Observation | I | | Observation | There are no (further) constraints on this element 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 laboratory reports, etc.
Data Type Observation Constraints- dom-2:If the resource is contained in another resource, it SHALL NOT contain nested Resources
contained.contained.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 or SHALL refer to the containing resource
contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() - dom-6:A resource should have narrative for robust management
text.`div`.exists() - dom-5:If a resource is contained in another resource, it SHALL NOT have a security label
contained.meta.security.empty() - 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
value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty() - 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]
|
identifier | S 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 Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CX / EI (occasionally, more often EI maps to a resource id or a URL)
- rim:II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]
- servd:Identifier
- workflow:Event.identifier
- w5:FiveWs.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
|
basedOn | Σ I | 0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | 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. For example, a MedicationRequest may require a patient to have laboratory test performed before it is dispensed.
Requirements Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon.
Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
Data Type Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1:SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings- rim:n/a
- rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- workflow:Event.basedOn
- v2:ORC
- rim:.inboundRelationship[typeCode=COMP].source[moodCode=EVN]
|
partOf | Σ I | 0..* | Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) | There are no (further) constraints on this element Element IdShort description Part of referenced event Alternate names Container Definition A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure.
Comments To link an Observation to an Encounter use encounter . See the Notes below for guidance on referencing another Observation.
Data Type Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1:SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings- rim:n/a
- rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- workflow:Event.partOf
- v2:Varies by domain
- rim:.outboundRelationship[typeCode=FLFS].target
|
status | S 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. ObservationStatus (required)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- workflow:Event.status
- w5:FiveWs.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"
|
category | S | 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. ObservationCategoryCodes (preferred)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE
- rim:CD
- orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
- w5:FiveWs.class
- rim:.outboundRelationship[typeCode="COMP].target[classCode="LIST", moodCode="EVN"].code
|
code | S 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.
Comments 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.
Data Type CodeableConcept Binding Codes identifying names of simple observations. LOINCCodes (example)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE
- rim:CD
- orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
- workflow:Event.code
- w5:FiveWs.what[x]
- sct-concept:< 363787002 |Observable entity| OR < 386053000 |Evaluation procedure|
- v2:OBX-3
- rim:code
- sct-attr:116680003 |Is a|
|
subject | S Σ I | 0..1 | MII-Reference(Patient | Group) | Element IdShort description A reference from one resource to another Definition A reference from one resource to another.
Requirements Observations have no value if you don't know who or what they're about.
Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
Data Type MII-Reference(Patient | Group) Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1:SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) - mii-reference-1:Either reference.reference OR reference.identifier exists
($this.reference.exists() or ($this.identifier.value.exists() and $this.identifier.system.exists())) xor $this.extension('http://hl7.org/fhir/StructureDefinition/data-absent-reason').exists()
Mappings- rim:n/a
- rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- workflow:Event.subject
- w5:FiveWs.subject[x]
- v2:PID-3
- rim:participation[typeCode=RTGT]
- w5:FiveWs.subject
|
focus | Σ I | 0..* | Reference(Resource) | There are no (further) constraints on this element Element IdShort description What the observation is about, when it is not about the subject of record Definition The actual focus of an observation when it is not the patient of record representing something or someone associated with the patient such as a spouse, parent, fetus, or donor. For example, fetus observations in a mother's record. The focus of an observation could also be an existing condition, an intervention, the subject's diet, another observation of the subject, or a body structure such as tumor or implanted device. An example use case would be using the Observation resource to capture whether the mother is trained to change her child's tracheostomy tube. In this example, the child is the patient of record and the mother is the focus.
Comments Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., "Blood Glucose") and does not need to be represented separately using this element. Use specimen if a reference to a specimen is required. If a code is required instead of a resource use either bodysite for bodysites or the standard extension focusCode.
Data Type Reference(Resource) Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1:SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings- rim:n/a
- rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- w5:FiveWs.subject[x]
- v2:OBX-3
- rim:participation[typeCode=SBJ]
- w5:FiveWs.subject
|
encounter | Σ I | 0..1 | Reference(Encounter) | There are no (further) constraints on this element Element IdShort description Healthcare event during which this observation is made Alternate names Context 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 but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).
