HRSA 2023 Uniform Data System (UDS) Patient Level Submission (PLS) (UDS+) FHIR IG
1.1.0 - STU1 Release 1.1 - 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 (v1.1.0: 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: 1.1.0
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..* AdverseEvent De-Identified UDS Plus AdverseEvent
... id S 0..1 id The de-identified AdverseEvent identifier created by the health center to send data to UDS+ Data Receiver
... text 0..0
... contained 0..0
... category S 0..* CodeableConcept product-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 S 1..1 CodeableConcept Type of the event itself in relation to the subject
... subject S 1..1 Reference(De-Identified UDS Plus Patient) Subject impacted by event
.... display 0..0
... encounter
.... display 0..0
... date SC 0..1 dateTime When the event occurred
uds-plus-advevent-1: All dateTime data elements should be truncated to a year only for de-identified resources.
... detected C 0..1 dateTime When the event was detected
uds-plus-advevent-2: All dateTime data elements should be truncated to a year only for de-identified resources.
... recordedDate SC 0..1 dateTime When the event was recorded
uds-plus-advevent-3: All dateTime data elements should be truncated to a year only for de-identified resources.
... recorder
.... display 0..0

doco Documentation for this format

Constraints

IdGradePath(s)DetailsRequirements
uds-plus-advevent-1errorAdverseEvent.dateAll dateTime data elements should be truncated to a year only for de-identified resources.
: $this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-2errorAdverseEvent.detectedAll dateTime data elements should be truncated to a year only for de-identified resources.
: $this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-3errorAdverseEvent.recordedDateAll dateTime data elements should be truncated to a year only for de-identified resources.
: $this is DateTime implies $this.toString().length() = 4
NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent De-Identified UDS Plus AdverseEvent
... id SΣ 0..1 id The de-identified AdverseEvent identifier created by the health center to send data to UDS+ Data Receiver
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... category SΣ 0..* CodeableConcept product-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 SΣ 1..1 CodeableConcept Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.

... subject SΣ 1..1 Reference(De-Identified UDS Plus Patient) Subject impacted by event
... date SΣC 0..1 dateTime When the event occurred
uds-plus-advevent-1: All dateTime data elements should be truncated to a year only for de-identified resources.
... detected ΣC 0..1 dateTime When the event was detected
uds-plus-advevent-2: All dateTime data elements should be truncated to a year only for de-identified resources.
... recordedDate SΣC 0..1 dateTime When the event was recorded
uds-plus-advevent-3: All dateTime data elements should be truncated to a year only for de-identified resources.

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
AdverseEvent.actualityrequiredAdverseEventActuality
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.categoryextensibleAdverseEventCategory
http://hl7.org/fhir/ValueSet/adverse-event-category
from the FHIR Standard
AdverseEvent.eventexampleSNOMEDCTClinicalFindings
http://hl7.org/fhir/ValueSet/adverse-event-type
from the FHIR Standard

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()
uds-plus-advevent-1errorAdverseEvent.dateAll dateTime data elements should be truncated to a year only for de-identified resources.
: $this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-2errorAdverseEvent.detectedAll dateTime data elements should be truncated to a year only for de-identified resources.
: $this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-3errorAdverseEvent.recordedDateAll dateTime data elements should be truncated to a year only for de-identified resources.
: $this is DateTime implies $this.toString().length() = 4
NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent De-Identified UDS Plus AdverseEvent
... id SΣ 0..1 id The de-identified AdverseEvent 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
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..1 Identifier Business identifier for the event
... actuality ?!SΣ 1..1 code actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.

... category SΣ 0..* CodeableConcept product-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 SΣ 1..1 CodeableConcept Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.

... subject SΣ 1..1 Reference(De-Identified UDS Plus Patient) Subject impacted by event
.... 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
... encounter Σ 0..1 Reference(Encounter) Encounter created as part of
.... 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
... date SΣC 0..1 dateTime When the event occurred
uds-plus-advevent-1: All dateTime data elements should be truncated to a year only for de-identified resources.
... detected ΣC 0..1 dateTime When the event was detected
uds-plus-advevent-2: All dateTime data elements should be truncated to a year only for de-identified resources.
... recordedDate SΣC 0..1 dateTime When the event was recorded
uds-plus-advevent-3: All dateTime data elements should be truncated to a year only for de-identified resources.
... resultingCondition Σ 0..* Reference(Condition) Effect on the subject due to this event
... location Σ 0..1 Reference(Location) Location where adverse event occurred
... seriousness Σ 0..1 CodeableConcept Seriousness of the event
Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.

... severity Σ 0..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome Σ 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder Σ 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) Who recorded the adverse event
.... 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
... contributor Σ 0..* Reference(Practitioner | PractitionerRole | Device) Who was involved in the adverse event or the potential adverse event
... suspectEntity Σ 0..* BackboneElement The suspected agent causing the adverse event
.... 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
.... instance Σ 1..1 Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) Refers to the specific entity that caused the adverse event
.... causality Σ 0..* BackboneElement Information on the possible cause of the event
..... 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
..... assessment Σ 0..1 CodeableConcept Assessment of if the entity caused the event
Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.

