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CHANGE: Used to only apply to implantable medical devices, now broadened to apply to ALL devices used in medical care
Specific ask: Feedback on whether Unique Device Identifier (UDI) should be one or two data elements (Unique Device Identifier—Implantable and Unique Device Identifier—Non-implantable). Is there an impact on standards development or information exchange to use one data element, Unique Device Identifier, to include both implantable and non-implantable devices?
Notes:
previoulsy previously rejected additional data element for test kit and instrument identifiers can now be covered by this
Unclear scope as to how many UDIs are needed for which items. Many healthcare disposables are devices from collection tubes, needles, gauze, quality controls, calibrators, instrument disposables like cuvettes,microscopes, slides, reagents, instruments, etc.
For example for a laboratory result, would the specimen collection container, additives, different bore needles used to collect, QC, calibrators, reagents, disposable reagent dispense tips, reagent cartridges, etc.
For a surgery, would the scope include all gauze, lab tests, instruments whether electronic or manual like knives, tubing, IV bags, etc.
For pathology, would this include each container, additive, fixative, slide, coverslip, oil for oil immersion, parrafin for blocks, microtome, instrument used in fixing tissue, staining slides, microscope, digital pathology slide scanner, reagent in each type of stain, each antibody in FISH, each reagent in PCR, etc.?
If broader scope, it would be a huge burden on all, especially laboratory professionals. HIT vendors need to ingest UDI info and associate/map with data elements, store, exchange/report, use, have functionality to search, sort, etc.
CHANGE: identifies LOINC as the standard to use - version 2.78
Notes:
Clarification needed if the operational definition is the laboratory order (test name) or laboratory order (entire requisition/CLIA Test Request which includes the test order name, ordering provider, Ask at Order Entry questions, specimen, etc.)
Recommend clarifying this includes all orders including reflexive orders, such as susceptibility testing orders, organism identification.
Performance Time (under Procedure):
CHANGE: UNLCEAR WHAT CHANGED.
Notes:
lab still does not have an equivalent for this data element to cover
CHANGE: Definition is now: Unit of measurement to report quantitative laboratory test results
Was called out as having updated definition, but definition remained unchanged, but UCUM updated from 2.1 to 2.2
Unclear if Units and UCUM need to be supported for non quantitative result values. May wish to request updated definition of when Units are reported by a laboratory, they are retained and UCUM is used as the standard
Updated versions of referenced code systems for these elements in the Laboratory Class:
Tests → LOINC version 2.78
Notes:
Values/Results → SNOMED US Edition September 2024
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Specimen Type → SNOMED US Edition September 2024
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Specimen source site → SNOMED US Edition September 2024
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Result Unit of Measure → UCUM 2.2
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Reference Range → UCUM 2.2
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Specimen Condition Acceptability → SNOMED US Edition September 2024
Notes:
This item should be split into two separate items to allign with CLIA requirements.
Specimen Reject Reason
Specimen Condition
Specification is not given as to where in the LIS or EHR this is reported/used. Currently in the LIS/APLIS, this is reported different ways in different areas for different test results.
Specimen Condition for a result reported as a panel usually involves a chartable comment field associated with a result value whether a number or * or other comment.
Said comment fields do not typically have capability to map to SNOMED CT codes. This functionality would need to be built across ALL HIT to support both sending and receiving.
The second way Specimen Condition is reported is as a laboratory result and value. The HIL Index is a common example. See https://pmc.ncbi.nlm.nih.gov/articles/PMC4071188/
A Basic Metabolic Panel may have a number of test results and the HIL Index reported, whether with a qualitative result value or a numeric value. The HIL Index is a laboratory result, which would be mapped to a LOINC code in accord to USCDI. The value of the HIL Index if numeric would not be mapped to a codesystem. However, if qualitative or semi-quantitative, it could be mapped to a SNOMED CT code (from the qualifier value hierarchy).
It’s unclear with USCDI, how the different modeling of this element would be handled in HIT, but also exchanges, whre USCDI is cited.
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