PanCareSurPass Project HL7 FHIR Implementation Guide
1.0.0 - release 150

PanCareSurPass Project HL7 FHIR Implementation Guide, published by PanCareSurPass Project. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/pcsp/ and changes regularly. See the Directory of published versions

## Resource Profile: CumulativeDoseChemoObsPcsp - Detailed Descriptions

Active as of 2026-01-16

Definitions for the Observation-cumulativeDoseChemo-eu-pcsp resource profile.

- Key Elements Table
- Differential Elements Table
- Snapshot Elements Table

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

0. Observation
Definition | Measurements and simple assertions made about a patient, device or other subject.
Short | Measurements and simple assertions
Comments | Used for simple observations such as device measurements, laboratory atomic results, vital signs, height, weight, smoking status, comments, etc. Other resources are used to provide context for observations such as laboratory reports, etc.
Control | 0..*
Is Modifier | false
Summary | false
Alternate Names | Vital Signs, Measurement, Results, Tests
Invariants | dom-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()`) 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.
Short | A 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.
Control | 0..1
Type | uri
Is Modifier | true 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 Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Observation.extension
Definition | An Extension 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.
Short | ExtensionAdditional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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())
Slicing | This element introduces a set of slices on `Observation.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
6. Observation.extension:statusReason
Slice Name | statusReason
Definition | Captures the reason for the current state of the resource.
Short | Reason for current status
Comments | This is generally only used for "exception" statuses such as "not-done", "suspended" or "cancelled". The reason for performing the event at all is captured in reasonCode, not here. (distinct reason codes for different statuses can be enforced using invariants if they are universal bindings).
Control | 0..1
Type | Extension(Event status reason) (Extension Type: CodeableConcept)
Is Modifier | false
Summary | false
Invariants | ele-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()`) ele-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())
8. 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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summary | false
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 Names | extensions, user content
Invariants | ele-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())
10. Observation.status
Definition | The status of the result value.
Short | Completion statusregistered | preliminary | final | amended +
Comments | This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.
Control | 1..1
Binding | The codes SHALL be taken from ObservationStatus http://hl7.org/fhir/ValueSet/observation-status|4.0.1 (required to `http://hl7.org/fhir/ValueSet/observation-status|4.0.1` ) Codes providing the status of an observation.
Type | code
Is Modifier | true 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 Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Need to track the status of individual results. Some results are finalized before the whole report is finalized.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Observation.category
Definition | A code that classifies the general type of observation being made.
Short | Classification of type of observation
Comments | In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.
Control | 0..*
Binding | The codes SHOULD be taken from ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category|4.0.1 (preferred to `http://hl7.org/fhir/ValueSet/observation-category|4.0.1` ) Codes for high level observation categories.
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | false
Requirements | Used for filtering what observations are retrieved and displayed.
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/observation-category", "code" : "procedure" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. Observation.code
Definition | Describes what was observed. Sometimes this is called the observation "name".
Short | Type of observation (code / type)
Comments | All code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.
Control | 1..1
Binding | For example codes, see LOINCCodes http://hl7.org/fhir/ValueSet/observation-codes|4.0.1 (example to `http://hl7.org/fhir/ValueSet/observation-codes|4.0.1` ) Codes identifying names of simple observations.
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Requirements | Knowing what kind of observation is being made is essential to understanding the observation.
Alternate Names | Name
Pattern Value | `{ "coding" : [{ "system" : "http://hl7.eu/fhir/ig/pcsp/CodeSystem/cs-generic-eu-pcsp", "code" : "cumulativeDose" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. 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.
Short | Who 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.
Control | 10..1
Type | Reference(Patient: PCSP, Patient, Group, Device, Location)
Is Modifier | false
Must Support | true
Summary | true
Requirements | Observations have no value if you don't know who or what they're about.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. Observation.value[x]
Definition | The information determined as a result of making the observation, if the information has a simple value.
Short | Actual 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.
Control | 10..1 This element is affected by the following invariants: obs-7
Type | Choice of: Quantity, CodeableConcept, dateTime, boolean, string, SampledData, Period, Ratio, integer, time, Range
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | true
Must Support Types | No must-support rules about the choice of types/profiles
Summary | true
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.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing | This element introduces a set of slices on `Observation.value[x]`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: type @ $this
20. Observation.value[x]:valueQuantity
Slice Name | valueQuantity
Definition | The information determined as a result of making the observation, if the information has a simple value.
