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 Clinical Result

Official URL: http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-observation-clinical-result | Version: 0.5.0 | Highlight text changes?
Active as of 2026-06-05 | Computable Name: USQualityCoreObservationClinicalResult
Copyright/Legal: Used by permission of HL7 International, all rights reserved Creative Commons License

The US Quality Core Observation Clinical Result Profile is based upon the US Core Observation Clinical Result Profile. Clinical results includes non-imaging and non-laboratory tests performed on a patient that results in structured or unstructured (narrative) findings specific to the patient, such as electrocardiogram (ECG), visual acuity exam, macular exam, or graded exercise testing (GXT), to facilitate the diagnosis and management of conditions. The US Quality Core Observation Clinical Result Profile profile 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:

- status: (USCDI+ Quality) (USCDI) registered | preliminary | final | amended | corrected | entered-in-error | unknown
- code: (USCDI+ Quality) (USCDI) Clinical Test or Procedure Name
- effective[x]: (USCDI+ Quality) (USCDI) Clinically relevant time/time-period for observation
- value[x]: (USCDI+ Quality) (USCDI) Result Value

Because this profile is derived from US Core, systems are also expected to support Must Support requirements and (USCDI) tagged elements inherited from US Core. The Formal Views section also provides the formal summary, definitions, terminology requirements, and mandatory element requirements.

### Profile Specific Implementation Guidance

To represent that an observation of this type intentionally did not occur for a medical, patient, or system reason, use the US Quality Core Observation Cancelled profile.

Usages:

- Refer to this Profile: US Quality Core DiagnosticReport Profile for Report and Note Exchange
- Examples for this Profile: Observation/clinical-result-heart-rate-rhythm
- 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..* | USCoreObservationClinicalResultProfile(6.1.0) | Measurements and simple assertions Constraints: obs-6, obs-7, us-core-2
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 | (USCDI+ Quality) (USCDI) registered | preliminary | final | amended | corrected | entered-in-error | unknown Binding: Non-Negative Observation Status (required)
Slices for category | S | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core | S | 0..* | CodeableConcept | (USCDI) Classification of type of observation Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
code | S Σ | 1..1 | CodeableConcept | (USCDI+ Quality) (USCDI) Clinical Test or Procedure Name Binding: LOINCCodes (extensible)
subject | S Σ | 1..1 | Reference(US Quality Core Patient) | (USCDI) Who and/or what the observation is about
effective[x] | S Σ C | 0..1 |  | (USCDI+ Quality) (USCDI) Clinically relevant time/time-period for observation Constraints: us-core-1
effectiveDateTime |  |  | dateTime S |
effectivePeriod |  |  | Period |
effectiveTiming |  |  | Timing |
effectiveInstant |  |  | instant |
value[x] | S Σ C | 0..1 |  | (USCDI+ Quality) (USCDI) Result Value Constraints: us-core-3
valueQuantity |  |  | Quantity S |
valueCodeableConcept |  |  | CodeableConcept S |
valueString |  |  | string S |
valueBoolean |  |  | boolean |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
dataAbsentReason | S C | 0..1 | CodeableConcept | (USCDI) Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
component | Σ | 0..* | BackboneElement | Component results
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.
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
Observation.status | Base | required | Non-Negative Observation Status | 📦0.5.0 | This IG
Observation.category | Base | preferred | Observation Category Codes | 📦4.0.1 | FHIR Std.
Observation.category:us-core | Base | required | US Core Clinical Result Observation Category | 📦7.0.0 | US Core v7.0
Observation.code | Base | extensible | LOINC Codes | 📦4.0.1 | FHIR Std.
Observation.dataAbsentReason | Base | extensible | DataAbsentReason | 📦4.0.1 | FHIR Std.
Observation.component.​code | Base | example | LOINC 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()`
us-core-1 | error | Observation.effective[x] | Datetime must be at least to day. | `$this is DateTime implies $this.toString().length() >= 10`
us-core-2 | error | Observation | If there is no component or hasMember element then either a value[x] or a data absent reason must be present | `(component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists())`
us-core-3 | error | Observation.value[x] | SHALL use UCUM for coded quantity units. | `value.ofType(Quantity).system.empty() or value.ofType(Quantity).system = 'http://unitsofmeasure.org'`

