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8.26 Resource BiologicallyDerivedProduct - Content

Orders and Observations icon Work GroupMaturity Level: 2 Trial UseSecurity Category: Patient Compartments: No defined compartments

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.

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)

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 it is a NutritionProduct, while if the product is for transplant, infusion, or injection it is a BiologicallyDerivedProduct. We note that this is remains a grey area, particularly around certain uses of human milk, that specific implementations can more specifically resolve.
  • 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.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. BiologicallyDerivedProduct TUDomainResourceThis resource reflects an instance of a biologically derived product

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

... productCode 0..1CodeableConceptA 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 Σ0..*IdentifierInstance identifier

... biologicalSourceEvent Σ0..1IdentifierAn 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..1stringA unique identifier for an aliquot of a product
... productStatus 0..1Codingavailable | unavailable | processed | applied | discarded
Binding: Biologically Derived Product Status (Example)
... expirationDate 0..1dateTimeDate, and where relevant time, of expiration
... collection 0..1BackboneElementHow this product was collected
.... collector 0..1Reference(Practitioner | PractitionerRole)Individual performing collection
.... source 0..1Reference(Patient | Organization)The patient who underwent the medical procedure to collect the product or the organization that facilitated the collection
.... collected[x] 0..1Time of product collection
..... collectedDateTimedateTime
..... collectedPeriodPeriod
.... procedure 0..1Reference(Procedure)The procedure involved in the collection
... storageTempRequirements 0..1RangeProduct storage temperature requirements
... property 0..*BackboneElementA property that is specific to this BiologicallyDerviedProduct instance

.... type 1..1CodeableConceptCode that specifies the property
Binding: Biologically Derived Product Property Type Codes (Example)
.... value[x] 1..1Property values
..... valueBooleanboolean
..... valueIntegerinteger
..... valueCodeableConceptCodeableConcept
..... valuePeriodPeriod
..... valueQuantityQuantity
..... valueRangeRange
..... valueRatioRatio
..... valueStringstring
..... valueAttachmentAttachment

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 conditionsproductCode : CodeableConcept [0..1] « null (Strength=Example) BiologicallyDerivedProductCod...?? »Parent product (if any) for this biologically-derived productparent : Reference [0..*] « BiologicallyDerivedProduct »Request to obtain and/or infuse this biologically derived productrequest : Reference [0..*] « ServiceRequest »Unique instance identifiers assigned to a biologically derived product. Note: This is a business identifier, not a resource identifieridentifier : 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 pooledbiologicalSourceEvent : Identifier [0..1]Processing facilities responsible for the labeling and distribution of this biologically derived productprocessingFacility : 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 identifiersdivision : string [0..1]The current status of the productproductStatus : Coding [0..1] « null (Strength=Example)BiologicallyDerivedProductSta...?? »Date, and where relevant time, of expirationexpirationDate : dateTime [0..1]The temperature requirements for storage of the biologically-derived productstorageTempRequirements : Range [0..1]CollectionHealthcare professional who is performing the collectioncollector : Reference [0..1] « Practitioner|PractitionerRole »The patient or entity, such as a hospital or vendor in the case of a processed/manipulated/manufactured product, providing the productsource : Reference [0..1] « Patient|Organization »Time of product collectioncollected[x] : DataType [0..1] « dateTime|Period »The procedure performed to collect the biologically derived productprocedure : Reference [0..1] « Procedure »PropertyCode that specifies the property. It should reference an established coding systemtype : CodeableConcept [1..1] « null (Strength=Example)BiologicallyDerivedProductPro...?? »Property valuesvalue[x] : DataType [1..1] « boolean|integer|CodeableConcept|Period| Quantity|Range|Ratio|string|Attachment »How this product was collectedcollection[0..1]A property that is specific to this BiologicallyDerviedProduct instanceproperty[0..*]

XML Template

<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><!-- 0..1 Reference(Practitioner|PractitionerRole) Individual performing collection --></collector>
  <source><!-- 0..1 Reference(Organization|Patient) The patient who underwent the medical procedure to collect the product or the organization that facilitated the collection --></source>
  <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" : "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 collection
    "source" : { Reference(Organization|Patient) }, // The patient who underwent the medical procedure to collect the product or 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:BiologicallyDerivedProduct;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .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 collection
    fhir:source [ Reference(Organization|Patient) ] ; # 0..1 The patient who underwent the medical procedure to collect the product or 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 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.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.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

NameFlagsCard.TypeDescription & Constraintsdoco
.. BiologicallyDerivedProduct TUDomainResourceThis resource reflects an instance of a biologically derived product

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

... productCode 0..1CodeableConceptA 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 Σ0..*IdentifierInstance identifier

