Brainstorming Notes

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 (as in regulations?) that LOINC mapping is still required and needs to be maintained (and at what frequency-i.e. per LOINC manual 90 days after release) Could this bullet be combined with second bullet.

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 ; or a very clear message is need to understand where the border is (or are). It is generally recognized that LOINC code shall adhere to the cleared Instruction For Use

• 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) Define Laboratory Developed Test.

• What about patient performed/home tests (home covid, pregnancy test, etc.)

• Need to implement higher level terms, avoidance of many-to-many mapping.

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

Brainstorming Goals for the LIVD file/database

• 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