structured data capture (sdc) patient safety event & adverse event reporting sub-working group...

Structured Data Capture (SDC) Patient Safety Event & Adverse Event Reporting Sub-Working Group February 3, 2014

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Agenda TopicTime Allotted Patient Safety Event and Adverse Event Reporting Sub-Working Group (PSE/AE SWG) Background Goals and Objectives SWG Approach & Activities Timeline SDC IG Specifications 15 minutes Patient Safety Event Reporting Role of Common Formats Why Use EHRs for Patient Safety Event Reporting? 12 minutes Adverse Event Reporting FDA Reporting and the AHRQ Common Formats Why use EHRs for Adverse Event Reporting? 12 minutes SDC PSE/AE SWG Pilot Program & Next Steps 10 minutes

Why are we here today? Our Elevator Pitch Lets 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 Focus SDC 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 templates 2.Standard for the structure or design of the form or template (container) 3.Standard for how EHRs interact with the form or template 4.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) 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 & Harmonization Use Case & Functional Requirements Pre- Discovery Structured Data Capture (SDC) Initiative: Standards & Harmonization WGs and Timeline FEB-MAR 13 OCT-NOV 13 APR-MAY 13 JUN-JUL 13 AUG-SEP 13DEC 13JAN-FEB 14 Kick Off 1/23/13 Evaluation... Technical Work Stream Technical Work Stream Standards SWG 3.EHR Interaction Standard 4.Auto-populate standard SDC All-Hands Work Group Use Case WG Forms SWG 1.CDE Structure Standard 2.Container/Template Standard Standards & Harmonization WG Content Work Stream Content Work Stream PSE/AE SWG AHRQ/FDA Lead PCOR Content SWG NLM Lead PH Tiger Team CDC 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 Approach Identify 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 Phases Activities Outputs 1 1 1 1 1 2 1 1 3 1 1 4 ~ 4 months ~ 6 to 10 months

PSE/AE SWG Timeline: Feb 2014 Feb 2015 Jan- Feb 14Mar- Apr 14May- Jun 14Jul- Aug 14Sept- Oct 14Nov- Dec 14Jan-Feb 15 Milestones PSE & AE Reporting Workflow Development CF Terminology Standards PSE/AE Pilots 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/AE CDEs/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 Mapping Structured 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 Director California 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 Formats Data 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. +

4 1 5 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 2 xx John Doe x x x x x External Repository SDC Scope

SDC PSE Data Flow: Provider to PSO to NPSD Provider Environment Non-identifiable

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 organizations 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 organizations 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 AHRQs 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: Drugs 21CFRPart11, 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: Devices 21CFR803.3 Medical 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, or ii.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 Guidelines Example

31 FDA Drug Data Elements AHRQ Common Formats Data 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

32 FDA Device Data Elements AHRQ Common Formats Data Elements Concomitant Medical Products and Therapy Dates User Facility or Importer Name/Address Relevant Tests Lab 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. Reporters Job FDA Device & Common Formats: Data Element Overlap

AE Device Conceptual Workflow Example AE Device Workflow (source: Mercy Health)

PSO Report Uses AHRQ Common Formats FDA Forms 3500/3500A Uses ICSR Healthcare Provider Environment 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

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+Initiativehttp://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+SWGhttp://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+Initiativehttp://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+Signuphttp://wiki.siframework.org/SDC+PSE+and+AE+SWG+Signup Step 3: Attend the weekly PSE/AE SWG Meetings Meeting Name: SDC PSE/AE SWG Day: Mondays (weekly) Next Meeting is February 10 Time: 1:00 - 2:00 pm Eastern URL: https://siframework1.webex.com/https://siframework1.webex.com/ Dial In Number: 1-650-479-3208 Access code: 665 726 037 Step 4: Participate as a Reference Implementation / Pilot Site

Step 4: Participate as a Pilot Get 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 Participation In 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])[email protected] Glenn Egelman ([email protected])[email protected] FDA Co-Lead Mitra Rocca ([email protected])[email protected] Terrie Reed ([email protected] )[email protected] SDC Initiative Coordinator Evelyn Gallego ([email protected])[email protected] SDC Pilot Support Lead Jenny Brush ([email protected])[email protected]

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