Summary

10.1.19.3 Complete Summary of the Mandatory Requirements

1. One status in Observation.statuswhich has a required binding to:

   • ObservationStatus value set.

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

   • a fixed Observation.category.coding.system="http://hl7.org/fhir/observation-category"
   • a fixed Observation.category.coding.code= "vital-signs"

3. A code in Observation.code

   • a fixed Observation.code.coding.system= "http://loinc.org"
   • a LOINC code in Observation.code.coding.code which has an extensible binding to:
     • Vital Signs value set.

4. One patient in Observation.subject

5. A date and time in effectiveDateTime or effectivePeriod

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

   • Each Observation.valueQuantity must have:
     • One numeric value in Observation.valueQuantity.value
     • a fixed Observation.valueQuantity.system="http://unitsofmeasure"
     • a UCUM unit code in Observation.valueQuantity.code which has an required binding to:
       • Vital Signs Units value set.
   • Observation.DataAbsentReason is bound to Observation Value Absent Reason value set.

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

   • a fixed Observation.component.code.coding.system ="<http://loinc.org>"
     • a LOINC code in Observation.code.coding.code which has an extensible binding to:
       • Vital Signs Units value set.

8. 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://unitsofmeasure.org>"
     • a UCUM unit code in Observation.component.valueQuantity.code which has an required binding to:
       • Vital Signs Units value set.
   • Observation.component.DataAbsentReason is bound to Observation Value Absent Reason value set.

9. When using a panel code to group observations, one or more reference to Vitals Signs Observations in Observation.related.target

   • a fixed Observation.related.type= "has-member"

Mandatory: 5 elements (+11 nested mandatory elements)
Must-Support: 22 elements
Fixed Value: 3 elements

Structures

This structure refers to these other structures:

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

<!-- Vital Signs Profile -->

<Observation xmlns="http://hl7.org/fhir"
>
  <!-- from Element: extension -->
 <id value="[id]"/><!-- 0..1 Logical id of this artifact -->
 <meta><!-- 0..1 Meta Metadata about the resource --></meta>
 <implicitRules value="[uri]"/><!-- 0..1 A set of rules under which this content was created -->
 <language value="[code]"/><!-- 0..1 Language of the resource content  -->
 <text><!-- 0..1 Narrative 
     Text summary of the resource, for human interpretation --></text>
 <contained><!-- 0..* Resource Contained, inline Resources --></contained>
 <modifierExtension><!-- 0..* Extension  Extensions that cannot be ignored  --></modifierExtension>
 <identifier><!-- 0..* Identifier 
     Business Identifier for observation --></identifier>
 <basedOn><!-- 0..* Reference(CarePlan)|Reference(DeviceRequest)|Reference(ImmunizationRecommendation)|Reference(MedicationRequest)|
   Reference(NutritionOrder)|Reference(ProcedureRequest)|Reference(ReferralRequest) Fulfills plan, proposal or order --></basedOn>
 <status value="[code]"/><!-- 1..1 registered | preliminary | final | amended +  -->
 <category><!--  1..* CodeableConcept Classification of  type of observation  --></category>
 <code><!-- 1..1 CodeableConcept Coded Responses from C-CDA Vital Sign Results  --></code>
 <subject><!-- 1..1 Reference(Patient) Who and/or what this is about --></subject>
 <context><!-- 0..1 Reference(Encounter)|Reference(EpisodeOfCare) 
     Healthcare event during which this observation is made --></context>
 <effective[x]><!--  1..1 dateTime|Period 
     Often just a dateTime for Vital Signs --></effective[x]>
 <issued value="[instant]"/><!-- 0..1 Date/Time this was made available -->
 <performer><!-- 0..* Reference(Practitioner)|Reference(Organization)|Reference(Patient)|Reference(RelatedPerson) 
     Who is responsible for the observation --></performer>
 <valueQuantity> 0..1 Quantity  <!-- 0..1 Vital Sign Value recorded with UCUM -->
  <value value="[decimal]"/><!-- 1..1 Numerical value (with implicit precision) -->
  <comparator value="[code]"/><!-- 0..1 < | <= | >= | > - how to understand the value  -->
  <unit value="[string]"/><!-- 1..1 Unit representation -->
  <system value="[uri]"/><!-- 1..1 System that defines coded unit form -->
  <code value="[code]"/><!-- 1..1 
      Coded responses from the common UCUM units for vital signs value set. -->
 </valueQuantity>
 <dataAbsentReason><!-- 0..1 CodeableConcept Why the result is missing  --></dataAbsentReason>
 <interpretation><!-- 0..1 CodeableConcept High, low, normal, etc.  --></interpretation>
 <comment value="[string]"/><!-- 0..1 Comments about result -->
 <bodySite><!-- 0..1 CodeableConcept Observed body part  --></bodySite>
 <method><!-- 0..1 CodeableConcept How it was done  --></method>
 <specimen><!-- 0..1 Reference(Specimen) Specimen used for this observation --></specimen>
 <device><!-- 0..1 Reference(Device)|Reference(DeviceMetric) (Measurement) Device --></device>
 <referenceRange>  0..* BackboneElement  <!--  0..* Provides guide for interpretation -->
  <modifierExtension><!-- 0..* Extension  Extensions that cannot be ignored  --></modifierExtension>
  <low><!-- 0..1 Quantity 
      Low Range, if relevant --></low>
  <high><!-- 0..1 Quantity 
      High Range, if relevant --></high>
  <type><!-- 0..1 CodeableConcept Reference range qualifier  --></type>
  <appliesTo><!-- 0..* CodeableConcept Reference range population  --></appliesTo>
  <age><!-- 0..1 Range 
      Applicable age range, if relevant --></age>
  <text value="[string]"/><!-- 0..1 Text based reference range in an observation -->
 </referenceRange>
 <related>  0..* BackboneElement  <!--  0..* Used when reporting vital signs panel components -->
  <modifierExtension><!-- 0..* Extension  Extensions that cannot be ignored  --></modifierExtension>
  <type value="[code]"/><!-- 1..1 has-member | derived-from | sequel-to | replaces | qualified-by | interfered-by  -->
  <target><!-- 1..1 Reference(Vital Signs Profile) 
      Resource that is related to this one --></target>
 </related>
 <component>  0..* BackboneElement  <!--  0..* Used when reporting systolic and diastolic blood pressure. -->
  <modifierExtension><!-- 0..* Extension  Extensions that cannot be ignored  --></modifierExtension>
  <code><!-- 1..1 CodeableConcept Type of component observation (code / type)  --></code>
  <valueQuantity> 0..1 Quantity  <!-- 0..1 Vital Sign Value recorded with UCUM -->
   <value value="[decimal]"/><!-- 1..1 Numerical value (with implicit precision) -->
   <comparator value="[code]"/><!-- 0..1 < | <= | >= | > - how to understand the value  -->
   <unit value="[string]"/><!-- 1..1 Unit representation -->
   <system value="[uri]"/><!-- 1..1 System that defines coded unit form -->
   <code value="[code]"/><!-- 1..1 
       Coded responses from the common UCUM units for vital signs value set. -->
  </valueQuantity>
  <dataAbsentReason><!-- 0..1 CodeableConcept Why the component result is missing  --></dataAbsentReason>
  <interpretation><!-- 0..1 CodeableConcept High, low, normal, etc.  --></interpretation>
  <referenceRange><!-- See #Observation.referenceRange  Provides guide for interpretation of component result --></referenceRange>
 </component>
</Observation>

