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LIVD FHIR IG Proposal

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LIVD Implementation Guide

Owning work group name

Orders & Observations YourWorkGroupName

Committee Approval Date:

August 3, 2018

Please enter the date that the committee approved this IGproposal

Contributing or Reviewing Work Groups

None.

  • Work Group Name
  • or link
  • or "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

Rob?


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 is connecting and configuring a device to the LIS.

As an LIS manager is configuring a device to be connected to the LIS, the suggested mappings can focus the LIS manager 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:

  • IICC
  • FDA
  • CDC
  • NLM
  • CMS
  • LIS vendors
  • 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. (WOULD BE GREAT TO PUT IN NAMES OF THOSE WHO HAVE DONE THAT).


Example Scenarios

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


IG Relationships

None.


Timelines

The target is to provide an initial for comment ballot in September 2018, and based on feedback and connectathon experience have a second ballot in January 2019 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