Name	Flags	Card.	Type	Description & Constraints
Observation			Observation	This profile also complies with the profile US Core Organization Profile
Slices for category		1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by value:$this
category:labCategory	S	1..1	CodeableConcept	Lab category Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
code		1..1	CodeableConcept	Type of observation (code / type) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/uv/cgm/CodeSystem/cgm-summary-codes-temporary
code		1..1	code	Symbol in syntax defined by the system Fixed Value: cgm-summary
subject	S	1..1	Reference(Patient | Group | Device | Location)	Patient for the report
Slices for effective[x]		1..1	Period	Clinically relevant time/time-period for observation Slice: Unordered, Open by type:$this
effective[x]:effectivePeriod	S	1..1	Period	Reporting period for the CGM summary
start	S	1..1	dateTime	Start date of the reporting period (YYYY-MM-DD)
end	S	1..1	dateTime	End date of the reporting period (YYYY-MM-DD)
Slices for hasMember		6..*	Reference(Observation | QuestionnaireResponse | MolecularSequence)	CGM summary observations Slice: Unordered, Open by value:resolve().code
hasMember:meanGlucoseMassPerVolume	S	0..1	Reference(Mean Glucose (Mass))	Mean Glucose (Mass) observation
hasMember:meanGlucoseMolesPerVolume	S	0..1	Reference(Mean Glucose (Molar))	Mean Glucose (Molar) observation
hasMember:timesInRanges	S	1..1	Reference(CGM Summary Times in Ranges)	Times in Ranges observation
hasMember:gmi	S	1..1	Reference(Glucose Management Indicator (GMI))	Glucose Management Indicator (GMI) observation
hasMember:cv	S	1..1	Reference(Coefficient of Variation (CV))	Coefficient of Variation (CV) observation
hasMember:daysOfWear	S	1..1	Reference(Days of Wear)	Days of Wear observation
hasMember:sensorActivePercentage	S	1..1	Reference(Sensor Active Percentage)	Sensor Active Percentage observation
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Measurements and simple assertions This profile also complies with the profile US Core Organization Profile 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
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!Σ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category		1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by value:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:labCategory	S	1..1	CodeableConcept	Lab category Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
code	Σ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/uv/cgm/CodeSystem/cgm-summary-codes-temporary
code		1..1	code	Symbol in syntax defined by the system Fixed Value: cgm-summary
subject	SΣ	1..1	Reference(Patient | Group | Device | Location)	Patient for the report
Slices for effective[x]	Σ	1..1	Period	Clinically relevant time/time-period for observation Slice: Unordered, Closed by type:$this
effective[x]:effectivePeriod	SΣ	1..1	Period	Reporting period for the CGM summary
start	SΣC	1..1	dateTime	Start date of the reporting period (YYYY-MM-DD)
end	SΣC	1..1	dateTime	End date of the reporting period (YYYY-MM-DD)
Slices for hasMember	Σ	6..*	Reference(Observation | QuestionnaireResponse | MolecularSequence)	CGM summary observations Slice: Unordered, Open by value:resolve().code
hasMember:meanGlucoseMassPerVolume	SΣ	0..1	Reference(Mean Glucose (Mass))	Mean Glucose (Mass) observation
hasMember:meanGlucoseMolesPerVolume	SΣ	0..1	Reference(Mean Glucose (Molar))	Mean Glucose (Molar) observation
hasMember:timesInRanges	SΣ	1..1	Reference(CGM Summary Times in Ranges)	Times in Ranges observation
hasMember:gmi	SΣ	1..1	Reference(Glucose Management Indicator (GMI))	Glucose Management Indicator (GMI) observation
hasMember:cv	SΣ	1..1	Reference(Coefficient of Variation (CV))	Coefficient of Variation (CV) observation
hasMember:daysOfWear	SΣ	1..1	Reference(Days of Wear)	Days of Wear observation
hasMember:sensorActivePercentage	SΣ	1..1	Reference(Sensor Active Percentage)	Sensor Active Percentage observation
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.status	required	ObservationStatus 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:labCategory	preferred	Pattern: laboratory http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.code	example	Pattern: cgm-summary http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Observation	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Observation	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Measurements and simple assertions This profile also complies with the profile US Core Organization Profile 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
id	Σ	0..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		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	?!Σ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category		1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by value:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:labCategory	S	1..1	CodeableConcept	Lab category 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	Σ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. 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://hl7.org/uv/cgm/CodeSystem/cgm-summary-codes-temporary
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: cgm-summary
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
subject	SΣ	1..1	Reference(Patient | Group | Device | Location)	Patient for the report
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
Slices for effective[x]	Σ	1..1	Period	Clinically relevant time/time-period for observation Slice: Unordered, Closed by type:$this
effective[x]:effectivePeriod	SΣ	1..1	Period	Reporting period for the CGM summary
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
start	SΣC	1..1	dateTime	Start date of the reporting period (YYYY-MM-DD)
end	SΣC	1..1	dateTime	End date of the reporting period (YYYY-MM-DD)
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]	ΣC	0..1		Actual 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 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		0..1	Reference(Specimen)	Specimen used for this observation
device		0..1	Reference(Device | DeviceMetric)	(Measurement) 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
Slices for hasMember	Σ	6..*	Reference(Observation | QuestionnaireResponse | MolecularSequence)	CGM summary observations Slice: Unordered, Open by value:resolve().code
hasMember:meanGlucoseMassPerVolume	SΣ	0..1	Reference(Mean Glucose (Mass))	Mean Glucose (Mass) observation
hasMember:meanGlucoseMolesPerVolume	SΣ	0..1	Reference(Mean Glucose (Molar))	Mean Glucose (Molar) observation
hasMember:timesInRanges	SΣ	1..1	Reference(CGM Summary Times in Ranges)	Times in Ranges observation
hasMember:gmi	SΣ	1..1	Reference(Glucose Management Indicator (GMI))	Glucose Management Indicator (GMI) observation
hasMember:cv	SΣ	1..1	Reference(Coefficient of Variation (CV))	Coefficient of Variation (CV) observation
hasMember:daysOfWear	SΣ	1..1	Reference(Days of Wear)	Days of Wear observation
hasMember:sensorActivePercentage	SΣ	1..1	Reference(Sensor Active Percentage)	Sensor Active Percentage observation
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	ObservationStatus 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:labCategory	preferred	Pattern: laboratory http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.code	example	Pattern: cgm-summary http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
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

