Introduction

This profile is used to represent de-identified Observation for Lab 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 Lab Result resource text element may contain information such as the Observation for Lab 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 Lab Result resource id should not be included in the De-identified Observation for Lab 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 Lab 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]

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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	UDSPlusClinicalResultObservation	De-Identified UDS Plus Lab Observation Constraints: obs-6, obs-7
Observation.id	S This element must be supported. Σ This element is included in summaries.	0..1	id	The de-identified Observation identifier created by the health center to send data to UDS+ Data Receiver
Observation.implicitRules	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created
Observation.Slices for extension				Content/Rules for all slices
Observation.Slices for extension.extension:deidentifiedIssuedTime		0..1	dateTime	Indicates the time with a precision of only Year. URL: http://fhir.org/guides/hrsa/uds-plus/StructureDefinition/uds-plus-deidentified-instant-extension
Observation.modifierExtension	?! This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored
Observation.status	?! This element is a modifier element. S This element must be supported. Σ This element is included in summaries.	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
Observation.category	S This element must be supported.	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
Observation.code	S This element must be supported. Σ This element is included in summaries.	1..1	CodeableConcept	Type of observation (code / type) Binding: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test
Observation.subject	S This element must be supported. Σ This element is included in summaries.	1..1	Reference(De-Identified UDS Plus Patient)	Who and/or what the observation is about
Observation.encounter	S This element must be supported. Σ This element is included in summaries.	0..1	Reference(De-Identified UDS Plus Encounter)	Healthcare event during which this observation is made
Observation.effective[x]	S This element must be supported. Σ This element is included in summaries. C	0..1		Clinically relevant time/time-period for observation Constraints: uds-plus-res-1, uds-plus-res-1a, uds-plus-res-1b, uds-plus-res-2, uds-plus-res-2a, uds-plus-res-2b, uds-plus-res-3, uds-plus-res-3a, uds-plus-res-3b, uds-plus-res-4, uds-plus-res-5, uds-plus-res-5a, uds-plus-res-5b
Observation.effective[x].effectiveDateTime			dateTime S This target must be supported.
Observation.effective[x].effectivePeriod			Period
Observation.effective[x].effectiveTiming			Timing
Observation.performer	S This element must be supported. Σ This element is included in summaries.	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Who is responsible for the observation
Observation.value[x]	S This element must be supported. Σ This element is included in summaries. C	0..1		Actual result Constraints: uds-plus-res-6, uds-plus-res-6a, uds-plus-res-6b, uds-plus-res-7, uds-plus-res-7a, uds-plus-res-7b, uds-plus-res-8, uds-plus-res-8a, uds-plus-res-8b
Observation.value[x].valueQuantity			Quantity S This type must be supported.
Observation.value[x].valueCodeableConcept			CodeableConcept S This type must be supported.
Observation.value[x].valueString			string S This target must be supported.
Observation.value[x].valueBoolean			boolean
Observation.value[x].valueInteger			integer
Observation.value[x].valueRange			Range
Observation.value[x].valueRatio			Ratio
Observation.value[x].valueSampledData			SampledData
Observation.value[x].valueDateTime			dateTime
Observation.value[x].valuePeriod			Period
Observation.bodySite	S This element must be supported.	0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
Observation.component	S This element must be supported. Σ This element is included in summaries.	0..*	BackboneElement	Component results
Observation.component.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Observation.component.code	S This element must be supported. Σ This element is included in summaries.	1..1	CodeableConcept	Type of component observation (code / type) Binding: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test
Observation.component.value[x]	S This element must be supported. Σ This element is included in summaries. C	0..1		Actual component result Constraints: uds-plus-res-9, uds-plus-res-9a, uds-plus-res-9b, uds-plus-res-10, uds-plus-res-10a, uds-plus-res-10b, uds-plus-res-11, uds-plus-res-11a, uds-plus-res-11b
Observation.component.value[x].valueQuantity			Quantity S This type must be supported.
Observation.component.value[x].valueCodeableConcept			CodeableConcept S This type must be supported.
Observation.component.value[x].valueString			string S This target must be supported.
Observation.component.value[x].valueBoolean			boolean
Observation.component.value[x].valueInteger			integer
Observation.component.value[x].valueRange			Range
Observation.component.value[x].valueRatio			Ratio
Observation.component.value[x].valueSampledData			SampledData
Observation.component.value[x].valueDateTime			dateTime
Observation.component.value[x].valuePeriod			Period
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	extensible	US Core Clinical Result Observation Category	📦6.1.0	US Core v6.1
Observation.code	Base	extensible	US Core Laboratory Test Codes	📦6.1.0	US Core v6.1
Observation.bodySite	Base	example	SNOMED CT Body Structures	📍4.0.1	FHIR Std.
Observation.component.​code	Base	extensible	US Core Laboratory Test Codes	📦6.1.0	US Core v6.1

