US Core Implementation Guide
6.0.0 - STU6 United States of America flag

This page is part of the US Core (v6.0.0: STU6) based on FHIR 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: US Core Observation Screening Assessment Profile

Official URL: http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-screening-assessment Version: 6.0.0
Active as of 2022-04-20 Computable Name: USCoreObservationScreeningAssessmentProfile

Copyright/Legal: Used by permission of HL7 International, all rights reserved Creative Commons License

The US Core Observation Screening Assessment Profile meets the requirements of the US Core Data for Interoperability (USCDI) Assessments. To promote interoperability and adoption through common implementation, it sets the minimum expectations for the Observation Resource to record, search, and fetch observations representing the questions and responses to surveys and screening and assessment tools. For example, a social history status such as education or food insecurity or an assessment of the patient’s cognitive, functional, or disability status. It can represent a single response, multiple responses, and multi-select “check all that apply” type questions. It identifies which core elements, extensions, vocabularies, and value sets SHALL be present in the resource and constrains the way the elements are used when using this profile. It provides the floor for standards development for specific use cases.

Example Usage Scenarios:

The following are example usage scenarios for this profile:

  • Query for screening or assessment results for a patient.
  • Record or update screening and assessment results belonging to a Patient

Mandatory and Must Support Data Elements

The following data elements must always be present (Mandatory definition) or must be supported if the data is present in the sending system (Must Support definition). They are presented below in a simple human-readable explanation. Profile-specific guidance and examples are provided as well. The Formal Views below provides the formal summary, definitions, and terminology requirements.

  1. a status
  2. a category code of “survey”
  3. a LOINC code, if available, which tells you the survey question
  4. a patient

Each Observation Must Support:

  1. additional categories that further specify the assessment or screening
  2. a time indicating when the survey was taken
  3. the answer or a reason why the data is absent*
    • if the result value is a numeric quantity and coded quantity units are used, UCUM is required.
  4. who answered the questions
  5. related questionnaire responses or observations that this observation is made from
  6. reference to observations that make up this observation**

* ** see guidance below

Profile Specific Implementation Guidance:

  • **See the Screening and Assessments guidance page for how this profile represents surveys, screenings, and assessments.
    • Each response to individual questions and each answer to a multi-select or “check all that apply” question is a separate US Core Screening and Assessments Observation. The question is communicated in Observation.code, and the answer is in Observation.value.
    • Multi-question screenings and assessments use the US Core Screening and Assessments Observation to represent a “panel” or grouping. The multi-question surveys or assessments Observation.code is an overarching assessment or screening code, and the Observation.value elementSHOULD be empty. Observation.hasMember references US Core Screening and Assessments Observations that represent the responses to each question in the screening or assessment.
  • A practitioner’s clinical observation or assertion about a patient’s health status, which is not a response to a screening or assessment question,SHOULD use the US Core Simple Observation Profile instead.
  • The category type ‘survey’ is required, and a set of categories that represent the USCDI data elements and further specify the assessment must be supported. Because of technical requirements, a value set with a Required Binding is needed for USCDI categories. However, other categories are permitted. The Observation.category element provides an efficient way of restricting search on observations to a given context such as survey observations. Example searches are shown in the Quick Start section below. However, clients need to understand that data categorization is somewhat subjective. The categorization applied by the source may not align with the client’s expectations. Clients may find it more useful to use queries based on a specific code or set of codes or to perform additional client side filtering of query results.
  • *An Observation without a value, SHALL include a reason why the data is absent unless there are 1) component observations, or 2) reporting panel observations using Observation.hasMember.
    • For further guidance see the Observation Grouping section in FHIR Specification.
    • Systems that never provide an observation without a value are not required to support Observation.dataAbsentReason.
  • *An Observation.component without a value, SHALL include a reason why the data is absent.
    • Systems that never provide a component observation without a component value are not required to support Observation.component.dataAbsentReason.
  • Although both Reference(US Core Observation Profile) or Reference(US Core QuestionnaireResponse Profile) are marked as MustSupport for Observation.derivedFrom, the server system are not required to support both, but SHALL support at least one.

