HRSA 2023 Uniform Data System (UDS) Patient Level Submission (PLS) (UDS+) FHIR IG
1.0.1 - STU1 Release 1 - Standard for Trial-Use International flag

This page is part of the HRSA Uniform Data System (UDS) Patient Level Submission (PLS) (UDS+ or uds-plus) FHIR IG (v1.0.1: STU1) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Resource Profile: De-Identified UDS Plus Clinical Result Observation

Official URL: http://fhir.org/guides/hrsa/uds-plus/StructureDefinition/uds-plus-clinical-result-observation Version: 1.0.1
Standards status: Trial-use Maturity Level: 2 Computable Name: UDSPlusClinicalResultObservation

The UDS+ profile is based on the Observation resource and establishes the core elements, extensions, vocabularies and value sets for representing clinical result observations for UDS+ program.

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]

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from Observation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 0..*ObservationDe-Identified UDS Plus Clinical Result Observation
... id S0..1idThe de-identified Observation identifier created by the health center to send data to UDS+ Data Receiver
... text 0..0
... contained 0..0
... category S1..*CodeableConceptClassification of type of observation
Binding: US Core Clinical Result Observation Category (extensible): The set of codes indicating the category of the observation


... code S1..1CodeableConceptType of observation (code / type)
Binding: LOINCCodes (extensible): The set of codes indicating the Observations

... subject S1..1Reference(De-Identified UDS Plus Patient)Who and/or what the observation is about
.... display 0..0
... encounter S0..1Reference(De-Identified UDS Plus Encounter)Healthcare event during which this observation is made
.... display 0..0
... effective[x] S0..1dateTime, Period, Timing, instantClinically relevant time/time-period for observation
... issued S0..1instantDate/Time this version was made available
... performer S0..*Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)Who is responsible for the observation
... value[x] S0..1Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, PeriodActual result
... bodySite S0..1CodeableConceptObserved body part
... component S0..*BackboneElementComponent results
.... code S1..1CodeableConceptType of component observation (code / type)
Binding: LOINCCodes (extensible): The set of codes indicating the Observations

.... value[x] S0..1Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, PeriodActual component result

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
Observation.categoryextensibleUSCoreClinicalResultObservationCategory
Observation.codeextensibleLOINCCodes (a valid code from LOINC)
Observation.component.codeextensibleLOINCCodes (a valid code from LOINC)
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*ObservationDe-Identified UDS Plus Clinical Result Observation
... id SΣ0..1idThe de-identified Observation identifier created by the health center to send data to UDS+ Data Receiver
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... category S1..*CodeableConceptClassification of type of observation
Binding: US Core Clinical Result Observation Category (extensible): The set of codes indicating the category of the observation


... code SΣ1..1CodeableConceptType of observation (code / type)
Binding: LOINCCodes (extensible): The set of codes indicating the Observations

... subject SΣ1..1Reference(De-Identified UDS Plus Patient)Who and/or what the observation is about
... encounter SΣ0..1Reference(De-Identified UDS Plus Encounter)Healthcare event during which this observation is made
... effective[x] SΣ0..1Clinically relevant time/time-period for observation
.... effectiveDateTimedateTime
.... effectivePeriodPeriod
.... effectiveTimingTiming
.... effectiveInstantinstant
... issued SΣ0..1instantDate/Time this version was made available
... performer SΣ0..*Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)Who is responsible for the observation
... value[x] SΣC0..1Actual result
.... valueQuantityQuantity
.... valueCodeableConceptCodeableConcept
.... valueStringstring
.... valueBooleanboolean
.... valueIntegerinteger
.... valueRangeRange
.... valueRatioRatio
.... valueSampledDataSampledData
.... valueTimetime
.... valueDateTimedateTime
.... valuePeriodPeriod
... bodySite S0..1CodeableConceptObserved body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.

... component SΣ0..*BackboneElementComponent results
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code SΣ1..1CodeableConceptType of component observation (code / type)
Binding: LOINCCodes (extensible): The set of codes indicating the Observations

.... value[x] SΣ0..1Actual component result
..... valueQuantityQuantity
..... valueCodeableConceptCodeableConcept
..... valueStringstring
..... valueBooleanboolean
..... valueIntegerinteger
..... valueRangeRange
..... valueRatioRatio
..... valueSampledDataSampledData
..... valueTimetime
..... valueDateTimedateTime
..... valuePeriodPeriod

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Observation.statusrequiredObservationStatus
Observation.categoryextensibleUSCoreClinicalResultObservationCategory
Observation.codeextensibleLOINCCodes (a valid code from LOINC)
Observation.bodySiteexampleSNOMEDCTBodyStructures
Observation.component.codeextensibleLOINCCodes (a valid code from LOINC)

