{ "description": "Extension of US Core lab result observation to capture attributes specific to solid-phase immuno-assay bead test results.\\r\\n\\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\\n\\r\\nThe bead has information about it's corresponding positive and negative controls.\\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\\r\\nbead-info\\r\\n - bead-id\\r\\n - type\\r\\n - control-type\\r\\n - HLA-target-type\\r\\n - HLA-target-serological-specificity\\r\\n - number of beads\\r\\n - sample-raw-MFI\\r\\n - formula\\r\\n - sample-adjusted-MFI\\r\\n - bead-interpretation\\r\\n - bead-plausible\\r\\n - bead-plausible-reason\\r\\n - Ref: working-sample-id\\r\\n - Ref: negative-control-bead-id\\r\\n - negative-control-serum-raw-MFI\\r\\n - negative-control-serum-adjusted-MFI\\r\\n - Ref: negative-control-serum-id\\r\\n - Ref: positive-control-bead-id\\r\\n - positive-control-serum-raw-MFI\\r\\n - positive-control-serum-adjusted-MFI\\r\\n - Ref: positive-control-serum-id", "_filename": "hla-immuno-assay-bead-observation.StructureDefinition.json", "package_name": "hla.antibody.report", "date": null, "derivation": "constraint", "publisher": "NMDP", "fhirVersion": "4.0.1", "purpose": "Part of HLA Antibody Diagnostic Report implementation guide to capture results specifically for immuno-assay bead results", "name": "HLAImmunoassayBeadObservation", "abstract": false, "type": "Observation", "experimental": null, "resourceType": "StructureDefinition", "title": "HLA Immunoassay Bead Observation", "package_version": "0.1.2", "status": "draft", "id": "bc4b3a78-5c8e-4f31-b115-614170da05ce", "kind": "resource", "url": "https://fhir.nmdp.org/ig/HlaAntibodyReport/StructureDefinition/hla-immunoassay-bead-observation", "version": "0.1.0", "differential": { "element": [ { "id": "Observation.identifier", "max": "1", "min": 1, "path": "Observation.identifier" }, { "id": "Observation.identifier.value", "min": 1, "path": "Observation.identifier.value", "label": "Bead Identifier", "mustSupport": true }, { "id": "Observation.partOf.reference", "min": 1, "path": "Observation.partOf.reference", "label": "HLA Antibody Diagnostic Report Ref", "mustSupport": true }, { "id": "Observation.code.coding.system", "min": 1, "path": "Observation.code.coding.system", "binding": { "strength": "required", "valueSet": "http://fhir.nmdp.org/terminology/HLAImmunoAssay" } }, { "id": "Observation.focus", "max": "0", "path": "Observation.focus" }, { "id": "Observation.encounter", "max": "0", "path": "Observation.encounter" }, { "id": "Observation.value[x]", "min": 1, "path": "Observation.value[x]", "type": [ { "code": "integer" } ], "label": "Raw MFI" }, { "id": "Observation.interpretation", "min": 1, "path": "Observation.interpretation", "slicing": { "rules": "open", "discriminator": [ { "path": "$this", "type": "value" } ] } }, { "id": "Observation.interpretation:bead-interpretation-classification-entity", "max": "1", "path": "Observation.interpretation", "short": "Bead result classification entity", "sliceName": "bead-interpretation-classification-entity", "definition": "Bead observation interpretation indicating the person or entity performing the interpretation of the bead result." }, { "id": "Observation.interpretation:bead-interpretation-classification-entity.coding.system", "max": "0", "path": "Observation.interpretation.coding.system", "mustSupport": false }, { "id": "Observation.interpretation:bead-interpretation-classification-entity.coding.code", "max": "0", "path": "Observation.interpretation.coding.code", "mustSupport": false }, { "id": "Observation.interpretation:bead-interpretation-classification-entity.text", "min": 1, "path": "Observation.interpretation.text", "label": "Classification Entity", "mustSupport": true }, { "id": "Observation.interpretation:bead-interpretation-classification", "max": "1", "path": "Observation.interpretation", "short": "Bead result classification", "sliceName": "bead-interpretation-classification", "definition": "Bead observation interpretation indicating the classification of the bead result." }, { "id": "Observation.interpretation:bead-interpretation-classification.coding.system", "min": 