structured data capture (sdc) patient safety event & adverse event reporting sub-working group
DESCRIPTION
Structured Data Capture (SDC) Patient Safety Event & Adverse Event Reporting Sub-Working Group. February 3, 2014. Meeting Etiquette. From S&I Framework to Participants: Hi everyone: remember to keep your phone on mute . All Panelists . - PowerPoint PPT PresentationTRANSCRIPT
Structured Data Capture (SDC)
Patient Safety Event & Adverse Event Reporting
Sub-Working GroupFebruary 3, 2014
Meeting Etiquette• 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
AgendaTopic Time Allotted Patient Safety Event and Adverse Event Reporting Sub-Working Group (PSE/AE SWG)
BackgroundGoals and ObjectivesSWG Approach & ActivitiesTimelineSDC IG Specifications
15 minutes
Patient Safety Event ReportingRole of Common FormatsWhy Use EHRs for Patient Safety Event Reporting?
12 minutes
Adverse Event ReportingFDA Reporting and the AHRQ Common FormatsWhy use EHRs for Adverse Event Reporting?
12 minutes
SDC PSE/AE SWG Pilot Program & Next Steps10 minutes
Why are we here today?Our Elevator Pitch…Let’s discuss…• How EHRs can be used to collect and transmit data for patient
safety and adverse event reporting• What the benefit of this new functionality is for you
– Decrease data collection burden by providers and staff– Provide standardized and structured approach for collection and
transmission of data– Reduce need to customize EHR and Health IT systems – Remove barriers to volunteer adverse events
• Why you should become a Pilot Site– Advance testing and validation of standards that will be included in
Meaningful Use and EHR Certification Criteria– Early adopter benefit of implementing new functionality
4
Background: SDC Scope of Work• Develop a standards-based architecture so that a
structured set of data can be accessed from EHRs and be stored for merging with comparable data for other relevant purposes to include: – The electronic Case Report Form (eCRF) used for clinical
research including PCOR– The Incident Report used for patient safety reporting leveraging
AHRQ ‘Common Formats’ and FDA Standard Form 3500/3500a– The Surveillance Case Report Form used for public health
reporting of infectious diseases– The collection of patient information used for Determination of
Coverage
5
Background: SDC Standards FocusSDC Initiative has identified four *standards that specify how EHR systems can capture and store structured data:1. Standard for the structure of the CDEs that will be used
to fill the specified forms or templates2. Standard for the structure or design of the form or
template (container)3. Standard for how EHRs interact with the form or template4. Standard to auto-populate form or template
6
• SDC standards identified are not ‘new’; most are mature standards being used across industry to meet specific interoperability specifications.
• SDC Standards are specified via the SDC Implementation Guide (consensus voting will begin this week)
Pilots &Testing …Standards & HarmonizationUse Case &
FunctionalRequirementsPre-
Discovery
Structured Data Capture (SDC) Initiative:Standards & Harmonization WGs and Timeline
FEB-MAR 13 OCT-NOV 13APR-MAY 13 JUN-JUL 13
AUG-SEP 13 DEC 13 JAN-FEB 14
Kick Off1/23/13
Evaluation...