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf 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-4errorObservationIf 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-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf 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()
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*ObservationDe-Identified UDS Plus Clinical Result Observation
... id SΣ0..1idThe de-identified Observation identifier created by the health center to send data to UDS+ Data Receiver
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierBusiness Identifier for observation
... basedOn Σ0..*Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)Fulfills plan, proposal or order
... partOf Σ0..*Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)Part of referenced event
... status ?!SΣ1..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... category S1..*CodeableConceptClassification of type of observation
Binding: US Core Clinical Result Observation Category (extensible): The set of codes indicating the category of the observation


... code SΣ1..1CodeableConceptType of observation (code / type)
Binding: LOINCCodes (extensible): The set of codes indicating the Observations

... subject SΣ1..1Reference(De-Identified UDS Plus Patient)Who and/or what the observation is about
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... reference ΣC0..1stringLiteral reference, Relative, internal or absolute URL
.... type Σ0..1uriType the reference refers to (e.g. "Patient")
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier Σ0..1IdentifierLogical reference, when literal reference is not known
... focus Σ0..*Reference(Resource)What the observation is about, when it is not about the subject of record
... encounter SΣ0..1Reference(De-Identified UDS Plus Encounter)Healthcare event during which this observation is made
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... reference ΣC0..1stringLiteral reference, Relative, internal or absolute URL
.... type Σ0..1uriType the reference refers to (e.g. "Patient")
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier Σ0..1IdentifierLogical reference, when literal reference is not known
... effective[x] SΣ0..1Clinically relevant time/time-period for observation
.... effectiveDateTimedateTime
.... effectivePeriodPeriod
.... effectiveTimingTiming
.... effectiveInstantinstant
... issued SΣ0..1instantDate/Time this version was made available
... performer SΣ0..*Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)Who is responsible for the observation
... value[x] SΣC0..1Actual result
.... valueQuantityQuantity
.... valueCodeableConceptCodeableConcept
.... valueStringstring
.... valueBooleanboolean
.... valueIntegerinteger
.... valueRangeRange
.... valueRatioRatio
.... valueSampledDataSampledData
.... valueTimetime
.... valueDateTimedateTime
.... valuePeriodPeriod
... dataAbsentReason C0..1CodeableConceptWhy the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... interpretation 0..*CodeableConceptHigh, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


... note 0..*AnnotationComments about the observation
... bodySite S0..1CodeableConceptObserved body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.

... method 0..1CodeableConceptHow it was done
Binding: ObservationMethods (example): Methods for simple observations.

... specimen 0..1Reference(Specimen)Specimen used for this observation
... device 0..1Reference(Device | DeviceMetric)(Measurement) Device
... referenceRange C0..*BackboneElementProvides guide for interpretation
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... low C0..1SimpleQuantityLow Range, if relevant
.... high C0..1SimpleQuantityHigh Range, if relevant
.... type 0..1CodeableConceptReference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.

.... appliesTo 0..*CodeableConceptReference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.


.... age 0..1RangeApplicable age range, if relevant
.... text 0..1stringText based reference range in an observation
... hasMember Σ0..*Reference(Observation | QuestionnaireResponse | MolecularSequence)Related resource that belongs to the Observation group
... derivedFrom Σ0..*Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)Related measurements the observation is made from
... component SΣ0..*BackboneElementComponent results
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code SΣ1..1CodeableConceptType of component observation (code / type)
Binding: LOINCCodes (extensible): The set of codes indicating the Observations

.... value[x] SΣ0..1Actual component result
..... valueQuantityQuantity
..... valueCodeableConceptCodeableConcept
..... valueStringstring
..... valueBooleanboolean
..... valueIntegerinteger
..... valueRangeRange
..... valueRatioRatio
..... valueSampledDataSampledData
..... valueTimetime
..... valueDateTimedateTime
..... valuePeriodPeriod
.... dataAbsentReason C0..1CodeableConceptWhy the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

.... interpretation 0..*CodeableConceptHigh, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


.... referenceRange 0..*See referenceRange (Observation)Provides guide for interpretation of component result

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Observation.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
Observation.statusrequiredObservationStatus
Observation.categoryextensibleUSCoreClinicalResultObservationCategory
Observation.codeextensibleLOINCCodes (a valid code from LOINC)
Observation.subject.typeextensibleResourceType
Observation.encounter.typeextensibleResourceType
Observation.dataAbsentReasonextensibleDataAbsentReason
Observation.interpretationextensibleObservationInterpretationCodes
Observation.bodySiteexampleSNOMEDCTBodyStructures
Observation.methodexampleObservationMethods
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
Observation.component.codeextensibleLOINCCodes (a valid code from LOINC)
Observation.component.dataAbsentReasonextensibleDataAbsentReason
Observation.component.interpretationextensibleObservationInterpretationCodes

