Structured Data Capture (SDC) Public Health Tiger Team June 25 th, 2013 1.

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Presentation transcript:

Structured Data Capture (SDC) Public Health Tiger Team June 25 th,

Public Health Tiger Team Overview Items Request for selection criteria template/guidance – User Story Michelle Williamson, RN, MSIS, CPHIT – Senior Health Informatics Scientist – CDC/National Center for Health Statistics Question and Answers Next Week 2

Public Health Tiger Team wiki ger+Team ger+Team Every Tuesday 2-3 pm – Dial In: – Access code: – URL: nstage/g.php?t=a&d= nstage/g.php?t=a&d= **This info will not change. 3

WIKI Capture+Initiative Capture+Initiative ger+Team ger+Team 4

Structured Data Capture Scope Define the necessary requirements (including metadata) which will drive the identification and harmonization of standards that will facilitate the collection of supplemental EHR-derived data Develop and validate a standards based data architecture so that a structured set of data can be accessed from EHRs and be stored for merger 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 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, as resources permit 5 5

Structured Data Capture Data Architecture Infrastructure will consist of four new standards that will enable EHRs to capture and store structured data: 1.Standard for 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 Standards will facilitate the collection of data so that any researcher, clinical trial sponsor, reporting and/or oversight entity can access and interpret the data in electronic format Will leverage existing standards such as XML and CDISC Retrieve Form for Data Capture (RFD) Standards will facilitate the collection of data so that any researcher, clinical trial sponsor, reporting and/or oversight entity can access and interpret the data in electronic format Will leverage existing standards such as XML and CDISC Retrieve Form for Data Capture (RFD) 6

What is a form manager A forms manager is a service that can be updated anytime to include – Data that isn’t found in the EHR. – Build upon existing Common Data Elements (not found within EHR) – Certified interaction with the EHR 7

Who hosts Forms Manager Open for discussion – Public Health can influence this – We can make that part of our decision making processes – Propose models for pilots – Public Health, HIE, central CDC hosting - all possibilities 8

EHR PH Form Sample Types of Reporting Quality Research Public Health Case Reporting (Pilot CDA) EHR and SDC Model ELR Immunization Cancer CDA Forms Repository Request Form (CDISC RFDC) Deliver Form Deliver data from form {Format Type, TBD} Example Types of Reporting CDEs Meta Data Business Logic Define Forms 9

EHR Form Sample Types of Reporting Quality Research Public Health Forms Repository Request Form (CDISC RFDC) Deliver Form CDEs Metadata Business Logic Vocab, order, skip patterns Define Forms Form Repository 10

Case Notification (Pilot CDA) Immunization Cancer CDA Deliver data from form {Format Type, TBD} Public Health Agency Public Health IIS Cancer Registries ELR/Disease Surveillance Systems ELR

Benefits Ability to receive data that wouldn’t otherwise be available within the EHR Ability to work in parallel with overall SDC community Influence and shape overall SDC effort Flexible architecture Reduce workflow with pre-population 12

What SDC is not… Is not replacing “CDA” Is not only Public Health focused Is not adding Common Data Elements (CDE) directly into the EHR 13

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Value of Engagement & Integration Targeted aspects of the Public Health Reporting Initiative (PHRi) are relevant to the planned efforts for the SDC Initiative The SDC initiative has a set-scope and timeline to move forward with, but has the opportunity for community involvement and also additional Content Work stream efforts The next slide outlines the Current Roadmap for SDC, and places PHRi could be involved are outlined in red 15

Pilots & Evaluation after September Standards & Harmonization Use Case & Functional Requirements Pre-Discovery Pre-Planning Overall Structured Data Capture (SDC) Initiative: Proposed Standards & Harmonization WGs and Timeline Dec ‘12Apr ‘13Jan ‘13Feb ‘13Mar ‘13May ‘13Jun ‘13Jul ‘13Aug ‘13Sept ‘13 Initiative Kick Off: 1/23/13 Pilots & Testing Evaluation Content Work stream Common Formats SWG… AHRQ Lead PCOR Content SWG… NLM Lead PHRi Content SWG… PH Lead SDC All-Hands WG Standards & Harmonization WG Use Case WG Standards SWG - (3) EHR Interaction Standard - (4) Auto-populate standard Form SWG - (1) CDE Standard - (2) Structure Standard Technical Work stream Potential PHRi Community involvement in SDC WGs Potential PHRi Content Work Stream 16

