Domain Analysis Model Development Guidelines Clinical Interoperability Council Working Group.

Domain Analysis Model Development Guidelines

Clinical Interoperability Council Working Group

Clinical Interoperability Council Working Group

Acknowledgment

• Anita WaldenPrepared the initial presentation, allowed the use of material from earlier presentations.

• Abdul-Malik ShakirProvided definition and discussion of DAM components based on work for NCI.

Purpose of a DAM:

Patient

Clinician

Healthcare Data Systems

Patient care

Quality Improvement

Research

Reimbursement

Post Marketing Safety

Decision Support

Administration & Mgt.

Public Health Reporting

…

Data Uses

Single Source Multiple Uses

Construction Procedures

• Standardize at source healthcare– Data element as atomic unit of exchange– Specificity sufficient for semantic interoperability

• Include all StakeholdersExamples– Public Health Representation CDC– Quality Imp. Professional Societies– Research representation CDISC,NIH,FDA

Goals for the Guide• Provide CIC DAM project groups with a guide on

developing Clinical DAMs• Promote reuse of DAM components in subsequent DAM

projects • Provide DAMs with similar designs: increase consistency

for smoother harmonization, for integration with other DAMs and HL7 artifacts

• Improve the quality of the specifications used to develop HL7 products: messages, EHR profiles, CDAs

Guide Table of Contents StatusIntroduction Complete

Objective Complete

DAM Definition Complete

Resources Complete

HL7 Project Process In progress

Tooling (Enterprise Architect, Excel, Word, CaDSR) In progress

DAM Modules Draft

Requirement Gathering Process Draft

DAM Modeling Styles In progress

Next Steps (DCMs, relationship between enumeration in DAM) In progress

What is a DAM?

• An analysis model developed to improve communication between stakeholders from different organizations. This requirements document is used to formally define and structure data and/or process information to develop specifications within HL7 (e.g., Messaging, EHR functional models, DCMs).

HL7 Educational Resources

Tutorials relating to working on DAMs:• Introduction to the HDF• Domain Analysis Modeling• Introduction to UML• Introduction to Project Insight• Introduction to V3

DAM and the HL7 Process

• First comes the project statement• Determine who is involved

– Collaborate with the relevant working groups– Include international communities & affiliates

• Follow the HDF/SAEF process• Ballot as an informative document

DAM Components

• An HL7 Domain Analysis Model (DAM) is not simply an information model.

• The DAM may include multiple diagram types. This section discusses the components of a DAM, and their relationships.

Components in a picture

Story BoardsData Elements

Use CasesActivitiesClasses,Attributes

Defines data requirements forMust correspond or map

Indicate CRUD/Define data supported

Illustrate/Define the workflow for

State ModelIndicates behaviorof key classes

Illustrate/Identify key functions for

ECCF (Enterprise Conformance and Compliance

Framework)

Story Board/Scenario• Rationale:

Provide a story of some relevant occurrence – sequence of events.• Example:

Wallace Wackyford, a Fun Store employee, submitted an adverse event report to the FDA to report an incident after being contacted by the principal of the Central Z Middle School. A black color face paint (item# 5), produced by Coverings Corporation, as listed on the label, was applied to the students as part of a special theme day. Approximately 300 students received an application of face paint with different brushes. The following day, approximately 70 - 80 students reported having a rash on their face. Later the number of rashes had accumulated to approximately 173. A dozen or so students sought medical treatment. Medical information was not included in the report from Mr. Wackyford. The report was sent electronically using a web-based form. The web-based form translates the information into an HL7 ICSR and routes the report to the appropriate FDA safety evaluator for analysis.

Use Cases• Rationale:

Provide a more formal treatment of requirements than the storyboard.

• Describes a sequence of actions that provide a measurable value to an actor.

