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Webinar Series 2014
• Integrating the Healthcare EnterpriseInternational
• Cardiology Domain Update
• Chris Melo, Philips Healthcare• Nick Gawrit, heartbase• Pamela Heller, ACC• Antje Schroeder, Siemens Healthcare
Cardiology Domain Update Agenda
Cardiology Domain Overview
Domain Profiles & Technical Frameworkso New profiles in 2013/2014o Additional profiles highlighted for 2015 Connectathono Technical Framework overview
Domain Organization o Planning & Technical Committeeso IHE International Membership
Q&A Session
Cardiology Domain Overview
IHE Cardiology was formed in 2003 to address issues specific to clinical workflow, information sharing and improved patient care in the clinical domain of cardiology.
Care Settings: hospital and cardiology physician practices
Sponsors: American College of Cardiology, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society
Closely related domainso Radiologyo Patient Care Coordinationo IT Infrastructureo Patient Care Deviceso Quality, Research and Public Health
Cardiology Domain – Key Trends
Care Coordinationo Consistent use of HL7 Clinical Document Architecture across all
clinical domains
o Common standards based nomenclature
o Support for Meaningful Use objectives and certification criteria
Registries, quality improvement programs, and researcho Profiling of standard data elements for both clinical and
secondary use
Expanded use of Electronic Health Record Systems in both the in-patient and ambulatory environments
o Need to access, exchange, and incorporate cardiology images and imaging information
Cardiology Domain – Recent Focus
Discrete data capture and codification profiles leveraging clinical guidelines and C-CDA:
• 2013/14 Electrophysiology Report Content – Implant/Explant (EPRC-IE) • 2013/14 Registry Content Submission - CathPCI (RCS-C) • 2012 Cath Report Content (CRC) – updated (Rev 1.3) in 2013• 2011 Cardiac Imaging Report Content (CIRC)
Cardiology workflow profiles with best practice in general imaging:• Cath/Echo/Nuclear-Medicine/ECG specializations to existing imaging
workflow and evidence gathering profiles.• Displayable Reports (DRPT) • Image Enabled Office (IEO)
New Profiles
• Electrophysiology Report Content – Implant/Explant (EPRC-IE) • Registry Content Submission - CathPCI (RCS-C)
EP Implant/Explant Report Content (EPRC-IE)
Procedure Note
DeviceManufacturers
ReferringPhysician
Leverage the Future of Healthcare Today
Why EPRC-IE
Content P
rofile?
Other Hospital
EP Physician
EP Lab
EP Device
Clinical & Technical Design Expertise
Clinical
Dr. David SlotwinerDr. Jerry Serwer Dr. Mahmoud Houmsse Marianne Paruch,RN • Renee Bianchetta,RN
TechnicalChris Melo (Philips)
Anthony Scinicariello (St.Jude Medical)
Scott Graunke (Medical Micrographics)
• Nicholas Gawrit (heartbase)
• Alex Kraus (Biotronic)• IHE Cardiology
Technical Committee
EP Implant/Explant Report Content (EPRC-IE)
Standard Conformance• HL7 C-CDA, IEEE
11073 MDC IDC, SNOMED, LOINC, RxNorm, ICD-9/10
Consumption• EHR, CVIS, • Hospital network,
hospital, Physician Practice, HIE
Reporting• Procedure Note• Device Manufacturers• ACC NCDR• Meaningful Use
Cost Control• Reduced FTEs - EP lab• Reduced FTEs - data
collection • Reduced FTEs -
transcription
Quality Improvement• Device appropriate use• Accurate reporting• Check and balance to
registry reporting
EPRC-IE
Why you needthis profile
EP Implant/Explant Report Content (EPRC-IE)
Report Scope
Implantable Cardioverter Defibrillator (ICD) Implant
Permanent Pacemaker (PPM) / Implantable Pulse Generator (IPG) Implant
Implantable Cardiac Monitor Implant
Lead Implant
ICD Explant
Generator Change
Lead Explant
Lead Abandonment
Imaging associated with Implant/Explant (e.g. venogram)
EP Implant/Explant Report Content (EPRC-IE)
Use Cases
Use Case #1: Report generated for ICD and/or lead implant/explant procedure in the EP Lab
• Create an EP Implant/Explant procedure note that utilizes industry standards and accepted industry nomenclature.
• Include discrete data points may be consumed by another system, like an EHR or CVIS.
• Allow data can flow between any system using this format.
Use Case #2: Review Procedure Report • Secondary uses of this report increase this profiles value.
o The referring physician who instigated/ordered the procedure, and other healthcare providers who manage subsequent patient care activities.
o Another person involved in downstream clinical or administrative data processing e.g., someone validating/source-checking for QA the original report as part of JCAHO audits.
o The Device Manufacturer who will receive registration of device information.
EP Implant/Explant Report Content (EPRC-IE)
Actors and Options
Content Creatoro Create an EPRC-IE document populating the required header elements,
sections, and entry content modules
o Group with a Time Client actor to synchronize its clock
Content Consumero Receive and process an EPRC-IE document, parsing the relevant header
elements, sections, and entries
o Implement the View option, the Discrete Data Import option, or both
Note: If implementing the Document Import or Section Import options, the Content Consumer must also implement the View option
EP Implant/Explant Report Content (EPRC-IE)
Header
•Specifies common context information for the Clinical Report
•Examples include: Patient Demographics, Physician, Date of Procedure, Procedure Type.
Section
•(3) New, (4) Re-used from CRC Profile, & (13) Unchanged C-CDA Sections
•Section Content Modules include Document Summary, Procedure Description, Medical History, Vital Signs, Procedure Indications.
Entry
•(5) New, (3) Re-used CRC entry content modules & (35) Unchanged C-CDA Entries.
•Entry Content Modules include Result Observation- Cardiac EPIE, Procedure Results Organizer- Cardiac EPIE, Plan of Care Activity Set- Cardiac.
