DataStandardsWales-Observation-Lab

The Observation resource is used to support diagnosis, monitor progress, determine baselines and patterns and even capture demographic characteristics. Most observations are simple name/value pair assertions with some metadata, but some observations group other observations together logically, or even are multi-component observations. Note that the DiagnosticReport resource provides a clinical or workflow context for a set of observations and the Observation resource is referenced by DiagnosticReport to represent laboratory, imaging, and other clinical and diagnostic data to form a complete report.

The DataStandardsWales-Observation-Lab profile is derived from the Data Standards Wales Obervation Profile and defines additional rules for use within health and care organisations in Wales.

Profile Inheritance

Formal Views of Profile Content

useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemΣ0..1uri
valueΣ0..1string
periodΣ I0..1Period
assignerΣ I0..1Reference(UK Core Organization)
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LaboratorySliceS1..1CodeableConceptBindingFixed Value
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useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
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dataAbsentReasonI0..1CodeableConceptBinding
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useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemΣ0..1uri
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assignerΣ I0..1Reference(UK Core Organization)
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typeΣ0..1uriBinding
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemΣ0..1uri
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typeΣ0..1uriBinding
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
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displayΣ0..1string
statusS Σ ?!1..1codeBinding
LaboratorySliceS1..1CodeableConceptBindingFixed Value
systemΣ1..1uriFixed Value
versionΣ0..1string
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systemΣ1..1uriFixed Value
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codeΣ1..1code
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userSelectedΣ0..1boolean
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referenceΣ I0..1string
typeΣ0..1uriBinding
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemΣ0..1uri
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typeΣ0..1uriBinding
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemΣ0..1uri
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typeΣ0..1uriBinding
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemΣ0..1uri
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periodΣ I0..1Period
assignerΣ I0..1Reference(UK Core Organization)
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effectiveDateTimedateTime
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effectiveTimingTiming
effectiveInstantinstant
issuedΣ0..1instant
referenceΣ I0..1string
typeΣ0..1uriBinding
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemΣ0..1uri
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dataAbsentReasonI0..1CodeableConceptBinding
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authorStringstring
authorReferenceReference(UK Core Organization | UK Core Patient | UK Core Practitioner | UK Core RelatedPerson)
timeΣ0..1dateTime
textΣ1..1markdown
systemΣ1..1uriFixed Value
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userSelectedΣ0..1boolean
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method0..1CodeableConceptBinding
referenceΣ I0..1string
typeΣ0..1uriBinding
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemΣ0..1uri
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assignerΣ I0..1Reference(UK Core Organization)
displayΣ0..1string
referenceΣ I0..1string
typeΣ0..1uriBinding
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemΣ0..1uri
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periodΣ I0..1Period
assignerΣ I0..1Reference(UK Core Organization)
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lowI0..1SimpleQuantity
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type0..1CodeableConceptBinding
appliesTo0..*CodeableConcept
ageI0..1Range
text0..1string
referenceΣ I0..1string
typeΣ0..1uriBinding
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemΣ0..1uri
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typeΣ0..1uriBinding
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemΣ0..1uri
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periodΣ I0..1Period
