Non-pharmacologic agent believed to cause a harmful or undesired physiologic response following exposure.
Examples include but are not limited to latex, eggs, pollen, and peanuts.
Applicable Vocabulary Standard(s)
Applicable Standards
Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) U.S. Edition, September 2022 Release
Submitted By: John D'Amore
/ Diameter Health
Data Element Information
Rationale for Separate Consideration
The data elements of drug class and medications do not cover all related allergies to clinical care. Latex will affect the use of products in the provisions of healthcare. Eggs may affect the selection of certain vaccines. Contrast media is important in the provision of specific imaging procedures.
Use Case Description(s)
Use Case Description
Non-medication allergies are important in the provision of clinical care. They may affect the selection of healthcare products used in services (e.g. latex for glove use and contrast media in imaging procedures) as well as the selection of specific medication or immunization therapies (e.g. egg allergies in vaccine selection and dust, mold or pollen for allergy medication selection). In addition, this data element could include food allergies, which may affect food service preparation for inpatient or custodial facilities.
Estimated number of stakeholders capturing, accessing using or exchanging
It is estimated that the over 4,000 hospitals as well as the vast majority of ambulatory care settings already record, capture and transmit information related to non-medication allergies.
Healthcare Aims
Improving patient experience of care (quality and/or satisfaction)
Improving the health of populations
Maturity of Use and Technical Specifications for Data Element
This data is in support of the advancement of non-medication allergies for inclusion in the United States Core Data for Interoperability under the Data Class of Allergies and Intolerances.
As part of a research project sponsored by the National Committee of Quality Assurance (NCQA) and a regional health information exchange in New York, Diameter Health was requested to examine data included in clinical documents, such as C-CDA, for 474 distinct facilities in 2020. These clinical documents are shared through health information exchange with other healthcare organizations routinely, in part to fulfill requirements for use of certified health information technology to record and transmit data related to USCDI. These facilities represented a mix of ambulatory care, inpatient and post-acute settings in New York. The project was sponsored as part of the emerging program for Data Aggregator Validation (DAV) launched by NCQA (https://www.ncqa.org/programs/data-and-information-technology/hit-and-data-certification/hedis-compliance-audit-certification/data-aggregator-validation/). These comments represent the perspective of Diameter Health and are not meant to represent the opinions, perspectives or policy of any other organization.
Over the data analysis of 474 organizations, over 80% of organizations recorded substance and food allergies in some patient records. The most common allergies were: latex, contrast media, shellfish, adhesive tape, dust, tree nuts, eggs, bees, pollen and peanuts. UNII and SNOMED were often used for these allergy observations in addition to free text, locally developed coding systems and other national vocabularies. In addition, prior work by HL7 has also profiled the frequency of allergies, which also includes non-medication allergies (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=482)
Diameter Health works with over 20 health information exchanges nationally as well as an array of health plans, health information technology vendors and governmental entities. The findings shared as part of this research supports observations from other clients.
While these allergies are commonly recorded, they are not currently part of the USCDI since they do not qualify as medication or drug class allergies. Diameter Health supports the addition of a new data element (or alternatively an expansion of existing elements) for the inclusion of this data in the USCDI. We believe that the recording and transmission of this information will improve patient safety as well as clinical decision making. We believe that the data from the field shows that this information is already widely recorded and exchanged among healthcare organizations. Please feel welcome to reach out if it would be helpful to share more details or to answer questions regarding this comment.
Number of organizations/individuals with which this data element has been electronically exchanged
5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders.
Supporting Artifacts
This data is in support of the advancement of non-medication allergies for inclusion in the United States Core Data for Interoperability under the Data Class of Allergies and Intolerances.
As part of a research project sponsored by the National Committee of Quality Assurance (NCQA) and a regional health information exchange in New York, Diameter Health was requested to examine data included in clinical documents, such as C-CDA, for 474 distinct facilities in 2020. These clinical documents are shared through health information exchange with other healthcare organizations routinely, in part to fulfill requirements for use of certified health information technology to record and transmit data related to USCDI. These facilities represented a mix of ambulatory care, inpatient and post-acute settings in New York. The project was sponsored as part of the emerging program for Data Aggregator Validation (DAV) launched by NCQA (https://www.ncqa.org/programs/data-and-information-technology/hit-and-data-certification/hedis-compliance-audit-certification/data-aggregator-validation/). These comments represent the perspective of Diameter Health and are not meant to represent the opinions, perspectives or policy of any other organization.
Over the data analysis of 474 organizations, over 80% of organizations recorded substance and food allergies in some patient records. The most common allergies were: latex, contrast media, shellfish, adhesive tape, dust, tree nuts, eggs, bees, pollen and peanuts. UNII and SNOMED were often used for these allergy observations in addition to free text, locally developed coding systems and other national vocabularies. In addition, prior work by HL7 has also profiled the frequency of allergies, which also includes non-medication allergies (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=482)
Diameter Health works with over 20 health information exchanges nationally as well as an array of health plans, health information technology vendors and governmental entities. The findings shared as part of this research supports observations from other clients.
While these allergies are commonly recorded, they are not currently part of the USCDI since they do not qualify as medication or drug class allergies. Diameter Health supports the addition of a new data element (or alternatively an expansion of existing elements) for the inclusion of this data in the USCDI. We believe that the recording and transmission of this information will improve patient safety as well as clinical decision making. We believe that the data from the field shows that this information is already widely recorded and exchanged among healthcare organizations. Please feel welcome to reach out if it would be helpful to share more details or to answer questions regarding this comment.
Potential Challenges
Restrictions on Standardization (e.g. proprietary code)
None
Restrictions on Use (e.g. licensing, user fees)
None
Privacy and Security Concerns
None
Estimate of Overall Burden
Adding this data element will add modest overhead for terminology support. While many systems already support terminologies like SNOMED and UNII that can record non-medication allergies, some track this information as free text (e.g. "Latex" rather than a reference to the specific SNOMED code). Clinicians routinely record and transmit this information today since it is important in the provision of safe and effective patient care.
The Texas Health Informatics Alliance (THIA) Policy and Standards Working Group supports the proposal for substance (non-medication). This has been very frustrating for nurses. Some organizations have determined that having the unit PharmD is vital to the success of this effort, which is very costly. Moreover, allergies are currently part of free-text search and the proposed standard would make these into an actual code that is much easier for medical professionals.
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 DrugOID: 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: 2.16.840.1.113762.1.4.1186.8which 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.
Submitted by hswmin on 2023-04-14
Allergies and Intolerances: Substance (Non-Medication)
The Texas Health Informatics Alliance (THIA) Policy and Standards Working Group supports the proposal for substance (non-medication). This has been very frustrating for nurses. Some organizations have determined that having the unit PharmD is vital to the success of this effort, which is very costly. Moreover, allergies are currently part of free-text search and the proposed standard would make these into an actual code that is much easier for medical professionals.