LIVD FHIR IG Proposal

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Approved 2018-08-08


LIVD Implementation Guide

Owning work group name

Orders & Observations

Committee Approval Date:

August 3, 2018

Contributing or Reviewing Work Groups

None.

FHIR Development Project Insight ID

1335

Scope of coverage

The LIVD Implementation Guide addresses the ability for IVD device manufacturers to communicate for each of their devices the suggested mapping of the IVD (InVitro Diagnostic) Test Codes to one or more LOINC codes.

As the initial scope does not include for manufacturers to provide FHIR based service APIs, rather providing the relevant resources in a Bundle using some form of download/file transfer, the various operations otherwise necessary are not included. Future versions will address that scope.

The consuming application will present the data in a format and context suitable to those who configure devices to interact with a Laboratory Information System (LIS) to ensure the appropriate LOINC code is used when a result is communicated from the device to the LIS>


IG Purpose

The IG enables consistent expression of the suggested mappings using an industry standard that enables consistency across manufacturers, as well as enabling a path to service based APIs to provide access to these mappings.


Content location

https://github.com/HL7/livd


Proposed IG realm and code

uv/livd


Maintenance Plan

The community (manufacturers, FDA, CDC, LIS vendors, and others) is already progressing scope to address suggested mapping of non-quantitative results for the device. As these and other capabilities are being addressed and service based APIs are being implemented, subsequent versions of the guide will be developed to address these requirements.


Short Description

The LIVD Implementation Guide provides a industry standard expression for an IVD device manufacturer's suggestions for a specific device's mapping from the internal, proprietary IVD test codes to suggested LOINC codes when a LIS manager is connecting and configuring a device to the LIS.


Long Description

The LIVD Implementation Guide provides a industry standard expression for an IVD device manufacturer's suggestions for a specific device's mapping from the internal, proprietary IVD test codes to suggested LOINC codes when a LIS manager/analyst is connecting and configuring a device to the LIS.

As an LIS manager/analyst is configuring a device to be connected to the LIS, the suggested mappings can focus the manager/analyst on the most likely LOINC codes to consider, thus enabling a choice relevant to the specific context of the device's use and purpose within the Laboratory that is more consistent across the industry.


Involved parties

The LIVD Implementation Guide is the result of a collaboration between representatives from the:

  • IVD Industry Connectivity Consortium (IICC)
  • FDA
  • CDC
  • NLM
  • CMS
  • ONC
  • IHE Pathology and Laboratory Medicine (PaLM) Technical Committee
  • Phast
  • LIS vendors
    • Orchard Software
    • Epic
    • Cerner Corporation
  • IVD instrument manufacturers
    • Abbott Laboratories
    • Roche Diagnostics International, Ltd
    • bioMerieux
  • Swiss Laboratory Interoperability Interest Group (Joint Venture of FAMH.ch, IHE-Suisse.ch, HL7.ch, SULM.ch)
  • and other interested parties


Expected implementations

Device manufacturers and LIS vendors are interested and expected to implement the initial version to publish LIVD mappings (manufacturers) and present the mappings in context of the LIS configuration process (LIS vendors). The initial version of the IG resulting from the For Comment ballot and connectathon will further inform the initial take-on by these parties.


Content sources

The LIVD Implementation Guide is based on the IICC whitepaper that describes an agreed to data set and format using JSON (not based on FHIR resource specifications) that is currently being published by various manufacturers.


Example Scenarios

The primary scenario is for a manufacturer to post the LIVD catalog (FHIR Bundle) on a website and/or distribute it as part of their device documentation, upon which a consuming app will ingest the LIVD catalog and present it as they best see fit.


IG Relationships

None.


Timelines

The target is to perform Connectathons through early 2019 and then have the first STU ballot in September 2019, and based on feedback and connectathon experience have a second ballot in January 2020 to solidify content and enable maturation and refinement per FMM stages.


When IG Proposal Is Complete

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

FMG Notes

Would like to see greater evidence of non-US participation for a UV-scoped guide

2019-06-21 Updated by the LIVD project team. See the additional participants listed above.