Membership - who do we need input from?
Standard Development Organizations
Regenstrief
SNOMED International
HL7
Federal agencies
FDA
CDC
NLM
NIH
CMS
Implementers (Labs, also cross-pollinate with implementation subcommittee)
Health Partners
University of Nebraska
Intermountain Healthcare
Memorial Sloan Kettering Cancer Center
IVD Industry (also cross-pollinate with industry subcommittee)
IICC representatives
Abbott
Biomerieux
Roche
LIS/LIMS vendors
Epic
Cerner (reached out)
Terminology Services (also cross-pollinate with tooling subcommittee)
3M
IMO
Clinical Architecture
Professional associations
Association of Public Health Laboratories (currently maintains the COVID-19 LIVD file)
College of American Pathologists (CAP)
ASCP
ASCLS
Others?
Industry Impact
Incentives
Providing review of mappings
Requirements in regulations (for example support for keeping mappings updated to the latest version (with an “as date”) of the mapped to standards)
Like to see that data instances of test data is being collected for regulatory use – so FDA would need to share the requirements
Industry is being asked by customers to provide LOINC mapping (not so much SNOMED codes yet) because there is a requirement for reporting to PH as well as for MU to have the tests be represented using LOINC
ONC should clearly state that LOINC mapping is still required and needs to be maintained (and at what frequency-i.e. per LOINC manual 90 days after release)
Issues
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
Ensure the LOINC - SNOMED CT collaborative agreement and how to deal with differences in approaches
Format Considerations
Current format is spreadsheet for manual review and use
Future formats should
support automatic mapping, if possible (no reason why it would not be possible)
support mapping assistance for manual selection
be easily searchable
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