BiologicallyDerivedProduct

Owning committee name

Orders & Observations

Committee Approval Date:

October 5, 2017

Contributing or Reviewing Work Groups

FHIR Resource Development Project Insight ID

OO project ID.

Scope of coverage

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 within the same blood group, 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, BiologicallyDerivedProduct, or transition from a Specimen to a 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 needs is a BiologicallyDerivedProduct as a source.  Note that a specimen or biologically derived product can be obtained through similar procedures such as sampling, harvesting, biopsy, or other techniques.

  • 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 forward where we do not care about the relationship with the originating donor(s) it is now considered and managed as a substance.

While these create some grey space between resources, once considered a BiologicallyDerivedProduct it does require specific data and processes to manage such products where a specific product cannot be represented by more than one resource.

RIM scope

No identified mappings to RIM 2.46 objects.

Resource appropriateness

Organs, tissues, and fluids obtained from one biological entity (person or animal) for the purpose of clinical application in another biological entity are neither Specimens ("used for diagnostic and environmental testing") nor Devices ("an instance or a type of a manufactured item") nor Medications (drug, ingredients, and packaging) nor Substances ("homogeneous material with a definite composition"). Furthermore, there is established a relationship, and a regulatory requirement for traceability, between two entities, the one or more sources (e.g., donor, animal) as applicable and the recipient.

Expected implementations

This will be used:

  1. to support transfer of information regarding individual products between the processor/labeler of the product and the receiving hospital facility (transfusion laboratory)
  2. to support hemovigilance and biovigilance activities including adverse event/reaction investigations and lookback
  3. to provide feedback to processors on clinical application
  4. in reporting clinical outcomes to the Center for International Blood and Marrow Transplant Research (CIBMTR) after hematopoietic cell transplant (bone marrow, peripheral blood stem cells, cord blood).

This resource is not used in C-CDA.

For reporting of clinical outcomes to CIBMTR (Center for International Blood and Marrow Transplant Research), source data would come from federated systems at the transplant center, e.g., from the EHR, transplant databases, labs.

The workflow using the BiologicallyDerivedProduct resource (e.g., request, procedure to apply) should follow the same patterns as other similar resources are handled (e.g., device, medication, nutrition product).

Content sources

For reporting of clinical outcomes to CIBMTR, source data would come from federated systems at the transplant center, e.g., from the EHR, transplant databases, labs

  • Patient undergoes hematopoetic cell transplantation (HCT) using autologous BiologicallyDerivedProduct
  • Patient undergoes HCT using HLA-matched BiologicallyDerivedProduct from another person
  • Patient receives post-HCT infusion of donor t-cells (BiologicallyDerivedProduct)
  • Patient receives blood (BiologicallyDerivedProduct) transfusion
  • Patient receives HLA-matched platelets (BiologicallyDerivedProduct)
  • Patient receives heart (BiologicallyDerivedProduct) transplant from deceased donor Patient
  • Patient donates kidney (BiologicallyDerivedProduct) for transplantation in another Patient
  • Patient received pig heart valve (BiologicallyDerivedProduct)

Example Scenarios

Autologous transplant (PBSC)

A patient diagnosed with multiple myeloma is scheduled for chemo therapy.
Prior to chemo therapy, the patient undergoes a peripheral blood stem cell (PBSC)
collection to restore their immune system post chemo therapy.
This product (PBSC) is then infused back into the patient post chemo therapy.

BiologicallyDerivedProduct:1

id: 1
collection.source -> Patient:1
collection.dateTime: 2020-06-01
request -> ServiceRequest:1

Allogenic transplant, multiple product (PBSC+CBU)

A patient diagnosed with acute myelogenous leukemia is scheduled for a hematopoietic cell transplantation (HCT).
The patient is typed for HLA and a search is performed for a compatible donor.
A compatible un-related donor is identified as well as a well-matched frozen cord blood unit (CBU).
The un-related donor and a sample from the CBU undergo confirmatory HLA typing and infectious disease assessment.
The patient undergoes preparative regimen prior to the HCT.
The related undergoes a bone marrow (BM) collection procedure shortly prior to the selected HCT date.
The collected BM product and the frozen CBU are transported to the center where the patient is undergoing the HCT.
The BM product and the CBU are then infused into the patient during the HCT.

BiologicallyDerivedProduct:1

id: 1
identifier:
system: http://terminology.organization1.org/product_id
value: [12345]
productCode: [bone marrow]
status: available
request -> ServiceRequest:2
collection
source -> Patient:2
dateTime: 2019-04-01
processing
additive -> Substance:1
timeDateTime: 2019-04-01


BiologicallyDerivedProduct:2

id: 2
identifier
system: http://terminology.organization2.org/cbu_id
value: 989251229
collection.source -> Organization:2
collection.dateTime: 2019-04-01
request -> ServiceRequest:2
storage[1]
temperature: -200
scale: celcius
duration
start: 2015-05-01
end: 2019-04-01

Bone Marrow transplant

A bone marrow extracted from one person (donor) in an Hematopoietic Cell Transplantation (HCT) into another person (recipient).


Blood Product Supply

A hospital transfusion laboratory requests a Blood Group A apheresis platelet unit to replenish stock.  The Blood Center supplies and dispatches the product.


BiologicallyDerivedProduct:1

id: 1

identifier:

system: https://www.isbt128.org/uri/MPHOUniqueIdentifier

value: A9999E3045A999921123456000001

productCode:

              coding:

                             system: https://www.isbt128.org/uri/ProductDescriptionCode

                             code: E3045

              text: Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated

status: available

quantity:1

storage:

              description: 20-24C

              duration:

                             end: 2021-08-02T23:59:00-05:00

Resource Relationships

Patient ("receiver" and "source")

Procedure (one for collection and one for transplantation, will need to add BiologicallyDerivedProduct to the "usedReference")

Practitioner (who collected product)

ProcedureRequest (for collection)

Substance (product processing)

DiagnosticReport (containing HLA-typing)

BiologicallyDerivedProduct ("parent" product for multi-day collections)

Timelines

This will follow the regular FHIR release progression.

gitHub Users

Kirt Schaper, Bob Milius

When Resource Proposal Is Complete

When you have completed your proposal, please send an email to FMGcontact@HL7.org

FMG Notes

1 Comment

  1. Will Rosenfeld

    Should this note how vaccines are outside the boundaries of this scope?