WHO Digital Documentation of COVID-19 Certificates (DDCC)
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This is the continuous build for version 1.0.0. This version is based on the current content of https://github.com/WorldHealthOrganization/ddcc and changes regularly.

Resource Profile: DDCCObservation - Detailed Descriptions

Draft as of 2024-01-19

Definitions for the DDCCObservation resource profile.

Guidance on how to interpret the contents of this table can be found here

0. Observation
2. Observation.category
Pattern Value&lt;valueCodeableConcept&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;coding&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://terminology.hl7.org/CodeSystem/observation-category&quot;/&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;code&nbsp;value=&quot;laboratory&quot;/&gt;<br/>&nbsp;&nbsp;&lt;/coding&gt;<br/>&lt;/valueCodeableConcept&gt;<br/>
4. Observation.code
LabelType of test
6. Observation.effective[x]
TypedateTime, Period
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
LabelDate and time of sample collection
8. Observation.value[x]
Control1..?
TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
[x] NoteSee Choice of Data Types for further information about how to use [x]
LabelTest result
10. Observation.method
BindingThe codes SHALL be taken from WHO Speciman Sample Origin (COVID-19)
Must Supporttrue

Guidance on how to interpret the contents of this table can be found here

0. Observation
Definition

This observation may represent the result of a simple laboratory test such as hematocrit or it may group the set of results produced by a multi-test study or panel such as a complete blood count, a dynamic function test, a urine specimen study. In the latter case, the observation carries the overall conclusion of the study and references the atomic results of the study as "has-member" child observations


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

ShortLaboratory result for a simple test or for a panel/studyMeasurements and simple assertions
Comments

Represents either a lab simple observation or the group of observations produced by a laboratory study.


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.

Control0..*
Is Modifierfalse
Summaryfalse
Alternate NamesVital Signs, Measurement, Results, Tests
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.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-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-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.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())
ips-2: if no "hasMember" element is present then Observation must have a" value" (value.exists() or hasMember.exists())
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.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())
2. Observation.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.

ShortA set of rules under which this content was created
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.

Control0..1
Typeuri
Is Modifiertrue because 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
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Observation.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).

ShortExtensions that cannot be ignored
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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
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
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
6. Observation.status
Definition

The status of the result value.

Shortregistered | preliminary | final | amended +
Comments

This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

Control1..1
BindingThe codes SHALL be taken from ObservationStatushttp://hl7.org/fhir/ValueSet/observation-status|4.0.1

Codes providing the status of an observation.

Typecode
Is Modifiertrue because 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
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to track the status of individual results. Some results are finalized before the whole report is finalized.

Fixed Valuefinal
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. Observation.category
Definition

A code that classifies the general type of observation being made. In this profile, fixed to "laboratory".


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

ShortConcept - reference to a terminology or just textClassification of type of observation
Comments

"laboratory" includes laboratory medicine and pathology


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.

Control10..*
This element is affected by the following invariants: ele-1
BindingThe codes SHOULD be taken from ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category

Codes for high level observation categories.

TypeCodeableConcept(Codeable Concept (IPS))
Is Modifierfalse
Requirements

Used for filtering what observations are retrieved and displayed.

Pattern Value&lt;valueCodeableConcept&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;coding&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://terminology.hl7.org/CodeSystem/observation-category&quot;/&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;code&nbsp;value=&quot;laboratory&quot;/&gt;<br/>&nbsp;&nbsp;&lt;/coding&gt;<br/>&lt;/valueCodeableConcept&gt;<br/>
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Observation.category. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • pattern @ $this
10. Observation.category:laboratory
Slice Namelaboratory
Definition

A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.


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

ShortConcept - reference to a terminology or just textClassification of type of observation
Comments

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.


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.

Control10..1*
This element is affected by the following invariants: ele-1
BindingThe codes SHOULD be taken from ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category

Codes for high level observation categories.

TypeCodeableConcept(Codeable Concept (IPS))
Is Modifierfalse
Must Supporttrue
Requirements

Used for filtering what observations are retrieved and displayed.

