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 R1.1Stephen.Hufnagel@tma.osd.mil , facilitator

January 23, 2012 – OriginalFebruary 24, 2012 – Last Updated

04/22/2023 DRAFT WORKING DOCUMENT 1

Call for ParticipationThis 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

CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List

04/22/2023 DRAFT WORKING DOCUMENT 2

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.

RED: delete, Blue: insert

CP.1.2 Manage Allergy, Intolerance and Adverse Reaction ListActivities Mapped-to System-Components

04/22/2023 DRAFT WORKING DOCUMENT 3

act CP.1.2 ACT Manage Allergy, Intolerance and Adv erse Reaction List

CP.1.2 Manage Allergy, Intolerance and Adv erse Reaction List

Manage Ev ents Manage Lists

Start END

Manage Records Manage Trusts Manage Business Rules

Allergy, Intolerance and Adverse

Reaction Ev ent

Allergy, Intolerance and Adv erse Reaction List

EHR-S Com

ponents

ListEv ent

Clinician Activities

Encounter

is-ais-a

CP.1.2 Manage Allergy, Intolerance and Adverse Reaction ListConceptual Information Model (CIM) Mapped to EHR-S Functions

04/22/2023 DRAFT WORKING DOCUMENT 4RED: delete, Blue: insert

class CP.1.2 CIM Manage Allergy, Intolerance and Adv erse Reaction List

CP.3.3 Manage Clinical Documents and Notes

CPS.9.3 Health Record Output

CPS.9.5 Ad Hoc Query and Rendering

CPS.3.9 Clinical Decision Support System Guidelines Updates

CP.6.2 Manage Immunization Administration

CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List

Allergy, Intolerance and Adverse Reaction List

Allergy, Intolerance and Adverse Reaction Event

Ev ent

List

Clinical Information

Record Infrastructure Trust Infrastructure

depends on

depends on

has-a

0..*

depends on

is-a

depends ondepends on

is-a deoends on

depends ondepends on

CP.1.2 Manage Allergy, Intolerance and Adverse Reaction ListConceptual Data Model (CDM)

04/22/2023 DRAFT WORKING DOCUMENT 5

class CP.1.2 LDM Manage Allergy, Intolerance and Adv erse Reaction List

Allergy, Intolerance and Adv erse Reaction List

Allergy, Intolerance and Adv erse Reaction Ev ent

- data of review- reaction type- severity

Ev ent

- 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

+ deactivate()+ justify()+ manage()

Allergy, Intolerance and Adverse Reaction type Enumeration

- adverse reaction- allergy- intolerance- No Known Allergies (NKA) - No Known Drug Allergies (NKDA)- unable to assess- unknown

Person-Role

- role

Ev ent Type Enumeration

- 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 fil l ing)- medication history received (external source)- order- other- procedure- registry- reminders & alerts- report- surgical- transfer

Role Enumeration

- authenticator- author- fil ler- guardian- other- patient- prescriber- provider- relative- stakeholder- witness

Trigger Enumeration

- drug- environment- food- other

List

+ define sort restrictions()+ fi l ter()+ link to problem-treatment()+ manage()+ manage reason for change ()+ sedine sort criteria()+ sort()

0..*0..*

04/22/2023 DRAFT WORKING DOCUMENT 6

CP.1.2 Manage Allergy, Intolerance and Adverse Reaction ListCDM Requirements-Traceability

req CP.1.2 RT Manage Allergy, Intolerance and Adv erse Reaction List

Allergy, Intolerance and Adverse Reaction Ev ent

- data of review- reaction type- severity

+ manage()

Ev ent

- change justi fication- circumstances- cl inical information- date (entry)- date (occurence)- date (review)- description- duration- information reviewed- information source- information validator- location- mechanism- metadata- person-role- status- time- trigger- type

+ deactivate()+ justify()+ manage()

CP.1.2#13 The system SHALL provide the abili ty to tag that the list of medications and other agents has been reviewed.

CP.1.2#01 The system SHALL provide the abi lity to manage true al lergy, intolerance, and adverse reaction to drug, food or environmental triggers as unique, discrete entries.

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#03 The system SHALL provide the abi lity to manage the reaction type as discrete data.

CP.1.2#04 The system SHALL provide the abi lity to manage the severity of an allergic or adverse reaction as discrete data.

CP.1.2#07 The system SHOULD provide the abi lity to manage the source of al lergy, intolerance, and adverse reaction information.

CP.1.2#14 They system SHALL provide the abili ty to capture and render the date on which allergy information was entered.

CP.1.2#15 The system SHOULD provide the abili ty to capture and render the approximate date of the allergy occurrence.

