Observation | I | | http://hl7.org/fhir/StructureDefinition/DomainResource | Element idShort description Measurements and simple assertions Alternate names Vital Signs, Measurement, Results, Tests Definition Measurements and simple assertions made about a patient, device or other subject.
Comments 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 lab reports, etc.
Data type http://hl7.org/fhir/StructureDefinition/DomainResource Constraints- dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
contained.contained.empty() - dom-1: If the resource is contained in another resource, it SHALL NOT contain any narrative
contained.text.empty() - dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() - dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource
contained.where(('#'+id in %resource.descendants().reference).not()).empty() - obs-7: If code is the same as a component code then the value element associated with the code SHALL NOT be present
value.empty() or code!=component.code - obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
dataAbsentReason.empty() or value.empty()
Mappings- rim: Entity. Role, or Act
- workflow: Event
- sct-concept: < 363787002 |Observable entity|
- v2: OBX
- rim: Observation[classCode=OBS, moodCode=EVN]
- w5: clinical.diagnostics
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id | Σ | 0..1 | id | There are no (further) constraints on this element Element idShort description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Comments The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
Data type id |
meta | Σ | 0..1 | Meta | There are no (further) constraints on this element Element idShort description Metadata about the resource Definition The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may not always be associated with version changes to the resource.
Data type Meta |
implicitRules | Σ ?! | 0..1 | uri | There are no (further) constraints on this element Element idObservation.implicitRules Short description A set of rules under which this content was created Definition A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content.
Comments Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element.
This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.
Data type uri |
language | | 0..1 | codeBinding | There are no (further) constraints on this element Element idShort description Language of the resource content Definition The base language in which the resource is written.
Comments Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
Data type code Binding A human language. ?? (extensible) |
text | I | 0..1 | Narrative | There are no (further) constraints on this element Element idShort description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display Definition A human-readable narrative that contains a summary of the resource, and may be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Comments Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded in formation is added later.
Data type Narrative Mappings |
contained | | 0..* | Resource | There are no (further) constraints on this element Element idShort description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources Definition These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.
Comments This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again.
Data type Resource Mappings- rim: Entity. Role, or Act
- rim: N/A
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extension | | 0..* | Extension | There are no (further) constraints on this element Element idShort description Additional Content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. In order 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Mappings |
modifierExtension | ?! | 0..* | Extension | There are no (further) constraints on this element Element idObservation.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Mappings |
identifier | Σ | 0..* | Identifier | There are no (further) constraints on this element Element idShort description Business Identifier for observation Definition A unique identifier assigned to this observation.
Requirements Allows observations to be distinguished and referenced.
Data type Identifier Mappings- workflow: Event.identifier
- v2: OBX.21 For OBX segments from systems without OBX-21 support a combination of ORC/OBR and OBX must be negotiated between trading partners to uniquely identify the OBX segment. Depending on how V2 has been implemented each of these may be an option: 1) OBR-3 + OBX-3 + OBX-4 or 2) OBR-3 + OBR-4 + OBX-3 + OBX-4 or 2) some other way to uniquely ID the OBR/ORC + OBX-3 + OBX-4.
- rim: id
- w5: id
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basedOn | Σ | 0..* | Reference(http://hl7.org/fhir/StructureDefinition/CarePlan | http://hl7.org/fhir/StructureDefinition/DeviceRequest | http://hl7.org/fhir/StructureDefinition/ImmunizationRecommendation | http://hl7.org/fhir/StructureDefinition/MedicationRequest | http://hl7.org/fhir/StructureDefinition/NutritionOrder | http://hl7.org/fhir/StructureDefinition/ProcedureRequest | http://hl7.org/fhir/StructureDefinition/ReferralRequest) | There are no (further) constraints on this element Element idShort description Fulfills plan, proposal or order Alternate names Fulfills Definition A plan, proposal or order that is fulfilled in whole or in part by this event.
Requirements Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon.
Data type Reference(http://hl7.org/fhir/StructureDefinition/CarePlan | http://hl7.org/fhir/StructureDefinition/DeviceRequest | http://hl7.org/fhir/StructureDefinition/ImmunizationRecommendation | http://hl7.org/fhir/StructureDefinition/MedicationRequest | http://hl7.org/fhir/StructureDefinition/NutritionOrder | http://hl7.org/fhir/StructureDefinition/ProcedureRequest | http://hl7.org/fhir/StructureDefinition/ReferralRequest) Mappings- workflow: Event.basedOn
- v2: ORC
- rim: .outboundRelationship[typeCode=FLFS].target
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status | Σ ?! | 1..1 | codeBinding | There are no (further) constraints on this element Element idShort description registered | preliminary | final | amended + Definition The status of the result value.
