Canadian Baseline
1.1.0 - CI Build Canada flag

Canadian Baseline, published by HL7 Canada - FHIR Implementation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7-Canada/ca-baseline/ and changes regularly. See the Directory of published versions

Resource Profile: Observation Profile (Laboratory Results)

Official URL: http://hl7.org/fhir/ca/baseline/StructureDefinition/profile-observation-results Version: 1.1.0
Draft as of 2022-03-25 Computable Name: ObservationProfileLaboratory

Proposed constraints on the Observation Resource to represent results produced by laboratory tests or panels/studies

CA Baseline Observation (Laboratory Results) Profile

While this profile does not currently apply MS constraints on the hasMember, referenceRange, interpretation or component elements, this profile is seeking community and implementer feedback on how these elements are being used to assess whether consistent patterns can be identified for use in the Canadian landscape for certain types of test results (e.g., panel, antibody, blood tests, etc)
Feedback can be provided through the Simplifier issue log for this profile.</p>

This Observation (Laboratory Results) profile further constrains the Observation (General Use) profile to represent results of laboratory tests.

This profile may represent a single value from a specific laboratory test (e.g. hematocrit) or it may represent a grouped set of results from a multi- test study or panel (e.g. complete blood count, urinalysis, electrolytes).

The Observation (Laboratory Results) profile reflects localization concepts in the Canadian context. 

Mandatory Data Elements

All elements or attributes within the FHIR specification have cardinality as part of their definition - a minimum number of required appearances and a maximum number of allowable appearances.

Most elements in the FHIR specification have a minimum cardinality of 0, so most elements are not required and subsequently they may be missing from a resource when it is exchanged between systems.

Required elements:

  • status of the result value
  • category to classify the general type of observation being made
  • category: laboratory (mandatory child element of above)
  • code to classify what was observed
  • reference to a subject

Note: if Observation.component is provided then Observation.component.value is mandatory.

Must Support Data Elements

Some elements are marked as Must Support. This means that implementations generating, receiving, or otherwise using resources with Must Support elements SHALL provide support for those elements in some meaningful way (see Must Support definition).

The following elements are marked as Must Support in the Observation (Laboratory Results) profile:

Must Support elements:

  • category
  • category:laboratory
  • code
  • reference to a subject
  • effective date
  • performer
  • value
  • component.code (if implementer supports component)
  • component.value[x] (if implementer supports component)

Data Absent Reason

If the minimum cardinality of an element or attribute is 1 AND information is missing AND the Responder knows the precise reason for the absence of data, then Responders SHOULD send the reason for the missing information using values from the valueset where it exists by using the DataAbsentReason extension.

An Observation without a value, SHOULD include a reason why the data is absent unless there are component observations, or references to other Observations that are grouped within it, i.e., unless there are component observations, or references to other Observations that are grouped within it then either ONE of Observation.value OR Observation.dataAbsentReason but NOT both should be present.

Note: The conformance language above was modified from SHALL to SHOULD to reflect the community decision to relax the invariant to account for Canadian implementations that have reason to not meet the rule given circumstances with R4 modeling for value expressions that is corrected in later versions of FHIR. At least one Canadian lab implementation uses an extension to communicate a result value in the form of a PDF (which R4 does not support under its existing value data types).

Usage Note

Observation (Laboratory Results) is intended to represent results of laboratory tests and studies. This profile constrains the Observation (General Use) resource to represent laboratory results in messages and patient summaries if no other, more specific profile is more appropriate.

The following list of examples is intended to represent some examples of typical use cases and is not exhaustive:

  • complete blood count
  • prothrombin time
  • basic metabolic panel
  • comprehensive metabolic panel
  • lipid panel
  • liver panel
  • thyroid stimulating hormone
  • hemoglobin a1c
  • culture and sensitivity

including the interpretations and reference ranges associated with the result(s).

