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Orders and Observations Work Group Maturity Level: 1Trial Use Use Context: Any

Definitions for the observation-genetics Profile.

Observation
Element IdObservation
Definition

Measurements and simple assertions made about a patient, device or other subject.

Cardinality0..*
Alternate NamesVital Signs, Measurement, Results, Tests
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.

Invariants
Inherited by this element
dom-2RuleIf the resource is contained in another resource, it SHALL NOT contain nested Resourcescontained.contained.empty()
dom-3RuleIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resourcecontained.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-4RuleIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdatedcontained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5RuleIf a resource is contained in another resource, it SHALL NOT have a security labelcontained.meta.security.empty()
dom-6GuidelineA resource should have narrative for robust managementtext.div.exists()
This is (only) a best practice guideline because:

When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.

obs-6RuledataAbsentReason SHALL only be present if Observation.value[x] is not presentdataAbsentReason.empty() or value.empty()
obs-7RuleIf Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be presentvalue.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
Observation.id
Element IdObservation.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

Cardinality0..1
Typestring
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.

Observation.meta
Element IdObservation.meta
Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

Cardinality0..1
TypeMeta
Observation.implicitRules
Element IdObservation.implicitRules
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. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Cardinality0..1
Typeuri
Is Modifiertrue (Reason: This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation)
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. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

Observation.language
Element IdObservation.language
Definition

The base language in which the resource is written.

Cardinality0..1
Terminology BindingA human language.
The codes SHOULD be taken from Common Languages
Typecode
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).

Observation.text
Element IdObservation.text
Definition

A human-readable narrative that contains a summary of the resource and can 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.

Cardinality0..1
TypeNarrative
Alternate Namesnarrative, html, xhtml, display
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 information is added later.

Observation.contained
Element IdObservation.contained
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.

Cardinality0..*
TypeResource
Alternate Namesinline resources, anonymous resources, contained resources
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. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

Observation.extension
Element IdObservation.extension
Definition

An Extension

Cardinality0..*
TypeExtension
SlicingThis element introduces a set of slices. The slicing rules are:
  • unordered
  • Open
  • discriminators: value:url
Observation.extension(Gene)
Element IdObservation.extension:Gene
Definition

A region (or regions) that includes all of the sequence elements necessary to encode a functional transcript. A gene may include regulatory regions, transcribed regions and/or other functional sequence regions (SO:0000704 ). This element is the official gene symbol approved by the HGNC, which is a short abbreviated form of the gene name (HGNC ). LOINC Code: (48018-6 ).

Cardinality0..1 This element is affected by the following invariants: ele-1
TypeExtension(Gene)
Comments

Other systems or genes not defined in HGNC (e.g., BCR-ABL fusion gene) can be added by using a local extension.

Invariants
Inherited by this element
ele-1RuleAll FHIR elements must have a @value or childrenhasValue() or (children().count() > id.count())
ext-1RuleMust have either extensions or value[x], not bothextension.exists() != value.exists()
Observation.extension(DNARegionName)
Element IdObservation.extension:DNARegionName
Definition

A human readable name for the region of interest. Typically Exon #, Intron # or other. NOTE: This is not standardized and is mainly for convenience and display purposes. LOINC Code: (47999-8 ).

Cardinality0..1 This element is affected by the following invariants: ele-1
TypeExtension(DNARegionName)
Invariants
Inherited by this element
ele-1RuleAll FHIR elements must have a @value or childrenhasValue() or (children().count() > id.count())
ext-1RuleMust have either extensions or value[x], not bothextension.exists() != value.exists()
Observation.extension(CopyNumberEvent)
Element IdObservation.extension:CopyNumberEvent
Definition

A variation that increases or decreases the copy number of a given region (SO:0001019 ). Values: amplification/deletion/LOH.

Cardinality0..1 This element is affected by the following invariants: ele-1
TypeExtension(CopyNumberEvent)
Comments

Loss of heterozygosity (LOH) is a functional variant whereby the sequence alteration causes a loss of function of one allele of a gene (SO:0001786 ).

Invariants
Inherited by this element
ele-1RuleAll FHIR elements must have a @value or childrenhasValue() or (children().count() > id.count())
ext-1RuleMust have either extensions or value[x], not bothextension.exists() != value.exists()
Observation.extension(GenomicSourceClass)
Element IdObservation.extension:GenomicSourceClass
Definition

Source of sample used to determine the sequence in sequencing lab -- germline, somatic, prenatal. LOINC Code: (48002-0 ).