Technically Interoperable & Clinically Functional
C-CDA Structure
EP Implant/Explant Report Content (EPRC-IE)
What is CDA
Re-Uses C-CDA Sections and Entries whenever possible
Utilizes the documentation style of C-CDA
Leverages concepts from C-CDA Procedure Note document type
C-CDA Structure
• 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 between healthcare providers and patients.
• HL7 Clinical Document Architecture Release 2 is a HL7 V3 normative standard.
EPRC-IE Relationship to C-CDA
Why C-CDA? o The HL7 Consolidated CDA is an Implementation Guide
which specifies a library of templates and details their use for a set of specific clinical document types.
o HL7 C-CDA Release 1.1 is an HL7 DSTU.
EP Implant/Explant Report Content (EPRC-IE)
EP Report – Pre-procedurePatient Information
Name: Fanta, Joseph Study Date: 27 June 2014 Medical Record #: 12345 Study Number: 123456
Birth Date: 6/25/43 Age: 70 Referring Physician: Dr. Maga Forbes Electrophysiologist: Dr. Johnny Fever Fellow/PA: Dr. Misty Fontue Medical History Joseph is a 70 year old male with an ischemic cardiomyopathy resulting in chronic systolic heart failure. In 1986, he underwent a CABG in London, UK. Despite optimal medical therapy, his LVEF remains severely reduced (20-25%) and he reports NYHA Class II-III symptoms of chronic systolic heart failure of dyspnea on exertion and orthopnea. Repeat cardiac catheterizations in 1996 and 2006 demonstrate no other suitable anatomy for revascularization. He is now referred to the lab for a single chamber ICD implantation for the primary prevention of sudden cardiac death. He denies palpitations or syncope. His underlying QRS width is 102ms.
Previous Procedures CABG Surgery (1986) Cardiac Catheterization (1996) Cardiac Catheterization (2006)
Problem Observations LVEF (20%) NYHA Class II No indication of palpitations or syncope Hypertension Hyperlipidemia DM
Family History The patient has no family history of cardiovascular disease. The patient was a former smoker. Family History – None Social History – Former Smoker
Home Medications: Lipitor 20mg, Atenolol 50mg, Cozaar 50mg, Imdur 60mg, Diltiazem 60mg, Cardura 4mb, Glyburide, Metformin, Vitamin D/Calcium, Restoril 30mg prn, NKDA
Allergies: nka
Physical Exam Height: 162.6cm/64.0 in. Baseline BP: 134/77 Weight: 61.0 kg/134.5 lb. Baseline HR: 75 BSA: 1.70 BMI: 23.1 Chest Exam: Clear Baseline Temp: 97 Extremities: No edema Procedure Indications:
Patient Information
Name: Fanta, Joseph Study Date: 27 June 2014 Medical Record #: 12345 Study Number: 123456
Birth Date: 6/25/43 Age: 70 Referring Physician: Dr. Maga Forbes Electrophysiologist: Dr. Johnny Fever Fellow/PA: Dr. Misty Fontue Medical History Joseph is a 70 year old male with an ischemic cardiomyopathy resulting in chronic systolic heart failure. In 1986, he underwent a CABG in London, UK. Despite optimal medical therapy, his LVEF remains severely reduced (20-25%) and he reports NYHA Class II-III symptoms of chronic systolic heart failure of dyspnea on exertion and orthopnea. Repeat cardiac catheterizations in 1996 and 2006 demonstrate no other suitable anatomy for revascularization. He is now referred to the lab for a single chamber ICD implantation for the primary prevention of sudden cardiac death. He denies palpitations or syncope. His underlying QRS width is 102ms.
Previous Procedures CABG Surgery (1986) Cardiac Catheterization (1996) Cardiac Catheterization (2006)
Problem Observations LVEF (20%) NYHA Class II No indication of palpitations or syncope Hypertension Hyperlipidemia DM
Family History The patient has no family history of cardiovascular disease. The patient was a former smoker. Family History – None Social History – Former Smoker
Home Medications: Lipitor 20mg, Atenolol 50mg, Cozaar 50mg, Imdur 60mg, Diltiazem 60mg, Cardura 4mb, Glyburide, Metformin, Vitamin D/Calcium, Restoril 30mg prn, NKDA
Allergies: nka
Physical Exam Height: 162.6cm/64.0 in. Baseline BP: 134/77 Weight: 61.0 kg/134.5 lb. Baseline HR: 75 BSA: 1.70 BMI: 23.1 Chest Exam: Clear Baseline Temp: 97 Extremities: No edema Procedure Indications:
Patient Information
Name: Fanta, Joseph Study Date: 27 June 2014 Medical Record #: 12345 Study Number: 123456
Birth Date: 6/25/43 Age: 70 Referring Physician: Dr. Maga Forbes Electrophysiologist: Dr. Johnny Fever Fellow/PA: Dr. Misty Fontue Medical History Joseph is a 70 year old male with an ischemic cardiomyopathy resulting in chronic systolic heart failure. In 1986, he underwent a CABG in London, UK. Despite optimal medical therapy, his LVEF remains severely reduced (20-25%) and he reports NYHA Class II-III symptoms of chronic systolic heart failure of dyspnea on exertion and orthopnea. Repeat cardiac catheterizations in 1996 and 2006 demonstrate no other suitable anatomy for revascularization. He is now referred to the lab for a single chamber ICD implantation for the primary prevention of sudden cardiac death. He denies palpitations or syncope. His underlying QRS width is 102ms.
