The Covid At Home FHIR Diagnostic Reports for Laboratory Results is based upon the The US Core Diagnostic Reports for Laboratory Results Profile. In addition to the requirements set in the US Core Diagnostic Report for Laboratory Results Profile to record, search, and fetch/send laboratory test results associated with a patient, this profile:

• References Covid 19 At-Home Laboratory Test Result @DiagnosticReport.result(Reference)
• Uses the supportingInfo Extension to hold answers to questions asked by the app at the time of the result scan or upload, such as if the patient is having Covid-like symptoms.

Laboratory results are grouped and summarized using the DiagnosticReport resource which references the US Core Lab Observation resource(s). Each Observation resource represents an individual laboratory test and result value or component result values, or a “nested” panel which references other observations. They can also be presented in report form or as free text. While the At-Home Covid test is a simple single result observation for each test taken - for similarities across similar devloping V2 to FHIR lab mapping and transformations, it was determined to reference the single result in a diagnistic report.

This profile abides by the same rules and contraints identified in the US Core profile with respect to which core elements, extensions, vocabularies and value sets SHALL be present in the resource when using the US Core Laboratory observation profile.

The intial Covid-At-Home use case encompasses both tests that were ordered and tests that are (OTC). However, neither the Apps nor the testing device will have knowledge of the order information, such as ordering provider. Should this information become available in the workflow DiagnosticReport.basedOn.Reference(ServiceEvent) and/or .basedOn.reference(ServiceEvent) will be constrained for this use.

Patient as performer of the test (Report or the lab observation) is not captured in the V2 message. Within FHIR this could be captured and represented with DiagnosticReport.performer.Reference(CareTeam).CareTeam.member.US CorePatientProfile when Public Health Departments are prepared to receive and store this information.

• Text Summary
• Differential Table
• Snapshot Table
• Snapshot Table (Must Support)
• All

