Harmful or undesired physiological responses associated with exposure to a substance.

Data Element
Reaction Severity
Description
The clinical assessment of a specific allergic reaction when it occurs (e.g., mild, moderate, severe).
Submitted By: Mr. Charles Gabrial / Federal Electronic Health Record Modernization (FEHRM) Office
Data Element Information
Data Element Description The clinical assessment of a specific allergic reaction when it occurs (e.g., mild, moderate, severe).
Rationale for Separate Consideration USCDI v6 currently has a data element, Reaction. In some systems, users will enter the Reaction, Severity and Criticality in the same Reaction text field. Reaction is a description of the adverse event believed to be due to exposure to a substance and is aligned with SNOWMED CT terminology. Examples: rash, anaphylaxis. Severity indicates the clinical intensity of a specific reaction event. Examples: mild, moderate, severe. Criticality is the clinical assessment of potential danger to the patient if they are re-exposed to the substance in the future (i.e., risk assessment going forward). Examples: low, high, unable-to-assess.
In practice, clinicians use all three elements (Reaction: “rash”; Severity: “mild”; and Criticality: “high”) to manage patient’s allergy. When the three elements are included in one text field, there is room for error in data exchange. Therefore, we are suggesting that the three elements be separate, as they are in recent technical specifications for HL7 FHIR.
Note that Criticality is currently a USCDI Level 2 data element candidate. We are suggesting that Severity also be a candidate data element.
Use Case Description(s)
Use Case Description A patient is prescribed amoxicillin and develops a mild rash. With current USCDI standards, the text field Reaction could be captured as “rash”, “mild rash”, “rash; mild”, “rash (mild)”, “rash (not severe)” or any variation describing the clinical observation of the reaction. The Severity of the reaction may not be accounted for in the text-based input. In codesets and standards such as SNOMED CT and HL7 FHIR, Severity is a separate qualifier value or attribute of Reaction with set values of “mild”, “moderate”, or “severe”. Clinicians use this Severity value to manage patient treatment. Some EHR and Health IT systems use this Severity value as an input to Clinical Decision Support calculations. For instance, a system may calculate Allergy Criticality based on the values submitted for the Reaction and Severity. Therefore, we believe that Severity should be articulated as a distinct element from Reaction to achieve a clear exchange of information.
Estimate the breadth of applicability of the use case(s) for this data element Level 2
ONC Priority
  • Address public health interoperability needs of reporting, investigation, and emergency response
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) From SNOMED CT Implementation Guide for Allergy, Hypersensitivity and Intolerance:
As a result of a request from HL7 to SNOMED International about the possibility of mapping some of the required HL7® FHIR® Value Sets to SNOMED CT, an analysis of the ability of SNOMED CT to accommodate those needs was performed by the SNOMED CT on FHIR Workgroup. The required value sets of the FHIR AllergyIntolerance resource were included in this analysis.
AllergyIntolerance.Reaction.Severity
It was assessed that there was a good match between the HL7 required value set and the SNOMED CT
https://docs.snomed.org/implementation-guides/allergy-implementation-guide/4-information-model-and-terminology-binding/4.2-terminology-bindings
Additional Specifications HL7 FHIR Release 5, 9.1 Resource AllergyIntolerance – Content
https://www.hl7.org/fhir/allergyintolerance.html

AllergyIntolerance.reaction.severity
Element Id AllergyIntolerance.reaction.severity
Definition Clinical assessment of the severity of the reaction event as a whole, potentially considering multiple different manifestations.
Short Display mild | moderate | severe (of event as a whole)
Cardinality
0..1
Terminology Binding
Allergy Intolerance Severity (Required)

Type
code

Summary
false
Comments It is acknowledged that this assessment is very subjective. There may be some specific practice domains where objective scales have been applied. Objective scales can be included in this model as extensions.
Current Use (Level 2) Captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer
Extent of exchange (Level 2) Between more than two production EHRs or other HIT modules using available interoperability standards
Supporting Artifacts 1) VA’s Lighthouse API, as part of the Federal EHR ecosystem, supports FHIR APIs to exchange allergy Severity with external providers and patients.
Example scenario:
• A veteran accesses their health data via the VA Health API (Lighthouse), which includes AllergyIntolerance resources.
• If the allergy record includes a reaction with severity, and the API returns it, this data can be shared with:
• External providers (via HIEs or Direct Messaging).
• Patients (via apps or Blue Button 2.0-style downloads).
2) The Joint Longitudinal Viewer (JLV) is a web-based application used by VA and DoD healthcare providers. JLV aggregates patient data from multiple sources, including Cerner PowerChart (which is a part of the MHS Genesis system for DoD healthcare records), the VA’s VistA/CPRS systems, and other healthcare systems. In the current JLV system, clinicians enter Reaction and Severity information. Criticality is then system-calculated.
Example scenario:
• A provider assesses a patient for an allergic reaction to latex and assigns Reaction = “rash” and Severity = “mild”; the Criticality field is automatically assigned as “low” with no ability for clinician to input
• If the provider changes Severity to “moderate” or “severe”, Criticality is changed to “high” by the system


https://developer.va.gov/explore/api/clinical-health/docs?version=current
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) No known proprietary or standardization restrictions. FHIR defines an ordinal scale to represent Severity: mild, moderate, severe. One challenge could be that assessment of whether a reaction is mild, moderate, or severe is subjective based on the clinician observing the reaction.
Restrictions on Use (e.g. licensing, user fees) N/A
Privacy and Security Concerns This data element would be covered by existing privacy and security regulations in the same manner as other data elements within the Allergies and Intolerances data class.
Estimate of Overall Burden Because Severity is a simple, ordinal value, it is relatively easy to develop, implement and exchange. In some EHRs, Severity is included as part of a text field describing the allergy reaction. We propose that breaking out Severity to a separate data element helps deliver important information to a clinician to support clinical decisions and inform treatment.
Other Implementation Challenges N/A
ASTP Evaluation Details
Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1
Maturity - Current Standards		 Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 2 - Data element is captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer.
Criterion #3
Maturity - Current Exchange		 Level 2 - Data element is electronically exchanged between more than two production EHRs or other HIT modules of different developers using available interoperability standards.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 2 - Use cases apply to most care settings or specialties.

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