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201809 LIVD

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Return to September 2018 Proposals

LIVD

Submitting WG/Project/Implementer Group

The LIVD Project Team within the OO workgroup is made of representatives of device manufacturers, LIS vendors, FDA, CDC, and other interested parties.

Justification

Based on the IICC whitepaper on IVD test code mapping the HL7 Orders & Observations workgroup set out with IICC to creatte an HL7 FHIR based implementation guide to enable exchange of the LIVD Publication.

Initially the exchange would not be using a FHIR based API, rather to exchange a file through another mechanism where the receiver would use it to create a representation to the user.  The primary objective of the connectathon is to validate that all relevant data is correctly represented using FHIR resources with accurate supporting implementation guidance.

Proposed Track Lead

  • TBD (candidates: Hans, Ed, others?)

See Connectathon_Track_Lead_Responsibilities

Expected participants

  • Manufacturer:
    • Abbott
  • Lab
    • TBD
  • Middleware/Device connections between device and LIS
    • TBD
  • LIS
    • TBD
  • RLNs
    • Applicable?

Roles

Device Manufacturer

The Device Manufacturer creates a Bundle for their LIVD Publication and make that available at least as a file (e-mail, Direct, CD, website link) or FHIR server (although latter is not expected to be interacted with current state).

Laboratory

The Laboratory, LIS or separate system, will receive the LIVD Bundle and present the content in a readable form, which may be a spreadsheet, online view, or otherwise.

Reference Network

Applicable??

Middleware/Device Connectivity

A middelware solution may be used to configure the test analyte mappings on behalf of an LIS as results flow from device to LIS. This role is therefore expected to be very similar, if not that same as that of a Lab/LIS, but separated for now to validate whether that is correct.

Scenarios

Scenario 1 - The manufacturer creates an LIVD Publication Bundle and makes it electronically available to either of the receivers. The receiver uses the LIVD Publication Bundle to render the content in their preferred format.

TestScript(s)

Security and Privacy Considerations

Connectathon Recap