detailed clinical models for medical device domain analysis model
DESCRIPTION
Detailed Clinical Models for Medical Device Domain Analysis Model. Guide to the HL7 May 2011 Ballot. Overview. Detailed Clinical Model (DCM) Atomic clinical information Promote semantic clarity and reuse - PowerPoint PPT PresentationTRANSCRIPT
1
Guide to the HL7 May 2011 Ballot
Detailed Clinical Models for Medical Device Domain Analysis Model
2
Overview
• Detailed Clinical Model (DCM)– Atomic clinical information– Promote semantic clarity and
reuse• Standard Terminology is built-in
rather than an afterthought (e.g. primary and secondary standard-based coding system)
• Structured information to support– Process improvement – Interoperability and automation
• Reusable in many contexts– New standards– Profiling existing standards– Application development– Interoperability
• Domain Analysis Model (DAM)– Describe the stakeholders
requirements to a integrators, developers, vendors, etc.
– Assist communication among stakeholder groups
– Uses a Std. modeling language (UML) improves communication, identifies main concepts, and leads to consensus
– Models can be used to generate code or other models (e.g. ontology)
– Methodology that supports the development of DCMs• Context for DCMs
3
Glossary• DAM: Domain Analysis
Model• UML: Unified Modeling
Language – a standard developed by the Object Management Group
• DCM: Detailed Clinical Model – reusable information models, standardized
• LOINC: Logical Observation Identifiers Names and Codes – standard codes for laboratory
• SNOMED-CT: Systematized Nomenclature of Medicine--Clinical Terms – Terminology System
• ISO: International Organization for Standardization – standards development organization
• HL7: Health Level Seven- healthcare interoperability standards development organization
• IHE: Integrating the Healthcare Enterprise – standards-related consortium
• Continua Health Alliance – standards-related consortium specialized in personal healthcare devices
4
May 2011: Ballot Details
• This ballot is informative and will expanded as new requirements and use cases are identified
• The ballot artifacts are intended to be used: – by providers
• To express semantic interoperability requirements (e.g. RFP)– by consortia (e.g. IHE, Continua Health Alliance)
• To develop Integration and Content Profile– by standard development organizations (e.g. HL7, ISO)
• To develop new standards for interoperability
• Ballot: V3 Ballot Domain Analysis Models:– http://www.hl7.org/v3ballot/html/dams/uvdmd/uvdmd.html
• Project Site: http://gforge.hl7.org/gf/project/dcmmd/– Releases: http://gforge.hl7.org/gf/project/dcmmd/frs/– Latest project artifacts
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Specification history
September 2010 - Draft for Comment
Initial version documenting the Domain Analysis for the following use cases: • Intubate Patient - Unplanned• Manage Patient on Ventilator• Liberate Patient from Ventilator, Planned
May 2011 - Informative
In addition to addressing the ballot comments, this ballot includes additional use cases that are a high priority for the project stakeholders.:
• Post-Operative Patient Transport• Patient-to-device Association• Time Synchronization for Networked Devices and for Legacy Devices
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Approach1. Gathered requirements
illustrated by scenarios, standard operating procedures, and stakeholder requirements
2. Use cases that were derived from clinical scenario illustrate the requirements in a precise way. Use cases identify the capabilities and user or system roles involved .
3. Next we elaborated the use cases as workflows, step by step, identify the type of information produced or required by each step
4. Refine the information structures (correspond to device data) required to support workflow– Includes standard
terminology bindings– Interoperability
• with the information systems
• between devices Consistent, repeatable
approach/methodology
class A: Approach and Ballot Content
DCM for Medical Device Ballot Publication
Annexes
1. Business/Clinical Use Case
«structured»2. Clinical Workflow
Specifies the scope of the specification;it is revised as new requirements are identified.