Data Type Reference(Encounter) Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1:SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings- rim:n/a
- rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- workflow:Event.context
- w5:FiveWs.context
- v2:PV1
- rim:inboundRelationship[typeCode=COMP].source[classCode=ENC, moodCode=EVN]
|
effective[x] | S 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. 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.
Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- workflow:Event.occurrence[x]
- w5:FiveWs.done[x]
- v2:OBX-14, and/or OBX-19 after v2.4 (depends on who observation made)
- rim:effectiveTime
|
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 |
effectiveTiming | | | Timing | There are no (further) constraints on this element Data Type Timing |
effectiveInstant | | | instant | There are no (further) constraints on this element Data Type instant |
issued | S Σ | 0..1 | instant | There are no (further) constraints on this element Element IdShort description Date/Time this version was made available Definition The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified.
Comments For Observations that don’t require review and verification, it may be the same as the lastUpdated time of the resource itself. For Observations that do require review and verification for certain updates, it might not be the same as the lastUpdated time of the resource itself due to a non-clinically significant update that doesn’t require the new version to be reviewed and verified again.
Data Type instant Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- w5:FiveWs.recorded
- v2:OBR.22 (or MSH.7), or perhaps OBX-19 (depends on who observation made)
- rim:participation[typeCode=AUT].time
|
performer | Σ I | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | 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.
Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
Data Type Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1:SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings- rim:n/a
- rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- workflow:Event.performer.actor
- w5:FiveWs.actor
- 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]
|
value[x] | S 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 might not if it is in error, or if it represents a group of observations.
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.
Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- sct-concept:< 441742003 |Evaluation finding|
- v2:OBX.2, OBX.5, OBX.6
- rim:value
- sct-attr:363714003 |Interprets|
|
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 |
valueInteger | | | integer | There are no (further) constraints on this element Data Type integer |
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 |
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 | S 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. DataAbsentReason (extensible)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE
- rim:CD
- orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
- v2:N/A
- rim:value.nullFlavor
|
interpretation | S | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element IdObservation.interpretation Short description High, low, normal, etc. Alternate names Abnormal Flag Definition A categorical assessment of an observation value. For example, high, low, normal.
Requirements For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.
Comments Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.
Data Type CodeableConcept Binding Codes identifying interpretations of observations. ObservationInterpretationCodes (extensible)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE
- rim:CD
- orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
- sct-concept:< 260245000 |Findings values|
- v2:OBX-8
- rim:interpretationCode
- sct-attr:363713009 |Has interpretation|
|
note | | 0..* | Annotation | There are no (further) constraints on this element Element IdShort description Comments about the observation Definition Comments about the observation or the results.
Requirements Need to be able to provide free text additional information.
Comments 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.
Data Type Annotation Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:N/A
- rim:Act
- v2:NTE.3 (partner NTE to OBX, or sometimes another (child?) OBX)
- rim:subjectOf.observationEvent[code="annotation"].value
|
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 bodySite.
Data Type CodeableConcept Binding Codes describing anatomical locations. May include laterality. SNOMEDCTBodyStructures (example)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE
- rim:CD
- orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
- sct-concept:< 123037004 |Body structure|
- v2:OBX-20
- rim:targetSiteCode
- sct-attr:718497002 |Inherent location|
|
method | S | 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. ObservationMethods (example)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE
- rim:CD
- orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
- v2:OBX-17
- rim:methodCode
|
specimen | S I | 0..1 | Reference(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(Specimen) Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1:SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings- rim:n/a
- rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- sct-concept:< 123038009 |Specimen|
- v2:SPM segment
- rim:participation[typeCode=SPC].specimen
- sct-attr:704319004 |Inherent in|
|
device | S I | 0..1 | Reference(Device | DeviceMetric) | There are no (further) constraints on this element Element IdShort description (Measurement) Device Definition The device used to generate the observation data.
Comments Note that this is not meant to represent a device involved in the transmission of the result, e.g., a gateway. Such devices may be documented using the Provenance resource where relevant.