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf 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-4errorObservationIf 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-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf 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:

Maturity: 2

Differential View

This structure is derived from Observation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 0..*ObservationDe-Identified UDS Plus Clinical Result Observation
... id S0..1idThe de-identified Observation identifier created by the health center to send data to UDS+ Data Receiver
... text 0..0
... contained 0..0
... category S1..*CodeableConceptClassification of type of observation
Binding: US Core Clinical Result Observation Category (extensible): The set of codes indicating the category of the observation


... code S1..1CodeableConceptType of observation (code / type)
Binding: LOINCCodes (extensible): The set of codes indicating the Observations

... subject S1..1Reference(De-Identified UDS Plus Patient)Who and/or what the observation is about
.... display 0..0
... encounter S0..1Reference(De-Identified UDS Plus Encounter)Healthcare event during which this observation is made
.... display 0..0
... effective[x] S0..1dateTime, Period, Timing, instantClinically relevant time/time-period for observation
... issued S0..1instantDate/Time this version was made available
... performer S0..*Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)Who is responsible for the observation
... value[x] S0..1Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, PeriodActual result
... bodySite S0..1CodeableConceptObserved body part
... component S0..*BackboneElementComponent results
.... code S1..1CodeableConceptType of component observation (code / type)
Binding: LOINCCodes (extensible): The set of codes indicating the Observations

.... value[x] S0..1Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, PeriodActual component result

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
Observation.categoryextensibleUSCoreClinicalResultObservationCategory
Observation.codeextensibleLOINCCodes (a valid code from LOINC)
Observation.component.codeextensibleLOINCCodes (a valid code from LOINC)

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*ObservationDe-Identified UDS Plus Clinical Result Observation
... id SΣ0..1idThe de-identified Observation identifier created by the health center to send data to UDS+ Data Receiver
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... category S1..*CodeableConceptClassification of type of observation
Binding: US Core Clinical Result Observation Category (extensible): The set of codes indicating the category of the observation


... code SΣ1..1CodeableConceptType of observation (code / type)
Binding: LOINCCodes (extensible): The set of codes indicating the Observations

... subject SΣ1..1Reference(De-Identified UDS Plus Patient)Who and/or what the observation is about
... encounter SΣ0..1Reference(De-Identified UDS Plus Encounter)Healthcare event during which this observation is made
... effective[x] SΣ0..1Clinically relevant time/time-period for observation
.... effectiveDateTimedateTime
.... effectivePeriodPeriod
.... effectiveTimingTiming
.... effectiveInstantinstant
... issued SΣ0..1instantDate/Time this version was made available
... performer SΣ0..*Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)Who is responsible for the observation
... value[x] SΣC0..1Actual result
.... valueQuantityQuantity
.... valueCodeableConceptCodeableConcept
.... valueStringstring
.... valueBooleanboolean
.... valueIntegerinteger
.... valueRangeRange
.... valueRatioRatio
.... valueSampledDataSampledData
.... valueTimetime
.... valueDateTimedateTime
.... valuePeriodPeriod
... bodySite S0..1CodeableConceptObserved body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.

... component SΣ0..*BackboneElementComponent results
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code SΣ1..1CodeableConceptType of component observation (code / type)
Binding: LOINCCodes (extensible): The set of codes indicating the Observations

.... value[x] SΣ0..1Actual component result
..... valueQuantityQuantity
..... valueCodeableConceptCodeableConcept
..... valueStringstring
..... valueBooleanboolean
..... valueIntegerinteger
..... valueRangeRange
..... valueRatioRatio
..... valueSampledDataSampledData
..... valueTimetime
..... valueDateTimedateTime
..... valuePeriodPeriod

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Observation.statusrequiredObservationStatus
Observation.categoryextensibleUSCoreClinicalResultObservationCategory
Observation.codeextensibleLOINCCodes (a valid code from LOINC)
Observation.bodySiteexampleSNOMEDCTBodyStructures
Observation.component.codeextensibleLOINCCodes (a valid code from LOINC)

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf 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-4errorObservationIf 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-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf 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

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*ObservationDe-Identified UDS Plus Clinical Result Observation
... id SΣ0..1idThe de-identified Observation identifier created by the health center to send data to UDS+ Data Receiver
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierBusiness Identifier for observation
... basedOn Σ0..*Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)Fulfills plan, proposal or order
... partOf Σ0..*Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)Part of referenced event
... status ?!SΣ1..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... category S1..*CodeableConceptClassification of type of observation
Binding: US Core Clinical Result Observation Category (extensible): The set of codes indicating the category of the observation