Observation (Laboratory Results) should not be used if one of the following profiles is applicable: (to be completed later)

Usage:

Formal Views of Profile Content

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

This structure is derived from ObservationProfile

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 0..* ObservationProfile Observation Profile
... status 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:laboratory SC 1..* CodeableConcept FHIR standard classification of type of observation
ca-baseline-category: SHALL have a category from 'http://terminology.hl7.org/CodeSystem/observation-category'
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: laboratory
... code S 1..1 CodeableConcept Type of observation (code / type)
Binding: LOINCCodes (preferred): LOINC codes identifying names of simple observations.

... effective[x] SC 0..1 Clinically relevant time/time-period for observation
ca-baseline-datetime: Datetime SHALL be at least to day
.... effectiveDateTime dateTime
.... effectivePeriod Period
... issued 0..1 instant Date/Time this version was made available
... performer S 0..* Reference(Practitioner Profile (General) | PractitionerRole Profile (General) | Organization Profile | Patient Profile) Who is responsible for the observation
... Slices for value[x] S 0..1 Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period Actual result
Slice: Unordered, Open by type:$this
.... value[x]:valueCodeableConcept C 0..1 CodeableConcept Actual result
ca-baseline-results-1: SHOULD use SNOMED CT for coded Results
..... coding 0..* Coding Code defined by a terminology system
...... system 1..1 uri FHIR standard classification of type of observation code system
...... code 1..1 code A code difining laboratory result
.... value[x]:valueQuantity 0..1 Quantity Actual result
..... value 1..1 decimal Numerical value (with implicit precision)
..... system C 0..1 uri System that defines coded unit form
ca-baseline-results-2: SHALL use UCUM for coded quantity units
Fixed Value: http://unitsofmeasure.org
... dataAbsentReason 0..1 CodeableConcept Why the result is missing
... interpretation 0..* CodeableConcept High, low, normal, etc.
... referenceRange 0..* BackboneElement Provides guide for interpretation
... hasMember 0..* Reference(Observation | QuestionnaireResponse | MolecularSequence) Related resource that belongs to the Observation group
... component 0..* BackboneElement Component results
.... code S 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (preferred): LOINC codes identifying names of simple observations.

.... Slices for value[x] S 0..1 Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period Actual component result
Slice: Unordered, Open by type:$this
..... value[x]:valueCodeableConcept C 0..1 CodeableConcept Actual component result
ca-baseline-results-1: SHOULD use SNOMED CT for coded Results
...... coding 0..* Coding FHIR standard classification of type of observation code system
....... system 1..1 uri FHIR standard classification of type of observation code system
....... code 1..1 code A code defining laboratory result
..... value[x]:valueQuantity 0..1 Quantity Actual component result
...... value 1..1 decimal Numerical value (with implicit precision)
...... system C 0..1 uri System that defines coded unit form
ca-baseline-results-2: SHALL use UCUM for coded quantity units
Fixed Value: http://unitsofmeasure.org
.... dataAbsentReason 0..1 CodeableConcept Why the component result is missing

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Observation.codepreferredLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component.codepreferredLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
ca-baseline-categoryerrorObservation.category:laboratorySHALL have a category from 'http://terminology.hl7.org/CodeSystem/observation-category'
: where(coding.system='http://terminology.hl7.org/CodeSystem/observation-category' and coding.code.exists()).exists()
ca-baseline-datetimeerrorObservation.effective[x]Datetime SHALL be at least to day
: ($this as dateTime).toString().length() >= 8
ca-baseline-results-1warningObservation.value[x]:valueCodeableConcept, Observation.component.value[x]:valueCodeableConceptSHOULD use SNOMED CT for coded Results
: valueCodeableConcept.coding.system.empty() or valueCodeableConcept.coding.system = 'http://snomed.info/sct'
ca-baseline-results-2errorObservation.value[x]:valueQuantity.system, Observation.component.value[x]:valueQuantity.systemSHALL use UCUM for coded quantity units
: where(valueQuantity.system='http://unitsofmeasure.org' and valueQuantity.value.exists()).exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* ObservationProfile Observation Profile
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
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... status ?!Σ 1..1 code registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

.... category:laboratory SC 1..* CodeableConcept FHIR standard classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


ca-baseline-category: SHALL have a category from 'http://terminology.hl7.org/CodeSystem/observation-category'

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: laboratory
... code SΣ 1..1 CodeableConcept Type of observation (code / type)
Binding: LOINCCodes (preferred): LOINC codes identifying names of simple observations.

