Introduction

This profile is used to represent de-identified Observation for Clinical Result information. The de-identification process has to remove all data elements not explicitly identified as “SUPPORTED” in the profile.

The HHS De-identification Guidance is to be followed to ensure appropriate level of de-identification is performed.

According to the HHS guidance, dates should not have a precision of more than the year. This means month and day cannot be included. This includes Observation for Lab Result.period.

In FHIR Resources, text elements and reference.display elements which provide human readable information to the providers may be generated using programs and tools from the data present within the resource. For e.g a Observation for Clinical Result resource text element may contain information such as the Observation for Clinical Result date, patient information. This type of information will enable identification of the individuals. In order to avoid inadvertent revealing of PII/PHI, text elements cannot be included in the De-identified FHIR resource and the submission will be rejected when text elements are present by the validation process.

Ids and References

The original Observation for Clinical Result resource id should not be included in the De-identified Observation for Clinical Result instance. Instead a new id should be created and provided as part of the FHIR resource. The Data Submitter should be capable of using the generated id to relink the data to the original Observation for Lab Result. All resource references to the Observation for Clinical Result submitted as part of the UDS+ report should refer to newly generated id.

Resource references cannot contain text element as it may contain PHI/PII. The text element for following references are not allowed

• subject
• encounter

Date Truncation

The Data Submitter has to truncate the following dates to only have a precision of year

• effective[x]

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

This structure is derived from Observation

Name	Flags	Card.	Type	Description & Constraints
Observation		0..*	Observation	De-Identified UDS Plus Clinical Result Observation
id	S	0..1	id	The de-identified Observation identifier created by the health center to send data to UDS+ Data Receiver
text		0..0
contained		0..0
status	S	1..1	code	registered | preliminary | final | amended +
category	S	1..*	CodeableConcept	Classification of type of observation Binding: US Core Clinical Result Observation Category (extensible): The set of codes indicating the category of the observation
code	S	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations
subject	S	1..1	Reference(De-Identified UDS Plus Patient)	Who and/or what the observation is about
display		0..0
encounter	S	0..1	Reference(De-Identified UDS Plus Encounter)	Healthcare event during which this observation is made
display		0..0
effective[x]	S	0..1	dateTime, Period, Timing, instant	Clinically relevant time/time-period for observation
issued	S	0..1	instant	Date/Time this version was made available
performer	S	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Who is responsible for the observation
value[x]	S	0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Actual result
bodySite	S	0..1	CodeableConcept	Observed body part
component	S	0..*	BackboneElement	Component results
code	S	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations
value[x]	S	0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Actual component result
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
Observation.category	extensible	USCoreClinicalResultObservationCategory
Observation.code	extensible	LOINCCodes (a valid code from LOINC)
Observation.component.code	extensible	LOINCCodes (a valid code from LOINC)

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	De-Identified UDS Plus Clinical Result Observation
id	SΣ	0..1	id	The de-identified Observation identifier created by the health center to send data to UDS+ Data Receiver
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!SΣ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
category	S	1..*	CodeableConcept	Classification of type of observation Binding: US Core Clinical Result Observation Category (extensible): The set of codes indicating the category of the observation
code	SΣ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations
subject	SΣ	1..1	Reference(De-Identified UDS Plus Patient)	Who and/or what the observation is about
encounter	SΣ	0..1	Reference(De-Identified UDS Plus Encounter)	Healthcare event during which this observation is made
effective[x]	SΣ	0..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
issued	SΣ	0..1	instant	Date/Time this version was made available
performer	SΣ	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Who is responsible for the observation
value[x]	SΣC	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
bodySite	S	0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
component	SΣ	0..*	BackboneElement	Component results
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	SΣ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations
value[x]	SΣ	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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Observation.status	required	ObservationStatus
Observation.category	extensible	USCoreClinicalResultObservationCategory
Observation.code	extensible	LOINCCodes (a valid code from LOINC)
Observation.bodySite	example	SNOMEDCTBodyStructures
Observation.component.code	extensible	LOINCCodes (a valid code from LOINC)

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	De-Identified UDS Plus Clinical Result Observation
id	SΣ	0..1	id	The de-identified Observation identifier created by the health center to send data to UDS+ Data Receiver
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
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): Codes providing the status of an observation.
category	S	1..*	CodeableConcept	Classification of type of observation Binding: US Core Clinical Result Observation Category (extensible): The set of codes indicating the category of the observation
code	SΣ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations
subject	SΣ	1..1	Reference(De-Identified UDS Plus Patient)	Who and/or what the observation is about
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣC	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
focus	Σ	0..*	Reference(Resource)	What the observation is about, when it is not about the subject of record
encounter	SΣ	0..1	Reference(De-Identified UDS Plus Encounter)	Healthcare event during which this observation is made
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣC	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
effective[x]	SΣ	0..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
issued	SΣ	0..1	instant	Date/Time this version was made available
performer	SΣ	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Who is responsible for the observation
value[x]	SΣC	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	S	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
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 | 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
component	SΣ	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	SΣ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations
value[x]	SΣ	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
Observation.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
Observation.status	required	ObservationStatus
Observation.category	extensible	USCoreClinicalResultObservationCategory
Observation.code	extensible	LOINCCodes (a valid code from LOINC)
Observation.subject.type	extensible	ResourceType
Observation.encounter.type	extensible	ResourceType
Observation.dataAbsentReason	extensible	DataAbsentReason
Observation.interpretation	extensible	ObservationInterpretationCodes
Observation.bodySite	example	SNOMEDCTBodyStructures
Observation.method	example	ObservationMethods
Observation.referenceRange.type	preferred	ObservationReferenceRangeMeaningCodes
Observation.referenceRange.appliesTo	example	ObservationReferenceRangeAppliesToCodes
Observation.component.code	extensible	LOINCCodes (a valid code from LOINC)
Observation.component.dataAbsentReason	extensible	DataAbsentReason
Observation.component.interpretation	extensible	ObservationInterpretationCodes