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 C0..*ObservationSurvey Observation
us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
us-core-3: SHALL use UCUM for coded quantity units.
... status S1..1code(USCDI) registered | preliminary | final | amended +
... Slices for category S1..*CodeableConcept(USCDI) Classification of type of observation
Slice: Unordered, Open by pattern:$this
.... category:survey S1..1CodeableConcept(USCDI) Classification of type of observation
Required Pattern: At least the following
..... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
...... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... code1..1codeSymbol in syntax defined by the system
Fixed Value: survey
.... category:screening-assessment S0..*CodeableConcept(USCDI) Classification of type of observation
Binding: US Core Screening Assessment Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets

... code S1..1CodeableConcept(USCDI) Type of observation (code / type)
Binding: US Core Survey Codes (preferred)
... subject S1..1Reference(US Core Patient Profile)(USCDI) Who and/or what the observation is about
... effective[x] SC0..1(USCDI) Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTimedateTime S
.... effectivePeriodPeriod
.... effectiveTimingTiming
.... effectiveInstantinstant
... performer S0..*Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile)(USCDI) Who is responsible for the observation
... value[x] SC0..1(USCDI) Actual result
.... valueQuantityQuantity S
.... valueCodeableConceptCodeableConcept S
.... valueStringstring S
.... valueBooleanboolean
.... valueIntegerinteger
.... valueRangeRange
.... valueRatioRatio
.... valueSampledDataSampledData
.... valueTimetime
.... valueDateTimedateTime
.... valuePeriodPeriod
... dataAbsentReason SC0..1CodeableConcept(USCDI) Why the result is missing
... hasMember S0..*Reference(US Core Observation Screening Assessment Profile S | QuestionnaireResponse | MolecularSequence)(USCDI) Reference to panel members or multi-select responses or multi-select responses
... derivedFrom S0..*Reference(US Core Observation Screening Assessment Profile S | US Core QuestionnaireResponse Profile S | US Core DocumentReference Profile | ImagingStudy | Media | MolecularSequence)(USCDI) Related Observation(s) or other resource the observation is made from

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
Observation.category:screening-assessmentrequiredUSCoreScreeningAssessmentObservationCategory (a valid code from US Core Category)
Observation.codepreferredUSCoreSurveyCodes

Constraints

IdGradePath(s)DetailsRequirements
us-core-1errorObservation.effective[x]Datetime must be at least to day.
: $this is DateTime implies $this.toString().length() >= 10
us-core-2errorObservationIf there is no component or hasMember element then either a value[x] or a data absent reason must be present
: (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists())
us-core-3errorObservationSHALL use UCUM for coded quantity units.
: valueQuantity.system.empty() or valueQuantity.system = 'http://unitsofmeasure.org'
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*ObservationSurvey Observation
us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
us-core-3: SHALL use UCUM for coded quantity units.
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... status ?!SΣ1..1code(USCDI) registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... Slices for category S1..*CodeableConcept(USCDI) Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


.... category:survey S1..1CodeableConcept(USCDI) Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.



Required Pattern: At least the following
..... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
...... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... code1..1codeSymbol in syntax defined by the system
Fixed Value: survey
.... category:screening-assessment S0..*CodeableConcept(USCDI) Classification of type of observation
Binding: US Core Screening Assessment Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets


... code SΣ1..1CodeableConcept(USCDI) Type of observation (code / type)
Binding: US Core Survey Codes (preferred)
... subject SΣ1..1Reference(US Core Patient Profile)(USCDI) Who and/or what the observation is about
... effective[x] SΣC0..1(USCDI) Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTimedateTime
... performer SΣ0..*Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile)(USCDI) Who is responsible for the observation
... value[x] SΣC0..1(USCDI) Actual result
.... valueQuantityQuantity
.... valueCodeableConceptCodeableConcept
.... valueStringstring
... dataAbsentReason SC0..1CodeableConcept(USCDI) Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... hasMember SΣ0..*Reference(US Core Observation Screening Assessment Profile)(USCDI) Reference to panel members or multi-select responses or multi-select responses
... derivedFrom SΣ0..*Reference(US Core Observation Screening Assessment Profile | US Core QuestionnaireResponse Profile)(USCDI) Related Observation(s) or other resource the observation is made from

