IE (Ireland) Core Implementation Guide
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Resource Profile: IE Core Observation Clinical Result Profile

Official URL: http://iehr.ai/fhir/ie/core/StructureDefinition/ie-core-observation-clinical-result Version: 1.0.0-ballot
Standards status: Trial-use Maturity Level: 3 Computable Name: IECoreObservationClinicalResultProfile
Other Identifiers: OID:1.3.6.1.4.1.54392.5.2690.42.38

Copyright/Legal: iEHR.ai, all rights reserved Creative Commons License

The IE Core Observation Clinical Result Profile is based upon the core FHIR Observation Resource and, along with the IE Core DiagnosticReport Profile, meets the IE Core Data for Interoperability (IECDI) requirements for Diagnostic Imaging and Clinical Tests Data Classes. This profile sets minimum expectations for the Observation resource to record and search non-laboratory clinical test results (e.g., radiology and other clinical observations generated from procedures). An example would be when a gastroenterologist reports the size of a polyp observed during a colonoscopy. This profile is the basis for the IE Core Laboratory Result Observation Profile, which defines additional data elements to record and search laboratory test results.

The IE Core Observation Clinical Result Profile sets minimum expectations to promote interoperability and adoption through common implementation. 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 clinical tests or diagnostic imaging results for a patient.
  • Record or update clinical tests or diagnostic imaging 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.

Each Observation Must Have:

  1. a status
  2. a category code
  3. a LOINC code, if available, which tells you what is being measured
  4. a patient

Each Observation Must Support:

  1. encounter associated with Observation
  2. a time indicating when the measurement was taken
  3. a result value
    • if the result value is a numeric quantity, a standard UCUM unit
  4. a reason why the data is absent*

* see guidance below

Profile Specific Implementation Guidance:

  • Servers SHOULD use the base FHIR Observation Category Codes. The Observation.category element provides an efficient way of restricting search on observations to a given context such as procedure, exam or laboratory 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.
  • Additional codes that translate or map to the Observation code or category codes are allowed. For example:
    • providing both a local code and a LOINC code
    • providing a more specific code, a SNOMED CT concept, or a system-specific code
  • Systems SHOULD support Observation.effectivePeriod to accurately represent measurements over time .
  • *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.
  • See the General Guidance page for further guidance on SNOMED and UCUM.
  • See the LOINC scale type to FHIR data type mapping for guidance on which Observation.value[x] data type to use based on the LOINC Type of Scale.
  • For a starter set of example clinical test LOINC codes, see [Appendix B in iEHR IE Core Data for Interoperability (IECDI) Task Force 2021 HITAC Phase 3 Recommendations Report Letter].
  • See the IE Core Laboratory Result Observation Profile to represent laboratory test results.

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 Measurements and simple assertions
ie-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:ie-core S 0..* CodeableConcept Classification of type of observation
Binding: IE Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets


... code S 1..1 CodeableConcept Clinical Test or Procedure Name
Binding: LOINCCodes (extensible): Codes identifying names of simple observations.

... subject S 1..1 Reference(IE Core Patient Profile S | Group | Device | IE Core Location Profile) Who and/or what the observation is about
... encounter S 0..1 Reference(IE Core Encounter Profile) Encounter associated with Observation
... effective[x] SC 0..1 Clinically relevant time/time-period for observation
ie-core-1: Datetime must be at least to day.
.... effectiveDateTime dateTime S
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... value[x] SC 0..1 Result Value
ie-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

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Observation.category:ie-corerequiredIECoreClinicalResultObservationCategory
http://iehr.ai/fhir/ie/core/ValueSet/ie-core-clinical-result-observation-category
from this IG
Observation.codeextensibleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
ie-core-1errorObservation.effective[x]Datetime must be at least to day.
: $this is dateTime implies $this.toString().length() >= 10
ie-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())
ie-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 Measurements and simple assertions
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
ie-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:ie-core S 0..* CodeableConcept Classification of type of observation
Binding: IE Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets


... code SΣ 1..1 CodeableConcept Clinical Test or Procedure Name
Binding: LOINCCodes (extensible): Codes identifying names of simple observations.

... subject SΣ 1..1 Reference(IE Core Patient Profile) Who and/or what the observation is about
... encounter SΣ 0..1 Reference(IE Core Encounter Profile) Encounter associated with Observation
... effective[x] SΣC 0..1 Clinically relevant time/time-period for observation
ie-core-1: Datetime must be at least to day.
.... effectiveDateTime dateTime
... value[x] SΣC 0..1 Result Value
ie-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.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
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:ie-corerequiredIECoreClinicalResultObservationCategory
http://iehr.ai/fhir/ie/core/ValueSet/ie-core-clinical-result-observation-category
from this IG
Observation.codeextensibleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
ie-core-1errorObservation.effective[x]Datetime must be at least to day.
: $this is dateTime implies $this.toString().length() >= 10
ie-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())
ie-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 Measurements and simple assertions
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
ie-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:ie-core S 0..* CodeableConcept Classification of type of observation
Binding: IE Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets


... code SΣ 1..1 CodeableConcept Clinical Test or Procedure Name
Binding: LOINCCodes (extensible): Codes identifying names of simple observations.

