusion? (The question refers to all stem cell products except for autologous marrow or autologous PBSC products.)
Description

WithHematopoieticStemCellInfusionProcedureAdverseEventAssociatedIndicator

Data type

text

Product Infusion
Description

Product Infusion

What type of Adverse Events associated with the stem cell infusion?
Description

HematopoieticStemCellGraftInfusionProcedureAdverseEventType

Data type

text

Did a particular stem cell infusion associated adverse event occur?
Description

WithHematopoieticStemCellInfusionProcedureAdverseEventOccurrenceIndicator

Data type

text

Did particular adverse events require medical intervention?
Description

WithHematopoieticStemCellInfusionProcedureAdverseEventMedicalInterventionorProcedureRequiredIndicator

Data type

text

Were particular adverse events resolved?
Description

WithHematopoieticStemCellInfusionProcedureAdverseEventResolutionIndicator

Data type

text

Specify (Answer only if the value for 2739534 is "Other expected AE" or "Other unexpected AE")
Description

HematopoieticStemCellGraftInfusionProcedureOtherAdverseEventSpecify

Data type

text

Product Infusion
Description

Product Infusion

In the Medical Director's judgement, was the adverse event a direct result of the infusion?
Description

AdverseEventDirectHematopoieticStemCellInfusionOutcomeIndicator

Data type

text

Specify the most likely cause of the adverse event :
Description

AdverseEventReasonType

Data type

text

Specify illness: (Answer only if the value for 2769598 is "Other illness")
Description

AdverseEventOtherDiseaseorDisorderTherapiesSpecify

Data type

text

Specify reason: (Answer only if the value for 2769598 is "Other reason")
Description

AdverseEventOtherReasonTherapiesSpecify

Data type

text

Donor Demographic Information
Description

Donor Demographic Information

Donor date of birth:
Description

TransplantDonorBirthDate

Data type

date

Date unknown
Description

TransplantDonorBirthDateValidationIndicator

Data type

text

Age of mother (approximate): (Cord blood unit only)
Description

MotherAgeValue

Data type

double

Measurement units
  • year
year
What is the reason for the mother's missing age? (Cord blood unit only)
Description

MotherAgeMissingValueReasonIndicator

Data type

text

Non-NMDP Cord Blood Unit (CBU) ID: (Cord blood unit only)
Description

HematopoieticStemCellTransplantationUmbilicalCordBloodTypeNotInstitution::NationalMarrowDonorProgramIdentifier

Data type

text

Is the CBU ID number also the ICCBBA ISBT 128 number? (Cord blood unit only)
Description

UmbilicalCordBloodUnitUniqueIdentifierSameInstitutionUniqueIdentifierIndicator

Data type

text

Name of cord blood bank providing CBU: (Cord blood unit only)
Description

TissueBankingInstitutionName

Data type

text

Donor Gender
Description

TransplantDonorGenderType

Data type

text

Was the donor ever pregnant?
Description

TissueDonorPregnancyIndicator

Data type

text

Specify number of pregnancies:
Description

TissueDonorPregnancyCount

Data type

double

What is the reason for the missing number of pregnancies?
Description

TissueDonorPregnancyCountMissingValueReasonIndicator

Data type

text

Donor's blood type and Rh factor:
Description

TissueDonorBloodTypeAndRhFactorType

Data type

text

Did this donor have a central line placed?
Description

TissueDonorCentralVenousAccessCatheterIndicator

Data type

text

Specify the site of the central line placement:
Description

TissueDonorCentralVenousAccessCatheterAnatomicSiteName

Data type

text

Specify site: (Answer only if the value for 2769666 is "Other site")
Description

TissueDonorCentralVenousAccessCatheterAnatomicSiteOtherSpecify

Data type

text

Donor's ethnicity:
Description

TissueDonorEthnicGroupCategory

Data type

text

Donor Demographic Information Part 2 / 2
Description

Donor Demographic Information Part 2 / 2

Donor's race (Mark the groups in which the donor is a member. Check all that apply )
Description

TissueDonorRaceType

Data type

text

Donor Demographic Information
Description

Donor Demographic Information

What is the relationship of the donor to the recipient?
Description

TissueDonorRecipientRelationshipType

Data type

text

Specify the relationship of the donor to the recipient: (Answer only if the value for 2784447 is "Other relative")
Description

TissueDonorOtherRecipientRelationshipType

Data type

text

Specify relationship: (Answer only if the value for 2728852 is "Other relative")
Description

TissueDonorOtherRecipientRelationshipText

Data type

text

Was the donor / product tested for potentially transplantable genetic diseases?
Description

TissueDonorGeneticTestingTransplantationTransmissionDiseaseorDisorderIndicator

Data type

text

Sickle cell anemia
Description

TissueDonorGeneticTestingSickleCellDiseaseIndicator

Data type

text

Thalassemia
Description

TissueDonorGeneticTestingThalassemiaIndicator

Data type

text

Other
Description

TissueDonorGeneticTestingOtherDiseaseorDisorderIndicator

Data type

text

Specify genetic disease: (Answer only if the value for 2772022 is "Yes")
Description

TissueDonorGeneticTestingOtherDiseaseorDisorderSpecify

Data type

text

Was the donor hospitalized (inpatient) during or after the collection? (Question applies only to allogeneic non-NMDP donors)
Description

TissueDonorDuringOrAfterHematopoieticStemCellCollectionHospitalizationIndicator

Data type

text

Did the donor experience any life-threatening complications during or after the collection? (Question applies only to allogeneic non-NMDP donors)
Description

TissueDonorDuringOrAfterHematopoieticStemCellCollectionLifeThreateningorDisablingAdverseEventIndicator

Data type

text

Specify complications: (Question applies only to allogeneic non-NMDP donors. Answer only if the value of CDE 2728986 is "Yes".)
Description

TissueDonorDuringOrAfterHematopoieticStemCellCollectionLifeThreateningorDisablingAdverseEventSpecify

Data type

text

Did the donor receive blood transfusions as a result of the collection? (Question applies only to allogeneic non-NMDP donors)
Description

TissueDonorHematopoieticStemCellCollectionOutcomeBloodTransfusionIndicator

Data type

text

Was the blood transfusion product autologous? (Question applies only to allogeneic non-NMDP donors )
Description

BloodTransfusionAutologousIndicator

Data type

text

Specify number of units: (For the autologous blood transfusion)
Description

BloodTransfusionAutologousUnitNumber

Data type

double

Was the blood transfusion product allogeneic (homologous)? (Question applies only to allogeneic non-NMDP donors)
Description

BloodTransfusionAllogenicIndicator

Data type

text

Specify number of units: (For the autologous blood transfusion)
Description

BloodTransfusionAllogenicUnitNumber

Data type

double

Did the donor die as a result of the collection? (Question applies only to allogeneic non-NMDP donors)
Description

TissueDonorHematopoieticStemCellCollectionOutcomeDeathIndicator

Data type

text

Specify cause of death: (Question applies only to allogeneic non-NMDP donors)
Description

TissueDonorHematopoieticStemCellCollectionOutcomeDeathReasonSpecify

Data type

text

Did the recipient submit a research sample? (Related donors only)
Description

RecipientResearchSpecimenIndicator

Data type

text

Research sample recipient ID:
Description

RecipientResearchSpecimenIdentificationNumber

Data type

double

Did the donor submit a research sample? (Related donors only)
Description

TissueDonorResearchSpecimenIndicator

Data type

text

Research sample donor ID: (Related donors only)
Description

TissueDonorResearchSpecimenIdentificationNumber

Data type

double

Author Information
Description

Author Information

First Name
Description

PersonGiven/FirstName

Data type

text

Last Name
Description

PersonFamily/LastName

Data type

text

Telephone number:
Description

ContactPersonLocationTelephoneNumber

Data type

text

Fax number:
Description

ContactPersonLocationFaxNumber

Data type

text

E-mail address:
Description

PersonEmailAddressText

Data type

text

Similar models

This form must be completed for all recipients who receive a HSCT product. If multiple HSCT products are infused it must be reported separately. A series of collections should be considered a single product when they are all from the same donor and use the same collection method and technique (and mobilization, if applicable), even if the collections are performed on different days.