Pattern Value&lt;valueCodeableConcept&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;coding&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://terminology.hl7.org/CodeSystem/observation-category&quot;/&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;code&nbsp;value=&quot;laboratory&quot;/&gt;<br/>&nbsp;&nbsp;&lt;/coding&gt;<br/>&lt;/valueCodeableConcept&gt;<br/>
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Observation.code
Definition

Describes what was observed. Sometimes this is called the observation "name". In this profile this code represents either a simple laboratory test or a laboratory study with multiple child observations


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

ShortConcept - reference to a terminology or just textType of observation (code / type)
Comments

In the context of this Observation-laboratory-uv-ips profile, when the observation plays the role of a grouper of member sub-observations, the code represent the group (for instance a panel code). In case no code is available, at least a text shall be provided.


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.

Control1..1
This element is affected by the following invariants: ele-1
BindingThe codes SHOULD be taken from For example codes, see Results Laboratory Observation - IPShttp://hl7.org/fhir/ValueSet/observation-codes
TypeCodeableConcept(Codeable Concept (IPS))
Is Modifierfalse
Must Supporttrue
Requirements

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

LabelType of test
Alternate NamesName
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. Observation.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.

ShortWho and/or what the observation is 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.

Control10..1
TypeReference(Patient (IPS), Group, Device, Location, Patient)
Is Modifierfalse
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
Summarytrue
Requirements

Observations have no value if you don't know who or what they're about.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. Observation.subject.reference
Definition

A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

ShortLiteral reference, Relative, internal or absolute URL
Comments

Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

Control10..1
This element is affected by the following invariants: ref-1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. Observation.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.

ShortClinically relevant time/time-period for observation
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.

Control10..1
TypedateTime, Period, Timing, instant
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

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

LabelDate and time of sample collection
Alternate NamesOccurrence
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Observation.effective[x].extension:data-absent-reason
Slice Namedata-absent-reason
Definition

Provides a reason why the effectiveTime is missing.

Shorteffective[x] absence reason
Control0..1
TypeExtension(Why value is missing) (Extension Type: code)
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
22. Observation.performer
Definition

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

ShortWho is responsible for the observation
Control10..*
TypeReference(Practitioner (IPS), PractitionerRole (IPS), Organization (IPS), CareTeam, Patient (IPS), RelatedPerson, Practitioner, PractitionerRole, Organization, Patient)
Is Modifierfalse
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
Summarytrue
Requirements

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

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. Observation.value[x]
Definition

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

ShortActual result
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.

Control10..1
This element is affected by the following invariants: obs-7
TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
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.

LabelTest result
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Observation.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • type @ $this
26. Observation.value[x]:valueString
Slice NamevalueString
Definition

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

ShortActual result
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.

Control0..1
This element is affected by the following invariants: obs-7
Typestring, dateTime, boolean, SampledData, Quantity, Period, Ratio, integer, time, Range, CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. Observation.value[x]:valueRange
Slice NamevalueRange
Definition

A set of ordered Quantities defined by a low and high limit.


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

ShortSet of values bounded by low and highActual result
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.


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.

Control0..1
This element is affected by the following invariants: ele-1, obs-7
TypeRange(Range (IPS)), dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
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.

Invariantsele-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))
30. Observation.value[x]:valueRatio
Slice NamevalueRatio
Definition

A relationship of two Quantity values - expressed as a numerator and a denominator.


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

ShortA ratio of two Quantity values - a numerator and a denominatorActual result
Comments

The Ratio datatype should only be used to express a relationship of two numbers if the relationship cannot be suitably expressed using a Quantity and a common unit. Where the denominator value is known to be fixed to "1", Quantity should be used instead of Ratio.


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.

Control0..1
This element is affected by the following invariants: ele-1, obs-7
TypeRatio(Ratio (IPS)), dateTime, boolean, string, SampledData, Quantity, Period, integer, time, Range, CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
rat-1: Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present ((numerator.empty() xor denominator.exists()) and (numerator.exists() or extension.exists()))
32. Observation.value[x]:valueTime
Slice NamevalueTime
Definition

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

ShortActual result
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.

Control0..1
This element is affected by the following invariants: obs-7
Typetime, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, Range, CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. Observation.value[x]:valueDateTime
Slice NamevalueDateTime
Definition

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

ShortActual result
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.

