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Your Healthcare Standards Conformance Partner

RIM Derived
and Influenced HL7 Standards
AbdulMalik Shakir
President and Chief Informatics Scientist
Health
Information Integration Infrastructure
Solutions
Hi3 Solutions is a privately owned Health Information Technology vendor
headquartered in Los Angeles, California.
We provide health information technology products, education, and consulting
services that enable our clients to engage effectively in health information
exchange, health data integration, and health care quality measurement .
Our mission is to accelerate the adoption and application of standards-based
health information exchange as a mean’s of improving healthcare outcomes
and facilitating compliance with evidence-based best practices in healthcare.

Slide Number: 2

© 2014 All Rights Reserved
Electronic Health Information Exchange
Claims/Prescriptions
Referral Process

Eligibility
Claim Status
Referral Process

Eligibility
Claim/Status

Payors

Pharmacies

Physicians

Public Health
Medical Records

Medical Society

Patient Data

Family Planning

Lab results

Mental Health

Hospitals

County/Community
Entities
Enrollment

Orders

Insurance Updates
Health Information

Results
Images

Testing Organizations
Lab/Images

Slide Number: 3

Employers
Government
Medicare/Medicaid

Patients/Consumers

© 2014 All Rights Reserved
Instructor
• AbdulMalik Shakir, President and Chief Informatics
Scientist for Hi3 Solutions.
• I have been an active HL7 member since 1991 and I’ve
made significant contributions to the development and
adoption of the HL7 standard.
• I am co-chair of the HL7 Modeling and Methodology
work group, former member of the HL7 Board of
Directors, and an active participant in many HL7
foundation and domain expert work groups.
• I am the author of the original RIM and provided
oversight for its maintenance from inception through its
first publication as an ANSI and then ISO standard.
Slide Number: 4

© 2014 All Rights Reserved
Session Overview
• This tutorial provides an introduction to the major
HL7 RIM derived and RIM influenced standards. The
student will also learn key aspects of the HL7 V3
Development Framework (HDF).
• Topics Covered:
– HL7 Development Framework
– HDF Methodology
– HL7 V3 Development Artifacts

– Sample V3 Clients and Projects

• This tutorial will assist in preparation for the HL7 v3
Certification exam.
Slide Number: 5

© 2014 All Rights Reserved
HL7 Development
Framework
Slide Number: 6

© 2014 All Rights Reserved
HDF Introduction
• The Health Level Seven Development Framework (HDF)
defines the processes, policies, and artifacts associated
with development of HL7 specifications and standards.
• The HL7 Development Framework (HDF):
– Expands HL7’s modeled-based approach for standards
development beyond messaging to its other standards such as
structured documents, context management, and standards
related to electronic health records;
– Facilitates increased participation of HL7 members, subject
matter experts, and implementers in the development of HL7
standards.
– Enables HL7 to remain the industry leader in model-driven
development of comprehensive standards for application
interoperability in the Health industry.
Slide Number: 7

© 2014 All Rights Reserved
HDF Background – Health Level Seven
• The mission of HL7 is to provide a comprehensive framework and
related standards for the exchange, integration, storage, and
retrieval of health information that support clinical practices and the
management, delivery and evaluation of health services.
• HL7 began developing standards in 1987 with the publication of its
messaging specification - the Application Protocol for Electronic
Data Exchange in Healthcare Environments.
• In the years since its founding, HL7 has evolved beyond traditional
messaging protocols to include clinical document architectures,
medical logic modules, service component specifications, and
standards, guidelines, and related services for the management of
electronic health records.

Slide Number: 8

© 2014 All Rights Reserved
The Family of HL7 Standards
•
•
•
•
•
•
•
•
•
•
Slide Number: 9

Standardization of knowledge representation (Arden / GELLO)
Virtual Medical Record for Clinical Decision Support (vMR-CDS)
Specification of components for context management (CMA)
Standardization of clinical document structures (CDA)
Electronic Health Record System Functional Model (EHR-S)
Application protocol for electronic data exchange in healthcare
environments (messages)
Support for use of healthcare services in a Service Oriented
Architecture (SOA)
Fast Healthcare Interoperability Resources (FHIR)
Specification of robust vocabulary definitions for use in clinical
messages and documents
Work in the area of security, privacy, confidentiality, and
accountability
© 2014 All Rights Reserved
HDF Background – HL7 V3 Methodology
• In 1992 HL7 made a fundamental shift in the method it
uses to develop its specifications and standards.
• The new methodology, referred to as HL7 Version 3.0
(or V3), is a model-driven standards development
methodology based upon object-oriented software
development practices.
• In January 1996, the HL7 Technical Steering Committee
adopted the model-driven approach and the Modeling
and Methodology Technical Committee assumed
primary responsibility for ongoing development of the V3
methodology.
Slide Number: 10

© 2014 All Rights Reserved
Slide Number: 11

© 2014 All Rights Reserved
HL7 Message Development Framework
• The HL7 Message Development Framework (MDF)
defines the HL7 V3 message development process.
• It identifies the phases, activities, and models used in the
process of developing HL7 message specifications.
• The HL7 MDF was first published in 1997. It has
undergone two major revisions since then; once in 1998
and again in 1999.
• The current version of the MDF (v3.3), published in
December 1999, has not been maintained.
• The HDF is a replacement for and an extension to the
HL7 Message Development Framework (MDF)
Slide Number: 12

© 2014 All Rights Reserved
HL7 V3 Methodology: What and How
Application
Role

Trigger
Event
Information Modeling

Storyboard

Sender

RIM
Derive

D-MIM

Receiver

Triggers

Restrict

References

R-MIM

Interaction
Example

Serialize

Interaction Modeling

HMD
Message Design

Storyboard
Example
Slide Number: 13

Content

Use Case Modeling

Restrict

Message
Type
© 2014 All Rights Reserved
HL7 V3 Design Models
RIM

RIM
Reference Information Model
(1)
Define a
D-MIM

D-MIM

D-MIM

Domain Message Information Model
(2)
Define a
R-MIM

R-MIM

R-MIM

Refined Message Information Model
(3)
Create
an HMD

HMD

HMD

Hierarchical Message Definition
Slide Number: 14

© 2014 All Rights Reserved
HL7
Development Framework
Methodology
Slide Number: 15

© 2014 All Rights Reserved
Seven Phases of the HDF Methodology

1. Project initiation
2. Requirements Documentation

3. Specification Modeling
4. Specification Documentation
5. Specification Approval
6. Specification Publication
7. Specification Profiling
Slide Number: 16

© 2014 All Rights Reserved
HDF Workflow Diagram
Initiate
Project

Project
Charter

Specify
Requirements

The HDF workflow is not a waterfall methodology.
Each phase builds upon the prior and may cause
prior activities to be revisited and their deliverables
adjusted.

Requirement
Specification

Reference
Models

Prepare Specification
Design Models

Specification
Design Models

Approve
Specification

Prepare
Specification

Pre-Approval
Specification
Conformance
Statement

Approved
Specification

Slide Number: 17

Publish
Approved
Specification

Published
Specification

Prepare Specification
Profiles

Specification
Profile

© 2014 All Rights Reserved
Project initiation
During project initiation the project is defined, a project plan is produced,
and project approval is obtained. The primary deliverable produced during
project initiation is the project charter.

Project
Initiation

Project
Charter

1.

Define project scope, objectives, and intended deliverables

2.

Identify project stakeholders, participants, and required resources

3.

Document project assumptions, constraints, and risk

4.

Prepare preliminary project plan and document inter-project dependencies

5.

Obtain project approval and launch the project

Slide Number: 18

© 2014 All Rights Reserved
Requirements Documentation
During requirements documentation the problem domain is defined, a
model of the domain is produced, and the problem domain model is
harmonized with HL7 reference models. The primary deliverable produced
during requirements documentation is the requirements specification.

Project
Charter

Requirements
Documentation

Requirements
Specification

1.
2.

Capture Process Flow: UML Activity Diagram

3.

Capture Structure: Domain Analysis Model and Glossary

4.

Capture Business Rules: Relationships, Triggers, and Constraints

5.

Slide Number: 19

Document Business Process: Dynamic Behavior and Static Structure

Harmonize the Domain Analysis Model with HL7 Reference Models

© 2014 All Rights Reserved
Specification Modeling
During specification modeling reference models are constrained into design
models through a process of iterative refinement driven by requirements
specifications and following specification design rules, conventions, and
guidelines. The primary deliverable produced during specification modeling
is a set of specification design models.

Requirements
Specification

Specification
Modeling

Specification
Design Models

1.
2.

Construct design models of behavioral views

3.

Define reusable design model components

4.

Construct design models of collaboration and interaction

5.
Slide Number: 20

Build design models of static information views

Harmonize design models with HL7 Reference Models
© 2014 All Rights Reserved
Specification Documentation
During specification Documentation the specification design models are
packaged into logical units, supplemented with explanatory text, and
prepared for approval. The primary deliverable produced during
specification documentation is a pre-approval specification.

Specification
Design Models

Specification
Documentation

Pre-Approval
Specification

1.
2.

Compose explanatory text, examples, and design rationale

3.

Update design models and requirement specifications

4.

Assemble a pre-approval specification package

5.

Slide Number: 21

Organize design model elements into logical packages

Submit specification for approval

© 2014 All Rights Reserved
Specification Approval
During specification approval the pre-approval specification is subjected to a
series of approvals steps. The specific approval steps vary by kind of
specification, level of approval, and realm of interest. The primary
deliverable produced during specification approval is an approved
specification.
Pre-Approval
Specification

Specification
Approval

Approved
Specification

1.
2.

Form a ballot pool and conduct specification ballot

3.

Assess negative ballots and affirmative comments

4.

Modify specification in response to ballot comments

5.

Slide Number: 22

Obtain TSC and Board approval to ballot specification

Resolve negative ballot responses and if necessary reballot

© 2014 All Rights Reserved
Specification Publication
During specification publication the approved specification is prepared for
prepared for publication and distribution. The primary deliverable produced
during specification publication is a published specification.

Approved
Specification

Specification
Publication

Published
Specification

1.
2.

Prepare specification for publication

3.

Submit publication to standards authorities (ANSI/ISO)

4.

Render the specification in various forms of publication media

5.

Slide Number: 23

Obtain TSC and Board approval to publish specification

Post and distribute approved specifications

© 2014 All Rights Reserved
Specification Profiling
During specification profiling specification models are further refined and specifications
furthered constrained following the same set of design rules, conventions, and guidelines
used in the development of the specification to produce a profile of the specification for
use in a particular environment by a defined community of users. The primary
deliverable produced during specification profiling is a set of specification profiles and
conformance statements.

Published
Specification

Specification
Profiling

Specification
Profiles and
Conformance
Statements

1.
2.

Further refine and constrain specification design models

3.

Document exceptions, extensions, and annotations to specifications

4.

Prepare and publish specification profile

5.
Slide Number: 24

Identify community of uses for published specification

Prepare and publish conformance statements
© 2014 All Rights Reserved
HDF Workflow Diagram
Initiate
Project

Project
Charter

Specify
Requirements

The HDF workflow is not a waterfall methodology.
Each phase builds upon the prior and may cause
prior activities to be revisited and their deliverables
adjusted.

Requirement
Specification

Reference
Models

Prepare Specification
Design Models

Specification
Design Models

Approve
Specification

Prepare
Specification

Pre-Approval
Specification
Conformance
Statement

Approved
Specification

Slide Number: 25

Publish
Approved
Specification

Published
Specification

Prepare Specification
Profiles

Specification
Profile

© 2014 All Rights Reserved
HL7 Version 3.0
Development Artifacts
Slide Number: 26

© 2014 All Rights Reserved
HL7 v3.0 Development Artifacts
Reference
Models

Reference
Information
Model

Datatype
Specification

Vocabulary
Specification

Design
Models

Interaction
Model

Design
Information
Model

Common
Message Type
Model

Content
Specifications

Hierarchical
Message
Definition

Message
Type
Definition

Implementation
Technology
Specification

Implementation
Profiles

Message
Profile
Specification

Localized
Message
Specification

Message
Conformance
Statements

Slide Number: 27

© 2014 All Rights Reserved
HL7 v3.0 Development Artifacts
Reference Models

Reference
Information
Model

The HL7 Reference Information Model is the
information model from which all other information
models and message specifications are derived.

Datatype
Specification

The HL7 Datatype Specification defines the structural
format of the data carried in an attribute and influences
the set of allowable values an attribute may assume.

Vocabulary
Specification

The HL7 Vocabulary Specification defines the set of all
concepts that can be taken as valid values in an instance
of a coded attribute or message element.

Slide Number: 28

© 2014 All Rights Reserved
HL7 v3.0 Development Artifacts
Design Models

Interaction
Model

An Interaction Model is a specification of information
exchanges within a particular domain as described in
storyboards and storyboard examples.

Design
Information
Model

A Domain Information Model is an information
structure that represents the information content for a
set of messages within a particular domain area.

Common
Message Type
Model
Slide Number: 29

A Common Message Type Model is a definition of a set
of common message components that can be
referenced in various message specifications.
© 2014 All Rights Reserved
HL7 v3.0 Messaging Artifacts
Message Specifications

Hierarchical
Message
Definition

Message
Type
Definition

Implementation
Technology
Specification
Slide Number: 30

An Hierarchical Message Definition is a specification
of message elements including a specification of their
grouping, sequence, optionality, and cardinality.

A Message Type Definition is a specification of a
collection of message elements and a set of rules for
constructing a message instance.

An Implementation Technology Specification is a
specification that describes how to construct HL7
messages using a specific implementation technology.
© 2014 All Rights Reserved
HL7 v3.0 Development Artifacts
Implementation Profiles

Localized
Message
Specification

Message
Profile
Specification

A Message Profile Specification is a description of a
particular or desired implementation of an HL7
Message standard or Localized Message specification.

Message
Conformance
Statement
Slide Number: 31

A Localized Message Specification is a refinement of a
HL7 message specification standard that is specified
and balloted by an HL7 International Affiliate.

A Message Conformance Statement is a comparison of
a particular messaging implementation and an HL7
message standard, localization, or profile.
© 2014 All Rights Reserved
HL7 V3 Message Design Models
TraumaRegistryExport
PreHosptialRelatedObservation (IDPH_RM00001)
classCode*: <= OBS
moodCode*: <= EVN
code: <= ExternallyDefinedActCodes
value: ANY [0..1]

VehicleProvider

Data content of HL7
messages used to export
data from the IDPH Trauma
Registry.

pertinentInformation 0..* pertinentPreHosptialRelatedObservation

1..1 owningVehicleProvider

typeCode*: <= PERT

Organization
addr : BAG<AD>
standardIndustryClassCode : CE

Patient
Place
confidentialityCode : CE
mobileInd : BL
veryImportantPersonCode : CE
addr : AD
directionsText : ED
Access
LicensedEntity
positionText : ED
approachSiteCode : CD
recertificationTime : TS
gpsText : ST
targetSiteCode : CD
gaugeQuantity : PQ

ActRelationship
typeCode : CS
inversionInd : BL
outboundRelationship contextControlCode : CS
0..n contextConductionInd : BL
sequenceNumber : INT
Person
1 source
priorityNumber : INT
addr : BAG<AD>
pauseQuantity : PQ
Act
Participation
maritalStatusCode : CE
checkpointCode : CS
classCode : CS
Entity
educationLevelCode : CE
typeCode : CS
Role
splitCode : CS
moodCode : CS
raceCode : SET<CE>
functionCode : CD
classCode : CS
player
joinCode : CS
classCode : CS
id : SET<II>
disabilityCode : SET<CE>
contextControlCode : CS
determinerCode : CS
negationInd : BL
0..1
0..n id : SET<II>
code : CD
livingArrangementCode : CE
sequenceNumber : INT
id : SET<II>
0..n
conjunctionCode : CS
negationInd : BL
playedRolecode : CE
1
religiousAffiliationCode : CE
negationInd : BL
code : CE
localVariableName : ST
negationInd : BL
1 derivationExpr : ST
ethnicGroupCode : SET<CE>
quantity : SET<PQ>
0..n noteText : ED
seperatableInd : BL
addr : BAG<AD>
text : ED
time : IVL<TS>
name : BAG<EN>
telecom : BAG<TEL>
0..n
statusCode : SET<CS>
modeCode : CE
desc : ED
statusCode : SET<CS>
effectiveTime : GTS
inboundRelationship
awarenessCode : CE
statusCode : SET<CS>
scopedRoleeffectiveTime : IVL<TS>
LivingSubject
activityTime : GTS
signatureCode : CE
existenceTime : IVL<TS>
0..n certificateText : ED
target
availabilityTime : TS
administrativeGenderCode : CE
signatureText : ED
telecom : BAG<TEL>
quantity : RTO
0..1
priorityCode : SET<CE>
birthTime : TS
performInd : BL
riskCode : CE
1
positionNumber : LIST<INT>
scoper
deceasedInd : BL
substitutionConditionCode : CE confidentialityCode : SET<CE>
...
handlingCode : CE
repeatNumber : IVL<INT>
deceasedTime : TS
DeviceTask
1 target 1source
interruptibleInd : BL
multipleBirthInd : BL
1
parameterValue : LIST<ANY>
levelCode : CE
inboundLink
multipleBirthOrderNumber : INT
WorkingList
0..n
outboundLink 0..n
independentInd : BL
Employee
organDonorInd : BL
ownershipLevelCode : CE
RoleLink
uncertaintyCode : CE
FinancialContract
jobCode : CE
typeCode : CS
reasonCode : SET<CE>
paymentTermsCode : CE
jobTitleName : SC
effectiveTime : IVL<TS>
languageCode : CE
jobClassCode : CE
Material
NonPersonLivingSubject
salaryTypeCode : CE
formCode : CE
strainText : ED
salaryQuantity : MO
InvoiceElement
genderStatusCode : CE
hazardExposureText : ED
SubstanceAdministration
modifierCode : SET<CE>
protectiveEquipmentText : ED
Observation
unitQuantity : RTO<PQ,PQ>
routeCode : CE
0..n
value : ANY
unitPriceAmt : RTO<MO,PQ>
approachSiteCode : SET<CD>
ManufacturedMaterial
LanguageCommunication
interpretationCode : SET<CE>
netAmt : MO
doseQuantity : IVL<PQ>
Procedure
methodCode : SET<CE>
factorNumber : REAL
rateQuantity : IVL<PQ>
lotNumberText : ST
languageCode : CE
methodCode : SET<CE>
targetSiteCode : SET<CD>
pointsNumber : REAL
doseCheckQuantity : SET<RTO>
expirationTime : IVL<TS>
modeCode : CE
approachSiteCode : SET<CD>
maxDoseQuantity : SET<RTO>
stabilityTime : IVL<TS>
proficiencyLevelCode : CE
targetSiteCode : SET<CD>
substitutionCode : CE
preferenceInd : BL
DiagnosticImage
subjectOrientationCode : CE
Container
Device
capacityQuantity : PQ
manufacturerModelName : SC
heightQuantity : PQ
softwareName : SC
localRemoteControlStateCode : CE
... diameterQuantity : PQ
capTypeCode : CE
alertLevelCode : CE
separatorTypeCode : CE
lastCalibrationTime : TS
barrierDeltaQuantity : PQ
bottomDeltaQuantity : PQ

PreHospitalVehicle

ManagedParticipation
id : SET<II>
statusCode : SET<CS>

PublicHealthCase
PatientEncounter
detectionMethodCode : CE
preAdmitTestInd : BL
transmissionModeCode : CE
admissionReferralSourceCode : CE
diseaseImportedCode : CE
lengthOfStayQuantity : PQ
dischargeDispositionCode : CE
specialCourtesiesCode : SET<CE>
specialAccommodationCode : SET<CE>
acuityLevelCode : CE

Supply
quantity : PQ
expectedUseTime : IVL<TS>

Diet
energyQuantity : PQ
carbohydrateQuantity : PQ

Account
name : ST
balanceAmt : MO
currencyCode : CE
interestRateQuantity : RTO<MO,PQ>
allowedBalanceQuantity : IVL<MO>
FinancialTransaction
amt : MO
creditExchangeRateQuantity : REAL
debitExchangeRateQuantity : REAL

classCode*: <= OWN
1..1 preHospitalVehicle
id: II [0..1] (VehiclNum)
participant
code: <= RoleCode (VehiclLevelID)
typeCode*: <= ParticipationType

InjuryLocation
classCode*: <= PLC
determinerCode*: <= INSTANCE
0..1 playingInjuryLocation
code: CV CWE [0..1] <= EntityCode (InjuryPlaceID)
addr: AD [0..1] (AddressScene)

MedicalStaffPerson

PreHospitalEncounter

MedicalStaff

classCode*: <= ENC
moodCode*: <= EVN
id: II [0..1] (crashNum)
activityTime: IVL<TS>

Role

classCode*: <= PROV
id: II [0..1] (MedicalStaffID)

performer

classCode*: <= ROL

predecessor

0..1 priorPreHospitalEncounter

0..1 medicalStaff

typeCode*: <= PRF

typeCode*: <= PREV
1..1 participant
location
Procedure
0..1 procedureLocation ProcedureLocation
typeCode*: <= LOC
classCode*: <= PROC
location
InjuryRelatedObservation
classCode*: <= SDLOC
moodCode*: <= EVN
0..* pertinentInjuryRelatedObservation
classCode*: <= OBS
0..* pertinentProcedure code: CV CWE <= ActCode (ICDCodeID) typeCode*: <= LOC code: <= RoleCode (ProcedLocateID)
Injury
pertinentInformation
moodCode*: <= EVN
PatientIncident
pertinentInformation7
activityTime: TS (ProcedDate)
classCode*: <= ACT
0..1 pertinentInjury
typeCode*: <= PERT
code: <= ExternallyDefinedActCodes
classCode*: <= ENC
typeCode*: <= PERT
moodCode*: <= EVN
pertinentInformation1 moodCode*: <= EVN
priorityCode: CV CWE [0..1] <= ActPriority sequenceNumber: INT [0..1] (InjurySequen)
activityTime: TS (InjuryDate)
component
typeCode*: <= PERT
value: [0..1]
TraumaParticipant
id: [1..*] (RegistNum)
typeCode*: <= COMP
code: CV CNE [0..1] <= ExternallyDefinedActCodes (PatientType)
statusCode: LIST<CS> CNE <= ActStatus (IDPHStatus)
0..* pertinentPatientIncidentRelatedObservation PatientIncidentRelatedObservation
PatientPerson
activityTime: TS (EDDate)
1..1 patient
classCode*: <= OBS
pertinentInformation2
classCode*: <= PSN
Patient
subject
moodCode*: <= EVN
0..1 playingTraumaParticipant
determinerCode*: <= INSTANCE
typeCode*: <= PERT
0..* patientIncidentRelatedObservation
classCode*: <= PAT
typeCode*: <= SBJ
code: <= ActCode
name: PN [0..1] (*Name)
id: II [0..1] (MedicaRecordNum)
reasonCode: CV CWE [0..1] <= ActReason
existenceTime: (Age)
Choice
1..1 patientPatientPerson
value: ANY [0..1]
administrativeGenderCode: CV CWE <= AdministrativeGender
Facility
(GenderID)
1..1 providerTraumaParticipant
classCode*: <= ORG
birthTime: (DateOfBirth)
0..* aRole aRole
VehicleProvider
determinerCode*: <= INSTANCE
addr: AD [0..1] (AddressHome)
TraumaParticipant
classCode*: <= ROL
origin
1..1 arrivalPatientTransfer
id:
raceCode: CV CWE [0..1] <= Race (RaceID)
classCode*: <= ORG
PatientTransfer
classCode*: <= ORG
typeCode*: <= ORG
code*: CS CNE <= EntityCode "FAC"
ethnicGroupCode: CV CWE [0..1] <= Ethnicity (EthnicID)
arrivedBy
determinerCode*: <= INSTANCE
determinerCode*: <= INSTANCE
classCode*: <= TRNS
1..1 owningVehicleProvider id: II [0..1] (VehiclProvide)
name:
typeCode*: <= ARR
id: [1..1] (HospitNum)
moodCode*: <= EVN
1..1 transferVehicle
code: <= EntityCode (MaxVehiclLevelID)
0..1 subjectChoice
code: CV CWE [0..1] <= EntityCode
activityTime: IVL<TS> (DischaDate to ArriveDate)
via
name: ON [0..1] (VehiclProvidName)
TransferVehicle
name: ON [0..1] (HospitName)
Hospital
reasonCode: CV CWE [0..1] <= TransferActReason (REASONTRANSFID) typeCode*: <= VIA
statusCode: CS CNE [0..1] <= EntityStatus (ActiveFacili)
classCode*: <= OWN
classCode*: <= ORG
pertinentInformation
addr: AD [0..1] (HospitCity)
id: II [0..1] (VehiclNum)
determinerCode*: <= INSTANCE
typeCode*: <= PERT
code: <= RoleCode (VehiclLevelID)
pertinentInformation3
id:
1..* pertinentTransferRelatedObservation
LicensedEntity 0..1 licensedEntity
1..1 pertinentHospitalVisit
code*: CS CNE <= EntityCode "HOSP"
typeCode*: <= PERT
destination
classCode*: <= LIC
name:
pertinentInformation5
TransferRelatedObservation
typeCode*: <= DST
id: II [0..1]
HospitalVisit
typeCode*: <= PERT
classCode*: <= OBS
classCode*: <= ENC
moodCode*: <= EVN
1..1 admittingProvider
moodCode*: <= EVN
AdmittingProvider
code: CV CWE <= ExternallyDefinedActCodes
code: CV CWE <= ActCode (AdmitServicID)
admitter
classCode*: <= PROV
value: PQ [0..1]
activityTime: TS (DischaDate)
id: II [0..1] (ADMITMEDICASTAFFID)
typeCode*: <= ADM
methodCode: CV CWE [0..1] <= ObservationMethod
dischargeDispositionCode: CV CWE [0..1]
code: CV CWE <= RoleCode (StaffTypeID)
0..* hospitalVisitPhysician
<= EncounterDischargeDisposition

responsibleParty

HospitalVisitPhysician
typeCode*: <= RESP
classCode*: <= PROV
time: TS
id: II [0..1]
code: CV CWE <= RoleCode (StaffTypeID)

