HRSA 2024 Uniform Data System (UDS) Patient Level Submission (PLS) (UDS+) FHIR IG
2.0.0 - STU2 Release 1 - Standard for Trial-Use International flag

This page is part of the HRSA Uniform Data System (UDS) Patient Level Submission (PLS) (UDS+ or uds-plus) FHIR IG (v2.0.0: STU2) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, 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: 2.0.0
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.

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* UDSPlusClinicalResultObservation De-Identified UDS Plus Lab Observation
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
dom-3: 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
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
dom-6: A resource should have narrative for robust management
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
ele-1: All FHIR elements must have a @value or children
... Slices for extension Content/Rules for all slices
.... extension: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
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
... status ?!SΣ 1..1 code registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.


ele-1: All FHIR elements must have a @value or children
... 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


ele-1: All FHIR elements must have a @value or children
... 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


ele-1: All FHIR elements must have a @value or children
... subject SΣ 1..1 Reference(De-Identified UDS Plus Patient) Who and/or what the observation is about
ele-1: All FHIR elements must have a @value or children
... encounter SΣ 0..1 Reference(De-Identified UDS Plus Encounter) Healthcare event during which this observation is made
ele-1: All FHIR elements must have a @value or children
... effective[x] SΣC 0..1 Clinically relevant time/time-period for observation
ele-1: All FHIR elements must have a @value or children
uds-plus-res-1: All dateTime data elements should be truncated to a year only for de-identified resources.
uds-plus-res-1a: All dateTime data elements should have valid year > 1900
uds-plus-res-1b: All dateTime data elements should have valid year < 2030
uds-plus-res-2: All Period.start data elements should be truncated to a year only for de-identified resources.
uds-plus-res-2a: All Period.start data elements should have valid year > 1900
uds-plus-res-2b: All Period.start data elements should have valid year < 2030
uds-plus-res-3: All Period.end data elements should be truncated to a year only for de-identified resources.
uds-plus-res-3a: All Period.end data elements should have valid year > 1900
uds-plus-res-3b: All Period.end data elements should have valid year < 2030
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.
uds-plus-res-5a: All Timing data elements should have valid year > 1900
uds-plus-res-5b: All Timing data elements should have valid year < 2030
.... effectiveDateTime dateTime
... performer SΣ 0..* Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Who is responsible for the observation
ele-1: All FHIR elements must have a @value or children
... value[x] SΣC 0..1 Actual result
ele-1: All FHIR elements must have a @value or children
uds-plus-res-6: All dateTime data elements should be truncated to a year only for de-identified resources.
uds-plus-res-6a: All dateTime data elements should have valid year > 1900
uds-plus-res-6b: All dateTime data elements should have valid year < 2030
uds-plus-res-7: All Period.start data elements should be truncated to a year only for de-identified resources.
uds-plus-res-7a: All Period.start data elements should have valid year > 1900
uds-plus-res-7b: All Period.start data elements should have valid year < 2030
uds-plus-res-8: All Period.end data elements should be truncated to a year only for de-identified resources.
uds-plus-res-8a: All Period.end data elements should have valid year > 1900
uds-plus-res-8b: All Period.end data elements should have valid year < 2030
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
... bodySite S 0..1 CodeableConcept Observed body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.


ele-1: All FHIR elements must have a @value or children
... component SΣ 0..* BackboneElement Component results
ele-1: All FHIR elements must have a @value or children
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... 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