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Registry Use Only
ClinicalDataFormSequenceNumber
Item
Sequence number:
double
ClinicalDataFormReceivedDate
Item
Date received:
date
Item Group
Identification Data
HematopoieticStemCellTransplantationRecipientInstitution::CenterforInternationalBloodandMarrowTransplantResearchFacilityNumber
Item
CIBMTR Center Number:
double
HematopoieticStemCellTransplantationRecipientIdentificationNumber
Item
CIBMTR Recipient ID:
double
HematopoieticStemCellTransplantationTissueDonorIdentificationNumber
Item
Donor ID:
double
HematopoieticStemCellTransplantationUmbilicalCordBloodTypeInstitution::NationalMarrowDonorProgramIdentifier
Item
NMDP Cord Blood Unit ID:
double
Code List
Non-NMDP Cord Blood Unit :
CL Item
Yes (Yes)
ClinicalDataFormTodayDate
Item
Today's date:
date
HematopoieticStemCellTransplantationOccurrenceDate
Item
Date of hematopoietic stem cell transplantation (HSCT) for which this form is being completed:
date
Item Group
Hsct Type
Item
What source was used for the hematopoietic stem cell transplantation?
text
Code List
What source was used for the hematopoietic stem cell transplantation?
CL Item
Autologous (Autologous)
CL Item
Unrelated Allogenic (Allogeneic, unrelated)
CL Item
Related Allogenic (Allogeneic, related)
CL Item
Syngeneic (Syngeneic (identical twin))
Item
Was a particular hematopoietic stem cell source used?
text
Code List
Was a particular hematopoietic stem cell source used?
CL Item
Yes (Yes)
Item Group
Product Type
Item
What type of hematopoietic stem cell transplant was used?
text
Code List
What type of hematopoietic stem cell transplant was used?
CL Item
Bone Marrow (Marrow)
CL Item
Peripheral Blood Stem Cell (PBSC)
CL Item
Umbilical Cord Blood (Cord blood)
CL Item
Multiple Umbilical Cord Blood (Multiple cord blood units infused)
CL Item
Other (Other)
Item
Was a particular hematopoietic stem cell transplant type used?
text
Code List
Was a particular hematopoietic stem cell transplant type used?
CL Item
Yes (Yes)
HematopoieticStemCellGraftOtherTypeSpecify
Item
Specify the other hematopoietic stem cell transplant type: (Answer only if the value for 2730912 is "Other". )
text
Item Group
Pre-collection Therapy
Item
Did the donor receive treatment, prior to any stem cell harvest, to enhance the product collection for this HSCT?
text
Code List
Did the donor receive treatment, prior to any stem cell harvest, to enhance the product collection for this HSCT?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
National Marrow Donor Program Donor (NMDP donor)
CL Item
Umbilical Cord Blood Unit (Cord blood unit)
Item
Chemotherapy (autologous only)
text
Code List
Chemotherapy (autologous only)
CL Item
Yes (Yes)
CL Item
No (No)
Item
Anti-CD20(rituximab,Rituxan) (autologous only)
text
Code List
Anti-CD20(rituximab,Rituxan) (autologous only)
CL Item
Yes (Yes)
CL Item
No (No)
Code List
Growth factor(s)
CL Item
Yes (Yes)
CL Item
No (No)
Code List
G-CSF
CL Item
Yes (Yes)
CL Item
No (No)
Code List
GM-CSF
CL Item
Yes (Yes)
CL Item
No (No)
Code List
Other growth factor(s)
CL Item
Yes (Yes)
CL Item
No (No)
PriorHarvestProcedureTissueDonorTreatOtherHematopoieticGrowthFactorTherapiesSpecify
Item
Specify (Answer only if the value for 2772114 is "Yes")
text
Code List
Other treatment
CL Item
Yes (Yes)
CL Item
No (No)
PriorHarvestProcedureTissueDonorOtherTreatSpecify
Item
Specify treatment: (Answer only if the value for 2773751 is "Yes")
text
Item Group
Product Collection
HematopoieticStemCellGraftCollectionDate
Item
Date of product collection:
date
Item
Was more than one collection required for this HSCT?
text
Code List
Was more than one collection required for this HSCT?
CL Item
Yes (Yes)
CL Item
No (No)
MultipleHematopoieticStemCellCollectionNextDayCount
Item
Specify the number of subsequent days of collection in this episode: (Complete a separate product form for each subsequent collection that was not part of this mobilization.)
double
Item
Were anticoagulants added to the product during collection?
text
Code List
Were anticoagulants added to the product during collection?
CL Item
Yes (Yes)
CL Item
No (No)
Item Group
Product Collection
Item
What anticoagulants were added to the product during collection?
text
Code List
What anticoagulants were added to the product during collection?
CL Item
Acid-citrate-dextrose (Acid-Citrate-Dextrose (ACD))
CL Item
Citrate Phosphate Dextrose (Citrate Phosphate Dextrose (CPD))
CL Item
Heparin (Heparin)
CL Item
Other (Other)
Item
Were particular anticoagulants added to the product during collection?
text
Code List
Were particular anticoagulants added to the product during collection?
CL Item
Yes (Yes)
CL Item
No (No)
DuringCollectionHematopoieticStemCellGraftCombinedOtherAnticoagulantAgentAdministrationTherapiesSpecify
Item
Specify the other anticoagulants (Answer only if the value for 2741578 is "Other")
text
Item Group
Product Transport And Receipt
Item
Was this product collected off-site and shipped to your facility?
text
Code List
Was this product collected off-site and shipped to your facility?
CL Item
Yes (Yes)
CL Item
No (No)
HematopoieticStemCellGraftAtFacilityReceivedDate
Item
Date of receipt of product at your facility:
date
HematopoieticStemCellGraftReceivedHourMinuteTime
Item
Time of receipt of product: (24-hour clock)
time
Item
Is time of receipt of product standard time or daylight savings time?
text
Code List
Is time of receipt of product standard time or daylight savings time?
CL Item
Standard Time (Standard time)
CL Item
Daylight Savings Time (Daylight Savings Time)
Item
Specify the shipping environment of the product(s):
text
Code List
Specify the shipping environment of the product(s):
CL Item
Freezing Gel Pack (Frozen Gel Pack)
CL Item
Freezing Umbilical Cord Blood Storage Unit (Frozen Cord Blood Unit (s))
CL Item
Ambient Temperature (Room Temperature per Transplant Center Request)
CL Item
Other Temperature (Other Temperature)
HematopoieticStemCellGraftArrivalFacilityShippingEnvironmentSpecifyText
Item
Specify shipping environment:
text
Item
Were the secondary containers (e.g., insulated shipping containers and unit cassette) intact when they arrived at your center? (Cord blood product only)
text
Code List
Were the secondary containers (e.g., insulated shipping containers and unit cassette) intact when they arrived at your center? (Cord blood product only)
CL Item
Yes (Yes)
CL Item
No (No)
Item
Was the cord blood unit completely frozen when it arrived at your center? (Cord blood product only)
text
Code List
Was the cord blood unit completely frozen when it arrived at your center? (Cord blood product only)
CL Item
Yes (Yes)
CL Item
No (No)
Item
Was the cord blood unit stored at your center prior to thawing? (Cord blood product only)
text
Code List
Was the cord blood unit stored at your center prior to thawing? (Cord blood product only)
CL Item
Yes (Yes)
CL Item
No (No)
Item
Specify the storage method used for the cord blood unit:
text
Code List
Specify the storage method used for the cord blood unit:
CL Item
Liquid Nitrogen (Liquid Nitrogen)
CL Item
Vapor Phase Cooling (Vapor Phase)
CL Item
Electricity Freezing (Electric Freezer)
UmbilicalCordBloodPriorThawAtFacilityStorageCelsiusScaleValue
Item
Temperature during storage:
double
UmbilicalCordBloodPriorThawAtFacilityStorageBeginDate
Item
Date storage started:
date
Item Group
Product Processing / Manipulation
Item
Was a fresh product received, then cryopreserved at your facility prior to infusion?
text
Code List
Was a fresh product received, then cryopreserved at your facility prior to infusion?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not Applicable (Not Applicable)
Item
Was the product thawed from a cryopreserved state prior to infusion?
text
Code List
Was the product thawed from a cryopreserved state prior to infusion?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Was the entire product thawed?
text
Code List
Was the entire product thawed?
CL Item
Yes (Yes)
CL Item
No (No)
Code List
Was a compartment of the bag thawed?
CL Item
Yes (Yes)
CL Item
No (No)
Code List
Were there multiple product bags?
CL Item
Yes (Yes)
CL Item
No (No)
PriorInfusionHematopoieticStemCellGraftMultipleBagDosingUnitThawCount
Item
Specify number of bags thawed:
double
HematopoieticStemCellGraftThawPriorInfusionBeginDate
Item
Date thawing process initiated:
date
HematopoieticStemCellGraftThawPriorInfusionBeginTime
Item
Time at initiation of thaw: (24-hour clock)
time
Item
Is the thawing begin time standard time or daylight savings time?
text
Code List
Is the thawing begin time standard time or daylight savings time?
CL Item
Standard Time (Standard time)
CL Item
Daylight Savings Time (Daylight Savings Time)
HematopoieticStemCellGraftThawPriorInfusionEndTime
Item
Time at completion of thaw : (24-hour clock)
time
Item
Is the thawing end time standard time or daylight savings time?
text
Code List
Is the thawing end time standard time or daylight savings time?
CL Item
Standard Time (Standard time)
CL Item
Daylight Savings Time (Daylight Savings Time)
Item
Was the primary container (e.g.,cord blood unit bag) intact upon thawing?
text
Code List
Was the primary container (e.g.,cord blood unit bag) intact upon thawing?
CL Item
Yes (Yes)
CL Item
No (No)
Item
What method was used to thaw the product?
text
Code List
What method was used to thaw the product?
CL Item
No Cell Wash (no wash - thawed at bedside,then infused)
CL Item
Dimethyl Sulfoxide Dilute (DMSO dilution - thawed in lab (added dextran and albumin), then infused)
CL Item
Cell Wash (washed - thawed in lab (added dextran and albumin),spun and reconstituted in dextran albumin,then infused)
CL Item
Other Method (other method)
HematopoieticStemCellGraftOtherThawMethodTypeSpecify
Item
Specify other thaw method: (Answer only if the value for 2789998 is "Other method")
text
Item
Did any adverse events or incidents occur while thawing the product?
text
Code List
Did any adverse events or incidents occur while thawing the product?
CL Item
Yes (Yes)
CL Item
No (No)