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Observation.statusrequiredObservationStatus
Observation.categorypreferredObservationCategoryCodes
Observation.category:surveypreferredPattern: survey
Observation.category:screening-assessmentrequiredUSCoreScreeningAssessmentObservationCategory (a valid code from US Core Category)
Observation.codepreferredUSCoreSurveyCodes
Observation.dataAbsentReasonextensibleDataAbsentReason

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()
us-core-1errorObservation.effective[x]Datetime must be at least to day.
: $this is DateTime implies $this.toString().length() >= 10
us-core-2errorObservationIf there is no component or hasMember element then either a value[x] or a data absent reason must be present
: (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists())
us-core-3errorObservationSHALL use UCUM for coded quantity units.
: valueQuantity.system.empty() or valueQuantity.system = 'http://unitsofmeasure.org'
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*ObservationSurvey Observation
us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
us-core-3: SHALL use UCUM for coded quantity units.
... id Σ0..1idLogical id of this artifact
... 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
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... 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..1code(USCDI) registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... Slices for category S1..*CodeableConcept(USCDI) Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


.... category:survey S1..1CodeableConcept(USCDI) Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.



Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... version0..1stringVersion of the system - if relevant
...... code1..1codeSymbol in syntax defined by the system
Fixed Value: survey
...... display0..1stringRepresentation defined by the system
...... userSelected0..1booleanIf this coding was chosen directly by the user
..... text0..1stringPlain text representation of the concept
.... category:screening-assessment S0..*CodeableConcept(USCDI) Classification of type of observation
Binding: US Core Screening Assessment Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets


... code SΣ1..1CodeableConcept(USCDI) Type of observation (code / type)
Binding: US Core Survey Codes (preferred)
... subject SΣ1..1Reference(US Core Patient Profile)(USCDI) Who and/or what the observation is about
... focus ΣTU0..*Reference(Resource)What the observation is about, when it is not about the subject of record
... encounter Σ0..1Reference(Encounter)Healthcare event during which this observation is made
... effective[x] SΣC0..1(USCDI) Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTimedateTime S
.... effectivePeriodPeriod
.... effectiveTimingTiming
.... effectiveInstantinstant
... issued Σ0..1instantDate/Time this version was made available
... performer SΣ0..*Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile)(USCDI) Who is responsible for the observation
... value[x] SΣC0..1(USCDI) Actual result
.... valueQuantityQuantity S
.... valueCodeableConceptCodeableConcept S
.... valueStringstring S
.... valueBooleanboolean
.... valueIntegerinteger
.... valueRangeRange
.... valueRatioRatio
.... valueSampledDataSampledData
.... valueTimetime
.... valueDateTimedateTime
.... valuePeriodPeriod
... dataAbsentReason SC0..1CodeableConcept(USCDI) Why 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 0..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 SΣ0..*Reference(US Core Observation Screening Assessment Profile S | QuestionnaireResponse | MolecularSequence)(USCDI) Reference to panel members or multi-select responses or multi-select responses
... derivedFrom SΣ0..*Reference(US Core Observation Screening Assessment Profile S | US Core QuestionnaireResponse Profile S | US Core DocumentReference Profile | ImagingStudy | Media | MolecularSequence)(USCDI) Related Observation(s) or other resource the observation is made from
... component Σ0..*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 Σ1..1CodeableConceptType of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

.... value[x] Σ0..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 / Code
Observation.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
Observation.statusrequiredObservationStatus
Observation.categorypreferredObservationCategoryCodes
Observation.category:surveypreferredPattern: survey
Observation.category:screening-assessmentrequiredUSCoreScreeningAssessmentObservationCategory (a valid code from US Core Category)
Observation.codepreferredUSCoreSurveyCodes
Observation.dataAbsentReasonextensibleDataAbsentReason
Observation.interpretationextensibleObservationInterpretationCodes
Observation.bodySiteexampleSNOMEDCTBodyStructures
Observation.methodexampleObservationMethods
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
Observation.component.dataAbsentReasonextensibleDataAbsentReason
Observation.component.interpretationextensibleObservationInterpretationCodes

