HRSA 2023 Uniform Data System (UDS) Patient Level Submission (PLS) (UDS+) FHIR IG
1.0.2 - STU1 Release 1 - Standard for Trial-Use International flag

HRSA 2023 Uniform Data System (UDS) Patient Level Submission (PLS) (UDS+) FHIR IG, published by HRSA BPHC. This guide is not an authorized publication; it is the continuous build for version 1.0.2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/drajer-health/uds-plus/ and changes regularly. See the Directory of published versions

Resource Profile: De-Identified UDS Plus Lab Observation

Official URL: http://fhir.org/guides/hrsa/uds-plus/StructureDefinition/uds-plus-lab-observation Version: 1.0.2
Standards status: Trial-use Maturity Level: 2 Computable Name: UDSPlusLabObservation

The UDS+ profile is based on the Observation resource and establishes the core elements, extensions, vocabularies and value sets for representing lab observations for UDS+ program.

Introduction

This profile is used to represent de-identified Observation for Lab 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 Lab Result resource text element may contain information such as the Observation for Lab 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 Lab Result resource id should not be included in the De-identified Observation for Lab 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 Lab 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

  • subject
  • encounter

Date Truncation

The Data Submitter has to truncate the following dates to only have a precision of year

  • effective[x]

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from UDSPlusClinicalResultObservation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 0..* UDSPlusClinicalResultObservation De-Identified UDS Plus Lab Observation
... code S 1..1 CodeableConcept Type of observation (code / type)
Binding: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test

... component
.... code S 1..1 CodeableConcept Type of component observation (code / type)
Binding: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test


doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Observation.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
Observation.component.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* UDSPlusClinicalResultObservation De-Identified UDS Plus Lab Observation
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
... 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
... Slices for extension Content/Rules for all slices
.... deidentifiedIssuedTime 0..1 dateTime Indicates the time with a precision of only Year.
URL: http://fhir.org/guides/hrsa/uds-plus/StructureDefinition/uds-plus-deidentified-instant-extension
... 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: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test

... 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] SΣC 0..1 Clinically relevant time/time-period for observation
uds-plus-res-1: All dateTime data elements should be truncated to a year only for de-identified resources.
uds-plus-res-2: All Period.start data elements should be truncated to a year only for de-identified resources.
uds-plus-res-3: All Period.emd data elements should be truncated to a year only for de-identified resources.
uds-plus-res-4: All Timing.event data elements should be truncated to a year only for de-identified resources.
uds-plus-res-5: All Timing.event data elements should be truncated to a year only for de-identified resources.
.... effectiveDateTime dateTime
... performer SΣ 0..* Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Who is responsible for the observation
... value[x] SΣC 0..1 Actual result
uds-plus-res-6: All dateTime data elements should be truncated to a year only for de-identified resources.
uds-plus-res-7: All Period.start data elements should be truncated to a year only for de-identified resources.
uds-plus-res-8: All Period.end data elements should be truncated to a year only for de-identified resources.
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
... 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: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test

.... value[x] SΣC 0..1 Actual component result
uds-plus-res-9: All dateTime data elements should be truncated to a year only for de-identified resources.
uds-plus-res-10: All Period.start data elements should be truncated to a year only for de-identified resources.
uds-plus-res-11: All Period.end data elements should be truncated to a year only for de-identified resources.
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Observation.statusrequiredObservationStatus
http://hl7.org/fhir/ValueSet/observation-status|4.0.1
from the FHIR Standard
Observation.categoryextensibleUSCoreClinicalResultObservationCategory
http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
Observation.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
Observation.bodySiteexampleSNOMEDCTBodyStructures
http://hl7.org/fhir/ValueSet/body-site
from the FHIR Standard
Observation.component.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf 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-4errorObservationIf 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-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf 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()
uds-plus-res-1errorObservation.effective[x]All dateTime data elements should be truncated to a year only for de-identified resources.
: $this is DateTime implies $this.toString().length() = 4
uds-plus-res-2errorObservation.effective[x]All Period.start data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-3errorObservation.effective[x]All Period.emd data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.end.exists() implies $this.end.toString().length() = 4
uds-plus-res-4errorObservation.effective[x]All Timing.event data elements should be truncated to a year only for de-identified resources.
: $this is Timing and Timing.event.exists() implies $this.event.count() = 1
uds-plus-res-5errorObservation.effective[x]All Timing.event data elements should be truncated to a year only for de-identified resources.
: $this is Timing and Timing.event.exists() implies $this.event.first().toString().length() = 4
uds-plus-res-6errorObservation.value[x]All dateTime data elements should be truncated to a year only for de-identified resources.
: $this is dateTime implies $this.toString().length() = 4
uds-plus-res-7errorObservation.value[x]All Period.start data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-8errorObservation.value[x]All Period.end data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.end.exists() implies $this.end.toString().length() = 4
uds-plus-res-9errorObservation.component.value[x]All dateTime data elements should be truncated to a year only for de-identified resources.
: $this is dateTime implies $this.toString().length() = 4
uds-plus-res-10errorObservation.component.value[x]All Period.start data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-11errorObservation.component.value[x]All Period.end data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.end.exists() implies $this.end.toString().length() = 4
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* UDSPlusClinicalResultObservation De-Identified UDS Plus Lab Observation
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
... 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.

