Laboratory observation obligations - Definitions - EHDS Logical Information Models v0.4.0

4. EHDSLaboratoryObservation.header.subject

Definition

Patient/subject information

Short Patient who is receiving health care. This patient might be different from the direct subject of the observation.

Control 1..1

http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSPatient

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR systems SHALL provide information about the subject of care (patient).

SHALL:display

EHR system SHALL render information about the subject of care in such a way that unambiguous assignment to the care subject is preserved.

SHALL:process

Information about the subject of care SHALL be processed by the EHR system in such a way that the identity of the subject of care cannot be confused.

6. EHDSLaboratoryObservation.header.identifier

Definition

Business identifier for the object, unique within its system. Supporting disambiguation between different contexts (systems/countries).

Short Business identifier for the object, unique within its system. Supporting disambiguation between different contexts (systems/countries).

Note This is a business identifier, not a resource identifier (see discussion)

Control 0..*

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

A business identifier of the observation SHALL be populated.

SHALL:process

EHR systems SHALL be able to process identifiers accordingly. Processing means mainly storing identifiers as part of the resource if EHR system stores it.

8. EHDSLaboratoryObservation.header.author[x]

Definition

Author(s) responsible for the provided information. The exact role of the responsible author varies across use cases and is specific to individual models.

Short Author(s) responsible for the provided information.

Control 0..*

Type Choice of: http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSHealthProfessional, http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSOrganisation, http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSDevice

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to populate known information about authorhip of the observation. Multiple authors could be provided.

SHOULD:display

If provided, EHR system SHOULD display information about authorship of the Observation.

10. EHDSLaboratoryObservation.header.date

Definition

Date and optionally time of authoring/issuing

Short Date and optionally time of authoring/issuing

Control 0..1

Primitive Value This primitive element may be present, or absent, or replaced by an extension

12. EHDSLaboratoryObservation.header.status

Definition

Status of the resource or document

Short Status of the resource or document

Control 1..1

HL7 Observation status

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

HL7 Observation status (e.g., “final,” “preliminary”) SHALL be provided.

SHALL:display

Always show status of the Observation, esp. If different from "final", e.g., “Status: preliminary” in UI and printouts; accept any valid status code.

14. EHDSLaboratoryObservation.header.source

Definition

Source of information (e.g. patient, patient's proxy). Used in case the patient has authored the information or the author has submitted patient-stated information.

Short Source of information (e.g. patient, patient's proxy). Used in case the patient has authored the information or the author has submitted patient-stated information.

Control 0..1

16. EHDSLaboratoryObservation.header.language

Definition

Language in which the resource is written. Language is expressed by the IETF language tag.

Short Language in which the resource is written. Language is expressed by the IETF language tag.

Control 0..1

BCP 47

18. EHDSLaboratoryObservation.header.directSubject[x]

Definition

The direct subject of the observation if different from the patient (subject of care), e.g. an observation of an implanted device. Additional types of subject may be allowed in implementations.

Short The direct subject of the observation if different from the patient (subject of care), e.g. an observation of an implanted device. Additional types of subject may be allowed in implementations.

Control 0..1

Type Choice of: http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSPatient, http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSLocation, http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSDevice, http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSHealthProfessional, http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSOrganisation, http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSProcedure

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

SHALL provide information about direct subject of the observation if diferent from the subject of care (another patient, animal or other allowed subject type).

SHALL:display

EHR system SHALL always display information about subject of the observation if different from subject of care.

20. EHDSLaboratoryObservation.observationDate[x]

Definition

Clinically relevant time or time period for the observation

Short Clinically relevant time or time period for the observation

Control 1..1

Type Choice of: dateTime, Period

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL be able to populate date and time and/or period for when the lab test was performed.

SHALL:display

Observation date or period SHALL be displayed if provided.

This element introduces a set of slices on EHDSLaboratoryObservation.observationDate[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:

type @ $this

22. EHDSLaboratoryObservation.observationDate[x]:observationDateDateTime

Slice Name observationDateDateTime

Definition

Clinically relevant time or time period for the observation

Short Clinically relevant time or time period for the observation

Control 0..1

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL be able to populate exact date and time when the lab test was performed.

SHALL:display

Show Observation Date in UI and print; accept any valid ISO 8601 dateTime.

24. EHDSLaboratoryObservation.observationDate[x]:observationDatePeriod

Slice Name observationDatePeriod

Definition

Clinically relevant time or time period for the observation

Short Clinically relevant time or time period for the observation

Control 0..1

Period

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

Lab system SHALL be able to populate period for when the lab test was performed.

SHALL:display

Show Observation Period; accept any valid Period (start ≤ end).

26. EHDSLaboratoryObservation.type

Definition

Observation type. Code and name representing the type of the observation using the agreed code systems.

Short Observation type. Code and name representing the type of the observation using the agreed code systems.

Control 1..1

LOINC, NPU, SNOMED CT

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Test code is mandatory element for identification of the kind of lab test performed from approved code system.

SHALL:display

Observation type is a mandatory element. EHR system SHALL display observation type. The type carries the correct semantic meaning of the observation. i.e. code and display name. Any valid CodeableConcept SHALL be accepted.

SHALL:process

Observation type SHALL be processed accordingly, this value should be taken into consideration especially when comparing result values.

28. EHDSLaboratoryObservation.originalName

Definition

Original (conventional) name of the observation as used in the local laboratory or clinical system.

Short Original (conventional) name of the observation as used in the local laboratory or clinical system.

Control 0..1

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If the lab system supplies its own original test name, it SHALL be provided.

SHOULD:display

Original (local) test name SHOULD be displayed, if provided.

30. EHDSLaboratoryObservation.method

Definition

Observation method (measurement principle) to obtain the result.

Short Observation method

Control 0..1

SNOMED CT

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL provide the specific method of measurement used to perform the observation if method of measurement is not included in the observation. Code.

SHALL:display

Observation method SHALL be displayed if provided.

SHALL:process

Observation method SHALL be consider when processing the resource, especially for comparability of result values.

32. EHDSLaboratoryObservation.specimen

Definition

Specimen used for this observation.

Short Specimen used for this observation.

Control 0..1

http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSSpecimen

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL provide information about specimen used for the observation if this information is known.

SHOULD:display

Information about specimen SHOULD be displayed if provided.

34. EHDSLaboratoryObservation.order

Definition

Identifies order and order placer this observation belongs to

Short Identifies order and order placer this observation belongs to

Control 0..1

http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSServiceRequest

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL be able to provide information about order (service request) that was the basis of the laboratory observation.

36. EHDSLaboratoryObservation.performer[x]

Definition

Performer of the observation. Some test could be performed by the patient himself or by a care giver. Those are in the scope of this deliverable under specified conditions.

Short Performer of the observation. Some test could be performed by the patient himself or by a care giver. Those are in the scope of this deliverable under specified conditions.

Control 0..*

Type Choice of: http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSOrganisation, http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSHealthProfessional, http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSPatient, http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSRelatedPerson

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

Lab system SHOULD provide information about performer of the test, if available. Test can be performed by professional, patient himself or by a care giver.

38. EHDSLaboratoryObservation.bodySite

Definition

Anatomic location and laterality where the observation was performed.

Short Anatomic location and laterality where the observation was performed.

Control 0..1

http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSBodyStructure

40. EHDSLaboratoryObservation.result

Definition

Result of the observation including text, numeric, coded, and other types of results of the measurement and measurement uncertainty. Content of the observation result will vary according to the type of the observation.