Data Type Reference(Device | DeviceMetric) Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1:SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings- rim:n/a
- rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- sct-concept:< 49062001 |Device|
- v2:OBX-17 / PRT -10
- rim:participation[typeCode=DEV]
- sct-attr:424226004 |Using device|
|
referenceRange | S 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. Multiple reference ranges are interpreted as an "OR". In other words, to represent two distinct target populations, two referenceRange elements would be used.
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 might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.
Data Type BackboneElement Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - obs-3:Must have at least a low or a high or text
low.exists() or high.exists() or text.exists()
Mappings- rim:n/a
- v2:OBX.7
- rim:outboundRelationship[typeCode=REFV]/target[classCode=OBS, moodCode=EVN]
|
low | I | 0..1 | SimpleQuantity | There are no (further) constraints on this element Element IdObservation.referenceRange.low Short description Low Range, if relevant Definition The value of the low bound of the reference range. The low bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the low bound is omitted, it is assumed to be meaningless (e.g. reference range is <=2.3).
Comments The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
Data Type SimpleQuantity Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - qty-3:If a code for the unit is present, the system SHALL also be present
code.empty() or system.exists() - sqty-1:The comparator is not used on a SimpleQuantity
comparator.empty()
Mappings- rim:n/a
- v2:SN (see also Range) or CQ
- rim:PQ, IVL<PQ>, MO, CO, depending on the values
- v2:OBX-7
- rim:value:IVL_PQ.low
|
high | I | 0..1 | SimpleQuantity | There are no (further) constraints on this element Element IdObservation.referenceRange.high Short description High Range, if relevant Definition The value of the high bound of the reference range. The high bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the high bound is omitted, it is assumed to be meaningless (e.g. reference range is >= 2.3).
Comments The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
Data Type SimpleQuantity Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - qty-3:If a code for the unit is present, the system SHALL also be present
code.empty() or system.exists() - sqty-1:The comparator is not used on a SimpleQuantity
comparator.empty()
Mappings- rim:n/a
- v2:SN (see also Range) or CQ
- rim:PQ, IVL<PQ>, MO, CO, depending on the values
- v2:OBX-7
- rim:value:IVL_PQ.high
|
type | | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element IdObservation.referenceRange.type Short description Reference range qualifier Definition Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range.
Requirements Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation.
Comments This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed.
Data Type CodeableConcept Binding Code for the meaning of a reference range. ObservationReferenceRangeMeaningCodes (preferred)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE
- rim:CD
- orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
- sct-concept:< 260245000 |Findings values| OR
< 365860008 |General clinical state finding|
OR
< 250171008 |Clinical history or observation findings| OR
< 415229000 |Racial group| OR
< 365400002 |Finding of puberty stage| OR
< 443938003 |Procedure carried out on subject|
- v2:OBX-10
- rim:interpretationCode
|
appliesTo | | 0..* | CodeableConcept | There are no (further) constraints on this element Element IdObservation.referenceRange.appliesTo Short description Reference range population Definition Codes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race. Multiple appliesTo are interpreted as an "AND" of the target populations. For example, to represent a target population of African American females, both a code of female and a code for African American would be used.
Requirements Need to be able to identify the target population for proper interpretation.
Comments This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed.
Data Type CodeableConcept Binding Codes identifying the population the reference range applies to. ObservationReferenceRangeAppliesToCodes (example)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE
- rim:CD
- orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
- sct-concept:< 260245000 |Findings values| OR
< 365860008 |General clinical state finding|
OR
< 250171008 |Clinical history or observation findings| OR
< 415229000 |Racial group| OR
< 365400002 |Finding of puberty stage| OR
< 443938003 |Procedure carried out on subject|
- v2:OBX-10
- rim:interpretationCode
|
age | I | 0..1 | Range | There are no (further) constraints on this element Element IdObservation.referenceRange.age Short description Applicable age range, if relevant Definition The age at which this reference range is applicable. This is a neonatal age (e.g. number of weeks at term) if the meaning says so.
Requirements Some analytes vary greatly over age.
Comments The stated low and high value are assumed to have arbitrarily high precision when it comes to determining which values are in the range. I.e. 1.99 is not in the range 2 -> 3.