Previous Procedures CABG Surgery (1986) Cardiac Catheterization (1996) Cardiac Catheterization (2006)
Problem Observations LVEF (20%) NYHA Class II No indication of palpitations or syncope Hypertension Hyperlipidemia DM
Family History The patient has no family history of cardiovascular disease. The patient was a former smoker. Family History – None Social History – Former Smoker
Home Medications: Lipitor 20mg, Atenolol 50mg, Cozaar 50mg, Imdur 60mg, Diltiazem 60mg, Cardura 4mb, Glyburide, Metformin, Vitamin D/Calcium, Restoril 30mg prn, NKDA
Allergies: nka
Physical Exam Height: 162.6cm/64.0 in. Baseline BP: 134/77 Weight: 61.0 kg/134.5 lb. Baseline HR: 75 BSA: 1.70 BMI: 23.1 Chest Exam: Clear Baseline Temp: 97 Extremities: No edema Procedure Indications:
Patient Information
Name: Fanta, Joseph Study Date: 27 June 2014 Medical Record #: 12345 Study Number: 123456
Birth Date: 6/25/43 Age: 70 Referring Physician: Dr. Maga Forbes Electrophysiologist: Dr. Johnny Fever Fellow/PA: Dr. Misty Fontue Medical History Joseph is a 70 year old male with an ischemic cardiomyopathy resulting in chronic systolic heart failure. In 1986, he underwent a CABG in London, UK. Despite optimal medical therapy, his LVEF remains severely reduced (20-25%) and he reports NYHA Class II-III symptoms of chronic systolic heart failure of dyspnea on exertion and orthopnea. Repeat cardiac catheterizations in 1996 and 2006 demonstrate no other suitable anatomy for revascularization. He is now referred to the lab for a single chamber ICD implantation for the primary prevention of sudden cardiac death. He denies palpitations or syncope. His underlying QRS width is 102ms.
Previous Procedures CABG Surgery (1986) Cardiac Catheterization (1996) Cardiac Catheterization (2006)
Problem Observations LVEF (20%) NYHA Class II No indication of palpitations or syncope Hypertension Hyperlipidemia DM
Family History The patient has no family history of cardiovascular disease. The patient was a former smoker. Family History – None Social History – Former Smoker
Home Medications: Lipitor 20mg, Atenolol 50mg, Cozaar 50mg, Imdur 60mg, Diltiazem 60mg, Cardura 4mb, Glyburide, Metformin, Vitamin D/Calcium, Restoril 30mg prn, NKDA
Allergies: nka
Physical Exam Height: 162.6cm/64.0 in. Baseline BP: 134/77 Weight: 61.0 kg/134.5 lb. Baseline HR: 75 BSA: 1.70 BMI: 23.1 Chest Exam: Clear Baseline Temp: 97 Extremities: No edema Procedure Indications:
Patient Information
Name: Fanta, Joseph Study Date: 27 June 2014 Medical Record #: 12345 Study Number: 123456
Birth Date: 6/25/43 Age: 70 Referring Physician: Dr. Maga Forbes Electrophysiologist: Dr. Johnny Fever Fellow/PA: Dr. Misty Fontue Medical History Joseph is a 70 year old male with an ischemic cardiomyopathy resulting in chronic systolic heart failure. In 1986, he underwent a CABG in London, UK. Despite optimal medical therapy, his LVEF remains severely reduced (20-25%) and he reports NYHA Class II-III symptoms of chronic systolic heart failure of dyspnea on exertion and orthopnea. Repeat cardiac catheterizations in 1996 and 2006 demonstrate no other suitable anatomy for revascularization. He is now referred to the lab for a single chamber ICD implantation for the primary prevention of sudden cardiac death. He denies palpitations or syncope. His underlying QRS width is 102ms.
Previous Procedures CABG Surgery (1986) Cardiac Catheterization (1996) Cardiac Catheterization (2006)
Problem Observations LVEF (20%) NYHA Class II No indication of palpitations or syncope Hypertension Hyperlipidemia DM
Family History The patient has no family history of cardiovascular disease. The patient was a former smoker. Family History – None Social History – Former Smoker
Home Medications: Lipitor 20mg, Atenolol 50mg, Cozaar 50mg, Imdur 60mg, Diltiazem 60mg, Cardura 4mb, Glyburide, Metformin, Vitamin D/Calcium, Restoril 30mg prn, NKDA
Allergies: nka
Physical Exam Height: 162.6cm/64.0 in. Baseline BP: 134/77 Weight: 61.0 kg/134.5 lb. Baseline HR: 75 BSA: 1.70 BMI: 23.1 Chest Exam: Clear Baseline Temp: 97 Extremities: No edema Procedure Indications:
Patient Information
Name: Fanta, Joseph Study Date: 27 June 2014 Medical Record #: 12345 Study Number: 123456
Birth Date: 6/25/43 Age: 70 Referring Physician: Dr. Maga Forbes Electrophysiologist: Dr. Johnny Fever Fellow/PA: Dr. Misty Fontue Medical History Joseph is a 70 year old male with an ischemic cardiomyopathy resulting in chronic systolic heart failure. In 1986, he underwent a CABG in London, UK. Despite optimal medical therapy, his LVEF remains severely reduced (20-25%) and he reports NYHA Class II-III symptoms of chronic systolic heart failure of dyspnea on exertion and orthopnea. Repeat cardiac catheterizations in 1996 and 2006 demonstrate no other suitable anatomy for revascularization. He is now referred to the lab for a single chamber ICD implantation for the primary prevention of sudden cardiac death. He denies palpitations or syncope. His underlying QRS width is 102ms.
