CSTE Comment - v5

CSTE is supportive of Riki Merrick's comment from April 2024.

Clarify the different formats supported by this data element

As previously commented the definition should be more precise and indicate relationships to other UCSDI elements, when required (first part copied from Regenstrief comment on USCDI+): Recorded value or findings of the analytical test performed on a specimen. Note that the scale of the test influences the format of this data element:
For quantitative tests the format is numeric or structured numeric (to support ranges, titers etc) and often must be interpreted in conjunction with the element "Result Unit of Measure"
For qualitative tests the format can be structured and is coded for ordinal or nominal scale or unstructured text (short or formatted) for narrative scale.
Vocabulary binding is only valid for coded qualitative result types - depending on the scale the binding shifts, so the binding should be more prescriptive based on scale of test:
For nominal scale often SCT in organism hierarchy, example value set: https://phinvads.cdc.gov/vads/ViewValueSet.action?id=64089FFA-B015-4DC7-B470-F20DF5B13BFA
For ordinal scale use SCT from qualifier hierarchy: https://phinvads.cdc.gov/vads/ViewValueSet.action?id=815C6DD4-C5A6-DF11-9BDD-0015173D1785

Corresponds to CLIA element in §493.1291(c)(6), §493.1291(c)(7) in CLIA 42 CFR 493.1291 - Test Report (http://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5#se42.5.493_11291)

Improve the defintion of the different types of result values

As highlighted in comment https://www.healthit.gov/isa/comment/7016 and also requested by https://www.healthit.gov/isa/comment/3231 including more detail around the type of results, with furhter constraint on the hierachies within SNOMED CT that properly represent the expected concepts:

narrative (not coded) - usable for human consumption

qualitative (coded) using different hierarchies within SNOMED CT: organism hierarchy for micro results, qualifier value for ordinal results, clinical findings for any others

quantitative using UCUM to express the unit of measure (as also pointed out in this comment: https://www.healthit.gov/isa/comment/3321)

APHL also supports the reconciliation (as requested in this comment: https://www.healthit.gov/isa/comment/11901) with this level 2 data element Laboratory Result Value but prefers that name for this element.

CAP Comment on Values/Results Data Element

The College of American Pathologists (CAP) recommends replacing this data element with the Level 2 data element Laboratory Result Value. 

Laboratory results (date and timestamps)

Vizient recommends adding to USCDI v3 Laboratory results (date and timestamps). Date and time stamps would allow for trending of labs over time. This could be especially helpful when initially adding patient data into Fast Healthcare Interoperability Resources (FHIR) databases since the upload date would be similar for all results.

Rename the element to Result Value; clarify its definition/use

This element should be called Result Value (to differentiate it from the performed test, which some also refer to as "result") (in v2 reported in OBX-5, in C-CDA and FHIR in observation.value).

While the definition indicates this captures structured and unstructured data it is missing all the detail around how to address the different formats:

• unstructured = narrative results use formated text, are human readable, but not easily usable for computers and harder to use in data comparison
• structured results fall into several categories and should be represented as follows:
  • For qualitative tests:
    • Coded to SNOMED CT drawn from organism hierarchy for organism names; drwan from qualifier hierachy for presence/absence findings and other ordinal results; drawn from clinical findings for pathology, microscopy, microbiology
    • include the original text the coding was based on, if different from the description of the code
  • For quantitative tests:
    • include (in a separate field) the units of measure – coded to UCUM) - this should NOT be sent as a string in a single result field
    • use a structured numeric datatype to allow support for ranges, ratios and smaller than/greater than statements 

This is a subtype of the proposed element Observation Value (https://www.healthit.gov/isa/taxonomy/term/1401/level-2), so if that is added clarification between when to use which would be needed.

This is a CLIA required element.

Applicable stsandards for lab results

The Regenstrief LOINC team recommends adding the following Applicable Standard(s) text to the Values/Results row: “SNOMED CT for qualitative results, UCUM units of measure to accompany quantitative results.”

Clarify applicable standards for lab results

There is a need for appropriate lab codes (LOINC and SNOMED) to pass from LIS to EHR.  The codes need to be readily available in the EHR.  We are aware that this is a known issue: https://www.healthit.gov/public-course/interoperability-lab-exchange/HITRC_lsn1085/docs/LIS_Implementation_Challenges_Guide.pdf

Lab results that are physical quantities should use UCUM for units.

Coded lab results for microorganisms should use SNOMED CT.  Antimicrobial susceptibility test interpretation should use HL7 V3 Observation Interpretation.