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation |  | 0..* | USCoreObservationClinicalResultProfile(6.1.0) | Measurements and simple assertions
status |  | 1..1 | code | (USCDI+ Quality) (USCDI) registered | preliminary | final | amended | corrected | entered-in-error | unknown Binding: Non-Negative Observation Status (required)
Slices for category |  | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core |  | 0..* | CodeableConcept | (USCDI) Classification of type of observation Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
code | Σ | 1..1 | CodeableConcept | (USCDI+ Quality) (USCDI) Clinical Test or Procedure Name Binding: LOINCCodes (extensible)
subject |  | 1..1 | Reference(US Quality Core Patient) | (USCDI) Who and/or what the observation is about
effective[x] |  | 0..1 |  | (USCDI+ Quality) (USCDI) Clinically relevant time/time-period for observation
effectiveDateTime |  |  | dateTime |
effectivePeriod |  |  | Period |
effectiveTiming |  |  | Timing |
effectiveInstant |  |  | instant |
value[x] |  | 0..1 |  | (USCDI+ Quality) (USCDI) Result Value
valueQuantity |  |  | Quantity |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueBoolean |  |  | boolean |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
dataAbsentReason |  | 0..1 | CodeableConcept | (USCDI) Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
component |  | 0..* | BackboneElement | Component results
Documentation for this format

#### Terminology Bindings (Differential)

Path | Status | Usage | ValueSet | Version | Source
Observation.status | Base | required | Non-Negative Observation Status | 📦0.5.0 | This IG
Observation.category | Base | preferred | Observation Category Codes | 📦4.0.1 | FHIR Std.
Observation.category:us-core | Base | required | US Core Clinical Result Observation Category | 📦7.0.0 | US Core v7.0
Observation.code | Base | extensible | LOINC Codes | 📦4.0.1 | FHIR Std.
Observation.dataAbsentReason | Base | extensible | DataAbsentReason | 📦4.0.1 | FHIR Std.

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | USCoreObservationClinicalResultProfile(6.1.0) | Measurements and simple assertions Constraints: obs-6, obs-7, us-core-2
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 | (USCDI+ Quality) (USCDI) registered | preliminary | final | amended | corrected | entered-in-error | unknown Binding: Non-Negative Observation Status (required)
Slices for category | S | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core | S | 0..* | CodeableConcept | (USCDI) Classification of type of observation Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
code | S Σ | 1..1 | CodeableConcept | (USCDI+ Quality) (USCDI) Clinical Test or Procedure Name Binding: LOINCCodes (extensible)
subject | S Σ | 1..1 | Reference(US Quality Core Patient) | (USCDI) 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 |  | (USCDI+ Quality) (USCDI) Clinically relevant time/time-period for observation Constraints: us-core-1
effectiveDateTime |  |  | dateTime S |
effectivePeriod |  |  | Period |
effectiveTiming |  |  | Timing |
effectiveInstant |  |  | instant |
issued | Σ | 0..1 | instant | Date/Time this version was made available
performer | Σ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | Who is responsible for the observation
value[x] | S Σ C | 0..1 |  | (USCDI+ Quality) (USCDI) Result Value Constraints: us-core-3
valueQuantity |  |  | Quantity S |
valueCodeableConcept |  |  | CodeableConcept S |
valueString |  |  | string S |
valueBoolean |  |  | boolean |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
dataAbsentReason | S C | 0..1 | CodeableConcept | (USCDI) 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 | Low Range, if relevant
high | C | 0..1 | SimpleQuantity | High Range, if relevant
type |  | 0..1 | CodeableConcept | Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
appliesTo |  | 0..* | CodeableConcept | Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
age |  | 0..1 | Range | Applicable age range, if relevant
text |  | 0..1 | string | Text based reference range in an observation
hasMember | Σ | 0..* | Reference(Observation | QuestionnaireResponse | MolecularSequence) | Related resource that belongs to the Observation group
derivedFrom | Σ | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Related measurements the observation is made from
component | Σ | 0..* | BackboneElement | Component results
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
code | Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
value[x] | Σ | 0..1 |  | Actual component result
valueQuantity |  |  | Quantity |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueBoolean |  |  | boolean |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueSampledData |  |  | SampledData |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
dataAbsentReason | C | 0..1 | CodeableConcept | Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation |  | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange |  | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result
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 | Non-Negative Observation Status | 📦0.5.0 | This IG
Observation.category | Base | preferred | Observation Category Codes | 📦4.0.1 | FHIR Std.
Observation.category:us-core | Base | required | US Core Clinical Result Observation Category | 📦7.0.0 | US Core v7.0
Observation.code | Base | extensible | LOINC Codes | 📦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 | 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()`
us-core-1 | error | Observation.effective[x] | Datetime must be at least to day. | `$this is DateTime implies $this.toString().length() >= 10`
us-core-2 | error | Observation | If there is no component or hasMember element then either a value[x] or a data absent reason must be present | `(component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists())`
us-core-3 | error | Observation.value[x] | SHALL use UCUM for coded quantity units. | `value.ofType(Quantity).system.empty() or value.ofType(Quantity).system = 'http://unitsofmeasure.org'`