Cardinality0..1 This element is affected by the following invariants: ele-1
TypeExtension(GenomicSourceClass)
Invariants
Inherited by this element
ele-1RuleAll FHIR elements must have a @value or childrenhasValue() or (children().count() > id.count())
ext-1RuleMust have either extensions or value[x], not bothextension.exists() != value.exists()
Observation.extension(Interpretation)
Element IdObservation.extension:Interpretation
Definition

Clinical Interpretations for variant. It's a reference to an Observation resource.

Cardinality0..1 This element is affected by the following invariants: ele-1
TypeExtension(Interpretation)
Invariants
Inherited by this element
ele-1RuleAll FHIR elements must have a @value or childrenhasValue() or (children().count() > id.count())
ext-1RuleMust have either extensions or value[x], not bothextension.exists() != value.exists()
Observation.extension(Variant)
Element IdObservation.extension:Variant
Definition

Variant information.

Cardinality0..1 This element is affected by the following invariants: ele-1
TypeExtension(Variant)
Invariants
Inherited by this element
ele-1RuleAll FHIR elements must have a @value or childrenhasValue() or (children().count() > id.count())
ext-1RuleMust have either extensions or value[x], not bothextension.exists() != value.exists()
Observation.extension(AminoAcidChange)
Element IdObservation.extension:AminoAcidChange
Definition

AminoAcidChange information.

Cardinality0..1 This element is affected by the following invariants: ele-1
TypeExtension(AminoAcidChange)
Comments

Loss of heterozygosity (LOH) is a functional variant whereby the sequence alteration causes a loss of function of one allele of a gene (SO:0001786 ).

Invariants
Inherited by this element
ele-1RuleAll FHIR elements must have a @value or childrenhasValue() or (children().count() > id.count())
ext-1RuleMust have either extensions or value[x], not bothextension.exists() != value.exists()
Observation.extension(Allele)
Element IdObservation.extension:Allele
Definition

Allele information.

Cardinality0..1 This element is affected by the following invariants: ele-1
TypeExtension(Allele)
Invariants
Inherited by this element
ele-1RuleAll FHIR elements must have a @value or childrenhasValue() or (children().count() > id.count())
ext-1RuleMust have either extensions or value[x], not bothextension.exists() != value.exists()
Observation.extension(Ancestry)
Element IdObservation.extension:Ancestry
Definition

Ancestry information.

Cardinality0..1 This element is affected by the following invariants: ele-1
TypeExtension(Ancestry)
Invariants
Inherited by this element
ele-1RuleAll FHIR elements must have a @value or childrenhasValue() or (children().count() > id.count())
ext-1RuleMust have either extensions or value[x], not bothextension.exists() != value.exists()
Observation.extension(PhaseSet)
Element IdObservation.extension:PhaseSet
Definition

Phase set information.

Cardinality0..* This element is affected by the following invariants: ele-1
TypeExtension(PhaseSet)
Invariants
Inherited by this element
ele-1RuleAll FHIR elements must have a @value or childrenhasValue() or (children().count() > id.count())
ext-1RuleMust have either extensions or value[x], not bothextension.exists() != value.exists()
Observation.modifierExtension
Element IdObservation.modifierExtension
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 and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Cardinality0..*
TypeExtension
Is Modifiertrue (Reason: Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them)
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions .

Alternate Namesextensions, user content
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.

Observation.identifier
Element IdObservation.identifier
Definition

A unique identifier assigned to this observation.

Cardinality0..*
TypeIdentifier
Requirements

Allows observations to be distinguished and referenced.

Observation.basedOn
Element IdObservation.basedOn
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.

Cardinality0..*
TypeReference(CarePlan)
Requirements

Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon.

Alternate NamesFulfills
Observation.partOf
Element IdObservation.partOf
Definition

A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure.

Cardinality0..*
TypeReference(MedicationAdministration)
Alternate NamesContainer
Comments

To link an Observation to an Encounter use encounter. See the Notes below for guidance on referencing another Observation.

Observation.status
Element IdObservation.status
Definition

The status of the result value.

