| Interoperability Standards Platform (ISP)

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

Data Element

Criticality

Description

Estimate of the potential clinical harm, or seriousness, of a reaction to an identified substance.

Submitted By: Sandi Mitchell / J P Systems, Inc.
Data Element Information
Use Case Description(s)
Use Case Description	To ensure interoperability across the healthcare ecosystem, national standardizing bodies must align. For example, if one standard body requires allergy criticality, then all standard bodies should require that same data element.
Estimate the breadth of applicability of the use case(s) for this data element	Level 1
ONC Priority	None of the above
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s)	HL7 FHIR R4 Allergy Intolerance Criticality, Rx Norm, SNOMED CT, National Drug Code (NDC) http://hl7.org/fhir/ValueSet/allergy-intolerance-criticality
Additional Specifications	HL7 FHIR R4 Allergy Intolerance Criticality
Current Use	(Level 1) Captured, stored, or accessed in at least one production EHR or HIT module
Extent of exchange	(Level 1) Between two production EHRs or other HIT modules using available interoperability standards
Supporting Artifacts	HL7 FHIR R4 http://hl7.org/fhir/ValueSet/allergy-intolerance-criticality
Potential Challenges
Restrictions on Standardization (e.g. proprietary code)	None
Restrictions on Use (e.g. licensing, user fees)	None
Privacy and Security Concerns	Standard HIPAA concerns.
Estimate of Overall Burden	Minimal burden to implement since the data element is already being exchanged. This data element impacts patient safety to ensure clinicians understand the criticality of the patient's allergy.
Other Implementation Challenges	Educational awareness for clinicians will be necessary since this field has replaced severity in clinical practice.

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 1 - Data element is captured, stored, or accessed in at least one production EHR or HIT module.
Criterion #3 Maturity - Current Exchange	Level 1 - Data element is electronically exchanged between two production EHRs or other HIT modules using available interoperability standards.
Criterion #4 Use Case(s) - Breadth of Applicability	Level 2 - Use cases apply to most care settings or specialties.

Comment

Submitted by rdillaire on 2025-05-12

CMS-CCSQ Supports Criticality for USCDI v6

Recommendation: CMS CCSQ recommends the Criticality element be added to final USCDI v6.

Rationale: CMS CCSQ supports Post-Acute Care Interoperability (PACIO)’s recommendation to include the Criticality data element in USCDI v6. Adding this data element to the Allergies and Intolerances data class is essential for improving patient safety and clinical decision-making. The Criticality data element complements existing USCDI elements by providing critical information about the severity and potential impact of allergic reactions, enabling healthcare providers to better assess risks and prioritize care. CMS CCSQ and PACIO share a commitment to enhancing data exchange and empowering providers to make informed, patient-centered decisions.

Submitted by jpatterson@mitre.org on 2025-04-11

PACIO Supports Advancement to USCDI V6

Data Class: Allergies and Intolerances Data Class
Data Element: Criticality (Level 2)
Recommendation: Advance Criticality data element from Level 2 to final USCDI v6.
Rationale: The PACIO Project Community* supports the earlier comments from CMS regarding food allergy intolerance, including the recommendation to advance the Criticality data element from Level 2 to inclusion in the final USCDI V6. The inclusion of the Criticality data element in the Allergies and Intolerances data class of USCDI V6 is a crucial for enhancing patient safety and clinical decision-making. The criticality data element is the necessary companion to the allergy or intolerance agent and the clinical manifestation, aka reaction, that have been included in the USCDI since V4. While the patient's allergy or intolerance agent and clinical manifestation (reaction) provide foundational information about what triggers a reaction and how it presents, the Criticality data element adds an essential layer by indicating the severity and potential impact of a future reaction. This allows healthcare providers to assess risks more accurately and prioritize interventions, ensuring that they can make informed decisions about prescribing medications, selecting alternative treatments, and avoiding agents that could trigger severe reactions. Citations are provided below:
- Goss FR, Zhou L, Plasek JM, Broverman C, Robinson G, Middleton B, Rocha RA. Evaluating standard terminologies for encoding allergy information. J Am Med Inform Assoc. 2013 Sep-Oct;20(5):969-79. doi: 10.1136/amiajnl-2012-000816. Epub 2013 Feb 9. PMID: 23396542; PMCID: PMC3756252.; https://pmc.ncbi.nlm.nih.gov/articles/PMC3756252/
- HL7 AllergyIntolerance – FHIR v5.0.0
* The PACIO (Post-Acute Care Interoperability) Project, established February 2019, is a collaborative effort between industry, government, and other stakeholders, with the goal of establishing a framework for the development of FHIR implementation guides to facilitate health information exchange.
Applicable standards: The PACIO Community also recommends including LOINC as an applicable standard, specifically the LOINC 82606-5 code “Allergy or intolerance criticality”, and the LOINC-based example answer list for criticality, LOINC LL4063-5. HL7 FHIR R4 Allergy Intolerance Criticality, Rx Norm, SNOMED-CT, the National Drug Code (NDC), and LOINC.