Overview: A harmonization and mapping of in vitro diagnostic (IVD) related codes to create infrastructure to support IVDs for future pre-and post-market needs, this project includes pilots planned in antimicrobial susceptibility/resistance, opioid screening and confirmatory testing, testing for acute kidney injury, and diagnosis of sepsis.
Impact for NESTcc: This project could assist in the mapping of relevant codes to improve interoperability of information related to IVDs.
Organization(s): The U.S. Food and Drug Administration (FDA)
Collaborators Include: 5 government offices, 7 IVD manufacturers, 5 healthcare systems, and 10 professional organizations and standards developers
Principal Investigator(s): Michael S. Waters, PhD (FDA)