TechnicalWork Stream
Standards SWG3. EHR Interaction Standard4. Auto-populate standard
SDC All-Hands Work Group
Use Case WG
Forms SWG1. CDE Structure Standard2. Container/Template Standard
Standards & Harmonization WG
ContentWork Stream
PSE/AE SWG…AHRQ/FDA Lead
PCOR Content SWG…NLM Lead
PH Tiger TeamCDC Lead
PSE/AE SWG Goals & Objectives• Goal:
– Validate, test and pilot the S&I SDC interoperability standards that specify how electronic health records (EHRs) can capture and transmit structured data for Patient Safety Event (PSE) and Adverse Event (AE) reporting
• Objectives: – Identify Common Data Elements (CDEs) and associated value sets,
leveraging AHRQ Common Formats, that can be used for PSE and AE reporting from EHRs
– Identify structured forms/templates these CDEs will populate, leveraging AHRQ Common Formats and FDA Form 3500/3500a
– Develop PSE and AE Reporting end-to-end workflow (from EHR system to AHRQ Repository and from EHR system to FDA repository)
– Identify 2 or more organizations to test and pilot the SDC Implementation Guide in a production or near production environment
PSE/AE SWG ApproachIdentify Content
Requirements
• Review & validate CF terminology standards
• Finalize PSE CDEs & Forms
• Finalize AE CDEs & Forms
• Identify PSE reporting workflow
• Identify AE reporting workflow
• PSE CDEs & Forms• AE CDEs & Forms• PSE Workflow• AE Workflow
Crosswalk Content Requirements to SDC Standards
• Harmonize PSE/AE CDEs
• Map PSE & AE CDEs and Forms to SDC IG Specifications
• Review SDC IG against workflow requirements
• Develop Gap Mitigation Plan for Pilots
• SDC Compliant PSE & AE CDEs & Forms
• SDC IG & PSE/AE Workflow Crosswalk
• PSE/AE Pilot Gap Mitigation Plan
Identify & Execute Pilot Projects
• Identify evaluation criteria for Pilot Proposals
• Review Pilot Proposals
• Finalize PSE/AE Pilot Projects
• Kick-off PSE & AE Pilot Projects
• Monitor Pilot Progress
• Pilot Evaluation Criteria• Pilot Proposals• Pilot Performance
Metrics Report• Pilot Status Reports
Evaluate Pilots & Update Standards
• Review Pilot Performance Metrics
• Identify Performance Trends
• Gather recommendations for SDC IG updates/revisions
• Develop PSE/AE IG Companion Guide (as applicable)
• Pilot Performance Trends Report
• PSE/AE IG Companion Guide
Phas
esAc
tiviti
esOu
tput
s
11 12 13 14
~ 4 months ~ 6 to 10 months
PSE/AE SWG Timeline: Feb 2014 – Feb 2015
Jan- Feb 14 Mar- Apr 14 May- Jun 14 Jul- Aug 14 Sept- Oct 14 Nov- Dec 14 Jan-Feb 15
Mile
ston
es
PSE & AE Reporting Workflow Development
CF Terminology Standards
PSE/AEPilots Close
PSE/AE SWG Launch
PSE/AE Pilots Wrap-Up
SDC IG & PSE/AE Workflow Crosswalk
PSE/AE Pilot Proposal Review
PSE/AE Pilot Monitoring & Evaluation
PSE/AECDEs/Forms
Mapped
PSE/AE Companion Guide Development
PSE/AE Workflows Complete
PSE/AE Companion Guide Complete
PSE & AE Reporting CDEs & Forms Review
PSE & AE CDEs/Forms Mapping to SDC Specifications
PSE/AE Pilot Gap Mitigation Plan
PSE/AE Pilots Gap Mitigation Plan Complete
SDC IG Specifications MappingStructured Data Capture Implementation Guide Document
Section 2.4: Specifies the attributes or characteristics (‘metadata’) by which to define data elements.
Section 2.5: Specifies the attributes or characteristics (‘metadata’) by which to define the structure of forms used for data entry.
SDC IG Transactions Crosswalk
Structured Data Capture Implementation Guide Document
Generic Workflow
SDC Transactions
PSE & AE Reporting Workflow
Out of Scope Activities• Identification of new AHRQ Common Formats data
elements (DEs) and forms – Will leverage Version 1.2 of the Common Formats– If new DEs are identified, they will be reviewed for inclusion in
future versions• Identification of new FDA Adverse Event Reporting data
elements and forms– Will leverage FDA Regulated Medical Product Terminologies
listed in NIH NCI EVS and MedWatch Standard Form 3500/3500a
• Identification of a new library, repository or registry to curate and manage PSE and AE DEs and forms
• Automating the selection of proper forms for PSE/AE submission
Patient Safety Event Reporting
Dr. William Munier, Director, Center for Quality Improvement and Patient Safety
Rory Jaffe, MD MBA, Executive DirectorCalifornia Hospital Patient Safety Organization
Role of Common Formats in SDC• AHRQ developing Common Formats over the past
six years• Common Formats represent common language for
patient safety reporting– Provide generic module outlining core Data Elements– Provide representation for event-specific Patient Safety
Report
Common FormatsData Elements (DEs) & Forms
16
Generic DEs• Reporter• Location• Harm Level• Patient
Demographics• Etc…
Event Specific DEs
• Blood & Blood Products
• Device & Medical or Surgical Supply
• Fall• Healthcare-
Associated Infection
• Etc….
