| Left: | US Core Laboratory Result Observation Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-lab) |
| Right: | Genomic Variant Profile (http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-genomic-variant) |
| Error | StructureDefinition.url | Values for url differ: 'http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-lab' vs 'http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-genomic-variant' |
| Error | StructureDefinition.version | Values for version differ: '7.0.0' vs '4.0.0' |
| Information | StructureDefinition.name | Values for name differ: 'USCoreLaboratoryResultObservationProfile' vs 'GenomicVariant' |
| Information | StructureDefinition.title | Values for title differ: 'US Core Laboratory Result Observation Profile' vs 'Genomic Variant Profile' |
| Information | StructureDefinition.date | Values for date differ: '2023-10-17' vs '2024-11-20T20:23:08+00:00' |
| Information | StructureDefinition.publisher | Values for publisher differ: 'HL7 International / Cross-Group Projects' vs 'HL7 International / Clinical Interoperability Council' |
| Error | StructureDefinition.baseDefinition | Values for baseDefinition differ: 'http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-clinical-result' vs 'http://hl7.org/fhir/uv/genomics-reporting/StructureDefinition/variant' |
| Information | StructureDefinition.short | Values for short differ: 'Measurements and simple assertions' vs 'Variant' |
| Warning | Observation.meta | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Additional content defined by implementations' vs 'Extension' |
| Information | StructureDefinition.definition | Values for definition differ: 'May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'An Extension' |
| Information | StructureDefinition.short | Values for short differ: 'Laboratory Test Name' vs '69548-6' |
| Information | StructureDefinition.definition | Values for definition differ: 'The name of the clinical test or procedure performed on a patient. A LOINC **SHALL** be used if the concept is present in LOINC.' vs 'Describes what was observed. Sometimes this is called the observation 'name'.' |
| 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 '*All* code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.' |
| Information | Observation.subject | Element minimum cardinalities differ: '1' vs '0' |
| Information | StructureDefinition.short | Values for short differ: 'Encounter associated with Observation' vs 'Healthcare event during which this observation is made' |
| Warning | Observation.encounter | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Result Value' vs 'Actual result' |
| 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 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.' vs 'The information determined as a result of making the observation, if the information has a simple value.' |
| Information | StructureDefinition.short | Values for short differ: 'Result interpretation' vs 'High, low, normal, etc.' |
| Information | StructureDefinition.comment | Values for comment differ: '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.' vs '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.' |
| Warning | Observation.interpretation | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Comments about the observation' vs 'Comments about the Observation that also contain a coded type' |
| Information | StructureDefinition.definition | Values for definition differ: 'Comments about the observation or the results.' vs 'A text note which also contains information about who made the statement and when.' |
| Information | StructureDefinition.comment | Values for comment differ: 'May include general statements about the observation, or statements about significant, unexpected or unreliable results values, or information about its source when relevant to its interpretation.' vs 'May include general statements about the observation, or statements about significant, unexpected or unreliable results values, or information about its source when relevant to its interpretation. The CodedAnnotation data type, while not allowing for or intending to make the content computable, does allow the author to indicate the type of note. This does not replace the use of interpretation, value, or component values. One important note is that Annotation is a FHIR data type, this is **NOT** about annotations in the genomic context.' |
| Information | StructureDefinition.requirements | Values for requirements differ: 'Need to be able to provide free text additional information.' vs 'Need to be able to provide free text additional information. Notes SHALL NOT contain information which can be captured in a structured way.' |
| Information | StructureDefinition.short | Values for short differ: 'How it was done' vs 'Sequencing | SNP array | PCR | Computational analysis | ...' |
| Warning | Observation.method | Elements differ in definition for mustSupport: 'false' vs 'true' |
| Information | StructureDefinition.short | Values for short differ: 'Result reference range' vs 'Not used in this profile' |
| Information | StructureDefinition.definition | Values for definition differ: 'Guidance on how to interpret the value by comparison to a normal or recommended range. Multiple reference ranges are interpreted as an 'OR'. In other words, to represent two distinct target populations, two `referenceRange` elements would be used.' vs 'Not used in this profile' |
| Information | StructureDefinition.comment | Values for comment differ: '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.' vs '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.' |
| Warning | Observation.referenceRange | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Related resource that belongs to the Observation group' vs 'Not used in this profile' |
| Information | StructureDefinition.definition | Values for definition differ: 'This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group.' vs 'Not used in this profile' |
| 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](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](http://hl7.org/fhir/R4/questionnaireresponse.html) into a final score and represent the score as an Observation.' |
| Warning | Observation.component | Elements differ in definition for mustSupport: 'false' vs 'true' |
| Name | Value | Comments | |
|---|---|---|---|
 abstract | false | ||
