description: 'HLA Antibody Diagnostic Report \r\n\r\nConsolidated laboratory report on the execution of solid-phase immunoassay \r\nBased 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\n\r\nThis includes metadata about the solid phase panel and a series of beads.\r\nElements:\r\n\r\nAssay\r\nA solid-phase-panel analysis.\r\nThis includes metadata about the solid phase panel and a series of beads.\r\nModifications/preparations/dilutions were done to a sample to create a working sample.\r\n\r\nElements:\r\n----------  \r\n            assay-id: A unique identifier for this assay.\r\n            assay-date:\r\n            working-sample:\r\n            interpretation:\r\n            interpretation-software: The software which was used for analysis of the solid-phase-panel results.\r\n            interpretation-software-version: The version of the software used for analysis of the solid-phase-panel results.\r\n            positive-serum-id: An identifier of the serum used as a positive control.\r\n            negative-serum-id: An identifier of the serum used as a negative control.\r\n            bead: Individual beads contained within this panel\r\n            Raw-MFI-divider: This constant is used for comparing multiple analysis machines.\r\n            Note: Sometimes these devices systematically have biases on the same sample, and this constant can be used to calibrate raw-MFI across multiple batches.\r\n\r\nAssay Kit\r\nElements:\r\n-----------\r\n            kit-manufacturer: The company or institution that developed the kit\r\n            kit-description:\r\n            catalog-number: A string identifying the specific kit or that was used in this analysis\r\n            lot-number: A string identifying the specific  lot that was used in this analysis\r\n\r\nAssay Interpretation\r\nAn Interpretation is where we put the results of an entire assay.\r\nThis includes which antigens/specificities are determined to be positive or negative.\r\n\r\nElements:\r\n------------\r\n            interpretation-context: “Clinical Interpretation”\r\n            reject-assay: Boolean if the assay was rejected or not.\r\n            reject-reason: Reason for rejecting entire assay\r\n            failure-code: Failure code from assay run\r\n            positive-specificities: HLA GLstring of positively reactive HLA\r\n            questionable-specificities: : HLA GLstring of questionably reactive HLA\r\n            negative-specificities: : HLA GLstring of negatively reactive HLA\r\n\r\nSample and Working Sample\r\nThis represents a sample, most likely of blood, which was drawn from a patient.\r\n\r\nElements:\r\n-----------\r\n            sample-id: A string with a unique identifier for this sample\r\n            sample-datetime: A dateTime which identifies the date and (optionally) the time when a sample was drawn.\r\n            testing-laboratory: A string with a unique identifier for the laboratory where this sample was drawn\r\n            assay: A number of \"assay\" elements specify an analysis performed on this sample\r\n \r\nA working sample is a part of a sample which is subjected to sample preparations and a subsequent solid-phase panel analysis.\r\n\r\nElements:\r\n-----------\r\n            working-sample-id: A unique identifier for this working sample.\r\n            treatment:\r\n            dilution:\r\n            solid-phase-panel:\r\n \r\nA treatment describes a process which was performed on a working sample in preparation for solid phase analysis.\r\n\r\nElements:\r\n-----------\r\n            method: \r\n\r\nA working sample may be diluted in preparation for solid-phase-panel analysis.\r\nThis element describes the ratio and substance used for dilution.\r\n\r\nElements:\r\n-----------\r\n            ratio: This is expected to be a dilution ratio, a floating point number usually between 0 and 1.\r\n            diluent: This is a text description of the diluent substance or buffer\r\n\r\n\r\nBead Result\r\nA single bead within a solid phase panel.\r\nThis bead usually has a specificity, which may be an allele name or a serological specificity.\r\nThe bead result has information about it''s corresponding positive and negative control beads.\r\n\r\nElements:\r\n----------\r\n            bead-info: Structure containing details on the specificity and identifiers of an individual bead\r\n            raw-data: Structure containing measured MFI or raw data as measured in the assay.\r\n            converted-data: Structure containing converted MFIs, formulas used, and interpretations of bead-specific results.\r\n            raw-MFI: Actual measured luminescense from assay\r\n            bead-count:  \r\n            formula: transformation appied to raw-MFI value to derive normalized value for clinical decision making\r\n            adjusted-MFI: Derived normalized value for clinical decision making\r\n            bead-interpretation: Bead level interpretation of result\r\n            bead-plausible: Boolean indicator for specific bead\r\n            \r\nBead Interpretation \r\nElements:\r\n----------\r\n            classification-entity: This is the individual or entity who has performed a bead interpretation.\r\n            interpretation-reason: This is the reason a bead has been interpreted. For example, a standard MFI threshold (e.g. 500) was used\r\n            bead-classification: A text Positive/Negative/Borderline/Unspecified classification.\r\n            bead-rank: a numerical bead rank specifying if there was reactivity on this bead.'
package_name: hla.antibody.report
derivation: constraint
name: HLAAntibodyDiagnosticReport
type: DiagnosticReport
elements:
  encounter: {index: 2}
  specimen:
    mustSupport: true
    index: 5
    slicing:
      rules: open
      discriminator:
      - {path: $this, type: pattern}
      min: null
      slices:
        HLAImmunoassayWorkingSample:
          match: {}
          schema:
            mustSupport: true
            index: 6
            elements:
              reference: {label: HLA Immunoassay Working Sample Reference, mustSupport: true, index: 7}
              type: {mustSupport: false, index: 8}
            required: [reference]
        negativeSerum:
          match: {}
          schema:
            mustSupport: true
            index: 9
            elements:
              reference: {label: Negative Serum Reference, index: 10}
            required: [reference]
        positiveSerum:
          match: {}
          schema:
            label: Positive Serum
            mustSupport: true
            index: 11
            elements:
              reference: {label: HLA Positive Serum Reference, mustSupport: true, index: 12}
            required: [reference]
  extension:
    type: Extension
    isModifier: false
    url: https://fhir.nmdp.org/StructureDefinition/HLAAntibodyDiagnosticReportExt
    index: 0
    slicing:
      slices:
        hLAAntibodyDiagnosticReportExt:
          match: {}
          schema: {type: Extension, isModifier: false, url: 'https://fhir.nmdp.org/StructureDefinition/HLAAntibodyDiagnosticReportExt', index: 0}
  resultsInterpreter:
    elements:
      reference: {mustSupport: true, index: 4}
  result:
    type: Reference
    index: 13
    elements:
      reference: {label: Immunoassay Observation, mustSupport: true, index: 14}
      display:
        pattern: {type: string, value: HLA Immunoassay Bead Observation}
        type: string
        index: 15
    required: [reference]
  identifier:
    elements:
      value: {mustSupport: true, index: 1}
    required: [value]
  imagingStudy: {index: 16}
  media: {index: 17}
  performer:
    elements:
      reference: {mustSupport: true, index: 3}
package_version: 0.0.1
extensions:
  hLAAntibodyDiagnosticReportExt: {url: 'https://fhir.nmdp.org/StructureDefinition/HLAAntibodyDiagnosticReportExt', type: Extension, isModifier: false, index: 0}
class: profile
kind: resource
url: https://fhir.nmdp.org/ig/HlaAntibodyReport/StructureDefinition/hla-antibody-diagnostic-report
base: http://hl7.org/fhir/us/core/StructureDefinition/us-core-diagnosticreport-lab
version: 0.1.0
required: [result]