STU 2 Ballot

This page is part of the Data Access Framework (v1.6.0: STU 2 Ballot 1) based on FHIR v1.6.0. . For a full list of available versions, see the Directory of published versions

D.4.1 StructureDefinition: DAF-core-resultobs

Laboratory results are grouped and summarized using the DiagnosticReport resource which reference Observation resources. Each Observation resource represents an individual laboratory test and result value, a “nested” panel (such as a microbial susceptibility panel) which references other observations, or rarely a laboratory test with component result values. This profile sets minimum expectations for the Observation resource resource to record, search and fetch laboratory test results associated with a patient. It identifies which core elements, extensions, vocabularies and value sets SHALL be present in the resource when using this profile.

Example Usage Scenarios:

The following are example usage scenarios for the DAF-Results profile:

  • Query for lab results belonging to a Patient
  • Query for all patients who have had a specific lab result available
  • Query for all patients with a lab test (e.g HbA1c) beyond the acceptable reference range
Mandatory Data Elements and Terminology

The following data-elements are mandatory (i.e data MUST be present). These are presented below in a simple human-readable explanation. Profile specific guidance and an example are provided as well. The Formal Profile Definition below provides the formal summary, definitions, and terminology requirements.

Each Observation must have:

  1. a status
  2. a category code of ‘laboratory’
  3. a LOINC code, if available, which tells you what is being measured
  4. a patient
  5. a result value and, if the result value is a numeric quantity, a standard UCUM unit

Each Observation should have:

  1. a time indicating when the measurement was taken
  2. a reference range if available

Profile specific implementation guidance:

  • Additional codes that translate or map to the Observation code or category codes are allowed. For example:
    • providing both a local system codes and a LOINC code that it map to
    • providing a more specific category codes such as “chemistry’, SNOMED CT concepts, or system specific codes in addition to the “laboratory” category code.
  • If there is no result then you have to supply a reason unless Observation is being used to group other results then there is no value. Instead, it includes composite values or references to other Observations
Example: Observation-Results Example: example

D.4.1.1 Formal Views of Profile Content

The official URL for this profile is: 

http://hl7.org/fhir/us/daf/StructureDefinition/daf-core-resultobs

This profile was published on Mon Aug 01 00:00:00 AEST 2016 as a draft by Health Level Seven International (FHIR-Infrastructure).

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

This structure is derived from Observation

Complete Summary of the Mandatory Requirements

  1. One status in Observation.status which has an required binding to:
  2. One 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=“laboratory”
  3. One code in Observation.code which has an extensible binding to:
    • LOINC Observation Codes
    • Other additional codes are allowed - e.g. system specific codes. All codes SHALL have a code system value
  4. One patient in Observation.subject
  5. Either one Observation.value or one code in Observation.DataAbsentReason (unless the Observation.code is a panel code)
    • Each Observation.valueQuantity must have:
      • One numeric value in Observation.valueQuantity.value
      • a fixed Observation.valueQuantity.system=“http://unitsofmeasure.org”
      • a UCUM units code in Observation.valueQuantity.code which has an required binding to: - ObservationStatus value set.
    • Each Observation.valueCodeableConcept must have either:
      1. a code in Observation.valueCodeableConcept.coding.code and code system in Observation.valueCodeableConcept.coding.sytem which has an preferred binding to:
      2. OR text in Observation.valueCodeableConcept.text
    • Observation.DataAbsentReason is bound to Observation Value Absent Reason Value set

Each Observation SHOULD have:

  1. A date and time in effectiveDateTime or effectivePeriod
  2. A reference range if applicable in Observation.referenceRange

This structure is derived from Observation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation I0..*daf-2: If there is no component or related element then either a value[x] or a data absent reason must be present
... status S1..1codeBinding: ObservationStatus (required)
... category S1..1CodeableConceptRequired Pattern: {"coding":[{"system":"http://hl7.org/fhir/observation-category","code":"laboratory"}]}
... code S1..1CodeableConceptBinding: LOINC Codes (extensible)
.... coding S1..*Coding
..... system S1..1uri
..... code S1..1code
..... display S0..1string
.... text S0..1string
... subject S1..1Reference(Profile daf-core-patient)
... effective[x] SI0..1dateTime, Perioddaf-1: Datetime must be at least to day.
... value[x] SIQuantity, CodeableConcept, string, Range, Ratio, SampledData, Attachment, time, dateTime, PeriodSlice: Unordered, Open, by @type
... value[x] S0..1QuantityBinding: UCUM units (required)
... value[x] S0..1CodeableConceptBinding: Observation Value Codes (SNOMED-CT) (preferred)
... value[x] S0..1string, Range, Ratio, SampledData, Attachment, time, dateTime, Period
... dataAbsentReason SI0..1CodeableConceptBinding: Observation Value Absent Reason (extensible)