+
Category Specific Forms
Generic Form
4
1
5
EHR System
External DataRepository
CDE Library
DisplayedForm
Sends requested form/template
Fills, stores/transmits structured data
Sends request for form/template
3 Converts, populates & displays form
Extract, Transform,& Load Data by form/ template
Forms Manager
Forms Filler
Actor Key
Structured Data Capture Conceptual Workflow
Form/ TemplateRepository
SpecifiedForm/Template
2
xx
John Doe x
x x
x x
Structured Captured Data
Form Library
External Repository
MetadataSource
SDC
Scop
e
IncidentReporting
SDC PSE Data Flow: Provider to PSO to NPSD
Prov
ider
Env
ironm
ent
Patient SafetyWork Product Network of Patient
Safety Databases
Provider
AHRQ National Quality Reports
Researchers/ Policy Makers
Non-
iden
tifiab
le
(NPSD)Patient Safety
Evaluation System
System
To be validated by SWG in Phase 1
SDC Use Case:Patient Safety User Story
A patient in a hospital setting receives healthcare services and the corresponding information (e.g., lab results, medication or medical product information, etc.) is entered or uploaded into the EHR system. One dose of diazepam 10 mg was ordered for the patient at 20:00. The order was not discontinued by the system and was listed on the Medication Administration Record (MAR). The patient was given a second dose of diazepam on the same day at 22:00. Patient remembers getting out of bed during the night to use the bathroom and falling. He was found lying next to his bed with forehead laceration requiring suturing. The adverse event has been identified by the Provider, and the known adverse event report form is requested within the EHR system, rendered, and populated with related patient information from the EHR. The auto-populated form is then displayed within the EHR System. Once initial information is entered by the Provider, the partially completed report is then stored in the organization’s incident reporting system. The patient safety/quality manager, risk manager, healthcare practitioner or other staff enters any additional information and completes the report. Once completed, additional analysis can be performed locally at the healthcare facility and/or the completed report can be sent to the organization’s PSO.
Why Use EHRs for PSE Reporting? The Problem
• HHS Office of Inspector General Reports:– 13.5% of hospitalized Medicare beneficiaries experience
series adverse events; additional 13.5% experienced temporary harm events
– Hospital staff did not report 86% of events to Incident Reporting Systems
• Inconsistent identification of adverse events within hospitals and across hospitals
• Confusion among front line staff regarding what constitutes an event to be reported
• Additional provider and staff burden to complete and submit a Patient Safety Event report (in addition to other reporting requirements)
Why Use EHRs for PSE Reporting? The Solution
• Decrease data collection burden for providers and staff– Single sign on enables collection and submission of data using
one system• EHRs using SDC standards can readily access and
render AHRQ authorized Common Formats (CF)– CF provide comprehensive set of modules for capturing patient
safety event data from ANY patient safety concern– CF provide standardized data elements and forms that can be
rendered by any EHR system using SDC standards• Reduce need to make site-specific modifications to EHR
system and affiliated systems to enable participation in patient safety event reporting
• Remove barriers to volunteer adverse event to AHRQ leading to improvements in population health
Adverse Event Reporting
Mitra Rocca, Associate Director, Medical Informatics, FDA
SDC Use Case:Adverse Event, Medical Device User Story
• On April 1, 2011, a 75 year old male with known heart disease was rushed to the Cardiac Catheterization Lab and a coronary stent was deployed per hospital protocol. After stent insertion, the deployment balloon was unable to be deflated. The balloon had to be forcibly retracted back into the guiding catheter. A second stent was introduced without problems. The scanning of multiple stents triggered a dialogue box within the EHR asking “Why is this device being returned?” If the answer indicates an adverse event, the EHR retrieves a FDA 3500A form, (or FDA 3500 form for voluntary reporting) auto-populates with patient and incident-specific data, and enters any additional information or text into the form. The ‘preliminary report’ is then stored on the hospitals Incident System and referred to the Patient Safety Officer/Risk Manager for further evaluation. Upon completion, the Safety Officer/Risk Manager can: 1) identify the root-cause and suggest/request corrective action; 2a) submit to FDA or FDA Center for Devices and Radiological Health, if necessary; 2b) submit a copy to the device manufacturer; and/or 3) submit to hospital affiliated PSO.