... biologicalSourceEvent Σ0..1IdentifierAn 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..1stringA unique identifier for an aliquot of a product
... productStatus 0..1Codingavailable | unavailable | processed | applied | discarded
Binding: Biologically Derived Product Status (Example)
... expirationDate 0..1dateTimeDate, and where relevant time, of expiration
... collection 0..1BackboneElementHow this product was collected
.... collector 0..1Reference(Practitioner | PractitionerRole)Individual performing collection
.... source 0..1Reference(Patient | Organization)The patient who underwent the medical procedure to collect the product or the organization that facilitated the collection
.... collected[x] 0..1Time of product collection
..... collectedDateTimedateTime
..... collectedPeriodPeriod
.... procedure 0..1Reference(Procedure)The procedure involved in the collection
... storageTempRequirements 0..1RangeProduct storage temperature requirements
... property 0..*BackboneElementA property that is specific to this BiologicallyDerviedProduct instance

.... type 1..1CodeableConceptCode that specifies the property
Binding: Biologically Derived Product Property Type Codes (Example)
.... value[x] 1..1Property values
..... valueBooleanboolean
..... valueIntegerinteger
..... valueCodeableConceptCodeableConcept
..... valuePeriodPeriod
..... valueQuantityQuantity
..... valueRangeRange
..... valueRatioRatio
..... valueStringstring
..... valueAttachmentAttachment

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 conditionsproductCode : CodeableConcept [0..1] « null (Strength=Example) BiologicallyDerivedProductCod...?? »Parent product (if any) for this biologically-derived productparent : Reference [0..*] « BiologicallyDerivedProduct »Request to obtain and/or infuse this biologically derived productrequest : Reference [0..*] « ServiceRequest »Unique instance identifiers assigned to a biologically derived product. Note: This is a business identifier, not a resource identifieridentifier : 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 pooledbiologicalSourceEvent : Identifier [0..1]Processing facilities responsible for the labeling and distribution of this biologically derived productprocessingFacility : 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 identifiersdivision : string [0..1]The current status of the productproductStatus : Coding [0..1] « null (Strength=Example)BiologicallyDerivedProductSta...?? »Date, and where relevant time, of expirationexpirationDate : dateTime [0..1]The temperature requirements for storage of the biologically-derived productstorageTempRequirements : Range [0..1]CollectionHealthcare professional who is performing the collectioncollector : Reference [0..1] « Practitioner|PractitionerRole »The patient or entity, such as a hospital or vendor in the case of a processed/manipulated/manufactured product, providing the productsource : Reference [0..1] « Patient|Organization »Time of product collectioncollected[x] : DataType [0..1] « dateTime|Period »The procedure performed to collect the biologically derived productprocedure : Reference [0..1] « Procedure »PropertyCode that specifies the property. It should reference an established coding systemtype : CodeableConcept [1..1] « null (Strength=Example)BiologicallyDerivedProductPro...?? »Property valuesvalue[x] : DataType [1..1] « boolean|integer|CodeableConcept|Period| Quantity|Range|Ratio|string|Attachment »How this product was collectedcollection[0..1]A property that is specific to this BiologicallyDerviedProduct instanceproperty[0..*]

XML Template

<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><!-- 0..1 Reference(Practitioner|PractitionerRole) Individual performing collection --></collector>
  <source><!-- 0..1 Reference(Organization|Patient) The patient who underwent the medical procedure to collect the product or the organization that facilitated the collection --></source>
  <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" : "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 collection
    "source" : { Reference(Organization|Patient) }, // The patient who underwent the medical procedure to collect the product or 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:BiologicallyDerivedProduct;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .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 collection
    fhir:source [ Reference(Organization|Patient) ] ; # 0..1 The patient who underwent the medical procedure to collect the product or 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 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.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.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

PathValueSetTypeDocumentation
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.

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.

NameTypeDescriptionExpressionIn Common
biological-source-eventtokenThe biological source for the biologically derived productBiologicallyDerivedProduct.biologicalSourceEvent
codetokenA code that identifies the kind of this biologically derived product (SNOMED CT code).BiologicallyDerivedProduct.productCode
collectorreferenceProcedure request to obtain this biologically derived product.BiologicallyDerivedProduct.collection.collector
identifiertokenIdentifierBiologicallyDerivedProduct.identifier
product-categorytokenBroad category of this product.BiologicallyDerivedProduct.productCategory
product-statustokenWhether the product is currently available.BiologicallyDerivedProduct.productStatus
requestreferenceProcedure request to obtain this biologically derived product.BiologicallyDerivedProduct.request
serial-numbertokenIdentifierBiologicallyDerivedProduct.identifier