EHR System Function and Information Model: Manage Allergy, Intolerance, and Adverse Reactions

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This document outlines the function to manage patient-specific allergy, intolerance, and adverse reaction lists in an Electronic Health Record system. It covers capturing, maintaining, and viewing allergen information over time, including patient-reported events and provider-verified notations. The purpose, description, activities, and conceptual information models related to managing allergies are detailed.


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  1. EHR System Function and Information Model (EHR-S FIM is based on EHR-S FM R2.0) CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List aka DC.1.4.1 in EHR-S FM R1.1 Stephen.Hufnagel@tma.osd.mil , facilitator January 23, 2012 Original February 24, 2012 Last Updated Call for Participation This work is being done by the HL7 EHR Interoperability Work-group, meeting every Tuesday at 4PM ET, dial-in: 1-770-657-9270, Passcode: 510269# The most current artifacts are at: http://wiki.hl7.org/index.php?title=EHR_Interoperability_WG 10/5/2024 DRAFT WORKING DOCUMENT 1

  2. CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List Statement: The purpose of this function is to Manage patient-specific allergy, intolerance and adverse reaction lists. Description: Allergens, including immunizations, and substances are identified and coded (whenever possible) and the list is captured and maintained over time. All pertinent dates, including patient-reported events, are stored and the description of the patient allergy and adverse reaction is modifiable over time. The entire allergy history, including reaction, for any allergen is viewable. The list(s) includes all reactions including those that are classifiable as a true allergy, intolerance, side effect or other adverse reaction to drug, food or environmental triggers. Notations indicating whether item is patient reported and/or provider verified are maintained. Example: (Notional Scenario) During an encounter, a health care professional might manage a patient s Allergy, Intolerance and Adverse Reaction List, according to scope of practice, organizational policy and/or jurisdictional law. DRAFT WORKING DOCUMENT RED: delete, Blue: insert 10/5/2024 2

  3. CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List Activities Mapped-to System-Components act CP.1.2 ACT Manage Allergy, Intolerance and Adverse Reaction List Manage Records Manage Trusts Manage Business Rules Clinician Activities CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List Manage Events Manage Lists Start Encounter END EHR-S Components List Event is-a is-a Allergy, Intolerance and Adverse Reaction Event Allergy, Intolerance and Adverse Reaction List 10/5/2024 DRAFT WORKING DOCUMENT 3

  4. CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List Conceptual Information Model (CIM) Mapped to EHR-S Functions class CP.1.2 CIM Manage Allergy, Intolerance and Adverse Reaction List List 0..* is-a deoends on depends on Allergy, Intolerance and Adverse Reaction List depends on depends on has-a CPS.9.5 Ad Hoc Query and Rendering CPS.9.3 Health Record Output Clinical Information Event depends on depends on is-a CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List CP.3.3 Manage Clinical Documents and Notes Allergy, Intolerance and Adverse Reaction Event depends on depends on CP.6.2 Manage Immunization Administration CPS.3.9 Clinical Decision Support System Guidelines Updates Record Infrastructure Trust Infrastructure DRAFT WORKING DOCUMENT RED: delete, Blue: insert 10/5/2024 4

  5. CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List Conceptual Data Model (CDM) class CP.1.2 LDM Manage Allergy, Intolerance and Adverse Reaction List Trigger Enumeration Event Event Type Enumeration - - - - - - - - - - - - - - - - - - - change justification circumstances clinical information date (entry) date (occurence) date (review) description duration information reviewed information source information validator location mechanism metadata person-role status time trigger type - - - - - - - - - - - - - - - - - - - - - - advanced directive adverse reaction allergy CDS Alerts CDS reminders CDS update clinical document or note discharge encounter intolerance medication (pharmacist change) medication (prescription dispensing) medication (prescription filling) medication history received (external source) order other procedure registry reminders & alerts report surgical transfer - - - - drug environment food other Person-Role 0..* 0..* - role Role Enumeration - - - - - - - - - - - authenticator author filler guardian other patient prescriber provider relative stakeholder witness + deactivate() + justify() + manage() Allergy, Intolerance and Adverse Reaction type Enumeration List Allergy, Intolerance and Adverse Reaction Event + define sort restrictions() + filter() + link to problem-treatment() + manage() + manage reason for change () + sedine sort criteria() + sort() - - - - - - - adverse reaction allergy intolerance No Known Allergies (NKA) No Known Drug Allergies (NKDA) unable to assess unknown - - - data of review reaction type severity Allergy, Intolerance and Adverse Reaction List 10/5/2024 DRAFT WORKING DOCUMENT 5

