US Core Implementation Guide
7.0.0 - STU7 United States of America flag

US Core Implementation Guide, published by HL7 International / Cross-Group Projects. This guide is not an authorized publication; it is the continuous build for version 7.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/US-Core/ and changes regularly. 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: 7.0.0
Standards status: Trial-use Maturity Level: 3 Computable Name: USCoreObservationScreeningAssessmentProfile
Other Identifiers: OID:2.16.840.1.113883.4.642.40.2.42.41

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

The US Core Observation Screening Assessment Profile inherits from the FHIR Observation resource; refer to it for scope and usage definitions. This profile meets the requirements of the U.S. Core Data for Interoperability (USCDI) Health Status Assessments Data Class. 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 cognitive, functional, or disability status. It can represent a single response, multiple responses, and multi-select “check all that apply” type questions. This profile specifies which core elements, extensions, vocabularies, and value sets SHALL be present in the resource and constrains how the elements are used. Providing the floor for standards development for specific use cases promotes interoperability and adoption. Before reviewing this profile, implementers are encouraged to read the Screening and Assessments guidance page, which documents the process of recording responses and capturing assertions/determinations resulting from surveys and questionnaires.

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 element SHOULD 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 is 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 C 0..* Observation Survey 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
... status S 1..1 code registered | preliminary | final | amended +
... Slices for category S 1..* CodeableConcept Classification of type of observation
Slice: Unordered, Open by pattern:$this
.... category:survey S 1..1 CodeableConcept Classification of type of observation
Required Pattern: At least the following
..... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: survey
.... category:screening-assessment S 0..* CodeableConcept 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 S 1..1 CodeableConcept Type of observation (code / type)
Binding: US Core Survey Codes (preferred)
... subject S 1..1 Reference(US Core Patient Profile S | Group | Device | US Core Location Profile) Who and/or what the observation is about
... effective[x] SC 0..1 Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTime dateTime S
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... performer S 0..* Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) Who is responsible for the observation
... value[x] SC 0..1 Actual result
us-core-3: SHALL use UCUM for coded quantity units.
.... valueQuantity Quantity S
.... valueCodeableConcept CodeableConcept S
.... valueString string S
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
... dataAbsentReason SC 0..1 CodeableConcept Why the result is missing
... hasMember S 0..* Reference(US Core Observation Screening Assessment Profile S | QuestionnaireResponse | MolecularSequence) Reference to panel members or multi-select responses or multi-select responses
... derivedFrom S 0..* Reference(US Core Observation Screening Assessment Profile S | US Core QuestionnaireResponse Profile S | US Core DocumentReference Profile | ImagingStudy | Media | MolecularSequence) 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Related Observation(s) or other resource the observation is made from

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Observation.category:screening-assessmentrequiredUSCoreScreeningAssessmentObservationCategory (a valid code from US Core Category)
http://hl7.org/fhir/us/core/ValueSet/us-core-screening-assessment-observation-category
from this IG
Observation.codepreferredUSCoreSurveyCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-survey-codes
from this IG

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-3errorObservation.value[x]SHALL use UCUM for coded quantity units.
: ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* Observation Survey Observation
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... status ?!SΣ 1..1 code registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... Slices for category S 1..* CodeableConcept Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


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



Required Pattern: At least the following
..... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: survey
.... category:screening-assessment S 0..* CodeableConcept 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 SΣ 1..1 CodeableConcept Type of observation (code / type)
Binding: US Core Survey Codes (preferred)
... subject SΣ 1..1 Reference(US Core Patient Profile) Who and/or what the observation is about
... effective[x] SΣC 0..1 Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTime dateTime
... performer SΣ 0..* Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) Who is responsible for the observation
... value[x] SΣC 0..1 Actual result
us-core-3: SHALL use UCUM for coded quantity units.
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
... dataAbsentReason SC 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... hasMember SΣ 0..* Reference(US Core Observation Screening Assessment Profile) Reference to panel members or multi-select responses or multi-select responses
... derivedFrom SΣ 0..* Reference(US Core Observation Screening Assessment Profile | US Core QuestionnaireResponse Profile) 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Related Observation(s) or other resource the observation is made from