Previous Procedures CABG Surgery (1986) Cardiac Catheterization (1996) Cardiac Catheterization (2006)
Problem Observations LVEF (20%) NYHA Class II No indication of palpitations or syncope Hypertension Hyperlipidemia DM
Family History The patient has no family history of cardiovascular disease. The patient was a former smoker. Family History – None Social History – Former Smoker
Home Medications: Lipitor 20mg, Atenolol 50mg, Cozaar 50mg, Imdur 60mg, Diltiazem 60mg, Cardura 4mb, Glyburide, Metformin, Vitamin D/Calcium, Restoril 30mg prn, NKDA
Allergies: nka
Physical Exam Height: 162.6cm/64.0 in. Baseline BP: 134/77 Weight: 61.0 kg/134.5 lb. Baseline HR: 75 BSA: 1.70 BMI: 23.1 Chest Exam: Clear Baseline Temp: 97 Extremities: No edema Procedure Indications:
Patient demographics- Header
Medical History- Cardiac Section
Family History Section
Current Medications Section
Allergies Section
Physical Exam Section
EPRC-IE Structure
EP Implant/Explant Report Content (EPRC-IE)
EP Report – Procedural
Procedure Indications Section
Anesthesia Section
Procedure Description- Cardiac EPIE Section
Complications Section
Procedure Activity Procedure – Cardiac EPIE Entry (under Procedure Description – Cardiac EPIE SectionDevice Observation EPIE (under Procedure Description – Cardiac EPIE Section)
EPRC-IE Structure
EP Implant/Explant Report Content (EPRC-IE)
Final Device Programming Ventricular Tachycardia Zone Detection Interval: 355 ms ATP Type: Burst ATP Sequences: 1 Shock 1: Energy 26J # of Shocks: 1 Shock 2: Energy 41J # of Shocks: 5
Ventricular Fibrillation Zone Detection Interval : 355 ms ATP Type: Burst ATP Sequences: 1
Shock 1: Energy 41J # of Shocks: 6 Monitor Zone Detection Interval : 400ms Bradycardia Parameters Lower Rate Limit : 40 6pm RV Setting Packing Amplitude : 4.0 V PV Setting Pacing – Pulse Width : 0.4 ms Amplitude Mean : 0.5 mV Detection Interval : 400 ms DFT Results
Induction Method
Induced Rhythm
Shock Energy (Joules)
Impedance (ohms)
Configuration Sensitivity Post DFT Rhythm
T-Wave Shock V Fib 16 70 RV Coil to Can Least NSR Conclusion The patient underwent successful single chamber ICD implantation for primary prophylaxis from sudden cardiac death. ICD therapy is indicated because tis patient has an LVEF of less than or equal to 35% due to an MI greater than 40 days ago and is NYHA functional class III. Plan Bedrest x 4 hours Chest x-ray to rule out pneumothorax and ECG upon arrival to the floor. No heparin or lovenox. This includes subcutaneous prophylactic dosing. Resume prior medications. Follow up in 2 weeks. Continue with IV Ancef to complete 24 hours dosing. Expect discharge tomorrow in the morning. Dr. Johnny Fever was present for the entire procedure, supervised its performance, and participated in all the key and critical portions as needed. Updated by Nurse Ratchet on 6/27/2014 4:55:43 PM. Dr. Johnny Fever electronically signed on 6/27/2014 4:57:23 PM with status of Final
EP Report – Results and Interpretations
Procedure Results – Cardiac EPIE Section
Final Device Programming Ventricular Tachycardia Zone Detection Interval: 355 ms ATP Type: Burst ATP Sequences: 1 Shock 1: Energy 26J # of Shocks: 1 Shock 2: Energy 41J # of Shocks: 5
Ventricular Fibrillation Zone Detection Interval : 355 ms ATP Type: Burst ATP Sequences: 1
Shock 1: Energy 41J # of Shocks: 6 Monitor Zone Detection Interval : 400ms Bradycardia Parameters Lower Rate Limit : 40 6pm RV Setting Packing Amplitude : 4.0 V PV Setting Pacing – Pulse Width : 0.4 ms Amplitude Mean : 0.5 mV Detection Interval : 400 ms DFT Results
Conclusion The patient underwent successful single chamber ICD implantation for primary prophylaxis from sudden cardiac death. ICD therapy is indicated because tis patient has an LVEF of less than or equal to 35% due to an MI greater than 40 days ago and is NYHA functional class III. Plan Bedrest x 4 hours Chest x-ray to rule out pneumothorax and ECG upon arrival to the floor. No heparin or lovenox. This includes subcutaneous prophylactic dosing. Resume prior medications. Follow up in 2 weeks. Continue with IV Ancef to complete 24 hours dosing. Expect discharge tomorrow in the morning. Dr. Johnny Fever was present for the entire procedure, supervised its performance, and participated in all the key and critical portions as needed. Updated by Nurse Ratchet on 6/27/2014 4:55:43 PM. Dr. Johnny Fever electronically signed on 6/27/2014 4:57:23 PM with status of Final
Final Device Programming Ventricular Tachycardia Zone Detection Interval: 355 ms ATP Type: Burst ATP Sequences: 1 Shock 1: Energy 26J # of Shocks: 1 Shock 2: Energy 41J # of Shocks: 5
Ventricular Fibrillation Zone Detection Interval : 355 ms ATP Type: Burst ATP Sequences: 1
Shock 1: Energy 41J # of Shocks: 6 Monitor Zone Detection Interval : 400ms Bradycardia Parameters Lower Rate Limit : 40 6pm RV Setting Packing Amplitude : 4.0 V PV Setting Pacing – Pulse Width : 0.4 ms Amplitude Mean : 0.5 mV Detection Interval : 400 ms DFT Results
Conclusion The patient underwent successful single chamber ICD implantation for primary prophylaxis from sudden cardiac death. ICD therapy is indicated because tis patient has an LVEF of less than or equal to 35% due to an MI greater than 40 days ago and is NYHA functional class III. Plan Bedrest x 4 hours Chest x-ray to rule out pneumothorax and ECG upon arrival to the floor. No heparin or lovenox. This includes subcutaneous prophylactic dosing. Resume prior medications. Follow up in 2 weeks. Continue with IV Ancef to complete 24 hours dosing. Expect discharge tomorrow in the morning. Dr. Johnny Fever was present for the entire procedure, supervised its performance, and participated in all the key and critical portions as needed. Updated by Nurse Ratchet on 6/27/2014 4:55:43 PM. Dr. Johnny Fever electronically signed on 6/27/2014 4:57:23 PM with status of Final