1, "path": "Observation.interpretation.coding.system", "binding": { "strength": "extensible", "valueSet": "http://fhir.nmdp.org/terminology/fhir/CodeSystem/hla-immunoassay-codes" }, "mustSupport": true }, { "id": "Observation.interpretation:bead-interpretation-classification.coding.code", "min": 1, "path": "Observation.interpretation.coding.code", "binding": { "strength": "extensible", "valueSet": "http://fhir.nmdp.org/terminology/hla-antibody-assay/bead-interpretation-classification" }, "mustSupport": true }, { "id": "Observation.interpretation:bead-interpretation-rank", "max": "1", "path": "Observation.interpretation", "short": "Bead result rank", "sliceName": "bead-interpretation-rank", "definition": "Bead observation interpretation indicating the rank of the bead result." }, { "id": "Observation.interpretation:bead-interpretation-rank.coding.system", "min": 1, "path": "Observation.interpretation.coding.system", "binding": { "strength": "required", "valueSet": "http://fhir.nmdp.org/terminology/fhir/CodeSystem/hla-immunoassay-codes" }, "mustSupport": true }, { "id": "Observation.interpretation:bead-interpretation-rank.coding.code", "min": 1, "path": "Observation.interpretation.coding.code", "binding": { "strength": "extensible", "valueSet": "http://fhir.nmdp.org/terminology/hla-antibody-assay/bead-interpretation-ranking" }, "mustSupport": true }, { "id": "Observation.interpretation:bead-plausible", "max": "1", "path": "Observation.interpretation", "short": "Bead result plausibility", "comment": "Categorical assessment of a laboratory value.", "sliceName": "bead-plausible", "definition": "Bead observation interpretation indicating the plausibility of the bead result." }, { "id": "Observation.interpretation:bead-plausible.coding", "max": "1", "path": "Observation.interpretation.coding" }, { "id": "Observation.interpretation:bead-plausible.coding.system", "min": 1, "path": "Observation.interpretation.coding.system", "binding": { "strength": "extensible", "valueSet": "http://fhir.nmdp.org/terminology/fhir/CodeSystem/hla-immunoassay-codes" }, "mustSupport": true }, { "id": "Observation.interpretation:bead-plausible.coding.code", "min": 1, "path": "Observation.interpretation.coding.code", "binding": { "strength": "required", "valueSet": "http://fhir.nmdp.org/terminology/fhir/ValueSet/hla-immunoassay-boolean" }, "mustSupport": true }, { "id": "Observation.interpretation:bead-plausible-reason", "max": "1", "path": "Observation.interpretation", "short": "Bead result plausibility reason", "comment": "Categorical assessment of a laboratory value.", "sliceName": "bead-plausible-reason", "definition": "Bead observation interpretation indicating the reason code for the plausibility assessment of the bead result." }, { "id": "Observation.interpretation:bead-plausible-reason.coding.system", "min": 1, "path": "Observation.interpretation.coding.system", "binding": { "strength": "extensible", "valueSet": "http://fhir.nmdp.org/terminology/fhir/CodeSystem/hla-immunoassay-codes" }, "mustSupport": true }, { "id": "Observation.interpretation:bead-plausible-reason.coding.code", "min": 1, "path": "Observation.interpretation.coding.code", "binding": { "strength": "extensible", "valueSet": "http://fhir.nmdp.org/terminology/fhir/ValueSet/hla-immunoassay-bead-plausible-reason" }, "mustSupport": true }, { "id": "Observation.bodySite", "max": "0", "path": "Observation.bodySite" }, { "id": "Observation.referenceRange", "max": "0", "path": "Observation.referenceRange" }, { "id": "Observation.component", "min": 1, "path": "Observation.component", "label": "bead-info", "slicing": { "rules": "open", "ordered": false, "discriminator": [ { "path": "$this", "type": "value" } ] }, "mustSupport": true }, { "id": "Observation.component.code.coding", "max": "1", "path": "Observation.component.code.coding" }, { "id": "Observation.component.code.coding.system", "code": [ { "display": "hla-target-type" } ], "path": "Observation.component.code.coding.system" }, { "id": "Observation.component.code.text", "min": 1, "path": "Observation.component.code.text", "fixedString": "HLA Immuno-assay Bead