Constraints

Id	Grade	Path(s)	Description	Expression
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()
uds-plus-res-1	error	Observation.effective[x]	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is DateTime implies $this.toString().length() = 4
uds-plus-res-10	error	Observation.component.value[x]	All Period.start data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-10a	error	Observation.component.value[x]	All Period.start data elements should have valid year > 1900	$this is Period and Period.start.exists() implies $this.start.toString() >= '1900'
uds-plus-res-10b	error	Observation.component.value[x]	All Period.start data elements should have valid year < 2030	$this is Period and Period.start.exists() implies $this.start.toString() <= '2030'
uds-plus-res-11a	error	Observation.component.value[x]	All Period.end data elements should have valid year > 1900	$this is Period and Period.end.exists() implies $this.end.toString() >= '1900'
uds-plus-res-11b	error	Observation.component.value[x]	All Period.end data elements should have valid year < 2030	$this is Period and Period.end.exists() implies $this.end.toString() <= '2030'
uds-plus-res-2	error	Observation.effective[x]	All Period.start data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-11	error	Observation.component.value[x]	All Period.end data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.end.exists() implies $this.end.toString().length() = 4
uds-plus-res-1a	error	Observation.effective[x]	All dateTime data elements should have valid year > 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-res-1b	error	Observation.effective[x]	All dateTime data elements should have valid year < 2030	$this is DateTime implies $this.toString() <= '2030'
uds-plus-res-2a	error	Observation.effective[x]	All Period.start data elements should have valid year > 1900	$this is Period and Period.start.exists() implies $this.start.toString() >= '1900'
uds-plus-res-2b	error	Observation.effective[x]	All Period.start data elements should have valid year < 2030	$this is Period and Period.start.exists() implies $this.start.toString() <= '2030'
uds-plus-res-3	error	Observation.effective[x]	All Period.end data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.end.exists() implies $this.end.toString().length() = 4
uds-plus-res-3a	error	Observation.effective[x]	All Period.end data elements should have valid year > 1900	$this is Period and Period.end.exists() implies $this.end.toString() >= '1900'
uds-plus-res-3b	error	Observation.effective[x]	All Period.end data elements should have valid year < 2030	$this is Period and Period.end.exists() implies $this.end.toString() <= '2030'
uds-plus-res-4	error	Observation.effective[x]	All Timing.event data elements should be truncated to a year only for de-identified resources.	$this is Timing and Timing.event.exists() implies $this.event.count() = 1
uds-plus-res-5	error	Observation.effective[x]	All Timing.event data elements should be truncated to a year only for de-identified resources.	$this is Timing and Timing.event.exists() implies $this.event.first().toString().length() = 4
uds-plus-res-5a	error	Observation.effective[x]	All Timing data elements should have valid year > 1900	$this is Timing and Timing.event.exists() implies $this.event.first().toString() >= '1900'
uds-plus-res-5b	error	Observation.effective[x]	All Timing data elements should have valid year < 2030	$this is Timing and Timing.event.exists() implies $this.event.first().toString() <= '2030'
uds-plus-res-6	error	Observation.value[x]	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is dateTime implies $this.toString().length() = 4
uds-plus-res-6a	error	Observation.value[x]	All dateTime data elements should have valid year > 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-res-6b	error	Observation.value[x]	All dateTime data elements should have valid year < 2030	$this is DateTime implies $this.toString() <= '2030'
uds-plus-res-7	error	Observation.value[x]	All Period.start data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-7a	error	Observation.value[x]	All Period.start data elements should have valid year > 1900	$this is Period and Period.start.exists() implies $this.start.toString() >= '1900'
uds-plus-res-7b	error	Observation.value[x]	All Period.start data elements should have valid year < 2030	$this is Period and Period.start.exists() implies $this.start.toString() <= '2030'
uds-plus-res-8	error	Observation.value[x]	All Period.end data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.end.exists() implies $this.end.toString().length() = 4
uds-plus-res-8a	error	Observation.value[x]	All Period.end data elements should have valid year > 1900	$this is Period and Period.end.exists() implies $this.end.toString() >= '1900'
uds-plus-res-8b	error	Observation.value[x]	All Period.end data elements should have valid year < 2030	$this is Period and Period.end.exists() implies $this.end.toString() <= '2030'
uds-plus-res-9	error	Observation.component.value[x]	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is dateTime implies $this.toString().length() = 4
uds-plus-res-9a	error	Observation.component.value[x]	All dateTime data elements should have valid year > 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-res-9b	error	Observation.component.value[x]	All dateTime data elements should have valid year < 2030	$this is DateTime implies $this.toString() <= '2030'

This structure is derived from UDSPlusClinicalResultObservation

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation		0..*	UDSPlusClinicalResultObservation	De-Identified UDS Plus Lab Observation
Observation.code	S This element must be supported.	1..1	CodeableConcept	Type of observation (code / type) Binding: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test
Observation.component
Observation.component.code	S This element must be supported.	1..1	CodeableConcept	Type of component observation (code / type) Binding: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Observation.code	Base	extensible	US Core Laboratory Test Codes	📦6.1.0	US Core v6.1
Observation.component.​code	Base	extensible	US Core Laboratory Test Codes	📦6.1.0	US Core v6.1

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	UDSPlusClinicalResultObservation	De-Identified UDS Plus Lab Observation Constraints: obs-6, obs-7
Observation.id	S This element must be supported. Σ This element is included in summaries.	0..1	id	The de-identified Observation identifier created by the health center to send data to UDS+ Data Receiver
Observation.meta	Σ This element is included in summaries.	0..1	Meta	Metadata about the resource
Observation.implicitRules	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created
Observation.language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
Observation.Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
Observation.Slices for extension.extension:deidentifiedIssuedTime		0..1	dateTime	Indicates the time with a precision of only Year. URL: http://fhir.org/guides/hrsa/uds-plus/StructureDefinition/uds-plus-deidentified-instant-extension
Observation.modifierExtension	?! This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored
Observation.identifier	Σ This element is included in summaries.	0..*	Identifier	Business Identifier for observation
Observation.basedOn	Σ This element is included in summaries.	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Fulfills plan, proposal or order
Observation.partOf	Σ This element is included in summaries.	0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)	Part of referenced event
Observation.status	?! This element is a modifier element. S This element must be supported. Σ This element is included in summaries.	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
Observation.category	S This element must be supported.	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
Observation.code	S This element must be supported. Σ This element is included in summaries.	1..1	CodeableConcept	Type of observation (code / type) Binding: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test
Observation.subject	S This element must be supported. Σ This element is included in summaries.	1..1	Reference(De-Identified UDS Plus Patient)	Who and/or what the observation is about
Observation.subject.id		0..1	string	Unique id for inter-element referencing
Observation.subject.extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Observation.subject.reference	Σ This element is included in summaries. C	0..1	string	Literal reference, Relative, internal or absolute URL
Observation.subject.type	Σ This element is included in summaries.	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).
Observation.subject.identifier	Σ This element is included in summaries.	0..1	Identifier	Logical reference, when literal reference is not known
Observation.focus	Σ This element is included in summaries.	0..*	Reference(Resource)	What the observation is about, when it is not about the subject of record
Observation.encounter	S This element must be supported. Σ This element is included in summaries.	0..1	Reference(De-Identified UDS Plus Encounter)	Healthcare event during which this observation is made
Observation.encounter.id		0..1	string	Unique id for inter-element referencing
Observation.encounter.extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Observation.encounter.reference	Σ This element is included in summaries. C	0..1	string	Literal reference, Relative, internal or absolute URL
Observation.encounter.type	Σ This element is included in summaries.	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).
Observation.encounter.identifier	Σ This element is included in summaries.	0..1	Identifier	Logical reference, when literal reference is not known
Observation.effective[x]	S This element must be supported. Σ This element is included in summaries. C	0..1		Clinically relevant time/time-period for observation Constraints: uds-plus-res-1, uds-plus-res-1a, uds-plus-res-1b, uds-plus-res-2, uds-plus-res-2a, uds-plus-res-2b, uds-plus-res-3, uds-plus-res-3a, uds-plus-res-3b, uds-plus-res-4, uds-plus-res-5, uds-plus-res-5a, uds-plus-res-5b
Observation.effective[x].effectiveDateTime			dateTime S This target must be supported.
Observation.effective[x].effectivePeriod			Period
Observation.effective[x].effectiveTiming			Timing
Observation.performer	S This element must be supported. Σ This element is included in summaries.	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Who is responsible for the observation
Observation.performer.id		0..1	string	Unique id for inter-element referencing
Observation.performer.extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Observation.performer.reference	Σ This element is included in summaries. C	0..1	string	Literal reference, Relative, internal or absolute URL
Observation.performer.type	Σ This element is included in summaries.	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).
Observation.performer.identifier	Σ This element is included in summaries.	0..1	Identifier	Logical reference, when literal reference is not known
Observation.value[x]	S This element must be supported. Σ This element is included in summaries. C	0..1		Actual result Constraints: uds-plus-res-6, uds-plus-res-6a, uds-plus-res-6b, uds-plus-res-7, uds-plus-res-7a, uds-plus-res-7b, uds-plus-res-8, uds-plus-res-8a, uds-plus-res-8b
Observation.value[x].valueQuantity			Quantity S This type must be supported.
Observation.value[x].valueCodeableConcept			CodeableConcept S This type must be supported.
Observation.value[x].valueString			string S This target must be supported.
Observation.value[x].valueBoolean			boolean
Observation.value[x].valueInteger			integer
Observation.value[x].valueRange			Range
Observation.value[x].valueRatio			Ratio
Observation.value[x].valueSampledData			SampledData
Observation.value[x].valueDateTime			dateTime
Observation.value[x].valuePeriod			Period
Observation.dataAbsentReason	C	0..1	CodeableConcept	Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
Observation.interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
Observation.bodySite	S This element must be supported.	0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
Observation.method		0..1	CodeableConcept	How it was done Binding: ObservationMethods (example): Methods for simple observations.
Observation.specimen		0..1	Reference(Specimen)	Specimen used for this observation
Observation.device		0..1	Reference(Device | DeviceMetric)	(Measurement) Device
Observation.referenceRange	C	0..*	BackboneElement	Provides guide for interpretation Constraints: obs-3
Observation.referenceRange.id		0..1	string	Unique id for inter-element referencing
Observation.referenceRange.extension		0..*	Extension	Additional content defined by implementations
Observation.referenceRange.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Observation.referenceRange.low	C	0..1	SimpleQuantity(4.0.1)	Low Range, if relevant Constraints: sqty-1
Observation.referenceRange.high	C	0..1	SimpleQuantity(4.0.1)	High Range, if relevant Constraints: sqty-1
Observation.referenceRange.type		0..1	CodeableConcept	Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
Observation.referenceRange.appliesTo		0..*	CodeableConcept	Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
Observation.referenceRange.age		0..1	Range	Applicable age range, if relevant
Observation.referenceRange.text		0..1	string	Text based reference range in an observation
Observation.hasMember	Σ This element is included in summaries.	0..*	Reference(Observation | QuestionnaireResponse | MolecularSequence)	Related resource that belongs to the Observation group
Observation.derivedFrom	Σ This element is included in summaries.	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from
Observation.component	S This element must be supported. Σ This element is included in summaries.	0..*	BackboneElement	Component results
Observation.component.id		0..1	string	Unique id for inter-element referencing
Observation.component.extension		0..*	Extension	Additional content defined by implementations
Observation.component.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Observation.component.code	S This element must be supported. Σ This element is included in summaries.	1..1	CodeableConcept	Type of component observation (code / type) Binding: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test