Short Result of the laboratory observation including text, numeric and coded results of the measurement and measurement uncertainty. Content of the observation result will vary according to the type of the observation.

Control 1..1

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL be able to provide test results in various forms: numeric, textual and coded.

SHALL:display

SHALL display results of the Observation.

42. EHDSLaboratoryObservation.result.value[x]

Definition

Observation result value according to the type of observation. Model covers only most frequently used data types but other data types can be used as well. Text result value should be used only if coded result value is not expected otherwise use valueCodeableConcept.text. For Quantity, Range and Ratio, result units of the measurement should be provided.

Short Observation result value according to the type of observation. Model covers only most frequently used data types but other data types can be used as well. Text result value should be used only if coded result value is not expected otherwise use valueCodeableConcept.text. For Quantity, Range and Ratio, result units of the measurement should be provided.

Control 0..1

UCUM for units, SNOMED CT for coded results

Type Choice of: string, Quantity, Range, Ratio, CodeableConcept

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

SHALL display results of the Observation.

This element introduces a set of slices on EHDSLaboratoryObservation.result.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:

type @ $this

44. EHDSLaboratoryObservation.result.value[x]:valueString

Slice Name valueString

Definition

Control 0..1

UCUM for units, SNOMED CT for coded results

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If only purely textual results are expected, it MUST be provided. Coded results are preferred in most cases.

SHALL:display

If present, SHALL display textual Result Value in UI and printouts; accept any string.

46. EHDSLaboratoryObservation.result.value[x]:valueQuantity

Slice Name valueQuantity

Definition

Control 0..1

UCUM for units, SNOMED CT for coded results

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

If present, SHALL display numeric Result Value in UI and printouts; accept any valid Quantity.

48. EHDSLaboratoryObservation.result.value[x]:valueRange

Slice Name valueRange

Definition

Control 0..1

UCUM for units, SNOMED CT for coded results

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

If present, SHALL display range Result Value in UI and printouts; accept any valid Range.

50. EHDSLaboratoryObservation.result.value[x]:valueRatio

Slice Name valueRatio

Definition

Control 0..1

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

If present, SHALL display ratio Result Value in UI and printouts; accept any valid Ratio.

52. EHDSLaboratoryObservation.result.value[x]:valueCodeableConcept

Slice Name valueCodeableConcept

Definition

Control 0..1

UCUM for units, SNOMED CT for coded results

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

If present, SHALL display coded Result Value in UI and printouts; accept any valid CodeableConcept.

54. EHDSLaboratoryObservation.result.uncertainty

Definition

Measurement uncertainty information about the observation result.

Short Measurement uncertainty type and interval if needed.

Control 0..1

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If the test reports uncertainty (e.g., “±0.1”), allow numeric entry of uncertainty. Store in Quantity or Range.

SHOULD:display

If present, SHOULD display uncertainty of measurement in UI and printouts. Show “Uncertainty: ±0.1”.

56. EHDSLaboratoryObservation.result.uncertainty.value

Definition

The numerical value of the measurement uncertainty.

Short The numerical value of the measurement uncertainty.

Control 1..1

Primitive Value This primitive element may be present, or absent, or replaced by an extension

58. EHDSLaboratoryObservation.result.uncertainty.type

Definition

Probability Distribution Type for uncertainty

Short Probability Distribution Type for uncertainty

Control 0..1

HL7 ProbabilityDistributionType

60. EHDSLaboratoryObservation.result.dataAbsentReason

Definition

Provides a reason why the expected value in the element Observation.value[x] is missing.

Short Provides a reason why the expected value in the element Observation.value[x] is missing.

Control 0..1

HL7 Data absent reason

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

If no result is available, lab system SHALL be able to provide data absent reason. Data absent reason SHOULD NOT be expressed as a test result value.

SHALL:display

If provided, display e.g. “No result: not‐performed” in UI and print; accept any valid dataAbsentReason without error.

62. EHDSLaboratoryObservation.referenceRange

Definition

Reference range, multiple reference ranges of different types could by provided. Provides guide for interpretation of the result.

Short Reference range, multiple reference ranges of different types could by provided. Provides guide for interpretation of the result.

Comments

Reference ranges are usually implied only for a numeric scale type. Use of the same units for reference range and value is implied.

Control 0..*

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Allow zero or more referenceRange entries (e.g., normal range “12–16 g/dL”). Populate each as a structured Range or coded description.

SHALL:display

If present, display each range clearly (e.g., “Reference: 12.0–16.0 g/dL”); accept any valid referenceRange structure.

64. EHDSLaboratoryObservation.referenceRange.low

Definition

Low limit of the reference range.

Short Low limit of the reference range.

Control 0..1

UCUM for units

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL populate Low value of the normal reference range, if known.

SHALL:display

66. EHDSLaboratoryObservation.referenceRange.high

Definition

High limit of the reference range.

Short High limit of the reference range.

Control 0..1

UCUM for units

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL populate High value of the normal reference range, if known

SHALL:display

68. EHDSLaboratoryObservation.referenceRange.normalValue

Definition

Normal value, if relevant for the reference range.

Short Normal value, if relevant for the reference range.

Control 0..1

SNOMED CT

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL populate Normal value of the normal reference range, if known.

SHALL:display

70. EHDSLaboratoryObservation.referenceRange.type

Definition

Type of reference range.

Short Type of reference range.

Control 0..1

HL7 Observation Reference Range Meaning Codes

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to populate type of the normal reference range.

SHALL:display

72. EHDSLaboratoryObservation.referenceRange.appliesTo

Definition

Codes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race. Multiple appliesTo are interpreted as an "AND" of the target populations.

Short Codes to indicate the target population this reference range applies to.

Comments

Multiple appliesTo are interpreted as an "AND" of the target populations.

Control 0..*

SNOMED CT, HL7 v3-Race

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to populate target population of the normal reference range.

74. EHDSLaboratoryObservation.referenceRange.age

Definition

Age range to which this reference range applies if applicable.

Short Age range to which this reference range applies if applicable.

Control 0..1

UCUM for units

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to populate age range for the normal reference range.

76. EHDSLaboratoryObservation.referenceRange.text

Definition

Text based reference range in an observation which may be used when a quantitative range is not appropriate for an observation. An example would be a reference value of "Negative" or a list or table of "normals".

Short Text based reference range in an observation.

Control 0..1

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL populate reference range, if known.

SHALL:display

78. EHDSLaboratoryObservation.interpretation

Definition

Information about reference intervals and result interpretation.

Short Information about reference intervals and result interpretation.

Control 0..*

SNOMED CT, HL7 ObservationInterpretation

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL be able to populate interpretation of the result in comparison with the reference range, if such range is available.

SHALL:display

Show each interpretation (e.g., “Interpretation: High”); accept any valid CodeableConcept.

80. EHDSLaboratoryObservation.note

Definition

Comments and narrative representation of the observation result and findings.

Short Comments and narrative representation of the observation result and findings.

Control 0..1

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL be able to populate textual comment to the test result value.

SHALL:display

If present, show “e.g. Result Note: Hemolysis observed” in UI and print; accept any string.

82. EHDSLaboratoryObservation.component

Definition

Component in case the observation consists of multiple sub-observations (e.g. blood pressure).

Short Component in case the observation consists of multiple sub-observations (e.g. blood pressure).

Control 0..*

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If the test has components, those component entries SHALL be provided. Each component’s sub-fields (code, result, etc.) follow the same obligations below. Components share all other elements with the parent observation.