EmergencyDepartmentRelatedObservation
0..1 pertinentEmergencyDepartmentEncounter
classCode*: <= OBS
moodCode*: <= EVN
0..* pertinentEmergencyDepartmentRelatedObservation
code: CV CWE <= ExternallyDefinedActCodes
pertinentInformation
classCode*: <= ENC
text:
moodCode*: <= EVN
typeCode*: <= PERT
activityTime: TS
activityTime: IVL<TS>
reasonCode: <= ActReason
dischargeDispositionCode: CV CWE <= EncounterDischargeDisposition
value: [0..1]
methodCode: CV CWE [0..1] <= ObservationMethod
component
targetSiteCode: CV CWE [0..1] <= HumanActSite
typeCode*: <= COMP

pertinentInformation
typeCode*: <= PERT

EmergencyDepartmentEncounter

0..* pertinentHospitalVisitRelatedObservation

HospitalVisitRelatedObservation

0..1 healthCareMedicalStaffPerson

MedicalStaffPerson

classCode*: <= OBS
moodCode*: <= EVN
code: CV CWE <= ExternallyDefinedActCodes
value: [0..1]

0..1 healthCareMedicalStaffPerson classCode*: <= PSN
determinerCode*: <= INSTANCE 0..1 healthCareMedicalStaffPerson
name: PN [0..1] (MedicaStaffName)

RIM

0..* emergencyDepartmentPhysicianAct

EmergencyDepartmentPhysician 0..* emergencyDepartmentPhysician
classCode*: <= PROV
performer
id: II [0..1]
typeCode*: <= PRF
code: CE CWE [0..1] <= RoleCode (StaffTypeID)

EmergencyDepartmentPhysicianAct
classCode*: <= ACT
moodCode*: <= EVN
code: CS CNE [0..1] <= ExternallyDefinedActCodes
activityTime*: TS [0..1]

D-MIM

Design Information Model
component
typeCode*: <= COMP

PatientIncidentRelatedObservation
InjuryLocation
classCode*: <= PLC
determinerCode*: <= INSTANCE
0..1 playingInjuryLocation
code: CV CWE [0..1] <= EntityCode (InjuryPlaceID)
addr: AD [0..1] (AddressScene)

classCode*: <= ROL

location

1..1 participant

typeCode*: <= LOC

InjuryRelatedObservation
0..* pertinentInjuryRelatedObservation
classCode*: <= OBS
pertinentInformation
moodCode*: <= EVN
typeCode*: <= PERT
code: <= ExternallyDefinedActCodes
priorityCode: CV CWE [0..1] <= ActPriority sequenceNumber: INT [0..1] (InjurySequen)
value: [0..1]

PatientPerson

classCode*: <= OBS
moodCode*: <= EVN
code: <= ActCode
reasonCode: CV CWE [0..1] <= ActReason
value: ANY [0..1]

Role

Injury

0..* patientIncidentRelatedObservation

pertinentInformation2 0..* pertinentPatientIncidentRelatedObservation
typeCode*: <= PERT

PatientIncident

classCode*: <= ACT
0..1 pertinentInjury
classCode*: <= ENC
moodCode*: <= EVN
pertinentInformation1 moodCode*: <= EVN
activityTime: TS (InjuryDate)
typeCode*: <= PERT
id: [1..*] (RegistNum)
code: CV CNE <= ExternallyDefinedActCodes (PatientType)
statusCode: LIST<CS> CNE <= ActStatus (IDPHStatus)
activityTime: TS (EDDate)
1..1 patient

classCode*: <= PSN
Patient
subject
determinerCode*: <= INSTANCE
classCode*: <= PAT
typeCode*: <= SBJ
name: PN [0..1] (*Name)
id: II [0..1] (MedicaRecordNum)
existenceTime: (Age)
1..1 patientPatientPerson
administrativeGenderCode: CV CWE <= AdministrativeGender
(GenderID)
1..1 providerTraumaParticipant
birthTime: (DateOfBirth)
addr: AD [0..1] (AddressHome)
TraumaParticipant
raceCode: CV CWE [0..1] <= Race (RaceID)
classCode*: <= ORG
ethnicGroupCode: CV CWE [0..1] <= Ethnicity (EthnicID)
determinerCode*: <= INSTANCE
id: [1..1] (HospitNum)
code: CV CWE [0..1] <= EntityCode
name: ON [0..1] (HospitName)
statusCode: CS CNE [0..1] <= EntityStatus (ActiveFacili)
addr: AD [0..1] (HospitCity)

R-MIM

Slide Number: 32

HMD

© 2014 All Rights Reserved
Design Information Model
Description
• Domain Message Information Models (D-MIMs) and
Refined Message Information Models (R-MIMs) are types
of Design Information Models.
• Design information models are composed of class clones
that are a restricted subset of the HL7 RIM.
• Class clones contain a subset of the attributes and
relationships that are defined for the RIM class upon which
the clone is based.
• Multiple class clones based upon the same RIM class may
be included in a design information model.
• Each class clone in a design information model is
assigned a unique name.
Slide Number: 33

© 2014 All Rights Reserved
Sample R-MIM Design Information Model
Laboratory Observation Order

(POLB_RM002100)

Common entry point for laboratory order
communication. This includes single one-time
typeCode*: <= COMP
orders as well as recurring orders. This is
contextControlCode*: [1..1]
Note:
used for recurring orders only if the filler
<= ContextControlNonPropagating "AN"
Includes both
splits recurring orders into their occurrences.
contextConductionInd*: [1..1] "true"
patient and the
sequenceNumber:
institution.
priorityNumber:
pauseQuantity:
0..1 patient *
0..1 roleName
CMET: (PAT)
splitCode:
ObservationOrder
recordTarget
ManufacturedProduct1
Organization
R_Patient
joinCode:
classCode*: <= OBS
typeCode*: <= RCT
classCode*: <= MANU
[universal]
seperatableInd: [1..1] "true"
classCode*: <= ORG
0..* observationOrder1
moodCode*: <= ORD
contextControlCode*: [1..1]
(COCT_MT050000)
determinerCode*: <= INSTANCE
id*: II [1..1]
<= ContextControlPropagating "OP"
0..1 manufacturerOrganization name*: ON [1..1]
code: CE CWE <= ObservationType (e.g. LOINC code)
1..1 manufacturedProduct *
0..* specimen *
consumable
0..* observationOrder2 * negationInd: [1..1] "false"
CMET: (SPEC)
subject
typeCode*: <= CSM
0..* substanceAdministrationStep *
derivationExpr:
R_Specimen
typeCode*: <= SBJ
text:
component2
SubstanceAdministrationStep
[universal]
contextControlCode*: [1..1]
statusCode*: CS CNE [1..1] <= ActStatus "active"
(COCT_MT080000)
<= ContextControlPropagating "OP"
typeCode*: <= COMP
classCode*: <= SBADM
effectiveTime: ("physiologically relevant time" aimed for)
contextControlCode*: [1..1]
moodCode*: <= x_ActMoodOrdPrmsEvn
activityTime: IVL<TS>
Note:
<= ContextControlNonPropagating "AN"
id*: II [1..1]
priorityCode: CE CWE [0..1] <= ActPriority "R"
For clinical observations that are made directly on the patient
contextConductionInd*: [1..1] "true"
code*: CE CWE <= SubstanceAdministrationActCode
confidentialityCode*: [1..*] <= Confidentiality "N"
instead of on some specimen.
sequenceNumber*: [1..1]
text*:
repeatNumber:
priorityNumber:
statusCode*: CS CNE [0..1]
0..1 roleName
1..1 assignedEntity *
interruptibleInd: "true"
CMET: (ASSIGNED)
pauseQuantity:
effectiveTime*: IVL<TS>
independentInd: "true"
author
R_Assigned
splitCode:
routeCode: <= RouteOfAdministration
methodCode: <= ObservationMethod
typeCode*: <= AUT
[universal]
joinCode:
doseQuantity: PQ
contextControlCode*: [1..1]
(COCT_MT090000)
targetSiteCode: <= ActSite
seperatableInd*: [1..1] "false"
rateQuantity: PQ
<= ContextControlPropagating "OP"
noteText: ST
Note:
time*: TS [1..1] (time of signature)
CMET: (ENC)
Includes both, the
componentOf1
modeCode*: CE CNE [1..1] <= ParticipationMode
A_Encounter
individual and the
typeCode*: <= COMP
signatureCode*: CS CNE [1..1]
[universal]
contextControlCode*: [1..1] <= ContextControlPropagating "OP"
signatureText:
provider organization.
(COCT_MT010000) contextConductionInd*: [1..1] "false"
0..1 encounter *
0..* assignedEntity

Drug

classCode*: <= MMAT
determinerCode*: <= INSTANCE
code*: [1..1] <= DrugEntity (Drug code)
quantity:
desc:
1..1 manufacturedDrug *

CMET: (AGNT)
R_Responsible
[universal]

Note:
This is the general almost completely unconstrained
ActRelationship. Its use includes composition (COMP),
occurrences (OCCR), master file references (INST),
fulfillment (FLFS) and replacement (RPLC) as well as
normal ranges (REFV), decision ranges (COND) and
goals. In the DMIM this is left unconstrained, in the
RMIMs these might be more constrained.

componentOf2

Accession

1..1 agent *

classCode*: <= ACSN
moodCode*: <= EVN
typeCode*: <= AUT id*: II [1..1]

author

(COCT_MT040000)

0..1 roleName

Note:
For Advanced Beneficiary Notices
or whenconsents are required for
testing (e.g., HIV related tests.)

CMET: (CONS)
A_Consent
[universal]
(COCT_MT470000)

Note:
The author of an ORDer is commonly
know as the "placer", the author of an
ordered promise or event is commonly
known as the "filler". The author owns
his Act, meaning that direct status
canges on this act can only be issued
by the Author.

typeCode*: <= COMP
contextControlCode*: [1..1]
<= ContextControlPropagating "OP"
contextConductionInd*: [1..1] "false"
0..* accession

subjectOf
typeCode*: <= SUBJ
contextControlCode*: [1..1]
<= ContextControlPropagating "OP"
contextConductionInd*: [1..1] "false"
0..* consent
0..* pertinentObservationSupporting

CMET: (OBS)
A_ObservationSupporting
[universal]
Note:
Identifies the "master"
or "service catalog"
entry of the
observation service
being performed. Use
this alone or in addition
to an observation
code to specify what
is being observed or
what is to be observed.

component1 / componentOf3

(COCT_MT120200)

0..1 assignedEntity
typeCode*: <= ENT
contextControlCode*: [1..1]
<= ContextControlPropagating "OP"
noteText: ST
time: TS (time entered into)
modeCode*: [1..1] <= "ELECTRONIC"

typeCode*: <= PERT
contextControlCode*: [1..1]
<= ContextControlNonPropagating "AN"
contextConductionInd*: [1..1] "true"
0..1 observationDefinition *

definition

classCode*: <= OBS
moodCode*: <= DEF
id: II [1..1]

typeCode*: <= INST
contextControlCode*: [1..1]
<= ContextControlNonPropagating "AN"
contextConductionInd*: [1..1] "true"

typeCode*: <= VRF
contextControlCode*: [1..1] <= ContextControl "OP"
noteText: ST
time*: TS [1..1] (time of signature)
modeCode*: [1..1] <= ParticipationMode
signatureCode*: [1..1] <= ParticipationSignature
signatureText:

dataEnterer

pertinentInformation

ObservationDefinition

verifier

0..1 assignedEntity

notificationContact
Note:
For orders: the designated performer, if known
and desired at time of ordering. For intents, the
promises and events, the "filler." For individual subtasks, used for the technician, etc.

typeCode*: <= NOT
contextControlCode*: [1..1]
<= ContextControlPropagating "OP"
0..* assignedEntity *

performer
typeCode*: <= PRF
contextControlCode*: [1..1]
<= ContextControlPropagating "OP"
0..* participant

consumable
typeCode*: <= CSM
contextControlCode*: [1..1]
<= ContextControlNonPropagating "ON"

0..*

CMET: (ROL)
R_Reagent
[universal]
(COCT_MT250000)

0..* orderOptions

controlVariable
typeCode*: <= CTRLV
contextControlCode*: [1..1]
<= ContextControlNonPropagating "AN"
contextConductionInd*: [1..1] "false"

CMET: (ACT)
A_OrderOptions
[universal]
(COCT_MT210000)

0..* priorObservation

replacementOf
typeCode*: <= RPLC
contextControlCode*: [1..1]
<= ContextControlNonPropagating "ON"
contextConductionInd*: [1..1] "true"

Slide Number: 34

© 2014 All Rights Reserved
Design Information Model Diagram

Drug
classCode*: <= MMAT
determinerCode*: <= INSTANCE
code*: [1..1] <= DrugEntity (Drug code)
quantity:
desc:
1..1 manufacturedDrug *

ManufacturedProduct1
classCode*: <= MANU

consumable

classCode*: <= ORG
determinerCode*: <= INSTANCE
0..1 manufacturerOrganization name*: ON [1..1]
1..1 manufacturedProduct *

typeCode*: <= CSM

SubstanceAdministrationStep
classCode*: <= SBADM
moodCode*: <= x_ActMoodOrdPrmsEvn
id*: II [1..1]
code*: CE CWE <= SubstanceAdministrationActCode
text*:
statusCode*: CS CNE [0..1]
effectiveTime*: IVL<TS>
routeCode: <= RouteOfAdministration
doseQuantity: PQ
rateQuantity: PQ

Slide Number: 35

Organization

• A Design Information Model
diagrams used a variety of
visual tools to document the
design.
• Entities, Roles, and Acts are
represented by rectangular
shapes colored Green, Yellow,
and Red respectively.
• Participations, Role Links, and
Act Relationships are
represented by arrow shapes
colored blue, gold, and pink
respectively.
• Bold font is used to denote
mandatory attributes.
© 2014 All Rights Reserved
HL7 V3 Modeling Tools

Slide Number: 36

© 2014 All Rights Reserved
HL7 V3 Modeling Tools
RIM

RIM

Rational
Rose

RIM
R-MIM

R-MIM
Designer

Reference
Model
Repository

RoseTree
HMD

HMD

R-MIM

Schema
Generator

XSD
Slide Number: 37

© 2014 All Rights Reserved
HL7 Version 3.0
Hierarchical Message
Definition
An Hierarchical Message Definition is a specification
of message elements including a specification of their
grouping, sequence, optionality, and cardinality.

Slide Number: 38

© 2014 All Rights Reserved
Hierarchical Message Definition

Slide Number: 39

© 2014 All Rights Reserved
Slide Number: 40

Message Type Specification(S)

Common Constraints

Message Element Specifications

Information Model Mapping

HMD Components

© 2014 All Rights Reserved
Slide Number: 41

Message Type Specification(S)

Common Constraints

Message Element Specifications

Mapping to the Information Model

HMD Components

© 2014 All Rights Reserved
HL7 XML Schema Generator
HL7 Vocabulary
Specification

Hierarchical Message
Definition

HL7 XML
Schema
Generator

XML Schema
Specification

HL7 Data Type
Specification

Slide Number: 42

© 2014 All Rights Reserved
Sample HL7 Constrained Information Model
A_AbnormalityAssessment
(COCT_RM420000UV)

Description: assessment of clinical findings, including lab test results,
for indications of the presence and severity of abnormal conditions

AbnormalityAssessment
classCode*: = "OBS"
moodCode*: = "EVN"
code*: CD CWE [1..1] <= V:ObservationType ("ADVERSE_REACTION")
statusCode*: CS CNE [1..1] <= V:ActStatusAbortedCancelledCompleted
activityTime*: TS.DATETIME [1..1]
value: CD CWE [0..1] <= V:AbnormalityAssessmentValue
methodCode: SET<CE> CWE [0..*] <= V:AbnormalityAssessmentMethod

outcome
typeCode*: = "OUTC"
contextConductionInd*: BL [1..1] ="true"
1..* assessmentOutcome *

AssessmentOutcome
AssessmentException
classCode*: = "OBS"
moodCode*: = "EVN"
code*: CD CWE [1..1] <= V:ObservationType ("ASSERTION")
value*: SC CWE [1..1] <= V:AssessmentExceptionValue

appendageOf

AbnormalityGrade

typeCode*: = "APND"
contextConductionInd*: BL [1..1] ="true"
0..* assessmentOutcomeAnnotation

AssessmentOutcomeAnnotation
classCode*: = "OBS"
moodCode*: = "EVN"
code*: CD CWE [1..1] <= V:ObservationType ("ASSERTION")
value*: SC CWE [1..1] <= V:AssessmentOutcomeAnnotationValue

classCode*: = "OBS"
moodCode*: = "EVN"
code*: CD CWE [1..1] <= V:ObservationType ("SEV")
uncertaintyCode: CE CNE [0..1] <= V:ActUncertainty
value*: CD CWE [1..1] <= V:AbnormalityGradeValue

Slide Number: 43

© 2014 All Rights Reserved
Example Schema Specification

Slide Number: 44

© 2014 All Rights Reserved
Core Schema
• Our generated schema is used in conjunction with core schema
specifications provided by HL7.
• The core schema specifications include infrastructure root, datatype
base, datatype, and vocabulary.
• The core schema specification include no domain content. They are
present only to facilitate interpretation of datatypes and validation of
structural vocabulary.
Core Schema
Our
Schema

Include

Datatype.XSD

Include

Include

Voc.XSD

Slide Number: 45

Infrastructure
Root.XSD

Include

Include

Include

Datatypebase.XSD

© 2014 All Rights Reserved
HL7 V3 Message Implementation Technology

XML Schema
Specification

Data

Hierarchical Message
Definition

HL7
Message
Creation
HL7-Conformant
Application

Slide Number: 46

Message
Instance

HL7
Message
Parsing

Data

HL7-Conformant
Application

© 2014 All Rights Reserved
Questions / Discussion

Slide Number: 47

© 2014 All Rights Reserved
The Family of HL7 Standards
•
•
•
•
•
•
•
•
•
•
Slide Number: 48

Standardization of knowledge representation (Arden / GELLO)
Virtual Medical Record for Clinical Decision Support (vMR-CDS)
Specification of components for context management (CMA)
Standardization of clinical document structures (CDA)
Electronic Health Record System Functional Model (EHR-S)
Application protocol for electronic data exchange in healthcare
environments (messages)
Support for use of healthcare services in a Service Oriented
Architecture (SOA)
Fast Healthcare Interoperability Resources (FHIR)
Specification of robust vocabulary definitions for use in clinical
messages and documents
Work in the area of security, privacy, confidentiality, and
accountability
© 2014 All Rights Reserved
RIM Derived and Influenced HL7 Standards
•

•

•

•

•
•
Slide Number: 49

Standardization of knowledge representation (Arden / GELLO)
Virtual Medical Record for Clinical Decision Support (vMR-CDS)
Specification of components for context management (CMA)
Standardization of clinical document structures (CDA)
Electronic Health Record System Functional Model (EHR-S)
Application protocol for electronic data exchange in healthcare
environments (messages)
Support for use of healthcare services in a Service Oriented
Architecture (SOA)
Fast Healthcare Interoperability Resources (FHIR)
Specification of robust vocabulary definitions for use in clinical
messages and documents
Work in the area of security, privacy, confidentiality, and
accountability
© 2014 All Rights Reserved
Sample HL7 V3 Clients and Projects
Clinical Trial Registration
and Results
Message Specification

Clinical Trial Registration and Results
Message Specification
UMTS Project Consolidated
Dictionary and IHE Content
Profile
Slide Number: 50

© 2014 All Rights Reserved
Clinical Trial Registration and Results
Message Specification

Slide Number: 51

© 2014 All Rights Reserved
CTRR Development Artifacts

Slide Number: 52

© 2014 All Rights Reserved
Document Identifiers and Keywords

Study Protocol
Document, Study
Description, Features,
and Overall Status

Study Outcome Measures and
Objectives

Study
Participants

Planned Activities,
Study Arms, and
References

Regulatory
Authorities, Application
Submissions and
Authorizations

Slide Number: 53

Study
Enrollment
Stratification
and Targets

Target Research
Products
(devices and
substances)

Study Sites and Study
Site Recruitment
Activities

© 2014 All Rights Reserved
RMIM to XSD

Slide Number: 54

© 2014 All Rights Reserved
Traversing the CTRR RMIM
Entry Point

Slide Number: 55

© 2014 All Rights Reserved
HMD – the RMIM serialized

Slide Number: 56

© 2014 All Rights Reserved
Study Protocol Document
XSD

Slide Number: 57

© 2014 All Rights Reserved
Subject XSD

Slide Number: 58

© 2014 All Rights Reserved
Clinical Trial Intent XSD

Slide Number: 59

© 2014 All Rights Reserved
National Trauma Registry Submission
CDA Document Specification

Slide Number: 60

© 2014 All Rights Reserved
Clinical Document Architecture (CDA)
• The HL7 Clinical Document Architecture (CDA) is a document
markup standard that specifies the structure and semantics of
"clinical documents" for the purpose of exchange.
• A clinical document contains observations and services and has the
following characteristics:
– Persistence – A clinical document continues to exist in an unaltered
state, for a time period defined by local and regulatory requirements.
– Stewardship – A clinical document is maintained by an organization
entrusted with its care.
– Potential for authentication - A clinical document is an assemblage of
information that is intended to be legally authenticated.
– Context - A clinical document establishes the default context for its
contents.
– Wholeness - Authentication of a clinical document applies to the whole
and does not apply to portions of the document without the full context
of the document.
– Human readability – A clinical document is human readable.
Slide Number: 61

© 2014 All Rights Reserved
Clinical Document Architecture
RMIM

Participating
Entities
Slide Number: 62

Clinical
Document

Structured
Document
Sections

Section Entries
© 2014 All Rights Reserved
NTDB CDA RMIM Subset
Patient

+recordTarget

EntryRelationship

ClinicalDocument
isSubjectOf

1..*

1
1
0..*

1

0..*

1 +target

1

communicates

+nested
0..*

+informer
Organization

0..*

1..*

DocumentSection

+source

+clinicalStatement
0..*

+nesting
0..1

SectionEntry
1..*

0..1
Act

Slide Number: 63

Observ ation

Encounter

Procedure

Organizer

© 2014 All Rights Reserved
From Data Dict. to CDA Impl. Guide

Slide Number: 64

© 2014 All Rights Reserved
Scope

Slide Number: 65

© 2014 All Rights Reserved
Implementation Guide Development

Slide Number: 66

© 2014 All Rights Reserved
DAM: a UML representation of
dictionary elements
2.0 Submission::
RegistrySubmissionTransaction

0..1
PreHospitalEcounter
+

arrivalDateTime :TS [0..1]
departureDateTime :TS [0..1]
dispatchDateTime :TS [0..1]
preHospitalTransportationMethodCode :TransportationMethod [0..*]

0..1

0..1
PreHospitalCirculatorySystemObserv ation

PreHospitalRespiratorySystemObserv ation

+
+

+
+

heartRateAmount :PQ
systolicBloodPressureAmount :PQ

arterialOxygenSaturationAmount :PQ
respiratoryRateAmount :PQ

0..1
PreHospitalNerv ousSystemObserv ation
+
+
+
+

Slide Number: 67

glasgowComaEyeResponseValue :INT
glasgowComaMotorResponseValue :INT
glasgowComaScoreValue :INT
glasgowComaVerbalResponseCode :INT

© 2014 All Rights Reserved
Organization of DAM Classes
1.0 Patients
+ Patient

3.0 Inj ury Ev ents

2.0 Submission
+ RegistrySubmissionTransaction

4.0 PreHospital Encounters

5.0 Hospital Care Episodes

+ InjuryEvent

+ PreHospitalCirculatorySystemObservation

+ HospitalCareEpisode

+ InjurySeverityObservation

+ PreHospitalEcounter

+ HospitalCirculatorySystemObservation

+ PreHospitalNervousSystemObservation

+ HospitalNervousSystemObservation

+ PreHospitalRespiratorySystemObservation

+ HospitalPhysiologicalObservation
+ HospitalRespiratorySystemObservation
+ 5.1 Emergency Hospital Encounters
+ 5.2 InpatientHospitalEncounters

Slide Number: 68

© 2014 All Rights Reserved
Dictionary to DAM
Element ID

D_01
D_02
D_03
D_04
D_05
D_06
D_07
D_08
D_09
D_10
D_11
D_12
DG_01
DG_02
DG_03
ED_01
ED_02
ED_03
ED_043
ED_05
ED_06
ED_07
ED_08
ED_09

NTDB Dictionary Element

D_01: PATIENT’S HOME ZIP CODE
D_02: PATIENT’S HOME COUNTRY
D_03: PATIENT’S HOME STATE
D_04: PATIENT’S HOME COUNTY
D_05: PATIENT’S HOME CITY
D_06: ALTERNATE HOME RESIDENCE
D_07: DATE OF BIRTH
D_08: AGE
D_09: AGE UNITS
D_10: RACE
D_11: ETHNICITY
D_12: SEX
DG_01: CO-MORBID CONDITIONS
DG_02: ICD-9 INJURY DIAGNOSES
DG_03: ICD-10 INJURY DIAGNOSES
ED_01: ED/HOSPITAL ARRIVAL DATE
ED_02: ED/HOSPITAL ARRIVAL TIME
ED_03: INITIAL ED/HOSPITAL SYSTOLIC BLOOD PRESSURE
ED_043: INITIAL ED/HOSPITAL PULSE RATE
ED_05: INITIAL ED/HOSPITAL TEMPERATURE
ED_06: INITIAL ED/HOSPITAL RESPIRATORY RATE
ED_07: INITIAL ED/HOSPITAL RESPIRATORY ASSISTANCE
ED_08: INITIAL ED/HOSPITAL OXYGEN SATURATION
ED_09: INITIAL ED/HOSPITAL SUPPLEMENTAL OXYGEN

