HRSA 2023 Uniform Data System (UDS) Patient Level Submission (PLS) (UDS+) FHIR IG
1.0.1 - STU1 Release 1 - Standard for Trial-Use
This page is part of the HRSA Uniform Data System (UDS) Patient Level Submission (PLS) (UDS+ or uds-plus) FHIR IG (v1.0.1: STU1) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions
Official URL: http://fhir.org/guides/hrsa/uds-plus/StructureDefinition/uds-plus-clinical-result-observation | Version: 1.0.1 | |||
Standards status: Trial-use | Maturity Level: 2 | Computable Name: UDSPlusClinicalResultObservation |
The UDS+ profile is based on the Observation resource and establishes the core elements, extensions, vocabularies and value sets for representing clinical result observations for UDS+ program.
This profile is used to represent de-identified Observation for Clinical Result information. The de-identification process has to remove all data elements not explicitly identified as “SUPPORTED” in the profile.
The HHS De-identification Guidance is to be followed to ensure appropriate level of de-identification is performed.
According to the HHS guidance, dates should not have a precision of more than the year. This means month and day cannot be included. This includes Observation for Lab Result.period.
In FHIR Resources, text elements and reference.display elements which provide human readable information to the providers may be generated using programs and tools from the data present within the resource. For e.g a Observation for Clinical Result resource text element may contain information such as the Observation for Clinical Result date, patient information. This type of information will enable identification of the individuals. In order to avoid inadvertent revealing of PII/PHI, text elements cannot be included in the De-identified FHIR resource and the submission will be rejected when text elements are present by the validation process.
Ids and References
The original Observation for Clinical Result resource id should not be included in the De-identified Observation for Clinical Result instance. Instead a new id should be created and provided as part of the FHIR resource. The Data Submitter should be capable of using the generated id to relink the data to the original Observation for Lab Result. All resource references to the Observation for Clinical Result submitted as part of the UDS+ report should refer to newly generated id.
Resource references cannot contain text element as it may contain PHI/PII. The text element for following references are not allowed
Date Truncation
The Data Submitter has to truncate the following dates to only have a precision of year
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from Observation
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Observation | 0..* | Observation | De-Identified UDS Plus Clinical Result Observation | |
id | S | 0..1 | id | The de-identified Observation identifier created by the health center to send data to UDS+ Data Receiver |
text | 0..0 | |||
contained | 0..0 | |||
status | S | 1..1 | code | registered | preliminary | final | amended + |
category | S | 1..* | CodeableConcept | Classification of type of observation Binding: US Core Clinical Result Observation Category (extensible): The set of codes indicating the category of the observation |
code | S | 1..1 | CodeableConcept | Type of observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations |
subject | S | 1..1 | Reference(De-Identified UDS Plus Patient) | Who and/or what the observation is about |
display | 0..0 | |||
encounter | S | 0..1 | Reference(De-Identified UDS Plus Encounter) | Healthcare event during which this observation is made |
display | 0..0 | |||
effective[x] | S | 0..1 | dateTime, Period, Timing, instant | Clinically relevant time/time-period for observation |
issued | S | 0..1 | instant | Date/Time this version was made available |
performer | S | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | Who is responsible for the observation |
value[x] | S | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Actual result |
bodySite | S | 0..1 | CodeableConcept | Observed body part |
component | S | 0..* | BackboneElement | Component results |
code | S | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations |
value[x] | S | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Actual component result |
Documentation for this format |
Path | Conformance | ValueSet |
Observation.category | extensible | USCoreClinicalResultObservationCategory |
Observation.code | extensible | LOINCCodes (a valid code from LOINC) |
Observation.component.code | extensible | LOINCCodes (a valid code from LOINC) |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Observation | C | 0..* | Observation | De-Identified UDS Plus Clinical Result Observation |
id | SΣ | 0..1 | id | The de-identified Observation identifier created by the health center to send data to UDS+ Data Receiver |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
status | ?!SΣ | 1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. |
category | S | 1..* | CodeableConcept | Classification of type of observation Binding: US Core Clinical Result Observation Category (extensible): The set of codes indicating the category of the observation |
code | SΣ | 1..1 | CodeableConcept | Type of observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations |
subject | SΣ | 1..1 | Reference(De-Identified UDS Plus Patient) | Who and/or what the observation is about |
encounter | SΣ | 0..1 | Reference(De-Identified UDS Plus Encounter) | Healthcare event during which this observation is made |
effective[x] | SΣ | 0..1 | Clinically relevant time/time-period for observation | |
effectiveDateTime | dateTime | |||
effectivePeriod | Period | |||
effectiveTiming | Timing | |||
effectiveInstant | instant | |||
issued | SΣ | 0..1 | instant | Date/Time this version was made available |
performer | SΣ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | Who is responsible for the observation |
value[x] | SΣC | 0..1 | Actual result | |
valueQuantity | Quantity | |||
valueCodeableConcept | CodeableConcept | |||
valueString | string | |||
valueBoolean | boolean | |||
valueInteger | integer | |||
valueRange | Range | |||
valueRatio | Ratio | |||
valueSampledData | SampledData | |||
valueTime | time | |||
valueDateTime | dateTime | |||
valuePeriod | Period | |||
bodySite | S | 0..1 | CodeableConcept | Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality. |
component | SΣ | 0..* | BackboneElement | Component results |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
code | SΣ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations |
value[x] | SΣ | 0..1 | Actual component result | |
valueQuantity | Quantity | |||
valueCodeableConcept | CodeableConcept | |||
valueString | string | |||
valueBoolean | boolean | |||
valueInteger | integer | |||
valueRange | Range | |||
valueRatio | Ratio | |||
valueSampledData | SampledData | |||
valueTime | time | |||
valueDateTime | dateTime | |||
valuePeriod | Period | |||
Documentation for this format |
Path | Conformance | ValueSet |
Observation.status | required | ObservationStatus |
Observation.category | extensible | USCoreClinicalResultObservationCategory |
Observation.code | extensible | LOINCCodes (a valid code from LOINC) |
Observation.bodySite | example | SNOMEDCTBodyStructures |
Observation.component.code | extensible | LOINCCodes (a valid code from LOINC) |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | Observation | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | Observation | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty() | |
obs-7 | error | Observation | If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty() |
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
Observation | C | 0..* | Observation | De-Identified UDS Plus Clinical Result Observation | ||||
id | SΣ | 0..1 | id | The de-identified Observation identifier created by the health center to send data to UDS+ Data Receiver | ||||
meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
identifier | Σ | 0..* | Identifier | Business Identifier for observation | ||||
basedOn | Σ | 0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order | ||||
partOf | Σ | 0..* | Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) | Part of referenced event | ||||
status | ?!SΣ | 1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. | ||||
category | S | 1..* | CodeableConcept | Classification of type of observation Binding: US Core Clinical Result Observation Category (extensible): The set of codes indicating the category of the observation | ||||
code | SΣ | 1..1 | CodeableConcept | Type of observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations | ||||
subject | SΣ | 1..1 | Reference(De-Identified UDS Plus Patient) | Who and/or what the observation is about | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
reference | ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
type | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). | ||||
identifier | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
focus | Σ | 0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record | ||||
encounter | SΣ | 0..1 | Reference(De-Identified UDS Plus Encounter) | Healthcare event during which this observation is made | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
reference | ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
type | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). | ||||
identifier | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
effective[x] | SΣ | 0..1 | Clinically relevant time/time-period for observation | |||||
effectiveDateTime | dateTime | |||||||
effectivePeriod | Period | |||||||
effectiveTiming | Timing | |||||||
effectiveInstant | instant | |||||||
issued | SΣ | 0..1 | instant | Date/Time this version was made available | ||||
performer | SΣ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | Who is responsible for the observation | ||||
value[x] | SΣC | 0..1 | Actual result | |||||
valueQuantity | Quantity | |||||||
valueCodeableConcept | CodeableConcept | |||||||
valueString | string | |||||||
valueBoolean | boolean | |||||||
valueInteger | integer | |||||||
valueRange | Range | |||||||
valueRatio | Ratio | |||||||
valueSampledData | SampledData | |||||||
valueTime | time | |||||||
valueDateTime | dateTime | |||||||
valuePeriod | Period | |||||||
dataAbsentReason | C | 0..1 | CodeableConcept | Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. | ||||
interpretation | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | |||||
note | 0..* | Annotation | Comments about the observation | |||||
bodySite | S | 0..1 | CodeableConcept | Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality. | ||||