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Observation	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Observation	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
obs-3	error	Observation.referenceRange	Must have at least a low or a high or text : low.exists() or high.exists() or text.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()

Summary

Mandatory: 12 elements
Must-Support: 12 elements

Structures

This structure refers to these other structures:

• Mean Glucose (Mass) (http://hl7.org/uv/cgm/StructureDefinition/cgm-summary-mean-glucose-mass-per-volume)
• Mean Glucose (Molar) (http://hl7.org/uv/cgm/StructureDefinition/cgm-summary-mean-glucose-moles-per-volume)
• CGM Summary Times in Ranges (http://hl7.org/uv/cgm/StructureDefinition/cgm-summary-times-in-ranges)
• Glucose Management Indicator (GMI) (http://hl7.org/uv/cgm/StructureDefinition/cgm-summary-gmi)
• Coefficient of Variation (CV) (http://hl7.org/uv/cgm/StructureDefinition/cgm-summary-coefficient-of-variation)
• Days of Wear (http://hl7.org/uv/cgm/StructureDefinition/cgm-summary-days-of-wear)
• Sensor Active Percentage (http://hl7.org/uv/cgm/StructureDefinition/cgm-summary-sensor-active-percentage)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Observation.category
• The element 1 is sliced based on the value of Observation.effective[x]
• The element 1 is sliced based on the value of Observation.hasMember

