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Short Description

Testing the At-Home In-Vitro Test Report Implementation Guide, which provides resources for use in transmitting At-Home In-Vitro Test results to local, state, territorial and federal health agencies.

Long Description

Point-of-care (POC) and At-Home In-Vitro Tests offer increased accessibility to needed diagnostic solutions during a pandemic. Test results provide value to both the individual taking the tests and also to public health authorities responsible for coordinating a regional and national response. Digital platforms are being developed that allow individual test results, with permission of the individual, to be captured, organized, and transmitted to public health systems. This IG gives test manufacturers, working in partnership with these digital platforms, guidance on how to send test results. With multiple tests already entering the market, there is a need for a unified strategy on data flow of test results from the apps to downstream systems. A national data exchange standard should be supported that guides data exchange from test results residing on individual users’ digital test applications to public health authorities, at both the federal and regional levels.

This implementation guide is for use in transmitting At-Home In-Vitro Test results to local, state, territorial and federal health agencies. It was developed as part of a collaborative project with the NIH/NIBIB, ONC, a vendor manufacturer of diagnostic healthcare products that makes one of the FDA approved At-Home In-Vitro Test kits, and an app developer who is a leading provider of secure interoperability solutions. The intention of this guide is to assist developers in producing and sending standardized FHIR test result data from tests performed at home. FHIR eases app development and the FHIR US Core IG is in a rapid adoption curve. This guide points to already existing US Core Guidance and other guidance with respect to FHIR Parameters, FHIR operations, and RESTful and SMART on FHIR information.

Type

Test an Implementation Guide

Related Tracks?

n/a

Call for participants

At-Home In-Vitro test manufacturers

Track Prerequisites

Knowledge of US Core,

Track Lead(s)

Dave deRoode

Track Lead Email(s)

david.deroode@lantanagroup.com

Specification Information

http://hl7.org/fhir/us/home-lab-report/

Zulip stream

https://chat.fhir.org/#narrow/stream/322481-At-Home-In-Vitro-Test-IG

Track Kick off Call

2-3pm ET Wednesday, 19 April, 2023

Microsoft Teams meeting

Join on your computer, mobile app or room device

Click here to join the meeting

Meeting ID: 227 249 972 04
Passcode: zGG863

Download Teams | Join on the web

Or call in (audio only)

+1 208-996-1659,,759937897#   United States, Boise

Phone Conference ID: 759 937 897#

Find a local number | Reset PIN

Recording: May 2023 Connectathon Track Kick Off - At Home In-Vitro Test Results FHIR IG

Testing Scenarios

System roles: 

  • At-Home Test Vendor application
  • Server acting as Public Health Agency system server
  • Hub that connects At-Home Test Vendor application to Public Health Agency system server
  • Generic FHIR Server with IG loaded
  • Server Acting as EHR system server

Scenarios

  • Patient performs At-Home Test
  • Patient either:
    • enters result of test into app
    • app is used to interpret result of test
  • Result is sent to app server
  • Result in FHIR Bundle format is sent to Hub, which then sends it to Public Health Agency
  • Result in FHIR Bundle format is sent to EHR System which updates patient's EHR record
  • Basic Level
    • Manually or use software to create a FHIR Bundle conformant to the IG
    • Validate FHIR Bundle with any of the following:
      • using Inferno framework/Leap Orbit test kits
      • manually with FHIR validator
  • Good
    • Use Postman to send FHIR Bundle to server
    • Use Postman to validate FHIR Bundle on server
    • Receive and validate Bundle in test software/server
  • Better
    • Use App Test Software to
      • create FHIR Bundle
      • validate FHIR Bundle
      • send FHIR Bundle to FHIR test server
    • Use App Test Software to
      • create FHIR Bundle
      • validate FHIR Bundle
      • send FHIR Bundle to Inferno test harness acting as Hub server or EHR system server
      • validate FHIR Bundle on Inferno acting as Hub server or EHR system server
  • Best
    • Public Health Reporting
      • Use App Test Software to send to Hub server, Hub then sends to Public Health Agency system server
      • App Test Software, Hub Server, and Public Health Agency system server validates
    • EHR Integration
      • Use App Test Software to send to EHR system server
      • App Test Software and EHR system server validates


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