Summary

Mandatory: 2 elements

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)

Slices

This structure defines the following Slices:

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

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | USCoreObservationClinicalResultProfile(6.1.0) | Measurements and simple assertions Constraints: obs-6, obs-7, us-core-2
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 | (USCDI+ Quality) (USCDI) registered | preliminary | final | amended | corrected | entered-in-error | unknown Binding: Non-Negative Observation Status (required)
Slices for category | S | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core | S | 0..* | CodeableConcept | (USCDI) Classification of type of observation Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
code | S Σ | 1..1 | CodeableConcept | (USCDI+ Quality) (USCDI) Clinical Test or Procedure Name Binding: LOINCCodes (extensible)
subject | S Σ | 1..1 | Reference(US Quality Core Patient) | (USCDI) Who and/or what the observation is about
effective[x] | S Σ C | 0..1 |  | (USCDI+ Quality) (USCDI) Clinically relevant time/time-period for observation Constraints: us-core-1
effectiveDateTime |  |  | dateTime S |
effectivePeriod |  |  | Period |
effectiveTiming |  |  | Timing |
effectiveInstant |  |  | instant |
value[x] | S Σ C | 0..1 |  | (USCDI+ Quality) (USCDI) Result Value Constraints: us-core-3
valueQuantity |  |  | Quantity S |
valueCodeableConcept |  |  | CodeableConcept S |
valueString |  |  | string S |
valueBoolean |  |  | boolean |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
dataAbsentReason | S C | 0..1 | CodeableConcept | (USCDI) Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
component | Σ | 0..* | BackboneElement | Component results
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.
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
Observation.status | Base | required | Non-Negative Observation Status | 📦0.5.0 | This IG
Observation.category | Base | preferred | Observation Category Codes | 📦4.0.1 | FHIR Std.
Observation.category:us-core | Base | required | US Core Clinical Result Observation Category | 📦7.0.0 | US Core v7.0
Observation.code | Base | extensible | LOINC Codes | 📦4.0.1 | FHIR Std.
Observation.dataAbsentReason | Base | extensible | DataAbsentReason | 📦4.0.1 | FHIR Std.
Observation.component.​code | Base | example | LOINC 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()`
us-core-1 | error | Observation.effective[x] | Datetime must be at least to day. | `$this is DateTime implies $this.toString().length() >= 10`
us-core-2 | error | Observation | If there is no component or hasMember element then either a value[x] or a data absent reason must be present | `(component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists())`
us-core-3 | error | Observation.value[x] | SHALL use UCUM for coded quantity units. | `value.ofType(Quantity).system.empty() or value.ofType(Quantity).system = 'http://unitsofmeasure.org'`

Differential View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation |  | 0..* | USCoreObservationClinicalResultProfile(6.1.0) | Measurements and simple assertions
status |  | 1..1 | code | (USCDI+ Quality) (USCDI) registered | preliminary | final | amended | corrected | entered-in-error | unknown Binding: Non-Negative Observation Status (required)
Slices for category |  | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core |  | 0..* | CodeableConcept | (USCDI) Classification of type of observation Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
code | Σ | 1..1 | CodeableConcept | (USCDI+ Quality) (USCDI) Clinical Test or Procedure Name Binding: LOINCCodes (extensible)
subject |  | 1..1 | Reference(US Quality Core Patient) | (USCDI) Who and/or what the observation is about
effective[x] |  | 0..1 |  | (USCDI+ Quality) (USCDI) Clinically relevant time/time-period for observation
effectiveDateTime |  |  | dateTime |
effectivePeriod |  |  | Period |
effectiveTiming |  |  | Timing |
effectiveInstant |  |  | instant |
value[x] |  | 0..1 |  | (USCDI+ Quality) (USCDI) Result Value
valueQuantity |  |  | Quantity |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueBoolean |  |  | boolean |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
dataAbsentReason |  | 0..1 | CodeableConcept | (USCDI) Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
component |  | 0..* | BackboneElement | Component results
Documentation for this format

