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  1. FHIR Specification Feedback
  2. FHIR-34910

Lab Result and Specimen Information for RBC Observation is Missing

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Details

    • Change Request
    • Status: Published (View Workflow)
    • Medium
    • Resolution: Not Persuasive with Modification
    • US Core (FHIR)
    • current
    • Cross-Group Projects
    • STU
    • Acme Lab Example
      BUN Example
      Blood Glucose Example
      CBC Example
      Erythrocytes Example
      Hemoglobin Example
      MCHC Example
      Metabolic Panel Example
      Neutrophils Example
      Serum CO2 Example
      Serum Calcium Example
      Serum Chloride Example
      Serum Creatinine Example
      Serum Potassium Example
      Serum Sodium Example
      Serum Total Bilirubin Example
      Urinalysis Example
      Urine Bacteria Example
      Urine Bilirubin Example
      Urine Clarity Example
      Urine Color Example
      Urine Epi Cells Example
      Urine Glucose Example
      Urine Hemoglobin Example
      Urine Ketone Example
      Urine Leukocyte Esterase Example
      Urine Nitrite Example
      Urine Protein Example
      Urine RBCsExample
      Urine WBCsExample
      Urine pH Example
      Urobilinogen Example
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      Background:

      This IG is unique because it describes a foundational set of profiles and associated FHIR Search API. Although this IG provide general guidances over select use cases, These use case are driven by USCDI requirements. For example see the SDOH Guidance for more information when exchanging Social Determinants of Health (SDOH) Service Requests. Nevertheless, the profiles are intended to be used by implementers and IG developers over a broad set of domains and use cases. To allow for this reuse the profiles set the minimum expectation for recording, searching, and fetching and thus contain few required elements and use broad or loosely bound terminologies. The expectation is that the implementer or implementation community will further constrain the US Profile for their particular use case, including primary clinical laboratory result reporting

      The examples used in US Core are intended to primarily to illustrate conformance to their corresponding profiles. Although we attempt to make them realistic, they are not representative of real world examples.

      Reasoning:

      We agree with the commenter that these examples do not meet the rigor of real world laboratory generated data. However we disagree that they need to. Their purpose is to illustrate conformant instances of US Core.

      We expect lab domain implementation communities to further constrain the US Core laboratory results profile for laboratory ordering and primary clinical laboratory result reporting and provide compliant examples.

      Proposed Changes:

      Add the following boilerplate to the introduction in the example page:

      These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like. Every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification nor are they fully representative of real world examples.

       As well, we will add boilerplate to the examples to indicate that are not CLIA compliant.  We will reduce the number of examples and ensure that they are as clinically valid as possible.

      Suggestion:

      Feel free to submit a new use case for consideration as a candidate for inclusion in US Core after reviewing  http://build.fhir.org/ig/HL7/US-Core/future-of-US-core.html

      Show
      Background: This IG is unique because it describes a foundational set of profiles and associated FHIR Search API. Although this IG provide general guidances over select use cases, These use case are driven by USCDI requirements. For example see the SDOH Guidance for more information when exchanging Social Determinants of Health (SDOH) Service Requests. Nevertheless, the profiles are intended to be used by implementers and IG developers over a broad set of domains and use cases. To allow for this reuse the profiles set the  minimum  expectation for recording, searching, and fetching and thus contain few required elements and use broad or loosely bound terminologies. The expectation is that the implementer or implementation community will further constrain the US Profile for their particular use case, including primary clinical laboratory result reporting The examples used in US Core are intended to primarily to illustrate conformance to their corresponding profiles. Although we attempt to make them realistic, they are not representative of real world examples. Reasoning: We agree with the commenter that these examples do not meet the rigor of real world laboratory generated data. However we disagree that they need to. Their purpose is to illustrate conformant instances of US Core. We expect lab domain implementation communities to further constrain the US Core laboratory results profile for laboratory ordering and primary clinical laboratory result reporting and provide compliant examples. Proposed Changes: Add the following boilerplate to the introduction in the example page: These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like. Every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification nor are they fully representative of real world examples.   As well, we will add boilerplate to the examples to indicate that are not CLIA compliant.  We will reduce the number of examples and ensure that they are as clinically valid as possible. Suggestion: Feel free to submit a new use case for consideration as a candidate for inclusion in US Core after reviewing   http://build.fhir.org/ig/HL7/US-Core/future-of-US-core.html
    • Brett Marquard / Riki Merrick : 18-2-2
    • Clarification
    • Non-substantive

    Description

      Lab results (Observations) are generated from analysis of specimens.  Result values, reference ranges, and interpretation of results is specimen dependent.  

      There is no "lab result" listed for most all these lab orders and results.  Exception is ACME WIle E Coyote Lipid panel which lists the individual results.  Rather a code is listed which would be mapped to the actual lab result obtained from the analysis of a specimen (which is also not indicated).  Code system names/terms should NOT be utilized to represent lab results or orders as they are dynamic and not static.

      These critical clinical data/info appears to be missing from the US Core Lab examples.  Also all panel/orders should be modeled in Service Request (CBC< Urinalysis, Metabolic Panel) and their results/observations "grouped per each pane order" in Diagnostic Report using based on.  Specimen collected which may be different than specimen upon which results are obtained from the performance of lab tests should be indicated for the order and results .

       

      Furthermore, these examples lack many CLIA requirements such as specimen info.  Kindly bring all US Core lab examples into compliance so they can be implemented in compliant manner.

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              apitkus Andrea Pitkus
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