Data Type Range Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - rng-2:If present, low SHALL have a lower value than high
low.empty() or high.empty() or (low <= high)
Mappings- rim:n/a
- v2:NR and also possibly SN (but see also quantity)
- rim:IVL<QTY[not(type="TS")]> [lowClosed="true" and highClosed="true"]or URG<QTY[not(type="TS")]>
- rim:outboundRelationship[typeCode=PRCN].targetObservationCriterion[code="age"].value
|
text | | 0..1 | string | There are no (further) constraints on this element Element IdObservation.referenceRange.text Short description Text based reference range in an observation Definition Text based reference range in an observation which may be used when a quantitative range is not appropriate for an observation. An example would be a reference value of "Negative" or a list or table of "normals".
Comments Note that FHIR strings SHALL NOT exceed 1MB in size
Data Type string Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:OBX-7
- rim:value:ST
|
hasMember | S Σ I | 0..* | Reference(Observation | QuestionnaireResponse | MolecularSequence) | There are no (further) constraints on this element Element IdShort description Related resource that belongs to the Observation group 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.
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.
Data Type Reference(Observation | QuestionnaireResponse | MolecularSequence) Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1:SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings- rim:n/a
- rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- v2:Relationships established by OBX-4 usage
- rim:outBoundRelationship
|
derivedFrom | S Σ I | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | There are no (further) constraints on this element Element IdShort description Related measurements the observation is made from 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.
Comments All the reference choices that are listed in this element can represent clinical observations and other measurements that may be the source for a derived value. The most common reference will be another Observation. For a discussion on the ways Observations can assembled in groups together, see Notes below.
Data Type Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1:SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings- rim:n/a
- rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- v2:Relationships established by OBX-4 usage
- rim:.targetObservation
|
component | S 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 Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:containment by OBX-4?
- rim:outBoundRelationship[typeCode=COMP]
|
code | Σ | 1..1 | CodeableConcept | There are no (further) constraints on this element Element IdObservation.component.code Short description Type of component observation (code / type) Definition Describes what was observed. Sometimes this is called the observation "code".
Requirements Knowing what kind of observation is being made is essential to understanding the observation.
Comments All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.
Data Type CodeableConcept Binding Codes identifying names of simple observations. LOINCCodes (example)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE
- rim:CD
- orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
- w5:FiveWs.what[x]
- sct-concept:< 363787002 |Observable entity| OR
< 386053000 |Evaluation procedure|
- v2:OBX-3
- rim:code
|
value[x] | Σ | 0..1 | | There are no (further) constraints on this element Element IdObservation.component.value[x] Short description Actual component 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 might not if it is in error, or if it represents a group of observations.
Comments Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). 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.
Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- sct-concept:363714003 |Interprets| < 441742003 |Evaluation finding|
- v2:OBX.2, OBX.5, OBX.6
- rim:value
- sct-attr:363714003 |Interprets|
|
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 |
valueInteger | | | integer | There are no (further) constraints on this element Data Type integer |
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 |
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.component.dataAbsentReason Short description Why the component result is missing Definition Provides a reason why the expected value in the element Observation.component.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 "test not done".
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. Because of these options, use-case agreements are required to interpret general observations for exceptional values.
Data Type CodeableConcept Binding Codes specifying why the result (`Observation.value[x]`) is missing. DataAbsentReason (extensible)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE
- rim:CD
- orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
- v2:N/A
- rim:value.nullFlavor
|
interpretation | | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element IdObservation.component.interpretation Short description High, low, normal, etc. Alternate names Abnormal Flag Definition A categorical assessment of an observation value. For example, high, low, normal.
Requirements For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.
Comments Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.
Data Type CodeableConcept Binding Codes identifying interpretations of observations. ObservationInterpretationCodes (extensible)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE
- rim:CD
- orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
- sct-concept:< 260245000 |Findings values|
- v2:OBX-8
- rim:interpretationCode
- sct-attr:363713009 |Has interpretation|
|
referenceRange | | 0..* | see (referenceRange) | There are no (further) constraints on this element Element IdObservation.component.referenceRange Short description Provides guide for interpretation of component result 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 might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.
Mappings- v2:OBX.7
- rim:outboundRelationship[typeCode=REFV]/target[classCode=OBS, moodCode=EVN]
|