Generated Narrative: StructureDefinition us-quality-core-adverseevent Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury #xD; actuality 1..1 code actual | potential #xD; category 0..* CodeableConcept (USCDI+ Quality) 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 #xD; event 1..1 CodeableConcept (USCDI+ Quality) Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event. #xD; subject 1..1 Reference(US Quality Core Patient | Group | US Quality Core Practitioner | US Quality Core RelatedPerson) Subject impacted by event #xD; encounter 0..1 Reference(US Quality Core Encounter) Encounter created as part of #xD; date 0..1 dateTime (USCDI+ Quality) #xD; detected 0..1 dateTime (USCDI+ Quality) When the event was detected #xD; recordedDate 0..1 dateTime (USCDI+ Quality) When the event was recorded #xD; resultingCondition 0..* Reference(US Quality Core Condition Problems Health Concerns | US Quality Core Condition Encounter Diagnosis) Effect on the subject due to this event #xD; location 0..1 Reference(US Quality Core Location) Location where adverse event occurred #xD; seriousness 0..1 CodeableConcept Seriousness of the event #xD; recorder 0..1 Reference(US Quality Core Patient | US Quality Core RelatedPerson | US Quality Core Practitioner | US Quality Core PractitionerRole) Who recorded the adverse event #xD; contributor 0..* Reference(US Quality Core Practitioner | US Quality Core PractitionerRole | US Quality Core Device | US Core Implantable Device Profile(6.1.0)) Who was involved in the adverse event or the potential adverse event #xD; suspectEntity 0..* BackboneElement The suspected agent causing the adverse event #xD; instance 1..1 Reference(US Quality Core Immunization | US Quality Core Procedure | US Quality Core Substance | US Quality Core Medication | US Quality Core MedicationAdministration | US Quality Core MedicationStatement | US Quality Core Device | US Core Implantable Device Profile(6.1.0)) (USCDI+ Quality) Refers to the specific entity that caused the adverse event #xD; causality 0..1 BackboneElement Information on the possible cause of the event #xD; subjectMedicalHistory 0..* Reference(US Quality Core Simple Observation | US Quality Core AllergyIntolerance | US Quality Core FamilyMemberHistory | US Quality Core Immunization | US Quality Core Procedure | US Quality Core Condition Problems Health Concerns | US Quality Core Condition Encounter Diagnosis) AdverseEvent.subjectMedicalHistory #xD; <img src="[binary]" alt="doco" style="background-color: inherit"/> Documentation for this format
Office of the National Coordinator for Health Information Technology (ONC)
An adverse event (AE) 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.
Medical care, research study or other healthcare event causing physical injury
Actual or potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death.
If the resource is contained in another resource, it SHALL NOT contain nested Resources
not(parent::f:contained and f:contained)
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()
not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))
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()
not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))
If a resource is contained in another resource, it SHALL NOT have a security label
When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.
A resource should have narrative for robust management
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
A set of rules under which this content was created
A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.
This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
The base language in which the resource is written.
Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
Text summary of the resource, for human interpretation
A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.
This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
Additional content defined by implementations
May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Must have either extensions or value[x], not both
exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Business identifiers assigned to this adverse event by the performer or other systems which remain constant as the resource is updated and propagates from server to server.
This is a business identifier, not a resource identifier (see [discussion](http://hl7.org/fhir/R4/resource.html#identifiers)). It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types. For example, multiple Patient and a Person resource instance might share the same social insurance number.
Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers.
Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely.
This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.
Overall nature of the adverse event, e.g. real or potential.
(USCDI+ Quality) 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
The overall type of event, intended for search and filtering purposes.
Overall categorization of the event, e.g. product-related or situational.
(USCDI+ Quality) Type of the event itself in relation to the subject
This element defines the specific type of event that occurred or that was prevented from occurring.
This subject or group impacted by the event.
If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.
Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.
The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated.
This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter. For example, if a medication administration was considered an adverse event because it resulted in a rash, then the encounter when the medication administration was given is the context. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the context.
The date (and perhaps time) when the adverse event occurred.
(USCDI+ Quality) When the event was detected
Estimated or actual date the AdverseEvent began, in the opinion of the reporter.
(USCDI+ Quality) When the event was recorded
The date on which the existence of the AdverseEvent was first recorded.
The recordedDate represents the date when this particular AdverseEvent record was created in the system, not the date of the most recent update. The date of the last record modification can be retrieved from the resource metadata.
Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).
The information about where the adverse event occurred.
Assessment whether this event was of real importance.
Overall seriousness of this event for the patient.
Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.seriousness - a severe rash might not be serious, but a mild heart problem is.
The severity of the adverse event itself, in direct relation to the subject.
resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Describes the type of outcome from the adverse event.
Information on who recorded the adverse event. May be the patient or a practitioner.
Who was involved in the adverse event or the potential adverse event
Parties that may or should contribute or have contributed information to the adverse event, which can consist of one or more activities. Such information includes information leading to the decision to perform the activity and how to perform the activity (e.g. consultant), information that the activity itself seeks to reveal (e.g. informant of clinical history), or information about what activity was performed (e.g. informant witness).
The suspected agent causing the adverse event
Describes the entity that is suspected to have caused the adverse event.
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Extensions that cannot be ignored even if unrecognized
May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
(USCDI+ Quality) Refers to the specific entity that caused the adverse event
Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.
Information on the possible cause of the event
Information on the possible cause of the event.
Assessment of if the entity caused the event
Assessment of if the entity caused the event.
Codes for the assessment of whether the entity caused the event.
ProbabilityScale | Bayesian | Checklist.