SHALL:display

If components exist, render each component details in UI and print; accept any valid component structure.

84. EHDSLaboratoryObservation.component.type

Definition

Code representing the observation using the agreed code systems.

Short Code representing the observation using the agreed code systems.

Control 1..1

LOINC, NPU, SNOMED CT

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Component code is mandatory element for identification of the kind of lab test performed from approved code system.

SHALL:display

SHALL:process

Observation type SHALL be processed accordingly, this value should be taken into consideration especially when comparing result values.

86. EHDSLaboratoryObservation.component.originalName

Definition

Original (user-friendly) name of the observation as used in the local laboratory or clinical system.

Short Original (user-friendly) name of the observation as used in the local laboratory or clinical system.

Control 0..1

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If the lab system supplies its own original test name, it SHALL be provided.

SHOULD:display

Original (local) test name SHOULD be displayed, if provided.

88. EHDSLaboratoryObservation.component.result

Definition

Short Result of the observation including text, numeric, coded, and other types of results of the measurement and measurement uncertainty. Content of the observation result will vary according to the type of the observation.

Control 1..1

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to provide test results in various forms: numeric, textual and coded.

SHALL:display

SHALL display results of the Observation.

90. EHDSLaboratoryObservation.component.result.value[x]

Definition

Control 0..1

UCUM for units, SNOMED CT for coded results

Type Choice of: string, Quantity, Range, Ratio, CodeableConcept

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

SHALL display results of the Observation.

This element introduces a set of slices on EHDSLaboratoryObservation.component.result.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:

type @ $this

92. EHDSLaboratoryObservation.component.result.value[x]:valueString

Slice Name valueString

Definition

Control 0..1

UCUM for units, SNOMED CT for coded results

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If only purely textual results are expected, it MUST be provided. Coded results are preferred in most cases.

SHALL:display

SHALL display results of the Observation.

94. EHDSLaboratoryObservation.component.result.value[x]:valueQuantity

Slice Name valueQuantity

Definition

Control 0..1

UCUM for units, SNOMED CT for coded results

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If lab system knows numeric result value or numeric range, it MUST be provided.

SHALL:display

SHALL display results of the Observation.

96. EHDSLaboratoryObservation.component.result.value[x]:valueRange

Slice Name valueRange

Definition

Control 0..1

UCUM for units, SNOMED CT for coded results

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

If present, SHALL display range Result Value in UI and printouts; accept any valid Range.

98. EHDSLaboratoryObservation.component.result.value[x]:valueRatio

Slice Name valueRatio

Definition

Control 0..1

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

If present, SHALL display ratio Result Value in UI and printouts; accept any valid Ratio.

100. EHDSLaboratoryObservation.component.result.value[x]:valueCodeableConcept

Slice Name valueCodeableConcept

Definition

Control 0..1

UCUM for units, SNOMED CT for coded results

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

If present, SHALL display coded Result Value in UI and printouts; accept any valid CodeableConcept.

102. EHDSLaboratoryObservation.component.result.uncertainty

Definition

Measurement uncertainty information about the observation result.

Short Measurement uncertainty type and interval if needed.

Control 0..1

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If the test reports uncertainty (e.g., “±0.1”), allow numeric entry of uncertainty. Store in Quantity or Range.

SHOULD:display

If present, SHOULD display uncertainty of measurement in UI and printouts. Show “Uncertainty: ±0.1”.

104. EHDSLaboratoryObservation.component.result.uncertainty.value

Definition

The numerical value of the measurement uncertainty.

Short The numerical value of the measurement uncertainty.

Control 1..1

Primitive Value This primitive element may be present, or absent, or replaced by an extension

106. EHDSLaboratoryObservation.component.result.uncertainty.type

Definition

Probability Distribution Type for uncertainty

Short Probability Distribution Type for uncertainty

Control 0..1

HL7 ProbabilityDistributionType

108. EHDSLaboratoryObservation.component.result.dataAbsentReason

Definition

Provides a reason why the expected value in the element component.value[x] is missing.

Short Provides a reason why the expected value in the element component.value[x] is missing.

Control 0..1

HL7 Data absent reason

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

If no result is available, lab system SHALL be able to provide data absent reason. Data absent reason SHOULD NOT be expressed as a test result value.

SHALL:display

If provided, display e.g. “No result: not‐performed” in UI and print; accept any valid dataAbsentReason without error.

110. EHDSLaboratoryObservation.component.referenceRange

Definition

Reference range, multiple reference ranges of different types could by provided. Provides guide for interpretation of the result.

Short Reference range, multiple reference ranges of different types could by provided. Provides guide for interpretation of the result.

Comments

Reference ranges are usually implied only for a numeric scale type. Use of the same units for reference range and value is implied.

Control 0..*

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Allow zero or more referenceRange entries (e.g., normal range “12–16 g/dL”). Populate each as a structured Range or coded description.

SHALL:display

If present, display each range clearly (e.g., “Reference: 12.0–16.0 g/dL”); accept any valid referenceRange structure.

112. EHDSLaboratoryObservation.component.referenceRange.low

Definition

Low limit of the reference range.

Short Low limit of the reference range.

Control 0..1

UCUM for units

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL populate Low value of the normal reference range, if known.

SHALL:display

114. EHDSLaboratoryObservation.component.referenceRange.high

Definition

High limit of the reference range.

Short High limit of the reference range.

Control 0..1

UCUM for units

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL populate High value of the normal reference range, if known

SHALL:display

116. EHDSLaboratoryObservation.component.referenceRange.normalValue

Definition

Normal value, if relevant for the reference range.

Short Normal value, if relevant for the reference range.

Control 0..1

SNOMED CT

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL populate Normal value of the normal reference range, if known.

SHALL:display

118. EHDSLaboratoryObservation.component.referenceRange.type

Definition

Type of reference range.

Short Type of reference range.

Control 0..1

HL7 Observation Reference Range Meaning Codes

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to populate type of the normal reference range.

SHALL:display

120. EHDSLaboratoryObservation.component.referenceRange.appliesTo

Definition

Short Codes to indicate the target population this reference range applies to.

Comments

Multiple appliesTo are interpreted as an "AND" of the target populations.

Control 0..*

SNOMED CT, HL7 v3-Race

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to populate target population of the normal reference range.

122. EHDSLaboratoryObservation.component.referenceRange.age

Definition

Age range to which this reference range applies if applicable.

Short Age range to which this reference range applies if applicable.

Control 0..1

UCUM for units

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to populate age range for the normal reference range.

124. EHDSLaboratoryObservation.component.referenceRange.text

Definition

Short Text based reference range in an observation.

Control 0..1

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL populate reference range, if known.

SHALL:display

126. EHDSLaboratoryObservation.component.interpretation

Definition

Information about reference intervals and result interpretation.

Short Information about reference intervals and result interpretation.

Control 0..*

SNOMED CT, HL7 ObservationInterpretation

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL be able to populate interpretation of the result in comparison with the reference range, if such range is available.

SHALL:display

Show each interpretation (e.g., “Interpretation: High”); accept any valid CodeableConcept.

128. EHDSLaboratoryObservation.derivedFrom[x]

Definition

Reference to the related resource from which the observation has been made. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.

Short Reference to the related resource from which the observation has been made. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.

