| Left: | US Core Laboratory Result Observation Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-lab) |
| Right: | US Core Laboratory Result Observation Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-lab) |
| Error | StructureDefinition.version | Values for version differ: '3.1.1' vs '7.0.0' |
| Information | StructureDefinition.date | Values for date differ: '2020-06-27' vs '2023-10-17' |
| Information | StructureDefinition.publisher | Values for publisher differ: 'HL7 US Realm Steering Committee' vs 'HL7 International / Cross-Group Projects' |
| Error | StructureDefinition.baseDefinition | Values for baseDefinition differ: 'http://hl7.org/fhir/StructureDefinition/Observation' vs 'http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-clinical-result' |
| Information | StructureDefinition.definition | Values for definition differ: 'This profile is created to meet the 2015 Edition Common Clinical Data Set 'Laboratory test(s) and Laboratory value(s)/result(s)' requirements.' vs 'Measurements and simple assertions made about a patient, device or other subject.' |
| Warning | Observation.meta | Elements differ in definition for mustSupport: 'false' vs 'true' |
| Information | StructureDefinition.definition | Values for definition differ: 'The test that was performed. A LOINC **SHALL** be used if the concept is present in LOINC.' vs 'The name of the clinical test or procedure performed on a patient. A LOINC **SHALL** be used if the concept is present in LOINC.' |
| Information | StructureDefinition.comment | Values for comment differ: 'The typical patterns for codes are: 1) a LOINC code either as a translation from a 'local' code or as a primary code, or 2) a local code only if no suitable LOINC exists, or 3) both the local and the LOINC translation. Systems SHALL be capable of sending the local code if one exists. When using LOINC , Use either the SHORTNAME or LONG_COMMON_NAME field for the display.' vs 'The typical patterns for codes are: 1) a LOINC code either as a translation from a 'local' code or as a primary code, or 2) a local code only if no suitable LOINC exists, or 3) both the local and the LOINC translation. Systems SHALL be capable of sending the local code if one exists. When using LOINC , Use either the SHORTNAME or LONG_COMMON_NAME field for the display.' |
| Information | StructureDefinition.short | Values for short differ: 'Healthcare event during which this observation is made' vs 'Encounter associated with Observation' |
| Warning | Observation.encounter | Elements differ in definition for mustSupport: 'false' vs 'true' |
| Information | StructureDefinition.definition | Values for definition differ: 'For lab tests this is the specimen collection date. For Ask at Order Entry Questions (AOE)'s this is the date the question was asked.' vs 'The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the 'physiologically relevant time'. This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.' |
| Information | StructureDefinition.definition | Values for definition differ: 'The Laboratory result value. If a coded value, the valueCodeableConcept.code **SHOULD** be selected from [SNOMED CT](http://hl7.org/fhir/ValueSet/uslab-obs-codedresults). If a numeric value, valueQuantity.code **SHALL** be selected from [UCUM](http://unitsofmeasure.org). A FHIR [UCUM Codes value set](http://hl7.org/fhir/STU3/valueset-ucum-units.html) that defines all UCUM codes is in the FHIR specification.' vs 'The Laboratory result value. If a coded value, the valueCodeableConcept.code **SHOULD** be selected from [SNOMED CT](http://hl7.org/fhir/ValueSet/uslab-obs-codedresults) if the concept exists. If a numeric value, valueQuantity.code **SHALL** be selected from [UCUM](http://unitsofmeasure.org). A FHIR [UCUM Codes value set](http://hl7.org/fhir/STU3/valueset-ucum-units.html) that defines all UCUM codes is in the FHIR specification.' |
| Information | StructureDefinition.short | Values for short differ: 'High, low, normal, etc.' vs 'Result interpretation' |
| Information | StructureDefinition.comment | Values for comment differ: 'Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.' vs 'Categorical assessment of a laboratory value, often in relation to a test's reference range. Examples include but are not limited to high, low, critical, and normal.' |
| Warning | Observation.interpretation | Elements differ in definition for mustSupport: 'false' vs 'true' |
| Warning | Observation.specimen | Elements differ in definition for mustSupport: 'false' vs 'true' |
| Information | StructureDefinition.short | Values for short differ: 'Provides guide for interpretation' vs 'Result reference range' |
| Information | StructureDefinition.comment | Values for comment differ: 'Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.' vs 'Upper and lower limit of test values expected for a designated population of individuals. Reference range values may differ by patient characteristics, laboratory test manufacturer and laboratory test performer.' |
