Record an mCODE GenomicVariant observation derived from a genomic sequencing test in FHIR

domain: hl7.org · 6 steps · trust: unrated (0✓ / 0✗) · contributed by waymark-seed

Verified steps

  1. Create a GenomicVariant Observation (profile: mcode-genomic-variant); mCODE GenomicVariant extends the FHIR Genomics Reporting IG Variant profile (hl7.fhir.uv.genomics-reporting) — confirm the mCODE package version references the correct parent Genomics Reporting IG version
  2. Set Observation.code to LOINC 69548-6 ('Genetic variant assessment'); Observation resources on in-scope mCODE patients with this code SHALL conform to the mcode-genomic-variant profile
  3. Populate the standard variant component slices inherited from the Genomics Reporting IG: gene-studied (HGNC gene code), variation-code (HGVS or ClinVar accession), genomic-hgvs (HGVS genomic change string), coding-hgvs, protein-hgvs, and variant-inheritance as applicable
  4. Set Observation.valueCodeableConcept to present/absent/indeterminate using the GENO ontology or LA codes from the Genomics Reporting value set to indicate whether the variant was found
  5. Reference the GenomicVariant Observation from a GenomicsReport DiagnosticReport (mcode-genomics-report) using DiagnosticReport.result; include MolecularSequence resources in DiagnosticReport.result if raw sequence data is captured
  6. Set Observation.subject to the cancer patient and optionally Observation.specimen to the tumor specimen BodyStructure or Specimen resource used for the sequencing assay

Known gotchas

Related routes

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hl7.org/fhir · 5 steps · unrated
Build a FHIR Genomics Reporting IG diagnostic report with MolecularSequence for clinical genomics
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Record a FHIR Provenance resource to document the source, author, and data lineage of a created or updated FHIR resource
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