Control 0..*

Type Choice of: http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSObservation, http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSLaboratoryObservation, http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSImagingStudy

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If this observation is derived from other resources (e.g., earlier lab or imaging results or in case of calculated test results from other observations) an information about related observations SHOULD be provided.

130. EHDSLaboratoryObservation.hasMember[x]

Definition

This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group.

Short This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group.

Control 0..*

Type Choice of: http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSLaboratoryObservation, http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSObservation

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If this is a pannel of tests or a test sequence, a reference to the member observation SHALL be provided.

132. EHDSLaboratoryObservation.triggeredBy[x]

Definition

References to the observation(s) that triggered the performance of this observation.

Short References to the observation(s) that triggered the performance of this observation.

Control 0..*

Type Choice of: http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSLaboratoryObservation, http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSObservation

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If this observation was triggered by another (e.g., reflex test), this information SHOULD be provided.

134. EHDSLaboratoryObservation.testKit

Definition

Laboratory test kit used during measurement.

Short Laboratory test kit used during measurement.

Control 0..1

http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSDevice

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

If a specific test kit was used (e.g., rapid antigen kit), provide an EHDSDevice information.

SHALL:process

EHR systems SHALL support correct processing of this information especially when comparing result values from different sources and SHOULD indicate this information in the UI.

136. EHDSLaboratoryObservation.calibrator

Definition

Information about which end-user calibrator the laboratory used for the measurement to indicate the metrological traceability chain.

Short Information about which end-user calibrator the laboratory used for the measurement to indicate the metrological traceability chain.

Control 0..1

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

If a calibrator identifier is known, provide relevant information identifier.

SHALL:process

EHR systems SHALL support correct processing of this information especially when comparing result values from different sources and SHOULD indicate this information in the UI.

138. EHDSLaboratoryObservation.accreditationStatus

Definition

Accreditation status of the laboratory for the observation.

Short Accreditation status of the laboratory for the observation.

Control 0..1

boolean

Primitive Value This primitive element may be present, or absent, or replaced by an extension

140. EHDSLaboratoryObservation.previousResults

Definition

Previous results of the same observation

Short Previous results of the same observation

Control 0..*

http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSLaboratoryObservation

142. EHDSLaboratoryObservation.pointOfCareTest

Definition

Indicates if the observation is a point-of-care test (POCT), i.e. an examination performed near or at the site of a patient.

Short Examination performed near or at the site of a patient.

Control 0..1

boolean

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Guidance on how to interpret the contents of this table can be foundhere

0. EHDSLaboratoryObservation

Logical Model Instances of this logical model are not marked to be the target of a Reference

2. EHDSLaboratoryObservation.header

4. EHDSLaboratoryObservation.header.subject

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR systems SHALL provide information about the subject of care (patient).

SHALL:display

EHR system SHALL render information about the subject of care in such a way that unambiguous assignment to the care subject is preserved.

SHALL:process

Information about the subject of care SHALL be processed by the EHR system in such a way that the identity of the subject of care cannot be confused.

6. EHDSLaboratoryObservation.header.identifier

Note This is a business identifier, not a resource identifier (see discussion)

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

A business identifier of the observation SHALL be populated.

SHALL:process

EHR systems SHALL be able to process identifiers accordingly. Processing means mainly storing identifiers as part of the resource if EHR system stores it.

8. EHDSLaboratoryObservation.header.author[x]

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to populate known information about authorhip of the observation. Multiple authors could be provided.

SHOULD:display

If provided, EHR system SHOULD display information about authorship of the Observation.

10. EHDSLaboratoryObservation.header.status

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

HL7 Observation status (e.g., “final,” “preliminary”) SHALL be provided.

SHALL:display

Always show status of the Observation, esp. If different from "final", e.g., “Status: preliminary” in UI and printouts; accept any valid status code.

12. EHDSLaboratoryObservation.header.directSubject[x]

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

SHALL provide information about direct subject of the observation if diferent from the subject of care (another patient, animal or other allowed subject type).

SHALL:display

EHR system SHALL always display information about subject of the observation if different from subject of care.

14. EHDSLaboratoryObservation.observationDate[x]

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL be able to populate date and time and/or period for when the lab test was performed.

SHALL:display

Observation date or period SHALL be displayed if provided.

This element introduces a set of slices on EHDSLaboratoryObservation.observationDate[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:

type @ $this

16. EHDSLaboratoryObservation.observationDate[x]:observationDateDateTime

Slice Name observationDateDateTime

Control 0..1

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL be able to populate exact date and time when the lab test was performed.

SHALL:display

Show Observation Date in UI and print; accept any valid ISO 8601 dateTime.

18. EHDSLaboratoryObservation.observationDate[x]:observationDatePeriod

Slice Name observationDatePeriod

Control 0..1

Period

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

Lab system SHALL be able to populate period for when the lab test was performed.

SHALL:display

Show Observation Period; accept any valid Period (start ≤ end).

20. EHDSLaboratoryObservation.type

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Test code is mandatory element for identification of the kind of lab test performed from approved code system.

SHALL:display

SHALL:process

Observation type SHALL be processed accordingly, this value should be taken into consideration especially when comparing result values.

22. EHDSLaboratoryObservation.originalName

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If the lab system supplies its own original test name, it SHALL be provided.

SHOULD:display

Original (local) test name SHOULD be displayed, if provided.

24. EHDSLaboratoryObservation.method

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL provide the specific method of measurement used to perform the observation if method of measurement is not included in the observation. Code.

SHALL:display

Observation method SHALL be displayed if provided.

SHALL:process

Observation method SHALL be consider when processing the resource, especially for comparability of result values.

26. EHDSLaboratoryObservation.specimen

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL provide information about specimen used for the observation if this information is known.

SHOULD:display

Information about specimen SHOULD be displayed if provided.

28. EHDSLaboratoryObservation.order

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL be able to provide information about order (service request) that was the basis of the laboratory observation.

30. EHDSLaboratoryObservation.performer[x]

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

Lab system SHOULD provide information about performer of the test, if available. Test can be performed by professional, patient himself or by a care giver.

32. EHDSLaboratoryObservation.result

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL be able to provide test results in various forms: numeric, textual and coded.

SHALL:display

SHALL display results of the Observation.

34. EHDSLaboratoryObservation.result.value[x]

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

SHALL display results of the Observation.

This element introduces a set of slices on EHDSLaboratoryObservation.result.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:

type @ $this

36. EHDSLaboratoryObservation.result.value[x]:valueString

Slice Name valueString

Control 0..1

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If only purely textual results are expected, it MUST be provided. Coded results are preferred in most cases.

SHALL:display

If present, SHALL display textual Result Value in UI and printouts; accept any string.

38. EHDSLaboratoryObservation.result.value[x]:valueQuantity

Slice Name valueQuantity

Control 0..1

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

If present, SHALL display numeric Result Value in UI and printouts; accept any valid Quantity.

40. EHDSLaboratoryObservation.result.value[x]:valueRange

Slice Name valueRange

Control 0..1

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

If present, SHALL display range Result Value in UI and printouts; accept any valid Range.

42. EHDSLaboratoryObservation.result.value[x]:valueRatio

Slice Name valueRatio

Control 0..1

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

If present, SHALL display ratio Result Value in UI and printouts; accept any valid Ratio.

44. EHDSLaboratoryObservation.result.value[x]:valueCodeableConcept

Slice Name valueCodeableConcept

Control 0..1

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

If present, SHALL display coded Result Value in UI and printouts; accept any valid CodeableConcept.