| Warning | Observation.referenceRange | Elements differ in definition for mustSupport: 'false' vs 'true' |
| Information | StructureDefinition.comment | Values for comment differ: 'When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see [Notes](http://hl7.org/fhir/R4/observation.html#obsgrouping) below. Note that a system may calculate results from [QuestionnaireResponse](http://hl7.org/fhir/R4/questionnaireresponse.html) into a final score and represent the score as an Observation.' vs 'When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see [Notes](http://hl7.org/fhir/R4/observation.html#obsgrouping) below. Note that a system may calculate results from [QuestionnaireResponse](questionnaireresponse.html) into a final score and represent the score as an Observation.' |
| Name | Value | Comments | |
|---|---|---|---|
 abstract | false | ||
| baseDefinition | http://hl7.org/fhir/StructureDefinition/Observation | http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-clinical-result |
|
| copyright | Used by permission of HL7 International, all rights reserved Creative Commons License |
| |
| date | 2020-06-27 | 2023-10-17 |
|
| description | Defines constraints and extensions on the Observation resource for the minimal set of data to query and retrieve laboratory test results | The US Core Laboratory Result Observation Profile is based upon the US Core Observation Clinical Result Profile and, along with the US Core DiagnosticReport Profile for Laboratory Results Reporting, meets the U.S. Core Data for Interoperability (USCDI) Laboratory requirements. Laboratory results are grouped and summarized using the DiagnosticReport resource, which references Observation resources. Each Observation resource represents an individual laboratory test and result value, a “nested” panel (such as a microbial susceptibility panel) that references other observations, or rarely a laboratory test with component result values. The US Core Laboratory Result Observation Profile sets minimum expectations for the Observation resource to record, search, and fetch laboratory test results associated with a patient to promote interoperability and adoption through common implementation. It identifies which core elements, extensions, vocabularies, and value sets SHALL be present in the resource and constrains the way the elements are used when using this profile. It provides the floor for standards development for specific use cases. |
|
| experimental | false | ||
| fhirVersion | 4.0.1 | ||
| jurisdiction | |||
 jurisdiction[0] | urn:iso:std:iso:3166#US | ||
| kind | resource | ||
| name | USCoreLaboratoryResultObservationProfile | ||
| publisher | HL7 US Realm Steering Committee | HL7 International / Cross-Group Projects |
|
| purpose | |||
| status | active | ||
| title | US Core Laboratory Result Observation Profile | ||
| type | Observation | ||
| url | http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-lab | ||
| version | 3.1.1 | 7.0.0 |
|
| Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | R Type | R Description & Constraints | Comments | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 Observation | C | 0..* | Observation | 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 | C | 0..* | USCoreObservationClinicalResultProfile | 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 | string | Logical id of this artifact | Σ | 0..1 | id | Logical id of this artifact | |||||||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | SΣ | 0..1 | Meta | Metadata about the resource |
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 id | 0..1 | string | Unique id for inter-element referencing |
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 Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url |
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| versionId | Σ | 0..1 | id | Version specific identifier |
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| lastUpdated | SΣ | 0..1 | instant | When the resource last changed |
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| source | Σ | 0..1 | uri | Identifies where the resource comes from |
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| profile | Σ | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to |
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| security | Σ | 0..* | Coding | Security Labels applied to this resource Binding: ?? (extensible): Security Labels from the Healthcare Privacy and Security Classification System. |
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| tag | Σ | 0..* | Coding | Tags applied to this resource Binding: ?? (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones". |
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| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ?!Σ | 0..1 | uri | A set of rules under which this content was created | |||||||||
| language | 0..1 | code | Language of the resource content Binding: ?? (preferred): A human language.
| 0..1 | code | Language of the resource content Binding: ?? (preferred): A human language.