Additional BindingsPurpose
AllLanguages Max Binding
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... deidentifiedIssuedTime 0..1 dateTime Indicates the time with a precision of only Year.
URL: http://fhir.org/guides/hrsa/uds-plus/StructureDefinition/uds-plus-deidentified-instant-extension
... 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: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test

... 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] SΣC 0..1 Clinically relevant time/time-period for observation
uds-plus-res-1: All dateTime data elements should be truncated to a year only for de-identified resources.
uds-plus-res-2: All Period.start data elements should be truncated to a year only for de-identified resources.
uds-plus-res-3: All Period.emd data elements should be truncated to a year only for de-identified resources.
uds-plus-res-4: All Timing.event data elements should be truncated to a year only for de-identified resources.
uds-plus-res-5: All Timing.event data elements should be truncated to a year only for de-identified resources.
.... effectiveDateTime dateTime S
.... effectivePeriod Period
.... effectiveTiming Timing
... performer SΣ 0..* Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Who is responsible for the observation
.... 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
... value[x] SΣC 0..1 Actual result
uds-plus-res-6: All dateTime data elements should be truncated to a year only for de-identified resources.
uds-plus-res-7: All Period.start data elements should be truncated to a year only for de-identified resources.
uds-plus-res-8: All Period.end data elements should be truncated to a year only for de-identified resources.
.... valueQuantity Quantity S
.... valueCodeableConcept CodeableConcept S
.... valueString string S
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... 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.


... 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
obs-3: Must have at least a low or a high or text
.... 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: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test

.... value[x] SΣC 0..1 Actual component result
uds-plus-res-9: All dateTime data elements should be truncated to a year only for de-identified resources.
uds-plus-res-10: All Period.start data elements should be truncated to a year only for de-identified resources.
uds-plus-res-11: All Period.end data elements should be truncated to a year only for de-identified resources.
..... valueQuantity Quantity S
..... valueCodeableConcept CodeableConcept S
..... valueString string S
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueRatio Ratio
..... valueSampledData SampledData
..... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Observation.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
Observation.statusrequiredObservationStatus
http://hl7.org/fhir/ValueSet/observation-status|4.0.1
from the FHIR Standard
Observation.categoryextensibleUSCoreClinicalResultObservationCategory
http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
Observation.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
Observation.subject.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
Observation.encounter.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
Observation.performer.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
Observation.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard
Observation.bodySiteexampleSNOMEDCTBodyStructures
http://hl7.org/fhir/ValueSet/body-site
from the FHIR Standard
Observation.methodexampleObservationMethods
http://hl7.org/fhir/ValueSet/observation-methods
from the FHIR Standard
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
http://hl7.org/fhir/ValueSet/referencerange-meaning
from the FHIR Standard
Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
http://hl7.org/fhir/ValueSet/referencerange-appliesto
from the FHIR Standard
Observation.component.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
Observation.component.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.component.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf 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-4errorObservationIf 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-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf 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()
uds-plus-res-1errorObservation.effective[x]All dateTime data elements should be truncated to a year only for de-identified resources.
: $this is DateTime implies $this.toString().length() = 4
uds-plus-res-2errorObservation.effective[x]All Period.start data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-3errorObservation.effective[x]All Period.emd data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.end.exists() implies $this.end.toString().length() = 4
uds-plus-res-4errorObservation.effective[x]All Timing.event data elements should be truncated to a year only for de-identified resources.
: $this is Timing and Timing.event.exists() implies $this.event.count() = 1
uds-plus-res-5errorObservation.effective[x]All Timing.event data elements should be truncated to a year only for de-identified resources.
: $this is Timing and Timing.event.exists() implies $this.event.first().toString().length() = 4
uds-plus-res-6errorObservation.value[x]All dateTime data elements should be truncated to a year only for de-identified resources.
: $this is dateTime implies $this.toString().length() = 4
uds-plus-res-7errorObservation.value[x]All Period.start data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-8errorObservation.value[x]All Period.end data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.end.exists() implies $this.end.toString().length() = 4
uds-plus-res-9errorObservation.component.value[x]All dateTime data elements should be truncated to a year only for de-identified resources.
: $this is dateTime implies $this.toString().length() = 4
uds-plus-res-10errorObservation.component.value[x]All Period.start data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-11errorObservation.component.value[x]All Period.end data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.end.exists() implies $this.end.toString().length() = 4

