Release 4B R5 Final QA

This page is part of the FHIR Specification (v4.3.0: R4B (v5.0.0-draft-final: Final QA Preview for R5 - STU see ballot notes ). The current version which supercedes this version is 5.0.0 . For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4

10.11 8.26 Resource BiologicallyDerivedProduct - Content

Orders and Observations icon Work Group Maturity Level : 0 2   Trial Use Security Category : Patient Compartments : Not linked to any 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.

10.11.1 8.26.1 Scope and Usage

Trial-Use Note: Note that this content This is preliminary has not undergone proper review by the appropriate Workgroups. A 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 8.26.2 Boundaries and Relationships

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

  • ProcedureRequest (for collection) Patient ("receiver" and "source") Practitioner (who collected product) 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.
  • Substance (product processing) 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.
  • 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.

10.11.3 8.26.3 References to this Resource

This resource is referenced by itself,

10.11.4 8.26.4 Resource Content

Structure

Σ Description of of processing Procesing code Procedure Codes (SNOMED CT) ( Example ) Any manipulation of product post-collection Description of manipulation Time of manipulation Product storage Description of storage Storage temperature Storage timeperiod
Name Flags Card. Type Description & Constraints doco
. . BiologicallyDerivedProduct TU DomainResource A material substance originating from 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..* 0..1 Identifier Coding External ids for this item organ | tissue | fluid | cells | biologicalAgent
Binding: Biologically Derived Product Category ( Example )
. . productCategory . productCode 0..1 code CodeableConcept organ | tissue | fluid | cells | biologicalAgent A code that identifies the kind of this biologically derived product
BiologicallyDerivedProductCategory Binding: Biologically Derived Product Codes ( Required Example )
. . productCode . parent 0..1 0..* CodeableConcept Reference ( BiologicallyDerivedProduct ) What this biologically derived The parent biologically-derived product is
BiologicallyDerivedProductCode ( Example )
. . request . identifier Σ 0..* Reference ( ServiceRequest Identifier ) Procedure request Instance identifier

. . quantity . biologicalSourceEvent Σ 0..1 integer Identifier The amount of An identifier that supports traceability to the event during which material in this biologically derived product from one or more biological entities was obtained or pooled
. . . parent processingFacility 0..* Reference ( BiologicallyDerivedProduct Organization ) BiologicallyDerivedProduct parent Processing facilities responsible for the labeling and distribution of this biologically derived product

. . collection . division 0..1 BackboneElement string How this A unique identifier for an aliquot of a product was collected
. . collector . productStatus 0..1 Reference ( Practitioner Coding available | PractitionerRole unavailable
Binding: Biologically Derived Product Status ( Example )
Individual performing collection
. . source . expirationDate 0..1 Reference ( Patient | Organization dateTime ) Who is product from Date, and where relevant time, of expiration
. . collected[x] . collection 0..1 BackboneElement Time of How this product collection was collected
. . . collectedDateTime . collector 0..1 dateTime Reference ( Practitioner | PractitionerRole ) Individual performing collection
. . . . source collectedPeriod 0..1 Period Reference ( Patient | Organization ) The patient who underwent the medical procedure to collect the product or the organization that facilitated the collection
. . processing . . collected[x] 0..* 0..1 BackboneElement Any processing Time of the product during collection
. . . . . description collectedDateTime 0..1 string dateTime
. . . procedure . . collectedPeriod 0..1 CodeableConcept Period
. . additive . storageTempRequirements 0..1 Reference ( Substance Range ) Substance added during processing Product storage temperature requirements
. . time[x] . property 0..1 0..* BackboneElement Time of processing A property that is specific to this BiologicallyDerviedProduct instance

. . . timeDateTime . type 1..1 dateTime CodeableConcept Code that specifies the property
Binding: Biologically Derived Product Property Type Codes ( Example )
. . timePeriod . . value[x] 1..1 Period Property values
. manipulation . . . . valueBoolean 0..1 BackboneElement boolean
. . . . . description valueInteger 0..1 string integer
. . . time[x] . . valueCodeableConcept 0..1 CodeableConcept
. . . . timeDateTime . valuePeriod dateTime Period
. . . . . timePeriod valueQuantity Period Quantity
. storage . . . . valueRange 0..* BackboneElement Range
. . . description . . valueRatio 0..1 string Ratio
. . . . . temperature valueString 0..1 decimal string
. . scale 0..1 code farenheit | celsius | kelvin BiologicallyDerivedProductStorageScale ( Required ) . . duration . valueAttachment 0..1 Period Attachment

