| Left: | US Core Observation Clinical Result Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-clinical-result) |
| Right: | Observation - Patient Question Answer (http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Observation-patient-question-answer) |
| 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/home-lab-report/StructureDefinition/Observation-patient-question-answer' |
| Error | StructureDefinition.version | Values for version differ: '6.0.0-ballot' vs '1.0.0' |
| Information | StructureDefinition.name | Values for name differ: 'USCoreObservationClinicalResultProfile' vs 'ObservationPatientQuestionAnswer' |
| Information | StructureDefinition.title | Values for title differ: 'US Core Observation Clinical Result Profile' vs 'Observation - Patient Question Answer' |
| Information | StructureDefinition.date | Values for date differ: '2022-04-20' vs '2023-03-25T16:46:40+00:00' |
| Information | StructureDefinition.publisher | Values for publisher differ: 'HL7 International - Cross-Group Projects' vs 'Orders and Observations' |
| Error | StructureDefinition.baseDefinition | Values for baseDefinition differ: 'http://hl7.org/fhir/StructureDefinition/Observation' vs 'http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-survey' |
| Warning | Observation | Elements differ in short: 'Measurements and simple assertions' vs 'Survey Observation' |
| Warning | Observation.category | Elements differ in requirements: 'Used for filtering what observations are retrieved and displayed.' vs 'To identify that observation is derived from a questionnaire.' |
| Warning | Observation.code | Elements differ in short: 'Clinical Test or Procedure Name' vs 'Questions asked of the patient by the app when recording or uploading their at-home in-vitro test results.' |
| Warning | Observation.code | Elements differ in definition: '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'.' |
| Warning | Observation.code | Elements differ in comments: '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.' |
| Error | Observation.code | Unable to resolve right value set http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1099.55 at Observation.code |
| Warning | Observation.effective[x] | Elements differ in definition: '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.' 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'.' |
| Warning | Observation.effective[x] | Elements differ in comments: 'At least a date should be present unless this observation is a historical report. For recording imprecise or 'fuzzy' times (For example, a blood glucose measurement taken 'after breakfast') use the [Timing] datatype which allow the measurement to be tied to regular life events.' vs 'At least a date should be present unless this observation is a historical report.' |
| Warning | Observation.performer | Elements differ in definition for mustSupport: 'false' vs 'true' |
| Warning | Observation.value[x] | Elements differ in short: 'Result Value' vs 'Answer given to a question asked of the patient by the app when recording or uploading their test results.' |
| Warning | Observation.value[x] | Elements differ in definition: 'The clinical test or procedure result value. If a numeric value, valueQuantity.code **SHALL** be selected from [UCUM]. A FHIR [UCUM Codes value set] 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.' |
| Warning | Observation.value[x] | Elements differ in comments: 'An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the [Notes section] below.' vs 'An observation may have a value if it represents an individual survey question and answer pair. An observation should not have a value if it represents a multi-question survey or multi-select “check all that apply” question. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value.' |
| Information | Observation.value[x] | Element minimum cardinalities differ: '0' vs '1' |
| Warning | Observation.dataAbsentReason | Elements differ in comments: 'Null or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be 'detected', 'not detected', 'inconclusive', or 'specimen unsatisfactory'. The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code 'error' could be used when the measurement was not completed. Note that an observation may only be reported if there are values to report. For example differential cell counts values may be reported only when > 0. Because of these options, use-case agreements are required to interpret general observations for null or exceptional values.' vs ''Null' or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For a given LOINC question, if the LOINC answer list includes concepts such as 'unknown' or 'not available', they should be used for Observation.value. Where these concepts are not part of the value set for Observation.value, the Observation.dataAbsentReason can be used if necessary and appropriate.' |
| Warning | Observation.hasMember | Elements differ in short: 'Related resource that belongs to the Observation group' vs 'Reference to panel or multi-select responses' |
| Warning | Observation.hasMember | Elements differ in definition: '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 'Aggregate set of Observations that represent question answer pairs for both multi-question surveys and multi-select questions.' |