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systemΣ1..1uriFixed Value
versionΣ0..1string
codeΣ1..1code
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userSelectedΣ0..1boolean
textΣ0..1string
valueQuantityQuantity
valueCodeableConceptCodeableConcept
valueStringstring
valueBooleanboolean
valueIntegerinteger
valueRangeRange
valueRatioRatio
valueSampledDataSampledData
valueTimetime
valueDateTimedateTime
valuePeriodPeriod
dataAbsentReasonI0..1CodeableConceptBinding
interpretation0..*CodeableConceptBinding
referenceRange0..*see (referenceRange)
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemΣ0..1uri
valueΣ0..1string
periodΣ I0..1Period
assignerΣ I0..1Reference(UK Core Organization)
referenceΣ I0..1string
typeΣ0..1uriBinding
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemΣ0..1uri
valueΣ0..1string
periodΣ I0..1Period
assignerΣ I0..1Reference(UK Core Organization)
displayΣ0..1string
referenceΣ I0..1string
typeΣ0..1uriBinding
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemΣ0..1uri
valueΣ0..1string
periodΣ I0..1Period
assignerΣ I0..1Reference(UK Core Organization)
displayΣ0..1string
statusS Σ ?!1..1codeBinding
LaboratorySliceS1..1CodeableConceptBindingFixed Value
systemΣ1..1uriFixed Value
versionΣ0..1string
codeΣ1..1code
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userSelectedΣ0..1boolean
systemΣ1..1uriFixed Value
versionΣ0..1string
codeΣ1..1code
displayΣ1..1string
userSelectedΣ0..1boolean
textΣ0..1string
referenceΣ I0..1string
typeΣ0..1uriBinding
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemΣ0..1uri
valueΣ0..1string
periodΣ I0..1Period
assignerΣ I0..1Reference(UK Core Organization)
displayΣ0..1string
referenceΣ I0..1string
typeΣ0..1uriBinding
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemΣ0..1uri
valueΣ0..1string
periodΣ I0..1Period
assignerΣ I0..1Reference(UK Core Organization)
displayΣ0..1string
referenceΣ I0..1string
typeΣ0..1uriBinding
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemΣ0..1uri
valueΣ0..1string
periodΣ I0..1Period
assignerΣ I0..1Reference(UK Core Organization)
displayΣ0..1string
effectiveDateTimedateTime
effectivePeriodPeriod
effectiveTimingTiming
effectiveInstantinstant
issuedΣ0..1instant
referenceΣ I0..1string
typeΣ0..1uriBinding
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemΣ0..1uri
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valueQuantityQuantity
valueCodeableConceptCodeableConcept
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valueBooleanboolean
valueIntegerinteger
valueRangeRange
valueRatioRatio
valueSampledDataSampledData
valueTimetime
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valuePeriodPeriod
dataAbsentReasonI0..1CodeableConceptBinding
interpretationS0..*CodeableConceptBinding
authorStringstring
authorReferenceReference(UK Core Organization | UK Core Patient | UK Core Practitioner | UK Core RelatedPerson)
timeΣ0..1dateTime
textΣ1..1markdown
systemΣ1..1uriFixed Value
versionΣ0..1string
codeΣ1..1code
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userSelectedΣ0..1boolean
textΣ0..1string
method0..1CodeableConceptBinding
referenceΣ I0..1string
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typeΣ0..1CodeableConceptBinding
systemΣ0..1uri
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displayΣ0..1string
referenceΣ I0..1string
typeΣ0..1uriBinding
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemΣ0..1uri
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periodΣ I0..1Period
assignerΣ I0..1Reference(UK Core Organization)
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lowI0..1SimpleQuantity
highI0..1SimpleQuantity
type0..1CodeableConceptBinding
appliesTo0..*CodeableConcept
ageI0..1Range
text0..1string
referenceΣ I0..1string
typeΣ0..1uriBinding
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemΣ0..1uri
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assignerΣ I0..1Reference(UK Core Organization)
displayΣ0..1string
referenceΣ I0..1string
typeΣ0..1uriBinding
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemΣ0..1uri
valueΣ0..1string
periodΣ I0..1Period
assignerΣ I0..1Reference(UK Core Organization)
displayΣ0..1string
systemΣ1..1uriFixed Value
versionΣ0..1string
codeΣ1..1code
displayΣ1..1string
userSelectedΣ0..1boolean
textΣ0..1string
valueQuantityQuantity
valueCodeableConceptCodeableConcept
valueStringstring
valueBooleanboolean
valueIntegerinteger
valueRangeRange
valueRatioRatio
valueSampledDataSampledData
valueTimetime
valueDateTimedateTime
valuePeriodPeriod
dataAbsentReasonI0..1CodeableConceptBinding
interpretation0..*CodeableConceptBinding
referenceRange0..*see (referenceRange)