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()

Differential View

This structure is derived from Observation

Name	Flags	Card.	Type	Description & Constraints
Observation		0..*	Observation	De-Identified UDS Plus Clinical Result Observation
id	S	0..1	id	The de-identified Observation identifier created by the health center to send data to UDS+ Data Receiver
text		0..0
contained		0..0
status	S	1..1	code	registered | preliminary | final | amended +
category	S	1..*	CodeableConcept	Classification of type of observation Binding: US Core Clinical Result Observation Category (extensible): The set of codes indicating the category of the observation
code	S	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations
subject	S	1..1	Reference(De-Identified UDS Plus Patient)	Who and/or what the observation is about
display		0..0
encounter	S	0..1	Reference(De-Identified UDS Plus Encounter)	Healthcare event during which this observation is made
display		0..0
effective[x]	S	0..1	dateTime, Period, Timing, instant	Clinically relevant time/time-period for observation
issued	S	0..1	instant	Date/Time this version was made available
performer	S	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Who is responsible for the observation
value[x]	S	0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Actual result
bodySite	S	0..1	CodeableConcept	Observed body part
component	S	0..*	BackboneElement	Component results
code	S	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations
value[x]	S	0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Actual component result
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
Observation.category	extensible	USCoreClinicalResultObservationCategory
Observation.code	extensible	LOINCCodes (a valid code from LOINC)
Observation.component.code	extensible	LOINCCodes (a valid code from LOINC)

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	De-Identified UDS Plus Clinical Result Observation
id	SΣ	0..1	id	The de-identified Observation identifier created by the health center to send data to UDS+ Data Receiver
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!SΣ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
category	S	1..*	CodeableConcept	Classification of type of observation Binding: US Core Clinical Result Observation Category (extensible): The set of codes indicating the category of the observation
code	SΣ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations
subject	SΣ	1..1	Reference(De-Identified UDS Plus Patient)	Who and/or what the observation is about
encounter	SΣ	0..1	Reference(De-Identified UDS Plus Encounter)	Healthcare event during which this observation is made
effective[x]	SΣ	0..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
issued	SΣ	0..1	instant	Date/Time this version was made available
performer	SΣ	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Who is responsible for the observation
value[x]	SΣC	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
bodySite	S	0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
component	SΣ	0..*	BackboneElement	Component results
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	SΣ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations
value[x]	SΣ	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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Observation.status	required	ObservationStatus
Observation.category	extensible	USCoreClinicalResultObservationCategory
Observation.code	extensible	LOINCCodes (a valid code from LOINC)
Observation.bodySite	example	SNOMEDCTBodyStructures
Observation.component.code	extensible	LOINCCodes (a valid code from LOINC)

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()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	De-Identified UDS Plus Clinical Result Observation
id	SΣ	0..1	id	The de-identified Observation identifier created by the health center to send data to UDS+ Data Receiver
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
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): Codes providing the status of an observation.
category	S	1..*	CodeableConcept	Classification of type of observation Binding: US Core Clinical Result Observation Category (extensible): The set of codes indicating the category of the observation
code	SΣ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations
subject	SΣ	1..1	Reference(De-Identified UDS Plus Patient)	Who and/or what the observation is about
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣC	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
focus	Σ	0..*	Reference(Resource)	What the observation is about, when it is not about the subject of record
encounter	SΣ	0..1	Reference(De-Identified UDS Plus Encounter)	Healthcare event during which this observation is made
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣC	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
effective[x]	SΣ	0..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
issued	SΣ	0..1	instant	Date/Time this version was made available
performer	SΣ	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Who is responsible for the observation
value[x]	SΣC	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	S	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
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 | 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
component	SΣ	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	SΣ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations
value[x]	SΣ	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
Observation.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
Observation.status	required	ObservationStatus
Observation.category	extensible	USCoreClinicalResultObservationCategory
Observation.code	extensible	LOINCCodes (a valid code from LOINC)
Observation.subject.type	extensible	ResourceType
Observation.encounter.type	extensible	ResourceType
Observation.dataAbsentReason	extensible	DataAbsentReason
Observation.interpretation	extensible	ObservationInterpretationCodes
Observation.bodySite	example	SNOMEDCTBodyStructures
Observation.method	example	ObservationMethods
Observation.referenceRange.type	preferred	ObservationReferenceRangeMeaningCodes
Observation.referenceRange.appliesTo	example	ObservationReferenceRangeAppliesToCodes
Observation.component.code	extensible	LOINCCodes (a valid code from LOINC)
Observation.component.dataAbsentReason	extensible	DataAbsentReason
Observation.component.interpretation	extensible	ObservationInterpretationCodes

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()

This structure is derived from Observation

Summary

Mandatory: 4 elements (1 nested mandatory element)
Must-Support: 14 elements
Prohibited: 4 elements

Structures

This structure refers to these other structures:

• De-Identified UDS Plus Patient (http://fhir.org/guides/hrsa/uds-plus/StructureDefinition/de-identified-uds-plus-patient)
• De-Identified UDS Plus Encounter (http://fhir.org/guides/hrsa/uds-plus/StructureDefinition/uds-plus-encounter)

Maturity: 2