46. EHDSLaboratoryObservation.result.uncertainty

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If the test reports uncertainty (e.g., “±0.1”), allow numeric entry of uncertainty. Store in Quantity or Range.

SHOULD:display

If present, SHOULD display uncertainty of measurement in UI and printouts. Show “Uncertainty: ±0.1”.

48. EHDSLaboratoryObservation.result.dataAbsentReason

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

If no result is available, lab system SHALL be able to provide data absent reason. Data absent reason SHOULD NOT be expressed as a test result value.

SHALL:display

If provided, display e.g. “No result: not‐performed” in UI and print; accept any valid dataAbsentReason without error.

50. EHDSLaboratoryObservation.referenceRange

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Allow zero or more referenceRange entries (e.g., normal range “12–16 g/dL”). Populate each as a structured Range or coded description.

SHALL:display

If present, display each range clearly (e.g., “Reference: 12.0–16.0 g/dL”); accept any valid referenceRange structure.

52. EHDSLaboratoryObservation.referenceRange.low

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL populate Low value of the normal reference range, if known.

SHALL:display

54. EHDSLaboratoryObservation.referenceRange.high

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL populate High value of the normal reference range, if known

SHALL:display

56. EHDSLaboratoryObservation.referenceRange.normalValue

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL populate Normal value of the normal reference range, if known.

SHALL:display

58. EHDSLaboratoryObservation.referenceRange.type

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to populate type of the normal reference range.

SHALL:display

60. EHDSLaboratoryObservation.referenceRange.appliesTo

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to populate target population of the normal reference range.

62. EHDSLaboratoryObservation.referenceRange.age

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to populate age range for the normal reference range.

64. EHDSLaboratoryObservation.referenceRange.text

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL populate reference range, if known.

SHALL:display

66. EHDSLaboratoryObservation.interpretation

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL be able to populate interpretation of the result in comparison with the reference range, if such range is available.

SHALL:display

Show each interpretation (e.g., “Interpretation: High”); accept any valid CodeableConcept.

68. EHDSLaboratoryObservation.note

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL be able to populate textual comment to the test result value.

SHALL:display

If present, show “e.g. Result Note: Hemolysis observed” in UI and print; accept any string.

70. EHDSLaboratoryObservation.component

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

SHALL:display

If components exist, render each component details in UI and print; accept any valid component structure.

72. EHDSLaboratoryObservation.component.type

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Component code is mandatory element for identification of the kind of lab test performed from approved code system.

SHALL:display

SHALL:process

Observation type SHALL be processed accordingly, this value should be taken into consideration especially when comparing result values.

74. EHDSLaboratoryObservation.component.originalName

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If the lab system supplies its own original test name, it SHALL be provided.

SHOULD:display

Original (local) test name SHOULD be displayed, if provided.

76. EHDSLaboratoryObservation.component.result

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to provide test results in various forms: numeric, textual and coded.

SHALL:display

SHALL display results of the Observation.

78. EHDSLaboratoryObservation.component.result.value[x]

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

SHALL display results of the Observation.

This element introduces a set of slices on EHDSLaboratoryObservation.component.result.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:

type @ $this

80. EHDSLaboratoryObservation.component.result.value[x]:valueString

Slice Name valueString

Control 0..1

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If only purely textual results are expected, it MUST be provided. Coded results are preferred in most cases.

SHALL:display

SHALL display results of the Observation.

82. EHDSLaboratoryObservation.component.result.value[x]:valueQuantity

Slice Name valueQuantity

Control 0..1

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If lab system knows numeric result value or numeric range, it MUST be provided.

SHALL:display

SHALL display results of the Observation.

84. EHDSLaboratoryObservation.component.result.value[x]:valueRange

Slice Name valueRange

Control 0..1

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

If present, SHALL display range Result Value in UI and printouts; accept any valid Range.

86. EHDSLaboratoryObservation.component.result.value[x]:valueRatio

Slice Name valueRatio

Control 0..1

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

If present, SHALL display ratio Result Value in UI and printouts; accept any valid Ratio.

88. EHDSLaboratoryObservation.component.result.value[x]:valueCodeableConcept

Slice Name valueCodeableConcept

Control 0..1

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

If present, SHALL display coded Result Value in UI and printouts; accept any valid CodeableConcept.

90. EHDSLaboratoryObservation.component.result.uncertainty

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If the test reports uncertainty (e.g., “±0.1”), allow numeric entry of uncertainty. Store in Quantity or Range.

SHOULD:display

If present, SHOULD display uncertainty of measurement in UI and printouts. Show “Uncertainty: ±0.1”.

92. EHDSLaboratoryObservation.component.result.dataAbsentReason

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

If no result is available, lab system SHALL be able to provide data absent reason. Data absent reason SHOULD NOT be expressed as a test result value.

SHALL:display

If provided, display e.g. “No result: not‐performed” in UI and print; accept any valid dataAbsentReason without error.

94. EHDSLaboratoryObservation.component.referenceRange

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Allow zero or more referenceRange entries (e.g., normal range “12–16 g/dL”). Populate each as a structured Range or coded description.

SHALL:display

If present, display each range clearly (e.g., “Reference: 12.0–16.0 g/dL”); accept any valid referenceRange structure.

96. EHDSLaboratoryObservation.component.referenceRange.low

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL populate Low value of the normal reference range, if known.

SHALL:display

98. EHDSLaboratoryObservation.component.referenceRange.high

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL populate High value of the normal reference range, if known

SHALL:display

100. EHDSLaboratoryObservation.component.referenceRange.normalValue

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL populate Normal value of the normal reference range, if known.

SHALL:display

102. EHDSLaboratoryObservation.component.referenceRange.type

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to populate type of the normal reference range.

SHALL:display

104. EHDSLaboratoryObservation.component.referenceRange.appliesTo

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to populate target population of the normal reference range.

106. EHDSLaboratoryObservation.component.referenceRange.age

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to populate age range for the normal reference range.

108. EHDSLaboratoryObservation.component.referenceRange.text

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL populate reference range, if known.

SHALL:display

110. EHDSLaboratoryObservation.component.interpretation

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL be able to populate interpretation of the result in comparison with the reference range, if such range is available.

SHALL:display

Show each interpretation (e.g., “Interpretation: High”); accept any valid CodeableConcept.

112. EHDSLaboratoryObservation.derivedFrom[x]

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

114. EHDSLaboratoryObservation.hasMember[x]

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If this is a pannel of tests or a test sequence, a reference to the member observation SHALL be provided.

116. EHDSLaboratoryObservation.triggeredBy[x]

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If this observation was triggered by another (e.g., reflex test), this information SHOULD be provided.

118. EHDSLaboratoryObservation.testKit

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

If a specific test kit was used (e.g., rapid antigen kit), provide an EHDSDevice information.

SHALL:process

EHR systems SHALL support correct processing of this information especially when comparing result values from different sources and SHOULD indicate this information in the UI.

120. EHDSLaboratoryObservation.calibrator

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

If a calibrator identifier is known, provide relevant information identifier.

SHALL:process

EHR systems SHALL support correct processing of this information especially when comparing result values from different sources and SHOULD indicate this information in the UI.

Guidance on how to interpret the contents of this table can be foundhere

0. EHDSLaboratoryObservation

Definition

Model for observation performed by laboratory

Short Laboratory observation model

Control 0..*

Is Modifier false

Logical Model Instances of this logical model are not marked to be the target of a Reference

2. EHDSLaboratoryObservation.header

Definition

Basic metadata for this information

Short Basic metadata for this information

Control 1..1

4. EHDSLaboratoryObservation.header.subject

Definition

Patient/subject information

Short Patient who is receiving health care. This patient might be different from the direct subject of the observation.