3. Analysis Information Model
DCM1
(from 4. Detailed Clinical Models)
DCM2
(from 4. Detailed Clinical Models)
Clinical Scenario(s)
4. Detailed Clinical Models
+ DCM1+ DCM2
Glossary
5. Data Types
(from Detailed Clinical Model (DCM) for Medical Devices)
«import»
«import»
«flow»
«import»
«flow»
basedOn
«flow»
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3
4
Ballot Document Structure and Process
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Actors to specify roles for business users relative to the use
cases in scope• Identify the users roles and/or system roles
for users and systems involved in the clinical scenario(s)
•
uc 1: Business/Clinical Use Case Actors
CareTeamMemberAuthorizedIntubator
RespiratoryTherapistNurse
Physician
Clinician
AuthorizedExtubator
Patient
Transporter
Is a Care Team Member…
Clinicianroles
Is a Clinician…
Care Team Memberroles
8
uc 1.1: Intubate Patient - Overview Diagram
Intubate Patient
AuthorizedIntubator(from Business Actors) CareTeamMember
(from Business Actors)
Patient(from Business Actors)
Intubate Patient
(from 2.1 Intubate Patient Workflow)
Process steps detailed here:
(from 1.5.1 Patient to Device Association)
Associate Device with a Patient at the Point-of-care (from 1.5.2 Time Synchronization)
Synchronize Time
«include»
«include»
perform procedure
participate
receive procedure/treatment
«trace»
Business Use Case Analysis to specify…
• Use Cases– Active verb– Based on
requirements andclinical scenarios
– Narrative description• Preconditions• Steps Workflow• Postconditions
• Actors– Participants in use cases– A role relative to the use
case• Users, systems
3
Actor participati
on
…based on WorkflowUse Case
Business Use Case
Reference to
workflow
Technical Use Case
Technical Use Case
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stm 1.5.a: Device Assignment and Configuration State Machine
Free Assigned
break association
assign the device to the patient[patient identity is verified]
Device State Transitio
nConditio
n
Device to Patient Association – State Transitions
• Patient associated to one more devices
• Device undergoes state changes– connected/
disconnected to patient
– settings configured
stm 1.5.b: Assigned Device States
Inactive
Active
patientready
patientnotavailable
[configure settings]
[connect patient]
[configure settings]
[disconnect patient]
[connect patient]
[configure setting]
Patient Ready
Patient Not Available
Device Assigned to a
Patient
10 C
linica
l Wor
kflow
act 2.2: Manage Patient on Ventilator
Nurse or Respiratory Therapist :ClinicianRespiratory Therapist :RespiratoryTherapist
1. Conduct respiratory assessment
Periodic oralarm-based
4. Apply suction
3. Need forsuction
6. Move tube to other side of mouth
7. Confirm tube placement
9. Change disposable materials
10. Provide oral care
11. Check monitors
12. Verify continuation of order and changes
Patient judged stable, ventilatorweaning check triggered
8. Disposablematerialsdue for change
«device_data»Alarm Status
(from 3.1 Information Analysis)
EHR-S and Device Data produced duringthe workflow or used during this workflow.
«EHR»Procedure
Documentation
(from 3.1 Information Analysis)
«EHR»Respiratory Consult
Order
(from 3.1 Information Analysis)
«device_data»Vital Signs
(from 3.1 Information Analysis)
«device_data»Pulse Oximetry
(from 3.1 Information Analysis)
Periodic oralcare
Oral carerequired
13. Optimize Ventialtor Setting
[yes]
[yes]
[no]
[update]
[use]
[yes]
[no]
[information updated]
[input information]
Role
Process Step
Information as input into a
step
Information produced by a step
Trigger
Device Data produced by a
step
Decision
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act 2.4 Transport Patient
ICU Nurse :Nurse:Transporter PACU Nurse :NurseAttending :Physician
1. Order Patient Transfer
Patient in PACU,connected to devices
«EHR»Transfer Order
(from 3.1 Information Analysis)2. Get patient history,
demographics, language
