BiologicallyDerivedProduct — Biological product
A bag of red blood cells, an organ for transplant, stem cells: any biological product tracked from donor to recipient. The FHIR foundation for transfusion and transplant services.
Purpose
BiologicallyDerivedProduct covers products of biological origin intended to be administered or transplanted: blood products (RBC, plasma, platelets), organs (kidney, liver, heart), tissues (cornea, bone, skin), haematopoietic stem cells. Traceability is critical for transfusion safety and transplant.
The ISBT 128 identifier (Information Standard for Blood and Transplant) is the international standard for labelling blood and tissue products. It enables traceability from donor to recipient — a regulatory requirement in the EU (FACT/JACIE) and the US (FDA / AABB).
Key elements
| Field | Type | Cardinality | Role |
|---|---|---|---|
productCategory | CodeableConcept | 0..1 | Category (organ, tissue, fluid, cells, biologicalAgent). |
productCode | CodeableConcept | 0..1 | Product code (HL7 v2-0913 table or other). |
parent | Reference(BiologicallyDerivedProduct)[] | 0..* | Parent product on splitting. |
request | Reference(ServiceRequest)[] | 0..* | Originating request. |
identifier | Identifier[] | 0..* | External identifiers (ISBT 128). |
biologicalSourceEvent | Identifier | 0..1 | Source collection event (DIN). |
processingFacility | Reference(Organization)[] | 0..* | Processing facility. |
division | string | 0..1 | Specific division of the bag. |
productStatus | Coding | 0..1 | Status (available, unavailable). |
expirationDate | dateTime | 0..1 | Expiry date. |
collection | BackboneElement | 0..1 | Donor, collector, date. |
storage | BackboneElement[] | 0..* | Temperature, duration, scale. |
JSON example
Red blood cell bag labelled with ISBT 128:
{
"resourceType": "BiologicallyDerivedProduct",
"id": "example-rbc-unit",
"productCategory": {
"coding": [{
"system": "http://terminology.hl7.org/CodeSystem/biologicallyderived-productcategory",
"code": "organ",
"display": "Blood, Sub-component or Derivative"
}]
},
"productCode": {
"coding": [{
"system": "http://terminology.hl7.org/CodeSystem/v2-0913",
"code": "RBC",
"display": "Red Blood Cells"
}]
},
"productStatus": {
"coding": [{
"system": "http://hl7.org/fhir/biologicallyderived-productstatus",
"code": "available"
}]
},
"identifier": [{
"system": "https://www.iccbba.org/isbt-128",
"value": "A99991234567890"
}],
"biologicalSourceEvent": {
"system": "https://hospital01.example.org/donation",
"value": "DON-2026-04501"
},
"expirationDate": "2026-06-19",
"collection": {
"collector": {
"reference": "Practitioner/donor-collector"
},
"source": {
"reference": "Patient/donor-12345"
},
"collectedDateTime": "2026-05-15T14:30:00+00:00"
},
"storage": [{
"description": "Stored at 4°C, continuous agitation",
"temperature": 4,
"scale": "celsius",
"duration": {
"start": "2026-05-15T15:00:00+00:00"
}
}]
}Common pitfalls
- Identifier without ISBT 128: prevents cross-facility consolidation and targeted recall on donor issues.
- Missing storage: cold chain is critical for RBC and platelets. A breach invalidates the unit.
- BiologicalSourceEvent vs Patient/donor: the donation event is distinct from donor identity — separation crucial for anonymity.
Related resources
- BiologicallyDerivedProductDispense — dispense to recipient.
- Specimen — lab specimen.
- Procedure — transfusion / transplant.
- ServiceRequest — product request.