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Observation.statusrequiredObservationStatus
http://hl7.org/fhir/ValueSet/observation-status|4.0.1
from the FHIR Standard
Observation.categorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:surveypreferredPattern: survey
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:screening-assessmentrequiredUSCoreScreeningAssessmentObservationCategory (a valid code from US Core Category)
http://hl7.org/fhir/us/core/ValueSet/us-core-screening-assessment-observation-category
from this IG
Observation.codepreferredUSCoreSurveyCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-survey-codes
from this IG
Observation.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard

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-3errorObservation.value[x]SHALL use UCUM for coded quantity units.
: ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* Observation Survey Observation
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business Identifier for observation
... basedOn Σ 0..* Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Fulfills plan, proposal or order
... partOf Σ 0..* Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) Part of referenced event
... status ?!SΣ 1..1 code registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... Slices for category S 1..* CodeableConcept Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


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



Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: survey
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
..... text 0..1 string Plain text representation of the concept
.... category:screening-assessment S 0..* CodeableConcept 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 SΣ 1..1 CodeableConcept Type of observation (code / type)
Binding: US Core Survey Codes (preferred)
... subject SΣ 1..1 Reference(US Core Patient Profile S | Group | Device | US Core Location Profile) Who and/or what the observation is about
... focus Σ 0..* Reference(Resource) What the observation is about, when it is not about the subject of record
... encounter Σ 0..1 Reference(Encounter) Healthcare event during which this observation is made
... effective[x] SΣC 0..1 Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTime dateTime S
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... issued Σ 0..1 instant Date/Time this version was made available
... performer SΣ 0..* Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) Who is responsible for the observation
... value[x] SΣC 0..1 Actual result
us-core-3: SHALL use UCUM for coded quantity units.
.... valueQuantity Quantity S
.... valueCodeableConcept CodeableConcept S
.... valueString string S
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
... dataAbsentReason SC 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

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


... note 0..* Annotation Comments about the observation
... bodySite 0..1 CodeableConcept Observed body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.

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

... specimen 0..1 Reference(Specimen) Specimen used for this observation
... device 0..1 Reference(Device | DeviceMetric) (Measurement) Device
... referenceRange C 0..* BackboneElement Provides guide for interpretation
obs-3: Must have at least a low or a high or text
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... low C 0..1 SimpleQuantity Low Range, if relevant
.... high C 0..1 SimpleQuantity High Range, if relevant
.... type 0..1 CodeableConcept Reference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.

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


.... age 0..1 Range Applicable age range, if relevant
.... text 0..1 string Text based reference range in an observation
... hasMember SΣ 0..* Reference(US Core Observation Screening Assessment Profile S | QuestionnaireResponse | MolecularSequence) Reference to panel members or multi-select responses or multi-select responses
... derivedFrom SΣ 0..* Reference(US Core Observation Screening Assessment Profile S | US Core QuestionnaireResponse Profile S | US Core DocumentReference Profile | ImagingStudy | Media | MolecularSequence) 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Related Observation(s) or other resource the observation is made from
... component Σ 0..* BackboneElement Component results
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

.... value[x] Σ 0..1 Actual component result
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueRatio Ratio
..... valueSampledData SampledData
..... valueTime time
..... valueDateTime dateTime
..... valuePeriod Period
.... dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

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


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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Observation.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
Observation.statusrequiredObservationStatus
http://hl7.org/fhir/ValueSet/observation-status|4.0.1
from the FHIR Standard
Observation.categorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:surveypreferredPattern: survey
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:screening-assessmentrequiredUSCoreScreeningAssessmentObservationCategory (a valid code from US Core Category)
http://hl7.org/fhir/us/core/ValueSet/us-core-screening-assessment-observation-category
from this IG
Observation.codepreferredUSCoreSurveyCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-survey-codes
from this IG
Observation.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard
Observation.bodySiteexampleSNOMEDCTBodyStructures
http://hl7.org/fhir/ValueSet/body-site
from the FHIR Standard
Observation.methodexampleObservationMethods
http://hl7.org/fhir/ValueSet/observation-methods
from the FHIR Standard
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
http://hl7.org/fhir/ValueSet/referencerange-meaning
from the FHIR Standard
Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
http://hl7.org/fhir/ValueSet/referencerange-appliesto
from the FHIR Standard
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.component.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard

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-3errorObservation.value[x]SHALL use UCUM for coded quantity units.
: ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'