| baseDefinition | http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-clinical-result | http://hl7.org/fhir/uv/genomics-reporting/StructureDefinition/variant |
|
| copyright | Used by permission of HL7 International, all rights reserved Creative Commons License |
| |
| date | 2023-10-17 | 2024-11-20T20:23:08+00:00 |
|
| description | 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. | Details about a set of changes in the tested sample compared to a reference sequence. The term variant can be used to describe an alteration that may be benign, pathogenic, or of unknown significance. The term variant is increasingly being used in place of the term mutation. Variants can be computed relative to reference sequence assembly from which it was identified. |
|
| experimental | false |
| |
| fhirVersion | 4.0.1 | ||
| jurisdiction | |||
 jurisdiction[0] | urn:iso:std:iso:3166#US | ||
| kind | resource | ||
| name | USCoreLaboratoryResultObservationProfile | GenomicVariant |
|
| publisher | HL7 International / Cross-Group Projects | HL7 International / Clinical Interoperability Council |
|
| purpose | |||
| status | active | ||
| title | US Core Laboratory Result Observation Profile | Genomic Variant Profile |
|
| type | Observation | ||
| url | http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-lab | http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-genomic-variant |
|
| version | 7.0.0 | 4.0.0 |
|
| Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | R Type | R Description & Constraints | Comments | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 Observation | C | 0..* | 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 | C | 0..* | Variant | Variant 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 | |||||||||
 id | Σ | 0..1 | id | Logical id of this artifact | Σ | 0..1 | id | Logical id of this artifact | |||||||||
 meta | SΣ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource |
| ||||||||
 id | 0..1 | string | Unique id for inter-element referencing |
| |||||||||||||
 Slices for 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 |
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| profile | Σ | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to |
| ||||||||||||
| security | Σ | 0..* | Coding | Security Labels applied to this resource Binding: ?? (extensible): Security Labels from the Healthcare Privacy and Security Classification System. |
| ||||||||||||
| 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". |
| ||||||||||||
| 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 | Extension Slice: Unordered, Open by value:url | |||||||||||
 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): Codes providing the status of an observation. | ?!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:$this Binding: ?? (preferred): Codes for high level observation categories. | S | 1..* | CodeableConcept | Classification of type of observation Slice: Unordered, Open by value:coding Binding: ?? (preferred): Codes for high level observation categories. | |||||||||
| code | SΣ | 1..1 | CodeableConcept | Laboratory Test Name Binding: ?? (extensible): Laboratory LOINC Codes | SΣ | 1..1 | CodeableConcept | 69548-6 Binding: ?? (example): Codes identifying names of simple observations. Required Pattern: {"coding":[{"system":"http://loinc.org","code":"69548-6"}]} | |||||||||
| subject | SΣ | 1..1 | Reference(US Core Patient Profile S | Group | Device | US Core Location Profile) | Who and/or what the observation is about | SΣ | 0..1 | Reference(Cancer Patient Profile) | Who and/or what the observation is about |
| ||||||||
| focus | Σ | 0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record | Σ | 0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record | |||||||||
| encounter | SΣ | 0..1 | Reference(US Core Encounter Profile) | Encounter associated with Observation | Σ | 0..1 | Reference(Encounter) | Healthcare event during which this observation is made |
| ||||||||
| effective[x] | SΣC | 0..1 | dateTime S, Period, Timing, instant | Clinically relevant time/time-period for observation us-core-1: Datetime must be at least to day. | SΣ | 0..1 | dateTime, Period, Timing, instant | Clinically relevant time/time-period for observation Slice: Unordered, Open by type:$this | |||||||||
| 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 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 | SΣC | 0..1 | CodeableConcept | Actual result Slice: Unordered, Closed by type:$this | |||||||||
| dataAbsentReason | SC | 0..1 | CodeableConcept | Why the result is missing Binding: ?? (extensible): Codes specifying why the result (Observation.value[x]) is missing. | SC | 0..1 | CodeableConcept | Why the result is missing Binding: ?? (extensible): Codes specifying why the result (Observation.value[x]) is missing. | |||||||||
| interpretation | S | 0..* | CodeableConcept | Result interpretation Binding: ?? (extensible): Observation Interpretation Codes | 0..* | CodeableConcept | High, low, normal, etc. Binding: ?? (extensible): Codes identifying interpretations of observations. |
| |||||||||
| note | 0..* | Annotation | Comments about the observation | 0..* | ?? | Comments about the Observation that also contain a coded type | |||||||||||
| 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. | S | 0..1 | CodeableConcept | Sequencing | SNP array | PCR | Computational analysis | ... Binding: ?? (extensible) |
| |||||||||
| specimen | S | 0..1 | Reference(US Core Specimen Profile) | Specimen used for this observation | S | 0..1 | Reference(Human Specimen Profile) | Specimen used for this observation | |||||||||
| device | 0..1 | Reference(Device | DeviceMetric) | (Measurement) 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. | C | 0..* | BackboneElement | Not used in this profile obs-3: Must have at least a low or a high or text |
| ||||||||
| 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) | Not used in this profile | |||||||||
| 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 | SΣ | 0..* | BackboneElement | Component results Slice: Unordered, Open by pattern:code |
| ||||||||
 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 (Observation) | Provides guide for interpretation of component result | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result | |||||||||||
| Documentation for this format | |||||||||||||||||