Generated Narrative: StructureDefinition EHDSObservationObligations Language: en Name Flags Card. Type Description & Constraints EHDSObservation 0..* EHDSObservation 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 SHOULD: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; 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 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 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 be provided. Provides guide for interpretation of the result. Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; component #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 #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 be provided. Provides guide for interpretation of the result. Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; Documentation for this format
Obligations for the logical model of general observation
Model for information about an oservation and its results.
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 if known.
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.
EHR system SHALL be able to populate date and time and/or period for when the test was performed.
Observation date or period SHALL be displayed if provided.
Clinically relevant time or time period for the observation
EHR system SHALL be able to populate exact date and time when the test was performed.
Show Observation Date in UI and print; accept any valid ISO 8601 dateTime.
EHR system SHALL be able to populate period for when the test was performed.
Show Observation Period; accept any valid Period (start ≤ end).
Test code is mandatory element for identification of the kind of 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 EHR 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.
Observation method (measurement principle) to obtain the result.
Identifies order and order placer this observation belongs to
EHR system SHALL 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.
EHR system SHALL be able to provide test results.
SHALL display results 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 EHR system knows numeric result value or numeric range, it MUST be provided.
If present, SHALL display numeric Result Value in UI and printouts; accept any valid Quantity/Range.
If the EHR system knows coded result value, it SHALL be provided.
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, EHR 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 be 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.
Normal value, if relevant for the reference range.
HL7 Observation Reference Range Meaning Codes
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.
Age range to which this reference range applies if applicable.
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\".
Information about reference intervals and result interpretation.
SNOMED CT, HL7 ObservationInterpretation
Comments and narrative representation of the observation result and findings.
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 test performed from approved code system.
Observation type is a mandatory element. EHR system SHOULD display observation type and SHALL process it accordingly. The type carries the correct semantic meaning of the observation. i.e. code and display name. Any valid CodeableConcept SHALL be accepted.
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.
Provides a reason why the expected value in the element component.value[x] is missing.
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.
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.