EHR System Function and Information Model (EHR-S FIM) Release 2.1 Prototype HL7 Project ID# 688

EHR System Function and Information Model
(EHR-S FIM) Release 2.1 Prototype
HL7 Project ID# 688

EHR-S FIM Immunization Capability
Executive Summary
Stephen.Hufnage.ctrl@tma.osd.mil , EHR WG facilitator
Nancy.Orvis@tma.osd.mil , DoD Point‐of‐Contact
February 9, 2012 – Original
March 1, 2012 – Last Update

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

3/1/2012 DRAFT WORKING DOCUMENT 1

Executive Summary
For EHR-S FIM Release 2.1, this prototype had the purpose to
1) add conceptual information and data models for each EHR-S function
• make the EHR-S FM easier to use for analysts and engineers
• verify and validate EHR-S FM Release 2.0
2) Service Aware Interoperability Framework (SAIF) DSTU demonstration
3) Support specific profiles (e.g., WG project DAMs, DIMs, DCMs).
The plan is to use the Sparx Enterprise Architect modeling tool to represent the
EHR-S FIM and then generate appropriate views, reports, XML and HTML
renderings of each EHR-S function’s scenarios, requirements, actors,
actions/activities, dependencies, business rules, information & data models.
The DoD-VA Joint Immunization Capability (JIC), HL7 EHR Diabetes project,
ISO 13940 Continuity-of-Care harmonization are proposed as a set of
demonstration prototypes of increasing complexity.

EHR‐S FM Release 2.0 Sections

• Overarching (O) – reference to Record and Trust Infrastructure
• Care Provision (CP) - 9 major subsections
• Care Provision Support (CPS) – 9 major subsections
• Population Health Support (POP) – 10 major subsections
• Administrative Support (AS) – 9 major subsections
• Record Infrastructure (RI) – 3 major subsections
• Trust Infrastructure (TI) – 9 major subsections


CP.6.2 Manage Immunization Administration

Statement: Capture and maintain discrete data concerning immunizations given to a patient including date
administered, type, manufacturer, lot number, and any allergic or adverse reactions. Facilitate the
interaction with an immunization registry to allow maintenance of a patient’s immunization history.

Description: During an encounter, recommendations based on accepted immunization schedules are
presented to the provider. Allergen and adverse reaction histories are checked prior to giving the
immunization. If an immunization is administered, discrete data elements associated with the immunization
including date, type, manufacturer and lot number are recorded. Any new adverse or allergic reactions are
noted. If required, a report is made to the public health immunization registry or other organization (e.g.
military unit commander, refugee program leadership).

Example: (Notional Scenario) During an encounter, recommendations based on accepted immunization
schedules and previous adverse or allergic reactions are presented to the provider. If an immunization is
administered, discrete data elements associated with the immunization are recorded and any new adverse
or allergic reactions are noted. Patient demographic information is harmonized with and reports are made
to the appropriate public health immunization registries and organizations (e.g., PHRs, schools), according
to scope of practice, organizational policy and/or jurisdictional law.

3/1/2012 RED: Recommend deletion, Blue: Recommended Insertion
DRAFT WORKING DOCUMENT 4

Immunization Management Capability
Models
1. CP.6.2 Clinician-Activities Mapped-to System-Components
2. CP.6.2 Conceptual Information Model (CIM) Mapped to EHR-S Functions
3. CIM for Immunization Management Capability
4. Immunization Management Information Exchanges Mapped-to Conformance Criteria (CC)
5. CDM for Advanced Directive
6. CDM for Allergy, Intolerance and Adverse Reaction Event
7. CDM for Clinical Decision Support (CDS)
8. CDM for Clinical Document or Note
9. CDM for Event
10. CDM for Lists
11. CDM for Immunization Event

CIM is Conceptual Information Model
CDM is Conceptual Data Model


EHR‐FIM
Model Legend
class Legend
linician Perspective

Activ ity associated w ith EHR-S Function

control flow Task w ithin Activ ity control fl ow

Start Acti vi ty End Activi ty
C

depends on

depends on
EH -S C ponent

Syatem Component 3 system component 4
System Component
om

+ attri bute 2 [SHALL CC]
- attri bute 1 [SHOULD or MAY CC] has-a i s-a (type)
aggregati on generali zati on
R

+ operati on [SHALL CC]() associ ati on
- operati on 2 [SHOULD or MAY CC]() System Component 2

«trace»
EH -S Function

FEAT URE: depends on FEAT URE 2
EHR-S Functi on
R

real izati on
"impl ements"

REQUIREMENT :
Conformance
Cri teri a


Description of Model Diagrams

The “Clinician-Activities Mapped to System-Components” show
• Row 1: operational activities performed by the clinician, indicating dependencies on
• Row 2: The EHR System components, which support the clinician’s activities.

The “CIM Mapped to EHR-S Functions” show
• System Components mapped to the defining EHR-S Functions

The Conceptual Data Model shows
• Attributes & operations for each System Component.

