This is a framework profile and can be the base of another profile that is further constrained to meet the requirements of a specific use case. See Observation - At-Home In-Vitro Test Result - COVID-19 for an example of such a profile.

The following elements are expected to be constrained to use case specific value sets:

• Observation.code - value set containing the use case specific test types (consult LIVD to obtain the values to be used for each particular use case)
• Observation.value - value set containing the use case specific test results (consult LIVD to obtain the values to be used for each particular use case)
• For Multiplex Assay tests that serve as a single test to diagnose infection caused by multiple viruses (e.g. CDC Flu SC2 Multiplex Assay for SARS-CoV-2, influenza A, and/or influenza B viruses) use Observation.hasMember to reference another Observation - At-Home In-Vitro Test Result.

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from USCoreLaboratoryResultObservationProfile

Name	Flags	Card.	Type	Description & Constraints
Observation			USCoreLaboratoryResultObservationProfile
id	S	1..1	id	Logical id of this artifact
Extension-at-home-in-vitro-test-proctored-info		0..1	(Complex)	Extension - At-Home In-Vitro Test Proctored Information URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Extension-at-home-in-vitro-test-proctored-info
status		1..1	code	At-Home Test result status final. V2: OBR-25, OBX-11 Fixed Value: final
code		1..1	CodeableConcept	At-Home Test performed code. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-3.1, OBX-3.2, OBX-3.3, OBX-3.7
subject		1..1	Reference(Patient - At Home In Vitro Test)	(USCDI) Who and/or what the observation is about
effective[x]		1..1	dateTime	At-Home Test date of interpretation/result date. The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset. NOTE: For multiplex tests, this field must match across all results. V2: OBX-7.1, OBX-19
issued	S	0..1	instant	At-Home Test result date released - when test item is done (in the at-home setting will mostly be the same as the Observation.effective[x], could be different when a proctor is involved - when the proctor releases the result). V2: OBR-22.1
performer	S	0..*	Reference(US Core Practitioner Profile | US Core PractitionerRole Profile | US Core Organization Profile | US Core CareTeam Profile | Patient - At Home In Vitro Test | US Core RelatedPerson Profile)	If the performer is not the patient being tested, specify the person performing the test.
value[x]		0..1	CodeableConcept	At-Home Test Result value. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-5.1, OBX-5.2, OBX-5.3, OBX-5.7
specimen		1..1	Reference(Specimen - At-Home In-Vitro Test)	The Specimen SHALL be from at-home sample. The referenced specifimen should contain a Specimen.identifier and a Specimen.identifier.assigner.
device	S	1..1	Reference(Device - At-Home In-Vitro Test)	The referenced device SHALL be at-home test device.
hasMember		0..*	Reference(Observation - At-Home In-Vitro Test Result)	Multiplex Assay tests that serve as a single test to diagnose infection caused by multiple viruses (e.g. CDC Flu SC2 Multiplex Assay for SARS-CoV-2, influenza A, and/or influenza B viruses) should be recorded using multiple Observation.hasMember elements.
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	USCoreLaboratoryResultObservationProfile	Measurements and simple assertions obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
id	SΣ	1..1	id	Logical id of this artifact
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Extension-at-home-in-vitro-test-proctored-info		0..1	(Complex)	Extension - At-Home In-Vitro Test Proctored Information URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Extension-at-home-in-vitro-test-proctored-info
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!SΣ	1..1	code	At-Home Test result status final. V2: OBR-25, OBX-11 Binding: ObservationStatus (required): Codes providing the status of an observation. Fixed Value: final
Slices for category	S	1..*	CodeableConcept	(USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core	S	1..1	CodeableConcept	(USCDI) Classification of type of observation Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets 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	SΣ	1..1	CodeableConcept	At-Home Test performed code. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-3.1, OBX-3.2, OBX-3.3, OBX-3.7 Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes
subject	SΣ	1..1	Reference(Patient - At Home In Vitro Test)	(USCDI) Who and/or what the observation is about
effective[x]	SΣC	1..1	dateTime	At-Home Test date of interpretation/result date. The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset. NOTE: For multiplex tests, this field must match across all results. V2: OBX-7.1, OBX-19 us-core-1: Datetime must be at least to day.
issued	SΣ	0..1	instant	At-Home Test result date released - when test item is done (in the at-home setting will mostly be the same as the Observation.effective[x], could be different when a proctor is involved - when the proctor releases the result). V2: OBR-22.1
performer	SΣ	0..*	Reference(US Core Practitioner Profile | US Core PractitionerRole Profile | US Core Organization Profile | US Core CareTeam Profile | Patient - At Home In Vitro Test | US Core RelatedPerson Profile)	If the performer is not the patient being tested, specify the person performing the test.
value[x]	SΣC	0..1	CodeableConcept	At-Home Test Result value. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-5.1, OBX-5.2, OBX-5.3, OBX-5.7 us-core-3: SHALL use UCUM for coded quantity units. us-core-4: SHOULD use Snomed CT for coded Results
dataAbsentReason	SC	0..1	CodeableConcept	(USCDI) Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
specimen	S	1..1	Reference(Specimen - At-Home In-Vitro Test)	The Specimen SHALL be from at-home sample. The referenced specifimen should contain a Specimen.identifier and a Specimen.identifier.assigner.
