Diagnostic Audiology Reporting Implementation Guide

1a. Project Name Diagnostic Audiology Reporting HL7 V2 Implementation Guide 1b. Project ID 1631 1c. Is Your Project an Investigative Project (aka PSS-Lite)? No 1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU? No 1e. Today's Date 1f. Name of standard being reaffirmed 1g. Project Artifact Information 1h. ISO/IEC Standard to Adopt 1i. Does the standard include excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption? 1j. Unit of Measure 2a. Primary/Sponsor WG Public Health 2d. Project Facilitator Oregon EHDI (Meuy Swafford, Heather Morrow-Almeida), Lura Daussat (Public Health Informatics Institute) 2e. Other Interested Parties (and roles) CDC EHDI team – co-sponsor the project and provide domain knowledge Xidong Deng, Marcus Gaffney, Eric Cahill, Winnie Chung American Speech Language Hearing Association (Julie Ambrose and Floyd Roye), American Audiology Association (Allison Grimes): Provide domain knowledge National Diagnostic Audiology Reporting Standards Work Group (see 6a) - Provide domain knowledge Patient Administration WG - subject matter experts for scheduling workflows Orders and Observations - subject matter experts for orders/observation and result 2f. Modeling Facilitator 2g. Publishing Facilitator Craig Newman 2h. Vocabulary Facilitator 2i. Domain Expert Representative Heather Morrow-Almeida, Shelby Atwill, Meuy Swafford 2j. Business Requirements Analyst 2k. Conformance Facilitator Craig Newman 2l. Other Facilitators 2m. Implementers 1) Oregon EHDI with Oregon Health & Science University and Epic 2) Rhode Island EHDI with hospitals and audiology clinics 3a. Project Scope Complete, timely and accurate reporting of diagnostic audiology results to State Early Hearing Detection and Intervention (EHDI) programs is critical to achieve the aim of preventing delays in the development of speech, language and social skills for children who are deaf or hard of hearing. Health Information Exchange (HIE) is a proven success for timely, complete and accurate reporting of newborn hearing screening results. An informatics-focused solution is needed to mirror the success of HIE for diagnostic audiology results. The proposed project aims to develop a HL7 v2 implementation guide to facilitate universal exchange of pediatric diagnostic audiology results between provider EHR and state EHDI information systems. The project will cover the following use cases: 1.Sharing diagnostic audiology visit information: this use case focus on exchange of information regarding a fulfilled audiology diagnostic evaluation appointment. This includes sending and receiving the following groups of data elements: •Patient demographics (Name, ID, mother or caregiver’s name, address, contact) •Audiology provider (Name, ID, address) •Appointment (date, time) •Diagnostic audiology tests performed •Results of the diagnostic evaluation: left ear, including type, severity, and configuration of hearing loss, if a diagnosis is made. •Results of the diagnostic evaluation: right ear, including type, severity, and configuration of hearing loss, if a diagnosis is made. •Results of diagnostic evaluation in the form of audiogram •Risk factors for congenital or late-onset hearing loss •Recommended referrals and follow-up tests or services 2.Sharing no show or change of appointment information: this use case focus on the provider notifying state EHDI program about a missed/change of scheduled diagnostic audiology appointment, so that the EHDI program can take appropriate actions to follow up with the patient. This includes sending and receiving information on •Patient demographics (Name, ID, mother or caregiver’s name, address, contact) •Audiology provider (name, ID, address) •Scheduled appointment (date, time) •No show, cancellation, or change of the appointment Attachments 3b. Project Need The goal of Early Hearing Detection and Intervention (EHDI) is to assure that all newborns receive a hearing screening by one month of age, infants who refer on newborn screening receive diagnostic evaluation by three months of age and infants diagnosed with hearing loss are enrolled into early intervention services by six months of age, also known as the EHDI 1-3-6 goals. The purpose of this timeline for hearing screening, diagnosis and intervention services is to maximize early access to language and communication for brain development for children who are deaf or hard of hearing. EHDI programs monitor and track infants’ progress in meeting these goals, using reports of hearing screening, diagnosis and intervention status. Timely, accurate and complete reporting for each of these steps is critical. Many state EHDI programs have legislative requirements related to tracking, monitoring and