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10.11 8.26 Resource BiologicallyDerivedProduct - Content

Responsible Owner: Orders and Observations icon Work Group Maturity Level : 0   Trial Use Security Category : Patient Compartments : Not linked to any defined compartments Patient , Practitioner

This resource reflects an instance of a biologically derived product. A material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity.

Trial-Use Note: Note that to Implementers: For an overview of this content is preliminary has not undergone proper review by resource and others in the appropriate Workgroups. Biologically Derived Product domain, also see the module page .

A This is a base resource that represents a material substance originating from a biological entity intended to be transplanted or infused into clinically applied (e.g., transplanted, infused, grafted) to another (possibly the same) biological entity. Examples include:

  • hematopoietic stem cells (bone marrow, peripheral blood, or cord blood extraction)
  • mesenchymal stromal cells
  • blood products (whole blood, red blood (whole, extracted cells, platelets, plasma, etc.)
  • organs (kidney, lung, heart, liver etc.)
  • tissues tissues, human (cornea, heart valves, blood vessels, skin, tendons, cartilage, bone)
  • tissues, non-human (porcine valves, porcine skin, bovine cardiac tissue, etc.)
  • ART tissue (sperm, oocyte, embryo)
  • manipulated cells (e.g. CAR T-cells)
  • human milk for immunological properties
  • topical products (serum eye drops, fibrin sealant)
  • fecal microbiota
  • regenerated tissue products (regenerated epidermis, regenerated corneal epithelium, regenerated trachea)
The workflow using this resource (e.g., request, administration) should be discussed and implemented in a consistent way as other similar resources are handled (e.g., device, medication)
10.11.2

This resource relates The following boundaries need to these other resource: be considered:

  • ProcedureRequest (for collection) Medication - If the product is derived from an individual or small pool, or is blood group specific, it is a BiologicallyDerivedProduct, otherwise it is to be considered a Medication.
  • Patient ("receiver" NutritionProduct - If the product is for dietary administration it is represented as a NutritionProduct. If the product is for transplant, infusion, therapeutic administration, or injection it is represented as a BiologicallyDerivedProduct. We note that this remains ambiguous, particularly around certain uses of donated human milk, and "source") Practitioner (who collected product) Substance (product processing) additional use cases may need to be clarified to determine the appropriate representation. Local implementation guidance may provide further direction.
  • DiagnosticReport (containing HLA-typing) Device - Some biologically derived products are considered a device within certain jurisdictions.
  • BiologicallyDerivedProduct ("parent" Specimen - A biologically derived product may involve the same material (e.g., tissue, blood, organ, etc.) as a specimen where the intended use determines whether to use Specimen or BiologicallyDerivedProduct. The focus of the Specimen is to conduct a diagnostic test, while the BiologicallyDerivedProduct is to use for multi-day collections) Procedure (one a clinical therapy or procedure on the same or different patient. E.g., blood used for collection and one a test is represented by a Specimen, while blood for transplantation, will need to add transfusion is represented as a BiologicallyDerivedProduct. A specimen can be obtained from a BiologicallyDerivedProduct thus creating a Specimen instance where Specimen.subject is a BiologicallyDerivedProduct as a source.
  • Substance - A substance is a homogeneous material with a definite composition that can be reproduced in the same way consistently. Certain substances may include or originate from biologically derived product, but from the point where the substance is identified by batch/lot number and any necessary links to the "usedReference") originating donor(s) are held within the manufacturing records the product can be considered and managed as a substance.
This resource is referenced by

Structure

A material substance originating from Identifier code 0..1 available | unavailable The amount 0..* BackboneElement 0..* Any processing of 0..1 0..1 0..1 string 0..1 Time of manipulation Product storage
Name Flags Card. Type Description & Constraints      Filter: Filters doco
. . BiologicallyDerivedProduct TU DomainResource This resource reflects an instance of a biological entity biologically derived product

Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension
. . . identifier productCategory 0..* Σ CodeableConcept A category or classification of the product
Binding: Biologically Derived Product Category ( Example )

0..*
. . . productCode External ids for 0..1 CodeableConcept A code that identifies the kind of this item biologically derived product
Binding: Biologically Derived Product Codes ( Example )
. . productCategory . parent 0..* Reference ( BiologicallyDerivedProduct ) The parent biologically-derived product

0..1
. . . productCode identifier Σ 0..* CodeableConcept Identifier Instance identifier

