R6 Ballot (3rd Draft) FHIR CI-Build

This page is part of the FHIR Specification v6.0.0-ballot3: Release 6 Ballot (3rd Draft) (see Ballot Notes ). The current version is 5.0.0 . For a full list Continuous Integration Build of available versions, see FHIR (will be incorrect/inconsistent at times).
See the Directory of published versions icon

8.27 8.26 Resource BiologicallyDerivedProduct - Content

Responsible Owner: Orders and Observations icon Work Group Maturity Level : 2   Trial Use Security Category : Patient Compartments : No 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.

8.27.1 8.26.1 Scope and Usage

Note to Implementers: For an overview of this resource and others in the Biologically Derived Product domain, also see the module page .

This is a base resource that represents a material substance originating from a biological entity intended to be 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 cells, platelets, plasma, etc.)
  • organs (kidney, lung, heart, liver etc.)
  • 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)

8.27.2 8.26.2 Boundaries and Relationships

The following boundaries need to be considered:

  • 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.
  • NutritionProduct - If the product is for normal human dietary consumption administration it is represented as a NutritionProduct, while if NutritionProduct. If the product is for transplant, infusion, therapeutic administration, or injection it is represented as a BiologicallyDerivedProduct. We note that this is remains a grey area, ambiguous, particularly around certain uses of donated human milk, that specific implementations can more specifically resolve. and additional use cases may need to be clarified to determine the appropriate representation. Local implementation guidance may provide further direction.
  • Device - Some biologically derived products are considered a device within certain jurisdictions.
  • 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 a clinical therapy or procedure on the same or different patient. E.g., blood used for a test is represented by a Specimen, while blood for 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 originating donor(s) are held within the manufacturing records the product can be considered and managed as a substance.
8.27.2.1 Nutrition Product If the product is for dietary administration it is represented as a NutritionProduct. If the product is for transplant, infusion, or injection it is represented as a BiologicallyDerivedProduct. We note that this remains a grey area, particularly around certain uses of donated human milk, and additional use cases may need to be clarified to determine the appropriate representation. Local implementation guidance may provide further direction.

8.27.3 8.26.3 References to this Resource

8.27.4 8.26.4 Resource Content

Structure

Name Flags Card. Type Description & Constraints      Filter: Filters doco
. . BiologicallyDerivedProduct TU DomainResource This resource reflects an instance of a biologically derived product

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

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

. . . identifier Σ 0..* Identifier Instance identifier

. . . biologicalSourceEvent Σ 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
. . . processingFacility 0..* Reference ( Organization ) Processing facilities responsible for the labeling and distribution of this biologically derived product

. . . division 0..1 string A unique identifier for an aliquot of a product
. . . productStatus 0..1 Coding available | unavailable | processed | applied | discarded
Binding: Biologically Derived Product Status ( Example )
. . . 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 | Organization ) The patient who underwent the medical procedure to collect the product or the
. . . . sourceOrganization 0..1 Reference ( Organization ) The organization that facilitated the collection
. . . . collected[x] 0..1 Time of product collection
. . . . . collectedDateTime dateTime
. . . . . collectedPeriod Period
. . . . procedure 0..1 Reference ( Procedure ) The procedure involved in the collection
. . . storageTempRequirements 0..1 Range Product storage temperature requirements
. . . property 0..* BackboneElement A property that is specific to this BiologicallyDerviedProduct instance

. . . . type 1..1 CodeableConcept Code that specifies the property
Binding: Biologically Derived Product Property Type Codes ( Example )
. . . . value[x] 1..1 Property values
. . . . . valueBoolean boolean
. . . . . valueInteger integer
. . . . . valueCodeableConcept CodeableConcept
. . . . . valuePeriod Period
. . . . . valueQuantity Quantity
. . . . . valueRange Range
. . . . . valueRatio Ratio
. . . . . valueString string
. . . . . valueAttachment Attachment

doco Documentation for this format icon

See the Extensions for this resource

UML Diagram ( Legend )

