1. Early Hearing Detection and Intervention (EHDI) Interoperability Pilot Project Presentation to CDC Health Information Innovation Consortium by Xidong Deng 1 Dina Dickerson 2 August 11, 2015 1.National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention 2.Oregon Health Authority 1

2. EHDI-IS and EHDI HIT Standards State-based EHDI information systems capable of identifying, matching, collecting, and reporting data on all occurrent births through the three components of the EHDI process (screening, diagnosis, and early intervention). NameTypeDescriptionStandard System [1] Newborn Screening Coding and Terminology GuideDataProvides codes and terminology for newborn hearing screening procedures, results, and risk factors for infant hearing loss. LOINC/SNOMED-CT [2] HL7 Version 2.6 Implementation Guide: Early Hearing Detection and Intervention (EHDI) Results MessageStandardizes how newborn hearing screening information is transmitted from a point of care device to an interested consumer, such as public health. HL7 v2 [3] IHE Quality, Research and Public Health Technical Framework Supplement: Newborn Admission Notification Information (NANI) MessageDescribes the content needed to communicate a timely newborn admission notification electronically from a birthing facility to public health to be used by newborn screening programs. HL7 v2, v3 message [4] IHE Quality, Research and Public Health Technical Framework Supplement: Early Hearing Detection and Intervention DocumentDefines how to exchange data required to populate a newborn’s Hearing Plan of Care document. HL7 CDA R2 [5] HL7 EHR-System Public Health Functional ProfileFunctionalDefines functional requirements and criteria to support public health- clinical information collection, management and exchanges for specific public health programs (domains). HL7 EHR-S Functional Model [6] IHE Quality, Research and Public Health Technical Framework Supplement: Quality Measure Execution- Early Hearing (QME-EH) QualityDescribes the content needed to communicate patient-level data to electronically monitor the performance of EHDI initiatives for newborns and young children. HL7 QRDA [7] Hearing Screening Before Hospital Discharge (NQF 1354 /CMS31v3) QualityElectronic clinical quality measure definition for newborn hearing screening quality reporting, adopted by the CMS EHR Incentive Program for Hospitals and Critical Access Hospitals HL7 HQMF

3. EHDI Standard-based Information Exchange EHDI Standards-based Information Exchange Labor & Delivery Newborn Hearing Screening Device State EHDI Information System Provider’s EHR System Hospital EHR System Federal Reporting [4] [3,4] [6] [5] [2] [6]

4. The IHE EHDI Profile The EHDI Profile defines how to exchange data required to populate a newborn’s Hearing Plan of Care document http://www.ihe.net/uploadedFiles/Documents/QRPH/IHE_QRPH_Suppl_EHDI.pdf http://wiki.ihe.net/index.php?title=PCD_Profile_DEC_Overview

5. 5 A Real Life Audiologist User Story

6. 6 Project Objective By June 30, 2015, in collaboration with CDC, OZ Systems, Oregon Health Authority (OHA), and OHA’s clinical trading partner, Oregon Health & Science University (OHSU), conduct an implementation of the Integrating the Healthcare Enterprise (IHE) EHDI Profile for the exchange of production hearing screening and care plan data between clinical and public health entities. EHDI Interoperability Pilot Project Charter, 2015

7. 7 Comparison of Oregon EHDI Pilot Phases 1 and 2 2012-13 Phase 1: Public Health Data Standards Consortium IHE Profile Early Hearing Care Plan (EHCP) Epic EHR test harness with simulated hearing screening result data RFD data capture EHDI-IS test database 2014-15 Phase 2: Public Health Informatics Institute IHE Profile Hearing Plan of Care (HPoC) Epic EHR live data captured via newborn assessment flowsheet IHE PCD-01 technical framework with EHR as Device Observation Reporter EHDI-IS live database

8. 8 Phase 2 Project Stages StageLead Process and content evaluation and mappingOHA Device observation reporterOHSU Device observation consumer/ content creatorOZ Content consumerOHA Standards conformance validation & scenariosLantana Data quality testingOHA Lessons learnedAll

9. 9 Mapping to HPoC

10. 10 Data flow Capture & ShareSendReceive, Consume & Repackage SendReceive & Consume ParticipantOHSU VPN OZ sFTP OHA RoleDevice Observation Reporter Device Observation Consumer/ Content Creator Content Consumer Content & Rules Hearing Screening Results Decision Support Rules Data Mapping Rules Demographics Discharge Date FormatEpic EHR HL7 v2HPoCEHDI-IS

