Canadian Baseline
1.2.0 - CI Build

Canadian Baseline, published by HL7 Canada - FHIR Implementation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.2.0 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: 1.2.0
Draft as of 2024-12-27 | 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)

Usages:

- Refer to this Profile: DiagnosticReport Profile for Laboratory Results Reporting

You can also check for usages in the FHIR IG Statistics

### Formal Views of Profile Content

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

- Key Elements Table
- Differential Table
- Snapshot Table
- Statistics/References
- All

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | ObservationProfile | Observation Profile Constraints: obs-6, obs-7, ca-baseline-results-1
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
status | ?!S 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 | S | 1..* | CodeableConcept | FHIR standard classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (Complex)
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
system |  | 1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 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 | S Σ | 1..1 | CodeableConcept | Type of observation (code / type) Binding: LOINCCodes (preferred): LOINC codes identifying names of simple observations.
subject | S Σ | 1..1 | Reference(Patient Profile | Group | Device | Location) | Who and/or what the observation is about
effective[x] | S Σ C | 0..1 |  | Clinically relevant time/time-period for observation Constraints: ca-baseline-datetime
effectiveDateTime |  |  | dateTime |
effectivePeriod |  |  | Period |
issued | Σ | 0..1 | instant | Date/Time this version was made available
performer | S Σ | 0..* | Reference(Practitioner Profile (General) | PractitionerRole Profile (General) | Organization Profile | Patient Profile) | Who is responsible for the observation
Slices for value[x] | S Σ C | 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 | S Σ C | 0..1 | CodeableConcept | Actual result
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 | S Σ C | 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 | Σ C | 0..1 | uri | System that defines coded unit form
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 Constraints: obs-3
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 | S Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (preferred): LOINC codes identifying names of simple observations.
Slices for value[x] | S Σ | 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 | S Σ | 0..1 | CodeableConcept | Actual component result
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 | S Σ | 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 | Σ C | 0..1 | uri | System that defines coded unit form
dataAbsentReason | C | 0..1 | CodeableConcept | Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
Observation.status | Base | required | ObservationStatus | 📍4.0.1 | FHIR Std.
Observation.category | Base | preferred | Observation Category Codes | 📍4.0.1 | FHIR Std.
Observation.category:laboratory | Base | preferred | Observation Category Codes | 📍4.0.1 | FHIR Std.
Observation.code | Base | preferred | LOINC Codes | 📦4.0.1 | FHIR Std.
Observation.value[x]:valueQuantity.​comparator | Base | required | QuantityComparator | 📍4.0.1 | FHIR Std.
Observation.dataAbsentReason | Base | extensible | DataAbsentReason | 📍4.0.1 | FHIR Std.
Observation.interpretation | Base | extensible | Observation Interpretation Codes | 📍4.0.1 | FHIR Std.
Observation.component.​code | Base | preferred | LOINC Codes | 📦4.0.1 | FHIR Std.
Observation.component.​value[x]:valueQuantity.​comparator | Base | required | QuantityComparator | 📍4.0.1 | FHIR Std.
Observation.component.​dataAbsentReason | Base | extensible | DataAbsentReason | 📍4.0.1 | FHIR Std.

#### Constraints

Id | Grade | Path(s) | Description | Expression
ca-baseline-datetime | error | Observation.effective[x] | Datetime SHALL be at least to day | `($this as dateTime).toString().length() >= 8`
ca-baseline-results-1 | warning | Observation | SHOULD use SNOMED CT for coded Results | `(component.value | value).ofType(Quantity).all(system = 'http://unitsofmeasure.org')`
dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | Observation | If 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-4 | error | Observation | If 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-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | Observation | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`
obs-3 | error | Observation.referenceRange | Must have at least a low or a high or text | `low.exists() or high.exists() or text.exists()`
obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present | `dataAbsentReason.empty() or value.empty()`
obs-7 | error | Observation | If 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