Item Group
Product Processing / Manipulation - Part 2
Item
Was the product manipulated prior to infusion?
text
Code List
Was the product manipulated prior to infusion?
CL Item
Yes (Yes)
CL Item
No (No)
Code List
Specify portion manipulated:
CL Item
Entire Hematopoietic Stem Cell Collection (Entire product)
CL Item
Part Hematopoietic Stem Cell Collection (Portion of product)
Item
ABO incompatibility (RBC depletion)
text
Code List
ABO incompatibility (RBC depletion)
CL Item
Yes (Yes)
CL Item
No (No)
Code List
Buffy coat preparation
CL Item
Yes (Yes)
CL Item
No (No)
Item
Cell separator (i.e., COBE Spectra)
text
Code List
Cell separator (i.e., COBE Spectra)
CL Item
Yes (Yes)
CL Item
No (No)
Item
Density gradient separation (i.e., Ficoll)
text
Code List
Density gradient separation (i.e., Ficoll)
CL Item
Yes (Yes)
CL Item
No (No)
Code List
Plasma removal
CL Item
Yes (Yes)
CL Item
No (No)
Item
Sedimentation (i.e., hetastarch)
text
Code List
Sedimentation (i.e., hetastarch)
CL Item
Yes (Yes)
CL Item
No (No)
Code List
Other
CL Item
Yes (Yes)
CL Item
No (No)
ErythrocyteCountReducedMethodOtherPerformedSpecify
Item
Specify: (Answer only if the value for 2774524 is "Yes" )
text
Code List
Ex-vivo expansion
CL Item
Yes (Yes)
CL Item
No (No)
Item
Genetic manipulation (gene transfer / transduction)
text
Code List
Genetic manipulation (gene transfer / transduction)
CL Item
Yes (Yes)
CL Item
No (No)
Code List
Volume reduction
CL Item
Yes (Yes)
CL Item
No (No)
Code List
CD34+ selection
CL Item
Yes (Yes)
CL Item
No (No)
Code List
Specify cell selection system used:
CL Item
Clinimax Cell Selection System (CliniMACS / CliniMax)
CL Item
Isolex Cell Selection System (Isolex)
CL Item
Other (Other)
HematopoieticProgenitorCellAntigenCD34PositiveSelectionHematopoieticStemCellGraftManipulationOtherDiagnostic,Therapeutic,andResearchEquipmentTherapiesSpecify
Item
Specify system: (Answer only if the value for 2786700 is "Other" )
text
Code List
T-cell depletion
CL Item
Yes (Yes)
CL Item
No (No)
Code List
antibody affinity column
CL Item
Yes (Yes)
CL Item
No (No)
Code List
antibody coated plates
CL Item
Yes (Yes)
CL Item
No (No)
Code List
antibody coated plates and soybean lectin
CL Item
Yes (Yes)
CL Item
No (No)
Code List
antibody and complement
CL Item
Yes (Yes)
CL Item
No (No)
Code List
antibody and toxin
CL Item
Yes (Yes)
CL Item
No (No)
Code List
immunomagnetic beads
CL Item
Yes (Yes)
CL Item
No (No)
Code List
elutriation
CL Item
Yes (Yes)
CL Item
No (No)
Code List
CD34 affinity column plus sheep red blood cell rosetting
CL Item
Yes (Yes)
CL Item
No (No)
Item
Other (Other T-cell depletion)
text
Code List
Other (Other T-cell depletion)
CL Item
Yes (Yes)
CL Item
No (No)
T-CellDepletionMethodOtherPerformedTherapiesSpecify
Item
Specify: (Answer only if the value for 2774740 is "Yes" )
text
Code List
Other manipulation
CL Item
Yes (Yes)
CL Item
No (No)
HematopoieticStemCellGraftManipulationOtherTechniqueTherapiesSpecify
Item
Specify: (Answer only if the value for 2744934 is "Yes" )
text
Item
Were antibodies used during product manipulation?
text
Code List
Were antibodies used during product manipulation?
CL Item
Yes (Yes)
CL Item
No (No)
Code List
anti CD2
CL Item
Yes (Yes)
CL Item
No (No)
Code List
anti CD3
CL Item
Yes (Yes)
CL Item
No (No)
Code List
anti CD4
CL Item
Yes (Yes)
CL Item
No (No)
Code List
anti CD5
CL Item
Yes (Yes)
CL Item
No (No)
Code List
anti CD6
CL Item
Yes (Yes)
CL Item
No (No)
Code List
anti CD7
CL Item
Yes (Yes)
CL Item
No (No)
Code List
anti CD8
CL Item
Yes (Yes)
CL Item
No (No)
Code List
anti CD34
CL Item
Yes (Yes)
CL Item
No (No)
Code List
anti TCR alpha / beta (T10-B9)
CL Item
Yes (Yes)
CL Item
No (No)
Code List
OKT-3
CL Item
Yes (Yes)
CL Item
No (No)
Code List
other CD3
CL Item
Yes (Yes)
CL Item
No (No)
DuringHematopoieticStemCellGraftManipulationOtherCD3ComplexAdministeredSpecify
Item
Specify (Answer only if the value for 2746342 is "Yes" )
text
Code List
anti CD52
CL Item
Yes (Yes)
CL Item
No (No)
Code List
campath-NOS
CL Item
Yes (Yes)
CL Item
No (No)
Code List
campath-1G
CL Item
Yes (Yes)
CL Item
No (No)
Code List
campath-1H
CL Item
Yes (Yes)
CL Item
No (No)
Code List
other antibody
CL Item
Yes (Yes)
CL Item
No (No)
DuringHematopoieticStemCellGraftManipulationOtherAntibodyAdministeredTherapiesSpecify
Item
Specify: (Answer only if the value for 2746486 is "Yes" )
text
Item Group
Autologous Products Only - Part 1 / 2
Item
Were tumor cells detected in the recipient or autologous product prior to HSCT?
text
Code List
Were tumor cells detected in the recipient or autologous product prior to HSCT?
CL Item
Yes (Yes)
CL Item
No (No)
Item Group
Autologous Products Only
Item
What tumor cell detection method was used ?
text
Code List
What tumor cell detection method was used ?
CL Item
Histopathology (Routine histopathology)
CL Item
Pcr, Polymerase Chain Reaction (Polymerase chain reaction(PCR))
CL Item
Other Molecular Techniques (Other molecular technique)
CL Item
Ihc, Immunohistochemistry (Immunohistochemistry)
CL Item
Cell Culture Techniques (Cell culture technique)
CL Item
Other (Other)
Item
Were particular tumor cell detection method used prior to HSCT?
text
Code List
Were particular tumor cell detection method used prior to HSCT?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Were tumor cells detected in circulating blood cells prior to HSCT?
text
Code List
Were tumor cells detected in circulating blood cells prior to HSCT?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not Done: C49484 (Not Done)
Item
Were tumor cells detected in bone marrow, in the interval between last systemic therapy and collection prior to HSCT?
text
Code List
Were tumor cells detected in bone marrow, in the interval between last systemic therapy and collection prior to HSCT?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not Done: C49484 (Not Done)
Item
Were tumor cells detected in collected cells, before purging prior to HSCT?
text
Code List
Were tumor cells detected in collected cells, before purging prior to HSCT?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not Done: C49484 (Not Done)
PriorHematopoieticStemCellTransplantationNeoplasticCellDetectionOtherMethodOccurrenceTherapiesSpecify
Item
Specify method (Answer only if the value for 2775544 is "Other molecular technique" OR "Other technique" )
text
Item Group
Autologous Products Only - Part 3 / 5
Item
Was the product treated to remove malignant cells (purged) ? (autologous product only)
text
Code List
Was the product treated to remove malignant cells (purged) ? (autologous product only)
CL Item
Yes (Yes)
CL Item
No (No)
Item Group
Autologous Products Only - 3 / 4
Item
What malignant cell removal method was used to treat the product?
text
Code List
What malignant cell removal method was used to treat the product?
CL Item
Monoclonal Antibody (Monoclonal antibody)
CL Item
Perfosfamide (4-hydroperoxycyclophosphamide(4HC))
CL Item
Mafosfamide (Mafosfamide)
CL Item
Other Medication (Other drug)
CL Item
Elutriative Centrifugation (Elutriation)
CL Item
Immunomagnetic Column (Immunomagnetic column)
CL Item
Toxin (Toxin)
CL Item
Hematopoietic Stem Cell Positive Selection (Positive stem cell selection(other than preparation of mononuclear fraction))
CL Item
Other Method (Other method)
Item
Was a particular malignant cell removal method used for product treatment?
text
Code List
Was a particular malignant cell removal method used for product treatment?
CL Item
Yes (Yes)
CL Item
No (No)
MalignantCellRemovedOtherMethodOccurrenceTherapiesSpecify
Item
Specify the other malignant cell removal method: (Answer only if the value for 2748795 is "Monoclonal antibody","Other drug", "Toxin","Positive stem cell selection" or "Other method".)
text
Item Group
Autologous Products Only Part 4 / 4
Item
What kind of method was used to detect tumor cells after purging?
text
Code List
What kind of method was used to detect tumor cells after purging?
CL Item
Histopathology (Routine histopathology)
CL Item
Pcr, Polymerase Chain Reaction (Polymerase chain reaction(PCR))
CL Item
Other Molecular Techniques (Other molecular technique)
CL Item
Ihc, Immunohistochemistry (Immunohistochemistry)
CL Item
Cell Culture Techniques (Cell culture technique)
CL Item
Other (Other)
Item
Was a particular tumor cell detection method used after purging?
text
Code List
Was a particular tumor cell detection method used after purging?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not Done: C49484 (Not Done)
PostMalignantCellRemovedNeoplasticCellDetectionOtherMethodOccurrenceTherapiesSpecify
Item
Specify the other tumor cells detection method (Answer only if the value for 2778929 is "Other")
text
Item Group
Product Analysis (all Products)
Item
Specify the time point in the product preparation that the product was analyzed:
text
Code List
Specify the time point in the product preparation that the product was analyzed:
CL Item
Arrival (Product arrival)
CL Item
Post Processing Prior Cryopreservation Prior Manipulation (Post-processing, pre-cryopreservation / manipulation)
CL Item
Post Thaw (Post-thaw)
CL Item
Post Manipulation (Post-manipulation)
CL Item
Infusion Timepoint (At infusion (final quantity infused))
HematopoieticStemCellGraftLaboratoryProcedureDate
Item
Date of product analysis:
date
HematopoieticStemCellGraftLaboratoryProcedureTotalVolumeValue
Item
Total volume of product: (one decimal place)
double
Item
What was the unit of measure for the total volume of the product being analyzed?
text
Code List
What was the unit of measure for the total volume of the product being analyzed?
CL Item
Milliliter (mL)
CL Item
Gram (g)
NucleatedBloodCellLaboratoryProcedureCellTotalInteger::2DecimalPlaceCount
Item
Nucleated cells: (Report the total number of cells not cells per kilogram)
double
NucleatedBloodCellLaboratoryProcedureExponentValue
Item
Nucleated cells exponent value:
double
Item
Not tested (Not tested for nucleated cells)
text
Code List
Not tested (Not tested for nucleated cells)
CL Item
Negation Test (Not tested)
