2026 US Quality Core Implementation Guide
0.5.0 - release

2026 US Quality Core Implementation Guide - Downloaded Version 0.5.0 See the Directory of published versions

## Resource Profile: US Quality Core Observation Cancelled

Official URL: http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-observationcancelled | Version: 0.5.0 | Highlight text changes?
Active as of 2026-06-05 | Computable Name: USQualityCoreObservationCancelled

Profile of ObservationCancelled for decision support/quality metrics. Defines the core set of elements and extensions for quality rule and measure authors.

### USCDI+ Quality Element Support Expectations

Systems are expected to support this profile as part of implementing USCDI+ Quality V1 in FHIR and meeting the conformance requirements of this guide.

The following elements are specifically relevant to USCDI+ Quality V1 data classes and elements. Systems are expected to support these elements as applicable to their role in US Quality Core data exchange. See the Must Support section of this guide for more information. These elements are tagged as (USCDI+ Quality) in the formal profile views.

USCDI+ Quality Elements:

- extension:notDoneReason: (USCDI+ Quality) Extension
- status: (USCDI+ Quality) registered | preliminary | final | amended +
- category: (USCDI+ Quality) Classification of type of observation
- code: (USCDI+ Quality) Type of observation (code / type)
- effective[x]: (USCDI+ Quality) Clinically relevant time/time-period for observation
- value[x]: (USCDI+ Quality) Actual result

The Formal Views section also provides the formal summary, definitions, terminology requirements, and mandatory element requirements.

### Profile Specific Implementation Guidance

This profile represents an observation that intentionally did not occur for a medical, patient, or system reason. To represent simple observations that did occur, use the US Quality Core Simple Observation profile.

Additional informational guidance for authoring CQL using this profile is provided in the CQL Authoring Usage (Informational) section of this page.

Usages:

- Examples for this Profile: Observation/negation-example and Observation/negation-with-code-example
- CapabilityStatements using this Profile: US Quality Core Client CapabilityStatement and US Quality Core Server CapabilityStatement

You can also check for usages in the FHIR IG Statistics

### Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

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

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | Observation | Measurements and simple assertions Constraints: obs-6, obs-7, ond-1
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:notDoneReason |  | 1..1 | CodeableConcept | (USCDI+ Quality) Extension URL: http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneReason Binding: USQualityCore Negation Reason Codes (extensible): The reason the event did not occur or was not performed
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
status | ?!Σ | 1..1 | code | (USCDI+ Quality) registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. Fixed Value: cancelled
category |  | 1..* | CodeableConcept | (USCDI+ Quality) Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
code | Σ | 1..1 | CodeableConcept | (USCDI+ Quality) Type of observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
Slices for extension |  |  |  | Content/Rules for all slices
extension:notDoneValueSet |  | 0..1 | canonical(ValueSet) | What was not done URL: http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet
subject | Σ | 1..1 | Reference(US Quality Core Patient) | Who and/or what the observation is about
effective[x] | Σ | 0..1 |  | (USCDI+ Quality) Clinically relevant time/time-period for observation
effectiveDateTime |  |  | dateTime |
effectivePeriod |  |  | Period |
effectiveTiming |  |  | Timing |
effectiveInstant |  |  | instant |
issued | Σ | 1..1 | instant | Date/Time this version was made available
performer | Σ | 0..* | Reference(US Quality Core Practitioner | US Quality Core Organization | US Quality Core Patient | US Quality Core RelatedPerson) | Who is responsible for the observation
Slices for value[x] | Σ C | 0..1 |  | (USCDI+ Quality) 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 | Σ C | 0..1 | CodeableConcept | Actual result Binding: US Core Observation Value Codes (SNOMED-CT) (preferred): SNOMED CT for coded results
interpretation |  | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
derivedFrom | Σ | 0..* | Reference(US Quality Core Simple Observation | US Quality Core QuestionnaireResponse | US Core DocumentReference Profile(6.1.0) | ImagingStudy | Media | MolecularSequence) | Related measurements the observation is made from
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.code | Base | example | LOINC Codes | 📍4.0.1 | FHIR Std.
Observation.value[x]:valueCodeableConcept | Base | preferred | US Core Observation Value Codes (SNOMED-CT) | 📦6.1.0 | US Core v6.1
Observation.interpretation | Base | extensible | Observation Interpretation Codes | 📦4.0.1 | FHIR Std.