CP.1.2#16 The system SHOULD provide the abi lity to manage allergy information as coded data.

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#18 The system SHOULD provide the ability to capture and render that the allergies are “Unknown” or “Unable to Assess Allergies".

CP.1.2#19 The system SHOULD provide the abi lity to capture the reason for “Unknown” or “Unable to Assess Allergies” documentation.

CP.1.2#20 The system SHOULD provide the abili ty to tag records and render to providers that the al lergies are “Unknown” or “Unable to Assess Allergies” and need to be updated.

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#22 The system SHOULD tag and render an indicator that interaction checking will not occur against free text allergies.

CP.1.2#24 The system SHOULD provide the abi lity to link al lergic reactions to specific treatment or diagnostic protocols.

CP.1.2#25 The system SHOULD conform to function CPS.4.2.1 (Support for Medication Interaction and Al lergy Checking) to render any potential interactions when capturing or maintaining allergies, intolerances or adverse reactions.

CP.1.2#26 The system SHOULD capture information that a provider was presented with and acknowledged a drug interaction notification.

Encounter

- differential diagnosis- disposition- follow up needed :boolean- follow up results

+ manage()

CPS.4.2.1 Support for Medication Interaction and Allergy Checking

04/22/2023 DRAFT WORKING DOCUMENT 7

CP.1.2 Manage Allergy, Intolerance and Adverse Reaction ListCDM Requirements-Traceability

req CP.1.2 RT Manage Allergy, Intolerance and Adverse Reaction List

Allergy, Intolerance and Adverse Reaction List

List

+ define sort restrictions()+ fi lter()+ 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#06 The system SHALL provide the abil ity to manage a report of No Known Drug Allergies (NKDA) for the patient.

CP.1.2#08 The system SHALL provide the abil ity to tag as deactivated an allergy, intolerance or adverse reaction.

CP.1.2#09 The system SHALL provide the abil i ty to capture as discrete data the reason for deactivation of an allergy, intolerance or adverse reaction.

CP.1.2#10 The system SHALL provide the ability to render allergies, intolerances and adverse reactions that have been deactivated.

CP.1.2#11 The system MAY provide the abili ty to render the list of al lergies, intolerances and adverse reactions in a user defined sort order.

CP.1.2#12 The system MAY restrict the abili ty to render the l ist in a user defined sort order.

CP.1.2#23 The system SHOULD provide the abi li ty to render historical al lergy information.

CP.1.2 Manage Allergy, Intolerance and Adverse Reaction ListDependencies

class CP.1.2 DEP Manage Allergy, Intolerance and Adverse Reaction List

CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List

CP.6.2 Manage Immunization Administration

CPS.3.9 Clinical Decision Support System Guidelines Updates

CPS.9.5 Ad Hoc Query and Rendering CPS.9.3 Health Record

Output

CP.3.3 Manage Clinical Documents and Notes

Record Infrastructure

+ RI.1 Record Lifecycle and Lifespan+ RI.2 Record Synchronization

+ RI.3 Record Archive and Restore

Trust Infrastructure

+ TI.1 Security+ TI.2 Audit

+ TI.3 Registry and Directory Services+ TI.4 Standard Terminology and Terminology Services

+ TI.5 Standards-Based Interoperabil ity

+ TI.6 Business Rules Management+ TI.7 Workflow Management

+ TI.8 Database Backup and Recovery

+ TI.9 System Management Operations and Performance

CP, CPS & AS

depend on

Action Verb Hierarches

04/22/2023 DRAFT WORKING DOCUMENT 9

Manage (Data)Capture Maintain Render Exchange Determine

Manage-Data-

VisibilityAuto-PopulateEnterImportReceive

Store Update Remove Extract Present Transmit ExportImportReceiveTransmit

Analyze Decide De-IdentifyHideMaskRe-IdentifyUnhideUnmask

ArchiveBackupDecryptEncryptRecoverRestoreSave

AnnotateAttestEditHarmonizeIntegrateLinkTag

DeletePurge

04/22/2023 DRAFT WORKING DOCUMENT 10

CP.1.2 Manage Allergy, Intolerance and Adverse Reaction ListRequirements

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.

RED: delete, Blue: insert

04/22/2023 DRAFT WORKING DOCUMENT 11

CP.1.2 Manage Allergy, Intolerance and Adverse Reaction ListRequirements

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 SHOULD provide the ability to capture and render that the allergies are “Unknown” or

“Unable to Assess Allergies".18. The system SHOULD provide 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.

RED: delete, Blue: insert

04/22/2023 DRAFT WORKING DOCUMENT 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.

RED: delete, Blue: insert

CP.1.2 Manage Allergy, Intolerance and Adverse Reaction ListDependencies

• 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