... subject SΣ 1..1 Reference(IE Core Patient Profile S | Group | Device | IE 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 SΣ 0..1 Reference(IE Core Encounter Profile) Encounter associated with Observation
... effective[x] SΣC 0..1 Clinically relevant time/time-period for observation
ie-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 Σ 0..* Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Who is responsible for the observation
... value[x] SΣC 0..1 Result Value
ie-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 Σ 0..* Reference(Observation | QuestionnaireResponse | MolecularSequence) Related resource that belongs to the Observation group
... derivedFrom Σ 0..* Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Related measurements the observation is made from
... component 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

PathConformanceValueSetURI
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:ie-corerequiredIECoreClinicalResultObservationCategory
http://iehr.ai/fhir/ie/core/ValueSet/ie-core-clinical-result-observation-category
from this IG
Observation.codeextensibleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
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
ie-core-1errorObservation.effective[x]Datetime must be at least to day.
: $this is dateTime implies $this.toString().length() >= 10
ie-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())
ie-core-3errorObservation.value[x]SHALL use UCUM for coded quantity units.
: ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'

This structure is derived from Observation

Summary

Mandatory: 2 elements
Must-Support: 9 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Observation.category

Maturity: 3

Differential View

This structure is derived from Observation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* Observation Measurements and simple assertions
ie-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:ie-core S 0..* CodeableConcept Classification of type of observation
Binding: IE Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets


... code S 1..1 CodeableConcept Clinical Test or Procedure Name
Binding: LOINCCodes (extensible): Codes identifying names of simple observations.

... subject S 1..1 Reference(IE Core Patient Profile S | Group | Device | IE Core Location Profile) Who and/or what the observation is about
... encounter S 0..1 Reference(IE Core Encounter Profile) Encounter associated with Observation
... effective[x] SC 0..1 Clinically relevant time/time-period for observation
ie-core-1: Datetime must be at least to day.
.... effectiveDateTime dateTime S
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... value[x] SC 0..1 Result Value
ie-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

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Observation.category:ie-corerequiredIECoreClinicalResultObservationCategory
http://iehr.ai/fhir/ie/core/ValueSet/ie-core-clinical-result-observation-category
from this IG
Observation.codeextensibleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
ie-core-1errorObservation.effective[x]Datetime must be at least to day.
: $this is dateTime implies $this.toString().length() >= 10
ie-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())
ie-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 Measurements and simple assertions
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
ie-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:ie-core S 0..* CodeableConcept Classification of type of observation
Binding: IE Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets


... code SΣ 1..1 CodeableConcept Clinical Test or Procedure Name
Binding: LOINCCodes (extensible): Codes identifying names of simple observations.

... subject SΣ 1..1 Reference(IE Core Patient Profile) Who and/or what the observation is about
... encounter SΣ 0..1 Reference(IE Core Encounter Profile) Encounter associated with Observation
... effective[x] SΣC 0..1 Clinically relevant time/time-period for observation
ie-core-1: Datetime must be at least to day.
.... effectiveDateTime dateTime
... value[x] SΣC 0..1 Result Value
ie-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.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
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:ie-corerequiredIECoreClinicalResultObservationCategory
http://iehr.ai/fhir/ie/core/ValueSet/ie-core-clinical-result-observation-category
from this IG
Observation.codeextensibleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
ie-core-1errorObservation.effective[x]Datetime must be at least to day.
: $this is dateTime implies $this.toString().length() >= 10
ie-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())
ie-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 Measurements and simple assertions
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
ie-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:ie-core S 0..* CodeableConcept Classification of type of observation
Binding: IE Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets


... code SΣ 1..1 CodeableConcept Clinical Test or Procedure Name
Binding: LOINCCodes (extensible): Codes identifying names of simple observations.

... subject SΣ 1..1 Reference(IE Core Patient Profile S | Group | Device | IE 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 SΣ 0..1 Reference(IE Core Encounter Profile) Encounter associated with Observation
... effective[x] SΣC 0..1 Clinically relevant time/time-period for observation
ie-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 Σ 0..* Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Who is responsible for the observation
... value[x] SΣC 0..1 Result Value
ie-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 Σ 0..* Reference(Observation | QuestionnaireResponse | MolecularSequence) Related resource that belongs to the Observation group
... derivedFrom Σ 0..* Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Related measurements the observation is made from
... component 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

PathConformanceValueSetURI
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:ie-corerequiredIECoreClinicalResultObservationCategory
http://iehr.ai/fhir/ie/core/ValueSet/ie-core-clinical-result-observation-category
from this IG
Observation.codeextensibleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
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
ie-core-1errorObservation.effective[x]Datetime must be at least to day.
: $this is dateTime implies $this.toString().length() >= 10
ie-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())
ie-core-3errorObservation.value[x]SHALL use UCUM for coded quantity units.
: ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'

This structure is derived from Observation

Summary

Mandatory: 2 elements
Must-Support: 9 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Observation.category

Maturity: 3

 

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 IE Core interactions to access this profile's information (Profile Support + Interaction Support). Note that systems that support only IE Core Profiles (Profile Only Support) are not required to support these interactions. See the IE 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 IE 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.

IE Core Scopes

Servers providing access to clinical results data SHALL support these IE Core SMART Scopes:

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

    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&code=http://loinc.org|44974-4
    2. GET [base]/Observation?patient=1134281&code=http://loinc.org|44974-4,http://loinc.org|44963-7,http://loinc.org|8601-7

    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=http://terminology.hl7.org/CodeSystem/observation-category|procedure&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=http://terminology.hl7.org/CodeSystem/observation-category|procedure&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&http://terminology.hl7.org/CodeSystem/observation-category|procedure&_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 IE 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|44974-4&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)