  6. CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List CDM Requirements-Traceability req CP.1.2 RT Manage Allergy, Intolerance and Adverse Reaction List CP.1.2#15 The system SHOULD provide the ability to capture and render the approximate date of the allergy occurrence. CP.1.2#19 The system SHOULD provide the ability to capture the reason for Unknown or Unable to Assess Allergies documentation. CP.1.2#24 The system SHOULD provide the ability to link allergic reactions to specific treatment or diagnostic protocols. CP.1.2#22 The system SHOULD tag and render an indicator that interaction checking will not occur against free text allergies. Event - - - - - - - - - - - - - - - - - - - change justification circumstances clinical information date (entry) date (occurence) date (review) description duration information reviewed information source information validator location mechanism metadata person-role status time trigger type CP.1.2#14 They system SHALL provide the ability to capture and render the date on which allergy information was entered. CP.1.2#16 The system SHOULD provide the ability to manage allergy information as coded data. CP.1.2#07 The system SHOULD provide the ability to manage the source of allergy, intolerance, and adverse reaction information. CP.1.2#21 The system SHOULD provide the ability to capture free text allergies and render them in a manner that distinguishes them from coded allergy entries. CP.1.2#20 The system SHOULD provide the ability to tag records and render to providers that the allergies are Unknown or Unable to Assess Allergies and need to be updated. + deactivate() + justify() + manage() CP.1.2#04 The system SHALL provide the ability to manage the severity of an allergic or adverse reaction as discrete data. CP.1.2#26 The system SHOULD capture information that a provider was presented with and acknowledged a drug interaction notification. CP.1.2#01 The system SHALL provide the ability to manage true allergy, intolerance, and adverse reaction to drug, food or environmental triggers as unique, discrete entries. Encounter CP.1.2#13 The system SHALL provide the ability to tag that the list of medications and other agents has been reviewed. - - - - differential diagnosis disposition follow up needed :boolean follow up results CP.1.2#18 The system SHOULD provide the ability to capture and render that the allergies are Unknown or Unable to Assess Allergies". + manage() CPS.4.2.1 Support for Medication Interaction and Allergy Checking Allergy, Intolerance and Adverse Reaction Event - - - data of review reaction type severity + manage() CP.1.2#25 The system SHOULD conform to function CPS.4.2.1 (Support for Medication Interaction and Allergy Checking) to render any potential interactions when capturing or maintaining allergies, intolerances or adverse reactions. CP.1.2#02 The system SHOULD provide the ability to manage the reason for entry or maintenance (including update or remove) of the allergy, intolerance or adverse reaction. CP.1.2#17 The system SHOULD provide the ability to capture and maintain the required documentation of allergies prior to completion of the medication order. CP.1.2#03 The system SHALL provide the ability to manage the reaction type as discrete data. 6 10/5/2024 DRAFT WORKING DOCUMENT

  7. CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List CDM Requirements-Traceability req CP.1.2 RT Manage Allergy, Intolerance and Adverse Reaction List CP.1.2#12 The system MAY restrict the ability to render the list in a user defined sort order. CP.1.2#11 The system MAY provide the ability to render the list of allergies, intolerances and adverse reactions in a user defined sort order. List CP.1.2#08 The system SHALL provide the ability to tag as deactivated an allergy, intolerance or adverse reaction. + define sort restrictions() + filter() + link to problem-treatment() + manage() + manage reason for change () + sedine sort criteria() + sort() CP.1.2#05 The system SHALL provide the ability to manage a report of No Known Allergies (NKA) for the patient. CP.1.2#10 The system SHALL provide the ability to render allergies, intolerances and adverse reactions that have been deactivated. Allergy, Intolerance and Adverse Reaction List CP.1.2#06 The system SHALL provide the ability to manage a report of No Known Drug Allergies (NKDA) for the patient. CP.1.2#09 The system SHALL provide the ability to capture as discrete data the reason for deactivation of an allergy, intolerance or adverse reaction. CP.1.2#23 The system SHOULD provide the ability to render historical allergy information. 7 10/5/2024 DRAFT WORKING DOCUMENT

