Generated Narrative: StructureDefinition EHDSLaboratoryObservationObligations Name Flags Card. Type Description & Constraints EHDSLaboratoryObservation 0..* EHDSLaboratoryObservation Laboratory observation model #xD; header #xD; subject O 1..1 EHDSPatient Patient who is receiving health care. This patient might be different from the direct subject of the observation. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer SHALL:process Consumer #xD; identifier O 0..* Identifier Business identifier for the object, unique within its system. Supporting disambiguation between different contexts (systems/countries). Obligations Actor SHALL:able-to-populate Producer SHALL:process Consumer #xD; author[x] O 0..* EHDSHealthProfessional, EHDSOrganisation, EHDSDevice Author(s) responsible for the provided information. Obligations Actor SHALL:able-to-populate Producer SHOULD:display Consumer #xD; status O 1..1 CodeableConcept Status of the resource or document Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; directSubject[x] O 0..1 EHDSPatient, EHDSLocation, EHDSDevice, EHDSHealthProfessional, EHDSOrganisation, EHDSProcedure 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. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; Slices for observationDate[x] O 1..1 dateTime, Period Clinically relevant time or time period for the observation Slice: Unordered, Open by type:$this Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; observationDate[x]:observationDateDateTime O 0..1 dateTime Clinically relevant time or time period for the observation Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; observationDate[x]:observationDatePeriod O 0..1 Period Clinically relevant time or time period for the observation Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; type O 1..1 CodeableConcept Observation type. Code and name representing the type of the observation using the agreed code systems. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer SHALL:process Consumer #xD; originalName O 0..1 string Original (conventional) name of the observation as used in the local laboratory or clinical system. Obligations Actor SHOULD:able-to-populate Producer SHOULD:display Consumer #xD; method O 0..1 CodeableConcept Observation method Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer SHALL:process Consumer #xD; specimen O 0..1 EHDSSpecimen Specimen used for this observation. Obligations Actor SHALL:able-to-populate Producer SHOULD:display Consumer #xD; order O 0..1 EHDSServiceRequest Identifies order and order placer this observation belongs to Obligations Actor SHALL:able-to-populate Producer #xD; performer[x] O 0..* EHDSOrganisation, EHDSHealthProfessional, EHDSPatient, EHDSRelatedPerson 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. Obligations Actor SHOULD:able-to-populate Producer #xD; result O 1..1 Base 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. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; Slices for value[x] O 0..1 string, Quantity, Range, Ratio, CodeableConcept 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. Slice: Unordered, Open by type:$this Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; value[x]:valueString O 0..1 string 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. Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; value[x]:valueQuantity O 0..1 Quantity 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. Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; value[x]:valueRange O 0..1 Range 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. Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; value[x]:valueRatio O 0..1 Ratio 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. Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; value[x]:valueCodeableConcept O 0..1 CodeableConcept 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. Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; uncertainty O 0..1 Base Measurement uncertainty type and interval if needed. Obligations Actor SHOULD:able-to-populate Producer SHOULD:display Consumer #xD; dataAbsentReason O 0..1 CodeableConcept Provides a reason why the expected value in the element Observation.value[x] is missing. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; referenceRange O 0..* Base Reference range, multiple reference ranges of different types could by provided. Provides guide for interpretation of the result. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; low O 0..1 Quantity Low limit of the reference range. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; high O 0..1 Quantity High limit of the reference range. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; normalValue O 0..1 CodeableConcept Normal value, if relevant for the reference range. Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; type O 0..1 CodeableConcept Type of reference range. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; appliesTo O 0..* CodeableConcept Codes to indicate the target population this reference range applies to. Obligations Actor SHALL:able-to-populate Producer #xD; age O 0..1 Range Age range to which this reference range applies if applicable. Obligations Actor SHALL:able-to-populate Producer #xD; text O 0..1 string Text based reference range in an observation. Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; interpretation O 0..* CodeableConcept Information about reference intervals and result interpretation. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; note O 0..1 string Comments and narrative representation of the observation result and findings. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; component O 0..* Base Component in case the observation consists of multiple sub-observations (e.g. blood pressure). Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; type O 1..1 CodeableConcept Code representing the observation using the agreed code systems. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer SHALL:process Consumer #xD; originalName O 0..1 string Original (user-friendly) name of the observation as used in the local laboratory or clinical system. Obligations Actor SHOULD:able-to-populate Producer SHOULD:display Consumer #xD; result O 1..1 Base 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. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; Slices for value[x] O 0..1 string, Quantity, Range, Ratio, CodeableConcept 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. Slice: Unordered, Open by type:$this Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; value[x]:valueString O 0..1 string 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. Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; value[x]:valueQuantity O 0..1 Quantity 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. Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; value[x]:valueRange O 0..1 Range 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. Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; value[x]:valueRatio O 0..1 Ratio 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. Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; value[x]:valueCodeableConcept O 0..1 CodeableConcept 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. Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; uncertainty O 0..1 Base Measurement uncertainty type and interval if needed. Obligations Actor SHOULD:able-to-populate Producer SHOULD:display Consumer #xD; dataAbsentReason O 0..1 CodeableConcept Provides a reason why the expected value in the element component.value[x] is missing. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; referenceRange O 0..* Base Reference range, multiple reference ranges of different types could by provided. Provides guide for interpretation of the result. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; low O 0..1 Quantity Low limit of the reference range. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; high O 0..1 Quantity High limit of the reference range. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; normalValue O 0..1 CodeableConcept Normal value, if relevant for the reference range. Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; type O 0..1 CodeableConcept Type of reference range. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; appliesTo O 0..* CodeableConcept Codes to indicate the target population this reference range applies to. Obligations Actor SHALL:able-to-populate Producer #xD; age O 0..1 Range Age range to which this reference range applies if applicable. Obligations Actor SHALL:able-to-populate Producer #xD; text O 0..1 string Text based reference range in an observation. Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; interpretation O 0..* CodeableConcept Information about reference intervals and result interpretation. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; derivedFrom[x] O 0..* EHDSObservation, EHDSLaboratoryObservation, EHDSImagingStudy 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. Obligations Actor SHOULD:able-to-populate Producer #xD; hasMember[x] O 0..* EHDSLaboratoryObservation, EHDSObservation 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. Obligations Actor SHOULD:able-to-populate Producer #xD; triggeredBy[x] O 0..* EHDSLaboratoryObservation, EHDSObservation References to the observation(s) that triggered the performance of this observation. Obligations Actor SHOULD:able-to-populate Producer #xD; testKit O 0..1 EHDSDevice Laboratory test kit used during measurement. Obligations Actor SHALL:able-to-populate Producer SHALL:process Consumer #xD; calibrator O 0..1 Identifier Information about which end-user calibrator the laboratory used for the measurement to indicate the metrological traceability chain. Obligations Actor SHALL:able-to-populate Producer SHALL:process Consumer #xD; Documentation for this format
Obligations for the logical model of laboratory observation
Model for observation performed by laboratory
EHR systems SHALL provide information about the subject of care (patient).
EHR system SHALL render information about the subject of care in such a way that unambiguous assignment to the care subject is preserved.
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.
Patient who is receiving health care. This patient might be different from the direct subject of the observation.
A business identifier of the observation SHALL be populated.
EHR systems SHALL be able to process identifiers accordingly. Processing means mainly storing identifiers as part of the resource if EHR system stores it.
Business identifier for the object, unique within its system. Supporting disambiguation between different contexts (systems/countries).
EHR system SHALL be able to populate known information about authorhip of the observation. Multiple authors could be provided.
If provided, EHR system SHOULD display information about authorship of the Observation.
Author(s) responsible for the provided information.
Author(s) responsible for the provided information. The exact role of the responsible author varies across use cases and is specific to individual models.
Date and optionally time of authoring/issuing
HL7 Observation status (e.g., “final,” “preliminary”) SHALL be provided.
Always show status of the Observation, esp. If different from "final", e.g., “Status: preliminary” in UI and printouts; accept any valid status code.
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.
Language in which the resource is written. Language is expressed by the IETF language tag.
SHALL provide information about direct subject of the observation if diferent from the subject of care (another patient, animal or other allowed subject type).
EHR system SHALL always display information about subject of the observation if different from subject of care.
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.
Lab system SHALL be able to populate date and time and/or period for when the lab test was performed.
Observation date or period SHALL be displayed if provided.
Clinically relevant time or time period for the observation
Lab system SHALL be able to populate exact date and time when the lab test was performed.
Show Observation Date in UI and print; accept any valid ISO 8601 dateTime.
Lab system SHALL be able to populate period for when the lab test was performed.
Show Observation Period; accept any valid Period (start ≤ end).
Test code is mandatory element for identification of the kind of lab test performed from approved code system.
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.
Observation type SHALL be processed accordingly, this value should be taken into consideration especially when comparing result values.
Observation type. Code and name representing the type of the observation using the agreed code systems.
If the lab system supplies its own original test name, it SHALL be provided.
Original (local) test name SHOULD be displayed, if provided.
Original (conventional) name of the observation as used in the local laboratory or clinical system.
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.
Observation method SHALL be displayed if provided.
Observation method SHALL be consider when processing the resource, especially for comparability of result values.
