Structured Data Capture (SDC)

Patient Safety Event & Adverse Event Reporting

Sub-Working GroupFebruary 3, 2014

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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 (rjaffe@chpso.org)• AHRQ Co-Leads

– Diane Cousins (Diane.Cousins@ahrq.hhs.gov)– Glenn Egelman (glenn.egelman@ahrq.hhs.gov)

• FDA Co-Lead– Mitra Rocca (mitra.rocca@fda.hhs.gov)– Terrie Reed (terrie.reed@fda.hhs.gov )

• SDC Initiative Coordinator– Evelyn Gallego (evelyn.gallego@siframework.org)

• SDC Pilot Support Lead– Jenny Brush (jenny.brush@esacinc.com)