hl7 working group session may 3-7, 2004 san antonio, tx
DESCRIPTION
Standards for Implantable Devices - Cardiac. HL7 Working Group Session May 3-7, 2004 San Antonio, TX. Overview. Project Progress Next Steps Artifact Review Appendix: Implantable Cardiac Device Overview Current Clinician Environment Implantable Device – Cardiac (IDC) Project Overview - PowerPoint PPT PresentationTRANSCRIPT
1www.HL7.org
HL7 Working Group SessionMay 3-7, 2004
San Antonio, TX
Standards for Implantable Devices - Cardiac
2
Overview
• Project Progress• Next Steps• Artifact Review• Appendix:
– Implantable Cardiac Device Overview– Current Clinician Environment– Implantable Device – Cardiac (IDC) Project
Overview– Participants
3
Project Progress
• Validated requirements through interviews and site visits• Compiled HL7 v3.0 artifacts for Device Summary
message– Storyboard– Application Roles– Trigger Event– Message Type– Interaction Diagram– Refined Message Information Model (R-MIM)– Hierarchical Message Definition (HMD)
• Identified nomenclature terms to be balloted via IEEE Vital Signs Nomenclature
4
Next Steps
• Obtain feedback from participants and enhance current artifacts
• Prepare Device Summary artifacts for ballot • Participate in enhancements to IEEE Vital
Signs Nomenclature• Gather additional requirements through
interviews and site visits• Create new HL7 v3.0 artifacts to support
additional messages in this area
5
Scenario Overview: Office Follow-Up
Place wandInterrogate
Device
Device Data SentTo EHR Using
HL7 ObservationMessage
Clinician ReviewsSettings / Events /
Patient Status
Change DeviceSettings?
Print Final Report
Program DeviceWith New Settings
Physician's EHRSends Follow-upLetters to PCP,
EP, Internist, etc.
No
Yes
Device SettingsAuto populate
Form(Printed for Patient
Record)
Discharge Patient
Patient InOffice forFollow-upHL7 Follow-Up
Order MessageSent to EP
EHR
In OfficeFollow-Up
Requested &Confirmed via
HL7 Messaging
Print Settings/Report
Device Data Inproprietary formatconverted to HL7Standard format
Post-implantDischargeProcessing
* Gray process flow boxesindicate HL7 messaging
6
Device Summary Data
•Aggregated set of data that is typically filed in the patient’s chart at follow-up
• Implanted Device Data Types:– Device Therapy Settings
• Pacing settings• Defibrillation settings
– Arrhythmia Logging Data • Event Counters
– Diagnostic Data • Diagnostics on device functionality (e.g., lead impedance,
sensing thresholds, pacing thresholds)
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Office Follow-Up: Interaction Diagram
Implantable DeviceInterrogation System
Electrophysiologyor CardiologyOrder Fulfiller
ObservationOrder Placer
Observation Order ActivateFulfillment Request
Observation Order ActivateConfirmation
Interrogation ObservationEvent Complete Notification
Observation Event CompleteNotification
Medical RecordsSystem
Original Document with Content (RCMR_IN000002)
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Office Follow-Up: Interactions, Roles & Trigger Events
Interaction Sending App Role Recv. App Role Trigger Event Message Type Observation Order Activate Fulfillment Request
Observation Order Global Placer
Observation Order Global Fulfiller (EP/Cardiology Dept System)
Observation Order Activate Fulfillment Request (Scheduled follow-up – post-implant)
General Observation Order
Observation Order Activate Confirmation
Observation Order Global Confirmer (EP/Cardiology Dept System)
Observation Order Global Confirmation Receiver
Observation Order Activate Confirmation (EP/Cardiology Dept System accepts ordered follow-up)
General Observation Order
Interrogation Observation Event Complete Notification
Interrogation Observation Event Informer (Implantable device interrogator, plus data conversion app)
Interrogation Observation Event Tracker (EP/Cardiology Dept System)
Interrogation Observation Event Complete Notification (Data retrieved from device and converted to standard format)
Implanted Cardiac Device Summary
