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

Data Element

Information from the submission form

Substance (Non-Medication)
Description
This describes allergens that affect clinical care which are not specifically a drug class or medication (i.e. other data elements within the Allergies and Intolerances data class). Examples of non-medication allergens that affect clinical care are latex, eggs, and contrast media.

Comment

Level 2 Data Class: Allergies and Intolerances

Level 2 Data Element: Substance (Non-Medication) While IMO agrees that documentation of non-medication allergies is important in clinical care, we do have concerns regarding maturity and use of the technical specifications cited to support the proposed Level 2 data element submissions in this data class. The following technical specifications are cited to support the proposed level 2 data elements in the Allergies and Intolerances data class:
  • C-CDA Implementation Guidance Conformance (CONF:1098-16324), for Substance or Device Allergy - Intolerance Observation (V2)
  • FHIR US Core Allergy Intolerance Profile: (v1.0.0: STU based on FHIR R3).
  • FHIR US Core Resource Profile: USCore AllergyIntolerance (v5.0.0 Preview CI Build)
The C-CDA specification for Substance or Device Allergy is not widely implemented and therefore does not meet the requirement as a Level 2 data element. The value set referenced in the specification, Substance Reactant for Intolerance OID: 2.16.840.1.113762.1.4.1010.1 is poorly curated. This value set contains over 47,000 codes, includes active pharmaceutical ingredients (single and multiple ingredient drugs and mix of branded and non-proprietary names), drugs used in veterinary medicine to include Ivermectin (Heartgard Plus) and Chlorhexidine Gluconate (Vet One), as well as codes for non-medications. Neither FHIR technical specification meets the critiera for a Level 1 or Level 2 data element as they have not been implemented in production environments. The FHIR R3 US Core Allergy Intolerance Profile references the value set, Substance Other Than Clinical Drug OID: 2.16.840.1.113762.1.4.1010.9. This value set is poorly curated, contains over 21,000 codes that include codes for antibodies, antigens and amino acids in addition to relevant content for non-medications.  It is also worth noting that the v5.0.0 FHIR AllergyIntolerance profile references an entirely different value set Common substances for allergy and intolerance documentation including refutations OID: 2.16.840.1.113762.1.4.1186.8 which includes substances, medications, and food.    IMO does not support the inclusion of Level 2 data elements (Substance (Non-Medication), Substance (Food)) in the Allergies and Intolerances Data Class in USCDI V3 as currently proposed.  IMO does not support the inclusion of Level 2 data elements (Substance (Non-Medication), Substance (Food)) in the Allergies and Intolerances Data Class in USCDI V3 as currently proposed. 

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