..... productRelatedness Σ 0..1 string AdverseEvent.suspectEntity.causalityProductRelatedness
..... author Σ 0..1 Reference(Practitioner | PractitionerRole) AdverseEvent.suspectEntity.causalityAuthor
..... method Σ 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.

... subjectMedicalHistory Σ 0..* Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) AdverseEvent.subjectMedicalHistory
... referenceDocument Σ 0..* Reference(DocumentReference) AdverseEvent.referenceDocument
... study Σ 0..* Reference(ResearchStudy) AdverseEvent.study

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
AdverseEvent.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
AdverseEvent.actualityrequiredAdverseEventActuality
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.categoryextensibleAdverseEventCategory
http://hl7.org/fhir/ValueSet/adverse-event-category
from the FHIR Standard
AdverseEvent.eventexampleSNOMEDCTClinicalFindings
http://hl7.org/fhir/ValueSet/adverse-event-type
from the FHIR Standard
AdverseEvent.subject.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
AdverseEvent.encounter.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
AdverseEvent.seriousnessexampleAdverseEventSeriousness
http://hl7.org/fhir/ValueSet/adverse-event-seriousness
from the FHIR Standard
AdverseEvent.severityrequiredAdverseEventSeverity
http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1
from the FHIR Standard
AdverseEvent.outcomerequiredAdverseEventOutcome
http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1
from the FHIR Standard
AdverseEvent.recorder.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
AdverseEvent.suspectEntity.causality.assessmentexampleAdverseEventCausalityAssessment
http://hl7.org/fhir/ValueSet/adverse-event-causality-assess
from the FHIR Standard
AdverseEvent.suspectEntity.causality.methodexampleAdverseEventCausalityMethod
http://hl7.org/fhir/ValueSet/adverse-event-causality-method
from the FHIR Standard

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()
uds-plus-advevent-1errorAdverseEvent.dateAll dateTime data elements should be truncated to a year only for de-identified resources.
: $this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-2errorAdverseEvent.detectedAll dateTime data elements should be truncated to a year only for de-identified resources.
: $this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-3errorAdverseEvent.recordedDateAll dateTime data elements should be truncated to a year only for de-identified resources.
: $this is DateTime implies $this.toString().length() = 4

This structure is derived from AdverseEvent

Summary

Mandatory: 3 elements
Must-Support: 7 elements
Prohibited: 5 elements

Structures

This structure refers to these other structures:

Maturity: 2

Differential View

This structure is derived from AdverseEvent

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent De-Identified UDS Plus AdverseEvent
... id S 0..1 id The de-identified AdverseEvent identifier created by the health center to send data to UDS+ Data Receiver
... text 0..0
... contained 0..0
... category S 0..* CodeableConcept product-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 S 1..1 CodeableConcept Type of the event itself in relation to the subject
... subject S 1..1 Reference(De-Identified UDS Plus Patient) Subject impacted by event
.... display 0..0
... encounter
.... display 0..0
... date SC 0..1 dateTime When the event occurred
uds-plus-advevent-1: All dateTime data elements should be truncated to a year only for de-identified resources.
... detected C 0..1 dateTime When the event was detected
uds-plus-advevent-2: All dateTime data elements should be truncated to a year only for de-identified resources.
... recordedDate SC 0..1 dateTime When the event was recorded
uds-plus-advevent-3: All dateTime data elements should be truncated to a year only for de-identified resources.
... recorder
.... display 0..0

doco Documentation for this format

Constraints

IdGradePath(s)DetailsRequirements
uds-plus-advevent-1errorAdverseEvent.dateAll dateTime data elements should be truncated to a year only for de-identified resources.
: $this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-2errorAdverseEvent.detectedAll dateTime data elements should be truncated to a year only for de-identified resources.
: $this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-3errorAdverseEvent.recordedDateAll dateTime data elements should be truncated to a year only for de-identified resources.
: $this is DateTime implies $this.toString().length() = 4

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent De-Identified UDS Plus AdverseEvent
... id SΣ 0..1 id The de-identified AdverseEvent identifier created by the health center to send data to UDS+ Data Receiver
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... category SΣ 0..* CodeableConcept product-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 SΣ 1..1 CodeableConcept Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.

... subject SΣ 1..1 Reference(De-Identified UDS Plus Patient) Subject impacted by event
... date SΣC 0..1 dateTime When the event occurred
uds-plus-advevent-1: All dateTime data elements should be truncated to a year only for de-identified resources.
... detected ΣC 0..1 dateTime When the event was detected
uds-plus-advevent-2: All dateTime data elements should be truncated to a year only for de-identified resources.
... recordedDate SΣC 0..1 dateTime When the event was recorded
uds-plus-advevent-3: All dateTime data elements should be truncated to a year only for de-identified resources.