Constraints

IdGradePath(s)DetailsRequirements
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()
us-core-1errorObservation.effective[x]Datetime must be at least to day.
: $this is DateTime implies $this.toString().length() >= 10

Differential View

This structure is derived from Observation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*ObservationSurvey Observation
us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
us-core-3: SHALL use UCUM for coded quantity units.
... status S1..1code(USCDI) registered | preliminary | final | amended +
... Slices for category S1..*CodeableConcept(USCDI) Classification of type of observation
Slice: Unordered, Open by pattern:$this
.... category:survey S1..1CodeableConcept(USCDI) Classification of type of observation
Required Pattern: At least the following
..... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
...... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... code1..1codeSymbol in syntax defined by the system
Fixed Value: survey
.... category:screening-assessment S0..*CodeableConcept(USCDI) Classification of type of observation
Binding: US Core Screening Assessment Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets

... code S1..1CodeableConcept(USCDI) Type of observation (code / type)
Binding: US Core Survey Codes (preferred)
... subject S1..1Reference(US Core Patient Profile)(USCDI) Who and/or what the observation is about
... effective[x] SC0..1(USCDI) Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTimedateTime S
.... effectivePeriodPeriod
.... effectiveTimingTiming
.... effectiveInstantinstant
... performer S0..*Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile)(USCDI) Who is responsible for the observation
... value[x] SC0..1(USCDI) Actual result
.... valueQuantityQuantity S
.... valueCodeableConceptCodeableConcept S
.... valueStringstring S
.... valueBooleanboolean
.... valueIntegerinteger
.... valueRangeRange
.... valueRatioRatio
.... valueSampledDataSampledData
.... valueTimetime
.... valueDateTimedateTime
.... valuePeriodPeriod
... dataAbsentReason SC0..1CodeableConcept(USCDI) Why the result is missing
... hasMember S0..*Reference(US Core Observation Screening Assessment Profile S | QuestionnaireResponse | MolecularSequence)(USCDI) Reference to panel members or multi-select responses or multi-select responses
... derivedFrom S0..*Reference(US Core Observation Screening Assessment Profile S | US Core QuestionnaireResponse Profile S | US Core DocumentReference Profile | ImagingStudy | Media | MolecularSequence)(USCDI) Related Observation(s) or other resource the observation is made from

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
Observation.category:screening-assessmentrequiredUSCoreScreeningAssessmentObservationCategory (a valid code from US Core Category)
Observation.codepreferredUSCoreSurveyCodes

Constraints

IdGradePath(s)DetailsRequirements
us-core-1errorObservation.effective[x]Datetime must be at least to day.
: $this is DateTime implies $this.toString().length() >= 10
us-core-2errorObservationIf there is no component or hasMember element then either a value[x] or a data absent reason must be present
: (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists())
us-core-3errorObservationSHALL use UCUM for coded quantity units.
: valueQuantity.system.empty() or valueQuantity.system = 'http://unitsofmeasure.org'

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*ObservationSurvey Observation
us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
us-core-3: SHALL use UCUM for coded quantity units.
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... status ?!SΣ1..1code(USCDI) registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... Slices for category S1..*CodeableConcept(USCDI) Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


.... category:survey S1..1CodeableConcept(USCDI) Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.



Required Pattern: At least the following
..... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
...... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... code1..1codeSymbol in syntax defined by the system
Fixed Value: survey
.... category:screening-assessment S0..*CodeableConcept(USCDI) Classification of type of observation
Binding: US Core Screening Assessment Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets


... code SΣ1..1CodeableConcept(USCDI) Type of observation (code / type)
Binding: US Core Survey Codes (preferred)
... subject SΣ1..1Reference(US Core Patient Profile)(USCDI) Who and/or what the observation is about
... effective[x] SΣC0..1(USCDI) Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTimedateTime
... performer SΣ0..*Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile)(USCDI) Who is responsible for the observation
... value[x] SΣC0..1(USCDI) Actual result
.... valueQuantityQuantity
.... valueCodeableConceptCodeableConcept
.... valueStringstring
... dataAbsentReason SC0..1CodeableConcept(USCDI) Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... hasMember SΣ0..*Reference(US Core Observation Screening Assessment Profile)(USCDI) Reference to panel members or multi-select responses or multi-select responses
... derivedFrom SΣ0..*Reference(US Core Observation Screening Assessment Profile | US Core QuestionnaireResponse Profile)(USCDI) Related Observation(s) or other resource the observation is made from