Differential View

This structure is derived from Observation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* Observation Survey 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
... status S 1..1 code registered | preliminary | final | amended +
... Slices for category S 1..* CodeableConcept Classification of type of observation
Slice: Unordered, Open by pattern:$this
.... category:survey S 1..1 CodeableConcept Classification of type of observation
Required Pattern: At least the following
..... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: survey
.... category:screening-assessment S 0..* CodeableConcept 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 S 1..1 CodeableConcept Type of observation (code / type)
Binding: US Core Survey Codes (preferred)
... subject S 1..1 Reference(US Core Patient Profile S | Group | Device | US Core Location Profile) Who and/or what the observation is about
... effective[x] SC 0..1 Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTime dateTime S
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... performer S 0..* Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) Who is responsible for the observation
... value[x] SC 0..1 Actual result
us-core-3: SHALL use UCUM for coded quantity units.
.... valueQuantity Quantity S
.... valueCodeableConcept CodeableConcept S
.... valueString string S
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
... dataAbsentReason SC 0..1 CodeableConcept Why the result is missing
... hasMember S 0..* Reference(US Core Observation Screening Assessment Profile S | QuestionnaireResponse | MolecularSequence) Reference to panel members or multi-select responses or multi-select responses
... derivedFrom S 0..* Reference(US Core Observation Screening Assessment Profile S | US Core QuestionnaireResponse Profile S | US Core DocumentReference Profile | ImagingStudy | Media | MolecularSequence) 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Related Observation(s) or other resource the observation is made from

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Observation.category:screening-assessmentrequiredUSCoreScreeningAssessmentObservationCategory (a valid code from US Core Category)
http://hl7.org/fhir/us/core/ValueSet/us-core-screening-assessment-observation-category
from this IG
Observation.codepreferredUSCoreSurveyCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-survey-codes
from this IG

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-3errorObservation.value[x]SHALL use UCUM for coded quantity units.
: ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* Observation Survey Observation
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... status ?!SΣ 1..1 code registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... Slices for category S 1..* CodeableConcept Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


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



Required Pattern: At least the following
..... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: survey
.... category:screening-assessment S 0..* CodeableConcept 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 SΣ 1..1 CodeableConcept Type of observation (code / type)
Binding: US Core Survey Codes (preferred)
... subject SΣ 1..1 Reference(US Core Patient Profile) Who and/or what the observation is about
... effective[x] SΣC 0..1 Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTime dateTime
... performer SΣ 0..* Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) Who is responsible for the observation
... value[x] SΣC 0..1 Actual result
us-core-3: SHALL use UCUM for coded quantity units.
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
... dataAbsentReason SC 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... hasMember SΣ 0..* Reference(US Core Observation Screening Assessment Profile) Reference to panel members or multi-select responses or multi-select responses
... derivedFrom SΣ 0..* Reference(US Core Observation Screening Assessment Profile | US Core QuestionnaireResponse Profile) 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Related Observation(s) or other resource the observation is made from

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Observation.statusrequiredObservationStatus
http://hl7.org/fhir/ValueSet/observation-status|4.0.1
from the FHIR Standard
Observation.categorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:surveypreferredPattern: survey
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:screening-assessmentrequiredUSCoreScreeningAssessmentObservationCategory (a valid code from US Core Category)
http://hl7.org/fhir/us/core/ValueSet/us-core-screening-assessment-observation-category
from this IG
Observation.codepreferredUSCoreSurveyCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-survey-codes
from this IG
Observation.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard

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-3errorObservation.value[x]SHALL use UCUM for coded quantity units.
: ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* Observation Survey Observation
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business Identifier for observation
... basedOn Σ 0..* Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Fulfills plan, proposal or order
... partOf Σ 0..* Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) Part of referenced event
... status ?!SΣ 1..1 code registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... Slices for category S 1..* CodeableConcept Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


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



Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: survey
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
..... text 0..1 string Plain text representation of the concept
.... category:screening-assessment S 0..* CodeableConcept 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 SΣ 1..1 CodeableConcept Type of observation (code / type)
Binding: US Core Survey Codes (preferred)
... subject SΣ 1..1 Reference(US Core Patient Profile S | Group | Device | US Core Location Profile) Who and/or what the observation is about
... focus Σ 0..* Reference(Resource) What the observation is about, when it is not about the subject of record
... encounter Σ 0..1 Reference(Encounter) Healthcare event during which this observation is made
... effective[x] SΣC 0..1 Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTime dateTime S
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... issued Σ 0..1 instant Date/Time this version was made available
... performer SΣ 0..* Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) Who is responsible for the observation
... value[x] SΣC 0..1 Actual result
us-core-3: SHALL use UCUM for coded quantity units.
.... valueQuantity Quantity S
.... valueCodeableConcept CodeableConcept S
.... valueString string S
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
... dataAbsentReason SC 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

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


... note 0..* Annotation Comments about the observation
... bodySite 0..1 CodeableConcept Observed body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.