«EHR»Patient Medical History
(from 3.1 Information Analysis)
4. Get allergy
5. Get medications
6. Get IV lines «device_config»
IV Line Information
(from 3.1 Information Analysis)
3. Get risk factors
«EHR»Risk factors
(from 3.1 Information Analysis)
7. Check disposable devices
«EHR»Flowsheet
(from 3.1 Information Analysis)
8. Submit a device request
«EHR»Device Characteristics
Record(from 3.1 Information Analysis)
«device_data»Operational Device
Settings(from 3.1 Information Analysis)
10. Check the need fortransport device
11. Transfer settings to the
transport device
14. Move patient
12. Send current device settings
9. Alert ICU/Destination
«EHR»Allergies
(from 3.1 Information Analysis)«EHR»
Medication
(from 3.1 Information Analysis)
15. ICU setup
«device_config»Personalized Device
Settings(from 3.1 Information Analysis)
13. Break device associations
16. Set up Devices
Transfercompleted
[device will bereplaced at thedestination]
[device is sentwith thepatient]
[transport deviceneeded]
P
ost-0
pera
tive
Tran
spor
t
12
act 2.4 Transport Patient
ICU Nurse :Nurse:Transporter PACU Nurse :NurseAttending :Physician
1. Order Patient Transfer
Patient in PACU,connected to devices
«EHR»Transfer Order
(from 3.1 Information Analysis)2. Get patient history,
demographics, language
«EHR»Patient Medical History
(from 3.1 Information Analysis)
4. Get allergy
5. Get medications
6. Get IV lines «device_config»
IV Line Information
(from 3.1 Information Analysis)
3. Get risk factors
«EHR»Risk factors
(from 3.1 Information Analysis)
7. Check disposable devices
«EHR»Flowsheet
(from 3.1 Information Analysis)
8. Submit a device request
«EHR»Device Characteristics
Record(from 3.1 Information Analysis)
«device_data»Operational Device
Settings(from 3.1 Information Analysis)
10. Check the need fortransport device
11. Transfer settings to the
transport device
14. Move patient
12. Send current device settings
9. Alert ICU/Destination
«EHR»Allergies
(from 3.1 Information Analysis)«EHR»
Medication
(from 3.1 Information Analysis)
15. ICU setup
«device_config»Personalized Device
Settings(from 3.1 Information Analysis)
13. Break device associations
16. Set up Devices
Transfercompleted
[device will bereplaced at thedestination]
[device is sentwith thepatient]
[transport deviceneeded]
P
ost-0
pera
tive
Tran
spor
t
13
act 2.4 Transport Patient
ICU Nurse :Nurse:Transporter PACU Nurse :NurseAttending :Physician
1. Order Patient Transfer
Patient in PACU,connected to devices
«EHR»Transfer Order
(from 3.1 Information Analysis)2. Get patient history,
demographics, language
«EHR»Patient Medical History
(from 3.1 Information Analysis)
4. Get allergy
5. Get medications
6. Get IV lines «device_config»
IV Line Information
(from 3.1 Information Analysis)
3. Get risk factors
«EHR»Risk factors
(from 3.1 Information Analysis)
7. Check disposable devices
«EHR»Flowsheet
(from 3.1 Information Analysis)
8. Submit a device request
«EHR»Device Characteristics
Record(from 3.1 Information Analysis)
«device_data»Operational Device
Settings(from 3.1 Information Analysis)
10. Check the need fortransport device
11. Transfer settings to the
transport device
14. Move patient
12. Send current device settings
9. Alert ICU/Destination
«EHR»Allergies
(from 3.1 Information Analysis)«EHR»
Medication
(from 3.1 Information Analysis)
15. ICU setup
«device_config»Personalized Device
Settings(from 3.1 Information Analysis)
13. Break device associations
16. Set up Devices
Transfercompleted
[device will bereplaced at thedestination]
[device is sentwith thepatient]
[transport deviceneeded]
P
ost-0
pera
tive
Tran
spor
t
14
Technical Use Case• Actors: System Roles• The process steps are
described as system interactions
• Synchronize Time is a high-priority requirements
sd 2.5.2.a :Time Synchronization for Networked Devices
NetworkedMedicalDevice
(from Technical Actors)
NetworkTime Server
(from Technical Actors)
1.0 send(Request)
1.1 SNTPData()
