STU 3 Candidate

This page is part of the FHIR Specification (v1.4.0: STU 3 Ballot 3). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3

4.31.17.2 StructureDefinition: VitalSigns

The official URL for this profile is: 

http://hl7.org/fhir/StructureDefinition/vitalsigns

Defines constraints and extensions on the Observation resource for use in querying and retrieving Vital Signs information.

This profile was published on Fri, Mar 25, 2016 00:00+1100 as a draft by Health Level Seven International (Orders and Observations Workgroup).

4.31.17.2.1 Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.

This structure is derived from Observation.

Summary

4.31.17.2.2 Complete Summary of the Mandatory Requirements

  1. One status in Observation.status

  2. One category in Observation.category which must have:

    • a fixed Observation.category.coding.system=“http:<i/>//hl7.org/fhir/observation-category>”
    • a fixed Observation.category.coding.code=“vital-signs”

  3. One code in Observation.code which must have

    • a fixed Observation.code.coding.system=“http:<i/>//loinc.org>”
    • a LOINC code in Observation.code.coding.code which must be taken from the Vital Signs valueset
    • Other additional codes are allowed - e.g. method specific LOINC Codes, SNOMED CT concepts, system specific codes. All codes SHALL have an system value

  4. Either one Observation.valueQuantity or, if there is no value, one code in Observation.DataAbsentReason (Note: See the comments in the table for exceptions)

    • Each Observation.valueQuantity must have:
      • One numeric value in Observation.valueQuantity.value
      • a fixed Observation.valueQuantity.system=“http:<i/>//unitsofmeasure.org>”
      • a UCUM unit code in Observation.valueQuantity.code which must be taken from the Vital Signs Units valueset
    • Observation.DataAbsentReason should be taken from the Observation Value Absent Reason Valueset

  5. When using a panel code to group component observations (Note: See the comments regarding blood pressure in the table), one or more Observation.component.code each of which must have:

    • a fixed Observation.component.code.coding.system=“http:<i/>//loinc.org>”
    • a LOINC code in Observation.component.code.coding.code taken from the column labeled “LOINC code” in the table

  6. Either one Observation.component.valueQuantity or, if there is no value, one code in Observation.component.DataAbsentReason

    • Each Observation.component.valueQuantity must have:
      • One numeric value in Observation.component.valueQuantity.value
      • a fixed Observation.component.valueQuantity.system=“http:<i/>//unitsofmeasure.org>”
      • a UCUM unit code in Observation.component.valueQuantity.code which must be taken from the Vital Signs Units valueset
    • The Observation.component.DataAbsentReason.code.coding.code should be taken from the Observation Value Absent Reason Valueset

  7. When using a panel code to group observations, one or more reference to Observations in Observation.related.target(Note: See the comments for Vital Signs in the table)

    • a fixed Observation.related.type=“has-member”

  8. One patient in Observation.subject

  9. A date and time in Observation.effectiveDateTime or Observation.effectivePeriod

Mandatory: 5 elements (+6 nested mandatory elements)
Must-Support: 30 elements
Fixed Value: 5 elements

This structure is derived from Observation.

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 0..*Observation
... status S1..1code
... category 0..1CodeableConcept
.... coding S1..*Coding
..... system S1..1uriFixed Value: http://hl7.org/fhir/observation-category
..... code S1..1codeFixed Value: vital-signs
... code S1..1CodeableConceptCoded Responses from C-CDA Vital Sign Results
Binding: Vital Signs (required)
.... coding S1..*Coding
..... system S1..1uri
..... code S1..1code
..... display S0..1string
... subject S1..1Reference(Patient | Group | Device | Location)
... effective[x] S1..1dateTime, PeriodOften just a dateTime for Vital Signs
... valueQuantity S0..1QuantityVital Sign Value recorded with UCUM
Binding: Vital Signs Units (required)
.... value S1..1decimal
.... unit S0..1string
.... system S1..1uriFixed Value: http://unitsofmeasure.org
.... code S1..1codeCoded responses from the common UCUM units for vital signs value set.
... dataAbsentReason S0..1CodeableConcept
... referenceRange S0..1BackboneElement
.... low S0..1SimpleQuantity
..... value S0..1decimal
..... unit S0..1string
..... system S0..1uriFixed Value: http://unitsofmeasure.org
..... code S0..1code
.... high S0..1SimpleQuantity
..... value S0..1decimal
..... unit S0..1string
..... system S0..1uriFixed Value: http://unitsofmeasure.org
..... code S0..1code
.... meaning S0..1CodeableConcept
.... text S0..1string