Short | Chemotherapy Cumulative DoseActual 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.
Control | 0..1 This element is affected by the following invariants: obs-7
Type | Quantity, dateTime, boolean, string, SampledData, Period, Ratio, integer, time, Range, CodeableConcept
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | true
Summary | true
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.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. Observation.value[x]:valueQuantity.value
Definition | The value of the measured amount. The value includes an implicit precision in the presentation of the value.
Short | Numerical value (with implicit precision)
Comments | The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
Control | 10..1
Type | decimal
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Precision is handled implicitly in almost all cases of measurement.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. Observation.value[x]:valueQuantity.comparator
Definition | How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
Short | < | <= | >= | > - how to understand the value
Control | 0..1
Binding | The codes SHALL be taken from QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1 (required to `http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1` ) How the Quantity should be understood and represented.
Type | code
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
Meaning if Missing | If there is no comparator, then there is no modification of the value
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. Observation.value[x]:valueQuantity.unit
Definition | A human-readable form of the unit.
Short | Unit representation
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. Observation.value[x]:valueQuantity.system
Definition | The identification of the system that provides the coded form of the unit.
Short | System that defines coded unit form
Control | 10..1 This element is affected by the following invariants: qty-3
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Need to know the system that defines the coded form of the unit.
Pattern Value | `http://unitsofmeasure.org`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. Observation.value[x]:valueQuantity.code
Definition | A computer processable form of the unit in some unit representation system.
Short | Coded form of the unit
Comments | The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
Control | 10..1
Binding | The codes SHALL be taken from For codes, see Chemotherapy cumulative dose units (required to `http://hl7.eu/fhir/ig/pcsp/ValueSet/ChemoUnitsVs` )
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. Observation.value[x]:valueCodeableConcept
Slice Name | valueCodeableConcept
Definition | The information determined as a result of making the observation, if the information has a simple value.
Short | Actual 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.
Control | 0..1 This element is affected by the following invariants: obs-7
Type | CodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Summary | true
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.
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/data-absent-reason", "code" : "unknown", "display" : "Unknown" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. Observation.dataAbsentReason
Definition | Provides a reason why the expected value in the element Observation.value[x] is missing.
Short | Not calculated or not known doseWhy 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". The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Note that an observation may only be reported if there are values to report. For example differential cell counts values may be reported only when > 0. Because of these options, use-case agreements are required to interpret general observations for null or exceptional values.
Control | 0..1 This element is affected by the following invariants: obs-6
Binding | The codes SHALL be taken from Unless not suitable, these codes SHALL be taken from Not Performed|Unknown http://hl7.org/fhir/ValueSet/data-absent-reason|4.0.1 (required to `http://hl7.eu/fhir/ig/pcsp/ValueSet/vs-npunk-eu-pcsp` )
Type | CodeableConcept
Is Modifier | false
Summary | false
Requirements | For many results it is necessary to handle exceptional values in measurements.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. Observation.method
Definition | Indicates the mechanism used to perform the observation.
Short | How it was done
Comments | Only used if not implicit in code for Observation.code.
Control | 0..1
Binding | The codes SHALL be taken from For example codes, see Calculated|Estimated http://hl7.org/fhir/ValueSet/observation-methods|4.0.1 (required to `http://hl7.eu/fhir/ig/pcsp/ValueSet/vs-calcest-eu-pcsp` )
Type | CodeableConcept
Is Modifier | false
Summary | false
Requirements | In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results.
Invariants | ele-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 foundhere

0. Observation
2. Observation.extension
Slicing | This element introduces a set of slices on `Observation.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
4. Observation.extension:statusReason
Slice Name | statusReason
Control | 0..1
Type | Extension(Event status reason) (Extension Type: CodeableConcept)
6. Observation.status
Short | Completion status
Must Support | true
8. Observation.category
Must Support | true
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/observation-category", "code" : "procedure" }] }`
10. Observation.code
Must Support | true
Pattern Value | `{ "coding" : [{ "system" : "http://hl7.eu/fhir/ig/pcsp/CodeSystem/cs-generic-eu-pcsp", "code" : "cumulativeDose" }] }`
12. Observation.subject
Control | 1..?
Type | Reference(Patient: PCSP)
Must Support | true
14. Observation.value[x]
Control | 1..?