Observation.component.value[x]	S This element must be supported. Σ This element is included in summaries. C	0..1		Actual component result Constraints: uds-plus-res-9, uds-plus-res-9a, uds-plus-res-9b, uds-plus-res-10, uds-plus-res-10a, uds-plus-res-10b, uds-plus-res-11, uds-plus-res-11a, uds-plus-res-11b
Observation.component.value[x].valueQuantity			Quantity S This type must be supported.
Observation.component.value[x].valueCodeableConcept			CodeableConcept S This type must be supported.
Observation.component.value[x].valueString			string S This target must be supported.
Observation.component.value[x].valueBoolean			boolean
Observation.component.value[x].valueInteger			integer
Observation.component.value[x].valueRange			Range
Observation.component.value[x].valueRatio			Ratio
Observation.component.value[x].valueSampledData			SampledData
Observation.component.value[x].valueDateTime			dateTime
Observation.component.value[x].valuePeriod			Period
Observation.component.dataAbsentReason	C	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
Observation.component.interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
Observation.component.referenceRange		0..*	See referenceRange (Observation)	Provides guide for interpretation of component result
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	extensible	US Core Clinical Result Observation Category	📦6.1.0	US Core v6.1
Observation.code	Base	extensible	US Core Laboratory Test Codes	📦6.1.0	US Core v6.1
Observation.subject.​type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
Observation.encounter.​type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
Observation.performer.​type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
Observation.dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.
Observation.bodySite	Base	example	SNOMED CT Body Structures	📍4.0.1	FHIR Std.
Observation.method	Base	example	Observation Methods	📍4.0.1	FHIR Std.
Observation.referenceRange.​type	Base	preferred	Observation Reference Range Meaning Codes	📍4.0.1	FHIR Std.
Observation.referenceRange.​appliesTo	Base	example	Observation Reference Range Applies To Codes	📍4.0.1	FHIR Std.
Observation.component.​code	Base	extensible	US Core Laboratory Test Codes	📦6.1.0	US Core v6.1
Observation.component.​dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.component.​interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
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()
sqty-1	error	Observation.referenceRange.low, Observation.referenceRange.high	The comparator is not used on a SimpleQuantity	comparator.empty()
uds-plus-res-1	error	Observation.effective[x]	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is DateTime implies $this.toString().length() = 4
uds-plus-res-10	error	Observation.component.value[x]	All Period.start data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-10a	error	Observation.component.value[x]	All Period.start data elements should have valid year > 1900	$this is Period and Period.start.exists() implies $this.start.toString() >= '1900'
uds-plus-res-10b	error	Observation.component.value[x]	All Period.start data elements should have valid year < 2030	$this is Period and Period.start.exists() implies $this.start.toString() <= '2030'
uds-plus-res-11a	error	Observation.component.value[x]	All Period.end data elements should have valid year > 1900	$this is Period and Period.end.exists() implies $this.end.toString() >= '1900'
uds-plus-res-11b	error	Observation.component.value[x]	All Period.end data elements should have valid year < 2030	$this is Period and Period.end.exists() implies $this.end.toString() <= '2030'
uds-plus-res-2	error	Observation.effective[x]	All Period.start data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-11	error	Observation.component.value[x]	All Period.end data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.end.exists() implies $this.end.toString().length() = 4
uds-plus-res-1a	error	Observation.effective[x]	All dateTime data elements should have valid year > 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-res-1b	error	Observation.effective[x]	All dateTime data elements should have valid year < 2030	$this is DateTime implies $this.toString() <= '2030'
uds-plus-res-2a	error	Observation.effective[x]	All Period.start data elements should have valid year > 1900	$this is Period and Period.start.exists() implies $this.start.toString() >= '1900'
uds-plus-res-2b	error	Observation.effective[x]	All Period.start data elements should have valid year < 2030	$this is Period and Period.start.exists() implies $this.start.toString() <= '2030'
uds-plus-res-3	error	Observation.effective[x]	All Period.end data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.end.exists() implies $this.end.toString().length() = 4
uds-plus-res-3a	error	Observation.effective[x]	All Period.end data elements should have valid year > 1900	$this is Period and Period.end.exists() implies $this.end.toString() >= '1900'
uds-plus-res-3b	error	Observation.effective[x]	All Period.end data elements should have valid year < 2030	$this is Period and Period.end.exists() implies $this.end.toString() <= '2030'
uds-plus-res-4	error	Observation.effective[x]	All Timing.event data elements should be truncated to a year only for de-identified resources.	$this is Timing and Timing.event.exists() implies $this.event.count() = 1
uds-plus-res-5	error	Observation.effective[x]	All Timing.event data elements should be truncated to a year only for de-identified resources.	$this is Timing and Timing.event.exists() implies $this.event.first().toString().length() = 4
uds-plus-res-5a	error	Observation.effective[x]	All Timing data elements should have valid year > 1900	$this is Timing and Timing.event.exists() implies $this.event.first().toString() >= '1900'
uds-plus-res-5b	error	Observation.effective[x]	All Timing data elements should have valid year < 2030	$this is Timing and Timing.event.exists() implies $this.event.first().toString() <= '2030'
uds-plus-res-6	error	Observation.value[x]	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is dateTime implies $this.toString().length() = 4
uds-plus-res-6a	error	Observation.value[x]	All dateTime data elements should have valid year > 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-res-6b	error	Observation.value[x]	All dateTime data elements should have valid year < 2030	$this is DateTime implies $this.toString() <= '2030'
uds-plus-res-7	error	Observation.value[x]	All Period.start data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-7a	error	Observation.value[x]	All Period.start data elements should have valid year > 1900	$this is Period and Period.start.exists() implies $this.start.toString() >= '1900'
uds-plus-res-7b	error	Observation.value[x]	All Period.start data elements should have valid year < 2030	$this is Period and Period.start.exists() implies $this.start.toString() <= '2030'
uds-plus-res-8	error	Observation.value[x]	All Period.end data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.end.exists() implies $this.end.toString().length() = 4
uds-plus-res-8a	error	Observation.value[x]	All Period.end data elements should have valid year > 1900	$this is Period and Period.end.exists() implies $this.end.toString() >= '1900'
uds-plus-res-8b	error	Observation.value[x]	All Period.end data elements should have valid year < 2030	$this is Period and Period.end.exists() implies $this.end.toString() <= '2030'
uds-plus-res-9	error	Observation.component.value[x]	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is dateTime implies $this.toString().length() = 4
uds-plus-res-9a	error	Observation.component.value[x]	All dateTime data elements should have valid year > 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-res-9b	error	Observation.component.value[x]	All dateTime data elements should have valid year < 2030	$this is DateTime implies $this.toString() <= '2030'