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation I0..*ObservationMeasurements and simple assertions
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: Component code SHALL not be same as observation code
... meta ∑0..1MetaMetadata about the resource
... implicitRules ?! ∑0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: IETF BCP-47 (required)
... text I0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional Content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier 0..*IdentifierUnique Id for this particular observation
... status ?! S∑1..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required)
... category 0..1CodeableConceptClassification of type of observation
Binding: Observation Category Codes (example)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... coding S ∑1..*CodingCode defined by a terminology system
..... extension 0..*ExtensionAdditional Content defined by implementations
..... system S ∑1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/observation-category
..... version ∑0..1stringVersion of the system - if relevant
..... code S ∑1..1codeSymbol in syntax defined by the system
Fixed Value: vital-signs
..... display ∑0..1stringRepresentation defined by the system
..... userSelected ∑0..1booleanIf this coding was chosen directly by the user
.... text ∑0..1stringPlain text representation of the concept
... code S ∑1..1CodeableConceptCoded Responses from C-CDA Vital Sign Results
Binding: Vital Signs (required)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... coding S ∑1..*CodingCode defined by a terminology system
..... extension 0..*ExtensionAdditional Content defined by implementations
..... system S ∑1..1uriIdentity of the terminology system
..... version ∑0..1stringVersion of the system - if relevant
..... code S ∑1..1codeSymbol in syntax defined by the system
..... display S ∑0..1stringRepresentation defined by the system
..... userSelected ∑0..1booleanIf this coding was chosen directly by the user
.... text ∑0..1stringPlain text representation of the concept
... subject S ∑1..1Reference(Patient | Group | Device | Location)Who and/or what this is about
... encounter 0..1Reference(Encounter)Healthcare event during which this observation is made
... effective[x] S ∑1..1dateTime, PeriodOften just a dateTime for Vital Signs
... issued ∑0..1instantDate/Time this was made available
... performer ∑0..*Reference(Practitioner | Organization | Patient | RelatedPerson)Who is responsible for the observation
... valueQuantity S ∑0..1QuantityVital Sign Value recorded with UCUM
Binding: Vital Signs Units (required)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... value S ∑1..1decimalNumerical value (with implicit precision)
.... comparator ?! ∑0..1code< | <= | >= | > - how to understand the value
Binding: QuantityComparator (required)
.... unit S ∑0..1stringUnit representation
.... system S ∑I1..1uriSystem that defines coded unit form
Fixed Value: http://unitsofmeasure.org
.... code S ∑1..1codeCoded responses from the common UCUM units for vital signs value set.
... dataAbsentReason S I0..1CodeableConceptWhy the result is missing
Binding: Observation Value Absent Reason (extensible)
... interpretation 0..1CodeableConceptHigh, low, normal, etc.
Binding: Observation Interpretation Codes (extensible)
... comment 0..1stringComments about result
... bodySite 0..1CodeableConceptObserved body part
Binding: SNOMED CT Body Structures (example)
... method 0..1CodeableConceptHow it was done
Binding: Observation Methods (example)
... specimen 0..1Reference(Specimen)Specimen used for this observation
... device 0..1Reference(Device | DeviceMetric)(Measurement) Device
... referenceRange S I0..1BackboneElementProvides guide for interpretation
obs-3: Must have at least a low or a high or text
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?! ∑0..*ExtensionExtensions that cannot be ignored
.... low S I0..1SimpleQuantityLow Range, if relevant
qty-3: If a code for the unit is present, the system SHALL also be present
sqty-1: The comparator is not used on a SimpleQuantity
..... extension 0..*ExtensionAdditional Content defined by implementations
..... value S ∑0..1decimalNumerical value (with implicit precision)
..... unit S ∑0..1stringUnit representation
..... system S ∑I0..1uriSystem that defines coded unit form
Fixed Value: http://unitsofmeasure.org
..... code S ∑0..1codeCoded form of the unit
.... high S I0..1SimpleQuantityHigh Range, if relevant
qty-3: If a code for the unit is present, the system SHALL also be present
sqty-1: The comparator is not used on a SimpleQuantity
..... extension 0..*ExtensionAdditional Content defined by implementations
..... value S ∑0..1decimalNumerical value (with implicit precision)
..... unit S ∑0..1stringUnit representation
..... system S ∑I0..1uriSystem that defines coded unit form
Fixed Value: http://unitsofmeasure.org
..... code S ∑0..1codeCoded form of the unit
.... meaning S0..1CodeableConceptIndicates the meaning/use of this range of this range
Binding: Observation Reference Range Meaning Codes (example)
.... age 0..1RangeApplicable age range, if relevant
.... text S0..1stringText based reference range in an observation
... related ∑0..*BackboneElementResource related to this observation
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?! ∑0..*ExtensionExtensions that cannot be ignored
.... type 0..1codehas-member | derived-from | sequel-to | replaces | qualified-by | interfered-by
Binding: ObservationRelationshipType (required)
.... target 1..1Reference(Observation | QuestionnaireResponse)Resource that is related to this one
... component ∑0..*BackboneElementComponent results
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?! ∑0..*ExtensionExtensions that cannot be ignored
.... code ∑ I1..1CodeableConceptType of component observation (code / type)
Binding: LOINC Codes (example)
.... value[x] ∑0..1Quantity, CodeableConcept, string, Range, Ratio, SampledData, Attachment, time, dateTime, PeriodActual component result
.... dataAbsentReason I0..1CodeableConceptWhy the component result is missing
Binding: Observation Value Absent Reason (extensible)
.... referenceRange 0..*Unknown reference to #referenceRange
Provides guide for interpretation of component result