... subject SΣ 1..1 Reference(Patient Profile | Group | Device | Location) Who and/or what the observation is about
... effective[x] SΣC 0..1 Clinically relevant time/time-period for observation
ca-baseline-datetime: Datetime SHALL be at least to day
.... effectiveDateTime dateTime
.... effectivePeriod Period
... issued Σ 0..1 instant Date/Time this version was made available
... performer SΣ 0..* Reference(Practitioner Profile (General) | PractitionerRole Profile (General) | Organization Profile | Patient Profile) Who is responsible for the observation
... Slices for value[x] SΣC 0..1 Actual result
Slice: Unordered, Open by type:$this
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
.... value[x]:valueCodeableConcept SΣC 0..1 CodeableConcept Actual result
ca-baseline-results-1: SHOULD use SNOMED CT for coded Results
..... coding Σ 0..* Coding Code defined by a terminology system
...... system Σ 1..1 uri FHIR standard classification of type of observation code system
...... code Σ 1..1 code A code difining laboratory result
.... value[x]:valueQuantity SΣC 0..1 Quantity Actual result
..... value Σ 1..1 decimal Numerical value (with implicit precision)
..... comparator ?!Σ 0..1 code < | <= | >= | > - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

..... system ΣC 0..1 uri System that defines coded unit form
ca-baseline-results-2: SHALL use UCUM for coded quantity units
Fixed Value: http://unitsofmeasure.org
... dataAbsentReason C 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.


... referenceRange C 0..* BackboneElement Provides guide for interpretation
obs-3: Must have at least a low or a high or text
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
... hasMember Σ 0..* Reference(Observation | QuestionnaireResponse | MolecularSequence) Related resource that belongs to the Observation group
... component Σ 0..* BackboneElement Component results
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code SΣ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (preferred): LOINC codes identifying names of simple observations.

.... Slices for value[x] SΣ 0..1 Actual component result
Slice: Unordered, Open by type:$this
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueRatio Ratio
..... valueSampledData SampledData
..... valueTime time
..... valueDateTime dateTime
..... valuePeriod Period
..... value[x]:valueCodeableConcept SΣC 0..1 CodeableConcept Actual component result
ca-baseline-results-1: SHOULD use SNOMED CT for coded Results
...... coding Σ 0..* Coding FHIR standard classification of type of observation code system
....... system Σ 1..1 uri FHIR standard classification of type of observation code system
....... code Σ 1..1 code A code defining laboratory result
..... value[x]:valueQuantity SΣ 0..1 Quantity Actual component result
...... value Σ 1..1 decimal Numerical value (with implicit precision)
...... comparator ?!Σ 0..1 code < | <= | >= | > - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... system ΣC 0..1 uri System that defines coded unit form
ca-baseline-results-2: SHALL use UCUM for coded quantity units
Fixed Value: http://unitsofmeasure.org
.... dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.