Cardinality1..1
Terminology BindingCodes providing the status of an observation.
The codes SHALL be taken from ObservationStatus
Typecode
Is Modifiertrue (Reason: This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid)
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.

Observation.category
Element IdObservation.category
Definition

A code that classifies the general type of observation being made.

Cardinality0..*
Terminology BindingCodes for high level observation categories.
The codes SHOULD be taken from Observation Category Codes
TypeCodeableConcept
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.

Observation.code
Element IdObservation.code
Definition

Describes what was observed. Sometimes this is called the observation "name".

Cardinality1..1
Terminology BindingCodes identifying names of simple observations.
For example codes, see LOINC Codes
TypeCodeableConcept
Requirements

Knowing what kind of observation is being made is essential to understanding the observation.

Alternate NamesName
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.

Observation.subject
Element IdObservation.subject
Definition

The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the focus element or the code itself specifies the actual focus of the observation.

Cardinality0..1
TypeReference(Patient)
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.

Observation.focus
Element IdObservation.focus
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.

Cardinality0..*
TypeReference(Resource)
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 .

Observation.encounter
Element IdObservation.encounter
Definition

The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made.

Cardinality0..1
TypeReference(Encounter)
Requirements

For some observations it may be important to know the link between an observation and a particular encounter.

Alternate NamesContext
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).

Observation.effective[x]
Element IdObservation.effective[x]
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.

Cardinality0..1
TypeChoice of: dateTime, Period, Timing, instant
[x] NoteSee Choice of Data Types for further information about how to use [x]
Requirements

Knowing when an observation was deemed true is important to its relevance as well as determining trends.

Alternate NamesOccurrence
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.

Observation.issued
Element IdObservation.issued
Definition

The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified.

Cardinality0..1
Typeinstant
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.

Observation.performer
Element IdObservation.performer
Definition

Who was responsible for asserting the observed value as "true".

Cardinality0..*
TypeReference(Practitioner)
Requirements

May give a degree of confidence in the observation and also indicates where follow-up questions should be directed.

Observation.value[x]
Element IdObservation.value[x]
Definition

The information determined as a result of making the observation, if the information has a simple value.

Cardinality0..1 This element is affected by the following invariants: obs-7
TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
[x] NoteSee Choice of Data Types for further information about how to use [x]
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.

Observation.dataAbsentReason
Element IdObservation.dataAbsentReason
Definition

Provides a reason why the expected value in the element Observation.value[x] is missing.

Cardinality0..1 This element is affected by the following invariants: obs-6
Terminology BindingCodes specifying why the result (`Observation.value[x]`) is missing.
The codes SHALL be taken from DataAbsentReason; other codes may be used where these codes are not suitable
TypeCodeableConcept
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.

Observation.interpretation
Element IdObservation.interpretation
Definition

A categorical assessment of an observation value. For example, high, low, normal.

Cardinality0..*
Terminology BindingCodes identifying interpretations of observations.
The codes SHALL be taken from Observation Interpretation Codes; other codes may be used where these codes are not suitable
TypeCodeableConcept
Requirements

For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

Alternate NamesAbnormal Flag
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.

Observation.note
Element IdObservation.note
Definition

Comments about the observation or the results.

Cardinality0..*
TypeAnnotation
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.

Observation.bodySite
Element IdObservation.bodySite
Definition

Indicates the site on the subject's body where the observation was made (i.e. the target site).

Cardinality0..1
Terminology BindingCodes describing anatomical locations. May include laterality.
For example codes, see SNOMED CT Body Structures
TypeCodeableConcept
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 .

Observation.method
Element IdObservation.method
Definition

Indicates the mechanism used to perform the observation.

Cardinality0..1
Terminology BindingMethods for simple observations.
For example codes, see Observation Methods
TypeCodeableConcept
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.

Observation.specimen
Element IdObservation.specimen
Definition

The specimen that was used when this observation was made.

Cardinality0..1
TypeReference(Specimen)
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).

Observation.device
Element IdObservation.device
Definition

The device used to generate the observation data.

Cardinality0..1
TypeReference(Device)
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.

Observation.referenceRange
Element IdObservation.referenceRange
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.

Cardinality0..*
TypeBackboneElement
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.

