Structured Data Capture (SDC) All Hands Meeting

1. Structured Data Capture (SDC)All Hands Meeting February 14, 2013

2. Meeting Etiquette From S&I Framework to Participants: Hi everyone: remember to keep your phone on mute  All Panelists • 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 • Hold = Elevator Music = frustrated speakers and participants • This meeting is being recorded • 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. • Send comments to All Panelists so they can be addressed publically in the chat, or discussed in the meeting (as appropriate).

3. Agenda

4. Welcome and Announcements Weekly Meetings Please check the meeting schedule weekly as the meeting link and call in numbers will change. • Structured Data Capture (SDC) Initiative holds weekly community meetings on Thursdays at 3:25 pm EST. • Please see the SDC Wiki Page for meeting information • http://wiki.siframework.org/Structured+Data+Capture+Initiative

5. HIMSS Attendance HIMSS Conference being held March 3-7 coincides with SDC All-Hands meeting planned for March 7th. The SDC All Hands Meeting scheduled for Thursday, March 7th has been CANCELLED. SDC Leads are making arrangements for an informal meet-and-greet during the conference. More information will be provided to the SDC community in the coming weeks.

6. SDC Project Charter Review Review and Comment • Thank you to everyone who has commented so far. • A reminder for anyone who has not yet reviewed the Charter - this is your opportunity to provide input! • Review and comment on the SDC Project Charter here: • http://wiki.siframework.org/Structured+Data+Capture+Charter+and+Members • All current comments have been reviewed by the SDC Team and deposed. You can review the SDC Lead responses in the comment spreadsheet at the bottom of the SDC Project Charter Page (same link as above).

7. Continue SDC Project Charter Review • Comment Period will CLOSE on Tuesday, February 19, 2013 at 8:00 pm Eastern. • Consensus Voting will OPEN on Thursday 21, 2013 at 8:00 am Eastern. • Today • Focus on Value Statement and Target Outcomes • Switch to Word document • Notes / comments / edits will be recorded in-line in the Word document.

8. AHRQ Common Formats

9. Common Formats • Common language for patient safety event reporting • Common language & definitions • Standardized rules for data collection • Standardize the patient safety event information collected

10. Structured Data Capture Conceptual Workflow CDE Library Finds form/template 2 Selects form/template 1 EHR System Converts, populates & displays form 3 Other domain AHRQ CDEs 4 Provider CDEs Inputs data [Common Formats] Specified Structured Displayed Form/Template Caches data Captured Data Form Library Form 5 xx Actor Key John Doe x 6 x Provider/ End User x Stores/ transmits data x x EHR System Patient Safety [Common Formats] Forms Clinical Research Other domain External Data CDEs Forms Repository Extract, Transform, & Load Data by form/ template 7 End User

11. Current Problem with Adverse Events and Reporting HHS Office of the Inspector General reports Nov 2010 and Jan 2012: • OIG reported that 13.5% of hospitalized Medicare beneficiaries experienced serious adverse events; an additional 13.5% experienced temporary harm events • Hospital staff did not report 86% of events to incident reporting systems • Inconsistent identification of adverse events • Confusion among front line staff • Reporting not identified as a worthwhile use of time

12. System Needs: Patient Safety Measurement Decrease data collection burden to end user Collect once & supply data to whatever agencies need reports Increase value to institution collecting the data, states, Federal agencies, & accreditors Enhance local patient safety and quality improvement Improving benchmarking of local performance with regional & national means

13. Common Formats • Authorized by Patient Safety Act in 2005 PSOs • Developed with a Federal work group comprising major health agencies (e.g., CDC, CMS, FDA, DOD, VA) • Incorporates input from public, industry • Reviewed by an NQF expert panel, which provides advice to AHRQ • Promulgated as “guidance” announced in the Federal Register • Approved by OMB (process & Formats)

14. Common Formats Development AHRQ reviews current public and private systems. AHRQ expands Common Formats to new areas based on feedback. AHRQ reviews current evidence base. AHRQ harmonizes when possible, create new content when needed. AHRQ refines and revises Common Formats based upon feedback. NQF convenes Common Formats Expert Panel to review comments. AHRQ presents draft event description to Federal Patient Safety Work Group. PSOs and vendors implement Common Formats in electronic systems. Patient Safety Work Group and subject matter experts help refine Common Formats. AHRQ publishes Common Formats on the web, announce availability and public comment via NQF in Federal Register.