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	UDSPlusClinicalResultObservation	De-Identified UDS Plus Lab Observation Constraints: obs-6, obs-7
Observation.id	S This element must be supported. Σ This element is included in summaries.	0..1	id	The de-identified Observation identifier created by the health center to send data to UDS+ Data Receiver
Observation.implicitRules	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created
Observation.Slices for extension				Content/Rules for all slices
Observation.Slices for extension.extension:deidentifiedIssuedTime		0..1	dateTime	Indicates the time with a precision of only Year. URL: http://fhir.org/guides/hrsa/uds-plus/StructureDefinition/uds-plus-deidentified-instant-extension
Observation.modifierExtension	?! This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored
Observation.status	?! This element is a modifier element. S This element must be supported. Σ This element is included in summaries.	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
Observation.category	S This element must be supported.	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
Observation.code	S This element must be supported. Σ This element is included in summaries.	1..1	CodeableConcept	Type of observation (code / type) Binding: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test
Observation.subject	S This element must be supported. Σ This element is included in summaries.	1..1	Reference(De-Identified UDS Plus Patient)	Who and/or what the observation is about
Observation.encounter	S This element must be supported. Σ This element is included in summaries.	0..1	Reference(De-Identified UDS Plus Encounter)	Healthcare event during which this observation is made
Observation.effective[x]	S This element must be supported. Σ This element is included in summaries. C	0..1		Clinically relevant time/time-period for observation Constraints: uds-plus-res-1, uds-plus-res-1a, uds-plus-res-1b, uds-plus-res-2, uds-plus-res-2a, uds-plus-res-2b, uds-plus-res-3, uds-plus-res-3a, uds-plus-res-3b, uds-plus-res-4, uds-plus-res-5, uds-plus-res-5a, uds-plus-res-5b
Observation.effective[x].effectiveDateTime			dateTime S This target must be supported.
Observation.effective[x].effectivePeriod			Period
Observation.effective[x].effectiveTiming			Timing
Observation.performer	S This element must be supported. Σ This element is included in summaries.	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Who is responsible for the observation
Observation.value[x]	S This element must be supported. Σ This element is included in summaries. C	0..1		Actual result Constraints: uds-plus-res-6, uds-plus-res-6a, uds-plus-res-6b, uds-plus-res-7, uds-plus-res-7a, uds-plus-res-7b, uds-plus-res-8, uds-plus-res-8a, uds-plus-res-8b
Observation.value[x].valueQuantity			Quantity S This type must be supported.
Observation.value[x].valueCodeableConcept			CodeableConcept S This type must be supported.
Observation.value[x].valueString			string S This target must be supported.
Observation.value[x].valueBoolean			boolean
Observation.value[x].valueInteger			integer
Observation.value[x].valueRange			Range
Observation.value[x].valueRatio			Ratio
Observation.value[x].valueSampledData			SampledData
Observation.value[x].valueDateTime			dateTime
Observation.value[x].valuePeriod			Period
Observation.bodySite	S This element must be supported.	0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
Observation.component	S This element must be supported. Σ This element is included in summaries.	0..*	BackboneElement	Component results
Observation.component.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Observation.component.code	S This element must be supported. Σ This element is included in summaries.	1..1	CodeableConcept	Type of component observation (code / type) Binding: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test
Observation.component.value[x]	S This element must be supported. Σ This element is included in summaries. C	0..1		Actual component result Constraints: uds-plus-res-9, uds-plus-res-9a, uds-plus-res-9b, uds-plus-res-10, uds-plus-res-10a, uds-plus-res-10b, uds-plus-res-11, uds-plus-res-11a, uds-plus-res-11b
Observation.component.value[x].valueQuantity			Quantity S This type must be supported.
Observation.component.value[x].valueCodeableConcept			CodeableConcept S This type must be supported.
Observation.component.value[x].valueString			string S This target must be supported.
Observation.component.value[x].valueBoolean			boolean
Observation.component.value[x].valueInteger			integer
Observation.component.value[x].valueRange			Range
Observation.component.value[x].valueRatio			Ratio
Observation.component.value[x].valueSampledData			SampledData
Observation.component.value[x].valueDateTime			dateTime
Observation.component.value[x].valuePeriod			Period
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	extensible	US Core Clinical Result Observation Category	📦6.1.0	US Core v6.1
Observation.code	Base	extensible	US Core Laboratory Test Codes	📦6.1.0	US Core v6.1
Observation.bodySite	Base	example	SNOMED CT Body Structures	📍4.0.1	FHIR Std.
Observation.component.​code	Base	extensible	US Core Laboratory Test Codes	📦6.1.0	US Core v6.1