11. 11 Data Flow Detail: OHSU Screening results message creation Epic user enters data into Newborn Assessment flowsheet and clicks File Epic generates HL7 result message carrying screening data OHSU interface engine transforms HL7 to meet EHDI specifications OZ receives screening data in HL7 messages Newborn patient discharge HPoC creation Epic user discharges newborn patient Epic generates HL7 ADT discharge message OHSU interface engine transforms HL7 to EHDI result with status of Final OZ receives Final result and triggers HPoC generation Data capture and file Epic generated HL7 message (easy) Interface engine transformed HL7 message to EHDI specifications (difficult)

12. 12 Data Flow Detail: OZ Systems Screening results and discharge message processing Receive and store HL7 messages via VPN tunnel into HPoC Mapper Send ACK or NACK validation message back to sender Apply logic to determine if HPoC is ready for creation (includes results + discharge data) If ready send HL7 message to HPoC Builder Newborn hearing screening HPoC creation HPoC Builder receives HL7 message from HPoC Mapper and populates CDA template HPoC Builder generates HPoC HPoC Builder validates HPoC against national standard HPoC delivered to OHA via sFTP regardless of validation results HPoC message sent to OHAHuman-readable HPoC

13. 13 lantanagroup.com ScenarioArtifacts 0Preliminary test to validate if testing environment is working as expected. AExpected case. Epic user enters all the hearing data and hits save. The patient is later discharged. BMultiple measurements. The Epic user enters the results over time. Maybe over days. This includes data that has been saved and then edited. The patient is later discharged. CDeleted Measurements. Values are entered and saved, but then the user winds up deleting all values again. The patient is later discharged. DDischarge without any screening results. EResults without discharge. FResults after discharge. Test Scenarios

14. Validation Scenarios 14 lantanagroup.com Outcome ContentArtifacts A1 – 09910001L: passR: referHS1; D; HPoC A2 – 09910002L: passR: referHS1; D; HPoC A3 – 09910003L: passR: not performedHS1; D; HPoC A4 – 09910004L: passR: not performedHS1; D; HPoC A5 – 09910005L: not performedR: not performedHS1; D; HPoC A6 – 09910006L: referR: referHS1; D; HPoC B2 – 09920002L: referR: passHS1; HS2; HS3; D; HPoC C1 – 09930001L: referR: referHS1; HS2; D; HPoC C2 – 09930002L: referR: passHS1; HS2; D; HPoC D1 – 09940001L: no informationR: no informationD; HPoC D2 – 09940002L: no informationR: no informationD; HPoC E1 – 09950001No HPoC HS1; HS2; E2 – 09950002No HPoC HS1; HS2; F1 – 09960001L: no informationR: no informationD; HPoC; HS1; F2 – 09960002L: no informationR: no informationD; HPoC; HS1;

15. Quality Review 249 HPoCs created > 228 processed > 224 unique records reviewed Demographics (4 fields) Address (1 field) Test Results (5 fields)

17. 17 Lessons Learned Planning The goals for a pilot should be clarified as distinct and separate from production-level implementation Collaboration Establish decision-making process and authority during planning phase Ensure all relevant parties attend team meetings, including EHDI program staff, IT staff, clinicians and EHR vendor representative Use shared communication and file-sharing tools Testing Testing scenarios may require time to develop, may be workflow dependent and may require multiple rounds of testing to finalize A minimum of one month's production data is needed to identify limitations of the testing scenarios Workflow Clinical workflow improvements should be evaluated, identified and implemented prior to the start of a technology project to ensure data integrity is at its best Standard Need flexibility with the standard to deal with reality of the clinical setting workflow and EHR – this does not happen in a vacuum Overall Sending newborn hearing screening data to OHA is not a priority for OHSU ITG

18. 18 Recommendations Develop testing mode capability that allows test cases to be re-run while preserving test scenario data to ease pilot testing for others Move HPoC creation to the State rather than hospitals Focus more on improving data quality and less on transport Funding and timelines need to be realistic Define the minimum/core standards, allow local control of implementation decisions National/academic standards specifications should be responsive and flexible to real life – rigidity is not realistic, and need for data trumps fidelity to the model

19. 19 Acknowledgements Oregon Health Authority Meuy Swafford Heather Morrow-Almeida Trong Nguyen Chia-Hua Yu Claudia Bingham Oregon Health & Science University Heather Durham Doug Clauder Tom Drury OZ Systems Teresa Finitzo Sarah Shaw Ken Pool Public Health Informatics Institute Jim Jellison Trish Miller Lantana Consulting Group Lisa Nelson CDC John Eichwald Marcus Gaffney

20. 20 Questions? Dina Dickerson dinapdx@gmail.com 503.804.8430 Xidong Deng xdeng@cdc.gov 404.498.6746