1.2 updateDeviceTime()
uc 1.5.a: Time Synchronization for Networked Devices
Synchronize Time
NetworkedMedicalDevice(from Technical Actors)
NetworkTime Server(from Technical Actors)
provide current timelook up current time
System role
Technical Use Case
System role
Technical Use Case
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Time Synchronization for Legacy Devices
• Legacy Devices are unable to synchronize time automatically – Missing network connection– Missing support for protocol
(SNTP)• Device Manager required to
– report device observation and parameters
– Synchronized – It supplies time correction
information (synchronized time)
uc 1.5.b: Time Syncrhonization for Legacy Devices
Synchronize Time
NetworkTime Server(from Technical Actors)
LegacyMedicalDevice(from Technical Actors)
DeviceManager(from Technical Actors)
correct timestamp, syncrhonize
provide current time
Device Manag
er
Medical
Device
Network Time
Server
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Time Synchronization +Time Correction
sd 2.5.2.b Time Correction/Substitution for Legacy Devices
LegacyMedicalDevice
(from Technical Actors)
DeviceManager
(from Technical Actors)
NursingFlowsheet
(from Technical Actors)
NetworkTime Server
(from Technical Actors)
ADT System
(from Technical Actors)
opt - DeviceManager is time synchronized
1.0 send(Request)
1.1 SNTPData()
1.2 AddPatient(ADT_A01)
1.3 deviceObservation(NCCLS)
1.4 addTimeStamp()
1.5 addPatientContext()
1.6 deviceObservation(ORU^R01)
Time correctio
n
Synchronization
Use case is realized differently for legacy devices vs. networked/interoperable devices
17
Patient to Device Association – Interoperable Medical Device
sd 2.5.1.a Patient to Device Association
DeviceManager
(from Technical Actors)
MedicalDevice
(from Technical Actors)
ADT System
(from Technical Actors)
NursingFlowsheet
(from Technical Actors)
opt - Look up patient based on inbound ADT
[ADT is supported]
alt - Barcode or device input
[Barcode Reader Supported]
The observation contains a reference to the Patient Info (.e.g. HL7 Version 2.x PID segment).
1.0 ADT(A01)
1.1 lookUpPatient(lastname)
1.2 patientInfo(name, mrn[0..1], account[..1], gender)
1.3 readPatientInfo(mrn, id)
1.4 persistPatientInfo(mrn, name[0..1], account[0..1])
1.5 perform measurements()
1.6 deviceObservation(ORU^R01)
1.7 deviceObservation(ORU^R01)
Choice 1: Using Hospital
Info System (ADT)
Choice 2: Enter at point-of-care
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sd 2.5.1.b: Patient to Device Association (Legacy Devices)
LegacyMedicalDevice
(from Technical Actors)
DeviceManager
(from Technical Actors)
ADT System
(from Technical Actors)
NursingFlowsheet
(from Technical Actors)
Clinician
(from Business Actors)
alt - User Assigns Device to Patient
opt - Configuration Assigns Device to Location
1.0 configure(bedLocation, deviceId)
1.1 managePatientEncounter(PV1, patientId, bedLocation)
1.2 assignDevice(deviceId, patienId, bedLocation)
1.3 assignDevice(deviceId, patientId, patientAccount[0..1])
1.4 deviceObservations(NCCLS)
1.5 addPatientContext()
1.6 addTimeStamp()
1.7 deviceObservations(ORU^R01)
Patient to Device Association – Legacy Medical Device
Choice 1: Location
based
Choice 3: Patient
association using Device
Manager
Device Manage
r
Choice 3: Patient
assigned at point-of-care
19
object 3.1: Information Analysis
«device_data»Alarm Status
«device,lab_result»ABG
«EHR»Procedure
Documentation
«EHR»Transfer Order
«device_data»Vital Signs
«EHR»Respiratory Consult Order
«EHR»Allergies
«device_data»Pulse Oximetry
«EHR»Device Characteristics
Record
«EHR»Flowsheet
«device_config»IV Line Information
«EHR»Chest X-ray Order, Image,
Interpretation
«EHR»Medication
«device_data»Operational Device
Settings «EHR»Patient Medical History
«device_config»Personalized Device
Settings
«device,EHR»Device Association
«EHR»Risk factors
«device_config»Ventilator Parameters
Device Configuration
EHR Data