• The formality includes:– Identifying use case actors, – showing how actors participate in use cases,– defining the associations between use cases

• Example: See over

ACT02.05: Referred From Prov ider

REF-UC01.00-Create Referral Order

REF-UC03.00-Assess Referral Order

ACT02.02: Referred To Prov ider

REF-UC02.00-Update Referral Order

REF-UC04.00-Obtain Information

«actor»ACT10.01:

Information Source

«extend»

«extend»

Name:Package:Version:Author:

Referral Management Use CasesReferral Management Use Cases1.0Salimah Shakir

Data Elements• Rationale: Represent the data in a way that is more

intuitive to clinicians (non modelers) than a class mode (or use case diagram, or activity diagram)

• Allows easy pulling from forms or existing lists• Easy to consider as the unit of data exchange

Example:

ITEM NUMBER DOMAIN (Therapeutic)SUB-DOMAIN(SUBCLASS)

SUB-DOMAIN CATEGORY

(CLASS, DataElement

Concept)

DATA ELEMENT

(ATTRIBUTE, Value Domain) DEFINITION Data Type PERMISSIBLE VALUES PERMISSIBLE VALUE DEFINITIONS CITATION

CommonMedical History

A record of the medical events involving the patient that occurred prior to this encounter. These events may be reported by the patient or come from past medical records.

Published CaBig CADSR model

1 Cardiovascular ACSMedical History

angina pectoris indicator

Indicator of w hether the patient has ever had an episode of angina pectoris. boolean

Published CaBig CADSR model

Example Part TwoData Element Name: History of peripheral vascular disease

Clinical Definition: Indicate if the patient has a history of peripheral vascular disease. This can include:

1. Claudication either with exertion or at rest.2. Amputation for arterial vascular insufficiency.3. Aorto-iliac occlusive disease reconstruction, peripheral vascular bypass surgery, angioplasty or stent; or percutaneous intervention to the extremities.4. Documented abdominal aortic aneurysm (AAA) repair or stent.5. Positive non-invasive/invasive test.

This does not include procedures such as vein stripping, carotid disease, or procedures originating above the diaphragm.

Valid Values: Yes, No

Class & Attribute Component• Rationale:

represent the information needs of the domain with more formality than the data element list– Show how data elements clump into classes– Define relationships between classes.

• Supports downstream migration:– Ease the creation of HL7 RIM based

specifications.– Create an entry point for CaDSR migration.

• Example: See over

class Diagnosis

Common::RegistrationAsPatient

+ evaluationReasonCode: char+ uniquePatientId: char

Specimen

+ bodySiteCode: char+ collectionDate: Date+ specimenTypeCode: char

TuberculosisDiagnosis

+ confirmationMethodCode: char+ diagnosisticConclusion: char+ effectiveDate: Date

BodySiteAffected

+ anatomicSiteCode: char+ primaryIndicator: boolean

Organism

+ genotypeCode: char+ mycobacteriumSpeciesCode: char

SocialHistory

+ dateOfRecording: Date+ riskFactorForTuberculosisExposure: char

ContactRelationship

+ contactTypeCode: char

SignsAndSymptoms

+ dateOfRecording: Date+ durationOfCough: int+ durationOfFever: int+ presenceOfCough: boolean+ underlyingPulmonaryDisease: char

BCGVaccination

+ mostRecentVaccinationDate: Date+ multipleVaccinationIndicator: boolean+ reportingMethodCode: char+ vaccinationTimingCode: char

Imaging::Image

+ imageDate: Date+ imageTypeCode: char+ imagingTimePointCode: char+ interpretationCode: char+ reportText: char

Susceptibility

+ challengedSubstanceCode: char+ compoundConcentration: int+ resultCode: char

TuberculinSkinTest

+ blisteringStatus: char+ interpretationCode: char+ mantouxStrengtn: int+ quantitativeResult: int

Common::Prov iderOrganization

+ name: char

Common::Person

+ dateOfBirth: Date+ dateOfDeath: Date+ deathIndicator: boolean+ emailAddress: char+ genderCode: char+ name: char+ postalAddress: char+ socialInsuranceNumber: char+ telephoneNumber: char

Common::PatientEncounter

+ chiefComplaint: char+ dischargeDate: int+ inpatientStatsIndicator: boolean+ startDate: Date

Common::Clinician

+ emailAddress: char+ name: char+ postalAddress: char+ professionalQualificationCode: char+ telephoneNumber: char

