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  1. FHIR Specification Feedback
  2. FHIR-37199

Update Device, BDP, and NutritionProduct .biologicalSource definition and comment

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    • Icon: Change Request Change Request
    • Resolution: Persuasive with Modification
    • Icon: Medium Medium
    • FHIR Core (FHIR)
    • R4
    • Orders & Observations
    • BiologicallyDerivedProduct
      Device
      NutritionProduct
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      Motion to update the definition and comments of .biologicalSource in Device, NutritionProduct, and BiologicallyDerivedProduct to:

      Name: biologicalSourceEvent

      Short Name: 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.

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      Motion to update the definition and comments of .biologicalSource in Device, NutritionProduct, and BiologicallyDerivedProduct to: Name: biologicalSourceEvent Short Name: 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.
    • Paul Ashford / David Barwin : 10-0-1
    • Enhancement
    • Non-compatible
    • R5

    Description

      To be in alignment with the changes to BDP around the donation identification number (device.distinctIdentifier) a more generic name "sourceIdentifier" should be used to support products that may have jurisdictional differences in product domain.

      Proposed changing the biologicallyDerivedProduct.sourceIdentifier and device.distinctIdentifier to the following element (and associated metadata):

      Element id: biologicalSource 

      Definition: An identifier that supports traceability to the biological entity that is the source of biological material in the product.

      Cardinality: 0..1

      Type: identifier (note – value and system is used to exchange the information about the identifier’s string and namespace of the unique identifier).

      Alternative names: Distinct Identification Code (DIC); Donation Identification Number (DIN)

      Comments: Necessary to support mandatory requirements for traceability from donor/source to recipient and vice versa.  The element is defined consistently across biologicallyDerivedProduct, nutritionProduct, and device.

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            jdlnolen John D.L. Nolen
            hbuitendijk Hans Buitendijk
            Marti Velezis
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              Created:
              Updated:
              Resolved: