QI-Core Implementation Guide
6.0.0 - STU6
QI-Core Implementation Guide
6.0.0 - STU6
This page is part of the Quality Improvement Core Framework (v6.0.0: STU6 (v6.0.0)) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions
| Official URL: http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-observation-lab | Version: 6.0.0 | |||
| 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.
| Glucose Laboratory Result Observation Example |
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from USCoreLaboratoryResultObservationProfile
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Observation | USCoreLaboratoryResultObservationProfile | |||
  status | 1..1 | code | (QI-Core)(USCDI) registered | prliminary | final | amended | corrected | entered-in-error | unknown Binding: Non-Negative Observation Status (required) | |
  Slices for category | 1..* | CodeableConcept | (QI-Core)(USCDI) 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-Core)(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 | (QI-Core)(USCDI) Laboratory Test Name Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes |
 subject | 1..1 | Reference(QICore Patient) | (QI-Core)(USCDI) Who and/or what the observation is about | |
 effective[x] | Σ | 0..1 | (QI-Core)(USCDI) Clinically relevant time/time-period for observation | |
 effectiveDateTime | dateTime | |||
| effectivePeriod | Period | |||
| effectiveTiming | Timing | |||
| effectiveInstant | instant | |||
| issued | Σ | 0..1 | instant | (QI-Core) Date/Time this version was made available |
| value[x] | 0..1 | (QI-Core)(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 | (QI-Core) High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| Observation.status | required | NonNegativeObservationStatushttp://hl7.org/fhir/us/qicore/ValueSet/qicore-non-negative-observation-statusfrom this IG | |
| Observation.category | preferred | ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-categoryfrom the FHIR Standard | |
| Observation.category:us-core | required | Pattern: laboratoryhttp://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category | |
| Observation.code | extensible | USCoreLaboratoryTestCodeshttp://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes | |
| Observation.interpretation | extensible | ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretationfrom the FHIR Standard |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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 |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
 modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| status | ?!SΣ | 1..1 | code | (QI-Core)(USCDI) registered | prliminary | final | amended | corrected | entered-in-error | unknown Binding: Non-Negative Observation Status (required) |
| Slices for category | S | 1..* | CodeableConcept | (QI-Core)(USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. |
| category:us-core | S | 1..1 | CodeableConcept | (QI-Core)(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 | SΣ | 1..1 | CodeableConcept | (QI-Core)(USCDI) Laboratory Test Name Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes |
| subject | SΣ | 1..1 | Reference(QICore Patient) | (QI-Core)(USCDI) Who and/or what the observation is about |
| effective[x] | SΣC | 0..1 | (QI-Core)(USCDI) 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-Core) Date/Time this version was made available |
| value[x] | SΣC | 0..1 | (QI-Core)(USCDI) 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 | (USCDI) Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. |
| interpretation | 0..* | CodeableConcept | (QI-Core) 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 |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| Observation.status | required | NonNegativeObservationStatushttp://hl7.org/fhir/us/qicore/ValueSet/qicore-non-negative-observation-statusfrom this IG | |
| Observation.category | preferred | ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-categoryfrom the FHIR Standard | |
| Observation.category:us-core | required | Pattern: laboratoryhttp://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category | |
| Observation.code | extensible | USCoreLaboratoryTestCodeshttp://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes | |
| Observation.dataAbsentReason | extensible | DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reasonfrom the FHIR Standard | |
| Observation.interpretation | extensible | ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretationfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Observation | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Observation | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty() | |
| obs-7 | error | Observation | If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty() | |
| us-core-1 | error | Observation.effective[x] | Datetime must be at least to day. : $this is DateTime implies $this.toString().length() >= 10 | |
| us-core-2 | error | Observation | If there is no component or hasMember element then either a value[x] or a data absent reason must be present : (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists()) | |
| us-core-3 | error | Observation.value[x] | SHALL use UCUM for coded quantity units. : value.ofType(Quantity).system.empty() or value.ofType(Quantity).system = 'http://unitsofmeasure.org' | |
| 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' |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| 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 | 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.