Treatment

+ AdministrationEvent

+ AdministrationRecorder

+ Assessment

+ CourseOfTreatment

+ DrugOrder

+ TreatmentInitiation

+ TreatmentInterruption

+ TreatmentTermination

+

(from TB_DAM)

HIVTesting

+ cd4AbsoluteCount: int+ cd4Percent: int+ specimenTypeCode: char+ testingDate: Date+ testTypeCode: char

SmearTest

+ InterpretationCode: char+ quantitativeResultCode: char+ SpecimenProcessingForSmearCode: char

InteferonGammaAssay

+ assayResultInterpretationCode: char+ elisaResult: int+ elispotResult: int

SolidMediaCulture

+ cultureMediaType: char+ resultCode: char

LiquidMediaCulture

+ cultureMediaType: char+ resultCode: char

Test

+ effectiveDateTime: int+ testingStatusCode: char+ typeCode: char

NucleicAcidAmplification

+ InterpretationCode: char

Imaging

+ Image

+ ImageEvolution

+ ImagingDetail

(from TB_DAM)

StatusSummaryInformation

+ bacillusCalmetteGuerinStatusCode: char+ chestRadiographStatusCode: char+ computerAssistedTomographyIndicator: boolean+ episodeTypeCode: char+ hivStatusIndicator: boolean+ hivStatusMethodCode: char+ hivTestingIndicator: boolean+ magneticResonanceImagingIndicator: boolean+ patientTuberculosisStatusCode: char+ predisposingMedicalHistoryIndicator: boolean+ statusEffectiveDate: Date+ studyEnrollmentIndicator: boolean+ susceptibilityTestingIndicator: boolean+ treatmentInterrruptionIndicator: boolean+ treatmentStatusCode: char+ tuberculosisTreatmentPhaseCode: char+ ultrasoundIndicator: boolean+ vaccineStatusCode: char

Name: DiagnosisAuthor: Mead WalkerVersion: 1.0Created: 7/1/2001 12:00:00 AMUpdated: 10/22/2007 2:59:44 PM

TuberculosisSymptom

+ dateOfOnsetOfTuberculosisSymptom: date- tuberculosisSymptomCode: char

MedicalHistory

+ predisposingMedicalHistory: char

+person

1

+signsAndSymptoms

0..1

+tuburculosisDiagnosis 1

+bodySiteAffectedCollection 0..*

+person

1+specimenCollection 0..*

+clinician

1+tuberculosisDiagnosisCollection

0..*

+sourcePerson1

+contactRelationshipCollection

0..*

+registrationAsPatient 1

+encounterCollection 0..*

+providerOrganization 1

+registrationAsPatientCollection

0..*

+person 1

+registrationAsPatientCollection 0..*

+organism

1

+susceptibilityCollection 0..*

+Person

1

+riskFactorCollection

0..*

+liquidMediaCulture 0..1

+organismCollection 0..*

+targetPerson0..1

+contactRelationshipCollection

0..*

+clinician1

+patientEncounterCollection 0..*

+SignsAndSymptoms

1

+MedicalHistoryCollection 0..*+signsAndSymptoms 1

+TuberculosisSymptomCollection 0..*

+specimen 0..1

+testCollection 0..*

+clnician

1

+riskFactorCollection 0..*

+person 1

+tuberculosisDiagnosisCollection0..*

+person

1

+bcgVaccinationCollection

0..*

+testCollection0..*

+person

1

+patientEncounter

0..1

+testCollection

0..*+clinician

1

+hivTestingCollection

0..*

+person 1

+hivTestingCollection

+Person

1

+StatusSummaryInformation

0..1

+person 1

+imageCollection

0..*

+clinician

1

+testCollection

0..*

+orderingClinician 1

+ImageCollection 0..*

+InterpretingClinician 1

+ImageCollection

+clinician1

+signsAndSymptoms 0..1

+solidMediaCulture 0..1

+organismCollection 0..*

+clinician1

+bcgVaccinationCollection 0..*

TB Class Component

class Diagnosis

Common::RegistrationAsPatient

+ evaluationReasonCode: char+ uniquePatientId: char

Specimen

+ bodySiteCode: char+ collectionDate: Date+ specimenTypeCode: char

TuberculosisDiagnosis

+ confirmationMethodCode: char+ diagnosisticConclusion: char+ effectiveDate: Date