method | 0..1 | CodeableConcept | How it was done Binding: ObservationMethods (example): Methods for simple observations. | |||||
specimen | 0..1 | Reference(Specimen) | Specimen used for this observation | |||||
device | 0..1 | Reference(Device | DeviceMetric) | (Measurement) Device | |||||
referenceRange | C | 0..* | BackboneElement | Provides guide for interpretation | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
low | C | 0..1 | SimpleQuantity | Low Range, if relevant | ||||
high | C | 0..1 | SimpleQuantity | High Range, if relevant | ||||
type | 0..1 | CodeableConcept | Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range. | |||||
appliesTo | 0..* | CodeableConcept | Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to. | |||||
age | 0..1 | Range | Applicable age range, if relevant | |||||
text | 0..1 | string | Text based reference range in an observation | |||||
hasMember | Σ | 0..* | Reference(Observation | QuestionnaireResponse | MolecularSequence) | Related resource that belongs to the Observation group | ||||
derivedFrom | Σ | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Related measurements the observation is made from | ||||
component | SΣ | 0..* | BackboneElement | Component results | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
code | SΣ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations | ||||
value[x] | SΣ | 0..1 | Actual component result | |||||
valueQuantity | Quantity | |||||||
valueCodeableConcept | CodeableConcept | |||||||
valueString | string | |||||||
valueBoolean | boolean | |||||||
valueInteger | integer | |||||||
valueRange | Range | |||||||
valueRatio | Ratio | |||||||
valueSampledData | SampledData | |||||||
valueTime | time | |||||||
valueDateTime | dateTime | |||||||
valuePeriod | Period | |||||||
dataAbsentReason | C | 0..1 | CodeableConcept | Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. | ||||
interpretation | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | |||||
referenceRange | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result | |||||
Documentation for this format |
Path | Conformance | ValueSet | ||||
Observation.language | preferred | CommonLanguages
| ||||
Observation.status | required | ObservationStatus | ||||
Observation.category | extensible | USCoreClinicalResultObservationCategory | ||||
Observation.code | extensible | LOINCCodes (a valid code from LOINC) | ||||
Observation.subject.type | extensible | ResourceType | ||||
Observation.encounter.type | extensible | ResourceType | ||||
Observation.dataAbsentReason | extensible | DataAbsentReason | ||||
Observation.interpretation | extensible | ObservationInterpretationCodes | ||||
Observation.bodySite | example | SNOMEDCTBodyStructures | ||||
Observation.method | example | ObservationMethods | ||||
Observation.referenceRange.type | preferred | ObservationReferenceRangeMeaningCodes | ||||
Observation.referenceRange.appliesTo | example | ObservationReferenceRangeAppliesToCodes | ||||
Observation.component.code | extensible | LOINCCodes (a valid code from LOINC) | ||||
Observation.component.dataAbsentReason | extensible | DataAbsentReason | ||||
Observation.component.interpretation | extensible | ObservationInterpretationCodes |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | Observation | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | Observation | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
obs-3 | error | Observation.referenceRange | Must have at least a low or a high or text : low.exists() or high.exists() or text.exists() | |
obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty() | |
obs-7 | error | Observation | If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty() |
This structure is derived from Observation
Summary
Mandatory: 4 elements (1 nested mandatory element)
Must-Support: 14 elements
Prohibited: 4 elements
Structures
This structure refers to these other structures:
Maturity: 2
Differential View
This structure is derived from Observation
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Observation | 0..* | Observation | De-Identified UDS Plus Clinical Result Observation | |
id | S | 0..1 | id | The de-identified Observation identifier created by the health center to send data to UDS+ Data Receiver |
text | 0..0 | |||
contained | 0..0 | |||
status | S | 1..1 | code | registered | preliminary | final | amended + |
category | S | 1..* | CodeableConcept | Classification of type of observation Binding: US Core Clinical Result Observation Category (extensible): The set of codes indicating the category of the observation |
code | S | 1..1 | CodeableConcept | Type of observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations |
subject | S | 1..1 | Reference(De-Identified UDS Plus Patient) | Who and/or what the observation is about |
display | 0..0 | |||
encounter | S | 0..1 | Reference(De-Identified UDS Plus Encounter) | Healthcare event during which this observation is made |
display | 0..0 | |||
effective[x] | S | 0..1 | dateTime, Period, Timing, instant | Clinically relevant time/time-period for observation |
issued | S | 0..1 | instant | Date/Time this version was made available |
performer | S | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | Who is responsible for the observation |
value[x] | S | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Actual result |
