QI-Core Implementation Guide
7.0.0-ballot - STU7 Ballot United States of America flag

This page is part of the Quality Improvement Core Framework (v7.0.0-ballot: STU7 (v7.0.0) Ballot) based on FHIR (HL7® FHIR® Standard) R4. The current version which supersedes this version is 7.0.1. For a full list of available versions, see the Directory of published versions

Resource Profile: QICore Laboratory Result Observation

Official URL: http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-observation-lab Version: 7.0.0-ballot
Active as of 2022-05-31 Computable Name: QICoreLaboratoryResultObservation

The QI-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.

Must Have:
  • status: (QI) registered | prliminary | final | amended | corrected | entered-in-error | unknown
  • category: (QI) Classification of type of observation
  • category: (QI) Classification of type of observation
  • code: (QI) Laboratory Test Name
  • subject: (QI) Who and/or what the observation is about
QI Elements:
  • effective[x]: (QI) Clinically relevant time/time-period for observation
  • issued: (QI) Date/Time this version was made available
  • value[x]: (QI) Result Value
  • interpretation: (QI) High, low, normal, etc.
Primary code path: code
(PCPath) This element is the primary code path for this resource CQL Retrieve


NOTE TO BALLOT REVIEWERS:
  • US Core 7.0, and thus QI-Core 7.0, has a new approach to USCDI requirements.
    • As noted in the US Core 7.0 Must Support section, US Core 7.0 no longer highlights mandatory (cardinality 1..* or 1..1) and Must Support elements with a (USCDI) indicator as such items must be supported for interoperability.
    • Those USCDI elements that are not mandatory or Must Support now include an indicator (ADDITIONAL USCDI) in US Core. QI-Core 7.0 does not reference USCDI elements; rather, users should access US Core 7.0 to understand its implementation of USCDI version 4.
  • We invite comments about the approach and suggestions for other options that would also avoid unnecessary noise or reading load to the QI-Core profile representation.
  • Further, QI-Core 7.0 does not discuss USCDI+Quality because at the time of ballot preparation, no published version of USCDI+Quality is available. We seek reviewer advice regarding how QI-Core might address future USCDI+Quality.

Usage

See the patterns page for implementation and usage patterns.

Examples

Glucose Laboratory Result Observation Example

Usage:

Formal Views of Profile Content

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

This structure is derived from USCoreLaboratoryResultObservationProfile

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation USCoreLaboratoryResultObservationProfile
... meta 0..1 Meta Metadata about the resource
.... lastUpdated 0..1 instant When the resource last changed
... status 1..1 code (QI) registered | prliminary | final | amended | corrected | entered-in-error | unknown
Binding: Non-Negative Observation Status (required)
... Slices for category 1..* CodeableConcept (QI) 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 (QI) 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
... subject 1..1 Reference(QICore Patient) (QI) Who and/or what the observation is about
... encounter 0..1 Reference(QICore Encounter) (QI) Encounter associated with Observation
... effective[x] Σ 0..1 (QI) Clinically relevant time/time-period for observation
.... effectiveDateTime dateTime
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... issued Σ 0..1 instant (QI) Date/Time this version was made available
... value[x] 0..1 (QI) Result Value
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
... interpretation 0..* CodeableConcept (QI) High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.



doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet / CodeURI
Observation.statusrequiredNonNegativeObservationStatus
http://hl7.org/fhir/us/qicore/ValueSet/qicore-non-negative-observation-status
from this IG
Observation.categorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:us-corerequiredPattern: laboratory
http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
Observation.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
Observation.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* USCoreLaboratoryResultObservationProfile Measurements and simple assertions
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
... meta SΣ 0..1 Meta Metadata about the resource
.... lastUpdated SΣ 0..1 instant When the resource last changed
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... Slices for category S 1..* CodeableConcept (QI) 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 (QI) 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 SΣ 1..1 CodeableConcept (QI) Laboratory Test Name
Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes

... subject SΣ 1..1 Reference(QICore Patient) (QI) Who and/or what the observation is about
... encounter SΣ 0..1 Reference(QICore Encounter) (QI) Encounter associated with Observation
... effective[x] SΣC 0..1 (QI) Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTime dateTime
... issued Σ 0..1 instant (QI) Date/Time this version was made available
... value[x] SΣC 0..1 (QI) Result Value
us-core-3: SHALL use UCUM for coded quantity units.
us-core-4: SHOULD use Snomed CT for coded Results
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
... dataAbsentReason SC 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... interpretation S 0..* CodeableConcept (QI) High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


... specimen S 0..1 Reference(US Core Specimen Profile) Specimen used for this observation
... referenceRange SC 0..* BackboneElement Result reference range
obs-3: Must have at least a low or a high or text
us-core-22: SHALL use UCUM for coded quantity units.
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Observation.statusrequiredNonNegativeObservationStatus
http://hl7.org/fhir/us/qicore/ValueSet/qicore-non-negative-observation-status
from this IG
Observation.categorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:us-corerequiredPattern: laboratory
http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
Observation.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
Observation.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorObservationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
: value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
us-core-1errorObservation.effective[x]Datetime must be at least to day.
: $this is dateTime implies $this.toString().length() >= 10
us-core-2errorObservationIf 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-3errorObservation.value[x]SHALL use UCUM for coded quantity units.
: ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'
us-core-4best practiceObservation.value[x]SHOULD use Snomed CT for coded Results
: ofType(CodeableConcept).coding.system.empty() or (ofType(CodeableConcept).coding.system contains 'http://snomed.info/sct')
us-core-22errorObservation.referenceRangeSHALL use UCUM for coded quantity units.
: (low.system.empty() or low.system = 'http://unitsofmeasure.org') and (high.system.empty() or high.system = 'http://unitsofmeasure.org')
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* USCoreLaboratoryResultObservationProfile Measurements and simple assertions
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
... id Σ 0..1 id Logical id of this artifact
... meta SΣ 0..1 Meta Metadata about the resource
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated SΣ 0..1 instant When the resource last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile Σ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".


... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business Identifier for observation
... basedOn Σ 0..* Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Fulfills plan, proposal or order
... partOf Σ 0..* Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) Part of referenced event
... status ?!SΣ 1..1 code (QI) registered | prliminary | final | amended | corrected | entered-in-error | unknown
Binding: Non-Negative Observation Status (required)
... Slices for category S 1..* CodeableConcept (QI) 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 (QI) 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 SΣ 1..1 CodeableConcept (QI) Laboratory Test Name
Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes

... subject SΣ 1..1 Reference(QICore Patient) (QI) 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 SΣ 0..1 Reference(QICore Encounter) (QI) Encounter associated with Observation
... effective[x] SΣC 0..1 (QI) Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTime dateTime S
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... issued Σ 0..1 instant (QI) 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] SΣC 0..1 (QI) Result Value
us-core-3: SHALL use UCUM for coded quantity units.
us-core-4: SHOULD use Snomed CT for coded Results
.... valueQuantity Quantity S
.... valueCodeableConcept CodeableConcept S
.... valueString string S
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
... dataAbsentReason SC 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... interpretation S 0..* CodeableConcept (QI) 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) Specimen used for this observation
... device 0..1 Reference(Device | DeviceMetric) (Measurement) Device
... referenceRange SC 0..* BackboneElement Result reference range
obs-3: Must have at least a low or a high or text
us-core-22: SHALL use UCUM for coded quantity units.
.... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Observation.meta.securityextensibleAll Security Labels
http://hl7.org/fhir/ValueSet/security-labels
from the FHIR Standard
Observation.meta.tagexampleCommonTags
http://hl7.org/fhir/ValueSet/common-tags
from the FHIR Standard
Observation.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
Observation.statusrequiredNonNegativeObservationStatus
http://hl7.org/fhir/us/qicore/ValueSet/qicore-non-negative-observation-status
from this IG
Observation.categorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:us-corerequiredPattern: laboratory
http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
Observation.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
Observation.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard
Observation.bodySiteexampleSNOMEDCTBodyStructures
http://hl7.org/fhir/ValueSet/body-site
from the FHIR Standard
Observation.methodexampleObservationMethods
http://hl7.org/fhir/ValueSet/observation-methods
from the FHIR Standard
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
http://hl7.org/fhir/ValueSet/referencerange-meaning
from the FHIR Standard
Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
http://hl7.org/fhir/ValueSet/referencerange-appliesto
from the FHIR Standard
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.component.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorObservationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
: value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
us-core-1errorObservation.effective[x]Datetime must be at least to day.
: $this is dateTime implies $this.toString().length() >= 10
us-core-2errorObservationIf 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-3errorObservation.value[x]SHALL use UCUM for coded quantity units.
: ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'
us-core-4best practiceObservation.value[x]SHOULD use Snomed CT for coded Results
: ofType(CodeableConcept).coding.system.empty() or (ofType(CodeableConcept).coding.system contains 'http://snomed.info/sct')
us-core-22errorObservation.referenceRangeSHALL use UCUM for coded quantity units.
: (low.system.empty() or low.system = 'http://unitsofmeasure.org') and (high.system.empty() or high.system = 'http://unitsofmeasure.org')