Post-procedure Diagnosis Section
Plan of Care – Cardiac Section
EPRC-IE Structure
EP Implant/Explant Report Content (EPRC-IE)
Vocabulary Constraints
Result observation constraints – defines complete sets of elements for observations, including codes and allowed values
Value sets provided for EP specific concept domains• Cardiac Problems/Concerns
• Body Site
• Cardiovascular Family History
• Contrast Agents Classes for Adverse Reactions
• Cardiac Lab Results
• Vital Sign Results
• Procedure Indications
• Contrast Agents
• Cardiac Activity Procedures
• Drug Classes and Specific Cardiac Drugs
• Rx Recommendations
• Procedure Findings Types
• Postprocedure Diagnoses
• Supported File Types
• Complications
EPRC-IE Structure
EP Implant/Explant Report Content (EPRC-IE)
Leveraged Relationships with Current Profiles & Standards
Other Cardiology Content Profiles
• Implantable Device – Cardiac – Observation (IDCO) Final Text
•Cardiac Imaging Report Content (CIRC) Profile – in Trial Implementation
•Cath Report Content (CRC) Profile – in Trial Implementation
•Registry Content Submission –CathPCI (RCS-C) Profile – CathPCI – in Trial Implementation
Actor Required Grouping
•Consistent Time (CT) – for Legal Authentication timestamp to be accurate
Cross Profile Considerations
•Displayable Reports (DRPT)•Cross-enterprise Document Sharing (XDS), Cross-enterprise Document Media Interchange (XDM), Cross-enterprise Reliable Interchange (XDR), Cross-enterprise Document Sharing for Imaging (XDS-I), and Cross-enterprise Reliable Document Interchange for Imaging (XDR-I)
•Portable Data for Imaging (PDI)•Retrieve Form for Data Capture (RFD)•Document Digital Signature (DSG)
EPRC-IE
EP Implant/Explant Report Content (EPRC-IE)
Registry Content Submission – CathPCI (RCS-C)
Registry Content Submission – CathPCI (RCS-C)
• CDA implementation guide for data to be submitted to the NCDR™ CathPCI Registry®.
• Authoring of profile led by the ACC-NCDR organization.• Aligns data content for Registry collection with
emerging best-practice in wider clinical data exploitation initiatives.
• Long term aim to increase consistency across cardiac registries.
• Leverages the C-CDA codes and structures in CRC profile while expanded to capture the additional information needed for NCDR Registry submission.
TRIAL
Registry Content Submission CathPCI - (RCS-C)
Clinical & Technical Design Expertise
Clinical• Richard E. Shaw, M.A., Ph.D.,
F.A.C.C, F.A.C.A. (Chair*)• H. Vernon Anderson, M.D.,
F.A.C.C. • John P. Erwin, III, M.D., F.A.C.C.,
F.A.H.A.• John C. Messenger, M.D.,
F.A.C.C.• David McManus, M.D., F.A.C.C.• William S. Weintraub, M.D.,
FACC• R. Jeffrey Westcott, M.D.,
F.A.C.C., FSCAI• Kalon K. L. Ho, M.D., F.A.C.C.• Joseph P. Drozda Jr., M.D.,
F.A.C.C.• Traci Connolly, B.S.N., M.S.,
R.N., C.P.H.Q., A.A.C.C.
Technical
• Ganesan Srinivasan (ACC)• Pamela Heller (ACC)• Nandhini Kuntipuram (ACC)• Abdul Malik Shakir (Hi3
Solutions)• Mead Walker (Hi3 Solutions)
Registry Content Submission CathPCI - (RCS-C)
NCDR Today
Non-standardizedNCDR
Hospitals using home grown systems
Hospitals using ACC’s web tool
Hospitals using software vendors
Software Vendors
Benchmarks & Dashboards
FDA Post Approval
ACC certification
ACC certification
Registry Content Submission CathPCI - (RCS-C)
An Interconnected Future
Standardized
NCDRICD,CPT, LOINC, SNOMED,
NDC
Hospitals Using EMRs / EHRs
Hospitals Using Home Grown Systems
Hospitals Using ACC’s web tool
Hospitals Using Software Vendors
EHRs & Software Vendors
Benchmarks & Dashboards
FDA Pre & Post Approval
Health Info Exchange
Industry
Standard Profiles
Patients
Remote Devices
CMS & Other Federal Govt
Aligned with CMS Meaningful Use
Application Providers
Health PlansHealth &
Fitness Device
ACC certification
Registry Content Submission CathPCI - (RCS-C)
Getting there…
• Harmonize Data Definitions
• Code the definitions using established vocabulary standards (e.g. LOINC, SNOMED-CT, RxNorm)
• Represent the encoding, structure and semantics of the clinical content using a standard architecture (HL7 CDA)
• Use a modular approach that facilitates re-use (HL7 CDA Templates)
The interconnected future depends on standards
Consolidated Data Dictionary +
Map to Standard Terminology and Code Systems
ICD, IMPACT
ACTION Registry GWTG
CathPCI,
PINNACLE, PVI
Registry Submission Transaction
HL7 Clinical Document
Architecture
Constraints and Rules
Registry Content Submission CathPCI - (RCS-C)
Actors and Options
• Content creator harvests the relevant encounter data for a submission period, organizes the data into a series of CDA document(s) and transmits the data as a single package to the clinical registry.– Registry can harvest data in RCS-C format directly from EMR or
similar systems– Registry can harvest data in RCS-C format from other IHE profiles
such as CRC• The clinical registry (system) receives the RCS-C document for
import. The data is transformed and added to the registry.
Registry Content Submission CathPCI - (RCS-C)
RCS-C and CRC harmonized coding• Physicians participated in the harmonization of codes and their
codesystems for clinical concepts across the RCS-C and CRC profiles.