Requirements Need to track the status of individual results. Some results are finalized before the whole report is finalized.
Comments This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.
Data type code Binding Codes providing the status of an observation. ?? (required)Mappings- workflow: Event.status
- sct-concept: < 445584004 |Report by finality status|
- v2: OBX-11
- rim: status Amended & Final are differentiated by whether it is the subject of a ControlAct event with a type of "revise"
- w5: status
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category | | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element idShort description Classification of type of observation Definition A code that classifies the general type of observation being made.
Requirements Used for filtering what observations are retrieved and displayed.
Comments In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.
Data type CodeableConcept Binding Codes for high level observation categories. ?? (preferred)Mappings- rim: .outboundRelationship[typeCode="COMP].target[classCode="LIST", moodCode="EVN"].code
- w5: class
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code | Σ | 1..1 | CodeableConcept | There are no (further) constraints on this element Element idShort description Type of observation (code / type) Alternate names Name Definition Describes what was observed. Sometimes this is called the observation "name".
Requirements Knowing what kind of observation is being made is essential to understanding the observation.
Data type CodeableConcept Binding Codes identifying names of simple observations. ?? (example)Mappings- workflow: Event.code
- sct-concept: < 363787002 |Observable entity| OR < 386053000 |Evaluation procedure|
- v2: OBX-3
- rim: code
- sct-attr: 116680003 |Is a|
- w5: what
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subject | Σ | 0..1 | Reference(http://hl7.org/fhir/StructureDefinition/Patient | http://hl7.org/fhir/StructureDefinition/Group | http://hl7.org/fhir/StructureDefinition/Device | http://hl7.org/fhir/StructureDefinition/Location) | There are no (further) constraints on this element Element idShort description Who and/or what this is about Definition The patient, or group of patients, location, or device whose characteristics (direct or indirect) are described by the observation and into whose record the observation is placed. Comments: Indirect characteristics may be those of a specimen, fetus, donor, other observer (for example a relative or EMT), or any observation made about the subject.
Requirements Observations have no value if you don't know who or what they're about.
Comments One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated.
If the target of the observation is different than the subject, the general extension observation-focal-subject. may be used. However, the distinction between the patient's own value for an observation versus that of the fetus, or the donor or blood product unit, etc., are often specified in the observation code.
Data type Reference(http://hl7.org/fhir/StructureDefinition/Patient | http://hl7.org/fhir/StructureDefinition/Group | http://hl7.org/fhir/StructureDefinition/Device | http://hl7.org/fhir/StructureDefinition/Location) Mappings- workflow: Event.subject
- v2: PID-3
- rim: participation[typeCode=SBJ]
- w5: who.focus
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context | | 0..1 | Reference(http://hl7.org/fhir/StructureDefinition/Encounter | http://hl7.org/fhir/StructureDefinition/EpisodeOfCare) | There are no (further) constraints on this element Element idShort description Healthcare event during which this observation is made Alternate names Encounter Definition The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made.
Requirements For some observations it may be important to know the link between an observation and a particular encounter.
Comments This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter or episode but still be tied to the context of the encounter or episode (e.g. pre-admission lab tests).
Data type Reference(http://hl7.org/fhir/StructureDefinition/Encounter | http://hl7.org/fhir/StructureDefinition/EpisodeOfCare) Mappings- workflow: Event.context
- v2: PV1
- rim: inboundRelationship[typeCode=COMP].source[classCode=ENC, moodCode=EVN]
- w5: context
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effective[x] | Σ | 0..1 | | There are no (further) constraints on this element Element idShort description Clinically relevant time/time-period for observation Alternate names Occurrence 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.
Requirements Knowing when an observation was deemed true is important to its relevance as well as determining trends.
Comments At least a date should be present unless this observation is a historical report.
Mappings- workflow: Event.occurrence[x]
- v2: OBX-14, and/or OBX-19 after v2.4 (depends on who observation made)
- rim: effectiveTime
- w5: when.done
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effectiveDateTime | | | dateTime | There are no (further) constraints on this element Data type dateTime |
effectivePeriod | | | Period | There are no (further) constraints on this element Data type Period |
issued | Σ | 0..1 | instant | There are no (further) constraints on this element Element idShort description Date/Time this was made available Definition The date and time this observation was made available to providers, typically after the results have been reviewed and verified.