doco Documentation for this format

todo

This structure is derived from Observation.

Summary

4.31.17.2.3 Complete Summary of the Mandatory Requirements

  1. One status in Observation.status

  2. One category in Observation.category which must have:

    • a fixed Observation.category.coding.system=“http:<i/>//hl7.org/fhir/observation-category>”
    • a fixed Observation.category.coding.code=“vital-signs”

  3. One code in Observation.code which must have

    • a fixed Observation.code.coding.system=“http:<i/>//loinc.org>”
    • a LOINC code in Observation.code.coding.code which must be taken from the Vital Signs valueset
    • Other additional codes are allowed - e.g. method specific LOINC Codes, SNOMED CT concepts, system specific codes. All codes SHALL have an system value

  4. Either one Observation.valueQuantity or, if there is no value, one code in Observation.DataAbsentReason (Note: See the comments in the table for exceptions)

    • Each Observation.valueQuantity must have:
      • One numeric value in Observation.valueQuantity.value
      • a fixed Observation.valueQuantity.system=“http:<i/>//unitsofmeasure.org>”
      • a UCUM unit code in Observation.valueQuantity.code which must be taken from the Vital Signs Units valueset
    • Observation.DataAbsentReason should be taken from the Observation Value Absent Reason Valueset

  5. When using a panel code to group component observations (Note: See the comments regarding blood pressure in the table), one or more Observation.component.code each of which must have:

    • a fixed Observation.component.code.coding.system=“http:<i/>//loinc.org>”
    • a LOINC code in Observation.component.code.coding.code taken from the column labeled “LOINC code” in the table

  6. Either one Observation.component.valueQuantity or, if there is no value, one code in Observation.component.DataAbsentReason

    • Each Observation.component.valueQuantity must have:
      • One numeric value in Observation.component.valueQuantity.value
      • a fixed Observation.component.valueQuantity.system=“http:<i/>//unitsofmeasure.org>”
      • a UCUM unit code in Observation.component.valueQuantity.code which must be taken from the Vital Signs Units valueset
    • The Observation.component.DataAbsentReason.code.coding.code should be taken from the Observation Value Absent Reason Valueset

  7. When using a panel code to group observations, one or more reference to Observations in Observation.related.target(Note: See the comments for Vital Signs in the table)

    • a fixed Observation.related.type=“has-member”

  8. One patient in Observation.subject

  9. A date and time in Observation.effectiveDateTime or Observation.effectivePeriod

Mandatory: 5 elements (+6 nested mandatory elements)
Must-Support: 30 elements
Fixed Value: 5 elements

Differential View

This structure is derived from Observation.