Type | Choice of: Quantity, CodeableConcept, dateTime, boolean, string, SampledData, Period, Ratio, integer, time, Range
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Must Support | true
Must Support Types | No must-support rules about the choice of types/profiles
Slicing | This element introduces a set of slices on `Observation.value[x]`. The slices areUnordered and Open, and can be differentiated using the following discriminators: type @ $this
16. Observation.value[x]:valueQuantity
Slice Name | valueQuantity
Short | Chemotherapy Cumulative Dose
Control | 0..1
Type | Quantity
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Must Support | true
18. Observation.value[x]:valueQuantity.value
Control | 1..?
Must Support | true
20. Observation.value[x]:valueQuantity.unit
Must Support | true
22. Observation.value[x]:valueQuantity.system
Control | 1..?
Must Support | true
Pattern Value | `http://unitsofmeasure.org`
24. Observation.value[x]:valueQuantity.code
Control | 1..?
Binding | The codes SHALL be taken from Chemotherapy cumulative dose units (required to `http://hl7.eu/fhir/ig/pcsp/ValueSet/ChemoUnitsVs` )
Must Support | true
26. Observation.value[x]:valueCodeableConcept
Slice Name | valueCodeableConcept
Control | 0..1
Type | CodeableConcept
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/data-absent-reason", "code" : "unknown", "display" : "Unknown" }] }`
28. Observation.dataAbsentReason
Short | Not calculated or not known dose
Binding | The codes SHALL be taken from Not Performed|Unknown (required to `http://hl7.eu/fhir/ig/pcsp/ValueSet/vs-npunk-eu-pcsp` )
30. Observation.method
Binding | The codes SHALL be taken from Calculated|Estimated (required to `http://hl7.eu/fhir/ig/pcsp/ValueSet/vs-calcest-eu-pcsp` )

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

0. Observation
Definition | Measurements and simple assertions made about a patient, device or other subject.
Short | Measurements and simple assertions
Comments | Used for simple observations such as device measurements, laboratory atomic results, vital signs, height, weight, smoking status, comments, etc. Other resources are used to provide context for observations such as laboratory reports, etc.
Control | 0..*
Is Modifier | false
Summary | false
Alternate Names | Vital Signs, Measurement, Results, Tests
Invariants | dom-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()`)
2. Observation.id
Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Short | Logical 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.
Control | 0..1
Type | id
Is Modifier | false
Summary | true
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.
Short | Metadata about the resource
Control | 0..1
Type | Meta
Is Modifier | false
Summary | true
Invariants | ele-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.
Short | A 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.
Control | 0..1
Type | uri
Is Modifier | true 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 Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-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.
Short | Language 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).
Control | 0..1
Binding | The codes SHOULD be taken from CommonLanguages (preferred to `http://hl7.org/fhir/ValueSet/languages|4.0.1` ) A human language.
Additional Bindings | Purpose
AllLanguages | Max Binding
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Invariants | ele-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.
Short | Text 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.
Control | 0..1
Type | Narrative
Is Modifier | false
Summary | false
Alternate Names | narrative, html, xhtml, display
Invariants | ele-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.
Short | Contained, 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.
Control | 0..*
Type | Resource
Is Modifier | false
Summary | false
Alternate Names | inline resources, anonymous resources, contained resources
14. Observation.extension
Definition | An Extension
Short | Extension
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Invariants | ele-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()`)
Slicing | This element introduces a set of slices on `Observation.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
16. Observation.extension:statusReason
Slice Name | statusReason
Definition | Captures the reason for the current state of the resource.
Short | Reason for current status
Comments | This is generally only used for "exception" statuses such as "not-done", "suspended" or "cancelled". The reason for performing the event at all is captured in reasonCode, not here. (distinct reason codes for different statuses can be enforced using invariants if they are universal bindings).
Control | 0..1
Type | Extension(Event status reason) (Extension Type: CodeableConcept)
Is Modifier | false
Summary | false
Invariants | ele-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.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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summary | false
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 Names | extensions, user content
Invariants | ele-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()`)
20. Observation.identifier
Definition | A unique identifier assigned to this observation.
Short | Business Identifier for observation
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..*
Type | Identifier
Is Modifier | false
Summary | true
Requirements | Allows observations to be distinguished and referenced.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
22. 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.
Short | Fulfills plan, proposal or order
Control | 0..*
Type | Reference(CarePlan, DeviceRequest, ImmunizationRecommendation, MedicationRequest, NutritionOrder, ServiceRequest)
Is Modifier | false
Summary | true
Requirements | Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon.