Slide Number: 69

DAM Package

2.0 Patients
2.0 Patients
2.0 Patients
2.0 Patients
2.0 Patients
2.0 Patients
2.0 Patients
2.0 Patients
2.0 Patients
2.0 Patients
2.0 Patients
2.0 Patients
5.0 Hospital Care Episodes
5.0 Hospital Care Episodes
5.0 Hospital Care Episodes
5.0 Hospital Care Episodes
5.0 Hospital Care Episodes
5.0 Hospital Care Episodes
5.0 Hospital Care Episodes
5.0 Hospital Care Episodes
5.0 Hospital Care Episodes
5.0 Hospital Care Episodes
5.0 Hospital Care Episodes
5.0 Hospital Care Episodes

DAM Class

Patient
Patient
Patient
Patient
Patient
Patient
Patient
Patient
Patient
Patient
Patient
Patient
HospitalCareEpisode
HospitalCareEpisode
HospitalCareEpisode
HospitalCareEpisode
HospitalCareEpisode
HospitalCirculatorySystemObservation
HospitalCirculatorySystemObservation
HospitalPhysiologicalObservation
HospitalRespiratorySystemObservation
HospitalRespiratorySystemObservation
HospitalRespiratorySystemObservation
HospitalRespiratorySystemObservation

DAM Attribute

postalAddress
postalAddress
postalAddress
postalAddress
postalAddress
residenceStatusCode
birthDate
eventRelatedAgeQuantity
eventRelatedAgeQuantity
raceCode
ethnicCode
genderCode
coMorbidConditionCode
injuryDiagnosisCode
injuryDiagnosisCode
arrivalDateTime
arrivalDateTime
systolicBloodPressureAmount
heartRateAmount
temperatureAmount
respiratoryRateAmount
respiratoryAssistanceIndicator
arterialOxygenSaturationAmount
supplementalOxygenIndicator

© 2014 All Rights Reserved
CIM: a CDA influenced UML
representation of dictionary elements
PreHospitalEncounterDetail::
PreHospitalEncounter

1

CDA RMIM

RespiratorySystemEntryRelationship
+
+

typeCode :CS = x_ActRelationsh...
contextConductionInd :BL = "true"

0..*
RespiratorySystemObserv ation

2

Domain Analysis
Model

+
+

classCode :CS = "OBS"
moodCode :CS = "EVN"

Constrained
Information Model

ArterialOxygenSaturationObserv ation
+
-

code :CD = ObservationType
value :PQ

::RespiratorySystemObservation
+ classCode :CS = "OBS"
+ moodCode :CS = "EVN"

Slide Number: 70

RespiratoryRateObserv ation
+
-

code :CD = ObservationType
value :PQ

::RespiratorySystemObservation
+ classCode :CS = "OBS"
+ moodCode :CS = "EVN"

© 2014 All Rights Reserved
Organization of CIM Classes
TraumaRegistrySubmissionDocument
+ HealthcareFacility
Patient
+ RecordTarget
+ Patient
+ PatientRole
+ PatientDetailSection

+ RegistryParticipant
+ StructuredBodyComponent
+ StucturedBody
+ Submitter
+ TraumaRegistrySubmissionDocument
+ Patient
+ InjuryEventSection

(from TraumaRegistrySubmissionDocument)

+ PreHospital Encounter Section
+ Hospital Care Episode Section
+ EntryPoint

Inj uryEv entSection

PreHospital Encounter Section

Hospital Care Episode Section

+ InjuryEventSection

+ PreHospitalEncounterSection

+ HospitalCareEpisodeSection

+ StructuredBodyInjuryEventComponent

+ StructoredBodyPreHospitalEncounterComponent

+ StructuredBodyHospitalCareEpisodeComponent

+ InjuryEventDetailEntry

+ PreHospitalEncounterDetail

+ HospitalCareEpisodeActivityDetail

(from TraumaRegistrySubmissionDocument)

Slide Number: 71

(from TraumaRegistrySubmissionDocument)

(from TraumaRegistrySubmissionDocument)

© 2014 All Rights Reserved
DAM to CIM

DAM Class

Patient
Patient
Patient
Patient
Patient
Patient
Patient
Patient
Patient
InjuryEvent
InjuryEvent
InjuryEvent
InjuryEvent
InjuryEvent
InjuryEvent
InjuryEvent
InjuryEvent
InjuryEvent
InjuryEvent
InjuryEvent
PreHospitalCirculatorySystemObservation
PreHospitalCirculatorySystemObservation
PreHospitalEncounter
PreHospitalEncounter

Slide Number: 72

DAM Attribute

birthDate
ethnicCode
eventRelatedAgeQuantity
genderCode
industryCode
occupationCode
postalAddress
raceCode
residenceStatusCode
abbreviatedInjuryCode
airbagDeploymentCode
bodyInjuryRegionCode
injurySeverityScoreValue
locationTypeCode
occurenceDateTime
postalAddress
primaryInjuryCauseCode
safetyEquipmentUsedCode
supplementalInjuryCauseCode
workRelatedEventInd
heartRateAmount
systolicBloodPressureAmount
arrivalDateTime
departureDateTime

CIM Class

Patient
Patient
PatientAgeObservation
Patient
PatientIndustryObservation
PatientOccupationObservation
PatientRole
Patient
PatientResidenceStatusObservation
AbreviatedInjuryObservation
AirbagDeploymentObservation
BodyInjuryObservation
SeverityScoreObservation
LocationTypeObservation
InjuryEventAct
PostalAddressObservation
PrimaryInjuryCauseObservation
SafetyEquipmentUsedObservation
SupplementalInjuryCauseObservation
WorkRelatedObservation
HeartRateObservation
SystolicBloodPressureObservation
PreHospitalEncounter
PreHospitalEncounter

CIM Attribute

birthTime
ethnicGroupCode
value
administrativeGenderCode
value
value
addr
raceCode
value
value
value
value
value
value
effectiveTime
value
value
value
value
value
value
value
effectiveTime
effectiveTime

© 2014 All Rights Reserved
IG: Dictionary elements represented
as templated CDA constraints

CDA RMIM

3

Constrained
Information Model

NTDB
Implementation Guide

EMS
Implementation Guide

Slide Number: 73

© 2014 All Rights Reserved
Organization of IG Templates

Slide Number: 74

© 2014 All Rights Reserved
Organization of IG Templates
Name:
Author:
Version:
Created:
Updated:

TraumaRegistrySubmissionDocument
Salimah Shakir
1.0
2/7/2013 9:30:31 PM
6/14/2013 12:01:15 AM

Legend

HEADER

EntryPoint

TraumaRegistrySubmissionDocument

Patient::PatientRole
1..1

Act
Entity

1

Role

+
+
+
+
-

classCode :CS = "DOCCLIN"
moodCode :CS = "EVN"
id :II
code :CE = DocumentType
effectiveTime :TS

RegistryParticipant
+

classCode :CS = "ASSIGNED"

1..1

1

Participation

1

1

ActRelationship

Submitter

StructuredBodyComponent
Foriegn Class

+
+

+
+

typeCode :CS = "COMP"
contextConductionInd :BL = "true"

typeCode :CS = "INF"
contextControlCode :CS = "OP"

1..1
Patient

1..1
HealthcareFacility

StucturedBody

+ RecordTarget

+
+

+ Patient

+
+
-

classCode :CS = "DOCBODY"
moodCode :CS = "EVN"

+ PatientRole

classCode :CS = "ORG"
determinerCode :CS = "INSTANCE"
id :II

+ PatientDetailSection
1

1

1

1

BODY
1..1
1..1
PatientDetailSection::PatientDetailSection

PatientDetailSection

Inj uryEv entSection::Inj uryEv entSection

Inj uryEv entSection

0..1
PreHospital Encounter Section::
PreHospitalEncounterSection

PreHospital Encounter Section

1..1
Hospital Care Episode Section::
HospitalCareEpisodeSection

Hospital Care Episode Section

+ PatientDetailSection

+ InjuryEventSection

+ PreHospitalEncounterSection

+ HospitalCareEpisodeSection

+ StucturedBodyPatientDetailComponent

+ StructuredBodyInjuryEventComponent

+ StructoredBodyPreHospitalEncounterComponent

+ StructuredBodyHospitalCareEpisodeComponent

+ PatientDemographicObservation

+ InjuryEventDetailEntry

+ PreHospitalEncounterDetail

+ HospitalCareEpisodeActivityDetail

+ PatientEmploymentObservation
(from Patient)

Slide Number: 75

ENTRIES
© 2014 All Rights Reserved
Dict to DAM to CIM to IG
NTDB Dictionary Element

D_01: PATIENT’S HOME ZIP CODE
D_02: PATIENT’S HOME COUNTRY
D_03: PATIENT’S HOME STATE
D_04: PATIENT’S HOME COUNTY
D_05: PATIENT’S HOME CITY
D_06: ALTERNATE HOME RESIDENCE
D_07: DATE OF BIRTH
D_08: AGE
D_09: AGE UNITS
D_10: RACE
D_11: ETHNICITY
D_12: SEX
DG_01: CO-MORBID CONDITIONS
DG_02: ICD-9 INJURY DIAGNOSES
DG_03: ICD-10 INJURY DIAGNOSES
ED_01: ED/HOSPITAL ARRIVAL DATE
ED_02: ED/HOSPITAL ARRIVAL TIME
ED_03: INITIAL ED/HOSPITAL SYSTOLIC BLOOD PRESSURE
ED_043: INITIAL ED/HOSPITAL PULSE RATE
ED_05: INITIAL ED/HOSPITAL TEMPERATURE
ED_06: INITIAL ED/HOSPITAL RESPIRATORY RATE
ED_07: INITIAL ED/HOSPITAL RESPIRATORY ASSISTANCE
ED_08: INITIAL ED/HOSPITAL OXYGEN SATURATION
ED_09: INITIAL ED/HOSPITAL SUPPLEMENTAL OXYGEN

Slide Number: 76

CDA Template

3.1 Trauma Registry Submission Document
3.1 Trauma Registry Submission Document
3.1 Trauma Registry Submission Document
3.1 Trauma Registry Submission Document
3.1 Trauma Registry Submission Document
5.3 Patient Demographic Observations Organizer
3.1 Trauma Registry Submission Document
5.3 Patient Demographic Observations Organizer
5.3 Patient Demographic Observations Organizer
5.3 Patient Demographic Observations Organizer
3.1 Trauma Registry Submission Document
3.1 Trauma Registry Submission Document
6.5 Hospital Care Episode Observation Organizer
6.5 Hospital Care Episode Observation Organizer
6.5 Hospital Care Episode Observation Organizer
5.1 Hospital Care Episode Encounter
5.1 Hospital Care Episode Encounter
6.1 Circulatory System Observation Entry
6.1 Circulatory System Observation Entry
6.7 Hospital Care Physiological Observation
6.16 Respiratory System Observation Entry
6.15 Respiratory System Observation
6.16 Respiratory System Observation Entry
6.15 Respiratory System Observation

CDA ITEM CDA Clone

8.c.111
8.c.111
8.c.111
8.c.111
8.c.111
42.c.iv
8.c.iv.4
43.c.iv
43.c.iv.1
44.c.iv
8.c.iv.5
8.c.iv.3
84.c.iv
85.c.iv
85.c.iv
31
31
63.c.iv
62.c.iv
100.c.iv
145.c.iv
140.c.iv
144.c.iv
141.c.iv

patientRole
patientRole
patientRole
patientRole
patientRole
observation
patient
observation
observation
observation
patient
patient
observation
observation
observation
encounter
encounter
observation
observation
observation
observation
observation
observation
observation

CDA Attribute

CDA CONF

addr
addr
addr
addr
addr
value
birthTime
value
value@unit
value
ethnicGroupCode
administrativeGenderCode
value
value
value
effectiveTime
effectiveTime
value
value
value
value
value
value
value

27773
27773
27773
27773
27773
30000
27776
30008
30455
30508
27778
27775
30385
30397
30397
30341
30341
29639
29633
30431
30092
30437
30085
30441

© 2014 All Rights Reserved
Trauma Registry Data
Submission IG

Slide Number: 77

© 2014 All Rights Reserved
Front Matter:
Introduction and Specification Overview
78

Slide Number: 78

© 2014 All Rights Reserved
Conformance Verbs
79

• The conformance verb keyword at the
start of a constraint ( SHALL , SHOULD ,
MAY, etc.) indicates usage conformance.
– SHALL is an indication that the constraint is to
be enforced without exception;
– SHOULD is an indication that the constraint is
optional but highly recommended; and
– MAY is an indication that the constraint is
optional and that adherence to the constraint
is at the discretion of the document creator.
Slide Number: 79

© 2014 All Rights Reserved
Cardinality
80

• The cardinality indicator (0..1, 0..*, 1..1, 1..*, etc.) specifies the
allowable occurrences within an instance.
• Thus, " MAY contain 0..1" and " SHOULD contain 0..1" both
allow for a document to omit the particular component, but the
latter is a stronger recommendation that the component be
included if it is known.
• The following cardinality indicators may be interpreted as
follows:
–
–
–
–
–

0..1 as contains zero or one
1..1 as contains exactly one
2..2 as contains exactly two
1..* as contains one or more
0..* as contains zero or more

• Each constraint is uniquely identified (e.g., "CONF:605") by
an identifier placed at or near the end of the constraint.
Slide Number: 80

© 2014 All Rights Reserved
Value Set Binding
• Value set bindings adhere to HL7 Vocabulary Working Group best
practices, and include both a conformance verb ( SHALL , SHOULD
, MAY, etc.) and an indication of DYNAMIC vs. STATIC binding.
• The use of SHALL requires that the component be valued with a
member from the cited value set; however, in every case any HL7
"null" value such as other (OTH) or unknown (UNK) may be used.
• STATIC binding means that the allowed values of the value set do
not change automatically as new values are added to a value set.
That is, the binding is to a single version of a value set.
• DYNAMIC binding means that the intent is to have the allowed
values for a coded item automatically change (expand or contract)
as the value set is maintained over time.

Slide Number: 81

© 2014 All Rights Reserved
Templates

Slide Number: 82

© 2014 All Rights Reserved
Document Template
83

Slide Number: 83

© 2014 All Rights Reserved
Section Templates

Slide Number: 84

© 2014 All Rights Reserved
Entry Templates

Slide Number: 85

© 2014 All Rights Reserved
Subentry Templates

Slide Number: 86

© 2014 All Rights Reserved
Vocabulary Tables

Slide Number: 87

© 2014 All Rights Reserved
Implementation Guide Development

Slide Number: 88

© 2014 All Rights Reserved
From Data Dict. to CDA Impl. Guide

Slide Number: 89

© 2014 All Rights Reserved
UMTS Project
Consolidated Dictionary and
IHE Content Profile Development

Slide Number: 90

© 2014 All Rights Reserved
UMTS Project Activities
Registry Elements

Semantic Analysis

1

00069 Dose Amount
00147 Duration
00070 Start Date Time
00306 Stop Date Time

MedicationTypeCode

Consolidated Dictionary

Initial Bolus
00776 Route

00307 Medication

2

DEI

Dictionary Element

00112

REI

Cardiac Arrest Indicator

Registry Element Name

Action.4135

RE Section

Coding Instructions

Context

Timing

Action.4140

Cardiac Arrest Pre-Hospital

Action.4145

Cardiac Arrest Outside Facility

Cardiac Arrest Indicator

Action.9035

Cardiac Arrest

H. In-Hospital Clinical Events

Indicate if the patient experienced an
episode of cardiac arrest in your facility.

Cardiac Arrest Indicator

CathPCI.5065 Cardiac Arrest w/in 24 Hours

D. Cath Lab Visit

Indicate if the patient has had an episode
of cardiac arrest within 24 hours of
procedure.

Cardiac Arrest Indicator

ICD.4080

Cardiac Arrest Pre-Hospital

C. History and Risk Factors

Indicate if the patient experienced
cardiac arrest due to arrhythmia.

History and Risk Factors

VTach/VFib Arrest Indicator ICD.4090

VTach/VFib Arrest

C. History and Risk Factors

Indicate if the cardiac arrest was a result
of ventricular tachycardia or ventricular
fibrillation.

History and Risk Factors

Bradycardia Arrest Indicator ICD.4095

Bradycardia Arrest

C. History and Risk Factors

Indicate if the cardiac arrest was a result
of bradycardia.

History and Risk Factors

00112

Cardiac Arrest Indicator

ICD.8005

Cardiac Arrest

H. Intra or Post Procedure Events

Indicate if the patient experienced
cardiac arrest.

Intra or Post Procedure

00112

Cardiac Arrest Indicator

Impact.8000 Cardiac Arrest

L. Intra and Post-Procedure Events

Indicate if there was a cardiac arrest event
that required CPR.

Intra or Post Procedure

00112

q24hr

Within 2 weeks

Cause

Cardiac Arrest at First Medical Contact C. Cardiac Status on First Medical Contact Indicate if the patient has had an episode First Medical Contact
of cardiac arrest.

Cardiac Arrest Indicator

00102

00238 Frequency

MedicationAdministration

Cardiac Arrest Indicator

00112

00800

q12hr

00112

00112

Initial Infusion

00112

00112

MedicationClassCode

Standard Clinical Code Systems

Location

C. Cardiac Status on First Medical Contact Indicate if the patient’s cardiac arrest was First Medical Contact
prior to arrival at the outside facility
and/or occurred during transfer from the
outside facility to this facility.
C. Cardiac Status on First Medical Contact Indicate if the patient’s cardiac arrest
First Medical Contact
occurred at the outside facility.

Cardiac Arrest Indicator

TVT.5035

D. Pre-Procedure Status

Indicate if the patient has had an episode of
cardiac arrest within 24 hours of the
procedure.

within 24 hours
of the procedure

First 24 Hours

PreHospital

Outside Facility

In Hospital

within 24 hours
of procedure

Pre-Hospital

Administered
Pre-Encounter
Timing

Intra-Encounter

00423 Status

Not Administered

Blinded

00303 Dose Code

Pre-Procedure

Intra-Procedure

ventricular tachycardia
or ventricular fibrillation

bradycardia

Contraindicated

At Discharge

Full

Reduced

Cardiac Arrest w/in 24 Hours

Other

During Follow-up

3

Conceptual Data Model

HL7 Reference Models
01.0 Submissions::ParticipantIdentifier
+

01.0 Submissions::SourceSystem

identifierValue :ST
identifierTypeCode :ParticipantIdentifier

-

versionIdentifier :ST

-

1

identifies

originates from
01.0 Submissions::Submission

01.0 Submissions::Participant
-

submited by

name :ST

-

1..* +
+

trialTypeCode :CD
researchStudyName :ST

1

identifier :ST
submissionTimePeriod :TS.DATE (IVL) 1..*
submissionDateTime :TS

01.0 Submissions::Registry

submited to
1 -

05.0 Ev ents::Ev entEv entRelation

identifier :ST {id}
versionIdentifier :ST {id}

+

Name:
Author:
Version:
Created:
Updated:

has target
0..*

+
0..* +
1

is part of

1

-

0..*

1

Procedure
methodCode : SET<CE>
approachSiteCode : SET<CD>
targetSiteCode : SET<CD>

has subject
name :EN.PN
birthDate :TS.DATE
sexCode :CD
hispanicIndicator :BL = No
ethnicityDetailCode :CD [0..*] (SET)
postalZoneIdentifier :II
residenceCountryCode :CD

indicationCode :CD [0..1]
abortedReasonCode :CD [0..*]

+

::Event
- methodCode :CD [0..*] (SET)
+ classificationCode :Clasification
+ contextCode :Context
- eventDateTime :TS [0..1] (IVL)
- statusCode :CD = Completed
- eventDuration :PQ.TIME [0..1]

is a type of

::Event
- methodCode :CD [0..*] (SET)
+ classificationCode :Clasification
+ contextCode :Context
- eventDateTime :TS [0..1] (IVL)
- statusCode :CD = Completed
- eventDuration :PQ.TIME [0..1]

1

1

1..*

InvoiceElement
modifierCode : SET<CE>
unitQuantity : RTO<PQ,PQ>
unitPriceAmt : RTO<MO,PQ>
netAmt : MO
factorNumber : REAL
pointsNumber : REAL

is part of
0..*

1 -

identifier :II
typeCode :CD
manufacturerName :EN.ON
deviceName :ST
universalDeviceIdentifier :II [0..1]

0..1

is part of

administers

-

deviceCounter :INT

is part of
0..*

06.0 Lesions::LesionTreatmentDetail

-

1..*

0..*

-

identifierValue :II
identifierTypeCode :PatientIdentifier

::ObservationEvent
+ observationTypeCode :CD

10.0 Medication Administration Ev ents::
Medication

02.0 Patients::PatientRace

02.0 Patients::PatientIdentifier
+

raceCode :CD
raceDetailCode :CD [0..*] (SET)

+
-

09.0 Procedures::ProcedureVascularAssessment

previouslyTreatedIndicator :BL = No
culpritLesionIndicator :BL = No

-

vesselNotAvailableIndicator :BL = No

09.0 Procedures::ArterialAccess

09.0 Procedures::ArterialClosure
is part of

::Event
- methodCode :CD [0..*] (SET)
+ classificationCode :Clasification
+ contextCode :Context
- eventDateTime :TS [0..1] (IVL)
- statusCode :CD = Completed
- eventDuration :PQ.TIME [0..1]

::Event
- methodCode :CD [0..*] (SET)
+ classificationCode :Clasification
+ contextCode :Context
- eventDateTime :TS [0..1] (IVL)
- statusCode :CD = Completed
- eventDuration :PQ.TIME [0..1]

0..1

1

0..*

::ObservationEvent
+ observationTypeCode :CD

::ObservationEvent
+ observationTypeCode :CD

::Event
- methodCode :CD [0..*] (SET)
+ classificationCode :Clasification
+ contextCode :Context
- eventDateTime :TS [0..1] (IVL)
- statusCode :CD = Completed
- eventDuration :PQ.TIME [0..1]

medicationCode :CD
name :ST

-

siteCounter :INT
directionalityTypeCode :CD [0..1]
vesselCode :CD

1..* {ordered} -

arterialClosureCounter :INT {id}
methodCode :CD [0..1]
undocumentedIndicator :BL = No

0..*

0..*

0..*

has target
is part of

is treatment of

1

06.0 Lesions::LesionTreatmentDev ice

Account
name : ST
balanceAmt : MO
currencyCode : CE
interestRateQuantity : RTO<MO,PQ>
allowedBalanceQuantity : IVL<MO>

1

1

06.0 Lesions::Lesion

06.0 Lesions::LesionAffectedVesselSegment

deviceCounter :INT

-

lesionCounter :INT {id}

0..*
04.0 Observ ations::Inv olv edAnatomicSite

is located in
0..* -

1

lesionLocationCode :CD
segmentCounter :INT

involved
1 -

0..*

typeCode :CD
lateralityCode :CD

1

0..*

is a type
of

+

involvementTypeCode :InvolvementType

is a type
of

is a type
of

Refers to (1..1)
07.0 Devices :: Device

1

08.0 AnatomicSites::AnatomicSite

affecting
-

0..*
06.0 Lesions::LesionDescriptor

08.0 AnatomicSites::VesselSegment

Primary Class

FinancialTransaction
amt : MO
creditExchangeRateQuantity : REAL
debitExchangeRateQuantity : REAL

-

::ObservationEvent
+ observationTypeCode :CD

-

is part of

::AnatomicSite
- typeCode :CD
- lateralityCode :CD

::Event
- methodCode :CD [0..*] (SET)
+ classificationCode :Clasification
+ contextCode :Context
- eventDateTime :TS [0..1] (IVL)
- statusCode :CD = Completed
- eventDuration :PQ.TIME [0..1]

Dependant Classes
Value Sets

08.0 AnatomicSites::AnatomicRegion

cardiovascularVesselCode :CD {id}
vesselTypeCode :CD

is part of

::AnatomicSite
- typeCode :CD
- lateralityCode :CD

0..*

anotomicRegionCode :CD

0..1

::AnatomicSite
- typeCode :CD
- lateralityCode :CD

0..*

+subsection
0..*

graftTypeCode :CD

4

Constrained Information Model
(Observ ation)
ParticipantIdentifierObserv ation

(Section)
RegistryParticipantDetailSection

(Patient)
Patient
+
+
+
+

#

classCode :CS = "PSN"
determinerCode :CS = "INSTANCE"
(Patient.name) name :EN.PN
(Patient.sexCode) administrativeGenderCode :CD
(Patient.birthDate) birthTime :TS.DATE
(Patient.hispanicIndicator) ethnicGroupCode :CD

classCode :CS = "DOCSECT"
moodCode :CS = "EVN"
code :CE = "RegistryPartic...

#
+

1..*

1

classCode :CS = "OBS"
moodCode :CS = "EVN"
(ParticipantIdentifier.typeCode) code :CD
(ParticipantIdentifier.identifierValue) value :CD

(Entry)
ParticipantIdentifierObserv ationEntry

1..1
-

ii. This observationThe entryRelationship, one [1..1] @moodCode="EVN"
b. SHALL contain exactly if present, SHALL contain exactly one [1..1]
(CONF:31970). @contextConductionInd="true" (CONF:31967).

(CONF:31969).
ii. This observation SHALL contain exactly one [1..1] @moodCode="EVN"
(CONF:31970).

iii. This observation SHALL contain exactly one [1..1] code (CONF:31971).

typeCode :CS = "COMP"
contextConductionIndicator :BL = "true"

5

iii. This observation SHALL contain exactly one [1..1] code (CONF:31971).

iv. This observation SHALL contain exactly one [1..1] value with @xsi:type="CD"
(CONF:31972).

::CardiovascularVessel
- cardiovascularVesselCode :CD {id}
- vesselTypeCode :CD
::AnatomicSite
- typeCode :CD
- lateralityCode :CD

HL7 Clinical Document Architecture RMIM

iii. This observationThe entryRelationship, one [1..1] code (CONF:31971). one [1..1] observation
c. SHALL contain exactly if present, SHALL contain exactly
iv. This observation(CONF:31968). exactly one [1..1] value with @xsi:type="CD"
SHALL contain
(CONF:31972).
i. This observation SHALL contain exactly one [1..1] @classCode="OBS"

ii. This observation SHALL contain exactly one [1..1] @moodCode="EVN"
(CONF:31970).