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | ObservationProfile | Observation Profile Constraints: ca-baseline-results-1
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:$this
category:laboratory | S | 1..* | CodeableConcept | FHIR standard classification of type of observation Required Pattern: At least the following
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (Complex)
system |  | 1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: laboratory
code | S | 1..1 | CodeableConcept | Type of observation (code / type) Binding: LOINCCodes (preferred): LOINC codes identifying names of simple observations.
subject | S | 1..1 | Reference(Patient Profile | Group | Device | Location) | Who and/or what the observation is about
effective[x] | S C | 0..1 |  | Clinically relevant time/time-period for observation Constraints: ca-baseline-datetime
effectiveDateTime |  |  | dateTime |
effectivePeriod |  |  | Period |
issued |  | 0..1 | instant | Date/Time this version was made available
performer | S | 0..* | Reference(Practitioner Profile (General) | PractitionerRole Profile (General) | Organization Profile | Patient Profile) | Who is responsible for the observation
Slices for value[x] | S | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Actual result Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept |  | 0..1 | CodeableConcept | Actual result
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 |  | 0..1 | uri | System that defines coded unit form
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 |  | 0..1 | CodeableConcept | Actual component result
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 |  | 0..1 | uri | System that defines coded unit form
dataAbsentReason |  | 0..1 | CodeableConcept | Why the component result is missing
Documentation for this format

#### Terminology Bindings (Differential)

Path | Status | Usage | ValueSet | Version | Source
Observation.code | Base | preferred | LOINC Codes | 📦4.0.1 | FHIR Std.
Observation.component.​code | Base | preferred | LOINC Codes | 📦4.0.1 | FHIR Std.

#### Constraints

Id | Grade | Path(s) | Description | Expression
ca-baseline-datetime | error | Observation.effective[x] | Datetime SHALL be at least to day | `($this as dateTime).toString().length() >= 8`
ca-baseline-results-1 | warning | Observation | SHOULD use SNOMED CT for coded Results | `(component.value | value).ofType(Quantity).all(system = 'http://unitsofmeasure.org')`

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | ObservationProfile | Observation Profile Constraints: obs-6, obs-7, ca-baseline-results-1
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 Bindings | Purpose
AllLanguages | Max Binding
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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 | ?!S 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 | S | 1..* | CodeableConcept | FHIR standard classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (Complex)
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
system |  | 1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 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 | S Σ | 1..1 | CodeableConcept | Type of observation (code / type) Binding: LOINCCodes (preferred): LOINC codes identifying names of simple observations.
subject | S Σ | 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] | S Σ C | 0..1 |  | Clinically relevant time/time-period for observation Constraints: ca-baseline-datetime
effectiveDateTime |  |  | dateTime |
effectivePeriod |  |  | Period |
issued | Σ | 0..1 | instant | Date/Time this version was made available
performer | S Σ | 0..* | Reference(Practitioner Profile (General) | PractitionerRole Profile (General) | Organization Profile | Patient Profile) | Who is responsible for the observation
Slices for value[x] | S Σ C | 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 | S Σ C | 0..1 | CodeableConcept | 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
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 | S Σ C | 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 | Σ C | 0..1 | uri | System that defines coded unit form
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 Constraints: obs-3
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(4.0.1) | Low Range, if relevant
high | C | 0..1 | SimpleQuantity(4.0.1) | 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 | S Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (preferred): LOINC codes identifying names of simple observations.
Slices for value[x] | S Σ | 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 | S Σ | 0..1 | CodeableConcept | 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
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 | S Σ | 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 | Σ C | 0..1 | uri | System that defines coded unit form
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
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
Observation.language | Base | preferred | Common Languages | 📍4.0.1 | FHIR Std.
Observation.status | Base | required | ObservationStatus | 📍4.0.1 | FHIR Std.
Observation.category | Base | preferred | Observation Category Codes | 📍4.0.1 | FHIR Std.
Observation.category:laboratory | Base | preferred | Observation Category Codes | 📍4.0.1 | FHIR Std.
Observation.code | Base | preferred | LOINC Codes | 📦4.0.1 | FHIR Std.
Observation.value[x]:valueQuantity.​comparator | Base | required | QuantityComparator | 📍4.0.1 | FHIR Std.
Observation.dataAbsentReason | Base | extensible | DataAbsentReason | 📍4.0.1 | FHIR Std.
Observation.interpretation | Base | extensible | Observation Interpretation Codes | 📍4.0.1 | FHIR Std.
Observation.bodySite | Base | example | SNOMED CT Body Structures | 📍4.0.1 | FHIR Std.
Observation.method | Base | example | Observation Methods | 📍4.0.1 | FHIR Std.
Observation.referenceRange.​type | Base | preferred | Observation Reference Range Meaning Codes | 📍4.0.1 | FHIR Std.
Observation.referenceRange.​appliesTo | Base | example | Observation Reference Range Applies To Codes | 📍4.0.1 | FHIR Std.
Observation.component.​code | Base | preferred | LOINC Codes | 📦4.0.1 | FHIR Std.
Observation.component.​value[x]:valueQuantity.​comparator | Base | required | QuantityComparator | 📍4.0.1 | FHIR Std.
Observation.component.​dataAbsentReason | Base | extensible | DataAbsentReason | 📍4.0.1 | FHIR Std.
Observation.component.​interpretation | Base | extensible | Observation Interpretation Codes | 📍4.0.1 | FHIR Std.