Mandatory and Must Support Data Elements

When an element is mandatory (min=1), the data is expected to always be present. Elements marked with an S must be supported by both producing and receiving systems and SHOULD be populated if the data exists.

Each Observation must have:

  1. A status
  2. A category of fixed value laboratory
  3. A code, if available, which tells you what is being measured
  4. A patient

Each Observation must support:

  1. An identifier *
  2. A category code
  3. A effective datetime for the observation
  4. A result value or a reason why the data is absent*
  5. A reference to one or more specimens
  6. A reference to one or more test results

*see Implementation Guidance for the identifier element below

Implementation Guidance

The DataStandardsWales-Observation profile may be used when presenting an Group or Result Observation resource. An Observation Group or panel, is used to group multiple result sets under an Observation Grouping.

Logical Model

Observation Group

  • The Observation.status field SHALL be populated to indicate whether the Observation is Preliminary or Final.
  • The Observation.category field SHALL be populated with a fixed value laboratory from the ValueSet http://hl7.org/fhir/ValueSet/observation-category.
  • The Observation.code field SHALL contain all available codes for the requested panel.
    • Codes assigned to the ObservationGroup by the Welsh Results and Reporting Service
    • Other Codes available such as SNOMED CT.

  • The Observation.identifier field SHOULD contain all available identifiers. Typical identifiers include:
    • Identifiers assigned to the DiagnosticReport by the Welsh Results and Reporting Service
    • Other identifiers assigned by other clinical system.
  • The Observation.effective field SHOULD be populated. The diagnostically relevant time (known as the “effective time” and typically the time of the procedure)*
  • The Observation.hasMember field SHOULD be populated. The references to all Observation Results for the panel should be available as hasMember references.

Observation Result

  • The Observation.status field SHALL be populated to indicate whether the Observation is Preliminary or Final.
  • The Observation.category field SHALL be populated with a fixed value laboratory from the ValueSet http://hl7.org/fhir/ValueSet/observation-category.
  • The Observation.code field SHALL contain all available codes for the requested panel.
    • Codes assigned to the ObservationResult by the Welsh Results and Reporting Service
    • Other Codes available such as SNOMED CT.

  • The Observation.identifier field SHOULD contain all available identifiers. Typical identifiers include:
    • Identifiers assigned to the DiagnosticReport by the Welsh Results and Reporting Service
    • Other identifiers assigned by other clinical system.
  • The Observation.effective field SHOULD be populated. The diagnostically relevant time (known as the “effective time” and typically the time of the procedure)
  • The Observation.value field SHOULD be populated. The observation result value should be populated if available as Quantity resource using the http://unitsofmeasure.org system.
  • The Observation.interpretation field SHOULD be populated. The observation result interpretation should be populated if available using http://hl7.org/fhir/ValueSet/observation-interpretation.
  • The Observation.referenceRange field SHOULD be populated. The observation result referenceRange should be populated if available using the http://unitsofmeasure.org system.

Mandatory Search Parameters

The following search parameters and search parameter combinations SHALL be supported:

  1. SHALL support searching using a combination of the patient and category search parameters:
    GET [base]/Observation?patient={Type/}[id]&category={http://hl7.org/fhir/ValueSet/observation-category|}laboratory
    
    Example:
    1. GET [base]/Observation?patient=23&category=laboratory
    2. GET [base]/Observation?patient:identifier=https://fhir.nhs.uk/Id/nhs-number|9912003444&category=laboratory

      Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and category. (how to search by reference and how to search by token)

  2. SHALL support searching using a combination of the patient and code search parameters:
    • including optional support for OR search on code (e.g. code={system|}[code],{system|}[code],...)
    GET [base]/Observation?patient={Type/}[id]&code={system|}[code]{,{system|}[code],...}
    
    Example:
    1. GET [base]/Observation?patient=23&code=http://snomed.info/sct|75367002
    2. GET [base]/Observation?patient:identifier=https://fhir.nhs.uk/Id/nhs-number|9912003444&code=http://snomed.info/sct|75367002

      Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and code. (how to search by reference and how to search by token)

  3. SHALL support searching using a combination of the patient and category and date search parameters:
    • including support for these date comparators: gt,lt,ge,le
    • including optional support for AND search on date (e.g.date=[date]&date=[date]]&...)
    GET [base]/Observation?patient={Type/}[id]&category={http://hl7.org/fhir/ValueSet/observation-category|}laboratory&date={gt|lt|ge|le}[date]{&date={gt|lt|ge|le}[date]&...}
    
    Example:
    1. GET [base]/Observation?patient=23&category=laboratory&date=ge2023-01-05T00:00:00Z
    2. GET [base]/Observation?patient:identifier=https://fhir.nhs.uk/Id/nhs-number|9912003444&category=laboratory&date=ge2023-01-05T00:00:00Z

      Implementation Notes: Fetches a bundle of all MedicationStatement resources for the specified subject and status code. (how to search by reference and how to search by token and how to search by date)

Optional Search Parameters

  1. SHOULD support searching using the combination of the patient and code and date search parameters:

    • including optional support for OR search on code (e.g. code={system|}[code],{system|}[code],...)
    • including support for these date comparators: gt,lt,ge,le
    • including optional support for AND search on date (e.g.date=[date]&date=[date]]&...)
    GET [base]/Observation?patient={Type/}[id]&code={system|}[code]{,{system|}[code],...}&date={gt|lt|ge|le}[date]{&date={gt|lt|ge|le}[date]&...}
    

    Example:

    1. GET [base]/Observation?patient=23&code=http://snomed.info/sct|75367002&date=ge2023-01-05T00:00:00Z
    2. GET [base]/Observation?patient:identifier=https://fhir.nhs.uk/Id/nhs-number|9912003444&code=http://snomed.info/sct|75367002&date=ge2023-01-05T00:00:00Z

      Implementation Notes: Fetches a bundle of all MedicationStatement resources for the specified subject and status code. (how to search by reference and how to search by token and how to search by date)