MononucleatedBloodCellLaboratoryProcedureCellTotalInteger::2DecimalPlaceCount
Item
Mononucleated cells: (Report the total number of cells not cells per kilogram)
double
MononucleatedBloodCellLaboratoryProcedureExponentValue
Item
Mononucleated cells exponent value:
double
Item
Not tested (Not tested for mononucleated cells)
text
Code List
Not tested (Not tested for mononucleated cells)
CL Item
Negation Test (Not tested)
NucleatedRedBloodCellLaboratoryProcedureCellTotalInteger::2DecimalPlaceCount
Item
Nucleated red blood cells: (Report the total number of cells not cells per kilogram)
double
NucleatedRedBloodCellLaboratoryProcedureExponentValue
Item
Nucleated red blood cells exponent value:
double
Item
Not tested (Not tested for nucleated red blood cells)
text
Code List
Not tested (Not tested for nucleated red blood cells)
CL Item
Negation Test (Not tested)
HematopoieticProgenitorCellAntigenCD34PresentCellLaboratoryProcedureCellTotalInteger::2DecimalPlaceCount
Item
CD34+ cells: (Report the total number of cells not cells per kilogram)
double
HematopoieticProgenitorCellAntigenCD34PresentCellLaboratoryProcedureExponentValue
Item
CD34+ cells exponent value:
double
Code List
Not tested (Not tested for CD34+ cells)
CL Item
Negation Test (Not tested)
CD3ComplexPresentCellLaboratoryProcedureCellTotalInteger::2DecimalPlaceCount
Item
CD3+ cells: (Report the total number of cells not cells per kilogram)
double
CD3ComplexPresentCellLaboratoryProcedureExponentValue
Item
CD3+ cells exponent value:
double
Item
Not tested (Not tested for CD3+ cells)
text
Code List
Not tested (Not tested for CD3+ cells)
CL Item
Negation Test (Not tested)
CD4AntigenPresentCellLaboratoryProcedureCellTotalInteger::2DecimalPlaceCount
Item
CD4+ cells: (Report the total number of cells not cells per kilogram)
double
CD4AntigenPresentCellLaboratoryProcedureExponentValue
Item
CD4+ cells exponent value:
double
Item
Not tested (Not tested for CD4+ cells)
text
Code List
Not tested (Not tested for CD4+ cells)
CL Item
Negation Test (Not tested)
CD8-PositiveT-LymphocytePresentCellLaboratoryProcedureCellTotalInteger::2DecimalPlaceCount
Item
CD8+ cells: (Report the total number of cells not cells per kilogram)
double
CD8-PositiveT-LymphocytePresentCellLaboratoryProcedureExponentValue
Item
CD8+ cells exponent value:
double
Code List
Not tested (Not tested for CD8+ cells)
CL Item
Negation Test (Not tested)
LaboratoryProcedureViableCellSpecimenOutcomePercentageValue
Item
Viability of cells
double
Item
Not tested (The cell viability not tested)
text
Code List
Not tested (The cell viability not tested)
CL Item
Negation Test (Not tested)
Item
Method of testing cell viability:
text
Code List
Method of testing cell viability:
CL Item
7-aminoactinomycin D (7-AAD)
CL Item
Propidium Iodide (Propidium iodide)
CL Item
Trypan Blue (Trypan blue)
CL Item
Other Method (Other method)
LaboratoryProcedureViableCellSpecimenOutcomeSpecify
Item
Specify other method: (Answer only if the value for 2760530 is "Other method")
text
Item
Were the colony-forming units (CFU) assessed after thawing? (cord blood product only)
text
Code List
Were the colony-forming units (CFU) assessed after thawing? (cord blood product only)
CL Item
Yes (Yes)
CL Item
No (No)
Item
Was there growth?
text
Code List
Was there growth?
CL Item
Yes (Yes)
CL Item
No (No)
LaboratoryProcedurePostThawColonyFormingUnitOutcomeTotalColonyCount
Item
Total colonies per product: (One decimal place with exponent "x10E5")
double
Item
Unknown (Total colonies per productunknown )
text
Code List
Unknown (Total colonies per productunknown )
CL Item
Unknown Not Applicable (Unknown/not applicable)
ColonyFormingUnitLaboratoryProcedurePostThawPerformedTotalColony-FormingUnit-GranulocyteMacrophageAssayCount
Item
Total CFU-GM: (One decimal place with exponent "x10E5")
double
Code List
Unknown (Total CFU-GMUnknown )
CL Item
Unknown Not Applicable (Unknown/not applicable)
Item
Were cultures performed before infusion to test the product(s) for bacterial or fungal infection? (complete for all cell products)
text
Code List
Were cultures performed before infusion to test the product(s) for bacterial or fungal infection? (complete for all cell products)
CL Item
Yes (Yes)
CL Item
No (No)
Code List
Specify results:
CL Item
Positive Finding (Positive)
CL Item
Negative Finding (Negative)
CL Item
Unknown (Unknown)
Code List
Specify organism names: (1st Organism Name)
CL Item
Acinetobacter (Acinetobacter)
CL Item
Actinomyces (Actinomyces)
CL Item
Bacillus (Bacillus)
CL Item
Bacteroides (Bacteroides (gracillis, uniformis, vulgaris, other species))
CL Item
Bordetella Pertussis (Bordetella pertussis (whooping cough))
CL Item
Borrelia Burgdorferi (Borrelia (lyme disease))
CL Item
Moraxella Catarrhalis (Branhamella or Moraxella catarrhalis (other species))
CL Item
Campylobacter (Campylobacter (all species))
CL Item
Capnocytophaga (Capnocytophaga)
CL Item
Chlamydophila Pneumoniae (Chlamydia (pneumoniae))
CL Item
Other Chlamydia (Other chlamydia)
CL Item
Chlamydia Not Otherwise Specified (Chlamydia, NOS)
CL Item
Citrobacter (Citrobacter (freundii, other species))
CL Item
Clostridium (Clostridium (all species except difficile))
CL Item
Clostridium Difficile (Clostridium difficile)
CL Item
Corynebacterium Jeikeium (Corynebacterium (jeikeium))
CL Item
Corynebacterium (Corynebacterium (all non-diptheria species))
CL Item
Coxiella (Coxiella)
CL Item
Enterobacter (Enterobacter)
CL Item
Vancomycin Resistant Enterococcus (Enterococcus, vancomycin resistant (VRE))
CL Item
Enterococcus (Enterococcus (all species))
CL Item
Escherichia Coli (Escherichia (also E. coli))
CL Item
Pseudomonas Oryzihabitans (Flavimonas oryzihabitans)
CL Item
Flavobacterium (Flavobacterium)
CL Item
Fusobacterium (Fusobacterium)
CL Item
Haemophilus (Haemophilus (all species, including influenzae))
CL Item
Helicobacter Pylori (Helicobacter pylori)
CL Item
Klebsiella (Klebsiella)
CL Item
Lactobacillus (Lactobacillus (bulgaricus, acidophilus, other species))
CL Item
Legionella (Legionella)
CL Item
Leptospira (Leptospira)
CL Item
C76356 (Leptotrichia buccalis)
CL Item
Leuconostoc (Leuconostoc (all species))
CL Item
Listeria (Listeria)
CL Item
Methylobacterium (Methylobacterium)
CL Item
Micrococcus Not Otherwise Specified (Micrococcus, NOS)
CL Item
Mycobacterium Avium Complex (Mycobacterium avium - intracellulare (MAC, MAI))
CL Item
Mycobacterium Species (Mycobacterium species (cheloneae, fortuitum, haemophilum, kansasii, mucogenicum))
CL Item
Mycobacterium Tuberculosis (Mycobacterium tuberculosis (tuberculosis, Koch bacillus))
CL Item
Other Mycobacterium (Other mycobacterium)
CL Item
Mycobacterium Not Otherwise Specified (Mycobacterium, NOS)
CL Item
Mycoplasma (Mycoplasma)
CL Item
Neisseria (Neisseria (gonorrhoeae, meningitidis, other species))
CL Item
Nocardia (Nocardia)
CL Item
Pasteurella Multocida (Pasteurella multocida)
CL Item
Propionibacterium Acnes (Propionibacterium (acnes, avidum, granulosum, other species))
CL Item
Proteus (Proteus)
CL Item
Pseudomonas (Pseudomonas (all species except cepacia & maltophilia))
CL Item
Burkholderia Cepacia (Pseudomonas or Burkholder cepacia)
CL Item
Stenotrophomonas Maltophilia (Pseudomonas or Stenotrophomonas or Xanthomonas maltophilia)
CL Item
Rhodococcus (Rhodococcus)
CL Item
Rickettsia (Rickettsia)
CL Item
Salmonella (Salmonella (all species))
CL Item
Serratia Marcescens (Serratia marcescens)
CL Item
Shigella (Shigella)
CL Item
Staphylococcus Coag Negative (Staphylococcus, coagulase negative)
CL Item
Staphylococcus Aureus (Staphylococcus aureus)
CL Item
Streptococcus Not Otherwise Specified (Staphylococcus, NOS)
CL Item
Rothia Mucilaginosa (Stomatococcus mucilaginosis)
CL Item
Streptococcus (Streptococcus (all species except Enterococcus))
CL Item
Streptococcus Pneumoniae (Streptococcus pneumoniae)
CL Item
Treponema (Treponema (syphilis))
CL Item
Vibrio (Vibrio (all species))
CL Item
Multiple Bacteria (Multiple bacteria at a single site)
CL Item
Other Bacteria (Other bacteria)
CL Item
Suspected Atypical Bacteria Infection (Suspected atypical bacterial infection)
CL Item
Suspected Bacteria Infection (Suspected bacterial infection)
CL Item
Candida Not Otherwise Specified (Candida, NOS)
CL Item
Candida Albicans (Candida albicans)
CL Item
Pichia Guilliermondii (Candida guillermondi)
CL Item
Issatchenkia Orientalis (Candida krusei)
CL Item
Clavispora Lusitaniae (Candida lusitaniae)
CL Item
Candida Parapsilosis (Candida parapsilosis)
CL Item
Candida Tropicalis (Candida tropicalis)
CL Item
Candida Glabrata (Candida (Torulopsis) glabrata)
CL Item
Other Candida (Other Candida)
CL Item
Aspergillus Not Otherwise Specified (Aspergillus, NOS)
CL Item
Aspergillus Flavus (Aspergillus flavus)
CL Item
Aspergillus Fumigatus (Aspergillus fumigatus)
CL Item
Aspergillus Niger (Aspergillus niger)
CL Item
Other Aspergillus (Other Aspergillus)
CL Item
Cryptococcosis (Cryptococcosus species)
CL Item
Fusarium (Fusarium species)
CL Item
Histoplasmosis (Histoplasmosis)
CL Item
Zygomycota Not Otherwise Specified (Zygomycetes, NOS)
CL Item
Zygomycosis (Mucormycosis)
CL Item
Rhizopus (Rhizopus)
CL Item
Yeast Not Otherwise Specified (Yeast, NOS)
CL Item
Other Fungi (Other fungus)
CL Item
Pneumocystis Pneumonia (Pneumocystis (PCP / PJP))
CL Item
Suspected Fungal Infection (Suspected fungal infection)
Code List
Specify organism names: (2nd Organism Name)
CL Item
Acinetobacter (Acinetobacter)
CL Item
Actinomyces (Actinomyces)
CL Item
Bacillus (Bacillus)
CL Item
Bacteroides (Bacteroides (gracillis, uniformis, vulgaris, other species))
CL Item
Bordetella Pertussis (Bordetella pertussis (whooping cough))
CL Item
Borrelia Burgdorferi (Borrelia (lyme disease))
CL Item
Moraxella Catarrhalis (Branhamella or Moraxella catarrhalis (other species))
CL Item
Campylobacter (Campylobacter (all species))
CL Item
Capnocytophaga (Capnocytophaga)
CL Item
Chlamydophila Pneumoniae (Chlamydia (pneumoniae))
CL Item
Other Chlamydia (Other chlamydia)
CL Item
Chlamydia Not Otherwise Specified (Chlamydia, NOS)
CL Item
Citrobacter (Citrobacter (freundii, other species))
