Initiatives of Potential Interest to the Public Health Tiger Team

1. Initiatives of Potential Interest to the Public Health Tiger Team July 15, 2014 Robert Dieterle

2. S&I Initiative Portfolio Snapshot: Transitions of Care Structured Data Capture In production • Data Access Framework EU/US eHealth Cooperation Active Initiatives • Blue Button Plus PDMP & HIT Integration ClinicalQualityFramework Data Provenance Public Health Lab Results Interface Community-Led* or Other Agency-Led Laboratory Orders Interface esMD Longitudinal Coordination of Care Direct Project (S&I Archetype) Data Segmentation for Privacy Inactive or Closed Initiatives Query Health HealtheDecisions * Community led initiatives leverage the S&I framework platform with minimal or no ONC funded contractor support. 2

3. S&I Laboratory Initiatives • Laboratory Reporting Interface (LRI) • Results Reporting • Laboratory Orders Interface (LOI) • Laboratory Orders • Laboratory electronic Directory of Services (eDOS) • Electronic Test Compendium • Laboratory Vocabulary Standards • LOINC Results • LOINC Orders • LOINC lab compendium • EHR Functional Requirements • Laboratory EHR Functional Model Profile • Laboratory Results Functional Requirements • Laboratory Orders Functional Requirements • LIS Functional Requirements • LIS Functional Model • Laboratory Orders Functional Requirements • Laboratory Results Functional Requirements

4. Laboratory Workgroup Professional Societies Regulatory and Accreditation Organizations Centers for Disease Control and Prevention (CDC) Laboratory Practice Standards Branch Centers for Medicare and Medicaid Services (CMS) Division of Laboratory Services College of American Pathologists (CAP) Office of the National Coordinator (ONC) Laboratory Reporting Tiger Team Association of Pathology Informatics (API) College of American Pathologists (CAP) HIT Suppliers Clinical Laboratories • CLIAC and its member’s professional organizations are represented multiple times (CLIA CDC CAP API) • At least 6 Pathologists are in regular attendance Cleveland Clinic Duke Medicine Emory University School of Medicine Henry Ford Health System LabCorp Massachusetts General Hospital Nebraska Methodist Hospital Quest Diagnostics Weill Cornell Medical College / New York Presbyterian Hospital Cerner Corporation Epic Meditech Sunquest

5. Participants CMS/DLS • Daniel Cajigas • Karen Dyer ONC • Robert Dieterle (Lead) • John Feikema CAP • Dr. Victor Brodsky Weill Cornell Medical College / New York Presbyterian Hospital • Julie Cantor-Weinberg • Dr. Raj C Dash Duke Medicine • Dr. Walter Henricks Cleveland Clinic • Mary Kennedy • Carolyn Knapik CDC/LPSB • Dr. Nancy Cornish • Dr. Anand Dighe Massachusetts General Hospital • MariBeth Gagnon • Anne Pollock • Megan Sawchuk API • Dr. Alexis Carter Emory University • Dr. J. Mark Tuthill Henry Ford Health System LabCorp • David Burgess • Don Chase • Cindy Johns Nebraska Methodist Hospital • Dr. Thomas Williams Quest Diagnostics • Gregory Lovell • Ken McCaslin • Virginia Sturmfels Cerner Corporation • DorthiBlair • Gaby Jewell • Dr. John David Nolen Epic • Craig Newman Meditech • Ellen Hawrylciw • Joe Wall SunquestInformation Systems • Laurecia Dailey-Evans • Megan Schmidt COLA • Dr. John Daly

6. Workgroup Goals Initial Reduce the time and cost to implement and verify (e.g. visual verification) laboratory result reporting interfaces, in the ambulatory environment, while maintaining the accuracy, completeness and usability of laboratory test result information viewed by the authorized person for safe and effective interpretation. Execution Phase Provide recommendations regarding the following subject areas to achieve the overall goal • Standards • Use of and changes to Implementation Guides for Laboratory Reporting Interface (LRI), Laboratory Orders Interface (LOI) and electronic Directory of Services (eDOS) • EHR Functional Requirements • Use of standard clinical vocabulary for laboratory testing • Testing and Certification • NIST validation suite use cases and data sets • NIST usability framework • EHR certification requirements • Policy • Guidance from CMS regarding CLIA • FDA guidance regarding laboratory testing and transfusion software • Accreditation Agencies’ relevant policies • CMS’s Conditions of Participation in regard to authentication of interpretive reports • ONC requirements for EHR certification and CMS requirements for meaningful use

7. Successes

8. Examples

9. Preliminary Recommendations

10. LOINC Orders Effort

11. LOINC Reporting Name Effort

12. EHR Functional Requirements • Create a LAB functional and behavioral requirements Implementation guide for EHR technology • Initial focus is “Incorporate” Lab Results • Compatible with the HL7 Laboratory Result Interface (LRI) implementation guide • Bridge/Harmonize with HL7 EHR Functional Model • Develop a generic conformance framework for specifying “incorporate” requirements • In the end – 3 Documents • EHR Functional Model Lab Results Incorporate Profile • Lab Results Incorporate Functional and Behavioral Requirements IG • Specific the LRI messaging requirements • Conformance framework for Incorporate