Control 1..1

http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSPatient

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR systems SHALL provide information about the subject of care (patient).

SHALL:display

EHR system SHALL render information about the subject of care in such a way that unambiguous assignment to the care subject is preserved.

SHALL:process

Information about the subject of care SHALL be processed by the EHR system in such a way that the identity of the subject of care cannot be confused.

6. EHDSLaboratoryObservation.header.identifier

Definition

Business identifier for the object, unique within its system. Supporting disambiguation between different contexts (systems/countries).

Short Business identifier for the object, unique within its system. Supporting disambiguation between different contexts (systems/countries).

Note This is a business identifier, not a resource identifier (see discussion)

Control 0..*

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

A business identifier of the observation SHALL be populated.

SHALL:process

EHR systems SHALL be able to process identifiers accordingly. Processing means mainly storing identifiers as part of the resource if EHR system stores it.

8. EHDSLaboratoryObservation.header.author[x]

Definition

Author(s) responsible for the provided information. The exact role of the responsible author varies across use cases and is specific to individual models.

Short Author(s) responsible for the provided information.

Control 0..*

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to populate known information about authorhip of the observation. Multiple authors could be provided.

SHOULD:display

If provided, EHR system SHOULD display information about authorship of the Observation.

10. EHDSLaboratoryObservation.header.date

Definition

Date and optionally time of authoring/issuing

Short Date and optionally time of authoring/issuing

Control 0..1

Primitive Value This primitive element may be present, or absent, or replaced by an extension

12. EHDSLaboratoryObservation.header.status

Definition

Status of the resource or document

Short Status of the resource or document

Control 1..1

HL7 Observation status

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

HL7 Observation status (e.g., “final,” “preliminary”) SHALL be provided.

SHALL:display

Always show status of the Observation, esp. If different from "final", e.g., “Status: preliminary” in UI and printouts; accept any valid status code.

14. EHDSLaboratoryObservation.header.source

Definition

Source of information (e.g. patient, patient's proxy). Used in case the patient has authored the information or the author has submitted patient-stated information.

Short Source of information (e.g. patient, patient's proxy). Used in case the patient has authored the information or the author has submitted patient-stated information.

Control 0..1

16. EHDSLaboratoryObservation.header.language

Definition

Language in which the resource is written. Language is expressed by the IETF language tag.

Short Language in which the resource is written. Language is expressed by the IETF language tag.

Control 0..1

BCP 47

18. EHDSLaboratoryObservation.header.directSubject[x]

Definition

The direct subject of the observation if different from the patient (subject of care), e.g. an observation of an implanted device. Additional types of subject may be allowed in implementations.

Short The direct subject of the observation if different from the patient (subject of care), e.g. an observation of an implanted device. Additional types of subject may be allowed in implementations.

Control 0..1

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

SHALL provide information about direct subject of the observation if diferent from the subject of care (another patient, animal or other allowed subject type).

SHALL:display

EHR system SHALL always display information about subject of the observation if different from subject of care.

20. EHDSLaboratoryObservation.observationDate[x]

Definition

Clinically relevant time or time period for the observation

Short Clinically relevant time or time period for the observation

Control 1..1

Type Choice of: dateTime, Period

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL be able to populate date and time and/or period for when the lab test was performed.

SHALL:display

Observation date or period SHALL be displayed if provided.

This element introduces a set of slices on EHDSLaboratoryObservation.observationDate[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:

type @ $this

22. EHDSLaboratoryObservation.observationDate[x]:observationDateDateTime

Slice Name observationDateDateTime

Definition

Clinically relevant time or time period for the observation

Short Clinically relevant time or time period for the observation

Control 0..1

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL be able to populate exact date and time when the lab test was performed.

SHALL:display

Show Observation Date in UI and print; accept any valid ISO 8601 dateTime.

24. EHDSLaboratoryObservation.observationDate[x]:observationDatePeriod

Slice Name observationDatePeriod

Definition

Clinically relevant time or time period for the observation

Short Clinically relevant time or time period for the observation

Control 0..1

Period

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

Lab system SHALL be able to populate period for when the lab test was performed.

SHALL:display

Show Observation Period; accept any valid Period (start ≤ end).

26. EHDSLaboratoryObservation.type

Definition

Observation type. Code and name representing the type of the observation using the agreed code systems.

Short Observation type. Code and name representing the type of the observation using the agreed code systems.

Control 1..1

LOINC, NPU, SNOMED CT

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Test code is mandatory element for identification of the kind of lab test performed from approved code system.

SHALL:display

SHALL:process

Observation type SHALL be processed accordingly, this value should be taken into consideration especially when comparing result values.

28. EHDSLaboratoryObservation.originalName

Definition

Original (conventional) name of the observation as used in the local laboratory or clinical system.

Short Original (conventional) name of the observation as used in the local laboratory or clinical system.

Control 0..1

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If the lab system supplies its own original test name, it SHALL be provided.

SHOULD:display

Original (local) test name SHOULD be displayed, if provided.

30. EHDSLaboratoryObservation.method

Definition

Observation method (measurement principle) to obtain the result.

Short Observation method

Control 0..1

SNOMED CT

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL provide the specific method of measurement used to perform the observation if method of measurement is not included in the observation. Code.

SHALL:display

Observation method SHALL be displayed if provided.

SHALL:process

Observation method SHALL be consider when processing the resource, especially for comparability of result values.

32. EHDSLaboratoryObservation.specimen

Definition

Specimen used for this observation.

Short Specimen used for this observation.

Control 0..1

http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSSpecimen

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL provide information about specimen used for the observation if this information is known.

SHOULD:display

Information about specimen SHOULD be displayed if provided.

34. EHDSLaboratoryObservation.order

Definition

Identifies order and order placer this observation belongs to

Short Identifies order and order placer this observation belongs to

Control 0..1

http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSServiceRequest

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL be able to provide information about order (service request) that was the basis of the laboratory observation.

36. EHDSLaboratoryObservation.performer[x]

Definition

Performer of the observation. Some test could be performed by the patient himself or by a care giver. Those are in the scope of this deliverable under specified conditions.

Short Performer of the observation. Some test could be performed by the patient himself or by a care giver. Those are in the scope of this deliverable under specified conditions.

Control 0..*

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

Lab system SHOULD provide information about performer of the test, if available. Test can be performed by professional, patient himself or by a care giver.

38. EHDSLaboratoryObservation.bodySite

Definition

Anatomic location and laterality where the observation was performed.

Short Anatomic location and laterality where the observation was performed.

Control 0..1

http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSBodyStructure

40. EHDSLaboratoryObservation.result

Definition

Control 1..1

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL be able to provide test results in various forms: numeric, textual and coded.

SHALL:display

SHALL display results of the Observation.

42. EHDSLaboratoryObservation.result.value[x]

Definition

Control 0..1

UCUM for units, SNOMED CT for coded results

Type Choice of: string, Quantity, Range, Ratio, CodeableConcept

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

SHALL display results of the Observation.

This element introduces a set of slices on EHDSLaboratoryObservation.result.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:

type @ $this

44. EHDSLaboratoryObservation.result.value[x]:valueString

Slice Name valueString

Definition

Control 0..1

UCUM for units, SNOMED CT for coded results

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If only purely textual results are expected, it MUST be provided. Coded results are preferred in most cases.