CL Item
Clostridium (Clostridium (all species except difficile))
CL Item
Clostridium Difficile (Clostridium difficile)
CL Item
Corynebacterium Jeikeium (Corynebacterium (jeikeium))
CL Item
Corynebacterium (Corynebacterium (all non-diptheria species))
CL Item
Coxiella (Coxiella)
CL Item
Enterobacter (Enterobacter)
CL Item
Vancomycin Resistant Enterococcus (Enterococcus, vancomycin resistant (VRE))
CL Item
Enterococcus (Enterococcus (all species))
CL Item
Escherichia Coli (Escherichia (also E. coli))
CL Item
Pseudomonas Oryzihabitans (Flavimonas oryzihabitans)
CL Item
Flavobacterium (Flavobacterium)
CL Item
Fusobacterium (Fusobacterium)
CL Item
Haemophilus (Haemophilus (all species, including influenzae))
CL Item
Helicobacter Pylori (Helicobacter pylori)
CL Item
Klebsiella (Klebsiella)
CL Item
Lactobacillus (Lactobacillus (bulgaricus, acidophilus, other species))
CL Item
Legionella (Legionella)
CL Item
Leptospira (Leptospira)
CL Item
C76356 (Leptotrichia buccalis)
CL Item
Leuconostoc (Leuconostoc (all species))
CL Item
Listeria (Listeria)
CL Item
Methylobacterium (Methylobacterium)
CL Item
Micrococcus Not Otherwise Specified (Micrococcus, NOS)
CL Item
Mycobacterium Avium Complex (Mycobacterium avium - intracellulare (MAC, MAI))
CL Item
Mycobacterium Species (Mycobacterium species (cheloneae, fortuitum, haemophilum, kansasii, mucogenicum))
CL Item
Mycobacterium Tuberculosis (Mycobacterium tuberculosis (tuberculosis, Koch bacillus))
CL Item
Other Mycobacterium (Other mycobacterium)
CL Item
Mycobacterium Not Otherwise Specified (Mycobacterium, NOS)
CL Item
Mycoplasma (Mycoplasma)
CL Item
Neisseria (Neisseria (gonorrhoeae, meningitidis, other species))
CL Item
Nocardia (Nocardia)
CL Item
Pasteurella Multocida (Pasteurella multocida)
CL Item
Propionibacterium Acnes (Propionibacterium (acnes, avidum, granulosum, other species))
CL Item
Proteus (Proteus)
CL Item
Pseudomonas (Pseudomonas (all species except cepacia & maltophilia))
CL Item
Burkholderia Cepacia (Pseudomonas or Burkholder cepacia)
CL Item
Stenotrophomonas Maltophilia (Pseudomonas or Stenotrophomonas or Xanthomonas maltophilia)
CL Item
Rhodococcus (Rhodococcus)
CL Item
Rickettsia (Rickettsia)
CL Item
Salmonella (Salmonella (all species))
CL Item
Serratia Marcescens (Serratia marcescens)
CL Item
Shigella (Shigella)
CL Item
Staphylococcus Coag Negative (Staphylococcus, coagulase negative)
CL Item
Staphylococcus Aureus (Staphylococcus aureus)
CL Item
Streptococcus Not Otherwise Specified (Staphylococcus, NOS)
CL Item
Rothia Mucilaginosa (Stomatococcus mucilaginosis)
CL Item
Streptococcus (Streptococcus (all species except Enterococcus))
CL Item
Streptococcus Pneumoniae (Streptococcus pneumoniae)
CL Item
Treponema (Treponema (syphilis))
CL Item
Vibrio (Vibrio (all species))
CL Item
Multiple Bacteria (Multiple bacteria at a single site)
CL Item
Other Bacteria (Other bacteria)
CL Item
Suspected Atypical Bacteria Infection (Suspected atypical bacterial infection)
CL Item
Suspected Bacteria Infection (Suspected bacterial infection)
CL Item
Candida Not Otherwise Specified (Candida, NOS)
CL Item
Candida Albicans (Candida albicans)
CL Item
Pichia Guilliermondii (Candida guillermondi)
CL Item
Issatchenkia Orientalis (Candida krusei)
CL Item
Clavispora Lusitaniae (Candida lusitaniae)
CL Item
Candida Parapsilosis (Candida parapsilosis)
CL Item
Candida Tropicalis (Candida tropicalis)
CL Item
Candida Glabrata (Candida (Torulopsis) glabrata)
CL Item
Other Candida (Other Candida)
CL Item
Aspergillus Not Otherwise Specified (Aspergillus, NOS)
CL Item
Aspergillus Flavus (Aspergillus flavus)
CL Item
Aspergillus Fumigatus (Aspergillus fumigatus)
CL Item
Aspergillus Niger (Aspergillus niger)
CL Item
Other Aspergillus (Other Aspergillus)
CL Item
Cryptococcosis (Cryptococcosus species)
CL Item
Fusarium (Fusarium species)
CL Item
Histoplasmosis (Histoplasmosis)
CL Item
Zygomycota Not Otherwise Specified (Zygomycetes, NOS)
CL Item
Zygomycosis (Mucormycosis)
CL Item
Rhizopus (Rhizopus)
CL Item
Yeast Not Otherwise Specified (Yeast, NOS)
CL Item
Other Fungi (Other fungus)
CL Item
Pneumocystis Pneumonia (Pneumocystis (PCP / PJP))
CL Item
Suspected Fungal Infection (Suspected fungal infection)
Code List
Specify organism names: (3rd Organism Name)
CL Item
Acinetobacter (Acinetobacter)
CL Item
Actinomyces (Actinomyces)
CL Item
Bacillus (Bacillus)
CL Item
Bacteroides (Bacteroides (gracillis, uniformis, vulgaris, other species))
CL Item
Bordetella Pertussis (Bordetella pertussis (whooping cough))
CL Item
Borrelia Burgdorferi (Borrelia (lyme disease))
CL Item
Moraxella Catarrhalis (Branhamella or Moraxella catarrhalis (other species))
CL Item
Campylobacter (Campylobacter (all species))
CL Item
Capnocytophaga (Capnocytophaga)
CL Item
Chlamydophila Pneumoniae (Chlamydia (pneumoniae))
CL Item
Other Chlamydia (Other chlamydia)
CL Item
Chlamydia Not Otherwise Specified (Chlamydia, NOS)
CL Item
Citrobacter (Citrobacter (freundii, other species))
CL Item
Clostridium (Clostridium (all species except difficile))
CL Item
Clostridium Difficile (Clostridium difficile)
CL Item
Corynebacterium Jeikeium (Corynebacterium (jeikeium))
CL Item
Corynebacterium (Corynebacterium (all non-diptheria species))
CL Item
Coxiella (Coxiella)
CL Item
Enterobacter (Enterobacter)
CL Item
Vancomycin Resistant Enterococcus (Enterococcus, vancomycin resistant (VRE))
CL Item
Enterococcus (Enterococcus (all species))
CL Item
Escherichia Coli (Escherichia (also E. coli))
CL Item
Pseudomonas Oryzihabitans (Flavimonas oryzihabitans)
CL Item
Flavobacterium (Flavobacterium)
CL Item
Fusobacterium (Fusobacterium)
CL Item
Haemophilus (Haemophilus (all species, including influenzae))
CL Item
Helicobacter Pylori (Helicobacter pylori)
CL Item
Klebsiella (Klebsiella)
CL Item
Lactobacillus (Lactobacillus (bulgaricus, acidophilus, other species))
CL Item
Legionella (Legionella)
CL Item
Leptospira (Leptospira)
CL Item
C76356 (Leptotrichia buccalis)
CL Item
Leuconostoc (Leuconostoc (all species))
CL Item
Listeria (Listeria)
CL Item
Methylobacterium (Methylobacterium)
CL Item
Micrococcus Not Otherwise Specified (Micrococcus, NOS)
CL Item
Mycobacterium Avium Complex (Mycobacterium avium - intracellulare (MAC, MAI))
CL Item
Mycobacterium Species (Mycobacterium species (cheloneae, fortuitum, haemophilum, kansasii, mucogenicum))
CL Item
Mycobacterium Tuberculosis (Mycobacterium tuberculosis (tuberculosis, Koch bacillus))
CL Item
Other Mycobacterium (Other mycobacterium)
CL Item
Mycobacterium Not Otherwise Specified (Mycobacterium, NOS)
CL Item
Mycoplasma (Mycoplasma)
CL Item
Neisseria (Neisseria (gonorrhoeae, meningitidis, other species))
CL Item
Nocardia (Nocardia)
CL Item
Pasteurella Multocida (Pasteurella multocida)
CL Item
Propionibacterium Acnes (Propionibacterium (acnes, avidum, granulosum, other species))
CL Item
Proteus (Proteus)
CL Item
Pseudomonas (Pseudomonas (all species except cepacia & maltophilia))
CL Item
Burkholderia Cepacia (Pseudomonas or Burkholder cepacia)
CL Item
Stenotrophomonas Maltophilia (Pseudomonas or Stenotrophomonas or Xanthomonas maltophilia)
CL Item
Rhodococcus (Rhodococcus)
CL Item
Rickettsia (Rickettsia)
CL Item
Salmonella (Salmonella (all species))
CL Item
Serratia Marcescens (Serratia marcescens)
CL Item
Shigella (Shigella)
CL Item
Staphylococcus Coag Negative (Staphylococcus, coagulase negative)
CL Item
Staphylococcus Aureus (Staphylococcus aureus)
CL Item
Streptococcus Not Otherwise Specified (Staphylococcus, NOS)
CL Item
Rothia Mucilaginosa (Stomatococcus mucilaginosis)
CL Item
Streptococcus (Streptococcus (all species except Enterococcus))
CL Item
Streptococcus Pneumoniae (Streptococcus pneumoniae)
CL Item
Treponema (Treponema (syphilis))
CL Item
Vibrio (Vibrio (all species))
CL Item
Multiple Bacteria (Multiple bacteria at a single site)
CL Item
Other Bacteria (Other bacteria)
CL Item
Suspected Atypical Bacteria Infection (Suspected atypical bacterial infection)
CL Item
Suspected Bacteria Infection (Suspected bacterial infection)
CL Item
Candida Not Otherwise Specified (Candida, NOS)
CL Item
Candida Albicans (Candida albicans)
CL Item
Pichia Guilliermondii (Candida guillermondi)
CL Item
Issatchenkia Orientalis (Candida krusei)
CL Item
Clavispora Lusitaniae (Candida lusitaniae)
CL Item
Candida Parapsilosis (Candida parapsilosis)
CL Item
Candida Tropicalis (Candida tropicalis)
CL Item
Candida Glabrata (Candida (Torulopsis) glabrata)
CL Item
Other Candida (Other Candida)
CL Item
Aspergillus Not Otherwise Specified (Aspergillus, NOS)
CL Item
Aspergillus Flavus (Aspergillus flavus)
CL Item
Aspergillus Fumigatus (Aspergillus fumigatus)
CL Item
Aspergillus Niger (Aspergillus niger)
CL Item
Other Aspergillus (Other Aspergillus)
CL Item
Cryptococcosis (Cryptococcosus species)
CL Item
Fusarium (Fusarium species)
CL Item
Histoplasmosis (Histoplasmosis)
CL Item
Zygomycota Not Otherwise Specified (Zygomycetes, NOS)
CL Item
Zygomycosis (Mucormycosis)
CL Item
Rhizopus (Rhizopus)
CL Item
Yeast Not Otherwise Specified (Yeast, NOS)
CL Item
Other Fungi (Other fungus)
CL Item
Pneumocystis Pneumonia (Pneumocystis (PCP / PJP))
CL Item
Suspected Fungal Infection (Suspected fungal infection)
Code List
Specify organism names: (4th Organism Name)
CL Item
Acinetobacter (Acinetobacter)
CL Item
Actinomyces (Actinomyces)
CL Item
Bacillus (Bacillus)
CL Item
Bacteroides (Bacteroides (gracillis, uniformis, vulgaris, other species))
CL Item
Bordetella Pertussis (Bordetella pertussis (whooping cough))
CL Item
Borrelia Burgdorferi (Borrelia (lyme disease))
CL Item
Moraxella Catarrhalis (Branhamella or Moraxella catarrhalis (other species))
CL Item
Campylobacter (Campylobacter (all species))
CL Item
Capnocytophaga (Capnocytophaga)
CL Item
Chlamydophila Pneumoniae (Chlamydia (pneumoniae))
CL Item
Other Chlamydia (Other chlamydia)
CL Item
Chlamydia Not Otherwise Specified (Chlamydia, NOS)
CL Item
Citrobacter (Citrobacter (freundii, other species))
CL Item
Clostridium (Clostridium (all species except difficile))
CL Item
Clostridium Difficile (Clostridium difficile)
CL Item