Observation Event Complete Notification
Observation Event Informer (EP/Cardiology Dept System)
Observation Event Tracker
Observation Event Complete Notification (Exam completion)
General Observation Event
Original Document with Content (RCMR_IN000002)
Document Originator (RCMR_AR000001) (EP/Cardiology Dept System)
Document Management System Content Required (RCMR_AR000003)
Original Document Notification (RCMR_TE000102)
Document Event, with Content (RCMR_MT000002)
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R-MIM
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Appendix
– Implantable Cardiac Device Overview– Current Clinician Environment– Implantable Device – Cardiac (IDC) Project
Overview
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Implantable Cardiac Device Overview
• Pacemakers• Implantable Cardioverter Defibrillators• Heart Failure devices• Sensors
• Programmer
• Implantable cardiac devices exist as siloed subsystems
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Current Clinician Environment
Implantable Cardiac Device
Data
Referring, Implanting &Following Physicians
Integrated EHR/HIS/CIS
Clinicians will prefer systems that integrate with their CIS
Data IntegrationOpportunity
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IDC Project Overview
Current Working Relationships• Project under the sponsorship of the O&O Tech. Cmte.• Participate in LAPOCT SIG and IEEE Joint Working Group• Work with IEEE on extending Nomenclature
Intended Working Relationships• Monitor the work of the Vocabulary Tech. Cmte.• This group will stay alert to and be prepared to work with any outside
organization with similar or related goals, including:– DICOM WG1– IEC (International Electrotechnical Commission) SC62D– IHE (Integrating the Healthcare Enterprise) Cardiology– NASPE (North American Society of Pacing and Electrophysiology) – Heart
Rhythm Society– SNOMED
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Participants
• Implantable Device Companies & Medical Instrument Companies
• Interested Clinicians• EHR Vendors• Providers• Payors• Remote Monitoring Companies• Electrophysiology (EP) Lab Diagnostic Vendors• Healthcare Consulting Companies
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Implantable Cardiac Device Process FlowImplantable Device Process Flow
Oth
er H
CP
rofe
ssio
nal
Pat
ient
Fo
llow
ing
Phy
sici
anIm
plan
ting
Phy
sici
anP
hysi
cian
Sta
ffR
efer
ring
Phy
sici
an Indication forPacemaker, ICD,
or HF DeviceTherapy
Implantation ofDevice
Post OperativeMonitoring in
HospitalDischarge
Post OperativeDevice
Management
Device Follow-up
History
- Placement of leads- Placement of device- Device testing andprogramming- Registration, that triggers: - Billing - Technical support - Device tracking
- 24-72 hrs- Wound care- Pain mgmt- Arrhythmia mgmt.- Fluid mgmt.
- Pre-discharge device &lead test- Pre-discharge chest x-ray- Post operative careinstructions
- Infection risks- Driving- Identification card- Restriction of Arm/Shoulder motion- Follow-up visit schedule- Emergency procedure- Other precautions
Follow-up Schedule- Initial: 7-10 days post-implant- Pacemaker: 6 mo. intervals- Defibrillator: 6 mo. intervals- HF Device: 3-6 mo intervals
DeviceInterrogation and/or Manipulation
- Surgical procedures - Inpatient - Outpatient- Diagnostic procedures(e.g., MRI)
Explant- Battery expiration- Qualified for new therapy protocol
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Device Data Overview
• Implanted Device Data Types:– Device Therapy Settings
• Pacing settings• Defibrillation settings • Therapy tuning features
– Arrhythmia Logging Data • Stored details on each episode• Electrograms and event markers before, during, and after an event
– Diagnostic Data • Trended diagnostics on device functionality (e.g., lead impedance, sensing
thresholds, pacing thresholds)• Diagnostic data for titration of patient therapy
– Data from in-clinic testing• Inductions• Various device status tests