{ // Vital Signs Profile
  // from Element: extension
    "meta" : { Meta }, //Metadata about the resource
    "implicitRules" : "<uri>", //A set of rules under which this content was created
    "language" : "<code>", //Language of the resource content 
    "text" : { Narrative }, //Text summary of the resource, for human interpretation
    "contained" : [{ Resource }], //Contained, inline Resources
    "modifierExtension" : [{ Extension }], //Extensions that cannot be ignored
    "identifier" : [{ Identifier }], //Business Identifier for observation
// value[x]: Fulfills plan, proposal or order. One of these 7:
    "basedOn" : [{ Reference(CarePlan) }], //Fulfills plan, proposal or order
    "basedOn" : [{ Reference(DeviceRequest) }], //Fulfills plan, proposal or order
    "basedOn" : [{ Reference(ImmunizationRecommendation) }], //Fulfills plan, proposal or order
    "basedOn" : [{ Reference(MedicationRequest) }], //Fulfills plan, proposal or order
    "basedOn" : [{ Reference(NutritionOrder) }], //Fulfills plan, proposal or order
    "basedOn" : [{ Reference(ProcedureRequest) }], //Fulfills plan, proposal or order
    "basedOn" : [{ Reference(ReferralRequest) }], //Fulfills plan, proposal or order
    "status" : "<code>", // R! registered | preliminary | final | amended + 
    "category" : [{ CodeableConcept }], // C? R! Classification of  type of observation 
    "code" : { CodeableConcept }, // R! Coded Responses from C-CDA Vital Sign Results 
    "subject" : { Reference(Patient) }, // R! Who and/or what this is about
// value[x]: Healthcare event during which this observation is made. One of these 2:
    "context" : { Reference(Encounter) }, //Healthcare event during which this observation is made
    "context" : { Reference(EpisodeOfCare) }, //Healthcare event during which this observation is made
// value[x]: Often just a dateTime for Vital Signs. One of these 2:
    "effectiveDateTime" : "<dateTime>", // C? R! Often just a dateTime for Vital Signs
    "effectivePeriod" : { Period }, // C? R! Often just a dateTime for Vital Signs
    "issued" : "<instant>", //Date/Time this was made available
// value[x]: Who is responsible for the observation. One of these 4:
    "performer" : [{ Reference(Practitioner) }], //Who is responsible for the observation
    "performer" : [{ Reference(Organization) }], //Who is responsible for the observation
    "performer" : [{ Reference(Patient) }], //Who is responsible for the observation
    "performer" : [{ Reference(RelatedPerson) }] //Who is responsible for the observation
    "valueQuantity" : { Quantity }, //Vital Sign Value recorded with UCUM 
    "dataAbsentReason" : { CodeableConcept }, //Why the result is missing 
    "interpretation" : { CodeableConcept }, //High, low, normal, etc. 
    "comment" : "<string>", //Comments about result
    "bodySite" : { CodeableConcept }, //Observed body part 
    "method" : { CodeableConcept }, //How it was done 
    "specimen" : { Reference(Specimen) }, //Specimen used for this observation
// value[x]: (Measurement) Device. One of these 2:
    "device" : { Reference(Device) }, //(Measurement) Device
    "device" : { Reference(DeviceMetric) }, //(Measurement) Device
    "referenceRange" : [{ BackboneElement }], // C?Provides guide for interpretation
    "related" : [{ BackboneElement }], // C?Used when reporting vital signs panel components
    "component" : [{ BackboneElement }], // C?Used when reporting systolic and diastolic blood pressure.
  }

Summary

10.1.19.4 Complete Summary of the Mandatory Requirements

1. One status in Observation.statuswhich has a required binding to:

   • ObservationStatus value set.

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

   • a fixed Observation.category.coding.system="http://hl7.org/fhir/observation-category"
   • a fixed Observation.category.coding.code= "vital-signs"

3. A code in Observation.code

   • a fixed Observation.code.coding.system= "http://loinc.org"
   • a LOINC code in Observation.code.coding.code which has an extensible binding to:
     • Vital Signs value set.

4. One patient in Observation.subject

5. A date and time in effectiveDateTime or effectivePeriod

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

   • Each Observation.valueQuantity must have:
     • One numeric value in Observation.valueQuantity.value
     • a fixed Observation.valueQuantity.system="http://unitsofmeasure"
     • a UCUM unit code in Observation.valueQuantity.code which has an required binding to:
       • Vital Signs Units value set.
   • Observation.DataAbsentReason is bound to Observation Value Absent Reason value set.

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

   • a fixed Observation.component.code.coding.system ="<http://loinc.org>"
     • a LOINC code in Observation.code.coding.code which has an extensible binding to:
       • Vital Signs Units value set.

8. 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://unitsofmeasure.org>"
     • a UCUM unit code in Observation.component.valueQuantity.code which has an required binding to:
       • Vital Signs Units value set.
   • Observation.component.DataAbsentReason is bound to Observation Value Absent Reason value set.

9. When using a panel code to group observations, one or more reference to Vitals Signs Observations in Observation.related.target

   • a fixed Observation.related.type= "has-member"

Mandatory: 5 elements (+11 nested mandatory elements)
Must-Support: 22 elements
Fixed Value: 3 elements

Structures

This structure refers to these other structures:

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

<!-- Vital Signs Profile -->

<Observation xmlns="http://hl7.org/fhir"
>
  <!-- from Element: extension -->
 <id value="[id]"/><!-- 0..1 Logical id of this artifact -->
 <meta><!-- 0..1 Meta Metadata about the resource --></meta>
 <implicitRules value="[uri]"/><!-- 0..1 A set of rules under which this content was created -->
 <language value="[code]"/><!-- 0..1 Language of the resource content  -->
 <text><!-- 0..1 Narrative 
     Text summary of the resource, for human interpretation --></text>
 <contained><!-- 0..* Resource Contained, inline Resources --></contained>
 <modifierExtension><!-- 0..* Extension  Extensions that cannot be ignored  --></modifierExtension>
 <identifier><!-- 0..* Identifier 
     Business Identifier for observation --></identifier>
 <basedOn><!-- 0..* Reference(CarePlan)|Reference(DeviceRequest)|Reference(ImmunizationRecommendation)|Reference(MedicationRequest)|
   Reference(NutritionOrder)|Reference(ProcedureRequest)|Reference(ReferralRequest) Fulfills plan, proposal or order --></basedOn>
 <status value="[code]"/><!-- 1..1 registered | preliminary | final | amended +  -->
 <category><!--  1..* CodeableConcept Classification of  type of observation  --></category>
 <code><!-- 1..1 CodeableConcept Coded Responses from C-CDA Vital Sign Results  --></code>
 <subject><!-- 1..1 Reference(Patient) Who and/or what this is about --></subject>
 <context><!-- 0..1 Reference(Encounter)|Reference(EpisodeOfCare) 
     Healthcare event during which this observation is made --></context>
 <effective[x]><!--  1..1 dateTime|Period 
     Often just a dateTime for Vital Signs --></effective[x]>
 <issued value="[instant]"/><!-- 0..1 Date/Time this was made available -->
 <performer><!-- 0..* Reference(Practitioner)|Reference(Organization)|Reference(Patient)|Reference(RelatedPerson) 
     Who is responsible for the observation --></performer>
 <valueQuantity> 0..1 Quantity  <!-- 0..1 Vital Sign Value recorded with UCUM -->
  <value value="[decimal]"/><!-- 1..1 Numerical value (with implicit precision) -->
  <comparator value="[code]"/><!-- 0..1 < | <= | >= | > - how to understand the value  -->
  <unit value="[string]"/><!-- 1..1 Unit representation -->
  <system value="[uri]"/><!-- 1..1 System that defines coded unit form -->
  <code value="[code]"/><!-- 1..1 
      Coded responses from the common UCUM units for vital signs value set. -->
 </valueQuantity>
 <dataAbsentReason><!-- 0..1 CodeableConcept Why the result is missing  --></dataAbsentReason>
 <interpretation><!-- 0..1 CodeableConcept High, low, normal, etc.  --></interpretation>
 <comment value="[string]"/><!-- 0..1 Comments about result -->
 <bodySite><!-- 0..1 CodeableConcept Observed body part  --></bodySite>
 <method><!-- 0..1 CodeableConcept How it was done  --></method>
 <specimen><!-- 0..1 Reference(Specimen) Specimen used for this observation --></specimen>
 <device><!-- 0..1 Reference(Device)|Reference(DeviceMetric) (Measurement) Device --></device>
 <referenceRange>  0..* BackboneElement  <!--  0..* Provides guide for interpretation -->
  <modifierExtension><!-- 0..* Extension  Extensions that cannot be ignored  --></modifierExtension>
  <low><!-- 0..1 Quantity 
      Low Range, if relevant --></low>
  <high><!-- 0..1 Quantity 
      High Range, if relevant --></high>
  <type><!-- 0..1 CodeableConcept Reference range qualifier  --></type>
  <appliesTo><!-- 0..* CodeableConcept Reference range population  --></appliesTo>
  <age><!-- 0..1 Range 
      Applicable age range, if relevant --></age>
  <text value="[string]"/><!-- 0..1 Text based reference range in an observation -->
 </referenceRange>
 <related>  0..* BackboneElement  <!--  0..* Used when reporting vital signs panel components -->
  <modifierExtension><!-- 0..* Extension  Extensions that cannot be ignored  --></modifierExtension>
  <type value="[code]"/><!-- 1..1 has-member | derived-from | sequel-to | replaces | qualified-by | interfered-by  -->
  <target><!-- 1..1 Reference(Vital Signs Profile) 
      Resource that is related to this one --></target>
 </related>
 <component>  0..* BackboneElement  <!--  0..* Used when reporting systolic and diastolic blood pressure. -->
  <modifierExtension><!-- 0..* Extension  Extensions that cannot be ignored  --></modifierExtension>
  <code><!-- 1..1 CodeableConcept Type of component observation (code / type)  --></code>
  <valueQuantity> 0..1 Quantity  <!-- 0..1 Vital Sign Value recorded with UCUM -->
   <value value="[decimal]"/><!-- 1..1 Numerical value (with implicit precision) -->
   <comparator value="[code]"/><!-- 0..1 < | <= | >= | > - how to understand the value  -->
   <unit value="[string]"/><!-- 1..1 Unit representation -->
   <system value="[uri]"/><!-- 1..1 System that defines coded unit form -->
   <code value="[code]"/><!-- 1..1 
       Coded responses from the common UCUM units for vital signs value set. -->
  </valueQuantity>
  <dataAbsentReason><!-- 0..1 CodeableConcept Why the component result is missing  --></dataAbsentReason>
  <interpretation><!-- 0..1 CodeableConcept High, low, normal, etc.  --></interpretation>
  <referenceRange><!-- See #Observation.referenceRange  Provides guide for interpretation of component result --></referenceRange>
 </component>
</Observation>

