ANSI Anti-Trust Policy:

Professional Associations, such as HL7, which bring together competing entities are subject to strict scrutiny under applicable antitrust laws. HL7 recognizes that the antitrust laws were enacted to promote fairness in competition and, as such, supports laws against monopoly and restraints of trade and their enforcement. Each individual participating in HL7 meetings and conferences, regardless of venue, is responsible for knowing the contents of and adhering to the HL7 Antitrust Policy as stated in §05.01 of the Governance and Operations Manual (GOM).

Meeting Details

Date: June 7, 2023

Time: 2PM

Coordinates:  Join Zoom meeting: | Meeting ID: 510 046 7805 | +1 929-436-2866-US (New York)


Meeting Notes

Next Meeting: June 14, 2023

------end of meeting-----

Summary of Request:

What should be the recommended way of representing a panel of tests in an Observation.  There are some minor though significant variations with the representation of a panel of tests between FHIR Core, US Core, IPS and AU Base, that we’re seeking guidance on the best way to retain international alignment.

  • The item we’re seeking clarification on is the presentation of a panel of tests, which may be (using FBC as an example):
    • Option 1) DiagnosticReport.code = FBC; DR.result(Observation = Hb), Observation = RCC, Observation = WBC etc for each individual component of the FBC
    • Option 2) DiagnosticReport.code = FBC, DR.result(Observation = FBC) with hasMember Observations for each individual component (Hb, RCC, WBC etc) of the FBC

  • For an individual test eg Heamoglobin (Hb):
    • For Option 1: DiagnosticReport.code = Hb, DR.result(Observation = Hb)
    • For Option 2: there are 2 possible scenarios:
      • a) DiagnsoticReport.code = Hb; DR.result(Observation = Hb)
        This scenario aligns with option 1) above; but if option 2 was the choice for panels then there would be one set of guidance for panels (observation of panels) and different guidance for individual tests
      • b) DiagnsoticReport.code = Hb; DR.result(Observation = Hb with an Observation.hasMember = Hb
        This scenario aligns with option 2) above where panels and single Observations are treated the same. This option seems like an overhead, but does provide alignment with how panels and individual tests are treated.

Looking at various IG’s:

  1.  US Core Laboratory Result Observation Profile: “Each Observation resource represents an individual laboratory test and result value, a “nested” panel (such as a microbial susceptibility panel) which references other observations, or rarely a laboratory test with component result values.” And refers to FHIR specification on Observation Grouping.
    It seems “panel of Observations” is for grouped tests within a panel eg Microbiology for microscopy, culture results etc. Hence US Core seems to align with option 1) above.
  2.  IPS: Observation Results: laboratory (IPS)
    “This observation may represent the result of a simple laboratory test such as hematocrit or it may group the set of results produced by a multi-test study or panel such as a complete blood count, a dynamic function test, a urine specimen study. In the latter case, the observation carries the overall conclusion of the study and or a global interpretation by the producer of the study, in the comment element; and references the atomic results of the study as “has-member” child observations.”
    “In case of a panel/study, the results of the panel appear as sub-observations. In this case this top-level Observation acts as a grouper of all the observations belonging to the panel or study.”
    Hence IPS seems to align with option2 above and it seems to treat individual tests as a direct Observation..
  3. AU Base & hence AU Core:
    AU Base Pathology Report – Usage Notes:
    1. When constructing a report for a study / panel:
      1. the individual component examinations are referenced by that grouping Observation in Observation.hasMember and not directly referenced in DiagnosticReport.result
      2. DiagnosticReport.code and the study / panel Observation Observation.code should be the same concept if the report contains only the results of that study / panel

AU Base Pathology Result – Usage notes:

    • a. When sending an observation that represents a study series or panel:
      • the group / panel code is sent in Observation.code
      • the overall comments are sent in Observation.note
      • the global interpretation by the producer of the study is sent in Observation.interpretation
      • individual results may be sent in Observation.component or by referencing individual observation results in Observation.hasMember

AU Base has gone a step further by providing guidance that the individual tests be treated the same as panels and hence have a test with a hasMember Observation with the result ie consistent treatment of the individual tests and panels.

To me the FHIR specification implies DiagnosticReport.result for sub-panels eg Microbiology.
IPS goes for FBC as a first level Observation and same with AU Base/Core.