USCDI V6 Suggestions

rLink: United States Core Data for Interoperability (USCDI)

Comments are due by September 30, 2024

Current discussion so far:

• In V5

  • Still missing these CLIA elements:

    • Laboratory Test Performed Date (this element’s definition needs to be fixed before it can be used)

    • Specimen collection date/time (may consider using Performance Time in the Procedure Class, since this is synonmous, when specimen collection is modeled as a procedure, which may not always be the case)

      • Specimen Collection Date/Time per CLIA

        • https://www.ecfr.gov/current/title-42/part-493#p-493.1241(c)(6)

        •  

  • Laboratory Order in Orders Class

    • May wish to cross reference Laboratory Class to alert folks that Laboatory Orders are in Orders Class. May also wish to note in Orders Class that other laboratory data elements are under Laboratory Class and Procedure for Specimens collected for laboratory orders.

    • Need to better understand the scope of the Laboratory Order data element

      • is it a single element or is this the test request (larger scope as per CLIA https://www.ecfr.gov/current/title-42/section-493.1241 ?)

      • If single element, suggest to rename this element to Ordered Test/Panel - defined as “The test(s) to be performed.”

• Specimen Condition Acceptability

  • Rename to Specimen Condition

  • Add new concept for Reject reason - a CLIA requirement

    • Specimen Reject Reason

• and ADDING a NEW concept

• Other elements still missing

  • Test Kit Unique Device Identifier

  • Laboratory results: date and timestamps (this is too broad to be helpful - should identify the trigger when dates should be recorded)

    • Specimen Collection Date/Time per CLIA

      • https://www.ecfr.gov/current/title-42/part-493#p-493.1241(c)(6)

    •  

    • Test Report Date per CLIA

      • https://www.ecfr.gov/current/title-42/part-493#p-493.1291(c)(3)

  • Accession number

  • Laboratory Test/Panel Code

  • Test Result Harmonization Status

  • Specimen Collection Method

    • It is a Level 0, USCDI data element: USCDI Data Element

    • This should not be using Procedure as a Specimen Collection Method (Dan, Riki). Discussion that certain tests such as bone marrow biopsy, CSF collection, polypectomy and surgical procedures are using Procedure terms, codes, etc. Other laboratory tests that are collected from venipuncture procedures (e.g. blood) are not using procedure terms in EHRs and LISs. Also discussion even though SPM 7 exists in LRI, ELR to indicate the specimen collection procedure mapped to a SNOMED Procedure code, it is not required in all cases and folks may or may not be populating the field. They also may be using precoordinated terms in the Specimen Type field such as “Urine Clean Catch” which includes the “clean catch” specimen collection procedure.

    • Want to avoid folks making up data elements too if specifications are not included or clear.

    • Question on what coding used for Specimen Collection. Currently in LOI, LRI in SPM 7 mapped to SNOMED Procedure Hierarchy codes.

    • Procedure or Specimen, which one/clarity

    • Which are considered procedures (e.g. surgical)

    • Conflating terms

      • Specimen type, source site, specimen collection method/procedure

      • For USCDI, as a reminder is the element in a certified health it, available to be exchanged?

        • USCDI doesn’t indicate the use case or where the element is exchanged (e.g. orders, results, PH exchanges)

    • Review of USCDI, Note bullets under Levels 2, 1, 0,

    • Comments on USCDI+ Cancer may refer to PH comments.. Duplicate comments not needed. Many data elements. Don’t have to double/comment twice.

    • Question: does that apply to multiple versions of same thing. Item carries forward in same platform (USCDI Or USCDI+, as they aren’t on the same platform). With versioning of USCDI, more common to indicate person continues to support comments made on date/time.

    • Question: Is there a movement to get a computerized reference. Comment may include a link to a whole implementation guide, but not an individual data element. Unclear at this time.

    • Question: Does data element need to be known or exchanged?

  • Instrument Unique Identifier

• What AP elements are missing?

• What Clinical Genomics elements are missing?