Alternate Names | Fulfills
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
24. 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.
Short | Part of referenced event
Comments | To link an Observation to an Encounter use `encounter`. See the Notes below for guidance on referencing another Observation.
Control | 0..*
Type | Reference(MedicationAdministration, MedicationDispense, MedicationStatement, Procedure, Immunization, ImagingStudy)
Is Modifier | false
Summary | true
Alternate Names | Container
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
26. Observation.status
Definition | The status of the result value.
Short | Completion status
Comments | This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.
Control | 1..1
Binding | The codes SHALL be taken from ObservationStatus (required to `http://hl7.org/fhir/ValueSet/observation-status|4.0.1` ) Codes providing the status of an observation.
Type | code
Is Modifier | true 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 Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Need to track the status of individual results. Some results are finalized before the whole report is finalized.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
28. Observation.category
Definition | A code that classifies the general type of observation being made.
Short | Classification of type of observation
Comments | In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.
Control | 0..*
Binding | The codes SHOULD be taken from ObservationCategoryCodes (preferred to `http://hl7.org/fhir/ValueSet/observation-category|4.0.1` ) Codes for high level observation categories.
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | false
Requirements | Used for filtering what observations are retrieved and displayed.
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/observation-category", "code" : "procedure" }] }`
Invariants | ele-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".
Short | Type of observation (code / type)
Comments | All code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.
Control | 1..1
Binding | For example codes, see LOINCCodes (example to `http://hl7.org/fhir/ValueSet/observation-codes|4.0.1` ) Codes identifying names of simple observations.
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Requirements | Knowing what kind of observation is being made is essential to understanding the observation.
Alternate Names | Name
Pattern Value | `{ "coding" : [{ "system" : "http://hl7.eu/fhir/ig/pcsp/CodeSystem/cs-generic-eu-pcsp", "code" : "cumulativeDose" }] }`
Invariants | ele-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.
Short | Who 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.
Control | 1..1
Type | Reference(Patient: PCSP)
Is Modifier | false
Must Support | true
Summary | true
Requirements | Observations have no value if you don't know who or what they're about.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
34. 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.
Short | What 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.
Control | 0..*
Type | Reference(Resource)
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
36. Observation.encounter
Definition | The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made.
Short | Healthcare 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).
Control | 0..1
Type | Reference(Encounter)
Is Modifier | false
Summary | true
Requirements | For some observations it may be important to know the link between an observation and a particular encounter.
Alternate Names | Context
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
38. 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.
Short | Clinically 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.
Control | 0..1
Type | Choice of: dateTime, Period, Timing, instant
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Knowing when an observation was deemed true is important to its relevance as well as determining trends.
Alternate Names | Occurrence
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
40. 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.
Short | Date/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.
Control | 0..1
Type | instant
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
42. Observation.performer
Definition | Who was responsible for asserting the observed value as "true".
Short | Who is responsible for the observation
Control | 0..*
Type | Reference(Practitioner, PractitionerRole, Organization, CareTeam, Patient, RelatedPerson)
Is Modifier | false
Summary | true
Requirements | May give a degree of confidence in the observation and also indicates where follow-up questions should be directed.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
44. Observation.value[x]
Definition | The information determined as a result of making the observation, if the information has a simple value.
Short | Actual 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.
Control | 1..1 This element is affected by the following invariants: obs-7
Type | Choice of: Quantity, CodeableConcept
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | true
Must Support Types | No must-support rules about the choice of types/profiles
Summary | true
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.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing | This element introduces a set of slices on `Observation.value[x]`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: type @ $this
46. Observation.value[x]:valueQuantity
Slice Name | valueQuantity
Definition | The information determined as a result of making the observation, if the information has a simple value.
Short | Chemotherapy Cumulative Dose
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.
Control | 0..1 This element is affected by the following invariants: obs-7
Type | Quantity
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | true
Summary | true
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.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
48. Observation.value[x]:valueQuantity.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
50. Observation.value[x]:valueQuantity.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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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()`)
Slicing | This element introduces a set of slices on `Observation.value[x].extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
52. Observation.value[x]:valueQuantity.value
Definition | The value of the measured amount. The value includes an implicit precision in the presentation of the value.
