| Left: | US Core Observation Clinical Result Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-clinical-result) |
| 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-clinical-result' vs 'http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-genomic-variant' |
| Error | StructureDefinition.version | Values for version differ: '7.0.0-ballot' vs '4.0.0-ballot' |
| Information | StructureDefinition.name | Values for name differ: 'USCoreObservationClinicalResultProfile' vs 'GenomicVariant' |
| Information | StructureDefinition.title | Values for title differ: 'US Core Observation Clinical Result Profile' vs 'Genomic Variant Profile' |
| Information | StructureDefinition.date | Values for date differ: '2023-10-17' vs '2024-04-10T14:01:17+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/StructureDefinition/Observation' vs 'http://hl7.org/fhir/uv/genomics-reporting/StructureDefinition/variant' |
| Information | StructureDefinition.short | Values for short differ: 'Measurements and simple assertions' vs 'Variant' |
| Information | StructureDefinition.definition | Values for definition differ: '\-' vs 'Measurements and simple assertions made about a patient, device or other subject.' |
| Information | StructureDefinition.comment | Values for comment differ: '\-' vs 'Used for simple observations such as device measurements, laboratory atomic results, vital signs, height, weight, smoking status, comments, etc. Other resources are used to provide context for observations such as laboratory reports, etc.' |
| 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: 'Clinical Test or Procedure 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 clinical test or procedure result value. 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: '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' |
| Warning | Observation.specimen | Elements differ in definition for mustSupport: 'false' vs 'true' |
| Information | StructureDefinition.short | Values for short differ: 'Provides guide for interpretation' 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.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/StructureDefinition/Observation | 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 | 2024-04-10T14:01:17+00:00 |
|
| description | The US Core Observation Clinical Result Profile is based upon the core FHIR Observation Resource and, along with the US Core DiagnosticReport Profile, meets the US Core Data for Interoperability (USCDI) requirements for *Diagnostic Imaging* and *Clinical Tests* Data Classes. This profile sets minimum expectations for the Observation resource to record and search non-laboratory clinical test results (e.g., radiology and other clinical observations generated from procedures). An example would be when a gastroenterologist reports the size of a polyp observed during a colonoscopy. This profile is the basis for the US Core Laboratory Result Observation Profile, which defines additional data elements to record and search laboratory test results. The US Core Observation Clinical Result Profile sets minimum expectations 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 | |||
| fhirVersion | 4.0.1 | ||
| jurisdiction | |||
 jurisdiction[0] | urn:iso:std:iso:3166#US | ||
| kind | resource | ||
| name | USCoreObservationClinicalResultProfile | GenomicVariant |
|
| publisher | HL7 International / Cross-Group Projects | HL7 International / Clinical Interoperability Council |
|
| purpose | |||
| status | active | ||
| title | US Core Observation Clinical Result Profile | Genomic Variant Profile |
|
| type | Observation | ||
| url | http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-clinical-result | http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-genomic-variant |
|
| version | 7.0.0-ballot | 4.0.0-ballot |
|
| 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..* | 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 | Σ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource | |||||||||
| 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:$this Binding: ?? (preferred): Codes for high level observation categories. | S | 1..* | CodeableConcept | Classification of type of observation Slice: Unordered, Open by value:coding Binding: ?? (preferred): Codes for high level observation categories. | |||||||||
| code | SΣ | 1..1 | CodeableConcept | Clinical Test or Procedure Name Binding: ?? (extensible) | SΣ | 1..1 | CodeableConcept | 69548-6 Binding: ?? (example): Codes identifying names of simple observations. Required Pattern: {"coding":[{"system":"http://loinc.org","code":"69548-6"}]} | |||||||||
| subject | SΣ | 1..1 | Reference(US Core Patient Profile S | Group | Device | US Core Location Profile) | Who and/or what the observation is about | SΣ | 0..1 | Reference(Cancer Patient Profile) | Who and/or what the observation is about |
| ||||||||
| focus | Σ | 0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record | Σ | 0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record | |||||||||
| encounter | SΣ | 0..1 | Reference(US Core Encounter Profile) | Encounter associated with Observation | Σ | 0..1 | Reference(Encounter) | Healthcare event during which this observation is made |
| ||||||||
| effective[x] | SΣC | 0..1 | dateTime S, Period, Timing, instant | Clinically relevant time/time-period for observation us-core-1: Datetime must be at least to day. | SΣ | 0..1 | dateTime, Period, Timing, instant | Clinically relevant time/time-period for observation Slice: Unordered, Open by type:$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. | 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 | 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. | |||||||||||
| 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 | 0..1 | Reference(Specimen) | 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 | C | 0..* | BackboneElement | Provides guide for interpretation obs-3: Must have at least a low or a high or text | 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 | |||||||||||||||||