#### Constraints

Id | Grade | Path(s) | Description | Expression
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-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()`
ond-1 | error | Observation | to indicate what observation was not recorded, either at least one coding in the code or a notDoneValueSet extension shall be provided | `code.extension('http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet').exists() xor code.coding.exists()`

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | Observation | Measurements and simple assertions Constraints: ond-1
Slices for extension |  |  |  | Content/Rules for all slices
extension:notDoneReason |  | 1..1 | CodeableConcept | (USCDI+ Quality) Extension URL: http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneReason Binding: USQualityCore Negation Reason Codes (extensible): The reason the event did not occur or was not performed
status |  | 1..1 | code | (USCDI+ Quality) registered | preliminary | final | amended + Fixed Value: cancelled
category |  | 1..* | CodeableConcept | (USCDI+ Quality) Classification of type of observation
code |  | 1..1 | CodeableConcept | (USCDI+ Quality) Type of observation (code / type)
Slices for extension |  |  |  | Content/Rules for all slices
extension:notDoneValueSet |  | 0..1 | canonical(ValueSet) | What was not done URL: http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet
subject |  | 1..1 | Reference(US Quality Core Patient) | Who and/or what the observation is about
effective[x] |  | 0..1 | dateTime, Period, Timing, instant | (USCDI+ Quality) Clinically relevant time/time-period for observation
issued |  | 1..1 | instant | Date/Time this version was made available
performer |  | 0..* | Reference(US Quality Core Practitioner | US Quality Core Organization | US Quality Core Patient | US Quality Core RelatedPerson) | Who is responsible for the observation
Slices for value[x] | Σ | 0..1 |  | (USCDI+ Quality) 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 |  | 0..1 | CodeableConcept | Actual result Binding: US Core Observation Value Codes (SNOMED-CT) (preferred): SNOMED CT for coded results
interpretation |  | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
derivedFrom |  | 0..* | Reference(US Quality Core Simple Observation | US Quality Core QuestionnaireResponse | US Core DocumentReference Profile(6.1.0) | ImagingStudy | Media | MolecularSequence) | Related measurements the observation is made from
Documentation for this format

#### Terminology Bindings (Differential)

Path | Status | Usage | ValueSet | Version | Source
Observation.value[x]:valueCodeableConcept | Base | preferred | US Core Observation Value Codes (SNOMED-CT) | 📦6.1.0 | US Core v6.1
Observation.interpretation | Base | extensible | Observation Interpretation Codes | 📦4.0.1 | FHIR Std.

#### Constraints

Id | Grade | Path(s) | Description | Expression
ond-1 | error | Observation | to indicate what observation was not recorded, either at least one coding in the code or a notDoneValueSet extension shall be provided | `code.extension('http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet').exists() xor code.coding.exists()`