Control0..1
This element is affected by the following invariants: obs-7
TypedateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range, CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. Observation.value[x]:valuePeriod
Slice NamevaluePeriod
Definition

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

ShortActual result
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.

Control0..1
This element is affected by the following invariants: obs-7
TypePeriod, dateTime, boolean, string, SampledData, Quantity, Ratio, integer, time, Range, CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. Observation.value[x]:valueQuantity
Slice NamevalueQuantity
Definition

A measured amount (or an amount that can potentially be measured). Note that measured amounts include amounts that are not precisely quantified, including amounts involving arbitrary units and floating currencies. This profile imposes that the code system for units be UCUM.


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

ShortA measured amount using UCUMActual result
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.


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.

Control0..1
This element is affected by the following invariants: ele-1, obs-7
TypeQuantity(Quantity (IPS)), dateTime, boolean, string, SampledData, Period, Ratio, integer, time, Range, CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
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.

Invariantsele-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())
40. Observation.value[x]:valueCodeableConcept
Slice NamevalueCodeableConcept
Definition

A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.


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

ShortConcept - reference to a terminology or just textActual result
Comments

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.


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.

Control0..1
This element is affected by the following invariants: ele-1, obs-7
BindingThe codes SHOULD be taken from For codes, see Results Coded Values Laboratory - IPS
Additional BindingsPurposeDocumentation
Results Blood Group - SNOMED CT IPS Free Setcandidate

Additional conformance binding to a blood group findings value set for laboratory result values from the SNOMED CT IPS free set for use globally (in SNOMED member and non-member jurisdictions).

Results Presence Absence - SNOMED CT IPS Free Setcandidate

Additional conformance binding to a presence and absence findings (qualifier values) value set for laboratory result values from the SNOMED CT IPS free set for use globally (in SNOMED member and non-member jurisdictions).

Results Microorganism - SNOMED CT IPS Free Setcandidate

Additional conformance binding to a microorganisms value set for laboratory result values from the SNOMED CT IPS free set for use globally (in SNOMED member and non-member jurisdictions).

TypeCodeableConcept(Codeable Concept (IPS)), dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. Observation.method
Definition

Indicates the mechanism used to perform the observation.

ShortHow it was done
Comments

Only used if not implicit in code for Observation.code.

Control0..1
BindingThe codes SHALL be taken from For example codes, see WHO Speciman Sample Origin (COVID-19)http://hl7.org/fhir/ValueSet/observation-methods
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summaryfalse
Requirements

In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
44. Observation.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.

ShortComponent results
Comments

For a discussion on the ways Observations can be assembled in groups together see Notes below.

Control0..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
46. Observation.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).

ShortExtensions that cannot be ignored even if unrecognized
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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
48. Observation.component.code
Definition

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

ShortType of component observation (code / type)
Comments

All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

Control1..1
BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes

Codes identifying names of simple observations.

TypeCodeableConcept
Is Modifierfalse
Summarytrue
Requirements

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

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

Guidance on how to interpret the contents of this table can be found here

0. Observation
Definition

This observation may represent the result of a simple laboratory test such as hematocrit or it may group the set of results produced by a multi-test study or panel such as a complete blood count, a dynamic function test, a urine specimen study. In the latter case, the observation carries the overall conclusion of the study and references the atomic results of the study as "has-member" child observations

ShortLaboratory result for a simple test or for a panel/study
Comments

Represents either a lab simple observation or the group of observations produced by a laboratory study.

Control0..*
Is Modifierfalse
Summaryfalse
Alternate NamesVital Signs, Measurement, Results, Tests
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.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-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-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.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())
ips-2: if no "hasMember" element is present then Observation must have a" value" (value.exists() or hasMember.exists())
2. Observation.id
Definition

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

ShortLogical id of this artifact
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.

Control0..1
Typeid
Is Modifierfalse
Summarytrue
4. Observation.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.

ShortMetadata about the resource
Control0..1
TypeMeta
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. Observation.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.

ShortA set of rules under which this content was created
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.

Control0..1
Typeuri
Is Modifiertrue because 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
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. Observation.language
Definition

The base language in which the resource is written.

ShortLanguage of the resource content
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).