bodySite | S | 0..1 | CodeableConcept | Observed body part |
component | S | 0..* | BackboneElement | Component results |
code | S | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations |
value[x] | S | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Actual component result |
Documentation for this format |
Path | Conformance | ValueSet |
Observation.category | extensible | USCoreClinicalResultObservationCategory |
Observation.code | extensible | LOINCCodes (a valid code from LOINC) |
Observation.component.code | extensible | LOINCCodes (a valid code from LOINC) |
Key Elements View
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Observation | C | 0..* | Observation | De-Identified UDS Plus Clinical Result Observation |
id | SΣ | 0..1 | id | The de-identified Observation identifier created by the health center to send data to UDS+ Data Receiver |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
status | ?!SΣ | 1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. |
category | S | 1..* | CodeableConcept | Classification of type of observation Binding: US Core Clinical Result Observation Category (extensible): The set of codes indicating the category of the observation |
code | SΣ | 1..1 | CodeableConcept | Type of observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations |
subject | SΣ | 1..1 | Reference(De-Identified UDS Plus Patient) | Who and/or what the observation is about |
encounter | SΣ | 0..1 | Reference(De-Identified UDS Plus Encounter) | Healthcare event during which this observation is made |
effective[x] | SΣ | 0..1 | Clinically relevant time/time-period for observation | |
effectiveDateTime | dateTime | |||
effectivePeriod | Period | |||
effectiveTiming | Timing | |||
effectiveInstant | instant | |||
issued | SΣ | 0..1 | instant | Date/Time this version was made available |
performer | SΣ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | Who is responsible for the observation |
value[x] | SΣC | 0..1 | Actual result | |
valueQuantity | Quantity | |||
valueCodeableConcept | CodeableConcept | |||
valueString | string | |||
valueBoolean | boolean | |||
valueInteger | integer | |||
valueRange | Range | |||
valueRatio | Ratio | |||
valueSampledData | SampledData | |||
valueTime | time | |||
valueDateTime | dateTime | |||
valuePeriod | Period | |||
bodySite | S | 0..1 | CodeableConcept | Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality. |
component | SΣ | 0..* | BackboneElement | Component results |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
code | SΣ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations |
value[x] | SΣ | 0..1 | Actual component result | |
valueQuantity | Quantity | |||
valueCodeableConcept | CodeableConcept | |||
valueString | string | |||
valueBoolean | boolean | |||
valueInteger | integer | |||
valueRange | Range | |||
valueRatio | Ratio | |||
valueSampledData | SampledData | |||
valueTime | time | |||
valueDateTime | dateTime | |||
valuePeriod | Period | |||
Documentation for this format |
Path | Conformance | ValueSet |
Observation.status | required | ObservationStatus |
Observation.category | extensible | USCoreClinicalResultObservationCategory |
Observation.code | extensible | LOINCCodes (a valid code from LOINC) |
Observation.bodySite | example | SNOMEDCTBodyStructures |
Observation.component.code | extensible | LOINCCodes (a valid code from LOINC) |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | Observation | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | Observation | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty() | |
obs-7 | error | Observation | If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty() |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
Observation | C | 0..* | Observation | De-Identified UDS Plus Clinical Result Observation | ||||
id | SΣ | 0..1 | id | The de-identified Observation identifier created by the health center to send data to UDS+ Data Receiver | ||||
meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
identifier | Σ | 0..* | Identifier | Business Identifier for observation | ||||
basedOn | Σ | 0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order | ||||
partOf | Σ | 0..* | Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) | Part of referenced event | ||||
status | ?!SΣ | 1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. | ||||
category | S | 1..* | CodeableConcept | Classification of type of observation Binding: US Core Clinical Result Observation Category (extensible): The set of codes indicating the category of the observation | ||||
code | SΣ | 1..1 | CodeableConcept | Type of observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations | ||||
subject | SΣ | 1..1 | Reference(De-Identified UDS Plus Patient) | Who and/or what the observation is about | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
reference | ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
type | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). | ||||
identifier | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
focus | Σ | 0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record | ||||
encounter | SΣ | 0..1 | Reference(De-Identified UDS Plus Encounter) | Healthcare event during which this observation is made | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
reference | ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
type | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). | ||||
identifier | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
effective[x] | SΣ | 0..1 | Clinically relevant time/time-period for observation | |||||
effectiveDateTime | dateTime | |||||||
effectivePeriod | Period | |||||||
effectiveTiming | Timing | |||||||
effectiveInstant | instant | |||||||
issued | SΣ | 0..1 | instant | Date/Time this version was made available | ||||
performer | SΣ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | Who is responsible for the observation | ||||
value[x] | SΣC | 0..1 | Actual result | |||||
valueQuantity | Quantity | |||||||
valueCodeableConcept | CodeableConcept | |||||||
valueString | string | |||||||
valueBoolean | boolean | |||||||
valueInteger | integer | |||||||
valueRange | Range | |||||||
valueRatio | Ratio | |||||||
valueSampledData | SampledData | |||||||
valueTime | time | |||||||
valueDateTime | dateTime | |||||||
valuePeriod | Period | |||||||
dataAbsentReason | C | 0..1 | CodeableConcept | Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. | ||||
interpretation | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | |||||
note | 0..* | Annotation | Comments about the observation | |||||
bodySite | S | 0..1 | CodeableConcept | Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality. | ||||
method | 0..1 | CodeableConcept | How it was done Binding: ObservationMethods (example): Methods for simple observations. | |||||
specimen | 0..1 | Reference(Specimen) | Specimen used for this observation | |||||
device | 0..1 | Reference(Device | DeviceMetric) | (Measurement) Device | |||||
referenceRange | C | 0..* | BackboneElement | Provides guide for interpretation | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
low | C | 0..1 | SimpleQuantity | Low Range, if relevant | ||||
high | C | 0..1 | SimpleQuantity | High Range, if relevant | ||||
type | 0..1 | CodeableConcept | Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range. | |||||
appliesTo | 0..* | CodeableConcept | Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to. | |||||
age | 0..1 | Range | Applicable age range, if relevant | |||||
text | 0..1 | string | Text based reference range in an observation | |||||
hasMember | Σ | 0..* | Reference(Observation | QuestionnaireResponse | MolecularSequence) | Related resource that belongs to the Observation group | ||||
derivedFrom | Σ | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Related measurements the observation is made from | ||||
component | SΣ | 0..* | BackboneElement | Component results | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
code | SΣ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (extensible): The set of codes indicating the Observations | ||||
value[x] | SΣ | 0..1 | Actual component result | |||||
valueQuantity | Quantity | |||||||
valueCodeableConcept | CodeableConcept | |||||||
valueString | string | |||||||
valueBoolean | boolean | |||||||
valueInteger | integer | |||||||
valueRange | Range | |||||||
valueRatio | Ratio | |||||||
valueSampledData | SampledData | |||||||
valueTime | time | |||||||
valueDateTime | dateTime | |||||||
valuePeriod | Period | |||||||
dataAbsentReason | C | 0..1 | CodeableConcept | Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. | ||||
interpretation | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | |||||
referenceRange | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result | |||||
Documentation for this format |
Path | Conformance | ValueSet | ||||
Observation.language | preferred | CommonLanguages
| ||||
Observation.status | required | ObservationStatus | ||||
Observation.category | extensible | USCoreClinicalResultObservationCategory | ||||
Observation.code | extensible | LOINCCodes (a valid code from LOINC) | ||||
Observation.subject.type | extensible | ResourceType | ||||
Observation.encounter.type | extensible | ResourceType | ||||
Observation.dataAbsentReason | extensible | DataAbsentReason | ||||
Observation.interpretation | extensible | ObservationInterpretationCodes | ||||
Observation.bodySite | example | SNOMEDCTBodyStructures | ||||
Observation.method | example | ObservationMethods | ||||
Observation.referenceRange.type | preferred | ObservationReferenceRangeMeaningCodes | ||||
Observation.referenceRange.appliesTo | example | ObservationReferenceRangeAppliesToCodes | ||||
Observation.component.code | extensible | LOINCCodes (a valid code from LOINC) | ||||
Observation.component.dataAbsentReason | extensible | DataAbsentReason | ||||
Observation.component.interpretation | extensible | ObservationInterpretationCodes |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | Observation | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | Observation | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
obs-3 | error | Observation.referenceRange | Must have at least a low or a high or text : low.exists() or high.exists() or text.exists() | |
obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty() | |
obs-7 | error | Observation | If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty() |
This structure is derived from Observation
Summary
Mandatory: 4 elements (1 nested mandatory element)
Must-Support: 14 elements
Prohibited: 4 elements
Structures
This structure refers to these other structures:
Maturity: 2
Other representations of profile: CSV, Excel, Schematron