ele-1: All FHIR elements must have a @value or children
.... value[x] SΣC 0..1 Actual component result
ele-1: All FHIR elements must have a @value or children
uds-plus-res-9: All dateTime data elements should be truncated to a year only for de-identified resources.
uds-plus-res-9a: All dateTime data elements should have valid year > 1900
uds-plus-res-9b: All dateTime data elements should have valid year < 2030
uds-plus-res-10: All Period.start data elements should be truncated to a year only for de-identified resources.
uds-plus-res-10a: All Period.start data elements should have valid year > 1900
uds-plus-res-10b: All Period.start data elements should have valid year < 2030
uds-plus-res-11: All Period.end data elements should be truncated to a year only for de-identified resources.
uds-plus-res-11a: All Period.end data elements should have valid year > 1900
uds-plus-res-11b: All Period.end data elements should have valid year < 2030
..... 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-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-10aerrorObservation.component.value[x]All Period.start data elements should have valid year > 1900
: $this is Period and Period.start.exists() implies $this.start.toString() >= '1900'
uds-plus-res-10berrorObservation.component.value[x]All Period.start data elements should have valid year < 2030
: $this is Period and Period.start.exists() implies $this.start.toString() <= '2030'
uds-plus-res-11aerrorObservation.component.value[x]All Period.end data elements should have valid year > 1900
: $this is Period and Period.end.exists() implies $this.end.toString() >= '1900'
uds-plus-res-11berrorObservation.component.value[x]All Period.end data elements should have valid year < 2030
: $this is Period and Period.end.exists() implies $this.end.toString() <= '2030'
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-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
uds-plus-res-1aerrorObservation.effective[x]All dateTime data elements should have valid year > 1900
: $this is DateTime implies $this.toString() >= '1900'
uds-plus-res-1berrorObservation.effective[x]All dateTime data elements should have valid year < 2030
: $this is DateTime implies $this.toString() <= '2030'
uds-plus-res-2aerrorObservation.effective[x]All Period.start data elements should have valid year > 1900
: $this is Period and Period.start.exists() implies $this.start.toString() >= '1900'
uds-plus-res-2berrorObservation.effective[x]All Period.start data elements should have valid year < 2030
: $this is Period and Period.start.exists() implies $this.start.toString() <= '2030'
uds-plus-res-3errorObservation.effective[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-3aerrorObservation.effective[x]All Period.end data elements should have valid year > 1900
: $this is Period and Period.end.exists() implies $this.end.toString() >= '1900'
uds-plus-res-3berrorObservation.effective[x]All Period.end data elements should have valid year < 2030
: $this is Period and Period.end.exists() implies $this.end.toString() <= '2030'
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-5aerrorObservation.effective[x]All Timing data elements should have valid year > 1900
: $this is Timing and Timing.event.exists() implies $this.event.first().toString() >= '1900'
uds-plus-res-5berrorObservation.effective[x]All Timing data elements should have valid year < 2030
: $this is Timing and Timing.event.exists() implies $this.event.first().toString() <= '2030'
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-6aerrorObservation.value[x]All dateTime data elements should have valid year > 1900
: $this is DateTime implies $this.toString() >= '1900'
uds-plus-res-6berrorObservation.value[x]All dateTime data elements should have valid year < 2030
: $this is DateTime implies $this.toString() <= '2030'
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-7aerrorObservation.value[x]All Period.start data elements should have valid year > 1900
: $this is Period and Period.start.exists() implies $this.start.toString() >= '1900'
uds-plus-res-7berrorObservation.value[x]All Period.start data elements should have valid year < 2030
: $this is Period and Period.start.exists() implies $this.start.toString() <= '2030'
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-8aerrorObservation.value[x]All Period.end data elements should have valid year > 1900
: $this is Period and Period.end.exists() implies $this.end.toString() >= '1900'
uds-plus-res-8berrorObservation.value[x]All Period.end data elements should have valid year < 2030
: $this is Period and Period.end.exists() implies $this.end.toString() <= '2030'
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-9aerrorObservation.component.value[x]All dateTime data elements should have valid year > 1900
: $this is DateTime implies $this.toString() >= '1900'
uds-plus-res-9berrorObservation.component.value[x]All dateTime data elements should have valid year < 2030
: $this is DateTime implies $this.toString() <= '2030'

 

Other representations of profile: CSV, Excel, Schematron