device	S	1..1	Reference(Device - At-Home In-Vitro Test)	The referenced device SHALL be at-home test device.
hasMember	Σ	0..*	Reference(Observation - At-Home In-Vitro Test Result)	Multiplex Assay tests that serve as a single test to diagnose infection caused by multiple viruses (e.g. CDC Flu SC2 Multiplex Assay for SARS-CoV-2, influenza A, and/or influenza B viruses) should be recorded using multiple Observation.hasMember elements.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.status	required	Fixed Value: final http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.category	preferred	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:us-core	required	Pattern: laboratory http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
Observation.code	extensible	USCoreLaboratoryTestCodes http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
Observation.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	USCoreLaboratoryResultObservationProfile	Measurements and simple assertions obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
id	SΣ	1..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
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): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
Extension-at-home-in-vitro-test-proctored-info		0..1	(Complex)	Extension - At-Home In-Vitro Test Proctored Information URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Extension-at-home-in-vitro-test-proctored-info
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	At-Home Test result status final. V2: OBR-25, OBX-11 Binding: ObservationStatus (required): Codes providing the status of an observation. Fixed Value: final
Slices for category	S	1..*	CodeableConcept	(USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core	S	1..1	CodeableConcept	(USCDI) Classification of type of observation Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets 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	At-Home Test performed code. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-3.1, OBX-3.2, OBX-3.3, OBX-3.7 Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes
subject	SΣ	1..1	Reference(Patient - At Home In Vitro Test)	(USCDI) 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]	SΣC	1..1	dateTime S	At-Home Test date of interpretation/result date. The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset. NOTE: For multiplex tests, this field must match across all results. V2: OBX-7.1, OBX-19 us-core-1: Datetime must be at least to day.
issued	SΣ	0..1	instant	At-Home Test result date released - when test item is done (in the at-home setting will mostly be the same as the Observation.effective[x], could be different when a proctor is involved - when the proctor releases the result). V2: OBR-22.1
performer	SΣ	0..*	Reference(US Core Practitioner Profile | US Core PractitionerRole Profile | US Core Organization Profile | US Core CareTeam Profile | Patient - At Home In Vitro Test | US Core RelatedPerson Profile)	If the performer is not the patient being tested, specify the person performing the test.
value[x]	SΣC	0..1	CodeableConcept S	At-Home Test Result value. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-5.1, OBX-5.2, OBX-5.3, OBX-5.7 us-core-3: SHALL use UCUM for coded quantity units. us-core-4: SHOULD use Snomed CT for coded Results
dataAbsentReason	SC	0..1	CodeableConcept	(USCDI) Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
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 - At-Home In-Vitro Test)	The Specimen SHALL be from at-home sample. The referenced specifimen should contain a Specimen.identifier and a Specimen.identifier.assigner.
device	S	1..1	Reference(Device - At-Home In-Vitro Test)	The referenced device SHALL be at-home test device.
referenceRange	C	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	C	0..1	SimpleQuantity	Low Range, if relevant
high	C	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 - At-Home In-Vitro Test Result)	Multiplex Assay tests that serve as a single test to diagnose infection caused by multiple viruses (e.g. CDC Flu SC2 Multiplex Assay for SARS-CoV-2, influenza A, and/or influenza B viruses) should be recorded using multiple Observation.hasMember elements.
derivedFrom	Σ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from
component	Σ	0..*	BackboneElement	Component results
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
code	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
value[x]	Σ	0..1		Actual component result
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
dataAbsentReason	C	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange		0..*	See referenceRange (Observation)	Provides guide for interpretation of component result
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
Observation.status	required	Fixed Value: final http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.category	preferred	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:us-core	required	Pattern: laboratory http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
Observation.code	extensible	USCoreLaboratoryTestCodes http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
Observation.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard
Observation.bodySite	example	SNOMEDCTBodyStructures http://hl7.org/fhir/ValueSet/body-site from the FHIR Standard
Observation.method	example	ObservationMethods http://hl7.org/fhir/ValueSet/observation-methods from the FHIR Standard
Observation.referenceRange.type	preferred	ObservationReferenceRangeMeaningCodes http://hl7.org/fhir/ValueSet/referencerange-meaning from the FHIR Standard
Observation.referenceRange.appliesTo	example	ObservationReferenceRangeAppliesToCodes http://hl7.org/fhir/ValueSet/referencerange-appliesto from the FHIR Standard
Observation.component.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.component.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.component.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard

Differential View

This structure is derived from USCoreLaboratoryResultObservationProfile

Name	Flags	Card.	Type	Description & Constraints
Observation			USCoreLaboratoryResultObservationProfile
id	S	1..1	id	Logical id of this artifact
Extension-at-home-in-vitro-test-proctored-info		0..1	(Complex)	Extension - At-Home In-Vitro Test Proctored Information URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Extension-at-home-in-vitro-test-proctored-info
status		1..1	code	At-Home Test result status final. V2: OBR-25, OBX-11 Fixed Value: final
code		1..1	CodeableConcept	At-Home Test performed code. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-3.1, OBX-3.2, OBX-3.3, OBX-3.7
subject		1..1	Reference(Patient - At Home In Vitro Test)	(USCDI) Who and/or what the observation is about
effective[x]		1..1	dateTime	At-Home Test date of interpretation/result date. The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset. NOTE: For multiplex tests, this field must match across all results. V2: OBX-7.1, OBX-19
issued	S	0..1	instant	At-Home Test result date released - when test item is done (in the at-home setting will mostly be the same as the Observation.effective[x], could be different when a proctor is involved - when the proctor releases the result). V2: OBR-22.1
performer	S	0..*	Reference(US Core Practitioner Profile | US Core PractitionerRole Profile | US Core Organization Profile | US Core CareTeam Profile | Patient - At Home In Vitro Test | US Core RelatedPerson Profile)	If the performer is not the patient being tested, specify the person performing the test.
value[x]		0..1	CodeableConcept	At-Home Test Result value. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-5.1, OBX-5.2, OBX-5.3, OBX-5.7
specimen		1..1	Reference(Specimen - At-Home In-Vitro Test)	The Specimen SHALL be from at-home sample. The referenced specifimen should contain a Specimen.identifier and a Specimen.identifier.assigner.
device	S	1..1	Reference(Device - At-Home In-Vitro Test)	The referenced device SHALL be at-home test device.
hasMember		0..*	Reference(Observation - At-Home In-Vitro Test Result)	Multiplex Assay tests that serve as a single test to diagnose infection caused by multiple viruses (e.g. CDC Flu SC2 Multiplex Assay for SARS-CoV-2, influenza A, and/or influenza B viruses) should be recorded using multiple Observation.hasMember elements.
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	USCoreLaboratoryResultObservationProfile	Measurements and simple assertions obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
id	SΣ	1..1	id	Logical id of this artifact
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Extension-at-home-in-vitro-test-proctored-info		0..1	(Complex)	Extension - At-Home In-Vitro Test Proctored Information URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Extension-at-home-in-vitro-test-proctored-info
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!SΣ	1..1	code	At-Home Test result status final. V2: OBR-25, OBX-11 Binding: ObservationStatus (required): Codes providing the status of an observation. Fixed Value: final
Slices for category	S	1..*	CodeableConcept	(USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core	S	1..1	CodeableConcept	(USCDI) Classification of type of observation Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets 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	SΣ	1..1	CodeableConcept	At-Home Test performed code. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-3.1, OBX-3.2, OBX-3.3, OBX-3.7 Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes
subject	SΣ	1..1	Reference(Patient - At Home In Vitro Test)	(USCDI) Who and/or what the observation is about
effective[x]	SΣC	1..1	dateTime	At-Home Test date of interpretation/result date. The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset. NOTE: For multiplex tests, this field must match across all results. V2: OBX-7.1, OBX-19 us-core-1: Datetime must be at least to day.
issued	SΣ	0..1	instant	At-Home Test result date released - when test item is done (in the at-home setting will mostly be the same as the Observation.effective[x], could be different when a proctor is involved - when the proctor releases the result). V2: OBR-22.1