08.0 AnatomicSites::Cardiov ascularGraft
-

Contains:

6. SHALL contain zeroSHALL containeffectiveTime (CONF:31963).
Table 1: ClincalEventObservationSubEntry Contexts
1. or one [0..1] exactly one [1..1] @classCode="OBS" (CONF:31958).
7. SHALL contain exactly one [1..1] value (CONF:31964).
2. SHALL containContained By:
exactly one [1..1] @moodCode="EVN" (CONF:31959).
Contains:
8. MAY contain zero or more [0..*] zero or one [0..1] @negationInd (CONF:31960).
3. MAY contain entryRelationship (CONF:31965).
a. The entryRelationship, if present,one [1..1] templateId="2.16.840.1.113883.3.2898.10.9999"
4. SHALL contain exactly SHALL contain exactly one [1..1]
This
@typeCode="OPTN" (CONF:31966). template is used to collect clinical event observations made within the scope of the
(CONF:31961).
encounter. Observations may be modified by observational semantic qualifiers.
b. The entryRelationship, if present,one [1..1] code exactly one [1..1]
5. SHALL contain exactly SHALL contain (CONF:31962).
@contextConductionInd="true" SHALL contain exactly one [1..1] @classCode="OBS" (CONF:31958).
1. (CONF:31967).
6. SHALL contain zero or one [0..1] effectiveTime (CONF:31963).
c. The entryRelationship, if present,one [1..1] valueexactlyone [1..1] observation
2. SHALL contain (CONF:31964).
7. SHALL contain exactly SHALL contain exactly one [1..1] @moodCode="EVN" (CONF:31959).
(CONF:31968).
3. MAY contain zero or one [0..1] @negationInd
8. MAY contain zero or more [0..*] entryRelationship (CONF:31965). (CONF:31960).
i. This observation SHALL contain exactly one [1..1] @classCode="OBS"
4. SHALL if present, SHALL contain exactly one [1..1]
a. The entryRelationship, contain exactly one [1..1] templateId="2.16.840.1.113883.3.2898.10.9999"
(CONF:31969).
(CONF:31961).
@typeCode="OPTN" (CONF:31966).
ii. This observation SHALL contain exactly one [1..1] @moodCode="EVN"
5. SHALL if present, SHALL contain exactly one [1..1]
b. The entryRelationship, contain exactly one [1..1] code (CONF:31962).
(CONF:31970).
@contextConductionInd="true" (CONF:31967).
6. SHALL contain zero or one [0..1] effectiveTime (CONF:31963).
iii. This observation SHALL contain exactly one [1..1] code (CONF:31971).
c. The entryRelationship, contain exactly one [1..1] value (CONF:31964).
if present, SHALL contain exactly one [1..1] observation
7. SHALL
iv. This observation SHALL contain exactly one [1..1] value with @xsi:type="CD"
(CONF:31968). MAY contain zero or more [0..*] entryRelationship (CONF:31965).
8.
(CONF:31972).
i. This observationThe entryRelationship, one [1..1] @classCode="OBS"
a. SHALL contain exactly if present, SHALL contain exactly one [1..1]
(CONF:31969). @typeCode="OPTN" (CONF:31966).

(CONF:31969).

is grouped by

is a type
of

Foreign Classes

08.0 AnatomicSites::Cardiov ascularVessel

vesselSegmentCode :CD {id}

Contained By:

ii. This observationThe entryRelationship, one [1..1] @moodCode="EVN"
b. SHALL contain exactly if present, SHALL contain exactly one [1..1]
(CONF:31970). @contextConductionInd="true" (CONF:31967).
iii. This observationThe entryRelationship, one [1..1] code (CONF:31971). one [1..1] observation
c. SHALL contain exactly if present, SHALL contain exactly
iv. This observation(CONF:31968). exactly one [1..1] value with @xsi:type="CD"
SHALL contain
(CONF:31972).
i. This observation SHALL contain exactly one [1..1] @classCode="OBS"

0..*

is treated by

Contains:

1

3. MAY contain zero or one [0..1] @negationInd (CONF:31960).

4. SHALL contain exactly one [1..1] templateId="2.16.840.1.113883.3.2898.10.9999"
1.1 ClincalEventObservationSubEntry
(CONF:31961).This template is used to collect clinical event observations made within the scope of the
[observation: templateId 2.16.840.1.113883.3.2898.10.9999 (closed)]
encounter. Observations may be modified by observational semantic qualifiers.
5. SHALL contain exactly one [1..1] code (CONF:31962).

Contains:

7. SHALL contain exactly one [1..1] value (CONF:31964).
2. SHALL containContained By:
exactly one [1..1] @moodCode="EVN" (CONF:31959).
Contains:
8. MAY contain zero or more [0..*] zero or one [0..1] @negationInd (CONF:31960).
3. MAY contain entryRelationship (CONF:31965).
a. The entryRelationship, if present,one [1..1] templateId="2.16.840.1.113883.3.2898.10.9999"
4. SHALL contain exactly SHALL contain exactly one [1..1]
This
@typeCode="OPTN" (CONF:31966). template is used to collect clinical event observations made within the scope of the
(CONF:31961).
encounter. Observations may be modified by observational semantic qualifiers.
b. The entryRelationship, if present,one [1..1] code exactly one [1..1]
5. SHALL contain exactly SHALL contain (CONF:31962).
@contextConductionInd="true" SHALL contain exactly one [1..1] @classCode="OBS" (CONF:31958).
1. (CONF:31967).
6. SHALL contain zero or one [0..1] effectiveTime (CONF:31963).
c. The entryRelationship, if present,one [1..1] valueexactlyone [1..1] observation
2. SHALL contain (CONF:31964).
7. SHALL contain exactly SHALL contain exactly one [1..1] @moodCode="EVN" (CONF:31959).
(CONF:31968).
3. MAY contain zero or one [0..1] @negationInd
8. MAY contain zero or more [0..*] entryRelationship (CONF:31965). (CONF:31960).
i. This observation SHALL contain exactly one [1..1] @classCode="OBS"
4. SHALL if present, SHALL contain exactly one [1..1]
a. The entryRelationship, contain exactly one [1..1] templateId="2.16.840.1.113883.3.2898.10.9999"
(CONF:31969).
(CONF:31961).
@typeCode="OPTN" (CONF:31966).
ii. This observation SHALL contain exactly one [1..1] @moodCode="EVN"
5. SHALL if present, SHALL contain exactly one [1..1]
b. The entryRelationship, contain exactly one [1..1] code (CONF:31962).
(CONF:31970).
@contextConductionInd="true" (CONF:31967).
6. SHALL contain zero or one [0..1] effectiveTime (CONF:31963).
iii. This observation SHALL contain exactly one [1..1] code (CONF:31971).
c. The entryRelationship, contain exactly one [1..1] value (CONF:31964).
7. SHALL if present, SHALL contain exactly one [1..1] observation
iv. This observation SHALL contain exactly one [1..1] value with @xsi:type="CD"
(CONF:31968). MAY contain zero or more [0..*] entryRelationship (CONF:31965).
8.
(CONF:31972).
i. This observationThe entryRelationship, one [1..1] @classCode="OBS"
a. SHALL contain exactly if present, SHALL contain exactly one [1..1]
(CONF:31969). @typeCode="OPTN" (CONF:31966).

1

0..*

Legend

Diet
energyQuantity : PQ
carbohydrateQuantity : PQ

is use of

0..* ::Event
- methodCode :CD [0..*] (SET)
+ classificationCode :Clasification
+ contextCode :Context
- eventDateTime :TS [0..1] (IVL)
- statusCode :CD = Completed
- eventDuration :PQ.TIME [0..1]

1

09.0 Procedures::ArterialClosureDev ice
identifies

Table 1: ClincalEventObservationSubEntry Contexts

SUBENTRY

1. SHALL contain exactly one [1..1] @classCode="OBS" (CONF:31958).
Table 1: ClincalEventObservationSubEntry Contexts
2. SHALL contain exactly one [1..1] @moodCode="EVN" R Y
S U B E N T (CONF:31959).

1

6. SHALL contain zeroSHALL containeffectiveTime (CONF:31963).
Table 1: ClincalEventObservationSubEntry Contexts
1. or one [0..1] exactly one [1..1] @classCode="OBS" (CONF:31958).

07.0 Dev ices::Dev ice

::ObservationEvent
+ observationTypeCode :CD

is use by

::Event
- methodCode :CD [0..*] (SET)
+ classificationCode :Clasification
+ contextCode :Context
- eventDateTime :TS [0..1] (IVL)
- statusCode :CD = Completed
- eventDuration :PQ.TIME [0..1]
1

is part of

Supply
quantity : PQ
expectedUseTime : IVL<TS>

procedureTypeCode :CD

::Intervention
- indicationCode :CD [0..1]
- abortedReasonCode :CD [0..*]

is a type
of

deviceCounter :INT {id}
statusCode :CD
abortedReasonCode :CD [0..1]

is use of

1 +

has subject
1..*

-

::Intervention
- indicationCode :CD [0..1]
- abortedReasonCode :CD [0..*]

02.0 Patients::Patient

0..1

0..*

09.0 Procedures::ProcedureDev iceUse
09.0 Procedures::Procedure
-

1

1.1 ClincalEventObservationSubEntry
This template is used to collect clinical event observations made within the scope of the
[observation: templateId 2.16.840.1.113883.3.2898.10.9999 (closed)]
encounter. Observations may be modified by observational semantic qualifiers.

3. MAY contain zero or one [0..1] @negationInd (CONF:31960).

4. SHALL contain exactly one [1..1] templateId="2.16.840.1.113883.3.2898.10.9999"
1.1 ClincalEventObservationSubEntry
(CONF:31961).This template is used to collect clinical event observations made within the scope of the
[observation: templateId 2.16.840.1.113883.3.2898.10.9999 (closed)]
encounter. Observations may be modified by observational semantic qualifiers.
5. SHALL contain exactly one [1..1] code (CONF:31962).

Contained By:

involving

0..*

02.0 Patients::ResearchStudyEnrollment

[observation: templateId 2.16.840.1.113883.3.2898.10.9999 (closed)]

Contained By:

Contains:

2. SHALL contain exactly one [1..1] @moodCode="EVN" R Y
S U B E N T (CONF:31959).

0..*

is part of

0..*

enrolledIndicator :BL = No

SUBENTRY

1. SHALL contain exactly one [1..1] @classCode="OBS" (CONF:31958).
Table 1: ClincalEventObservationSubEntry Contexts

::Event
- methodCode :CD [0..*] (SET)
+ classificationCode :Clasification
+ contextCode :Context
- eventDateTime :TS [0..1] (IVL)
- statusCode :CD = Completed
- eventDuration :PQ.TIME [0..1]

is referred to by (0..*)
06.0 Lesions :: LesionTreatmentDevice

1

-

1

1.1 ClincalEventObservationSubEntry
This template is used to collect clinical event observations made within the scope of the
[observation: templateId 2.16.840.1.113883.3.2898.10.9999 (closed)]
encounter. Observations may be modified by observational semantic qualifiers.

1

05.0 Events::Intervention

0..*

DiagnosticImage
subjectOrientationCode : CE

Contained By:

observationResultTypeCode :CD
conditionOnsetDateTime :TS [0..1]
+child
estimatedOnsiteDateIndicator :BL = No
0..*
missingOnsetTimeIndicator :BL = No
observationValue :ANY
observationValueNegationIndicator :BL = No

07.0 Dev ices::Dev iceDescriptor
::ObservationEvent
+ observationTypeCode :CD

::Event
- methodCode :CD [0..*] (SET)
+ classificationCode :Clasification
+ contextCode :Context
- eventDateTime :TS [0..1] (IVL)
- statusCode :CD = Completed
- eventDuration :PQ.TIME [0..1]

09.0 Procedures::ProcedureLesion

Observation
value : ANY
interpretationCode : SET<CE>
methodCode : SET<CE>
targetSiteCode : SET<CD>

0..* +

is part of

::ObservationEvent
+ observationTypeCode :CD

10.0 Medication Administration Ev ents::
MedicationAdministrationEv ent

SUBENTRY
ClincalEventObservationSubEntry

Table 1: ClincalEventObservationSubEntry Contexts
is grouped by
+parent
0..1
04.0 Observ ations::Observ ationResult

04.0 Observ ations::
Observ ationEv ent
observationTypeCode :CD

0..*

relationshipTypeCode :RelationshipType

is a type
of

1

1
1.1

ClincalEventObservationSubEntry
[observation: templateId 2.16.840.1.113883.3.2898.10.9999 (closed)]

name :EN.PN
identifier :II
isCertifiedIndicator :BL = No
0..*

+

::Event
- methodCode :CD [0..*] (SET)
+ classificationCode :Clasification
+ contextCode :Context
- eventDateTime :TS [0..1] (IVL)
- statusCode :CD = Completed
- eventDuration :PQ.TIME [0..1]

is a type
of

09.0 Procedures::ProcedureDescriptor
0..*

03.0 CareEpisodes::Ev entEpisodeRelation
+

SUBENTRY

performed by

0..*

methodCode :CD [0..*] (SET)
classificationCode :Clasification
contextCode :Context
eventDateTime :TS [0..1] (IVL)
statusCode :CD = Completed
eventDuration :PQ.TIME [0..1]

has source
has target

within context of

1

SubstanceAdministration
routeCode : CE
approachSiteCode : SET<CD>
doseQuantity : IVL<PQ>
rateQuantity : IVL<PQ>
doseCheckQuantity : SET<RTO>
maxDoseQuantity : SET<RTO>
substitutionCode : CE

PublicHealthCase
PatientEncounter
detectionMethodCode : CE
preAdmitTestInd : BL
transmissionModeCode : CE
admissionReferralSourceCode : CE
diseaseImportedCode : CE
lengthOfStayQuantity : PQ
dischargeDispositionCode : CE
specialCourtesiesCode : SET<CE>
specialAccommodationCode : SET<CE>
acuityLevelCode : CE

1.1

NCDR DAM Classes
Salimah Shakir
1.0
11/12/2012 7:02:00 PM
8/26/2013 1:05:44 PM

1

05.0 Ev ents::Ev ent

arrivalDateTime :TS
dischargeDate :TS.DATE
payorTypeCode :CD [1..*] (SET)
admissionSourceCode :CD
dischargeDispositionCode :CD
1

has source

is grouped by

0..*

-

05.0 Ev ents::Ev entPerformer

relationshipTypeCode :RelationshipType

0..*
03.0 CareEpisodes::CareEpisode
02.0 Patients::ClinicalTrial

Registry Specific Business Rules

identifier :ST {id}

is used by

salaryTypeCode : CE
salaryQuantity : MO
hazardExposureText : ED
protectiveEquipmentText : ED

0..n
LanguageCommunication
languageCode : CE
modeCode : CE
proficiencyLevelCode : CE
preferenceInd : BL

1

has subject

formCode : CE

ManufacturedMaterial
lotNumberText : ST
expirationTime : IVL<TS>
stabilityTime : IVL<TS>

Container
Device
capacityQuantity : PQ
manufacturerModelName : SC
heightQuantity : PQ
softwareName : SC
localRemoteControlStateCode : CE
... diameterQuantity : PQ
capTypeCode : CE
alertLevelCode : CE
separatorTypeCode : CE
lastCalibrationTime : TS
barrierDeltaQuantity : PQ
bottomDeltaQuantity : PQ

HL7 & IHE Content Profiles

01.0 Submissions::SourceSystemProv ider

provided by

1..*

1

is part of

ActRelationship
typeCode : CS
inversionInd : BL
outboundRelationship contextControlCode : CS
Access
LicensedEntity
0..n contextConductionInd : BL
approachSiteCode : CD
recertificationTime : TS
sequenceNumber : INT
targetSiteCode : CD
1 source
priorityNumber : INT
gaugeQuantity : PQ
pauseQuantity : PQ
Act
Participation
checkpointCode : CS
classCode : CS
Entity
typeCode : CS
Role
splitCode : CS
moodCode : CS
functionCode : CD
classCode : CS
player
joinCode : CS
classCode : CS
id : SET<II>
contextControlCode : CS
determinerCode : CS
negationInd : BL
0..1
code : CD
0..n id : SET<II>
sequenceNumber : INT
id : SET<II>
0..n
conjunctionCode : CS
negationInd : BL
1
playedRolecode : CE
negationInd : BL
code : CE
localVariableName : ST
negationInd : BL
1 derivationExpr : ST
quantity : SET<PQ>
0..n noteText : ED
seperatableInd : BL
addr : BAG<AD>
text : ED
time : IVL<TS>
name : BAG<EN>
telecom : BAG<TEL>
0..n
statusCode : SET<CS>
modeCode : CE
desc : ED
statusCode : SET<CS>
effectiveTime : GTS
inboundRelationship
awarenessCode : CE
statusCode : SET<CS>
scopedRole
effectiveTime : IVL<TS>
activityTime : GTS
signatureCode : CE
existenceTime : IVL<TS>
0..n certificateText : ED
target
availabilityTime : TS
signatureText : ED
telecom : BAG<TEL>
quantity : RTO
0..1
priorityCode : SET<CE>
performInd : BL
riskCode : CE
1
positionNumber : LIST<INT>
scoper
substitutionConditionCode : CE confidentialityCode : SET<CE>
...
handlingCode : CE
repeatNumber : IVL<INT>
DeviceTask
1 target 1source
interruptibleInd : BL
1
parameterValue : LIST<ANY>
levelCode : CE
inboundLink
WorkingList
0..n
outboundLink 0..n
independentInd : BL
Employee
ownershipLevelCode : CE
RoleLink
uncertaintyCode : CE
FinancialContract
jobCode : CE
typeCode : CS
reasonCode : SET<CE>
paymentTermsCode : CE
jobTitleName : SC
effectiveTime : IVL<TS>
languageCode : CE
jobClassCode : CE
Material

treated

NonPersonLivingSubject
strainText : ED
genderStatusCode : CE

ManagedParticipation
id : SET<II>
statusCode : SET<CS>

assigns

LivingSubject
administrativeGenderCode : CE
birthTime : TS
deceasedInd : BL
deceasedTime : TS
multipleBirthInd : BL
multipleBirthOrderNumber : INT
organDonorInd : BL

Patient
confidentialityCode : CE
veryImportantPersonCode : CE

is a trait of

Person
addr : BAG<AD>
maritalStatusCode : CE
educationLevelCode : CE
raceCode : SET<CE>
disabilityCode : SET<CE>
livingArrangementCode : CE
religiousAffiliationCode : CE
ethnicGroupCode : SET<CE>

Place
mobileInd : BL
addr : AD
directionsText : ED
positionText : ED
gpsText : ST

1..*

1

0..*

Organization
addr : BAG<AD>
standardIndustryClassCode : CE

iv. This observation SHALL contain exactly one [1..1] value with @xsi:type="CD"
(CONF:31972).

UMTS CDA Template Library

6

Registry Specific Content Profiles
1

SUBENTRY

1.1

ClincalEventObservationSubEntry
[observation: templateId 2.16.840.1.113883.3.2898.10.9999 (closed)]

1
(StructuredBodyComponent)
RegistryParticipantDetailComponent

Entry Point
(ClinicalDocumentComponent)
DocumentComponent

(RecordTarget)
RecordTarget
-

isPlayedBy

classCode :CS = "PAT"
(PatientIdentifier.identifierValue) id :II

-

typeCode :CS = "RCT"
contextControlCode :CS = "OP"

-

typeCode :CS = "COMP"
contextConductionIndicator :BL = "true"

Table 1: ClincalEventObservationSubEntry Contexts

(Entry)
PatientIdentifierObserv ationEntry

typeCode :CS = "COMP"
contextConductionIndicator :BL = "true"

-

Contained By:

typeCode :CS = "COMP"
contextConductionIndicator :BL = "true"

(ClinicalDocument)
CathPCIRegistryDocument

1..1

1

+
#
+

classCode :CS = "DOCCLIN"
moodCode :CS = "EVN"
id :II
code :CE = "CATHPCI"
effectiveTime :TS

-

1..1

(Observ ation)
PatientIdentifierObserv ation

(Section)
PatientDetailSection

(StructuredBody)
DocumentBody
1

classCode :CS = "DOCBODY"
moodCode :CS = "EVN"

1..1

1

#

classCode :CS = "DOCSECT"
moodCode :CS = "EVN"
code :CE = "PatientDetail"

1

0..*

#
+

classCode :CS = "OBS"
moodCode :CS = "EVN"
(PatientIdentifier.typeCode) code :CD
(PatientIdentifier.identifierValue) value :CD

1

1
1
(StructuredBodyComponent)
PatientDetailComponent

(StructuredBodyComponent)
SubmissionDetailComponent

(Custodian)
Custodian
-

-

typeCode :CS = "CST"

-

typeCode :CS = "COMP"
contextConductionIndicator :BL = "true"

(Entry)
PatientRaceObserv ationEntry

typeCode :CS = "COMP"
contextConductionIndicator :BL = "true"

-

1..1

typeCode :CS = "COMP"
contextConductionIndicator :BL = "true"

1..1

1..1
(CustodianOrganization)
Participant
+
+

classCode :CS = "ORG"
determinerCode :CS = "INSTANCE"
(ParticipantIdentifier.identifierValue) id :II
(Participant.name) name :EN.ON

(Section)
SubmissionDetailSection

(AssignedCustodian)
ParticipantRole

isScopedBy
1

1..1

-

#

classCode :CS = "ASSIGNED"

(Observ ation)
PatientRaceObserv ation

classCode :CS = "DOCSECT"
moodCode :CS = "EVN"
code :CE = "SubmissionDetail"

#
+

1

classCode :CS = "OBS"
moodCode :CS = "EVN"
code :CD = "PatientRace"
(PatientRace.raceCode) value :CD [1..*] (SET)

(Entry)
SubmissionActEntry
-

typeCode :CS = "COMP"
contextConductionIndicator :BL = "true"
1..1
(Act)
SubmissionAct
+
+

classCode :CS = "ACT"
moodCode :CS = "EVN"
(Submission.identifier) id :II
(Submission.submissionTimePeriod) effectiveTime :TS (IVL)

(ParticipantRole)
TargetRegistry
1

1..1

-

classCode :CS = "MMAT"
1..1

1

(ClinicalStatementParticipant)
Author
-

(ClinicalStatementParticipant)
Receiv er

typeCode :CS = "AUT"
contextControlCode :CS = "OP"

-

isPlayedBy

typeCode :CS = "RCV"
contextControlCode :CS = "OP"

1..1
1

(Dev ice)
DataCollectionSystem
+

classCode :CS = "DEV"
determinerCode :CS = "INSTANCE"
(SourceSystem.versionIdentifier) id :II

(ParticipantRole)
SourceSystem

isPlayedBy
1

1..1

-

1

SUBENTRY

Contains:

1.1 ClincalEventObservationSubEntry
This template is used to collect clinical event observations made within the scope of the
[observation: templateId 2.16.840.1.113883.3.2898.10.9999 (closed)]
encounter. Observations may be modified by observational semantic qualifiers.

1

1..1
(PatientRole)
PatientRole
+

(Dev ice)
RegistrySystem

classCode :CS = "MMAT"
+
+
isScopedBy

classCode :CS = "DEV"
determinerCode :CS = "INSTANCE"
(Registry.identifier) id.root :II.root
(RegistryVersionIdentifier) id.extension :II.extension

1. SHALL contain exactly one [1..1] @classCode="OBS" (CONF:31958).
Table 1: ClincalEventObservationSubEntry Contexts

1

2. SHALL contain exactly one [1..1] @moodCode="EVN" R Y
S U B E N T (CONF:31959).
Contained By:

Contains:

3. MAY contain zero or one [0..1] @negationInd (CONF:31960).

4. SHALL contain exactly one [1..1] templateId="2.16.840.1.113883.3.2898.10.9999"
1.1 ClincalEventObservationSubEntry
(CONF:31961).This template is used to collect clinical event observations made within the scope of the
[observation: templateId 2.16.840.1.113883.3.2898.10.9999 (closed)]
encounter. Observations may be modified by observational semantic qualifiers.
5. SHALL contain exactly one [1..1] code (CONF:31962).
6. SHALL contain zeroSHALL containeffectiveTime (CONF:31963).
Table 1: ClincalEventObservationSubEntry Contexts
1. or one [0..1] exactly one [1..1] @classCode="OBS" (CONF:31958).
7. SHALL contain exactly one [1..1] value (CONF:31964).
2. SHALL containContained By:
exactly one [1..1] @moodCode="EVN" (CONF:31959).
Contains:
8. MAY contain zero or more [0..*] zero or one [0..1] @negationInd (CONF:31960).
3. MAY contain entryRelationship (CONF:31965).
a. The entryRelationship, if present,one [1..1] templateId="2.16.840.1.113883.3.2898.10.9999"
4. SHALL contain exactly SHALL contain exactly one [1..1]
This
@typeCode="OPTN" (CONF:31966). template is used to collect clinical event observations made within the scope of the
(CONF:31961).
encounter. Observations may be modified by observational semantic qualifiers.
b. The entryRelationship, if present,one [1..1] code exactly one [1..1]
5. SHALL contain exactly SHALL contain (CONF:31962).
@contextConductionInd="true" SHALL contain exactly one [1..1] @classCode="OBS" (CONF:31958).
1. (CONF:31967).
6. SHALL contain zero or one [0..1] effectiveTime (CONF:31963).
c. The entryRelationship, if present,one [1..1] valueexactlyone [1..1] observation
2. SHALL contain (CONF:31964).
7. SHALL contain exactly SHALL contain exactly one [1..1] @moodCode="EVN" (CONF:31959).
(CONF:31968).
3. MAY contain zero or one [0..1] @negationInd
8. MAY contain zero or more [0..*] entryRelationship (CONF:31965). (CONF:31960).
i. This observation SHALL contain exactly one [1..1] @classCode="OBS"
4. SHALL if present, SHALL contain exactly one [1..1]
a. The entryRelationship, contain exactly one [1..1] templateId="2.16.840.1.113883.3.2898.10.9999"
(CONF:31969).
(CONF:31961).
@typeCode="OPTN" (CONF:31966).
ii. This observation SHALL contain exactly one [1..1] @moodCode="EVN"
5. SHALL if present, SHALL contain exactly one [1..1]
b. The entryRelationship, contain exactly one [1..1] code (CONF:31962).
(CONF:31970).
@contextConductionInd="true" (CONF:31967).
6. SHALL contain zero or one [0..1] effectiveTime (CONF:31963).
iii. This observation SHALL contain exactly one [1..1] code (CONF:31971).
c. The entryRelationship, contain exactly one [1..1] value (CONF:31964).
7. SHALL if present, SHALL contain exactly one [1..1] observation
iv. This observation SHALL contain exactly one [1..1] value with @xsi:type="CD"
(CONF:31968). MAY contain zero or more [0..*] entryRelationship (CONF:31965).
8.
(CONF:31972).
i. This observationThe entryRelationship, one [1..1] @classCode="OBS"
a. SHALL contain exactly if present, SHALL contain exactly one [1..1]
(CONF:31969). @typeCode="OPTN" (CONF:31966).
ii. This observationThe entryRelationship, one [1..1] @moodCode="EVN"
b. SHALL contain exactly if present, SHALL contain exactly one [1..1]
(CONF:31970). @contextConductionInd="true" (CONF:31967).
iii. This observationThe entryRelationship, one [1..1] code (CONF:31971). one [1..1] observation
c. SHALL contain exactly if present, SHALL contain exactly
iv. This observation(CONF:31968). exactly one [1..1] value with @xsi:type="CD"
SHALL contain
(CONF:31972).
i. This observation SHALL contain exactly one [1..1] @classCode="OBS"
(CONF:31969).
ii. This observation SHALL contain exactly one [1..1] @moodCode="EVN"
(CONF:31970).
iii. This observation SHALL contain exactly one [1..1] code (CONF:31971).
iv. This observation SHALL contain exactly one [1..1] value with @xsi:type="CD"
(CONF:31972).

