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.

Comment

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.

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