Background• 2005: Formed an interagency committee to develop
AHRQ Common Formats– Collaborated with CDER, CDRH and CBER to gather adverse
event reporting requirements• 2013: Continued Collaboration with CDRH to include UDI
in AHRQ’s Common Formats• Interest in aligning workflow for AE reporting from EHRs
with that of PSE reporting from EHRs• FDA conducted the following demonstration projects:
– ASTER • Collaborated in the pilot with Partners Healthcare System and Pfizer• Conducted the pilot (FHA Interoperability Showcase, HIMSS 2010)
– ASTER-D • DIA Interoperability Showcase 2011• Demonstration Project with Mercy Health (ended 12-31-2013)
FDA AE Reporting Regulations:Drugs21CFRPart11, Section: 314.80
Adverse drug experience. Any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: An adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action.
FDA AE Reporting Regulations:Devices21CFR803.3Medical Device Reporting (or reportable event)1. An event that user facilities become aware of that
reasonably suggests that a device has or may have caused or contributed to a death or serious injury; or
2. An event that manufacturers or importers become aware of that reasonably suggests that one of their marketed devices:i. May have caused or contributed to a death or serious injury, orii. Has malfunctioned and that the device or a similar device
marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Types of FDA AE Reporting• Mandatory Adverse Event Reporting
– Leveraging Standard Form 3500a• Voluntary Adverse Event Reporting
– Leveraging Standard Form 3500
Mandatory AE reporting: MedWatch Standard Form 3500A
28
Voluntary AE reporting: MedWatch Standard Form 3500
29
AE Reporting GuidelinesExample
31
FDA DrugData Elements
AHRQ Common FormatsData Elements
• Patient Identifiers• Provider Identifiers• Preexisting Medical • History• Frequency• Indication• …..
• Stage of Process, when event occurred?
• Compounded preparation• …
•RoA/ Intended administration route
•Expiration Date
FDA Drug & Common Formats: Data Element Overlap SAMPLE
32
FDA DeviceData Elements
AHRQ Common FormatsData Elements
• Concomitant Medical • Products and Therapy Dates• User Facility or Importer
Name/Address• Relevant TestsLab Data, Including Dates• Other Relevant History,
Including Preexisting Medical Conditions
• …
• Briefly describe the location where the event occurred or where the unsafe condition exists
• Patient's Medical Record No.• Was any intervention attempted
in order to "rescue" the patient (i.e., to prevent, to minimize, or to reverse harm)?
• …
• Was a device intended for a single use reused in the event or unsafe condition?