Comments Updated when the result is updated.
Data type instant Mappings- v2: OBR.22 (or MSH.7), or perhaps OBX-19 (depends on who observation made)
- rim: participation[typeCode=AUT].time
- w5: when.recorded
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performer | Σ | 0..* | Reference(http://hl7.org/fhir/StructureDefinition/Practitioner | http://hl7.org/fhir/StructureDefinition/Organization | http://hl7.org/fhir/StructureDefinition/Patient | http://hl7.org/fhir/StructureDefinition/RelatedPerson) | There are no (further) constraints on this element Element idShort description Who is responsible for the observation Definition Who was responsible for asserting the observed value as "true".
Requirements May give a degree of confidence in the observation and also indicates where follow-up questions should be directed.
Data type Reference(http://hl7.org/fhir/StructureDefinition/Practitioner | http://hl7.org/fhir/StructureDefinition/Organization | http://hl7.org/fhir/StructureDefinition/Patient | http://hl7.org/fhir/StructureDefinition/RelatedPerson) Mappings- workflow: Event.performer
- v2: OBX.15 / (Practitioner) OBX-16, PRT-5:PRT-4='RO' / (Device) OBX-18 , PRT-10:PRT-4='EQUIP' / (Organization) OBX-23, PRT-8:PRT-4='PO'
- rim: participation[typeCode=PRF]
- w5: who.actor
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value[x] | Σ I | 0..1 | | There are no (further) constraints on this element Element idShort description Actual result Definition The information determined as a result of making the observation, if the information has a simple value.
Requirements An observation exists to have a value, though it may not if it is in error, or if it represents a group of observations.
Comments Normally, an observation will have either a single value or a set of related observations. A few observations (e.g. Apgar score) may have both a value and related observations (for an Apgar score, the observations from which the measure is derived). If a value is present, the datatype for this element should be determined by Observation.code. This element has a variable name depending on the type as follows: valueQuantity, valueCodeableConcept, valueString, valueBoolean, valueRange, valueRatio, valueSampledData, valueAttachment, valueTime, valueDateTime, or valuePeriod. (The name format is "'value' + the type name" with a capital on the first letter of the type).
If the data element is usually coded or if the type associated with the Observation.value defines a coded value, use CodeableConcept instead of string datatype even if the value is uncoded text. A value set is bound to the ValueCodeableConcept element. For further discussion and examples see the notes section below.
Mappings- workflow: Event.notDone, Event.notDoneReason (maps to valeu[x] or dataAbsentReason)
- sct-concept: < 441742003 |Evaluation finding|
- v2: OBX.2, OBX.5, OBX.6
- rim: value
- sct-attr: 363714003 |Interprets|
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valueQuantity | | | Quantity | There are no (further) constraints on this element Data type Quantity |
valueCodeableConcept | | | CodeableConcept | There are no (further) constraints on this element Data type CodeableConcept |
valueString | | | string | There are no (further) constraints on this element Data type string |
valueBoolean | | | boolean | There are no (further) constraints on this element Data type boolean |
valueRange | | | Range | There are no (further) constraints on this element Data type Range |
valueRatio | | | Ratio | There are no (further) constraints on this element Data type Ratio |
valueSampledData | | | SampledData | There are no (further) constraints on this element Data type SampledData |
valueAttachment | | | Attachment | There are no (further) constraints on this element Data type Attachment |
valueTime | | | time | There are no (further) constraints on this element Data type time |
valueDateTime | | | dateTime | There are no (further) constraints on this element Data type dateTime |
valuePeriod | | | Period | There are no (further) constraints on this element Data type Period |
dataAbsentReason | I | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idObservation.dataAbsentReason Short description Why the result is missing Definition Provides a reason why the expected value in the element Observation.value[x] is missing.
Requirements For many results it is necessary to handle exceptional values in measurements.
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.
Data type CodeableConcept Binding Codes specifying why the result (Observation.value[x]) is missing. ?? (extensible)Mappings- workflow: Event.notDone, Event.notDoneReason (maps to valeu[x] or dataAbsentReason)
- v2: N/A
- rim: value.nullFlavor
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interpretation | | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idObservation.interpretation Short description High, low, normal, etc. Alternate names Abnormal Flag Definition The assessment made based on the result of the observation. Intended as a simple compact code often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result. Otherwise known as abnormal flag.