Name	Flags	Card.	Type	Description & Constraints
Observation			Observation	This profile also complies with the profile US Core Organization Profile
Slices for category		1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by value:$this
category:labCategory	S	1..1	CodeableConcept	Lab category Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
code		1..1	CodeableConcept	Type of observation (code / type) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/uv/cgm/CodeSystem/cgm-summary-codes-temporary
code		1..1	code	Symbol in syntax defined by the system Fixed Value: cgm-summary
subject	S	1..1	Reference(Patient | Group | Device | Location)	Patient for the report
Slices for effective[x]		1..1	Period	Clinically relevant time/time-period for observation Slice: Unordered, Open by type:$this
effective[x]:effectivePeriod	S	1..1	Period	Reporting period for the CGM summary
start	S	1..1	dateTime	Start date of the reporting period (YYYY-MM-DD)
end	S	1..1	dateTime	End date of the reporting period (YYYY-MM-DD)
Slices for hasMember		6..*	Reference(Observation | QuestionnaireResponse | MolecularSequence)	CGM summary observations Slice: Unordered, Open by value:resolve().code
hasMember:meanGlucoseMassPerVolume	S	0..1	Reference(Mean Glucose (Mass))	Mean Glucose (Mass) observation
hasMember:meanGlucoseMolesPerVolume	S	0..1	Reference(Mean Glucose (Molar))	Mean Glucose (Molar) observation
hasMember:timesInRanges	S	1..1	Reference(CGM Summary Times in Ranges)	Times in Ranges observation
hasMember:gmi	S	1..1	Reference(Glucose Management Indicator (GMI))	Glucose Management Indicator (GMI) observation
hasMember:cv	S	1..1	Reference(Coefficient of Variation (CV))	Coefficient of Variation (CV) observation
hasMember:daysOfWear	S	1..1	Reference(Days of Wear)	Days of Wear observation
hasMember:sensorActivePercentage	S	1..1	Reference(Sensor Active Percentage)	Sensor Active Percentage observation
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Measurements and simple assertions This profile also complies with the profile US Core Organization Profile 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
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!Σ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category		1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by value:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:labCategory	S	1..1	CodeableConcept	Lab category Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
code	Σ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/uv/cgm/CodeSystem/cgm-summary-codes-temporary
code		1..1	code	Symbol in syntax defined by the system Fixed Value: cgm-summary
subject	SΣ	1..1	Reference(Patient | Group | Device | Location)	Patient for the report
Slices for effective[x]	Σ	1..1	Period	Clinically relevant time/time-period for observation Slice: Unordered, Closed by type:$this
effective[x]:effectivePeriod	SΣ	1..1	Period	Reporting period for the CGM summary
start	SΣC	1..1	dateTime	Start date of the reporting period (YYYY-MM-DD)
end	SΣC	1..1	dateTime	End date of the reporting period (YYYY-MM-DD)
Slices for hasMember	Σ	6..*	Reference(Observation | QuestionnaireResponse | MolecularSequence)	CGM summary observations Slice: Unordered, Open by value:resolve().code
hasMember:meanGlucoseMassPerVolume	SΣ	0..1	Reference(Mean Glucose (Mass))	Mean Glucose (Mass) observation
hasMember:meanGlucoseMolesPerVolume	SΣ	0..1	Reference(Mean Glucose (Molar))	Mean Glucose (Molar) observation
hasMember:timesInRanges	SΣ	1..1	Reference(CGM Summary Times in Ranges)	Times in Ranges observation
hasMember:gmi	SΣ	1..1	Reference(Glucose Management Indicator (GMI))	Glucose Management Indicator (GMI) observation
hasMember:cv	SΣ	1..1	Reference(Coefficient of Variation (CV))	Coefficient of Variation (CV) observation
hasMember:daysOfWear	SΣ	1..1	Reference(Days of Wear)	Days of Wear observation
hasMember:sensorActivePercentage	SΣ	1..1	Reference(Sensor Active Percentage)	Sensor Active Percentage observation
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.status	required	ObservationStatus 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:labCategory	preferred	Pattern: laboratory http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.code	example	Pattern: cgm-summary http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Observation	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Observation	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Measurements and simple assertions This profile also complies with the profile US Core Organization Profile 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
id	Σ	0..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		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	?!Σ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category		1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by value:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:labCategory	S	1..1	CodeableConcept	Lab category 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	Σ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. 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://hl7.org/uv/cgm/CodeSystem/cgm-summary-codes-temporary
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: cgm-summary
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
subject	SΣ	1..1	Reference(Patient | Group | Device | Location)	Patient for the report
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
Slices for effective[x]	Σ	1..1	Period	Clinically relevant time/time-period for observation Slice: Unordered, Closed by type:$this
effective[x]:effectivePeriod	SΣ	1..1	Period	Reporting period for the CGM summary
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
start	SΣC	1..1	dateTime	Start date of the reporting period (YYYY-MM-DD)
end	SΣC	1..1	dateTime	End date of the reporting period (YYYY-MM-DD)
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]	ΣC	0..1		Actual 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 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		0..1	Reference(Specimen)	Specimen used for this observation
device		0..1	Reference(Device | DeviceMetric)	(Measurement) 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
Slices for hasMember	Σ	6..*	Reference(Observation | QuestionnaireResponse | MolecularSequence)	CGM summary observations Slice: Unordered, Open by value:resolve().code
hasMember:meanGlucoseMassPerVolume	SΣ	0..1	Reference(Mean Glucose (Mass))	Mean Glucose (Mass) observation
hasMember:meanGlucoseMolesPerVolume	SΣ	0..1	Reference(Mean Glucose (Molar))	Mean Glucose (Molar) observation
hasMember:timesInRanges	SΣ	1..1	Reference(CGM Summary Times in Ranges)	Times in Ranges observation
hasMember:gmi	SΣ	1..1	Reference(Glucose Management Indicator (GMI))	Glucose Management Indicator (GMI) observation
hasMember:cv	SΣ	1..1	Reference(Coefficient of Variation (CV))	Coefficient of Variation (CV) observation
hasMember:daysOfWear	SΣ	1..1	Reference(Days of Wear)	Days of Wear observation
hasMember:sensorActivePercentage	SΣ	1..1	Reference(Sensor Active Percentage)	Sensor Active Percentage observation
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	ObservationStatus 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:labCategory	preferred	Pattern: laboratory http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.code	example	Pattern: cgm-summary http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
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

