US Quality Core Implementation Guide
0.1.0 - cibuild

US Quality Core Implementation Guide, published by ASTP. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/FHIR/us-quality-core/ and changes regularly. See the Directory of published versions

## Resource Profile: US Quality Core Laboratory Result Observation

Official URL: http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-observation-lab | Version: 0.1.0
Active as of 2022-05-31 | Computable Name: USQualityCoreLaboratoryResultObservation

The US Quality Core Laboratory Result Observation Profile is based upon the US Laboratory Result Observation Resource. Defines the core set of elements and extensions for quality rule and measure authors.

Usage

See the patterns page for implementation and usage patterns.

### Examples

Glucose Laboratory Result Observation Example

USCDI+ Quality Elements:

- status: (USCDI+ Quality) registered \| prliminary \| final \| amended \| corrected \| entered-in-error \| unknown
- category: (USCDI+ Quality) Classification of type of observation
- category:us-core: (USCDI+ Quality) (USCDI) Classification of type of observation
- code: (USCDI+ Quality) (USCDI) Laboratory Test Name
- issued: (USCDI+ Quality) Date/Time this version was made available
- value[x]: (USCDI+ Quality) (USCDI) Result Value
- interpretation: (USCDI+ Quality) High, low, normal, etc.

Usages:

- Refer to this Profile: US Quality Core DiagnosticReport Profile for Laboratory Results Reporting and US Quality Core DiagnosticReport Profile for Report and Note Exchange
- Examples for this Profile: Observation/laboratory-result-observation-example-blood-glucose
- 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 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..* | USCoreLaboratoryResultObservationProfile | 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) registered | prliminary | final | amended | corrected | entered-in-error | unknown Binding: Non-Negative Observation Status (required)
Slices for category | S | 1..* | CodeableConcept | (USCDI+ Quality) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core | S | 1..1 | CodeableConcept | (USCDI+ Quality) (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 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 | (USCDI+ Quality) (USCDI) Laboratory Test Name Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes
subject | S Σ | 1..1 | Reference(US Quality Core Patient) | Who and/or what the observation is about
effective[x] | S Σ C | 0..1 |  | 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 | (USCDI+ Quality) Date/Time this version was made available
value[x] | S Σ C | 0..1 |  | (USCDI+ Quality) (USCDI) Result Value Constraints: us-core-3, us-core-4
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 | (USCDI+ Quality) High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
specimen | S | 0..1 | Reference(US Core Specimen Profile) | (USCDI) Specimen used for this observation
referenceRange | C | 0..* | BackboneElement | Result reference range Constraints: obs-3
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
Observation.status | Base | required | Non-Negative Observation Status | 📦0.1.0 | 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 | 📦6.1.0 | US Core v6.1
Observation.code | Base | extensible | US Core Laboratory Test Codes | 📦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.

#### 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'`
us-core-4 | best practice | Observation.value[x] | SHOULD use Snomed CT for coded Results | `value.ofType(CodeableConcept).coding.system.empty() or value.ofType(CodeableConcept).coding.system = 'http://snomed.info/sct'`

This structure is derived from USCoreLaboratoryResultObservationProfile

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation |  | 0..* | USCoreLaboratoryResultObservationProfile | Measurements and simple assertions
status |  | 1..1 | code | (USCDI+ Quality) registered | prliminary | final | amended | corrected | entered-in-error | unknown Binding: Non-Negative Observation Status (required)
Slices for category |  | 1..* | CodeableConcept | (USCDI+ Quality) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core |  | 1..1 | CodeableConcept | (USCDI+ Quality) (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 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 | Σ | 1..1 | CodeableConcept | (USCDI+ Quality) (USCDI) Laboratory Test Name Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes
subject |  | 1..1 | Reference(US Quality Core Patient) | Who and/or what the observation is about
effective[x] | Σ | 0..1 |  | Clinically relevant time/time-period for observation
effectiveDateTime |  |  | dateTime |
effectivePeriod |  |  | Period |
effectiveTiming |  |  | Timing |
effectiveInstant |  |  | instant |
issued | Σ | 0..1 | instant | (USCDI+ Quality) Date/Time this version was made available
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 |
interpretation |  | 0..* | CodeableConcept | (USCDI+ Quality) High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
specimen |  | 0..1 | Reference(US Core Specimen Profile) | (USCDI) Specimen used for this observation
referenceRange |  | 0..* | BackboneElement | Result reference range
Documentation for this format

#### Terminology Bindings (Differential)

Path | Status | Usage | ValueSet | Version | Source
Observation.status | Base | required | Non-Negative Observation Status | 📦0.1.0 | 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 | 📦6.1.0 | US Core v6.1
Observation.code | Base | extensible | US Core Laboratory Test Codes | 📦6.1.0 | US Core v6.1
Observation.interpretation | Base | extensible | Observation Interpretation Codes | 📦4.0.1 | FHIR Std.