The “Information Exchanges Mapped-to Conformance Criteria” show
• Basis for information exchanges

CDM Requirements-Traceability Shows
• Derivation of attributes and operations for each Component


Clinician‐Activities Mapped‐to EHR‐S Components
act CP.6.2 ACT Manage Immunization Administration

Manage Records Manage Trusts Manage Business
Rules

depends on depends on depends on
C lin ic ia n


Manage Manage Manage Manage
Manage Manage Manage
Ev ents Immunization Lists Documents &
Start Terminology Regestries Reports End
E n c o u n te r

Schedules Notes

Ev ent Immunization List Document Terminology Registry Report
Schedule or Note
E H R -S C o m p o n e n ts

is-a
is-a ia-a
is-a is-a
Registry -
Allergy, Immunization Immunization List Clinical Document or Note Immunization
Intolerance and Ev ent (Public Health)
Adv erse is-a
Reaction Ev ent
Adv anced Directiv e Ev ent Adv anced Directiv e

3/1/2012 RED: delete, Blue: insert

EHR-S Components Mapped to Supporting Functions
class CP.6.2 CIM Manage Immunization Administration

CP, CPS & AS
Registry
List
Clinical Document or Note

Document or Note

Immunization
Registry (Public AS.4.1 Manage Registry
Health) Communication
Encounter

Immunization List Report Ev ent Terminology

Adv anced Directiv e
document or note

CPS.9.4 Standard Immunization Allergy, Intolerance and
Immunization Report Generation Ev ent Adv erse Reaction Ev ent
History

CPS.1.7.2 Manage Patient
CP.3.2 Manage Patient
Advance Directives
Clinical Measurements


CP.1.6 Manage Immunization List

CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List

Trust Infrastructure Record Infrastructure

3/1/2012 RED: delete, Blue: insert

Conceptual Information Model (CIM)
class CIM Immunization Management Capability

Clinical and Clinical Support System Components

is-a
Registry - Registry EHR System Medical Dev ice
Immunization
(Public Health)
CDS-Clinical
Decision Support
Encounter

Clinical
has-a
Information

0..* 1..* 0..*
has-a has-a
Document or Note Ev ent List
0..*

is-a is-a is-a is-a is-a ia-a
is-a is-a
Report Clinical Document Medication Immunization Allergy, Intolerance
Immunization Medication
or Note Ev ent Ev ent and Adv erse
List List
Reaction Ev ent

is-a is-a is-a

Reminder Adv anced Adv anced Immunization Immunization CDS Allergy, Intolerance Immunization Patients Requiring
or Alert Directiv e Directiv e Ev ent Schedule Witheld Ev ent Update and Adv erse History Follow up List
document or note Reaction List

Template
Terminology Problem List

Record Infrastructure Trust Infrastructure


Information Exchanges Mapped-to Conformance Criteria (CC)
class CP.6.2 IE Manage Immunization Administration

CP.3.3#07 AS.4.1#04

Medical Device EHR System Demographic Registry
Information
other EHR - reminders or alerts (structured) - clinical information
Systems - demographic information
+ manage() - organization (source)
SHALL CCs have
bolded borders. + Manage 'Do Not Recusitste"() - patient
See individual EHR‐S - provider (source)
Function’s slide deck - type
for CC details at:
http://wiki.hl7.org/index.
php?title=EHR_Interop - manage()
erability_WG

is-a

Registry -
AS.4.1#02 AS.4.1#05 AS.4.1#03 AS.4.1#01 Immunization
(Public Health)


Immunization Management Information Exchange
Conformance Criteria (CC) Applicable to Information Exchange
CP.3.3#07 The system SHOULD provide the ability to link encounters, orders, medical equipment, prosthetic/orthotic devices, medications, and notes to one or
more problems (Ref: CP.1.4 [Manage Problem List] cc#9).
AS.4.1#01 The system SHOULD provide the ability to exchange structured demographic and clinical information with registries (e.g., local, disease-specific,
notifiable, patient, provider, organization, or health services registries).
AS.4.1#02 The system MAY provide the ability to render and tag registry information as reviewed and the information's related assessment of validity or
applicability for clinical, financial or administrative activities.
AS.4.1#03 The system SHOULD provide the ability to maintain information received from registries (e.g., local, disease-specific, notifiable, patient, provider,
organization, or health services registries).
AS.4.1#04 The system MAY provide the ability to receive structured demographic and clinical information from registries.
AS.4.1#05 The system SHOULD provide the ability to harmonize system information with registry information.


Advanced Directive
Conceptual Data Model (CDM) Traceable to Conformance Criteria (CC)
class RT Adv anced Directiv e

SHALL CCs have
Ev ent
bolded borders. CPS.1.7.2#03
+ date (occurence)
See individual EHR‐S + time (occurence)
CP.3.3#09

Function’s slide deck - change justification
- circumstances
for CC details at: - clinical information Document or Note
CP.3.3#11

http://wiki.hl7.org/index. - date (entry)
+ authenticator
- date (review)
php?title=EHR_Interop - description
+ author
CP.3.3#10

erability_WG - duration
+
+
date
facility
- information reviewed has-a CP.3.3#02
+ patient
- information source
+ type
- information validator
+ status
- location CP.3.3#03 CP.6.2#02
- mechanism
+ render()
- metadata
+ capture() CP.6.2#06
- person-role CP.3.3#08
+ update()
- status
CPS.1.7.2#01 + tag()
- trigger CP.3.3#05
- type is-a