This structure is derived from UDSPlusClinicalResultObservation

Summary

Mandatory: 1 element(1 nested mandatory element)
Must-Support: 2 elements

Maturity: 2

Differential View

This structure is derived from UDSPlusClinicalResultObservation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 0..* UDSPlusClinicalResultObservation De-Identified UDS Plus Lab Observation
... code S 1..1 CodeableConcept Type of observation (code / type)
Binding: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test

... component
.... code S 1..1 CodeableConcept Type of component observation (code / type)
Binding: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test


doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Observation.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
Observation.component.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* UDSPlusClinicalResultObservation De-Identified UDS Plus Lab Observation
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
... 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
... Slices for extension Content/Rules for all slices
.... deidentifiedIssuedTime 0..1 dateTime Indicates the time with a precision of only Year.
URL: http://fhir.org/guides/hrsa/uds-plus/StructureDefinition/uds-plus-deidentified-instant-extension
... 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: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test

... 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] SΣC 0..1 Clinically relevant time/time-period for observation
uds-plus-res-1: All dateTime data elements should be truncated to a year only for de-identified resources.
uds-plus-res-2: All Period.start data elements should be truncated to a year only for de-identified resources.
uds-plus-res-3: All Period.emd data elements should be truncated to a year only for de-identified resources.
uds-plus-res-4: All Timing.event data elements should be truncated to a year only for de-identified resources.
uds-plus-res-5: All Timing.event data elements should be truncated to a year only for de-identified resources.
.... effectiveDateTime dateTime
... performer SΣ 0..* Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Who is responsible for the observation
... value[x] SΣC 0..1 Actual result
uds-plus-res-6: All dateTime data elements should be truncated to a year only for de-identified resources.
uds-plus-res-7: All Period.start data elements should be truncated to a year only for de-identified resources.
uds-plus-res-8: All Period.end data elements should be truncated to a year only for de-identified resources.
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
... 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: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test

.... value[x] SΣC 0..1 Actual component result
uds-plus-res-9: All dateTime data elements should be truncated to a year only for de-identified resources.
uds-plus-res-10: All Period.start data elements should be truncated to a year only for de-identified resources.
uds-plus-res-11: All Period.end data elements should be truncated to a year only for de-identified resources.
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Observation.statusrequiredObservationStatus
http://hl7.org/fhir/ValueSet/observation-status|4.0.1
from the FHIR Standard
Observation.categoryextensibleUSCoreClinicalResultObservationCategory
http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
Observation.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
Observation.bodySiteexampleSNOMEDCTBodyStructures
http://hl7.org/fhir/ValueSet/body-site
from the FHIR Standard
Observation.component.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf 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-4errorObservationIf 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-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf 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()
uds-plus-res-1errorObservation.effective[x]All dateTime data elements should be truncated to a year only for de-identified resources.
: $this is DateTime implies $this.toString().length() = 4
uds-plus-res-2errorObservation.effective[x]All Period.start data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-3errorObservation.effective[x]All Period.emd data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.end.exists() implies $this.end.toString().length() = 4
uds-plus-res-4errorObservation.effective[x]All Timing.event data elements should be truncated to a year only for de-identified resources.
: $this is Timing and Timing.event.exists() implies $this.event.count() = 1
uds-plus-res-5errorObservation.effective[x]All Timing.event data elements should be truncated to a year only for de-identified resources.
: $this is Timing and Timing.event.exists() implies $this.event.first().toString().length() = 4
uds-plus-res-6errorObservation.value[x]All dateTime data elements should be truncated to a year only for de-identified resources.
: $this is dateTime implies $this.toString().length() = 4
uds-plus-res-7errorObservation.value[x]All Period.start data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-8errorObservation.value[x]All Period.end data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.end.exists() implies $this.end.toString().length() = 4
uds-plus-res-9errorObservation.component.value[x]All dateTime data elements should be truncated to a year only for de-identified resources.
: $this is dateTime implies $this.toString().length() = 4
uds-plus-res-10errorObservation.component.value[x]All Period.start data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-11errorObservation.component.value[x]All Period.end data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.end.exists() implies $this.end.toString().length() = 4

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* UDSPlusClinicalResultObservation De-Identified UDS Plus Lab Observation
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
... 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.