(Entity)
SourceSystemProv ider
+

Slide Number: 91

classCode :CS = "ORG"
determinerCode :CS = "INSTANCE"
(SourceSystemProvider.identifier) id :II

© 2014 All Rights Reserved
1. Semantic Analysis
Registry Elements

Topic Area Mind Map
00069 Dose Amount
00147 Duration
00070 Start Date Time
00306 Stop Date Time

MedicationTypeCode

Initial Bolus
00776 Route

MedicationClassCode

00307 Medication

Initial Infusion

q12hr

00238 Frequency

MedicationAdministration

q24hr

Within 2 weeks

First 24 Hours
Administered
Pre-Encounter

Intra-Encounter

Timing

00423 Status

Intra-Procedure

At Discharge

Not Administered

Blinded

00303 Dose Code

Pre-Procedure

Contraindicated

Full

Reduced

Other

During Follow-up

Decompose composite registry elements
Into interrelated atomic concepts

Slide Number: 92

© 2014 All Rights Reserved
Rim derived and influenced hl7 standards
Rim derived and influenced hl7 standards
Rim derived and influenced hl7 standards
Rim derived and influenced hl7 standards
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Rim derived and influenced hl7 standards

  • 1. Your Healthcare Standards Conformance Partner RIM Derived and Influenced HL7 Standards AbdulMalik Shakir President and Chief Informatics Scientist
  • 2. Health Information Integration Infrastructure Solutions Hi3 Solutions is a privately owned Health Information Technology vendor headquartered in Los Angeles, California. We provide health information technology products, education, and consulting services that enable our clients to engage effectively in health information exchange, health data integration, and health care quality measurement . Our mission is to accelerate the adoption and application of standards-based health information exchange as a mean’s of improving healthcare outcomes and facilitating compliance with evidence-based best practices in healthcare. Slide Number: 2 © 2014 All Rights Reserved
  • 3. Electronic Health Information Exchange Claims/Prescriptions Referral Process Eligibility Claim Status Referral Process Eligibility Claim/Status Payors Pharmacies Physicians Public Health Medical Records Medical Society Patient Data Family Planning Lab results Mental Health Hospitals County/Community Entities Enrollment Orders Insurance Updates Health Information Results Images Testing Organizations Lab/Images Slide Number: 3 Employers Government Medicare/Medicaid Patients/Consumers © 2014 All Rights Reserved
  • 4. Instructor • AbdulMalik Shakir, President and Chief Informatics Scientist for Hi3 Solutions. • I have been an active HL7 member since 1991 and I’ve made significant contributions to the development and adoption of the HL7 standard. • I am co-chair of the HL7 Modeling and Methodology work group, former member of the HL7 Board of Directors, and an active participant in many HL7 foundation and domain expert work groups. • I am the author of the original RIM and provided oversight for its maintenance from inception through its first publication as an ANSI and then ISO standard. Slide Number: 4 © 2014 All Rights Reserved
  • 5. Session Overview • This tutorial provides an introduction to the major HL7 RIM derived and RIM influenced standards. The student will also learn key aspects of the HL7 V3 Development Framework (HDF). • Topics Covered: – HL7 Development Framework – HDF Methodology – HL7 V3 Development Artifacts – Sample V3 Clients and Projects • This tutorial will assist in preparation for the HL7 v3 Certification exam. Slide Number: 5 © 2014 All Rights Reserved
  • 6. HL7 Development Framework Slide Number: 6 © 2014 All Rights Reserved
  • 7. HDF Introduction • The Health Level Seven Development Framework (HDF) defines the processes, policies, and artifacts associated with development of HL7 specifications and standards. • The HL7 Development Framework (HDF): – Expands HL7’s modeled-based approach for standards development beyond messaging to its other standards such as structured documents, context management, and standards related to electronic health records; – Facilitates increased participation of HL7 members, subject matter experts, and implementers in the development of HL7 standards. – Enables HL7 to remain the industry leader in model-driven development of comprehensive standards for application interoperability in the Health industry. Slide Number: 7 © 2014 All Rights Reserved
  • 8. HDF Background – Health Level Seven • The mission of HL7 is to provide a comprehensive framework and related standards for the exchange, integration, storage, and retrieval of health information that support clinical practices and the management, delivery and evaluation of health services. • HL7 began developing standards in 1987 with the publication of its messaging specification - the Application Protocol for Electronic Data Exchange in Healthcare Environments. • In the years since its founding, HL7 has evolved beyond traditional messaging protocols to include clinical document architectures, medical logic modules, service component specifications, and standards, guidelines, and related services for the management of electronic health records. Slide Number: 8 © 2014 All Rights Reserved
  • 9. The Family of HL7 Standards • • • • • • • • • • Slide Number: 9 Standardization of knowledge representation (Arden / GELLO) Virtual Medical Record for Clinical Decision Support (vMR-CDS) Specification of components for context management (CMA) Standardization of clinical document structures (CDA) Electronic Health Record System Functional Model (EHR-S) Application protocol for electronic data exchange in healthcare environments (messages) Support for use of healthcare services in a Service Oriented Architecture (SOA) Fast Healthcare Interoperability Resources (FHIR) Specification of robust vocabulary definitions for use in clinical messages and documents Work in the area of security, privacy, confidentiality, and accountability © 2014 All Rights Reserved
  • 10. HDF Background – HL7 V3 Methodology • In 1992 HL7 made a fundamental shift in the method it uses to develop its specifications and standards. • The new methodology, referred to as HL7 Version 3.0 (or V3), is a model-driven standards development methodology based upon object-oriented software development practices. • In January 1996, the HL7 Technical Steering Committee adopted the model-driven approach and the Modeling and Methodology Technical Committee assumed primary responsibility for ongoing development of the V3 methodology. Slide Number: 10 © 2014 All Rights Reserved
  • 11. Slide Number: 11 © 2014 All Rights Reserved
  • 12. HL7 Message Development Framework • The HL7 Message Development Framework (MDF) defines the HL7 V3 message development process. • It identifies the phases, activities, and models used in the process of developing HL7 message specifications. • The HL7 MDF was first published in 1997. It has undergone two major revisions since then; once in 1998 and again in 1999. • The current version of the MDF (v3.3), published in December 1999, has not been maintained. • The HDF is a replacement for and an extension to the HL7 Message Development Framework (MDF) Slide Number: 12 © 2014 All Rights Reserved
  • 13. HL7 V3 Methodology: What and How Application Role Trigger Event Information Modeling Storyboard Sender RIM Derive D-MIM Receiver Triggers Restrict References R-MIM Interaction Example Serialize Interaction Modeling HMD Message Design Storyboard Example Slide Number: 13 Content Use Case Modeling Restrict Message Type © 2014 All Rights Reserved
  • 14. HL7 V3 Design Models RIM RIM Reference Information Model (1) Define a D-MIM D-MIM D-MIM Domain Message Information Model (2) Define a R-MIM R-MIM R-MIM Refined Message Information Model (3) Create an HMD HMD HMD Hierarchical Message Definition Slide Number: 14 © 2014 All Rights Reserved
  • 15. HL7 Development Framework Methodology Slide Number: 15 © 2014 All Rights Reserved
  • 16. Seven Phases of the HDF Methodology 1. Project initiation 2. Requirements Documentation 3. Specification Modeling 4. Specification Documentation 5. Specification Approval 6. Specification Publication 7. Specification Profiling Slide Number: 16 © 2014 All Rights Reserved
  • 17. HDF Workflow Diagram Initiate Project Project Charter Specify Requirements The HDF workflow is not a waterfall methodology. Each phase builds upon the prior and may cause prior activities to be revisited and their deliverables adjusted. Requirement Specification Reference Models Prepare Specification Design Models Specification Design Models Approve Specification Prepare Specification Pre-Approval Specification Conformance Statement Approved Specification Slide Number: 17 Publish Approved Specification Published Specification Prepare Specification Profiles Specification Profile © 2014 All Rights Reserved
  • 18. Project initiation During project initiation the project is defined, a project plan is produced, and project approval is obtained. The primary deliverable produced during project initiation is the project charter. Project Initiation Project Charter 1. Define project scope, objectives, and intended deliverables 2. Identify project stakeholders, participants, and required resources 3. Document project assumptions, constraints, and risk 4. Prepare preliminary project plan and document inter-project dependencies 5. Obtain project approval and launch the project Slide Number: 18 © 2014 All Rights Reserved
  • 19. Requirements Documentation During requirements documentation the problem domain is defined, a model of the domain is produced, and the problem domain model is harmonized with HL7 reference models. The primary deliverable produced during requirements documentation is the requirements specification. Project Charter Requirements Documentation Requirements Specification 1. 2. Capture Process Flow: UML Activity Diagram 3. Capture Structure: Domain Analysis Model and Glossary 4. Capture Business Rules: Relationships, Triggers, and Constraints 5. Slide Number: 19 Document Business Process: Dynamic Behavior and Static Structure Harmonize the Domain Analysis Model with HL7 Reference Models © 2014 All Rights Reserved
  • 20. Specification Modeling During specification modeling reference models are constrained into design models through a process of iterative refinement driven by requirements specifications and following specification design rules, conventions, and guidelines. The primary deliverable produced during specification modeling is a set of specification design models. Requirements Specification Specification Modeling Specification Design Models 1. 2. Construct design models of behavioral views 3. Define reusable design model components 4. Construct design models of collaboration and interaction 5. Slide Number: 20 Build design models of static information views Harmonize design models with HL7 Reference Models © 2014 All Rights Reserved
  • 21. Specification Documentation During specification Documentation the specification design models are packaged into logical units, supplemented with explanatory text, and prepared for approval. The primary deliverable produced during specification documentation is a pre-approval specification. Specification Design Models Specification Documentation Pre-Approval Specification 1. 2. Compose explanatory text, examples, and design rationale 3. Update design models and requirement specifications 4. Assemble a pre-approval specification package 5. Slide Number: 21 Organize design model elements into logical packages Submit specification for approval © 2014 All Rights Reserved
  • 22. Specification Approval During specification approval the pre-approval specification is subjected to a series of approvals steps. The specific approval steps vary by kind of specification, level of approval, and realm of interest. The primary deliverable produced during specification approval is an approved specification. Pre-Approval Specification Specification Approval Approved Specification 1. 2. Form a ballot pool and conduct specification ballot 3. Assess negative ballots and affirmative comments 4. Modify specification in response to ballot comments 5. Slide Number: 22 Obtain TSC and Board approval to ballot specification Resolve negative ballot responses and if necessary reballot © 2014 All Rights Reserved
  • 23. Specification Publication During specification publication the approved specification is prepared for prepared for publication and distribution. The primary deliverable produced during specification publication is a published specification. Approved Specification Specification Publication Published Specification 1. 2. Prepare specification for publication 3. Submit publication to standards authorities (ANSI/ISO) 4. Render the specification in various forms of publication media 5. Slide Number: 23 Obtain TSC and Board approval to publish specification Post and distribute approved specifications © 2014 All Rights Reserved
  • 24. Specification Profiling During specification profiling specification models are further refined and specifications furthered constrained following the same set of design rules, conventions, and guidelines used in the development of the specification to produce a profile of the specification for use in a particular environment by a defined community of users. The primary deliverable produced during specification profiling is a set of specification profiles and conformance statements. Published Specification Specification Profiling Specification Profiles and Conformance Statements 1. 2. Further refine and constrain specification design models 3. Document exceptions, extensions, and annotations to specifications 4. Prepare and publish specification profile 5. Slide Number: 24 Identify community of uses for published specification Prepare and publish conformance statements © 2014 All Rights Reserved
  • 25. HDF Workflow Diagram Initiate Project Project Charter Specify Requirements The HDF workflow is not a waterfall methodology. Each phase builds upon the prior and may cause prior activities to be revisited and their deliverables adjusted. Requirement Specification Reference Models Prepare Specification Design Models Specification Design Models Approve Specification Prepare Specification Pre-Approval Specification Conformance Statement Approved Specification Slide Number: 25 Publish Approved Specification Published Specification Prepare Specification Profiles Specification Profile © 2014 All Rights Reserved
  • 26. HL7 Version 3.0 Development Artifacts Slide Number: 26 © 2014 All Rights Reserved
  • 27. HL7 v3.0 Development Artifacts Reference Models Reference Information Model Datatype Specification Vocabulary Specification Design Models Interaction Model Design Information Model Common Message Type Model Content Specifications Hierarchical Message Definition Message Type Definition Implementation Technology Specification Implementation Profiles Message Profile Specification Localized Message Specification Message Conformance Statements Slide Number: 27 © 2014 All Rights Reserved
  • 28. HL7 v3.0 Development Artifacts Reference Models Reference Information Model The HL7 Reference Information Model is the information model from which all other information models and message specifications are derived. Datatype Specification The HL7 Datatype Specification defines the structural format of the data carried in an attribute and influences the set of allowable values an attribute may assume. Vocabulary Specification The HL7 Vocabulary Specification defines the set of all concepts that can be taken as valid values in an instance of a coded attribute or message element. Slide Number: 28 © 2014 All Rights Reserved
  • 29. HL7 v3.0 Development Artifacts Design Models Interaction Model An Interaction Model is a specification of information exchanges within a particular domain as described in storyboards and storyboard examples. Design Information Model A Domain Information Model is an information structure that represents the information content for a set of messages within a particular domain area. Common Message Type Model Slide Number: 29 A Common Message Type Model is a definition of a set of common message components that can be referenced in various message specifications. © 2014 All Rights Reserved
  • 30. HL7 v3.0 Messaging Artifacts Message Specifications Hierarchical Message Definition Message Type Definition Implementation Technology Specification Slide Number: 30 An Hierarchical Message Definition is a specification of message elements including a specification of their grouping, sequence, optionality, and cardinality. A Message Type Definition is a specification of a collection of message elements and a set of rules for constructing a message instance. An Implementation Technology Specification is a specification that describes how to construct HL7 messages using a specific implementation technology. © 2014 All Rights Reserved
  • 31. HL7 v3.0 Development Artifacts Implementation Profiles Localized Message Specification Message Profile Specification A Message Profile Specification is a description of a particular or desired implementation of an HL7 Message standard or Localized Message specification. Message Conformance Statement Slide Number: 31 A Localized Message Specification is a refinement of a HL7 message specification standard that is specified and balloted by an HL7 International Affiliate. A Message Conformance Statement is a comparison of a particular messaging implementation and an HL7 message standard, localization, or profile. © 2014 All Rights Reserved
  • 32. HL7 V3 Message Design Models TraumaRegistryExport PreHosptialRelatedObservation (IDPH_RM00001) classCode*: <= OBS moodCode*: <= EVN code: <= ExternallyDefinedActCodes value: ANY [0..1] VehicleProvider Data content of HL7 messages used to export data from the IDPH Trauma Registry. pertinentInformation 0..* pertinentPreHosptialRelatedObservation 1..1 owningVehicleProvider typeCode*: <= PERT Organization addr : BAG<AD> standardIndustryClassCode : CE Patient Place confidentialityCode : CE mobileInd : BL veryImportantPersonCode : CE addr : AD directionsText : ED Access LicensedEntity positionText : ED approachSiteCode : CD recertificationTime : TS gpsText : ST targetSiteCode : CD gaugeQuantity : PQ ActRelationship typeCode : CS inversionInd : BL outboundRelationship contextControlCode : CS 0..n contextConductionInd : BL sequenceNumber : INT Person 1 source priorityNumber : INT addr : BAG<AD> pauseQuantity : PQ Act Participation maritalStatusCode : CE checkpointCode : CS classCode : CS Entity educationLevelCode : CE typeCode : CS Role splitCode : CS moodCode : CS raceCode : SET<CE> functionCode : CD classCode : CS player joinCode : CS classCode : CS id : SET<II> disabilityCode : SET<CE> contextControlCode : CS determinerCode : CS negationInd : BL 0..1 0..n id : SET<II> code : CD livingArrangementCode : CE sequenceNumber : INT id : SET<II> 0..n conjunctionCode : CS negationInd : BL playedRolecode : CE 1 religiousAffiliationCode : CE negationInd : BL code : CE localVariableName : ST negationInd : BL 1 derivationExpr : ST ethnicGroupCode : SET<CE> quantity : SET<PQ> 0..n noteText : ED seperatableInd : BL addr : BAG<AD> text : ED time : IVL<TS> name : BAG<EN> telecom : BAG<TEL> 0..n statusCode : SET<CS> modeCode : CE desc : ED statusCode : SET<CS> effectiveTime : GTS inboundRelationship awarenessCode : CE statusCode : SET<CS> scopedRoleeffectiveTime : IVL<TS> LivingSubject activityTime : GTS signatureCode : CE existenceTime : IVL<TS> 0..n certificateText : ED target availabilityTime : TS administrativeGenderCode : CE signatureText : ED telecom : BAG<TEL> quantity : RTO 0..1 priorityCode : SET<CE> birthTime : TS performInd : BL riskCode : CE 1 positionNumber : LIST<INT> scoper deceasedInd : BL substitutionConditionCode : CE confidentialityCode : SET<CE> ... handlingCode : CE repeatNumber : IVL<INT> deceasedTime : TS DeviceTask 1 target 1source interruptibleInd : BL multipleBirthInd : BL 1 parameterValue : LIST<ANY> levelCode : CE inboundLink multipleBirthOrderNumber : INT WorkingList 0..n outboundLink 0..n independentInd : BL Employee organDonorInd : BL ownershipLevelCode : CE RoleLink uncertaintyCode : CE FinancialContract jobCode : CE typeCode : CS reasonCode : SET<CE> paymentTermsCode : CE jobTitleName : SC effectiveTime : IVL<TS> languageCode : CE jobClassCode : CE Material NonPersonLivingSubject salaryTypeCode : CE formCode : CE strainText : ED salaryQuantity : MO InvoiceElement genderStatusCode : CE hazardExposureText : ED SubstanceAdministration modifierCode : SET<CE> protectiveEquipmentText : ED Observation unitQuantity : RTO<PQ,PQ> routeCode : CE 0..n value : ANY unitPriceAmt : RTO<MO,PQ> approachSiteCode : SET<CD> ManufacturedMaterial LanguageCommunication interpretationCode : SET<CE> netAmt : MO doseQuantity : IVL<PQ> Procedure methodCode : SET<CE> factorNumber : REAL rateQuantity : IVL<PQ> lotNumberText : ST languageCode : CE methodCode : SET<CE> targetSiteCode : SET<CD> pointsNumber : REAL doseCheckQuantity : SET<RTO> expirationTime : IVL<TS> modeCode : CE approachSiteCode : SET<CD> maxDoseQuantity : SET<RTO> stabilityTime : IVL<TS> proficiencyLevelCode : CE targetSiteCode : SET<CD> substitutionCode : CE preferenceInd : BL DiagnosticImage subjectOrientationCode : CE Container Device capacityQuantity : PQ manufacturerModelName : SC heightQuantity : PQ softwareName : SC localRemoteControlStateCode : CE ... diameterQuantity : PQ capTypeCode : CE alertLevelCode : CE separatorTypeCode : CE lastCalibrationTime : TS barrierDeltaQuantity : PQ bottomDeltaQuantity : PQ PreHospitalVehicle ManagedParticipation id : SET<II> statusCode : SET<CS> PublicHealthCase PatientEncounter detectionMethodCode : CE preAdmitTestInd : BL transmissionModeCode : CE admissionReferralSourceCode : CE diseaseImportedCode : CE lengthOfStayQuantity : PQ dischargeDispositionCode : CE specialCourtesiesCode : SET<CE> specialAccommodationCode : SET<CE> acuityLevelCode : CE Supply quantity : PQ expectedUseTime : IVL<TS> Diet energyQuantity : PQ carbohydrateQuantity : PQ Account name : ST balanceAmt : MO currencyCode : CE interestRateQuantity : RTO<MO,PQ> allowedBalanceQuantity : IVL<MO> FinancialTransaction amt : MO creditExchangeRateQuantity : REAL debitExchangeRateQuantity : REAL classCode*: <= OWN 1..1 preHospitalVehicle id: II [0..1] (VehiclNum) participant code: <= RoleCode (VehiclLevelID) typeCode*: <= ParticipationType InjuryLocation classCode*: <= PLC determinerCode*: <= INSTANCE 0..1 playingInjuryLocation code: CV CWE [0..1] <= EntityCode (InjuryPlaceID) addr: AD [0..1] (AddressScene) MedicalStaffPerson PreHospitalEncounter MedicalStaff classCode*: <= ENC moodCode*: <= EVN id: II [0..1] (crashNum) activityTime: IVL<TS> Role classCode*: <= PROV id: II [0..1] (MedicalStaffID) performer classCode*: <= ROL predecessor 0..1 priorPreHospitalEncounter 0..1 medicalStaff typeCode*: <= PRF typeCode*: <= PREV 1..1 participant location Procedure 0..1 procedureLocation ProcedureLocation typeCode*: <= LOC classCode*: <= PROC location InjuryRelatedObservation classCode*: <= SDLOC moodCode*: <= EVN 0..* pertinentInjuryRelatedObservation classCode*: <= OBS 0..* pertinentProcedure code: CV CWE <= ActCode (ICDCodeID) typeCode*: <= LOC code: <= RoleCode (ProcedLocateID) Injury pertinentInformation moodCode*: <= EVN PatientIncident pertinentInformation7 activityTime: TS (ProcedDate) classCode*: <= ACT 0..1 pertinentInjury typeCode*: <= PERT code: <= ExternallyDefinedActCodes classCode*: <= ENC typeCode*: <= PERT moodCode*: <= EVN pertinentInformation1 moodCode*: <= EVN priorityCode: CV CWE [0..1] <= ActPriority sequenceNumber: INT [0..1] (InjurySequen) activityTime: TS (InjuryDate) component typeCode*: <= PERT value: [0..1] TraumaParticipant id: [1..