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

... specimen 0..1 Reference(Specimen) Specimen used for this observation
... device 0..1 Reference(Device | DeviceMetric) (Measurement) Device
... referenceRange C 0..* BackboneElement Provides guide for interpretation
obs-3: Must have at least a low or a high or text
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... low C 0..1 SimpleQuantity Low Range, if relevant
.... high C 0..1 SimpleQuantity High Range, if relevant
.... type 0..1 CodeableConcept Reference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.

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


.... age 0..1 Range Applicable age range, if relevant
.... text 0..1 string Text based reference range in an observation
... hasMember SΣ 0..* Reference(US Core Observation Screening Assessment Profile S | QuestionnaireResponse | MolecularSequence) Reference to panel members or multi-select responses or multi-select responses
... derivedFrom SΣ 0..* Reference(US Core Observation Screening Assessment Profile S | US Core QuestionnaireResponse Profile S | US Core DocumentReference Profile | ImagingStudy | Media | MolecularSequence) 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Related Observation(s) or other resource the observation is made from
... component Σ 0..* BackboneElement Component results
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

.... value[x] Σ 0..1 Actual component result
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueRatio Ratio
..... valueSampledData SampledData
..... valueTime time
..... valueDateTime dateTime
..... valuePeriod Period
.... dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

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


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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Observation.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
Observation.statusrequiredObservationStatus
http://hl7.org/fhir/ValueSet/observation-status|4.0.1
from the FHIR Standard
Observation.categorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:surveypreferredPattern: survey
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:screening-assessmentrequiredUSCoreScreeningAssessmentObservationCategory (a valid code from US Core Category)
http://hl7.org/fhir/us/core/ValueSet/us-core-screening-assessment-observation-category
from this IG
Observation.codepreferredUSCoreSurveyCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-survey-codes
from this IG
Observation.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard
Observation.bodySiteexampleSNOMEDCTBodyStructures
http://hl7.org/fhir/ValueSet/body-site
from the FHIR Standard
Observation.methodexampleObservationMethods
http://hl7.org/fhir/ValueSet/observation-methods
from the FHIR Standard
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
http://hl7.org/fhir/ValueSet/referencerange-meaning
from the FHIR Standard
Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
http://hl7.org/fhir/ValueSet/referencerange-appliesto
from the FHIR Standard
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.component.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard

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-3errorObservation.value[x]SHALL use UCUM for coded quantity units.
: ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'

 

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.

  • See the Scopes Format section for a description of the SMART scopes syntax.
  • See the Search Syntax section for a description of the US Core search syntax.
  • 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.

US Core Scopes

Servers providing access to assessment data SHALL support these US Core SMART Scopes:

  • resource level scopes: <patient|user|system>/Observation.rs

  • granular scopes: <patient|user|system>.Observation.rs?category=http://terminology.hl7.org/CodeSystem/observation-category|survey

  • granular scopes: <patient|user|system>.Observation.rs?category=http://hl7.org/fhir/us/core/CodeSystem/us-core-category|sdoh

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=http://terminology.hl7.org/CodeSystem/observation-category|laboratory

    Example:

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

    Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and a category code = laboratory (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&amp;code=http://loinc.org|9271-8
    2. GET [base]/Observation?patient=1134281&amp;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=http://terminology.hl7.org/CodeSystem/observation-category|laboratory&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 = laboratory (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=http://terminology.hl7.org/CodeSystem/observation-category|laboratory&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 = laboratory and status (how to search by reference and how to search by token)

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

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

    Example:

    1. GET [base]Observation?patient=555580&survey&_lastUpdated=ge2024-01-01T00:00:00Z

    Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and category and _lastUpdated. See the US Core General Guidance page for Searching Using lastUpdated. (how to search by reference and how to search by token and how to search by date)

  3. 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)