This structure is derived from USCoreLaboratoryResultObservationProfile

Summary

Mandatory: 3 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

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

Differential View

This structure is derived from USCoreLaboratoryResultObservationProfile

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation USCoreLaboratoryResultObservationProfile
... meta 0..1 Meta Metadata about the resource
.... lastUpdated 0..1 instant When the resource last changed
... status 1..1 code (QI) registered | prliminary | final | amended | corrected | entered-in-error | unknown
Binding: Non-Negative Observation Status (required)
... Slices for category 1..* CodeableConcept (QI) 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 (QI) 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
... subject 1..1 Reference(QICore Patient) (QI) Who and/or what the observation is about
... encounter 0..1 Reference(QICore Encounter) (QI) Encounter associated with Observation
... effective[x] Σ 0..1 (QI) Clinically relevant time/time-period for observation
.... effectiveDateTime dateTime
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... issued Σ 0..1 instant (QI) Date/Time this version was made available
... value[x] 0..1 (QI) Result Value
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
... interpretation 0..* CodeableConcept (QI) High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.



doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet / CodeURI
Observation.statusrequiredNonNegativeObservationStatus
http://hl7.org/fhir/us/qicore/ValueSet/qicore-non-negative-observation-status
from this IG
Observation.categorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:us-corerequiredPattern: laboratory
http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
Observation.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
Observation.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* USCoreLaboratoryResultObservationProfile Measurements and simple assertions
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
... meta SΣ 0..1 Meta Metadata about the resource
.... lastUpdated SΣ 0..1 instant When the resource last changed
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... Slices for category S 1..* CodeableConcept (QI) 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 (QI) 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 SΣ 1..1 CodeableConcept (QI) Laboratory Test Name
Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes

... subject SΣ 1..1 Reference(QICore Patient) (QI) Who and/or what the observation is about
... encounter SΣ 0..1 Reference(QICore Encounter) (QI) Encounter associated with Observation
... effective[x] SΣC 0..1 (QI) Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTime dateTime
... issued Σ 0..1 instant (QI) Date/Time this version was made available
... value[x] SΣC 0..1 (QI) Result Value
us-core-3: SHALL use UCUM for coded quantity units.
us-core-4: SHOULD use Snomed CT for coded Results
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
... dataAbsentReason SC 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... interpretation S 0..* CodeableConcept (QI) High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


... specimen S 0..1 Reference(US Core Specimen Profile) Specimen used for this observation
... referenceRange SC 0..* BackboneElement Result reference range
obs-3: Must have at least a low or a high or text
us-core-22: SHALL use UCUM for coded quantity units.
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Observation.statusrequiredNonNegativeObservationStatus
http://hl7.org/fhir/us/qicore/ValueSet/qicore-non-negative-observation-status
from this IG
Observation.categorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:us-corerequiredPattern: laboratory
http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
Observation.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
Observation.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorObservationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
: value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
us-core-1errorObservation.effective[x]Datetime must be at least to day.
: $this is dateTime implies $this.toString().length() >= 10
us-core-2errorObservationIf 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-3errorObservation.value[x]SHALL use UCUM for coded quantity units.
: ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'
us-core-4best practiceObservation.value[x]SHOULD use Snomed CT for coded Results
: ofType(CodeableConcept).coding.system.empty() or (ofType(CodeableConcept).coding.system contains 'http://snomed.info/sct')
us-core-22errorObservation.referenceRangeSHALL use UCUM for coded quantity units.
: (low.system.empty() or low.system = 'http://unitsofmeasure.org') and (high.system.empty() or high.system = 'http://unitsofmeasure.org')