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:laboratorypreferredPattern: laboratory
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.codepreferredLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.value[x]:valueQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1
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.component.codepreferredLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component.value[x]:valueQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1
from the FHIR Standard
Observation.component.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
ca-baseline-categoryerrorObservation.category:laboratorySHALL have a category from 'http://terminology.hl7.org/CodeSystem/observation-category'
: where(coding.system='http://terminology.hl7.org/CodeSystem/observation-category' and coding.code.exists()).exists()
ca-baseline-datetimeerrorObservation.effective[x]Datetime SHALL be at least to day
: ($this as dateTime).toString().length() >= 8
ca-baseline-results-1warningObservation.value[x]:valueCodeableConcept, Observation.component.value[x]:valueCodeableConceptSHOULD use SNOMED CT for coded Results
: valueCodeableConcept.coding.system.empty() or valueCodeableConcept.coding.system = 'http://snomed.info/sct'
ca-baseline-results-2errorObservation.value[x]:valueQuantity.system, Observation.component.value[x]:valueQuantity.systemSHALL use UCUM for coded quantity units
: where(valueQuantity.system='http://unitsofmeasure.org' and valueQuantity.value.exists()).exists()
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorObservationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
: value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* ObservationProfile Observation Profile
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
... 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 ?!Σ 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:laboratory SC 1..* CodeableConcept FHIR standard classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


ca-baseline-category: SHALL have a category from 'http://terminology.hl7.org/CodeSystem/observation-category'

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: laboratory
...... 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
... code SΣ 1..1 CodeableConcept Type of observation (code / type)
Binding: LOINCCodes (preferred): LOINC codes identifying names of simple observations.

... subject SΣ 1..1 Reference(Patient Profile | Group | Device | Location) 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
ca-baseline-datetime: Datetime SHALL be at least to day
.... effectiveDateTime dateTime
.... effectivePeriod Period
... issued Σ 0..1 instant Date/Time this version was made available
... performer SΣ 0..* Reference(Practitioner Profile (General) | PractitionerRole Profile (General) | Organization Profile | Patient Profile) Who is responsible for the observation
... Slices for value[x] SΣC 0..1 Actual result
Slice: Unordered, Open by type:$this
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
.... value[x]:valueCodeableConcept SΣC 0..1 CodeableConcept Actual result
ca-baseline-results-1: SHOULD use SNOMED CT for coded Results
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 0..* Coding Code defined by a terminology system
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri FHIR standard classification of type of observation code system
...... version Σ 0..1 string Version of the system - if relevant
...... code Σ 1..1 code A code difining laboratory result
...... display Σ 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... value[x]:valueQuantity SΣC 0..1 Quantity Actual result
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... value Σ 1..1 decimal Numerical value (with implicit precision)
..... comparator ?!Σ 0..1 code < | <= | >= | > - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

..... unit Σ 0..1 string Unit representation
..... system ΣC 0..1 uri System that defines coded unit form
ca-baseline-results-2: SHALL use UCUM for coded quantity units
Fixed Value: http://unitsofmeasure.org
..... code Σ 0..1 code Coded form of the unit
... dataAbsentReason C 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 SΣ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (preferred): LOINC codes identifying names of simple observations.

.... Slices for value[x] SΣ 0..1 Actual component result
Slice: Unordered, Open by type:$this
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueRatio Ratio
..... valueSampledData SampledData
..... valueTime time
..... valueDateTime dateTime
..... valuePeriod Period
..... value[x]:valueCodeableConcept SΣC 0..1 CodeableConcept Actual component result
ca-baseline-results-1: SHOULD use SNOMED CT for coded Results
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding FHIR standard classification of type of observation code system
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri FHIR standard classification of type of observation code system
....... version Σ 0..1 string Version of the system - if relevant
....... code Σ 1..1 code A code defining laboratory result
....... display Σ 0..1 string Representation defined by the system
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... value[x]:valueQuantity SΣ 0..1 Quantity Actual component result
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... value Σ 1..1 decimal Numerical value (with implicit precision)
...... comparator ?!Σ 0..1 code < | <= | >= | > - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... unit Σ 0..1 string Unit representation
...... system ΣC 0..1 uri System that defines coded unit form
ca-baseline-results-2: SHALL use UCUM for coded quantity units
Fixed Value: http://unitsofmeasure.org
...... code Σ 0..1 code Coded form of the unit
.... 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:laboratorypreferredPattern: laboratory
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.codepreferredLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.value[x]:valueQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1
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.codepreferredLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component.value[x]:valueQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1
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
ca-baseline-categoryerrorObservation.category:laboratorySHALL have a category from 'http://terminology.hl7.org/CodeSystem/observation-category'
: where(coding.system='http://terminology.hl7.org/CodeSystem/observation-category' and coding.code.exists()).exists()
ca-baseline-datetimeerrorObservation.effective[x]Datetime SHALL be at least to day
: ($this as dateTime).toString().length() >= 8
ca-baseline-results-1warningObservation.value[x]:valueCodeableConcept, Observation.component.value[x]:valueCodeableConceptSHOULD use SNOMED CT for coded Results
: valueCodeableConcept.coding.system.empty() or valueCodeableConcept.coding.system = 'http://snomed.info/sct'
ca-baseline-results-2errorObservation.value[x]:valueQuantity.system, Observation.component.value[x]:valueQuantity.systemSHALL use UCUM for coded quantity units
: where(valueQuantity.system='http://unitsofmeasure.org' and valueQuantity.value.exists()).exists()
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorObservationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
: value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()

