DetectedIssue

Indicates an actual or potential clinical issue with or between one or more active or proposed clinical actions for a patient; e.g. Drug-drug interaction, Ineffective treatment frequency, Procedure-condition conflict, etc.

Schema

Elements

Name	Required	Type	Description
identifier		Identifier[]	Unique id for the detected issue Details Business identifier associated with the detected issue record.
status	✓	code	registered | preliminary | final | amended + Details Indicates the status of the detected issue. This element is labeled as a modifier because the status contains the codes cancelled and entered-in-error that mark the issue as not currently valid.
code		CodeableConcept	Issue Category, e.g. drug-drug, duplicate therapy, etc. Details Identifies the general type of issue identified.
severity		code	high | moderate | low Details Indicates the degree of importance associated with the identified issue based on the potential impact on the patient.
patient		Reference<Patient>	Associated patient Details Indicates the patient whose record the detected issue is associated with.
identified[x]		dateTime, Period	When identified Details The date or period when the detected issue was initially identified.
author		Reference< Practitioner | PractitionerRole | Device >	The provider or device that identified the issue Details Individual or device responsible for the issue being raised. For example, a decision support application or a pharmacist conducting a medication review.
implicated		Reference<Resource>[]	Problem resource Details Indicates the resource representing the current activity or proposed activity that is potentially problematic. There's an implicit constraint on the number of implicated resources based on DetectedIssue.type; e.g. For drug-drug, there would be more than one. For timing, there would typically only be one.
evidence		DetectedIssueEvidence[]	Supporting evidence Details Supporting evidence or manifestations that provide the basis for identifying the detected issue such as a GuidanceResponse or MeasureReport.
id		string	Unique id for inter-element referencing Details Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
extension		Extension[]	Additional content defined by implementations Details 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. 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.
modifierExtension		Extension[]	Extensions that cannot be ignored even if unrecognized Details 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). 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.
code		CodeableConcept[]	Manifestation Details A manifestation that led to the recording of this detected issue.
detail		Reference<Resource>[]	Supporting information Details Links to resources that constitute evidence for the detected issue such as a GuidanceResponse or MeasureReport.
detail		string	Description and context Details A textual explanation of the detected issue. Should focus on information not covered elsewhere as discrete data - no need to duplicate the narrative.
reference		uri	Authority for issue Details The literature, knowledge-base or similar reference that describes the propensity for the detected issue identified.
mitigation		DetectedIssueMitigation[]	Step taken to address Details Indicates an action that has been taken or is committed to reduce or eliminate the likelihood of the risk identified by the detected issue from manifesting. Can also reflect an observation of known mitigating factors that may reduce/eliminate the need for any action.
id		string	Unique id for inter-element referencing Details Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
extension		Extension[]	Additional content defined by implementations Details 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. 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.
modifierExtension		Extension[]	Extensions that cannot be ignored even if unrecognized Details 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). 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.
action	✓	CodeableConcept	What mitigation? Details Describes the action that was taken or the observation that was made that reduces/eliminates the risk associated with the identified issue. The "text" component can be used for detail or when no appropriate code exists.
date		dateTime	Date committed Details Indicates when the mitigating action was documented. This might not be the same as when the mitigating step was actually taken.
author		Reference<Practitioner | PractitionerRole>	Who is committing? Details Identifies the practitioner who determined the mitigation and takes responsibility for the mitigation step occurring.