13. Problem Statement: MU-2 Criterion • Patient Safety • Common expectations for handling Lab Results • Consistent implementations for handling Lab Results • Regulatory Requirements • CLIA – general requirements (need more specificity) • Lack of Specificity of MU Requirements • Transmit Laboratory Results OK • LRI IG provides detailed requirements • Used by LIS (and EHRs with LIS module) for sending lab result messages to ambulatory EHR technology • Receive Laboratory Results OK • LRI IG provides detailed requirements • Used by ambulatory EHR technology for receiving lab result messages from LIS (or EHRs with LIS module) • Incorporate Laboratory Results NOT OK • LRI IG provides no guidance (not that it should, it is an interface specification) • MU-2 Criterion: “Incorporate Lab Results” – What does that mean? • Needed by ambulatory EHR technology for determining what to do with the data elements in the lab result messages received from LIS (or EHRs with LIS module)

14. Incorporate Lab Results – What does it mean? • HL7, S&I Framework, and NIST collaborate to produce the conformance framework • Community subject matter experts determine the laboratory result-specific requirements • The combination of the conformance framework and requirements = Functional and Behavioral Requirements (defining capabilities, such as Incorporate Lab Results) High-Level • HL7 GCIT, EHR, & OO WG • NIST • S&I Framework Conformance Framework (Applicable to other domains) Functional and Behavioral Requirements EHR Functional Model Lab Profile Lab Results Interface (LRI) IG Requirements Community SMEs Very Specific

15. Incorporate Lab Results • Incorporating lab results involves Storing data elements that were received in the LRI message (elements in scope) • Stored data elements are associated (linked) with a patient record • Stored data elements may be combined (linked) together in the EHR system to provide capabilities such as • Clinical Decision Support • A Public Health Report sent by an EHR system • A Laboratory Results Report display Order A B 2 1 Lab Results Store Associate Use Patient Record Incorporate Link/combine specific data elements received in LRI message Lab Results Associate Provider

16. Test Framework – Incorporate Data

17. esMD • Author of Record -- Digital Signatures for: • Transactions • Bundles of documents • HL7 CDA • Electronic Determination of Coverage (eDoC) • Standards for communication of medical records for • Prior-authorization • Pre-payment review • Post payment Audit • Use of structured and coded elements for specific user stories • Power Mobility Devices • Lower Limb Prosthetics

18. Structured Data Capture Charter/Scope Summary Identify the functional and technical specifications to enable an EHR system to retrieve, display, and fill a structured form or template, and store/submit the completed form to an external repository. Technical Work Streams (focused on the four guidance areas: • Data Element Structure, Form/Template Structure • EHR-Interaction, and Auto-population of Forms) • SDC SOAP/SAML IG (complete – balloting) • SDC FHIR Profile IG (in progress) Content Work Streams (to identify domain-specific data elements, form templates and pilots) • Patient Safety Event/Adverse Event (PSE/AE) • Patient-Centered Outcomes Research (PCOR) • Public Health Tiger Team (Led by CDC/ONC; across CQF, SDC and DAF Initiatives) 3 use cases identified (cancer reporting, early detection and case reporting); • Prior-authorization / e-clinical templates (within the esMD pilots) Two Implementation Guides • SDC SOAP/SAML IG (Complete - Balloting) • Consensus-approved SOAP/SAML IG published on 3/18/14 • SDC FHIR Profile IG (Under Development) • Scope is to create implementation guidance on the use of FHIR Profile(s) for SDC on new Data Element and existing Questionnaire/Questionnaire Answers resources. • Will be balloted through HL7 as Comment-Only in Sep 2014; DSTU in Jan 2015 (aligned with HL7 FHIR Resources publication)

20. Data Provenance Charter/Scope Summary The Data Provenance Initiative aims to establish a standardized way of capturing (including inbound, system generated, and outbound provenance), retaining, and exchanging the unaltered provenance of health information. Goals : • Establish guidance for handling data provenance in the content standards including the level to which provenance could be applied • Establish the minimum set of provenance data elements and vocabulary bindings • Standardize the provenance capabilities Tiger Team Notice for Intent to Ballot approved on 6/30/2014 (HL7) for ballot during the September 2014 HL7 Ballot Cycle • Community Based Collaborative Care (CBCC) WG approved on 4/29/2014- HL7 Co-Sponsor • Structured Docs (SDC) WG approved 06/19/2014 – HL7 Co-Sponsor • US Realm Task force approved 4/29/2014 • Domain Experts Steering Division (DESD) approved 5/28/2014

21. Conclusion • Multiple Initiatives of interest to the Public Health Tiger Team • The Laboratory Effort at ONC/S&I/HL7 • Orders, Results, Compendium • EHR Functional Requirements • LOINC results, orders, names • Laboratory Workgroup • Provided guidance for MU2/3 EHR certification • Provided guidance for standards, certification and policy • esMD • Digital Signatures • CDA templates • SDC • Ability to gather information based on templates external to an EHR • Data Provenance • Source and history of data