What this biologically derived product is
. . status . biologicalSourceEvent Σ 0..1 code Identifier An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled
BiologicallyDerivedProductStatus ( Required )
. . . request processingFacility 0..* Reference ( ServiceRequest Organization ) Processing facilities responsible for the labeling and distribution of this biologically derived product
Procedure request
. . . quantity division 0..1 integer string A unique identifier for an aliquot of this biologically derived a product
. . parent . productStatus 0..1 Coding Reference available | unavailable | processed | applied | discarded
Binding: Biologically Derived Product Status ( BiologicallyDerivedProduct Example ) BiologicallyDerivedProduct parent
. . collection . expirationDate 0..1 dateTime Date, and where relevant time, of expiration
0..1
. . . collection 0..1 BackboneElement How this product was collected
. . . . collector 0..1 Reference ( Practitioner | PractitionerRole ) Individual performing the collection
. . . source . sourcePatient 0..1 Reference ( Patient | ) The patient who underwent the medical procedure to collect the product
.... sourceOrganization 0..1 Reference ( Organization ) The organization that facilitated the collection
Who is product from
. . . . collected[x] 0..1 Time of product collection
. . . . . collectedDateTime dateTime
. . . . . collectedPeriod Period
. . processing . . procedure 0..1 BackboneElement Reference ( Procedure ) The procedure involved in the product during collection
. . description . storageTempRequirements 0..1 string Range Product storage temperature requirements
Description of of processing
. . procedure . property 0..* CodeableConcept BackboneElement A property that is specific to this BiologicallyDerviedProduct instance
Procesing code
Procedure Codes (SNOMED CT) ( Example )
. . . additive . type 1..1 CodeableConcept Reference Code that specifies the property
Binding: Biologically Derived Product Property Type Codes ( Substance Example )
Substance added during processing
. . . . time[x] value[x] 1..1 Property values
Time of processing
. . . . . timeDateTime valueBoolean dateTime boolean
. . timePeriod Period manipulation 0..1 BackboneElement Any manipulation of product post-collection . . . description valueInteger 0..1 Description of manipulation time[x] integer
. . . . timeDateTime . valueCodeableConcept dateTime CodeableConcept
. . . . . timePeriod valuePeriod Period
. storage . . . . valueQuantity 0..* BackboneElement Quantity
. . . description . . valueRange 0..1 string Range Description of storage
. . . temperature . . valueRatio 0..1 decimal Ratio Storage temperature
. . . scale . . valueString 0..1 code string farenheit | celsius | kelvin BiologicallyDerivedProductStorageScale ( Required )
. . . duration . . valueAttachment 0..1 Period Attachment Storage timeperiod

doco Documentation for this format icon

See the Extensions for this resource

UML Diagram ( Legend )

BiologicallyDerivedProduct ( DomainResource ) This records identifiers associated with this biologically derived product instance that are defined by business processes and/or used to refer to it when a direct URL reference to the resource itself is not appropriate (e.g. in CDA documents, or in written / printed documentation) identifier : Identifier [0..*] Broad A category or classification of this product the product. Products may be assigned multiple categories, for example a human heart valve can be categorized as an 'MPHO' and 'tissue' productCategory : code CodeableConcept [0..1] [0..*] « Biologically Derived Product Category. (Strength=Required) null (Strength=Example) BiologicallyDerivedProductCat... ! ?? » A code codified value that identifies the kind systematically supports characterization and classification of this biologically derived product (SNOMED Ctcode) medical products of human origin inclusive of processing conditions such as additives, volumes and handling conditions productCode : CodeableConcept [0..1] « null (Strength=Example) BiologicallyDerivedProductCod... ?? » Whether the Parent product (if any) for this biologically-derived product is currently available status parent : code Reference [0..1] [0..*] « Biologically Derived Product Status. (Strength=Required) BiologicallyDerivedProductSta... ! BiologicallyDerivedProduct » Procedure request Request to obtain and/or infuse this biologically derived product request : Reference [0..*] « ServiceRequest » Number of discrete units within Unique instance identifiers assigned to a biologically derived product. Note: This is a business identifier, not a resource identifier identifier : Identifier [0..*] An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled quantity biologicalSourceEvent : integer Identifier [0..1] Parent Processing facilities responsible for the labeling and distribution of this biologically derived product (if any) parent processingFacility : Reference [0..*] « BiologicallyDerivedProduct Organization » Collection Healthcare professional who is performing A unique identifier for an aliquot of a product. Used to distinguish individual aliquots of a product carrying the collection same biologicalSource and productCode identifiers collector division : Reference string [0..1] « Practitioner | PractitionerRole » The patient or entity, such as a hospital or vendor in the case current status of a processed/manipulated/manufactured product, providing the product source productStatus : Reference Coding [0..1] « Patient | Organization null (Strength=Example) BiologicallyDerivedProductSta... ?? » Time Date, and where relevant time, of product collection expiration collected[x] expirationDate : Type dateTime [0..1] « dateTime The temperature requirements for storage of the biologically-derived product storageTempRequirements | Period : Range » [0..1] Processing Collection Description of of processing Healthcare professional who is performing the collection description collector : string Reference [0..1] « Practitioner | PractitionerRole » Procesing code The patient providing the product procedure sourcePatient : CodeableConcept Reference [0..1] « Biologically Derived Product Procedure. (Strength=Example) ProcedureCodes(SNOMEDCT) Patient ?? » Substance added during processing The entity, such as a hospital or vendor in the case of a processed/manipulated/manufactured product, providing the product additive sourceOrganization : Reference [0..1] « Substance Organization » Time of processing product collection time[x] collected[x] : Type DataType [0..1] « dateTime | Period » Manipulation Description of manipulation description : string [0..1] Time of manipulation The procedure performed to collect the biologically derived product time[x] procedure : Type Reference [0..1] « dateTime | Period Procedure » Storage Property Description of storage Code that specifies the property. It should reference an established coding system description type : string CodeableConcept [0..1] [1..1] « Storage temperature null (Strength=Example) temperature : decimal BiologicallyDerivedProductPro... [0..1] ?? » Temperature scale used Property values scale value[x] : code DataType [0..1] [1..1] « BiologicallyDerived Product Storage Scale. (Strength=Required) BiologicallyDerivedProductSto... ! » boolean | integer | CodeableConcept | Period | Storage timeperiod duration Quantity : Period | Range [0..1] | Ratio | string | Attachment » How this product was collected collection [0..1] Any processing of the product during collection that does not change the fundamental nature of the product. For example adding anti-coagulants during the collection of Peripheral Blood Stem Cells processing [0..*] Any manipulation of product post-collection A property that is intended to alter the product. For example a buffy-coat enrichment or CD8 reduction of Peripheral Blood Stem Cells specific to make it more suitable for infusion manipulation [0..1] Product storage this BiologicallyDerviedProduct instance storage property [0..*]

