{
  "resourceType": "StructureDefinition",
  "language": "English",
  "url": "https://fhir.nmdp.org/ig/HlaAntibodyReport/StructureDefinition/hla-antibody-diagnostic-report",
  "version": "0.2.0",
  "name": "HLAAntibodyDiagnosticReport",
  "title": "HLA Antibody Diagnostic Report",
  "status": "draft",
  "publisher": "NMDP",
  "contact": [
    {
      "name": "David Wroe",
      "telecom": [
        {
          "system": "email",
          "value": "fhir@nmdp.org",
          "use": "work"
        }
      ]
    }
  ],
  "description": "# HLA Antibody Diagnostic Report\r\n\r\nA consolidated laboratory report on the execution of solid-phase immunoassay based on the work of the HAML working group, maintained [here](https://github.com/immunomath/haml).\r\n\r\nHLA-based antibody assay results and expert interpretation for a solid-phase-panel analysis.\r\nThis includes metadata about the solid phase panel and a series of beads.\r\n\r\n---\r\n\r\n## Assay\r\n\r\nA solid-phase-panel analysis with modifications/preparations/dilutions applied to a sample to create a working sample.\r\n\r\n### Elements\r\n\r\n* **assay-id**: A unique identifier for this assay\r\n* **assay-date**\r\n* **assay-kit**\r\n* **working-sample**\r\n* **assay-interpretation**\r\n* **negative-serum**: Reference for the negative control serum\r\n* **positive-serum**: Reference for the positive control serum\r\n* **target-bead-observation**: Individual beads contained within this panel\r\n* **control-bead-observation**: Individual beads contained within this panel\r\n\r\n---\r\n\r\n## Assay Kit Elements\r\n\r\n* **kit-manufacturer**: Company or institution that developed the kit\r\n* **kit-description**\r\n* **solid-phase-panel**\r\n* **catalog-number**: Identifier for the specific kit used\r\n* **lot-number**: Identifier for the lot used\r\n* **interpretation-software**: Software used for analysis\r\n* **interpretation-software-version**: Version of the software used\r\n* **Raw-MFI-divider**: Constant used for comparing multiple analysis machines\r\n  * *Note*: Devices may have systematic biases on the same sample. This constant helps calibrate raw MFI across batches.\r\n\r\n---\r\n\r\n## Assay Interpretation\r\n\r\nInterpretation includes the outcome of the assay: which antigens/specificities are positive or negative.\r\n\r\n### Elements\r\n\r\n* **interpretation-context**: `\"Clinical Interpretation\"`\r\n* **reject-assay**: Boolean indicating if the assay was rejected\r\n* **reject-reason**: Reason for rejecting the assay\r\n* **failure-code**: Failure code from the assay run\r\n* **negative-specificities**: HLA GLstring of negatively reactive HLA\r\n* **positive-specificities**: HLA GLstring of positively reactive HLA\r\n* **questionable-specificities**: HLA GLstring of questionably reactive HLA\r\n\r\n---\r\n\r\n## Working Sample\r\n\r\nA sample (likely blood) drawn from a patient.\r\n\r\n### Elements\r\n\r\n* **working-sample-id**: Unique identifier for this sample\r\n* **sample-datetime**: Date and time when the sample was drawn\r\n* **testing-laboratory**: Identifier for the lab\r\n\r\n### Working Sample (Preparation)\r\n\r\nA processed portion of the sample prepared for panel analysis.\r\n\r\n#### Elements\r\n\r\n* **treatment**: Process performed during preparation\r\n* **method**: Ex. dilution\r\n* **diluent**: Description of the diluent substance/buffer\r\n* **ratio**: Dilution ratio (usually between 0 and 1)\r\n\r\n---\r\n\r\n## Serum\r\n\r\nControl serum for assay.\r\n\r\n### Elements\r\n\r\n* **serum-id**: Unique identifier for this sample\r\n* **control-type**: Negative or positive control serum\r\n\r\n---\r\n\r\n## Target Bead Result\r\n\r\nDescribes a single bead within a solid phase panel.\r\n\r\n### Elements\r\n\r\n* **bead-info**: Specificity and identifiers of the bead\r\n* **bead-type**: Target\r\n* **sample-ref**: Working sample\r\n* **raw-MFI**: Actual measured luminescence\r\n* **bead-count**\r\n* **formula**: Transformation applied to raw-MFI\r\n* **adjusted-MFI**: Normalized value for clinical decision-making\r\n* **bead-interpretation**: Interpretation of bead result\r\n* **bead-plausible**: Boolean indicator of bead plausibility\r\n\r\n---\r\n\r\n### Target Bead Interpretation Elements\r\n\r\n* **classification-entity**: Person/entity who performed interpretation\r\n* **interpretation-reason**: Rationale (e.g., MFI threshold of 500)\r\n* **bead-classification**: *Positive* / *Negative* / *Borderline* / *Unspecified*\r\n* **bead-rank**: Numerical rank of bead reactivity\r\n\r\n---\r\n\r\n## Control Bead Result\r\n\r\nDescribes a single control bead within a solid phase panel.\r\n\r\n### Elements\r\n\r\n* **bead-info**: Specificity and identifiers of the bead\r\n* **target-bead-ref**: Target bead reference of the control bead\r\n* **sample-ref**: Working sample, negative or positive control serum\r\n* **bead-type**: Negative or positive control bead\r\n* **raw-MFI**: Actual measured luminescence\r\n* **bead-count**\r\n* **formula**: Transformation applied to raw-MFI\r\n* **adjusted-MFI**: Normalized value for clinical decision-making\r\n\r\n---",