CP.3.3#07
+ deactivate()
+ justify()
Adv anced Directiv e Type Enumeration CP.3.3#14
+ manage()
- Do Not Recusitate (DNR) Order
- Durable Power of Attorney Clinical Document or CP.3.3#15
- Living Will Note
Adv anced Directiv e Ev ent - other CP.3.3#17
- disposition
- Preferred Interventions for Known Conditions
CPS.1.7.2#02 + advanced directive captured :boolean - signature
+ person completing AD - structured :boolean CP.3.3#04
+ relationship to patient
+ circumstances (of receipt) Adv anced - manage()
CPS.1.7.2#08 CP.3.3#12
+ circumstances (of review) Directiv e Rev iew + render()
+ date (received) + tag()
0..* - circumstances CP.3.3#01
CPS.1.7.2#07 + date (recinded)
- date Adv anced
+ date (review) 0..* is-a
- reviewer Directiv e Author
+ date (signed/completed) CP.3.3#16
+ date (updated) Adv anced
CPS.1.7.2#06 - date signed
+ Review Directiv e
- name CPS.1.7.2#05
+ type
- relationship
- time signed
CPS.1.7.2#04


Advanced Directive
Conformance Criteria (CC) Applicable to This Component
CP.3.3#01 The system SHALL provide the ability to capture and render clinical documentation (henceforth "documentation") including original, update by amendment in order to correct,
and addenda.
CPS.1.7.2#08 The system SHALL provide the ability to manage the date and/or time an advance directives paper document was signed/completed.
CP.3.3#02 The system SHALL provide the ability to capture free text documentation.
CP.3.3#03 The system MAY present documentation templates (structured or free text) to facilitate creating documentation.
CP.3.3#04 The system SHALL provide the ability to present other existing documentation within the patient's EHR while new creating documentation.
CP.3.3#05 The system SHOULD provide the ability to link documentation for a specific patient with a given event (e.g., office visit, phone communication, e-mail consult, lab result).
CP.3.3#07 The system SHOULD provide the ability to link encounters, orders, medical equipment, prosthetic/orthotic devices, medications, and notes to one or more problems (Ref:
CP.1.4 [Manage Problem List] cc#9).
CP.3.3#08 The system SHALL provide the ability to update documentation prior to finalizing it.
CP.3.3#09 The system SHALL provide the ability to tag a document or note as final.
CP.3.3#10 The system SHALL provide the ability to render the author(s) and authenticator(s) of documentation when the documentation is rendered.
CP.3.3#11 The system SHALL provide the ability to render documents based on document metadata (e.g., note type, date range, facility, author, authenticator and patient).
CP.3.3#12 The system MAY provide the ability for providers to capture clinical documentation using standard choices for disposition (e.g., reviewed and filed, recall patient, or future
follow-up).
CP.3.3#14 The system SHOULD provide the ability to render clinical documentation using an integrated charting or documentation tool (e.g., notes, flow-sheets, radiology views, or
laboratory views).
CP.3.3#15 The system MAY provide the ability to capture clinical documentation using specialized charting tools for patient-specific requirements (e.g., age - neonates, pediatrics,
geriatrics; condition - impaired renal function; medication).
CP.3.3#16 The system SHOULD provide the ability to capture, maintain and render transition-of-care related information.
CP.3.3#17 The system SHOULD provide the ability to tag the status of clinical documentation (e.g., preliminary, final, signed).
CP.6.2#02 The system MAY auto-populate the immunization administration record as a by-product of verification of administering provider, patient, medication, dose, route and time
according to scope of practice, organizational policy and/or jurisdictiona
CP.6.2#06 The system SHOULD provide the ability to link standard codes (e.g. NDC, LOINC, SNOMED or CPT) with discrete data elements associated with an immunization.
CPS.1.7.2#01 The system SHALL provide the ability to manage advance directive information including the type of directive, relevant dates (e.g., received, reviewed, rescinded, updated),
circumstances under which the directives were received, and the ...
CPS.1.7.2#02 The system SHALL render an indication that advance directive(s) have been captured.
CPS.1.7.2#03 The system SHALL provide the ability to render the type of advance directives captured for the patient (e.g., living will, durable power of attorney, preferred interventions for
known conditions, or the existence of a "Do Not Resuscitate" ...
CPS.1.7.2#04 The system SHALL provide the ability to manage “Do Not Resuscitate” orders.
CPS.1.7.2#05 The system SHOULD conform to function CPS.2.4 (Support Externally Sourced Clinical Images) in order to capture scanned patient advance directive documents and/or
“Do Not Resuscitate” orders.
CPS.1.7.2#06 The system SHALL provide the ability to manage the date and circumstances of the most recent review of the advanced directives.
CPS.1.7.2#07 The system SHALL provide the ability to manage the name and relationship of the principal completing the advance directive for the patient.


Advanced Directive Allergy, Intolerance and Adverse Reaction Event
class RT Allergy, Intolerance and Adv erse Reaction Ev ent
SHALL CCs have
bolded borders.
Ev ent
See individual EHR‐S
+ date (occurence) Function’s slide deck
+ ti me (occurence)
for CC details at:
- change j usti fi cati on
Clinical - ci rcumstances http://wiki.hl7.org/index.
Information - cl i ni cal i nformati on php?title=EHR_Interop
- type - date (entry)
erability_WG
- date (revi ew)
- descri pti on
- durati on
- i nformati on revi ewed
- i nformati on source
- i nformati on val i dator
- l ocati on
CP.6.2#09 - mechani sm
- metadata
- person-rol e
CP.1.2#04 CP.1.2#25
- status
- tri gger
- type
CP.1.2#16
CP.1.2#07
+ deacti vate()
CP.1.2#17 + j usti fy()
+ manage() CP.1.2#02