This structure is derived from USCoreDiagnosticReportProfileLaboratoryReporting

Name	Flags	Card.	Type	Description & Constraints
DiagnosticReport		0..*	USCoreDiagnosticReportProfileLaboratoryReporting	A Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
id	S	0..1	string	Logical id of this artifact
meta	S	1..1	Meta	The Meta.source SHALL replicate and hold the App ID. It is known that App IDs are typically managed and housed in the App Launch. Care will need to be taken so that these IDs match
id	S	1..1	string	App ID will likely be combination of ID + versionID
versionId	S	1..1	id	App ID will likely be combination of ID + versionID
extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:supportingInformationSymptomPresence	S	1..1	Extension	The supportingInformation Extension will house answers the patient supplied to questions asked by the Covid at home App Fixed Value: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
extension:supportingInformationSymptomOnset	S	1..1	Extension	Extension Fixed Value: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
identifier	S	0..*	Identifier	Business identifier for report
status		1..1	code	registered | partial | preliminary | final + Fixed Value: final
code	S	1..1	CodeableConcept	US Core Laboratory Report Order Code Binding: CovidAtHomeTests (required): This set of value contains LOINC codes appropriate for and currently used for at home covid testa
effective[x]	I	1..1	dateTime	Specimen Collection Datetime or Period eJXl1xkh: The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset. For example YYYY-MM-DDTHH:mm+/-HH:NN
result	S	1..1	Reference(Covid 19 At-Home Laboratory Test Result)	Observations Binding: (unbound) (required)
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
DiagnosticReport		0..*	USCoreDiagnosticReportProfileLaboratoryReporting	A Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
id	SΣ	0..1	string	Logical id of this artifact
meta	SΣ	1..1	Meta	The Meta.source SHALL replicate and hold the App ID. It is known that App IDs are typically managed and housed in the App Launch. Care will need to be taken so that these IDs match
id	S	1..1	string	App ID will likely be combination of ID + versionID
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
versionId	SΣ	1..1	id	App ID will likely be combination of ID + versionID
lastUpdated	Σ	0..1	instant	When the resource version last changed
source	Σ	0..1	uri	Identifies where the resource comes from
profile	Σ	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to
security	Σ	0..*	Coding	Security Labels applied to this resource Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
tag	Σ	0..*	Coding	Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred) Max Binding: AllLanguages: A human language.
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:supportingInformationSymptomPresence	S	1..1	Extension	The supportingInformation Extension will house answers the patient supplied to questions asked by the Covid at home App Fixed Value: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
extension:supportingInformationSymptomOnset	S	1..1	Extension	Extension Fixed Value: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..*	Identifier	Business identifier for report
basedOn		0..*	Reference(CarePlan | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	What was requested
status	?!SΣ	1..1	code	registered | partial | preliminary | final + Binding: DiagnosticReportStatus (required) Fixed Value: final
category	SΣ	1..*	(Slice Definition)	Service category Slice: Unordered, Open by pattern:$this Binding: DiagnosticServiceSectionCodes (example): Codes for diagnostic service sections.
category:LaboratorySlice	SΣ	1..1	CodeableConcept	Service category Binding: DiagnosticServiceSectionCodes (example): Codes for diagnostic service sections. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0074
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: LAB
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
code	SΣ	1..1	CodeableConcept	US Core Laboratory Report Order Code Binding: CovidAtHomeTests (required): This set of value contains LOINC codes appropriate for and currently used for at home covid testa
subject	SΣ	1..1	Reference(US Core Patient Profile)	The subject of the report - usually, but not always, the patient
encounter	Σ	0..1	Reference(Encounter)	Health care event when test ordered
effective[x]	SΣI	1..1	dateTime	Specimen Collection Datetime or Period eJXl1xkh: The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset. For example YYYY-MM-DDTHH:mm+/-HH:NN
issued	SΣ	1..1	instant	DateTime this version was made
performer	SΣ	0..*	Reference(US Core Practitioner Profile | US Core Organization Profile)	Responsible Diagnostic Service
resultsInterpreter	Σ	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam)	Primary result interpreter
specimen		0..*	Reference(Specimen)	Specimens this report is based on
result	S	1..1	Reference(Covid 19 At-Home Laboratory Test Result)	Observations
imagingStudy		0..*	Reference(ImagingStudy)	Reference to full details of imaging associated with the diagnostic report
media	Σ	0..*	BackboneElement	Key images associated with this report
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
comment		0..1	string	Comment about the image (e.g. explanation)
link	Σ	1..1	Reference(Media)	Reference to the image source
conclusion		0..1	string	Clinical conclusion (interpretation) of test results
conclusionCode		0..*	CodeableConcept	Codes for the clinical conclusion of test results Binding: SNOMEDCTClinicalFindings (example): Diagnosis codes provided as adjuncts to the report.
presentedForm		0..*	Attachment	Entire report as issued
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
DiagnosticReport		0..*	USCoreDiagnosticReportProfileLaboratoryReporting	A Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
id	Σ	0..1	string	Logical id of this artifact
meta	Σ	1..1	Meta	The Meta.source SHALL replicate and hold the App ID. It is known that App IDs are typically managed and housed in the App Launch. Care will need to be taken so that these IDs match
id		1..1	string	App ID will likely be combination of ID + versionID
versionId	Σ	1..1	id	App ID will likely be combination of ID + versionID
extension:supportingInformationSymptomPresence		1..1	Extension	The supportingInformation Extension will house answers the patient supplied to questions asked by the Covid at home App Fixed Value: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
extension:supportingInformationSymptomOnset		1..1	Extension	Extension Fixed Value: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
identifier	Σ	0..*	Identifier	Business identifier for report
status	?!Σ	1..1	code	registered | partial | preliminary | final + Binding: DiagnosticReportStatus (required) Fixed Value: final
category	Σ	1..*	(Slice Definition)	Service category Slice: Unordered, Open by pattern:$this Binding: DiagnosticServiceSectionCodes (example): Codes for diagnostic service sections.
category:LaboratorySlice	Σ	1..1	CodeableConcept	Service category Binding: DiagnosticServiceSectionCodes (example): Codes for diagnostic service sections. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0074
code		1..1	code	Symbol in syntax defined by the system Fixed Value: LAB
code	Σ	1..1	CodeableConcept	US Core Laboratory Report Order Code Binding: CovidAtHomeTests (required): This set of value contains LOINC codes appropriate for and currently used for at home covid testa
subject	Σ	1..1	Reference(US Core Patient Profile)	The subject of the report - usually, but not always, the patient
effective[x]	ΣI	1..1	dateTime	Specimen Collection Datetime or Period eJXl1xkh: The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset. For example YYYY-MM-DDTHH:mm+/-HH:NN
issued	Σ	1..1	instant	DateTime this version was made
performer	Σ	0..*	Reference(US Core Practitioner Profile | US Core Organization Profile)	Responsible Diagnostic Service
result		1..1	Reference(Covid 19 At-Home Laboratory Test Result)	Observations
Documentation for this format

This structure is derived from USCoreDiagnosticReportProfileLaboratoryReporting

Summary

Mandatory: 6 elements
Must-Support: 9 elements
Fixed Value: 3 elements

Structures

This structure refers to these other structures:

• http://homeCovid.com/fhir/structuredefinition/ConditionRelatedSymptomsBoolean
• http://homeCovid.com/fhir/structuredefinition/DateTimeSymptomOnset
• http://homeCovid.com/fhir/structuredefinition/LabObsHomeCovid