SHALL:display

If present, SHALL display textual Result Value in UI and printouts; accept any string.

46. EHDSLaboratoryObservation.result.value[x]:valueQuantity

Slice Name valueQuantity

Definition

Control 0..1

UCUM for units, SNOMED CT for coded results

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

If present, SHALL display numeric Result Value in UI and printouts; accept any valid Quantity.

48. EHDSLaboratoryObservation.result.value[x]:valueRange

Slice Name valueRange

Definition

Control 0..1

UCUM for units, SNOMED CT for coded results

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

If present, SHALL display range Result Value in UI and printouts; accept any valid Range.

50. EHDSLaboratoryObservation.result.value[x]:valueRatio

Slice Name valueRatio

Definition

Control 0..1

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

If present, SHALL display ratio Result Value in UI and printouts; accept any valid Ratio.

52. EHDSLaboratoryObservation.result.value[x]:valueCodeableConcept

Slice Name valueCodeableConcept

Definition

Control 0..1

UCUM for units, SNOMED CT for coded results

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

If present, SHALL display coded Result Value in UI and printouts; accept any valid CodeableConcept.

54. EHDSLaboratoryObservation.result.uncertainty

Definition

Measurement uncertainty information about the observation result.

Short Measurement uncertainty type and interval if needed.

Control 0..1

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If the test reports uncertainty (e.g., “±0.1”), allow numeric entry of uncertainty. Store in Quantity or Range.

SHOULD:display

If present, SHOULD display uncertainty of measurement in UI and printouts. Show “Uncertainty: ±0.1”.

56. EHDSLaboratoryObservation.result.uncertainty.value

Definition

The numerical value of the measurement uncertainty.

Short The numerical value of the measurement uncertainty.

Control 1..1

Primitive Value This primitive element may be present, or absent, or replaced by an extension

58. EHDSLaboratoryObservation.result.uncertainty.type

Definition

Probability Distribution Type for uncertainty

Short Probability Distribution Type for uncertainty

Control 0..1

HL7 ProbabilityDistributionType

60. EHDSLaboratoryObservation.result.dataAbsentReason

Definition

Provides a reason why the expected value in the element Observation.value[x] is missing.

Short Provides a reason why the expected value in the element Observation.value[x] is missing.

Control 0..1

HL7 Data absent reason

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

If no result is available, lab system SHALL be able to provide data absent reason. Data absent reason SHOULD NOT be expressed as a test result value.

SHALL:display

If provided, display e.g. “No result: not‐performed” in UI and print; accept any valid dataAbsentReason without error.

62. EHDSLaboratoryObservation.referenceRange

Definition

Reference range, multiple reference ranges of different types could by provided. Provides guide for interpretation of the result.

Short Reference range, multiple reference ranges of different types could by provided. Provides guide for interpretation of the result.

Comments

Reference ranges are usually implied only for a numeric scale type. Use of the same units for reference range and value is implied.

Control 0..*

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Allow zero or more referenceRange entries (e.g., normal range “12–16 g/dL”). Populate each as a structured Range or coded description.

SHALL:display

If present, display each range clearly (e.g., “Reference: 12.0–16.0 g/dL”); accept any valid referenceRange structure.

64. EHDSLaboratoryObservation.referenceRange.low

Definition

Low limit of the reference range.

Short Low limit of the reference range.

Control 0..1

UCUM for units

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL populate Low value of the normal reference range, if known.

SHALL:display

66. EHDSLaboratoryObservation.referenceRange.high

Definition

High limit of the reference range.

Short High limit of the reference range.

Control 0..1

UCUM for units

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL populate High value of the normal reference range, if known

SHALL:display

68. EHDSLaboratoryObservation.referenceRange.normalValue

Definition

Normal value, if relevant for the reference range.

Short Normal value, if relevant for the reference range.

Control 0..1

SNOMED CT

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL populate Normal value of the normal reference range, if known.

SHALL:display

70. EHDSLaboratoryObservation.referenceRange.type

Definition

Type of reference range.

Short Type of reference range.

Control 0..1

HL7 Observation Reference Range Meaning Codes

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to populate type of the normal reference range.

SHALL:display

72. EHDSLaboratoryObservation.referenceRange.appliesTo

Definition

Short Codes to indicate the target population this reference range applies to.

Comments

Multiple appliesTo are interpreted as an "AND" of the target populations.

Control 0..*

SNOMED CT, HL7 v3-Race

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to populate target population of the normal reference range.

74. EHDSLaboratoryObservation.referenceRange.age

Definition

Age range to which this reference range applies if applicable.

Short Age range to which this reference range applies if applicable.

Control 0..1

UCUM for units

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to populate age range for the normal reference range.

76. EHDSLaboratoryObservation.referenceRange.text

Definition

Short Text based reference range in an observation.

Control 0..1

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL populate reference range, if known.

SHALL:display

78. EHDSLaboratoryObservation.interpretation

Definition

Information about reference intervals and result interpretation.

Short Information about reference intervals and result interpretation.

Control 0..*

SNOMED CT, HL7 ObservationInterpretation

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL be able to populate interpretation of the result in comparison with the reference range, if such range is available.

SHALL:display

Show each interpretation (e.g., “Interpretation: High”); accept any valid CodeableConcept.

80. EHDSLaboratoryObservation.note

Definition

Comments and narrative representation of the observation result and findings.

Short Comments and narrative representation of the observation result and findings.

Control 0..1

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL be able to populate textual comment to the test result value.

SHALL:display

If present, show “e.g. Result Note: Hemolysis observed” in UI and print; accept any string.

82. EHDSLaboratoryObservation.component

Definition

Component in case the observation consists of multiple sub-observations (e.g. blood pressure).

Short Component in case the observation consists of multiple sub-observations (e.g. blood pressure).

Control 0..*

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

SHALL:display

If components exist, render each component details in UI and print; accept any valid component structure.

84. EHDSLaboratoryObservation.component.type

Definition

Code representing the observation using the agreed code systems.

Short Code representing the observation using the agreed code systems.

Control 1..1

LOINC, NPU, SNOMED CT

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Component code is mandatory element for identification of the kind of lab test performed from approved code system.

SHALL:display

SHALL:process

Observation type SHALL be processed accordingly, this value should be taken into consideration especially when comparing result values.

86. EHDSLaboratoryObservation.component.originalName

Definition

Original (user-friendly) name of the observation as used in the local laboratory or clinical system.

Short Original (user-friendly) name of the observation as used in the local laboratory or clinical system.

Control 0..1

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If the lab system supplies its own original test name, it SHALL be provided.

SHOULD:display

Original (local) test name SHOULD be displayed, if provided.

88. EHDSLaboratoryObservation.component.result

Definition

Control 1..1

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to provide test results in various forms: numeric, textual and coded.

SHALL:display

SHALL display results of the Observation.

90. EHDSLaboratoryObservation.component.result.value[x]

Definition

Control 0..1

UCUM for units, SNOMED CT for coded results

Type Choice of: string, Quantity, Range, Ratio, CodeableConcept

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

SHALL display results of the Observation.

This element introduces a set of slices on EHDSLaboratoryObservation.component.result.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:

type @ $this

92. EHDSLaboratoryObservation.component.result.value[x]:valueString

Slice Name valueString

Definition

Control 0..1

UCUM for units, SNOMED CT for coded results

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If only purely textual results are expected, it MUST be provided. Coded results are preferred in most cases.

