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Vendors thought that the FDA would hold them accountable for encouraging “off-label use” based on the interpretation of the LOINC code(s) published
Vendors may want to limit access to their mappings to paying customers only (or at least know who is downloading LIVD files)
Vendors operate internationally, so need to ensure mappings are not just US regulation focused
Will IVD vendors provide all LOINCs for an analyte/assay, including all timed, challenge, stimulation/suppression, calculated, ratios, etc.? (even those which the IVD vendor may be unaware on instance basis such as which challenge, stimulant, suppression was used for a lab’s protocol for endocrine tests-glucose, insulin, growth hormone, ACTH, cortisol, etc.?)
300+ glucose tolerance tests. 75 g bolus 1 hour post glucola challenge
2 hr timed urine calcium
Serum Calcium/Creatinine ratio; Spot Urine Calcium/Creatinine Ratio
Total Volume, specimen source and Ask at Order Entry (AOE) LOINCs
“generic interpretations” (not specific for any test result) Immunologist review of results; Coagulation panel interpretation, Service Comment, etc.
Calculated tests: eGFR (each formula such as male/female), 24 hr urine calcium rate (utilizing hours of collection and total volume in the calculation),
What level of granularity of LOINC is provided?
serum glucose
serum glucose post challenge
serum glucose 1 hour post challenge
serum glucose 1 hr post challenge glucose
serum glucose 1 hr post 100g glucose challenge
serum glucose 1 hr post 100g glucose oral bolus challenge
What about test results where there is no LOINC yet or at the granularity/specificity needed?
What about Lab Developed Tests (may be from performing lab-such as reference or public health lab, not vendor)
What about patient performed/home tests (home covid, pregnancy test, etc.)
Need to implement higher level terms, avoidance of many-to-many mapping.
Data aggregation
Aggregation using LOINC Axis
Allows laboratory data to be aggregated based on the component, property, timing, system, scale, and/or method
Does not require additional LIVD data elements to support
Method specific to “methodless” data aggregation
Identify the “methodless” LOINC code which may be used to aggregate data from method specific laboratory test / LOINC codes
Used when the method used to perform the laboratory test does not alter the clinical interpretation of the result
May require the addition of a data element to support an “Archetype” LOINC code in order to support a stated definition made by a LOINC author.
May be determine computationally negating the need for a data element.
LOINC Groups
Manually identified groups of LOINC codes for a specific purpose
Results from individual LOINC group components may or may not be allowed to be aggregated together
“Archetype” code typically assigned by LOINC author indicating that individual LOINC codes in the group may be aggregated.
May require additional LIVD data elements to support
Clinical aggregation
The LOINC Multi-axial hierarchy in addition to LOINC parts may be used to provide useful categorization for data aggregation to be used in the display of results on user interfaces
Example - Group all laboratory results that are Chemistry or Chemistry - challenge
LP29693-6 | Laboratory |
LP343631-0 | Chemistry and Chemistry - challenge
2339-0 | Glucose [Mass/volume] in Blood
May or may not require data element(s) in the LIVD file to support if a standardized leaf-level is defined.
Custom data aggregation
Out-of-scope for this iteration of LIVD as no standardized data element(s) would be definable.
Standards Development Issues
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