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type: resourceresource: BiologicallyDerivedProduct

BiologicallyDerivedProduct

Introduction

Scope and Usage

Note to Balloters: To ensure this resource is ready for Normative status, we are seeking ballot comment on the substantive content. The key changes made since R5 include:

  • Change to the .collection backbone with respect to the collection source. This includes updates to the corresponding search parameters.

  • Addition of a Notes section: biologicallyderivedproduct.html#8.25.5 to include information on how to handle information about the intended recipient.

  • The following artifacts have been moved to the [OO Incubator IG|https://build.fhir.org/ig/HL7/oo-incubator]

  • The Medical Product of Human Origin (MPHO) Profile is still under development.

  • The BiologicallyDerivedProductDispense resource. Additional work needs to be done on dispensing and administering biologically derived products.

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:

Boundaries and Relationships

The following boundaries need to be considered:

Background and Context

Provides additional detail on exactly how the resource is to be used

Notes

Notes

Intended Recipients

In some areas of medicine, it is important to record the intended recipient for designated or directed BiologicallyDerivedProducts. The intended recipient represents the individual for whom the product was originally collected or manufactured, reflecting the purpose or intent behind its creation. This may differ from the actual recipient of the product during administration. Even in cases where the BiologicallyDerivedProduct is ultimately dispensed or administered to a different patient, the original intended recipient remains a factual and traceable aspect of the product’s history and should be persisted. This can be an important regulatory or accreditation requirement.

There are two approaches to representing the intended recipient of a designated or directed BiologicallyDerivedProduct:

  1. Within the collection order:
    • Use ServiceRequest.subject to indicate the patient from whom the product is being collected, and ServiceRequest.focus to reference the patient who is the intended recipient. This approach associates the intended recipient with the order rather than the product itself.
  2. Within the BiologicallyDerivedProduct resource:
    • Use the core extension biologicallyderivedproduct-intendedRecipient to explicitly record the intended recipient directly on the BiologicallyDerivedProduct. This approach ensures the intent remains associated with the product throughout its lifecycle, independent of any ordering context.

Preferred approach: The second approach is recommended, as it maintains the intended recipient as an intrinsic attribute of the BiologicallyDerivedProduct, supporting long-term traceability even if the original ServiceRequest is no longer available.

Note to Implementers: At the time of authorship, the biologicallyderivedproduct-intendedRecipient extension had not yet been published. It will be included in the FHIR Extension Pack when available. Feedback from implementers is welcomed to inform further refinement and usage guidance.

Important: When PHI from multiple patients (e.g., donor and recipient) is represented within a single BiologicallyDerivedProduct resource, systems should apply appropriate access controls and redaction practices to ensure that users only see the data they are authorized to view. Implementers should follow established standards such as ISBT 128, which governs when donor PHI may be included versus when coded identifiers (e.g., WMDA GRID) should be used.

StructureDefinition

Elements (Simplified)

Mappings

Implementation Guide

implementationguide-BiologicallyDerivedProduct-core.xml

<?xml version="1.0" encoding="UTF-8"?>

<ImplementationGuide xmlns="http://hl7.org/fhir">
  <id value="BiologicallyDerivedProduct-core"/>
  <version value="0.1"/>
  <name value="BiologicallyDerivedProductCore"/>
  <title value="Biologically Derived Product Core"/>
  <status value="draft"/>
  <date value="2024-10-11T00:00:00.000"/>
  <publisher value="HL7 International / Orders and Observations"/>
  <description value="Core profiles and extensions used with or related to the BiologicallyDerivedProduct resource"/>
  <definition>
    <resource>
      <reference>
        <reference value="StructureDefinition/medicalproductofhumanorigin"/>
      </reference>
    </resource>
  </definition>
</ImplementationGuide>

Resource Packs

list-BiologicallyDerivedProduct-packs.xml

<?xml version="1.0" encoding="UTF-8"?>

<List xmlns="http://hl7.org/fhir">
  <id value="BiologicallyDerivedProduct-packs"/>
  <status value="current"/>
  <mode value="working"/>
  <entry>
    <item>
      <reference value="ImplementationGuide/BiologicallyDerivedProduct-core"/>
    </item>
  </entry>
</List>

Search Parameters

Full Search Parameters

Examples

Full Examples

Mapping Exceptions

biologicallyderivedproduct-fivews-mapping-exceptions.xml

Unmapped Elements