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Vanguard

Basics

Vanguard

1578
Ballot - STU to Normative


FHIR Implementation Guide

Create New Standard

Details

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/).


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.



Orig target dates: Informative: Target: Jan 2020 STU: Target: May 2020 Normative: Target: Jan 2021


https://confluence.hl7.org/display/CIC/VANGUARD+PSS https://confluence.hl7.org/display/CIC/VANGUARD


Clinical Information Modeling Initiative (CIMI), FHIR R5, Clinical Quality Language (CQL)

Clinical and Public Health Laboratories, Quality Reporting Agencies, Regulatory Agency, Payors,Clinical and Public Health Laboratories; Local and State Departments of Health; Healthcare Institutions (hospitals, long term care, home care, mental health),EHR, PHR; Clinical Decision Support Systems

PenRad, Cognitive Medical Systems

Submission for review by US Regulatory groups by end of 2020

Central Line Care; Central Venous Access; Vascular Access


Yes



2019 October: R. Esmond and S. Huff will pursue the FMG, SD and TSC approvals. They don't anticipate balloting earlier than May 2020 cycle, if that even.
Organization & Realm

Universal

People

Stan Huff



Clinical Interoperability Council Work Group

Clinical Genomics Work Group

Status & Dates

Active

On Hold

06/27/2019

01/01/2023

2023 Jan WGM/Ballot

01/01/2023

2023 Jan WGM/Ballot

Approvals

01/06/2020


Not Needed


All Received




System Info