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 category of this product productCategory : code Coding [0..1] « null (Strength=Required) (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) BiologicallyDerivedProductCode?? BiologicallyDerivedProductCod... ?? » Whether the Parent product (if any) for this biologically-derived product is currently available status parent : code Reference [0..1] [0..*] « null (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 » 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] Whether the product is currently available 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 entity, such as a hospital or vendor in the case of a processed/manipulated/manufactured product, providing the product source : Reference [0..1] « Patient | Organization » Time of product collection collected[x] : Element DataType [0..1] « dateTime | Period » Processing Description of of processing description : string [0..1] Property Procesing code Code that specifies the property. It should reference an established coding system procedure type : CodeableConcept [0..1] [1..1] « null (Strength=Example) ProcedureCodes(SNOMEDCT) BiologicallyDerivedProductPro... ?? » Substance added during processing Property values additive value[x] : Reference DataType [0..1] [1..1] « Substance » Time of processing time[x] boolean : Element | integer [0..1] « dateTime | CodeableConcept | Period » Manipulation Description of manipulation description : string [0..1] | Time of manipulation time[x] : Element [0..1] « dateTime Quantity | Period Range » Storage Description of storage description | Ratio : | string [0..1] Storage temperature temperature : decimal [0..1] Temperature scale used scale : code | Attachment [0..1] « null (Strength=Required) BiologicallyDerivedProductSto... ! » Storage timeperiod duration : Period [0..1] 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..1 Coding organ | tissue | fluid | cells | biologicalAgent --></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 --></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>

  <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]>
 </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" : { Coding }, // organ | tissue | fluid | cells | biologicalAgent
  "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
  "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 }
  },
  "
    "
    "
    "
    
    ">"
    " }
  }],
  "
    "
    
    ">"
    " }
  },
  "
    "
    "
    "
    "

  "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 Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  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:
  ], ...;

  fhir:productCategory [ Coding ] ; # 0..1 organ | tissue | fluid | cells | biologicalAgent
  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
  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: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 R4

BiologicallyDerivedProduct
BiologicallyDerivedProduct.productCategory
  • No Changes Type changed from code to Coding
  • 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.storageTempRequirements
  • Added Element
BiologicallyDerivedProduct.property
  • Added Element
BiologicallyDerivedProduct.property.type
  • Added Mandatory Element
BiologicallyDerivedProduct.property.value[x]
  • Added Mandatory Element
BiologicallyDerivedProduct.status
  • deleted
BiologicallyDerivedProduct.quantity
  • deleted
BiologicallyDerivedProduct.processing
  • deleted
BiologicallyDerivedProduct.manipulation
  • deleted
BiologicallyDerivedProduct.storage
  • deleted

See the Full Difference for further information

This analysis is available as XML or JSON .

Conversions between R3 and R4

Structure

Σ Description of of processing Procesing code Procedure Codes (SNOMED CT) ( Example ) Any manipulation of product post-collection Description of manipulation Time of manipulation Product storage Description of storage Storage temperature Storage timeperiod
Name Flags Card. Type Description & Constraints doco
. . BiologicallyDerivedProduct TU DomainResource A material substance originating from 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..* 0..1 Identifier Coding External ids for this item organ | tissue | fluid | cells | biologicalAgent
Binding: Biologically Derived Product Category ( Example )
. . productCategory . productCode 0..1 code CodeableConcept organ | tissue | fluid | cells | biologicalAgent A code that identifies the kind of this biologically derived product
BiologicallyDerivedProductCategory Binding: Biologically Derived Product Codes ( Required Example )
. . productCode . parent 0..1 0..* CodeableConcept Reference ( BiologicallyDerivedProduct ) What this biologically derived The parent biologically-derived product is
BiologicallyDerivedProductCode ( Example )
. . request . identifier Σ 0..* Reference ( ServiceRequest Identifier ) Procedure request Instance identifier

. . quantity . biologicalSourceEvent Σ 0..1 integer Identifier The amount of An identifier that supports traceability to the event during which material in this biologically derived product from one or more biological entities was obtained or pooled
. . . parent processingFacility 0..* Reference ( BiologicallyDerivedProduct Organization ) BiologicallyDerivedProduct parent Processing facilities responsible for the labeling and distribution of this biologically derived product

. . collection . division 0..1 BackboneElement string How this A unique identifier for an aliquot of a product was collected
. . collector . productStatus 0..1 Reference ( Practitioner Coding available | PractitionerRole unavailable
Binding: Biologically Derived Product Status ( Example )
Individual performing collection
. . source . expirationDate 0..1 Reference ( Patient | Organization dateTime ) Who is product from Date, and where relevant time, of expiration
. . collected[x] . collection 0..1 BackboneElement Time of How this product collection was collected
. . . collectedDateTime . collector 0..1 dateTime Reference ( Practitioner | PractitionerRole ) Individual performing collection
. . . . source collectedPeriod 0..1 Period Reference ( Patient | Organization ) The patient who underwent the medical procedure to collect the product or the organization that facilitated the collection
. . processing . . collected[x] 0..* 0..1 BackboneElement Any processing Time of the product during collection
. . . . . description collectedDateTime 0..1 string dateTime
. . . procedure . . collectedPeriod 0..1 CodeableConcept Period
. . additive . storageTempRequirements 0..1 Reference ( Substance Range ) Substance added during processing Product storage temperature requirements
. . time[x] . property 0..1 0..* BackboneElement Time of processing A property that is specific to this BiologicallyDerviedProduct instance