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 0..*Observation
... status S1..1code
... category 0..1CodeableConcept
.... coding S1..*Coding
..... system S1..1uriFixed Value: http://hl7.org/fhir/observation-category
..... code S1..1codeFixed Value: vital-signs
... code S1..1CodeableConceptCoded Responses from C-CDA Vital Sign Results
Binding: Vital Signs (required)
.... coding S1..*Coding
..... system S1..1uri
..... code S1..1code
..... display S0..1string
... subject S1..1Reference(Patient | Group | Device | Location)
... effective[x] S1..1dateTime, PeriodOften just a dateTime for Vital Signs
... valueQuantity S0..1QuantityVital Sign Value recorded with UCUM
Binding: Vital Signs Units (required)
.... value S1..1decimal
.... unit S0..1string
.... system S1..1uriFixed Value: http://unitsofmeasure.org
.... code S1..1codeCoded responses from the common UCUM units for vital signs value set.
... dataAbsentReason S0..1CodeableConcept
... referenceRange S0..1BackboneElement
.... low S0..1SimpleQuantity
..... value S0..1decimal
..... unit S0..1string
..... system S0..1uriFixed Value: http://unitsofmeasure.org
..... code S0..1code
.... high S0..1SimpleQuantity
..... value S0..1decimal
..... unit S0..1string
..... system S0..1uriFixed Value: http://unitsofmeasure.org
..... code S0..1code
.... meaning S0..1CodeableConcept
.... text S0..1string

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation I0..*ObservationMeasurements and simple assertions
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: Component code SHALL not be same as observation code
... meta ∑0..1MetaMetadata about the resource
... implicitRules ?! ∑0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: IETF BCP-47 (required)
... text I0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional Content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier 0..*IdentifierUnique Id for this particular observation
... status ?! S∑1..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required)
... category 0..1CodeableConceptClassification of type of observation
Binding: Observation Category Codes (example)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... coding S ∑1..*CodingCode defined by a terminology system
..... extension 0..*ExtensionAdditional Content defined by implementations
..... system S ∑1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/observation-category
..... version ∑0..1stringVersion of the system - if relevant
..... code S ∑1..1codeSymbol in syntax defined by the system
Fixed Value: vital-signs
..... display ∑0..1stringRepresentation defined by the system
..... userSelected ∑0..1booleanIf this coding was chosen directly by the user
.... text ∑0..1stringPlain text representation of the concept
... code S ∑1..1CodeableConceptCoded Responses from C-CDA Vital Sign Results
Binding: Vital Signs (required)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... coding S ∑1..*CodingCode defined by a terminology system
..... extension 0..*ExtensionAdditional Content defined by implementations
..... system S ∑1..1uriIdentity of the terminology system
..... version ∑0..1stringVersion of the system - if relevant
..... code S ∑1..1codeSymbol in syntax defined by the system
..... display S ∑0..1stringRepresentation defined by the system
..... userSelected ∑0..1booleanIf this coding was chosen directly by the user
.... text ∑0..1stringPlain text representation of the concept
... subject S ∑1..1Reference(Patient | Group | Device | Location)Who and/or what this is about
... encounter 0..1Reference(Encounter)Healthcare event during which this observation is made
... effective[x] S ∑1..1dateTime, PeriodOften just a dateTime for Vital Signs
... issued ∑0..1instantDate/Time this was made available
... performer ∑0..*Reference(Practitioner | Organization | Patient | RelatedPerson)Who is responsible for the observation
... valueQuantity S ∑0..1QuantityVital Sign Value recorded with UCUM
Binding: Vital Signs Units (required)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... value S ∑1..1decimalNumerical value (with implicit precision)
.... comparator ?! ∑0..1code< | <= | >= | > - how to understand the value
Binding: QuantityComparator (required)
.... unit S ∑0..1stringUnit representation
.... system S ∑I1..1uriSystem that defines coded unit form
Fixed Value: http://unitsofmeasure.org
.... code S ∑1..1codeCoded responses from the common UCUM units for vital signs value set.
... dataAbsentReason S I0..1CodeableConceptWhy the result is missing
Binding: Observation Value Absent Reason (extensible)
... interpretation 0..1CodeableConceptHigh, low, normal, etc.
Binding: Observation Interpretation Codes (extensible)
... comment 0..1stringComments about result
... bodySite 0..1CodeableConceptObserved body part
Binding: SNOMED CT Body Structures (example)
... method 0..1CodeableConceptHow it was done
Binding: Observation Methods (example)
... specimen 0..1Reference(Specimen)Specimen used for this observation
... device 0..1Reference(Device | DeviceMetric)(Measurement) Device
... referenceRange S I0..1BackboneElementProvides guide for interpretation
obs-3: Must have at least a low or a high or text
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?! ∑0..*ExtensionExtensions that cannot be ignored
.... low S I0..1SimpleQuantityLow Range, if relevant
qty-3: If a code for the unit is present, the system SHALL also be present
sqty-1: The comparator is not used on a SimpleQuantity
..... extension 0..*ExtensionAdditional Content defined by implementations
..... value S ∑0..1decimalNumerical value (with implicit precision)
..... unit S ∑0..1stringUnit representation
..... system S ∑I0..1uriSystem that defines coded unit form
Fixed Value: http://unitsofmeasure.org
..... code S ∑0..1codeCoded form of the unit
.... high S I0..1SimpleQuantityHigh Range, if relevant
qty-3: If a code for the unit is present, the system SHALL also be present
sqty-1: The comparator is not used on a SimpleQuantity
..... extension 0..*ExtensionAdditional Content defined by implementations
..... value S ∑0..1decimalNumerical value (with implicit precision)
..... unit S ∑0..1stringUnit representation
..... system S ∑I0..1uriSystem that defines coded unit form
Fixed Value: http://unitsofmeasure.org
..... code S ∑0..1codeCoded form of the unit
.... meaning S0..1CodeableConceptIndicates the meaning/use of this range of this range
Binding: Observation Reference Range Meaning Codes (example)
.... age 0..1RangeApplicable age range, if relevant
.... text S0..1stringText based reference range in an observation
... related ∑0..*BackboneElementResource related to this observation
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?! ∑0..*ExtensionExtensions that cannot be ignored
.... type 0..1codehas-member | derived-from | sequel-to | replaces | qualified-by | interfered-by
Binding: ObservationRelationshipType (required)
.... target 1..1Reference(Observation | QuestionnaireResponse)Resource that is related to this one
... component ∑0..*BackboneElementComponent results
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?! ∑0..*ExtensionExtensions that cannot be ignored
.... code ∑ I1..1CodeableConceptType of component observation (code / type)
Binding: LOINC Codes (example)
.... value[x] ∑0..1Quantity, CodeableConcept, string, Range, Ratio, SampledData, Attachment, time, dateTime, PeriodActual component result
.... dataAbsentReason I0..1CodeableConceptWhy the component result is missing
Binding: Observation Value Absent Reason (extensible)
.... referenceRange 0..*Unknown reference to #referenceRange
Provides guide for interpretation of component result