Corynebacterium Jeikeium (Corynebacterium (jeikeium))
CL Item
Corynebacterium (Corynebacterium (all non-diptheria species))
CL Item
Coxiella (Coxiella)
CL Item
Enterobacter (Enterobacter)
CL Item
Vancomycin Resistant Enterococcus (Enterococcus, vancomycin resistant (VRE))
CL Item
Enterococcus (Enterococcus (all species))
CL Item
Escherichia Coli (Escherichia (also E. coli))
CL Item
Pseudomonas Oryzihabitans (Flavimonas oryzihabitans)
CL Item
Flavobacterium (Flavobacterium)
CL Item
Fusobacterium (Fusobacterium)
CL Item
Haemophilus (Haemophilus (all species, including influenzae))
CL Item
Helicobacter Pylori (Helicobacter pylori)
CL Item
Klebsiella (Klebsiella)
CL Item
Lactobacillus (Lactobacillus (bulgaricus, acidophilus, other species))
CL Item
Legionella (Legionella)
CL Item
Leptospira (Leptospira)
CL Item
C76356 (Leptotrichia buccalis)
CL Item
Leuconostoc (Leuconostoc (all species))
CL Item
Listeria (Listeria)
CL Item
Methylobacterium (Methylobacterium)
CL Item
Micrococcus Not Otherwise Specified (Micrococcus, NOS)
CL Item
Mycobacterium Avium Complex (Mycobacterium avium - intracellulare (MAC, MAI))
CL Item
Mycobacterium Species (Mycobacterium species (cheloneae, fortuitum, haemophilum, kansasii, mucogenicum))
CL Item
Mycobacterium Tuberculosis (Mycobacterium tuberculosis (tuberculosis, Koch bacillus))
CL Item
Other Mycobacterium (Other mycobacterium)
CL Item
Mycobacterium Not Otherwise Specified (Mycobacterium, NOS)
CL Item
Mycoplasma (Mycoplasma)
CL Item
Neisseria (Neisseria (gonorrhoeae, meningitidis, other species))
CL Item
Nocardia (Nocardia)
CL Item
Pasteurella Multocida (Pasteurella multocida)
CL Item
Propionibacterium Acnes (Propionibacterium (acnes, avidum, granulosum, other species))
CL Item
Proteus (Proteus)
CL Item
Pseudomonas (Pseudomonas (all species except cepacia & maltophilia))
CL Item
Burkholderia Cepacia (Pseudomonas or Burkholder cepacia)
CL Item
Stenotrophomonas Maltophilia (Pseudomonas or Stenotrophomonas or Xanthomonas maltophilia)
CL Item
Rhodococcus (Rhodococcus)
CL Item
Rickettsia (Rickettsia)
CL Item
Salmonella (Salmonella (all species))
CL Item
Serratia Marcescens (Serratia marcescens)
CL Item
Shigella (Shigella)
CL Item
Staphylococcus Coag Negative (Staphylococcus, coagulase negative)
CL Item
Staphylococcus Aureus (Staphylococcus aureus)
CL Item
Streptococcus Not Otherwise Specified (Staphylococcus, NOS)
CL Item
Rothia Mucilaginosa (Stomatococcus mucilaginosis)
CL Item
Streptococcus (Streptococcus (all species except Enterococcus))
CL Item
Streptococcus Pneumoniae (Streptococcus pneumoniae)
CL Item
Treponema (Treponema (syphilis))
CL Item
Vibrio (Vibrio (all species))
CL Item
Multiple Bacteria (Multiple bacteria at a single site)
CL Item
Other Bacteria (Other bacteria)
CL Item
Suspected Atypical Bacteria Infection (Suspected atypical bacterial infection)
CL Item
Suspected Bacteria Infection (Suspected bacterial infection)
CL Item
Candida Not Otherwise Specified (Candida, NOS)
CL Item
Candida Albicans (Candida albicans)
CL Item
Pichia Guilliermondii (Candida guillermondi)
CL Item
Issatchenkia Orientalis (Candida krusei)
CL Item
Clavispora Lusitaniae (Candida lusitaniae)
CL Item
Candida Parapsilosis (Candida parapsilosis)
CL Item
Candida Tropicalis (Candida tropicalis)
CL Item
Candida Glabrata (Candida (Torulopsis) glabrata)
CL Item
Other Candida (Other Candida)
CL Item
Aspergillus Not Otherwise Specified (Aspergillus, NOS)
CL Item
Aspergillus Flavus (Aspergillus flavus)
CL Item
Aspergillus Fumigatus (Aspergillus fumigatus)
CL Item
Aspergillus Niger (Aspergillus niger)
CL Item
Other Aspergillus (Other Aspergillus)
CL Item
Cryptococcosis (Cryptococcosus species)
CL Item
Fusarium (Fusarium species)
CL Item
Histoplasmosis (Histoplasmosis)
CL Item
Zygomycota Not Otherwise Specified (Zygomycetes, NOS)
CL Item
Zygomycosis (Mucormycosis)
CL Item
Rhizopus (Rhizopus)
CL Item
Yeast Not Otherwise Specified (Yeast, NOS)
CL Item
Other Fungi (Other fungus)
CL Item
Pneumocystis Pneumonia (Pneumocystis (PCP / PJP))
CL Item
Suspected Fungal Infection (Suspected fungal infection)
Code List
Specify organism names: (5th Organism Name)
CL Item
Acinetobacter (Acinetobacter)
CL Item
Actinomyces (Actinomyces)
CL Item
Bacillus (Bacillus)
CL Item
Bacteroides (Bacteroides (gracillis, uniformis, vulgaris, other species))
CL Item
Bordetella Pertussis (Bordetella pertussis (whooping cough))
CL Item
Borrelia Burgdorferi (Borrelia (lyme disease))
CL Item
Moraxella Catarrhalis (Branhamella or Moraxella catarrhalis (other species))
CL Item
Campylobacter (Campylobacter (all species))
CL Item
Capnocytophaga (Capnocytophaga)
CL Item
Chlamydophila Pneumoniae (Chlamydia (pneumoniae))
CL Item
Other Chlamydia (Other chlamydia)
CL Item
Chlamydia Not Otherwise Specified (Chlamydia, NOS)
CL Item
Citrobacter (Citrobacter (freundii, other species))
CL Item
Clostridium (Clostridium (all species except difficile))
CL Item
Clostridium Difficile (Clostridium difficile)
CL Item
Corynebacterium Jeikeium (Corynebacterium (jeikeium))
CL Item
Corynebacterium (Corynebacterium (all non-diptheria species))
CL Item
Coxiella (Coxiella)
CL Item
Enterobacter (Enterobacter)
CL Item
Vancomycin Resistant Enterococcus (Enterococcus, vancomycin resistant (VRE))
CL Item
Enterococcus (Enterococcus (all species))
CL Item
Escherichia Coli (Escherichia (also E. coli))
CL Item
Pseudomonas Oryzihabitans (Flavimonas oryzihabitans)
CL Item
Flavobacterium (Flavobacterium)
CL Item
Fusobacterium (Fusobacterium)
CL Item
Haemophilus (Haemophilus (all species, including influenzae))
CL Item
Helicobacter Pylori (Helicobacter pylori)
CL Item
Klebsiella (Klebsiella)
CL Item
Lactobacillus (Lactobacillus (bulgaricus, acidophilus, other species))
CL Item
Legionella (Legionella)
CL Item
Leptospira (Leptospira)
CL Item
C76356 (Leptotrichia buccalis)
CL Item
Leuconostoc (Leuconostoc (all species))
CL Item
Listeria (Listeria)
CL Item
Methylobacterium (Methylobacterium)
CL Item
Micrococcus Not Otherwise Specified (Micrococcus, NOS)
CL Item
Mycobacterium Avium Complex (Mycobacterium avium - intracellulare (MAC, MAI))
CL Item
Mycobacterium Species (Mycobacterium species (cheloneae, fortuitum, haemophilum, kansasii, mucogenicum))
CL Item
Mycobacterium Tuberculosis (Mycobacterium tuberculosis (tuberculosis, Koch bacillus))
CL Item
Other Mycobacterium (Other mycobacterium)
CL Item
Mycobacterium Not Otherwise Specified (Mycobacterium, NOS)
CL Item
Mycoplasma (Mycoplasma)
CL Item
Neisseria (Neisseria (gonorrhoeae, meningitidis, other species))
CL Item
Nocardia (Nocardia)
CL Item
Pasteurella Multocida (Pasteurella multocida)
CL Item
Propionibacterium Acnes (Propionibacterium (acnes, avidum, granulosum, other species))
CL Item
Proteus (Proteus)
CL Item
Pseudomonas (Pseudomonas (all species except cepacia & maltophilia))
CL Item
Burkholderia Cepacia (Pseudomonas or Burkholder cepacia)
CL Item
Stenotrophomonas Maltophilia (Pseudomonas or Stenotrophomonas or Xanthomonas maltophilia)
CL Item
Rhodococcus (Rhodococcus)
CL Item
Rickettsia (Rickettsia)
CL Item
Salmonella (Salmonella (all species))
CL Item
Serratia Marcescens (Serratia marcescens)
CL Item
Shigella (Shigella)
CL Item
Staphylococcus Coag Negative (Staphylococcus, coagulase negative)
CL Item
Staphylococcus Aureus (Staphylococcus aureus)
CL Item
Streptococcus Not Otherwise Specified (Staphylococcus, NOS)
CL Item
Rothia Mucilaginosa (Stomatococcus mucilaginosis)
CL Item
Streptococcus (Streptococcus (all species except Enterococcus))
CL Item
Streptococcus Pneumoniae (Streptococcus pneumoniae)
CL Item
Treponema (Treponema (syphilis))
CL Item
Vibrio (Vibrio (all species))
CL Item
Multiple Bacteria (Multiple bacteria at a single site)
CL Item
Other Bacteria (Other bacteria)
CL Item
Suspected Atypical Bacteria Infection (Suspected atypical bacterial infection)
CL Item
Suspected Bacteria Infection (Suspected bacterial infection)
CL Item
Candida Not Otherwise Specified (Candida, NOS)
CL Item
Candida Albicans (Candida albicans)
CL Item
Pichia Guilliermondii (Candida guillermondi)
CL Item
Issatchenkia Orientalis (Candida krusei)
CL Item
Clavispora Lusitaniae (Candida lusitaniae)
CL Item
Candida Parapsilosis (Candida parapsilosis)
CL Item
Candida Tropicalis (Candida tropicalis)
CL Item
Candida Glabrata (Candida (Torulopsis) glabrata)
CL Item
Other Candida (Other Candida)
CL Item
Aspergillus Not Otherwise Specified (Aspergillus, NOS)
CL Item
Aspergillus Flavus (Aspergillus flavus)
CL Item
Aspergillus Fumigatus (Aspergillus fumigatus)
CL Item
Aspergillus Niger (Aspergillus niger)
CL Item
Other Aspergillus (Other Aspergillus)
CL Item
Cryptococcosis (Cryptococcosus species)
CL Item
Fusarium (Fusarium species)
CL Item
Histoplasmosis (Histoplasmosis)
CL Item
Zygomycota Not Otherwise Specified (Zygomycetes, NOS)
CL Item
Zygomycosis (Mucormycosis)
CL Item
Rhizopus (Rhizopus)
CL Item
Yeast Not Otherwise Specified (Yeast, NOS)
CL Item
Other Fungi (Other fungus)
CL Item
Pneumocystis Pneumonia (Pneumocystis (PCP / PJP))
CL Item
Suspected Fungal Infection (Suspected fungal infection)
Code List
Specify organism names: (6th Organism Name)
CL Item
Acinetobacter (Acinetobacter)
CL Item
Actinomyces (Actinomyces)
CL Item
Bacillus (Bacillus)
CL Item
Bacteroides (Bacteroides (gracillis, uniformis, vulgaris, other species))
CL Item
Bordetella Pertussis (Bordetella pertussis (whooping cough))
CL Item
Borrelia Burgdorferi (Borrelia (lyme disease))
CL Item
Moraxella Catarrhalis (Branhamella or Moraxella catarrhalis (other species))
CL Item
Campylobacter (Campylobacter (all species))
CL Item
Capnocytophaga (Capnocytophaga)
CL Item
Chlamydophila Pneumoniae (Chlamydia (pneumoniae))
CL Item
Other Chlamydia (Other chlamydia)
CL Item
Chlamydia Not Otherwise Specified (Chlamydia, NOS)
CL Item
Citrobacter (Citrobacter (freundii, other species))
CL Item
Clostridium (Clostridium (all species except difficile))
CL Item
Clostridium Difficile (Clostridium difficile)
CL Item
Corynebacterium Jeikeium (Corynebacterium (jeikeium))
CL Item
Corynebacterium (Corynebacterium (all non-diptheria species))
CL Item
