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Initiatives of Potential Interest to the Public Health Tiger Team

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Presentation on theme: "Initiatives of Potential Interest to the Public Health Tiger Team"— Presentation transcript:

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

2 S&I Initiative Portfolio Snapshot:
Pre-Discovery Use Case Harmonization RI, Test & Pilot Evaluation Structured Data Capture In production Data Access Framework Active Initiatives EU/US eHealth Cooperation Blue Button Plus PDMP & HIT Integration Clinical Quality Framework Data Provenance Public Health Community-Led* or Other Agency-Led Lab Results Interface Laboratory Orders Interface esMD Longitudinal Coordination of Care Direct Project (S&I Archetype) Data Segmentation for Privacy Inactive or Closed Initiatives Transitions of Care Query Health Health eDecisions * 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

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) Clinical Laboratories HIT Suppliers 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 ONC CMS/DLS CAP CDC/LPSB API LabCorp
Robert Dieterle (Lead) John Feikema CMS/DLS Daniel Cajigas Karen Dyer 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 Dorthi Blair Gaby Jewell Dr. John David Nolen Epic Craig Newman Meditech Ellen Hawrylciw Joe Wall Sunquest Information Systems Laurecia Dailey-Evans Megan Schmidt COLA Dr. John Daly

6 Workgroup Goals Initial Execution Phase Standards
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 Meaningful Use Stage 2 EHR certification
Test Report definition CLIA required elements and best practice elements EHR behaviors for certification Cancel test behaviors Reflex and add-on testing definitions and behaviors Results status and succession Anatomic Pathology Reporting Cardinality and Error Handling

8 Examples CLIA required elements and best practice elements
Required 42 CFR (c)(1-7) Best practice additions from CLIA regulations and laboratory best practice EHR behaviors for certification Matching to patient /order Store and/or display required and best practice information, for example: Patient name Patient identifiers Gender / Age Specimen information Cancel test behaviors Provider cancel including lab status indicators Lab cancel Appropriate cancel transactions and notifications Reflex and add-on testing definitions and behaviors Provider add-on Reflex testing as defined by agreement between lab and provider Includes Microbiology use case

9 Preliminary Recommendations
Standards Reliable delivery of test results (Delivery Notification) Support PDFs for complex reports Support for Laboratory Validation Transactions (TBD) Recommendations regarding Test Report display usability Recommendation regarding the use of clinical vocabularies such as LOINC, SNOMED and UCUM Testable Behaviors (Required and Best Practice) Consuming reported data Displaying information in the Test Report Saving information required for validation of EHR behaviors EHR Certification and Testing Use cases and test data to validate support for all common data types, limits and common usability problems Focus on the “Test Report” Policy CLIA guidance to ensure that laboratories that adhere to the recommendations and use the new procedures satisfy CLIA EHR interface validation requirements

10 Goal: Participants LOINC Orders Effort
To create a standard LOINC definition for 90 % (by volume) of ambulatory test orders Participants ONC S&I Workgroup Open to all stakeholders Input to LOI / eDoS Initiative CDC Provides workgroup leadership NLM Provides clinical and standards leadership Provides analytical support Regenstrief Institute Supports LOINC Provides expertise in establishing new LOINC codes CHCF Provides funding for data collection Part of ongoing support of laboratory standardization initiatives

11 LOINC Reporting Name Effort
Goal: To create a standard LOINC names for ordering and reporting (long and short name) Participants ONC Leadership Work with policy issues EHR Certification CDC Provides expertise to consolidate industry examples and support overall effort NLM Provides clinical and standards leadership Provides analytical support Regenstrief Institute Supports LOINC Provides expertise in establishing new LOINC name LOINC_NUM COMPONENT SHORTNAME LONG_COMMON_NAME 7655-4 Ambrosia bidentata Ab.IgE Southern Ragweed IgE Qn Southern Ragweed IgE Ab [Units/volume] in Serum Ambrosia bidentata Ab.IgE.RAST class Southern Ragweed IgE RAST Ql Southern Ragweed IgE Ab RAST class in Serum Beta 2 globulin Beta2 Glob SerPl Elph-mCnc Beta 2 globulin [Mass/volume] in Serum or Plasma by Electrophoresis Beta2 Glob 24h Ur Elph-mRate Beta 2 globulin [Mass/time] in 24 hour Urine by Electrophoresis Beta2 Glob Fld Elph-mCnc Beta 2 globulin [Mass/volume] in Body fluid by Electrophoresis Beta2 Glob Ur Elph-mCnc Beta 2 globulin [Mass/volume] in Urine by Electrophoresis Beta2 Glob CSF Elph-mCnc Beta 2 globulin [Mass/volume] in Cerebral spinal fluid by Electrophoresis

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 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 EHR Functional Model Conformance Framework HL7 GCIT, EHR, & OO WG NIST S&I Framework Lab Profile (Applicable to other domains) Lab Results Interface (LRI) IG Functional and Behavioral Requirements Community SMEs Requirements 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 2 A B Lab Results Store Associate Use 1 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)

19

20 Data Provenance Charter/Scope Summary Goals : Tiger Team
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

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