Invariants
Inherited by this element
ele-1RuleAll FHIR elements must have a @value or childrenhasValue() or (children().count() > id.count())
obs-3RuleMust have at least a low or a high or textlow.exists() or high.exists() or text.exists()
Observation.referenceRange.id
Element IdObservation.referenceRange.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Cardinality0..1
Typestring
Observation.referenceRange.extension
Element IdObservation.referenceRange.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Cardinality0..*
TypeExtension
Alternate Namesextensions, user content
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.

Observation.referenceRange.modifierExtension
Element IdObservation.referenceRange.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Cardinality0..*
TypeExtension
Is Modifiertrue (Reason: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them)
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions .

Alternate Namesextensions, user content, modifiers
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.

Observation.referenceRange.low
Element IdObservation.referenceRange.low
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).

Cardinality0..1 This element is affected by the following invariants: obs-3
TypeQuantity(SimpleQuantity)
Observation.referenceRange.high
Element IdObservation.referenceRange.high
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).

Cardinality0..1 This element is affected by the following invariants: obs-3
TypeQuantity(SimpleQuantity)
Observation.referenceRange.type
Element IdObservation.referenceRange.type
Definition

Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range.

Cardinality0..1
Terminology BindingCode for the meaning of a reference range.
The codes SHOULD be taken from Observation Reference Range Meaning Codes
TypeCodeableConcept
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.

Observation.referenceRange.appliesTo
Element IdObservation.referenceRange.appliesTo
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.

Cardinality0..*
Terminology BindingCodes identifying the population the reference range applies to.
For example codes, see Observation Reference Range Applies To Codes
TypeCodeableConcept
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.

Observation.referenceRange.age
Element IdObservation.referenceRange.age
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.

Cardinality0..1
TypeRange
Requirements

Some analytes vary greatly over age.

Observation.referenceRange.text
Element IdObservation.referenceRange.text
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".

Cardinality0..1
Typestring
Observation.hasMember
Element IdObservation.hasMember
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.

Cardinality0..*
TypeReference(Observation)
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.

Observation.derivedFrom
Element IdObservation.derivedFrom
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.

Cardinality0..*
TypeReference(DocumentReference)
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.

Observation.component
Element IdObservation.component
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.

Cardinality0..*
TypeBackboneElement
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.

Invariants
Inherited by this element
ele-1RuleAll FHIR elements must have a @value or childrenhasValue() or (children().count() > id.count())
Observation.component.id
Element IdObservation.component.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Cardinality0..1
Typestring
Observation.component.extension
Element IdObservation.component.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Cardinality0..*
TypeExtension
Alternate Namesextensions, user content
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.

Observation.component.modifierExtension
Element IdObservation.component.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Cardinality0..*
TypeExtension
Is Modifiertrue (Reason: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them)
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions .

Alternate Namesextensions, user content, modifiers
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.

Observation.component.code
Element IdObservation.component.code
Definition

Describes what was observed. Sometimes this is called the observation "code".

Cardinality1..1
Terminology BindingCodes identifying names of simple observations.
For example codes, see LOINC Codes
TypeCodeableConcept
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.

Observation.component.value[x]
Element IdObservation.component.value[x]
Definition

The information determined as a result of making the observation, if the information has a simple value.

Cardinality0..1
TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
[x] NoteSee Choice of Data Types for further information about how to use [x]
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.

Observation.component.dataAbsentReason
Element IdObservation.component.dataAbsentReason
Definition

Provides a reason why the expected value in the element Observation.component.value[x] is missing.

Cardinality0..1 This element is affected by the following invariants: obs-6
Terminology BindingCodes specifying why the result (`Observation.value[x]`) is missing.
The codes SHALL be taken from DataAbsentReason; other codes may be used where these codes are not suitable
TypeCodeableConcept
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.

Observation.component.interpretation
Element IdObservation.component.interpretation
Definition

A categorical assessment of an observation value. For example, high, low, normal.

Cardinality0..*
Terminology BindingCodes identifying interpretations of observations.
The codes SHALL be taken from Observation Interpretation Codes; other codes may be used where these codes are not suitable
TypeCodeableConcept
Requirements

For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

Alternate NamesAbnormal Flag
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.

Observation.component.referenceRange
Element IdObservation.component.referenceRange
Definition

Guidance on how to interpret the value by comparison to a normal or recommended range.

Cardinality0..*
TypeSee Observation.referenceRange
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.