XML Template

<<a href="biologicallyderivedproduct-definitions.html#BiologicallyDerivedProduct" title="A material substance originating from a biological entity intended to be transplanted or infused

<BiologicallyDerivedProduct xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <</identifier>
 <
 <</productCode>
 <
 <</request>
 <
 <</parent>

 <productCategory><!-- 0..* CodeableConcept A category or classification of the product --></productCategory>
 <productCode><!-- 0..1 CodeableConcept A code that identifies the kind of this biologically derived product --></productCode>
 <parent><!-- 0..* Reference(BiologicallyDerivedProduct) The parent biologically-derived product --></parent>
 <request><!-- 0..* Reference(ServiceRequest) Request to obtain and/or infuse this product --></request>
 <identifier><!-- 0..* Identifier Instance identifier --></identifier>
 <biologicalSourceEvent><!-- 0..1 Identifier An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled --></biologicalSourceEvent>
 <processingFacility><!-- 0..* Reference(Organization) Processing facilities responsible for the labeling and distribution of this biologically derived product --></processingFacility>
 <division value="[string]"/><!-- 0..1 A unique identifier for an aliquot of a product -->
 <productStatus><!-- 0..1 Coding available | unavailable | processed | applied | discarded --></productStatus>
 <expirationDate value="[dateTime]"/><!-- 0..1 Date, and where relevant time, of expiration -->

 <collection>  <!-- 0..1 How this product was collected -->
  <</collector>
  <</source>

  <collector><!-- 0..1 Reference(Practitioner|PractitionerRole) Individual performing the collection --></collector>
  <sourcePatient><!-- 0..1 Reference(Patient) The patient who underwent the medical procedure to collect the product --></sourcePatient>
  <sourceOrganization><!-- 0..1 Reference(Organization) The organization that facilitated the collection --></sourceOrganization>

  <collected[x]><!-- 0..1 dateTime|Period Time of product collection --></collected[x]>
  <procedure><!-- 0..1 Reference(Procedure) The procedure involved in the collection --></procedure>

 </collection>
 <
  <
  <</procedure>
  <</additive>
  <</time[x]>
 </processing>
 <
  <
  <</time[x]>
 </manipulation>
 <
  <
  <
  <
  <</duration>
 </storage>

 <storageTempRequirements><!-- 0..1 Range Product storage temperature requirements --></storageTempRequirements>
 <property>  <!-- 0..* A property that is specific to this BiologicallyDerviedProduct instance -->
  <type><!-- 1..1 CodeableConcept Code that specifies the property --></type>
  <value[x]><!-- 1..1 boolean|integer|CodeableConcept|Period|Quantity|Range|
    Ratio|string|Attachment Property values --></value[x]>

 </property>

</BiologicallyDerivedProduct>

JSON Template

{doco
  "resourceType" : "<a href="biologicallyderivedproduct-definitions.html#BiologicallyDerivedProduct" title="A material substance originating from a biological entity intended to be transplanted or infused

  "resourceType" : "BiologicallyDerivedProduct",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "
  "
  "
  "
  "
  "
  "

  "productCategory" : [{ CodeableConcept }], // A category or classification of the product
  "productCode" : { CodeableConcept }, // A code that identifies the kind of this biologically derived product
  "parent" : [{ Reference(BiologicallyDerivedProduct) }], // The parent biologically-derived product
  "request" : [{ Reference(ServiceRequest) }], // Request to obtain and/or infuse this product
  "identifier" : [{ Identifier }], // Instance identifier
  "biologicalSourceEvent" : { Identifier }, // An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled
  "processingFacility" : [{ Reference(Organization) }], // Processing facilities responsible for the labeling and distribution of this biologically derived product
  "division" : "<string>", // A unique identifier for an aliquot of a product
  "productStatus" : { Coding }, // available | unavailable | processed | applied | discarded
  "expirationDate" : "<dateTime>", // Date, and where relevant time, of expiration

  "collection" : { // How this product was collected
    "
    "

    "collector" : { Reference(Practitioner|PractitionerRole) }, // Individual performing the collection
    "sourcePatient" : { Reference(Patient) }, // The patient who underwent the medical procedure to collect the product
    "sourceOrganization" : { Reference(Organization) }, // The organization that facilitated the collection

    // collected[x]: Time of product collection. One of these 2:
    ">"
    " }
  },
  "
    "
    "
    "
    
    ">"
    " }
  }],
  "
    "
    
    ">"
    " }

    "collectedDateTime" : "<dateTime>",
    "collectedPeriod" : { Period },
    "procedure" : { Reference(Procedure) } // The procedure involved in the collection

  },
  "
    "
    "
    "
    "

  "storageTempRequirements" : { Range }, // Product storage temperature requirements
  "property" : [{ // A property that is specific to this BiologicallyDerviedProduct instance
    "type" : { CodeableConcept }, // R!  Code that specifies the property
    // value[x]: Property values. One of these 9:

    "valueBoolean" : <boolean>,
    "valueInteger" : <integer>,
    "valueCodeableConcept" : { CodeableConcept },
    "valuePeriod" : { Period },
    "valueQuantity" : { Quantity },
    "valueRange" : { Range },
    "valueRatio" : { Ratio },
    "valueString" : "<string>",
    "valueAttachment" : { Attachment }

  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:<a href="biologicallyderivedproduct-definitions.html#BiologicallyDerivedProduct" title="A material substance originating from a biological entity intended to be transplanted or infused

[ a fhir:BiologicallyDerivedProduct;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from 
  # from 
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
    fhir:
    fhir:
    # . One of these 2
      fhir: ]
      fhir: ]
  ];
  fhir:
    fhir:
    fhir:
    fhir:
    # . One of these 2
      fhir: ]
      fhir: ]
  ], ...;
  fhir:
    fhir:
    # . One of these 2
      fhir: ]
      fhir: ]
  ];
  fhir:
    fhir:
    fhir:
    fhir:
    fhir:
  ], ...;

