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There is currently no single standard terminology that fully describes laboratory data sufficiently to support clinical interoperability. Laboratory concepts should therefore be represented by a unique name that represents a comprehensive standardized set of uniform codes and descriptions that fully describe the laboratory test, and the same test should be described by the same set of standardized codes in every instance. The standardized codes assigned to a particular IVD test should be curated by either both, the IVD manufacturer of the assay or and an authoritative body (such as SHIELD).
1.1 Test Order/Reporting Name
The precise name of the test being ordered by the clinician should be represented by the a unique LOINC Order Code (for countries not utilizing LOINC, this would be represented by the corresponding . The unique LOINC codes should be mapped to a similarly unique SNOMED CT code that shares the exact same meaning in LOINC and SNOMED CT terms). This is so that countries not utilizing LOINC can have clear guidance on which corresponding SNOMED CT code should be used and vice versa.
1.2 Laboratory Test Results (Observation Values)
Laboratory test result values can be quantitative (often with units of measure) or qualitative. Qualitative results can be ordinal, nominal or narrative. Quantitative results should use consistent units of measurements to avoid interpretation errors.
1.21 Component/Analyte
The component or analyte of the test being performed should be represented by the LOINC performable code (for countries not utilizing LOINC, this would be represented by the corresponding . The unique LOINC codes should be mapped to a similarly unique SNOMED CT code that shares the exact same meaning in LOINC and SNOMED CT terms).
1.22 Qualitative Results
Ordinal , and nominal or narrative results should be represented by SNOMED CT Codes. Ordinal , and nominal and narrative results should be standardized across lab vendor platforms for similar assays that represent the same test.
1.3 Specimen
The specimen on which the test is performed and its attributes [Specimen Type, Collection Method, Different Focus (Maternal vs Fetal)] should be represented with the SNOMED CT code..
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