QI-Core Implementation Guide
4.1.0 - release

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## Resource Profile: QICoreAdverseEvent

Defining URL: | http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-adverseevent
Version: | 4.1.0
Name: | QICoreAdverseEvent
Status: | Draft as of 8/22/18
Definition: | An adverse event is an untoward occurrence during treatment that should be reported, for example, to a clinical study sponsor or safety oversight organization. AEs include reportable serious medical errors such as those defined by National Quality Forum (see http://www.qualityforum.org/Topics/ SREs/List_of_SREs.aspx), and Patient Safety Healthcare Events as defined by AHRQ. Some AEs can involve conditions such as "recurring headaches" but others do not, such as accidental falls, surgical errors, sexual abuse of patient, and sudden death. An adverse event can also be an unsafe condition that increases the probability of a patient safety event, and near-misses. An adverse event can be caused by exposure to some agent (e.g., a medication, immunization, food, or environmental agent). An adverse reaction can range from a mild reaction, such as a harmless rash to a severe and life-threatening condition. They can occur immediately or develop over time. For example, a patient may develop a rash after taking a particular medication.
Publisher: | http://www.hl7.org/Special/committees/cqi/index.cfm
Source Resource: | XML / JSON / Turtle

The official URL for this profile is:

    http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-adverseevent

Usage

See the patterns page for implementation and usage patterns.

### Examples

Mild Rash Example

### Formal Views of Profile Content

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

- Text Summary
- Differential Table
- Snapshot Table
- Snapshot Table (Must Support)
- All

This structure is derived from AdverseEvent

Summary

Mandatory: 2 elements
Must-Support: 7 elements

Structures

This structure refers to these other structures:

- QICorePatient (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-patient)
- QICorePractitioner (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-practitioner)
- QICoreRelatedPerson (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-relatedperson)
- QICoreEncounter (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-encounter)
- QICoreLocation (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-location)
- QICorePractitionerRole (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-practitionerrole)
- QICoreImmunization (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-immunization)
- QICoreProcedure (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-procedure)
- QICoreSubstance (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-substance)
- QICoreMedication (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medication)
- QICoreMedicationAdministration (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medicationadministration)
- QICoreMedicationStatement (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medicationstatement)
- QICoreDevice (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-device)

This structure is derived from AdverseEvent

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury
actuality | S | 1..1 | code | actual | potential
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(QICorePatient | Group | QICorePractitioner | QICoreRelatedPerson) | Subject impacted by event
encounter | S | 0..1 | Reference(QICoreEncounter) | Encounter created as part of
date |  | 0..1 | dateTime | When the event occurred
resultingCondition | S | 0..* | Reference(Condition) | Effect on the subject due to this event
location |  | 0..1 | Reference(QICoreLocation) | Location where adverse event occurred
recorder |  | 0..1 | Reference(QICorePatient | QICoreRelatedPerson | QICorePractitioner | QICorePractitionerRole) | Who recorded the adverse event
suspectEntity |  | 0..* | BackboneElement | The suspected agent causing the adverse event
instance | S | 1..1 | Reference(QICoreImmunization | QICoreProcedure | QICoreSubstance | QICoreMedication | QICoreMedicationAdministration | QICoreMedicationStatement | QICoreDevice) | Refers to the specific entity that caused the adverse event
causality |  | 0..1 | BackboneElement | Information on the possible cause of the event
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury
id | Σ | 0..1 | string | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred) Max Binding: AllLanguages: A human language.
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation
contained |  | 0..* | Resource | Contained, inline Resources
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 | ?!S Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
category | S Σ | 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 | S Σ | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
subject | S Σ | 1..1 | Reference(QICorePatient | Group | QICorePractitioner | QICoreRelatedPerson) | Subject impacted by event
encounter | S Σ | 0..1 | Reference(QICoreEncounter) | Encounter created as part of
date | Σ | 0..1 | dateTime | When the event occurred
detected | Σ | 0..1 | dateTime | When the event was detected
recordedDate | Σ | 0..1 | dateTime | When the event was recorded
resultingCondition | S Σ | 0..* | Reference(Condition) | Effect on the subject due to this event
location | Σ | 0..1 | Reference(QICoreLocation) | 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(QICorePatient | QICoreRelatedPerson | QICorePractitioner | QICorePractitionerRole) | Who recorded the adverse event
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 | S Σ | 1..1 | Reference(QICoreImmunization | QICoreProcedure | QICoreSubstance | QICoreMedication | QICoreMedicationAdministration | QICoreMedicationStatement | QICoreDevice) | Refers to the specific entity that caused the adverse event
causality | Σ | 0..1 | 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
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury
actuality | ?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
category | Σ | 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 | Σ | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
subject | Σ | 1..1 | Reference(QICorePatient | Group | QICorePractitioner | QICoreRelatedPerson) | Subject impacted by event
encounter | Σ | 0..1 | Reference(QICoreEncounter) | Encounter created as part of
resultingCondition | Σ | 0..* | Reference(Condition) | Effect on the subject due to this event
suspectEntity | Σ | 0..* | BackboneElement | The suspected agent causing the adverse event
instance | Σ | 1..1 | Reference(QICoreImmunization | QICoreProcedure | QICoreSubstance | QICoreMedication | QICoreMedicationAdministration | QICoreMedicationStatement | QICoreDevice) | Refers to the specific entity that caused the adverse event
Documentation for this format