Constraints

Id	Grade	Path(s)	Description	Expression
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()
uds-plus-res-1	error	Observation.effective[x]	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is DateTime implies $this.toString().length() = 4
uds-plus-res-10	error	Observation.component.value[x]	All Period.start data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-10a	error	Observation.component.value[x]	All Period.start data elements should have valid year > 1900	$this is Period and Period.start.exists() implies $this.start.toString() >= '1900'
uds-plus-res-10b	error	Observation.component.value[x]	All Period.start data elements should have valid year < 2030	$this is Period and Period.start.exists() implies $this.start.toString() <= '2030'
uds-plus-res-11a	error	Observation.component.value[x]	All Period.end data elements should have valid year > 1900	$this is Period and Period.end.exists() implies $this.end.toString() >= '1900'
uds-plus-res-11b	error	Observation.component.value[x]	All Period.end data elements should have valid year < 2030	$this is Period and Period.end.exists() implies $this.end.toString() <= '2030'
uds-plus-res-2	error	Observation.effective[x]	All Period.start data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-11	error	Observation.component.value[x]	All Period.end data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.end.exists() implies $this.end.toString().length() = 4
uds-plus-res-1a	error	Observation.effective[x]	All dateTime data elements should have valid year > 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-res-1b	error	Observation.effective[x]	All dateTime data elements should have valid year < 2030	$this is DateTime implies $this.toString() <= '2030'
uds-plus-res-2a	error	Observation.effective[x]	All Period.start data elements should have valid year > 1900	$this is Period and Period.start.exists() implies $this.start.toString() >= '1900'
uds-plus-res-2b	error	Observation.effective[x]	All Period.start data elements should have valid year < 2030	$this is Period and Period.start.exists() implies $this.start.toString() <= '2030'
uds-plus-res-3	error	Observation.effective[x]	All Period.end data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.end.exists() implies $this.end.toString().length() = 4
uds-plus-res-3a	error	Observation.effective[x]	All Period.end data elements should have valid year > 1900	$this is Period and Period.end.exists() implies $this.end.toString() >= '1900'
uds-plus-res-3b	error	Observation.effective[x]	All Period.end data elements should have valid year < 2030	$this is Period and Period.end.exists() implies $this.end.toString() <= '2030'
uds-plus-res-4	error	Observation.effective[x]	All Timing.event data elements should be truncated to a year only for de-identified resources.	$this is Timing and Timing.event.exists() implies $this.event.count() = 1
uds-plus-res-5	error	Observation.effective[x]	All Timing.event data elements should be truncated to a year only for de-identified resources.	$this is Timing and Timing.event.exists() implies $this.event.first().toString().length() = 4
uds-plus-res-5a	error	Observation.effective[x]	All Timing data elements should have valid year > 1900	$this is Timing and Timing.event.exists() implies $this.event.first().toString() >= '1900'
uds-plus-res-5b	error	Observation.effective[x]	All Timing data elements should have valid year < 2030	$this is Timing and Timing.event.exists() implies $this.event.first().toString() <= '2030'
uds-plus-res-6	error	Observation.value[x]	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is dateTime implies $this.toString().length() = 4
uds-plus-res-6a	error	Observation.value[x]	All dateTime data elements should have valid year > 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-res-6b	error	Observation.value[x]	All dateTime data elements should have valid year < 2030	$this is DateTime implies $this.toString() <= '2030'
uds-plus-res-7	error	Observation.value[x]	All Period.start data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-7a	error	Observation.value[x]	All Period.start data elements should have valid year > 1900	$this is Period and Period.start.exists() implies $this.start.toString() >= '1900'
uds-plus-res-7b	error	Observation.value[x]	All Period.start data elements should have valid year < 2030	$this is Period and Period.start.exists() implies $this.start.toString() <= '2030'
uds-plus-res-8	error	Observation.value[x]	All Period.end data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.end.exists() implies $this.end.toString().length() = 4
uds-plus-res-8a	error	Observation.value[x]	All Period.end data elements should have valid year > 1900	$this is Period and Period.end.exists() implies $this.end.toString() >= '1900'
uds-plus-res-8b	error	Observation.value[x]	All Period.end data elements should have valid year < 2030	$this is Period and Period.end.exists() implies $this.end.toString() <= '2030'
uds-plus-res-9	error	Observation.component.value[x]	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is dateTime implies $this.toString().length() = 4
uds-plus-res-9a	error	Observation.component.value[x]	All dateTime data elements should have valid year > 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-res-9b	error	Observation.component.value[x]	All dateTime data elements should have valid year < 2030	$this is DateTime implies $this.toString() <= '2030'

Differential View

This structure is derived from UDSPlusClinicalResultObservation

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation		0..*	UDSPlusClinicalResultObservation	De-Identified UDS Plus Lab Observation
Observation.code	S This element must be supported.	1..1	CodeableConcept	Type of observation (code / type) Binding: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test
Observation.component
Observation.component.code	S This element must be supported.	1..1	CodeableConcept	Type of component observation (code / type) Binding: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Observation.code	Base	extensible	US Core Laboratory Test Codes	📦6.1.0	US Core v6.1
Observation.component.​code	Base	extensible	US Core Laboratory Test Codes	📦6.1.0	US Core v6.1

