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

• Constrains and binds observationCode to an at home Covid lab tests value set. (a subset of the required US Core LOINC lab codes)
• Observation.value to a value set of SNOMED CT codes appropriate for at hone covid test result values (a subset of the required US Core SNOMED CT lab result values)
• Sets forth some ID requirements in the referenced Device and Sample resources

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.

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

This structure is derived from USCoreLaboratoryResultObservationProfile

Name	Flags	Card.	Type	Description & Constraints
Observation		0..*	USCoreLaboratoryResultObservationProfile	Measurements and simple assertions
id	S	1..1	string	Logical id of this artifact
meta		0..1	Meta	Metadata about the resource
id		0..1	string	Unique id for inter-element referencing
versionId		0..1	id	Version specific identifier
status		1..1	code	registered | preliminary | final | amended + Fixed Value: final
code		1..1	CodeableConcept	Covid At Home Tests Binding: CovidAtHomeTests (extensible): This set of values contains Covid 19 LOINC concepts that are appropriate for at-home tests
effective[x]	S	1..1	dateTime	The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset
value[x]	S	1..1	CodeableConcept	At Home Covid Test Result Values Binding: covidathomevalues (required): This set of values contains SNOMED CT concepts suitable for at home Covid test results
specimen	S	1..1	Reference(Specimen)	The Specimen SHALL be from at-home sample.
id		1..1	string	The referenced specimen SHALL contain a Specimen.identifier and a Specimen.identifier.assigner
device	S	1..1	Reference(Device | DeviceMetric)	The referenced device SHALL be an home covid test device.
id		1..1	string	The referenced device SHALL contain a Device.udiCarrier.deviceIdentifier. The initial project will use the Quidel QuickVue UDI see: (https://accessgudid.nlm.nih.gov/devices/30014613339373) To find other at home device UDIs, please see GUDID data base: https://accessgudid.nlm.nih.gov/help/search/basic-search
component		0..0
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Observation	I	0..*	USCoreLaboratoryResultObservationProfile	Measurements and simple assertions
id	SΣ	1..1	string	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
versionId	Σ	0..1	id	Version specific identifier
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	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business Identifier for observation
basedOn	Σ	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Fulfills plan, proposal or order
partOf	Σ	0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)	Part of referenced event
status	?!SΣ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required) Fixed Value: final
category	S	1..*	(Slice Definition)	Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:Laboratory	S	1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. 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/observation-category
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
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	Covid At Home Tests Binding: CovidAtHomeTests (extensible): This set of values contains Covid 19 LOINC concepts that are appropriate for at-home tests
subject	SΣ	1..1	Reference(US Core Patient Profile)	Who and/or what the observation is about
focus	Σ	0..*	Reference(Resource)	What the observation is about, when it is not about the subject of record
encounter	Σ	0..1	Reference(Encounter)	Healthcare event during which this observation is made
effective[x]	SΣI	1..1	dateTime	The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset
issued	Σ	0..1	instant	Date/Time this version was made available
performer	Σ	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Who is responsible for the observation
value[x]	SΣI	1..1	CodeableConcept	At Home Covid Test Result Values Binding: covidathomevalues (required): This set of values contains SNOMED CT concepts suitable for at home Covid test results
dataAbsentReason	SI	0..1	CodeableConcept	Why the result is missing Binding: DataAbsentReason (extensible)
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note		0..*	Annotation	Comments about the observation
bodySite		0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method		0..1	CodeableConcept	How it was done Binding: ObservationMethods (example): Methods for simple observations.
specimen	S	1..1	Reference(Specimen)	The Specimen SHALL be from at-home sample.
id		1..1	string	The referenced specimen SHALL contain a Specimen.identifier and a Specimen.identifier.assigner
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣI	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
device	S	1..1	Reference(Device | DeviceMetric)	The referenced device SHALL be an home covid test device.
id		1..1	string	The referenced device SHALL contain a Device.udiCarrier.deviceIdentifier. The initial project will use the Quidel QuickVue UDI see: (https://accessgudid.nlm.nih.gov/devices/30014613339373) To find other at home device UDIs, please see GUDID data base: https://accessgudid.nlm.nih.gov/help/search/basic-search
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣI	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
referenceRange	I	0..*	BackboneElement	Provides guide for interpretation obs-3: Must have at least a low or a high or text
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
low	I	0..1	SimpleQuantity	Low Range, if relevant
high	I	0..1	SimpleQuantity	High Range, if relevant
type		0..1	CodeableConcept	Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
appliesTo		0..*	CodeableConcept	Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
age		0..1	Range	Applicable age range, if relevant
text		0..1	string	Text based reference range in an observation
hasMember	Σ	0..*	Reference(Observation | QuestionnaireResponse | MolecularSequence)	Related resource that belongs to the Observation group
derivedFrom	Σ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Observation	I	0..*	USCoreLaboratoryResultObservationProfile	Measurements and simple assertions
id	Σ	1..1	string	Logical id of this artifact
status	?!Σ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required) Fixed Value: final
category		1..*	(Slice Definition)	Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:Laboratory		1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. 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/observation-category
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
code	Σ	1..1	CodeableConcept	Covid At Home Tests Binding: CovidAtHomeTests (extensible): This set of values contains Covid 19 LOINC concepts that are appropriate for at-home tests
subject	Σ	1..1	Reference(US Core Patient Profile)	Who and/or what the observation is about
effective[x]	ΣI	1..1	dateTime	The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset
value[x]	ΣI	1..1	CodeableConcept	At Home Covid Test Result Values Binding: covidathomevalues (required): This set of values contains SNOMED CT concepts suitable for at home Covid test results
dataAbsentReason	I	0..1	CodeableConcept	Why the result is missing Binding: DataAbsentReason (extensible)
specimen		1..1	Reference(Specimen)	The Specimen SHALL be from at-home sample.
device		1..1	Reference(Device | DeviceMetric)	The referenced device SHALL be an home covid test device.
Documentation for this format