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | Observation | Measurements and simple assertions Constraints: obs-6, obs-7, ond-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
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:notDoneReason |  | 1..1 | CodeableConcept | (USCDI+ Quality) Extension URL: http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneReason Binding: USQualityCore Negation Reason Codes (extensible): The reason the event did not occur or was not performed
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 | (USCDI+ Quality) registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. Fixed Value: cancelled
category |  | 1..* | CodeableConcept | (USCDI+ Quality) Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
code | Σ | 1..1 | CodeableConcept | (USCDI+ Quality) Type of observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
id |  | 0..1 | string | Unique id for inter-element referencing
Slices for extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
extension:notDoneValueSet |  | 0..1 | canonical(ValueSet) | What was not done URL: http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | Σ | 0..1 | string | Plain text representation of the concept
subject | Σ | 1..1 | Reference(US Quality Core Patient) | 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] | Σ | 0..1 |  | (USCDI+ Quality) Clinically relevant time/time-period for observation
effectiveDateTime |  |  | dateTime |
effectivePeriod |  |  | Period |
effectiveTiming |  |  | Timing |
effectiveInstant |  |  | instant |
issued | Σ | 1..1 | instant | Date/Time this version was made available
performer | Σ | 0..* | Reference(US Quality Core Practitioner | US Quality Core Organization | US Quality Core Patient | US Quality Core RelatedPerson) | Who is responsible for the observation
Slices for value[x] | Σ C | 0..1 |  | (USCDI+ Quality) 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 | Σ C | 0..1 | CodeableConcept | Actual result Binding: US Core Observation Value Codes (SNOMED-CT) (preferred): SNOMED CT for coded results
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(US Quality Core Simple Observation | US Quality Core QuestionnaireResponse | US Core DocumentReference Profile(6.1.0) | ImagingStudy | Media | MolecularSequence) | Related measurements the observation is made from
component | Σ | 0..* | BackboneElement | Component results
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
code | Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
value[x] | Σ | 0..1 |  | Actual component result
valueQuantity |  |  | Quantity |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueBoolean |  |  | boolean |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueSampledData |  |  | SampledData |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
dataAbsentReason | C | 0..1 | CodeableConcept | Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation |  | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange |  | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result
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.code | Base | example | LOINC Codes | 📍4.0.1 | FHIR Std.
Observation.value[x]:valueCodeableConcept | Base | preferred | US Core Observation Value Codes (SNOMED-CT) | 📦6.1.0 | US Core v6.1
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 | example | LOINC Codes | 📍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
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()`
ond-1 | error | Observation | to indicate what observation was not recorded, either at least one coding in the code or a notDoneValueSet extension shall be provided | `code.extension('http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet').exists() xor code.coding.exists()`

Summary

Mandatory: 6 elements
Fixed: 1 element

Structures

This structure refers to these other structures:

- US Quality Core Patient (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-patient)
- US Quality Core Practitioner (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-practitioner)
- US Quality Core Organization (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-organization)
- US Quality Core RelatedPerson (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-relatedperson)
- US Quality Core Simple Observation (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-simple-observation)
- US Quality Core QuestionnaireResponse (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-questionnaireresponse)
- US Core DocumentReference Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-documentreference|6.1.0)

Extensions

This structure refers to these extensions:

- http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneReason
- http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet

Slices

This structure defines the following Slices:

- The element 1 is sliced based on the value of Observation.value[x]

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | Observation | Measurements and simple assertions Constraints: obs-6, obs-7, ond-1
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:notDoneReason |  | 1..1 | CodeableConcept | (USCDI+ Quality) Extension URL: http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneReason Binding: USQualityCore Negation Reason Codes (extensible): The reason the event did not occur or was not performed
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
status | ?!Σ | 1..1 | code | (USCDI+ Quality) registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. Fixed Value: cancelled
category |  | 1..* | CodeableConcept | (USCDI+ Quality) Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
code | Σ | 1..1 | CodeableConcept | (USCDI+ Quality) Type of observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
Slices for extension |  |  |  | Content/Rules for all slices
extension:notDoneValueSet |  | 0..1 | canonical(ValueSet) | What was not done URL: http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet
subject | Σ | 1..1 | Reference(US Quality Core Patient) | Who and/or what the observation is about
effective[x] | Σ | 0..1 |  | (USCDI+ Quality) Clinically relevant time/time-period for observation
effectiveDateTime |  |  | dateTime |
effectivePeriod |  |  | Period |
effectiveTiming |  |  | Timing |
effectiveInstant |  |  | instant |
issued | Σ | 1..1 | instant | Date/Time this version was made available
performer | Σ | 0..* | Reference(US Quality Core Practitioner | US Quality Core Organization | US Quality Core Patient | US Quality Core RelatedPerson) | Who is responsible for the observation
Slices for value[x] | Σ C | 0..1 |  | (USCDI+ Quality) 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 | Σ C | 0..1 | CodeableConcept | Actual result Binding: US Core Observation Value Codes (SNOMED-CT) (preferred): SNOMED CT for coded results
interpretation |  | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
derivedFrom | Σ | 0..* | Reference(US Quality Core Simple Observation | US Quality Core QuestionnaireResponse | US Core DocumentReference Profile(6.1.0) | ImagingStudy | Media | MolecularSequence) | Related measurements the observation is made from
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.code | Base | example | LOINC Codes | 📍4.0.1 | FHIR Std.
Observation.value[x]:valueCodeableConcept | Base | preferred | US Core Observation Value Codes (SNOMED-CT) | 📦6.1.0 | US Core v6.1
Observation.interpretation | Base | extensible | Observation Interpretation Codes | 📦4.0.1 | FHIR Std.