  8. CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List Dependencies

  9. Action Verb Hierarches Manage (Data) Manage- Data- Visibility De-Identify Hide Mask Re-Identify Unhide Unmask Capture Maintain Render Exchange Determine Auto- Populate Enter Import Receive Store Update Remove Extract Present Transmit Export Import Receive Transmit Analyze Decide Archive Backup Decrypt Encrypt Recover Restore Save Annotate Attest Edit Harmoniz e Integrate Link Tag Delete Purge 10/5/2024 DRAFT WORKING DOCUMENT 9

  10. CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List Requirements 1. 1. The system SHALL provide the ability to manage true allergy, intolerance, and adverse reaction to drug, food or environmental triggers as unique, discrete entries. 2. 2. The system SHOULD provide the ability to manage the reason for entry or maintenance (including update or remove) of the allergy, intolerance or adverse reaction. 3. 3. The system SHALL provide the ability to manage the reaction type as discrete data. 4. 4. The system SHALL provide the ability to manage the severity of an allergic or adverse reaction as discrete data. 5. 5. The system SHALL provide the ability to manage a report of No Known Allergies (NKA) for the patient. 6. 6. The system SHALL provide the ability to manage a report of No Known Drug Allergies (NKDA) for the patient. 7. 7. The system SHOULD provide the ability to manage the source of allergy, intolerance, and adverse reaction information. 8. 8. The system SHALL provide the ability to tag as deactivated an allergy, intolerance or adverse reaction. 9. 9. The system SHALL provide the ability to capture as discrete data the reason for deactivation of an allergy, intolerance or adverse reaction. DRAFT WORKING DOCUMENT RED: delete, Blue: insert 10 10/5/2024

  11. CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List Requirements 10. 11. The system MAY provide the ability to render the list of allergies, intolerances and adverse reactions in a user defined sort order. 11. The system MAY restrict the ability to render the list in a user defined sort order. 12. 12. The system SHALL provide the ability to tag that the list of medications and other agents has been reviewed. 13. 13. They system SHALL provide the ability to capture and render the date on which allergy information was entered. 14. 14. The system SHOULD provide the ability to capture and render the approximate date of the allergy occurrence. 15. The system SHOULD provide the ability to manage allergy information as coded data. 16. The system SHOULD provide the ability to capture and maintain the required documentation of allergies prior to completion of the medication order. 17. The system SHOULDprovide the ability to capture and render that the allergies are Unknown or Unable to Assess Allergies". 18. The system SHOULDprovide the ability to capture the reason for Unknown or Unable to Assess Allergies documentation. 19. The system SHOULD provide the ability to tag records and render to providers that the allergies are Unknown or Unable to Assess Allergies and need to be updated. DRAFT WORKING DOCUMENT RED: delete, Blue: insert 10/5/2024 11

  12. CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List (Requirements) 20. The system SHOULD provide the ability to capture free text allergies and render them in a manner that distinguishes them from coded allergy entries. 21. The system SHOULD tag and render an indicator that interaction checking will not occur against free text allergies. 22. The system SHOULD provide the ability to render historical allergy information. 23. The system SHOULD provide the ability to link allergic reactions to specific treatment or diagnostic protocols. 24. The system SHOULD conform to function CPS.4.2.1 (Support for Medication Interaction and Allergy Checking) to render any potential interactions when capturing or maintaining allergies, intolerances or adverse reactions. 25. The system SHOULD capture information that a provider was presented with and acknowledged a drug interaction notification. DRAFT WORKING DOCUMENT RED: delete, Blue: insert 10/5/2024 12

  13. CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List Dependencies CPS.3.9 Clinical Decision Support System Guidelines Updates CPS.4.2 Support for Medication and Immunization Ordering CPS.9.3 Health Record Output CPS.9.5 Ad Hoc Query and Report Generation OVERARCHING: Trust Infrastructure Record Infrastructure

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