{ // Vital Signs Profile
  // from Element: extension
    "meta" : { Meta }, //Metadata about the resource
    "implicitRules" : "<uri>", //A set of rules under which this content was created
    "language" : "<code>", //Language of the resource content 
    "text" : { Narrative }, //Text summary of the resource, for human interpretation
    "contained" : [{ Resource }], //Contained, inline Resources
    "modifierExtension" : [{ Extension }], //Extensions that cannot be ignored
    "identifier" : [{ Identifier }], //Business Identifier for observation
// value[x]: Fulfills plan, proposal or order. One of these 7:
    "basedOn" : [{ Reference(CarePlan) }], //Fulfills plan, proposal or order
    "basedOn" : [{ Reference(DeviceRequest) }], //Fulfills plan, proposal or order
    "basedOn" : [{ Reference(ImmunizationRecommendation) }], //Fulfills plan, proposal or order
    "basedOn" : [{ Reference(MedicationRequest) }], //Fulfills plan, proposal or order
    "basedOn" : [{ Reference(NutritionOrder) }], //Fulfills plan, proposal or order
    "basedOn" : [{ Reference(ProcedureRequest) }], //Fulfills plan, proposal or order
    "basedOn" : [{ Reference(ReferralRequest) }], //Fulfills plan, proposal or order
    "status" : "<code>", // R! registered | preliminary | final | amended + 
    "category" : [{ CodeableConcept }], // C? R! Classification of  type of observation 
    "code" : { CodeableConcept }, // R! Coded Responses from C-CDA Vital Sign Results 
    "subject" : { Reference(Patient) }, // R! Who and/or what this is about
// value[x]: Healthcare event during which this observation is made. One of these 2:
    "context" : { Reference(Encounter) }, //Healthcare event during which this observation is made
    "context" : { Reference(EpisodeOfCare) }, //Healthcare event during which this observation is made
// value[x]: Often just a dateTime for Vital Signs. One of these 2:
    "effectiveDateTime" : "<dateTime>", // C? R! Often just a dateTime for Vital Signs
    "effectivePeriod" : { Period }, // C? R! Often just a dateTime for Vital Signs
    "issued" : "<instant>", //Date/Time this was made available
// value[x]: Who is responsible for the observation. One of these 4:
    "performer" : [{ Reference(Practitioner) }], //Who is responsible for the observation
    "performer" : [{ Reference(Organization) }], //Who is responsible for the observation
    "performer" : [{ Reference(Patient) }], //Who is responsible for the observation
    "performer" : [{ Reference(RelatedPerson) }] //Who is responsible for the observation
    "valueQuantity" : { Quantity }, //Vital Sign Value recorded with UCUM 
    "dataAbsentReason" : { CodeableConcept }, //Why the result is missing 
    "interpretation" : { CodeableConcept }, //High, low, normal, etc. 
    "comment" : "<string>", //Comments about result
    "bodySite" : { CodeableConcept }, //Observed body part 
    "method" : { CodeableConcept }, //How it was done 
    "specimen" : { Reference(Specimen) }, //Specimen used for this observation
// value[x]: (Measurement) Device. One of these 2:
    "device" : { Reference(Device) }, //(Measurement) Device
    "device" : { Reference(DeviceMetric) }, //(Measurement) Device
    "referenceRange" : [{ BackboneElement }], // C?Provides guide for interpretation
    "related" : [{ BackboneElement }], // C?Used when reporting vital signs panel components
    "component" : [{ BackboneElement }], // C?Used when reporting systolic and diastolic blood pressure.
  }