| |||||
| 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-Core)(USCDI) registered | prliminary | final | amended | corrected | entered-in-error | unknown Binding: Non-Negative Observation Status (required) | ||||
| Slices for category | S | 1..* | CodeableConcept | (QI-Core)(USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. | ||||
| category:us-core | S | 1..1 | CodeableConcept | (QI-Core)(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 | SΣ | 1..1 | CodeableConcept | (QI-Core)(USCDI) Laboratory Test Name Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes | ||||
| subject | SΣ | 1..1 | Reference(QICore Patient) | (QI-Core)(USCDI) Who and/or what the observation is about | ||||
| focus | Σ | 0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record | ||||
| encounter | Σ | 0..1 | Reference(Encounter) | Healthcare event during which this observation is made | ||||
| effective[x] | SΣC | 0..1 | (QI-Core)(USCDI) 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-Core) 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-Core)(USCDI) 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 | |||||||
| valueTime | time | |||||||
| valueDateTime | dateTime | |||||||
| valuePeriod | Period | |||||||
| dataAbsentReason | SC | 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 | (QI-Core) 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 | Provides guide for interpretation obs-3: Must have at least a low or a high or text | ||||
| 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 | ||||||||
| Path | Conformance | ValueSet / Code | URI | |||
| Observation.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| Observation.status | required | NonNegativeObservationStatushttp://hl7.org/fhir/us/qicore/ValueSet/qicore-non-negative-observation-statusfrom this IG | ||||
| Observation.category | preferred | ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-categoryfrom the FHIR Standard | ||||
| Observation.category:us-core | required | Pattern: laboratoryhttp://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category | ||||
| Observation.code | extensible | USCoreLaboratoryTestCodeshttp://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes | ||||
| Observation.dataAbsentReason | extensible | DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reasonfrom the FHIR Standard | ||||
| Observation.interpretation | extensible | ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretationfrom the FHIR Standard | ||||
| Observation.bodySite | example | SNOMEDCTBodyStructureshttp://hl7.org/fhir/ValueSet/body-sitefrom the FHIR Standard | ||||
| Observation.method | example | ObservationMethodshttp://hl7.org/fhir/ValueSet/observation-methodsfrom the FHIR Standard | ||||
| Observation.referenceRange.type | preferred | ObservationReferenceRangeMeaningCodeshttp://hl7.org/fhir/ValueSet/referencerange-meaningfrom the FHIR Standard | ||||
| Observation.referenceRange.appliesTo | example | ObservationReferenceRangeAppliesToCodeshttp://hl7.org/fhir/ValueSet/referencerange-appliestofrom the FHIR Standard | ||||
| Observation.component.code | example | LOINCCodes (a valid code from LOINC)http://hl7.org/fhir/ValueSet/observation-codesfrom the FHIR Standard | ||||
| Observation.component.dataAbsentReason | extensible | DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reasonfrom the FHIR Standard | ||||
| Observation.component.interpretation | extensible | ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretationfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| 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 $this.toString().length() >= 10 | |
| us-core-2 | error | Observation | If there is no component or hasMember element then either a value[x] or a data absent reason must be present : (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists()) | |
| us-core-3 | error | Observation.value[x] | SHALL use UCUM for coded quantity units. : value.ofType(Quantity).system.empty() or value.ofType(Quantity).system = 'http://unitsofmeasure.org' | |
| us-core-4 | best practice | Observation.value[x] | SHOULD use Snomed CT for coded Results : value.ofType(CodeableConcept).coding.system.empty() or value.ofType(CodeableConcept).coding.system = 'http://snomed.info/sct' |
This structure is derived from USCoreLaboratoryResultObservationProfile
Summary
Mandatory: 3 elements
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Differential View
This structure is derived from USCoreLaboratoryResultObservationProfile
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Observation | USCoreLaboratoryResultObservationProfile | |||
| status | 1..1 | code | (QI-Core)(USCDI) registered | prliminary | final | amended | corrected | entered-in-error | unknown Binding: Non-Negative Observation Status (required) | |
| Slices for category | 1..* | CodeableConcept | (QI-Core)(USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. | |
| category:us-core | 1..1 | CodeableConcept | (QI-Core)(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 | (QI-Core)(USCDI) Laboratory Test Name Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes |
| subject | 1..1 | Reference(QICore Patient) | (QI-Core)(USCDI) Who and/or what the observation is about | |
| effective[x] | Σ | 0..1 | (QI-Core)(USCDI) Clinically relevant time/time-period for observation | |
| effectiveDateTime | dateTime | |||
| effectivePeriod | Period | |||
| effectiveTiming | Timing | |||
| effectiveInstant | instant | |||
| issued | Σ | 0..1 | instant | (QI-Core) Date/Time this version was made available |
| value[x] | 0..1 | (QI-Core)(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 | (QI-Core) High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| Observation.status | required | NonNegativeObservationStatushttp://hl7.org/fhir/us/qicore/ValueSet/qicore-non-negative-observation-statusfrom this IG | |
| Observation.category | preferred | ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-categoryfrom the FHIR Standard | |
| Observation.category:us-core | required | Pattern: laboratoryhttp://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category | |
| Observation.code | extensible | USCoreLaboratoryTestCodeshttp://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes | |
| Observation.interpretation | extensible | ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretationfrom the FHIR Standard |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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 |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| status | ?!SΣ | 1..1 | code | (QI-Core)(USCDI) registered | prliminary | final | amended | corrected | entered-in-error | unknown Binding: Non-Negative Observation Status (required) |
