BiologicallyDerivedProduct FHIR Resource Proposal

BiologicallyDerivedProduct

Owning committee name

Orders & Observations

Committee Approval Date:

Please enter the date that the committee approved this Resource proposal October 5, 2017

Contributing or Reviewing Work Groups

• Patient Care
• Pharmacy

FHIR Resource Development Project Insight ID

1128 Patient Care FHIR resource review

Scope of coverage

A material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity.

Examples include:

• hematopoietic stem cells (bone marrow, peripheral blood, or cord blood extraction)
• blood (whole, extracted cells, plasma, etc)
• organs
• tissues (porcine valves, skin, bovine cardiac tissue, etc.)
• manipulated cells (e.g. CAR T-cells)

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)

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 infusion, transplantation or grafting to 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 between two entities, the donor and the recipient.

Expected implementations

This will be used 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 CCDA.

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)

Resource Relationships

ProcedureRequest (for collection)

Patient ("receiver" and "source")

Practitioner (who collected product)

Substance (product processing)

DiagnosticReport (containing HLA-typing)

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

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

Timelines

ready by Jan 2018 connectathon

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When Resource Proposal Is Complete

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