• Report Date• Gender• UDI• Model No.• Serial No. • Reporter’s Job
FDA Device & Common Formats: Data Element Overlap SAMPLE
AE Device Conceptual Workflow • Example AE Device Workflow (source: Mercy Health)
PSO ReportUses AHRQ Common Formats
FDA Forms 3500/3500AUses ICSR
Heal
thca
re P
rovi
der E
nviro
nmen
t
Incidence Reporting System
AE Reporting Conceptual Workflow
Why Use EHRs for AE Reporting? • Data collection is incorporated at the point of care• Fits into the healthcare providers workflow• Eliminate duplicate data entry• Light foot print for EHRs and other affiliated clinical
information systems• Remove barriers to voluntary adverse event reporting to
FDA and mandatory as appropriate leading to improvements in population health
AHRQ – FDA Data Element Harmonization Effort
FDA Individual
Case Safety Reports
SDC PSE/AE Pilot Program
Aim for Pilot Program• Bring awareness on available national standards that will
facilitate how PSE and AE data is collected and reported by EHR systems
• Identify additional content and workflow requirements for reporting
• Provide tools and guidance for managing and evaluating SDC PSE & AE Pilot Projects
• Create a forum to share lessons learned and best practices
• Real world evaluation of SDC Implementation Guide (IG)– Is this implementable? Useable?
• Harmonize PSE & AE data elements and forms
Why Pilot SDC Standards?• Demonstrate compliance with AHRQ PSE & FDA AE
Reporting Requirements• Increase efficiency of development and maintenance of
SDC standards• Advance Stage 3 Meaningful Use of EHRs Learning
Health System where patient information can flow securely from EHRs to other systems
• Validate criteria for inclusion in ONC EHR Certification Program
• Reduce data collection burden on health care providers• Improve comparability of data to better inform research,
quality reporting and ultimately, influence patient care• Contribute to the PSO community• Be recognized as an early adopter
Efficiencies in Reporting to Federal Agencies
Provider
Patient SafetyWork Product
MedWatchForm 3500
MedWatchForm 3500a
Vaccine Safety
Call for Participation• The Patient Safety Event and Adverse Event Sub-working
Group (PSE/AE SWG) is open for anyone to join. • This sub-working group will meet weekly by webinar and
teleconference. • Meeting information can be found on the SDC Wiki:
– http://wiki.siframework.org/Structured+Data+Capture+Initiative
• PSE/AE SWG Wiki Page– http://wiki.siframework.org/Structured+Data+Capture+Patient+Safety+Eve
nt+and+Adverse+Event+SWG
• To make this sub-workgroup a success, we need the help of community members who are eager to make rapid progress on this important project.
Next Steps• Step 1: If you are not yet a member of the SDC Initiative,
please follow the steps for joining here– http://wiki.siframework.org/Structured+Data+Capture+Join+the+Initiative
• Step 2: Join the PSE/AE SWG– http://wiki.siframework.org/SDC+PSE+and+AE+SWG+Signup
• Step 3: Attend the weekly PSE/AE SWG MeetingsMeeting Name: SDC PSE/AE SWGDay: Mondays (weekly) – Next Meeting is February 10Time: 1:00 - 2:00 pm EasternURL: https://siframework1.webex.com/ Dial In Number: 1-650-479-3208Access code: 665 726 037
• Step 4: Participate as a Reference Implementation / Pilot Site…
Step 4: Participate as a PilotGet Started – Fill out the Pilots Interest Survey!
If you or your organization are interested in
participating, please fill out the short SDC Pilots survey.
http://wiki.siframework.org/Structured+Data+Capture+Pilots
SDC Community ParticipationIn addition to NIH/NLM, AHRQ and FDA participation in the SDC Initiative, other key stakeholders include:• CMS• CDC• DoD/VA Interagency Program Office• ASPE• PCORi• NCI• Standards Development Organizations: IHE, HL7,
CDISC, ISO• Vendors: Allscripts, Siemens, McKesson, Cerner,
Greenway, Oz Systems, KBCore
SDC PSE/AE SWG Contacts• PSE/AE SWG Community Lead
– Dr. Rory Jaffe ([email protected])• AHRQ Co-Leads
– Diane Cousins ([email protected])– Glenn Egelman ([email protected])
• FDA Co-Lead– Mitra Rocca ([email protected])– Terrie Reed ([email protected] )
• SDC Initiative Coordinator– Evelyn Gallego ([email protected])
• SDC Pilot Support Lead– Jenny Brush ([email protected])