1September, 2005 What IHE Delivers

IHE-Cardiology Technical IHE-Cardiology Technical CommitteeCommittee

EP Key Data ElementsEP Key Data Elements

February 21, 2011February 21, 2011

Bryan Jennings - Medical Micrographics Bryan Jennings - Medical Micrographics

Nick Gawrit - HeartBaseNick Gawrit - HeartBase

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AbstractAbstract

Define a medical data format for Define a medical data format for clinical documents containing at clinical documents containing at a minimum:a minimum:

Patient Conditions Patient Conditions

EP Lab procedure dataEP Lab procedure data

Discharge SummaryDischarge Summary

Pointers to other materialPointers to other material

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Problem StatementProblem Statement

There is a need to be able to extract these data There is a need to be able to extract these data elements from the medical record in an elements from the medical record in an automated, standards based data model that automated, standards based data model that can operate in a cross-platform environment can operate in a cross-platform environment across multiple electronic health records and across multiple electronic health records and cardiac rhythm management devices cardiac rhythm management devices regardless of vendor. regardless of vendor.

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Development of Data StandardsDevelopment of Data Standards

Currently, clinical personnel, data managers, Currently, clinical personnel, data managers, clinical investigators, and FDA reviewers clinical investigators, and FDA reviewers

must cope with a must cope with a plethora of data formatsplethora of data formats and and conventions. Some clinical investigators conventions. Some clinical investigators

report the presence of report the presence of many different many different computer systems for data entrycomputer systems for data entry at their sites at their sites

(for various trials), each of which uses (for various trials), each of which uses different data conventions. Lack of different data conventions. Lack of

standardization is not only inefficient, it standardization is not only inefficient, it multiplies the potential for error. …multiplies the potential for error. …

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Current StateCurrent StateData Capture: Some Sites Looks Like ThisData Capture: Some Sites Looks Like This

The virtual version of this mess – multiple web apps on one workstation – is scant improvement.

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Standards UsedStandards Used

CDA Release 2.0CDA Release 2.0

ASTM/HL7 Continuity of Care Document (CCD)ASTM/HL7 Continuity of Care Document (CCD)

HL7 V3 Laboratory DMIM HL7 V3 Laboratory DMIM

HL7 Care Record SummaryHL7 Care Record Summary

LOINC & SNOMEDLOINC & SNOMED

HIPAA Lab Claim Attachment NPRMHIPAA Lab Claim Attachment NPRM

Document Digital SignatureDocument Digital Signature

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Use CaseUse Case

1.1. Health care provider needs to collect data Health care provider needs to collect data to submit to the ACC NCDR-ICD Registryto submit to the ACC NCDR-ICD Registry

2.2. EMR System would like to display Key EMR System would like to display Key Cardiology data in a meaningful wayCardiology data in a meaningful way

3.3. EP Lab System produces data but needs EP Lab System produces data but needs to integrate with other systems to to integrate with other systems to facilitate data sharingfacilitate data sharing

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Systems that contain data (to name a few)Systems that contain data (to name a few)

Boston ScientificBoston ScientificSt. Jude MedicalSt. Jude MedicalMedtronicMedtronicBiotronikBiotronikSiemens SyngoSiemens SyngoSiemens Axiom SensisSiemens Axiom SensisBardBardEP MedicalEP MedicalPrucka (GE) Prucka (GE) Witt (Phillips)Witt (Phillips)

LumedxLumedxBiosenseBiosenseMacLab (GE)MacLab (GE)MergeMergeMcKessonMcKessonCernerCernerEpicEpicNextGenNextGenAllscriptsAllscripts

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Boston Scientific

EP Medical

Medtronic

St. Jude Medical

GE Prucka

Epic

Siemens

Biotronik

Goal: A Common TerminologyGoal: A Common Terminology

Philips Witt

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ScopeScope

The clinical CDA document is: The clinical CDA document is: A report of A report of a set of final resultsa set of final results (the fulfillment process (the fulfillment process

being completed) will also be shared later as “historical being completed) will also be shared later as “historical information”.information”.

