GAO Ballot Package

This page is part of the FHIR Specification (v1.1.0: STU 3 Ballot 1). 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 R2

This is a frozen snapshot of the FHIR specification created for the purpose of balloting the GAO implementation Guide. It includes draft changes that may be part of the future DSTU 2.1 release but further change is expected. Readers should focus solely on the GAO implementation content, and FHIR DSTU 2 for other purposes.

4.29.10.1 StructureDefinition: DeviceMetricObservation

The official URL for this profile is: 

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

This profile describes the direct or derived, qualitative or quantitative physiological measurement, setting, or calculation data produced by a medical device or a device component.

This profile was published on Mon, Nov 17, 2014 00:00+1100 as a draft by Health Level Seven International (Health Care Devices).

4.29.10.2 Scope and Usage

The DeviceMetricObservation profile describes the direct or derived, qualitative or quantitative physiological measurement, setting, or calculation data produced by a medical device or a device component.

4.29.10.2.1 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

Mandatory: 5 elements (+1 nested mandatory element)
Must-Support: 13 elements
Prohibited: 4 elements

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 S0..*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)
... code S ∑1..1CodeableConceptType of observation (code / type)
Binding: LOINC Codes (example)
... subject S ∑1..1Reference(Patient | Device)Who and/or what this is about
... effectiveDateTime S ∑1..1dateTimeClinically relevant time/time-period for observation
... performer ∑0..*Reference(Practitioner | Organization | Patient | RelatedPerson)Who is responsible for the observation
... value[x] S ∑0..1Quantity, CodeableConcept, string, Range, Ratio, SampledData, Attachment, time, dateTime, PeriodActual result
... interpretation 0..1CodeableConceptHigh, low, normal, etc.
Binding: Observation Interpretation Codes (extensible)
... comments 0..1stringComments about result
... bodySite S0..1CodeableConceptObserved body part
Binding: SNOMED CT Body Structures (example)
... method S0..1CodeableConceptHow it was done
Binding: Observation Methods (example)
... device S1..1Reference(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 I0..1SimpleQuantityLow Range, if relevant
.... high I0..1SimpleQuantityHigh Range, if relevant
.... meaning 0..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 0..1stringText based reference range in an observation
... related S ∑0..1BackboneElementResource related to this observation
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
.... type S0..1codehas-member | derived-from | sequel-to | replaces | qualified-by | interfered-by
Binding: ObservationRelationshipType (required)
.... target S1..1Reference(Observation)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..*See Observation.referenceRangeProvides guide for interpretation of component result

doco Documentation for this format

todo

This structure is derived from Observation.

Summary

Mandatory: 5 elements (+1 nested mandatory element)
Must-Support: 13 elements
Prohibited: 4 elements

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 S0..*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)
... code S ∑1..1CodeableConceptType of observation (code / type)
Binding: LOINC Codes (example)
... subject S ∑1..1Reference(Patient | Device)Who and/or what this is about
... effectiveDateTime S ∑1..1dateTimeClinically relevant time/time-period for observation
... performer ∑0..*Reference(Practitioner | Organization | Patient | RelatedPerson)Who is responsible for the observation
... value[x] S ∑0..1Quantity, CodeableConcept, string, Range, Ratio, SampledData, Attachment, time, dateTime, PeriodActual result
... interpretation 0..1CodeableConceptHigh, low, normal, etc.
Binding: Observation Interpretation Codes (extensible)
... comments 0..1stringComments about result
... bodySite S0..1CodeableConceptObserved body part
Binding: SNOMED CT Body Structures (example)
... method S0..1CodeableConceptHow it was done
Binding: Observation Methods (example)
... device S1..1Reference(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 I0..1SimpleQuantityLow Range, if relevant
.... high I0..1SimpleQuantityHigh Range, if relevant
.... meaning 0..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 0..1stringText based reference range in an observation
... related S ∑0..1BackboneElementResource related to this observation
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
.... type S0..1codehas-member | derived-from | sequel-to | replaces | qualified-by | interfered-by
Binding: ObservationRelationshipType (required)
.... target S1..1Reference(Observation)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..*See Observation.referenceRangeProvides guide for interpretation of component result

doco Documentation for this format

XML Template

JSON Template

todo

 

Other representations of profile: Schematron

4.29.10.2.2 Terminology Bindings

PathNameConformanceValueSet
Observation.language?extrequiredhttp://tools.ietf.org/html/bcp47
Observation.statusObservationStatusrequiredObservationStatus
Observation.categoryObservation Category CodesexampleObservation Category Codes
Observation.codeLOINC CodesexampleLOINC Codes
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

4.29.10.2.3 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))
For the initial scope, this DeviceMetricObservation profile is only applicable to describe a measurement that is produced by any medical device that implements or derives from the ISO/IEEE 11073 standard. .