CP.1.2#19 i s-a CP.1.2#01

Allergy, Intolerance
CP.1.2#22 and Adv erse CP.1.2#03
Reaction Ev ent

CP.1.2#24 - data of revi ew CP.1.2#18
- reacti on type
- severi ty
CP.1.2#13
CP.1.2#26 - type

+ manage() CP.1.2#21
CP.6.2#04


Advanced Directive Allergy, Intolerance and Adverse Reaction Event
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.
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 ability to manage the reaction type as discrete data.
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#07 The system SHOULD provide the ability to manage the source of allergy, intolerance, and adverse reaction information.
CP.1.2#13 The system SHALL provide the ability to tag that the list of medications and other agents has been reviewed.
CP.1.2#16 The system SHOULD provide the ability 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 ability to capture the reason for “Unknown” or “Unable to Assess Allergies” documentation.
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 ability to link allergic 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 Allergy 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.
CP.6.2#04 The system SHOULD provide the ability to capture, in a discrete field, an allergy/adverse reaction to a specific unization.
CP.6.2#09 The system SHALL conform to function CP.1.2 (Manage Allergy, Intolerance and Adverse Reaction List).


Clinical Decision Support
class RT Clinical Decision Support (CDS)

SHALL CCs have Ev ent
bolded borders. + date (occurence)
See individual EHR‐S + ti m e (occurence)
- change j usti fi cati on
Function’s slide deck - ci rcum stances
for CC details at: - cl i ni cal i nform ati on
http://wiki.hl7.org/index. -
-
date (entry)
date (revi ew)
php?title=EHR_Interop - descri pti on
erability_WG - durati on
- i nform ati on revi ewed
- i nform ati on source
- i nform ati on val i dator
- l ocati on
CPS.3.9#04 - m echani sm
- m etadata
- person-rol e
- status
CDS-Clinical Decision - tri gger
Support - type

CPS.3.9#01 - m ai ntai n() + deacti vate()
+ j usti fy()
+ m anage()

i s-a

CDS Update CPS.3.9#03

- date (update)
- versi on

- m anage() CPS.3.9#02

CDS Content CDS Rules


Clinical Decision Support
CPS.3.9#01 The system SHALL provide the ability to maintain the clinical content or rules utilized to generate clinical decision support reminders and alerts.
CPS.3.9#02 The system SHOULD provide the ability to render information that will allow validation that the most applicable version (of the decision support rules)
is utilized for the update.
CPS.3.9#03 The system SHOULD capture the date of update of the decision support rules.
CPS.3.9#04 The system MAY tag {track} and store {retain} the version used when guidelines are provided in a patient encounter.


class RT Clinical Document or Note

CPS.1.7.2#03
Document or Note

+ authenti cator CPS.1.7.2#01
+ author
Document or Note Type Enumeration + date CP.3.3#11
+ faci l i ty
- addenda CP.3.3#10
+ pati ent
- ori gi nal
+ type
- updated by am endm ent i n order to correct
+ status CP.3.3#02

Document or Note + render() CP.3.3#08
Status Enumeration + capture()
+ update() CP.3.3#09
- fi nal + tag()
- prel i m i nary
CP.3.3#03
- si gned

i s-a
Clinical Document or Template CP.3.3#04
Note Disposition - type
Enumeration CP.3.3#16

- future fol l ow-up
Clinical Document or CP.3.3#14
- recal l pati ent
- revi ewed and fi l es Note
CP.3.3#15
- di sposi ti on
- si gnature
Clinical Document or CP.6.2#06
- structured :bool ean
Note Type Enumeration
- m anage() CP.6.2#02
«enum » + render()
+ ori gi nal + tag() CP.3.3#07
+ addenda
+ update CP.3.3#12
i s-a
CP.3.3#05
Adv anced
SHALL CCs have bolded borders. Directiv e CP.3.3#17
See individual EHR‐S Function’s slide Unstructured
deck for CC details at: Document CP.3.3#01

http://wiki.hl7.org/index.php?title=EHR_Int
eroperability_WG
CPS.1.7.2#04 CPS.1.7.2#05