*] (RegistNum) typeCode*: <= COMP code: CV CNE [0..1] <= ExternallyDefinedActCodes (PatientType) statusCode: LIST<CS> CNE <= ActStatus (IDPHStatus) 0..* pertinentPatientIncidentRelatedObservation PatientIncidentRelatedObservation PatientPerson activityTime: TS (EDDate) 1..1 patient classCode*: <= OBS pertinentInformation2 classCode*: <= PSN Patient subject moodCode*: <= EVN 0..1 playingTraumaParticipant determinerCode*: <= INSTANCE typeCode*: <= PERT 0..* patientIncidentRelatedObservation classCode*: <= PAT typeCode*: <= SBJ code: <= ActCode name: PN [0..1] (*Name) id: II [0..1] (MedicaRecordNum) reasonCode: CV CWE [0..1] <= ActReason existenceTime: (Age) Choice 1..1 patientPatientPerson value: ANY [0..1] administrativeGenderCode: CV CWE <= AdministrativeGender Facility (GenderID) 1..1 providerTraumaParticipant classCode*: <= ORG birthTime: (DateOfBirth) 0..* aRole aRole VehicleProvider determinerCode*: <= INSTANCE addr: AD [0..1] (AddressHome) TraumaParticipant classCode*: <= ROL origin 1..1 arrivalPatientTransfer id: raceCode: CV CWE [0..1] <= Race (RaceID) classCode*: <= ORG PatientTransfer classCode*: <= ORG typeCode*: <= ORG code*: CS CNE <= EntityCode "FAC" ethnicGroupCode: CV CWE [0..1] <= Ethnicity (EthnicID) arrivedBy determinerCode*: <= INSTANCE determinerCode*: <= INSTANCE classCode*: <= TRNS 1..1 owningVehicleProvider id: II [0..1] (VehiclProvide) name: typeCode*: <= ARR id: [1..1] (HospitNum) moodCode*: <= EVN 1..1 transferVehicle code: <= EntityCode (MaxVehiclLevelID) 0..1 subjectChoice code: CV CWE [0..1] <= EntityCode activityTime: IVL<TS> (DischaDate to ArriveDate) via name: ON [0..1] (VehiclProvidName) TransferVehicle name: ON [0..1] (HospitName) Hospital reasonCode: CV CWE [0..1] <= TransferActReason (REASONTRANSFID) typeCode*: <= VIA statusCode: CS CNE [0..1] <= EntityStatus (ActiveFacili) classCode*: <= OWN classCode*: <= ORG pertinentInformation addr: AD [0..1] (HospitCity) id: II [0..1] (VehiclNum) determinerCode*: <= INSTANCE typeCode*: <= PERT code: <= RoleCode (VehiclLevelID) pertinentInformation3 id: 1..* pertinentTransferRelatedObservation LicensedEntity 0..1 licensedEntity 1..1 pertinentHospitalVisit code*: CS CNE <= EntityCode "HOSP" typeCode*: <= PERT destination classCode*: <= LIC name: pertinentInformation5 TransferRelatedObservation typeCode*: <= DST id: II [0..1] HospitalVisit typeCode*: <= PERT classCode*: <= OBS classCode*: <= ENC moodCode*: <= EVN 1..1 admittingProvider moodCode*: <= EVN AdmittingProvider code: CV CWE <= ExternallyDefinedActCodes code: CV CWE <= ActCode (AdmitServicID) admitter classCode*: <= PROV value: PQ [0..1] activityTime: TS (DischaDate) id: II [0..1] (ADMITMEDICASTAFFID) typeCode*: <= ADM methodCode: CV CWE [0..1] <= ObservationMethod dischargeDispositionCode: CV CWE [0..1] code: CV CWE <= RoleCode (StaffTypeID) 0..* hospitalVisitPhysician <= EncounterDischargeDisposition responsibleParty HospitalVisitPhysician typeCode*: <= RESP classCode*: <= PROV time: TS id: II [0..1] code: CV CWE <= RoleCode (StaffTypeID) EmergencyDepartmentRelatedObservation 0..1 pertinentEmergencyDepartmentEncounter classCode*: <= OBS moodCode*: <= EVN 0..* pertinentEmergencyDepartmentRelatedObservation code: CV CWE <= ExternallyDefinedActCodes pertinentInformation classCode*: <= ENC text: moodCode*: <= EVN typeCode*: <= PERT activityTime: TS activityTime: IVL<TS> reasonCode: <= ActReason dischargeDispositionCode: CV CWE <= EncounterDischargeDisposition value: [0..1] methodCode: CV CWE [0..1] <= ObservationMethod component targetSiteCode: CV CWE [0..1] <= HumanActSite typeCode*: <= COMP pertinentInformation typeCode*: <= PERT EmergencyDepartmentEncounter 0..* pertinentHospitalVisitRelatedObservation HospitalVisitRelatedObservation 0..1 healthCareMedicalStaffPerson MedicalStaffPerson classCode*: <= OBS moodCode*: <= EVN code: CV CWE <= ExternallyDefinedActCodes value: [0..1] 0..1 healthCareMedicalStaffPerson classCode*: <= PSN determinerCode*: <= INSTANCE 0..1 healthCareMedicalStaffPerson name: PN [0..1] (MedicaStaffName) RIM 0..* emergencyDepartmentPhysicianAct EmergencyDepartmentPhysician 0..* emergencyDepartmentPhysician classCode*: <= PROV performer id: II [0..1] typeCode*: <= PRF code: CE CWE [0..1] <= RoleCode (StaffTypeID) EmergencyDepartmentPhysicianAct classCode*: <= ACT moodCode*: <= EVN code: CS CNE [0..1] <= ExternallyDefinedActCodes activityTime*: TS [0..1] D-MIM Design Information Model component typeCode*: <= COMP PatientIncidentRelatedObservation InjuryLocation classCode*: <= PLC determinerCode*: <= INSTANCE 0..1 playingInjuryLocation code: CV CWE [0..1] <= EntityCode (InjuryPlaceID) addr: AD [0..1] (AddressScene) classCode*: <= ROL location 1..1 participant typeCode*: <= LOC InjuryRelatedObservation 0..* pertinentInjuryRelatedObservation classCode*: <= OBS pertinentInformation moodCode*: <= EVN typeCode*: <= PERT code: <= ExternallyDefinedActCodes priorityCode: CV CWE [0..1] <= ActPriority sequenceNumber: INT [0..1] (InjurySequen) value: [0..1] PatientPerson classCode*: <= OBS moodCode*: <= EVN code: <= ActCode reasonCode: CV CWE [0..1] <= ActReason value: ANY [0..1] Role Injury 0..* patientIncidentRelatedObservation pertinentInformation2 0..* pertinentPatientIncidentRelatedObservation typeCode*: <= PERT PatientIncident classCode*: <= ACT 0..1 pertinentInjury classCode*: <= ENC moodCode*: <= EVN pertinentInformation1 moodCode*: <= EVN activityTime: TS (InjuryDate) typeCode*: <= PERT id: [1..*] (RegistNum) code: CV CNE <= ExternallyDefinedActCodes (PatientType) statusCode: LIST<CS> CNE <= ActStatus (IDPHStatus) activityTime: TS (EDDate) 1..1 patient classCode*: <= PSN Patient subject determinerCode*: <= INSTANCE classCode*: <= PAT typeCode*: <= SBJ name: PN [0..1] (*Name) id: II [0..1] (MedicaRecordNum) existenceTime: (Age) 1..1 patientPatientPerson administrativeGenderCode: CV CWE <= AdministrativeGender (GenderID) 1..1 providerTraumaParticipant birthTime: (DateOfBirth) addr: AD [0..1] (AddressHome) TraumaParticipant raceCode: CV CWE [0..1] <= Race (RaceID) classCode*: <= ORG ethnicGroupCode: CV CWE [0..1] <= Ethnicity (EthnicID) determinerCode*: <= INSTANCE id: [1..1] (HospitNum) code: CV CWE [0..1] <= EntityCode name: ON [0..1] (HospitName) statusCode: CS CNE [0..1] <= EntityStatus (ActiveFacili) addr: AD [0..1] (HospitCity) R-MIM Slide Number: 32 HMD © 2014 All Rights Reserved
  • 33. Design Information Model Description • Domain Message Information Models (D-MIMs) and Refined Message Information Models (R-MIMs) are types of Design Information Models. • Design information models are composed of class clones that are a restricted subset of the HL7 RIM. • Class clones contain a subset of the attributes and relationships that are defined for the RIM class upon which the clone is based. • Multiple class clones based upon the same RIM class may be included in a design information model. • Each class clone in a design information model is assigned a unique name. Slide Number: 33 © 2014 All Rights Reserved
  • 34. Sample R-MIM Design Information Model Laboratory Observation Order (POLB_RM002100) Common entry point for laboratory order communication. This includes single one-time typeCode*: <= COMP orders as well as recurring orders. This is contextControlCode*: [1..1] Note: used for recurring orders only if the filler <= ContextControlNonPropagating "AN" Includes both splits recurring orders into their occurrences. contextConductionInd*: [1..1] "true" patient and the sequenceNumber: institution. priorityNumber: pauseQuantity: 0..1 patient * 0..1 roleName CMET: (PAT) splitCode: ObservationOrder recordTarget ManufacturedProduct1 Organization R_Patient joinCode: classCode*: <= OBS typeCode*: <= RCT classCode*: <= MANU [universal] seperatableInd: [1..1] "true" classCode*: <= ORG 0..* observationOrder1 moodCode*: <= ORD contextControlCode*: [1..1] (COCT_MT050000) determinerCode*: <= INSTANCE id*: II [1..1] <= ContextControlPropagating "OP" 0..1 manufacturerOrganization name*: ON [1..1] code: CE CWE <= ObservationType (e.g. LOINC code) 1..1 manufacturedProduct * 0..* specimen * consumable 0..* observationOrder2 * negationInd: [1..1] "false" CMET: (SPEC) subject typeCode*: <= CSM 0..* substanceAdministrationStep * derivationExpr: R_Specimen typeCode*: <= SBJ text: component2 SubstanceAdministrationStep [universal] contextControlCode*: [1..1] statusCode*: CS CNE [1..1] <= ActStatus "active" (COCT_MT080000) <= ContextControlPropagating "OP" typeCode*: <= COMP classCode*: <= SBADM effectiveTime: ("physiologically relevant time" aimed for) contextControlCode*: [1..1] moodCode*: <= x_ActMoodOrdPrmsEvn activityTime: IVL<TS> Note: <= ContextControlNonPropagating "AN" id*: II [1..1] priorityCode: CE CWE [0..1] <= ActPriority "R" For clinical observations that are made directly on the patient contextConductionInd*: [1..1] "true" code*: CE CWE <= SubstanceAdministrationActCode confidentialityCode*: [1..*] <= Confidentiality "N" instead of on some specimen. sequenceNumber*: [1..1] text*: repeatNumber: priorityNumber: statusCode*: CS CNE [0..1] 0..1 roleName 1..1 assignedEntity * interruptibleInd: "true" CMET: (ASSIGNED) pauseQuantity: effectiveTime*: IVL<TS> independentInd: "true" author R_Assigned splitCode: routeCode: <= RouteOfAdministration methodCode: <= ObservationMethod typeCode*: <= AUT [universal] joinCode: doseQuantity: PQ contextControlCode*: [1..1] (COCT_MT090000) targetSiteCode: <= ActSite seperatableInd*: [1..1] "false" rateQuantity: PQ <= ContextControlPropagating "OP" noteText: ST Note: time*: TS [1..1] (time of signature) CMET: (ENC) Includes both, the componentOf1 modeCode*: CE CNE [1..1] <= ParticipationMode A_Encounter individual and the typeCode*: <= COMP signatureCode*: CS CNE [1..1] [universal] contextControlCode*: [1..1] <= ContextControlPropagating "OP" signatureText: provider organization. (COCT_MT010000) contextConductionInd*: [1..1] "false" 0..1 encounter * 0..* assignedEntity Drug classCode*: <= MMAT determinerCode*: <= INSTANCE code*: [1..1] <= DrugEntity (Drug code) quantity: desc: 1..1 manufacturedDrug * CMET: (AGNT) R_Responsible [universal] Note: This is the general almost completely unconstrained ActRelationship. Its use includes composition (COMP), occurrences (OCCR), master file references (INST), fulfillment (FLFS) and replacement (RPLC) as well as normal ranges (REFV), decision ranges (COND) and goals. In the DMIM this is left unconstrained, in the RMIMs these might be more constrained. componentOf2 Accession 1..1 agent * classCode*: <= ACSN moodCode*: <= EVN typeCode*: <= AUT id*: II [1..1] author (COCT_MT040000) 0..1 roleName Note: For Advanced Beneficiary Notices or whenconsents are required for testing (e.g., HIV related tests.) CMET: (CONS) A_Consent [universal] (COCT_MT470000) Note: The author of an ORDer is commonly know as the "placer", the author of an ordered promise or event is commonly known as the "filler". The author owns his Act, meaning that direct status canges on this act can only be issued by the Author. typeCode*: <= COMP contextControlCode*: [1..1] <= ContextControlPropagating "OP" contextConductionInd*: [1..1] "false" 0..* accession subjectOf typeCode*: <= SUBJ contextControlCode*: [1..1] <= ContextControlPropagating "OP" contextConductionInd*: [1..1] "false" 0..* consent 0..* pertinentObservationSupporting CMET: (OBS) A_ObservationSupporting [universal] Note: Identifies the "master" or "service catalog" entry of the observation service being performed. Use this alone or in addition to an observation code to specify what is being observed or what is to be observed. component1 / componentOf3 (COCT_MT120200) 0..1 assignedEntity typeCode*: <= ENT contextControlCode*: [1..1] <= ContextControlPropagating "OP" noteText: ST time: TS (time entered into) modeCode*: [1..1] <= "ELECTRONIC" typeCode*: <= PERT contextControlCode*: [1..1] <= ContextControlNonPropagating "AN" contextConductionInd*: [1..1] "true" 0..1 observationDefinition * definition classCode*: <= OBS moodCode*: <= DEF id: II [1..1] typeCode*: <= INST contextControlCode*: [1..1] <= ContextControlNonPropagating "AN" contextConductionInd*: [1..1] "true" typeCode*: <= VRF contextControlCode*: [1..1] <= ContextControl "OP" noteText: ST time*: TS [1..1] (time of signature) modeCode*: [1..1] <= ParticipationMode signatureCode*: [1..1] <= ParticipationSignature signatureText: dataEnterer pertinentInformation ObservationDefinition verifier 0..1 assignedEntity notificationContact Note: For orders: the designated performer, if known and desired at time of ordering. For intents, the promises and events, the "filler." For individual subtasks, used for the technician, etc. typeCode*: <= NOT contextControlCode*: [1..1] <= ContextControlPropagating "OP" 0..* assignedEntity * performer typeCode*: <= PRF contextControlCode*: [1..1] <= ContextControlPropagating "OP" 0..* participant consumable typeCode*: <= CSM contextControlCode*: [1..1] <= ContextControlNonPropagating "ON" 0..* CMET: (ROL) R_Reagent [universal] (COCT_MT250000) 0..* orderOptions controlVariable typeCode*: <= CTRLV contextControlCode*: [1..1] <= ContextControlNonPropagating "AN" contextConductionInd*: [1..1] "false" CMET: (ACT) A_OrderOptions [universal] (COCT_MT210000) 0..* priorObservation replacementOf typeCode*: <= RPLC contextControlCode*: [1..1] <= ContextControlNonPropagating "ON" contextConductionInd*: [1..1] "true" Slide Number: 34 © 2014 All Rights Reserved
  • 35. Design Information Model Diagram Drug classCode*: <= MMAT determinerCode*: <= INSTANCE code*: [1..1] <= DrugEntity (Drug code) quantity: desc: 1..1 manufacturedDrug * ManufacturedProduct1 classCode*: <= MANU consumable classCode*: <= ORG determinerCode*: <= INSTANCE 0..1 manufacturerOrganization name*: ON [1..1] 1..1 manufacturedProduct * typeCode*: <= CSM SubstanceAdministrationStep classCode*: <= SBADM moodCode*: <= x_ActMoodOrdPrmsEvn id*: II [1..1] code*: CE CWE <= SubstanceAdministrationActCode text*: statusCode*: CS CNE [0..1] effectiveTime*: IVL<TS> routeCode: <= RouteOfAdministration doseQuantity: PQ rateQuantity: PQ Slide Number: 35 Organization • A Design Information Model diagrams used a variety of visual tools to document the design. • Entities, Roles, and Acts are represented by rectangular shapes colored Green, Yellow, and Red respectively. • Participations, Role Links, and Act Relationships are represented by arrow shapes colored blue, gold, and pink respectively. • Bold font is used to denote mandatory attributes. © 2014 All Rights Reserved
  • 36. HL7 V3 Modeling Tools Slide Number: 36 © 2014 All Rights Reserved
  • 37. HL7 V3 Modeling Tools RIM RIM Rational Rose RIM R-MIM R-MIM Designer Reference Model Repository RoseTree HMD HMD R-MIM Schema Generator XSD Slide Number: 37 © 2014 All Rights Reserved
  • 38. HL7 Version 3.0 Hierarchical Message Definition An Hierarchical Message Definition is a specification of message elements including a specification of their grouping, sequence, optionality, and cardinality. Slide Number: 38 © 2014 All Rights Reserved
  • 39. Hierarchical Message Definition Slide Number: 39 © 2014 All Rights Reserved
  • 40. Slide Number: 40 Message Type Specification(S) Common Constraints Message Element Specifications Information Model Mapping HMD Components © 2014 All Rights Reserved
  • 41. Slide Number: 41 Message Type Specification(S) Common Constraints Message Element Specifications Mapping to the Information Model HMD Components © 2014 All Rights Reserved
  • 42. HL7 XML Schema Generator HL7 Vocabulary Specification Hierarchical Message Definition HL7 XML Schema Generator XML Schema Specification HL7 Data Type Specification Slide Number: 42 © 2014 All Rights Reserved
  • 43. Sample HL7 Constrained Information Model A_AbnormalityAssessment (COCT_RM420000UV) Description: assessment of clinical findings, including lab test results, for indications of the presence and severity of abnormal conditions AbnormalityAssessment classCode*: = "OBS" moodCode*: = "EVN" code*: CD CWE [1..1] <= V:ObservationType ("ADVERSE_REACTION") statusCode*: CS CNE [1..1] <= V:ActStatusAbortedCancelledCompleted activityTime*: TS.DATETIME [1..1] value: CD CWE [0..1] <= V:AbnormalityAssessmentValue methodCode: SET<CE> CWE [0..*] <= V:AbnormalityAssessmentMethod outcome typeCode*: = "OUTC" contextConductionInd*: BL [1..1] ="true" 1..* assessmentOutcome * AssessmentOutcome AssessmentException classCode*: = "OBS" moodCode*: = "EVN" code*: CD CWE [1..1] <= V:ObservationType ("ASSERTION") value*: SC CWE [1..1] <= V:AssessmentExceptionValue appendageOf AbnormalityGrade typeCode*: = "APND" contextConductionInd*: BL [1..1] ="true" 0..* assessmentOutcomeAnnotation AssessmentOutcomeAnnotation classCode*: = "OBS" moodCode*: = "EVN" code*: CD CWE [1..1] <= V:ObservationType ("ASSERTION") value*: SC CWE [1..1] <= V:AssessmentOutcomeAnnotationValue classCode*: = "OBS" moodCode*: = "EVN" code*: CD CWE [1..1] <= V:ObservationType ("SEV") uncertaintyCode: CE CNE [0..1] <= V:ActUncertainty value*: CD CWE [1..1] <= V:AbnormalityGradeValue Slide Number: 43 © 2014 All Rights Reserved
  • 44. Example Schema Specification Slide Number: 44 © 2014 All Rights Reserved
  • 45. Core Schema • Our generated schema is used in conjunction with core schema specifications provided by HL7. • The core schema specifications include infrastructure root, datatype base, datatype, and vocabulary. • The core schema specification include no domain content. They are present only to facilitate interpretation of datatypes and validation of structural vocabulary. Core Schema Our Schema Include Datatype.XSD Include Include Voc.XSD Slide Number: 45 Infrastructure Root.XSD Include Include Include Datatypebase.XSD © 2014 All Rights Reserved
  • 46. HL7 V3 Message Implementation Technology XML Schema Specification Data Hierarchical Message Definition HL7 Message Creation HL7-Conformant Application Slide Number: 46 Message Instance HL7 Message Parsing Data HL7-Conformant Application © 2014 All Rights Reserved
  • 47. Questions / Discussion Slide Number: 47 © 2014 All Rights Reserved
  • 48. The Family of HL7 Standards • • • • • • • • • • Slide Number: 48 Standardization of knowledge representation (Arden / GELLO) Virtual Medical Record for Clinical Decision Support (vMR-CDS) Specification of components for context management (CMA) Standardization of clinical document structures (CDA) Electronic Health Record System Functional Model (EHR-S) Application protocol for electronic data exchange in healthcare environments (messages) Support for use of healthcare services in a Service Oriented Architecture (SOA) Fast Healthcare Interoperability Resources (FHIR) Specification of robust vocabulary definitions for use in clinical messages and documents Work in the area of security, privacy, confidentiality, and accountability © 2014 All Rights Reserved
  • 49. RIM Derived and Influenced HL7 Standards •  •  •  •  • • Slide Number: 49 Standardization of knowledge representation (Arden / GELLO) Virtual Medical Record for Clinical Decision Support (vMR-CDS) Specification of components for context management (CMA) Standardization of clinical document structures (CDA) Electronic Health Record System Functional Model (EHR-S) Application protocol for electronic data exchange in healthcare environments (messages) Support for use of healthcare services in a Service Oriented Architecture (SOA) Fast Healthcare Interoperability Resources (FHIR) Specification of robust vocabulary definitions for use in clinical messages and documents Work in the area of security, privacy, confidentiality, and accountability © 2014 All Rights Reserved
  • 50. Sample HL7 V3 Clients and Projects Clinical Trial Registration and Results Message Specification Clinical Trial Registration and Results Message Specification UMTS Project Consolidated Dictionary and IHE Content Profile Slide Number: 50 © 2014 All Rights Reserved
  • 51. Clinical Trial Registration and Results Message Specification Slide Number: 51 © 2014 All Rights Reserved
  • 52. CTRR Development Artifacts Slide Number: 52 © 2014 All Rights Reserved
  • 53. Document Identifiers and Keywords Study Protocol Document, Study Description, Features, and Overall Status Study Outcome Measures and Objectives Study Participants Planned Activities, Study Arms, and References Regulatory Authorities, Application Submissions and Authorizations Slide Number: 53 Study Enrollment Stratification and Targets Target Research Products (devices and substances) Study Sites and Study Site Recruitment Activities © 2014 All Rights Reserved
  • 54. RMIM to XSD Slide Number: 54 © 2014 All Rights Reserved
  • 55. Traversing the CTRR RMIM Entry Point Slide Number: 55 © 2014 All Rights Reserved
  • 56. HMD – the RMIM serialized Slide Number: 56 © 2014 All Rights Reserved
  • 57. Study Protocol Document XSD Slide Number: 57 © 2014 All Rights Reserved
  • 58. Subject XSD Slide Number: 58 © 2014 All Rights Reserved
  • 59. Clinical Trial Intent XSD Slide Number: 59 © 2014 All Rights Reserved
  • 60. National Trauma Registry Submission CDA Document Specification Slide Number: 60 © 2014 All Rights Reserved
  • 61. Clinical Document Architecture (CDA) • The HL7 Clinical Document Architecture (CDA) is a document markup standard that specifies the structure and semantics of "clinical documents" for the purpose of exchange. • A clinical document contains observations and services and has the following characteristics: – Persistence – A clinical document continues to exist in an unaltered state, for a time period defined by local and regulatory requirements. – Stewardship – A clinical document is maintained by an organization entrusted with its care. – Potential for authentication - A clinical document is an assemblage of information that is intended to be legally authenticated. – Context - A clinical document establishes the default context for its contents. – Wholeness - Authentication of a clinical document applies to the whole and does not apply to portions of the document without the full context of the document. – Human readability – A clinical document is human readable. Slide Number: 61 © 2014 All Rights Reserved
  • 62. Clinical Document Architecture RMIM Participating Entities Slide Number: 62 Clinical Document Structured Document Sections Section Entries © 2014 All Rights Reserved
  • 63. NTDB CDA RMIM Subset Patient +recordTarget EntryRelationship ClinicalDocument isSubjectOf 1..* 1 1 0..* 1 0..* 1 +target 1 communicates +nested 0..* +informer Organization 0..* 1..* DocumentSection +source +clinicalStatement 0..* +nesting 0..1 SectionEntry 1..* 0..1 Act Slide Number: 63 Observ ation Encounter Procedure Organizer © 2014 All Rights Reserved
  • 64. From Data Dict. to CDA Impl. Guide Slide Number: 64 © 2014 All Rights Reserved
  • 65. Scope Slide Number: 65 © 2014 All Rights Reserved
  • 66. Implementation Guide Development Slide Number: 66 © 2014 All Rights Reserved
  • 67. DAM: a UML representation of dictionary elements 2.0 Submission:: RegistrySubmissionTransaction 0..1 PreHospitalEcounter + arrivalDateTime :TS [0..1] departureDateTime :TS [0..1] dispatchDateTime :TS [0..1] preHospitalTransportationMethodCode :TransportationMethod [0..*] 0..1 0..1 PreHospitalCirculatorySystemObserv ation PreHospitalRespiratorySystemObserv ation + + + + heartRateAmount :PQ systolicBloodPressureAmount :PQ arterialOxygenSaturationAmount :PQ respiratoryRateAmount :PQ 0..1 PreHospitalNerv ousSystemObserv ation + + + + Slide Number: 67 glasgowComaEyeResponseValue :INT glasgowComaMotorResponseValue :INT glasgowComaScoreValue :INT glasgowComaVerbalResponseCode :INT © 2014 All Rights Reserved