This structure is derived from ObservationProfile

Summary

Mandatory: 3 elements(6 nested mandatory elements)
Must-Support: 9 elements
Fixed: 2 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
  • The element 1 is sliced based on the value of Observation.value[x]
  • The element 1 is sliced based on the value of Observation.component.value[x]

Differential View

This structure is derived from ObservationProfile

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 0..* ObservationProfile Observation Profile
... status 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:laboratory SC 1..* CodeableConcept FHIR standard classification of type of observation
ca-baseline-category: SHALL have a category from 'http://terminology.hl7.org/CodeSystem/observation-category'
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: laboratory
... code S 1..1 CodeableConcept Type of observation (code / type)
Binding: LOINCCodes (preferred): LOINC codes identifying names of simple observations.

... effective[x] SC 0..1 Clinically relevant time/time-period for observation
ca-baseline-datetime: Datetime SHALL be at least to day
.... effectiveDateTime dateTime
.... effectivePeriod Period
... issued 0..1 instant Date/Time this version was made available
... performer S 0..* Reference(Practitioner Profile (General) | PractitionerRole Profile (General) | Organization Profile | Patient Profile) Who is responsible for the observation
... Slices for value[x] S 0..1 Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period Actual result
Slice: Unordered, Open by type:$this
.... value[x]:valueCodeableConcept C 0..1 CodeableConcept Actual result
ca-baseline-results-1: SHOULD use SNOMED CT for coded Results
..... coding 0..* Coding Code defined by a terminology system
...... system 1..1 uri FHIR standard classification of type of observation code system
...... code 1..1 code A code difining laboratory result
.... value[x]:valueQuantity 0..1 Quantity Actual result
..... value 1..1 decimal Numerical value (with implicit precision)
..... system C 0..1 uri System that defines coded unit form
ca-baseline-results-2: SHALL use UCUM for coded quantity units
Fixed Value: http://unitsofmeasure.org
... dataAbsentReason 0..1 CodeableConcept Why the result is missing
... interpretation 0..* CodeableConcept High, low, normal, etc.
... referenceRange 0..* BackboneElement Provides guide for interpretation
... hasMember 0..* Reference(Observation | QuestionnaireResponse | MolecularSequence) Related resource that belongs to the Observation group
... component 0..* BackboneElement Component results
.... code S 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (preferred): LOINC codes identifying names of simple observations.