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | USCoreLaboratoryResultObservationProfile | 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) registered | prliminary | final | amended | corrected | entered-in-error | unknown Binding: Non-Negative Observation Status (required)
Slices for category | S | 1..* | CodeableConcept | (USCDI+ Quality) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core | S | 1..1 | CodeableConcept | (USCDI+ Quality) (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 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 | (USCDI+ Quality) (USCDI) Laboratory Test Name Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes
subject | S 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] | S Σ C | 0..1 |  | 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 | (USCDI+ Quality) 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, us-core-4
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 | (USCDI+ Quality) 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 | S | 0..1 | Reference(US Core Specimen Profile) | (USCDI) Specimen used for this observation
device |  | 0..1 | Reference(Device | DeviceMetric) | (Measurement) Device
referenceRange | C | 0..* | BackboneElement | Result reference range 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 | 📦0.1.0 | 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 | 📦6.1.0 | US Core v6.1
Observation.code | Base | extensible | US Core Laboratory Test Codes | 📦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()`
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'`
us-core-4 | best practice | Observation.value[x] | SHOULD use Snomed CT for coded Results | `value.ofType(CodeableConcept).coding.system.empty() or value.ofType(CodeableConcept).coding.system = 'http://snomed.info/sct'`

This structure is derived from USCoreLaboratoryResultObservationProfile

Summary

Mandatory: 3 elements

Structures

This structure refers to these other structures:

- US Quality Core Patient (http://fhir.org/guides/astp/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..* | USCoreLaboratoryResultObservationProfile | 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) registered | prliminary | final | amended | corrected | entered-in-error | unknown Binding: Non-Negative Observation Status (required)
Slices for category | S | 1..* | CodeableConcept | (USCDI+ Quality) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core | S | 1..1 | CodeableConcept | (USCDI+ Quality) (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 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 | (USCDI+ Quality) (USCDI) Laboratory Test Name Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes
subject | S Σ | 1..1 | Reference(US Quality Core Patient) | Who and/or what the observation is about
effective[x] | S Σ C | 0..1 |  | 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 | (USCDI+ Quality) Date/Time this version was made available
value[x] | S Σ C | 0..1 |  | (USCDI+ Quality) (USCDI) Result Value Constraints: us-core-3, us-core-4
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 | (USCDI+ Quality) High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
specimen | S | 0..1 | Reference(US Core Specimen Profile) | (USCDI) Specimen used for this observation
referenceRange | C | 0..* | BackboneElement | Result reference range Constraints: obs-3
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
Observation.status | Base | required | Non-Negative Observation Status | 📦0.1.0 | 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 | 📦6.1.0 | US Core v6.1
Observation.code | Base | extensible | US Core Laboratory Test Codes | 📦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.

#### 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'`
us-core-4 | best practice | Observation.value[x] | SHOULD use Snomed CT for coded Results | `value.ofType(CodeableConcept).coding.system.empty() or value.ofType(CodeableConcept).coding.system = 'http://snomed.info/sct'`

Differential View

This structure is derived from USCoreLaboratoryResultObservationProfile

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation |  | 0..* | USCoreLaboratoryResultObservationProfile | Measurements and simple assertions
status |  | 1..1 | code | (USCDI+ Quality) registered | prliminary | final | amended | corrected | entered-in-error | unknown Binding: Non-Negative Observation Status (required)
Slices for category |  | 1..* | CodeableConcept | (USCDI+ Quality) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core |  | 1..1 | CodeableConcept | (USCDI+ Quality) (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 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 | Σ | 1..1 | CodeableConcept | (USCDI+ Quality) (USCDI) Laboratory Test Name Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes
subject |  | 1..1 | Reference(US Quality Core Patient) | Who and/or what the observation is about
effective[x] | Σ | 0..1 |  | Clinically relevant time/time-period for observation
effectiveDateTime |  |  | dateTime |
effectivePeriod |  |  | Period |
effectiveTiming |  |  | Timing |
effectiveInstant |  |  | instant |
issued | Σ | 0..1 | instant | (USCDI+ Quality) Date/Time this version was made available
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 |
interpretation |  | 0..* | CodeableConcept | (USCDI+ Quality) High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
specimen |  | 0..1 | Reference(US Core Specimen Profile) | (USCDI) Specimen used for this observation
referenceRange |  | 0..* | BackboneElement | Result reference range
Documentation for this format

#### Terminology Bindings (Differential)

Path | Status | Usage | ValueSet | Version | Source
Observation.status | Base | required | Non-Negative Observation Status | 📦0.1.0 | 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 | 📦6.1.0 | US Core v6.1
Observation.code | Base | extensible | US Core Laboratory Test Codes | 📦6.1.0 | US Core v6.1
Observation.interpretation | Base | extensible | Observation Interpretation Codes | 📦4.0.1 | FHIR Std.

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | USCoreLaboratoryResultObservationProfile | 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) registered | prliminary | final | amended | corrected | entered-in-error | unknown Binding: Non-Negative Observation Status (required)
Slices for category | S | 1..* | CodeableConcept | (USCDI+ Quality) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core | S | 1..1 | CodeableConcept | (USCDI+ Quality) (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 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 | (USCDI+ Quality) (USCDI) Laboratory Test Name Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes
subject | S 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] | S Σ C | 0..1 |  | 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 | (USCDI+ Quality) 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, us-core-4
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 | (USCDI+ Quality) 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 | S | 0..1 | Reference(US Core Specimen Profile) | (USCDI) Specimen used for this observation
device |  | 0..1 | Reference(Device | DeviceMetric) | (Measurement) Device
referenceRange | C | 0..* | BackboneElement | Result reference range 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 | 📦0.1.0 | 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 | 📦6.1.0 | US Core v6.1
Observation.code | Base | extensible | US Core Laboratory Test Codes | 📦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()`
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'`
us-core-4 | best practice | Observation.value[x] | SHOULD use Snomed CT for coded Results | `value.ofType(CodeableConcept).coding.system.empty() or value.ofType(CodeableConcept).coding.system = 'http://snomed.info/sct'`

This structure is derived from USCoreLaboratoryResultObservationProfile

Summary

Mandatory: 3 elements

Structures

This structure refers to these other structures:

- US Quality Core Patient (http://fhir.org/guides/astp/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