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 11/29/2018 DRAFT WORKING DOCUMENT

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. 11/29/2018 RED: delete, Blue: insert DRAFT WORKING DOCUMENT

DRAFT WORKING DOCUMENT CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List Activities Mapped-to System-Components 11/29/2018 DRAFT WORKING DOCUMENT

CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List Conceptual Information Model (CIM) Mapped to EHR-S Functions RED: delete, Blue: insert 11/29/2018 DRAFT WORKING DOCUMENT

DRAFT WORKING DOCUMENT CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List Conceptual Data Model (CDM) 11/29/2018 DRAFT WORKING DOCUMENT

DRAFT WORKING DOCUMENT CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List CDM Requirements-Traceability 11/29/2018 DRAFT WORKING DOCUMENT

DRAFT WORKING DOCUMENT CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List CDM Requirements-Traceability 11/29/2018 DRAFT WORKING DOCUMENT

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

Action Verb Hierarches Manage (Data) Capture Maintain Render Exchange Determine Manage- Data- Visibility Auto-Populate Enter Import Receive Store Update Remove Extract Present Transmit Export Analyze Decide De-Identify Hide Mask Re-Identify Unhide Unmask Archive Backup Decrypt Encrypt Recover Restore Save Annotate Attest Edit Harmonize Integrate Link Tag Delete Purge 11/29/2018 DRAFT WORKING DOCUMENT

CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List Requirements 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. 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. The system SHALL provide the ability to manage the reaction type as discrete data. 4. The system SHALL provide the ability to manage the severity of an allergic or adverse reaction as discrete data. 5. The system SHALL provide the ability to manage a report of No Known Allergies (NKA) for the patient. 6. The system SHALL provide the ability to manage a report of No Known Drug Allergies (NKDA) for the patient. 7. The system SHOULD provide the ability to manage the source of allergy, intolerance, and adverse reaction information. 8. The system SHALL provide the ability to tag as deactivated an allergy, intolerance or adverse reaction. 9. The system SHALL provide the ability to capture as discrete data the reason for deactivation of an allergy, intolerance or adverse reaction. RED: delete, Blue: insert DRAFT WORKING DOCUMENT 11/29/2018

CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List Requirements 11. The system MAY provide the ability to render the list of allergies, intolerances and adverse reactions in a user defined sort order. The system MAY restrict the ability to render the list in a user defined sort order. 12. The system SHALL provide the ability to tag that the list of medications and other agents has been reviewed. 13. They system SHALL provide the ability to capture and render the date on which allergy information was entered. 14. The system SHOULD provide the ability to capture and render the approximate date of the allergy occurrence. The system SHOULD provide the ability to manage allergy information as coded data. The system SHOULD provide the ability to capture and maintain the required documentation of allergies prior to completion of the medication order. The system SHOULD provide the ability to capture and render that the allergies are “Unknown” or “Unable to Assess Allergies". The system SHOULD provide the ability to capture the reason for “Unknown” or “Unable to Assess Allergies” documentation. 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. 11/29/2018 RED: delete, Blue: insert DRAFT WORKING DOCUMENT

CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List (Requirements) The system SHOULD provide the ability to capture free text allergies and render them in a manner that distinguishes them from coded allergy entries. The system SHOULD tag and render an indicator that interaction checking will not occur against free text allergies. The system SHOULD provide the ability to render historical allergy information. The system SHOULD provide the ability to link allergic reactions to specific treatment or diagnostic protocols. 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. The system SHOULD capture information that a provider was presented with and acknowledged a drug interaction notification. 11/29/2018 RED: delete, Blue: insert DRAFT WORKING DOCUMENT

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