Registry Content Submission CathPCI - (RCS-C)
Registry Content Submission-CathPCI
Major highlights:• Patient Demographics• History and Risk Factors• Pre-procedure Activities• Procedure Session
(including lesion treatment and devices used)
• Procedure Medications administered
• Procedure Events• Laboratory Results• Discharge Medications
Registry Content Submission CathPCI - (RCS-C)
RCS-C Structure
RCS-C HeaderThe RCS-C Header captures information about:• Registry Submission Identifier
• Submission Type• Submission ID• Submission Date
• Patient• NCDR Patient Identifier• SSN• Hospital Patient Identifier• Name• Gender• Birth time
• Vendor Software• Software name & version• Vendor name
• Healthcare Facility• Participant NPI• Participant name• Participant ID
• NCDR Registry• Registry name and version • Registry ID
Displayable Report Workflow (DRPT)• Cardiology reports typically
include lots of graphics • Addresses workflow between a
reporting application and the departmental info system and/or the EMR
− Possible report archiving to PACS
• Report format may be PDF or HL7 CDA
• Applicable to other clinical domains!
RCS-C: Structured BodyThe RCS-C structured body includes a:
•Patient Demographics Section - captures patient information which is stable across encounters within a reporting period.
•Encounter Section – captures the episode of care which may be multiple encounters in a reporting period.
•History and Risk Factor Section – captures the history and risk factors from the entire history or specified period of time before the procedure.
RCS-C: Pre-procedure Activity Organizer
The Pre-procedure Activity Organizer captures data from the Clinical Evaluation prior to the procedure. This information includes:
•Indications
•Procedures – non-invasive tests
•Laboratory Results
•Test Results – cardiac and stress test results
•Medications – current
RCS-C Lesion EntryThe Lesion Entry captures observations about the lesion before and after the intervention and devices used. This information includes:
•Identifying the culprit lesion
•Percentage stenosis prior to treatment
•Procedures performed to confirm stenosis
•Idenfitying if it’s a previously treated lesion and how it was treated
•Diameter, Size of intracoronary device
RCS-C: Pre-intervention Lesion Observation Entry
RCS-C: Discharge Section
The Discharge Section captures observations and medications after the procedure session:
•Discharge status
• Alive or deceased
• Cardiac Rehabilitation referral
•Discharge medications
• ACE Inhibitors
• Aspirin
Trial Implementation for RCS-C
The RCS-C wiki page provides an overview to the profile and includes a sample CDA document and sample data collection form for download.
The CathPCI V4.4 (RCS-C) profile will be offered for interoperability-testing at the IHE NA Connectathon 2015. If you are interested in participating please refer to http://iheusa.org/connectathon.aspx for additional information
If you have questions about the CathPCI Registry, please contact ncdr_vendor@acc.org.
Registry Content Submission CathPCI - (RCS-C)
Other Profiles highlighted for the 2015 Connectathon
Image-Enabled Office
• Bi-directional integration of medical imaging equipment and office EHR
• Leverages in-patient workflow concepts to minimize impact on imaging devices, but adapted to use with office EHR (EHR-S)
• EHR – PACS image display integration using Web technologies• Integrated EHR-System is an optional integration of an EHR with
the image “order filler” (scheduling and management) function• Can be implemented with 3rd party software components
without having to expose internal order transactions• Agnostic to EHR and PACS deployment technology (on-site,
hosted, SaaS, cloud, etc.)
TRIAL
Cath Report Content (CRC)
TRIAL
• Based on >100 discrete cath & PCI procedure data elements, fully modeled using non-proprietary SNOMED, LOINC, and DICOM terminologies
• Is not a direct specialization of any existing HL7 CDA document template ID. However, some parts were based on:
– IHE Cardiology CIRC content profile– HL7 Implementation Guide for CDA Release 2: IHE Health Story Consolidation,
Release 1.1 DSTU -July 2012 (C-CDA) Procedure Note.
• Allows structured representation of lesions, coronary anatomy and devices
• Supports data import into longitudinal patient tracking databases• First step to wider secondary use of report data (outcomes research,
quality metrics and quality improvement)• Leverages HL7 CDA capability for both human readable narrative and
robust XML-encoded data elements.
Technical Framework Overview
Profiles & Technical Frameworks
• IHE Technical Frameworks• Final Text: Current version 5.0• Trial Implementation: Supplements• http://www.ihe.net/Technical_Framework/index.cfm#cardiology
• Brief descriptions of Profiles developed by Cardiology Domain
• http://wiki.ihe.net/index.php?title=Profiles#IHE_Cardiology_Profiles
Overview
FINAL
TRIAL
Profiles & Technical FrameworksWorkflow in the in-patient environment
• Profiles aligned with IHE Radiology workflow
– Scheduled and unscheduled cardiac
imaging exams, including multimodality
– Management of data, demographic and
procedure identifiers
– Cardiovascular Information Systems,
PACS, imaging and waveform
modalities: X-ray and hemo (cath lab),
Echo, Nuclear imaging analysis and
reporting workstations– Consistent, robust workflow
minimizes manual procedure management tasks
• Cardiac Catheterization Workflow
• Echocardiography Workflow
• Stress (ECG + imaging) Workflow
• Evidence Documents (cardiology specialization)
• Displayable Reports Workflow
• Intravascular Imaging Option for Cardiac Catheterization Workflow
FINAL
TRIAL
Profiles & Technical FrameworksWorkflow in the ambulatory environment
• Image-Enabled Office– Bi-directional integration of medical
imaging equipment and office EHR
– Not limited to cardiology – applies to orthopedics, women’s health, gastroenterology, even primary care
– Ambulatory office EHRs, mini-PACS (or cloud PACS), imaging modalities
– Supports the USA Meaningful Use criteria for EHR with imaging
TRIAL
Displayable Report Workflow (DRPT)• Cardiology reports typically
include lots of graphics • Addresses workflow between a
reporting application and the departmental info system and/or the EMR
− Possible report archiving to PACS
• Report format may be PDF or HL7 CDA
• Applicable to other clinical domains!