Control0..1
BindingThe codes SHOULD be taken from CommonLanguages: A human language.
Additional BindingsPurpose
AllLanguagesMax Binding
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. Observation.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.

ShortText summary of the resource, for human interpretation
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.

Control0..1
TypeNarrative
Is Modifierfalse
Summaryfalse
Alternate Namesnarrative, html, xhtml, display
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Observation.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.

ShortContained, inline 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.

Control0..*
TypeResource
Is Modifierfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
14. Observation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the resource. 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.

ShortAdditional content defined by implementations
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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
16. Observation.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.

ShortExtensions that cannot be ignored
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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
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
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
18. Observation.identifier
Definition

A unique identifier assigned to this observation.

ShortBusiness Identifier for observation
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Is Modifierfalse
Summarytrue
Requirements

Allows observations to be distinguished and referenced.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Observation.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.

ShortFulfills plan, proposal or order
Control0..*
TypeReference(CarePlan, DeviceRequest, ImmunizationRecommendation, MedicationRequest, NutritionOrder, ServiceRequest)
Is Modifierfalse
Summarytrue
Requirements

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

Alternate NamesFulfills
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. Observation.partOf
Definition

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

ShortPart of referenced event
Comments

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

Control0..*
TypeReference(MedicationAdministration, MedicationDispense, MedicationStatement, Procedure, Immunization, ImagingStudy)
Is Modifierfalse
Summarytrue
Alternate NamesContainer
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. Observation.status
Definition

The status of the result value.

Shortregistered | preliminary | final | amended +
Comments

This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

Control1..1
BindingThe codes SHALL be taken from ObservationStatus: Codes providing the status of an observation.
Typecode
Is Modifiertrue because 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
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to track the status of individual results. Some results are finalized before the whole report is finalized.

Fixed Valuefinal
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. Observation.category
Definition

A code that classifies the general type of observation being made. In this profile, fixed to "laboratory".

ShortConcept - reference to a terminology or just text
Comments

"laboratory" includes laboratory medicine and pathology

Control1..*
This element is affected by the following invariants: ele-1
BindingThe codes SHOULD be taken from ObservationCategoryCodes: Codes for high level observation categories.
TypeCodeableConcept(Codeable Concept (IPS))
Is Modifierfalse
Requirements

Used for filtering what observations are retrieved and displayed.

Pattern Value&lt;valueCodeableConcept&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;coding&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://terminology.hl7.org/CodeSystem/observation-category&quot;/&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;code&nbsp;value=&quot;laboratory&quot;/&gt;<br/>&nbsp;&nbsp;&lt;/coding&gt;<br/>&lt;/valueCodeableConcept&gt;<br/>
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Observation.category. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • pattern @ $this
28. Observation.category:laboratory
Slice Namelaboratory
Definition

A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.

ShortConcept - reference to a terminology or just text
Comments

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Control1..1
This element is affected by the following invariants: ele-1
BindingThe codes SHOULD be taken from ObservationCategoryCodes: Codes for high level observation categories.
TypeCodeableConcept(Codeable Concept (IPS))
Is Modifierfalse
Must Supporttrue
Requirements

Used for filtering what observations are retrieved and displayed.

Pattern Value&lt;valueCodeableConcept&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;coding&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://terminology.hl7.org/CodeSystem/observation-category&quot;/&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;code&nbsp;value=&quot;laboratory&quot;/&gt;<br/>&nbsp;&nbsp;&lt;/coding&gt;<br/>&lt;/valueCodeableConcept&gt;<br/>
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. Observation.code
Definition

Describes what was observed. Sometimes this is called the observation "name". In this profile this code represents either a simple laboratory test or a laboratory study with multiple child observations

ShortConcept - reference to a terminology or just text
Comments

In the context of this Observation-laboratory-uv-ips profile, when the observation plays the role of a grouper of member sub-observations, the code represent the group (for instance a panel code). In case no code is available, at least a text shall be provided.

Control1..1
This element is affected by the following invariants: ele-1
BindingThe codes SHOULD be taken from Results Laboratory Observation - IPS
TypeCodeableConcept(Codeable Concept (IPS))
Is Modifierfalse
Must Supporttrue
Requirements

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

LabelType of test
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. Observation.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.