#### Constraints

Id | Grade | Path(s) | Description | Expression
ca-baseline-datetime | error | Observation.effective[x] | Datetime SHALL be at least to day | `($this as dateTime).toString().length() >= 8`
ca-baseline-results-1 | warning | Observation | SHOULD use SNOMED CT for coded Results | `(component.value | value).ofType(Quantity).all(system = 'http://unitsofmeasure.org')`
dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | Observation | If 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-4 | error | Observation | If 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-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | Observation | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`
obs-3 | error | Observation.referenceRange | Must have at least a low or a high or text | `low.exists() or high.exists() or text.exists()`
obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present | `dataAbsentReason.empty() or value.empty()`
obs-7 | error | Observation | If 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: 10 elements

Structures

This structure refers to these other structures:

- Patient Profile (http://hl7.org/fhir/ca/baseline/StructureDefinition/profile-patient)
- Practitioner Profile (General) (http://hl7.org/fhir/ca/baseline/StructureDefinition/profile-practitioner)
- PractitionerRole Profile (General) (http://hl7.org/fhir/ca/baseline/StructureDefinition/profile-practitionerrole)
- Organization Profile (http://hl7.org/fhir/ca/baseline/StructureDefinition/profile-organization)

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]

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | ObservationProfile | Observation Profile Constraints: obs-6, obs-7, ca-baseline-results-1
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
status | ?!S 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 | S | 1..* | CodeableConcept | FHIR standard classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (Complex)
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
system |  | 1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 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 | S Σ | 1..1 | CodeableConcept | Type of observation (code / type) Binding: LOINCCodes (preferred): LOINC codes identifying names of simple observations.
subject | S Σ | 1..1 | Reference(Patient Profile | Group | Device | Location) | Who and/or what the observation is about
effective[x] | S Σ C | 0..1 |  | Clinically relevant time/time-period for observation Constraints: ca-baseline-datetime
effectiveDateTime |  |  | dateTime |
effectivePeriod |  |  | Period |
issued | Σ | 0..1 | instant | Date/Time this version was made available
performer | S Σ | 0..* | Reference(Practitioner Profile (General) | PractitionerRole Profile (General) | Organization Profile | Patient Profile) | Who is responsible for the observation
Slices for value[x] | S Σ C | 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 | S Σ C | 0..1 | CodeableConcept | Actual result
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 | S Σ C | 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 | Σ C | 0..1 | uri | System that defines coded unit form
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 Constraints: obs-3
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 | S Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (preferred): LOINC codes identifying names of simple observations.
Slices for value[x] | S Σ | 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 | S Σ | 0..1 | CodeableConcept | Actual component result
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 | S Σ | 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 | Σ C | 0..1 | uri | System that defines coded unit form
dataAbsentReason | C | 0..1 | CodeableConcept | Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
Observation.status | Base | required | ObservationStatus | 📍4.0.1 | FHIR Std.
Observation.category | Base | preferred | Observation Category Codes | 📍4.0.1 | FHIR Std.
Observation.category:laboratory | Base | preferred | Observation Category Codes | 📍4.0.1 | FHIR Std.
Observation.code | Base | preferred | LOINC Codes | 📦4.0.1 | FHIR Std.
Observation.value[x]:valueQuantity.​comparator | Base | required | QuantityComparator | 📍4.0.1 | FHIR Std.
Observation.dataAbsentReason | Base | extensible | DataAbsentReason | 📍4.0.1 | FHIR Std.
Observation.interpretation | Base | extensible | Observation Interpretation Codes | 📍4.0.1 | FHIR Std.
Observation.component.​code | Base | preferred | LOINC Codes | 📦4.0.1 | FHIR Std.
Observation.component.​value[x]:valueQuantity.​comparator | Base | required | QuantityComparator | 📍4.0.1 | FHIR Std.
Observation.component.​dataAbsentReason | Base | extensible | DataAbsentReason | 📍4.0.1 | FHIR Std.