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation I0..*Measurements and simple assertions
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
dom-1: If the resource is contained in another resource, it SHALL NOT contain any narrative
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource
obs-7: If code is the same as a component code then the value element associated with the code SHALL NOT be present
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
daf-2: If there is no component or related element then either a value[x] or a data absent reason must be present
... id ∑0..1idLogical id of this artifact
... 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: Common Languages (extensible)
... 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 ?!S1..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required)
... category S1..1CodeableConceptClassification of type of observation
Binding: Observation Category Codes (example)
Required Pattern: {"coding":[{"system":"http://hl7.org/fhir/observation-category","code":"laboratory"}]}
... code S1..1CodeableConceptType of observation (code / type)
Binding: LOINC Codes (extensible)
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... coding S1..*CodingCode defined by a terminology system
..... id 0..1stringxml:id (or equivalent in JSON)
..... extension 0..*ExtensionAdditional Content defined by implementations
..... system S1..1uriIdentity of the terminology system
..... version ∑0..1stringVersion of the system - if relevant
..... code S1..1codeSymbol in syntax defined by the system
..... display S0..1stringRepresentation defined by the system
..... userSelected ∑0..1booleanIf this coding was chosen directly by the user
.... text S0..1stringPlain text representation of the concept
... subject S1..1Reference(Profile daf-core-patient)Who and/or what this is about
... encounter 0..1Reference(Encounter)Healthcare event during which this observation is made
... effective[x] SI0..1dateTime, PeriodClinically relevant time/time-period for observation
daf-1: Datetime must be at least to day.
... issued ∑0..1instantDate/Time this was made available
... performer ∑0..*Reference(Practitioner | Organization | Patient | RelatedPerson)Who is responsible for the observation
... value[x] ∑IQuantity, CodeableConcept, string, Range, Ratio, SampledData, Attachment, time, dateTime, PeriodActual result
Slice: Unordered, Open, by @type
... value[x] SI0..1Quantity, CodeableConcept, string, Range, Ratio, SampledData, Attachment, time, dateTime, PeriodActual result
... valueQuantity SI0..1QuantityActual result
Binding: UCUM units (required)
... valueCodeableConcept SI0..1CodeableConceptActual result
Binding: Observation Value Codes (SNOMED-CT) (preferred)
... value[x] SI0..1string, Range, Ratio, SampledData, Attachment, time, dateTime, PeriodActual result
... dataAbsentReason SI0..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 I0..*BackboneElementProvides guide for interpretation
obs-3: Must have at least a low or a high or text
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?!∑0..*ExtensionExtensions that cannot be ignored
.... low I0..1SimpleQuantityLow Range, if relevant
.... high I0..1SimpleQuantityHigh Range, if relevant
.... meaning 0..*CodeableConceptReference range qualifier
Binding: Observation Reference Range Meaning Codes (example)
.... age 0..1RangeApplicable age range, if relevant
.... text 0..1stringText based reference range in an observation
... related ∑0..*BackboneElementResource related to this observation
.... id 0..1stringxml:id (or equivalent in JSON)
.... 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 | Sequence)Resource that is related to this one
... component ∑0..*BackboneElementComponent results
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?!∑0..*ExtensionExtensions that cannot be ignored
.... code ∑1..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)
.... interpretation 0..1CodeableConceptHigh, low, normal, etc.
Binding: Observation Interpretation Codes (extensible)
.... referenceRange 0..*Unknown reference to #Observation:dafcoreobs.referenceRange
Provides guide for interpretation of component result

doco Documentation for this format

yet to be done: Xml template

yet to be done: Json template

This structure is derived from Observation

Summary

Mandatory: 7 elements
Must-Support: 15 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element Observation.value[x] is sliced based on the value of @type

Differential View

This structure is derived from Observation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation I0..*daf-2: If there is no component or related element then either a value[x] or a data absent reason must be present
... status S1..1codeBinding: ObservationStatus (required)
... category S1..1CodeableConceptRequired Pattern: {"coding":[{"system":"http://hl7.org/fhir/observation-category","code":"laboratory"}]}
... code S1..1CodeableConceptBinding: LOINC Codes (extensible)
.... coding S1..*Coding
..... system S1..1uri
..... code S1..1code
..... display S0..1string
.... text S0..1string
... subject S1..1Reference(Profile daf-core-patient)
... effective[x] SI0..1dateTime, Perioddaf-1: Datetime must be at least to day.
... value[x] SIQuantity, CodeableConcept, string, Range, Ratio, SampledData, Attachment, time, dateTime, PeriodSlice: Unordered, Open, by @type
... value[x] S0..1QuantityBinding: UCUM units (required)
... value[x] S0..1CodeableConceptBinding: Observation Value Codes (SNOMED-CT) (preferred)
... value[x] S0..1string, Range, Ratio, SampledData, Attachment, time, dateTime, Period
... dataAbsentReason SI0..1CodeableConceptBinding: Observation Value Absent Reason (extensible)