Applicable SDC Public Health User Story Reportable Condition User Story A Provider has identified a patient with a reportable condition. Using an existing EHR system, the Provider requests the reportable condition form electronically from the jurisdictional public health organization or entity. In the background, the EHR system sends information already collected about the patient to a forms manager. The Provider now sees the jurisdictional public health reportable condition form inside his or her own EHR/EMR system. Conveniently, most of the data are already pre-populated in this form. The Provider verifies the pre-populated data, adds any missing data, and then submits the form. The Provider receives a response that confirms that the report was submitted to Public Health electronically and received by the public health information system. 17

Building Upon PHRI Efforts Some user stories need to be consolidated into more generic use cases Common data elements great start, but may need some more work to consolidate and add metadata Consolidation important because of the concept of pre-population 18

Benefits of SDC Model Streamlined process with forms manager to update data elements for future inclusion. – EHR CDE updates no longer an option – interaction with EHR and Forms Manager certified, so no changes needed for EHR vendor – Not as difficult with forms manager approach - one change could be incorporated by multiple vendors H7N9 example - new questions about travel history not in EHR easy to add 19

Activities for Public Health Domain 1.Criteria for prioritization 2.Actual prioritization 3.Review of Common Data Elements from PHRI 4.Identification of future CDE tasks 20

Possible user story's need to be considered Vital Record: CDC’s National Center for Health Statistics (NCHS) Environmental Communicable 21

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NIH Definition for ‘Common Data Element’ NIH CDE Resource Portal defines ‘common data element’ CDE as: A data element that is common to multiple data sets across different studies Emphasis is on the intentional use of CDEs to improve data quality and promote data sharing Types of CDEs include: – Universal: CDEs that may be used in studies, regardless of the specific disease or condition – Domain-specific: CDEs that are designed and intended for use in studies of a particular topic, disease or condition, body system or classification – Required: CDEs that are required or expected, as a mater of institutional policy – Core: CDEs that are required or expected to be collected in particular classes of studies 23 Source: 23

NIH Common Data Element (CDE) Resource Portal 24 Provides single point-of-entry for information about NIH- supported CDE initiatives and CDE tools & resources Enables browsing of descriptive summaries of the CDE initiatives and of the subject areas to which they apply Links out to repositories containing the data elements themselves. Version 1.0 launched in January 2013 Contains information on 16 NIH-supported initiatives Future enhancements: additional NIH and HHS initiatives, improved navigation 24

Current and Targeted PHRi Engagement 25 OrganizationUser StoriesAll HandsUse CaseContentFormsStandardsPilots FDA FDA Spontaneous Triggered Event Reporting FDA Spontaneous Triggered Event Reporting #2 (ASTER-D) Medical Device Reporting (FDA-CDRH) CDC Cancer Impact of Work on Health Newborn Hearing Screening Public Health Case Reporting Currently Engaged OrganizationUser StoriesAll HandsUse CaseContentFormsStandardsPilots MN State Minnesota Dept of Health - Communicable Diseases (ASTHO) NE State Cardiovascular Disease (NDHHS) Agilex Syndromic Measure Reporting Quality Reporting PHDSC Communicable Disease Case Reporting MI State Michigan Disease Surveillance System - Public Health Communicable Disease Surveillance System OR State Oregon Health Authority - Mandated Disease Reporting WI State UW MED - PHINEX: UW Medical Record - Public Health Information Exchange Targeted for Engagement

Other PHRI Use Cases TBD 26 User Story Adverse Events Immunization Information Systems (AIRA) Chronic Disease Cancer Genetics – BRCA National Health Care Surveys Child Health Birth Defects Reporting Birth Event Reporting Early Hearing Detection and Intervention (EHDI) Health Information Exchanges (HIEs) and Immunizations Immunization Immunization Information Systems (AIRA) Maine CDC - Data Research and Vital Statistics User Story Communicable Diseases Florida Dept of Health - Enteric Disease Reporting Healthcare-Associated Infections Michigan Disease Surveillance System - Public Health Communicable Disease Surveillance System Minnesota Dept of Health - Communicable Diseases (ASTHO) South Dakota Communicable Disease Reporting User Story Infrastructure, Quality, Research Admin Use of Health Data National Health Care Surveys PH Reporting User Story Model Public Health Data Quality Assurance Quality Reporting Registration for Public Health Reporting Healthcare-Associated Infections