Device Observations
Shared Objects
Information Derived from Workflow Analysis
• High-level, identifies the information used or produced, precursors to DCMs
Device Observati
on
Device Configuratio
n
Common/Shared
Information
EHR Data Required
20
object 3.1: Information Analysis
«device_data»Alarm Status
«device,lab_result»ABG
«EHR»Procedure
Documentation
«EHR»Transfer Order
«device_data»Vital Signs
«EHR»Respiratory Consult Order
«EHR»Allergies
«device_data»Pulse Oximetry
«EHR»Device Characteristics
Record
«EHR»Flowsheet
«device_config»IV Line Information
«EHR»Chest X-ray Order, Image,
Interpretation
«EHR»Medication
«device_data»Operational Device
Settings «EHR»Patient Medical History
«device_config»Personalized Device
Settings
«device,EHR»Device Association
«EHR»Risk factors
«device_config»Ventilator Parameters
Device Configuration
EHR Data
Device Observations
Shared Objects
Focus of the analysis: Medical Device Interoperability
• Emphasis on device-to-device and device-to-system interoperability and automation
• We specify the structure of relevant types of data
Device Observati
on
Device Configurati
onCommon/Shared
Information
21
Information Analysis to specify context for DCMs
class 3.2.b: Medical Device Analysis
Device{abstract}
+ deviceIdentifier: InstanceIdentifier [1..*]+ type: CodedValue+ modelNumber: InstanceIdentifier+ vendorId: Id+ softwareVersion: Text
Clinician
+ id: InstanceIdentifier+ name: PersonName
ParameterConfiguration
+ parameterCode: CodedValue+ parameterValue: PhysicalQuantity+ effectiveTime: PointInTime+ allowableRange: PhysicalQuantityInterval
PatientReference
+ id: InstanceIdentifier [1..*]+ account: InstanceIdentifier [0..1]+ name: PersonName [0..1]+ gender: CodedValue [0..1]+ birthDate: PointInTime [0..1]
ReportedAlarmStatus
+ severityCode: CodedValue::Alarm+ eventCode: CodedValue+ userMessage: Text+ statusCode: CodedValue
Alarm{abstract}
+ eventCode: CodedValue+ userMessage: Text+ statusCode: CodedValue
Resolution
+ date: PointInTime
DeviceAssignment
+ assignmentTime: PointInTime+ unassignmentTime: PointInTime
DeviceConfiguration
+ mode
DeviceObservations
«EHR»Respiratory
Consult Order
(from 3.1 Information Analysis)
PerformanceSpecification
+ accuracy: CodeValueNullable [0..1]+ precision: CodeValueNullable [0..1]+ qualityOfService: CodeValueNullable [0..1]
AlarmEventConfiguration
::Alarm+ eventCode: CodedValue+ userMessage: Text+ statusCode: CodedValue
DeviceMeasurement
+ code: CodedValue+ value: PhysicalQuantity+ effectiveTime: PointInTime+ measurementMethod: CodedValue [0..*]+ abnormalFlag: CodedValue [0..1]+ bodyPosition: CodedValue [0..1]+ bodySite: CodedValue [0..1]+ correctedEffectiveTime: PointInTime [0..1]
Verification
+ time: PointInTime
ReferenceRange
+ normalRange: PhysicalQuantityInterval+ instrumentalExtremeRange: PhysicalQuantityInterval [0..1]+ physiologicalExtremeRange: PhysicalQuantityInterval [0..1]+ patientExtremeRange: PhysicalQuantityInterval [0..1]
+configuration
observations
operatedBy
1+observation
*
verfiedBy
+performance
+referenceRange
1..*
+parameterConfiguration
+alarmConfiguration+alarmReported
attribute
class
association
repetitions
data type for
date/time
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DCMs provide the final level of detail : Standard Terminology
class 4.1.b: DCMs representing Ventilator SettingsVentilatorSetting
«DCM»PressureSupport
::ParameterConfiguration+ parameterCode: CodedValue+ parameterValue: PhysicalQuantity+ effectiveTime: PointInTime+ allowableRange: PhysicalQuantityInterval
constraints{'parameterCode' is encoded and fixed to '20079-0'}{'parameterValue' is expressed in ...}{Not applicable if ventilator is set to volume control mode}
::VentilatorSetting{ 'parameterCode' is encoded using LOINC }{ Use Cases }
DCM Candidat
e
Parameter
properties
Terminology
Constraints
Inherited Constraint
s
Is a “Ventilator Setting”Reusable data that may
be used in information exchanges