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8.27 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.

8.27.1 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 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 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.

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 References to this Resource

8.27.4 Resource Content

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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 collection
.... source 0..1 Reference(Patient | Organization) 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
..... 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

 

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 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.

8.27.5 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.

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. 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