  "purpose": "Immunoassay of a patient to identify presence of reactive levels of non-self antibodies to be used in the determination of adverse reactions in the selection of unrelated donor transplant.",
  "fhirVersion": "4.0.1",
  "kind": "resource",
  "abstract": false,
  "type": "DiagnosticReport",
  "baseDefinition": "http://hl7.org/fhir/us/core/StructureDefinition/us-core-diagnosticreport-lab",
  "derivation": "constraint",
  "differential": {
    "element": [
      {
        "id": "DiagnosticReport",
        "path": "DiagnosticReport",
        "short": "An HLA Antibody Diagnostic Report - a combination of request information, atomic results and result interpretations",
        "definition": "The findings and interpretation of diagnostic  tests performed on patients including specimens derived from these. The report includes clinical context such as requesting and provider information, and some mix of atomic results, images, textual and coded interpretations, and formatted representation of diagnostic reports."
      },
      {
        "id": "DiagnosticReport.extension:hLAAntibodyDiagnosticReportExt",
        "path": "DiagnosticReport.extension",
        "sliceName": "hLAAntibodyDiagnosticReportExt",
        "type": [
          {
            "code": "Extension",
            "profile": [
              "https://fhir.nmdp.org/StructureDefinition/HLAAntibodyDiagnosticReportExt"
            ]
          }
        ]
      },
      {
        "id": "DiagnosticReport.identifier.value",
        "path": "DiagnosticReport.identifier.value",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "DiagnosticReport.encounter",
        "path": "DiagnosticReport.encounter",
        "max": "0"
      },
      {
        "id": "DiagnosticReport.performer.reference",
        "path": "DiagnosticReport.performer.reference",
        "mustSupport": true
      },
      {
        "id": "DiagnosticReport.resultsInterpreter.reference",
        "path": "DiagnosticReport.resultsInterpreter.reference",
        "mustSupport": true
      },
      {
        "id": "DiagnosticReport.specimen",
        "path": "DiagnosticReport.specimen",
        "slicing": {
          "discriminator": [
            {
              "type": "pattern",
              "path": "$this"
            }
          ],
          "rules": "open"
        },
        "mustSupport": true
      },
      {
        "id": "DiagnosticReport.specimen:HLAImmunoassayWorkingSample",
        "path": "DiagnosticReport.specimen",
        "sliceName": "HLAImmunoassayWorkingSample",
        "max": "1",
        "mustSupport": true
      },
      {
        "id": "DiagnosticReport.specimen:HLAImmunoassayWorkingSample.reference",
        "path": "DiagnosticReport.specimen.reference",
        "label": "HLA Immunoassay Working Sample Reference",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "DiagnosticReport.specimen:HLAImmunoassayWorkingSample.type",
        "path": "DiagnosticReport.specimen.type",
        "mustSupport": false
      },
      {
        "id": "DiagnosticReport.specimen:negativeSerum",
        "path": "DiagnosticReport.specimen",
        "sliceName": "negativeSerum",
        "max": "1",
        "mustSupport": true
      },
      {
        "id": "DiagnosticReport.specimen:negativeSerum.reference",
        "path": "DiagnosticReport.specimen.reference",
        "label": "Negative Serum Reference",
        "min": 1
      },
      {
        "id": "DiagnosticReport.specimen:positiveSerum",
        "path": "DiagnosticReport.specimen",
        "sliceName": "positiveSerum",
        "label": "Positive Serum",
        "max": "1",
        "mustSupport": true
      },
      {
        "id": "DiagnosticReport.specimen:positiveSerum.reference",
        "path": "DiagnosticReport.specimen.reference",
        "label": "HLA Positive Serum Reference",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "DiagnosticReport.result",
        "path": "DiagnosticReport.result",
        "min": 1,
        "type": [
          {
            "code": "Reference",
            "aggregation": [
              "contained",
              "referenced",
              "bundled"
            ]
          }
        ]
      },
      {
        "id": "DiagnosticReport.result.reference",
        "path": "DiagnosticReport.result.reference",
        "label": "Immunoassay Observation",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "DiagnosticReport.result.display",
        "path": "DiagnosticReport.result.display",
        "fixedString": "HLA Immunoassay Bead Observation"
      },
      {
        "id": "DiagnosticReport.media",
        "path": "DiagnosticReport.media",
        "max": "0"
      }
    ]
  }
}