performer	SΣ	0..*	Reference(US Core Practitioner Profile | US Core PractitionerRole Profile | US Core Organization Profile | US Core CareTeam Profile | Patient - At Home In Vitro Test | US Core RelatedPerson Profile)	If the performer is not the patient being tested, specify the person performing the test.
value[x]	SΣC	0..1	CodeableConcept	At-Home Test Result value. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-5.1, OBX-5.2, OBX-5.3, OBX-5.7 us-core-3: SHALL use UCUM for coded quantity units. us-core-4: SHOULD use Snomed CT for coded Results
dataAbsentReason	SC	0..1	CodeableConcept	(USCDI) Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
specimen	S	1..1	Reference(Specimen - At-Home In-Vitro Test)	The Specimen SHALL be from at-home sample. The referenced specifimen should contain a Specimen.identifier and a Specimen.identifier.assigner.
device	S	1..1	Reference(Device - At-Home In-Vitro Test)	The referenced device SHALL be at-home test device.
hasMember	Σ	0..*	Reference(Observation - At-Home In-Vitro Test Result)	Multiplex Assay tests that serve as a single test to diagnose infection caused by multiple viruses (e.g. CDC Flu SC2 Multiplex Assay for SARS-CoV-2, influenza A, and/or influenza B viruses) should be recorded using multiple Observation.hasMember elements.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.status	required	Fixed Value: final http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.category	preferred	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:us-core	required	Pattern: laboratory http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
Observation.code	extensible	USCoreLaboratoryTestCodes http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
Observation.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	USCoreLaboratoryResultObservationProfile	Measurements and simple assertions obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
id	SΣ	1..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
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): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
Extension-at-home-in-vitro-test-proctored-info		0..1	(Complex)	Extension - At-Home In-Vitro Test Proctored Information URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Extension-at-home-in-vitro-test-proctored-info
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	At-Home Test result status final. V2: OBR-25, OBX-11 Binding: ObservationStatus (required): Codes providing the status of an observation. Fixed Value: final
Slices for category	S	1..*	CodeableConcept	(USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core	S	1..1	CodeableConcept	(USCDI) Classification of type of observation Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets 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	At-Home Test performed code. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-3.1, OBX-3.2, OBX-3.3, OBX-3.7 Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes
subject	SΣ	1..1	Reference(Patient - At Home In Vitro Test)	(USCDI) 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]	SΣC	1..1	dateTime S	At-Home Test date of interpretation/result date. The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset. NOTE: For multiplex tests, this field must match across all results. V2: OBX-7.1, OBX-19 us-core-1: Datetime must be at least to day.
issued	SΣ	0..1	instant	At-Home Test result date released - when test item is done (in the at-home setting will mostly be the same as the Observation.effective[x], could be different when a proctor is involved - when the proctor releases the result). V2: OBR-22.1
performer	SΣ	0..*	Reference(US Core Practitioner Profile | US Core PractitionerRole Profile | US Core Organization Profile | US Core CareTeam Profile | Patient - At Home In Vitro Test | US Core RelatedPerson Profile)	If the performer is not the patient being tested, specify the person performing the test.
