VANGUARD PSS

1a. Project Name VANGUARD PSS 1b. Project ID 1578 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 Clinical Interoperability Council 2b. Co-Sponsor WG Clinical Information Modeling Initiative 2c. Co-Sponsor Level of Involvement Request formal content review prior to ballot 2d. Project Facilitator Stan Huff 2e. Other Interested Parties (and roles) Nursing Knowledge Big Data Science Initiative 2f. Modeling Facilitator Richard Esmond 2g. Publishing Facilitator Richard Esmond 2h. Vocabulary Facilitator Susan Matney 2i. Domain Expert Representative Kevin Baskin, James Morrison, Julia Skapik 2j. Business Requirements Analyst Kevin Baskin 2k. Conformance Facilitator Richard Esmond 2l. Other Facilitators 2m. Implementers PenRad, Cognitive Medical Systems 3a. Project Scope Work with stakeholders across the spectrum to collaboratively define logical clinical models related to central venous access and relevant to longitudinal patient management. Scope begins at the identification of need for access through venous pathway evaluation, device selection and insertion, use, device and venous pathway salvage with applications for monitoring, safety, and clinical effectiveness. This includes continuing care across device, disease and patient life cycles, device safety and effectiveness evaluation, cost and quality analysis, decision support, and development and communication of relevant standards and guidelines. Stakeholders will include patients, families and support groups, multidisciplinary clinical experts (clinical providers and researchers), healthcare institutions, industry representatives (catheter manufacturing and health IT), payers, other interested private agencies and government agencies (including FDA, AHRQ, NLM, ONC, CMSS, CDC, NIH, DOD, and VA). Detailed Clinical Models will be compatible with emerging HL7 interoperability standards. CIMI/CIMPL, FHIR and CQL compatibility are to be the initial priority for implementation. FHIR Profiles, FHIR Extensions and Implementation Guides will be the final deliverable work-products. The work will be project managed by the VANGUARD registry leads with technical support and direction from a group of highly experienced modeling SMEs (Huff, Esmond, McDonald) who will provide quality assurance, validation and problem solving for content. The primary modeling team will be comprised of clinical domain SMEs who will be trained by a modeling expert on the method of creating models and will use a modeling IG (optimally one reviewed by or generated from HSPC). This team will be comprised of US clinicians from VANGUARD and Australian members from AVATAR (https://www.avatargroup.org.au/). Attachments 3b. Project Need Detailed clinical models and FHIR Profiles are required to support reliable and consistent capture and exchange of interoperable medical records. This content, if coded, could be entered into the US Core Dataset for Interoperability (USCDI) under the 21st Century Cures Act. The use case costs billions of dollars a year in procedures and complications, with central line associated bloodstream infections having a mortality rate of 12-25%. Better tracking and monitoring of these devices could allow prevention and mitigation of risks and costs. Clinical Decision Support, Clinical Quality Metrics, Evidence-based and Precision Medicine all require a standardized specification for computable data-elements (aka Clinical Models). This project will define, review and ballot those required specifications and publish them in all appropriate formats. 3c. Security Risk No 3d. External Drivers Submission for review by US Regulatory groups by end of 2020 3e. Objectives/Deliverables and Target Dates STU: Jan 2021 Normative: Sept 2022 3f. Common Names / Keywords / Aliases: Central Line Care; Central Venous Access; Vascular Access 3g. Lineage 3h. Project Dependencies Clinical Information Modeling Initiative (CIMI), FHIR STU4, Clinical Quality Language (CQL) 3i. HL7-Managed Project Document Repository URL: VANGUARD 3j. Backwards Compatibility No 3k. Additional Backwards Compatibility Information (if applicable) 3l. Using Current V3 Data Types? 3l. Reason for not using current V3 data types? 3m. External Vocabularies Yes 3n. List of Vocabularies SNOMED CT, LOINC, NCI 3o. Earliest prior release and/or version to which the compatibility applies 4a. Products FHIR Extensions, FHIR Implementation Guide, FHIR Profiles 4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to? v4 4c. FHIR Profiles Version 4d. Please define your New Product Definition 4d. Please define your New Product Family 5a. Project Intent Create new 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 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 Part of public-private partnership Medical Device Epidemiology Network (MDEpiNet) 6b. Content Already Developed 20% 6c. Content externally developed? No 6d. List Developers of Externally Developed Content 6e. Is this a hosted (externally funded) project? No 6f. Stakeholders Clinical and Public Health Laboratories, Quality Reporting Agencies, Regulatory Agency, Payors 6f. Other Stakeholders 6g. Vendors EHR, PHR, Clinical Decision Support Systems 6g. Other Vendors 6h. Providers Clinical and Public Health Laboratories, Local and State Departments of Health, Healthcare Institutions (hospitals, long term care, home care, mental health) 6h. Other Providers 6i. Realm Universal 7d. US Realm Approval Date 7a. Management Group(s) to Review PSS FHIR 7b. Sponsoring WG Approval Date Jun 27, 2019 7c. Co-Sponsor Approval Date May 23, 2019 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 Nov 06, 2019 7g. V2 MG Approval Date 7h. Architecture Review Board Approval Date 7i. Steering Division Approval Date Nov 22, 2019 7j. TSC Approval Date Jan 06, 2020