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9.10 Resource DetectedIssue - Content

Clinical Decision Support icon Work GroupMaturity Level: 3 Trial UseSecurity Category: Patient Compartments: Device, Group, Patient, Practitioner

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, gaps in care, etc.

9.10.1 Scope and 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
  • Gaps in care

This resource represents a specific instance of a potential issue for a particular patient. It is not intended to represent general patient-independent knowledge, the ClinicalUseDefinition resource is defined for that purpose. 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, AdverseEvent 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.

9.10.2 Boundaries and 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.

9.10.3 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.

9.10.4 References to this Resource

9.10.5 Resource Content

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. DetectedIssue TU DomainResource Clinical issue with action

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ 0..* Identifier Business identifier for detected issue

... status ?!Σ 1..1 code preliminary | final | entered-in-error | unknown | mitigated
Binding: Detected Issue Status (Required)
... category Σ 0..* CodeableConcept High level categorization of detected issue
Binding: Detected Issue Category (Preferred)

... severity Σ 0..1 CodeableConcept high | moderate | low
Binding: Detected Issue Severity (Preferred)
... subject Σ 0..1 Reference(Patient | Group | Device | Location | Organization | Procedure | Practitioner | Medication | Substance | BiologicallyDerivedProduct | NutritionProduct) Associated subject
... encounter Σ 0..1 Reference(Encounter) Encounter the detected issue is part of
... identified[x] Σ 0..1 When detected issue occurred/is occurring
.... identifiedDateTime dateTime
.... identifiedPeriod Period
.... identifiedTiming Timing
... author Σ 0..1 Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Device) The provider or device that identified the issue
... implicated Σ 0..* Reference(Any) Problem resource

... evidence 0..* BackboneElement Supporting evidence

.... code 0..* CodeableConcept Manifestation
Binding: Manifestation and Symptom Codes (Example)

.... detail 0..* Reference(Any) Supporting information

... detail 0..1 markdown Description and context
... reference 0..1 uri Authority for issue
... mitigation 0..* BackboneElement Step taken to address

.... action 1..1 CodeableConcept What mitigation?
Binding: Detected Issue Mitigation Action (Preferred)
.... date 0..1 dateTime Date committed
.... author 0..1 Reference(Practitioner | PractitionerRole) Who is committing?
.... note 0..* Annotation Additional notes about the mitigation


doco Documentation for this format icon

See the Extensions for this resource

 

Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis

9.10.5.1 Terminology Bindings

Path ValueSet Type Documentation
DetectedIssue.status DetectedIssueStatus Required

Indicates the status of a detected issue
DetectedIssue.category DetectedIssueCategory Preferred

Kinds of issues or contraindications, such as 'drug-drug interaction', 'duplicate therapy', etc.
DetectedIssue.code DetectedIssueCode Preferred

Codes for issues or contraindications, such as 'drug-drug interaction', 'duplicate therapy', etc.
DetectedIssue.severity DetectedIssueSeverity Preferred

Indicates the potential degree of impact of the identified issue on the patient.
DetectedIssue.evidence.code ManifestationAndSymptomCodes Example

Example value set for Manifestation and Symptom codes.
DetectedIssue.mitigation.action DetectedIssueMitigationAction Preferred

Kinds of mitigating actions and observations that can be associated with a detected issue or contraindication, such as 'added concurrent therapy', 'prior therapy documented', etc.

9.10.6 Linking to Detected Issues

DetectedIssue follows the pattern of linking from the resource created "second". As DetectedIssue originates in response to one or more other existing records, it points to those records rather than being pointed to from them.

In some cases, a detected issue might be associated with a single record. When this occurs, it may be stored as a contained resource within the implicated resource provided that there is no expected need to search for the detected issue directly. However, with detected issues that implicate multiple records, containment is more problematic. In some workflows, a detected issue might be deemed to be "owned" by the record whose creation triggers the contraindication being created - i.e. the "second" or "last" record. However, where multiple actions are proposed as part of a single submission, there can be no single owner and containment will not be feasible.

If there is a strong need to point from an implicated resource to DetectedIssue and containment is not appropriate, an extension can be used.

9.10.7 Workflow Challenges

DetectedIssue is a resource that is frequently associated with workflow challenges where frequent alerts that are not clinically relevant result in clinicians tuning out (or turning off) the content and thus missing relevant alerts. Give consideration to this issue before making heavy use of this resource.

9.10.8 Open Issues

  • Are author, reference and/or mitigation (and its various parts) all part of the 80%?

9.10.9 Search Parameters

Search parameters for this resource. See also the full list of search parameters for this resource, and check the Extensions registry for search parameters on extensions related to this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

Name Type Description Expression In Common
author reference The provider or device that identified the issue DetectedIssue.author
(Practitioner, Device, Patient, PractitionerRole, RelatedPerson)
category token Issue Category, e.g. drug-drug, duplicate therapy, etc. DetectedIssue.category
code token Issue Type, e.g. drug-drug, duplicate therapy, etc. DetectedIssue.code 21 Resources
identified date When identified DetectedIssue.identified.ofType(dateTime) | DetectedIssue.identified.ofType(Period)
identifier token Unique id for the detected issue DetectedIssue.identifier 65 Resources
implicated reference Problem resource DetectedIssue.implicated
(Any)
patient reference Associated patient DetectedIssue.subject.where(resolve() is Patient)
(Patient)		 65 Resources
status token The status of the issue DetectedIssue.status
subject reference Associated subject DetectedIssue.subject
(Practitioner, Group, Organization, BiologicallyDerivedProduct, NutritionProduct, Device, Medication, Patient, Procedure, Substance, Location)