  # from Resource: fhir:id, fhir:meta, fhir:implicitRules, and fhir:language
  # from DomainResource: fhir:text, fhir:contained, fhir:extension, and fhir:modifierExtension
  fhir:productCategory  ( [ CodeableConcept ] ... ) ; # 0..* A category or classification of the product
  fhir:productCode [ CodeableConcept ] ; # 0..1 A code that identifies the kind of this biologically derived product
  fhir:parent  ( [ Reference(BiologicallyDerivedProduct) ] ... ) ; # 0..* The parent biologically-derived product
  fhir:request  ( [ Reference(ServiceRequest) ] ... ) ; # 0..* Request to obtain and/or infuse this product
  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Instance identifier
  fhir:biologicalSourceEvent [ Identifier ] ; # 0..1 An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled
  fhir:processingFacility  ( [ Reference(Organization) ] ... ) ; # 0..* Processing facilities responsible for the labeling and distribution of this biologically derived product
  fhir:division [ string ] ; # 0..1 A unique identifier for an aliquot of a product
  fhir:productStatus [ Coding ] ; # 0..1 available | unavailable | processed | applied | discarded
  fhir:expirationDate [ dateTime ] ; # 0..1 Date, and where relevant time, of expiration
  fhir:collection [ # 0..1 How this product was collected
    fhir:collector [ Reference(Practitioner|PractitionerRole) ] ; # 0..1 Individual performing the collection
    fhir:sourcePatient [ Reference(Patient) ] ; # 0..1 The patient who underwent the medical procedure to collect the product
    fhir:sourceOrganization [ Reference(Organization) ] ; # 0..1 The organization that facilitated the collection
    # collected[x] : 0..1 Time of product collection. One of these 2
      fhir:collected [  a fhir:DateTime ; dateTime ]
      fhir:collected [  a fhir:Period ; Period ]
    fhir:procedure [ Reference(Procedure) ] ; # 0..1 The procedure involved in the collection
  ] ;
  fhir:storageTempRequirements [ Range ] ; # 0..1 Product storage temperature requirements
  fhir:property ( [ # 0..* A property that is specific to this BiologicallyDerviedProduct instance
    fhir:type [ CodeableConcept ] ; # 1..1 Code that specifies the property
    # value[x] : 1..1 Property values. One of these 9
      fhir:value [  a fhir:Boolean ; boolean ]
      fhir:value [  a fhir:Integer ; integer ]
      fhir:value [  a fhir:CodeableConcept ; CodeableConcept ]
      fhir:value [  a fhir:Period ; Period ]
      fhir:value [  a fhir:Quantity ; Quantity ]
      fhir:value [  a fhir:Range ; Range ]
      fhir:value [  a fhir:Ratio ; Ratio ]
      fhir:value [  a fhir:String ; string ]
      fhir:value [  a fhir:Attachment ; Attachment ]
  ] ... ) ;

]

Changes since R3 from both R4 and R4B

BiologicallyDerivedProduct
BiologicallyDerivedProduct.productCategory
  • Max Cardinality changed from 1 to *
  • Type changed from code to CodeableConcept
  • Remove Binding `http://hl7.org/fhir/ValueSet/product-category|4.0.0` (required)
BiologicallyDerivedProduct.biologicalSourceEvent
  • Added Element
BiologicallyDerivedProduct.processingFacility
  • Added Element
BiologicallyDerivedProduct.division
  • Added Element
BiologicallyDerivedProduct.productStatus
  • Added Element
BiologicallyDerivedProduct.expirationDate
  • Added Element
BiologicallyDerivedProduct.collection.sourcePatient
  • Added Element
BiologicallyDerivedProduct.collection.sourceOrganization
  • Added Element
BiologicallyDerivedProduct.collection.procedure
  • Added Element
BiologicallyDerivedProduct.storageTempRequirements
  • Added Element
BiologicallyDerivedProduct.property
  • Added Element
BiologicallyDerivedProduct.property.type
  • Added Mandatory Element
BiologicallyDerivedProduct.property.value[x]
  • Added Mandatory Element
BiologicallyDerivedProduct.status
  • Deleted (-> BiologicallyDerivedProduct.productStatus)
BiologicallyDerivedProduct.quantity
  • Deleted (-> BiologicallyDerivedProduct.property.valueQuantity)
BiologicallyDerivedProduct.collection.source
  • Deleted
BiologicallyDerivedProduct.processing
  • Deleted (-> BiologicallyDerivedProduct.collection)
BiologicallyDerivedProduct.manipulation
  • Deleted (-> BiologicallyDerivedProduct.collection)
BiologicallyDerivedProduct.storage
  • Deleted (-> BiologicallyDerivedProduct.storageTempRequirements)

This resource did not exist in Release 2 See the Full Difference for further information

This analysis is available for R4 as XML or JSON and for R4B as XML or JSON .

Structure

A material substance originating from Identifier code 0..1 available | unavailable The amount 0..* 0..1 0..* Any processing of 0..1 0..1 0..1 string Product storage
Name Flags Card. Type Description & Constraints      Filter: Filters doco
. . BiologicallyDerivedProduct TU DomainResource This resource reflects an instance of a biological entity biologically derived product

Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension
. . . identifier productCategory 0..* Σ CodeableConcept A category or classification of the product
Binding: Biologically Derived Product Category ( Example )

0..*
. . . productCode External ids for 0..1 CodeableConcept A code that identifies the kind of this item biologically derived product
Binding: Biologically Derived Product Codes ( Example )
. . productCategory . parent 0..* Reference ( BiologicallyDerivedProduct ) The parent biologically-derived product

0..1
. . . productCode identifier Σ 0..* CodeableConcept Identifier Instance identifier

What this biologically derived product is
. . status . biologicalSourceEvent Σ 0..1 code Identifier An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled
BiologicallyDerivedProductStatus ( Required )
. . . request processingFacility 0..* Reference ( ServiceRequest Organization ) Processing facilities responsible for the labeling and distribution of this biologically derived product
Procedure request
. . . quantity division 0..1 integer string A unique identifier for an aliquot of this biologically derived a product
. . parent . productStatus 0..1 Coding Reference available | unavailable | processed | applied | discarded
Binding: Biologically Derived Product Status ( BiologicallyDerivedProduct Example ) BiologicallyDerivedProduct parent
. . collection . expirationDate 0..1 dateTime Date, and where relevant time, of expiration
. . . collection 0..1 BackboneElement How this product was collected
. . . . collector 0..1 Reference ( Practitioner | PractitionerRole ) Individual performing the collection
. . . source . sourcePatient 0..1 Reference ( Patient | ) The patient who underwent the medical procedure to collect the product
.... sourceOrganization 0..1 Reference ( Organization ) The organization that facilitated the collection
Who is product from
. . . . collected[x] 0..1 Time of product collection
. . . . . collectedDateTime dateTime
. . . . . collectedPeriod Period
. . processing . . procedure 0..1 BackboneElement Reference ( Procedure ) The procedure involved in the product during collection
. . description . storageTempRequirements 0..1 string Range Product storage temperature requirements
Description of of processing
. . procedure . property 0..* CodeableConcept BackboneElement A property that is specific to this BiologicallyDerviedProduct instance
Procesing code
Procedure Codes (SNOMED CT) ( Example )
. . . additive . type 1..1 CodeableConcept Reference Code that specifies the property
Binding: Biologically Derived Product Property Type Codes ( Substance Example )
Substance added during processing
. . . . time[x] value[x] 1..1 Property values
Time of processing
. . . . . timeDateTime valueBoolean dateTime boolean
. . timePeriod Period manipulation 0..1 BackboneElement Any manipulation of product post-collection . . . description valueInteger 0..1 Description of manipulation time[x] integer 0..1 Time of manipulation
. . . . timeDateTime . valueCodeableConcept dateTime CodeableConcept
. . . . . timePeriod valuePeriod Period
. storage . . . . valueQuantity 0..* BackboneElement Quantity
. . . description . . valueRange 0..1 string Range Description of storage
. . . temperature . . valueRatio 0..1 decimal Ratio Storage temperature
. . . scale . . valueString 0..1 code string farenheit | celsius | kelvin BiologicallyDerivedProductStorageScale ( Required )
. . . duration . . valueAttachment 0..1 Period Attachment Storage timeperiod

doco Documentation for this format icon

See the Extensions for this resource

UML Diagram ( Legend )

BiologicallyDerivedProduct ( DomainResource ) This records identifiers associated with this biologically derived product instance that are defined by business processes and/or used to refer to it when a direct URL reference to the resource itself is not appropriate (e.g. in CDA documents, or in written / printed documentation) identifier : Identifier [0..*] Broad A category or classification of this product the product. Products may be assigned multiple categories, for example a human heart valve can be categorized as an 'MPHO' and 'tissue' productCategory : code CodeableConcept [0..1] [0..*] « Biologically Derived Product Category. (Strength=Required) null (Strength=Example) BiologicallyDerivedProductCat... ! ?? » A code codified value that identifies the kind systematically supports characterization and classification of this biologically derived product (SNOMED Ctcode) medical products of human origin inclusive of processing conditions such as additives, volumes and handling conditions productCode : CodeableConcept [0..1] « null (Strength=Example) BiologicallyDerivedProductCod... ?? » Whether the Parent product (if any) for this biologically-derived product is currently available status parent : code Reference [0..1] [0..*] « Biologically Derived Product Status. (Strength=Required) BiologicallyDerivedProductSta... ! BiologicallyDerivedProduct » Procedure request Request to obtain and/or infuse this biologically derived product request : Reference [0..*] « ServiceRequest » Number of discrete units within Unique instance identifiers assigned to a biologically derived product. Note: This is a business identifier, not a resource identifier identifier : Identifier [0..*] An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled quantity biologicalSourceEvent : integer Identifier [0..1] Parent Processing facilities responsible for the labeling and distribution of this biologically derived product (if any) parent processingFacility : Reference [0..*] « BiologicallyDerivedProduct Organization » Collection Healthcare professional who is performing A unique identifier for an aliquot of a product. Used to distinguish individual aliquots of a product carrying the collection same biologicalSource and productCode identifiers collector division : Reference string [0..1] « Practitioner | PractitionerRole » The patient or entity, such as a hospital or vendor in the case current status of a processed/manipulated/manufactured product, providing the product source productStatus : Reference Coding [0..1] « Patient | Organization null (Strength=Example) BiologicallyDerivedProductSta... ?? » Time Date, and where relevant time, of product collection expiration collected[x] expirationDate : Type dateTime [0..1] « dateTime The temperature requirements for storage of the biologically-derived product storageTempRequirements | Period : Range » [0..1] Processing Collection Description of of processing Healthcare professional who is performing the collection description collector : string Reference [0..1] « Practitioner | PractitionerRole » Procesing code The patient providing the product procedure sourcePatient : CodeableConcept Reference [0..1] « Biologically Derived Product Procedure. (Strength=Example) ProcedureCodes(SNOMEDCT) Patient ?? » Substance added during processing The entity, such as a hospital or vendor in the case of a processed/manipulated/manufactured product, providing the product additive sourceOrganization : Reference [0..1] « Substance Organization » Time of processing product collection time[x] collected[x] : Type DataType [0..1] « dateTime | Period » Manipulation Description of manipulation description : string [0..1] Time of manipulation The procedure performed to collect the biologically derived product time[x] procedure : Type Reference [0..1] « dateTime | Period Procedure » Storage Property Description of storage Code that specifies the property. It should reference an established coding system description type : string CodeableConcept [0..1] [1..1] « Storage temperature null (Strength=Example) temperature : decimal BiologicallyDerivedProductPro... [0..1] ?? » Temperature scale used Property values scale value[x] : code DataType [0..1] [1..1] « BiologicallyDerived Product Storage Scale. (Strength=Required) BiologicallyDerivedProductSto... ! » boolean | integer | CodeableConcept | Period | Storage timeperiod duration Quantity : Period | Range [0..1] | Ratio | string | Attachment » How this product was collected collection [0..1] Any processing of the product during collection that does not change the fundamental nature of the product. For example adding anti-coagulants during the collection of Peripheral Blood Stem Cells processing [0..*] Any manipulation of product post-collection A property that is intended to alter the product. For example a buffy-coat enrichment or CD8 reduction of Peripheral Blood Stem Cells specific to make it more suitable for infusion manipulation [0..1] Product storage this BiologicallyDerviedProduct instance storage property [0..*]