| Warning | Observation.hasMember | Elements differ in comments: '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] below. Note that a system may calculate results from [QuestionnaireResponse] into a final score and represent the score as an Observation.' vs 'This grouping element is used to represent surveys that group several questions together or individual questions with “check all that apply” responses. For example in the simplest case a flat multi-question survey where the 'panel' observation is the survey instrument itself and instead of an `Observation.value` the `hasMember` element references other Observation that represent the individual questions answer pairs. In a survey that has a heirarchical grouping of questions, the observation 'panels' can be nested. Because surveys can be arbitrarily complex structurally, not all survey structures can be represented using this Observation grouping pattern.' |
| Warning | Observation.hasMember | Elements differ in definition for mustSupport: 'false' vs 'true' |
| Warning | Observation.derivedFrom | Elements differ in short: 'Related measurements the observation is made from' vs 'Related Observations or QuestionnaireResponses that the observation is made from' |
| Warning | Observation.derivedFrom | Elements differ in definition: 'The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.' vs 'Observations or QuestionnaireResponses from which this observation value is derived.' |
| Warning | Observation.derivedFrom | Elements differ in definition for mustSupport: 'false' vs 'true' |
| Error | Observation.derivedFrom | Type Mismatch: Reference([CanonicalType[http://hl7.org/fhir/StructureDefinition/DocumentReference], CanonicalType[http://hl7.org/fhir/StructureDefinition/ImagingStudy], CanonicalType[http://hl7.org/fhir/StructureDefinition/Media], CanonicalType[http://hl7.org/fhir/StructureDefinition/QuestionnaireResponse], CanonicalType[http://hl7.org/fhir/StructureDefinition/Observation], CanonicalType[http://hl7.org/fhir/StructureDefinition/MolecularSequence]]) vs Reference([CanonicalType[http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-survey], CanonicalType[http://hl7.org/fhir/us/core/StructureDefinition/us-core-questionnaireresponse], CanonicalType[http://hl7.org/fhir/us/core/StructureDefinition/us-core-documentreference], CanonicalType[http://hl7.org/fhir/StructureDefinition/ImagingStudy], CanonicalType[http://hl7.org/fhir/StructureDefinition/Media], CanonicalType[http://hl7.org/fhir/StructureDefinition/MolecularSequence]]) |
| Name | Value | Comments | |
|---|---|---|---|
 abstract | false | ||
| baseDefinition | http://hl7.org/fhir/StructureDefinition/Observation | http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-survey |
|
| copyright | Used by permission of HL7 International, all rights reserved Creative Commons License |
| |
| date | 2022-04-20 | 2023-03-25T16:46:40+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 when using this profile. It provides the floor for standards development for specific use cases. | This profile constrains the FHIR Observation Resource to represent an answer given to a question asked of the patient by the app when recording or uploading their test results. |
|
| experimental | |||
| fhirVersion | 4.0.1 | ||
| jurisdiction | |||
 jurisdiction[0] | urn:iso:std:iso:3166#US | ||
| kind | resource | ||
| name | USCoreObservationClinicalResultProfile | ObservationPatientQuestionAnswer |
|
| publisher | HL7 International - Cross-Group Projects | Orders and Observations |
|
| purpose | |||
| status | active | ||
| title | US Core Observation Clinical Result Profile | Observation - Patient Question Answer |
|
| type | Observation | ||
| url | http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-clinical-result | http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Observation-patient-question-answer |
|
| version | 6.0.0-ballot | 1.0.0 |
|
| 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..* | USCoreObservationSurveyProfile | Survey Observation |
| ||||||||
 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 | 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:$this Binding: ?? (preferred): Codes for high level observation categories. | S | 1..* | CodeableConcept | Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ?? (preferred): Codes for high level observation categories. |
| ||||||||
| code | SΣ | 1..1 | CodeableConcept | Clinical Test or Procedure Name Binding: ?? (extensible) | SΣ | 1..1 | CodeableConcept | Questions asked of the patient by the app when recording or uploading their at-home in-vitro test results. Binding: ?? (extensible): Clinical Focus Clinical FocusThis set of values contains concepts representing questions asked of the patient by the app when recording or uploading their at-home in-vitro test results. |
| ||||||||
| 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) | 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 | 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 |
| ||||||||
| 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 | SΣ | 0..* | Reference(US Core Practitioner Profile S | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) | 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 | 1..1 | Quantity S, CodeableConcept S, string S, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Answer given to a question asked of the patient by the app when recording or uploading their test results. |
| ||||||||
| 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..* | 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 | SΣ | 0..* | Reference(US Core Observation Survey Profile S | US Core QuestionnaireResponse Profile | MolecularSequence) | Reference to panel or multi-select responses |
| ||||||||
| derivedFrom | Σ | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Related measurements the observation is made from | SΣ | 0..* | Reference(US Core Observation Survey Profile S | US Core QuestionnaireResponse Profile S | US Core DocumentReference Profile | ImagingStudy | Media | MolecularSequence) | Related Observations or QuestionnaireResponses that 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 | |||||||||||||||||