Information", "mustSupport": true }, { "id": "Observation.component:bead-hla-target-type", "max": "1", "min": 1, "path": "Observation.component", "sliceName": "bead-hla-target-type", "mustSupport": true }, { "id": "Observation.component:bead-hla-target-type.code.coding.display", "path": "Observation.component.code.coding.display", "label": "hla-target-serological-specificity" }, { "id": "Observation.component:bead-hla-target-type.code.text", "min": 1, "path": "Observation.component.code.text", "label": "hla-target-type" }, { "id": "Observation.component:bead-hla-target-type.value[x]", "min": 1, "path": "Observation.component.value[x]", "type": [ { "code": "string" } ], "binding": { "strength": "required", "valueSet": "http://fhir.nmdp.org/terminology/glstring" } }, { "id": "Observation.component:bead-hla-target-serological-specificity", "max": "1", "min": 1, "path": "Observation.component", "label": "hla-target-serological-specificity", "sliceName": "bead-hla-target-serological-specificity", "mustSupport": true }, { "id": "Observation.component:bead-hla-target-serological-specificity.code.coding.display", "path": "Observation.component.code.coding.display", "mustSupport": false }, { "id": "Observation.component:bead-hla-target-serological-specificity.code.text", "path": "Observation.component.code.text", "label": "hla-target-serological-specificity", "mustSupport": true }, { "id": "Observation.component:bead-hla-target-serological-specificity.value[x]", "min": 1, "path": "Observation.component.value[x]", "type": [ { "code": "string" } ], "binding": { "strength": "required", "valueSet": "http://fhir.nmdp.org/terminology/glstring" }, "mustSupport": true }, { "id": "Observation.component:bead-type", "max": "1", "min": 1, "path": "Observation.component", "sliceName": "bead-type", "mustSupport": true }, { "id": "Observation.component:bead-type.code.coding.system", "min": 1, "path": "Observation.component.code.coding.system", "binding": { "strength": "extensible", "valueSet": "http://fhir.nmdp.org/terminology/fhir/CodeSystem/hla-immunoassay-codes" }, "mustSupport": true }, { "id": "Observation.component:bead-type.code.coding.code", "min": 1, "path": "Observation.component.code.coding.code", "binding": { "strength": "extensible", "valueSet": "http://fhir.nmdp.org/terminology/fhir/ValueSet/hla-immunoassay-bead-type" }, "mustSupport": true }, { "id": "Observation.component:bead-type.code.text", "path": "Observation.component.code.text", "mustSupport": false }, { "id": "Observation.component:bead-type.value[x]", "path": "Observation.component.value[x]", "mustSupport": false }, { "id": "Observation.component:bead-count", "max": "1", "path": "Observation.component", "sliceName": "bead-count" }, { "id": "Observation.component:bead-count.code.text", "min": 1, "path": "Observation.component.code.text", "label": "bead-count" }, { "id": "Observation.component:bead-count.value[x]", "min": 1, "path": "Observation.component.value[x]", "type": [ { "code": "integer" } ] }, { "id": "Observation.component:bead-conversion-formula", "max": "1", "path": "Observation.component", "sliceName": "bead-conversion-formula" }, { "id": "Observation.component:bead-conversion-formula.code.text", "min": 1, "path": "Observation.component.code.text", "label": "bead-conversion-formula" }, { "id": "Observation.component:bead-conversion-formula.value[x]", "min": 1, "path": "Observation.component.value[x]", "type": [ { "code": "string" } ] }, { "id": "Observation.component:bead-converted-mfi", "max": "1", "min": 1, "path": "Observation.component", "sliceName": "bead-converted-mfi", "mustSupport": true }, { "id": "Observation.component:bead-converted-mfi.code.text", "min": 1, "path": "Observation.component.code.text", "label": "bead-converted-mfi", "mustSupport": true }, { "id": "Observation.component:bead-converted-mfi.value[x]", "min": 1, "path": "Observation.component.value[x]", "type": [ { "code": "integer" } ], "mustSupport": true } ] }, "contact": [ { "name": "David Wroe", "telecom": [ { "use": "work", "value": "dwroe@nmdp.org", "system": "email" } ] } ], "baseDefinition": "http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-lab" }