XML Template

<<a href="biologicallyderivedproduct-definitions.html#BiologicallyDerivedProduct" title="A material substance originating from a biological entity intended to be transplanted or infused

<BiologicallyDerivedProduct xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <</identifier>
 <
 <</productCode>
 <
 <</request>
 <
 <</parent>

 <productCategory><!-- 0..* CodeableConcept A category or classification of the product --></productCategory>
 <productCode><!-- 0..1 CodeableConcept A code that identifies the kind of this biologically derived product --></productCode>
 <parent><!-- 0..* Reference(BiologicallyDerivedProduct) The parent biologically-derived product --></parent>
 <request><!-- 0..* Reference(ServiceRequest) Request to obtain and/or infuse this product --></request>
 <identifier><!-- 0..* Identifier Instance identifier --></identifier>
 <biologicalSourceEvent><!-- 0..1 Identifier An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled --></biologicalSourceEvent>
 <processingFacility><!-- 0..* Reference(Organization) Processing facilities responsible for the labeling and distribution of this biologically derived product --></processingFacility>
 <division value="[string]"/><!-- 0..1 A unique identifier for an aliquot of a product -->
 <productStatus><!-- 0..1 Coding available | unavailable | processed | applied | discarded --></productStatus>
 <expirationDate value="[dateTime]"/><!-- 0..1 Date, and where relevant time, of expiration -->

 <collection>  <!-- 0..1 How this product was collected -->
  <</collector>
  <</source>

  <collector><!-- 0..1 Reference(Practitioner|PractitionerRole) Individual performing the collection --></collector>
  <sourcePatient><!-- 0..1 Reference(Patient) The patient who underwent the medical procedure to collect the product --></sourcePatient>
  <sourceOrganization><!-- 0..1 Reference(Organization) The organization that facilitated the collection --></sourceOrganization>

  <collected[x]><!-- 0..1 dateTime|Period Time of product collection --></collected[x]>
  <procedure><!-- 0..1 Reference(Procedure) The procedure involved in the collection --></procedure>

 </collection>
 <
  <
  <</procedure>
  <</additive>
  <</time[x]>
 </processing>
 <
  <
  <</time[x]>
 </manipulation>
 <
  <
  <
  <
  <</duration>
 </storage>

 <storageTempRequirements><!-- 0..1 Range Product storage temperature requirements --></storageTempRequirements>
 <property>  <!-- 0..* A property that is specific to this BiologicallyDerviedProduct instance -->
  <type><!-- 1..1 CodeableConcept Code that specifies the property --></type>
  <value[x]><!-- 1..1 boolean|integer|CodeableConcept|Period|Quantity|Range|
    Ratio|string|Attachment Property values --></value[x]>

 </property>

</BiologicallyDerivedProduct>

JSON Template

{doco
  "resourceType" : "<a href="biologicallyderivedproduct-definitions.html#BiologicallyDerivedProduct" title="A material substance originating from a biological entity intended to be transplanted or infused

  "resourceType" : "BiologicallyDerivedProduct",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "
  "
  "
  "
  "
  "
  "

  "productCategory" : [{ CodeableConcept }], // A category or classification of the product
  "productCode" : { CodeableConcept }, // A code that identifies the kind of this biologically derived product
  "parent" : [{ Reference(BiologicallyDerivedProduct) }], // The parent biologically-derived product
  "request" : [{ Reference(ServiceRequest) }], // Request to obtain and/or infuse this product
  "identifier" : [{ Identifier }], // Instance identifier
  "biologicalSourceEvent" : { Identifier }, // An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled
  "processingFacility" : [{ Reference(Organization) }], // Processing facilities responsible for the labeling and distribution of this biologically derived product
  "division" : "<string>", // A unique identifier for an aliquot of a product
  "productStatus" : { Coding }, // available | unavailable | processed | applied | discarded
  "expirationDate" : "<dateTime>", // Date, and where relevant time, of expiration

  "collection" : { // How this product was collected
    "
    "

    "collector" : { Reference(Practitioner|PractitionerRole) }, // Individual performing the collection
    "sourcePatient" : { Reference(Patient) }, // The patient who underwent the medical procedure to collect the product
    "sourceOrganization" : { Reference(Organization) }, // The organization that facilitated the collection