| Slices for category | S | 1..* | CodeableConcept | (QI-Core)(USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. |
| category:us-core | S | 1..1 | CodeableConcept | (QI-Core)(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 | SΣ | 1..1 | CodeableConcept | (QI-Core)(USCDI) Laboratory Test Name Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes |
| subject | SΣ | 1..1 | Reference(QICore Patient) | (QI-Core)(USCDI) Who and/or what the observation is about |
| effective[x] | SΣC | 0..1 | (QI-Core)(USCDI) 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-Core) Date/Time this version was made available |
| value[x] | SΣC | 0..1 | (QI-Core)(USCDI) 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 | (USCDI) Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. |
| interpretation | 0..* | CodeableConcept | (QI-Core) 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 |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| Observation.status | required | NonNegativeObservationStatushttp://hl7.org/fhir/us/qicore/ValueSet/qicore-non-negative-observation-statusfrom this IG | |
| Observation.category | preferred | ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-categoryfrom the FHIR Standard | |
| Observation.category:us-core | required | Pattern: laboratoryhttp://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category | |
| Observation.code | extensible | USCoreLaboratoryTestCodeshttp://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes | |
| Observation.dataAbsentReason | extensible | DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reasonfrom the FHIR Standard | |
| Observation.interpretation | extensible | ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretationfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Observation | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Observation | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty() | |
| obs-7 | error | Observation | If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty() | |
| us-core-1 | error | Observation.effective[x] | Datetime must be at least to day. : $this is DateTime implies $this.toString().length() >= 10 | |
| us-core-2 | error | Observation | If there is no component or hasMember element then either a value[x] or a data absent reason must be present : (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists()) | |
| us-core-3 | error | Observation.value[x] | SHALL use UCUM for coded quantity units. : value.ofType(Quantity).system.empty() or value.ofType(Quantity).system = 'http://unitsofmeasure.org' | |
| 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' |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| 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 | 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.
| |||||
| 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-Core)(USCDI) registered | prliminary | final | amended | corrected | entered-in-error | unknown Binding: Non-Negative Observation Status (required) | ||||
| Slices for category | S | 1..* | CodeableConcept | (QI-Core)(USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. | ||||
| category:us-core | S | 1..1 | CodeableConcept | (QI-Core)(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 | SΣ | 1..1 | CodeableConcept | (QI-Core)(USCDI) Laboratory Test Name Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes | ||||
| subject | SΣ | 1..1 | Reference(QICore Patient) | (QI-Core)(USCDI) Who and/or what the observation is about | ||||
| focus | Σ | 0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record | ||||
| encounter | Σ | 0..1 | Reference(Encounter) | Healthcare event during which this observation is made | ||||
| effective[x] | SΣC | 0..1 | (QI-Core)(USCDI) 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-Core) 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-Core)(USCDI) 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 | |||||||
| valueTime | time | |||||||
| valueDateTime | dateTime | |||||||
| valuePeriod | Period | |||||||
| dataAbsentReason | SC | 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 | (QI-Core) 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 | Provides guide for interpretation obs-3: Must have at least a low or a high or text | ||||
| 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 | ||||||||
| Path | Conformance | ValueSet / Code | URI | |||
| Observation.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| Observation.status | required | NonNegativeObservationStatushttp://hl7.org/fhir/us/qicore/ValueSet/qicore-non-negative-observation-statusfrom this IG | ||||
| Observation.category | preferred | ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-categoryfrom the FHIR Standard | ||||
| Observation.category:us-core | required | Pattern: laboratoryhttp://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category | ||||
| Observation.code | extensible | USCoreLaboratoryTestCodeshttp://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes | ||||
| Observation.dataAbsentReason | extensible | DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reasonfrom the FHIR Standard | ||||
| Observation.interpretation | extensible | ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretationfrom the FHIR Standard | ||||
| Observation.bodySite | example | SNOMEDCTBodyStructureshttp://hl7.org/fhir/ValueSet/body-sitefrom the FHIR Standard | ||||
| Observation.method | example | ObservationMethodshttp://hl7.org/fhir/ValueSet/observation-methodsfrom the FHIR Standard | ||||
| Observation.referenceRange.type | preferred | ObservationReferenceRangeMeaningCodeshttp://hl7.org/fhir/ValueSet/referencerange-meaningfrom the FHIR Standard | ||||
| Observation.referenceRange.appliesTo | example | ObservationReferenceRangeAppliesToCodeshttp://hl7.org/fhir/ValueSet/referencerange-appliestofrom the FHIR Standard | ||||
| Observation.component.code | example | LOINCCodes (a valid code from LOINC)http://hl7.org/fhir/ValueSet/observation-codesfrom the FHIR Standard | ||||
| Observation.component.dataAbsentReason | extensible | DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reasonfrom the FHIR Standard | ||||
| Observation.component.interpretation | extensible | ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretationfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| 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:
Slices
This structure defines the following Slices:
Other representations of profile: CSV, Excel, Schematron
IG © 2019+ HL7 International / Clinical Quality Information. Package hl7.fhir.us.qicore#6.0.0 based on FHIR 4.0.1. Generated 2024-03-01
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