To propose steps for creation of LIVD file entries for all IVD tests, available in a centralized repository with or without mapping review. Define the initial design and develop a sustainability and steady state plan for use of LIVD specifically and for other SHIELD standards in the future Ultimate goal is to have data used in patient care, research public health be comparable - need to have support for the full data model for the complete meaning of the test |
Items in scope: Current: Produce a white paper that is citable with the requirements Gather requirements for a LIVD file repository and develop related budget item for development Develop a plan for steady state operationally Develop process to add and review new data elements Develop process for submission, optional review and feedback on content Should include a QA process as part of the submission for either new data elements as well as content
financially
Develop and recommend a SHIELD endorsed standards implementation plan Creation of LIVD Catalog by IVD Manufacturers - increase number of manufacturers creating catalog LAW adoption - increase number of instruments supporting IHE LAW Get more of the standards used in SHIELD as part of Recognized Consensus Standards: Medical Devices (fda.gov) currently listed: LOINC, SNOMED, POCT1A missing: UCUM, CLSI AUTO16 / LAW, IHE profiles
Identify mapping content applicable to a LIVD catalog for terminology alignment (this WG definds the elements, the Vocab and Standards identifies the best approach) Identify which of the data elements are needed in the data flow and which are needed for reference within LIDR
Future:
LIDR WG Parking Lot |
Items out of scope: Harmonization of lab tests - this is important work for clinical interoperability, but is not terminology related, requires lab studies etc (we are interested in documenting the elements needed to better understand the test results) Information modeling around how data from different tests are put to use in LIS / EHR-s data exchange Calculations (e.g. Creatinine ratio) (this may be part of the standards and terminology working group) additional assessments made by humans (this may be part of the standards and terminology working group)
Parking Lot Dealing with calculations / additional observations (in LIDR or elsewhere) Calibrators Provide guidance on best terminology representation for specific methods (TBD in which committee) test cut-offs (included into instrument vs determined on-site)
|
Workplan |
Prior work: https://aphlinformatics.atlassian.net/wiki/spaces/SLC |