Observation method (measurement principle) to obtain the result.
Lab system SHALL provide information about specimen used for the observation if this information is known.
Information about specimen SHOULD be displayed if provided.
Lab system SHALL be able to provide information about order (service request) that was the basis of the laboratory observation.
Identifies order and order placer this observation belongs to
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.
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.
Anatomic location and laterality where the observation was performed.
Lab system SHALL be able to provide test results in various forms: numeric, textual and coded.
SHALL display results of the Observation.
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.
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.
EHR system SHALL be able to provide test result values in various forms: numeric, textual and coded.
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.
UCUM for units, SNOMED CT for coded results
If only purely textual results are expected, it MUST be provided. Coded results are preferred in most cases.
If present, SHALL display textual Result Value in UI and printouts; accept any string.
If present, SHALL display numeric Result Value in UI and printouts; accept any valid Quantity.
If present, SHALL display range Result Value in UI and printouts; accept any valid Range.
If present, SHALL display ratio Result Value in UI and printouts; accept any valid Ratio.
If present, SHALL display coded Result Value in UI and printouts; accept any valid CodeableConcept.
If the test reports uncertainty (e.g., “±0.1”), allow numeric entry of uncertainty. Store in Quantity or Range.
If present, SHOULD display uncertainty of measurement in UI and printouts. Show “Uncertainty: ±0.1”.
Measurement uncertainty type and interval if needed.
Measurement uncertainty information about the observation result.
The numerical value of the measurement uncertainty.
Probability Distribution Type for uncertainty
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.
If provided, display e.g. “No result: not‐performed” in UI and print; accept any valid dataAbsentReason without error.
Provides a reason why the expected value in the element Observation.value[x] is missing.
Allow zero or more referenceRange entries (e.g., normal range “12–16 g/dL”). Populate each as a structured Range or coded description.
If present, display each range clearly (e.g., “Reference: 12.0–16.0 g/dL”); accept any valid referenceRange structure.
Reference range, multiple reference ranges of different types could by provided. Provides guide for interpretation of the result.
Reference ranges are usually implied only for a numeric scale type. Use of the same units for reference range and value is implied.
EHR system SHALL populate Low value of the normal reference range, if known.
EHR system SHALL populate High value of the normal reference range, if known
EHR system SHALL populate Normal value of the normal reference range, if known.
Normal value, if relevant for the reference range.
EHR system SHALL be able to populate type of the normal reference range.
HL7 Observation Reference Range Meaning Codes
EHR system SHALL be able to populate target population of the normal reference range.
Codes to indicate the target population this reference range applies to.
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.
Multiple appliesTo are interpreted as an "AND" of the target populations.
EHR system SHALL be able to populate age range for the normal reference range.
Age range to which this reference range applies if applicable.
EHR system SHALL populate reference range, if known.
Text based reference range in an observation.
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\".
Lab system SHALL be able to populate interpretation of the result in comparison with the reference range, if such range is available.
Show each interpretation (e.g., “Interpretation: High”); accept any valid CodeableConcept.
Information about reference intervals and result interpretation.
SNOMED CT, HL7 ObservationInterpretation
Lab system SHALL be able to populate textual comment to the test result value.
If present, show “e.g. Result Note: Hemolysis observed” in UI and print; accept any string.
Comments and narrative representation of the observation result and findings.
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.
If components exist, render each component details in UI and print; accept any valid component structure.
Component in case the observation consists of multiple sub-observations (e.g. blood pressure).
Component code is mandatory element for identification of the kind of lab test performed from approved code system.
Code representing the observation using the agreed code systems.
Original (user-friendly) name of the observation as used in the local laboratory or clinical system.
EHR system SHALL be able to provide test results in various forms: numeric, textual and coded.
If lab system knows numeric result value or numeric range, it MUST be provided.
Provides a reason why the expected value in the element component.value[x] is missing.
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.
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.
If this is a pannel of tests or a test sequence, a reference to the member observation SHALL be provided.
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.
If this observation was triggered by another (e.g., reflex test), this information SHOULD be provided.
References to the observation(s) that triggered the performance of this observation.
If a specific test kit was used (e.g., rapid antigen kit), provide an EHDSDevice information.
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.
Laboratory test kit used during measurement.
If a calibrator identifier is known, provide relevant information identifier.
Information about which end-user calibrator the laboratory used for the measurement to indicate the metrological traceability chain.
Accreditation status of the laboratory for the observation.
Previous results of the same observation
Examination performed near or at the site of a patient.
Indicates if the observation is a point-of-care test (POCT), i.e. an examination performed near or at the site of a patient.