Human-readableHuman-readable, shared between care providers of , shared between care providers of various specialties and patients (e.g. through a PHR)various specialties and patients (e.g. through a PHR)

May contain May contain machine readable coded entriesmachine readable coded entries (decision (decision support, registry submissions)support, registry submissions)

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A CDA content profile is…A CDA content profile is…A sharable information component that can be exchanged… within an HIE or RHIO via Media or USB Device via Reliable Messages Point to Point

Document content using standards CDA Release 2.0 HL7 Care Record Summary ASTM/HL7 Continuity of Care Document

More complex documents have a library of reusable parts

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Where Can Cardiology Use CDA?Where Can Cardiology Use CDA?

Clinical Reports (Cath, Echo, EP, etc.)Clinical Reports (Cath, Echo, EP, etc.) to go along with our pretty DICOM imagesto go along with our pretty DICOM images

Analyses of raw image and waveform dataAnalyses of raw image and waveform data backing up the Clinical Reportbacking up the Clinical Report

Documentation of the procedureDocumentation of the procedure provide context for the raw data and analysesprovide context for the raw data and analyses

Input to a clinical and Registry databaseInput to a clinical and Registry database for patient care over time, or outcomes analysisfor patient care over time, or outcomes analysis

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Value PropositionValue Proposition

Supports interchange of PHR InformationSupports interchange of PHR Information

Patient DemographicsPatient Demographics

Procedure and Device InformationProcedure and Device Information

Current and Prior ResultsCurrent and Prior Results

Medications, Problems, AllergiesMedications, Problems, Allergies

Diagnoses HistoryDiagnoses History

Other InformationOther Information

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ACC-ICD Registry Pre-Populated in InterfaceACC-ICD Registry Pre-Populated in Interface

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ACC-Cath PCI Registry Pre-PopulatedACC-Cath PCI Registry Pre-Populated

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ICD Data Acquisition WorkflowICD Data Acquisition Workflow

Patient Encounter in ICD Lab

Case completed in Lab and electronically signed

EP Lab data exported to external processing queue

Data processed into format needed for ICD Registry

EP Lab data validated by clinical user

Non-EP Lab data added for submission completion

Registry Submission validated using NCDR tools

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Retrieve Forms for Data Capture (RFD)Retrieve Forms for Data Capture (RFD)

provides a method for gathering data provides a method for gathering data

within a user’s current application within a user’s current application

to meet the requirements of an external to meet the requirements of an external systemsystem

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Retrieve Forms for Data CaptureRetrieve Forms for Data Capture

A standard way of displaying external data A standard way of displaying external data capture forms inside an EHR.capture forms inside an EHR.

Many-to-many integration – any EHR can Many-to-many integration – any EHR can retrieve forms from many external systems.retrieve forms from many external systems.

Low barrier of entry for EHR and external Low barrier of entry for EHR and external systems.systems.

Flexible profile to accommodate both low-tech Flexible profile to accommodate both low-tech and sophisticated implementations.and sophisticated implementations.

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Retrieve Forms for Data captureRetrieve Forms for Data capture

Initial Phase – Done!Initial Phase – Done! Define standard format for formsDefine standard format for forms Define standard method for retrieving and submitting Define standard method for retrieving and submitting

formsforms

Content Profile Phase for Cardiology – now!Content Profile Phase for Cardiology – now! Provide domain-specific form requirementsProvide domain-specific form requirements Enable form population from EHR mapped dataEnable form population from EHR mapped data

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RFD Profile Actors and TransactionsRFD Profile Actors and Transactions

Form Manager

B

Form Receiver

C

Form Filler

A

Form Archiver

D

Form Manager – Form Receiver pairing is a statically defined business relationship based upon the domain, e.g., clinical trials, drug safety, public health, that can be embedded within the RFD Forms

Form Filler – Form Archiver(s) pairing is a dynamic, Form Filler defined business relationship that cannot be embedded within the RFD Form

Form Archiver

D

Form Archiver

D

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RFD WorldRFD WorldClinical Trials Sponsor

Federal or State Agency

Disease Registry

Drug Safety Data Collection Agency

Paired Form

Manager / Form

Receiver

Physician Office

CN-1

A robust Form Filler

Paired Form

Manager / Form

Receiver

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Example of RFD Form Filler opened in an Example of RFD Form Filler opened in an EMREMR

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RFD Displays and Archives Data for Many UsesRFD Displays and Archives Data for Many Uses

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