Clinical Notes

Rename and change definition - 2 options

Rename to Narrative Laboratory Consultation Note - that is closer to what the definition describes

If this remains a Laboratory Report, then it needs to include ALL CLIA required elements: –see here for references: Specifics on the CLIA Regulation are found at http://www.cdc.gov/clia/. Interpretative Guidelines on the elements required in a report may be found at http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html.

That means all these elements MUST be in the EHR) and these elements must be clearly connected (same report) – bolded elements already exist in USCDI v2, italicized are level 2 elements in USCDI: - the full report is represented either by Laboratory Report Narrative (which should be renamed to just Laboratory Report) or Pathology Report Narrative (which should be renamed to just Patology Report), depending on the domain.

• Patient Name
• Patient DOB
• Patient Sex
• Specimen Collection Date Time (also referred to as clinically relevant observation date/time) – the USCDI element is called Laboratory Test Performed Date, which is misleading  for a laboratory test this is the specimen collection date/time; it also exists in level 2 as the specimen collection Date/time
• Test ordered
• Test Name (represented in LOINC by Observation Code)
• Result Value (with proper coding, if applicable) – the same as Observation Value
• Result value units
• Reference range
• Abnormal flags
• Result status (to be able to indicate a correction) at the result level
• Result status for all of the results that are part of the same test order
• Test Result date/time could be the same as Observation Timing – this is the same as Clinically relevant time for NON –lab observations
• Ordering provider (name and/or ID) – could potentially be covered under Care Team member Name and Care Team member ID and Care team member Role
• Performing Organization name (and/or ID) – could potentially be covered under Observation Performer and Facility Name and Facility Identifier and Facility Managing Organization Identifier or
• Performing Organization address – could potentially be covered under Facility Address
• Performing Organization Medical Director – could potentially be covered under Care Team member Name and Care Team member ID and Care team member Role
• Specimen ID assigned by the testing lab (referred to by some labs as accession number, though that is ambiguous, as each lab has different polices as to what it calls an accession - but may need to be captured as such in the EHR) – this is the primary way a sample is identified in the lab
• Specimen type (in some cases that is captured with the test name, but it really should be able to be sent separately!)
• Specimen source site (may be included in the specimen type, when that is pre-coordinated) – if more than one specimen attribute besides type is supported, this should be the next one – allows for composites of tissue + source site or swab + source site
• Specimen collection method (may be included in the specimen type, when that is pre-coordinated)
• Result comments (to explain results, specimen condition, corrections etc.)
• Depending on type of lab report:
  • Principal Result Interpreter (person name and/or ID) for pathology results – could potentially be covered under Care Team member Name and Care Team member ID and Care team member Role
  • Other clinically relevant information
  • Specimen quality
  • Specimen reject reason

Rename and change definition

• We suggest that in the Laboratory data class Laboratory Report Narrative and Pathology Report Narrative data elements be refocused to be Laboratory Report and Pathology Report:
  • clearly define that each report is inclusive of the relevant/applicable narrative, numeric, and encoded data in a structured format.
  • Limiting to ONLY narrative is inappropriate and counterproductive in getting more structured data be made available; a typical laboratory report often has less narrative as a pathology report, just providing narrative separately from the encoded and/or numeric data is not appropriate.