ShortWho and/or what the observation is 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.

Control1..1
TypeReference(Patient (IPS), Group, Device, Location)
Is Modifierfalse
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
Summarytrue
Requirements

Observations have no value if you don't know who or what they're about.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. Observation.subject.id
Definition

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

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
36. Observation.subject.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.

ShortAdditional content defined by implementations
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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Observation.subject.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
38. Observation.subject.reference
Definition

A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

ShortLiteral reference, Relative, internal or absolute URL
Comments

Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

Control1..1
This element is affected by the following invariants: ref-1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. Observation.subject.type
Definition

The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

ShortType the reference refers to (e.g. "Patient")
Comments

This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

Control0..1
BindingUnless not suitable, these codes SHALL be taken from ResourceType: Aa resource (or, for logical models, the URI of the logical model).
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. Observation.subject.identifier
Definition

An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

ShortLogical reference, when literal reference is not known
Comments

When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
TypeIdentifier
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
44. Observation.subject.display
Definition

Plain text narrative that identifies the resource in addition to the resource reference.

ShortText alternative for the resource
Comments

This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
46. Observation.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.

ShortWhat the observation is about, when it is not about the subject of record
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.

Control0..*
TypeReference(Resource)
Is Modifierfalse
Standards StatusTrial Use (from Trial Use)
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. Observation.encounter
Definition

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

ShortHealthcare event during which this observation is made
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).

Control0..1
TypeReference(Encounter)
Is Modifierfalse
Summarytrue
Requirements

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

Alternate NamesContext
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
50. Observation.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.

ShortClinically relevant time/time-period for observation
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.

Control1..1
TypedateTime
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

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

LabelDate and time of sample collection
Alternate NamesOccurrence
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
52. Observation.effective[x].id
Definition

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

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
54. Observation.effective[x].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.

ShortAdditional content defined by implementations
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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Observation.effective[x].extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
56. Observation.effective[x].extension:data-absent-reason
Slice Namedata-absent-reason
Definition

Provides a reason why the effectiveTime is missing.

Shorteffective[x] absence reason
Control0..1
TypeExtension(Why value is missing) (Extension Type: code)
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
58. Observation.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.

ShortDate/Time this version was made available
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.

Control0..1
Typeinstant
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
60. Observation.performer
Definition

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

ShortWho is responsible for the observation
Control1..*
TypeReference(Practitioner (IPS), PractitionerRole (IPS), Organization (IPS), CareTeam, Patient (IPS), RelatedPerson)
Is Modifierfalse
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
Summarytrue
Requirements

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

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
62. Observation.value[x]
Definition

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

ShortActual result
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.

Control1..1
This element is affected by the following invariants: obs-7
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
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.

LabelTest result
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Observation.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • type @ $this
64. Observation.value[x]:valueString
Slice NamevalueString
Definition

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

ShortActual result
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.

Control0..1
This element is affected by the following invariants: obs-7
Typestring
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
66. Observation.value[x]:valueRange
Slice NamevalueRange
Definition

A set of ordered Quantities defined by a low and high limit.

ShortSet of values bounded by low and high
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.

Control0..1
This element is affected by the following invariants: ele-1
TypeRange(Range (IPS))
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
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.

Invariantsele-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))
68. Observation.value[x]:valueRatio
Slice NamevalueRatio
Definition

A relationship of two Quantity values - expressed as a numerator and a denominator.

ShortA ratio of two Quantity values - a numerator and a denominator
Comments

The Ratio datatype should only be used to express a relationship of two numbers if the relationship cannot be suitably expressed using a Quantity and a common unit. Where the denominator value is known to be fixed to "1", Quantity should be used instead of Ratio.

Control0..1
This element is affected by the following invariants: ele-1
TypeRatio(Ratio (IPS))
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
rat-1: Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present ((numerator.empty() xor denominator.exists()) and (numerator.exists() or extension.exists()))
70. Observation.value[x]:valueTime
Slice NamevalueTime
Definition

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

ShortActual result
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.

Control0..1
This element is affected by the following invariants: obs-7
Typetime
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
72. Observation.value[x]:valueDateTime
Slice NamevalueDateTime
Definition

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

ShortActual result
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.