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Observation.statusrequiredObservationStatus
Observation.categorypreferredObservationCategoryCodes
Observation.category:surveypreferredPattern: survey
Observation.category:screening-assessmentrequiredUSCoreScreeningAssessmentObservationCategory (a valid code from US Core Category)
Observation.codepreferredUSCoreSurveyCodes
Observation.dataAbsentReasonextensibleDataAbsentReason

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()
us-core-1errorObservation.effective[x]Datetime must be at least to day.
: $this is DateTime implies $this.toString().length() >= 10
us-core-2errorObservationIf there is no component or hasMember element then either a value[x] or a data absent reason must be present
: (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists())
us-core-3errorObservationSHALL use UCUM for coded quantity units.
: valueQuantity.system.empty() or valueQuantity.system = 'http://unitsofmeasure.org'

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*ObservationSurvey Observation
us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
us-core-3: SHALL use UCUM for coded quantity units.
... id Σ0..1idLogical id of this artifact
... 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
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... 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..1code(USCDI) registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... Slices for category S1..*CodeableConcept(USCDI) Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


.... category:survey S1..1CodeableConcept(USCDI) Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.



Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... version0..1stringVersion of the system - if relevant
...... code1..1codeSymbol in syntax defined by the system
Fixed Value: survey
...... display0..1stringRepresentation defined by the system
...... userSelected0..1booleanIf this coding was chosen directly by the user
..... text0..1stringPlain text representation of the concept
.... category:screening-assessment S0..*CodeableConcept(USCDI) Classification of type of observation
Binding: US Core Screening Assessment Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets


... code SΣ1..1CodeableConcept(USCDI) Type of observation (code / type)
Binding: US Core Survey Codes (preferred)
... subject SΣ1..1Reference(US Core Patient Profile)(USCDI) Who and/or what the observation is about
... focus ΣTU0..*Reference(Resource)What the observation is about, when it is not about the subject of record
... encounter Σ0..1Reference(Encounter)Healthcare event during which this observation is made
... effective[x] SΣC0..1(USCDI) Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTimedateTime S
.... effectivePeriodPeriod
.... effectiveTimingTiming
.... effectiveInstantinstant
... issued Σ0..1instantDate/Time this version was made available
... performer SΣ0..*Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile)(USCDI) Who is responsible for the observation
... value[x] SΣC0..1(USCDI) Actual result
.... valueQuantityQuantity S
.... valueCodeableConceptCodeableConcept S
.... valueStringstring S
.... valueBooleanboolean
.... valueIntegerinteger
.... valueRangeRange
.... valueRatioRatio
.... valueSampledDataSampledData
.... valueTimetime
.... valueDateTimedateTime
.... valuePeriodPeriod
... dataAbsentReason SC0..1CodeableConcept(USCDI) Why 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 0..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 SΣ0..*Reference(US Core Observation Screening Assessment Profile S | QuestionnaireResponse | MolecularSequence)(USCDI) Reference to panel members or multi-select responses or multi-select responses
... derivedFrom SΣ0..*Reference(US Core Observation Screening Assessment Profile S | US Core QuestionnaireResponse Profile S | US Core DocumentReference Profile | ImagingStudy | Media | MolecularSequence)(USCDI) Related Observation(s) or other resource the observation is made from
... component Σ0..*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 Σ1..1CodeableConceptType of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

.... value[x] Σ0..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 / Code
Observation.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
Observation.statusrequiredObservationStatus
Observation.categorypreferredObservationCategoryCodes
Observation.category:surveypreferredPattern: survey
Observation.category:screening-assessmentrequiredUSCoreScreeningAssessmentObservationCategory (a valid code from US Core Category)
Observation.codepreferredUSCoreSurveyCodes
Observation.dataAbsentReasonextensibleDataAbsentReason
Observation.interpretationextensibleObservationInterpretationCodes
Observation.bodySiteexampleSNOMEDCTBodyStructures
Observation.methodexampleObservationMethods
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
Observation.component.dataAbsentReasonextensibleDataAbsentReason
Observation.component.interpretationextensibleObservationInterpretationCodes