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Observation	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Observation	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
obs-3	error	Observation.referenceRange	Must have at least a low or a high or text : low.exists() or high.exists() or text.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()

Summary

Mandatory: 12 elements
Must-Support: 12 elements

Structures

This structure refers to these other structures:

• Mean Glucose (Mass) (http://hl7.org/uv/cgm/StructureDefinition/cgm-summary-mean-glucose-mass-per-volume)
• Mean Glucose (Molar) (http://hl7.org/uv/cgm/StructureDefinition/cgm-summary-mean-glucose-moles-per-volume)
• CGM Summary Times in Ranges (http://hl7.org/uv/cgm/StructureDefinition/cgm-summary-times-in-ranges)
• Glucose Management Indicator (GMI) (http://hl7.org/uv/cgm/StructureDefinition/cgm-summary-gmi)
• Coefficient of Variation (CV) (http://hl7.org/uv/cgm/StructureDefinition/cgm-summary-coefficient-of-variation)
• Days of Wear (http://hl7.org/uv/cgm/StructureDefinition/cgm-summary-days-of-wear)
• Sensor Active Percentage (http://hl7.org/uv/cgm/StructureDefinition/cgm-summary-sensor-active-percentage)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Observation.category
• The element 1 is sliced based on the value of Observation.effective[x]
• The element 1 is sliced based on the value of Observation.hasMember