This structure is derived from AdverseEvent

Summary

Mandatory: 2 elements
Must-Support: 7 elements

Structures

This structure refers to these other structures:

- QICorePatient (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-patient)
- QICorePractitioner (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-practitioner)
- QICoreRelatedPerson (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-relatedperson)
- QICoreEncounter (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-encounter)
- QICoreLocation (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-location)
- QICorePractitionerRole (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-practitionerrole)
- QICoreImmunization (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-immunization)
- QICoreProcedure (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-procedure)
- QICoreSubstance (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-substance)
- QICoreMedication (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medication)
- QICoreMedicationAdministration (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medicationadministration)
- QICoreMedicationStatement (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medicationstatement)
- QICoreDevice (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-device)

Differential View

This structure is derived from AdverseEvent

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury
actuality | S | 1..1 | code | actual | potential
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(QICorePatient | Group | QICorePractitioner | QICoreRelatedPerson) | Subject impacted by event
encounter | S | 0..1 | Reference(QICoreEncounter) | Encounter created as part of
date |  | 0..1 | dateTime | When the event occurred
resultingCondition | S | 0..* | Reference(Condition) | Effect on the subject due to this event
location |  | 0..1 | Reference(QICoreLocation) | Location where adverse event occurred
recorder |  | 0..1 | Reference(QICorePatient | QICoreRelatedPerson | QICorePractitioner | QICorePractitionerRole) | Who recorded the adverse event
suspectEntity |  | 0..* | BackboneElement | The suspected agent causing the adverse event
instance | S | 1..1 | Reference(QICoreImmunization | QICoreProcedure | QICoreSubstance | QICoreMedication | QICoreMedicationAdministration | QICoreMedicationStatement | QICoreDevice) | Refers to the specific entity that caused the adverse event
causality |  | 0..1 | BackboneElement | Information on the possible cause of the event
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury
id | Σ | 0..1 | string | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred) Max Binding: AllLanguages: A human language.
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation
contained |  | 0..* | Resource | Contained, inline Resources
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 | ?!S Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
category | S Σ | 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 | S Σ | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
subject | S Σ | 1..1 | Reference(QICorePatient | Group | QICorePractitioner | QICoreRelatedPerson) | Subject impacted by event
encounter | S Σ | 0..1 | Reference(QICoreEncounter) | Encounter created as part of
date | Σ | 0..1 | dateTime | When the event occurred
detected | Σ | 0..1 | dateTime | When the event was detected
recordedDate | Σ | 0..1 | dateTime | When the event was recorded
resultingCondition | S Σ | 0..* | Reference(Condition) | Effect on the subject due to this event
location | Σ | 0..1 | Reference(QICoreLocation) | 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(QICorePatient | QICoreRelatedPerson | QICorePractitioner | QICorePractitionerRole) | Who recorded the adverse event
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 | S Σ | 1..1 | Reference(QICoreImmunization | QICoreProcedure | QICoreSubstance | QICoreMedication | QICoreMedicationAdministration | QICoreMedicationStatement | QICoreDevice) | Refers to the specific entity that caused the adverse event
causality | Σ | 0..1 | 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
Documentation for this format

Other representations of profile: CSV, Excel, Schematron

#### Terminology Bindings

Path | Conformance | ValueSet
AdverseEvent.language | preferred | CommonLanguages Max Binding: AllLanguages
AdverseEvent.actuality | required | AdverseEventActuality
AdverseEvent.category | extensible | AdverseEventCategory
AdverseEvent.event | example | SNOMEDCTClinicalFindings
AdverseEvent.seriousness | example | AdverseEventSeriousness
AdverseEvent.severity | required | AdverseEventSeverity
AdverseEvent.outcome | required | AdverseEventOutcome
AdverseEvent.suspectEntity.causality.assessment | example | AdverseEventCausalityAssessment
AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethod

#### Constraints

Id | Grade | Path | Details | Requirements
dom-2 | error | AdverseEvent | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | AdverseEvent | 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 | AdverseEvent | 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 | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | Best Practice | AdverseEvent | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | AdverseEvent.meta | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.implicitRules | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.language | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.text | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.extension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | AdverseEvent.extension | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
ele-1 | error | AdverseEvent.modifierExtension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | AdverseEvent.modifierExtension | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
ele-1 | error | AdverseEvent.identifier | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.actuality | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.category | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.event | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.subject | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.encounter | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.date | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.detected | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.recordedDate | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.resultingCondition | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.location | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.seriousness | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.severity | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.outcome | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.recorder | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.contributor | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.suspectEntity | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.suspectEntity.extension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | AdverseEvent.suspectEntity.extension | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
ele-1 | error | AdverseEvent.suspectEntity.modifierExtension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | AdverseEvent.suspectEntity.modifierExtension | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
ele-1 | error | AdverseEvent.suspectEntity.instance | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.suspectEntity.causality | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.suspectEntity.causality.extension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | AdverseEvent.suspectEntity.causality.extension | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
ele-1 | error | AdverseEvent.suspectEntity.causality.modifierExtension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | AdverseEvent.suspectEntity.causality.modifierExtension | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
ele-1 | error | AdverseEvent.suspectEntity.causality.assessment | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.suspectEntity.causality.productRelatedness | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.suspectEntity.causality.author | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.suspectEntity.causality.method | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.subjectMedicalHistory | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.referenceDocument | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ele-1 | error | AdverseEvent.study | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |