| Left: | US Core Observation Clinical Result Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-clinical-result) |
| Right: | AECountObservation (http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-aecountobservation) |
| 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/icsr-ae-reporting/StructureDefinition/icsr-aecountobservation' |
| Error | StructureDefinition.version | Values for version differ: '6.1.0' vs '1.0.1' |
| Information | StructureDefinition.name | Values for name differ: 'USCoreObservationClinicalResultProfile' vs 'AECountObservation' |
| Information | StructureDefinition.status | Values for status differ: 'active' vs 'draft' |
| Information | StructureDefinition.date | Values for date differ: '2022-04-20' vs '2023-08-29T21:40:08+00:00' |
| Information | StructureDefinition.publisher | Values for publisher differ: 'HL7 International - Cross-Group Projects' vs 'Biomedical Research & Regulation WG' |
| 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: '(USCDI) registered | preliminary | final | amended +' vs 'registered | preliminary | final | amended +' |
| Information | StructureDefinition.short | Values for short differ: '(USCDI) Classification of type of observation' vs 'Classification of type of observation' |
| Warning | Observation.category | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | Observation.category | Element minimum cardinalities differ: '1' vs '0' |
| Information | StructureDefinition.short | Values for short differ: '(USCDI) Clinical Test or Procedure Name' vs 'Type of observation (code / type)' |
| 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 | StructureDefinition.short | Values for short differ: '(USCDI) Who and/or what the observation is about' vs 'Who and/or what the observation is about' |
| Warning | Observation.subject | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | Observation.subject | Element minimum cardinalities differ: '1' vs '0' |
| Information | StructureDefinition.short | Values for short differ: '(USCDI) Clinically relevant time/time-period for observation' vs 'Clinically relevant time/time-period for observation' |
| Warning | Observation.effective[x] | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: '(USCDI) 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 | Observation.value[x] | Element minimum cardinalities differ: '0' vs '1' |
| Information | StructureDefinition.short | Values for short differ: '(USCDI) Why the result is missing' vs 'Why the result is missing' |
| Warning | Observation.dataAbsentReason | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Name | Value | Comments | |
|---|---|---|---|
 abstract | false | ||
| baseDefinition | http://hl7.org/fhir/StructureDefinition/Observation | ||
| copyright | Used by permission of HL7 International, all rights reserved Creative Commons License |
| |
| date | 2022-04-20 | 2023-08-29T21:40:08+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. | Recording the number of Adverse Events that were detected by the algorithm |
|
| experimental | |||
| fhirVersion | 4.0.1 | ||
| jurisdiction | |||
 jurisdiction[0] | urn:iso:std:iso:3166#US | ||
| kind | resource | ||
| name | USCoreObservationClinicalResultProfile | AECountObservation |
|
| publisher | HL7 International - Cross-Group Projects | Biomedical Research & Regulation WG |
|
| purpose | |||
| status | active | draft |
|
| title | US Core Observation Clinical Result Profile |
| |
| type | Observation | ||
| url | http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-clinical-result | http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-aecountobservation |
|
| version | 6.1.0 | 1.0.1 |
|
| Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | L Type | L Description & Constraints | Comments | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 Observation | C | 0..* | Observation | Measurements and simple assertions 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..* | Observation | Measurements and simple assertions | |||||||||
 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 | 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 | (USCDI) 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. Required Pattern: final | |||||||||
| Slices for category | S | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ?? (preferred): Codes for high level observation categories. | 0..* | CodeableConcept | Classification of type of observation Binding: ?? (preferred): Codes for high level observation categories. |
| |||||||||
| code | SΣ | 1..1 | CodeableConcept | (USCDI) Clinical Test or Procedure Name Binding: ?? (extensible) | SΣ | 1..1 | CodeableConcept | Type of observation (code / type) Binding: ?? (example): Codes identifying names of simple observations. Required Pattern: {"coding":[{"system":"http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/DataSourceObservationCodeCS","code":"AdverseEventCount"}]} | |||||||||
| subject | SΣ | 1..1 | Reference(US Core Patient Profile) | (USCDI) Who and/or what the observation is about | Σ | 0..1 | Reference(Patient | Group | Device | Location) | 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 | ΣTU | 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 | Σ | 0..1 | Reference(Encounter) | Healthcare event during which this observation is made | |||||||||
| effective[x] | SΣC | 0..1 | dateTime S, Period, Timing, instant | (USCDI) Clinically relevant time/time-period for observation us-core-1: Datetime must be at least to day. | Σ | 0..1 | dateTime, Period, Timing, instant | Clinically relevant time/time-period for observation |
| ||||||||
| 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 | (USCDI) Result Value us-core-3: SHALL use UCUM for coded quantity units. | SΣC | 1..1 | integer | Actual result |
| ||||||||
| dataAbsentReason | SC | 0..1 | CodeableConcept | (USCDI) Why the result is missing Binding: ?? (extensible): Codes specifying why the result (Observation.value[x]) is missing. | C | 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..* | 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 | 0..1 | Reference(Specimen) | 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 | C | 0..* | BackboneElement | Provides guide for interpretation | |||||||||
 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 (Observation) | Provides guide for interpretation of component result | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result | |||||||||||
| Documentation for this format | |||||||||||||||||