... code SΣ1..1CodeableConceptType of observation (code / type)
Binding: LOINCCodes (extensible): The set of codes indicating the Observations

... subject SΣ1..1Reference(De-Identified UDS Plus Patient)Who and/or what the observation is about
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... reference ΣC0..1stringLiteral reference, Relative, internal or absolute URL
.... type Σ0..1uriType the reference refers to (e.g. "Patient")
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier Σ0..1IdentifierLogical reference, when literal reference is not known
... focus Σ0..*Reference(Resource)What the observation is about, when it is not about the subject of record
... encounter SΣ0..1Reference(De-Identified UDS Plus Encounter)Healthcare event during which this observation is made
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... reference ΣC0..1stringLiteral reference, Relative, internal or absolute URL
.... type Σ0..1uriType the reference refers to (e.g. "Patient")
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier Σ0..1IdentifierLogical reference, when literal reference is not known
... effective[x] SΣ0..1Clinically relevant time/time-period for observation
.... effectiveDateTimedateTime
.... effectivePeriodPeriod
.... effectiveTimingTiming
.... effectiveInstantinstant
... issued SΣ0..1instantDate/Time this version was made available
... performer SΣ0..*Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)Who is responsible for the observation
... value[x] SΣC0..1Actual result
.... valueQuantityQuantity
.... valueCodeableConceptCodeableConcept
.... valueStringstring
.... valueBooleanboolean
.... valueIntegerinteger
.... valueRangeRange
.... valueRatioRatio
.... valueSampledDataSampledData
.... valueTimetime
.... valueDateTimedateTime
.... valuePeriodPeriod
... dataAbsentReason C0..1CodeableConceptWhy the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... interpretation 0..*CodeableConceptHigh, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


... note 0..*AnnotationComments about the observation
... bodySite S0..1CodeableConceptObserved body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.

... method 0..1CodeableConceptHow it was done
Binding: ObservationMethods (example): Methods for simple observations.

... specimen 0..1Reference(Specimen)Specimen used for this observation
... device 0..1Reference(Device | DeviceMetric)(Measurement) Device
... referenceRange C0..*BackboneElementProvides guide for interpretation
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... low C0..1SimpleQuantityLow Range, if relevant
.... high C0..1SimpleQuantityHigh Range, if relevant
.... type 0..1CodeableConceptReference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.

.... appliesTo 0..*CodeableConceptReference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.


.... age 0..1RangeApplicable age range, if relevant
.... text 0..1stringText based reference range in an observation
... hasMember Σ0..*Reference(Observation | QuestionnaireResponse | MolecularSequence)Related resource that belongs to the Observation group
... derivedFrom Σ0..*Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)Related measurements the observation is made from
... component SΣ0..*BackboneElementComponent results
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code SΣ1..1CodeableConceptType of component observation (code / type)
Binding: LOINCCodes (extensible): The set of codes indicating the Observations

.... value[x] SΣ0..1Actual component result
..... valueQuantityQuantity
..... valueCodeableConceptCodeableConcept
..... valueStringstring
..... valueBooleanboolean
..... valueIntegerinteger
..... valueRangeRange
..... valueRatioRatio
..... valueSampledDataSampledData
..... valueTimetime
..... valueDateTimedateTime
..... valuePeriodPeriod
.... dataAbsentReason C0..1CodeableConceptWhy the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

.... interpretation 0..*CodeableConceptHigh, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


.... referenceRange 0..*See referenceRange (Observation)Provides guide for interpretation of component result

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Observation.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
Observation.statusrequiredObservationStatus
Observation.categoryextensibleUSCoreClinicalResultObservationCategory
Observation.codeextensibleLOINCCodes (a valid code from LOINC)
Observation.subject.typeextensibleResourceType
Observation.encounter.typeextensibleResourceType
Observation.dataAbsentReasonextensibleDataAbsentReason
Observation.interpretationextensibleObservationInterpretationCodes
Observation.bodySiteexampleSNOMEDCTBodyStructures
Observation.methodexampleObservationMethods
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
Observation.component.codeextensibleLOINCCodes (a valid code from LOINC)
Observation.component.dataAbsentReasonextensibleDataAbsentReason
Observation.component.interpretationextensibleObservationInterpretationCodes

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf 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-4errorObservationIf 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-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf 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:

Maturity: 2

 

Other representations of profile: CSV, Excel, Schematron