CP.3.3#01 The system SHALL provide the ability to capture and render clinical documentation (henceforth "documentation") including original, update by
amendment in order to correct, and addenda.
CP.3.3#02 The system SHALL provide the ability to capture free text documentation.
CP.3.3#03 The system MAY present documentation templates (structured or free text) to facilitate creating documentation.
CP.3.3#04 The system SHALL provide the ability to present other existing documentation within the patient's EHR while new creating documentation.
CP.3.3#05 The system SHOULD provide the ability to link documentation for a specific patient with a given event (e.g., office visit, phone communication, e-mail
consult, lab result).
CP.3.3#07 The system SHOULD provide the ability to link encounters, orders, medical equipment, prosthetic/orthotic devices, medications, and notes to one or
more problems (Ref: CP.1.4 [Manage Problem List] cc#9).
CP.3.3#08 The system SHALL provide the ability to update documentation prior to finalizing it.
CP.3.3#09 The system SHALL provide the ability to tag a document or note as final.
CP.3.3#10 The system SHALL provide the ability to render the author(s) and authenticator(s) of documentation when the documentation is rendered.
CP.3.3#11 The system SHALL provide the ability to render documents based on document metadata (e.g., note type, date range, facility, author, authenticator
and patient).
CP.3.3#12 The system MAY provide the ability for providers to capture clinical documentation using standard choices for disposition (e.g., reviewed and filed,
recall patient, or future follow-up).
CP.3.3#14 The system SHOULD provide the ability to render clinical documentation using an integrated charting or documentation tool (e.g., notes, flow-sheets,
radiology views, or laboratory views).
CP.3.3#15 The system MAY provide the ability to capture clinical documentation using specialized charting tools for patient-specific requirements (e.g., age -
neonates, pediatrics, geriatrics; condition - impaired renal function; medication).
CP.3.3#16 The system SHOULD provide the ability to capture, maintain and render transition-of-care related information.
CP.6.2#02 The system MAY auto-populate the immunization administration record as a by-product of verification of administering provider, patient, medication,
dose, route and time according to scope of practice, organizational policy and/or jurisdictiona
CP.6.2#06 The system SHOULD provide the ability to link standard codes (e.g. NDC, LOINC, SNOMED or CPT) with discrete data elements associated with an
immunization.
CPS.1.7.2#01 The system SHALL provide the ability to manage advance directive information including the type of directive, relevant dates (e.g., received,
reviewed, rescinded, updated), circumstances under which the directives were received, and the ...
CPS.1.7.2#03 The system SHALL provide the ability to render the type of advance directives captured for the patient (e.g., living will, durable power of attorney,
preferred interventions for known conditions, or the existence of a "Do Not Resuscitate" ...
CPS.1.7.2#04 The system SHALL provide the ability to manage “Do Not Resuscitate” orders.
CPS.1.7.2#05 The system SHOULD conform to function CPS.2.4 (Support Externally Sourced Clinical Images) in order to capture scanned patient advance
directive documents and/or “Do Not Resuscitate” orders.

Event
class RT Ev ent
SHALL CCs have
bolded borders.
Terminology Clinical
Information See individual EHR‐S
- code set Function’s slide deck
Trigger
- type
Enumeration for CC details at:
+ manage()
- drug CP.1.3#08
- environment php?title=EHR_Interop
- food erability_WG
- other CP.1.3#13

Person-Role Ev ent Type Enumeration
Ev ent CP.1.2#15
- person identifier 1..* 1..* - advanced directive
- role + date (occurence) - adverse reaction
Demographic
+ time (occurence) - allergy
Information CP.1.2#25
- change justification - CDS Alerts
- date & Time - circumstances - CDS reminders
Clinical Document or - clinical information
- identifier - CDS update
Note - date (entry) CPS.3.9#04
- location - clinical document or note
- disposition - date (review) - discharge
- signature - description - encounter
- structured :boolean - duration CP.1.2#14 - intolerance
- information reviewed - medication (pharmacist change)
- manage() - information source - medication (prescription dispensing)
+ render() - information validator - medication (prescription filling)
CP.1.3#10
Demographic + tag() - location - medication history received (external source)
Information - mechanism - order
(structured) - metadata - other
Ev ent-Status - person-role CP.1.3#05
- procedure
Enumeration - status - registry
- trigger - reminders & alerts
- active - type AS.4.1#02 - report
- completed
- deactive - surgical
+ deactivate() - transfer
- erroneously captured + justify() CP.1.6#02
- pending + manage()

Event
CP.1.6#02 The system SHALL provide the ability to manage, as discrete data elements, data associated with any immunization given including date and time of
administration, immunization type and series, lot number and manufacturer, dose and administration
CP.1.3#05 The system SHALL provide the ability to capture medications not reported on existing medication lists or medication histories.
CP.1.3#08 The system SHALL provide the ability to tag a medication as erroneously captured and excluded from the presentation of current medications.
CP.1.3#10 The system SHOULD provide the ability to capture and render information regarding the filling of prescriptions.
CP.1.3#13 The system SHALL provide the ability to capture that a medication history is unavailable or incomplete.
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#15 The system SHOULD provide the ability to capture and render the approximate date of the allergy occurrence.
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.
AS.4.1#02 The system MAY provide the ability to render and tag registry information as reviewed and the information's related assessment of validity or
applicability for clinical, financial or administrative activities.


Lists
class RT List

List CP.1.2#12

CP.1.4#08
- define sort restrictions()
- define sort criteria()
- filter()
- link to problem-treatment() CP.1.2#11
- manage()
CP.3.3#06 - manage reason for change ()
is-a
- sort()
SHALL CCs have
bolded borders.
See individual EHR‐S
ia-a Function’s slide deck
is-a for CC details at:
php?title=EHR_Interop
erability_WG

Immunization List
Allergy, Intolerance
Medication Patients Requiring
and Adv erse + analyze() CP.3.3#18
List Followup List
Reaction List + manage()


Lists
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.
CP.1.2#12 The system MAY restrict the ability to render the list in a user defined sort order.
CP.1.4#08 The system SHOULD provide the ability to render the list in a user defined sort order.
CP.3.3#18 The system SHOULD provide the ability to tag and render lists of patients requiring follow up contact (e.g., laboratory callbacks, radiology callbacks,
left without being seen).
CP.3.3#06 The system SHOULD provide the ability to render the list in a user defined sort order (Ref: CP.1.4 [Manage Problem List] cc#8).