Coxiella (Coxiella)
CL Item
Enterobacter (Enterobacter)
CL Item
Vancomycin Resistant Enterococcus (Enterococcus, vancomycin resistant (VRE))
CL Item
Enterococcus (Enterococcus (all species))
CL Item
Escherichia Coli (Escherichia (also E. coli))
CL Item
Pseudomonas Oryzihabitans (Flavimonas oryzihabitans)
CL Item
Flavobacterium (Flavobacterium)
CL Item
Fusobacterium (Fusobacterium)
CL Item
Haemophilus (Haemophilus (all species, including influenzae))
CL Item
Helicobacter Pylori (Helicobacter pylori)
CL Item
Klebsiella (Klebsiella)
CL Item
Lactobacillus (Lactobacillus (bulgaricus, acidophilus, other species))
CL Item
Legionella (Legionella)
CL Item
Leptospira (Leptospira)
CL Item
C76356 (Leptotrichia buccalis)
CL Item
Leuconostoc (Leuconostoc (all species))
CL Item
Listeria (Listeria)
CL Item
Methylobacterium (Methylobacterium)
CL Item
Micrococcus Not Otherwise Specified (Micrococcus, NOS)
CL Item
Mycobacterium Avium Complex (Mycobacterium avium - intracellulare (MAC, MAI))
CL Item
Mycobacterium Species (Mycobacterium species (cheloneae, fortuitum, haemophilum, kansasii, mucogenicum))
CL Item
Mycobacterium Tuberculosis (Mycobacterium tuberculosis (tuberculosis, Koch bacillus))
CL Item
Other Mycobacterium (Other mycobacterium)
CL Item
Mycobacterium Not Otherwise Specified (Mycobacterium, NOS)
CL Item
Mycoplasma (Mycoplasma)
CL Item
Neisseria (Neisseria (gonorrhoeae, meningitidis, other species))
CL Item
Nocardia (Nocardia)
CL Item
Pasteurella Multocida (Pasteurella multocida)
CL Item
Propionibacterium Acnes (Propionibacterium (acnes, avidum, granulosum, other species))
CL Item
Proteus (Proteus)
CL Item
Pseudomonas (Pseudomonas (all species except cepacia & maltophilia))
CL Item
Burkholderia Cepacia (Pseudomonas or Burkholder cepacia)
CL Item
Stenotrophomonas Maltophilia (Pseudomonas or Stenotrophomonas or Xanthomonas maltophilia)
CL Item
Rhodococcus (Rhodococcus)
CL Item
Rickettsia (Rickettsia)
CL Item
Salmonella (Salmonella (all species))
CL Item
Serratia Marcescens (Serratia marcescens)
CL Item
Shigella (Shigella)
CL Item
Staphylococcus Coag Negative (Staphylococcus, coagulase negative)
CL Item
Staphylococcus Aureus (Staphylococcus aureus)
CL Item
Streptococcus Not Otherwise Specified (Staphylococcus, NOS)
CL Item
Rothia Mucilaginosa (Stomatococcus mucilaginosis)
CL Item
Streptococcus (Streptococcus (all species except Enterococcus))
CL Item
Streptococcus Pneumoniae (Streptococcus pneumoniae)
CL Item
Treponema (Treponema (syphilis))
CL Item
Vibrio (Vibrio (all species))
CL Item
Multiple Bacteria (Multiple bacteria at a single site)
CL Item
Other Bacteria (Other bacteria)
CL Item
Suspected Atypical Bacteria Infection (Suspected atypical bacterial infection)
CL Item
Suspected Bacteria Infection (Suspected bacterial infection)
CL Item
Candida Not Otherwise Specified (Candida, NOS)
CL Item
Candida Albicans (Candida albicans)
CL Item
Pichia Guilliermondii (Candida guillermondi)
CL Item
Issatchenkia Orientalis (Candida krusei)
CL Item
Clavispora Lusitaniae (Candida lusitaniae)
CL Item
Candida Parapsilosis (Candida parapsilosis)
CL Item
Candida Tropicalis (Candida tropicalis)
CL Item
Candida Glabrata (Candida (Torulopsis) glabrata)
CL Item
Other Candida (Other Candida)
CL Item
Aspergillus Not Otherwise Specified (Aspergillus, NOS)
CL Item
Aspergillus Flavus (Aspergillus flavus)
CL Item
Aspergillus Fumigatus (Aspergillus fumigatus)
CL Item
Aspergillus Niger (Aspergillus niger)
CL Item
Other Aspergillus (Other Aspergillus)
CL Item
Cryptococcosis (Cryptococcosus species)
CL Item
Fusarium (Fusarium species)
CL Item
Histoplasmosis (Histoplasmosis)
CL Item
Zygomycota Not Otherwise Specified (Zygomycetes, NOS)
CL Item
Zygomycosis (Mucormycosis)
CL Item
Rhizopus (Rhizopus)
CL Item
Yeast Not Otherwise Specified (Yeast, NOS)
CL Item
Other Fungi (Other fungus)
CL Item
Pneumocystis Pneumonia (Pneumocystis (PCP / PJP))
CL Item
Suspected Fungal Infection (Suspected fungal infection)
PriorInfusionProcedureCultureProcedureBacteriaFungiInfectiousDisorderOtherOrganismSpecify
Item
If codes 198, 209, 219, or 259, specify organism: (Answer only if the value for 2784429, 2784431,2784433,2784435,2784437 and 2784439 is "Other bacteria, specify","Other Candida, specify",Other Aspergillus, specify" or "Other fungus, specify".)
text
Item Group
Product Infusion
Item
Was more than one product infused? (e.g., marrow and PBSC,PBSC and cord blood, two different cords, etc.)
text
Code List
Was more than one product infused? (e.g., marrow and PBSC,PBSC and cord blood, two different cords, etc.)
CL Item
Yes (Yes)
CL Item
No (No)
Item
Was the product infusion described on this insert intended to produce hematopoietic engraftment?
text
Code List
Was the product infusion described on this insert intended to produce hematopoietic engraftment?
CL Item
Yes (Yes)
CL Item
No (No)
MultipleHematopoieticStemCellGraftInfusionProcedureDate
Item
Date of this product infusion:
date
HematopoieticStemCellGraftInfusionProcedureBeginTime
Item
Time product infusion initiated (24-hour clock):
time
Item
Is it the standard time or daylight savings time?
text
Code List
Is it the standard time or daylight savings time?
CL Item
Standard Time (Standard time)
CL Item
Daylight Savings Time (Daylight Savings Time)
HematopoieticStemCellGraftInfusionProcedureEndTime
Item
Time product infusion completed (24-hour clock):
time
Item
Is it the standard time or daylight savings time?
text
Code List
Is it the standard time or daylight savings time?
CL Item
Standard Time (Standard time)
CL Item
Daylight Savings Time (Daylight Savings Time)
HematopoieticStemCellGraftCombinedAdditiveInfusionProcedureTotalVolumeValue
Item
Total volume of product plus additives infused: (One decimal place with Unit of Measure "ml")
double
Item
Specify the route of product infusion:
text
Code List
Specify the route of product infusion:
CL Item
Intravenous Route Of Administration (Intravenous)
CL Item
Intramedullary Route Of Administration (Intramedullary)
CL Item
Intraperitoneal Route Of Administration (Intraperitoneal)
CL Item
Other Route Of Administration (Other route of infusion)
HematopoieticStemCellGraftInfusionProcedureOtherRouteofAdministrationTherapiesSpecify
Item
Specify route of infusion:
text
Item
Did the volume of infused product include any added agents?
text
Code List
Did the volume of infused product include any added agents?
CL Item
Yes (Yes)
CL Item
No (No)
Item Group
Product Infusion - Part 2 / 3
Item
What kind of additives are included in volume of infused product?
text
Code List
What kind of additives are included in volume of infused product?
CL Item
Acid-citrate-dextrose (Acid-Citrate-Dextrose (ACD))
CL Item
Albumin (Albumin)
CL Item
Antibiotic (Antibiotic)
CL Item
Dextran Sulfate Sodium (Dextran)
CL Item
Heparin (Heparin)
CL Item
Other (Other)
Item
Were particular additives included in volume of infused product?
text
Code List
Were particular additives included in volume of infused product?
CL Item
Yes (Yes)
CL Item
No (No)
WithinHematopoieticStemCellGraftInfusionProcedureOtherAdditiveAdministeredTherapiesSpecify
Item
Specify agent: (Answer only if the value for 2740356 is "Other")
text
Item Group
Product Infusion
Item
Was the entire volume of product infused?
text
Code List
Was the entire volume of product infused?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Specify what happened to the reserved portion:
text
Code List
Specify what happened to the reserved portion:
CL Item
Destruction (Discarded)
CL Item
Cryopreservation (Cryopreserved for future use)
CL Item
Other Endpoints (Other fate)
ReservationPartEndPointSpecifyText
Item
Specify: (Answer only if the value for 2769592 is "Other fate")
text
Item
Were there any adverse events or incidents associated with the stem cell infusion? (The question refers to all stem cell products except for autologous marrow or autologous PBSC products.)
text
Code List
Were there any adverse events or incidents associated with the stem cell infusion? (The question refers to all stem cell products except for autologous marrow or autologous PBSC products.)
CL Item
Yes (Yes)
CL Item
No (No)
Item Group
Product Infusion
Item
What type of Adverse Events associated with the stem cell infusion?
text
Code List
What type of Adverse Events associated with the stem cell infusion?
CL Item
Bradycardia (Brachycardia)
CL Item
Chest Pain (Chest tightness/pain)
CL Item
At Infusion Time Chills (Chills at time of infusion)
CL Item
Fever <= 103 F Within 24 Hours Of Infusion (Fever less than or equal to 103 F within 24 hours of infusion)
CL Item
Fever > 103 F Within 24 Hours Of Infusion (Fever greater than 103 F within 24 hours of infusion)
CL Item
Whole Hemoglobinuria (Gross hemoglobinuria)
CL Item
Headache (Headache)
CL Item
Urticaria (Hives)
CL Item
Hypertension (Hypertension)
CL Item
Hypotension (Hypotension)
CL Item
Required Oxygen Hypoxia (Hypoxia requiring oxygen(O2) support)
CL Item
Nausea (Nausea)
CL Item
Ctcae Grade 1 Rigors And Chills (Rigors, mild)
CL Item
Ctcae Grade 3 Rigors And Chills (Rigors, severe)
CL Item
Dyspnea (Shortness of breath(SOB))
CL Item
Tachycardia (Tachycardia)
CL Item
Vomiting (Vomiting)
CL Item
Other Expected Adverse Event (Other expected AE)
CL Item
Other Unexpected Adverse Event (Other unexpected AE)
Item
Did a particular stem cell infusion associated adverse event occur?
text
Code List
Did a particular stem cell infusion associated adverse event occur?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Did particular adverse events require medical intervention?
text
Code List
Did particular adverse events require medical intervention?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Were particular adverse events resolved?
text
Code List
Were particular adverse events resolved?
CL Item
Yes (Yes)
CL Item
No (No)
HematopoieticStemCellGraftInfusionProcedureOtherAdverseEventSpecify
Item
Specify (Answer only if the value for 2739534 is "Other expected AE" or "Other unexpected AE")
text
Item Group
Product Infusion
Item
In the Medical Director's judgement, was the adverse event a direct result of the infusion?