#### Constraints

Id | Grade | Path(s) | Description | Expression
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-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()`
ond-1 | error | Observation | to indicate what observation was not recorded, either at least one coding in the code or a notDoneValueSet extension shall be provided | `code.extension('http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet').exists() xor code.coding.exists()`

Differential View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | Observation | Measurements and simple assertions Constraints: ond-1
Slices for extension |  |  |  | Content/Rules for all slices
extension:notDoneReason |  | 1..1 | CodeableConcept | (USCDI+ Quality) Extension URL: http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneReason Binding: USQualityCore Negation Reason Codes (extensible): The reason the event did not occur or was not performed
status |  | 1..1 | code | (USCDI+ Quality) registered | preliminary | final | amended + Fixed Value: cancelled
category |  | 1..* | CodeableConcept | (USCDI+ Quality) Classification of type of observation
code |  | 1..1 | CodeableConcept | (USCDI+ Quality) Type of observation (code / type)
Slices for extension |  |  |  | Content/Rules for all slices
extension:notDoneValueSet |  | 0..1 | canonical(ValueSet) | What was not done URL: http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet
subject |  | 1..1 | Reference(US Quality Core Patient) | Who and/or what the observation is about
effective[x] |  | 0..1 | dateTime, Period, Timing, instant | (USCDI+ Quality) Clinically relevant time/time-period for observation
issued |  | 1..1 | instant | Date/Time this version was made available
performer |  | 0..* | Reference(US Quality Core Practitioner | US Quality Core Organization | US Quality Core Patient | US Quality Core RelatedPerson) | Who is responsible for the observation
Slices for value[x] | Σ | 0..1 |  | (USCDI+ Quality) 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 |  | 0..1 | CodeableConcept | Actual result Binding: US Core Observation Value Codes (SNOMED-CT) (preferred): SNOMED CT for coded results
interpretation |  | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
derivedFrom |  | 0..* | Reference(US Quality Core Simple Observation | US Quality Core QuestionnaireResponse | US Core DocumentReference Profile(6.1.0) | ImagingStudy | Media | MolecularSequence) | Related measurements the observation is made from
Documentation for this format

#### Terminology Bindings (Differential)

Path | Status | Usage | ValueSet | Version | Source
Observation.value[x]:valueCodeableConcept | Base | preferred | US Core Observation Value Codes (SNOMED-CT) | 📦6.1.0 | US Core v6.1
Observation.interpretation | Base | extensible | Observation Interpretation Codes | 📦4.0.1 | FHIR Std.