#### Terminology Bindings (Differential)

Path | Status | Usage | ValueSet | Version | Source
Observation.status | Base | required | Non-Negative Observation Status | 📦0.5.0 | This IG
Observation.category | Base | preferred | Observation Category Codes | 📦4.0.1 | FHIR Std.
Observation.category:us-core | Base | required | US Core Clinical Result Observation Category | 📦7.0.0 | US Core v7.0
Observation.code | Base | extensible | LOINC Codes | 📦4.0.1 | FHIR Std.
Observation.dataAbsentReason | Base | extensible | DataAbsentReason | 📦4.0.1 | FHIR Std.

Snapshot ViewView

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | USCoreObservationClinicalResultProfile(6.1.0) | Measurements and simple assertions Constraints: obs-6, obs-7, us-core-2
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 | (USCDI+ Quality) (USCDI) registered | preliminary | final | amended | corrected | entered-in-error | unknown Binding: Non-Negative Observation Status (required)
Slices for category | S | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core | S | 0..* | CodeableConcept | (USCDI) Classification of type of observation Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
code | S Σ | 1..1 | CodeableConcept | (USCDI+ Quality) (USCDI) Clinical Test or Procedure Name Binding: LOINCCodes (extensible)
subject | S Σ | 1..1 | Reference(US Quality Core Patient) | (USCDI) 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 |  | (USCDI+ Quality) (USCDI) Clinically relevant time/time-period for observation Constraints: us-core-1
effectiveDateTime |  |  | dateTime S |
effectivePeriod |  |  | Period |
effectiveTiming |  |  | Timing |
effectiveInstant |  |  | instant |
issued | Σ | 0..1 | instant | Date/Time this version was made available
performer | Σ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | Who is responsible for the observation
value[x] | S Σ C | 0..1 |  | (USCDI+ Quality) (USCDI) Result Value Constraints: us-core-3
valueQuantity |  |  | Quantity S |
valueCodeableConcept |  |  | CodeableConcept S |
valueString |  |  | string S |
valueBoolean |  |  | boolean |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
dataAbsentReason | S C | 0..1 | CodeableConcept | (USCDI) 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 | Low Range, if relevant
high | C | 0..1 | SimpleQuantity | High Range, if relevant
type |  | 0..1 | CodeableConcept | Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
appliesTo |  | 0..* | CodeableConcept | Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
age |  | 0..1 | Range | Applicable age range, if relevant
text |  | 0..1 | string | Text based reference range in an observation
hasMember | Σ | 0..* | Reference(Observation | QuestionnaireResponse | MolecularSequence) | Related resource that belongs to the Observation group
derivedFrom | Σ | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Related measurements the observation is made from
component | Σ | 0..* | BackboneElement | Component results
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
code | Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
value[x] | Σ | 0..1 |  | Actual component result
valueQuantity |  |  | Quantity |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueBoolean |  |  | boolean |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueSampledData |  |  | SampledData |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
dataAbsentReason | C | 0..1 | CodeableConcept | Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation |  | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange |  | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result
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 | Non-Negative Observation Status | 📦0.5.0 | This IG
Observation.category | Base | preferred | Observation Category Codes | 📦4.0.1 | FHIR Std.
Observation.category:us-core | Base | required | US Core Clinical Result Observation Category | 📦7.0.0 | US Core v7.0
Observation.code | Base | extensible | LOINC Codes | 📦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 | 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()`
us-core-1 | error | Observation.effective[x] | Datetime must be at least to day. | `$this is DateTime implies $this.toString().length() >= 10`
us-core-2 | error | Observation | If there is no component or hasMember element then either a value[x] or a data absent reason must be present | `(component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists())`
us-core-3 | error | Observation.value[x] | SHALL use UCUM for coded quantity units. | `value.ofType(Quantity).system.empty() or value.ofType(Quantity).system = 'http://unitsofmeasure.org'`

Summary

Mandatory: 2 elements

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)

Slices

This structure defines the following Slices:

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

Other representations of profile: CSV, Excel, Schematron