TRIAL
Profiles & Technical FrameworksReporting
Report Content:• CDA structured report (XML) to
facilitate consistency, accuracy, and semantic interoperability of imaging findings:• Cardiac Imaging Report Content
(CIRC)− Based on ACC/AHA 2008 Key Data
Elements for Cardiac Imaging
• Cath Report Content (CRC)− Based on ACC/AHA 2008 Cardiac
Catheterization Report Prototype and ACC-NCDR CathPCI Registry v4.4 Coder’s Data Dictionary
• Electrophysiology Report Content− Based on 2011 Cardiac EP Key Data
Elements white paper published in 2011
• Registry Content Submission – Cath/PCI (RCS-C)
Profiles & Technical FrameworksECG Workflow
• Retrieve ECG for Display
– Access to ECGs from everywhere in the hospital
– Resting ECGs, Holter ECGs
– ECG Management Systems, EMRs, workstations
– Simplified and standardized Web-based access to ECGs; No need for ‘printed ECGs’
• Resting ECG Workflow
– Multi-system workflow for the most common cardiology exam
– Scheduled/unscheduled, post-exam reconciliation
– Cardiovascular Information Systems, ECG Management Systems, ECG devices and workstations, PACS and imaging workstations, EMRs
– Components and workflow shared with imaging
TRIALFINAL
Profiles & Technical Frameworks
• Radiology– Scheduled Workflow (CT/MR/NM)– Nuclear Medicine Image (cardiac)– Evidence Documents, Key Image
Note– Portable Data for Imaging, XDS-I,
Import Reconciliation•Patient Care Devices– Implantable Device - Cardiac -
Observations– Device Enterprise Communication– Waveform Content Message
•Patient Care Coordination– Medical Summary – ED Referral
• IT Infrastructure– XDS, ATNA, Consistent Time– PIX, PDQ, PAM– Retrieve Form for Data Capture
Cardiology Relevant Profiles in Other Domains
Domain organization
IHE Cardiology Planning Committee
Contact Information• Secretary Paul Dow
pdow@acc.org • Co-Chair Alan Katz, MD
alan.katz@chsli.org • Co-Chair David Slotwiner, MD
dslotwin@nshs.edu • Committee’s wiki page http://
wiki.ihe.net/index.php?title=Cardiology_Planning_Committee
Responsibilities • Identifying priority issues for the
cardiology community− Liaison to sponsor
organizations• Soliciting and developing IHE
Profile Proposals− Now soliciting proposals!
• Evaluation of Technical Committee work
• Marketing IHE Cardiology profiles to user community
IHE Cardiology Technical Committee
Contact Information• Secretary Paul Dow
pdow@acc.org • Co-Chair Nick Gawrit ngawrit@
heartbase.net• Co-Chair Antje Schroeder
aschroeder@siemens.com • Committee’s wiki page http://
wiki.ihe.net/index.php?title=Cardiology_Technical_Committee
Responsibilities • Development of IHE Profiles
and white papers• Maintenance of IHE Cardiology
Technical Frameworks• Liaison with other IHE domains• Support for Planning
Committee marketing
How to Participate in IHE Cardiology?
• Apply for IHE International Organizational Membership• Visit: www.ihe.net/apply • Approved monthly by IHE International Board • Review IHE's 400+ Organizational Members
• Participate in IHE Domains & Committees• IHE Organizational Members only• 12 Clinical and Operational Domains • Each Domain has one planning and one technical committee
• Non-members participate in comment periods and implement IHE Technical Frameworks
• For more details on IHE’s domains and its processes please refer to other webinars at http://www.ihe.net/Webinars/
IHE International Membership is Free.
How to Participate in IHE Cardiology?
• Committee work typically follows the IHE Profile Cycle Annual cycle• ~18 months from profile proposal to Connectathon• Each IHE domain has its own independent schedule• Opportunities for IHE members and non-members to participate in
cycle • For a detailed schedule please refer to http://wiki.ihe.net/index.php?
title=Cardiology
IHE’s Profile Development Cycle
IHE Profiles Drafted & Revised
months 5-11
Trial Implementation PostedPublished
For PublicComment
IHE Technical Framework
Supplement Developed
Install Interoperable products in
Clinical Settings
worldwide
Install Interoperable products in
Clinical Settings
worldwide
Demonstrate at a
or ACC / HRS / ESC …
Demonstrate at a
or ACC / HRS / ESC …
IHE Improves, Safety, Quality and Efficiency
inClinical
Settings
IHE Call for Proposals Opens IHE Call for Proposals Opens
Profile Selection by Committees
months 1-4
months 12-18
Publish in IHE’s Product Registry
Test at IHE Connectathons
Thank you for your attention
Questions?
EPRC–IE Header Elements
• code - is selected from a value set specific for EP lab reporting.
• recordTarget – identifies the patient whose health information is described in this clinical document for the procedure.
• author – represents the creator(s) of the clinical document content.
• custodian – represents the organization that is in charge of maintaining the clinical document.
• legalAuthenticator – identifies the single person legally responsible for the document. This profile does not support the exchange of preliminary unapproved procedure reports.
• authenticator – identifies participants that attest to the accuracy of the information in the clinical document.
• inFulfillmentOf – represents orders that are fulfilled by this clinical document. For EPRC, the order/id is the Accession Number used in the DICOM imaging data.
• authorization – contains information about patient consents for the procedure and for the anesthesia.
• componentOf – contains information about the encompassing encounter for the clinical procedures documented in this report. This includes the clinical setting (location and organization). It also allows for the referring provider, the referring cardiologist, an attending physician and a responsible physician to be identified.
• documentationOf/serviceEvent – represents the EP procedures that are being documented. This also documents the primary performer and any assistants involved in each procedure.
EP Implant/Explant Report Content (EPRC-IE)
EPRC–IE Section Content Modules (20 total)
New sections (3)• Document Summary - EPRC
Includes a summary of most significant aspects of the procedures in a narrative form. It is a condensed form of the full narrative report whose structure has no constraint.
• Procedure Description – Cardiac EPIE Adds support for device specific observations.