15. How do Common Formats work? • Comprehensive set of modules allows for capture of patient safety event data from ANY patient safety concern • Incidents – patient safety events that reached the patient, whether or not there was harm • Near misses (or close calls) – patient safety events that did not reach the patient • Unsafe conditions – any circumstance that increases the probability of a patient safety event

16. How do Common Formats work? • Comprehensive modules cover all types of events: • Common events • Rare events (includes NQF Serious Reportable Events) • Modular design allows for expansion • Addition of new topics • Expansion to new settings

17. How do Common Formats work? • Generic modules – information (CDEs) common to all events • Example- reporter, location, harm level, patient demographics, contributing factors • Event specific modules • CDEs limited to discrete topic areas: • Blood, Devices (including HIT), Falls, Healthcare Associated Infections, Medications, Perinatal, Pressure Ulcer, Surgery & Anesthesia, VTE

18. Common Formats as part of CDE • The Common Formats can be used to create a complete initial patient safety report for healthcare providers and PSOs. • Generic CDEs paired with Event Specific CDEs make a complete patient safety report • AHRQ technical specifications for local data collection using the Common Formats define the form/template to assemble the pertinent data elements for each type of incident in a precise order

19. What is a Common Format? What does it look like? 1.1 A fall is a sudden, unintended, uncontrolled downward displacement of a patient’s body to the ground or other object (e.g., onto a bed, chair, or bedside mat).. 1.1.1 Inclusions 1.1.1.1 A fall not known to be assisted 1.1.1.2 Assisted fall - when patient begins to fall and is assisted to the ground by another person 1.1.2 Exclusions 1.1.2.1 A fall resulting from a purposeful action or violent blow (e.g., a patient pushes another patient) 1.1.2.2 Near fall – loss of balance that does not result in a fall

20. What is a Common Format? What does it look like? 1. Was the fall unassisted or assisted? CHECK ONE a. Unassisted b. Assisted c. Unknown

21. Generic Common Formats

22. Hospital Common Formats For all events, Common Formats assess general information. Generic Common Formats – General Information

23. Hospital Common Formats If the event is covered by an Event-Specific Format, additional information will be requested Medication Generic Common Formats – General Information

24. Hospital Common Formats If the event involves more than one type of adverse action, e.g., a malfunctioning device that administers too much drug, then more than one event-specific Format will be invoked. Medication Device Generic Common Formats – General Information

25. Hospital Common Formats Narratives are collected on all adverse events. While they are not useful at a national level, they are invaluable at the local level. Narrative Medication Device Generic Common Formats – General Information

26. CDEs and AHRQ Common Formats • Providers may have needs for data elements not included in the AHRQ Common Formats • Local requirements (hospital or state specific) • Specialty details • Research needs • Modular framework allows for addition of elements that are important to other users

27. Event Summary Report

28. Common Formats Components • Incident – 168 data elements may apply • Near miss – 102 data elements may apply • Unsafe condition – 55 data elements may apply • No more than 65 of these data elements could reasonably be expected to be documented in (& thus accessible from) a mature EHR

29. SDC Data Flow: Provider to PSO to NPSD EHR Structured Data Capture Provider Environment User: AHRQ National Quality Reports Incident Reporting System User: Patient Safety Organization (PSO) Patient Safety Work Product Privacy Protection Center (PPC) Network of Patient Safety Databases (NPSD) Patient Safety Organization (PSO) User: Provider Other Qualified Sources User: Researchers and Policy Makers

30. Common Formats and SDC Challenges • Need to fully align both the formats and CDE used by the Common Formats with those data standards identified for Meaningful Use • Need to identify how to maximally take advantage of the potential for a more direct relationship between the Common Formats and the EHRs: • Is there enough information extractable for auto population of incident reporting system “forms” to make a meaningful difference? • Will structured data capture efficiently fit into the clinical work flow • Reduce time to complete reports? • Increase volume of reports to incident reporting systems?

31. National Drivers forAdoption of the Common Formats • Institute of Medicine Report on Health IT and Patient Safety, November 2011 – recommends use of the Common Formats, as well as PSOs, for reporting IT-related adverse events • Office of the Inspector General (HHS) – 2011 & 2012 reports on adverse events in hospitals recommend surveyors/accreditors evaluate hospitals regarding their use of the Common Formats • CMS – is working with AHRQ to align CMS programs, including survey & certification, with the Common Formats • FDA – has been working for nearly two years with AHRQ to align its device-reporting system, MedSun, with Common Formats. • Office of the National Coordinator for HIT – requested challenge award proposals for adverse event reporting using Common Formats & PSOs; new S&I Framework Initiative focuses on Structured Data Capture

32. Common Formats on the Web https://www.psoppc.org Dr. Amy Helwig amy.helwig@ahrq.hhs.gov

33. Next Steps • HOMEWORK: Comment on the Project Charter: • http://wiki.siframework.org/Structured+Data+Capture+Charter+and+Members • Next Work Group Meeting • Thursday, February 21, 2013 from 3:30pm - 4:30pm Eastern • http://wiki.siframework.org/Structured+Data+Capture+Initiative • Reminder: All SDC Announcements, Meeting Schedules, Agendas, Minutes, Reference Materials, Use Case, Project Charter and general information will be posted on the SDC Wiki page • http://wiki.siframework.org/Structured+Data+Capture+Initiative

34. Contact Information • For questions, please contact your support leads • 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)