SHALL:display

SHALL display results of the Observation.

94. EHDSLaboratoryObservation.component.result.value[x]:valueQuantity

Slice Name valueQuantity

Definition

Control 0..1

UCUM for units, SNOMED CT for coded results

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If lab system knows numeric result value or numeric range, it MUST be provided.

SHALL:display

SHALL display results of the Observation.

96. EHDSLaboratoryObservation.component.result.value[x]:valueRange

Slice Name valueRange

Definition

Control 0..1

UCUM for units, SNOMED CT for coded results

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

If present, SHALL display range Result Value in UI and printouts; accept any valid Range.

98. EHDSLaboratoryObservation.component.result.value[x]:valueRatio

Slice Name valueRatio

Definition

Control 0..1

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

If present, SHALL display ratio Result Value in UI and printouts; accept any valid Ratio.

100. EHDSLaboratoryObservation.component.result.value[x]:valueCodeableConcept

Slice Name valueCodeableConcept

Definition

Control 0..1

UCUM for units, SNOMED CT for coded results

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.

SHALL:display

If present, SHALL display coded Result Value in UI and printouts; accept any valid CodeableConcept.

102. EHDSLaboratoryObservation.component.result.uncertainty

Definition

Measurement uncertainty information about the observation result.

Short Measurement uncertainty type and interval if needed.

Control 0..1

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If the test reports uncertainty (e.g., “±0.1”), allow numeric entry of uncertainty. Store in Quantity or Range.

SHOULD:display

If present, SHOULD display uncertainty of measurement in UI and printouts. Show “Uncertainty: ±0.1”.

104. EHDSLaboratoryObservation.component.result.uncertainty.value

Definition

The numerical value of the measurement uncertainty.

Short The numerical value of the measurement uncertainty.

Control 1..1

Primitive Value This primitive element may be present, or absent, or replaced by an extension

106. EHDSLaboratoryObservation.component.result.uncertainty.type

Definition

Probability Distribution Type for uncertainty

Short Probability Distribution Type for uncertainty

Control 0..1

HL7 ProbabilityDistributionType

108. EHDSLaboratoryObservation.component.result.dataAbsentReason

Definition

Provides a reason why the expected value in the element component.value[x] is missing.

Short Provides a reason why the expected value in the element component.value[x] is missing.

Control 0..1

HL7 Data absent reason

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

If no result is available, lab system SHALL be able to provide data absent reason. Data absent reason SHOULD NOT be expressed as a test result value.

SHALL:display

If provided, display e.g. “No result: not‐performed” in UI and print; accept any valid dataAbsentReason without error.

110. EHDSLaboratoryObservation.component.referenceRange

Definition

Reference range, multiple reference ranges of different types could by provided. Provides guide for interpretation of the result.

Short Reference range, multiple reference ranges of different types could by provided. Provides guide for interpretation of the result.

Comments

Reference ranges are usually implied only for a numeric scale type. Use of the same units for reference range and value is implied.

Control 0..*

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Allow zero or more referenceRange entries (e.g., normal range “12–16 g/dL”). Populate each as a structured Range or coded description.

SHALL:display

If present, display each range clearly (e.g., “Reference: 12.0–16.0 g/dL”); accept any valid referenceRange structure.

112. EHDSLaboratoryObservation.component.referenceRange.low

Definition

Low limit of the reference range.

Short Low limit of the reference range.

Control 0..1

UCUM for units

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL populate Low value of the normal reference range, if known.

SHALL:display

114. EHDSLaboratoryObservation.component.referenceRange.high

Definition

High limit of the reference range.

Short High limit of the reference range.

Control 0..1

UCUM for units

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL populate High value of the normal reference range, if known

SHALL:display

116. EHDSLaboratoryObservation.component.referenceRange.normalValue

Definition

Normal value, if relevant for the reference range.

Short Normal value, if relevant for the reference range.

Control 0..1

SNOMED CT

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL populate Normal value of the normal reference range, if known.

SHALL:display

118. EHDSLaboratoryObservation.component.referenceRange.type

Definition

Type of reference range.

Short Type of reference range.

Control 0..1

HL7 Observation Reference Range Meaning Codes

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to populate type of the normal reference range.

SHALL:display

120. EHDSLaboratoryObservation.component.referenceRange.appliesTo

Definition

Short Codes to indicate the target population this reference range applies to.

Comments

Multiple appliesTo are interpreted as an "AND" of the target populations.

Control 0..*

SNOMED CT, HL7 v3-Race

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to populate target population of the normal reference range.

122. EHDSLaboratoryObservation.component.referenceRange.age

Definition

Age range to which this reference range applies if applicable.

Short Age range to which this reference range applies if applicable.

Control 0..1

UCUM for units

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

EHR system SHALL be able to populate age range for the normal reference range.

124. EHDSLaboratoryObservation.component.referenceRange.text

Definition

Short Text based reference range in an observation.

Control 0..1

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

EHR system SHALL populate reference range, if known.

SHALL:display

126. EHDSLaboratoryObservation.component.interpretation

Definition

Information about reference intervals and result interpretation.

Short Information about reference intervals and result interpretation.

Control 0..*

SNOMED CT, HL7 ObservationInterpretation

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

Lab system SHALL be able to populate interpretation of the result in comparison with the reference range, if such range is available.

SHALL:display

Show each interpretation (e.g., “Interpretation: High”); accept any valid CodeableConcept.

128. EHDSLaboratoryObservation.derivedFrom[x]

Definition

Reference to the related resource from which the observation has been made. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.

Short Reference to the related resource from which the observation has been made. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.

Control 0..*

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

130. EHDSLaboratoryObservation.hasMember[x]

Definition

This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group.

Short This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group.

Control 0..*

Type Choice of: http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSLaboratoryObservation, http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSObservation

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If this is a pannel of tests or a test sequence, a reference to the member observation SHALL be provided.

132. EHDSLaboratoryObservation.triggeredBy[x]

Definition

References to the observation(s) that triggered the performance of this observation.

Short References to the observation(s) that triggered the performance of this observation.

Control 0..*

Type Choice of: http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSLaboratoryObservation, http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSObservation

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Obligations

Obligations

Actor

Documentation

SHOULD:able-to-populate

If this observation was triggered by another (e.g., reflex test), this information SHOULD be provided.

134. EHDSLaboratoryObservation.testKit

Definition

Laboratory test kit used during measurement.

Short Laboratory test kit used during measurement.

Control 0..1

http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSDevice

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

If a specific test kit was used (e.g., rapid antigen kit), provide an EHDSDevice information.

SHALL:process

EHR systems SHALL support correct processing of this information especially when comparing result values from different sources and SHOULD indicate this information in the UI.

136. EHDSLaboratoryObservation.calibrator

Definition

Information about which end-user calibrator the laboratory used for the measurement to indicate the metrological traceability chain.

Short Information about which end-user calibrator the laboratory used for the measurement to indicate the metrological traceability chain.

Control 0..1

Obligations

Obligations

Actor

Documentation

SHALL:able-to-populate

If a calibrator identifier is known, provide relevant information identifier.

SHALL:process

EHR systems SHALL support correct processing of this information especially when comparing result values from different sources and SHOULD indicate this information in the UI.

138. EHDSLaboratoryObservation.accreditationStatus

Definition

Accreditation status of the laboratory for the observation.

Short Accreditation status of the laboratory for the observation.

Control 0..1