.... Slices for value[x] S 0..1 Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period Actual component result
Slice: Unordered, Open by type:$this
..... value[x]:valueCodeableConcept C 0..1 CodeableConcept Actual component result
ca-baseline-results-1: SHOULD use SNOMED CT for coded Results
...... coding 0..* Coding FHIR standard classification of type of observation code system
....... system 1..1 uri FHIR standard classification of type of observation code system
....... code 1..1 code A code defining laboratory result
..... value[x]:valueQuantity 0..1 Quantity Actual component result
...... value 1..1 decimal Numerical value (with implicit precision)
...... system C 0..1 uri System that defines coded unit form
ca-baseline-results-2: SHALL use UCUM for coded quantity units
Fixed Value: http://unitsofmeasure.org
.... dataAbsentReason 0..1 CodeableConcept Why the component result is missing

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Observation.codepreferredLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component.codepreferredLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
ca-baseline-categoryerrorObservation.category:laboratorySHALL have a category from 'http://terminology.hl7.org/CodeSystem/observation-category'
: where(coding.system='http://terminology.hl7.org/CodeSystem/observation-category' and coding.code.exists()).exists()
ca-baseline-datetimeerrorObservation.effective[x]Datetime SHALL be at least to day
: ($this as dateTime).toString().length() >= 8
ca-baseline-results-1warningObservation.value[x]:valueCodeableConcept, Observation.component.value[x]:valueCodeableConceptSHOULD use SNOMED CT for coded Results
: valueCodeableConcept.coding.system.empty() or valueCodeableConcept.coding.system = 'http://snomed.info/sct'
ca-baseline-results-2errorObservation.value[x]:valueQuantity.system, Observation.component.value[x]:valueQuantity.systemSHALL use UCUM for coded quantity units
: where(valueQuantity.system='http://unitsofmeasure.org' and valueQuantity.value.exists()).exists()

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* ObservationProfile Observation Profile
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
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... status ?!Σ 1..1 code registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

.... category:laboratory SC 1..* CodeableConcept FHIR standard classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


ca-baseline-category: SHALL have a category from 'http://terminology.hl7.org/CodeSystem/observation-category'

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: laboratory
... code SΣ 1..1 CodeableConcept Type of observation (code / type)
Binding: LOINCCodes (preferred): LOINC codes identifying names of simple observations.

... subject SΣ 1..1 Reference(Patient Profile | Group | Device | Location) Who and/or what the observation is about
... effective[x] SΣC 0..1 Clinically relevant time/time-period for observation
ca-baseline-datetime: Datetime SHALL be at least to day
.... effectiveDateTime dateTime
.... effectivePeriod Period
... issued Σ 0..1 instant Date/Time this version was made available
... performer SΣ 0..* Reference(Practitioner Profile (General) | PractitionerRole Profile (General) | Organization Profile | Patient Profile) Who is responsible for the observation
... Slices for value[x] SΣC 0..1 Actual result
Slice: Unordered, Open by type:$this
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
.... value[x]:valueCodeableConcept SΣC 0..1 CodeableConcept Actual result
ca-baseline-results-1: SHOULD use SNOMED CT for coded Results
..... coding Σ 0..* Coding Code defined by a terminology system
...... system Σ 1..1 uri FHIR standard classification of type of observation code system
...... code Σ 1..1 code A code difining laboratory result
.... value[x]:valueQuantity SΣC 0..1 Quantity Actual result
..... value Σ 1..1 decimal Numerical value (with implicit precision)
..... comparator ?!Σ 0..1 code < | <= | >= | > - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

..... system ΣC 0..1 uri System that defines coded unit form
ca-baseline-results-2: SHALL use UCUM for coded quantity units
Fixed Value: http://unitsofmeasure.org
... dataAbsentReason C 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.


... referenceRange C 0..* BackboneElement Provides guide for interpretation
obs-3: Must have at least a low or a high or text
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
... hasMember Σ 0..* Reference(Observation | QuestionnaireResponse | MolecularSequence) Related resource that belongs to the Observation group
... component Σ 0..* BackboneElement Component results
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code SΣ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (preferred): LOINC codes identifying names of simple observations.