Immunization Event
class RT Immunization Ev ent

CP.1.2#13 CP.1.6#02
Encounter Ev ent

- differential diagnosis + date (occurence)
CP.6.2#17
CP.3.3#12 - disposition + time (occurence) SHALL CCs have
- follow up activities - change justification
- follow up needed :boolean - circumstances
bolded borders.
- follow up results - clinical information See individual EHR‐S CP.6.2#16
CP.6.2#03
- type - date (entry) Function’s slide deck
- date (review)
+ manage() - description for CC details at: CP.6.2#21
CP.3.3#19 has-a - duration http://wiki.hl7.org/index.
- information reviewed
- information source php?title=EHR_Interop CP.6.2#22
CP.3.3#13
1..* - information validator erability_WG
- location
CP.6.2#06
- mechanism
CP.3.3#18 CPS.3.9#04 - metadata
- person-role CP.6.2#02
- status
CP.1.2#20 - trigger is-a
- type CP.6.2#23
Immunization Ev ent

+ deactivate() + date (recommended booster)
+ justify() + immunization type CP.6.2#18
Immunization Future + manage() + series (immunization)
0..*
Booster - dose
- educational information received :boolean CP.6.2#10
- immunization type 0..*
- encounter
- recommended date
- future booster
- healthcare organization CP.6.2#20
health care - immunization order
organisation - immunization provider
- justification-immunization refusal CP.6.2#05
- lot
- manufacturer
- ordered immunization due date CP.6.2#19
- receipt of immunization preference
is-a
Immunization Witheld - receiving entity (educational information)
Ev ent - refusal of vaccine type CP.6.2#01
- route of administration
+ exception reason - time (administration)
+ withholding provider CP.1.6#05
CP.1.6#03 - type


Immunization Event
CP.1.2#13 The system SHALL provide the ability to tag that the list of medications and other agents has been reviewed.
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.
CP.1.6#02 The system SHALL provide the ability to manage, as discrete data elements, data associated with any immunization given including date and time of administration,
immunization type and series, lot number and manufacturer, dose and administration
CP.1.6#03 The system SHALL provide the ability to manage, as discrete elements, data associated with any immunization withheld (including date and time, immunization type, series,
exception reason and immunization-withholding provider).
CP.1.6#05 The system SHALL provide the ability to capture the currently recommended date for an immunization booster dose with each immunization, if needed.
CP.3.3#12 The system MAY provide the ability for providers to capture clinical documentation using standard choices for disposition (e.g., reviewed and filed, recall patient, or future
follow-up).
CP.3.3#13 The system MAY provide the ability to capture, maintain and render the clinician’s differential diagnosis and the list of diagnoses that the clinician has considered in the
evaluation of the patient.
CP.3.3#18 The system SHOULD provide the ability to tag and render lists of patients requiring follow up contact (e.g., laboratory callbacks, radiology callbacks, left without being seen).
CP.3.3#19 The system SHOULD provide the ability to capture patient follow-up contact activities (e.g., laboratory callbacks, radiology callbacks, left without being seen).
CP.6.2#01 The system SHALL provide the ability to capture, maintain and render immunization administration details as discrete data, including:(1) the immunization name/type, strength
and dose;(2) date and time of administration;(3) manufacturer, lot numb
CP.6.2#02 The system MAY auto-populate the immunization administration record as a by-product of verification of administering provider, patient, medication, dose, route and time
according to scope of practice, organizational policy and/or jurisdictiona
CP.6.2#03 The system SHALL provide the ability to determine and render required immunizations, and when they are due, based on widely accepted immunization schedules, when
rendering encounter information.
CP.6.2#05 The system SHALL conform to function CP.3.2 (Manage Patient Clinical Measurements) to capture other clinical data pertinent to the immunization administration (e.g., vital
signs).
CP.6.2#06 The system SHOULD provide the ability to link standard codes (e.g. NDC, LOINC, SNOMED or CPT) with discrete data elements associated with an immunization.
CP.6.2#10 The system SHOULD transmit required immunization administration information to a public health immunization registry according to scope of practice, organizational policy
and/or jurisdictional law.
CP.6.2#16 The system SHALL provide the ability to render the immunization order as written (i.e., exact clinician order language) when rendering administration information.
CP.6.2#17 The system SHALL provide the ability to determine due and overdue ordered immunizations and render a notification.
CP.6.2#18 The system SHALL provide the ability to render a patient educational information regarding the administration (e.g., Vaccine Information Statement (VIS)).
CP.6.2#19 The system SHALL provide the ability to capture that patient educational information (e.g., VIS) was provided at the time of immunization administration.
CP.6.2#20 The system SHALL provide the ability to capture documentation that patient educational information (e.g., VIS) was provided at the time of immunization administration.
CP.6.2#21 The system SHALL provide the ability to capture the receiving entity (e.g., patient, representative, organization) when patient education information is provided at the time of
immunization administration.
CP.6.2#22 The system SHOULD provide the ability to capture and maintain immunization refusal reasons as discrete data.
CP.6.2#23 The system SHOULD provide the ability to capture patient preferences regarding receipt of immunization (e.g. refusal of certain vaccine types) at time of immunization
administration.