    // collected[x]: Time of product collection. One of these 2:
    ">"
    " }
  },
  "
    "
    "
    "
    
    ">"
    " }
  }],
  "
    "
    
    ">"
    " }

    "collectedDateTime" : "<dateTime>",
    "collectedPeriod" : { Period },
    "procedure" : { Reference(Procedure) } // The procedure involved in the collection

  },
  "
    "
    "
    "
    "

  "storageTempRequirements" : { Range }, // Product storage temperature requirements
  "property" : [{ // A property that is specific to this BiologicallyDerviedProduct instance
    "type" : { CodeableConcept }, // R!  Code that specifies the property
    // value[x]: Property values. One of these 9:

    "valueBoolean" : <boolean>,
    "valueInteger" : <integer>,
    "valueCodeableConcept" : { CodeableConcept },
    "valuePeriod" : { Period },
    "valueQuantity" : { Quantity },
    "valueRange" : { Range },
    "valueRatio" : { Ratio },
    "valueString" : "<string>",
    "valueAttachment" : { Attachment }

  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:<a href="biologicallyderivedproduct-definitions.html#BiologicallyDerivedProduct" title="A material substance originating from a biological entity intended to be transplanted or infused

[ a fhir:BiologicallyDerivedProduct;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from 
  # from 
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
    fhir:
    fhir:
    # . One of these 2
      fhir: ]
      fhir: ]
  ];
  fhir:
    fhir:
    fhir:
    fhir:
    # . One of these 2
      fhir: ]
      fhir: ]
  ], ...;
  fhir:
    fhir:
    # . One of these 2
      fhir: ]
      fhir: ]
  ];
  fhir:
    fhir:
    fhir:
    fhir:
    fhir:
  ], ...;

  # from Resource: fhir:id, fhir:meta, fhir:implicitRules, and fhir:language
  # from DomainResource: fhir:text, fhir:contained, fhir:extension, and fhir:modifierExtension
  fhir:productCategory  ( [ CodeableConcept ] ... ) ; # 0..* A category or classification of the product
  fhir:productCode [ CodeableConcept ] ; # 0..1 A code that identifies the kind of this biologically derived product
  fhir:parent  ( [ Reference(BiologicallyDerivedProduct) ] ... ) ; # 0..* The parent biologically-derived product
  fhir:request  ( [ Reference(ServiceRequest) ] ... ) ; # 0..* Request to obtain and/or infuse this product
  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Instance identifier
  fhir:biologicalSourceEvent [ Identifier ] ; # 0..1 An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled
  fhir:processingFacility  ( [ Reference(Organization) ] ... ) ; # 0..* Processing facilities responsible for the labeling and distribution of this biologically derived product
  fhir:division [ string ] ; # 0..1 A unique identifier for an aliquot of a product
  fhir:productStatus [ Coding ] ; # 0..1 available | unavailable | processed | applied | discarded
  fhir:expirationDate [ dateTime ] ; # 0..1 Date, and where relevant time, of expiration
  fhir:collection [ # 0..1 How this product was collected
    fhir:collector [ Reference(Practitioner|PractitionerRole) ] ; # 0..1 Individual performing the collection
    fhir:sourcePatient [ Reference(Patient) ] ; # 0..1 The patient who underwent the medical procedure to collect the product
    fhir:sourceOrganization [ Reference(Organization) ] ; # 0..1 The organization that facilitated the collection
    # collected[x] : 0..1 Time of product collection. One of these 2
      fhir:collected [  a fhir:DateTime ; dateTime ]
      fhir:collected [  a fhir:Period ; Period ]
    fhir:procedure [ Reference(Procedure) ] ; # 0..1 The procedure involved in the collection
  ] ;
  fhir:storageTempRequirements [ Range ] ; # 0..1 Product storage temperature requirements
  fhir:property ( [ # 0..* A property that is specific to this BiologicallyDerviedProduct instance
    fhir:type [ CodeableConcept ] ; # 1..1 Code that specifies the property
    # value[x] : 1..1 Property values. One of these 9
      fhir:value [  a fhir:Boolean ; boolean ]
      fhir:value [  a fhir:Integer ; integer ]
      fhir:value [  a fhir:CodeableConcept ; CodeableConcept ]
      fhir:value [  a fhir:Period ; Period ]
      fhir:value [  a fhir:Quantity ; Quantity ]
      fhir:value [  a fhir:Range ; Range ]
      fhir:value [  a fhir:Ratio ; Ratio ]
      fhir:value [  a fhir:String ; string ]
      fhir:value [  a fhir:Attachment ; Attachment ]
  ] ... ) ;

]

Changes since Release 3 from both R4 and R4B

BiologicallyDerivedProduct
BiologicallyDerivedProduct.productCategory
  • Max Cardinality changed from 1 to *
  • Type changed from code to CodeableConcept
  • Remove Binding `http://hl7.org/fhir/ValueSet/product-category|4.0.0` (required)
BiologicallyDerivedProduct.biologicalSourceEvent
  • Added Element
BiologicallyDerivedProduct.processingFacility
  • Added Element
BiologicallyDerivedProduct.division
  • Added Element
BiologicallyDerivedProduct.productStatus
  • Added Element
BiologicallyDerivedProduct.expirationDate
  • Added Element
BiologicallyDerivedProduct.collection.sourcePatient
  • Added Element
BiologicallyDerivedProduct.collection.sourceOrganization
  • Added Element
BiologicallyDerivedProduct.collection.procedure
  • Added Element
BiologicallyDerivedProduct.storageTempRequirements
  • Added Element
BiologicallyDerivedProduct.property
  • Added Element
BiologicallyDerivedProduct.property.type
  • Added Mandatory Element
BiologicallyDerivedProduct.property.value[x]
  • Added Mandatory Element
BiologicallyDerivedProduct.status
  • Deleted (-> BiologicallyDerivedProduct.productStatus)
BiologicallyDerivedProduct.quantity
  • Deleted (-> BiologicallyDerivedProduct.property.valueQuantity)
BiologicallyDerivedProduct.collection.source
  • Deleted
BiologicallyDerivedProduct.processing
  • Deleted (-> BiologicallyDerivedProduct.collection)
BiologicallyDerivedProduct.manipulation
  • Deleted (-> BiologicallyDerivedProduct.collection)
BiologicallyDerivedProduct.storage
  • Deleted (-> BiologicallyDerivedProduct.storageTempRequirements)

