CDISC Use of LOINC Codes 2015-04-22
LOINC Code Definition Component Property Time System Scale Method Analyte: Sodium, IgG, HIV-1 Antibody Property Defines the nature of the UOM Examples: Mass Concentration (mg/dL), Count, Time Time Time span of test: Point in Time, 24 Hour Clearance System Specimen type: Whole Blood, Serum, Urine Scale Nature of the result value: Qualitative, Ordinal, Quantitative Method Test Method: Ion Selective Electrode (ISE), Dip Stick, Methodless
Example LOINC Codes Component Property Time System Scale Method Glucose MCNC PT SER QN SCNC Creatinine UR Creatinine Clearance SRAT 24H HIV1 Antibody ACNC ORD EIA IB
CDISC Strengths Post Coordinated Codes (CDISC) Separate fields for each concept Much better fit for Data Warehouses, Statistical Analysis, Informatics, Data Mining etc. Pre-Coordinated Codes (LOINC) Single Code includes multiple concepts Much better fit for real time, machine to machine messaging
CDISC Issues with LOINC Property SI vs. Conventional may be different codes (e.g. glucose mg/dL vs mmol/L) Methods Does CDISC FDA want method specific vs. methodless codes. Does performing lab (LBNAM) really override method? Time Draws Does CDISC/FDA want time draw specific codes for true challenge tests (e.g. post-dose glucose)?
Why/How to Use LOINC What is the business driver to use LOINC Codes? Should LOINC codes be in the transmission model, or as metadata in SHARE? If we do LOINC codes (US based), why not SNOMED (EU, Canada, Australia based)?