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	UDSPlusClinicalResultObservation	De-Identified UDS Plus Lab Observation Constraints: obs-6, obs-7
Observation.id	S This element must be supported. Σ This element is included in summaries.	0..1	id	The de-identified Observation identifier created by the health center to send data to UDS+ Data Receiver
Observation.meta	Σ This element is included in summaries.	0..1	Meta	Metadata about the resource
Observation.implicitRules	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created
Observation.language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
Observation.Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
Observation.Slices for extension.extension:deidentifiedIssuedTime		0..1	dateTime	Indicates the time with a precision of only Year. URL: http://fhir.org/guides/hrsa/uds-plus/StructureDefinition/uds-plus-deidentified-instant-extension
Observation.modifierExtension	?! This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored
Observation.identifier	Σ This element is included in summaries.	0..*	Identifier	Business Identifier for observation
Observation.basedOn	Σ This element is included in summaries.	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Fulfills plan, proposal or order
Observation.partOf	Σ This element is included in summaries.	0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)	Part of referenced event
Observation.status	?! This element is a modifier element. S This element must be supported. Σ This element is included in summaries.	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
Observation.category	S This element must be supported.	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
Observation.code	S This element must be supported. Σ This element is included in summaries.	1..1	CodeableConcept	Type of observation (code / type) Binding: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test
Observation.subject	S This element must be supported. Σ This element is included in summaries.	1..1	Reference(De-Identified UDS Plus Patient)	Who and/or what the observation is about
Observation.subject.id		0..1	string	Unique id for inter-element referencing
Observation.subject.extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Observation.subject.reference	Σ This element is included in summaries. C	0..1	string	Literal reference, Relative, internal or absolute URL
Observation.subject.type	Σ This element is included in summaries.	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).
Observation.subject.identifier	Σ This element is included in summaries.	0..1	Identifier	Logical reference, when literal reference is not known
Observation.focus	Σ This element is included in summaries.	0..*	Reference(Resource)	What the observation is about, when it is not about the subject of record
Observation.encounter	S This element must be supported. Σ This element is included in summaries.	0..1	Reference(De-Identified UDS Plus Encounter)	Healthcare event during which this observation is made
Observation.encounter.id		0..1	string	Unique id for inter-element referencing
Observation.encounter.extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Observation.encounter.reference	Σ This element is included in summaries. C	0..1	string	Literal reference, Relative, internal or absolute URL
Observation.encounter.type	Σ This element is included in summaries.	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).
Observation.encounter.identifier	Σ This element is included in summaries.	0..1	Identifier	Logical reference, when literal reference is not known
Observation.effective[x]	S This element must be supported. Σ This element is included in summaries. C	0..1		Clinically relevant time/time-period for observation Constraints: uds-plus-res-1, uds-plus-res-1a, uds-plus-res-1b, uds-plus-res-2, uds-plus-res-2a, uds-plus-res-2b, uds-plus-res-3, uds-plus-res-3a, uds-plus-res-3b, uds-plus-res-4, uds-plus-res-5, uds-plus-res-5a, uds-plus-res-5b
Observation.effective[x].effectiveDateTime			dateTime S This target must be supported.
Observation.effective[x].effectivePeriod			Period
Observation.effective[x].effectiveTiming			Timing
Observation.performer	S This element must be supported. Σ This element is included in summaries.	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Who is responsible for the observation
Observation.performer.id		0..1	string	Unique id for inter-element referencing
Observation.performer.extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Observation.performer.reference	Σ This element is included in summaries. C	0..1	string	Literal reference, Relative, internal or absolute URL
Observation.performer.type	Σ This element is included in summaries.	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).
Observation.performer.identifier	Σ This element is included in summaries.	0..1	Identifier	Logical reference, when literal reference is not known
Observation.value[x]	S This element must be supported. Σ This element is included in summaries. C	0..1		Actual result Constraints: uds-plus-res-6, uds-plus-res-6a, uds-plus-res-6b, uds-plus-res-7, uds-plus-res-7a, uds-plus-res-7b, uds-plus-res-8, uds-plus-res-8a, uds-plus-res-8b
Observation.value[x].valueQuantity			Quantity S This type must be supported.
Observation.value[x].valueCodeableConcept			CodeableConcept S This type must be supported.
Observation.value[x].valueString			string S This target must be supported.
Observation.value[x].valueBoolean			boolean
Observation.value[x].valueInteger			integer
Observation.value[x].valueRange			Range
Observation.value[x].valueRatio			Ratio
Observation.value[x].valueSampledData			SampledData
Observation.value[x].valueDateTime			dateTime
Observation.value[x].valuePeriod			Period
Observation.dataAbsentReason	C	0..1	CodeableConcept	Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
Observation.interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
Observation.bodySite	S This element must be supported.	0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
Observation.method		0..1	CodeableConcept	How it was done Binding: ObservationMethods (example): Methods for simple observations.
Observation.specimen		0..1	Reference(Specimen)	Specimen used for this observation
Observation.device		0..1	Reference(Device | DeviceMetric)	(Measurement) Device
Observation.referenceRange	C	0..*	BackboneElement	Provides guide for interpretation Constraints: obs-3
Observation.referenceRange.id		0..1	string	Unique id for inter-element referencing
Observation.referenceRange.extension		0..*	Extension	Additional content defined by implementations
Observation.referenceRange.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Observation.referenceRange.low	C	0..1	SimpleQuantity(4.0.1)	Low Range, if relevant Constraints: sqty-1
Observation.referenceRange.high	C	0..1	SimpleQuantity(4.0.1)	High Range, if relevant Constraints: sqty-1
Observation.referenceRange.type		0..1	CodeableConcept	Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
Observation.referenceRange.appliesTo		0..*	CodeableConcept	Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
Observation.referenceRange.age		0..1	Range	Applicable age range, if relevant
Observation.referenceRange.text		0..1	string	Text based reference range in an observation
Observation.hasMember	Σ This element is included in summaries.	0..*	Reference(Observation | QuestionnaireResponse | MolecularSequence)	Related resource that belongs to the Observation group
Observation.derivedFrom	Σ This element is included in summaries.	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from
Observation.component	S This element must be supported. Σ This element is included in summaries.	0..*	BackboneElement	Component results
Observation.component.id		0..1	string	Unique id for inter-element referencing
Observation.component.extension		0..*	Extension	Additional content defined by implementations
Observation.component.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Observation.component.code	S This element must be supported. Σ This element is included in summaries.	1..1	CodeableConcept	Type of component observation (code / type) Binding: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test