BiologicallyDerivedProduct ( DomainResource ) A category or classification of the product. Products may be assigned multiple categories, for example a human heart valve can be categorized as an 'MPHO' and 'tissue' productCategory : CodeableConcept [0..*] « null (Strength=Example) BiologicallyDerivedProductCat... ?? » A codified value that systematically supports characterization and classification of medical products of human origin inclusive of processing conditions such as additives, volumes and handling conditions productCode : CodeableConcept [0..1] « null (Strength=Example) BiologicallyDerivedProductCod... ?? » Parent product (if any) for this biologically-derived product parent : Reference [0..*] « BiologicallyDerivedProduct » Request to obtain and/or infuse this biologically derived product request : Reference [0..*] « ServiceRequest » 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 biologicalSourceEvent : Identifier [0..1] Processing facilities responsible for the labeling and distribution of this biologically derived product processingFacility : Reference [0..*] « Organization » A unique identifier for an aliquot of a product. Used to distinguish individual aliquots of a product carrying the same biologicalSource and productCode identifiers division : string [0..1] The current status of the product productStatus : Coding [0..1] « null (Strength=Example) BiologicallyDerivedProductSta... ?? » Date, and where relevant time, of expiration expirationDate : dateTime [0..1] The temperature requirements for storage of the biologically-derived product storageTempRequirements : Range [0..1] Collection Healthcare professional who is performing the collection collector : Reference [0..1] « Practitioner | PractitionerRole » The patient or providing the product sourcePatient : Reference [0..1] « Patient » The entity, such as a hospital or vendor in the case of a processed/manipulated/manufactured product, providing the product source sourceOrganization : Reference [0..1] « Patient | Organization » Time of product collection collected[x] : DataType [0..1] « dateTime | Period » The procedure performed to collect the biologically derived product procedure : Reference [0..1] « Procedure » Property Code that specifies the property. It should reference an established coding system type : CodeableConcept [1..1] « null (Strength=Example) BiologicallyDerivedProductPro... ?? » Property values value[x] : DataType [1..1] « boolean | integer | CodeableConcept | Period | Quantity | Range | Ratio | string | Attachment » How this product was collected collection [0..1] A property that is specific to this BiologicallyDerviedProduct instance property [0..*]

XML Template 

<<a href="biologicallyderivedproduct-definitions.html#BiologicallyDerivedProduct" title="This resource reflects an instance of a biologically derived product. 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 -->
 <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>
 <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="This resource reflects an instance of a biologically derived product. 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="This resource reflects an instance of a biologically derived product. 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 

  # 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:
    fhir:

    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: ]

      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: ]
      fhir: ]

      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: ]

      fhir:value [  a fhir:String ; string ]

      fhir:value [  a fhir:Attachment ; Attachment ]
  ] ... ) ;
]

Changes 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)

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

Name Flags Card. Type Description & Constraints      Filter: Filters doco
. . BiologicallyDerivedProduct TU DomainResource This resource reflects an instance of a biologically derived product

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

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

. . . identifier Σ 0..* Identifier Instance identifier

. . . biologicalSourceEvent Σ 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
. . . processingFacility 0..* Reference ( Organization ) Processing facilities responsible for the labeling and distribution of this biologically derived product

. . . division 0..1 string A unique identifier for an aliquot of a product
. . . productStatus 0..1 Coding available | unavailable | processed | applied | discarded
Binding: Biologically Derived Product Status ( Example )
. . . 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 | Organization ) The patient who underwent the medical procedure to collect the product or the
. . . . sourceOrganization 0..1 Reference ( Organization ) The organization that facilitated the collection
. . . . collected[x] 0..1 Time of product collection
. . . . . collectedDateTime dateTime
. . . . . collectedPeriod Period
. . . . procedure 0..1 Reference ( Procedure ) The procedure involved in the collection
. . . storageTempRequirements 0..1 Range Product storage temperature requirements
. . . property 0..* BackboneElement A property that is specific to this BiologicallyDerviedProduct instance

. . . . type 1..1 CodeableConcept Code that specifies the property
Binding: Biologically Derived Product Property Type Codes ( Example )
. . . . value[x] 1..1 Property values
. . . . . valueBoolean boolean
. . . . . valueInteger integer
. . . . . valueCodeableConcept CodeableConcept
. . . . . valuePeriod Period
. . . . . valueQuantity Quantity
. . . . . valueRange Range
. . . . . valueRatio Ratio
. . . . . valueString string
. . . . . valueAttachment Attachment

doco Documentation for this format icon

See the Extensions for this resource

UML Diagram ( Legend )