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* USCoreLaboratoryResultObservationProfile Measurements and simple assertions
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
... id Σ 0..1 id Logical id of this artifact
... meta SΣ 0..1 Meta Metadata about the resource
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated SΣ 0..1 instant When the resource last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile Σ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".


... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business Identifier for observation
... basedOn Σ 0..* Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Fulfills plan, proposal or order
... partOf Σ 0..* Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) Part of referenced event
... status ?!SΣ 1..1 code (QI) registered | prliminary | final | amended | corrected | entered-in-error | unknown
Binding: Non-Negative Observation Status (required)
... Slices for category S 1..* CodeableConcept (QI) 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 (QI) 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 SΣ 1..1 CodeableConcept (QI) Laboratory Test Name
Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes

... subject SΣ 1..1 Reference(QICore Patient) (QI) 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 SΣ 0..1 Reference(QICore Encounter) (QI) Encounter associated with Observation
... effective[x] SΣC 0..1 (QI) Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTime dateTime S
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... issued Σ 0..1 instant (QI) 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] SΣC 0..1 (QI) Result Value
us-core-3: SHALL use UCUM for coded quantity units.
us-core-4: SHOULD use Snomed CT for coded Results
.... valueQuantity Quantity S
.... valueCodeableConcept CodeableConcept S
.... valueString string S
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
... dataAbsentReason SC 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... interpretation S 0..* CodeableConcept (QI) 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) Specimen used for this observation
... device 0..1 Reference(Device | DeviceMetric) (Measurement) Device
... referenceRange SC 0..* BackboneElement Result reference range
obs-3: Must have at least a low or a high or text
us-core-22: SHALL use UCUM for coded quantity units.
.... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Observation.meta.securityextensibleAll Security Labels
http://hl7.org/fhir/ValueSet/security-labels
from the FHIR Standard
Observation.meta.tagexampleCommonTags
http://hl7.org/fhir/ValueSet/common-tags
from the FHIR Standard
Observation.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
Observation.statusrequiredNonNegativeObservationStatus
http://hl7.org/fhir/us/qicore/ValueSet/qicore-non-negative-observation-status
from this IG
Observation.categorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:us-corerequiredPattern: laboratory
http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
Observation.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
Observation.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard
Observation.bodySiteexampleSNOMEDCTBodyStructures
http://hl7.org/fhir/ValueSet/body-site
from the FHIR Standard
Observation.methodexampleObservationMethods
http://hl7.org/fhir/ValueSet/observation-methods
from the FHIR Standard
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
http://hl7.org/fhir/ValueSet/referencerange-meaning
from the FHIR Standard
Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
http://hl7.org/fhir/ValueSet/referencerange-appliesto
from the FHIR Standard
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.component.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorObservationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
: value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
us-core-1errorObservation.effective[x]Datetime must be at least to day.
: $this is dateTime implies $this.toString().length() >= 10
us-core-2errorObservationIf 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-3errorObservation.value[x]SHALL use UCUM for coded quantity units.
: ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'
us-core-4best practiceObservation.value[x]SHOULD use Snomed CT for coded Results
: ofType(CodeableConcept).coding.system.empty() or (ofType(CodeableConcept).coding.system contains 'http://snomed.info/sct')
us-core-22errorObservation.referenceRangeSHALL use UCUM for coded quantity units.
: (low.system.empty() or low.system = 'http://unitsofmeasure.org') and (high.system.empty() or high.system = 'http://unitsofmeasure.org')

This structure is derived from USCoreLaboratoryResultObservationProfile

Summary

Mandatory: 3 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

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

 

Other representations of profile: CSV, Excel, Schematron