HRSA 2024 Uniform Data System (UDS) Patient Level Submission (PLS) (UDS+) FHIR IG
2.0.0 - STU2 Release 1 - Standard for Trial-Use
HRSA 2024 Uniform Data System (UDS) Patient Level Submission (PLS) (UDS+) FHIR IG
2.0.0 - STU2 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 (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
| 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.
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
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.
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  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 | |
 modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored 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 | |||
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Observation.status | required | ObservationStatushttp://hl7.org/fhir/ValueSet/observation-status|4.0.1from the FHIR Standard | |
| Observation.category | extensible | USCoreClinicalResultObservationCategoryhttp://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category | |
| Observation.code | extensible | USCoreLaboratoryTestCodeshttp://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes | |
| Observation.bodySite | example | SNOMEDCTBodyStructureshttp://hl7.org/fhir/ValueSet/body-sitefrom the FHIR Standard | |
| Observation.component.code | extensible | USCoreLaboratoryTestCodeshttp://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes |
| 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() | |
| uds-plus-res-1 | error | Observation.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-10 | error | Observation.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-10a | error | Observation.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-10b | error | Observation.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-11a | error | Observation.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-11b | error | Observation.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-2 | error | Observation.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-11 | error | Observation.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-1a | error | Observation.effective[x] | All dateTime data elements should have valid year > 1900 : $this is DateTime implies $this.toString() >= '1900' | |
| uds-plus-res-1b | error | Observation.effective[x] | All dateTime data elements should have valid year < 2030 : $this is DateTime implies $this.toString() <= '2030' | |
| uds-plus-res-2a | error | Observation.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-2b | error | Observation.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-3 | error | Observation.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-3a | error | Observation.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-3b | error | Observation.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-4 | error | Observation.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-5 | error | Observation.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-5a | error | Observation.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-5b | error | Observation.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-6 | error | Observation.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-6a | error | Observation.value[x] | All dateTime data elements should have valid year > 1900 : $this is DateTime implies $this.toString() >= '1900' | |
| uds-plus-res-6b | error | Observation.value[x] | All dateTime data elements should have valid year < 2030 : $this is DateTime implies $this.toString() <= '2030' | |
| uds-plus-res-7 | error | Observation.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-7a | error | Observation.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-7b | error | Observation.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-8 | error | Observation.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-8a | error | Observation.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-8b | error | Observation.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-9 | error | Observation.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-9a | error | Observation.component.value[x] | All dateTime data elements should have valid year > 1900 : $this is DateTime implies $this.toString() >= '1900' | |
| uds-plus-res-9b | error | Observation.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