Methodology
Sparx Enterprise Architect views were used to create a separate slide set for an
Immunization Management Capability based on of CP.6.2 Manage
Immunization Administration and its “See Also” Dependencies (defined on
“Prototype Scope” Slide) following these steps:
1. Create Component Traceability View for each EHR‐S Function
• Start with applicable reusable components and their data elements
• Based on Conformance Criteria, add additional function‐specific components
• Based on Conformance Criteria, add additional attributes or operations
– Indicate SHALL attributes or operations as “public” with a preceeding “+”
– Indicate SHOULD or MAY attributes or operations as “private” with a preceeding “‐”
2. Create Conceptual Information Model (CIM) view from step 1.
3. Create Conceptual Data Model (CDM) view from step 1.
• Map EHR‐S Components to supporting EHR‐S Functions (“See Also” Dependencies)
4. Create Activity Model for the function.
• Map Activities to EHR‐S Components
5. Create Information Exchanges Mapped‐to Conformance Criteria
This Executive Summary was created from the resultant model.


Issues
1. What is normative within the EHR-S Information Model.
– Activity Diagrams map operational-activities to system components-and-functions.
• Recommend informative
– Conceptual Information Models
• set of components and their relationships? … recommend informative
– Conceptual Data Models (many-to-many mappings from functions-to-components)
• Set of components and their data elements per EHR-S Function … recommend normative
• Distinguish between elements derived from SHALLs vs. those from SHOULDs and MAYs

2. Criteria to determine the “See Also” Dependencies.
– EHR-S Function dependency with other Functions conformance criteria
– Dependency relationship with derived EHR-S Function’s entities
3. How will we represent the Information Model for Ballot.
– Tool generated Graphic representation (e.g., same as Immunization Prototype)
• Will ISO accept this?
– Textural listing of components and data elements similar to
• HITSP/C83 CDA Content Modules and
• HITSP/C154 Data Dictionary

Recommendations

• EHR-S FIM needs the following additional functions and components:
1. Manage Business Rules
2. Clinical Decision Support (CDS)
• Make EHR-S Conceptual Data Model (CDM) Normative
1. Remove data elements (e.g., component attributes) from conformance criteria.
• EHR-S FM CP-section should be hierarchically organized.
1. an EHR-S managing encounters; where,
2. each encounters are sets of events, documents and lists.
3. Finally, events, documents and lists are decomposed into types.
4. Benefits:
• Reduced conformance criteria duplication
• Increased conformance criteria consistency


Conclusions
• EHR-S FIM can be the conceptual foundation for Interoperability
Specifications, refined into:
– HL7 Domain analysis Models (DAMs) and Detailed Clinical Models (DCL)
– Logical Perspectives
– Implementable Perspectives (Physical or Serialiazable Models)
• Messages, Documents, Services

• EHR-S FIM can be composed into higher level capabilities by functional
analysts and system engineers
– Encourage reuse of EHR-S FIM components
– Avoid duplication and “stovepipe applications”
• EHR-S FIM can populate portions of the HL7 SAIF for WGs
– Information and Computational Dimensions
– Conceptual Perspective
• An Enterprise Architecture tool is essential to maintain consistency

Next Steps / To Do / Help Needed
• SMEs verify and validate Conceptual Data Models (CDMs)
• Do the remaining EHR-S Functions
– Overarching (O) – reference to Record and Trust Infrastructure
– Care Provision (CP) - 9 header areas
– Care Provision Support (CPS) – 9 header areas
– Population Health Support (POP) – 10 header areas
– Administrative Support (AS) – 9 header areas
– Record Infrastructure (RI) – 3 header areas
– Trust Infrastructure (TI) – 9 header areas


Reference Information

• Glossary of Key Terms
• HL7 SAIF Enterprise Compliance and Conformance Framework (ECCF)
• EHR-S FIM Verb Hierarchy
• Observations by reviewers
• Backup Slides

EHR-S FM R2 ballot package can be downloaded at:
http://wiki.hl7.org/index.php?title=December_2011_Ballot_Package


Glossary of Terms
• A conceptual information model identifies the highest-level concepts in a domain and the relationships between each
concept; however, no attributes are specified and no primary key is specified. Conceptual models are typically human
readable though there are ways to build conceptual models that systems can process, such as, the Web Ontology
Language (OWL). http://www.w3.org/TR/owl-features/
• A logical information model fully describes the data, without regard to how the data will be physically
implemented in the database. Features of a logical information model typically include the following:
– All concepts and relationships between them are defined.
– All attributes for each concept are specified.
– Business terms for concepts and attributes are agreed upon and used. (These terms should be part of the agreed upon common
terminology.)
– The primary key for each concept is specified.
– Foreign keys (keys identifying the relationship between different entities) are specified.
– Normalization occurs at this level.


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


Notional Set of HL7 Artifacts within a SAIF
Enterprise Compliance and Conformance Framework (ECCF)

Enterprise Information Computational Engineering Technical
ECCF Dimension
“Why” - Policy
Dimension
“What” - Content
Dimension
“Who/How” - Behavior
Dimension
“Where” - Implementation
Dimension
“Where” - Deployments

 Business  Inventory of Reusable  Inventory of
• Mission, • Scenarios • SW Platforms, Layers
 Inventory of
• Vision,  Inventory of Reusable • Business Activities • SW Environments
• HW Platforms
• Scope , • Entities • System Functions • SW Components
Conceptual  Inventory of • Associations  Requirements • SW Services
• HW Environments
• Network Devices
Perspective • Contracts - PSSs
• Capabilities - RIM
• Information
 Information Models
• Accountability, Roles
• Conformance Criteria
• Technical
Requirements
• Communication
Devices
• Policies  Data Models • Profiles, Behaviors • Enterprise Service Bus
 Technical Requirements
• Procedures • Interactions and  Key Performance
• Info. Exchanges Parameters