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation I0..*Measurements and simple assertions
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
dom-1: If the resource is contained in another resource, it SHALL NOT contain any narrative
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource
obs-7: If code is the same as a component code then the value element associated with the code SHALL NOT be present
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
daf-2: If there is no component or related element then either a value[x] or a data absent reason must be present
... id ∑0..1idLogical id of this artifact
... 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: Common Languages (extensible)
... 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 ?!S1..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required)
... category S1..1CodeableConceptClassification of type of observation
Binding: Observation Category Codes (example)
Required Pattern: {"coding":[{"system":"http://hl7.org/fhir/observation-category","code":"laboratory"}]}
... code S1..1CodeableConceptType of observation (code / type)
Binding: LOINC Codes (extensible)
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... coding S1..*CodingCode defined by a terminology system
..... id 0..1stringxml:id (or equivalent in JSON)
..... extension 0..*ExtensionAdditional Content defined by implementations
..... system S1..1uriIdentity of the terminology system
..... version ∑0..1stringVersion of the system - if relevant
..... code S1..1codeSymbol in syntax defined by the system
..... display S0..1stringRepresentation defined by the system
..... userSelected ∑0..1booleanIf this coding was chosen directly by the user
.... text S0..1stringPlain text representation of the concept
... subject S1..1Reference(Profile daf-core-patient)Who and/or what this is about
... encounter 0..1Reference(Encounter)Healthcare event during which this observation is made
... effective[x] SI0..1dateTime, PeriodClinically relevant time/time-period for observation
daf-1: Datetime must be at least to day.
... issued ∑0..1instantDate/Time this was made available
... performer ∑0..*Reference(Practitioner | Organization | Patient | RelatedPerson)Who is responsible for the observation
... value[x] ∑IQuantity, CodeableConcept, string, Range, Ratio, SampledData, Attachment, time, dateTime, PeriodActual result
Slice: Unordered, Open, by @type
... value[x] SI0..1Quantity, CodeableConcept, string, Range, Ratio, SampledData, Attachment, time, dateTime, PeriodActual result
... valueQuantity SI0..1QuantityActual result
Binding: UCUM units (required)
... valueCodeableConcept SI0..1CodeableConceptActual result
Binding: Observation Value Codes (SNOMED-CT) (preferred)
... value[x] SI0..1string, Range, Ratio, SampledData, Attachment, time, dateTime, PeriodActual result
... dataAbsentReason SI0..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 I0..*BackboneElementProvides guide for interpretation
obs-3: Must have at least a low or a high or text
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?!∑0..*ExtensionExtensions that cannot be ignored
.... low I0..1SimpleQuantityLow Range, if relevant
.... high I0..1SimpleQuantityHigh Range, if relevant
.... meaning 0..*CodeableConceptReference range qualifier
Binding: Observation Reference Range Meaning Codes (example)
.... age 0..1RangeApplicable age range, if relevant
.... text 0..1stringText based reference range in an observation
... related ∑0..*BackboneElementResource related to this observation
.... id 0..1stringxml:id (or equivalent in JSON)
.... 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 | Sequence)Resource that is related to this one
... component ∑0..*BackboneElementComponent results
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?!∑0..*ExtensionExtensions that cannot be ignored
.... code ∑1..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)
.... interpretation 0..1CodeableConceptHigh, low, normal, etc.
Binding: Observation Interpretation Codes (extensible)
.... referenceRange 0..*Unknown reference to #Observation:dafcoreobs.referenceRange
Provides guide for interpretation of component result

doco Documentation for this format

XML Template

yet to be done: Xml template

JSON Template

yet to be done: Json template

Downloads: StructureDefinition: (XML, JSON), Schema: XML Schematron

 

D.4.1.2 Terminology Bindings

Terminology Bindings

PathNameConformanceValueSet
Observation.languageCommon LanguagesextensibleCommon Languages
Observation.statusObservationStatusrequiredObservationStatus
Observation.categoryObservation Category CodesexampleObservation Category Codes
Observation.codeLOINC CodesextensibleLOINC Codes
Observation.valueQuantityUCUM unitsrequiredUCUM units
Observation.valueCodeableConceptObservation Value Codes (SNOMED-CT)preferredObservation Value Codes (SNOMED-CT)
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
Observation.component.interpretationObservation Interpretation CodesextensibleObservation Interpretation Codes

D.4.1.3 Constraints

Constraints

IdPathDetailsRequirements
dom-2ObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
XPath: not(parent::f:contained and f:contained)
dom-1ObservationIf the resource is contained in another resource, it SHALL NOT contain any narrative
XPath: not(parent::f:contained and f:text)
dom-4ObservationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
XPath: not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))
dom-3ObservationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource
XPath: not(exists(for $id in f:contained/*/@id return $id[not(ancestor::f:contained/parent::*/descendant::f:reference/@value=concat('#', $id))]))
obs-7ObservationIf code is the same as a component code then the value element associated with the code SHALL NOT be present
XPath: not(exists(f:value)) or not(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-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')])))
daf-2ObservationIf there is no component or related element then either a value[x] or a data absent reason must be present
XPath: exists(f:component) or exists(f:related) or exists(f:*[starts-with(local-name(.), 'value)]) or exists(f:dataAbsentReason)
daf-1Observation.effective[x]Datetime must be at least to day.
XPath: f:matches(effectiveDateTime,/\d{4}-[01]\d-[0-3]\dT[0-2]\d:[0-5]\d([+-][0-2]\d:[0-5]\d|Z)/)
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))
.