• Procedure Results – Cardiac EPIE Adds support for device specific observations.
Re-used from CRC profile (4)• Medical History – Cardiac
Adds support for coded problem observation and procedures.
• Pre-Procedure Results – Cardiac Adds support for results in external documents.
• Plan of Care – Cardiac Includes specialized Plan of Care Activity Act with
elements.
• Key Images – Cardiac Contains narrative description of and references to
DICOM Image Information Objects that illustrate the findings of the procedure reported.
Unchanged sections (13)• Allergies• Family History• Social History• Physical Exam• Vital Signs• Planned Procedure• Procedure Indications• Anesthesia• Medications Administered• Procedure Disposition• Complications• Postprocedure Diagnosis• DICOM Object Catalog
EP Implant/Explant Report Content (EPRC-IE)
EPRC–IE Entry Content Modules
Unchanged entry content modules (~35)
New entry content modules (5)• Procedure Device Organizer – Cardiac EPIE
contains a set of observations related to a device used during a procedure• Device Observation –EPIE
represents observations made of devices used during a procedure• Procedure Activity Procedure – Cardiac EPIE
Extends to support entryRelationship to a Procedure Device Organizer and a Lesion Observation
• Result Observation – Cardiac EPIE Extends to support an entryRelationship to a Severity Observation
• Procedure Results Organizer – Cardiac EPIE Extends to include entryRelationship to a Lesion Observation
Re-used CRC entry content modules (3)• Problem Observation – Cardiac
Extends the Problem Observation Entry with an entryRelationship for a Severity Observation
• Result Organizer – Cardiac Extends to support references to external documents for results
• Plan of Care Activity Act – Cardiac Extends to support code, statusCode, and effectiveTime elementsEP Implant/Explant Report Content (EPRC-IE)
Electrophysiology Implant/Explant Report Content (EPRC-IE)
Completes the original 2011-2012 proposal request for a cardiac electrophysiology report content profile.
Leverages • Cardiac EP Key Data Elements white paper published in 2011: http://
www.ihe.net/Technical_Framework/upload/IHE_CARD_WP_Cardiac_EP_Key_Data_Elements_Rev1-0_PC_2011-08-05.pdf
• Existing IHE profiles like IDCO, CRC and CIRC• Standardized Nomenclature – IEEE 11073 MDC IDC, LOINC,
SNOMED• Registry Specifications – ACC NCDR – ICD• HL7 CDA, Consolidate CDA
Brings the benefits of structured reports to the EP lab. This is a critical first step to a profile that uses the EP procedure clinical report as pre-population data for submission to a registry.
Includes ICD, PPM/IPG, IPG and lead implants and explants.
TRIAL
New Supplement target for 2015 connectathon
EP Implant/Explant Report Content (EPRC-IE)
EPRC-IE
Electrophysiology Lab Procedure Reporting
TRIAL
<ClinicalDocument xmlns=“urn:hl7-org:v3”> <typeId extension=”POCD_HD000040” root=”2.16.840.1.113883.1.3”/> <templateId root=“1.3.6.1.4.1.19376.1.4.1.1.3”/> <id root=“” extension=“”/> <code code=“34896-1” displayName=“Interventional Procedure Note -
Cardiology” codeSystem=“2.16.840.1.113883.6.1” codeSystemName=“LOINC”/> <title>Cardiac Catheterization Report</title> <effectiveTime value=“201407231245”/> <confidentialityCode code=“N” displayName=“Normal” codeSystem=“2.16.840.1.113883.5.25” codeSystemName=“Confidentiality”/> <componentOf> <encompassingEncounter> <id extension=“IHE-CardtemplateId” root=“1.3.6.1.4.1.19376.1.4.1.3.1”/> <effectiveTime value=”20140723”/> <code code=“425435003” codeSystem=“2.16.840.1.113883.6.96” codeSystemName="SNOMED CT" displayName="Implantation of cardioverter
defibrillator with one electrode lead “>
– “EP Lab Report Content” profile defines a HL7 CDA structured report (XML) to facilitate consistency, accuracy, and semantic interoperability of ICD and lead implants and explant procedure reports and findings
– Based on “NCDR ICD Registry version 1.2 Coder’s Data Dictionary”
– Affected systems include: Cardiovascular Information Systems, EHR systems, EP lab analysis and reporting workstations
– Aligned with HL7 Implementation Guide for CDA Release 2: IHE Health Story Consolidation, Release 1.1 DSTU
– Related links:• http://www.ihe.net/Technical_Framework/index.cfm#cardiology • http://wiki.ihe.net/index.php?title=Electrophysiology_Report_Cont
ent• http://ihe.net/uploadedFiles/Documents/Cardiology/IHE_CARD_Su
ppl_EPRC-IE.pdf
• http://ihe.net/uploadedFiles/Documents/Cardiology/IHE_CARD_Suppl_EPRC-IE_Rev1.1_TI_2014-04-30_SampleXMLDocument_(noXSL).xml
EP Implant/Explant Report Content (EPRC-IE)
EP Report Content (EPRC-IE) TRIAL
• Based on >100 discrete EP procedure data elements, fully modeled using non-proprietary SNOMED, LOINC, DICOM, and IEEE 11073-10103 MDC IDC terminologies
• Created as a new HL7 CDA document template ID using existing sections and entries wherever feasible.
– IHE Cardiology CRC content profile– HL7 Implementation Guide for CDA Release 2: IHE Health Story Consolidation,
Release 1.1 DSTU -July 2012 (C-CDA) Procedure Note. • Structured representation of devices including generators, batteries, and leads, and testing
results• Supported data import into longitudinal patient tracking databases• First step to wider secondary use of report data (outcomes research, quality metrics and
quality improvement)• Leveraged HL7 CDA capability for both human readable narrative and robust XML-
encoded data elements.• Reviewed existing industry leading EP facilities focused on reporting workflow and report
content.
EP Implant/Explant Report Content (EPRC-IE)
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