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At-Home Test Report (Jira PSS-1892)

Basics

At-Home Test Report (Jira PSS-1892)

1742
Ballot - STU to Normative


FHIR Implementation Guide

Implementation Guide

Details

??The purpose of this project is to ballot and publish a framework for At-Home Test Result Reports Implementation Guide (IG). The first iteration of the guide represents Covid At-Home Test Results.

A draft IG (https://trifolia-fhir.lantanagroup.com/igs/lantana_hapi_r4/homeCovid/index.html) has been developed that describes the use of HL7 FHIR to send at home Covid test results to local, state, territorial and Federal health agencies. Over time other test result types will be profiled.

An HL7 v2 to FHIR mapping table will also be included in the IG. The project will update and ballot the IGs through open and transparent HL7 ballot process to gain community input and support.

The draft IG currently constrains the following profiles for the use case of sending results from Covid tests performed at home to public health systems:

- US Core Laboratory Result Observation

- US Core Diagnostic Report for Laboratory Results

- FHIR Observation Resource for

- Presence or absence of symptoms

- Date and Time of symptom onset

The draft IG is currently being piloted in a 3-5 States with plans to pilot in multiple new states in the coming months. You can find more information about current piloting efforts utilizing this IG at https://www.nibib.nih.gov/covid-at-home-test-result-reporting-standards-analysis.


There is no focused guidance describing the use of HL7 standards (V2 and FHIR) to send at home test results to local, state, territorial and federal health agencies. While most Public Health systems currently receive only V2 messages, we anticipate a near future where FHIR will be received and processed by Public Health systems. This project will examine the challenges and opportunities of FHIR vs V2 within Public Health using the implementation of the draft IG and will use the HL7 process to gain stakeholder consensus. The scope of the initial IG and that the draft IG is already being implemented in approximately 5 states will lend itself well to testing the waters of FHIR flowing into Public Health Systems.

Point-of-care (POC) and at-home tests offer increased accessibility to needed diagnostic solutions during a pandemic. Test results have value to 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. Test manufacturers, working in partnership with these digital platforms, are seeking guidance on where 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.



At-Home Test Result Reports Implementation Guide (IG). - Target: 2021 May (Ballot STU )


Will add a Confluence Page once we get WG sponsorship PSS: https://jira.hl7.org/browse/PSS-1892?src=confmacro

ONC/NIH

Need too be sure to align with other existing Covid FHIR lab profiles/ IGs where appropriate (e.g. When reconciled and published the COVID-19 FHIR Profile Library IG (http://hl7.org/fhir/us/covid19library/2021Sep/index.html)

Standards Development Organizations (SDOs), Other (specify in Misc. Notes below),N/A

State of Tennessee, North Carolina, and a many more are piloting


At-Home Test Result Report


N/A

N/A

No

2025 May: TSC approved a 2-year STU extension request 2024 July: TSC approved Unballoted STU Update Publication Request for HL7 FHIR R4 Implementation Guide: At-Home In-Vitro Test Report, Edition 1.1 2023 February: TSC approved STU Publication Request for HL7 FHIR R2 Implementation Guide: At-Home In-Vitro Test Report 2023 January: R. Merrick: Project status should be working on publication, as we have posted the recon spreadsheet and requested withdrawal. We anticipate having the publication request ready for review by OO by early February. 2022 June: R. Merrick: please update the project insight for the At-Home PSS - we had a change in sponsorship during the PPS approval process. Stakeholders: Association/Goverment Agency, Consultant, Healthcare IT Vendors, Healthcare Provider/user, Patients, Providers, Standards Development Organizations (SDOs), Vendor/Manufacturer
Organization & Realm

Realm Specific - Enter "U.S." or name of HL7 Affiliate below

U.S.
People

Matthew Rahn



Orders and Observations Work Group

Orders and Observations Work Group

Status & Dates

Active

STU - Test Period/Accepting Comments

11/11/2021

05/01/2027

2027 May WGM/Ballot

05/01/2026

2026 May WGM/Ballot

2022 Sept Ballot Cycle Info: STU Ballot results: Met basic vote requirements. 2 Negatives to reconcile Document Name: HL7 FHIR R2 Implementation Guide: At-Home In-Vitro Test Report - US Realm (See Jira Ballot Dashboard)
Approvals

01/24/2022


Received


All Received




FHIR Management Group -- Agreed -- (PSS-1924)
US Realm -- Agreed -- (PSS-1926)
System Info

168788

PSS-1892



02/02/2026

Jira Project Service