Transcript Document
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
[email protected] , 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
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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.
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CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List
Activities Mapped-to System-Components
act CP.1.2 ACT Manage Allergy, Intolerance and Adv erse Reaction List
Encounter
Clinician Activities
Manage Records
Manage Trusts
Manage Business
Rules
CP.1.2 Manage Allergy, Intolerance and Adv erse Reaction List
Manage Ev ents
Manage Lists
EHR-S Components
Start
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END
Ev ent
List
is-a
is-a
Allergy, Intolerance
and Adv erse
Reaction Ev ent
Allergy, Intolerance
and Adv erse
Reaction List
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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 Adv erse Reaction List
List
0..*
is-a
has-a
Clinical
Information
deoends on
Allergy, Intolerance and
Adv erse Reaction List
depends on
depends on
CPS.9.5 Ad Hoc
Query and Rendering
Ev ent
depends on
is-a
Allergy, Intolerance and
Adv erse Reaction Ev ent
depends on
CPS.9.3 Health
Record Output
depends on
CP.1.2 Manage Allergy,
Intolerance and Adverse
Reaction List
CP.3.3 Manage Clinical
Documents and Notes
CP.6.2 Manage
Immunization
Administration
CPS.3.9 Clinical Decision
Support System Guidelines
Updates
depends on
Record Infrastructure
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depends on
Trust Infrastructure
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CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List
Conceptual Data Model (CDM)
class CP.1.2 LDM Manage Allergy, Intolerance and Adv erse Reaction List
Trigger
Enumeration
-
Ev ent
drug
environment
food
other
Person-Role
-
role
0..*
0..*
Role Enumeration
-
authenticator
author
filler
guardian
other
patient
prescriber
provider
relative
stakeholder
witness
Allergy, Intolerance and Adv erse
Reaction type Enumeration
-
adverse reaction
allergy
intolerance
No Known Allergies (NKA)
No Known Drug Allergies (NKDA)
unable to assess
unknown
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Ev ent 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
+
+
+
deactivate()
justify()
manage()
-
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
List
Allergy, Intolerance and
Adv erse Reaction Ev ent
-
data of review
reaction type
severity
Allergy, Intolerance
and Adv erse
Reaction List
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+
+
+
+
+
+
+
define sort restrictions()
filter()
link to problem-treatment()
manage()
manage reason for change ()
sedine sort criteria()
sort()
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CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List
CDM Requirements-Traceability
req CP.1.2 RT Manage Allergy, Intolerance and Adv erse Reaction List
CP.1.2#15 T he system
SHOULD provide the ability
to capture and render the
approximate date of the
allergy occurrence.
Ev ent
CP.1.2#14 T hey system
SHALL provide the ability to
capture and render the date
on which allergy information
was entered.
CP.1.2#20 T he 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.
CP.1.2#13 T he system
SHALL provide the ability to
tag that the list of
medications and other
agents has been reviewed.
-
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()
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CP.1.2#24 T he system
SHOULD provide the ability
to link allergic reactions to
specific treatment or
diagnostic protocols.
CP.1.2#22 T he system
SHOULD tag and render an
indicator that interaction
checking will not occur
against free text allergies.
CP.1.2#16 T he system
SHOULD provide the ability
to manage allergy
information as coded data.
CP.1.2#07 T he system
SHOULD provide the ability
to manage the source of
allergy, intolerance, and
adverse reaction
information.
CP.1.2#21 T he 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#04 T he system
SHALL provide the ability to
manage the severity of an
allergic or adverse reaction
as discrete data.
CP.1.2#26 T he system
SHOULD capture
information that a provider
was presented with and
acknowledged a drug
interaction notification.
CP.1.2#01 T he system
SHALL provide the ability to
manage true allergy,
intolerance, and adverse
reaction to drug, food or
environmental triggers as
unique, discrete entries.
Encounter
-
differential diagnosis
disposition
follow up needed :boolean
follow up results
+
manage()
CPS.4.2.1 Support for
Medication Interaction and
Allergy Checking
CP.1.2#25 T he 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#19 T he system
SHOULD provide the ability
to capture the reason for
“Unknown” or “Unable to
Assess Allergies”
documentation.
CP.1.2#18 T he system
SHOULD provide the ability
to capture and render that
the allergies are “Unknown”
or “Unable to Assess
Allergies".
Allergy, Intolerance and
Adv erse Reaction Ev ent
-
data of review
reaction type
severity
+
manage()
CP.1.2#02 T he 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 T he system
SHOULD provide the ability
to capture and maintain the
required documentation of
allergies prior to completion
of the medication order.
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CP.1.2#03 T he system
SHALL provide the ability to
manage the reaction type as
discrete data.
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CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List
CDM Requirements-Traceability
req CP.1.2 RT Manage Allergy, Intolerance and Adv erse 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()
Allergy, Intolerance
and Adv erse
Reaction List
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.
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#23 The system
SHOULD provide the ability
to render historical allergy
information.
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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.
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CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List
Dependencies
Action Verb Hierarches
Manage (Data)
Capture
AutoPopulate
Enter
Import
Receive
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Maintain
Render
Store
Update
Remove Extract
Archive
Backup
Decrypt
Encrypt
Recover
Restore
Save
Annotate
Attest
Edit
Harmoniz
e
Integrate
Link
Tag
Delete
Purge
Present
Exchange
Transmit
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Export
Import
Receive
Transmit
Determine
Analyze
Decide
ManageDataVisibility
De-Identify
Hide
Mask
Re-Identify
Unhide
Unmask
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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.
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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 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.
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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.
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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