This page is part of the At-Home In-Vitro Test Report (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions

HL7 V2 Fields and OTC Example Message

COVID-19 At-Home In-Vitro Test Report and V2

This test implementation project will start out with sending the COVID-19 At-Home In-Vitro Test Reports as V2 lab messages due to Public Health Departments familiarity with V2. Longer term the intent is to leverage FHIR for app creativity, growth and interoperability. For as long as needed to comply with Public Health Department dependecies on V2, the Apps will be designed to transform from FHIR to V2.

Within the intial V2 message, many of the segments contain “hard coded” information. Some examples of this are ordering information and app IDs. Even if the COVID-19 At-Home In-Vitro Test is an ordered test (as opposed to an OTC test) neither the App nor the assay test at the start of the test implementation will have knowledge of ordering information. This draft FHIR IG aligns, where appropriate, with known and documented FHIR to V2 mappings. In some cases, where the V2 message is hardcoded or constrained to a specific value, the FHIR spec (at this time) is not further constrained beyond what is present in US Core, but the elements and attibutes are available for use and may be noted in comments.

COVID-19 At-Home In-Vitro Test Report to V2 and FHIR Profile Elements Mapping Table

In-Vitro At-Home Test V2 FHIR Mapping.xlsx

V2 Example Messages

The following child pages represent the 2 types of home tests in the intial project. The two scenarios are described below.

At-Home In-Vitro Test Over the Counter Purchase

Patient buys and performs testing, result is obtained via an App that then does the reporting; this may result in limited data fidelity (no verification): a) that the person tested = patient, b) of how the specimen was collected, c) if the test procedure was followed, d) if the interpretation of the result and subsequent reporting is accurate, unless the app preforms the interpretation, e) data about the patient is accurate)

The following segments are constrained:

• Ordering Provider First Name (ORC-12.3/OBR-16.3) = “SA.OverTheCounter”
• Ordering Facility Name (ORC-21.1) = “SA.OverTheCounter”
• Ordering Facility Address (ORC-22) = <Copy patient address (PID-11)>
• Ordering Facility Phone (ORC-23) = <Copy Patient Home Phone (PID-13); if not available, use default value ^^^^111^1111111>
• Performing Facility Name (OBX-23.1) = “SA.OverTheCounter”
• Performing Facility CLIA (OBX-15.1 and OBX-23.10) = 00Z0000014
• Performing Facility Address (OBX-24) = “11 Fake AtHome Test Street^^Yakutat^AK^99689^^^^02282”
• Allowed test kits with EUA for this purpose:
• Ellume’s COVID-19 Home Test_Ellume Limited -– OBX-17.1 = Ellume COVID-19 Home Test_Ellume Limited_EUA
• Cue Health Inc’s Cue COVID-19 Test for Home and Over The Counter (OTC) Use – OBX-17.1 =
• Example message is for Ellume’s COVID-19 Home Test sent by OneAbbott: InterPartner~CentralizedELR~OneAbbott~AIMSPlatform~Test~Test~2021012816241013~STOP~TestMessageSA.OTC_AL_FINAL

At-Home In-Vitro Test with Prescription

Patient is prescribed the test, obtains the kit, sample collection and test performance is unsupervised, result is obtained via app that then does the reporting; this may result in limited data fidelity (no verification): a) that the person tested = patient, b) of how the specimen was collected, c) if the test procedure was followed, d) if the interpretation of the result and subsequent reporting is accurate; however, data about the patient should be accurate – since it is coming from the provider’s health record.

The following segments are constrained:

• Ordering Facility Name (ORC-21.1) = <Copy Ordering Provider Name (ORC-12/OBR-16), if no separate facility>
• Ordering Facility Address (ORC-22) = <Copy Ordering Provider Address (ORC-24), if no separate facility>
• Ordering Facility Phone (ORC-23) = <Copy Callback number (ORC-14/OBR17), if no separate facility number, else use default value ^^^^111^1111111>
• Performing Facility Name (OBX-23.1) = “SA.Prescription”
• Performing Facility CLIA (OBX-15.1 and OBX-23.10) = 00Z0000015
• Performing Facility Address (OBX-24) = “12 Fake AtHome Test Street^^Yakutat^AK^99689^^^^02282”
• Allowed test kits with EUA for this purpose:
• Lucira Health, Inc.’s Lucira COVID-19 All-In-One Test Kit – OBX-17.1 =Lucira COVID-19 All-In-One Test Kit_Lucira Health, Inc._EUA (will soon be updated in LIVD to: 00810055970001_DIT)
• Quidel Corporation’s QuickVue At-Home COVID-19 Test – OBX-17.1 = QuickVue At-Home COVID-19 Test_Quidel Corporation_EUA (will soon be updated in LIVD to: 30014613339373_DIT)
• Example message is for Quidel Corporation’s QuickVue At-Home COVID-19 Test sent by OneAbbott: InterPartner~CentralizedELR~OneAbbott~AIMSPlatform~Test~Test~2021012816241013~STOP~TestMessageSA.Prescription_AL_FINAL