Control0..1
This element is affected by the following invariants: obs-7
TypedateTime
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
74. Observation.value[x]:valuePeriod
Slice NamevaluePeriod
Definition

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

ShortActual result
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.

Control0..1
This element is affected by the following invariants: obs-7
TypePeriod
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
76. Observation.value[x]:valueQuantity
Slice NamevalueQuantity
Definition

A measured amount (or an amount that can potentially be measured). Note that measured amounts include amounts that are not precisely quantified, including amounts involving arbitrary units and floating currencies. This profile imposes that the code system for units be UCUM.

ShortA measured amount using UCUM
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.

Control0..1
This element is affected by the following invariants: ele-1
TypeQuantity(Quantity (IPS))
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
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.

Invariantsele-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())
78. Observation.value[x]:valueCodeableConcept
Slice NamevalueCodeableConcept
Definition

A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.

ShortConcept - reference to a terminology or just text
Comments

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Control0..1
This element is affected by the following invariants: ele-1
BindingThe codes SHOULD be taken from Results Coded Values Laboratory - IPS
Additional BindingsPurposeDocumentation
Results Blood Group - SNOMED CT IPS Free Setcandidate

Additional conformance binding to a blood group findings value set for laboratory result values from the SNOMED CT IPS free set for use globally (in SNOMED member and non-member jurisdictions).

Results Presence Absence - SNOMED CT IPS Free Setcandidate

Additional conformance binding to a presence and absence findings (qualifier values) value set for laboratory result values from the SNOMED CT IPS free set for use globally (in SNOMED member and non-member jurisdictions).

Results Microorganism - SNOMED CT IPS Free Setcandidate

Additional conformance binding to a microorganisms value set for laboratory result values from the SNOMED CT IPS free set for use globally (in SNOMED member and non-member jurisdictions).

TypeCodeableConcept(Codeable Concept (IPS))
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
80. Observation.dataAbsentReason
Definition

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

ShortWhy the result is missing
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".

Control0..1
This element is affected by the following invariants: obs-6
BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason: Codes specifying why the result (Observation.value[x]) is missing.
TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Requirements

For many results it is necessary to handle exceptional values in measurements.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
82. Observation.interpretation
Definition

A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.

ShortConcept - reference to a terminology or just text
Comments

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Control0..*
This element is affected by the following invariants: ele-1
BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes: Codes identifying interpretations of observations.
TypeCodeableConcept(Codeable Concept (IPS))
Is Modifierfalse
Requirements

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

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
84. Observation.note
Definition

Comments about the observation or the results.

ShortComments about the observation
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.

Control0..*
TypeAnnotation
Is Modifierfalse
Summaryfalse
Requirements

Need to be able to provide free text additional information.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
86. Observation.bodySite
Definition

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

ShortObserved body part
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.

Control0..1
BindingFor example codes, see SNOMEDCTBodyStructures: Codes describing anatomical locations. May include laterality.
TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
88. Observation.method
Definition

Indicates the mechanism used to perform the observation.

ShortHow it was done
Comments

Only used if not implicit in code for Observation.code.

Control0..1
BindingThe codes SHALL be taken from WHO Speciman Sample Origin (COVID-19)
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summaryfalse
Requirements

In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
90. Observation.specimen
Definition

The specimen that was used when this observation was made.

ShortSpecimen used for this observation
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).

Control0..1
TypeReference(Specimen (IPS))
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
92. Observation.device
Definition

The device used to generate the observation data.

Short(Measurement) 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.

Control0..1
TypeReference(Device, DeviceMetric)
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
94. Observation.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.

ShortProvides guide for interpretation
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.

Control0..*
TypeBackboneElement
Is Modifierfalse
Summaryfalse
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.

Invariantsele-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())
96. Observation.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.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
98. Observation.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.

ShortAdditional content defined by implementations
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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
100. Observation.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.

ShortExtensions that cannot be ignored even if unrecognized
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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
102. Observation.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).

ShortLow Range, if relevant
Control0..1
This element is affected by the following invariants: obs-3
TypeQuantity(SimpleQuantity)
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
104. Observation.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).