.... Slices for value[x] SΣ 0..1 Actual component result
Slice: Unordered, Open by type:$this
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueRatio Ratio
..... valueSampledData SampledData
..... valueTime time
..... valueDateTime dateTime
..... valuePeriod Period
..... value[x]:valueCodeableConcept SΣC 0..1 CodeableConcept Actual component result
ca-baseline-results-1: SHOULD use SNOMED CT for coded Results
...... coding Σ 0..* Coding FHIR standard classification of type of observation code system
....... system Σ 1..1 uri FHIR standard classification of type of observation code system
....... code Σ 1..1 code A code defining laboratory result
..... value[x]:valueQuantity SΣ 0..1 Quantity Actual component result
...... value Σ 1..1 decimal Numerical value (with implicit precision)
...... comparator ?!Σ 0..1 code < | <= | >= | > - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... system ΣC 0..1 uri System that defines coded unit form
ca-baseline-results-2: SHALL use UCUM for coded quantity units
Fixed Value: http://unitsofmeasure.org
.... dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.


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:laboratorypreferredPattern: laboratory
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.codepreferredLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.value[x]:valueQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1
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.component.codepreferredLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component.value[x]:valueQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1
from the FHIR Standard
Observation.component.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
ca-baseline-categoryerrorObservation.category:laboratorySHALL have a category from 'http://terminology.hl7.org/CodeSystem/observation-category'
: where(coding.system='http://terminology.hl7.org/CodeSystem/observation-category' and coding.code.exists()).exists()
ca-baseline-datetimeerrorObservation.effective[x]Datetime SHALL be at least to day
: ($this as dateTime).toString().length() >= 8
ca-baseline-results-1warningObservation.value[x]:valueCodeableConcept, Observation.component.value[x]:valueCodeableConceptSHOULD use SNOMED CT for coded Results
: valueCodeableConcept.coding.system.empty() or valueCodeableConcept.coding.system = 'http://snomed.info/sct'
ca-baseline-results-2errorObservation.value[x]:valueQuantity.system, Observation.component.value[x]:valueQuantity.systemSHALL use UCUM for coded quantity units
: where(valueQuantity.system='http://unitsofmeasure.org' and valueQuantity.value.exists()).exists()
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorObservationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
: value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* ObservationProfile Observation Profile
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
... 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 ?!Σ 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:laboratory SC 1..* CodeableConcept FHIR standard classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


ca-baseline-category: SHALL have a category from 'http://terminology.hl7.org/CodeSystem/observation-category'

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: laboratory
...... 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
... code SΣ 1..1 CodeableConcept Type of observation (code / type)
Binding: LOINCCodes (preferred): LOINC codes identifying names of simple observations.

... subject SΣ 1..1 Reference(Patient Profile | Group | Device | Location) 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
ca-baseline-datetime: Datetime SHALL be at least to day
.... effectiveDateTime dateTime
.... effectivePeriod Period
... issued Σ 0..1 instant Date/Time this version was made available
... performer SΣ 0..* Reference(Practitioner Profile (General) | PractitionerRole Profile (General) | Organization Profile | Patient Profile) Who is responsible for the observation
... Slices for value[x] SΣC 0..1 Actual result
Slice: Unordered, Open by type:$this
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
.... value[x]:valueCodeableConcept SΣC 0..1 CodeableConcept Actual result
ca-baseline-results-1: SHOULD use SNOMED CT for coded Results
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 0..* Coding Code defined by a terminology system
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri FHIR standard classification of type of observation code system
...... version Σ 0..1 string Version of the system - if relevant
...... code Σ 1..1 code A code difining laboratory result
...... display Σ 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... value[x]:valueQuantity SΣC 0..1 Quantity Actual result
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... value Σ 1..1 decimal Numerical value (with implicit precision)
..... comparator ?!Σ 0..1 code < | <= | >= | > - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

..... unit Σ 0..1 string Unit representation
..... system ΣC 0..1 uri System that defines coded unit form
ca-baseline-results-2: SHALL use UCUM for coded quantity units
Fixed Value: http://unitsofmeasure.org
..... code Σ 0..1 code Coded form of the unit
... dataAbsentReason C 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 SΣ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (preferred): LOINC codes identifying names of simple observations.