Requirements For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.
Data type CodeableConcept Binding Codes identifying interpretations of observations. ?? (extensible)Mappings- sct-concept: < 260245000 |Findings values|
- v2: OBX-8
- rim: interpretationCode
- sct-attr: 363713009 |Has interpretation|
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bodySite | | 0..1 | CodeableConcept | There are no (further) constraints on this element Element idShort description Observed body part Definition Indicates the site on the subject's body where the observation was made (i.e. the target site).
Comments Only used if not implicit in code found in Observation.code. In many systems, this may be represented as a related observation instead of an inline component. If the use case requires BodySite to be handled as a separate resource (e.g. to identify and track separately) then use the standard extension body-site-instance.
Data type CodeableConcept Binding Codes describing anatomical locations. May include laterality. ?? (example)Mappings- sct-concept: < 123037004 |Body structure|
- v2: OBX-20
- rim: targetSiteCode
- sct-attr: 718497002 |Inherent location|
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method | | 0..1 | CodeableConcept | There are no (further) constraints on this element Element idShort description How it was done Definition Indicates the mechanism used to perform the observation.
Requirements In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results.
Comments Only used if not implicit in code for Observation.code.
Data type CodeableConcept Binding Methods for simple observations. ?? (example)Mappings- v2: OBX-17
- rim: methodCode
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specimen | | 0..1 | Reference(http://hl7.org/fhir/StructureDefinition/Specimen) | There are no (further) constraints on this element Element idShort description Specimen used for this observation Definition The specimen that was used when this observation was made.
Comments Should only be used if not implicit in code found in Observation.code . Observations are not made on specimens themselves; they are made on a subject, but in many cases by the means of a specimen. Note that although specimens are often involved, they are not always tracked and reported explicitly. Also note that observation resources may be used in contexts that track the specimen explicitly (e.g. Diagnostic Report).
Data type Reference(http://hl7.org/fhir/StructureDefinition/Specimen) Mappings- sct-concept: < 123038009 |Specimen|
- v2: SPM segment
- rim: participation[typeCode=SPC].specimen
- sct-attr: 704319004 |Inherent in|
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device | | 0..1 | Reference(http://hl7.org/fhir/StructureDefinition/Device | http://hl7.org/fhir/StructureDefinition/DeviceMetric) | There are no (further) constraints on this element Element idShort description (Measurement) Device Definition The device used to generate the observation data.
Comments An extension should be used if further typing of the device is needed. Devices used to support obtaining an observation can be represented using either an extension or through the Observation.related element.
Data type Reference(http://hl7.org/fhir/StructureDefinition/Device | http://hl7.org/fhir/StructureDefinition/DeviceMetric) Mappings- sct-concept: < 49062001 |Device|
- v2: OBX-17 / PRT -10
- rim: participation[typeCode=DEV]
- sct-attr: 424226004 |Using device|
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referenceRange | I | 0..* | BackboneElement | There are no (further) constraints on this element Element idObservation.referenceRange Short description Provides guide for interpretation Definition Guidance on how to interpret the value by comparison to a normal or recommended range.
Requirements Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.
Comments 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 may 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.
Data type BackboneElement Constraints- obs-3: Must have at least a low or a high or text
low.exists() or high.exists() or text.exists()
Mappings- v2: OBX.7
- rim: outboundRelationship[typeCode=REFV]/target[classCode=OBS, moodCode=EVN]
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related | Σ | 0..* | BackboneElement | There are no (further) constraints on this element Element idShort description Resource related to this observation Definition A reference to another resource (usually another Observation) whose relationship is defined by the relationship type code.
Requirements Normally, an observation will have either a value or a set of related observations. A few observations (e.g. Apgar score) may have both a value and a set of related observations or sometimes a QuestionnaireResponse from which the measure is derived.
Comments For a discussion on the ways Observations can assembled in groups together see Notes below.
Data type BackboneElement Mappings- v2: Relationships established by OBX-4 usage
- rim: outBoundRelationship
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component | Σ | 0..* | BackboneElement | There are no (further) constraints on this element Element idShort description Component results Definition Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.
Requirements Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.
Comments For a discussion on the ways Observations can be assembled in groups together see Notes below.
Data type BackboneElement Mappings- v2: containment by OBX-4?
- rim: outBoundRelationship[typeCode=COMP]
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