  • 68. Organization of DAM Classes 1.0 Patients + Patient 3.0 Inj ury Ev ents 2.0 Submission + RegistrySubmissionTransaction 4.0 PreHospital Encounters 5.0 Hospital Care Episodes + InjuryEvent + PreHospitalCirculatorySystemObservation + HospitalCareEpisode + InjurySeverityObservation + PreHospitalEcounter + HospitalCirculatorySystemObservation + PreHospitalNervousSystemObservation + HospitalNervousSystemObservation + PreHospitalRespiratorySystemObservation + HospitalPhysiologicalObservation + HospitalRespiratorySystemObservation + 5.1 Emergency Hospital Encounters + 5.2 InpatientHospitalEncounters Slide Number: 68 © 2014 All Rights Reserved
  • 69. Dictionary to DAM Element ID D_01 D_02 D_03 D_04 D_05 D_06 D_07 D_08 D_09 D_10 D_11 D_12 DG_01 DG_02 DG_03 ED_01 ED_02 ED_03 ED_043 ED_05 ED_06 ED_07 ED_08 ED_09 NTDB Dictionary Element D_01: PATIENT’S HOME ZIP CODE D_02: PATIENT’S HOME COUNTRY D_03: PATIENT’S HOME STATE D_04: PATIENT’S HOME COUNTY D_05: PATIENT’S HOME CITY D_06: ALTERNATE HOME RESIDENCE D_07: DATE OF BIRTH D_08: AGE D_09: AGE UNITS D_10: RACE D_11: ETHNICITY D_12: SEX DG_01: CO-MORBID CONDITIONS DG_02: ICD-9 INJURY DIAGNOSES DG_03: ICD-10 INJURY DIAGNOSES ED_01: ED/HOSPITAL ARRIVAL DATE ED_02: ED/HOSPITAL ARRIVAL TIME ED_03: INITIAL ED/HOSPITAL SYSTOLIC BLOOD PRESSURE ED_043: INITIAL ED/HOSPITAL PULSE RATE ED_05: INITIAL ED/HOSPITAL TEMPERATURE ED_06: INITIAL ED/HOSPITAL RESPIRATORY RATE ED_07: INITIAL ED/HOSPITAL RESPIRATORY ASSISTANCE ED_08: INITIAL ED/HOSPITAL OXYGEN SATURATION ED_09: INITIAL ED/HOSPITAL SUPPLEMENTAL OXYGEN Slide Number: 69 DAM Package 2.0 Patients 2.0 Patients 2.0 Patients 2.0 Patients 2.0 Patients 2.0 Patients 2.0 Patients 2.0 Patients 2.0 Patients 2.0 Patients 2.0 Patients 2.0 Patients 5.0 Hospital Care Episodes 5.0 Hospital Care Episodes 5.0 Hospital Care Episodes 5.0 Hospital Care Episodes 5.0 Hospital Care Episodes 5.0 Hospital Care Episodes 5.0 Hospital Care Episodes 5.0 Hospital Care Episodes 5.0 Hospital Care Episodes 5.0 Hospital Care Episodes 5.0 Hospital Care Episodes 5.0 Hospital Care Episodes DAM Class Patient Patient Patient Patient Patient Patient Patient Patient Patient Patient Patient Patient HospitalCareEpisode HospitalCareEpisode HospitalCareEpisode HospitalCareEpisode HospitalCareEpisode HospitalCirculatorySystemObservation HospitalCirculatorySystemObservation HospitalPhysiologicalObservation HospitalRespiratorySystemObservation HospitalRespiratorySystemObservation HospitalRespiratorySystemObservation HospitalRespiratorySystemObservation DAM Attribute postalAddress postalAddress postalAddress postalAddress postalAddress residenceStatusCode birthDate eventRelatedAgeQuantity eventRelatedAgeQuantity raceCode ethnicCode genderCode coMorbidConditionCode injuryDiagnosisCode injuryDiagnosisCode arrivalDateTime arrivalDateTime systolicBloodPressureAmount heartRateAmount temperatureAmount respiratoryRateAmount respiratoryAssistanceIndicator arterialOxygenSaturationAmount supplementalOxygenIndicator © 2014 All Rights Reserved
  • 70. CIM: a CDA influenced UML representation of dictionary elements PreHospitalEncounterDetail:: PreHospitalEncounter 1 CDA RMIM RespiratorySystemEntryRelationship + + typeCode :CS = x_ActRelationsh... contextConductionInd :BL = "true" 0..* RespiratorySystemObserv ation 2 Domain Analysis Model + + classCode :CS = "OBS" moodCode :CS = "EVN" Constrained Information Model ArterialOxygenSaturationObserv ation + - code :CD = ObservationType value :PQ ::RespiratorySystemObservation + classCode :CS = "OBS" + moodCode :CS = "EVN" Slide Number: 70 RespiratoryRateObserv ation + - code :CD = ObservationType value :PQ ::RespiratorySystemObservation + classCode :CS = "OBS" + moodCode :CS = "EVN" © 2014 All Rights Reserved
  • 71. Organization of CIM Classes TraumaRegistrySubmissionDocument + HealthcareFacility Patient + RecordTarget + Patient + PatientRole + PatientDetailSection + RegistryParticipant + StructuredBodyComponent + StucturedBody + Submitter + TraumaRegistrySubmissionDocument + Patient + InjuryEventSection (from TraumaRegistrySubmissionDocument) + PreHospital Encounter Section + Hospital Care Episode Section + EntryPoint Inj uryEv entSection PreHospital Encounter Section Hospital Care Episode Section + InjuryEventSection + PreHospitalEncounterSection + HospitalCareEpisodeSection + StructuredBodyInjuryEventComponent + StructoredBodyPreHospitalEncounterComponent + StructuredBodyHospitalCareEpisodeComponent + InjuryEventDetailEntry + PreHospitalEncounterDetail + HospitalCareEpisodeActivityDetail (from TraumaRegistrySubmissionDocument) Slide Number: 71 (from TraumaRegistrySubmissionDocument) (from TraumaRegistrySubmissionDocument) © 2014 All Rights Reserved
  • 72. DAM to CIM DAM Class Patient Patient Patient Patient Patient Patient Patient Patient Patient InjuryEvent InjuryEvent InjuryEvent InjuryEvent InjuryEvent InjuryEvent InjuryEvent InjuryEvent InjuryEvent InjuryEvent InjuryEvent PreHospitalCirculatorySystemObservation PreHospitalCirculatorySystemObservation PreHospitalEncounter PreHospitalEncounter Slide Number: 72 DAM Attribute birthDate ethnicCode eventRelatedAgeQuantity genderCode industryCode occupationCode postalAddress raceCode residenceStatusCode abbreviatedInjuryCode airbagDeploymentCode bodyInjuryRegionCode injurySeverityScoreValue locationTypeCode occurenceDateTime postalAddress primaryInjuryCauseCode safetyEquipmentUsedCode supplementalInjuryCauseCode workRelatedEventInd heartRateAmount systolicBloodPressureAmount arrivalDateTime departureDateTime CIM Class Patient Patient PatientAgeObservation Patient PatientIndustryObservation PatientOccupationObservation PatientRole Patient PatientResidenceStatusObservation AbreviatedInjuryObservation AirbagDeploymentObservation BodyInjuryObservation SeverityScoreObservation LocationTypeObservation InjuryEventAct PostalAddressObservation PrimaryInjuryCauseObservation SafetyEquipmentUsedObservation SupplementalInjuryCauseObservation WorkRelatedObservation HeartRateObservation SystolicBloodPressureObservation PreHospitalEncounter PreHospitalEncounter CIM Attribute birthTime ethnicGroupCode value administrativeGenderCode value value addr raceCode value value value value value value effectiveTime value value value value value value value effectiveTime effectiveTime © 2014 All Rights Reserved
  • 73. IG: Dictionary elements represented as templated CDA constraints CDA RMIM 3 Constrained Information Model NTDB Implementation Guide EMS Implementation Guide Slide Number: 73 © 2014 All Rights Reserved
  • 74. Organization of IG Templates Slide Number: 74 © 2014 All Rights Reserved
  • 75. Organization of IG Templates Name: Author: Version: Created: Updated: TraumaRegistrySubmissionDocument Salimah Shakir 1.0 2/7/2013 9:30:31 PM 6/14/2013 12:01:15 AM Legend HEADER EntryPoint TraumaRegistrySubmissionDocument Patient::PatientRole 1..1 Act Entity 1 Role + + + + - classCode :CS = "DOCCLIN" moodCode :CS = "EVN" id :II code :CE = DocumentType effectiveTime :TS RegistryParticipant + classCode :CS = "ASSIGNED" 1..1 1 Participation 1 1 ActRelationship Submitter StructuredBodyComponent Foriegn Class + + + + typeCode :CS = "COMP" contextConductionInd :BL = "true" typeCode :CS = "INF" contextControlCode :CS = "OP" 1..1 Patient 1..1 HealthcareFacility StucturedBody + RecordTarget + + + Patient + + - classCode :CS = "DOCBODY" moodCode :CS = "EVN" + PatientRole classCode :CS = "ORG" determinerCode :CS = "INSTANCE" id :II + PatientDetailSection 1 1 1 1 BODY 1..1 1..1 PatientDetailSection::PatientDetailSection PatientDetailSection Inj uryEv entSection::Inj uryEv entSection Inj uryEv entSection 0..1 PreHospital Encounter Section:: PreHospitalEncounterSection PreHospital Encounter Section 1..1 Hospital Care Episode Section:: HospitalCareEpisodeSection Hospital Care Episode Section + PatientDetailSection + InjuryEventSection + PreHospitalEncounterSection + HospitalCareEpisodeSection + StucturedBodyPatientDetailComponent + StructuredBodyInjuryEventComponent + StructoredBodyPreHospitalEncounterComponent + StructuredBodyHospitalCareEpisodeComponent + PatientDemographicObservation + InjuryEventDetailEntry + PreHospitalEncounterDetail + HospitalCareEpisodeActivityDetail + PatientEmploymentObservation (from Patient) Slide Number: 75 ENTRIES © 2014 All Rights Reserved
  • 76. Dict to DAM to CIM to IG NTDB Dictionary Element D_01: PATIENT’S HOME ZIP CODE D_02: PATIENT’S HOME COUNTRY D_03: PATIENT’S HOME STATE D_04: PATIENT’S HOME COUNTY D_05: PATIENT’S HOME CITY D_06: ALTERNATE HOME RESIDENCE D_07: DATE OF BIRTH D_08: AGE D_09: AGE UNITS D_10: RACE D_11: ETHNICITY D_12: SEX DG_01: CO-MORBID CONDITIONS DG_02: ICD-9 INJURY DIAGNOSES DG_03: ICD-10 INJURY DIAGNOSES ED_01: ED/HOSPITAL ARRIVAL DATE ED_02: ED/HOSPITAL ARRIVAL TIME ED_03: INITIAL ED/HOSPITAL SYSTOLIC BLOOD PRESSURE ED_043: INITIAL ED/HOSPITAL PULSE RATE ED_05: INITIAL ED/HOSPITAL TEMPERATURE ED_06: INITIAL ED/HOSPITAL RESPIRATORY RATE ED_07: INITIAL ED/HOSPITAL RESPIRATORY ASSISTANCE ED_08: INITIAL ED/HOSPITAL OXYGEN SATURATION ED_09: INITIAL ED/HOSPITAL SUPPLEMENTAL OXYGEN Slide Number: 76 CDA Template 3.1 Trauma Registry Submission Document 3.1 Trauma Registry Submission Document 3.1 Trauma Registry Submission Document 3.1 Trauma Registry Submission Document 3.1 Trauma Registry Submission Document 5.3 Patient Demographic Observations Organizer 3.1 Trauma Registry Submission Document 5.3 Patient Demographic Observations Organizer 5.3 Patient Demographic Observations Organizer 5.3 Patient Demographic Observations Organizer 3.1 Trauma Registry Submission Document 3.1 Trauma Registry Submission Document 6.5 Hospital Care Episode Observation Organizer 6.5 Hospital Care Episode Observation Organizer 6.5 Hospital Care Episode Observation Organizer 5.1 Hospital Care Episode Encounter 5.1 Hospital Care Episode Encounter 6.1 Circulatory System Observation Entry 6.1 Circulatory System Observation Entry 6.7 Hospital Care Physiological Observation 6.16 Respiratory System Observation Entry 6.15 Respiratory System Observation 6.16 Respiratory System Observation Entry 6.15 Respiratory System Observation CDA ITEM CDA Clone 8.c.111 8.c.111 8.c.111 8.c.111 8.c.111 42.c.iv 8.c.iv.4 43.c.iv 43.c.iv.1 44.c.iv 8.c.iv.5 8.c.iv.3 84.c.iv 85.c.iv 85.c.iv 31 31 63.c.iv 62.c.iv 100.c.iv 145.c.iv 140.c.iv 144.c.iv 141.c.iv patientRole patientRole patientRole patientRole patientRole observation patient observation observation observation patient patient observation observation observation encounter encounter observation observation observation observation observation observation observation CDA Attribute CDA CONF addr addr addr addr addr value birthTime value value@unit value ethnicGroupCode administrativeGenderCode value value value effectiveTime effectiveTime value value value value value value value 27773 27773 27773 27773 27773 30000 27776 30008 30455 30508 27778 27775 30385 30397 30397 30341 30341 29639 29633 30431 30092 30437 30085 30441 © 2014 All Rights Reserved
  • 77. Trauma Registry Data Submission IG Slide Number: 77 © 2014 All Rights Reserved
  • 78. Front Matter: Introduction and Specification Overview 78 Slide Number: 78 © 2014 All Rights Reserved
  • 79. Conformance Verbs 79 • The conformance verb keyword at the start of a constraint ( SHALL , SHOULD , MAY, etc.) indicates usage conformance. – SHALL is an indication that the constraint is to be enforced without exception; – SHOULD is an indication that the constraint is optional but highly recommended; and – MAY is an indication that the constraint is optional and that adherence to the constraint is at the discretion of the document creator. Slide Number: 79 © 2014 All Rights Reserved
  • 80. Cardinality 80 • The cardinality indicator (0..1, 0..*, 1..1, 1..*, etc.) specifies the allowable occurrences within an instance. • Thus, " MAY contain 0..1" and " SHOULD contain 0..1" both allow for a document to omit the particular component, but the latter is a stronger recommendation that the component be included if it is known. • The following cardinality indicators may be interpreted as follows: – – – – – 0..1 as contains zero or one 1..1 as contains exactly one 2..2 as contains exactly two 1..* as contains one or more 0..* as contains zero or more • Each constraint is uniquely identified (e.g., "CONF:605") by an identifier placed at or near the end of the constraint. Slide Number: 80 © 2014 All Rights Reserved
  • 81. Value Set Binding • Value set bindings adhere to HL7 Vocabulary Working Group best practices, and include both a conformance verb ( SHALL , SHOULD , MAY, etc.) and an indication of DYNAMIC vs. STATIC binding. • The use of SHALL requires that the component be valued with a member from the cited value set; however, in every case any HL7 "null" value such as other (OTH) or unknown (UNK) may be used. • STATIC binding means that the allowed values of the value set do not change automatically as new values are added to a value set. That is, the binding is to a single version of a value set. • DYNAMIC binding means that the intent is to have the allowed values for a coded item automatically change (expand or contract) as the value set is maintained over time. Slide Number: 81 © 2014 All Rights Reserved
  • 82. Templates Slide Number: 82 © 2014 All Rights Reserved
  • 83. Document Template 83 Slide Number: 83 © 2014 All Rights Reserved
  • 84. Section Templates Slide Number: 84 © 2014 All Rights Reserved
  • 85. Entry Templates Slide Number: 85 © 2014 All Rights Reserved
  • 86. Subentry Templates Slide Number: 86 © 2014 All Rights Reserved
  • 87. Vocabulary Tables Slide Number: 87 © 2014 All Rights Reserved
  • 88. Implementation Guide Development Slide Number: 88 © 2014 All Rights Reserved
  • 89. From Data Dict. to CDA Impl. Guide Slide Number: 89 © 2014 All Rights Reserved
  • 90. UMTS Project Consolidated Dictionary and IHE Content Profile Development Slide Number: 90 © 2014 All Rights Reserved
  • 91. UMTS Project Activities Registry Elements Semantic Analysis 1 00069 Dose Amount 00147 Duration 00070 Start Date Time 00306 Stop Date Time MedicationTypeCode Consolidated Dictionary Initial Bolus 00776 Route 00307 Medication 2 DEI Dictionary Element 00112 REI Cardiac Arrest Indicator Registry Element Name Action.4135 RE Section Coding Instructions Context Timing Action.4140 Cardiac Arrest Pre-Hospital Action.4145 Cardiac Arrest Outside Facility Cardiac Arrest Indicator Action.9035 Cardiac Arrest H. In-Hospital Clinical Events Indicate if the patient experienced an episode of cardiac arrest in your facility. Cardiac Arrest Indicator CathPCI.5065 Cardiac Arrest w/in 24 Hours D. Cath Lab Visit Indicate if the patient has had an episode of cardiac arrest within 24 hours of procedure. Cardiac Arrest Indicator ICD.4080 Cardiac Arrest Pre-Hospital C. History and Risk Factors Indicate if the patient experienced cardiac arrest due to arrhythmia. History and Risk Factors VTach/VFib Arrest Indicator ICD.4090 VTach/VFib Arrest C. History and Risk Factors Indicate if the cardiac arrest was a result of ventricular tachycardia or ventricular fibrillation. History and Risk Factors Bradycardia Arrest Indicator ICD.4095 Bradycardia Arrest C. History and Risk Factors Indicate if the cardiac arrest was a result of bradycardia. History and Risk Factors 00112 Cardiac Arrest Indicator ICD.8005 Cardiac Arrest H. Intra or Post Procedure Events Indicate if the patient experienced cardiac arrest. Intra or Post Procedure 00112 Cardiac Arrest Indicator Impact.8000 Cardiac Arrest L. Intra and Post-Procedure Events Indicate if there was a cardiac arrest event that required CPR. Intra or Post Procedure 00112 q24hr Within 2 weeks Cause Cardiac Arrest at First Medical Contact C. Cardiac Status on First Medical Contact Indicate if the patient has had an episode First Medical Contact of cardiac arrest. Cardiac Arrest Indicator 00102 00238 Frequency MedicationAdministration Cardiac Arrest Indicator 00112 00800 q12hr 00112 00112 Initial Infusion 00112 00112 MedicationClassCode Standard Clinical Code Systems Location C. Cardiac Status on First Medical Contact Indicate if the patient’s cardiac arrest was First Medical Contact prior to arrival at the outside facility and/or occurred during transfer from the outside facility to this facility. C. Cardiac Status on First Medical Contact Indicate if the patient’s cardiac arrest First Medical Contact occurred at the outside facility. Cardiac Arrest Indicator TVT.5035 D. Pre-Procedure Status Indicate if the patient has had an episode of cardiac arrest within 24 hours of the procedure. within 24 hours of the procedure First 24 Hours PreHospital Outside Facility In Hospital within 24 hours of procedure Pre-Hospital Administered Pre-Encounter Timing Intra-Encounter 00423 Status Not Administered Blinded 00303 Dose Code Pre-Procedure Intra-Procedure ventricular tachycardia or ventricular fibrillation bradycardia Contraindicated At Discharge Full Reduced Cardiac Arrest w/in 24 Hours Other During Follow-up 3 Conceptual Data Model HL7 Reference Models 01.0 Submissions::ParticipantIdentifier + 01.0 Submissions::SourceSystem identifierValue :ST identifierTypeCode :ParticipantIdentifier - versionIdentifier :ST - 1 identifies originates from 01.0 Submissions::Submission 01.0 Submissions::Participant - submited by name :ST - 1..* + + trialTypeCode :CD researchStudyName :ST 1 identifier :ST submissionTimePeriod :TS.DATE (IVL) 1..* submissionDateTime :TS 01.0 Submissions::Registry submited to 1 - 05.0 Ev ents::Ev entEv entRelation identifier :ST {id} versionIdentifier :ST {id} + Name: Author: Version: Created: Updated: has target 0..* + 0..* + 1 is part of 1 - 0..* 1 Procedure methodCode : SET<CE> approachSiteCode : SET<CD> targetSiteCode : SET<CD> has subject name :EN.PN birthDate :TS.DATE sexCode :CD hispanicIndicator :BL = No ethnicityDetailCode :CD [0..*] (SET) postalZoneIdentifier :II residenceCountryCode :CD indicationCode :CD [0..1] abortedReasonCode :CD [0..*] + ::Event - methodCode :CD [0..*] (SET) + classificationCode :Clasification + contextCode :Context - eventDateTime :TS [0..1] (IVL) - statusCode :CD = Completed - eventDuration :PQ.TIME [0..1] is a type of ::Event - methodCode :CD [0..*] (SET) + classificationCode :Clasification + contextCode :Context - eventDateTime :TS [0..1] (IVL) - statusCode :CD = Completed - eventDuration :PQ.TIME [0..1] 1 1 1..* InvoiceElement modifierCode : SET<CE> unitQuantity : RTO<PQ,PQ> unitPriceAmt : RTO<MO,PQ> netAmt : MO factorNumber : REAL pointsNumber : REAL is part of 0..* 1 - identifier :II typeCode :CD manufacturerName :EN.ON deviceName :ST universalDeviceIdentifier :II [0..1] 0..1 is part of administers - deviceCounter :INT is part of 0..* 06.0 Lesions::LesionTreatmentDetail - 1..* 0..* - identifierValue :II identifierTypeCode :PatientIdentifier ::ObservationEvent + observationTypeCode :CD 10.0 Medication Administration Ev ents:: Medication 02.0 Patients::PatientRace 02.0 Patients::PatientIdentifier + raceCode :CD raceDetailCode :CD [0..*] (SET) + - 09.0 Procedures::ProcedureVascularAssessment previouslyTreatedIndicator :BL = No culpritLesionIndicator :BL = No - vesselNotAvailableIndicator :BL = No 09.0 Procedures::ArterialAccess 09.0 Procedures::ArterialClosure is part of ::Event - methodCode :CD [0..*] (SET) + classificationCode :Clasification + contextCode :Context - eventDateTime :TS [0..1] (IVL) - statusCode :CD = Completed - eventDuration :PQ.TIME [0..1] ::Event - methodCode :CD [0..*] (SET) + classificationCode :Clasification + contextCode :Context - eventDateTime :TS [0..1] (IVL) - statusCode :CD = Completed - eventDuration :PQ.TIME [0..1] 0..1 1 0..* ::ObservationEvent + observationTypeCode :CD ::ObservationEvent + observationTypeCode :CD ::Event - methodCode :CD [0..*] (SET) + classificationCode :Clasification + contextCode :Context - eventDateTime :TS [0..1] (IVL) - statusCode :CD = Completed - eventDuration :PQ.TIME [0..1] medicationCode :CD name :ST - siteCounter :INT directionalityTypeCode :CD [0..1] vesselCode :CD 1..* {ordered} - arterialClosureCounter :INT {id} methodCode :CD [0..1] undocumentedIndicator :BL = No 0..* 0..* 0..* has target is part of is treatment of 1 06.0 Lesions::LesionTreatmentDev ice Account name : ST balanceAmt : MO currencyCode : CE interestRateQuantity : RTO<MO,PQ> allowedBalanceQuantity : IVL<MO> 1 1 06.0 Lesions::Lesion 06.0 Lesions::LesionAffectedVesselSegment deviceCounter :INT - lesionCounter :INT {id} 0..* 04.0 Observ ations::Inv olv edAnatomicSite is located in 0..* - 1 lesionLocationCode :CD segmentCounter :INT involved 1 - 0..* typeCode :CD lateralityCode :CD 1 0..* is a type of + involvementTypeCode :InvolvementType is a type of is a type of Refers to (1..1) 07.0 Devices :: Device 1 08.0 AnatomicSites::AnatomicSite affecting - 0..* 06.0 Lesions::LesionDescriptor 08.0 AnatomicSites::VesselSegment Primary Class FinancialTransaction amt : MO creditExchangeRateQuantity : REAL debitExchangeRateQuantity : REAL - ::ObservationEvent + observationTypeCode :CD - is part of ::AnatomicSite - typeCode :CD - lateralityCode :CD ::Event - methodCode :CD [0..*] (SET) + classificationCode :Clasification + contextCode :Context - eventDateTime :TS [0..1] (IVL) - statusCode :CD = Completed - eventDuration :PQ.TIME [0..1] Dependant Classes Value Sets 08.0 AnatomicSites::AnatomicRegion cardiovascularVesselCode :CD {id} vesselTypeCode :CD is part of ::AnatomicSite - typeCode :CD - lateralityCode :CD 0..* anotomicRegionCode :CD 0..1 ::AnatomicSite - typeCode :CD - lateralityCode :CD 0..* +subsection 0..* graftTypeCode :CD 4 Constrained Information Model (Observ ation) ParticipantIdentifierObserv ation (Section) RegistryParticipantDetailSection (Patient) Patient + + + + # classCode :CS = "PSN" determinerCode :CS = "INSTANCE" (Patient.name) name :EN.PN (Patient.sexCode) administrativeGenderCode :CD (Patient.birthDate) birthTime :TS.DATE (Patient.hispanicIndicator) ethnicGroupCode :CD classCode :CS = "DOCSECT" moodCode :CS = "EVN" code :CE = "RegistryPartic... # + 1..* 1 classCode :CS = "OBS" moodCode :CS = "EVN" (ParticipantIdentifier.typeCode) code :CD (ParticipantIdentifier.identifierValue) value :CD (Entry) ParticipantIdentifierObserv ationEntry 1..1 - ii. This observationThe entryRelationship, one [1..1] @moodCode="EVN" b. SHALL contain exactly if present, SHALL contain exactly one [1..1] (CONF:31970). @contextConductionInd="true" (CONF:31967). (CONF:31969). ii. This observation SHALL contain exactly one [1..1] @moodCode="EVN" (CONF:31970). iii. This observation SHALL contain exactly one [1..1] code (CONF:31971). typeCode :CS = "COMP" contextConductionIndicator :BL = "true" 5 iii. This observation SHALL contain exactly one [1..1] code (CONF:31971). iv. This observation SHALL contain exactly one [1..1] value with @xsi:type="CD" (CONF:31972). ::CardiovascularVessel - cardiovascularVesselCode :CD {id} - vesselTypeCode :CD ::AnatomicSite - typeCode :CD - lateralityCode :CD HL7 Clinical Document Architecture RMIM iii. This observationThe entryRelationship, one [1..1] code (CONF:31971). one [1..1] observation c. SHALL contain exactly if present, SHALL contain exactly iv. This observation(CONF:31968). exactly one [1..1] value with @xsi:type="CD" SHALL contain (CONF:31972). i. This observation SHALL contain exactly one [1..1] @classCode="OBS" ii. This observation SHALL contain exactly one [1..1] @moodCode="EVN" (CONF:31970). 08.0 AnatomicSites::Cardiov ascularGraft - Contains: 6. SHALL contain zeroSHALL containeffectiveTime (CONF:31963). Table 1: ClincalEventObservationSubEntry Contexts 1. or one [0..1] exactly one [1..1] @classCode="OBS" (CONF:31958). 7. SHALL contain exactly one [1..1] value (CONF:31964). 