text
Code List
In the Medical Director's judgement, was the adverse event a direct result of the infusion?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Specify the most likely cause of the adverse event :
text
Code List
Specify the most likely cause of the adverse event :
CL Item
Relationship Regimen (Regimen related)
CL Item
Hematopoietic Stem Cell Transplant Reaction (Product reaction)
CL Item
Medication Reaction (Drug reaction)
CL Item
Other Diseases And Disorders (Other illness)
CL Item
Other Reason (Other reason)
AdverseEventOtherDiseaseorDisorderTherapiesSpecify
Item
Specify illness: (Answer only if the value for 2769598 is "Other illness")
text
AdverseEventOtherReasonTherapiesSpecify
Item
Specify reason: (Answer only if the value for 2769598 is "Other reason")
text
Item Group
Donor Demographic Information
TransplantDonorBirthDate
Item
Donor date of birth:
date
Code List
Date unknown
CL Item
Date Unknown (date unknown)
MotherAgeValue
Item
Age of mother (approximate): (Cord blood unit only)
double
Item
What is the reason for the mother's missing age? (Cord blood unit only)
text
Code List
What is the reason for the mother's missing age? (Cord blood unit only)
CL Item
Unknown Not Applicable (Unknown/not applicable)
HematopoieticStemCellTransplantationUmbilicalCordBloodTypeNotInstitution::NationalMarrowDonorProgramIdentifier
Item
Non-NMDP Cord Blood Unit (CBU) ID: (Cord blood unit only)
text
Item
Is the CBU ID number also the ICCBBA ISBT 128 number? (Cord blood unit only)
text
Code List
Is the CBU ID number also the ICCBBA ISBT 128 number? (Cord blood unit only)
CL Item
Yes (Yes)
CL Item
No (No)
TissueBankingInstitutionName
Item
Name of cord blood bank providing CBU: (Cord blood unit only)
text
Item
Donor Gender
text
Code List
Donor Gender
CL Item
Male (male)
CL Item
Female (female)
Item
Was the donor ever pregnant?
text
Code List
Was the donor ever pregnant?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
CL Item
Not Applicable (Not Applicable)
TissueDonorPregnancyCount
Item
Specify number of pregnancies:
double
Item
What is the reason for the missing number of pregnancies?
text
Code List
What is the reason for the missing number of pregnancies?
CL Item
Unknown Not Applicable (Unknown/not applicable)
Item
Donor's blood type and Rh factor:
text
Code List
Donor's blood type and Rh factor:
CL Item
Blood Group A Rh Positive Blood Group (A positive)
CL Item
Blood Group A Rh Negative Blood Group (A negative)
CL Item
Blood Group B Rh Positive Blood Group (B positive)
CL Item
Blood Group B Rh Negative Blood Group (B negative)
CL Item
Blood Group Ab Rh Positive Blood Group (AB positive)
CL Item
Blood Group Ab Rh Negative Blood Group (AB negative)
CL Item
Blood Group O Rh Positive Blood Group (O positive)
CL Item
Blood Group O Rh Negative Blood Group (O negative)
CL Item
Unknown (unknown)
Item
Did this donor have a central line placed?
text
Code List
Did this donor have a central line placed?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not Applicable (Not Applicable)
Item
Specify the site of the central line placement:
text
Code List
Specify the site of the central line placement:
CL Item
Femoral Vein (Femoral)
CL Item
Subclavian Vein (Subclavian)
CL Item
Internal Jugular Vein (Internal jugular)
CL Item
Other Anatomic Site (Other site)
TissueDonorCentralVenousAccessCatheterAnatomicSiteOtherSpecify
Item
Specify site: (Answer only if the value for 2769666 is "Other site")
text
Item
Donor's ethnicity:
text
Code List
Donor's ethnicity:
CL Item
A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (Hispanic or Latino)
CL Item
A Person Not Meeting The Definition For Hispanic Or Latino. (Not Hispanic or Latino)
CL Item
Could Not Be Determined Or Unsure (Unknown)
Item Group
Donor Demographic Information Part 2 / 2
Item
Donor's race (Mark the groups in which the donor is a member. Check all that apply )
text
Code List
Donor's race (Mark the groups in which the donor is a member. Check all that apply )
CL Item
Eastern European (Eastern European)
CL Item
Mediterranean (Mediterranean)
CL Item
Middle Eastern (Middle Eastern)
CL Item
North Coast Of Africa (North Coast of Africa)
CL Item
North American (North American)
CL Item
Northern European (Northern European)
CL Item
Western European (Western European)
CL Item
White Caribbean (White Caribbean)
CL Item
White South Or Central American (White South or Central American)
CL Item
Other White (Other White)
CL Item
African (African (both parents born in Africa))
CL Item
African American (African American)
CL Item
African Caribbean (Black Caribbean)
CL Item
Black South Or Central American (Black South or Central American)
CL Item
Alaska Native (Alaskan Native or Aleut)
CL Item
American Indian (North American Indian)
CL Item
South Or Central American Indian (American Indian, South or Central America)
CL Item
Caribbean Indian (Caribbean Indian)
CL Item
South Asian (South Asian)
CL Item
Filipino (Filipino (Pilipino))
CL Item
Japanese (Japanese)
CL Item
Korean (Korean)
CL Item
Chinese (Chinese)
CL Item
Vietnamese (Vietnamese)
CL Item
Other South Asian (Other Southeast Asian)
CL Item
Guamanian (Guamanian)
CL Item
Hawaiian (Hawaiian)
CL Item
Samoan (Samoan)
CL Item
Other Native Hawaiian Or Other Pacific Islander (Other Pacific Islander)
CL Item
Response Declined (Declines to provide race)
CL Item
Unknown (Race unknown)
Item Group
Donor Demographic Information
Item
What is the relationship of the donor to the recipient?
text
Code List
What is the relationship of the donor to the recipient?
CL Item
Sibling (Sibling)
CL Item
Recipient Child (Recipient's child)
CL Item
Other Relative (Other relative)
CL Item
Unrelated (Unrelated)
Item
Specify the relationship of the donor to the recipient: (Answer only if the value for 2784447 is "Other relative")
text
Code List
Specify the relationship of the donor to the recipient: (Answer only if the value for 2784447 is "Other relative")
CL Item
Parent (Parent)
CL Item
Aunt (Aunt)
CL Item
Uncle (Uncle)
CL Item
Cousin (Cousin)
CL Item
Other Relative (Other relative)
TissueDonorOtherRecipientRelationshipText
Item
Specify relationship: (Answer only if the value for 2728852 is "Other relative")
text
Item
Was the donor / product tested for potentially transplantable genetic diseases?
text
Code List
Was the donor / product tested for potentially transplantable genetic diseases?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
Code List
Sickle cell anemia
CL Item
Yes (Yes)
CL Item
No (No)
Code List
Thalassemia
CL Item
Yes (Yes)
CL Item
No (No)
Code List
Other
CL Item
Yes (Yes)
CL Item
No (No)
TissueDonorGeneticTestingOtherDiseaseorDisorderSpecify
Item
Specify genetic disease: (Answer only if the value for 2772022 is "Yes")
text
Item
Was the donor hospitalized (inpatient) during or after the collection? (Question applies only to allogeneic non-NMDP donors)
text
Code List
Was the donor hospitalized (inpatient) during or after the collection? (Question applies only to allogeneic non-NMDP donors)
CL Item
Yes (Yes)
CL Item
No (No)
Item
Did the donor experience any life-threatening complications during or after the collection? (Question applies only to allogeneic non-NMDP donors)
text
Code List
Did the donor experience any life-threatening complications during or after the collection? (Question applies only to allogeneic non-NMDP donors)
CL Item
Yes (Yes)
CL Item
No (No)
TissueDonorDuringOrAfterHematopoieticStemCellCollectionLifeThreateningorDisablingAdverseEventSpecify
Item
Specify complications: (Question applies only to allogeneic non-NMDP donors. Answer only if the value of CDE 2728986 is "Yes".)
text
Item
Did the donor receive blood transfusions as a result of the collection? (Question applies only to allogeneic non-NMDP donors)
text
Code List
Did the donor receive blood transfusions as a result of the collection? (Question applies only to allogeneic non-NMDP donors)
CL Item
Yes (Yes)
CL Item
No (No)
Item
Was the blood transfusion product autologous? (Question applies only to allogeneic non-NMDP donors )
text
Code List
Was the blood transfusion product autologous? (Question applies only to allogeneic non-NMDP donors )
CL Item
Yes (Yes)
CL Item
No (No)
BloodTransfusionAutologousUnitNumber
Item
Specify number of units: (For the autologous blood transfusion)
double
Item
Was the blood transfusion product allogeneic (homologous)? (Question applies only to allogeneic non-NMDP donors)
text
Code List
Was the blood transfusion product allogeneic (homologous)? (Question applies only to allogeneic non-NMDP donors)
CL Item
Yes (Yes)
CL Item
No (No)
BloodTransfusionAllogenicUnitNumber
Item
Specify number of units: (For the autologous blood transfusion)
double
Item
Did the donor die as a result of the collection? (Question applies only to allogeneic non-NMDP donors)
text
Code List
Did the donor die as a result of the collection? (Question applies only to allogeneic non-NMDP donors)
CL Item
Yes (Yes)
CL Item
No (No)
TissueDonorHematopoieticStemCellCollectionOutcomeDeathReasonSpecify
Item
Specify cause of death: (Question applies only to allogeneic non-NMDP donors)
text
Item
Did the recipient submit a research sample? (Related donors only)
text
Code List
Did the recipient submit a research sample? (Related donors only)
CL Item
Yes (Yes)
CL Item
No (No)
RecipientResearchSpecimenIdentificationNumber
Item
Research sample recipient ID:
double
Item
Did the donor submit a research sample? (Related donors only)
text
Code List
Did the donor submit a research sample? (Related donors only)
CL Item
Yes (Yes)
CL Item
No (No)
TissueDonorResearchSpecimenIdentificationNumber
Item
Research sample donor ID: (Related donors only)
double
Item Group
Author Information
PersonGiven/FirstName
Item
First Name
text
PersonFamily/LastName
Item
Last Name
text
ContactPersonLocationTelephoneNumber
Item
Telephone number:
text
ContactPersonLocationFaxNumber
Item
Fax number:
text
PersonEmailAddressText
Item
E-mail address:
text

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