Constraints

IdGradePath(s)DetailsRequirements
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()
us-core-1errorObservation.effective[x]Datetime must be at least to day.
: $this is DateTime implies $this.toString().length() >= 10

 

Other representations of profile: CSV, Excel, Schematron

Notes:

Quick Start

Below is an overview of the required Server RESTful FHIR interactions for this profile - for example, search and read operations - when supporting the US Core interactions to access this profile’s information (Profile Support + Interaction Support). Note that systems that support only US Core Profiles (Profile Only Support) are not required to support these interactions. See the US Core Server CapabilityStatement for a complete list of supported RESTful interactions for this IG.

  • The syntax used to describe the interactions is described here.

  • Servers providing access to survey data can use US Core SMART Scopes for:
    • resource level scopes (for example, patient/Observation.rs)
    • granular scopes (for example, patient.Observation.rs?category=http://terminology.hl7.org/CodeSystem/observation-category|survey).
  • See the General Requirements section for additional rules and expectations when a server requires status parameters.
  • See the General Guidance section for additional guidance on searching for multiple patients.

Mandatory Search Parameters:

The following search parameters and search parameter combinations SHALL be supported:

  1. SHALL support searching using the combination of the patient and category search parameters:

    GET [base]/Observation?patient={Type/}[id]&category={system|}survey

    Example:

    1. GET [base]/Observation?patient=1134281&category=survey

    Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and a category code = survey (how to search by reference and how to search by token)

  2. SHALL support searching using the combination of the patient and code search parameters:
    • including optional support for OR search on code (e.g.code={system|}[code],{system|}[code],...)

    GET [base]/Observation?patient={Type/}[id]&code={system|}[code]{,{system|}[code],...}

    Example:

    1. GET [base]/Observation?patient=1134281&code=http://loinc.org|9271-8
    2. GET [base]/Observation?patient=1134281&code=http://loinc.org|9271-8,http://loinc.org|32405-3,http://loinc.org|32403-8

    Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and observation code(s). SHOULD support search by multiple report codes. The Observation code parameter searches `Observation.code only. (how to search by reference and how to search by token)

  3. SHALL support searching using the combination of the patient and category and date search parameters:
    • including support for these date comparators: gt,lt,ge,le
    • including optional support for AND search on date (e.g.date=[date]&date=[date]]&...)

    GET [base]/Observation?patient={Type/}[id]&category={system|}survey&date={gt|lt|ge|le}[date]{&date={gt|lt|ge|le}[date]&...}

    Example:

    1. GET [base]Observation?patient=555580&category=survey&date=ge2018-03-14T00:00:00Z

    Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and date and a category code = survey (how to search by reference and how to search by token and how to search by date)

Optional Search Parameters:

The following search parameter combinations SHOULD be supported:

  1. SHOULD support searching using the combination of the patient and category and status search parameters:
    • including support for OR search on status (e.g.status={system|}[code],{system|}[code],...)

    GET [base]/Observation?patient={Type/}[id]&category={system|}survey&status={system|}[code]{,{system|}[code],...}

    Example:

    1. GET [base]/Observation?patient=1134281&category=survey&status=final

    Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and category = survey and status (how to search by reference and how to search by token)

  2. SHOULD support searching using the combination of the patient and code and date search parameters:
    • including optional support for OR search on code (e.g.code={system|}[code],{system|}[code],...)
    • including support for these date comparators: gt,lt,ge,le
    • including optional support for AND search on date (e.g.date=[date]&date=[date]]&...)

    GET [base]/Observation?patient={Type/}[id]&code={system|}[code]{,{system|}[code],...}&date={gt|lt|ge|le}[date]{&date={gt|lt|ge|le}[date]&...}

    Example:

    1. GET [base]Observation?patient=555580&code=http://loinc.org|9271-8&date=ge2019-01-01T00:00:00Z

    Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and date and report code(s). SHOULD support search by multiple report codes. (how to search by reference and how to search by token and how to search by date)