ShortHigh Range, if relevant
Control0..1
This element is affected by the following invariants: obs-3
TypeQuantity(SimpleQuantity)
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
106. Observation.referenceRange.type
Definition

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

ShortReference range qualifier
Comments

This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed.

Control0..1
BindingThe codes SHOULD be taken from ObservationReferenceRangeMeaningCodes: Code for the meaning of a reference range.
TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Requirements

Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
108. Observation.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.

ShortReference range population
Comments

This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed.

Control0..*
BindingFor example codes, see ObservationReferenceRangeAppliesToCodes: Codes identifying the population the reference range applies to.
TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Requirements

Need to be able to identify the target population for proper interpretation.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
110. Observation.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.

ShortApplicable age range, if relevant
Control0..1
TypeRange
Is Modifierfalse
Summaryfalse
Requirements

Some analytes vary greatly over age.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
112. Observation.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".

ShortText based reference range in an observation
Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
114. Observation.hasMember
Definition

A reference to another Observation profiled by Observation-results-laboratory-uv-ips. The target observation (for instance an individual test member of a panel) is considered as a sub-observation of the current one, which plays the role of a grouper.

ShortRelated resource that belongs to the Observation group
Comments

This element is used in the context of international patient summary when there is a need to group a collection of observations, because they belong to the same panel, or because they share a common interpretation comment, or a common media attachment (illustrative image or graph). In these cases, the current observation is the grouper, and its set of sub-observations are related observations using the type "has-member". For a discussion on the ways Observations can be assembled in groups together see Observation Grouping.

Control0..*
TypeReference(Observation Results: laboratory (IPS), Observation Results (IPS))
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
116. Observation.hasMember.id
Definition

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

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
118. Observation.hasMember.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.

ShortAdditional content defined by implementations
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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Observation.hasMember.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
120. Observation.hasMember.reference
Definition

A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

ShortLiteral reference, Relative, internal or absolute URL
Comments

Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

Control0..1
This element is affected by the following invariants: ref-1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
122. Observation.hasMember.type
Definition

The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

ShortType the reference refers to (e.g. "Patient")
Comments

This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

Control0..1
BindingUnless not suitable, these codes SHALL be taken from ResourceType: Aa resource (or, for logical models, the URI of the logical model).
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
124. Observation.hasMember.identifier
Definition

An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

ShortLogical reference, when literal reference is not known
Comments

When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
TypeIdentifier
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
126. Observation.hasMember.display
Definition

Plain text narrative that identifies the resource in addition to the resource reference.

ShortText alternative for the resource
Comments

This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
128. Observation.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.

ShortRelated measurements the observation is made from
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.

Control0..*
TypeReference(DocumentReference, ImagingStudy, Media, QuestionnaireResponse, Observation, MolecularSequence)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
130. Observation.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.

ShortComponent results
Comments

For a discussion on the ways Observations can be assembled in groups together see Notes below.

Control0..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
132. Observation.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.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
134. Observation.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.

ShortAdditional content defined by implementations
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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
136. Observation.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.

ShortExtensions that cannot be ignored even if unrecognized
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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
138. Observation.component.code
Definition

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

ShortType of component observation (code / type)
Comments

All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

Control1..1
BindingFor example codes, see LOINCCodes: Codes identifying names of simple observations.
TypeCodeableConcept
Is Modifierfalse
Summarytrue
Requirements

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

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
140. Observation.component.value[x]
Definition

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

ShortActual component result
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.

Control0..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]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
142. Observation.component.dataAbsentReason
Definition

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

ShortWhy the component result is missing
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".

Control0..1
This element is affected by the following invariants: obs-6
BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason: Codes specifying why the result (Observation.value[x]) is missing.
TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Requirements

For many results it is necessary to handle exceptional values in measurements.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
144. Observation.component.interpretation
Definition

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

ShortHigh, low, normal, etc.
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.

Control0..*
BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes: Codes identifying interpretations of observations.
TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Requirements

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

Alternate NamesAbnormal Flag
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
146. Observation.component.referenceRange
Definition

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

ShortProvides guide for interpretation of component result
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.

Control0..*
TypeSee ttp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
Is Modifierfalse
Summaryfalse
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))