2. SHALL containContained By: exactly one [1..1] @moodCode="EVN" (CONF:31959). Contains: 8. MAY contain zero or more [0..*] zero or one [0..1] @negationInd (CONF:31960). 3. MAY contain entryRelationship (CONF:31965). a. The entryRelationship, if present,one [1..1] templateId="2.16.840.1.113883.3.2898.10.9999" 4. SHALL contain exactly SHALL contain exactly one [1..1] This @typeCode="OPTN" (CONF:31966). template is used to collect clinical event observations made within the scope of the (CONF:31961). encounter. Observations may be modified by observational semantic qualifiers. b. The entryRelationship, if present,one [1..1] code exactly one [1..1] 5. SHALL contain exactly SHALL contain (CONF:31962). @contextConductionInd="true" SHALL contain exactly one [1..1] @classCode="OBS" (CONF:31958). 1. (CONF:31967). 6. SHALL contain zero or one [0..1] effectiveTime (CONF:31963). c. The entryRelationship, if present,one [1..1] valueexactlyone [1..1] observation 2. SHALL contain (CONF:31964). 7. SHALL contain exactly SHALL contain exactly one [1..1] @moodCode="EVN" (CONF:31959). (CONF:31968). 3. MAY contain zero or one [0..1] @negationInd 8. MAY contain zero or more [0..*] entryRelationship (CONF:31965). (CONF:31960). i. This observation SHALL contain exactly one [1..1] @classCode="OBS" 4. SHALL if present, SHALL contain exactly one [1..1] a. The entryRelationship, contain exactly one [1..1] templateId="2.16.840.1.113883.3.2898.10.9999" (CONF:31969). (CONF:31961). @typeCode="OPTN" (CONF:31966). ii. This observation SHALL contain exactly one [1..1] @moodCode="EVN" 5. SHALL if present, SHALL contain exactly one [1..1] b. The entryRelationship, contain exactly one [1..1] code (CONF:31962). (CONF:31970). @contextConductionInd="true" (CONF:31967). 6. SHALL contain zero or one [0..1] effectiveTime (CONF:31963). iii. This observation SHALL contain exactly one [1..1] code (CONF:31971). c. The entryRelationship, contain exactly one [1..1] value (CONF:31964). if present, SHALL contain exactly one [1..1] observation 7. SHALL iv. This observation SHALL contain exactly one [1..1] value with @xsi:type="CD" (CONF:31968). MAY contain zero or more [0..*] entryRelationship (CONF:31965). 8. (CONF:31972). i. This observationThe entryRelationship, one [1..1] @classCode="OBS" a. SHALL contain exactly if present, SHALL contain exactly one [1..1] (CONF:31969). @typeCode="OPTN" (CONF:31966). (CONF:31969). is grouped by is a type of Foreign Classes 08.0 AnatomicSites::Cardiov ascularVessel vesselSegmentCode :CD {id} Contained By: ii. This observationThe entryRelationship, one [1..1] @moodCode="EVN" b. SHALL contain exactly if present, SHALL contain exactly one [1..1] (CONF:31970). @contextConductionInd="true" (CONF:31967). iii. This observationThe entryRelationship, one [1..1] code (CONF:31971). one [1..1] observation c. SHALL contain exactly if present, SHALL contain exactly iv. This observation(CONF:31968). exactly one [1..1] value with @xsi:type="CD" SHALL contain (CONF:31972). i. This observation SHALL contain exactly one [1..1] @classCode="OBS" 0..* is treated by Contains: 1 3. MAY contain zero or one [0..1] @negationInd (CONF:31960). 4. SHALL contain exactly one [1..1] templateId="2.16.840.1.113883.3.2898.10.9999" 1.1 ClincalEventObservationSubEntry (CONF:31961).This template is used to collect clinical event observations made within the scope of the [observation: templateId 2.16.840.1.113883.3.2898.10.9999 (closed)] encounter. Observations may be modified by observational semantic qualifiers. 5. SHALL contain exactly one [1..1] code (CONF:31962). Contains: 7. SHALL contain exactly one [1..1] value (CONF:31964). 2. SHALL containContained By: exactly one [1..1] @moodCode="EVN" (CONF:31959). Contains: 8. MAY contain zero or more [0..*] zero or one [0..1] @negationInd (CONF:31960). 3. MAY contain entryRelationship (CONF:31965). a. The entryRelationship, if present,one [1..1] templateId="2.16.840.1.113883.3.2898.10.9999" 4. SHALL contain exactly SHALL contain exactly one [1..1] This @typeCode="OPTN" (CONF:31966). template is used to collect clinical event observations made within the scope of the (CONF:31961). encounter. Observations may be modified by observational semantic qualifiers. b. The entryRelationship, if present,one [1..1] code exactly one [1..1] 5. SHALL contain exactly SHALL contain (CONF:31962). @contextConductionInd="true" SHALL contain exactly one [1..1] @classCode="OBS" (CONF:31958). 1. (CONF:31967). 6. SHALL contain zero or one [0..1] effectiveTime (CONF:31963). c. The entryRelationship, if present,one [1..1] valueexactlyone [1..1] observation 2. SHALL contain (CONF:31964). 7. SHALL contain exactly SHALL contain exactly one [1..1] @moodCode="EVN" (CONF:31959). (CONF:31968). 3. MAY contain zero or one [0..1] @negationInd 8. MAY contain zero or more [0..*] entryRelationship (CONF:31965). (CONF:31960). i. This observation SHALL contain exactly one [1..1] @classCode="OBS" 4. SHALL if present, SHALL contain exactly one [1..1] a. The entryRelationship, contain exactly one [1..1] templateId="2.16.840.1.113883.3.2898.10.9999" (CONF:31969). (CONF:31961). @typeCode="OPTN" (CONF:31966). ii. This observation SHALL contain exactly one [1..1] @moodCode="EVN" 5. SHALL if present, SHALL contain exactly one [1..1] b. The entryRelationship, contain exactly one [1..1] code (CONF:31962). (CONF:31970). @contextConductionInd="true" (CONF:31967). 6. SHALL contain zero or one [0..1] effectiveTime (CONF:31963). iii. This observation SHALL contain exactly one [1..1] code (CONF:31971). c. The entryRelationship, contain exactly one [1..1] value (CONF:31964). 7. SHALL if present, SHALL contain exactly one [1..1] observation iv. This observation SHALL contain exactly one [1..1] value with @xsi:type="CD" (CONF:31968). MAY contain zero or more [0..*] entryRelationship (CONF:31965). 8. (CONF:31972). i. This observationThe entryRelationship, one [1..1] @classCode="OBS" a. SHALL contain exactly if present, SHALL contain exactly one [1..1] (CONF:31969). @typeCode="OPTN" (CONF:31966). 1 0..* Legend Diet energyQuantity : PQ carbohydrateQuantity : PQ is use of 0..* ::Event - methodCode :CD [0..*] (SET) + classificationCode :Clasification + contextCode :Context - eventDateTime :TS [0..1] (IVL) - statusCode :CD = Completed - eventDuration :PQ.TIME [0..1] 1 09.0 Procedures::ArterialClosureDev ice identifies Table 1: ClincalEventObservationSubEntry Contexts SUBENTRY 1. SHALL contain exactly one [1..1] @classCode="OBS" (CONF:31958). Table 1: ClincalEventObservationSubEntry Contexts 2. SHALL contain exactly one [1..1] @moodCode="EVN" R Y S U B E N T (CONF:31959). 1 6. SHALL contain zeroSHALL containeffectiveTime (CONF:31963). Table 1: ClincalEventObservationSubEntry Contexts 1. or one [0..1] exactly one [1..1] @classCode="OBS" (CONF:31958). 07.0 Dev ices::Dev ice ::ObservationEvent + observationTypeCode :CD is use by ::Event - methodCode :CD [0..*] (SET) + classificationCode :Clasification + contextCode :Context - eventDateTime :TS [0..1] (IVL) - statusCode :CD = Completed - eventDuration :PQ.TIME [0..1] 1 is part of Supply quantity : PQ expectedUseTime : IVL<TS> procedureTypeCode :CD ::Intervention - indicationCode :CD [0..1] - abortedReasonCode :CD [0..*] is a type of deviceCounter :INT {id} statusCode :CD abortedReasonCode :CD [0..1] is use of 1 + has subject 1..* - ::Intervention - indicationCode :CD [0..1] - abortedReasonCode :CD [0..*] 02.0 Patients::Patient 0..1 0..* 09.0 Procedures::ProcedureDev iceUse 09.0 Procedures::Procedure - 1 1.1 ClincalEventObservationSubEntry This template is used to collect clinical event observations made within the scope of the [observation: templateId 2.16.840.1.113883.3.2898.10.9999 (closed)] encounter. Observations may be modified by observational semantic qualifiers. 3. MAY contain zero or one [0..1] @negationInd (CONF:31960). 4. SHALL contain exactly one [1..1] templateId="2.16.840.1.113883.3.2898.10.9999" 1.1 ClincalEventObservationSubEntry (CONF:31961).This template is used to collect clinical event observations made within the scope of the [observation: templateId 2.16.840.1.113883.3.2898.10.9999 (closed)] encounter. Observations may be modified by observational semantic qualifiers. 5. SHALL contain exactly one [1..1] code (CONF:31962). Contained By: involving 0..* 02.0 Patients::ResearchStudyEnrollment [observation: templateId 2.16.840.1.113883.3.2898.10.9999 (closed)] Contained By: Contains: 2. SHALL contain exactly one [1..1] @moodCode="EVN" R Y S U B E N T (CONF:31959). 0..* is part of 0..* enrolledIndicator :BL = No SUBENTRY 1. SHALL contain exactly one [1..1] @classCode="OBS" (CONF:31958). Table 1: ClincalEventObservationSubEntry Contexts ::Event - methodCode :CD [0..*] (SET) + classificationCode :Clasification + contextCode :Context - eventDateTime :TS [0..1] (IVL) - statusCode :CD = Completed - eventDuration :PQ.TIME [0..1] is referred to by (0..*) 06.0 Lesions :: LesionTreatmentDevice 1 - 1 1.1 ClincalEventObservationSubEntry This template is used to collect clinical event observations made within the scope of the [observation: templateId 2.16.840.1.113883.3.2898.10.9999 (closed)] encounter. Observations may be modified by observational semantic qualifiers. 1 05.0 Events::Intervention 0..* DiagnosticImage subjectOrientationCode : CE Contained By: observationResultTypeCode :CD conditionOnsetDateTime :TS [0..1] +child estimatedOnsiteDateIndicator :BL = No 0..* missingOnsetTimeIndicator :BL = No observationValue :ANY observationValueNegationIndicator :BL = No 07.0 Dev ices::Dev iceDescriptor ::ObservationEvent + observationTypeCode :CD ::Event - methodCode :CD [0..*] (SET) + classificationCode :Clasification + contextCode :Context - eventDateTime :TS [0..1] (IVL) - statusCode :CD = Completed - eventDuration :PQ.TIME [0..1] 09.0 Procedures::ProcedureLesion Observation value : ANY interpretationCode : SET<CE> methodCode : SET<CE> targetSiteCode : SET<CD> 0..* + is part of ::ObservationEvent + observationTypeCode :CD 10.0 Medication Administration Ev ents:: MedicationAdministrationEv ent SUBENTRY ClincalEventObservationSubEntry Table 1: ClincalEventObservationSubEntry Contexts is grouped by +parent 0..1 04.0 Observ ations::Observ ationResult 04.0 Observ ations:: Observ ationEv ent observationTypeCode :CD 0..* relationshipTypeCode :RelationshipType is a type of 1 1 1.1 ClincalEventObservationSubEntry [observation: templateId 2.16.840.1.113883.3.2898.10.9999 (closed)] name :EN.PN identifier :II isCertifiedIndicator :BL = No 0..* + ::Event - methodCode :CD [0..*] (SET) + classificationCode :Clasification + contextCode :Context - eventDateTime :TS [0..1] (IVL) - statusCode :CD = Completed - eventDuration :PQ.TIME [0..1] is a type of 09.0 Procedures::ProcedureDescriptor 0..* 03.0 CareEpisodes::Ev entEpisodeRelation + SUBENTRY performed by 0..* methodCode :CD [0..*] (SET) classificationCode :Clasification contextCode :Context eventDateTime :TS [0..1] (IVL) statusCode :CD = Completed eventDuration :PQ.TIME [0..1] has source has target within context of 1 SubstanceAdministration routeCode : CE approachSiteCode : SET<CD> doseQuantity : IVL<PQ> rateQuantity : IVL<PQ> doseCheckQuantity : SET<RTO> maxDoseQuantity : SET<RTO> substitutionCode : CE PublicHealthCase PatientEncounter detectionMethodCode : CE preAdmitTestInd : BL transmissionModeCode : CE admissionReferralSourceCode : CE diseaseImportedCode : CE lengthOfStayQuantity : PQ dischargeDispositionCode : CE specialCourtesiesCode : SET<CE> specialAccommodationCode : SET<CE> acuityLevelCode : CE 1.1 NCDR DAM Classes Salimah Shakir 1.0 11/12/2012 7:02:00 PM 8/26/2013 1:05:44 PM 1 05.0 Ev ents::Ev ent arrivalDateTime :TS dischargeDate :TS.DATE payorTypeCode :CD [1..*] (SET) admissionSourceCode :CD dischargeDispositionCode :CD 1 has source is grouped by 0..* - 05.0 Ev ents::Ev entPerformer relationshipTypeCode :RelationshipType 0..* 03.0 CareEpisodes::CareEpisode 02.0 Patients::ClinicalTrial Registry Specific Business Rules identifier :ST {id} is used by salaryTypeCode : CE salaryQuantity : MO hazardExposureText : ED protectiveEquipmentText : ED 0..n LanguageCommunication languageCode : CE modeCode : CE proficiencyLevelCode : CE preferenceInd : BL 1 has subject formCode : CE ManufacturedMaterial lotNumberText : ST expirationTime : IVL<TS> stabilityTime : IVL<TS> Container Device capacityQuantity : PQ manufacturerModelName : SC heightQuantity : PQ softwareName : SC localRemoteControlStateCode : CE ... diameterQuantity : PQ capTypeCode : CE alertLevelCode : CE separatorTypeCode : CE lastCalibrationTime : TS barrierDeltaQuantity : PQ bottomDeltaQuantity : PQ HL7 & IHE Content Profiles 01.0 Submissions::SourceSystemProv ider provided by 1..* 1 is part of ActRelationship typeCode : CS inversionInd : BL outboundRelationship contextControlCode : CS Access LicensedEntity 0..n contextConductionInd : BL approachSiteCode : CD recertificationTime : TS sequenceNumber : INT targetSiteCode : CD 1 source priorityNumber : INT gaugeQuantity : PQ pauseQuantity : PQ Act Participation checkpointCode : CS classCode : CS Entity typeCode : CS Role splitCode : CS moodCode : CS functionCode : CD classCode : CS player joinCode : CS classCode : CS id : SET<II> contextControlCode : CS determinerCode : CS negationInd : BL 0..1 code : CD 0..n id : SET<II> sequenceNumber : INT id : SET<II> 0..n conjunctionCode : CS negationInd : BL 1 playedRolecode : CE negationInd : BL code : CE localVariableName : ST negationInd : BL 1 derivationExpr : ST quantity : SET<PQ> 0..n noteText : ED seperatableInd : BL addr : BAG<AD> text : ED time : IVL<TS> name : BAG<EN> telecom : BAG<TEL> 0..n statusCode : SET<CS> modeCode : CE desc : ED statusCode : SET<CS> effectiveTime : GTS inboundRelationship awarenessCode : CE statusCode : SET<CS> scopedRole effectiveTime : IVL<TS> activityTime : GTS signatureCode : CE existenceTime : IVL<TS> 0..n certificateText : ED target availabilityTime : TS signatureText : ED telecom : BAG<TEL> quantity : RTO 0..1 priorityCode : SET<CE> performInd : BL riskCode : CE 1 positionNumber : LIST<INT> scoper substitutionConditionCode : CE confidentialityCode : SET<CE> ... handlingCode : CE repeatNumber : IVL<INT> DeviceTask 1 target 1source interruptibleInd : BL 1 parameterValue : LIST<ANY> levelCode : CE inboundLink WorkingList 0..n outboundLink 0..n independentInd : BL Employee ownershipLevelCode : CE RoleLink uncertaintyCode : CE FinancialContract jobCode : CE typeCode : CS reasonCode : SET<CE> paymentTermsCode : CE jobTitleName : SC effectiveTime : IVL<TS> languageCode : CE jobClassCode : CE Material treated NonPersonLivingSubject strainText : ED genderStatusCode : CE ManagedParticipation id : SET<II> statusCode : SET<CS> assigns LivingSubject administrativeGenderCode : CE birthTime : TS deceasedInd : BL deceasedTime : TS multipleBirthInd : BL multipleBirthOrderNumber : INT organDonorInd : BL Patient confidentialityCode : CE veryImportantPersonCode : CE is a trait of Person addr : BAG<AD> maritalStatusCode : CE educationLevelCode : CE raceCode : SET<CE> disabilityCode : SET<CE> livingArrangementCode : CE religiousAffiliationCode : CE ethnicGroupCode : SET<CE> Place mobileInd : BL addr : AD directionsText : ED positionText : ED gpsText : ST 1..* 1 0..* Organization addr : BAG<AD> standardIndustryClassCode : CE iv. This observation SHALL contain exactly one [1..1] value with @xsi:type="CD" (CONF:31972). UMTS CDA Template Library 6 Registry Specific Content Profiles 1 SUBENTRY 1.1 ClincalEventObservationSubEntry [observation: templateId 2.16.840.1.113883.3.2898.10.9999 (closed)] 1 (StructuredBodyComponent) RegistryParticipantDetailComponent Entry Point (ClinicalDocumentComponent) DocumentComponent (RecordTarget) RecordTarget - isPlayedBy classCode :CS = "PAT" (PatientIdentifier.identifierValue) id :II - typeCode :CS = "RCT" contextControlCode :CS = "OP" - typeCode :CS = "COMP" contextConductionIndicator :BL = "true" Table 1: ClincalEventObservationSubEntry Contexts (Entry) PatientIdentifierObserv ationEntry typeCode :CS = "COMP" contextConductionIndicator :BL = "true" - Contained By: typeCode :CS = "COMP" contextConductionIndicator :BL = "true" (ClinicalDocument) CathPCIRegistryDocument 1..1 1 + # + classCode :CS = "DOCCLIN" moodCode :CS = "EVN" id :II code :CE = "CATHPCI" effectiveTime :TS - 1..1 (Observ ation) PatientIdentifierObserv ation (Section) PatientDetailSection (StructuredBody) DocumentBody 1 classCode :CS = "DOCBODY" moodCode :CS = "EVN" 1..1 1 # classCode :CS = "DOCSECT" moodCode :CS = "EVN" code :CE = "PatientDetail" 1 0..* # + classCode :CS = "OBS" moodCode :CS = "EVN" (PatientIdentifier.typeCode) code :CD (PatientIdentifier.identifierValue) value :CD 1 1 1 (StructuredBodyComponent) PatientDetailComponent (StructuredBodyComponent) SubmissionDetailComponent (Custodian) Custodian - - typeCode :CS = "CST" - typeCode :CS = "COMP" contextConductionIndicator :BL = "true" (Entry) PatientRaceObserv ationEntry typeCode :CS = "COMP" contextConductionIndicator :BL = "true" - 1..1 typeCode :CS = "COMP" contextConductionIndicator :BL = "true" 1..1 1..1 (CustodianOrganization) Participant + + classCode :CS = "ORG" determinerCode :CS = "INSTANCE" (ParticipantIdentifier.identifierValue) id :II (Participant.name) name :EN.ON (Section) SubmissionDetailSection (AssignedCustodian) ParticipantRole isScopedBy 1 1..1 - # classCode :CS = "ASSIGNED" (Observ ation) PatientRaceObserv ation classCode :CS = "DOCSECT" moodCode :CS = "EVN" code :CE = "SubmissionDetail" # + 1 classCode :CS = "OBS" moodCode :CS = "EVN" code :CD = "PatientRace" (PatientRace.raceCode) value :CD [1..*] (SET) (Entry) SubmissionActEntry - typeCode :CS = "COMP" contextConductionIndicator :BL = "true" 1..1 (Act) SubmissionAct + + classCode :CS = "ACT" moodCode :CS = "EVN" (Submission.identifier) id :II (Submission.submissionTimePeriod) effectiveTime :TS (IVL) (ParticipantRole) TargetRegistry 1 1..1 - classCode :CS = "MMAT" 1..1 1 (ClinicalStatementParticipant) Author - (ClinicalStatementParticipant) Receiv er typeCode :CS = "AUT" contextControlCode :CS = "OP" - isPlayedBy typeCode :CS = "RCV" contextControlCode :CS = "OP" 1..1 1 (Dev ice) DataCollectionSystem + classCode :CS = "DEV" determinerCode :CS = "INSTANCE" (SourceSystem.versionIdentifier) id :II (ParticipantRole) SourceSystem isPlayedBy 1 1..1 - 1 SUBENTRY Contains: 1.1 ClincalEventObservationSubEntry This template is used to collect clinical event observations made within the scope of the [observation: templateId 2.16.840.1.113883.3.2898.10.9999 (closed)] encounter. Observations may be modified by observational semantic qualifiers. 1 1..1 (PatientRole) PatientRole + (Dev ice) RegistrySystem classCode :CS = "MMAT" + + isScopedBy classCode :CS = "DEV" determinerCode :CS = "INSTANCE" (Registry.identifier) id.root :II.root (RegistryVersionIdentifier) id.extension :II.extension 1. SHALL contain exactly one [1..1] @classCode="OBS" (CONF:31958). Table 1: ClincalEventObservationSubEntry Contexts 1 2. SHALL contain exactly one [1..1] @moodCode="EVN" R Y S U B E N T (CONF:31959). Contained By: Contains: 3. MAY contain zero or one [0..1] @negationInd (CONF:31960). 4. SHALL contain exactly one [1..1] templateId="2.16.840.1.113883.3.2898.10.9999" 1.1 ClincalEventObservationSubEntry (CONF:31961).This template is used to collect clinical event observations made within the scope of the [observation: templateId 2.16.840.1.113883.3.2898.10.9999 (closed)] encounter. Observations may be modified by observational semantic qualifiers. 5. SHALL contain exactly one [1..1] code (CONF:31962). 6. SHALL contain zeroSHALL containeffectiveTime (CONF:31963). Table 1: ClincalEventObservationSubEntry Contexts 1. or one [0..1] exactly one [1..1] @classCode="OBS" (CONF:31958). 7. SHALL contain exactly one [1..1] value (CONF:31964). 2. SHALL containContained By: exactly one [1..1] @moodCode="EVN" (CONF:31959). Contains: 8. MAY contain zero or more [0..*] zero or one [0..1] @negationInd (CONF:31960). 3. MAY contain entryRelationship (CONF:31965). a. The entryRelationship, if present,one [1..1] templateId="2.16.840.1.113883.3.2898.10.9999" 4. SHALL contain exactly SHALL contain exactly one [1..1] This @typeCode="OPTN" (CONF:31966). template is used to collect clinical event observations made within the scope of the (CONF:31961). encounter. Observations may be modified by observational semantic qualifiers. b. The entryRelationship, if present,one [1..1] code exactly one [1..1] 5. SHALL contain exactly SHALL contain (CONF:31962). @contextConductionInd="true" SHALL contain exactly one [1..1] @classCode="OBS" (CONF:31958). 1. (CONF:31967). 6. SHALL contain zero or one [0..1] effectiveTime (CONF:31963). c. The entryRelationship, if present,one [1..1] valueexactlyone [1..1] observation 2. SHALL contain (CONF:31964). 7. SHALL contain exactly SHALL contain exactly one [1..1] @moodCode="EVN" (CONF:31959). (CONF:31968). 3. MAY contain zero or one [0..1] @negationInd 8. MAY contain zero or more [0..*] entryRelationship (CONF:31965). (CONF:31960). i. This observation SHALL contain exactly one [1..1] @classCode="OBS" 4. SHALL if present, SHALL contain exactly one [1..1] a. The entryRelationship, contain exactly one [1..1] templateId="2.16.840.1.113883.3.2898.10.9999" (CONF:31969). (CONF:31961). @typeCode="OPTN" (CONF:31966). ii. This observation SHALL contain exactly one [1..1] @moodCode="EVN" 5. SHALL if present, SHALL contain exactly one [1..1] b. The entryRelationship, contain exactly one [1..1] code (CONF:31962). (CONF:31970). @contextConductionInd="true" (CONF:31967). 6. SHALL contain zero or one [0..1] effectiveTime (CONF:31963). iii. This observation SHALL contain exactly one [1..1] code (CONF:31971). c. The entryRelationship, contain exactly one [1..1] value (CONF:31964). 7. SHALL if present, SHALL contain exactly one [1..1] observation iv. This observation SHALL contain exactly one [1..1] value with @xsi:type="CD" (CONF:31968). MAY contain zero or more [0..*] entryRelationship (CONF:31965). 8. (CONF:31972). i. This observationThe entryRelationship, one [1..1] @classCode="OBS" a. SHALL contain exactly if present, SHALL contain exactly one [1..1] (CONF:31969). @typeCode="OPTN" (CONF:31966). ii. This observationThe entryRelationship, one [1..1] @moodCode="EVN" b. SHALL contain exactly if present, SHALL contain exactly one [1..1] (CONF:31970). @contextConductionInd="true" (CONF:31967). iii. This observationThe entryRelationship, one [1..1] code (CONF:31971). one [1..1] observation c. SHALL contain exactly if present, SHALL contain exactly iv. This observation(CONF:31968). exactly one [1..1] value with @xsi:type="CD" SHALL contain (CONF:31972). i. This observation SHALL contain exactly one [1..1] @classCode="OBS" (CONF:31969). ii. This observation SHALL contain exactly one [1..1] @moodCode="EVN" (CONF:31970). iii. This observation SHALL contain exactly one [1..1] code (CONF:31971). iv. This observation SHALL contain exactly one [1..1] value with @xsi:type="CD" (CONF:31972). (Entity) SourceSystemProv ider + Slide Number: 91 classCode :CS = "ORG" determinerCode :CS = "INSTANCE" (SourceSystemProvider.identifier) id :II © 2014 All Rights Reserved
  • 92. 1. Semantic Analysis Registry Elements Topic Area Mind Map 00069 Dose Amount 00147 Duration 00070 Start Date Time 00306 Stop Date Time MedicationTypeCode Initial Bolus 00776 Route MedicationClassCode 00307 Medication Initial Infusion q12hr 00238 Frequency MedicationAdministration q24hr Within 2 weeks First 24 Hours Administered Pre-Encounter Intra-Encounter Timing 00423 Status Intra-Procedure At Discharge Not Administered Blinded 00303 Dose Code Pre-Procedure Contraindicated Full Reduced Other During Follow-up Decompose composite registry elements Into interrelated atomic concepts Slide Number: 92 © 2014 All Rights Reserved