This resource did not exist in Release 2 See the Full Difference for further information

This analysis is available for R4 as XML or JSON and for R4B as XML or JSON .

 

See the Profiles & Extensions and the alternate Additional definitions: Master Definition XML + JSON , XML Schema / Schematron + JSON Schema , ShEx (for Turtle ) + see the extensions , the spreadsheet version & the dependency analysis

BiologicallyDerivedProduct.productCode Unknown
Path Definition ValueSet Type Reference Documentation
BiologicallyDerivedProduct.productCategory BiologicallyDerivedProductCategory Example

Biologically Derived Product Category.

BiologicallyDerivedProduct.productCode BiologicallyDerivedProductCodes Required Example BiologicallyDerivedProductCategory

This value set enumerates ISBT 128 Product Description Codes© published by ICCBBA as a part of the ISBT 128 standard. These codes support characterization and classification of medical products of human origin inclusive of processing conditions such as additives, volumes and handling conditions.

BiologicallyDerivedProduct.productStatus BiologicallyDerivedProductStatus Example

Biologically Derived Product Code. Status.

BiologicallyDerivedProduct.property.type BiologicallyDerivedProductPropertyTypeCodes Example No details provided

This value set can enumerate ISBT 128 Codes published by ICCBBA as a part of the ISBT 128 standard. These example codes represent data elements defined in ST-027 ISBT 128 Dictionary of Standard Data Elements and are used to define data structure and format expectations for electronic exchange with the ISBT 128 standard.

In some areas of medicine, it is important to record the intended recipient for designated or directed BiologicallyDerivedProducts. The intended recipient represents the individual for whom the product was originally collected or manufactured, reflecting the purpose or intent behind its creation. This may differ from the actual recipient of the product during administration. Even in cases where the BiologicallyDerivedProduct is ultimately dispensed or administered to a different patient, the original intended recipient remains a factual and traceable aspect of the product’s history and should be persisted. This can be an important regulatory or accreditation requirement.

There are two approaches to representing the intended recipient of a designated or directed BiologicallyDerivedProduct:

  1. Within the collection order:
    • Use ServiceRequest.subject to indicate the patient from whom the product is being collected, and ServiceRequest.focus to reference the patient who is the intended recipient. This approach associates the intended recipient with the order rather than the product itself.
  2. Within the BiologicallyDerivedProduct resource:
    • Use the core extension biologicallyderivedproduct-intendedRecipient to explicitly record the intended recipient directly on the BiologicallyDerivedProduct. This approach ensures the intent remains associated with the product throughout its lifecycle, independent of any ordering context.

Preferred approach: The second approach is recommended, as it maintains the intended recipient as an intrinsic attribute of the BiologicallyDerivedProduct, supporting long-term traceability even if the original ServiceRequest is no longer available.

Note to Implementers: At the time of authorship, the biologicallyderivedproduct-intendedRecipient extension had not yet been published. It will be included in the FHIR Extension Pack icon when available. Feedback from implementers is welcomed to inform further refinement and usage guidance.

Important: When PHI from multiple patients (e.g., donor and recipient) is represented within a single BiologicallyDerivedProduct resource, systems should apply appropriate access controls and redaction practices to ensure that users only see the data they are authorized to view. Implementers should follow established standards such as ISBT 128, which governs when donor PHI may be included versus when coded identifiers (e.g., WMDA GRID) should be used.

Search parameters for this resource. See also the full list of search parameters for this resource , and check the Extensions registry for search parameters on extensions related to this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

BiologicallyDerivedProduct.status BiologicallyDerivedProductStatus BiologicallyDerivedProduct.processing.procedure ProcedureCodes(SNOMEDCT) BiologicallyDerivedProduct.storage.scale BiologicallyDerivedProductStorageScale
Name Type Description Expression In Common
biological-source-event token The biological source for the biologically derived product BiologicallyDerivedProduct.biologicalSourceEvent Biologically Derived Product Status.
code Required token A code that identifies the kind of this biologically derived product BiologicallyDerivedProduct.productCode
collector reference Individual performing the collection BiologicallyDerivedProduct.collection.collector
( Practitioner , PractitionerRole )
identifier token Identifier BiologicallyDerivedProduct.identifier 59 Resources Biologically Derived Product Procedure.
parent Example reference The parent biologically derived product BiologicallyDerivedProduct.parent
( BiologicallyDerivedProduct )
patient reference The patient who underwent the procedure to collect the product BiologicallyDerivedProduct.collection.sourcePatient
( Patient )
61 Resources
product-category BiologicallyDerived Product Storage Scale. token Broad category of this product BiologicallyDerivedProduct.productCategory
product-status Required token Whether the product is currently available BiologicallyDerivedProduct.productStatus
request reference Request associated with the biologically derived product BiologicallyDerivedProduct.request
( ServiceRequest )
serial-number token Identifier BiologicallyDerivedProduct.identifier