communicating the results of hearing screenings, diagnoses and intervention services. Diagnostic audiology results are reported to EHDI programs in various formats and methods, but typically via paper documentation or direct data entry into an EHDI Information System. These methods rely on audiologists to actively provide results and involves duplication of data entry as the results already exist in the electronic health record. Late and missing documentation of results have been ongoing challenges to EHDI programs across the country for years, leading to unnecessary effort by EHDI program staff, confusing communications with families and providers, and sometimes, late access to critical services for children identified as deaf or hard of hearing. The developmental trajectory for children who are deaf or hard of hearing is at risk. Newborn hearing screening HL7 standards are successfully in use and have proven success in improving the timeliness and completeness of reporting. State EHDI programs and pediatric audiologists have expressed the need and value for a standard HL7 reporting methodology for diagnostic audiology data as well. This ballot is intended to fulfill the promise of HL7 standards for diagnostic audiology data. 3c. Security Risk No 3d. External Drivers LOINC and/or SNOMED-CT codes need to be established for missing core data elements and value sets. 3e. Objectives/Deliverables and Target Dates Submit for STU Ballot (First Ballot Cycle) - 2021 Jan Complete STU Reconciliation - April 2021 Submit for 2nd STU Ballot - May 2021 Request STU Publication - September 2021 STU Period – 12 months - September 2022 Submit for Normative Ballot - September 2022 Complete Normative Reconciliation - January 2023 Receive ANSI Approval - ? 3f. Common Names / Keywords / Aliases: Diagnostic Audiology Reporting Implementation Guide for HL7 V2, EHDI HL7 V2 IG 3g. Lineage N/A 3h. Project Dependencies N/A 3i. HL7-Managed Project Document Repository URL: https://confluence.hl7.org/display/PHWG/Diagnostic+Audiology+Reporting+Implementation+Guide 3j. Backwards Compatibility Unknown 3k. Additional Backwards Compatibility Information (if applicable) 3l. Using Current V3 Data Types? No 3l. Reason for not using current V3 data types? 3m. External Vocabularies Yes 3n. List of Vocabularies LOINC, SNOMED-CT, ICD10, CPT, UCUM 3o. Earliest prior release and/or version to which the compatibility applies 4a. Products V2 Messages - Clinical 4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to? 4c. FHIR Profiles Version 4d. Please define your New Product Definition 4d. Please define your New Product Family 5a. Project Intent Implementation Guide (IG) will be created/modified 5a. White Paper Type 5a. Is the project adopting/endorsing an externally developed IG? No 5a. Externally developed IG is to be (select one) 5a. Specify external organization 5a. Revising Current Standard Info 5b. Project Ballot Type STU to Normative 5c. Additional Ballot Info 5d. Joint Copyright No 5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval. no 6a. External Project Collaboration State EHDI Programs: IL, NH, NC, GA, MN, ND, WA, IA, NE, FL, OR, RI American Speech Language Hearing Association (ASHA) Hospitals/University Audiology: Boston Children’s Hospital, UCLA Medical Center, University of Miami, YKHC, Oregon Health & Science University, and Oregon Legacy Health System HIT Standards: Public Health Informatics Institute, and Regenstrief Institute EHDI-IS/Hospital IT: OZ Systems Public Health Informatics Consulting: HLN Consulting, LLC 6b. Content Already Developed The workgroup has identified a list of core data elements and a proposed HL7 V2 message 6c. Content externally developed? No 6d. List Developers of Externally Developed Content 6e. Is this a hosted (externally funded) project? Yes 6f. Stakeholders 6f. Other Stakeholders 6g. Vendors EHR, PHR, Equipment, Health Care IT, Other 6g. Other Vendors 6h. Providers Local and State Departments of Health, Healthcare Institutions (hospitals, long term care, home care, mental health), Other 6h. Other Providers Audiologist 6i. Realm U.S. Realm Specific 7d. US Realm Approval Date Aug 18, 2020 7a. Management Group(s) to Review PSS V2 7b. Sponsoring WG Approval Date Jun 04, 2020 7c. Co-Sponsor Approval Date 7c. Co-Sponsor 2 Approval Date 7c. Co-Sponsor 3 Approval Date 7c. Co-Sponsor 4 Approval Date 7c. Co-Sponsor 5 Approval Date 7c. Co-Sponsor 6 Approval Date 7c. Co-Sponsor 7 Approval Date 7c. Co-Sponsor 8 Approval Date 7c. Co-Sponsor 9 Approval Date 7c. Co-Sponsor 10 Approval Date 7e. CDA MG Approval Date 7f. FMG Approval Date 7g. V2 MG Approval Date Jun 05, 2020 7h. Architecture Review Board Approval Date 7i. Steering Division Approval Date Sep 10, 2020 7j. TSC Approval Date Sep 28, 2020