Differential View

This structure is derived from USCoreDiagnosticReportProfileLaboratoryReporting

Name	Flags	Card.	Type	Description & Constraints
DiagnosticReport		0..*	USCoreDiagnosticReportProfileLaboratoryReporting	A Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
id	S	0..1	string	Logical id of this artifact
meta	S	1..1	Meta	The Meta.source SHALL replicate and hold the App ID. It is known that App IDs are typically managed and housed in the App Launch. Care will need to be taken so that these IDs match
id	S	1..1	string	App ID will likely be combination of ID + versionID
versionId	S	1..1	id	App ID will likely be combination of ID + versionID
extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:supportingInformationSymptomPresence	S	1..1	Extension	The supportingInformation Extension will house answers the patient supplied to questions asked by the Covid at home App Fixed Value: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
extension:supportingInformationSymptomOnset	S	1..1	Extension	Extension Fixed Value: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
identifier	S	0..*	Identifier	Business identifier for report
status		1..1	code	registered | partial | preliminary | final + Fixed Value: final
code	S	1..1	CodeableConcept	US Core Laboratory Report Order Code Binding: CovidAtHomeTests (required): This set of value contains LOINC codes appropriate for and currently used for at home covid testa
effective[x]	I	1..1	dateTime	Specimen Collection Datetime or Period eJXl1xkh: The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset. For example YYYY-MM-DDTHH:mm+/-HH:NN
result	S	1..1	Reference(Covid 19 At-Home Laboratory Test Result)	Observations Binding: (unbound) (required)
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
DiagnosticReport		0..*	USCoreDiagnosticReportProfileLaboratoryReporting	A Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
id	SΣ	0..1	string	Logical id of this artifact
meta	SΣ	1..1	Meta	The Meta.source SHALL replicate and hold the App ID. It is known that App IDs are typically managed and housed in the App Launch. Care will need to be taken so that these IDs match
id	S	1..1	string	App ID will likely be combination of ID + versionID
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
versionId	SΣ	1..1	id	App ID will likely be combination of ID + versionID
lastUpdated	Σ	0..1	instant	When the resource version last changed
source	Σ	0..1	uri	Identifies where the resource comes from
profile	Σ	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to
security	Σ	0..*	Coding	Security Labels applied to this resource Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
tag	Σ	0..*	Coding	Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred) Max Binding: AllLanguages: A human language.
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:supportingInformationSymptomPresence	S	1..1	Extension	The supportingInformation Extension will house answers the patient supplied to questions asked by the Covid at home App Fixed Value: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
extension:supportingInformationSymptomOnset	S	1..1	Extension	Extension Fixed Value: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..*	Identifier	Business identifier for report
basedOn		0..*	Reference(CarePlan | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	What was requested
status	?!SΣ	1..1	code	registered | partial | preliminary | final + Binding: DiagnosticReportStatus (required) Fixed Value: final
category	SΣ	1..*	(Slice Definition)	Service category Slice: Unordered, Open by pattern:$this Binding: DiagnosticServiceSectionCodes (example): Codes for diagnostic service sections.
category:LaboratorySlice	SΣ	1..1	CodeableConcept	Service category Binding: DiagnosticServiceSectionCodes (example): Codes for diagnostic service sections. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0074
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: LAB
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
code	SΣ	1..1	CodeableConcept	US Core Laboratory Report Order Code Binding: CovidAtHomeTests (required): This set of value contains LOINC codes appropriate for and currently used for at home covid testa
subject	SΣ	1..1	Reference(US Core Patient Profile)	The subject of the report - usually, but not always, the patient
encounter	Σ	0..1	Reference(Encounter)	Health care event when test ordered
effective[x]	SΣI	1..1	dateTime	Specimen Collection Datetime or Period eJXl1xkh: The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset. For example YYYY-MM-DDTHH:mm+/-HH:NN
issued	SΣ	1..1	instant	DateTime this version was made
performer	SΣ	0..*	Reference(US Core Practitioner Profile | US Core Organization Profile)	Responsible Diagnostic Service
resultsInterpreter	Σ	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam)	Primary result interpreter
specimen		0..*	Reference(Specimen)	Specimens this report is based on
result	S	1..1	Reference(Covid 19 At-Home Laboratory Test Result)	Observations
imagingStudy		0..*	Reference(ImagingStudy)	Reference to full details of imaging associated with the diagnostic report
media	Σ	0..*	BackboneElement	Key images associated with this report
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
comment		0..1	string	Comment about the image (e.g. explanation)
link	Σ	1..1	Reference(Media)	Reference to the image source
conclusion		0..1	string	Clinical conclusion (interpretation) of test results
conclusionCode		0..*	CodeableConcept	Codes for the clinical conclusion of test results Binding: SNOMEDCTClinicalFindings (example): Diagnosis codes provided as adjuncts to the report.
presentedForm		0..*	Attachment	Entire report as issued
Documentation for this format