HRSA 2023 Uniform Data System (UDS) Patient Level Submission (PLS) (UDS+) FHIR IG
1.0.1 - STU1 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 (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

Resource Profile: De-Identified UDS Plus AdverseEvent

Official URL: http://fhir.org/guides/hrsa/uds-plus/StructureDefinition/uds-plus-adverseevent Version: 1.0.1
Standards status: Trial-use Maturity Level: 2 Computable Name: UDSPlusAdverseEvent

The UDS+ profile is based on the AdverseEvent resource and establishes the core elements, extensions, vocabularies and value sets for representing Allergies and Intolerances for UDS+ program.

Introduction

This profile is used to represent de-identified AdverseEvent 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 AdverseEvent.recorded and date elements.

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 AdverseEvent resource text element may contain information such as the AdverseEvent dates, 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 AdverseEvent resource id should not be included in the De-identified AdverseEvent 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 AdverseEvent. All resource references to the AdverseEvent 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

Date Truncation

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

  • date
  • recordedDate

Usage:

Formal Views of Profile Content

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

This structure is derived from AdverseEvent

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventDe-Identified UDS Plus AdverseEvent
... id S0..1idThe de-identified AdverseEvent identifier created by the health center to send data to UDS+ Data Receiver
... text 0..0
... contained 0..0
... category S0..*CodeableConceptproduct-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
... event S1..1CodeableConceptType of the event itself in relation to the subject
... subject S1..1Reference(De-Identified UDS Plus Patient)Subject impacted by event
.... display 0..0
... date S0..1dateTimeWhen the event occurred
... recordedDate S0..1dateTimeWhen the event was recorded

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventDe-Identified UDS Plus AdverseEvent
... id SΣ0..1idThe de-identified AdverseEvent identifier created by the health center to send data to UDS+ Data Receiver
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... category SΣ0..*CodeableConceptproduct-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.


... event SΣ1..1CodeableConceptType of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.

... subject SΣ1..1Reference(De-Identified UDS Plus Patient)Subject impacted by event
... date SΣ0..1dateTimeWhen the event occurred
... recordedDate SΣ0..1dateTimeWhen the event was recorded

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
AdverseEvent.actualityrequiredAdverseEventActuality
AdverseEvent.categoryextensibleAdverseEventCategory
AdverseEvent.eventexampleSNOMEDCTClinicalFindings

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorAdverseEventIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorAdverseEventIf 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-4errorAdverseEventIf 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-5errorAdverseEventIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceAdverseEventA 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()
NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventDe-Identified UDS Plus AdverseEvent
... id SΣ0..1idThe de-identified AdverseEvent identifier created by the health center to send data to UDS+ Data Receiver
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..1IdentifierBusiness identifier for the event
... actuality ?!SΣ1..1codeactual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.

... category SΣ0..*CodeableConceptproduct-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.


... event SΣ1..1CodeableConceptType of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.

... subject SΣ1..1Reference(De-Identified UDS Plus Patient)Subject impacted by event
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... reference ΣC0..1stringLiteral reference, Relative, internal or absolute URL
.... type Σ0..1uriType the reference refers to (e.g. "Patient")
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier Σ0..1IdentifierLogical reference, when literal reference is not known
... encounter Σ0..1Reference(Encounter)Encounter created as part of
... date SΣ0..1dateTimeWhen the event occurred
... detected Σ0..1dateTimeWhen the event was detected
... recordedDate SΣ0..1dateTimeWhen the event was recorded
... resultingCondition Σ0..*Reference(Condition)Effect on the subject due to this event
... location Σ0..1Reference(Location)Location where adverse event occurred
... seriousness Σ0..1CodeableConceptSeriousness of the event
Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.

... severity Σ0..1CodeableConceptmild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome Σ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder Σ0..1Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)Who recorded the adverse event
... contributor Σ0..*Reference(Practitioner | PractitionerRole | Device)Who was involved in the adverse event or the potential adverse event
... suspectEntity Σ0..*BackboneElementThe suspected agent causing the adverse event
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... instance Σ1..1Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device)Refers to the specific entity that caused the adverse event
.... causality Σ0..*BackboneElementInformation on the possible cause of the event
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... assessment Σ0..1CodeableConceptAssessment of if the entity caused the event
Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.

..... productRelatedness Σ0..1stringAdverseEvent.suspectEntity.causalityProductRelatedness
..... author Σ0..1Reference(Practitioner | PractitionerRole)AdverseEvent.suspectEntity.causalityAuthor
..... method Σ0..1CodeableConceptProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.

... subjectMedicalHistory Σ0..*Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference)AdverseEvent.subjectMedicalHistory
... referenceDocument Σ0..*Reference(DocumentReference)AdverseEvent.referenceDocument
... study Σ0..*Reference(ResearchStudy)AdverseEvent.study

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
AdverseEvent.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
AdverseEvent.actualityrequiredAdverseEventActuality
AdverseEvent.categoryextensibleAdverseEventCategory
AdverseEvent.eventexampleSNOMEDCTClinicalFindings
AdverseEvent.subject.typeextensibleResourceType
AdverseEvent.seriousnessexampleAdverseEventSeriousness
AdverseEvent.severityrequiredAdverseEventSeverity
AdverseEvent.outcomerequiredAdverseEventOutcome
AdverseEvent.suspectEntity.causality.assessmentexampleAdverseEventCausalityAssessment
AdverseEvent.suspectEntity.causality.methodexampleAdverseEventCausalityMethod