 Specifications
• Scenario Events
 Information Models • Use Cases
 Models, Capabilities,  Models, Capabilities,
• Domain IM • Workflow Use Cases
 Business Policies Features and Versions for Features and Versions for
• Detailed Clinical • Components
Logical  Governance
 Implementation Guides
 Terminologies Interfaces
• SW Environments
• SW Capabilities
• HW Platforms
• HW Environments
Perspective  Design Constraints
 Value Sets
 Content Specifications
 Collaboration Actors
• Collaboration Types
• SW Libraries • Network Devices
 Organization Contracts • SW Services • Communication
• CCD • Collaboration Roles
• SW Transports Devices
• RMIM  Function Types
 Interface Types
 Service Contracts

 Business Nodes  Schemas for  SW Specifications for  HW Deployment
 Business Rules • Databases  Automation Units • Applications Specifications
Implementable  Business Procedures • Messages  Technical Interfaces • GUIs  HW Execution Context
Perspective  Business Workflows
 Technology Specific
• Documents
• Services
 Technical Operations
 Orchestration Scripts
• Components
 SW Deployment
 HW Application Bindings
 HW Deployment Topology
Standards • Transformations Topologies  HW Platform Bindings

Responsibility: HL7 Organization | EHR-S FIM | HL7 WG Projects | Development Organization
See notes page for ECCF description 35

Observation [David Baas]
• From where I’m sitting, deriving conceptual information models based on the conformance criteria
could be useful for consuming a functional profile. I would assume it could be used as reference
for developing a domain analysis model for a project, to fill in blanks of conceptual information not
expressed by clinical SMEs, and to shorten the learning curve for projects required to adopt the
conformance criteria. Regardless of how modeling evolved on the project, the CDM would still be
a bridge to validate addressing information needs at a high level. I would not foresee using the
CDM or other artifacts verbatim in modeling for a specific project because some the
relationships/associations expressed appear to be more subjective than explicit representation of
the conformance criteria. I suggest annotating whether the relationships in the CDM represent
explicit conformance criteria or not. For those that are not explicit (SHALL), it should be clear
implementers have no obligation to portray those relationships the way they are expressed
in the model.
• In reviewing the other artifacts (activity diagrams, and conceptual information model) I was a little
concerned that the content suggested a more prescriptive view of EHR functionality, which I’m not
sure is a good thing. In the case of the activity diagrams being prototyped, I can see they are not
attempting to sequence how tasks within an activity are executed, but using activity diagrams
suggests that is the intended direction. I think that path would be too restrictive for implementers. I
think the CIM raises more questions than it answers. This is another one where I think it best left
to specific implementation projects. Perhaps other folks will provide a different perspective, but I
think the CDM content is the most useful for understanding the conformance criteria for greater
adoption.

Observation [Kevin Coonan, HL7 Patient Care WG Co‐chair]
• We have been having a lot of discussions in patient care, clinical statement, CIMI and MnM regarding representation of clinical
content. One of the most important is the recognition and separation of dynamic uses / extracts of information one would see in an
EHR-S GUI or CDA v. an information model suited for information exchange, persistence, transformation, analytics, decision
support. A good example of this is the common notions of a “problem list”, “allergy list” or “list of immunizations”. These are artifacts
we are used to seeing in paper charts, since there was no other effective means to address longitudinal data which otherwise would
be scattered in the linear ordering progress notes. In fact, HL7 defines these working lists as ‘..collects a dynamic list of individual
instances of Act via ActRelationship which reflects the need of an individual worker, team of workers, or an organization to manage
lists of acts for many different clinical and administrative reasons. Examples of working lists include problem lists, goal lists, allergy
lists, and to-do lists.’
• There are also design patterns well suited for static semantics from the (being revised for May ballot) Patient Care domain, all of
which are different entry points into a common model. These include a pattern for a Care Record, which corresponds best to the
conventional notion of the documentation of an encounter. The Care Record, however, has entries which follow the Health Concern
pattern and the Care Plan pattern.
• Health Concerns are anything which affects one’s health which need to be managed/tracked over time. These includes risks,
diseases, problems, allergies/intolerances to medications, social circumstances, and complications.
• The Care Plan documents interventions, treatments and orders. Care Plans can have embedded logic, e.g. stating a specific action
should (not) be taken if a specific criterion is met. So things like immunization schedules, insulin sliding scales/sick day rules, or
complex oncology protocols have a common design basis. While we are used to thinking of Concerns and Plans as future looking,
the same pattern is used to document things which have happened (e.g. procedure which has been completed), so the Care Plan
includes not just what is currently being done, what is planned, but also what has been done in the past.
• An instance of an encounter’s documentation therefore would have elements from the Care Record (e.g. the signs/symptoms
discovered at the time of the encounter), Health Concerns (in a linear narrative like a CDA these typically are organized into the
familiar ‘lists’, e.g. allergy list, problem list, PMH), and Care Plan (again in ‘lists’—e.g. medication list). An encounter would also
expect to generate new Care Plans and new Health Concerns as part of the clinical decision making. (The A&P in Weed’s POMR).
• By separating the model of use (various lists) from model of meaning (the Patient Care Domain Model plus the derived detailed
clinical models which bind terminology, etc.) we can most effectively devise those specifications needed for given use cases.


EHR System Function and Information Model (EHR-S FIM) Release 2.1 Prototype HL7 Project ID# 688

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