#### Constraints

Id | Grade | Path(s) | Description | Expression
ca-baseline-datetime | error | Observation.effective[x] | Datetime SHALL be at least to day | `($this as dateTime).toString().length() >= 8`
ca-baseline-results-1 | warning | Observation | SHOULD use SNOMED CT for coded Results | `(component.value | value).ofType(Quantity).all(system = 'http://unitsofmeasure.org')`
dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | Observation | If 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-4 | error | Observation | If 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-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | Observation | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`
obs-3 | error | Observation.referenceRange | Must have at least a low or a high or text | `low.exists() or high.exists() or text.exists()`
obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present | `dataAbsentReason.empty() or value.empty()`
obs-7 | error | Observation | If 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()`

Differential View

This structure is derived from ObservationProfile

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | ObservationProfile | Observation Profile Constraints: ca-baseline-results-1
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:$this
category:laboratory | S | 1..* | CodeableConcept | FHIR standard classification of type of observation Required Pattern: At least the following
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (Complex)
system |  | 1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: laboratory
code | S | 1..1 | CodeableConcept | Type of observation (code / type) Binding: LOINCCodes (preferred): LOINC codes identifying names of simple observations.
subject | S | 1..1 | Reference(Patient Profile | Group | Device | Location) | Who and/or what the observation is about
effective[x] | S C | 0..1 |  | Clinically relevant time/time-period for observation Constraints: ca-baseline-datetime
effectiveDateTime |  |  | dateTime |
effectivePeriod |  |  | Period |
issued |  | 0..1 | instant | Date/Time this version was made available
performer | S | 0..* | Reference(Practitioner Profile (General) | PractitionerRole Profile (General) | Organization Profile | Patient Profile) | Who is responsible for the observation
Slices for value[x] | S | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Actual result Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept |  | 0..1 | CodeableConcept | Actual result
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 |  | 0..1 | uri | System that defines coded unit form
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 |  | 0..1 | CodeableConcept | Actual component result
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 |  | 0..1 | uri | System that defines coded unit form
dataAbsentReason |  | 0..1 | CodeableConcept | Why the component result is missing
Documentation for this format

#### Terminology Bindings (Differential)

Path | Status | Usage | ValueSet | Version | Source
Observation.code | Base | preferred | LOINC Codes | 📦4.0.1 | FHIR Std.
Observation.component.​code | Base | preferred | LOINC Codes | 📦4.0.1 | FHIR Std.

#### Constraints

Id | Grade | Path(s) | Description | Expression
ca-baseline-datetime | error | Observation.effective[x] | Datetime SHALL be at least to day | `($this as dateTime).toString().length() >= 8`
ca-baseline-results-1 | warning | Observation | SHOULD use SNOMED CT for coded Results | `(component.value | value).ofType(Quantity).all(system = 'http://unitsofmeasure.org')`

