Structured Data Capture (SDC)
All Hands Meeting
April 4, 2013
Meeting Etiquette
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Remember: If you are not speaking, please keep your
phone on mute
Do not put your phone on hold. If you need to take a call,
hang up and dial in again when finished with your other call
o Hold = Elevator Music = frustrated speakers and
participants
This meeting is being recorded
o Another reason to keep your phone on mute when not
speaking
Use the “Chat” feature for questions, comments and
items you would like the moderator or other participants to
know.
From S&I Framework to Participants:
o Send comments to All Panelists so they can be
Hi everyone: remember to keep your
addressed publically in the chat, or discussed in the phone on mute 
meeting (as appropriate).
All Panelists
2
Agenda
Topic
Time Allotted
Welcome and Announcements
Meeting Reminders & Announcements
Join the Initiative
SDC Roadmap
10 minutes
Use Case
Timeline Review
SDC Use Case Comments & Disposition
Review Functional Requirements
40 minutes
Next Steps / Homework
5 minutes
Community Presentation: Aster-D Demonstration
30 minutes
3
Meeting Reminders & Announcements
• Structured Data Capture (SDC) Initiative holds weekly
community meetings on Thursdays at 3:25 pm EST.
– Next meeting is scheduled for April 11, 2013 from 3:25 pm –
5:00 pm Eastern.
– Next meeting will focus on the Candidate Standards List
– See the SDC Wiki Page for meeting information
– http://wiki.siframework.org/Structured+Data+Capture+Initiative
Please check the meeting schedule weekly as the meeting link and
call in numbers will change.
4
All Hands Meetings Extended
• Spring Concert Series Continues
– Demonstrations by SDC relevant community members and
stakeholders
• All Hands Meetings has been extended by ½ hour to
accommodate these presentations.
– 3:25 to 4:30 pm Eastern: All Hands Community Working Meeting
– 4:30 to 5:00 pm Eastern: Scheduled Presentation
• Today’s Presentation
– ASTER-D
• Upcoming Presentations
– 11APR13: Candidate Standards Presentation (confirmed)
Join the SDC Initiative
• To join the Structured Data Capture (SDC) Initiative, go here:
http://wiki.siframework.org/Join+Structured+Data+Capture+Initiative.
• Joining the initiative ensures that you are included on initiative
communications and announcements. You may join as an Interested
Party or a Committed Member. (More information about these two
options is on the Join page.)
• Thank you! Your commitment and participation are critical to our
success.
Structured Data Capture (SDC) Initiative:
Proposed Standards & Harmonization WGs and Timeline
Dec ‘12
Jan ‘13
Feb ‘13
Mar ‘13
Apr ‘13
May ‘13
Jun ‘13
Jul ‘13
Initiative Kick Off: 1/23/13
Pilots & Evaluation
after September
Use Case & Functional
Requirements
Pre-Planning
Aug ‘13
Pre-Discovery
Standards & Harmonization
Sept ‘13
Pilots &
Testing
Evaluation
SDC All-Hands WG
Use Case WG
Standards & Harmonization WG
Form SWG
- (1) CDE Standard
- (2) Structure Standard
Standards SWG
- (3) EHR Interaction Standard
- (4) Auto-populate standard
Technical
Work stream
Common Formats SWG…
AHRQ Lead
Content
Work stream
PCOR Content SWG…
NLM Lead
Structured Data Capture Initiative
Proposed Use Case & Functional Requirements Development Timeline
Week
Target
Date
All Hands WG Meeting Tasks
1
2/28
Use Case Kick-Off & UC Process Overview
Introduce: Assumptions, Pre/Post Conditions
-
3/7
2
3/14
User Stories, Pre/Post
Conditions
3
3/21
User Stories, Actors & Roles
4
3/28
Base Flow, Activity Diagram
5
4/4
6
Homework
due Tuesday COB
Review: Charter content, Context
Diagram, Assumptions
Cancelled for HIMSS
Finalize: Context Diagram,
Assumptions
Review: User Stories
Finalize: Actors/Roles, Pre/Post Conditions
Draft: User Stories
Review: Actors & Roles, Pre/Post Conditions
Review: User Stories
Finalize: User Stories
Review: Base Flow, Activity Diagram
Functional Requirements
Finalize: Base Flow, Activity
Diagram
Review: Functional Requirements
4/11
Functional Requirements,
Sequence Diagram
Review: Functional Requirements,
Sequence Diagram
Review: Functional Requirements,
Sequence Diagram
7
4/18
Data Requirements
Finalize: Functional Requirements,
Sequence Diagram
Review: Data Requirements, Risks,
Issues, & Obstacles
8
4/25
Data Requirements, Risks,
Issues, & Obstacles
Review: Data Requirements, Risks,
Issues, & Obstacles
Review: Data Requirements, Risks,
Issues, & Obstacles
9
5/2
Finalize: Data Requirements, Risks, Issues, & Obstacles
10
5/9
Full Review
11
5/16
End-to-End Review (5/10-5/20)
12
5/23
Consensus (5/24-5/29)
FINAL CONSENSUS
None
End-to-End Review (5/10-5/20)
End-to-End Review due 5/20
Cast consensus vote
SDC Use Case Comments
• See spreadsheet.
SDC Use Case
Functional Requirements
• See word document.
Next Steps
• HOMEWORK
– Provide comments to all posted content on wiki
– http://wiki.siframework.org/Structured+Data+Capture+Use+Case+Comments
• Next Work Group Meeting
– Will focus on the Candidate Standards List
– Thursday, April 11, 2013 from 3:30pm – 5:00pm Eastern
• http://wiki.siframework.org/Structured+Data+Capture+Initiative
• Reminder: All SDC Announcements, Meeting Schedules, Agendas,
Minutes, References, Use Cases, and Project Charter are posted on
the SDC Wiki page
– http://wiki.siframework.org/Structured+Data+Capture+Initiative
Community Presentation
• Topic: ASTER-D
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ASTER-D
Project Overview and Demo
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ASTER-D Team
Project Sponsor:
FDA CDRH
- Terrie Reed; Director, Informatics
- Leslie Tompkins; Informatics Team
Project Contributors:
Quintiles – Outcome
- Dan Levy; Vice President, Information Technology
- Tom Taylor; Sr. Project Manager
Mercy
- Joe Drozda; MD
- Project Team includes: Paul Helmering, James Roach, Karen Call, Ben Graf, Pallavi
Chandak, Mark Ramach
Children’s National
- Brian Jacobs; MD
- Lorenzo Nicholson; Project Manager
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ASTER-D Goals
Increase the number and quality of device adverse event reports, currently being underreported, by streamlining the time it takes to complete and submit a 3500A form. The
project also supports an FDA initiative to collect Unique Device Identifiers (UDI).
The Adverse Spontaneous Triggered Events Reporting (ASTER) study demonstrated that
facilitated, “triggered reporting” increased the number of adverse events reported by
clinicians. CDRH is piloting ASTER-D to facilitate the use of hospital EHRs and Incident
Reporting Systems to detect and automatically report select devices associated adverse events
to the FDA.
The creation of systems that facilitate triggered or automatic reporting of selected devicerelated adverse events via the EHR to the FDA as part of a clinician’s normal work flow is likely
to increase the number and quality of adverse event reports, decrease under-reporting, and
more regularly alert the FDA of potential device-related concerns. *
* Source: Center for Devices and Radiological Health, U.S. Food and Drug Administration.
Strengthening Our National System for Medical Device Postmarket Surveillance, (Sept.
2012).
*
ASTER-D Project Overview
Method:
Enable the 3500A form within an EHR / incident reporting system via RFD at a
determined trigger to:
a) Pre-populate appropriate data into the 3500A, reducing the data entry burden.
b) Improve data quality by adding edit checks and warnings.
Current Status:
Mercy implemented an AE reporting interface with pre-population of data, including UDI,
from their EHR and incident reporting systems.
Outcome has developed a Safety Information Exchange (SIE), a set of cloud-based
services, which host the 3500A form. RFD has been enabled to serve the form within
Mercy’s interface.
3500A data are collected and transformed to the HL7 ICSR format for submission to
FDA.
Next Steps:
Dry-run testing of Mercy.
Incorporating Children's National into the project.
3-month data submission by each partner.
Publication of final findings.
3500A to HL7 ISCR
SDC &
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ASTER-D Synergy
SDC Use Case Model:
SDC & ASTER-D Synergy
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EHR (Form Filler)
1
Selects form/template
4
Form/Template Repository
2
Finds form/template
External Data Repository
7
5
Extract, transform & load data
by form/template
Caches data
Inputs data
3
Converts, populates and
displays form
6
Stores/transmits data
• A potential Adverse Event occurs.
•Via RFD (Retrieve Form for Data Capture), the 3500A form is surfaced within the EHR (or other form filler).
• After review of the AE, with the potential for manual entry of additional data, the completed AE is ready for
submission to FDA.
• A complete and approved 3500A form is transformed to HL7 ICSR and transmitted to the FDA’s eMDR
(Electronic Medical Device Reporting).
• The AE data are ultimately stored in MAUDE (Manufacturer and User Facility Device Experience Database).
*
ASTER-D Demo
Q&A
Thank You!
Contact Information
• For questions, please contact your support leads
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Initiative Coordinator: Evelyn Gallego (evelyn.gallego@siframework.org)
Project Manager: Jenny Brush (jenny.brush@esacinc.com)
PM Support: Zachary May (zachary.may@esacinc.com)
Use Case/Requirements Lead: Jennifer Sisto (jennifer.t.sisto@accenturefederal.com)
Standards Development Lead: Caryn Just (caryn.k.just@accenturefederal.com)