BiologicallyDerivedProduct ( DomainResource ) A category or classification of the product. Products may be assigned multiple categories, for example a human heart valve can be categorized as an 'MPHO' and 'tissue' productCategory : CodeableConcept [0..*] « null (Strength=Example) BiologicallyDerivedProductCat... ?? » A codified value that systematically supports characterization and classification of medical products of human origin inclusive of processing conditions such as additives, volumes and handling conditions productCode : CodeableConcept [0..1] « null (Strength=Example) BiologicallyDerivedProductCod... ?? » Parent product (if any) for this biologically-derived product parent : Reference [0..*] « BiologicallyDerivedProduct » Request to obtain and/or infuse this biologically derived product request : Reference [0..*] « ServiceRequest » 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 biologicalSourceEvent : Identifier [0..1] Processing facilities responsible for the labeling and distribution of this biologically derived product processingFacility : Reference [0..*] « Organization » A unique identifier for an aliquot of a product. Used to distinguish individual aliquots of a product carrying the same biologicalSource and productCode identifiers division : string [0..1] The current status of the product productStatus : Coding [0..1] « null (Strength=Example) BiologicallyDerivedProductSta... ?? » Date, and where relevant time, of expiration expirationDate : dateTime [0..1] The temperature requirements for storage of the biologically-derived product storageTempRequirements : Range [0..1] Collection Healthcare professional who is performing the collection collector : Reference [0..1] « Practitioner | PractitionerRole » The patient or providing the product sourcePatient : Reference [0..1] « Patient » The entity, such as a hospital or vendor in the case of a processed/manipulated/manufactured product, providing the product source sourceOrganization : Reference [0..1] « Patient | Organization » Time of product collection collected[x] : DataType [0..1] « dateTime | Period » The procedure performed to collect the biologically derived product procedure : Reference [0..1] « Procedure » Property Code that specifies the property. It should reference an established coding system type : CodeableConcept [1..1] « null (Strength=Example) BiologicallyDerivedProductPro... ?? » Property values value[x] : DataType [1..1] « boolean | integer | CodeableConcept | Period | Quantity | Range | Ratio | string | Attachment » How this product was collected collection [0..1] A property that is specific to this BiologicallyDerviedProduct instance property [0..*]

XML Template 

<<a href="biologicallyderivedproduct-definitions.html#BiologicallyDerivedProduct" title="This resource reflects an instance of a biologically derived product. 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 -->
 <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>
 <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="This resource reflects an instance of a biologically derived product. 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="This resource reflects an instance of a biologically derived product. 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 

  # 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:
    fhir:

    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: ]

      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: ]
      fhir: ]

      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: ]

      fhir:value [  a fhir:String ; string ]

      fhir:value [  a fhir:Attachment ; Attachment ]
  ] ... ) ;
]

Changes 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)

See the Full Difference for further information

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

 

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

8.27.4.1 8.26.4.1 Terminology Bindings

Path ValueSet Type Documentation
BiologicallyDerivedProduct.productCategory BiologicallyDerivedProductCategory Example

Biologically Derived Product Category.

BiologicallyDerivedProduct.productCode BiologicallyDerivedProductCodes Example

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 Status.

BiologicallyDerivedProduct.property.type BiologicallyDerivedProductPropertyTypeCodes Example

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.

8.26.5 Notes

8.26.5.1 Intended Recipients

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.

8.27.5 8.26.6 Search Parameters

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.

Name Type Description Expression In Common
biological-source-event token The biological source for the biologically derived product BiologicallyDerivedProduct.biologicalSourceEvent
code token A code that identifies the kind of this biologically derived product (SNOMED CT code). BiologicallyDerivedProduct.productCode
collector reference Procedure request to obtain this biologically derived product. Individual performing the collection BiologicallyDerivedProduct.collection.collector
( Practitioner , PractitionerRole )
identifier token Identifier BiologicallyDerivedProduct.identifier 59 Resources
parent 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 token Broad category of this product. product BiologicallyDerivedProduct.productCategory
product-status token Whether the product is currently available. available BiologicallyDerivedProduct.productStatus
request reference Procedure request to obtain this Request associated with the biologically derived product. product BiologicallyDerivedProduct.request
( ServiceRequest )
serial-number token Identifier BiologicallyDerivedProduct.identifier