1c. Is Your Project an Investigative Project (aka PSS-Lite)?
1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU?
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
2e. Other Interested Parties (and roles)
Nursing Knowledge Big Data Science Initiative
2f. Modeling Facilitator
2g. Publishing Facilitator
2h. Vocabulary Facilitator
2i. Domain Expert Representative
Kevin Baskin, James Morrison, Julia Skapik
2j. Business Requirements Analyst
2k. Conformance Facilitator
2l. Other Facilitators
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/).
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
3d. External Drivers
Submission for review by US Regulatory groups by end of 2020
3e. Objectives/Deliverables and Target Dates
Informative: May 2020
STU: Sept 2020
Normative: Jan 2021
3f. Common Names / Keywords / Aliases:
Central Line Care; Central Venous Access; Vascular Access
3h. Project Dependencies
Clinical Information Modeling Initiative (CIMI), FHIR STU4, Clinical Quality Language (CQL)