HL7 Implementation Guide(s) for CDA® Release 2 & FHIR® Release 4: Healthcare Associated Infection Reports

1a. Project Name HL7 Implementation Guide(s) for CDA® Release 2 & FHIR® Release 4: Healthcare Associated Infection Reports 1b. Project ID 1192 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 Structured Documents 2d. Project Facilitator Andrea Benin (aqb4@cdc.gov) 2e. Other Interested Parties (and roles) 2f. Modeling Facilitator Sarah Gaunt (sarah.gaunt@lantanagroup.com), Austin Kreisler (AUSTIN.J.KREISLER@leidos.com) 2g. Publishing Facilitator Sarah Gaunt (sarah.gaunt@lantanagroup.com) 2h. Vocabulary Facilitator Sarah Gaunt (sarah.gaunt@lantanagroup.com) 2i. Domain Expert Representative 2j. Business Requirements Analyst Ahmed Tahir (tahira@leidos.com) 2k. Conformance Facilitator 2l. Other Facilitators 2m. Implementers CDC/NHSN Epic 3a. Project Scope With cooperation from CDC and Healthcare Associated Infections (HAI) software vendors, this project will develop Normative Release 4 of the HL7 Implementation Guide for CDA® Release 2: Healthcare Associated Infection Reports. The implementation guide will continue to support electronic submission of HAI data to the National Healthcare Safety Network. It is the intent of this project to incrementally move to Release 4 of the IG via a series of new DSTU releases, each with incremental changes in scope over time as well as the planned introduction of at least one new HAI Report. Potential incremental changes include but are not limited to: • Addition or deletion of data elements for existing HAI reports • Further alignment of existing HAI IG templates with C-CDA templates One likely major change for Normative Release 4 is the inclusion of a new HAI CDA report • Inclusion of COVID-19 data Continue to develop a FHIR Implementation Guide in parallel with the CDA Implementation Guide. This new standard will include several STU releases on the path to a Normative Release 1 of the HL7 Implementation Guide for FHIR Release 4: Healthcare Associated Infection Reports. This PSS likely will not see a Normative release of the FHIR IG. The FHIR and CDA implementation guides will be aligned (i.e. if there is a change made in one product, that change will need to be made in the other product). The approach will primarily use the Questionnaire and QuestionnaireResponse resources (note: these resources will not go normative in FHIR R4), though other resources will be used as needed. CDC is providing NHSN developers, vocabulary experts and CDA experts to support this project. SDWG will devote committee time to review the design and draft specification before ballot, as well as to support ballot reconciliation. Attachments 3b. Project Need The CDC’s National Healthcare Safety Network (NHSN) is being used by the Centers for Medicare and Medicaid Services and 30 states plus the District of Columbia as the technical infrastructure by which they obtain healthcare-associated infection and quality measure data. Currently, more than 12,000 facilities are reporting data into NHSN. This project revises existing reports and adds new ones to collect data that are relevant to CDC’s surveillance plan. 3c. Security Risk Yes 3d. External Drivers CDC/NHSN Application Release cycles 3e. Objectives/Deliverables and Target Dates Aug 2020: CDA R2 Normative Release 3 IG Publication (publication date depends on COVID-19 requirements) Sept 2020: CDA R2 Normative Release 4, STU Release 1 IG Ballot (includes COVID-19 requirements) TBD: Additional HAI CDA IG STU Releases TBD: Additional FHIR IG Releases (release type depends on used FHIR resource maturity levels) Sept 2022: CDA R4 Normative Release IG ballot Dec 2022: Project End Date 3f. Common Names / Keywords / Aliases: HAI CDA IG, NHSN CDA IG, HAI, HAI FHIR IG 3g. Lineage HL7 Implementation Guide for CDA® Release 2: Healthcare Associated Infection (HAI) Reports, Release 3 – US Realm 3h. Project Dependencies HAI CDA IG Release 3 passing Normative ballot and subsequent publication 3i. HL7-Managed Project Document Repository URL: FHIR: https://github.com/HL7/HAI 3j. Backwards Compatibility No 3k. Additional Backwards Compatibility Information (if applicable) 3l. Using Current V3 Data Types? No 3l. Reason for not using current V3 data types? CDA R2 (and FHIR) 3m. External Vocabularies Yes 3n. List of Vocabularies SNOMED CD, LOINC, cdcNHSN, RxNorm, Standard Occupational Classification, NUCCProviderCodes, UMLS, CVS, ABC Codabar, ISBT-128, CPT-4 3o. Earliest prior release and/or version to which the compatibility applies 4a. Products FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, V3 Documents – Clinical (e.g. CDA) 4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to? R4 4c. FHIR Profiles Version R4 4d. Please define your New Product Definition 4d. Please define your New Product Family 5a. Project Intent Revise current standard 5a. White Paper Type 5a. Is the project adopting/endorsing an externally developed IG? 5a. Externally developed IG is to be (select one) 5a. Specify external organization 5a. Revising Current Standard Info - HL7 Implementation Guide for CDA® Release 2: Healthcare Associated Infection (HAI) Reports, Release 3 – US Realm - Published: 2020 - Additional (new) reports are being added to the IG - The new standard would normally be considered a replacement, but Release 3 of the IG is being included in US Federal Regulation and needs to remain available for implementers. 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 6b. Content Already Developed 6c. Content externally developed? 6d. List Developers of Externally Developed Content 6e. Is this a hosted (externally funded) project? 6f. Stakeholders Quality Reporting Agencies, Regulatory Agency 6f. Other Stakeholders 6g. Vendors Health Care IT 6g. Other Vendors 6h. Providers Local and State Departments of Health, Healthcare Institutions (hospitals, long term care, home care, mental health) 6h. Other Providers 6i. Realm U.S. Realm Specific 7d. US Realm Approval Date Jun 09, 2020 7a. Management Group(s) to Review PSS CDA, FHIR 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 Jun 17, 2020 7f. FMG Approval Date Jun 10, 2020 7g. V2 MG Approval Date 7h. Architecture Review Board Approval Date 7i. Steering Division Approval Date Jun 23, 2020 7j. TSC Approval Date