structured data capture (sdc) all hands meeting april 4, 2013
TRANSCRIPT
Structured Data Capture (SDC)All Hands Meeting
April 4, 2013
Meeting Etiquette
2
• 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.o Send comments to All Panelists so they can be
addressed publically in the chat, or discussed in the meeting (as appropriate).
From S&I Framework to Participants:Hi everyone: remember to keep your phone on mute
All Panelists
Agenda
Topic Time Allotted
Welcome and AnnouncementsMeeting Reminders & AnnouncementsJoin the InitiativeSDC Roadmap
10 minutes
Use Case Timeline ReviewSDC Use Case Comments & DispositionReview 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
4
Please check the meeting schedule weekly as the meeting link and call in numbers will change.
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.
Pilots & Evaluationafter September
Standards & Harmonization
Use Case & Functional Requirements
Pre-Discovery
Pre-Planning
Structured Data Capture (SDC) Initiative:Proposed Standards & Harmonization WGs and Timeline
Dec ‘12 Apr ‘13Jan ‘13 Feb ‘13 Mar ‘13 May ‘13 Jun ‘13 Jul ‘13 Aug ‘13 Sept ‘13Initiative Kick Off: 1/23/13
Pilots & Testing
Evaluation
Standards SWG- (3) EHR Interaction Standard- (4) Auto-populate standard
Form SWG- (1) CDE Standard- (2) Structure Standard
TechnicalWork stream
ContentWork stream
SDC All-Hands WG
Use Case WG
Common Formats SWG…AHRQ Lead
PCOR Content SWG…NLM Lead
Standards & Harmonization WG
Week TargetDate All Hands WG Meeting Tasks Homework
due Tuesday COB
1 2/28 Use Case Kick-Off & UC Process OverviewIntroduce: Assumptions, Pre/Post Conditions
Review: Charter content, Context Diagram, Assumptions
- 3/7 Cancelled for HIMSS
2 3/14 User Stories, Pre/Post Conditions
Finalize: Context Diagram, Assumptions
Draft: User StoriesReview: Actors & Roles, Pre/Post Conditions
3 3/21 User Stories, Actors & Roles Review: User StoriesFinalize: Actors/Roles, Pre/Post Conditions Review: User Stories
4 3/28 Base Flow, Activity Diagram Finalize: User Stories Review: Base Flow, Activity Diagram
5 4/4 Functional Requirements Finalize: Base Flow, Activity Diagram Review: Functional Requirements
6 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 None
10 5/9 Full Review End-to-End Review (5/10-5/20)
11 5/16 End-to-End Review (5/10-5/20) End-to-End Review due 5/20
12 5/23 Consensus (5/24-5/29) Cast consensus vote
FINAL CONSENSUS
Structured Data Capture InitiativeProposed Use Case & Functional Requirements Development Timeline
SDC Use Case Comments
• See spreadsheet.
SDC Use CaseFunctional 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
* ASTER-DProject Overview and Demo
* ASTER-D TeamProject 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
* ASTER-D GoalsIncrease the number and quality of device adverse event reports, currently being under-reported, 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 device-related 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).
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.
* ASTER-D Project Overview
3500A to HL7 ISCR
SDC & * ASTER-D Synergy SDC Use Case Model:
• 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).
1 Selects form/template2 Finds form/template
3 Converts, populates and displays form
4 Inputs data
5 Caches data
6 Stores/transmits data
7 Extract, transform & load data by form/template
SDC &* ASTER-D Synergy EHR (Form Filler) External Data RepositoryForm/Template Repository
* ASTER-D Demo
Q & A
Thank You!
Contact Information
• For questions, please contact your support leads– Initiative Coordinator: Evelyn Gallego ([email protected])– Project Manager: Jenny Brush ([email protected])– PM Support: Zachary May ([email protected])– Use Case/Requirements Lead: Jennifer Sisto ([email protected])– Standards Development Lead: Caryn Just ([email protected])