type: resource-definitionsresource: BiologicallyDerivedProduct

BiologicallyDerivedProduct Definitions

BiologicallyDerivedProduct

This resource reflects an instance of a biologically derived product

Definition: 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.

Comments: Substances include, but are not limited to: whole blood, bone marrow, organs, and manipulated blood cells.

Cardinality: 0..*

Mappings: rim=Material[classCode= Observation[classCode=OBS, moodCode=EVN]; w5=clinical.general

BiologicallyDerivedProduct.productCategory

A category or classification of the product

Definition: 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'.

Cardinality: 0..*

Type: CodeableConcept

Binding: example:product-category

BiologicallyDerivedProduct.productCode

A code that identifies the kind of this biologically derived product

Definition: 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.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:biologicallyderived-productcodes

Mappings: ISBT128Code=Product Description Code. Required for ISBT 128 labeled products

BiologicallyDerivedProduct.parent

The parent biologically-derived product

Definition: Parent product (if any) for this biologically-derived product.

Comments: For products that have multiple collections. For example Peripheral Blood Stem Cells may be collected over several days from a single donor and the donation split into in multiple containers which must be linked to the parent donation.

Cardinality: 0..*

Type: Reference(BiologicallyDerivedProduct)

BiologicallyDerivedProduct.request

Request to obtain and/or infuse this product

Definition: Request to obtain and/or infuse this biologically derived product.

Cardinality: 0..*

Type: Reference(ServiceRequest)

BiologicallyDerivedProduct.identifier

Instance identifier

Definition: Unique instance identifiers assigned to a biologically derived product. Note: This is a business identifier, not a resource identifier.

Comments: This identifier should uniquely identify the product instance in the business domain. Ideally it should be a globally unique identifier under the control of an ISO/IEC 15459 Issuing Agency.

Cardinality: 0..*

Type: Identifier

Summary: true

Mappings: w5=FiveWs.identifier; v2=IAM-7; rim=id; ISBT128Code=MPHO Unique Identifier. Required for ISBT 128 labeled products

BiologicallyDerivedProduct.biologicalSourceEvent

An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled

Definition: An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled.

Comments: Necessary to support mandatory requirements for traceability from donor/source to recipient and vice versa, while also satisfying donor anonymity requirements. The element is defined consistently across BiologicallyDerivedProduct, NutritionProduct, and Device. The identifier references an event that links to a single biological entity such as a blood donor, or to multiple biological entities (e.g. when the product is an embryo or a pooled platelet product). A single biologicalSourceEvent identifier may appear on multiple products of many types derived from a single donation event or source extraction. As an example, a single donation event may provide 2 kidneys and a liver for organ transplantation, 2 corneas for eye surgery, heart valves and arterial tissue for cardiovascular surgery, multiple skin grafts, tendons, multiple shaped bone grafts and a large number of bone putty/paste products; and each of them may be assigned to the same biological source event identifier.

Cardinality: 0..1

Type: Identifier

Summary: true

Mappings: w5=FiveWs.identifier; ISBT128Code=Donation Identification Number. Required for ISBT 128 labeled products

BiologicallyDerivedProduct.processingFacility

Processing facilities responsible for the labeling and distribution of this biologically derived product

Definition: Processing facilities responsible for the labeling and distribution of this biologically derived product.

Cardinality: 0..*

Type: Reference(Organization)

Mappings: ISBT128Code=Processing Facility Identification Number

BiologicallyDerivedProduct.division

A unique identifier for an aliquot of a product

Definition: A unique identifier for an aliquot of a product. Used to distinguish individual aliquots of a product carrying the same biologicalSource and productCode identifiers.

Cardinality: 0..1

Type: string

Mappings: ISBT128Code=Division Identifier. Required for ISBT 128 labeled products

BiologicallyDerivedProduct.productStatus

available | unavailable | processed | applied | discarded

Definition: The current status of the product.

Cardinality: 0..1

Type: Coding

Binding: example:biologicallyderived-product-status

BiologicallyDerivedProduct.expirationDate

Date, and where relevant time, of expiration

Definition: Date, and where relevant time, of expiration.

Cardinality: 0..1

Type: dateTime

Mappings: ISBT128Code=Expiration Date and Time ISO

BiologicallyDerivedProduct.collection

How this product was collected

Definition: How this product was collected.

Cardinality: 0..1

Type: BackboneElement

BiologicallyDerivedProduct.collection.collector

Individual performing the collection

Definition: Healthcare professional who is performing the collection.

Cardinality: 0..1

Type: Reference(Practitioner, PractitionerRole)

BiologicallyDerivedProduct.collection.sourcePatient

The patient who underwent the medical procedure to collect the product

Definition: The patient providing the product.

Comments: The collection.source may reference an identifiable patient. Implementers shall ensure the appropriate data access controls are established.

Cardinality: 0..1

Type: Reference(Patient)

Mappings: ISBT128Code=Global Registration Identifier for Donors

BiologicallyDerivedProduct.collection.sourceOrganization

The organization that facilitated the collection

Definition: The entity, such as a hospital or vendor in the case of a processed/manipulated/manufactured product, providing the product.

Cardinality: 0..1

Type: Reference(Organization)

BiologicallyDerivedProduct.collection.collected[x]

Time of product collection

Definition: Time of product collection.

Cardinality: 0..1

Type: dateTime, Period

BiologicallyDerivedProduct.collection.procedure

The procedure involved in the collection

Definition: The procedure performed to collect the biologically derived product.

Cardinality: 0..1

Type: Reference(Procedure)

BiologicallyDerivedProduct.storageTempRequirements

Product storage temperature requirements

Definition: The temperature requirements for storage of the biologically-derived product.

Comments: May be extracted from information held in the productCode element.

Cardinality: 0..1

Type: Range

BiologicallyDerivedProduct.property

A property that is specific to this BiologicallyDerviedProduct instance

Definition: A property that is specific to this BiologicallyDerviedProduct instance.

Comments: Property can be used to provide information on a wide range of additional information specific to a particular biologicallyDerivedProduct.

Cardinality: 0..*

Type: BackboneElement

BiologicallyDerivedProduct.property.type

Code that specifies the property

Definition: Code that specifies the property. It should reference an established coding system.

Comments: The element is identified by name and system URI in the type. Some types may have multiple occurrences.

Cardinality: 1..1

Type: CodeableConcept

Binding: example:biologicallyderived-product-property-type-codes

BiologicallyDerivedProduct.property.value[x]

Property values

Definition: Property values.

Comments: The value should be provided as a boolean, integer, CodeableConcept, period, quantity, range, ratio, or attachment. The description can be a string only when these others are not available.

Cardinality: 1..1

Type: boolean, integer, CodeableConcept, Period, Quantity, Range, Ratio, string, Attachment