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Laboratory

Data Element

Applicable Standard(s)

Tests
  • USCDI v1: Logical Observation Identifiers Names and Codes (LOINC®) version 2.67
  • Draft USCDI v2: Logical Observation Identifiers Names and Codes (LOINC®) version 2.69
Values/Results

Data Element

Applicable Standard(s)

Laboratory Report Narrative
  • This data element was reclassified from Clinical Notes to Laboratory
Pathology Report Narrative
  • This data element was reclassified from Clinical Notes to Laboratory
Tests
  • USCDI v1: Logical Observation Identifiers Names and Codes (LOINC®) version 2.67
  • Draft USCDI v2: Logical Observation Identifiers Names and Codes (LOINC®) version 2.69
Values/Results

Comment

"Report Narrative" Data Elements

Moving the existing Laboratory Report Narrative and Pathology Report Narrative data elements to this section in the Draft USCDI v2 does not resolve the core issue that these data elements are vague and untethered to any structures or bindings to applicable standards that would help clarify their intended meaning. Laboratory Report Narrative Many laboratory test results ARE narrative and are reported as such. Is this for that? If so, is this not already covered in the Values/Tests Data Element? Is it meant for the "interpretation" data element or just general comments/disclaimers/annotations? Is it meant to mean the primary diagnostic report or a secondary consultation note? These kinds of clarifications are necessary for understanding the appropriateness of terminology bindings. I concur with the LOINC Committee recommendation to remove this data element. Pathology Report Narrative Implementers and systems are bit more clear on the notion of a (anatomic) Pathology Report, but it is important to recognize that they exist in various "flavors" from pure narrative, to "structured", to synoptic. See the NAACCR Pathology Laboratory Electronic Reporting, Version 5.0 – May 2020(revised July 2020) standard for more detail on these distinctions, including the reference to the CAP's definition of synoptic reporting. (Note that this standard also specifies relevant structures and terminologies).  In addition to NAACCR's standard, there are other examples of fully defined templates for these structured documents, including IHE's Anatomic Pathology Structured Report. By labeling this data element as Pathology Report Narrative we are confusing implementers about whether only certain styles or formats of pathology reports are required (i.e. only those as text narrative) or certain portions of the whole report. Rather, I believe the intent is more broad...to capture all of these "flavors" and to remain agnostic about the exchange format (HL7v2, CDA, FHIR, etc).  In addition to using to a more precise structure for specifying this as a domain-specific profile (vs a "data element"), I recommend that this USCDI entity be renamed to simply Pathology Report. In the definition and bindings to relevant standards, it would also be helpful to clarify whether this is intended to a) cover anatomic (e.g. surgical) pathology reports only or b) any report by a pathologist (general pathology, also encompassing clinical pathology).

No mention of units of measure...

  • The section on laboratory makes no mention of units of measure. Without units of measure, structured results lose most of their value. FHIR requires UCUM units for all quantiles (with a few exceptions) https://www.hl7.org/fhir/datatypes.html#Quantity. C-CDA also specifies UCUM. UCUM is designed for converting values in one unit to another commensurate unit. See https://ucum.nlm.nih.gov/ for tools that validate and convert UCUM codes.
  • For vital signs, ONC has explicit requirements for UCUM units of measure and ONC’s standard for delivering reportable disease requires UCUM units. I think a previous  version of USCDI also required UCUM units. FHIR specifies UCUM for all quantitative. Since ONC requires FHIR, USCDI should not have a different approach. Result producers can still deliver the historic units of measure sting with the UCUM units.
  • From a sample of 9 billion LOINC mapped test, close to 90% of the total volume of laboratory test are quantitate, so getting the units right is important.

Narrative laboratory and pathology report

  • The specification for laboratory results narrative and pathology results narrative are very unclear. They say they contain the consulting specialist’s interpretation of the laboratory or pathology report respectively. Are these talking about consultants who are not responsible for the lab report or pathology report respectively, or the report generated by the lab or pathologist? Realize also that such reports contain a lot more than an interpretation.
  • This raises the question of the standard order codes. For laboratory reports, the order and diagnostic report code will usually be a LOINC code. US Core FHIR, which ONC requires all EHRs to support, specifies LOINC codes for the order code when an appropriate LOINC code is available.
  • USCDI does specify codes for orders and diagnostic exports of imaging tests but says nothing about order codes or diagnostic report codes for laboratory tests. US Core FHIR which is requires by ONC specifies LOINC codes (when one exists) for this purpose. Why the discordance?

Common pattern needed for Laboratory and Pathology Data Elements

To present a more consistent way of putting forth testing for Laboratory and Pathology information, we recommend creating a consistent set of data elements and a similar set of definitions and relationships.  The Order expresses the test when it is in an “ordered” state whereas the Test, expresses the test when it is in a “completed” state.  The value/result is the measured value determined by the test as its “results”. The report contains information about the order, the test and the value/result along with other narrative explaining the assessment of the results. Recommended Data Elements: Laboratory Order Laboratory Test Laboratory Value/Result Laboratory Report Pathology Order Pathology Test Pathology Value/Result       Pathology Report

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