| 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 |
|
| Maturity of Use and Technical Specifications for Data Element | |
| Applicable Standard(s) | SNOMED Substance Hierarchy. This code system is already referenced in the C-CDA Implementation Guidance (see conformance CONF:1098-16324). It is already support in the Value Set Authority Center through value set "Substance Reactant for Intolerance" (https://vsac.nlm.nih.gov/valueset/2.16.840.1.113762.1.4.1010.1/expansion) . This information is also supported in FHIR http://hl7.org/fhir/us/core/stu1/ValueSet-us-core-substance-sct.html https://vsac.nlm.nih.gov/valueset/2.16.840.1.113762.1.4.1010.1/expansion |
| Additional Specifications | C-CDA 2.1 FHIR US Core Allergy Intolerance Profile (http://hl7.org/fhir/us/core/stu1/ValueSet-us-core-substance-sct.html) |
| Current Use | Extensively used in production environments |
| 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. |
| 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. |
| Other Implementation Challenges | None |
Harmful or undesired physiological responses associated with exposure to a substance.
Data Element |
Additional Information |
|---|---|
| Substance (Non-Medication)
Description
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
|
Submitted by aphillips@imoh… on 2022-04-28
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.