Public Health Work Plan PhaseActivityTimeline 1Pre-PlanningInitiate April 22 nd 2CDE and Form/Template Identification Initiate June 18 th 3Pilot Concept/ Engagement Initiate July 22 27

Step 3: Pilot TBD Step 2: CDE DefineDevelop Incorporate Step 1: Use Case Prioritization and Select Work plans 28

Proposed User Stories Vital Statistics (NCHS) Hospital care survey (NCHS) Vaccine Adverse Event Reporting (VAERS) (HLN) School/camp/day care physical form (HLN) Adverse event reporting to FDA (JPHIT) Early Hearing Detection and Intervention (EHDI) / Newborn Hearing Screening. (NCBDDD) Cancer Registry Reporting (NCCDHP) 29

Step 1: Use Case List Potential Use Cases and Prioritization of Criteria Prioritization Select 30

Common Data Element CDE: Understand CDE and Metadata Forms Manager DEFINE: CDE and Meta Data DEVELOP: Vocab, Business Logic, Structure INCORPORATE: Alignment of template and content standards 31

Pre-Planning SDC Public Health Overview Webinars Solicit membership and support Begin conceptualizing use cases and pilots Prepare and kick-off SDC Public Health Work Group week of June 10 th. 32

CDE and Form Template Identification Identify PHRi user stories to incorporate with SDC Conduct CDE Overview session Facilitate WG identification of CDE’s for PH reporting Facilitate WG identification of forms/templates for PH Reporting 33

Pilot Engagement Develop pilot engagement plan Develop Pilot Summary Document Monitor Pilot Progress 34

Overall SDC Engagement Participate in SDC All-Hands meetings Participate in SDC Technical SWG Meetings Present PH CDE to SDC Community 35

FAQ’s What specific data elements will be included? Streamlined or varied? How CDA fits into SDC? Lessons learned from use cases Overlap with PHRi 36

Thoughts, Comments, Questions? Contact: Jim (James) Daniel, ONC John M. Saindon, CDC 37

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S&I Framework Overview Specific health interoperability initiatives guide the design and development of a fully integrated and connected health information system. An S&I Initiative focuses on a single challenge with a set of value-creating goals and outcomes, and the development of content, technical specifications and reusable tools and services. Call for Participation: The overall success of the S&I Framework is dependent upon volunteer experts from the healthcare industry and we welcome any interested party to get involved in S&I Framework Initiatives, participate in discussions and provide comments and feedback by joining the Wiki:

Overall SDC S&I Framework Phases & Likely Structured Data Capture Activities 40 PhasePlanned Activities Pre-Discovery  Development of Initiative Synopsis  Development of Initiative Charter  Definition of Goals & Initiative Outcomes Discovery  Creation/Validation of Use Cases, User Stories & Functional Requirements  Identification of interoperability gaps, barriers, obstacles and costs  Review of Vocabulary Implementation  Creation of aligned specification  Documentation of relevant specifications and reference implementations such as guides, design documents, etc.  Validation of Vocabulary  Development of testing tools and reference implementation tools Pilot  Validation of aligned specifications, testing tools, and reference implementation tools  Revision of documentation and tools Evaluation  Measurement of initiative success against goals and outcomes  Identification of best practices and lessons learned from pilots for wider scale deployment  Identification of hard and soft policy tools that could be considered for wider scale deployments 40 We are here

SDC Data Requirements in UC Transactions Form / Template Repository to EHR System Request for Form / Template Structured Data to External Data Repository Patient Data Form Description Context Privacy & Security Non-Patient Data specific to domain Actions Patient Data Form Description Context Privacy & Security Non-Patient Data specific to domain Patient Data Context Privacy & Security Form Description EHR System Form/Template Repository External Data Repository Request for Form/Template Optional Patient Data Send requested Form/Template Optionally populated Send completed Form/Template structured data 41

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