.... Slices for value[x] SΣ 0..1 Actual component result
Slice: Unordered, Open by type:$this
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueRatio Ratio
..... valueSampledData SampledData
..... valueTime time
..... valueDateTime dateTime
..... valuePeriod Period
..... value[x]:valueCodeableConcept SΣC 0..1 CodeableConcept Actual component result
ca-baseline-results-1: SHOULD use SNOMED CT for coded Results
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding FHIR standard classification of type of observation code system
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri FHIR standard classification of type of observation code system
....... version Σ 0..1 string Version of the system - if relevant
....... code Σ 1..1 code A code defining laboratory result
....... display Σ 0..1 string Representation defined by the system
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... value[x]:valueQuantity SΣ 0..1 Quantity Actual component result
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... value Σ 1..1 decimal Numerical value (with implicit precision)
...... comparator ?!Σ 0..1 code < | <= | >= | > - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... unit Σ 0..1 string Unit representation
...... system ΣC 0..1 uri System that defines coded unit form
ca-baseline-results-2: SHALL use UCUM for coded quantity units
Fixed Value: http://unitsofmeasure.org
...... code Σ 0..1 code Coded form of the unit
.... 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:laboratorypreferredPattern: laboratory
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.codepreferredLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.value[x]:valueQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1
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.codepreferredLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component.value[x]:valueQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1
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
ca-baseline-categoryerrorObservation.category:laboratorySHALL have a category from 'http://terminology.hl7.org/CodeSystem/observation-category'
: where(coding.system='http://terminology.hl7.org/CodeSystem/observation-category' and coding.code.exists()).exists()
ca-baseline-datetimeerrorObservation.effective[x]Datetime SHALL be at least to day
: ($this as dateTime).toString().length() >= 8
ca-baseline-results-1warningObservation.value[x]:valueCodeableConcept, Observation.component.value[x]:valueCodeableConceptSHOULD use SNOMED CT for coded Results
: valueCodeableConcept.coding.system.empty() or valueCodeableConcept.coding.system = 'http://snomed.info/sct'
ca-baseline-results-2errorObservation.value[x]:valueQuantity.system, Observation.component.value[x]:valueQuantity.systemSHALL use UCUM for coded quantity units
: where(valueQuantity.system='http://unitsofmeasure.org' and valueQuantity.value.exists()).exists()
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorObservationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
: value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()

This structure is derived from ObservationProfile

Summary

Mandatory: 3 elements(6 nested mandatory elements)
Must-Support: 9 elements
Fixed: 2 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
  • The element 1 is sliced based on the value of Observation.value[x]
  • The element 1 is sliced based on the value of Observation.component.value[x]

 

Other representations of profile: CSV, Excel, Schematron

Notes:

Using codes in Observation

Additional codes that translate or map to the Observation code or category codes are allowed (see CodeableConcept data type). For example: providing both a local code and LOINC code providing a more specific category codes, SNOMED CT concept, or system specific codes.

Category

The Observation.category specifies a code that classifies the general type of observation being made. The Observation.category element is CodeableConcept data type and more than one code is allowed. For interoperability reason one of the codes SHOULD be from the FHIR standard defined Observation Category Codes. Local codes are allowed as well. In case of using local codes to better classify the type both category.coding.system and category.coding.code SHOULD be provided.

Code

The Observation.code element describes what was observed. Sometimes this is called the observation "name".

The pan-Canadian LOINC Observation Code Database (pCLOCD) is recommended for use in a Canadian context. Code System URI is https://fhir.infoway-inforoute.ca/CodeSystem/pCLOCD

value[x]

If the result value is a code:

  • both valueCodeableConcept.coding.system and valueCodeableConcept.coding.code SHALL be present
  • a code from SNOMED CT SHOULD be used
  • additional codes that translate or map Observation code or category codes are allowed

If the result value is a numeric quantity:

  • valueQuantity.value , valueQuantity.unit and valueQuantity.sytem SHALL be present
  • a standard UCUM unit SHALL be used.