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorAdverseEventIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorAdverseEventIf 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-4errorAdverseEventIf 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-5errorAdverseEventIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceAdverseEventA 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()

This structure is derived from AdverseEvent

Summary

Mandatory: 3 elements
Must-Support: 7 elements
Prohibited: 3 elements

Structures

This structure refers to these other structures:

Maturity: 2

Differential View

This structure is derived from AdverseEvent

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventDe-Identified UDS Plus AdverseEvent
... id S0..1idThe de-identified AdverseEvent identifier created by the health center to send data to UDS+ Data Receiver
... text 0..0
... contained 0..0
... category S0..*CodeableConceptproduct-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
... event S1..1CodeableConceptType of the event itself in relation to the subject
... subject S1..1Reference(De-Identified UDS Plus Patient)Subject impacted by event
.... display 0..0
... date S0..1dateTimeWhen the event occurred
... recordedDate S0..1dateTimeWhen the event was recorded

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventDe-Identified UDS Plus AdverseEvent
... id SΣ0..1idThe de-identified AdverseEvent identifier created by the health center to send data to UDS+ Data Receiver
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... category SΣ0..*CodeableConceptproduct-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.


... event SΣ1..1CodeableConceptType of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.

... subject SΣ1..1Reference(De-Identified UDS Plus Patient)Subject impacted by event
... date SΣ0..1dateTimeWhen the event occurred
... recordedDate SΣ0..1dateTimeWhen the event was recorded

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
AdverseEvent.actualityrequiredAdverseEventActuality
AdverseEvent.categoryextensibleAdverseEventCategory
AdverseEvent.eventexampleSNOMEDCTClinicalFindings

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorAdverseEventIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorAdverseEventIf 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-4errorAdverseEventIf 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-5errorAdverseEventIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceAdverseEventA 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()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventDe-Identified UDS Plus AdverseEvent
... id SΣ0..1idThe de-identified AdverseEvent identifier created by the health center to send data to UDS+ Data Receiver
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..1IdentifierBusiness identifier for the event
... actuality ?!SΣ1..1codeactual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.

... category SΣ0..*CodeableConceptproduct-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.


... event SΣ1..1CodeableConceptType of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.

... subject SΣ1..1Reference(De-Identified UDS Plus Patient)Subject impacted by event
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... reference ΣC0..1stringLiteral reference, Relative, internal or absolute URL
.... type Σ0..1uriType the reference refers to (e.g. "Patient")
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier Σ0..1IdentifierLogical reference, when literal reference is not known
... encounter Σ0..1Reference(Encounter)Encounter created as part of
... date SΣ0..1dateTimeWhen the event occurred
... detected Σ0..1dateTimeWhen the event was detected
... recordedDate SΣ0..1dateTimeWhen the event was recorded
... resultingCondition Σ0..*Reference(Condition)Effect on the subject due to this event
... location Σ0..1Reference(Location)Location where adverse event occurred
... seriousness Σ0..1CodeableConceptSeriousness of the event
Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.

... severity Σ0..1CodeableConceptmild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome Σ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder Σ0..1Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)Who recorded the adverse event
... contributor Σ0..*Reference(Practitioner | PractitionerRole | Device)Who was involved in the adverse event or the potential adverse event
... suspectEntity Σ0..*BackboneElementThe suspected agent causing the adverse event
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... instance Σ1..1Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device)Refers to the specific entity that caused the adverse event
.... causality Σ0..*BackboneElementInformation on the possible cause of the event
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... assessment Σ0..1CodeableConceptAssessment of if the entity caused the event
Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.

..... productRelatedness Σ0..1stringAdverseEvent.suspectEntity.causalityProductRelatedness
..... author Σ0..1Reference(Practitioner | PractitionerRole)AdverseEvent.suspectEntity.causalityAuthor
..... method Σ0..1CodeableConceptProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.

... subjectMedicalHistory Σ0..*Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference)AdverseEvent.subjectMedicalHistory
... referenceDocument Σ0..*Reference(DocumentReference)AdverseEvent.referenceDocument
... study Σ0..*Reference(ResearchStudy)AdverseEvent.study

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
AdverseEvent.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
AdverseEvent.actualityrequiredAdverseEventActuality
AdverseEvent.categoryextensibleAdverseEventCategory
AdverseEvent.eventexampleSNOMEDCTClinicalFindings
AdverseEvent.subject.typeextensibleResourceType
AdverseEvent.seriousnessexampleAdverseEventSeriousness
AdverseEvent.severityrequiredAdverseEventSeverity
AdverseEvent.outcomerequiredAdverseEventOutcome
AdverseEvent.suspectEntity.causality.assessmentexampleAdverseEventCausalityAssessment
AdverseEvent.suspectEntity.causality.methodexampleAdverseEventCausalityMethod

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorAdverseEventIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorAdverseEventIf 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-4errorAdverseEventIf 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-5errorAdverseEventIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceAdverseEventA 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()

This structure is derived from AdverseEvent

Summary

Mandatory: 3 elements
Must-Support: 7 elements
Prohibited: 3 elements

Structures

This structure refers to these other structures:

Maturity: 2

 

Other representations of profile: CSV, Excel, Schematron