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Standardize lab data classification to allow its interoperability over a broad array of uses/systems.
Data from the lab would be safely and easily be interpretable to the following uses/systems.
Multi-institutional Research: multi-institutional studies for data aggregation and analysis.
Public Health: Data aggregation for monitoring of public heath and answering public health questions.
Individual Patient’s Data: Lab data from multiple health institutions would easily be aggregated and interpretable based on a single patient. Possibly the patient will have their own database with their health information which they can grant access to other health institutions they are seeking services from.
Test Quality and Monitoring: Ability to create a database of instruments on a national level. There may be ways to use moving average data for monitoring. If standard QC data can also be included, this could be another way of monitoring instrument quality on a national level. Some vendors already do this.
Ensure scalability of interoperability to other unknown/future systems by including all needed data elements in LIVD file/database.
Data elements need to allow enough specificity of a test result to allow aggregations and trending of clinically identical data types.
We need to identify what those data elements are:
We already have LOINC (5 dimensions, sometimes 6)
Component: Basically, the analyte being measured or tested for.
Property: A category of measurement. It is related to units of measure, however, does not define the actual measurement. i.e. molar concentration is a property, but does not define if it is in mol/L or mmol/dL, etc. More specificity is needed to aggregate data with different units of measure.
Time aspect: Measurement at a single point of time versus over a period of time, i.e. 24 hour urine.
System: Basically, the sample type. i.e. serum, whole blood, nasopharyngeal swab, CSF, etc.
Scale: Quantitative versusQualitative (ordinal versus nominal), etc.
Method: Methodology of the lab test, i.e. immunoassay versus enzymatic activity versus conductance, etc. Not always included. Maybe we should recommend that LOINC always include it. However, even instruments using the same “method” are not always equivocal.
Missing:
LIVD Unique Row Identifier: A unique row identifier would be useful for future automated tools for mapping. It also allows a combination of UID to be under one code.
Units of Measure: (add to LIVD as separate column - currenlty captured in the text of Vendor Results Comments - TBD if using SNOMED or UCUM - this is mostly to build for the future to account for CLIA regulation))
Analyzer ID: (in LIVD = instument UID)
one may need more than 1 UDI to fully describe one IDV setting : hardware / firmware / software (depending on the element classification as IVD)
QC Data: Often already linked to Analyzer ID. (not yet in LIVD - if this is part of the manufactuer, then could be here, or as metadata in the GUUID about the analyer, if 1:1 relationship - woudl not affect selection of LOINC)
Test Kit ID: Often linked to Analyzer ID. (in LIVD = instument UID)
Manufacturer Harmonization Calibration/Standardization ID: This is calibration that happens during the assay development - does not happen all the time, but should in the future, if a standard exists for the analyte being tested for. Multiple analyzer IDs can have the same calibration ID where data could theoretically be aggregated safely.
o Non-LIVD ID: (Identifiers out of scope for LIVD)
Lab ID
Proficiency Testing ID
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