BodySiteAffected

+ anatomicSiteCode: char+ primaryIndicator: boolean

Organism

+ genotypeCode: char+ mycobacteriumSpeciesCode: char

SocialHistory

+ dateOfRecording: Date+ riskFactorForTuberculosisExposure: char

ContactRelationship

+ contactTypeCode: char

SignsAndSymptoms

+ dateOfRecording: Date+ durationOfCough: int+ durationOfFever: int+ presenceOfCough: boolean+ underlyingPulmonaryDisease: char

BCGVaccination

+ mostRecentVaccinationDate: Date+ multipleVaccinationIndicator: boolean+ reportingMethodCode: char+ vaccinationTimingCode: char

Imaging::Image

+ imageDate: Date+ imageTypeCode: char+ imagingTimePointCode: char+ interpretationCode: char+ reportText: char

Susceptibility

+ challengedSubstanceCode: char+ compoundConcentration: int+ resultCode: char

TuberculinSkinTest

+ blisteringStatus: char+ interpretationCode: char+ mantouxStrengtn: int+ quantitativeResult: int

Common::Prov iderOrganization

+ name: char

Common::Person

+ dateOfBirth: Date+ dateOfDeath: Date+ deathIndicator: boolean+ emailAddress: char+ genderCode: char+ name: char+ postalAddress: char+ socialInsuranceNumber: char+ telephoneNumber: char

Common::PatientEncounter

+ chiefComplaint: char+ dischargeDate: int+ inpatientStatsIndicator: boolean+ startDate: Date

Common::Clinician

+ emailAddress: char+ name: char+ postalAddress: char+ professionalQualificationCode: char+ telephoneNumber: char

Treatment

+ AdministrationEvent

+ AdministrationRecorder

+ Assessment

+ CourseOfTreatment

+ DrugOrder

+ TreatmentInitiation

+ TreatmentInterruption

+ TreatmentTermination

+

(from TB_DAM)

HIVTesting

+ cd4AbsoluteCount: int+ cd4Percent: int+ specimenTypeCode: char+ testingDate: Date+ testTypeCode: char

SmearTest

+ InterpretationCode: char+ quantitativeResultCode: char+ SpecimenProcessingForSmearCode: char

InteferonGammaAssay

+ assayResultInterpretationCode: char+ elisaResult: int+ elispotResult: int

SolidMediaCulture

+ cultureMediaType: char+ resultCode: char

LiquidMediaCulture

+ cultureMediaType: char+ resultCode: char

Test

+ effectiveDateTime: int+ testingStatusCode: char+ typeCode: char

NucleicAcidAmplification

+ InterpretationCode: char

Imaging

+ Image

+ ImageEvolution

+ ImagingDetail

(from TB_DAM)

StatusSummaryInformation

+ bacil lusCalmetteGuerinStatusCode: char+ chestRadiographStatusCode: char+ computerAssistedTomographyIndicator: boolean+ episodeTypeCode: char+ hivStatusIndicator: boolean+ hivStatusMethodCode: char+ hivTestingIndicator: boolean+ magneticResonanceImagingIndicator: boolean+ patientTuberculosisStatusCode: char+ predisposingMedicalHistoryIndicator: boolean+ statusEffectiveDate: Date+ studyEnrollmentIndicator: boolean+ susceptibil ityTestingIndicator: boolean+ treatmentInterrruptionIndicator: boolean+ treatmentStatusCode: char+ tuberculosisTreatmentPhaseCode: char+ ultrasoundIndicator: boolean+ vaccineStatusCode: char

Name: DiagnosisAuthor: Mead WalkerVersion: 1.0Created: 7/1/2001 12:00:00 AMUpdated: 10/22/2007 2:59:44 PM