This structure is derived from USCoreLaboratoryResultObservationProfile

Summary

Mandatory: 7 elements
Must-Support: 5 elements
Fixed Value: 1 element
Prohibited: 1 element

Differential View

This structure is derived from USCoreLaboratoryResultObservationProfile

Name	Flags	Card.	Type	Description & Constraints
Observation		0..*	USCoreLaboratoryResultObservationProfile	Measurements and simple assertions
id	S	1..1	string	Logical id of this artifact
meta		0..1	Meta	Metadata about the resource
id		0..1	string	Unique id for inter-element referencing
versionId		0..1	id	Version specific identifier
status		1..1	code	registered | preliminary | final | amended + Fixed Value: final
code		1..1	CodeableConcept	Covid At Home Tests Binding: CovidAtHomeTests (extensible): This set of values contains Covid 19 LOINC concepts that are appropriate for at-home tests
effective[x]	S	1..1	dateTime	The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset
value[x]	S	1..1	CodeableConcept	At Home Covid Test Result Values Binding: covidathomevalues (required): This set of values contains SNOMED CT concepts suitable for at home Covid test results
specimen	S	1..1	Reference(Specimen)	The Specimen SHALL be from at-home sample.
id		1..1	string	The referenced specimen SHALL contain a Specimen.identifier and a Specimen.identifier.assigner
device	S	1..1	Reference(Device | DeviceMetric)	The referenced device SHALL be an home covid test device.
id		1..1	string	The referenced device SHALL contain a Device.udiCarrier.deviceIdentifier. The initial project will use the Quidel QuickVue UDI see: (https://accessgudid.nlm.nih.gov/devices/30014613339373) To find other at home device UDIs, please see GUDID data base: https://accessgudid.nlm.nih.gov/help/search/basic-search
component		0..0
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Observation	I	0..*	USCoreLaboratoryResultObservationProfile	Measurements and simple assertions
id	SΣ	1..1	string	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
versionId	Σ	0..1	id	Version specific identifier
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	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business Identifier for observation
basedOn	Σ	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Fulfills plan, proposal or order
partOf	Σ	0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)	Part of referenced event
status	?!SΣ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required) Fixed Value: final
category	S	1..*	(Slice Definition)	Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:Laboratory	S	1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. 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/observation-category
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
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	Covid At Home Tests Binding: CovidAtHomeTests (extensible): This set of values contains Covid 19 LOINC concepts that are appropriate for at-home tests
subject	SΣ	1..1	Reference(US Core Patient Profile)	Who and/or what the observation is about
focus	Σ	0..*	Reference(Resource)	What the observation is about, when it is not about the subject of record
encounter	Σ	0..1	Reference(Encounter)	Healthcare event during which this observation is made
effective[x]	SΣI	1..1	dateTime	The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset
issued	Σ	0..1	instant	Date/Time this version was made available
performer	Σ	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Who is responsible for the observation
value[x]	SΣI	1..1	CodeableConcept	At Home Covid Test Result Values Binding: covidathomevalues (required): This set of values contains SNOMED CT concepts suitable for at home Covid test results
dataAbsentReason	SI	0..1	CodeableConcept	Why the result is missing Binding: DataAbsentReason (extensible)
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note		0..*	Annotation	Comments about the observation
bodySite		0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method		0..1	CodeableConcept	How it was done Binding: ObservationMethods (example): Methods for simple observations.
specimen	S	1..1	Reference(Specimen)	The Specimen SHALL be from at-home sample.
id		1..1	string	The referenced specimen SHALL contain a Specimen.identifier and a Specimen.identifier.assigner
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣI	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
device	S	1..1	Reference(Device | DeviceMetric)	The referenced device SHALL be an home covid test device.
id		1..1	string	The referenced device SHALL contain a Device.udiCarrier.deviceIdentifier. The initial project will use the Quidel QuickVue UDI see: (https://accessgudid.nlm.nih.gov/devices/30014613339373) To find other at home device UDIs, please see GUDID data base: https://accessgudid.nlm.nih.gov/help/search/basic-search
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣI	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
referenceRange	I	0..*	BackboneElement	Provides guide for interpretation obs-3: Must have at least a low or a high or text
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
low	I	0..1	SimpleQuantity	Low Range, if relevant
high	I	0..1	SimpleQuantity	High Range, if relevant
type		0..1	CodeableConcept	Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
appliesTo		0..*	CodeableConcept	Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
age		0..1	Range	Applicable age range, if relevant
text		0..1	string	Text based reference range in an observation
hasMember	Σ	0..*	Reference(Observation | QuestionnaireResponse | MolecularSequence)	Related resource that belongs to the Observation group
derivedFrom	Σ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from
Documentation for this format