. . . timeDateTime . type 1..1 dateTime CodeableConcept Code that specifies the property
Binding: Biologically Derived Product Property Type Codes ( Example )
. . timePeriod . . value[x] 1..1 Period Property values
. manipulation . . . . valueBoolean 0..1 BackboneElement boolean
. . . . . description valueInteger 0..1 string integer
. . . time[x] . . valueCodeableConcept 0..1 CodeableConcept
. . . . timeDateTime . valuePeriod dateTime Period
. . . . . timePeriod valueQuantity Period Quantity
. storage . . . . valueRange 0..* BackboneElement Range
. . . description . . valueRatio 0..1 string Ratio
. . . . . temperature valueString 0..1 decimal string
. . scale 0..1 code farenheit | celsius | kelvin BiologicallyDerivedProductStorageScale ( Required ) . . duration . valueAttachment 0..1 Period Attachment

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 category of this product productCategory : code Coding [0..1] « null (Strength=Required) (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) BiologicallyDerivedProductCode?? BiologicallyDerivedProductCod... ?? » Whether the Parent product (if any) for this biologically-derived product is currently available status parent : code Reference [0..1] [0..*] « null (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 » 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] Whether the product is currently available 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 entity, such as a hospital or vendor in the case of a processed/manipulated/manufactured product, providing the product source : Reference [0..1] « Patient | Organization » Time of product collection collected[x] : Element DataType [0..1] « dateTime | Period » Processing Description of of processing description : string [0..1] Property Procesing code Code that specifies the property. It should reference an established coding system procedure type : CodeableConcept [0..1] [1..1] « null (Strength=Example) ProcedureCodes(SNOMEDCT) BiologicallyDerivedProductPro... ?? » Substance added during processing Property values additive value[x] : Reference DataType [0..1] [1..1] « Substance » Time of processing time[x] boolean : Element | integer [0..1] « dateTime | CodeableConcept | Period » Manipulation Description of manipulation description : string [0..1] | Time of manipulation time[x] : Element [0..1] « dateTime Quantity | Period Range » Storage Description of storage description | Ratio : | string [0..1] Storage temperature temperature : decimal [0..1] Temperature scale used scale : code | Attachment [0..1] « null (Strength=Required) BiologicallyDerivedProductSto... ! » Storage timeperiod duration : Period [0..1] 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..1 Coding organ | tissue | fluid | cells | biologicalAgent --></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 --></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>

  <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]>
 </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" : { Coding }, // organ | tissue | fluid | cells | biologicalAgent
  "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
  "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 }
  },
  "
    "
    "
    "
    
    ">"
    " }
  }],
  "
    "
    
    ">"
    " }
  },
  "
    "
    "
    "
    "

  "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 Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  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:
  ], ...;

  fhir:productCategory [ Coding ] ; # 0..1 organ | tissue | fluid | cells | biologicalAgent
  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
  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: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 4

BiologicallyDerivedProduct
BiologicallyDerivedProduct.productCategory
  • No Changes Type changed from code to Coding
  • 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.storageTempRequirements
  • Added Element
BiologicallyDerivedProduct.property
  • Added Element
BiologicallyDerivedProduct.property.type
  • Added Mandatory Element
BiologicallyDerivedProduct.property.value[x]
  • Added Mandatory Element
BiologicallyDerivedProduct.status
  • deleted
BiologicallyDerivedProduct.quantity
  • deleted
BiologicallyDerivedProduct.processing
  • deleted
BiologicallyDerivedProduct.manipulation
  • deleted
BiologicallyDerivedProduct.storage
  • deleted

See the Full Difference for further information

This analysis is available as XML or JSON .

Conversions between R3 and R4

 

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

10.11.4.1 8.26.4.1 Terminology Bindings

BiologicallyDerivedProduct.status BiologicallyDerivedProduct.processing.procedure
Path Definition ValueSet Type Reference Documentation
BiologicallyDerivedProduct.productCategory BiologicallyDerivedProductCategory Required Example BiologicallyDerivedProductCategory

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 Required Example BiologicallyDerivedProductStatus

Biologically Derived Product Status.

BiologicallyDerivedProduct.property.type BiologicallyDerivedProductPropertyTypeCodes Example ProcedureCodes(SNOMEDCT)

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 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.

BiologicallyDerivedProduct.storage.scale Required
Name Type Description Expression In Common
biological-source-event token The biological source for the biologically derived product BiologicallyDerivedProduct.biologicalSourceEvent
code BiologicallyDerivedProductStorageScale 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. BiologicallyDerivedProduct.collection.collector
( Practitioner , PractitionerRole )
identifier token Identifier BiologicallyDerivedProduct.identifier
product-category token Broad category of this product. BiologicallyDerivedProduct.productCategory
product-status token Whether the product is currently available. BiologicallyDerivedProduct.productStatus
request reference Procedure request to obtain this biologically derived product. BiologicallyDerivedProduct.request
( ServiceRequest )
serial-number token Identifier BiologicallyDerivedProduct.identifier