value[x]	SΣC	0..1	CodeableConcept S	At-Home Test Result value. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-5.1, OBX-5.2, OBX-5.3, OBX-5.7 us-core-3: SHALL use UCUM for coded quantity units. us-core-4: SHOULD use Snomed CT for coded Results
dataAbsentReason	SC	0..1	CodeableConcept	(USCDI) Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
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 - At-Home In-Vitro Test)	The Specimen SHALL be from at-home sample. The referenced specifimen should contain a Specimen.identifier and a Specimen.identifier.assigner.
device	S	1..1	Reference(Device - At-Home In-Vitro Test)	The referenced device SHALL be at-home test device.
referenceRange	C	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	C	0..1	SimpleQuantity	Low Range, if relevant
high	C	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 - At-Home In-Vitro Test Result)	Multiplex Assay tests that serve as a single test to diagnose infection caused by multiple viruses (e.g. CDC Flu SC2 Multiplex Assay for SARS-CoV-2, influenza A, and/or influenza B viruses) should be recorded using multiple Observation.hasMember elements.
derivedFrom	Σ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from
component	Σ	0..*	BackboneElement	Component results
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
code	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
value[x]	Σ	0..1		Actual component result
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
dataAbsentReason	C	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange		0..*	See referenceRange (Observation)	Provides guide for interpretation of component result
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
Observation.status	required	Fixed Value: final http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.category	preferred	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:us-core	required	Pattern: laboratory http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
Observation.code	extensible	USCoreLaboratoryTestCodes http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
Observation.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard
Observation.bodySite	example	SNOMEDCTBodyStructures http://hl7.org/fhir/ValueSet/body-site from the FHIR Standard
Observation.method	example	ObservationMethods http://hl7.org/fhir/ValueSet/observation-methods from the FHIR Standard
Observation.referenceRange.type	preferred	ObservationReferenceRangeMeaningCodes http://hl7.org/fhir/ValueSet/referencerange-meaning from the FHIR Standard
Observation.referenceRange.appliesTo	example	ObservationReferenceRangeAppliesToCodes http://hl7.org/fhir/ValueSet/referencerange-appliesto from the FHIR Standard
Observation.component.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.component.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.component.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard

This structure is derived from USCoreLaboratoryResultObservationProfile

Summary

Mandatory: 4 elements
Must-Support: 4 elements
Fixed: 1 element

Structures

This structure refers to these other structures:

• Patient - At Home In Vitro Test (http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Patient-at-home-in-vitro-test)
• US Core Practitioner Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitioner)
• US Core PractitionerRole Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitionerrole)
• US Core Organization Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-organization)
• US Core CareTeam Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-careteam)
• US Core RelatedPerson Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-relatedperson)
• Specimen - At-Home In-Vitro Test (http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Specimen-at-home-in-vitro-test)
• Device - At-Home In-Vitro Test (http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Device-at-home-in-vitro-test)
• Observation - At-Home In-Vitro Test Result (http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Observation-at-home-in-vitro-test-result)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Extension-at-home-in-vitro-test-proctored-info