Observation.component.value[x]	S This element must be supported. Σ This element is included in summaries. C	0..1		Actual component result Constraints: uds-plus-res-9, uds-plus-res-9a, uds-plus-res-9b, uds-plus-res-10, uds-plus-res-10a, uds-plus-res-10b, uds-plus-res-11, uds-plus-res-11a, uds-plus-res-11b
Observation.component.value[x].valueQuantity			Quantity S This type must be supported.
Observation.component.value[x].valueCodeableConcept			CodeableConcept S This type must be supported.
Observation.component.value[x].valueString			string S This target must be supported.
Observation.component.value[x].valueBoolean			boolean
Observation.component.value[x].valueInteger			integer
Observation.component.value[x].valueRange			Range
Observation.component.value[x].valueRatio			Ratio
Observation.component.value[x].valueSampledData			SampledData
Observation.component.value[x].valueDateTime			dateTime
Observation.component.value[x].valuePeriod			Period
Observation.component.dataAbsentReason	C	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
Observation.component.interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
Observation.component.referenceRange		0..*	See referenceRange (Observation)	Provides guide for interpretation of component result
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	extensible	US Core Clinical Result Observation Category	📦6.1.0	US Core v6.1
Observation.code	Base	extensible	US Core Laboratory Test Codes	📦6.1.0	US Core v6.1
Observation.subject.​type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
Observation.encounter.​type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
Observation.performer.​type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
Observation.dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.
Observation.bodySite	Base	example	SNOMED CT Body Structures	📍4.0.1	FHIR Std.
Observation.method	Base	example	Observation Methods	📍4.0.1	FHIR Std.
Observation.referenceRange.​type	Base	preferred	Observation Reference Range Meaning Codes	📍4.0.1	FHIR Std.
Observation.referenceRange.​appliesTo	Base	example	Observation Reference Range Applies To Codes	📍4.0.1	FHIR Std.
Observation.component.​code	Base	extensible	US Core Laboratory Test Codes	📦6.1.0	US Core v6.1
Observation.component.​dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.component.​interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
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()
sqty-1	error	Observation.referenceRange.low, Observation.referenceRange.high	The comparator is not used on a SimpleQuantity	comparator.empty()
uds-plus-res-1	error	Observation.effective[x]	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is DateTime implies $this.toString().length() = 4
uds-plus-res-10	error	Observation.component.value[x]	All Period.start data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-10a	error	Observation.component.value[x]	All Period.start data elements should have valid year > 1900	$this is Period and Period.start.exists() implies $this.start.toString() >= '1900'
uds-plus-res-10b	error	Observation.component.value[x]	All Period.start data elements should have valid year < 2030	$this is Period and Period.start.exists() implies $this.start.toString() <= '2030'
uds-plus-res-11a	error	Observation.component.value[x]	All Period.end data elements should have valid year > 1900	$this is Period and Period.end.exists() implies $this.end.toString() >= '1900'
uds-plus-res-11b	error	Observation.component.value[x]	All Period.end data elements should have valid year < 2030	$this is Period and Period.end.exists() implies $this.end.toString() <= '2030'
uds-plus-res-2	error	Observation.effective[x]	All Period.start data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-11	error	Observation.component.value[x]	All Period.end data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.end.exists() implies $this.end.toString().length() = 4
uds-plus-res-1a	error	Observation.effective[x]	All dateTime data elements should have valid year > 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-res-1b	error	Observation.effective[x]	All dateTime data elements should have valid year < 2030	$this is DateTime implies $this.toString() <= '2030'
uds-plus-res-2a	error	Observation.effective[x]	All Period.start data elements should have valid year > 1900	$this is Period and Period.start.exists() implies $this.start.toString() >= '1900'
uds-plus-res-2b	error	Observation.effective[x]	All Period.start data elements should have valid year < 2030	$this is Period and Period.start.exists() implies $this.start.toString() <= '2030'
uds-plus-res-3	error	Observation.effective[x]	All Period.end data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.end.exists() implies $this.end.toString().length() = 4
uds-plus-res-3a	error	Observation.effective[x]	All Period.end data elements should have valid year > 1900	$this is Period and Period.end.exists() implies $this.end.toString() >= '1900'
uds-plus-res-3b	error	Observation.effective[x]	All Period.end data elements should have valid year < 2030	$this is Period and Period.end.exists() implies $this.end.toString() <= '2030'
uds-plus-res-4	error	Observation.effective[x]	All Timing.event data elements should be truncated to a year only for de-identified resources.	$this is Timing and Timing.event.exists() implies $this.event.count() = 1
uds-plus-res-5	error	Observation.effective[x]	All Timing.event data elements should be truncated to a year only for de-identified resources.	$this is Timing and Timing.event.exists() implies $this.event.first().toString().length() = 4
uds-plus-res-5a	error	Observation.effective[x]	All Timing data elements should have valid year > 1900	$this is Timing and Timing.event.exists() implies $this.event.first().toString() >= '1900'
uds-plus-res-5b	error	Observation.effective[x]	All Timing data elements should have valid year < 2030	$this is Timing and Timing.event.exists() implies $this.event.first().toString() <= '2030'
uds-plus-res-6	error	Observation.value[x]	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is dateTime implies $this.toString().length() = 4
uds-plus-res-6a	error	Observation.value[x]	All dateTime data elements should have valid year > 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-res-6b	error	Observation.value[x]	All dateTime data elements should have valid year < 2030	$this is DateTime implies $this.toString() <= '2030'
uds-plus-res-7	error	Observation.value[x]	All Period.start data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-7a	error	Observation.value[x]	All Period.start data elements should have valid year > 1900	$this is Period and Period.start.exists() implies $this.start.toString() >= '1900'
uds-plus-res-7b	error	Observation.value[x]	All Period.start data elements should have valid year < 2030	$this is Period and Period.start.exists() implies $this.start.toString() <= '2030'
uds-plus-res-8	error	Observation.value[x]	All Period.end data elements should be truncated to a year only for de-identified resources.	$this is Period and Period.end.exists() implies $this.end.toString().length() = 4
uds-plus-res-8a	error	Observation.value[x]	All Period.end data elements should have valid year > 1900	$this is Period and Period.end.exists() implies $this.end.toString() >= '1900'
uds-plus-res-8b	error	Observation.value[x]	All Period.end data elements should have valid year < 2030	$this is Period and Period.end.exists() implies $this.end.toString() <= '2030'
uds-plus-res-9	error	Observation.component.value[x]	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is dateTime implies $this.toString().length() = 4
uds-plus-res-9a	error	Observation.component.value[x]	All dateTime data elements should have valid year > 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-res-9b	error	Observation.component.value[x]	All dateTime data elements should have valid year < 2030	$this is DateTime implies $this.toString() <= '2030'

This structure is derived from UDSPlusClinicalResultObservation

Summary

Mandatory: 1 element(1 nested mandatory element)
Must-Support: 2 elements

Maturity: 2