Additional BindingsPurpose
AllLanguages Max Binding
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... deidentifiedIssuedTime 0..1 dateTime Indicates the time with a precision of only Year.
URL: http://fhir.org/guides/hrsa/uds-plus/StructureDefinition/uds-plus-deidentified-instant-extension
... 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: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test

... 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] SΣC 0..1 Clinically relevant time/time-period for observation
uds-plus-res-1: All dateTime data elements should be truncated to a year only for de-identified resources.
uds-plus-res-2: All Period.start data elements should be truncated to a year only for de-identified resources.
uds-plus-res-3: All Period.emd data elements should be truncated to a year only for de-identified resources.
uds-plus-res-4: All Timing.event data elements should be truncated to a year only for de-identified resources.
uds-plus-res-5: All Timing.event data elements should be truncated to a year only for de-identified resources.
.... effectiveDateTime dateTime S
.... effectivePeriod Period
.... effectiveTiming Timing
... performer SΣ 0..* Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Who is responsible for the observation
.... 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
... value[x] SΣC 0..1 Actual result
uds-plus-res-6: All dateTime data elements should be truncated to a year only for de-identified resources.
uds-plus-res-7: All Period.start data elements should be truncated to a year only for de-identified resources.
uds-plus-res-8: All Period.end data elements should be truncated to a year only for de-identified resources.
.... valueQuantity Quantity S
.... valueCodeableConcept CodeableConcept S
.... valueString string S
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... 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.


... 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
obs-3: Must have at least a low or a high or text
.... 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: US Core Laboratory Test Codes (extensible): The set of codes identifying the lab test

.... value[x] SΣC 0..1 Actual component result
uds-plus-res-9: All dateTime data elements should be truncated to a year only for de-identified resources.
uds-plus-res-10: All Period.start data elements should be truncated to a year only for de-identified resources.
uds-plus-res-11: All Period.end data elements should be truncated to a year only for de-identified resources.
..... valueQuantity Quantity S
..... valueCodeableConcept CodeableConcept S
..... valueString string S
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueRatio Ratio
..... valueSampledData SampledData
..... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Observation.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
Observation.statusrequiredObservationStatus
http://hl7.org/fhir/ValueSet/observation-status|4.0.1
from the FHIR Standard
Observation.categoryextensibleUSCoreClinicalResultObservationCategory
http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
Observation.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
Observation.subject.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
Observation.encounter.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
Observation.performer.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
Observation.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard
Observation.bodySiteexampleSNOMEDCTBodyStructures
http://hl7.org/fhir/ValueSet/body-site
from the FHIR Standard
Observation.methodexampleObservationMethods
http://hl7.org/fhir/ValueSet/observation-methods
from the FHIR Standard
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
http://hl7.org/fhir/ValueSet/referencerange-meaning
from the FHIR Standard
Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
http://hl7.org/fhir/ValueSet/referencerange-appliesto
from the FHIR Standard
Observation.component.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
Observation.component.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.component.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf 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-4errorObservationIf 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-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf 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()
uds-plus-res-1errorObservation.effective[x]All dateTime data elements should be truncated to a year only for de-identified resources.
: $this is DateTime implies $this.toString().length() = 4
uds-plus-res-2errorObservation.effective[x]All Period.start data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-3errorObservation.effective[x]All Period.emd data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.end.exists() implies $this.end.toString().length() = 4
uds-plus-res-4errorObservation.effective[x]All Timing.event data elements should be truncated to a year only for de-identified resources.
: $this is Timing and Timing.event.exists() implies $this.event.count() = 1
uds-plus-res-5errorObservation.effective[x]All Timing.event data elements should be truncated to a year only for de-identified resources.
: $this is Timing and Timing.event.exists() implies $this.event.first().toString().length() = 4
uds-plus-res-6errorObservation.value[x]All dateTime data elements should be truncated to a year only for de-identified resources.
: $this is dateTime implies $this.toString().length() = 4
uds-plus-res-7errorObservation.value[x]All Period.start data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-8errorObservation.value[x]All Period.end data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.end.exists() implies $this.end.toString().length() = 4
uds-plus-res-9errorObservation.component.value[x]All dateTime data elements should be truncated to a year only for de-identified resources.
: $this is dateTime implies $this.toString().length() = 4
uds-plus-res-10errorObservation.component.value[x]All Period.start data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.start.exists() implies $this.start.toString().length() = 4
uds-plus-res-11errorObservation.component.value[x]All Period.end data elements should be truncated to a year only for de-identified resources.
: $this is Period and Period.end.exists() implies $this.end.toString().length() = 4

This structure is derived from UDSPlusClinicalResultObservation

Summary

Mandatory: 1 element(1 nested mandatory element)
Must-Support: 2 elements

Maturity: 2

 

Other representations of profile: CSV, Excel, Schematron