The LIVD Implementation Guide is the result of a combined IICC and HL7 project team to express the content into FHIR profiles. The following individuals supported creating this guide:
- Pam Banning - 3M
- Hans Buitendijk - Cerner
- Rob Hausam - Hausam Consulting
- Ed Heierman - Abbott
- Riki Merrick - Association of Public Health Laboratories
- JD Nolen - Mercy Children's Hospital
- Andrea Pitkus
- Dan Rutz - Epic
- Kathy Walsh - LabCorp
- David Burgess - LabCorp
- Ron van Duyne - CDC
- Michael Waters - FDA
The Food and Drug Administration (FDA ) supports the development and use of the LIVD Implementation Guide.
The FDA recognized that with the increasing implementation of electronic health records (EHR), there has been a greater demand to standardize the way that in vitro diagnostic (IVD) tests are coded. Efforts to harmonize and standardize information captured and stored in electronic healthcare systems carry important implications for public health, including expediting access to patient diagnostic information for healthcare providers, reducing burdens on laboratories for connecting new diagnostic systems to Laboratory Information Systems (LIS), and facilitating the use of healthcare information for decision support tools, in addition to many more potential uses.
At present, LOINC is the IVD coding system that is most widely used by clinical laboratories and EHRs, and is the IVD coding standard recommended by the Office of the National Coordinator for Health Information Technology (ONC) in the U.S. Department of Health and Human Services (HHS) as an essential part of meaningful use. LOINC is a partially FDA-recognized consensus standard, where the recognition is limited to IVD tests.
FDA strongly supports the use of an FDA-recognized consensus standard as the mechanism to communicate or disseminate the LOINC codes provided by manufacturers . The LOINC transmission document for IVDs (LIVD) standard is one standard explicitly developed for this purpose by the IVD Industry Connectivity Consortium (IICC), and can be found at the following location: http://ivdconnectivity.org/livd/. The LIVD Implementation Guide is based on this work.
The development of the LIVD Specification and Implementation Guide was an international effort, as highlighted by the involvement of the following organizations:
- IVD Industry Connectivity Consortium (IICC)
- IHE Pathology and Laboratory Medicine (PaLM) Technical Committee
- LIS vendors
- Cerner Corporation
- Orchard Software
- IVD instrument manufacturers
- Abbott Laboratories
- Becton Dickenson
- Roche Diagnostics International, Ltd
- Swiss Laboratory Interoperability Interest Group (Joint Venture of FAMH.ch, IHE-Suisse.ch, HL7.ch, SULM.ch)