TuberculosisSymptom

+ dateOfOnsetOfTuberculosisSymptom: date- tuberculosisSymptomCode: char

MedicalHistory

+ predisposingMedicalHistory: char

+person

1

+signsAndSymptoms

0..1

+tuburculosisDiagnosis 1

+bodySiteAffectedCollection 0..*

+person

1+specimenCollection 0..*

+clinician

1+tuberculosisDiagnosisCollection

0..*

+sourcePerson1

+contactRelationshipCollection

0..*

+registrationAsPatient 1

+encounterCollection 0..*

+providerOrganization 1

+registrationAsPatientCollection

0..*

+person 1

+registrationAsPatientCollection 0..*

+organism

1

+susceptibil ityCollection 0..*

+Person

1

+riskFactorCollection

0..*

+liquidMediaCulture 0..1

+organismCollection 0..*

+targetPerson0..1

+contactRelationshipCollection

0..*

+clinician1

+patientEncounterCollection 0..*

+SignsAndSymptoms

1

+MedicalHistoryCollection 0..*+signsAndSymptoms 1

+TuberculosisSymptomCollection 0..*

+specimen 0..1

+testCollection 0..*

+clnician

1

+riskFactorCollection 0..*

+person 1

+tuberculosisDiagnosisCollection

0..*

+person

1

+bcgVaccinationCollection

0..*

+testCollection0..*

+person

1

+patientEncounter

0..1

+testCollection

0..*+clinician

1

+hivTestingCollection

0..*

+person 1

+hivTestingCollection

+Person

1

+StatusSummaryInformation

0..1

+person 1

+imageCollection

0..*

+clinician

1

+testCollection

0..*

+orderingClinician 1

+ImageCollection 0..*

+InterpretingClinician 1

+ImageCollection

+clinician1

+signsAndSymptoms 0..1

+solidMediaCulture 0..1

+organismCollection 0..*

+clinician1

+bcgVaccinationCollection 0..*

Class Model & Data Elements

• Both represent the information content of the DAM

• Can often be reviewed separately:– Clinicians reading the list of elements– Modelers & HL7ists examining the class

diagram, class descriptions, attribute descriptions.

• Keeping these synchronized can be difficult. It always involves work.

Activity Component• Rationale:

Express workflow within the domain – Identify specific activities, – Show the sequence and conditionality of

activities,– Use “swim lanes” to provide hints on where

data exchanges take place.

• Example: See over

act ACS Ev aluation

Interv iew & History Clinical Presentation

Perform cardiacbiomarker testing

Characterize Chest Pain

Ev aluate Results

Initiate ECG monitoring

Non-cardiacevent

SymptomsSuggestive

of ACS

Initiate Anti-IschemicMedical Therapy

ACSDiagnosis?

Repeat cardiac biomarkertesting

Observ e

Perform stress test Ev aluate LV function

Not ACS,discontinue

ACSprotocol

Unstable Angina / NonST-Segment Elev ation MI

AdministerAntiplatelet/Anticoagulant

Therapy

Admit toHospital

ACSDiagnosis?

ACSDiagnosis?

Discharge Plan

Discharge

ST Segment Elev ation MI

FollowSTEMI

Guidelines

ECG Report

Lab Results

Stress Test

Report

LV Function Results

Stable Angina

Follow ChronicStable Angina

Guidelines

ST Elevation?

Monitor Patient

Continue to ACS

Treatment diagram

Transfer

Patient identified incommunity setting

Patient identified inclinical setting

[Yes]

[Possible orConfirmed]

[Undiagnosed]

[ACS]

[No]

[Yes]

[Yes]

[Ifordered]

[Ifordered]

[No]

[No]

[No]

[No]

Cardio-vascular DAM Activity Component

Cardio-vascular DAM Activity Component

State Machine Component

• Rationale: Show the behavior of an individual class within the class diagram. When used for critical classes, it exposes the need for a service or message specification.

• Example: So far, we don’t have a DAM that has built one.

Working with a Data Repository

Class Components are deposited in CaDSR and therefore the requirements should follow their submission criteria

Next Steps

• Complete Modeling Guides for each Model Component

• Work with development teams to use and improve the modeling guide

• Support fuller implementation of DAM building into the HL7 process

Are there any questions?