Short | Numerical value (with implicit precision)
Comments | The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
Control | 1..1
Type | decimal
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Precision is handled implicitly in almost all cases of measurement.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
54. Observation.value[x]:valueQuantity.comparator
Definition | How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
Short | < | <= | >= | > - how to understand the value
Control | 0..1
Binding | The codes SHALL be taken from QuantityComparator (required to `http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1` ) How the Quantity should be understood and represented.
Type | code
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
Meaning if Missing | If there is no comparator, then there is no modification of the value
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
56. Observation.value[x]:valueQuantity.unit
Definition | A human-readable form of the unit.
Short | Unit representation
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
58. Observation.value[x]:valueQuantity.system
Definition | The identification of the system that provides the coded form of the unit.
Short | System that defines coded unit form
Control | 1..1 This element is affected by the following invariants: qty-3
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Need to know the system that defines the coded form of the unit.
Pattern Value | `http://unitsofmeasure.org`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
60. Observation.value[x]:valueQuantity.code
Definition | A computer processable form of the unit in some unit representation system.
Short | Coded form of the unit
Comments | The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
Control | 1..1
Binding | The codes SHALL be taken from Chemotherapy cumulative dose units (required to `http://hl7.eu/fhir/ig/pcsp/ValueSet/ChemoUnitsVs` )
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
62. Observation.value[x]:valueCodeableConcept
Slice Name | valueCodeableConcept
Definition | The information determined as a result of making the observation, if the information has a simple value.
Short | Actual 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.
Control | 0..1 This element is affected by the following invariants: obs-7
Type | CodeableConcept
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Summary | true
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.
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/data-absent-reason", "code" : "unknown", "display" : "Unknown" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
64. Observation.dataAbsentReason
Definition | Provides a reason why the expected value in the element Observation.value[x] is missing.
Short | Not calculated or not known dose
Comments | Null or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "specimen unsatisfactory". The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Note that an observation may only be reported if there are values to report. For example differential cell counts values may be reported only when > 0. Because of these options, use-case agreements are required to interpret general observations for null or exceptional values.
Control | 0..1 This element is affected by the following invariants: obs-6
Binding | The codes SHALL be taken from Not Performed|Unknown (required to `http://hl7.eu/fhir/ig/pcsp/ValueSet/vs-npunk-eu-pcsp` )
Type | CodeableConcept
Is Modifier | false
Summary | false
Requirements | For many results it is necessary to handle exceptional values in measurements.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
66. Observation.interpretation
Definition | A categorical assessment of an observation value. For example, high, low, normal.
Short | High, 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.
Control | 0..*
Binding | Unless not suitable, these codes SHALL be taken from ObservationInterpretationCodes (extensible to `http://hl7.org/fhir/ValueSet/observation-interpretation|4.0.1` ) Codes identifying interpretations of observations.
Type | CodeableConcept
Is Modifier | false
Summary | false
Requirements | For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.
Alternate Names | Abnormal Flag
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
68. Observation.note
Definition | Comments about the observation or the results.
Short | Comments 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.
Control | 0..*
Type | Annotation
Is Modifier | false
Summary | false
Requirements | Need to be able to provide free text additional information.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
70. Observation.bodySite
Definition | Indicates the site on the subject's body where the observation was made (i.e. the target site).
Short | Observed 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. If the use case requires BodySite to be handled as a separate resource (e.g. to identify and track separately) then use the standard extension bodySite.
Control | 0..1
Binding | For example codes, see SNOMEDCTBodyStructures (example to `http://hl7.org/fhir/ValueSet/body-site|4.0.1` ) Codes describing anatomical locations. May include laterality.
Type | CodeableConcept
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
72. Observation.method
Definition | Indicates the mechanism used to perform the observation.
Short | How it was done
Comments | Only used if not implicit in code for Observation.code.
Control | 0..1
Binding | The codes SHALL be taken from Calculated|Estimated (required to `http://hl7.eu/fhir/ig/pcsp/ValueSet/vs-calcest-eu-pcsp` )
Type | CodeableConcept
Is Modifier | false
Summary | false
Requirements | In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
74. Observation.specimen
Definition | The specimen that was used when this observation was made.
Short | Specimen 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).
Control | 0..1
Type | Reference(Specimen)
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
76. 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.
Control | 0..1
Type | Reference(Device, DeviceMetric)
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
78. 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.
Short | Provides 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.
Control | 0..*
Type | BackboneElement
Is Modifier | false
Summary | false
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.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) obs-3: Must have at least a low or a high or text (`low.exists() or high.exists() or text.exists()`)
80. 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.
Short | Unique id for inter-element referencing
Control | 0..1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
82. 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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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()`)
84. 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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | ele-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()`)
86. 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).
Short | Low Range, if relevant
Control | 0..1 This element is affected by the following invariants: obs-3
Type | Quantity(SimpleQuantity)
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
88. 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).
Short | High Range, if relevant
Control | 0..1 This element is affected by the following invariants: obs-3
Type | Quantity(SimpleQuantity)
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
90. 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.
Short | Reference 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.
Control | 0..1
Binding | The codes SHOULD be taken from ObservationReferenceRangeMeaningCodes (preferred to `http://hl7.org/fhir/ValueSet/referencerange-meaning|4.0.1` ) Code for the meaning of a reference range.
Type | CodeableConcept
Is Modifier | false
Summary | false
Requirements | Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
92. 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.
Short | Reference 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.
Control | 0..*
Binding | For example codes, see ObservationReferenceRangeAppliesToCodes (example to `http://hl7.org/fhir/ValueSet/referencerange-appliesto|4.0.1` ) Codes identifying the population the reference range applies to.
Type | CodeableConcept
Is Modifier | false
Summary | false
Requirements | Need to be able to identify the target population for proper interpretation.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
94. 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.
Short | Applicable age range, if relevant
Control | 0..1
Type | Range
Is Modifier | false
Summary | false
Requirements | Some analytes vary greatly over age.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
96. 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".
Short | Text based reference range in an observation
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
98. Observation.hasMember
Definition | This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group.
Short | Related resource that belongs to the Observation group
Comments | When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see Notes below. Note that a system may calculate results from QuestionnaireResponse into a final score and represent the score as an Observation.
Control | 0..*
Type | Reference(Observation, QuestionnaireResponse, MolecularSequence)
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
100. 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.
Short | Related 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.
Control | 0..*
Type | Reference(DocumentReference, ImagingStudy, Media, QuestionnaireResponse, Observation, MolecularSequence)
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
102. 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.
Short | Component results
Comments | For a discussion on the ways Observations can be assembled in groups together see Notes below.
Control | 0..*
Type | BackboneElement
Is Modifier | false
Summary | true
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.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
104. 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.
Short | Unique id for inter-element referencing
Control | 0..1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
106. 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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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()`)
108. 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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | ele-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()`)
110. Observation.component.code
Definition | Describes what was observed. Sometimes this is called the observation "code".
Short | Type 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.
Control | 1..1
Binding | For example codes, see LOINCCodes (example to `http://hl7.org/fhir/ValueSet/observation-codes|4.0.1` ) Codes identifying names of simple observations.
Type | CodeableConcept
Is Modifier | false
Summary | true
Requirements | Knowing what kind of observation is being made is essential to understanding the observation.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
112. Observation.component.value[x]
Definition | The information determined as a result of making the observation, if the information has a simple value.
Short | Actual 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.
Control | 0..1
Type | Choice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
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.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
114. Observation.component.dataAbsentReason
Definition | Provides a reason why the expected value in the element Observation.component.value[x] is missing.
Short | Why 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". The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.
Control | 0..1 This element is affected by the following invariants: obs-6
Binding | Unless not suitable, these codes SHALL be taken from DataAbsentReason (extensible to `http://hl7.org/fhir/ValueSet/data-absent-reason|4.0.1` ) Codes specifying why the result (`Observation.value[x]`) is missing.
Type | CodeableConcept
Is Modifier | false
Summary | false
Requirements | For many results it is necessary to handle exceptional values in measurements.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
116. Observation.component.interpretation
Definition | A categorical assessment of an observation value. For example, high, low, normal.
Short | High, 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.
Control | 0..*
Binding | Unless not suitable, these codes SHALL be taken from ObservationInterpretationCodes (extensible to `http://hl7.org/fhir/ValueSet/observation-interpretation|4.0.1` ) Codes identifying interpretations of observations.
Type | CodeableConcept
Is Modifier | false
Summary | false
Requirements | For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.
Alternate Names | Abnormal Flag
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
118. Observation.component.referenceRange
Definition | Guidance on how to interpret the value by comparison to a normal or recommended range.
Short | Provides 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.
Control | 0..*
Type | Seettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
Is Modifier | false
Summary | false
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.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)