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | ObservationProfile | Observation Profile Constraints: obs-6, obs-7, ca-baseline-results-1
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 Bindings | Purpose
AllLanguages | Max Binding
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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 | ?!S 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 | S | 1..* | CodeableConcept | FHIR standard classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (Complex)
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
system |  | 1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 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 | S Σ | 1..1 | CodeableConcept | Type of observation (code / type) Binding: LOINCCodes (preferred): LOINC codes identifying names of simple observations.
subject | S Σ | 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] | S Σ C | 0..1 |  | Clinically relevant time/time-period for observation Constraints: ca-baseline-datetime
effectiveDateTime |  |  | dateTime |
effectivePeriod |  |  | Period |
issued | Σ | 0..1 | instant | Date/Time this version was made available
performer | S Σ | 0..* | Reference(Practitioner Profile (General) | PractitionerRole Profile (General) | Organization Profile | Patient Profile) | Who is responsible for the observation
Slices for value[x] | S Σ C | 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 | S Σ C | 0..1 | CodeableConcept | 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
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 | S Σ C | 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 | Σ C | 0..1 | uri | System that defines coded unit form
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 Constraints: obs-3
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(4.0.1) | Low Range, if relevant
high | C | 0..1 | SimpleQuantity(4.0.1) | 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 | S Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (preferred): LOINC codes identifying names of simple observations.
Slices for value[x] | S Σ | 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 | S Σ | 0..1 | CodeableConcept | 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
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 | S Σ | 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 | Σ C | 0..1 | uri | System that defines coded unit form
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
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
Observation.language | Base | preferred | Common Languages | 📍4.0.1 | FHIR Std.
Observation.status | Base | required | ObservationStatus | 📍4.0.1 | FHIR Std.
Observation.category | Base | preferred | Observation Category Codes | 📍4.0.1 | FHIR Std.
Observation.category:laboratory | Base | preferred | Observation Category Codes | 📍4.0.1 | FHIR Std.
Observation.code | Base | preferred | LOINC Codes | 📦4.0.1 | FHIR Std.
Observation.value[x]:valueQuantity.​comparator | Base | required | QuantityComparator | 📍4.0.1 | FHIR Std.
Observation.dataAbsentReason | Base | extensible | DataAbsentReason | 📍4.0.1 | FHIR Std.
Observation.interpretation | Base | extensible | Observation Interpretation Codes | 📍4.0.1 | FHIR Std.
Observation.bodySite | Base | example | SNOMED CT Body Structures | 📍4.0.1 | FHIR Std.
Observation.method | Base | example | Observation Methods | 📍4.0.1 | FHIR Std.
Observation.referenceRange.​type | Base | preferred | Observation Reference Range Meaning Codes | 📍4.0.1 | FHIR Std.
Observation.referenceRange.​appliesTo | Base | example | Observation Reference Range Applies To Codes | 📍4.0.1 | FHIR Std.
Observation.component.​code | Base | preferred | LOINC Codes | 📦4.0.1 | FHIR Std.
Observation.component.​value[x]:valueQuantity.​comparator | Base | required | QuantityComparator | 📍4.0.1 | FHIR Std.
Observation.component.​dataAbsentReason | Base | extensible | DataAbsentReason | 📍4.0.1 | FHIR Std.
Observation.component.​interpretation | Base | extensible | Observation Interpretation Codes | 📍4.0.1 | FHIR Std.

#### Constraints

Id | Grade | Path(s) | Description | Expression
ca-baseline-datetime | error | Observation.effective[x] | Datetime SHALL be at least to day | `($this as dateTime).toString().length() >= 8`
ca-baseline-results-1 | warning | Observation | SHOULD use SNOMED CT for coded Results | `(component.value | value).ofType(Quantity).all(system = 'http://unitsofmeasure.org')`
dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | Observation | If 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-4 | error | Observation | If 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-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | Observation | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`
obs-3 | error | Observation.referenceRange | Must have at least a low or a high or text | `low.exists() or high.exists() or text.exists()`
obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present | `dataAbsentReason.empty() or value.empty()`
obs-7 | error | Observation | If 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: 10 elements

Structures

This structure refers to these other structures:

- Patient Profile (http://hl7.org/fhir/ca/baseline/StructureDefinition/profile-patient)
- Practitioner Profile (General) (http://hl7.org/fhir/ca/baseline/StructureDefinition/profile-practitioner)
- PractitionerRole Profile (General) (http://hl7.org/fhir/ca/baseline/StructureDefinition/profile-practitionerrole)
- Organization Profile (http://hl7.org/fhir/ca/baseline/StructureDefinition/profile-organization)

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.