Search Parameters

Name	Type	Description	Expression
identifier	token	Unique id for the detected issue	DetectedIssue.identifier
patient	reference	Associated patient	DetectedIssue.patient
author	reference	The provider or device that identified the issue	DetectedIssue.author
code	token	Issue Category, e.g. drug-drug, duplicate therapy, etc.	DetectedIssue.code
identified	date	When identified	DetectedIssue.identified
implicated	reference	Problem resource	DetectedIssue.implicated
status	token	The status of the detected issue	DetectedIssue.status

Inherited Elements

Name	Required	Type	Description
id		string	Logical id of this artifact Details 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.
meta		Meta	Metadata about the resource Details 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.
implicitRules		uri	A set of rules under which this content was created Details 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.
language		code	Language of the resource content Details 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		Narrative	Text summary of the resource, for human interpretation Details 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.
contained		Resource[]	Contained, inline Resources Details 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.
extension		Extension[]	Additional content defined by implementations Details 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.
modifierExtension		Extension[]	Extensions that cannot be ignored Details 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). 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.

Usage

This resource is an event resource from a FHIR workflow perspective - see Workflow, specifically Event.

This resource applies to various circumstances where there is a concern about an existing or proposed set of clinical activity. The issue could relate to single, proposed, or multiple actions. It does not apply to technical issues (e.g. lack of user permissions) but could relate to violation of patient consent limitations. Examples include:

• Drug-drug interactions
• Inappropriate therapy (wrong dose, frequency, body site)
• Duplicate therapy

This resource represents a specific instance of a potential issue for a particular patient. It is not intended to represent general patient-independent knowledge. This resource is also not intended to be used in defining general prohibitions on actions such as "No NSAIDs", "No solid oral dose forms" or "No MRIs - metallic tattoos". These guidelines can be captured using the AllergyIntolerance, and/or Flag resources. Similarly, this resource is not to be used to capture clinical facts that may imply contraindications such as pregnancy, breast feeding, patient preferences, past procedures, etc. These would be represented using Condition, Procedure or other resources.

Relationships

This resource only applies to documenting a risk associated with a specific planned or ongoing action, or the lack of an action which should be planned - not a general propensity to risk. The latter would be handled using AllergyIntolerance for substance-specific issues or Flag for other types of issues. In addition, the resource represents patient-specific and time-bound risk manifestations, not generic knowledge statements about risks that can exist.

This resource is limited to clinical issues associated with a proposed or ongoing action. It does not cover technical issues such as lack of permission, duplicate identifiers, insufficient data, and other business rule violations. Technical issues are conveyed using the OperationOutcome resource. It is possible to have both OperationOutcome and DetectedIssue together, where the OperationOutcome might indicate that a requested action was rejected due to a clinical issue and the DetectedIssue provides the details of the issue.

Background and Context

Detected issues are typically identified by decision support systems. However, they may also be captured directly by clinicians. The latter typically happens for one of two reasons:

1. A clinician wishes to communicate an issue to another clinician whose responsibility would be to resolve it (e.g. a pharmacist identifying an issue with a prescription prior to putting it on hold)
2. A clinician wishes to pre-emptively identify that an issue is known and is being managed (to avoid red flags being raised as part of downstream workflow); e.g. Submitting a new order and including a link to a "duplicate therapy" issue with mitigation indicating that the therapy is not considered to be duplicate.

Decision-support generated issues can result from calling a decision-support engine directly (e.g. via a custom OperationDefinition) or as part of an attempt to perform some other function (creating an order, submitting an insurance claim, capturing a medication list). When the issues are generated as a by-product of performing some other sort of action, they may be included in the "response" to the requested action in the same manner as an OperationOutcome. In fact, both may be present - the OperationOutcome indicating that there was a warning or error associated with the request and a DetectedIssue providing the clinical details. (The OperationOutcome could point to the DetectedIssue via an extension.)

In those circumstances where requested operations are rejected as a result of a detected issue, the workflow may support allowing the operation to be re-tried, provided that the identified issue is included as part of the submission (possibly also including a mitigation). In doing so, the sender acknowledges the issue and takes responsibility for it, thus allowing the requested operation to proceed. See Linking to Detected Issues for guidance on how a DetectedIssue instance might be included as part of another operation.

Systems that require such workflows should document expected behavior as part of their CapabilityStatement declarations.

Referenced By

• MedicationDispense
• MedicationKnowledge
• MedicationRequest