doco Documentation for this format

XML Template

JSON Template

todo

 

Other representations of profile: Schematron

4.31.17.2.4 Terminology Bindings

PathNameConformanceValueSet
Observation.language?extrequiredhttp://tools.ietf.org/html/bcp47
Observation.statusObservationStatusrequiredObservationStatus
Observation.categoryObservation Category CodesexampleObservation Category Codes
Observation.codeVital SignsrequiredVital Signs
Observation.valueQuantityVital Signs UnitsrequiredVital Signs Units
Observation.valueQuantity.comparatorQuantityComparatorrequiredQuantityComparator
Observation.dataAbsentReasonObservation Value Absent ReasonextensibleObservation Value Absent Reason
Observation.interpretationObservation Interpretation CodesextensibleObservation Interpretation Codes
Observation.bodySiteSNOMED CT Body StructuresexampleSNOMED CT Body Structures
Observation.methodObservation MethodsexampleObservation Methods
Observation.referenceRange.meaningObservation Reference Range Meaning CodesexampleObservation Reference Range Meaning Codes
Observation.related.typeObservationRelationshipTyperequiredObservationRelationshipType
Observation.component.codeLOINC CodesexampleLOINC Codes
Observation.component.dataAbsentReasonObservation Value Absent ReasonextensibleObservation Value Absent Reason

4.31.17.2.5 Constraints

IdPathDetailsRequirements
obs-6ObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
XPath: not(exists(f:dataAbsentReason)) or (not(exists(*[starts-with(local-name(.), 'value')])))
obs-7ObservationComponent code SHALL not be same as observation code
XPath: not(exists(f:component/f:code)) or count(for $coding in f:code/f:coding return parent::*/f:component/f:code/f:coding[f:code/@value=$coding/f:code/@value and f:system/@value=$coding/f:system/@value])=0
obs-3Observation.referenceRangeMust have at least a low or a high or text
XPath: (exists(f:low) or exists(f:high)or exists(f:text))
qty-3Observation.referenceRange.lowIf a code for the unit is present, the system SHALL also be present
XPath: not(exists(f:code)) or exists(f:system)
sqty-1Observation.referenceRange.lowThe comparator is not used on a SimpleQuantity
XPath: not(exists(f:comparator))
qty-3Observation.referenceRange.highIf a code for the unit is present, the system SHALL also be present
XPath: not(exists(f:code)) or exists(f:system)
sqty-1Observation.referenceRange.highThe comparator is not used on a SimpleQuantity
XPath: not(exists(f:comparator))
.