#### Constraints

Id | Grade | Path(s) | Description | Expression
ond-1 | error | Observation | to indicate what observation was not recorded, either at least one coding in the code or a notDoneValueSet extension shall be provided | `code.extension('http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet').exists() xor code.coding.exists()`

Snapshot ViewView

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | Observation | Measurements and simple assertions Constraints: obs-6, obs-7, ond-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
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:notDoneReason |  | 1..1 | CodeableConcept | (USCDI+ Quality) Extension URL: http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneReason Binding: USQualityCore Negation Reason Codes (extensible): The reason the event did not occur or was not performed
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 | (USCDI+ Quality) registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. Fixed Value: cancelled
category |  | 1..* | CodeableConcept | (USCDI+ Quality) Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
code | Σ | 1..1 | CodeableConcept | (USCDI+ Quality) Type of observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
id |  | 0..1 | string | Unique id for inter-element referencing
Slices for extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
extension:notDoneValueSet |  | 0..1 | canonical(ValueSet) | What was not done URL: http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | Σ | 0..1 | string | Plain text representation of the concept
subject | Σ | 1..1 | Reference(US Quality Core Patient) | 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] | Σ | 0..1 |  | (USCDI+ Quality) Clinically relevant time/time-period for observation
effectiveDateTime |  |  | dateTime |
effectivePeriod |  |  | Period |
effectiveTiming |  |  | Timing |
effectiveInstant |  |  | instant |
issued | Σ | 1..1 | instant | Date/Time this version was made available
performer | Σ | 0..* | Reference(US Quality Core Practitioner | US Quality Core Organization | US Quality Core Patient | US Quality Core RelatedPerson) | Who is responsible for the observation
Slices for value[x] | Σ C | 0..1 |  | (USCDI+ Quality) 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 | Σ C | 0..1 | CodeableConcept | Actual result Binding: US Core Observation Value Codes (SNOMED-CT) (preferred): SNOMED CT for coded results
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(US Quality Core Simple Observation | US Quality Core QuestionnaireResponse | US Core DocumentReference Profile(6.1.0) | ImagingStudy | Media | MolecularSequence) | Related measurements the observation is made from
component | Σ | 0..* | BackboneElement | Component results
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
code | Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
value[x] | Σ | 0..1 |  | Actual component result
valueQuantity |  |  | Quantity |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueBoolean |  |  | boolean |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueSampledData |  |  | SampledData |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
dataAbsentReason | C | 0..1 | CodeableConcept | Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation |  | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange |  | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result
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.code | Base | example | LOINC Codes | 📍4.0.1 | FHIR Std.
Observation.value[x]:valueCodeableConcept | Base | preferred | US Core Observation Value Codes (SNOMED-CT) | 📦6.1.0 | US Core v6.1
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 | example | LOINC Codes | 📍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
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()`
ond-1 | error | Observation | to indicate what observation was not recorded, either at least one coding in the code or a notDoneValueSet extension shall be provided | `code.extension('http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet').exists() xor code.coding.exists()`

Summary

Mandatory: 6 elements
Fixed: 1 element

Structures

This structure refers to these other structures:

- US Quality Core Patient (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-patient)
- US Quality Core Practitioner (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-practitioner)
- US Quality Core Organization (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-organization)
- US Quality Core RelatedPerson (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-relatedperson)
- US Quality Core Simple Observation (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-simple-observation)
- US Quality Core QuestionnaireResponse (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-questionnaireresponse)
- US Core DocumentReference Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-documentreference|6.1.0)

Extensions

This structure refers to these extensions:

- http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneReason
- http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet

Slices

This structure defines the following Slices:

- The element 1 is sliced based on the value of Observation.value[x]

Other representations of profile: CSV, Excel, Schematron

### Notes:

#### CQL Authoring Usage (Informational)

The Simple Observation and ObservationCancelled profiles represent the positive and negative statements for an observation. To ensure instances retrieved meet negative intent, applications should check the status element as illustrated in this example:

    define "Pap Test Refused":
      ["ObservationCancelled": "Pap Test"] PapTest
        where PapTest.notDoneReason in "Patient Refusal"

Note that when a more specific observation, such as a Blood Pressure, is negated, the resource instance should conform to both the specific observation profile and the general negation profile.

For a more complete discussion of representation of negation within US Quality Core and quality improvement artifacts, see the Negation in US Quality Core topic.