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
AdverseEvent.actualityrequiredAdverseEventActuality
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.categoryextensibleAdverseEventCategory
http://hl7.org/fhir/ValueSet/adverse-event-category
from the FHIR Standard
AdverseEvent.eventexampleSNOMEDCTClinicalFindings
http://hl7.org/fhir/ValueSet/adverse-event-type
from the FHIR Standard

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()
uds-plus-advevent-1errorAdverseEvent.dateAll dateTime data elements should be truncated to a year only for de-identified resources.
: $this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-2errorAdverseEvent.detectedAll dateTime data elements should be truncated to a year only for de-identified resources.
: $this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-3errorAdverseEvent.recordedDateAll dateTime data elements should be truncated to a year only for de-identified resources.
: $this is DateTime implies $this.toString().length() = 4

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent De-Identified UDS Plus AdverseEvent
... id SΣ 0..1 id The de-identified AdverseEvent 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
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..1 Identifier Business identifier for the event
... actuality ?!SΣ 1..1 code actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.

... category SΣ 0..* CodeableConcept product-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 SΣ 1..1 CodeableConcept Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.

... subject SΣ 1..1 Reference(De-Identified UDS Plus Patient) Subject impacted by event
.... 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
... encounter Σ 0..1 Reference(Encounter) Encounter created as part of
.... 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
... date SΣC 0..1 dateTime When the event occurred
uds-plus-advevent-1: All dateTime data elements should be truncated to a year only for de-identified resources.
... detected ΣC 0..1 dateTime When the event was detected
uds-plus-advevent-2: All dateTime data elements should be truncated to a year only for de-identified resources.
... recordedDate SΣC 0..1 dateTime When the event was recorded
uds-plus-advevent-3: All dateTime data elements should be truncated to a year only for de-identified resources.
... resultingCondition Σ 0..* Reference(Condition) Effect on the subject due to this event
... location Σ 0..1 Reference(Location) Location where adverse event occurred
... seriousness Σ 0..1 CodeableConcept Seriousness of the event
Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.

... severity Σ 0..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome Σ 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder Σ 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) Who recorded the adverse event
.... 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
... contributor Σ 0..* Reference(Practitioner | PractitionerRole | Device) Who was involved in the adverse event or the potential adverse event
... suspectEntity Σ 0..* BackboneElement The suspected agent causing the adverse event
.... 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
.... instance Σ 1..1 Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) Refers to the specific entity that caused the adverse event
.... causality Σ 0..* BackboneElement Information on the possible cause of the event
..... 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
..... assessment Σ 0..1 CodeableConcept Assessment of if the entity caused the event
Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.

..... productRelatedness Σ 0..1 string AdverseEvent.suspectEntity.causalityProductRelatedness
..... author Σ 0..1 Reference(Practitioner | PractitionerRole) AdverseEvent.suspectEntity.causalityAuthor
..... method Σ 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.

... subjectMedicalHistory Σ 0..* Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) AdverseEvent.subjectMedicalHistory
... referenceDocument Σ 0..* Reference(DocumentReference) AdverseEvent.referenceDocument
... study Σ 0..* Reference(ResearchStudy) AdverseEvent.study

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
AdverseEvent.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
AdverseEvent.actualityrequiredAdverseEventActuality
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.categoryextensibleAdverseEventCategory
http://hl7.org/fhir/ValueSet/adverse-event-category
from the FHIR Standard
AdverseEvent.eventexampleSNOMEDCTClinicalFindings
http://hl7.org/fhir/ValueSet/adverse-event-type
from the FHIR Standard
AdverseEvent.subject.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
AdverseEvent.encounter.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
AdverseEvent.seriousnessexampleAdverseEventSeriousness
http://hl7.org/fhir/ValueSet/adverse-event-seriousness
from the FHIR Standard
AdverseEvent.severityrequiredAdverseEventSeverity
http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1
from the FHIR Standard
AdverseEvent.outcomerequiredAdverseEventOutcome
http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1
from the FHIR Standard
AdverseEvent.recorder.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
AdverseEvent.suspectEntity.causality.assessmentexampleAdverseEventCausalityAssessment
http://hl7.org/fhir/ValueSet/adverse-event-causality-assess
from the FHIR Standard
AdverseEvent.suspectEntity.causality.methodexampleAdverseEventCausalityMethod
http://hl7.org/fhir/ValueSet/adverse-event-causality-method
from the FHIR Standard

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()
uds-plus-advevent-1errorAdverseEvent.dateAll dateTime data elements should be truncated to a year only for de-identified resources.
: $this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-2errorAdverseEvent.detectedAll dateTime data elements should be truncated to a year only for de-identified resources.
: $this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-3errorAdverseEvent.recordedDateAll dateTime data elements should be truncated to a year only for de-identified resources.
: $this is DateTime implies $this.toString().length() = 4

This structure is derived from AdverseEvent

Summary

Mandatory: 3 elements
Must-Support: 7 elements
Prohibited: 5 elements

Structures

This structure refers to these other structures:

Maturity: 2

 

Other representations of profile: CSV, Excel, Schematron