| |||||||||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||||||||
| contained | 0..* | Resource | Contained, inline Resources | 0..* | Resource | Contained, inline Resources | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
 modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ?! | 0..* | Extension | Extensions that cannot be ignored | |||||||||
| identifier | Σ | 0..* | Identifier | Business Identifier for observation | Σ | 0..* | Identifier | Business Identifier for observation | |||||||||
| basedOn | Σ | 0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order | 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 | Σ | 0..* | Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) | Part of referenced event | |||||||||
| status | ?!SΣ | 1..1 | code | registered | preliminary | final | amended + Binding: ?? (required) | ?!SΣ | 1..1 | code | registered | preliminary | final | amended + Binding: ?? (required): Codes providing the status of an observation. | |||||||||
| Slices for category | S | 1..* | CodeableConcept | Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ?? (preferred): Codes for high level observation categories. | S | 1..* | CodeableConcept | Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ?? (preferred): Codes for high level observation categories. | |||||||||
| code | SΣ | 1..1 | CodeableConcept | Laboratory Test Name Binding: ?? (extensible): LOINC codes | SΣ | 1..1 | CodeableConcept | Laboratory Test Name Binding: ?? (extensible): Laboratory LOINC Codes | |||||||||
| subject | SΣ | 1..1 | Reference(US Core Patient Profile) | Who and/or what the observation is about | SΣ | 1..1 | Reference(US Core Patient Profile S | Group | Device | US Core Location Profile) | Who and/or what the observation is about | |||||||||
| focus | ΣTU | 0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record | 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 | SΣ | 0..1 | Reference(US Core Encounter Profile) | Encounter associated with Observation |
| ||||||||
| effective[x] | SΣC | 0..1 | dateTime, Period | Clinically relevant time/time-period for observation us-core-1: Datetime must be at least to day. | SΣC | 0..1 | dateTime S, Period, Timing, instant | Clinically relevant time/time-period for observation us-core-1: Datetime must be at least to day. | |||||||||
| issued | Σ | 0..1 | instant | Date/Time this version was made available | Σ | 0..1 | instant | Date/Time this version was made available | |||||||||
| performer | Σ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | Who is responsible for the observation | Σ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | Who is responsible for the observation | |||||||||
| value[x] | SΣC | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Result Value us-core-4: SHOULD use Snomed CT for coded Results us-core-3: SHALL use UCUM for coded quantity units. | SΣC | 0..1 | Quantity S, CodeableConcept S, string S, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Result Value us-core-3: SHALL use UCUM for coded quantity units. us-core-4: SHOULD use Snomed CT for coded Results | |||||||||
| dataAbsentReason | SC | 0..1 | CodeableConcept | Why the result is missing Binding: ?? (extensible) | SC | 0..1 | CodeableConcept | Why the result is missing Binding: ?? (extensible): Codes specifying why the result (Observation.value[x]) is missing. | |||||||||
| interpretation | 0..* | CodeableConcept | High, low, normal, etc. Binding: ?? (extensible): Codes identifying interpretations of observations. | S | 0..* | CodeableConcept | Result interpretation Binding: ?? (extensible): Observation Interpretation Codes |
| |||||||||
| note | 0..* | Annotation | Comments about the observation | 0..* | Annotation | Comments about the observation | |||||||||||
| bodySite | 0..1 | CodeableConcept | Observed body part Binding: ?? (example): Codes describing anatomical locations. May include laterality. | 0..1 | CodeableConcept | Observed body part Binding: ?? (example): Codes describing anatomical locations. May include laterality. | |||||||||||
| method | 0..1 | CodeableConcept | How it was done Binding: ?? (example): Methods for simple observations. | 0..1 | CodeableConcept | How it was done Binding: ?? (example): Methods for simple observations. | |||||||||||
| specimen | 0..1 | Reference(Specimen) | Specimen used for this observation | S | 0..1 | Reference(US Core Specimen Profile) | Specimen used for this observation |
| |||||||||
| device | 0..1 | Reference(Device | DeviceMetric) | (Measurement) 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 | 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 | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| low | C | 0..1 | ?? | Low Range, if relevant | C | 0..1 | ?? | Low Range, if relevant | |||||||||
| high | C | 0..1 | ?? | High Range, if relevant | C | 0..1 | ?? | High Range, if relevant | |||||||||
| type | 0..1 | CodeableConcept | Reference range qualifier Binding: ?? (preferred): Code for the meaning of a reference range. | 0..1 | CodeableConcept | Reference range qualifier Binding: ?? (preferred): Code for the meaning of a reference range. | |||||||||||
| appliesTo | 0..* | CodeableConcept | Reference range population Binding: ?? (example): Codes identifying the population the reference range applies to. | 0..* | CodeableConcept | Reference range population Binding: ?? (example): Codes identifying the population the reference range applies to. | |||||||||||
| age | 0..1 | Range | Applicable age range, if relevant | 0..1 | Range | Applicable age range, if relevant | |||||||||||
| text | 0..1 | string | Text based reference range in an observation | 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 | 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 | Σ | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Related measurements the observation is made from | |||||||||
| component | Σ | 0..* | BackboneElement | Component results | Σ | 0..* | BackboneElement | Component results | |||||||||
 id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| code | Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: ?? (example): Codes identifying names of simple observations. | Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: ?? (example): Codes identifying names of simple observations. | |||||||||
| value[x] | Σ | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Actual component result | Σ | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Actual component result | |||||||||
| dataAbsentReason | C | 0..1 | CodeableConcept | Why the component result is missing Binding: ?? (extensible): Codes specifying why the result (Observation.value[x]) is missing. | C | 0..1 | CodeableConcept | Why the component result is missing Binding: ?? (extensible): Codes specifying why the result (Observation.value[x]) is missing. | |||||||||
| interpretation | 0..* | CodeableConcept | High, low, normal, etc. Binding: ?? (extensible): Codes identifying interpretations of observations. | 0..* | CodeableConcept | High, low, normal, etc. Binding: ?? (extensible): Codes identifying interpretations of observations. | |||||||||||
 referenceRange | 0..* | See referenceRange | Provides guide for interpretation of component result | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result | |||||||||||
| Documentation for this format | |||||||||||||||||